Regulatory Matters. With respect to each Product: (a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities. (b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority. (c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto. (d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. (e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy. (f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,. (g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects. (h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.
Appears in 4 contracts
Sources: Credit Agreement (Heartflow, Inc.), Credit Agreement (Heartflow, Inc.), Credit Agreement (Heartflow, Inc.)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) is a complete and accurate list Clinical Trials. None of all material the Company’s product candidates have received marketing approval from any Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required noticesclinical and preclinical studies and trials conducted by or on behalf of or sponsored by the Company or its subsidiaries, registrations and listingsor in which the Company or its subsidiaries participated, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products Company’s product candidates, including any such studies and trials that are described in the Registration Statement, the General Disclosure Package and the Final Prospectus, or the results of which are referred to in the Registration Statement, the General Disclosure Package and the Final Prospectus, as applicable (collectively, “Company Trials”), were, and if still pending are, being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with all applicable statutes, rules, regulations and policies of the Regulatory Authorities and current good clinical practices and good laboratory practices, standard medical and scientific research procedures and any applicable rules, regulations and policies of the jurisdiction in which such trials and studies are being conducted; the descriptions in the Registration Statement, the General Disclosure Package and the Final Prospectus of the results of any Company Trials are accurate and complete descriptions in all material respects and fairly present the data derived therefrom; the Company and its subsidiaries have no knowledge of any other studies or trials not described in the Registration Statement, the General Disclosure Package and the Final Prospectus, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement, the General Disclosure Package and the Final Prospectus; the Company and its subsidiaries have operated at all times and are currently in compliance in all material respects with all applicable statutes, rules, regulations and policies of the Regulatory Authorities; neither the Company nor its subsidiaries have received, nor does the Company or its subsidiaries have knowledge after due inquiry that any of its collaboration partners has received, any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of Company Trials, and, to the Company’s and its subsidiaries’ knowledge, there are no reasonable grounds for the last five same. The Company and its subsidiaries have obtained (5or caused to be obtained) years have been timely filed informed consent by or on behalf of each human subject who participated in a Company Trial. In using or disclosing patient information received by the Company or its subsidiaries in connection with a Company Trial, the FDA Company and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and its subsidiaries have complied in all material respects with all applicable laws and regulationsregulatory rules or requirements, (ii) all clinical including, without limitation, the Health Insurance Portability and pre-clinical trials, if any, Accountability Act of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries 1996 and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) thereunder. To the Company’s knowledge, none of all applicable Governmental Authorities, including the Company Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain engaged in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related theretoscientific misconduct.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.
Appears in 4 contracts
Sources: Underwriting Agreement (Neoleukin Therapeutics, Inc.), Underwriting Agreement (Neoleukin Therapeutics, Inc.), Underwriting Agreement (Aquinox Pharmaceuticals, Inc)
Regulatory Matters. With respect to each Product:
(a) Set The Borrower and its Subsidiaries have conducted and conduct their business in material compliance with all applicable U.S. federal, state, local or foreign laws, statutes, ordinances, rules, regulations, judgments, orders, injunctions, decrees, arbitration awards and Key Permits issued by any Governmental Authority (collectively, “Laws”).
(i) Borrower LDTs were researched, developed, designed, and validated solely by Borrower in material compliance with all applicable Laws, including the FDCA, CLIA, Privacy Laws and state laws, and have been and continue to be performed, marketed, and conducted in material compliance with all applicable Laws, including the FDCA, FTC Act, CLIA, Privacy Laws and state laws, including the laws of New York.
(ii) Borrower Medical Devices have been and are being researched, developed, designed, investigated, manufactured, marketed, and distributed in material compliance with all applicable Laws, including the FDCA, the FTC Act, Privacy Laws and state laws.
(b) Except as set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating 6.18(b), to the Credit Parties and their SubsidiariesBorrower’s knowledge, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally no investigation by any Governmental Authority with respect to the Borrower is pending or threatened, and beneficially owned exclusively by (ii) the Credit Parties and their SubsidiariesBorrower has not received any written communication from any Person (including any Governmental Authority) of any noncompliance with any Laws or any written communication from any Governmental Authority of any material issues, problems, or concerns regarding the quality or performance of the Products.
(c) Except as applicableset forth on Schedule 6.18(c), the Borrower holds free and clear of all Liens other than Permitted Liens, and (ii) as applicableexcept those permitted pursuant to Section 8.3, validly registered and on file with all Key Permits, including all authorizations under the applicable Governmental AuthorityFDCA, in compliance with all filing and maintenance requirements (including any fee requirements) thereofCLIA, and are in good standingstate laws, valid necessary for the research and enforceable with development and commercialization of the applicable Governmental Authority. All required notices, registrations Products and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings to carry on Borrower’s business with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities.
(b) (i) Products. All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been madesuch Key Permits are valid, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect and Borrower is in compliance with all the necessary material terms and requisite Regulatory Authorizationsconditions of such Key Permits. The Credit Parties and their Subsidiaries Borrower has not received any written notice that any Key Permits have been or are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act being revoked, withdrawn, suspended or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related theretochallenged.
(d) Except as set forth on Schedule 6.19(d6.18(d), (i) the Borrower has made available to Lender all Key Permits and material written correspondence submitted to or received from FDA, CMS, or other Governmental Authority (including minutes and official contact reports relating to any material written communications with any Governmental Authority) in the Borrower’s possession or control, and (ii) there has been no Credit Party nor material untrue statement of fact and no fraudulent statement made by the Borrower, any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product the Subsidiaries, or any Product Development and Commercialization Activities related thereto which representedof their respective agents or representatives to the FDA, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C ActCMS, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d)Governmental Authority, and there have has been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed failure to disclose a any material fact required to be disclosed to the FDA or any other Regulatory Governmental Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(fe) Except as set forth on Schedule 6.19(f6.18(e), no Credit Party nor right of the Borrower to receive reimbursements pursuant to any government program or private program has ever been terminated or otherwise materially adversely affected as a result of any investigation or enforcement action, whether by any Governmental Authority or other Third Party, and the Borrower has not been the subject of any inspection, investigation, or audit, by any Governmental Authority for the purpose of any alleged improper activity.
(f) To Borrower’s knowledge, there is no arrangement relating to the Borrower providing for any rebates, kickbacks or other forms of compensation that are unlawful to be paid to any Person in return for the referral of business or for the arrangement for recommendation of such referrals. All ▇▇▇▇▇▇▇▇ by the Borrower for its Subsidiaries has received services have been true and correct in all material respects (other than any written notice that inadvertent errors corrected in the FDA ordinary course of business) and, to the Borrower’s knowledge, are in compliance with all applicable Laws, including the Federal False Claim Act or any other applicable Regulatory Authority has commenced state false claim or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,fraud Law.
(g) Except as set forth on Schedule 6.19(g6.18(g), the clinicalBorrower has not, preclinicaland to the knowledge of the Borrower, safety no officer, director, employee or agent of the Borrower has (i) been convicted of, charged with, or to the Borrower’s knowledge, investigated for any federal or state health program-related offense or any other offense related to healthcare or been excluded or suspended from participation in any such program; or within the past five (5) years, been convicted of, charged with or, to the Borrower’s knowledge, investigated for a violation of Laws related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances, or been subject to any judgment, stipulation, order or decree of, or criminal or civil fine or penalty imposed by, any Governmental Authority related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances; (ii) been convicted of any crime or engaged in any conduct for which debarment is mandated or permitted by 21 U.S.C. § 335a, and, to the Borrower’s knowledge, no such debarment proceedings or investigations are pending or threatened; or (iii) been convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in the federal health care programs under Section 1128 of the Social Security Act or any similar applicable Law.
(h) Except as set forth on Schedule 6.18(h), all studies, tests and preclinical and clinical trials conducted relating to the Products, by or on behalf of the Borrower and the Subsidiaries and, to the knowledge of the Borrower, their respective licensees, licensors and Third Party services providers and consultants, have been conducted, and are currently being conducted, in all material respects, in accordance with all applicable Laws, procedures and controls pursuant to, where applicable, current good clinical practices and current good laboratory practices and other studies applicable laws, rules regulations. All results of such studies, tests and trials, and all other material information related to such studies, tests and trials, have been made available to the Lender as requested by it. To the extent necessary by applicable Law, the Borrower has obtained all necessary Regulatory Authorizations material to the conduct of its business required to be obtained by it, including an IDE for the conduct of any clinical investigations conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respectsBorrower.
(hi) To the Borrower’s knowledge, none of the clinical investigators in any clinical trial conducted by or on behalf of the Borrower has been or is disqualified or otherwise sanctioned by the FDA, the Department of Health and Human Services, or any Governmental Authority and, to the Borrower’s knowledge, no such disqualification, or other sanction of any such clinical investigator is pending or threatened. The Borrower has not received any written communication from the FDA or any other Governmental Authority requiring or threatening the termination or suspension of any clinical trials conducted by, or on behalf of, the Borrower.
(j) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s cause the Borrower or any of its Subsidiaries’ ownership of or rights under (or the license or the right Subsidiaries to use, as the case may be) require any Regulatory Authorizations relating to the Products in any material manner, and no consent not already required of the Borrower or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoits Subsidiaries.
Appears in 4 contracts
Sources: Credit Agreement (Natera, Inc.), Credit Agreement (Natera, Inc.), Credit Agreement (Natera, Inc.)
Regulatory Matters. With respect to each Product:
(a) Set forth Except as disclosed on Schedule 6.19(a3.22(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (Parent Disclosure Schedule, Parent has obtained and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are is in compliance in all material respects with all certifications, approvals and clearances from the FDA, etc. necessary in order to carry out its business and the businesses of each Parent Subsidiary as currently conducted, including without limitation developing pharmaceutical products in any and all geographic areas in which Parent or any Parent Subsidiary is currently, or have previously, developed pharmaceutical products.
(b) All nonclinical laboratory studies of pharmaceutical products have been and are being conducted in all material respects in compliance with all applicable statutesfederal, state, local and foreign laws, rules and regulations (including all Healthcare Laws including, without limitation, any reporting requirements thereof) and Regulatory Authorizations) with accepted standards of all applicable Governmental Authorities, including the FDA good laboratory practice. All clinical trials of pharmaceutical products have been and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance being conducted in all material respects in compliance with all applicable registration federal, state, local and listing foreign laws, rules and regulations (including, without limitation, any reporting requirements set forth in the FD&C Act or equivalent regulation thereof) and with accepted standards of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related theretogood clinical practice.
(dc) Except as set forth on Schedule 6.19(d), no Credit Party Neither Parent nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, Parent Subsidiary nor any officer, employee or agent thereof, of Parent or any Parent Subsidiary has made an any untrue statement of a material fact or fraudulent statements statement to the FDA FDA, etc. or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA FDA, etc. Parent has provided the Company with copies of any and all notice of inspectional observations, establishment inspection reports and any other documents received from the FDA, etc. that indicate or suggest material lack of compliance with the regulatory requirements of the FDA, etc. Parent has made available to the Company for review all correspondence to or from the FDA, etc., minutes of meetings with the FDA, etc., written reports of phone conversations, visits or other contact with the FDA, etc., notices of inspectional observations, establishment inspection reports, and all other documents in its possession concerning communications to or from the FDA, etc., or prepared by the FDA, etc., which bear in any way on Parent's or any other Regulatory AuthorityParent Subsidiary's compliance with regulatory requirements of the FDA, etc. or committed an act, made a statement, or failed to make a statement that, at on the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements likelihood of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any timing of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) approval of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,pharmaceutical product.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.
Appears in 4 contracts
Sources: Merger Agreement (Ribogene Inc / Ca/), Merger Agreement (Cypros Pharmaceutical Corp), Merger Agreement (Cypros Pharmaceutical Corp)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally The Company and beneficially owned exclusively its Subsidiaries are in compliance, in all material respects, with all applicable laws administered or issued by the Credit Parties United States Food and their SubsidiariesDrug Administration (the “FDA”) or the similar governmental entity in any applicable jurisdiction (together with the FDA, the “Regulating Authority”).
(ii) The Company and its Subsidiaries have obtained all necessary and applicable exemptions, approvals, clearances, authorizations, licenses and registrations required by Regulating Authorities to permit the development, manufacture, pre-clinical and clinical testing of its products, if any, as applicable, free presently conducted in jurisdictions where the Company and clear of its Subsidiaries currently conduct such activities. The Company and its Subsidiaries have properly registered any human clinical trials to the extent required by applicable law.
(iii) All preclinical and clinical studies conducted by or (to the Company’s Knowledge) for the Company and its Subsidiaries (i) have been conducted in accordance with recognized good clinical and good laboratory practices in all Liens other than Permitted Liensmaterial respects, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, are in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted administered or promulgated by the Credit Parties Regulating Authority regarding preclinical and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(hiv) The transactions contemplated There have been no recalls ordered or adverse regulatory actions taken (or, to the Company’s Knowledge, threatened) by the Loan Documents (FDA or contemplated any other Regulating Authority with respect to any of the products of the Company and its Subsidiaries, if any, including any facilities where any such products are manufactured, processed, packaged or stored by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of Company and its Subsidiaries’ ownership of .
(v) No false information or rights under (significant omission has been made in any products application or the license or the right to use, as the case may be) any Regulatory Authorizations relating products-related submission to the Products in any material mannerRegulating Authority by or, to the Company’s Knowledge, on behalf of the Company and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoits Subsidiaries.
Appears in 3 contracts
Sources: Securities Purchase Agreement (World Heart Corp), Securities Purchase Agreement (World Heart Corp), Securities Purchase Agreement (World Heart Corp)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) is a complete Sanofi shall be solely responsible for all regulatory filings and accurate list communications with each Regulatory Health Authority including, without limitation, for the preparation and filing of all material INDs and applications for pricing and reimbursement approval and for providing, in the format required by Regulatory Authorizations Health Authorities, the data and information required to be submitted to such Regulatory Health Authorities as part of a Drug Approval Application for a Program Product, including data from all Clinical Trials and all Manufacturing and controls information required for Regulatory Approval of such Program Product by the Regulatory Health Authorities. Sanofi shall own all right, title and interest in and to any Regulatory Filings and all Regulatory Approvals relating to the Credit Parties Program Compounds or Program Products and their Subsidiariesthey shall be held in the name of Sanofi or its designated Affiliate, Sanofi Licensee, Sublicensee or other designee. Ardelyx shall duly execute and deliver or cause to be duly executed and delivered, such instruments and shall, at Sanofi’s cost and expense, do and cause to be done such acts and things, including the conduct filing of their businesssuch assignments, agreements, documents and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiariesinstruments, as applicable, free may be necessary under or as Sanofi may reasonably request in connection with or to carry out more effectively the purpose of or to better assure and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authoritiesconfirm unto Sanofi its rights under this Section 4.5(a).
(b) (i) All regulatory filings required by any Regulatory Authority During the Term, through the DAC, or in respect otherwise, if the DAC has been terminated pursuant to Section 3.2, Sanofi shall report to Ardelyx regarding the status of any Regulatory Authorization with respect to any each pending or proposed IND application or Drug Approval Application covering a Program Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory AuthorityTerritory.
(c) The Credit Parties, their Subsidiaries If Ardelyx has exercised the Co-Promote Option (as described in Section 5.1 below) the following provisions of this Section 4.5(c) shall apply during the term of the [***] Certain information in this document has been omitted and filed separately with the agents thereof are in compliance in all material respects with all applicable statutes, rules Securities and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related theretoExchange Commission. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities Confidential treatment has been requested with respect to the Products omitted portions. Co-Promote Agreement: Sanofi shall keep Ardelyx informed on an ongoing basis regarding the schedule and process for the preparation of the Drug Approval Application in respect of the relevant Co-Promote Product in the U.S. Territory, provide final (or close to final) drafts of those sections of the Drug Approval Application requested by Ardelyx, and permit Ardelyx to review and comment on sections of such drafts in parallel with Sanofi’s review process and in compliance with the timelines Sanofi has stipulated for its internal purposes, and Sanofi shall use reasonable efforts to incorporate Ardelyx’s comments therein. Notwithstanding the aforesaid, if the Parties are unable to achieve a consensus regarding any comments made or changes proposed by Ardelyx, Sanofi shall make the final determination as to whether and when to file the Drug Approval Application as well as the form and content thereof. The purpose of such foregoing interactions shall be to identify and resolve any potential reasonable concerns of Ardelyx in advance of the proposed filing of such Drug Approval Applications (and in particular the initial Drug Approval Application) in the U.S. Territory. Following the filing of the initial Drug Approval Application in the U.S. Territory, Sanofi shall continue to work with Ardelyx in the manner outlined above in this Section 4.5(c) in connection with any subsequent Drug Approval Applications in the U.S. Territory for the Co-Promote Product in respect of which Ardelyx has exercised the Co-Promote Option, and Sanofi shall provide Ardelyx with a copy in electronic form of all Product Development and Commercialization Activities related theretofilings to Regulatory Health Authorities in the U.S. Territory that it makes hereunder in connection with such foregoing Drug Approval Applications. Sanofi shall further promptly furnish Ardelyx with copies of all material correspondence or minutes from any material meetings with any Regulatory Health Authority, in each case relating to any such Drug Approval Application in the U.S. Territory.
(d) Except as set forth on Schedule 6.19(d)If Ardelyx has exercised the Co-Promote Option, no Credit Party nor the following provisions of this Section 4.5(d) shall apply during the term of the Co-Promote Agreement: Sanofi shall notify Ardelyx of any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings request for [***] and Sanofi shall allow [***]. The foregoing shall apply with respect to any Product [***]. Sanofi shall as soon as reasonably practicable furnish Ardelyx with copies of all substantive correspondence Sanofi has had with the FDA, and contact reports concerning substantive conversations or any Product Development and Commercialization Activities related thereto which represented, in substantive meetings with the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C ActFDA, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in relating to any applicable year within the last five (5) yearssuch Drug Approval Application for a Co-Promote Product.
(e) No Credit PartyIf Ardelyx has exercised the Co-Promote Option, nor and any of its Subsidiaries, nor any officer, employee Regulatory Health Authority threatens or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, initiates any action to withdraw any Regulatory Authorizationremove a Co-Promote Product from the market in the U.S. Territory, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities Sanofi shall notify Ardelyx of such Credit Party or such Subsidiarycommunication as promptly as reasonably practical under the circumstances, in each case, which represented, in the aggregate, 15% or more of Net Sales but in any applicable year,event within [***] of receipt of such communication from the Regulatory Health Authority.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.
Appears in 3 contracts
Sources: License Agreement (Ardelyx, Inc.), License Agreement (Ardelyx, Inc.), License Agreement (Ardelyx, Inc.)
Regulatory Matters. With respect to each Product:
In the event that Celgene determines that any regulatory filings for any Licensed Antibodies and/or Licensed Products are required for any activities hereunder, including INDs, ▇▇▇▇ and other Regulatory Approvals (a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable), free and clear of all Liens other than Permitted Liens, and then Celgene (iior its designee) as applicable, validly registered and on file with shall have the applicable Governmental Authoritysole right, in compliance with all filing its discretion, to seek to obtain and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all maintain such regulatory filings (in its or its designee’s name). In addition, Celgene (or its designee) shall have the sole right to communicate and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects otherwise interact with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d)Licensed Antibodies and/or Licensed Products, no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings including with respect to any Product Regulatory Materials in connection therewith. Prothena (and its Affiliates) shall have no right to, and shall not, make any regulatory filings related to any Licensed Antibodies and/or Licensed Products or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from otherwise interact with any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements Authorities with respect to the FDA or any other Regulatory AuthorityLicensed Antibodies and/or Licensed Products; provided that, failed to disclose a material fact required to be disclosed as and to the FDA or any other extent reasonably requested by Celgene in writing, Prothena shall interact with Regulatory Authority, or committed an act, made a statement, or failed Authorities in connection with Licensed Antibodies and/or Licensed Products with respect to make a statement that, at matters related to the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests Licensed Program activities conducted by or on behalf of Prothena under the Master Collaboration Agreement or sponsored by with respect to any Prothena Ongoing Program Activities. Notwithstanding the Credit Parties foregoing, until such time as a given Existing Regulatory Material is assigned and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted transferred to Celgene in accordance with Section 2.2.1 or 2.2.2 (as applicable), Prothena shall be responsible for all applicable communications and interactions with Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions Authorities with respect to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to usesuch Existing Regulatory Material; provided that, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with any such activities by Prothena, Prothena shall, to the transactions contemplated herebyextent reasonably requested by Celgene, consult and coordinate with Celgene with respect thereto (including allowing Celgene to attend or participate in any meetings or other interactions with Regulatory Authorities to the Liens granted extent such attendance is not prohibited or limited by such Regulatory Authority) and Prothena shall accommodate and comply with any reasonable requests made by Celgene in connection herewith therewith (including that Prothena shall submit to Celgene a copy of any proposed filings and correspondence with any Regulatory Authority for Celgene’s review and approval prior to submission thereof). At the exercise request of rights Celgene, Prothena shall reasonably assist Celgene in communications and remedies filings with Regulatory Authorities with respect theretoto the Licensed Antibodies and/or Licensed Products.
Appears in 3 contracts
Sources: Global License Agreement (Prothena Corp Public LTD Co), Master Collaboration Agreement (Prothena Corp PLC), Master Collaboration Agreement (Prothena Corp PLC)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) is a complete Each of CZFS, CZFSAC and accurate list of FCCB has timely filed all material Regulatory Authorizations relating reports, registrations and statements, together with any amendments required to the Credit Parties and their Subsidiariesbe made with respect thereto, the conduct of their businessthat it was required to file since January 1, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file 2020 with the applicable any Governmental Authority, and has paid all fees and assessments due and payable in compliance with all filing connection therewith. Except for normal examinations conducted by any Governmental Authority in the regular course of the business of CZFS, CZFSAC and/or FCCB, no Governmental Authority has initiated any proceeding, or to the Knowledge of CZFS, investigation into the business or operations of CZFS, CZFSAC and/or FCCB, since January 1, 2020. FCCB is “well-capitalized” as defined in applicable laws and maintenance requirements (including any fee requirements) thereofregulations, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications FCCB has a Community Reinvestment Act rating of “satisfactory” or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authoritiesbetter.
(b) (i) All regulatory filings Other than as set forth in CZFS Disclosure Schedule 4.11, since January 1, 2020, CZFS has timely filed with the SEC and NASDAQ all documents required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development the Securities Act and Commercialization Activities which representedthe Exchange Act and such documents, in as the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years same may have been madeamended, and all such filings above such threshold are complete and correct and have complied complied, at the time filed with the SEC, in all material respects with all applicable laws the Securities Act and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory AuthorityExchange Act.
(c) The Credit PartiesNeither CZFS, FCCB nor any of their Subsidiaries respective properties is a party to or is subject to any Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or engaged in the insurance of deposits (including, without limitation, the PADOBS and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory AuthorizationsFRB) of all applicable Governmental Authorities, including or the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act supervision or equivalent regulation of each other it. Neither CZFS nor FCCB has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority having jurisdiction over that such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of all issuing or requesting) any Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related theretoOrder.
(d) Except Neither CZFS nor FCCB is a party to any agreement with any individual or group regarding CRA matters and neither CZFS nor FCCB has any Knowledge of, nor has CZFS or FCCB been advised in writing of or has any reason to believe (based on CZFS’s Home Mortgage Disclosure Act data for the year ended December 31, 2021, filed with the FDIC, or otherwise) that any facts or circumstances exist, which would cause CZFS or FCCB: (a) to be deemed not to be in satisfactory compliance with the CRA, and the regulations promulgated thereunder, or to be assigned a rating for CRA purposes by Bank Regulators of lower than “satisfactory”; (b) to be deemed to be operating in material violation of the federal Bank Secrecy Act, as set forth on Schedule 6.19(damended, and its implementing regulations (31 C.F.R. Chapter X), no Credit Party nor the USA PATRIOT Act, and the regulations promulgated thereunder, any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings order issued with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in anti-money laundering by the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 U.S. Department of the FD&C ActTreasury’s Office of Foreign Assets Control, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d)applicable anti-money laundering statute, there have been no recalls, market withdrawals, field notifications rule or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, regulation; or (for example c) to be deemed not to be in material compliance with the case of a recall) initiated by Credit Party applicable requirements contained in any federal and state privacy or any of its Subsidiariesdata security laws and regulations, relating to any Products which representedincluding, without limitation, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any Title V of the Products is misbranded or adulterated ▇▇▇▇▇-▇▇▇▇▇-▇▇▇▇▇▇ Act of 1999 and regulations promulgated thereunder, as defined in well as the FD&C Act, in each case provisions of the foregoinginformation security program adopted by CZFS pursuant to 12 C.F.R. Part ▇▇▇, which represented▇▇▇▇▇▇▇ ▇, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g)▇▇▇▇▇▇▇▇ D. Furthermore, the clinical, preclinical, safety CZFS Board has adopted and other studies CZFS has implemented an anti-money laundering program that contains adequate and tests conducted appropriate customer identification verification procedures that has not been deemed ineffective by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with and that meets the transactions contemplated hereby, including requirements of Sections 352 and 326 and all other applicable provisions of the Liens granted in connection herewith USA PATRIOT Act and the exercise of rights and remedies with respect theretoregulations thereunder.
Appears in 3 contracts
Sources: Merger Agreement (HV Bancorp, Inc.), Merger Agreement (HV Bancorp, Inc.), Merger Agreement (Citizens Financial Services Inc)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d)7.1(kk) and (i) each Loan Party has obtained and holds in its name all Material Licenses required by the FDA, no Credit Health Canada or any other Governmental Authority, for the conduct of their Business as currently conducted, to permit any manufacturing, distribution, sales, testing, marketing or research and development activities of such Loan Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings to date (the “Activities to Date”) with respect to any Product each Product; (B) all such Material Licenses are in full force and effect and no event has occurred which allows, or any Product Development and Commercialization Activities related thereto which representedafter notice or lapse of time would allow, in the aggregate, 15% revocation or more of Net Sales termination thereof or results in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 other material impairment of the FD&C Actrights of the holder of any Material License; (C) each Loan Party in compliance in all respects with all terms and conditions of each Material License, and with all Applicable Laws and requirements pertaining to the Activities to Date with respect to each Product; (D) each Loan Party is in compliance with all Applicable Laws regarding registration or notification for the site at which the Products are manufactured, processed, packed, held for distribution or from which and into which they are distributed; (ii) all manufacturing operations performed by or on behalf of each Loan Party are in compliance with current good manufacturing practice requirements and Applicable Laws and Material Licenses; and (iii) each Loan Party is in compliance with all reporting requirements for all Material Licenses, including, without limitation plant registrations.
(ii) All applications, notifications, submissions, information, claims, reports and statistics, and other data and conclusions derived therefrom, utilized as the basis for or submitted in connection with any and all requests for a Material License from the FDA, Health Canada, or other Governmental Authority relating to the Loan Parties or the Business or Products, when submitted to the FDA, Health Canada, United States Department of Agriculture or other Governmental Authority were true, complete and correct in all material respects as of the date of submission and any necessary or required updates, changes, corrections or modification have been submitted to the FDA, Health Canada, or other similar communication from any Regulatory Authority within Governmental Authority. The claims for the last five Products are valid and supported by proper research, design, testing, analysis and disclosure.
(5iii) years. Except as set forth on out in Schedule 6.19(d7.1(kk), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened each Product that is subject to the Applicable Laws promulgated by any a Regulatory Authority, is manufactured, packaged, labelled, imported, exported, stored, distributed, sold (whether or not for consideration), advertised and marketed in compliance with all such Applicable Laws, (except for example in the case of a recallimmaterial non-compliance) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales as well as all material terms and conditions imposed in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any Licenses and permits issued in respect of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) yearsProducts.
(eiv) No Credit PartyNone of the Loan Parties nor, nor any to the knowledge of its Subsidiariesthe Borrower, nor any officer, employee employee, contractor or agent thereof, of the Loan Parties has ever made an untrue statement of a material fact or fraudulent statements statement to the FDA a Regulatory Authority or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other a Regulatory Authority, or committed an any act, made a any statement, or failed to make a statement thatany statement, at the time such disclosure was made (or was not made), could that would reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery Bribery, and Illegal Gratuities, ,” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or Health Canada or other Governmental Authority to invoke any similar policypolicy or law.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.
Appears in 3 contracts
Sources: Loan Agreement (Synergy CHC Corp.), Loan Agreement (Synergy CHC Corp.), Loan Agreement (Synergy CHC Corp.)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a(i) The Company and each of its Subsidiaries are, and since January 1, 2016, has been in material compliance with all applicable Health Care Laws, which affect the business, Product Candidates, properties, assets and activities of the Company or any of its Subsidiaries, (ii) there is a complete no pending or, to the Company’s Knowledge, threatened in writing Action against the Company or any of its Subsidiaries alleging any violation by the Company of any such Health Care Law, (iii) each Product Candidate has been developed, manufactured, labeled, stored, tested and accurate list otherwise produced in material compliance with applicable Health Care Laws, (iv) each of the Company and its Subsidiaries holds, and is operating and has operated in material compliance with, all material Regulatory Authorizations required by applicable Health Care Laws relating to the Credit Parties and their Subsidiaries, the conduct of their business, Product Candidates, properties, assets and activities of the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally Company and beneficially owned exclusively by the Credit Parties and their its Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (iiv) as applicable, validly registered each of the Company and on file with the applicable Governmental Authority, in compliance with its Subsidiaries has fulfilled and performed all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings its material obligations with respect to such Regulatory Authorizations and, to the Products for Knowledge of the last five (5) years have been timely filed with the FDA and all other applicable Governmental AuthoritiesCompany, no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof.
(b) With respect to each Product Candidate, the Company has made available to Parent complete and accurate copies of all material applications (iincluding each IND), registrations, licenses, waivers, accreditations, authorizations, approvals, and clinical and preclinical data in the possession or control of the Company and its Subsidiaries and all material written correspondence between the Company or its Subsidiaries and the applicable Regulatory Authorities (including minutes and official contact reports of communications with any applicable Regulatory Authorities) and all material supporting documents, in each case as requested by Parent.
(c) All regulatory filings required preclinical and clinical trials conducted by the Company or any of its Subsidiaries, or by any Person acting on behalf of the Company or any of Subsidiaries, are being, or have been, conducted in material compliance with the required experimental protocols, procedures and controls, and all applicable Health Care Laws, including the FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312, all applicable requirements of Good Clinical Practices and Good Laboratory Practices, informed consent and the requirements and conditions imposed by the relevant “Institutional Review Board,” as such term is defined by the FDA, and all applicable Health Care Laws of the relevant Regulatory Authorities outside the United States. No clinical trial conducted by the Company or any of its Subsidiaries or by any Person acting on behalf of the Company or any of its Subsidiaries has been terminated or suspended by the FDA or any other applicable Regulatory Authority or Institutional Review Board, and neither the FDA nor any other applicable Regulatory Authority has commenced or threatened in respect writing to initiate, any action to place a clinical hold order on, or otherwise terminate, delay, suspend or materially restrict, any proposed or ongoing clinical trial conducted or proposed to be conducted by the Company or any of its Subsidiaries or by any Regulatory Authorization Person acting on behalf of the Company or any of its Subsidiaries.
(d) All manufacturing operations conducted by the Company and its Subsidiaries, or, to the Knowledge of the Company, by any Person acting on behalf of, or for the benefit of, the Company or its Subsidiaries, with respect to any Product or any Product Development and Commercialization Activities which represented, Candidate being used in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all human clinical and pre-clinical trials, if any, of investigational Products trials have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects in accordance with all the applicable statutesrequirements of Good Manufacturing Practices. None of the Company, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authoritiesits Subsidiaries, including the FDA and all other Regulatory Authoritiesor, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth Knowledge of the Company, any Person acting on Schedule 6.19(d), no Credit Party nor behalf of the Company or any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings has, with respect to any Product Candidate, (i) been subject to a Regulatory Authority (including FDA) shutdown or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% import or more of Net Sales in any applicable year, including export prohibition or (ii) received any FDA Form 483 483, or other Regulatory Authority notice of inspectional observations, notices of violations, Warning Letters, “warning letters,” “untitled letters, criminal proceeding notices under Section 305 ” or written requests or requirements to make any change to any Product Candidate or any of the FD&C ActCompany’s or its Subsidiaries’ processes or procedures, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications correspondence or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved notice from the FDA or any other Regulatory Authority indicating any breach in respect of the Company or violation of its Subsidiaries or their respective business operations alleging or asserting noncompliance with any applicable Health Care Law, permit or such requests or requirements of a Regulatory AuthorizationAuthority and, including that any to the Knowledge of the Products Company, neither the FDA nor any other Regulatory Authority is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) yearsconsidering such action.
(e) No Credit PartyAll applications, nor any of its Subsidiariesnotifications, nor any officersubmissions, employee information, claims, reports, statistics and other data required to be filed, maintained or agent thereof, has made an untrue statement of a material fact or fraudulent statements furnished to the FDA or any other Regulatory AuthorityAuthority by the Company or its Subsidiaries for any Product Candidate have been so filed, failed to disclose a material fact required to be disclosed to maintained or furnished. All applications, notifications, submissions, information, claims, reports, statistics and other data submitted in connection with any and all Regulatory Authorizations from the FDA or any other Regulatory Authority relating to the Company and its Subsidiaries, their business operations, Product Candidates, when submitted to the FDA or such other Regulatory Authority were complete and accurate in all material respects as of the date of submission and any necessary or required updates, changes, corrections or modifications to such applications, submissions, information and data have been submitted to the FDA or such other Regulatory Authority. None of the Company, its Subsidiaries, or any of their respective officers, employees, agents or, to the Knowledge of the Company, any clinical investigator acting for the Company or any of its Subsidiaries, has committed an any act, made a statement, any statement or failed to make a any statement that, at the time such disclosure was made (or was not made), could that would reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting with respect to “Fraud, Untrue Statements of Material Facts, Bribery Bribery, and Illegal Gratuities, ” set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. None of the Company, its Subsidiaries, or any of its officers, employees, agents or, to the Knowledge of the Company, any clinical investigator acting for the Company or any of its Subsidiaries, has been convicted of any crime or engaged in any conduct that would reasonably be expected to result, or has resulted, in (i) debarment under 21 U.S.C. Section 335a or any similar policyLaw, or (ii) exclusion under 42 U.S.C. Section 1320a-7 or any similar Law.
(f) Except as set forth No Product Candidate that is or has been manufactured, tested, distributed, or marketed by or on Schedule 6.19(f), no Credit Party nor behalf of the Company or any of its Subsidiaries has been recalled, withdrawn, suspended or discontinued (whether voluntarily or otherwise). No proceedings (whether completed or pending) seeking the recall, withdrawal, suspension or seizure of any such Product Candidate or pre-market approvals or marketing authorizations are pending or, to the Knowledge of the Company, threatened in writing against the Company or any of its Subsidiaries or any of its Affiliates, nor have any such proceedings been pending since January 1, 2016. The Company and its Subsidiaries have made available to Parent all information about adverse drug experiences obtained or otherwise received by the Company from any written notice source, in the United States or outside the United States, including information derived from clinical investigations prior to any market authorization approvals, commercial marketing experience, clinical investigations, surveillance studies or registries, reports in the scientific literature and unpublished scientific papers relating to any Product Candidate that is or has been manufactured, tested, distributed, or marketed by or on behalf of the Company or any of its licensors or licensees in the possession of the Company (or to which it has access). In addition, the Company and its Subsidiaries have timely filed all annual and periodic reports, amendments and safety reports required for any of its Product Candidates required to be made to the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,Authority.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety The Company and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or its Subsidiaries have complied in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance all material respects with all applicable Regulatory Authorizations security and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights privacy standards regarding protected health information under (or i) the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, Health Insurance Portability and no consent or other authorization Accountability Act of any Governmental Authority is required in connection with the transactions contemplated hereby1996 (18 U.S.C. Section 3801 et. seq.), including the Liens granted regulations promulgated thereunder and (ii) any applicable state or foreign privacy Laws applicable in connection herewith and any other jurisdiction in which the exercise of rights and remedies with respect theretoCompany or its Subsidiaries operate.
Appears in 3 contracts
Sources: Merger Agreement, Merger Agreement (Seattle Genetics Inc /Wa), Merger Agreement (Cascadian Therapeutics, Inc.)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) is a complete Each of NBT and accurate list of NBT Bank has timely filed all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required noticesreports, registrations and listingsstatements, supplemental applications together with any amendments required to be made with respect thereto, that it was required to file since January 1, 2022 with any Governmental Authority and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority in the regular course of the business of NBT and/or NBT Bank, no Governmental Authority has initiated any proceeding, or notificationsto the Knowledge of NBT, reports (including field alertsinvestigation into the business or operations of NBT and/or NBT Bank, medical device reports (MDRs) and other reports of adverse experiences since January 1, 2022. There is no unresolved violation or product malfunctions, and reports of corrections or removal) and other required filings matter requiring attention by any Governmental Authority with respect to the Products for the last five (5) years have been timely filed with the FDA any report or statement relating to any examinations of NBT Bank. Each of NBT and all other NBT Bank is “well-capitalized” as defined in applicable Governmental Authoritieslaws and regulations, and NBT Bank has a Community Reinvestment Act rating of “satisfactory” or better.
(b) (i) All regulatory filings Since January 1, 2022, NBT has timely filed with the SEC and NASDAQ all documents required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development the Securities Act and Commercialization Activities which representedthe Exchange Act and such documents, in as the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years same may have been madeamended, and all such filings above such threshold are complete and correct and have complied complied, at the time filed with the SEC, in all material respects with all applicable laws the Securities Act and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory AuthorityExchange Act.
(c) The Credit PartiesNeither NBT, NBT Bank nor any of their Subsidiaries respective properties is a party to or is subject to any Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or institutions engaged in the insurance of deposits (including, without limitation, the OCC and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory AuthorizationsFRB) of all applicable Governmental Authorities, including or the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act supervision or equivalent regulation of each other it. Neither NBT nor NBT Bank has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority having jurisdiction over that such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of all issuing or requesting) any Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related theretoOrder.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any Without limiting the generality of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g8.10(b), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating parties acknowledge that this Section 4.11 is subject to the Products in any material manner, and no consent or other authorization limitations of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoSection 8.10(b) hereof.
Appears in 3 contracts
Sources: Merger Agreement (Evans Bancorp Inc), Merger Agreement (NBT Bancorp Inc), Merger Agreement (Evans Bancorp Inc)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) is a complete Following the transfer of an IND to AstraZeneca pursuant to Section 2.13, AstraZeneca shall be solely responsible for all regulatory filings and accurate list communications with each Regulatory Health Authority with respect to that IND, and AstraZeneca shall be solely responsible for any and all subsequent filings and communications with the Regulatory Health Authority including, without limitation, for the preparation and filing of all material additional INDs (except in relation to such IND(s) as are retained by Ardelyx pursuant to Section 2.13) and for providing, in the format required by Regulatory Authorizations relating Health Authorities, the data and information required to be submitted to such Regulatory Health Authorities for Regulatory Approval of Licensed Products, including without limitation data from all Clinical Trials and all Manufacturing and controls information required for Regulatory Approval of such Licensed Product by the Regulatory Health Authorities. AstraZeneca shall, subject to the Credit Parties conditions and their Subsidiarieswithin the limitations set forth in Section 4.4(a), the conduct of their business, and the use Commercially Reasonable Efforts to obtain Regulatory Approval for Licensed Products (on a per Product basis). All such material Regulatory Authorizations are in (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted LiensMajor Markets, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect countries where AstraZeneca determines at its sole discretion that it is commercially viable to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authoritiesdo so.
(b) (i) All regulatory filings required During the Term, whether through the DCC while such committee is in effect, or by any Regulatory Authority providing Information and Materials directly to Ardelyx after the DCC has been disbanded, AstraZeneca shall report to Ardelyx regarding the status of each pending or in respect of any Regulatory Authorization with respect to any proposed IND application or Drug Approval Application covering a Licensed Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory AuthorityTerritory.
(c) The Credit PartiesIf Ardelyx has exercised the Co-Promote Option (as described in Section 7.1 below) the following shall apply: AstraZeneca shall keep Ardelyx informed on an ongoing basis regarding the schedule and process for the preparation of the Drug Approval Application in respect of the relevant Co-Promote Product in the U.S. Territory, their Subsidiaries provide final (or close to final) drafts of those sections of the Drug Approval Application requested by Ardelyx, and the agents thereof are permit Ardelyx to review and comment on sections of such drafts in parallel with AstraZeneca’s review process and in compliance with the timelines AstraZeneca has stipulated for its internal purposes, and AstraZeneca shall use reasonable efforts to incorporate Ardelyx’s comments therein. Notwithstanding the aforesaid, if the Parties are unable to achieve a consensus regarding any comments made or changes proposed by Ardelyx, AstraZeneca shall make the final determination as to whether and when to file the Drug Approval Application as well as the form and content thereof. The purpose of such foregoing interactions shall be to identify and resolve any potential reasonable concerns of Ardelyx in advance of the proposed filing of such Drug Approval Applications (and in particular the initial Drug Approval Application) in the U.S. Territory. Following the filing of the initial Drug Approval Application in the U.S. Territory, AstraZeneca shall continue to work with Ardelyx in the manner outlined above in this Section 4.6(c) in connection with any subsequent Drug Approval Applications in the U.S. Territory for the Co-Promote Product in respect of which Ardelyx has exercised the Co-Promote Option, and AstraZeneca shall provide Ardelyx with a copy in electronic form of all filings to Regulatory Health Authorities in the U.S. Territory that it makes hereunder in connection with such foregoing Drug Approval Applications. AstraZeneca shall further promptly furnish Ardelyx with copies of all material respects correspondence or minutes from any material meetings with all applicable statutesany Regulatory Health Authority, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect in each case relating to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth any such Drug Approval Application in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related theretoU.S. Territory.
(d) Except as set forth on Schedule 6.19(d)During the period when the DCC is in effect, no Credit Party nor AstraZeneca shall notify Ardelyx of any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings request for [***] and AstraZeneca shall allow [***]. The foregoing shall apply with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more [***]. AstraZeneca shall as soon as reasonably practicable furnish Ardelyx with copies of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from all substantive correspondence AstraZeneca has had with any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d)Health Authority, there have been no recalls, market withdrawals, field notifications and contact reports concerning substantive conversations or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by substantive meetings with any Regulatory Health Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of relating to any such IND or Drug Approval Application. As from the foregoingdate when the DCC is disbanded, which representedArdelyx’s rights hereunder shall cease, provided, however, that if Ardelyx has exercised the Co-Promote Option, then during the period when the SCC is in effect, Ardelyx shall have the aggregate, 15% or more of Net Sales rights set out in this subsection (d) but such rights shall (i) be limited to the U.S. Territory and the Co-Promote Product and (ii) further be limited such that Ardelyx may participate as an observer in any applicable year within meeting or conference call as set forth above only to the last five (5) yearsextent invited to do so by AstraZeneca.
(e) No Credit Party, nor Ardelyx shall notify AstraZeneca of any request for a meeting or substantive telephone conference call with any Regulatory Health Authority relating to any IND or IND equivalent for which Ardelyx is the sponsor and Ardelyx shall allow one (1) representative of its Subsidiaries, nor AstraZeneca to participate as an observer in any officer, employee such meeting or agent thereof, conference call. The foregoing shall apply with respect to meetings or conferences initiated by Ardelyx or by a Regulatory Health Authority. [***] Certain information in this document has made an untrue statement of a material fact or fraudulent statements been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policyomitted portions.
(f) Except as set forth on Schedule 6.19(f)If Ardelyx has exercised the Co-Promote Option, no Credit Party nor and any of its Subsidiaries has received any written notice that the FDA Regulatory Health Authority threatens or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, initiates any action to withdraw any Regulatory Authorization, requested the recall remove a Licensed Product (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participatedthe Co-Promote Option has been exercised) from the market in the U.S. Territory, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respectsAstraZeneca shall notify Ardelyx of such communication within [***] of receipt by AstraZeneca.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.
Appears in 3 contracts
Sources: License Agreement (Ardelyx, Inc.), License Agreement (Ardelyx, Inc.), License Agreement (Ardelyx, Inc.)
Regulatory Matters. With respect to each Product:
(a) Set All existing Registrations held by Reliant as of the date of this Agreement are set forth on in Schedule 6.19(a) 1.1.102. Reliant is a complete the sole and accurate list exclusive owner of all material Regulatory Authorizations relating the Registrations. Reliant has delivered to the Credit Parties Purchaser true and their Subsidiariescorrect copies of the Registrations and has made available to the Purchaser copies of material written communications between Reliant, on the conduct of their businessone hand, and the Products FDA or any other applicable Medical Product Regulatory Authority, on the other hand, since October 11, 2000 (on a per the “Reliant Acquisition Date”), and any existing written summaries of material discussions between Reliant and the FDA or any other applicable Medical Product basis). All such material Regulatory Authorizations are Authority since the Reliant Acquisition Date, including, without limitation, copies of (i) legally all warning letters, FD-483s, notices of adverse findings and beneficially owned exclusively similar correspondence received by Reliant from the Credit Parties and their SubsidiariesFDA since the Reliant Acquisition Date, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file all audit reports relating to audits for compliance with the applicable Governmental Authority, in compliance with all filing Act performed since the Reliant Acquisition Date and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect submitted to the Products for the last five FDA; (5iii) years have been timely filed with any document concerning any significant oral or written communication received from the FDA by Reliant (whether directly or via any third party) since the Reliant Acquisition Date; and all (iv) any written notification from the FDA or any other applicable Governmental AuthoritiesMedical Product Regulatory Authority indicating that the Product is misbranded or adulterated as defined in the Act. Reliant has delivered any of the foregoing materials sent to or received by the third party manufacturer of the Product that are currently in Reliant’s possession.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect The promotion, distribution, marketing and sale and, to Reliant’s Knowledge, manufacture of any Regulatory Authorization with respect to any the Product or any Product Development and Commercialization Activities which represented, in the aggregateTerritory has been conducted in compliance with the Registrations and all applicable Laws, 15% or more including the Act and the PDM Act. The Registrations required for the manufacturing, promotion, marketing, sale and distribution of Net Sales in any applicable year, the Product in the last five (5) years have been made, Territory are in full force and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authorityeffect.
(c) The Credit PartiesThere are no proceedings pending against Reliant or, their Subsidiaries and to Reliant’s Knowledge, threatened which could result in the agents thereof are revocation, cancellation or suspension of any Registrations listed in Schedule 1.1.102.
(d) Reliant is in compliance in all material respects with all Laws applicable statutesto the ownership, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) operation, storage, distribution, marketing, pricing, sale, promotion, warehousing, packaging, labeling, handling and/or testing of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect Acquired Assets and, to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d)Knowledge of Reliant, no Credit Party nor has not received any notice that any non-compliance of its Subsidiaries has received from any Regulatory Authority the foregoing or any notice of alleged manufacturing non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Actbeing alleged, in each case of except to the foregoing, which represented, in extent that such non-compliance has been remedied or to the aggregate, 15% or more of Net Sales in any applicable year within extent the last five (5) yearsfailure to comply therewith has not had a Material Adverse Effect.
(e) No Credit PartyReliant has not received any written or, nor to Reliant’s Knowledge, other notice of proceedings from a Governmental Authority alleging that the Product or any of its Subsidiariesthe Acquired Assets or the ownership, nor manufacturing, operation, storage, distribution, marketing, pricing, sale, promotion, warehousing, packaging, labeling, handling and/or testing thereof is in violation of any officerapplicable Law and such violation has not been remedied, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time except for such disclosure was made (or was violations that would not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of have Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policyAdverse Effect.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries Reliant has received any written notice that completed and timely filed all annual or other reports required by the FDA or any other applicable Medical Product Regulatory Authority has commenced or initiated, or threatened in order to commence or initiate, any action to withdraw any Regulatory Authorization, requested maintain the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,Registrations.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.
Appears in 3 contracts
Sources: Asset Purchase Agreement (Reliant Pharmaceuticals, Inc.), Asset Purchase Agreement (Reliant Pharmaceuticals, Inc.), Asset Purchase Agreement (Reliant Pharmaceuticals, Inc.)
Regulatory Matters. With respect to each Product:
(a) Set Except as expressly set forth on Schedule 6.19(a) is a complete in Section 8.10 or the Transition Services Agreement, from and accurate list of all material Regulatory Authorizations relating to after the Credit Parties Closing, Purchaser, at its cost, shall be solely responsible and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are liable for (i) legally taking all actions, paying all fees and beneficially owned exclusively conducting all communication with the appropriate Governmental Authority required by Applicable Law in respect of the Credit Parties Regulatory Approvals, including preparing and their Subsidiariesfiling all reports (including adverse drug experience reports) with the appropriate Governmental or Regulatory Authority (whether the Product is sold before or after transfer of such Regulatory Approval), as applicable(ii) taking all actions and conducting all communication with third parties in respect of the Product sold pursuant to such Regulatory Approval (whether sold before or after transfer of such Regulatory Approval), free and clear of including responding to all Liens other than Permitted Lienscomplaints in respect thereof, including complaints related to tampering or contamination, and (iiiii) as applicable, validly registered investigating all complaints and on file with adverse drug experiences in respect of the applicable Governmental Authority, in compliance with all filing and maintenance requirements Product sold pursuant to such Regulatory Approval (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications whether sold before or notifications, reports (including field alerts, medical device reports (MDRs) and other reports after transfer of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authoritiessuch Regulatory Approval).
(b) From and after the Closing, and subject to Section 8.10 hereof and the Transition Services Agreement, Seller promptly (i) All regulatory filings and in any event within the time periods required by any Regulatory Authority Applicable Law) shall notify Purchaser within three (3) Business Days if Seller receives a complaint or a report of an adverse drug experience in respect of any Regulatory Authorization the Product. In addition, Seller shall cooperate with respect Purchaser’s reasonable requests and use commercially reasonable efforts to assist Purchaser in connection with the investigation of and response to any Product complaint or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed adverse drug experience related to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory AuthorityProduct sold by Seller.
(c) The Credit PartiesFrom and after the Closing, their Subsidiaries Purchaser, at its cost, shall be solely responsible and liable for conducting all voluntary and involuntary recalls of units of the agents thereof are Product sold pursuant to such Regulatory Approval (whether sold before or after transfer of such Regulatory Approval), including recalls required by any Governmental Authority and recalls of units of the Product sold by Seller deemed necessary by Seller in compliance in all material respects with all applicable statutesits reasonable discretion; provided, rules however, that Seller shall reimburse Purchaser for the reasonable expenses and regulations (including all Healthcare Laws and Regulatory Authorizations) costs of all applicable Governmental Authoritiesconducting recalls relating to Product sold by or on behalf of Seller prior to the Closing, including the FDA costs of notifying customers, the costs associated with shipment of such recalled Product, the price paid for such Inventory, and all other Regulatory Authorities, reasonable credits extended to customers in connection with respect to each Product and all Product Development and Commercialization Activities related theretothe recall. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth Seller shall notify Purchaser promptly in the FD&C Act or equivalent regulation event that a recall of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related theretosold by Seller is necessary.
(d) Except as set forth on Schedule 6.19(d)Seller shall, no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which representedwithin fifteen (15) days after the Closing, in notify the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any transfer of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements Regulatory Approvals to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted Purchaser in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respectsApplicable Laws.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.
Appears in 3 contracts
Sources: Asset Purchase Agreement (Horizon Pharma PLC), Asset Purchase Agreement (Vidara Therapeutics International LTD), Asset Purchase Agreement (Intermune Inc)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(aExcept as would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, each of the Company and its Subsidiaries holds or is in the process of acquiring (A) is a complete all authorizations under the U.S. Food, Drug, and accurate list Cosmetic Act of all material Regulatory Authorizations relating to 1938 (the Credit Parties and their Subsidiaries, the conduct of their business“FDCA”), and the applicable regulations of the U.S. Food and Drug Administration (the “FDA”) promulgated thereunder, (B) all authorizations under the U.S. Federal Insecticide, Fungicide and Rodenticide Act of 1910 (the “FIFRA”), the U.S. Food Quality Protection Act of 1996 (the “FQPA”) and the applicable regulations of the U.S. Environmental Protection Agency (the “EPA”) promulgated thereunder and (C) authorizations of the FDA, U.S. Department of Agriculture (“USDA”) and any other applicable Governmental Entity that are concerned with the quality, identity, strength, purity, safety, efficacy, manufacturing, marketing, distribution, sale, pricing, import or export of any of the Company Products (on any such Governmental Entity, a per Product basis“Company Regulatory Agency”), in each case, that is necessary for the lawful operation of the businesses of the Company or any of its Subsidiaries as currently conducted (the “Company Regulatory Permits”). All Except as would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, all such material Company Regulatory Authorizations Permits are (i) legally valid and beneficially owned exclusively by in full force and effect and the Credit Parties Company and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, its Subsidiaries are in compliance with the terms of all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental AuthoritiesCompany Regulatory Permits.
(b) (i) All regulatory filings required by any Regulatory Authority Except as would not reasonably be expected to have, individually or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more a Company Material Adverse Effect, each of Net Sales the Company and its Subsidiaries is in compliance with all regulations and requirements of the FDA, USDA, EPA and other Company Regulatory Agencies, including any applicable yearGood Manufacturing Practices, Hazard Analysis Critical Control Point (HACCP) requirements, labeling requirements, testing requirements and protocols, shipping requirements, record keeping and reporting requirements, monitoring requirements, packaging or repackaging requirements, laboratory controls, storage and warehousing procedures and marketing restrictions. Except as would not reasonably be expected to have, individually or in the last five (5) years aggregate, a Company Material Adverse Effect, since January 1, 2019, all Company Products have been madeproduced, distributed, labeled, marketed and sold, and all raw materials and ingredients in such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their complianceprocured, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutesApplicable Laws governing the procurement, rules production, distribution, labeling and regulations (including all Healthcare Laws and Regulatory Authorizations) sale of all applicable Governmental Authoritiessuch products, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related theretoraw materials or ingredients. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d)would not reasonably be expected to have, no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance individually or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable yeara Company Material Adverse Effect, including any FDA Form 483 inspectional observationssince January 1, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d)2019, there have been no recalls, market withdrawalswithdrawals or suspensions with respect to any Company Products produced, field notifications distributed, labeled, marketed or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened sold by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party Company or any of its Subsidiaries. Except as would not reasonably be expected to have, relating to any Products which represented, individually or in the aggregate, 15% or more of Net Sales in any applicable year within a Company Material Adverse Effect, since January 1, 2019, neither the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party Company nor any of its Subsidiaries has received any written notice that the FDA of or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiateotherwise is aware of, any action Company Regulatory Agency untitled letters, warning letters, notices of warning or withholding, suspension or withdrawal of inspection, seizure, criminal referral or other similar federal, state or private enforcement actions with respect to withdraw any Regulatory Authorizationsuch Company Products. Except as would not reasonably be expected to have, requested the recall (whether by correction individually or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% a Company Material Adverse Effect, since January 1, 2019, neither the Company nor any of its Subsidiaries is subject (or more of Net Sales in has been subject) to any applicable year,adverse inspection finding, recall, investigation, penalty assessment, audit or other compliance or enforcement action by the FDA, USDA, EPA and other Company Regulatory Agencies.
(gc) Except as set forth on Schedule 6.19(g), Neither the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or Company nor any of its Subsidiaries’ ownership of Subsidiaries is party to any corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or rights under (similar agreements with or imposed by any Company Regulatory Agency, except as would not reasonably be expected to have, individually or in the license or the right to useaggregate, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoa Company Material Adverse Effect.
Appears in 2 contracts
Sources: Merger Agreement (Bioceres Crop Solutions Corp.), Merger Agreement (Marrone Bio Innovations Inc)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(aEach of Parent’s Subsidiaries that engages in the sale of electricity at wholesale (other than any such Subsidiaries that own one or more facilities that constitute a “qualifying facility” as such term is defined under PURPA and the rules and regulations of FERC that are entitled to exemption from regulation under Section 205 of the FPA) is regulated as a complete “public utility” under the FPA and accurate list has market-based rate authorization to make such sales at market-based rates. Each of all material Regulatory Authorizations relating to the Credit Parties Parent’s Subsidiaries that directly owns generating facilities and operates their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, power generation facilities in compliance with all filing and maintenance requirements (including any fee requirements) thereofapplicable standards of NERC, and other than non-compliance that would not reasonably be expected to have, individually or in the aggregate, a material impact on Parent. There are in good standingno pending, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for Knowledge of Parent, threatened, judicial or administrative proceedings to revoke a Parent’s Subsidiary’s market-based rate authorization. To the last five (5) years have been timely filed with Knowledge of Parent, there are no facts that are reasonably likely to cause any of Parent’s Subsidiaries that sell electricity at wholesale to lose its market-based rate authorization, if applicable, other than where such loss would not reasonably be expected to have, individually or in the FDA and all other applicable Governmental Authoritiesaggregate, a material impact on Parent.
(b) All filings (iother than immaterial filings) All regulatory filings required to be made by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product Parent or any Product Development of its Subsidiaries since January 1, 2009, with the FERC under the FPA, the NRC under the Atomic Energy Act, the Department of Energy and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable yearstate public utility commissions, in as the last five (5) years case may be, have been made, including all forms, statements, reports, agreements and all documents, exhibits, amendments and supplements appertaining thereto, including all rates, tariffs and related documents, and all such filings above such threshold are complete and correct and have complied in all material respects complied, as of their respective dates, with all applicable laws requirements of applicable statutes and regulationsthe rules and regulations promulgated thereunder, (ii) all clinical and pre-clinical trials, if any, except for filings the failure of investigational Products have been and are being conducted by which to make or the Credit Parties and their Subsidiaries failure of which to make in accordance compliance with all applicable laws requirements of applicable statutes and the rules and regulations along with appropriate monitoring of clinical investigator trial sites for their compliancepromulgated thereunder, and (iii) would not reasonably be expected to have, individually or in the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all aggregate, a material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authorityimpact on Parent.
(c) The Credit PartiesSince January 1, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes2008, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party neither Parent nor any of its Subsidiaries has received any written notice that or, to Parent’s Knowledge, other communication from the FDA NERC regarding any actual or any other applicable Regulatory Authority has commenced or initiatedpossible material violation of, or threatened material failure to commence or initiatecomply with, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,Law.
(gd) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted This Section 5.13 excludes any representation or warranty by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s Parent or any of its Subsidiaries’ ownership Subsidiaries or any Joint Venture of or rights under (or the license or the right Parent with respect to use, as the case may be) any Regulatory Authorizations matters relating to the Products or arising under Environmental Laws or Hazardous Materials which are addressed in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoSection 5.8.
Appears in 2 contracts
Sources: Merger Agreement (Constellation Energy Group Inc), Merger Agreement (Exelon Corp)
Regulatory Matters. With respect to each Product:
(a) Set forth Neither AstraZeneca, any of its Affiliates nor, to AstraZeneca’s Knowledge, any Merck Party, or any Person on Schedule 6.19(a) behalf of any of the foregoing, is a complete and accurate list of all material Regulatory Authorizations relating to Exploiting any Other Products in the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental AuthoritiesHorizon Territory.
(b) (i) All regulatory filings required by any AstraZeneca, or an Affiliate of AstraZeneca, owns all Regulatory Authority or in respect of any Approvals and Regulatory Authorization with respect Documentation necessary to any conduct the Product or any Product Development and Commercialization Activities which represented, Business in the aggregate, 15% or more Horizon Territory as currently conducted and such Regulatory Approvals are in full force and effect. AstraZeneca has the right to grant the right of Net Sales in any applicable year, in reference and use under the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries Licensed Regulatory Documentation to Horizon in accordance with all the License Agreement. Neither AstraZeneca nor its Affiliates has received any written communication from any Governmental Authority threatening to withdraw or suspend any such Regulatory Approvals. No proceeding is pending or, to AstraZeneca’s Knowledge, threatened regarding the revocation of any such Regulatory Approval. AstraZeneca and its Affiliates have not voluntarily or involuntarily surrendered, terminated or permitted to lapse or expire any Regulatory Approval used or maintained by them in the conduct of the Product Business, except where any such Regulatory Approval has been not renewed in the ordinary course of business. AstraZeneca or its Affiliates have filed with the applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and Governmental Authority all material communications between representatives filings, declarations, listings, registrations, reports or submissions, including adverse event reports required in connection with the conduct of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit PartiesProduct Business. All such filings, their Subsidiaries and the agents thereof are declarations, listings, registrations, reports or submissions were in compliance in all material respects with all applicable statutesLaws when filed, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all no deficiencies have been asserted by any applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, Authority with respect to each Product and all Product Development and Commercialization Activities related theretoany such filings, declarations, listings, registrations, reports or submissions. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d), no Credit Party Neither AstraZeneca nor any of its Subsidiaries has received from Affiliates is in violation of the terms of any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in Approval for the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) yearsHorizon Territory.
(ec) No Credit Party, nor There has not been any of its Subsidiaries, nor any officer, employee product recall or agent thereof, has made an untrue statement of a material fact market withdrawal or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests replacement conducted by or on behalf of AstraZeneca concerning the Product in the Horizon Territory or sponsored any product recall, market withdrawal or replacement conducted by or on behalf of any Third Party as a result of any alleged defect in the Credit Parties Product in the Horizon Territory. AstraZeneca has made available to Horizon copies of material field alerts, dear doctor letters, complaints and their Subsidiaries, notices of alleged defect or adverse reaction with respect to the Product in respect of which any Products or Product candidates under development the Horizon Territory that have participated, were (been received in writing by AstraZeneca and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respectsits Affiliates.
(hd) The transactions contemplated Product has been Manufactured in compliance with applicable Law, including cGMP, and applicable Regulatory Approvals. Neither AstraZeneca nor any Affiliate or Third Party engaged by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to useit, as the case may be) any Regulatory Authorizations relating to the Products in any material mannercapacity, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated herebyManufacture of the Product has received in the past [...***...] years or is currently subject to a Warning Letter (as defined in the Act) with respect to any facility manufacturing Product for Exploitation in the Horizon Territory. Subject to backorders or delays in the ordinary course, including AstraZeneca or its Affiliate has fulfilled all purchase orders submitted for the Liens granted Product in the Horizon Territory.
(e) All studies, tests and preclinical and clinical trials conducted by or on behalf of AstraZeneca or its Affiliates relating to the Product were conducted, and all studies, tests and trials currently being conducted by or on behalf of AstraZeneca or its Affiliates in connection herewith with the clinical trials listed in Section 3.1.9(e) of the Disclosure Schedules are being conducted, in either case in all material respects in accordance with cGCP and other applicable Laws. AstraZeneca has completed all pediatric assessments or postmarketing commitments required by the exercise of rights and remedies FDA with respect theretoto the Product in the Horizon Territory. Neither AstraZeneca nor any Affiliate of AstraZeneca has received any written notices or correspondence from any applicable Governmental Authority requiring the termination, suspension, material modification or clinical hold of any clinical trials listed in Section 3.1.9(e) of the Disclosure Schedules.
Appears in 2 contracts
Sources: Asset Purchase Agreement (Horizon Pharma, Inc.), Asset Purchase Agreement (Horizon Pharma, Inc.)
Regulatory Matters. With respect to each Product:
(a) Set Subject to Pernix’s performance of the Services and its responsibility for the operations of the Company as set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiariesherein, the conduct Company under the oversight and supervision of their businessPernix (through the Company Officers) shall have responsibility and decision making-authority for its regulatory activities, including communications and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiariesfilings with any Governmental Authorities, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products Product in and out of the Territory. As such pertains to the Corporate Services provided by Pernix, the Company shall promptly share with Pernix any written correspondence and/or communications of any kind that it receives from a Governmental Authority, including but not limited to copies of any and all Regulatory Materials and Regulatory Approvals (including all correspondence with Governmental Authorities) and keep Pernix promptly informed of the submission to Governmental Authorities of any significant Regulatory Materials, meetings with Governmental Authorities, and its receipt of, or any material changes to existing, Regulatory Approvals, in the case of this clause (ii), for the last five (5) years have been timely filed Product, whether in or outside the Territory. In connection with obtaining and maintaining the Regulatory Approvals in the Territory in connection with the FDA Distribution Service, Pernix shall have the right to reference during the Term any and all of the data submitted in support of the Regulatory Materials and Regulatory Approvals, including any Company Intellectual Property. The Company shall be the legal owner of the Regulatory Approvals associated with the Product in the Territory. At times and upon agreement by the Parties, as part of the Corporate Services, the Company may appoint Pernix as its agent with respect to such Regulatory Materials and Regulatory Approvals, including the right to file Regulatory Materials or take any other applicable Governmental Authoritiesactions required by (or advisable under) Applicable Law or this Agreement in respect of the Product in the Territory on behalf of the Company.
(b) (i) All Pernix and its Affiliates shall have the responsibility in the Territory for complying with all Applicable Laws, regulatory filings and reporting requirements required to be undertaken by any Regulatory Authority or Pernix acting as a distributor of the Product in respect the Territory. Pernix shall promptly notify the appropriate, designated persons within the Company of any Regulatory Authorization report of an adverse drug reaction/experience concerning the Product to the extent known by Pernix. Pernix shall cooperate with respect the Company as necessary to report such adverse drug reaction/experience when so required as a distributor of the Product under Applicable Laws. Pernix shall also promptly notify the appropriate, designated persons within the Company of any material complaints related to the Product or any of which the applicable personnel of Pernix becomes aware regarding problems with the Product Development other than those associated with adverse drug reactions/experiences. Subject to the foregoing, the Company shall be responsible for the timely reporting of all relevant adverse drug reactions/experiences, Product quality, Product complaints and Commercialization Activities which representedsafety data relating to the #90879273v29 Product to the appropriate Governmental Authorities in and outside of the Territory, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with Applicable Law and requirements of Governmental Authorities in the Territory or the applicable jurisdiction outside of the Territory, as the case may be. As such pertains to the Corporate Services provided by Pernix, the Company shall promptly share all applicable laws and regulations along such reports with appropriate monitoring of clinical investigator trial sites for their compliancePernix, and (iii) the Credit Parties and their Subsidiaries have disclosed in all cases shall use its commercially reasonably efforts to provide such reports to Pernix before or simultaneous to the Agent all issuance of such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authorityreports to Governmental Authorities.
(c) The Credit Parties, their Subsidiaries Company shall use its commercially reasonable efforts to obtain and maintain all Regulatory Approvals in the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related theretoTerritory. The Credit Parties and their Subsidiaries have and maintain in full force and effect Company shall be responsible for all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects Product-related communications with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other any Governmental Authority having jurisdiction over such Person. The Credit Parties in or outside of the Territory regarding the Product, unless previously agreed between the Company and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related theretoPernix.
(d) Except as set forth on Schedule 6.19(d), no Credit Each Party nor shall keep the other Party reasonably informed in writing in a timely manner of any of its Subsidiaries has received from information that such Party receives that (i) raises any Regulatory Authority any notice of alleged non-compliance material concerns regarding the safety or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 efficacy of the FD&C Act, Product; (ii) indicates or any other similar communication from any Regulatory Authority within suggests a potential material liability of either Party to third parties (including Governmental Authorities) in connection with the last five Product; (5iii) years. Except as set forth on Schedule 6.19(d), there have been no recalls, is reasonably likely to lead to a recall or market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations withdrawal of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, the Product; or (for example in iv) relates to the case of Product and is reasonably likely to have a recall) initiated by Credit Party material impact on a Regulatory Approval or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any commercialization of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) yearsProduct.
(e) No Credit PartyAt the request of designated persons within the Company, nor any of its SubsidiariesPernix will supply distribution information and other information reasonably requested by the Company, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority purposes of inclusion into the Company’s Annual Report to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policyFDA.
(f) Except as set forth on Schedule 6.19(fPernix shall ensure that the Distribution Service activities of Pernix, its Affiliates, Pernix Parties and sublicensees related to the Product shall be compliant with Applicable Laws. Pernix shall ensure that Pernix, its Affiliates, Pernix Parties and sublicensees shall not use any Promotional Materials not expressly approved for Pernix’s use by the Company Board (or its delegee). “Promotional Materials” means all sales representative training materials and all written, printed, graphic, electronic, audio or video matter, including, but not limited to, journal advertisements, sales aids, formulary binders, reprints, direct mail, direct-to-consumer advertising, Internet postings, broadcast advertisements and sales reminder aids (for example, scratch pads, pens and other such items), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA used or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether intended for use by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with any promotion, distribution, marketing, advertising, importation, use, offer for sale, or sale of the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoProduct.
Appears in 2 contracts
Sources: Services Agreement (Pernix Therapeutics Holdings, Inc.), Services Agreement
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(aEach of Rockets’ Subsidiaries that engages in the sale of electricity at wholesale (other than any such Subsidiaries that exclusively own solely one or more facilities that constitute a “qualifying facility” as such term is defined under the Public Utility Regulatory Policies Act (“PURPA”) and that qualify for exemption from regulation under Section 205 of the FPA pursuant to the rules and regulations of FERC) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally regulated as a “public utility” under the FPA and beneficially owned exclusively has been authorized by the Credit Parties FERC, pursuant to the FPA, to make sales at market-based rates or (ii) located within the Electric Reliability Council of Texas (“ERCOT”) and their Subsidiariesregistered as a “Power Generation Company” with the PUCT. Each of Rockets’ Subsidiaries that directly owns generating facilities has obtained an order from the FERC finding it to be, or has self-certified itself to the FERC as, an “Exempt Wholesale Generator” under either the Public Utility Holding Company Act of 1935 (“PUHCA 1935”) or the Public Utility Holding Company Act of 2005 (“PUHCA 2005”) or has obtained an order from the FERC finding it to be, or has self-certified itself to the FERC as, or is entitled to exemption from regulation as, a qualifying facility under PURPA. Neither Rockets nor any of its Subsidiaries are subject to the books and records requirements of FERC under Part 366 of the FERC’s Rules and Regulations (18 C.F.R. Part 366 (2009)). There are no pending or, to the Knowledge of Rockets, threatened judicial or administrative proceedings to revoke a Subsidiary’s market-based rate authorization, “Exempt Wholesale Generator” status or qualifying facility status, as applicable. To the Knowledge of Rockets, free and clear there are no events, facts or conditions that are reasonably likely to cause: (i) any of all Liens other than Permitted Liens, and Rockets’ Subsidiaries that sell electricity at wholesale to lose its market-based rate authorization; or (ii) any of Rockets’ Subsidiaries that directly owns generating facilities to lose its status as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authoritiesan “Exempt Wholesale Generator” under PUHCA 2005.
(b) (i) All regulatory filings required to be made by any Regulatory Authority Rockets or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice during the three (3) years preceding the date hereof with the FERC under the FPA or PUHCA 2005, the Department of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which representedEnergy, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA PUCT or any other applicable Regulatory Authority has commenced or initiatedstate public utility commissions, or threatened to commence with any governing ISO or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to useregional reliability entity, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, have been made, including all forms, statements, reports, agreements and all documents, exhibits, amendments and supplements appertaining thereto, including all rates, tariffs and related documents, and no consent all such filings complied, as of their respective dates, with all applicable requirements of applicable Law, except for filings the failure of which to make or other authorization the failure of any Governmental Authority is required which to make in connection compliance with all applicable Law, would not reasonably be expected to have, individually or in the transactions contemplated herebyaggregate, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoa Rockets Material Adverse Effect.
Appears in 2 contracts
Sources: Merger Agreement (Vistra Energy Corp), Merger Agreement (Dynegy Inc.)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis)Products. All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in material compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All material required notices, registrations and listings, applications, supplemental applications or notifications, reports (including recalls, field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removalexperiences) and other required material filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities.
(b) (i) All material regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are materially complete and correct and have complied in all material respects with all applicable laws and regulationsHealthcare Laws, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in material accordance with all applicable laws and regulations Healthcare Laws along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such material regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are and for the past three (3) years have been in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any material written notice of alleged non-compliance, potential non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable yearthereto, including any FDA Form 483 inspectional observations483, notices of violations or potential violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five three (53) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any material breach or violation of any applicable Regulatory Authorization, including that any of the Products is are misbranded or adulterated as defined in the FD&C Act, in each case of or the foregoingrules and regulations promulgated thereunder, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the a recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in material accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respectsLaws.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.
Appears in 2 contracts
Sources: Credit Agreement and Guaranty (Adma Biologics, Inc.), Credit Agreement (Adma Biologics, Inc.)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(aAll Products which have been developed by Geron as of the date hereof (the “Geron Products”) is a complete and accurate list of all material Regulatory Authorizations relating that are subject to the Credit Parties and their Subsidiaries, jurisdiction of the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years FDA have been timely filed with the FDA and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are developed in compliance in all material respects with all applicable statutesrequirements, rules if any, under the Food and regulations Drug and Cosmetic Act (including “FDCA”), the Public Health Service Act and their applicable implementing regulations.
(b) To the Knowledge of Geron, all Healthcare Laws preclinical studies and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA clinical trials and all other Regulatory Authoritiespreclinical research, clinical development and manufacturing activities conducted by or on behalf of Geron with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries the Technology have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance been conducted in all material respects with all applicable registration and listing requirements set forth Legal Requirements, including those relating to protection of human subjects.
(c) All manufacturing operations conducted by Geron with respect to Geron Products being used in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere human clinical trials have been conducted in accordance, in all material respects to respects, with the FDA’s cGMP regulations. To the Knowledge of Geron, all applicable regulations manufacturing operations conducted for the benefit of all Regulatory Authorities Geron with respect to the Geron Products and being used in human clinical trials have been conducted in accordance, in all Product Development and Commercialization Activities related theretomaterial respects, with the FDA’s cGMP regulations.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 As of the FD&C Actdate of this Agreement, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries Geron has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened in writing to commence or initiate, any action to withdraw suspend any Regulatory Authorizationclinical trial relating to the Technology.
(e) Neither Geron nor, requested to the recall (whether by correction or removal) Knowledge of any Products or commenced or initiated or threatened to commence or initiateGeron, any action Representatives acting for Geron, has committed any act, made any statement in writing or failed to enjoin make any Product Development statement in writing that would reasonably be expected to provide a valid basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Commercialization Activities Illegal Gratuities” set forth in 56 Fed. Reg 46191 (September 10, 1991) and any amendments thereto.
(f) As of such Credit Party the date hereof, there are no Proceedings pending with respect to a violation by Geron of the FDCA, FDA regulations adopted thereunder, the Controlled Substance Act or such Subsidiary, in each case, which represented, in any other Legal Requirement promulgated by a Governmental Body with respect to the aggregate, 15% or more of Net Sales in any applicable year,Geron Products.
(g) Except as set forth on Schedule 6.19(g)To the Knowledge of Geron, there have been no reports of any serious adverse events affecting any patients participating in the clinicalGRNOPC1 clinical trials for spinal cord injury that, preclinicalprior to the Closing, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respectsbeen determined to be product-related.
(h) The transactions Regulatory Filings identified in Schedule 1.1(h) include all material documents filed with the FDA by or on behalf of Geron relating to the Technology of the type contemplated by the Loan Documents (or contemplated by the conditions to effectiveness definition of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoFilings.
Appears in 2 contracts
Sources: Asset Contribution Agreement (Biotime Inc), Asset Contribution Agreement (Geron Corp)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) Each of Parent’s Subsidiaries that engages in the sale of electricity at wholesale is regulated as a complete “public utility” under the FPA and accurate list of all material Regulatory Authorizations relating has been authorized by the FERC, pursuant to the Credit Parties and their SubsidiariesFPA, to make such sales at market-based rates. Each of Parent’s Subsidiaries that directly owns generating facilities has obtained an order from the conduct FERC finding it to be, or has self-certified itself to the FERC as, an Exempt Wholesale Generator under PUHCA or the Public Utility Holding Act of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries1935, as applicable, free and clear pursuant to Part 366 of all Liens other than Permitted Liensthe FERC’s Rules and Regulations (18 C.F.R. Part 366 (2009)), and (ii) if applicable. There are no pending, or to the knowledge of Parent, threatened, judicial or administrative proceedings to revoke a Subsidiary’s market-based rate authorization or Exempt Wholesale Generator status, as applicable. To the knowledge of Parent, validly registered and on file with the applicable Governmental Authoritythere are no facts that are reasonably likely to cause any of Parent’s Subsidiaries that sell electricity at wholesale to lose its market-based rate authorization or any of Parents Subsidiaries that directly own generating facilities to lose its status as an Exempt Wholesale Generator under PUHCA. Neither Parent nor any of its Subsidiaries owns, directly or indirectly, any interest in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications nuclear generation station or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences manages or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authoritiesoperates any nuclear generation station.
(b) All filings (iother than immaterial filings) All regulatory filings required to be made by any Regulatory Authority Parent or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice during the three years preceding the date hereof, with the FERC under the FPA, the Public Utility Holding Company Act of alleged non-compliance 1935 or adverse findings with respect to any Product PUHCA, the Department of Energy or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to usestate public utility commissions, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, have been made, including all forms, statements, reports, agreements and all documents, exhibits, amendments and supplements appertaining thereto, including all rates, tariffs and related documents, and no consent or other authorization all such filings complied, as of any Governmental Authority is required in connection their respective dates, with the transactions contemplated hereby, including the Liens granted in connection herewith all applicable requirements of applicable statutes and the exercise rules and regulations promulgated thereunder, except for filings the failure of rights which to make or the failure of which to make in compliance with all applicable requirements of applicable statutes and remedies with respect theretothe rules and regulations promulgated thereunder, would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
Appears in 2 contracts
Sources: Merger Agreement (Mirant Corp), Merger Agreement (Rri Energy Inc)
Regulatory Matters. With respect Regulatory activities will be jointly carried out by the Project Team under the guidance of the JDC. All Regulatory Filings and Regulatory Approvals that relate to each Product:
(a) Set forth on Schedule 6.19(a) is a complete Shared Products shall be filed by and accurate list held in the name of [***] or its relevant Affiliates. [***] shall use Commercially Reasonable Efforts, in consultation with [***] to seek to obtain and maintain Regulatory Approval for the Shared Product in the Field. [***] will oversee, monitor and manage all material Regulatory Authorizations relating to the Credit Parties regulatory interactions, communications and their Subsidiaries, the conduct of their businessfilings with, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiariessubmissions to, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products Shared Products. [***], in consultation with [***], will control all regulatory activities with respect to the Shared Products, including determining the labeling strategy and the content of submissions; provided that [***] may review and comment on such strategies and submissions. Vertex will prepare all regulatory submissions and provide [***] with advance drafts of any material documents or other material [***] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. correspondence pertaining to the Shared Products, including any proposed labeling, that [***] plans to submit to any Regulatory Authority. [***] may provide comments regarding such documents and other correspondence prior to their submission, which comments [***] will consider in good faith. [***] will provide [***] with copies of all material submissions it makes to, and all material correspondence it receives from, a Regulatory Authority pertaining to a Regulatory Approval of a Shared Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor within [***] after receipt. [***] will provide [***] with reasonable advance notice of any of its Subsidiaries has received from meeting or teleconference with any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which representedthe Shared Products. Subject to Applicable Law, in [***] will have the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except right to participate as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws observer in all material respectsmeetings, conferences and discussions by [***] with Regulatory Authorities pertaining to Development of the Shared Products or Regulatory Approval of the Shared Products.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.
Appears in 2 contracts
Sources: Strategic Collaboration, Option and License Agreement (CRISPR Therapeutics AG), Strategic Collaboration, Option and License Agreement (CRISPR Therapeutics AG)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a6.18(a) is a complete and accurate list as of the Closing Date of all material Regulatory Authorizations relating to the Credit Parties and their SubsidiariesLoan Parties, the conduct of their business, business and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicableLoan Parties, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in material compliance with all registration, filing and maintenance requirements (including any fee requirements) thereof, and are (iii) in good standing, valid and enforceable with the applicable Governmental AuthorityAuthority in all material respects. All required and material notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and or other reports of adverse experiences or product malfunctions, and reports of corrections or removalexperiences) and other required and material filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities.
(b) (i) All material regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization or Product Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct in all material respects and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with each Loan Party according to all applicable laws and regulations in all material respects along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have each Loan Party has disclosed to the Agent Lender all such material regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) each Loan Party and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries Borrower and each other Loan Party and the Borrower’s agents and the agents thereof of each other Loan Party are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws Regulatory Authorizations and Regulatory Product Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties Borrower and their Subsidiaries have each other Loan Party has and maintain maintains in full force and effect all the necessary and requisite Regulatory Authorizations and Product Authorizations. The Credit Parties Borrower and their Subsidiaries are each other Loan Party is in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere Each Loan Party adheres in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d), no Credit Party Neither the Borrower nor any of its Subsidiaries other Loan Party has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable yearthereto, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) yearsAuthority. Except as set forth on Schedule 6.19(d), there There have been no seizures conducted or, to the Borrower’s knowledge, threatened by any Regulatory Authority with respect to any Product, and no recalls, market withdrawals, field notifications or corrections, detentions, seizuresnotifications, notifications or allegations of misbranding or adulteration or safety alerts conducted, requestedrequested or, or to the Borrower’s knowledge, threatened by any Regulatory AuthorityAuthority with respect to any Product, and no recalls, market withdrawals, field notifications, notifications of misbranding or (for example in adulteration or safety alerts have been conducted, requested or, to the case of a recall) initiated Borrower’s knowledge, threatened by Credit Party or any of its Subsidiaries, Regulatory Authority relating to any Products which represented, in Products. Neither the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party Borrower nor any of its Subsidiaries other Loan Party has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Product Authorization or Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of Act or the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) yearsrules and regulations promulgated thereunder.
(e) No Credit Party, Neither the Borrower nor any of its Subsidiaries, other Loan Party nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party Neither the Borrower nor any of its Subsidiaries other Loan Party has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or, to the knowledge of the Borrower or any such Loan Party, threatened to commence or initiate, any action to withdraw any Regulatory Authorization, Authorization or Product Authorization or requested the recall (whether by correction or removal) of any Products or commenced or initiated or, to the knowledge of the Borrower or any such Loan Party, threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of the Borrower or any such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,Loan Party.
(g) Except as set forth on Schedule 6.19(g), the The clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties Borrower and their Subsidiarieseach other Loan Party, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted materially in accordance with standard medical and scientific research procedures and all applicable Regulatory Authorizations Product Authorizations. The Borrower and Healthcare Laws each other Loan Party has operated within, and currently is in compliance in all material respects.
(h) The transactions contemplated by respects with, all applicable laws, Product Authorizations and Regulatory Authorizations, as well as the rules and regulations of the FDA and each other Regulatory Authority. Neither the Borrower nor any other Loan Documents (Party has received any notices or contemplated by other correspondence from the conditions to effectiveness FDA or any other Regulatory Authority requiring the termination or suspension of any Loan Document) will not impair any Credit Party’s clinical, preclinical, safety or other studies or tests used to support regulatory clearance of, or any of its Subsidiaries’ ownership of Product Authorization or rights under (or the license or the right to useRegulatory Authorization for, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoProduct.
Appears in 2 contracts
Sources: Credit Agreement (Alliqua BioMedical, Inc.), Credit Agreement (Alliqua BioMedical, Inc.)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally Each of the Company and beneficially owned exclusively by its Subsidiaries has all Licenses necessary to conduct its business as presently conducted, including all such Licenses of the Credit Parties United States Food and their Subsidiaries, as applicable, free and clear of all Liens Drug Administration (the “FDA”) or any other than Permitted Liens, and applicable U.S. or foreign drug regulatory authority (ii) as applicable, validly registered and on file collectively with the applicable Governmental AuthorityFDA, in compliance with all filing and maintenance requirements the “Regulatory Authorities”) necessary to conduct its business as presently conducted (including any fee requirements) thereofcollectively, and are in good standingthe “Regulatory Licenses”), valid and enforceable with except those Licenses the applicable Governmental Authority. All required noticesabsence of which, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority individually or in respect the aggregate with other such absences, would not reasonably be expected to have a Company Material Adverse Effect and would not reasonably be expected to prevent, materially delay or materially impair the consummation of the transactions contemplated hereby. There has not occurred any revocation or termination of any Regulatory Authorization with respect to any Product License, or any Product Development and Commercialization Activities which representedmaterial impairment of the rights of the Company or its Subsidiaries under any Regulatory License, except for any such revocation, termination or impairment that, individually or in the aggregateaggregate with other such revocations, 15% or more of Net Sales in any applicable yearterminations and impairments, in the last five (5) years would not reasonably be expected to have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives a Company Material Adverse Effect. Each of the Credit Parties (Company and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their its Subsidiaries and the agents thereof are has operated in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act administered or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened enforced by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed except where the failure so to disclose a material fact required to be disclosed to comply, individually or in the FDA or any aggregate with other Regulatory Authoritysuch failures, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was would not made), could reasonably be expected to provide have a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Company Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policyAdverse Effect.
(fii) Except as set forth on Schedule 6.19(f)Since January 1, no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated2009, or threatened to commence or initiateall preclinical studies and clinical trials, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or or, to the Knowledge of the Company, on behalf of the Company or sponsored by the Credit Parties and their Subsidiariesits Subsidiaries have been and, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) are being conducted in accordance compliance with all applicable Laws (including those pertaining to Good Laboratory Practice and Good Clinical Practice contained in 21 C.F.R. Part 58 and Part 312 and all applicable requirements relating to protection of human subjects contained in 21 C.F.R. Parts 50, 54 and 56), except for noncompliances that, individually or in the aggregate with other such noncompliances, would not reasonably be expected to have a Company Material Adverse Effect. Since January 1, 2009, except for such exceptions that, individually or in the aggregate with other such exceptions, would not reasonably be expected to have a Company Material Adverse Effect, no clinical trial conducted by or, to the knowledge of the executive officers of the Company, on behalf of the Company or its Subsidiaries has been terminated or suspended prior to completion for safety or other non-business reasons, and neither the FDA nor any other applicable Regulatory Authorizations and Healthcare Laws in all material respectsAuthority, clinical investigator that has participated or is participating in, or institutional review board that has or has had jurisdiction over, a clinical trial conducted by or, to the Knowledge of the Company, on behalf of the Company or its Subsidiaries has commenced, or, to the Knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any ongoing clinical investigation conducted by or, to the Knowledge of the Company, on behalf of the Company or its Subsidiaries.
(hiii) The transactions contemplated by Since January 1, 2009, (A) neither the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or Company nor any of its Subsidiaries nor, to the Knowledge of the Company, any of their officers, directors, employees or agents has been convicted of any crime or engaged in any conduct that in any such case has resulted, or is reasonably likely to result, in debarment under 21 U.S.C. Section 335a and (B) neither the Company nor any of its Subsidiaries has hired any employee under debarment or used a vendor that, to the Knowledge of the Company, employed any person under debarment.
(iv) The Company has made available to Parent complete and correct copies of each Investigational New Drug Application, each similar state or foreign regulatory filing made on behalf of the Company or its Subsidiaries’ ownership , including all related supplements, amendments and annual reports, and all correspondence between the Company and any of or rights under (or the license or the right to use, as the case may be) its Affiliates on one hand and any Regulatory Authorizations relating Authority on the other hand.
(v) Since January 1, 2009 to the Products in any material mannerdate of this Agreement, and no consent each medicinal or other authorization of any Governmental Authority pharmaceutical product that is required in connection with the transactions contemplated herebyor has been researched, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.developed, manufactured, labeled, supplied, promoted, co-promoted, co-developed, co-marketed,
Appears in 2 contracts
Sources: Merger Agreement (Shire PLC), Merger Agreement (Dyax Corp)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect The businesses of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years Borrowers have been made, and all such filings above such threshold are complete and correct and have complied being conducted in compliance in all material respects with all applicable laws Law, including the Healthcare Laws, and regulationsall Permits, (ii) each Product (whether manufactured by Accuray or any of its Subsidiaries, any of their respective Affiliates or by a third party manufacturer under contract to Accuray or any of its Subsidiaries) has been, and currently is, being researched, developed, designed, investigated, manufactured, made, assembled, stored, packaged, labeled, marketed and distributed in compliance with all clinical applicable Law, including, without limitation, the Healthcare Laws, all required Permits, cGMP, QSR, the Device Master Record as defined in 21 CFR 820.181 and pre-clinical trialsDocument Controls under 21 CFR 820.40 and all Product specifications as established in company documentation, if any, of investigational Products have been and are being conducted by except to the extent any failure to so comply could not reasonably be expected to result in any adverse consequences to the Credit Parties (other than immaterial consequences), (iii) each contract between Accuray and their any of its Subsidiaries on the one hand, and any third party manufacturer on the other hand contain (and Accuray and each of its Subsidiaries implement), appropriate quality assurance arrangements in accordance with FDA requirements, (iv) Accuray and its Subsidiaries are in compliance in all material respects with applicable Law governing reporting and recordkeeping of Product modifications, adverse event reporting, reporting of corrections and removals, and recordkeeping for each Product, and all manufacturing and release documents and records are true and accurate in all material respects, and (v) neither Accuray nor any of its Subsidiaries has received or been subject to any written or oral communications from the FDA, the NRC or any other Governmental Authority asserting that Accuray, any such Subsidiary or any such Product was not in compliance in any material respect with any applicable Law or any Permit.
(b) Other than routine surveillance audits and inspections, no investigation by any Governmental Authority with respect to Accuray or any of its Subsidiary is pending or, to the knowledge of the Credit Parties, threatened. None of Accuray or any of its Subsidiaries has received any written or oral communication from any Governmental Authority of any noncompliance with any Law or any written or oral communication from any Governmental Authority or accrediting organization of any material issues, problems, or concerns regarding the quality or performance of the Products.
(c) Accuray and its Subsidiaries own, free and clear of all Liens, except Liens securing the Obligations, all Permits, including all authorizations under the FD&C Act, other United States federal laws, and all applicable state and foreign laws, necessary (i) for the research and development and commercialization of the Products, including, without limitation, all Permits necessary in connection with testing, manufacturing, marketing or selling of such Products, as such testing, manufacturing, marketing or selling are currently being conducted, and (ii) to carry on the business of Accuray and each of its Subsidiaries. All such Permits are valid and in full force and effect and Accuray and each Subsidiary is in compliance in all material respects with all terms and conditions of such Permits. None of Accuray or any Subsidiary has received any written notice from any Governmental Authority that any Permit has been or is being revoked, withdrawn, suspended or challenged or that such Governmental Authority is conducting an investigation or review thereof or has issued any order or recommendation stating that the development, testing and/or manufacturing of such Product should cease or that such Product should be withdrawn from the marketplace.
(d) There have been no adverse clinical test results which have or could reasonably be expected to have a materially adverse impact on Accuray or any of its Subsidiaries, and there have been no Product recalls or voluntary Product withdrawals from any market (other than specific and discrete batches or lots not made in conjunction with a larger recall).
(e) Neither Accuray nor any of its Subsidiaries have experienced any significant failures in its manufacturing of any Product such that the amount of such Product successfully manufactured by Accuray or any of its Subsidiaries in accordance with all applicable laws specifications thereof and regulations along the required payments related thereto in any twelve (12) month period have decreased by more than twenty percent (20%) with appropriate monitoring respect to the quantities of clinical investigator trial sites for such Product produced in the prior twelve (12) month period.
(f) There has been no material untrue statement of fact and no fraudulent statement made by Accuray or any of its Subsidiaries or any of their compliancerespective agents or representatives to the FDA, NRC, or any other Governmental Authority, and (iii) the Credit Parties and their Subsidiaries have there has been no failure to disclose any material fact required to be disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and FDA, NRC or any Regulatory other Governmental Authority.
(cg) The To the best knowledge of the Credit Parties, their no insurance company, managed care organization or Governmental Authority has (i) terminated coverage or reimbursement for procedures and treatments performed using the CyberKnife and TomoTherapy Products, or (ii) reduced the scope of coverage or the rate of reimbursement it provides for procedures and treatments performed using the CyberKnife and TomoTherapy Products, and, in the case of this clause (ii), such reduction could reasonably be expected to have a materially adverse impact on the revenues of Accuray and its Subsidiaries. None of Accuray or any of its Subsidiaries has been the subject of any “for cause” inspection, investigation or audit by any Governmental Authority in connection with any alleged improper activity.
(h) There is no arrangement relating to Accuray or any of its Subsidiaries providing for any rebates, kickbacks or other forms of compensation or remuneration that are unlawful to be paid to any Person to induce, or in return for obtaining or the referral of business or for the arrangement for recommendation of such referrals. All ▇▇▇▇▇▇▇▇ by Accuray and the agents thereof each of its Subsidiaries for its services have been true and correct in all material respects and are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental AuthoritiesLaw, including the FDA Healthcare Laws.
(i) None of Accuray or any of its Subsidiaries, or, to the knowledge of the Credit Parties, any individual who is an officer, director, employee or manager of Accuray or any of its Subsidiaries has been convicted of, charged with or, to the knowledge of the Credit Parties, investigated for any federal or state health program-related offense or been excluded or suspended from participation in any such program; or, to the knowledge of the Credit Parties, within the past five (5) years, has been convicted of, charged with or, to the knowledge of the Credit Parties, investigated for a violation of any Law related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances, or has been subject to any judgment, stipulation, order or decree of, or criminal or civil fine or penalty imposed by, any Governmental Authority related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances. None of Accuray or any of its Subsidiaries or, to the knowledge of the Credit Parties, any individual who is an officer, director, employee or manager of Accuray or any of its Subsidiaries has been convicted of any crime or engaged in any conduct including but not limited to any misrepresentation to any Governmental Authority or that has otherwise resulted or would reasonably be expected to result in a debarment or exclusion (i) under 21 U.S.C. Section 335a, or (ii) any similar applicable Law. No debarment proceedings or investigations in respect of the business of Accuray or any of its Subsidiaries are pending or, to the knowledge of the Credit Parties, threatened against Accuray or any of its Subsidiaries or any individual who is an officer, director, employee or manager of Accuray or any of its Subsidiaries.
(j) All studies, tests and all other Regulatory Authoritiespreclinical and clinical trials conducted relating to the Products, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their sponsored by Accuray or any of its Subsidiaries have been conducted, and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance currently being conducted, in all material respects in accordance with all applicable registration Law and listing requirements set forth in IDEs, including procedures and controls pursuant to, where applicable, current good clinical practices and current good laboratory practices and other applicable laws, rules regulations. To the FD&C Act extent required by applicable Law, Accuray and each of its Subsidiaries has obtained all necessary authorizations from Governmental Authorities and IECs, including an IDE for the conduct of any clinical investigations conducted by or equivalent regulation on behalf of each other Governmental Authority having jurisdiction over Accuray or such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related theretoSubsidiary, as applicable.
(dk) Except as set forth on Schedule 6.19(d)To the knowledge of the Credit Parties, none of the clinical investigators in any clinical trial sponsored by Accuray or any of its Subsidiaries has been or is disqualified or otherwise sanctioned by the FDA, the Department of Health and Human Services, or any Governmental Authority and, to the knowledge of the Credit Parties, no Credit Party nor such disqualification, or other sanction of any such clinical investigator is pending or threatened. None of Accuray or any of its Subsidiaries has received from any Regulatory the FDA or other applicable Governmental Authority any notice notices or correspondence requiring or threatening the termination, suspension, material modification or clinical hold of alleged non-compliance any studies, tests or adverse findings clinical trials with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoProducts.
Appears in 2 contracts
Sources: Credit and Security Agreement (Accuray Inc), Credit and Security Agreement (Accuray Inc)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) is a complete Each of NBT and accurate list of NBT Bank has timely filed all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required noticesreports, registrations and listingsstatements, supplemental applications together with any amendments required to be made with respect thereto, that it was required to file since January 1, 2020 with any Governmental Authority and has paid all fees and assessments due and payable in connection therewith. Except for normal examinations conducted by any Governmental Authority in the regular course of the business of NBT and/or NBT Bank, no Governmental Authority has initiated any proceeding, or notificationsto the Knowledge of NBT, reports (including field alertsinvestigation into the business or operations of NBT and/or NBT Bank, medical device reports (MDRs) and other reports of adverse experiences since January 1, 2020. There is no unresolved violation or product malfunctions, and reports of corrections or removal) and other required filings matter requiring attention by any Governmental Authority with respect to the Products for the last five (5) years have been timely filed with the FDA any report or statement relating to any examinations of NBT Bank. Each of NBT and all other NBT Bank is “well-capitalized” as defined in applicable Governmental Authoritieslaws and regulations, and NBT Bank has a Community Reinvestment Act rating of “satisfactory” or better.
(b) (i) All regulatory filings Other than as set forth in NBT Disclosure Schedule 4.11, since January 1, 2020, NBT has timely filed with the SEC and NASDAQ all documents required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development the Securities Act and Commercialization Activities which representedthe Exchange Act and such documents, in as the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years same may have been madeamended, and all such filings above such threshold are complete and correct and have complied complied, at the time filed with the SEC, in all material respects with all applicable laws the Securities Act and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory AuthorityExchange Act.
(c) The Credit PartiesNeither NBT, NBT Bank nor any of their Subsidiaries respective properties is a party to or is subject to any Regulatory Order from any Governmental Authority charged with the supervision or regulation of financial institutions or issuers of securities or institutions engaged in the insurance of deposits (including, without limitation, the OCC and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory AuthorizationsFRB) of all applicable Governmental Authorities, including or the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act supervision or equivalent regulation of each other it. Neither NBT nor NBT Bank has been advised by, or has any Knowledge of facts which could give rise to an advisory notice by, any Governmental Authority having jurisdiction over that such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations Governmental Authority is contemplating issuing or requesting (or is considering the appropriateness of all issuing or requesting) any Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related theretoOrder.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any Without limiting the generality of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g8.10(b), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating parties acknowledge that this Section 4.11 is subject to the Products in any material manner, and no consent or other authorization limitations of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoSection 8.10(b) hereof.
Appears in 2 contracts
Sources: Merger Agreement (NBT Bancorp Inc), Merger Agreement (Salisbury Bancorp, Inc.)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) is Except as has not had, individually or in the aggregate, a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their SubsidiariesMaterial Adverse Effect, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally each of the Acquired Corporations holds all Governmental Authorizations under the FDCA (including Section 510(k) thereof) and beneficially owned exclusively the European Medical Device Directive (“MDD”), and all Governmental Authorizations of any applicable Governmental Body that has regulatory authority over the quality, identity, safety, efficacy, manufacturing, marketing, distribution, sale, pricing, import or export of the products currently sold by the Credit Parties and their SubsidiariesAcquired Corporations (“Company Product”) (any such Governmental Body, as applicable, free and clear a “Company Regulatory Agency”) necessary for the lawful operation of all Liens other than Permitted Liens, and the businesses of the Acquired Corporations in each jurisdiction in which such Acquired Corporation operates (the “Company Regulatory Permits”); (ii) as applicable, validly registered all such Company Regulatory Permits are valid and on file with in full force and effect; and (iii) the applicable Governmental Authority, Company is in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports terms of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental AuthoritiesCompany Regulatory Permits.
(b) (i) All regulatory filings required by any Regulatory Authority Except as has not had, individually or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more a Material Adverse Effect, the businesses of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and each Acquired Corporation are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliancecompliance with, and have appropriate internal controls that are reasonably designed to ensure compliance with, as applicable, (iiii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations FDCA (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in Section 510 of the FD&C FDCA (21 U.S.C. § 360) and 21 C.F.R. Part 807); (ii) any applicable comparable foreign Legal Requirements for any Company Products (including the MDD); (iii) Legal Requirements set forth in title XVIII or XIX of the Social Security Act including, without limitation, the mandatory reporting and return of overpayments (42 U.S.C. § 1320a-7k(d)) requirements, (iv) state and provincial anti-kickback, anti-solicitation, patient brokering, patient capping, or equivalent regulation fee-splitting laws; (v) if, and to the extent applicable, federal, state or provincial licensing, disclosure and reporting requirements for Company Products; (vi) if, and to the extent applicable, the Health Insurance Portability and Accountability Act of each 1996 (42 U.S.C. § 1320d et seq.), as amended by the Health Information Technology for Economic and Clinical Health Act, and any federal, state, or local privacy, security, data breach reporting or other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities Legal Requirements with respect to the Products collection, protection, security, confidentiality, use, transfer, and disclosure of all Product Development personally identifiable information collected or maintained by or on behalf of each Acquired Corporation (“Personal Data”); (vii) reporting and Commercialization Activities related theretoother requirements relating to financial relationships between health care providers and pharmaceutical manufacturers, including the federal Physician Payments Sunshine Act (42 U.S.C. §1320a-7h), state “sunshine acts” and gift ban or reporting statutes, and the Code on Interactions with health Care Professionals as promulgated by the Pharmaceutical Research and Manufacturers of America; (viii) any Legal Requirement regulating ordering, prescribing, storing or distributing controlled substances or radioactive materials; (ix) any applicable Legal Requirement regulating the handling and disposal of bio-hazards, pharmaceutical or medical waste and (x) the applicable rules and regulations promulgated pursuant to all such applicable Legal Requirements, each as amended from time to time (collectively, “Company Healthcare Laws”). Since January 1, 2015, no Acquired Corporation has received any written notification from any Company Regulatory Agency, including without limitation the FDA and the Department of Health and Human Services or any other “notified body” or “competent authority” or corresponding Company Regulatory Agency in any jurisdiction, of noncompliance by, or liability of the Acquired Corporation under, any Company Healthcare Laws, except where such noncompliance or liability has not had, individually or in the aggregate, a Material Adverse Effect on the Acquired Corporations.
(c) No Acquired Corporation nor to the knowledge of the Company any stockholder, director, officer, employee, agent or contractor of an Acquired Corporation (i) has been assessed a civil monetary penalty under Section 1128A of the Social Security Act or any regulations promulgated thereunder; (ii) has been debarred, excluded, or suspended from participating in any federal or state health care program (as such terms are defined by the Social Security Act) or other third party payment program, or from receiving a contract or subcontract paid in whole or in part by federal or state funds; (iii) is or has been a party to any corporate integrity agreement, corporate compliance agreement, monitoring agreement, deferred prosecution agreement, consent decree, settlement order, or similar agreements with or imposed by any Company Regulatory Agency and, to the Company’s knowledge, no such action is currently proposed or pending a corporate integrity agreement, as a result of an alleged violation of any Company Healthcare Law; (iv) has been convicted of any criminal offense under any Company Healthcare Law; (v) is or has been a party to or subject to any criminal, civil or administrative action or proceeding, or to the knowledge of the Company, any threatened action or proceeding, concerning any of the matters described in clauses (i) through (iv) above.
(d) Except as set forth on Schedule 6.19(d)As of the date hereof, no Credit Party nor Acquired Corporation (i) is subject to any pending or, to its knowledge, threatened investigation by a Company Regulatory Agency or any unsealed qui tam action, (ii) has received or been served with any search warrant, subpoena or civil investigative demand from any Company Regulatory Agency; (iii) is subject to any statement of deficiencies for which there is not an approved plan of correction, the conditions of which have been or are being fully met; and (iv) is subject to any pending or, to its knowledge, threatened notice or action to suspend, revoke, or modify any Governmental Authorization, and no Acquired Corporation has reason to believe that any such action is likely to occur.
(e) All pre-clinical and clinical investigations conducted or sponsored by each Acquired Corporation are being conducted in compliance with all applicable Legal Requirements administered or issued by the applicable Company Regulatory Agencies, including, without limitation, (i) FDA standards for conducting non-clinical laboratory studies contained in Title 21 Part 58 of the Code of Federal Regulations, (ii) FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials contained in Title 21 Parts 50, 54, 56 and 812 of the Code of Federal Regulations, (iii) any comparable foreign Legal Requirements for any of its Subsidiaries the foregoing or other Legal Requirements regulating the conduct of pre-clinical and clinical investigations and (iv) federal, state and provincial Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that, individually or in the aggregate, has not had a Material Adverse Effect on the Acquired Corporations.
(f) Since January 1, 2015, no Acquired Corporation has received any written notice from the FDA (including any Regulatory Authority inspection reports on Form 483) or any notice foreign agency with jurisdiction over the marketing, sale, use, handling and control, safety, efficacy, reliability, or manufacturing of alleged non-compliance medical devices which would reasonably be expected to lead to the denial, suspension or adverse findings revocation of any application or grant for marketing approval with respect to any material Company Product currently pending before or any Product Development and Commercialization Activities related thereto which representedpreviously cleared by the FDA or such other Company Regulatory Agency.
(g) Since January 1, in the aggregate2015, 15% or more of Net Sales in any applicable yearall reports, including any FDA Form 483 inspectional observationsdocuments, claims, permits, notices and Medical Device Reports of violationsadverse events (“MDRs”) required to be filed, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, maintained or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating furnished to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Company Regulatory Authority indicating any breach Agency by the Acquired Corporations have been so filed, maintained or violation of any applicable Regulatory Authorizationfurnished in a timely manner, including that any of the Products is misbranded except where failure to file, maintain or adulterated as defined in the FD&C Actfurnish such reports, in each case of the foregoingdocuments, which representedclaims, permits, notices or MDRs has not had, individually or in the aggregate, 15% a Material Adverse Effect. All such reports, documents, claims, permits and notices were complete and accurate in all material respects on the date filed (or more were corrected in or supplemented by a subsequent filing if subject to such a Legal Requirement). None of Net Sales in any applicable year within the last five (5) years.
(e) No Credit PartyAcquired Corporations, nor any nor, to the knowledge of its Subsidiariesthe Company, nor any officer, employee employee, agent or agent thereofdistributor of the Acquired Corporations, has made an untrue statement of a material fact or a fraudulent statements statement to the FDA or any other Company Regulatory AuthorityAgency, failed to disclose a material fact required to be disclosed to the FDA or any other Company Regulatory AuthorityAgency, or committed an act, made a statement, or failed to make a statement statement, in each such case, related to the business of the Acquired Corporations, that, at the time such disclosure was made (or was not made), could would reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery Bribery, and Illegal Gratuities, ” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that for the FDA or any other applicable Company Regulatory Authority has commenced or initiatedAgency to invoke any similar policy. None of the Acquired Corporations, or threatened nor, to commence or initiatethe knowledge of the Company, any action to withdraw any Regulatory Authorizationofficer, requested employee, agent or distributor of the recall (whether by correction Acquired Corporations, has been debarred or removal) convicted of any Products crime or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales engaged in any applicable year,conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Legal Requirement or authorized by 21 U.S.C. § 335a(b) or any similar Legal Requirement.
(gh) Except as set forth on Schedule 6.19(g)As to each Company Product or Company Product candidate subject to the FDCA, the clinicalregulations of the FDA promulgated thereunder or similar Legal Requirement in any foreign jurisdiction (including the MDD) that is or has been developed, preclinicalmanufactured, safety and other studies and tests conducted tested, distributed or marketed by or on behalf of or sponsored by the Credit Parties and their SubsidiariesAcquired Corporations, except, as has not had, individually or in respect of which any Products the aggregate, a Material Adverse Effect, each such Company Product or Company Product candidates under development have participatedcandidate is being or has been developed, were (manufactured, stored, distributed and if still pending, are) being conducted marketed in accordance compliance with all applicable Regulatory Authorizations Legal Requirements, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and Healthcare Laws security. There is no action or proceeding pending or, to the knowledge of the Company, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in all material respectseach case alleging any violation applicable to any Company Product or Company Product candidate by the Acquired Corporations of any Legal Requirement, except, as has not had, individually or in the aggregate, a Material Adverse Effect.
(hi) The transactions contemplated Since January 1, 2015, each of the Acquired Corporations have neither voluntarily nor involuntarily initiated, conducted or issued, caused to be initiated, conducted or issued any “Class I” or “Class II” recall or material field corrective action, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged material lack of safety, efficacy or regulatory compliance of any Company Product or is currently considering initiating, conducting or issuing any “Class I” or “Class II” recall of any Company Product. Since January 1, 2015, the Acquired Corporations have not received any written notice from the FDA or any other Company Regulatory Agency regarding, (i) the recall, market withdrawal or replacement of any Company Product sold or intended to be sold by the Loan Documents Acquired Corporations, (ii) a change in the marketing classification or contemplated by a material change in the conditions to effectiveness labeling of any Loan Documentsuch Company Products, or (iii) will not impair any Credit Party’s a termination, enjoinment or any suspension of its Subsidiaries’ ownership the manufacturing, marketing, or distribution of such Company Products that in each case, has had or rights under (or would reasonably be expected to have a material impact on the license or business of the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoAcquired Corporations.
Appears in 2 contracts
Sources: Agreement and Plan of Merger (Zeltiq Aesthetics Inc), Merger Agreement (Zeltiq Aesthetics Inc)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) is a complete Subject to any obligations of Seller under the Transition Services Agreement, from and accurate list of all material Regulatory Authorizations relating to after the Credit Parties Closing Date, Purchaser, at its cost, shall be solely responsible and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are liable for (i) legally taking all actions, paying all fees and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of conducting all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file communication with the applicable Governmental AuthorityAuthority required by Law in respect of the Applicable Permits, in compliance with including preparing and filing all filing and maintenance requirements reports (including any fee requirementsadverse drug experience reports) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required noticesAuthority (whether the Product is sold before or after transfer of the Registrations), registrations (ii) taking all actions and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings conducting all communication with Third Parties with respect to Product sold pursuant to the Products for Registrations (whether sold before or after transfer of the last five Registrations), including responding to all complaints in respect thereof, including complaints related to tampering or contamination, (5iii) years have been timely filed investigating all complaints and adverse drug experiences with respect to Product sold pursuant to the Registrations (whether sold before or after transfer of the Registrations), and (iv) carrying out any Phase IV post approval commitment (such as patient surveys) consistent with those described on Schedule 4.10(g) of the Seller Disclosure Schedule. At Purchaser's reasonable request, Seller shall cooperate, at its own expense, in connection with the FDA and all other applicable Governmental Authoritiesactivities of Purchaser contemplated by this Section 8.6(a).
(b) From and after the Closing Date, Seller shall promptly notify the Purchaser of complaints or reports received of an adverse drug experience with respect to the Product.
(ic) All regulatory filings Subject to the terms in the Supply Agreement with respect to Product Manufactured by Seller, from and after the Closing Date, Purchaser, at its cost, shall be solely responsible and liable for conducting all voluntary and involuntary recalls of units of the Product sold pursuant to such Registrations (whether sold before or after transfer of such Registrations), including recalls required by any Regulatory applicable Governmental Authority and recalls of units of the Product sold by Seller deemed necessary by Seller in its reasonable discretion; provided, however, that Seller shall reimburse Purchaser for the reasonable expenses and costs of conducting recalls relating to Product sold by or on behalf of Seller prior to the Closing, including the costs of notifying customers, the costs associated with shipment of such recalled Product, the price paid for such Product, and reasonable credits extended to customers in respect connection with the recall, provided that such recall is not attributable to the negligence or willful misconduct of Purchaser in conducting the Business. Seller promptly shall notify Purchaser in the event that a recall of the Product sold by Seller is necessary, and at Purchaser's reasonable request, Seller shall cooperate, at its own expense, in connection with any Regulatory Authorization such recall. *** Certain information on this page has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to any Product the omitted portions.
(d) To the extent not otherwise previously completed pursuant to Sections 3.2(a)(ii) or any Product Development and Commercialization Activities which represented3.2(a)(iii), in Seller shall, within fifteen (15) days of the aggregateClosing Date, 15% or more notify the FDA of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, transfer of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries Registrations to Purchaser in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) yearsLaws.
(e) No Credit PartyTo the extent not otherwise previously completed pursuant to Section 3.2(b)(iv), nor any Purchaser shall, within fifteen (15) days of the Closing Date, notify the FDA of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement assumption of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted Registrations from Seller in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respectsLaws.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.
Appears in 2 contracts
Sources: Asset Purchase and Sale Agreement (Prometheus Laboratories Inc), Asset Purchase and Sale Agreement (Prometheus Laboratories Inc)
Regulatory Matters. With respect The nonclinical studies and clinical trials conducted by or to each Product:
the Company’s Knowledge on behalf of the Company that are described in the General Disclosure Package and the Prospectus (athe “Company Studies and Trials”) Set forth on Schedule 6.19(a) is a complete and accurate list of were and, if still pending, are being, conducted in all material Regulatory Authorizations relating respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards, except as described in the General Disclosure Package; the descriptions of the results of the Company Studies and Trials contained in the General Disclosure Package and Prospectus are accurate in all material respects; the Company has no Knowledge of any other studies or trials not described in the General Disclosure Package and the Prospectus, the results of which are inconsistent with or reasonably call into question the results described or referred to in the General Disclosure Package and the Prospectus; and the Company has not received any written notices or other correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials except where such termination, suspension or material modification would not reasonably be expected to have a Material Adverse Effect, and to the Credit Parties Company’s Knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and their SubsidiariesTrials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have Company has complied in all material respects with all applicable laws and regulationsregulatory rules or requirements, (ii) all including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical and pre-clinical trials, if any, of investigational Products have investigator or has been and are being conducted found by the Credit Parties FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring operations of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof its suppliers are operated in compliance in all material respects with all applicable statutes, rules rules, and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 comparable regulatory agencies outside of the FD&C Act, or any other similar communication from any Regulatory Authority within United States to which the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products Company is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) yearssubject.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.
Appears in 2 contracts
Sources: Underwriting Agreement (Molecular Templates, Inc.), Underwriting Agreement (Molecular Templates, Inc.)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) is Except as would not reasonably be expected to have a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their SubsidiariesMaterial Adverse Effect, the conduct of their businesseach Acquired Corporation is, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiariessince January 1, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority2022 has been, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all healthcare-related Legal Requirements, in each case as applicable laws to the operation of its business, including (i) the FDCA and regulations, the regulations promulgated thereunder; (ii) all clinical the Public Health Service Act (42 U.S.C. § 262) and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, promulgated thereunder; and (iii) the Credit Parties federal Medicare and their Subsidiaries Medicaid statutes. No Acquired Corporation is subject to any ongoing enforcement, regulatory or administrative proceedings against such Acquired Corporation alleging non-compliance with the FDCA or similar Legal Requirements, and no such enforcement, regulatory or administrative proceeding has been threatened in writing, and there are no circumstances of such noncompliance that occurred or existed on or prior to January 1, 2022 that remain active or for which the Company could have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authorityongoing liability.
(cb) The Credit PartiesAcquired Corporations hold all Regulatory Permits required for their business as currently conducted, their Subsidiaries and the agents thereof each such Regulatory Permit is valid and in full force and effect. The Acquired Corporations are in compliance in all material respects with all applicable statutesthe terms and requirements of such Regulatory Permits. Since January 1, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all 2022, no material deficiencies have been asserted in writing by any applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings Body with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 Regulatory Permits of the FD&C ActAcquired Corporations, and there are no such deficiencies that occurred or existed on or prior to January 1, 2022 that remain active or for which the Company could have any other similar communication from any Regulatory Authority within ongoing liability.
(c) To the last five (5) years. Except as set forth on Schedule 6.19(d)knowledge of the Company, there all preclinical and clinical investigations sponsored by the Acquired Corporations have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example and are being conducted in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any material compliance with applicable year within the last five (5) yearshealthcare-related Legal Requirements. No Credit Party nor any of its Subsidiaries Acquired Corporation has received any written notification that remains unresolved notice from the FDA or any other Regulatory Authority indicating Governmental Body performing functions similar to those performed by the FDA with respect to any breach ongoing clinical or violation preclinical studies or tests requiring or recommending the termination, suspension or material modification of such studies or tests.
(d) The Acquired Corporations have filed with the FDA or any other Governmental Body performing functions similar to those performed by the FDA all required material filings, declarations, listings, registrations, reports or submissions. All such filings, declarations, listings, registrations, reports or submissions were in material compliance with applicable Legal Requirements when filed or have been supplemented in a subsequent filing, and no material deficiencies have been asserted in writing by any applicable Regulatory AuthorizationGovernmental Body with respect to any such filings, including that any of the Products is misbranded declarations, listings, registrations, reports or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) yearssubmissions.
(e) No Credit PartyTo the knowledge of the Company, nor any of its Subsidiaries, nor any officer, employee or agent thereof, no Acquired Corporation has (i) made an untrue statement of a material fact or fraudulent statements statement to the FDA or any other Regulatory AuthorityGovernmental Body, (ii) failed to disclose a material fact required to be disclosed to the FDA or (iii) committed any other Regulatory Authority, or committed an act, made a statement, any statement or failed to make any statement, that (in any such case) establishes a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a reasonable basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery Bribery, and Illegal GratuitiesGratuities Final Policy. As of the date of this Agreement, set forth no Acquired Corporation is the subject of any pending or, to the knowledge of the Company, threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. No Acquired Corporation nor, to the knowledge of the Company, any officers, employees, or agents of the Company has been debarred, excluded from participation in 56 Fed. Reg. 46191 federal healthcare programs or convicted of any crime or engaged in any conduct that would reasonably be expected to result in (September 10, 1991A) debarment under 21 U.S.C. § 335a or any similar policyLegal Requirement or (B) exclusion under 42 U.S.C. § 1320a-7 or any similar Legal Requirement.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries No Acquired Corporation has received any written notice that the FDA either voluntarily or any other applicable Regulatory Authority has commenced or involuntarily initiated, conducted or threatened issued, or caused to commence be initiated, conducted or initiateissued, any action to withdraw any Regulatory Authorizationrecall, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiatefield notifications, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiaryfield corrections, in each casewarning, which represented“dear doctor” letter, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinicalinvestigator notice, safety and alert or other studies and tests conducted by notice or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations action relating to an alleged lack of safety, efficacy or regulatory compliance of the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoCompany Product.
Appears in 2 contracts
Sources: Agreement and Plan of Merger (Sage Therapeutics, Inc.), Merger Agreement (Supernus Pharmaceuticals, Inc.)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(aExcept as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, (i) is a complete each of Parent and accurate list of its Subsidiaries holds (A) all material Regulatory Authorizations relating to authorizations under the Credit Parties and their SubsidiariesFDCA, the conduct of their businessPHSA, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by regulations of the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted LiensFDA promulgated thereunder, and (iiB) as applicable, validly registered and on file authorizations of any applicable Governmental Authority that are concerned with the applicable quality, identity, strength, purity, safety, efficacy, manufacturing, marketing, distribution, sale, pricing, import or export of any of the Parent Products (any such Governmental Authority, a “Parent Regulatory Agency”) necessary for the lawful operating of the businesses of Parent or any of its Subsidiaries as currently conducted (the “Parent Regulatory Permits”); (ii) all such Parent Regulatory Permits are valid and in full force and effect; and (iii) Parent and its Subsidiaries are in compliance with the terms of all filing and maintenance requirements (including any fee requirements) thereof, and Parent Regulatory Permits. All Parent Regulatory Permits are in good standingfull force and effect, valid except where the failure to be in full force and enforceable with effect has not had and would not reasonably be expected to have, individually or in the applicable Governmental Authority. All required noticesaggregate, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authoritiesa Parent Material Adverse Effect.
(b) (i) All regulatory filings required Neither Parent nor any of its Subsidiaries are party to any material corporate integrity agreements, monitoring agreements, consent decrees, settlement orders, or similar agreements with or imposed by any Parent Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory AuthorityAgency.
(c) The Credit PartiesAll pre-clinical and clinical investigations in respect of a Parent Product or Parent Product candidate conducted or sponsored by Parent or any of its Subsidiaries are being and, their Subsidiaries and the agents thereof are since January 1, 2017 have been, conducted in compliance in all material respects with all Applicable Laws administered or issued by the applicable statutes, rules and regulations (including all Healthcare Laws and Parent Regulatory Authorizations) of all applicable Governmental AuthoritiesAgencies, including (i) FDA standards for the FDA design, conduct, performance, monitoring, auditing, recording, analysis and all other Regulatory Authoritiesreporting of clinical trials contained in Title 21 parts 50, with respect 54, 56, 312, 314 and 320 of the Code of Federal Regulations and (ii) any applicable federal, state and provincial Applicable Laws restricting the collection, use and disclosure of individually identifiable health information and personal information, except, in each case, for such noncompliance that has not had and would not reasonably be expected to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth have, individually or in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related theretoaggregate, a Parent Material Adverse Effect.
(d) Except as set forth on Schedule 6.19(d)has not had and would not reasonably be expected to have, no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance individually or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable yeara Parent Material Adverse Effect, including any FDA Form 483 inspectional observationsduring the period beginning on January 1, notices of violations2017 and ending on the date hereof, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party neither Parent nor any of its Subsidiaries has received any written notification that remains unresolved notice from the FDA or the EMA or any foreign agency with jurisdiction over the development, marketing, labeling, sale, use handling and control, safety, efficacy, reliability, or manufacturing of the Parent Products which would reasonably be expected to lead to the denial, limitation, revocation, or rescission of any of the Parent Regulatory Permits or of any application for marketing approval currently pending before the FDA or such other Parent Regulatory Agency.
(e) During the period beginning on January 1, 2017 and ending on the date hereof, all reports, documents, claims, permits and notices required to be filed, maintained or furnished to the FDA or any other Parent Regulatory Authority indicating any breach Agency by Parent and its Subsidiaries have been so filed, maintained or violation of any applicable Regulatory Authorizationfurnished, including that any of the Products is misbranded except where failure to file, maintain or adulterated as defined in the FD&C Actfurnish such reports, in each case of the foregoingdocuments, which representedclaims, permits or notices have not had and would not reasonably be expected to have, individually or in the aggregate, 15% a Parent Material Adverse Effect. All such reports, documents, claims, permits and notices were true and complete in all material respects on the date filed (or more of Net Sales were corrected in any applicable year within the last five (5) years.
(e) No Credit Partyor supplemented by a subsequent filing). Since January 1, 2017, neither Parent nor any of its Subsidiaries, nor nor, to the knowledge of Parent, any officer, employee employee, agent or agent thereofdistributor of Parent or any of its Subsidiaries, has made an untrue statement of a material fact or a fraudulent statements statement to the FDA or any other Parent Regulatory AuthorityAgency, failed to disclose a material fact required to be disclosed to the FDA or any other Parent Regulatory AuthorityAgency, or committed an act, made a statement, or failed to make a statement statement, in each such case, related to the business of Parent or any of its Subsidiaries, that, at the time such disclosure was made (or was not made), could would reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for the FDA or any other Parent Regulatory Agency to invoke any similar policy, except for any act or statement or failure to make a statement that has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, since January 1, 2017, (i) neither Parent nor any of its Subsidiaries, nor, to the knowledge of Parent, any officer, employee, agent or distributor of Parent or any of its Subsidiaries, has been debarred or convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Applicable Law or authorized by 21 U.S.C. § 335a(b) or any similar Applicable Law applicable in other jurisdictions in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by Parent to be sold; and (ii) neither Parent nor any of its Subsidiaries, nor, to the knowledge of the Parent, any officer, employee, agent or distributor of Parent or any of its Subsidiaries, has been excluded from participation in any federal health care program or convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in any federal health care program under Section 1128 of the Social Security Act of 1935, as amended, or any similar Applicable Law or program.
(f) Except as set forth has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, as to each Parent Product or Parent Product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder or any similar Applicable Law in any foreign jurisdiction in which material quantities of any of the Parent Products or Parent Product candidates are sold or intended by Parent or any of its Subsidiaries to be sold that is or has been developed, manufactured, tested, distributed or marketed by or on Schedule 6.19(f)behalf of Parent or any of its Subsidiaries, each such Parent Product or Parent Product candidate is being or has been developed, manufactured, stored, distributed and marketed in compliance with all Applicable Laws, including those relating to investigational use, marketing approval, current good manufacturing practices, packaging, labeling, advertising, record keeping, reporting, and security. There is no Credit Party action or proceeding pending or, to the knowledge of Parent, threatened, including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall, in each case alleging any violation applicable to any Parent Product or Parent Product candidate by Parent or any of its Subsidiaries of any Applicable Law, except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(g) Except as has not had and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, during the period beginning on January 1, 2017 and ending on the date hereof, neither Parent nor any of its Subsidiaries have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any material recall, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, or other notice or action to wholesalers, distributors, retailers, healthcare professionals or patients relating to an alleged lack of safety, efficacy or regulatory compliance of any Parent Product. To the knowledge of Parent, there are no facts as of the date hereof which are reasonably likely to cause, and neither Parent nor any of its Subsidiaries has received any written notice that from the FDA or any other applicable Parent Regulatory Authority has commenced Agency during the period beginning on January 1, 2017 and ending on the date hereof regarding (i) the recall, market withdrawal or initiatedreplacement of any Parent Product sold or intended to be sold by Parent or its Subsidiaries (other than recalls, withdrawals or replacements that are not material to Parent and its Subsidiaries, taken as a whole), (ii) a material change in the marketing classification or a material change in the labeling of any such Parent Products, (iii) a termination or suspension of the manufacturing, marketing, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities distribution of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their SubsidiariesParent Products, or (iv) a material negative change in respect reimbursement status of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respectsa Parent Product.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.
Appears in 2 contracts
Sources: Merger Agreement (Celgene Corp /De/), Merger Agreement (Bristol Myers Squibb Co)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to Until the Credit Parties and their SubsidiariesFirst Closing Date, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are Seller shall be solely responsible for (i) legally taking all actions, paying all fees and beneficially owned exclusively conducting all communication with the appropriate Regulatory Authority required by Law in respect of Regulatory Approvals, including preparing and filing all reports (including adverse drug experience reports, product deviation reports, annual reports, with the Credit Parties appropriate Regulatory Authority), (ii) submitting all applications for marketing authorizations of new drugs, where such authorizations have not yet been granted, and their Subsidiaries, as applicable, free and clear variation of all Liens other than Permitted Liensexisting authorizations, and (iiiii) as applicable, validly registered investigating all complaints and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse drug experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authoritiessold pursuant to such Regulatory Approvals.
(b) Until the Second Closing Date, Seller shall be solely responsible for (i) All regulatory filings taking all actions, paying all fees and conducting all communication with the appropriate Regulatory Authority required by Law in respect of Regulatory Approvals solely for the PTB Indication, including preparing and filing all reports (including adverse drug experience reports, product deviation reports, annual reports, with the appropriate Regulatory Authority), (ii) submitting all applications for marketing authorizations of new drugs solely for the PTB Indication, where such authorizations have not yet been granted, and variation of existing authorizations, and (iii) investigating all complaints and adverse drug experiences with respect to Products sold pursuant to such Regulatory Approvals. The costs incurred by Seller for activities pursuant to this Section 8.5(b) shall constitute Development Costs of Seller subject to the Seller Development Costs Cap.
(c) From and after the First Closing, Buyer, at its cost shall be solely responsible for taking all actions and conducting all communication with third parties with respect to Products sold pursuant to such Regulatory Approvals (whether sold before or after transfer of such Regulatory Approval), including responding to all complaints in respect thereof, including complaints related to tampering, contamination, or counterfeiting.
(d) Seller shall provide Buyer with such data as is reasonably necessary to comply with Buyer’s reporting obligations for Best Price (as defined at 42 U.S.C. § 1396r-8(c)(1)(C)), Average Manufacturers Price (as defined at 42 U.S.C. § 1396r-8(k)(1)) and Average Sales Price (as defined at 42 U.S.C. § 1395w-3(a)(c)) for such period as is reasonably necessary, not to exceed one (1) year after the First Closing Date.
(e) From and after the First Closing Date, Buyer promptly (and in any event within the time periods required by Law) shall notify Seller within three (3) Business Days if Buyer receives a complaint or a report of an adverse drug experience with respect to Products. In addition, Buyer shall cooperate with Seller’s reasonable requests and use Commercially Reasonable Efforts to assist Seller in connection with the investigation of and response to any complaint or adverse drug experience related to Products sold by Buyer.
(f) From and after the First Closing Date, Buyer shall be responsible for (i) conducting all voluntary and mandatory recalls of units of Products sold pursuant to such Regulatory Approvals (whether sold before or after transfer of such Regulatory Approval), including recalls required by any Regulatory Authority or and recalls of units of Products sold by Seller deemed necessary by Seller in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulationsits reasonable discretion, (ii) conducting all clinical communications and pre-clinical trials, if any, of investigational Products have been and are being conducted by submitting all required reports to any Regulatory Authority concerning the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, recalls and (iii) notifying customers and consumers about the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related theretorecalls. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth Seller promptly shall notify Buyer in the FD&C Act or equivalent regulation event that a recall of each other Governmental Authority having jurisdiction over such PersonProducts sold by Seller is necessary. The Credit Parties Seller shall be responsible for all costs associated with recalls of Products sold prior to First Closing Date; provided, however, if Buyer and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Seller sell Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorizationsame lot, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to then Buyer and Seller shall be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis responsible for the FDA or any other Regulatory Authority cost of recalls of Products sold from such lot in proportion to invoke its policy respecting Fraud, Untrue Statements their pro-rata sales of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of from such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,lot.
(g) Except as set forth on Schedule 6.19(g)Seller and Buyer each agree to promptly prepare and file whatever filings, the clinical, preclinical, safety and other studies and tests conducted by requests or on behalf of applications are required or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance deemed advisable to be filed with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including Transactions and transfer and assumption of the Liens granted in connection herewith Regulatory Approvals and to cooperate with one another as reasonably necessary to accomplish the exercise of rights and remedies with respect theretoforegoing.
Appears in 2 contracts
Sources: Purchase and Collaboration Agreement (Watson Pharmaceuticals Inc), Purchase and Collaboration Agreement (Columbia Laboratories Inc)
Regulatory Matters. With respect the exception of the drug master file (or equivalent) for Licensed Vaccines and Licensed Products ("CureVac DMF") and all Manufacturing permits and authorizations necessary for the Manufacture of the Licensed Vaccines, BI shall be solely responsible for all regulatory matters including the filing for approvals to each Product:
(a) Set forth the Licensed Vaccines and Licensed Products in the Field. BI shall own, directly or through an Affiliate, all Regulatory Approvals. With the exception only of matters which require prompt attendance, CureVac shall have the right and the obligation to review and comment on Schedule 6.19(a) is a complete all regulatory filings inasmuch as they relate to the Licensed Vaccines and accurate list Licensed Products, and BI will take such comments into reasonable consideration. Furthermore, BI will provide copies of all regulatory approvals and material correspondence with Regulatory Authorizations Authorities in the Major Market Countries relating to the Credit Parties Clinical Trials with respect to Licensed Vaccines and their SubsidiariesLicensed Products to CureVac, and will reasonably consider a request by CureVac to participate in a meeting with Regulatory Authorities. Notwithstanding the conduct foregoing, CureVac shall have the right and the obligation to participate in a meeting with Regulatory Authorities if and to the extent such meeting relates to the CMC Development. For the avoidance of their businessdoubt, BI will have final say on all regulatory matters of the Licensed Vaccines, and the dispute resolution process laid down in Sections 8.5 and 8.6 of this Agreement does not apply. CureVac shall use Commercially Reasonable Efforts to support BI on all regulatory matters with respect to the Non-clinical and Clinical Development and Commercialization of the Licensed Vaccines and Licensed Products (on a per Product basis)and shall maintain all permits and authorizations necessary for the Manufacture of the Licensed Vaccines, including the CureVac DMF. All such material Regulatory Authorizations are CureVac shall use Commercially Reasonable Efforts to generate and provide to BI (i) legally CMC Development-related and beneficially owned exclusively by the Credit Parties Manufacturing-related documentation, data and their Subsidiariesreports, as applicable, free and clear of all Liens other than Permitted Liensincluding those listed in Exhibit 4.3, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) CMC Development-related technical and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Actassistance, in each case (i) and (ii) as reasonably required for obtaining Regulatory Approvals and for required interactions with Regulatory Authorities regarding the Licensed Vaccines, including scientific advices. In addition to the obligations under Section 10 below, BI shall ensure that such CMC Development- and/or Manufacturing-related documentation, data and reports are not circulated within Bl’s and Bl’s Affiliates’ organizations except as required for the purposes mentioned in the foregoing sentence. Each Party shall designate one or more individual(s) to facilitate the provision of the foregoingdocumentation, which representedmaterials, data and reports as described in this Section 4.3. To the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit extent required by a Party, nor a BI Affiliate or a CureVac Affiliate to achieve or maintain regulatory clinical trial and/or marketing application approvals or to comply with any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements related requests from regulatory authorities related to the FDA Licensed Vaccines, or, if so required by CureVac or by a CureVac Affiliate, to any RNA based product owned or in-licensed by CureVac or its Affiliate, the Parties shall authorize and hereby authorize each other or their respective Affiliate (but not licensees of the other Party) to cross reference to the sections of the IND/regulatory dossiers of the clinical trials related to vaccines or RNA based products Controlled by the other Party or its Affiliate and to any other Regulatory Authority, failed relevant regulatory filings and any other relevant documentation Controlled by the other Party or its Affiliate. The Parties shall inform each other in writing prior to disclose any such cross-referencing. BI shall consider in good faith any request by CureVac to authorize a material fact required future licensee of CureVac to be disclosed cross-reference to the FDA sections of the IND/regulatory dossiers of the Clinical Trials related to Licensed Vaccine or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 FedLicensed Product. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.EXCLUSIVE COLLABORATION AND LICENSE AGREEMENT CONFIDENTIAL
Appears in 2 contracts
Sources: Exclusive Collaboration and License Agreement (CureVac B.V.), Exclusive Collaboration and License Agreement (CureVac B.V.)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(aEach of the Company’s Subsidiaries that engages in the sale of electricity at wholesale (other than any such Subsidiaries that own one or more facilities that constitute a “qualifying facility” as such term is defined under PURPA and the rules and regulations of FERC that are entitled to exemption from regulation under Section 205 of the FPA) is regulated as a complete “public utility” under the FPA and accurate list has market-based rate authorization to make such sales at market-based rates. Each of all material Regulatory Authorizations relating to the Credit Parties Company’s Subsidiaries that directly owns generating facilities and operates their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, power generation facilities in compliance with all filing and maintenance requirements (including any fee requirements) thereofapplicable standards of NERC, and other than non-compliance that would not reasonably be expected to have, individually or in the aggregate, a material impact on the Company. There are in good standingno pending, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for Knowledge of the last five (5) years have been timely filed with Company, threatened, judicial or administrative proceedings to revoke a Company’s Subsidiary’s market-based rate authorization. To the FDA and all Knowledge of the Company, there are no facts that are reasonably likely to cause any of the Company’s Subsidiaries that sell electricity at wholesale to lose its market-based rate authorization, if applicable, other applicable Governmental Authoritiesthan where such loss would not reasonably be expected to have, individually or in the aggregate, a material impact on the Company.
(b) All filings (iother than immaterial filings) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted be made by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their complianceCompany, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development Company Joint Venture since January 1, 2009, with the FERC under the FPA, the NRC under the Atomic Energy Act, the Department of Energy and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to usestate public utility commissions, as the case may be, have been made, including all forms, statements, reports, agreements and all documents, exhibits, amendments and supplements appertaining thereto, including all rates, tariffs and related documents, and all such filings complied, as of their respective dates, with all applicable requirements of applicable statutes and the rules and regulations promulgated thereunder, except for filings the failure of which to make or the failure of which to make in compliance with all applicable requirements of applicable statutes and the rules and regulations promulgated thereunder, would not reasonably be expected to have, individually or in the aggregate, a material impact on the Company.
(c) Since January 1, 2008, neither the Company, any Regulatory Authorizations of its Subsidiaries nor CENG has received any written notice or, to the Company’s Knowledge, other communication from the NERC regarding any actual or possible material violation of, or material failure to comply with, any Law.
(d) This Section 4.13 excludes any representation or warranty by the Company or any of its Subsidiaries or any Company Joint Venture with respect to matters relating to the Products or arising under Environmental Laws or Hazardous Materials which are addressed in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoSection 4.8.
Appears in 2 contracts
Sources: Merger Agreement (Constellation Energy Group Inc), Merger Agreement (Exelon Corp)
Regulatory Matters. With respect to each Product:
(a) Set forth on Section 4.16(a) of the Parent Disclosure Schedule 6.19(alists each Parent Subsidiary that is subject to regulation by a state regulatory commission as a public utility or public service company (or similar designation) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products states where such Parent Subsidiary is subject to such regulation (on a per Product basisthe “Regulated Parent Subsidiaries”). All such material Regulatory Authorizations are Other than as set forth in Section 4.16(a) of the Parent Disclosure Schedule, as of the date hereof, neither Parent nor any Parent Subsidiary is subject to regulation as a public utility or public service company (ior similar designation) legally by any state in the U.S. or in any foreign country. No asset of Parent or any of the Regulated Parent Subsidiaries is currently disallowed from recovery in rates based on its value and beneficially owned exclusively by the Credit Parties and their Subsidiariesassociated expenses in any ratemaking procedure before any Applicable PSC, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities.
(b) All filings (iother than immaterial filings) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA made by Parent or any other Regulatory AuthorityParent Subsidiary since January 1, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in 2023 with any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety state public utility commissions and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to usestate Law, as the case may be, have been made, including all forms, statements, reports, agreements and all documents, exhibits, amendments and supplements appertaining thereto, including all rates, tariffs, franchises, service agreements, and related documents, and all such filings complied, as of their respective dates, with all applicable requirements of applicable Laws, except for filings the failure of which to make or the failure of which to make in compliance with all applicable requirements of applicable Laws, would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) Each of Parent and the Parent Subsidiaries, as applicable, is legally entitled to provide services in all areas (i) where it currently provides service to its customers and (ii) as identified in its respective Permits, in each case, except for failures to be so entitled that would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(d) As of the date hereof, neither Parent nor any Regulatory Authorizations relating Parent Subsidiary all or part of whose rates or services are regulated by a Governmental Entity (i) is a party to any rate proceeding before a Governmental Entity with respect to rates charged by Parent or any Parent Subsidiary other than in the ordinary course of business consistent with past practice, (ii) other than as set forth in Section 4.16(d) of the Parent Disclosure Schedule, has rates in any amounts that have been or are being collected subject to refund, pending final resolution of any rate proceeding pending before a Governmental Entity or on appeal to a court (other than rates based on estimated costs or revenues that are subject to adjustment once the actual costs or revenues become known) or (iii) is a party to any contract with any Governmental Entity entered into other than in the ordinary course of business consistent with past practice imposing conditions on rates or services in effect as of the date hereof or which, to the Products Knowledge of Parent, are as of the date hereof scheduled to go into effect at a later time, except, in any material mannerthe case of clauses (i) through (iii), and no consent that would not reasonably be expected to have, individually or other authorization of any Governmental Authority is required in connection with the transactions contemplated herebyaggregate, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoa Parent Material Adverse Effect.
Appears in 2 contracts
Sources: Merger Agreement (American Water Works Company, Inc.), Merger Agreement (Essential Utilities, Inc.)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to All Permits held by the Credit Parties and their Subsidiaries, the conduct of their business, Borrower and the Products (on a per Product basis). All such material Regulatory Authorizations Subsidiaries are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicableBorrower or such Subsidiary, free and clear of all Liens other than Permitted LiensLiens permitted pursuant to Section 8.3, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority, it being understood and agreed that, as of the Closing Date, the Borrower and its Subsidiaries do not have medical device clearances or approvals from the FDA for its LDTs. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities, except where the failure to file the same would not, whether individually or in the aggregate, reasonably be expected to have a Material Adverse Effect.
(b) Except in each case as would not reasonably be expected to have a Material Adverse Effect, since January 1, 2019, (i) All regulatory filings required by the Products, as well as the business of the Borrower and the Subsidiaries, comply with (A) all applicable Laws, including, without limitation, applicable requirements of CLIA and the FD&C Act (it being understood and agreed that, as of the Closing Date, the Borrower and its Subsidiaries do not have medical device clearances or approvals from the FDA for its LDTs), and (B) the terms of all Product Authorizations and other Permits; (ii) all laboratory testing services have been conducted in compliance with CLIA and all federal and state laws regarding laboratory testing services; (iii) all LDTs have been designed, developed, validated, and performed in compliance with CLIA, the FD&C Act, and all federal and state laws regarding laboratory testing services; (iv) none of the Borrower and the Subsidiaries, or, to the knowledge of the Borrower, their respective suppliers, have received any Regulatory Authority inspection reports, warning letters, untitled letters or in respect of any Regulatory Authorization similar documents with respect to any Product and/or with respect to the business of the Borrower and/or the Subsidiaries, from any Governmental Authority that assert lack of compliance with any applicable Laws (other than inspection reports that do not contain material findings or that have been remedied); (v) none of the Borrower or any of the Subsidiaries has received any written notice of, or otherwise have knowledge of, any pending regulatory enforcement action, investigation, or inquiry against the Borrower or any of the Subsidiaries or, to the knowledge of the Borrower, any of their respective suppliers, with respect to the Products; (vi) to the knowledge of the Borrower, there have been no Product Development recalls, safety alerts, withdrawals, clinical holds, marketing suspensions, removals, seizures, injunctions or the like conducted, undertaken or issued by any Person, whether or not at the request, demand or order of any Governmental Authority or otherwise, with respect to any Product nor, to the knowledge of the Borrower, has any such action been requested, demanded, or ordered by any Governmental Authority; (vii) to the knowledge of the Borrower, none of the Borrower or any of the Subsidiaries has received any written notice of (A) any criminal, injunctive, seizure, detention or civil penalty actions that have at any time been commenced or threatened in writing by any Governmental Authority with respect to or in connection with any Products, or (B) any consent decrees (including plea agreements) which relate to any Products; and Commercialization Activities which represented(viii) to the knowledge of the Borrower, in there is no basis for commencement of any criminal, injunctive, seizure, detention, or civil penalty actions by any Governmental Authority relating to the aggregateProducts or for issuance of any consent decrees. To the knowledge of the Borrower, 15% none of the Borrower or more any of Net Sales in the Subsidiaries is employing or utilizing the services of any individual who has been debarred or suspended under any applicable yearLaw since January 1, in the last five (5) years have 2019, other than, with respect to a Delayed Draw Closing Date, any employee or service provider that has been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted terminated by the Credit Parties and their Borrower reasonably promptly following the Borrower or its Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring becoming aware of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authoritysuspension or debarment.
(c) The Credit PartiesAs of the Closing Date (and, their except as would not reasonably be expected to result in a Material Adverse Effect, as of each Delayed Draw Closing Date), none of the Borrower or the Subsidiaries has received any written notice from, any Governmental Authority or an institutional review board or ethics committee alleging any material non-compliance with applicable laws or GCPs or otherwise requiring the termination or suspension any clinical trial (in-whole or in-part) conducted, or being conducted, by or on behalf of the Borrower and the agents thereof are Subsidiaries with respect to any Product. Except as would not reasonably be expected to have a Material Adverse Effect, no clinical trial conducted, or being conducted, by or on behalf of the Borrower, and/or the Subsidiaries with respect to any Product has used, or is using, any clinical investigator who has been disqualified from conducting clinical investigations by FDA or other Governmental Authority.
(d) Except in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authoritieseach case as would not reasonably be expected to have a Material Adverse Effect, with respect to the Products, since January 1, 2019: (i) all activities (including, without limitation, testing, validating, performing, marketing, sale, recordkeeping) by the Borrower or any of the Subsidiaries and, to the knowledge of the Borrower, their respective suppliers relating to the Products have been conducted, and are currently being conducted, in compliance with the applicable requirements of CLIA, the FD&C Act, other applicable requirements of Governmental Authorities, and (ii) none of the Borrower or any of the Subsidiaries, or, to the knowledge of the Borrower, any of their respective suppliers, has received written notice or threat of commencement of action by any Governmental Authority to withdraw its approval of any Product, to enjoin or prevent the performance of any LDT or otherwise prevent Borrower or any of its Subsidiaries from performing laboratory services, or to otherwise disrupt the business of the Borrower and the Subsidiaries, in each Product case, it being understood and agreed that, as of the Closing Date, the Borrower and its Subsidiaries do not have medical device clearances or approvals from the FDA for its LDTs.
(e) [Reserved].
(f) [Reserved].
(g) Except as would not have a Material Adverse Effect, all Product Development studies, tests and Commercialization Activities related thereto. The Credit Parties preclinical and their clinical trials relating to the Products conducted by or on behalf of the Borrower or any of the Subsidiaries have been conducted, and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are currently being conducted, in compliance in all material respects with all applicable registration Laws, including, but not limited to, applicable provisions of the CLIA and listing requirements set forth in the FD&C Act Act, including applicable GCPs and applicable GLPs, it being understood and agreed that, as of the Closing Date, the Borrower and its Subsidiaries do not have medical device clearances or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to approvals from the Products and all Product Development and Commercialization Activities related theretoFDA for its LDTs.
(dh) To the Borrower’s knowledge, there has been no untrue statement of fact and no fraudulent statement made by the Borrower or any of the Subsidiaries at the time such statements were made, or to the knowledge of the Borrower, any of their respective agents or representatives (when acting in such capacity) in any filing with the CMS, the FDA or any other Governmental Authority, and there has been no failure to disclose any fact required to be disclosed to any Regulatory Agency, in each case, except where the failure to do so would not reasonably be expected to result in a Material Adverse Effect.
(i) Except as set forth on Schedule 6.19(d6.18(i), no Credit Party nor any as of its the Closing Date (and, except as would not reasonably be expected to result in a Material Adverse Effect, as of each Delayed Draw Closing Date), the Borrower and the Subsidiaries has received from any Regulatory Authority any notice of alleged non-are in material compliance or adverse findings with respect to any Product or any Product Development federal and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable yearstate fraud and abuse laws, including any FDA Form 483 inspectional observationsthe federal Anti-Kickback Statute, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C False Claims Act, the Foreign Corrupt Practices Act, and similar applicable state, federal or any other similar communication from any Regulatory Authority within the last five (5) yearsforeign laws. Except as set forth on Schedule 6.19(d6.18(i), there have been no recallsfrom January 1, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements 2019 to the FDA or any other Regulatory AuthorityClosing Date (and, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was except as would not made), could reasonably be expected to provide result in a basis for Material Adverse Effect, from January 1, 2019 to each Delayed Draw Closing Date), none of the FDA Borrower or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its the Subsidiaries has received any written notice that from the FDA United States Department of Justice, any U.S. Attorney, any State Attorney General, or any other applicable Regulatory similar Governmental Authority has commenced or initiated, or threatened to commence or initiate, alleging any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) violation of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales laws in any material respect. The Borrower and its Subsidiaries have established and implemented a compliance program designed to ensure material compliance with federal and state fraud and abuse laws, including the federal Anti-Kickback Statute, the False Claims Act, the Foreign Corrupt Practices Act, and similar applicable year,state, federal or foreign laws.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(hj) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not materially impair any Credit Partythe Borrower’s or any of its the Subsidiaries’ ownership of or rights under (or the license or the other right to use, as the case may be) any Regulatory Authorizations Key Permits relating to the Products Products.
(k) [Reserved].
(l) Except as set forth on Schedule 6.18(l), since January 1, 2019, none of the Borrower or any of the Subsidiaries, nor, to the Borrower’s knowledge, any individual who is an officer, director, manager or employee of the Borrower or any of the Subsidiaries has been convicted of or, to the Borrower’s knowledge, charged with or investigated for any federal or state health program-related offense or any other offense related to healthcare or been excluded or suspended from participation in any material mannersuch program, and no consent or other authorization except, as of any Governmental Authority Delayed Draw Closing Date, for any such individuals who have been promptly terminated by the Borrower or its Subsidiaries following such conviction or charge or as would not reasonably be expected to result in a Material Adverse Effect. Except as set forth on Schedule 6.18(l), since January 1, 2019, none of the Borrower or any of the Subsidiaries, nor, to the Borrower’s knowledge, any individual who is required an officer or director of the Borrower or any of the Subsidiaries has been convicted of any crime that has resulted or would reasonably be expected to result in connection with a debarment or exclusion under (i) 21 U.S.C. Section 335a or (ii) any similar applicable Law, except, as of any Delayed Draw Closing Date, for any such individuals who have been promptly terminated by the transactions contemplated herebyBorrower or its Subsidiaries following such conviction or charge or as would not reasonably be expected to result in a Material Adverse Effect. Except as set forth on Schedule 6.18(l), including from January 1, 2019 through the Liens granted Closing Date (and, except as would not reasonably be expected to result in connection herewith and a Material Adverse Effect, from January 1, 2019 through each Delayed Draw Closing Date), no debarment proceedings or investigations in respect of the exercise business of rights and remedies with respect theretothe Borrower or any of the Subsidiaries are pending or, to the Borrower’s knowledge, threatened against the Borrower, any of the Subsidiaries or any individual who is an officer, director, manager or employee of the Borrower or any of the Subsidiaries.
Appears in 2 contracts
Sources: Credit Agreement (Caris Life Sciences, Inc.), Credit Agreement (Caris Life Sciences, Inc.)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(aEach of Mavericks’ Subsidiaries that engages in the sale of electricity at wholesale (other than any such Subsidiaries that exclusively own solely one or more facilities that constitute a “qualifying facility” as such term is defined under PURPA and that qualify for exemption from regulation under Section 205 of the FPA pursuant to the rules and regulations of FERC) is located within ERCOT and registered as a complete and accurate list “Power Generation Company” with the PUCT. Each of all material Regulatory Authorizations relating Mavericks’ Subsidiaries that directly owns generating facilities has obtained an order from the FERC finding it to be, or has self-certified itself to the Credit Parties FERC as, an “Exempt Wholesale Generator” under either PUHCA 1935 or PUHCA 2005 or has obtained an order from the FERC finding it to be, or has self-certified itself to the FERC as, or is entitled to exemption from regulation as, a qualifying facility under PURPA. Neither Mavericks nor any of its Subsidiaries are subject to the books and their Subsidiaries, records requirements of FERC under Part 366 of the conduct of their business, FERC’s Rules and the Products Regulations (on a per Product basis18 C.F.R. Part 366 (2009)). All such material Regulatory Authorizations There are (i) legally and beneficially owned exclusively by no pending or, to the Credit Parties and their SubsidiariesKnowledge of Mavericks, threatened judicial or administrative proceedings to revoke a Subsidiary’s “Exempt Wholesale Generator” status or qualifying facility status, as applicable. To the Knowledge of Mavericks, free and clear there are no events, facts or conditions that are reasonably likely to cause any of all Liens other than Permitted Liens, and (ii) Mavericks’ Subsidiaries that directly owns generating facilities to lose its status as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authoritiesan “Exempt Wholesale Generator” under PUHCA 2005.
(b) (i) All regulatory filings required to be made by any Regulatory Authority Mavericks or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any during the three (3) years preceding the date hereof with the FERC under the FPA or PUHCA 2005, the Department of Energy, the Nuclear Regulatory Authority any notice Commission (“NRC”) under the Atomic Energy Act of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five 1954 (5) years. Except as set forth on Schedule 6.19(d“AEA”), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA PUCT or any other applicable Regulatory Authority has commenced or initiatedstate public utility commissions, or threatened to commence with any governing ISO or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to useregional reliability entity, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, have been made, including all forms, statements, reports, agreements and all documents, exhibits, amendments and supplements appertaining thereto, including all rates, tariffs and related documents, and no consent all such filings complied, as of their respective dates, with all applicable requirements of applicable Law, except for filings the failure of which to make or other authorization the failure of which to make in compliance with all applicable Law, would not reasonably be expected to have, individually or in the aggregate, a Mavericks Material Adverse Effect.
(c) Except as would not reasonably be expected to have, individually or in the aggregate, a Mavericks Material Adverse Effect, (i) the operations of Comanche Peak by Mavericks and its Subsidiaries are, and since January 1, 2016, have been conducted, in compliance with all Mavericks Permits, including those Mavericks Permits providing for (A) the development and maintenance of emergency plans designed to respond to any unplanned releases of radioactive materials from Comanche Peak, (B) the handling and storage of spent nuclear fuel at Comanche Peak, (C) decommissioning planning for Comanche Peak, and (D) the maintenance of insurance against a nuclear incident, and (ii) (A) the operations of Comanche Peak are not the subject of any Governmental Authority outstanding notices of violation, any ongoing proceeding, heightened or additional inspections above the NRC baseline inspection program or requests for information from the NRC or any other agency with jurisdiction over such facility and (B) Comanche Peak is required not listed by the NRC in connection with the transactions contemplated hereby, including “unacceptable performance” column of the Liens granted in connection herewith and NRC Action Matrix as a part of the exercise NRC’s Assessment of rights and remedies with respect theretoLicensee Performance.
Appears in 2 contracts
Sources: Merger Agreement (Vistra Energy Corp), Merger Agreement (Dynegy Inc.)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(aThe Acquired Corporations have filed with the applicable regulatory authorities (including the FDA or any other Governmental Body performing functions similar to those performed by the FDA) is a complete all required material filings, declarations, listings, registrations, reports or submissions, including but not limited to adverse event reports and accurate list of all material Regulatory Authorizations relating aggregate safety reports that are required to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis)be filed. All such filings, declarations, listings, registrations, reports or submissions were in material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Lienscompliance with applicable Legal Requirements when filed, and (ii) as applicable, validly registered and on file with the no deficiencies have been asserted by any applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings Body with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authoritiesany such filings, declarations, listing, registrations, reports or submissions.
(b) Except as would not reasonably be expected to have a Material Adverse Effect, (i) All regulatory filings required all preclinical and clinical investigations sponsored by any Regulatory Authority or in respect the Acquired Corporations, and, to the Knowledge of any Regulatory Authorization the Company, all activities with respect to any Product the Acquired Corporations conducted by contract manufacturing organizations, contract research organizations or any Product Development and Commercialization Activities which representedother suppliers of the Acquired Corporations, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties in material compliance with applicable Legal Requirements, rules, regulations and their Subsidiaries in accordance with all applicable laws guidances, including Good Clinical Practices and current Good Manufacturing Practices requirements, Environmental Laws, other laws, rules and regulations along with appropriate monitoring relating to occupational safety and health, and federal and state laws, rules, regulations and guidances restricting the use and disclosure of clinical investigator trial sites for their complianceindividually identifiable health information, and (iiiii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives Knowledge of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit PartiesCompany, their Subsidiaries and all collaborators of the agents thereof Acquired Corporations are in compliance with applicable safety data reporting obligations and have provided the Acquired Corporations with material safety data and serious adverse events from collaborator studies. To the Knowledge of the Company, all safety data from collaborator studies is consistent in all material respects with all applicable statutes, rules the safety data made available to Parent and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related theretoPurchaser. The Credit Parties and their Subsidiaries Acquired Corporations have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has not received any written notification that remains unresolved notices or other correspondence from the FDA or any other Regulatory Authority indicating any breach foreign, federal, state or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded local governmental or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.regulatory authority performing functions
Appears in 2 contracts
Sources: Merger Agreement (Merck & Co., Inc.), Merger Agreement (Immune Design Corp.)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(aThe Company’s lixivaptan product candidate (“Lixivaptan”) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their businessbeing, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally at all times since January 1, 2007 has been, developed, tested, manufactured and beneficially owned exclusively by the Credit Parties and their Subsidiariesstored, as applicable, free in compliance in all material respects with the Federal Food, Drug and clear of all Liens other than Permitted LiensCosmetic Act (the “FDA Act”) and applicable regulations issued thereunder by the United States Food and Drug Administration (“FDA”), and (ii) including, as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance those requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect relating to the Products for the last five (5) years have been timely filed with the FDA FDA’s current good manufacturing practices, good laboratory practices and all other applicable Governmental Authoritiesgood clinical practices.
(b) The Company has made available to the Buyer as of the date of this Agreement a complete and correct copy of each New Drug Application (“NDA”) and each Investigational New Drug application (“IND”) submitted to the FDA with respect to Lixivaptan, including all supplements and amendments thereto. The Company has completed and analyzed all clinical investigations, preclinical investigations, and any other studies, analyses, or other work necessary to compile and submit the Lixivaptan NDA for substantive review by FDA. The Lixivaptan NDA is complete, accurate, and in compliance, in each case in all material respects, with all relevant provisions of the FDC Act and FDA regulations and guidances, including but not limited to the content and format requirements set forth at 21 C.F.R. sec. 314.50.
(c) The clinical trials conducted by the Company or any of its Subsidiaries with respect to Lixivaptan were conducted in all material respects in accordance with all applicable clinical trial protocols and applicable requirements of the FDA and any Institutional Review Board (“IRB”), including, as applicable, the FDA’s good clinical practices and good laboratory practices regulations.
(d) None of the Company nor any of its Subsidiaries is subject to any investigation that is pending and of which the Company or such Subsidiary has been notified in writing or, to the Company’s Knowledge, which has been threatened, in each case by (i) All regulatory filings required by the FDA or (ii) the Department of Health and Human Services Office of Inspector General or Department of Justice pursuant to the Federal Healthcare Program Anti-Kickback Statute (42 U.S.C. §1320a-7b(b) (known as the “Anti-Kickback Statute”) or the Federal False Claims Act (31 U.S.C. §3729).
(e) To the Company’s Knowledge, none of the Company nor any Regulatory Authority of its Subsidiaries has submitted any claim for payment to any government healthcare program in connection with any referrals related to Lixivaptan that violated in any material respect any applicable self-referral Law, including the Federal Ethics in Patient Referrals Act, 42 U.S.C. §1395nn (known as the “▇▇▇▇▇ Law”), or any applicable state self-referral law.
(f) To the Company’s Knowledge, none of the Company nor any of its Subsidiaries has submitted any claim for payment to any government healthcare program related to Lixivaptan in respect material violation of any Regulatory Authorization with respect laws relating to any Product false claim or fraud, including the Federal False Claim Act, 31 U.S.C. § 3729, or any Product Development applicable state false claim or fraud law.
(g) The Company and Commercialization Activities which represented, in the aggregate, 15% or more each of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have its Subsidiaries has complied in all material respects with all applicable laws security and regulationsprivacy standards regarding protected health information under (i) the Health Insurance Portability and Accountability Act of 1996, including the regulations promulgated thereunder (collectively “HIPAA”) and (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,state privacy laws.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.
Appears in 2 contracts
Sources: Merger Agreement (Centessa Pharmaceuticals LTD), Merger Agreement (Cornerstone Therapeutics Inc)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their businessEach Acquired Corporation is, and since the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental AuthorityApplicable Date has been, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all Health Care Laws, in each case as applicable laws and regulationsto the operation of its business. Since the Applicable Date, no Acquired Corporation, nor, to the knowledge of the Company, any third parties that have performed or are performing any development, collaboration, manufacturing, testing, quality control, batch release, distribution or shipment activities on behalf of an Acquired Corporation or with respect to a Product Candidate, including any CMO, CRO, Clinical Trial site or investigator, while acting in such capacity (each, a “Collaboration Partner”) (i) has been subject to any enforcement, regulatory or administrative proceedings alleging non-compliance with any Health Care Laws; (ii) all clinical and pre-clinical trialshas received written notice threatening any such enforcement, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and regulatory or administrative proceeding; or (iii) has been issued a FDA Form 483, warning letter, notice of violation of Health Care Laws, or similar correspondence from any Governmental Body, except where any such issuance or violation would not be reasonably expected, individually or in the Credit Parties and their Subsidiaries have disclosed aggregate, to be material to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory AuthorityAcquired Corporations taken as a whole.
(cb) Since the Applicable Date, the Acquired Corporations have held all Regulatory Permits required for their business as then-conducted, and each Regulatory Permit required for their business as currently conducted is valid and in in full force and effect. The Credit Parties, their Subsidiaries and the agents thereof Acquired Corporations are in compliance in all material respects with all applicable statutesthe terms and requirements of such Regulatory Permits. Since the Applicable Date, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all no deficiencies have been asserted in writing by any applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings Body with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 Regulatory Permits of the FD&C ActAcquired Corporations. None of the Acquired Corporations has received written notice that any material Regulatory Permit will not or is likely not to be issued.
(c) To the knowledge of the Company, all preclinical and clinical investigations, studies, or any other similar communication from any Regulatory Authority within trials (“Clinical Trials”) sponsored or conducted by or on behalf of the last five (5) years. Except as set forth on Schedule 6.19(d), there Acquired Corporations have been no recallsand are being conducted in material compliance with applicable Health Care Laws and Data Privacy Laws. No Acquired Corporation, market withdrawalsnor, field notifications or correctionsto the knowledge of the Company, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiariestheir Collaboration Partners or other Persons acting directly on their behalf, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved notice or other correspondence from the FDA or any other Regulatory Authority indicating Governmental Body performing functions similar to those performed by the FDA with respect to any breach ongoing Clinical Trial requiring or violation recommending a clinical hold, or the termination, suspension or material modification of any applicable Regulatory Authorizationsuch Clinical Trials.
(d) The Acquired Corporations have filed with the FDA or any other Governmental Body performing functions similar to those performed by the FDA all required material filings, declarations, listings, registrations, reports or submissions, including that but not limited to adverse event reports, and any of the Products is misbranded required updates, corrections or adulterated as defined in the FD&C Act, in modifications to each case of the foregoing. All such filings, which representeddeclarations, listings, registrations, reports or submissions were in the aggregatematerial compliance with applicable Health Care Laws when filed, 15% or more of Net Sales and no deficiencies have been asserted in writing by any applicable year within the last five (5) yearsGovernmental Body with respect thereto.
(e) No Credit PartyTo the knowledge of the Company, nor no Acquired Corporation, nor, to the knowledge of the Company, any of Collaboration Partner or other Person acting directly on its Subsidiaries, nor any officer, employee or agent thereof, behalf has (i) made an untrue statement of a material fact or fraudulent statements statement to the FDA or any other Regulatory AuthorityGovernmental Body, (ii) failed to disclose a material fact required to be disclosed to the FDA or (iii) committed any other Regulatory Authority, or committed an act, made a statement, any statement or failed to make any statement, that (in any such case) establishes a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a reasonable basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery Bribery, and Illegal GratuitiesGratuities Final Policy or for any Governmental Body to invoke a similar policy that may be applicable in another jurisdiction to an Acquired Corporation. No Acquired Corporation is the subject of any pending or, set forth to the knowledge of the Company, threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. No Acquired Corporation nor, to the knowledge of the Company, any Collaboration Partner, officer, employee, agent or other Person acting on behalf of any Acquired Corporation has been debarred or disqualified, excluded from participation in 56 Fed. Reg. 46191 federal healthcare programs or convicted of any crime or engaged in any conduct that would reasonably be expected to result in (September 10, 1991A) debarment under 21 U.S.C. § 335a or any similar policyLegal Requirement, (B) exclusion under 42 U.S.C. § 1320a-7 or any similar Legal Requirement, or (C) disqualification pursuant to 21 CFR Part 312.70 or any similar Legal Requirement.
(f) Except as set forth on Schedule 6.19(f)Since the Applicable Date, no Credit Party nor any of its Subsidiaries has the Acquired Corporations have not received any written notice from a Governmental Body that any of their products are misbranded as defined in 21 U.S.C. § 352 or adulterated as defined in 21 U.S.C. § 351, as amended, and the FDA or any other applicable Regulatory Authority has commenced or initiatedrules and regulations promulgated thereunder, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, as defined in each case, which represented, in the aggregate, 15% or more of Net Sales comparable Legal Requirements in any applicable year,jurisdiction.
(g) Except as set forth on Schedule 6.19(g)has not had, and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, the clinicalAcquired Corporations and, preclinicalto the knowledge of the Company, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their SubsidiariesCollaboration Partners, or other Persons acting directly on their behalf have prepared, submitted and implemented timely responses and, as applicable, any corrective action plans required to be prepared and submitted in respect response to all internal or third-party audits, inspections, investigations or examinations of which any Products or the Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (Candidates or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoAcquired Corporation’s business.
Appears in 2 contracts
Sources: Acquisition Agreement, Merger Agreement (IVERIC Bio, Inc.)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) Each of the Company’s Subsidiaries that engages in the sale of electricity at wholesale is regulated as a complete “public utility” under the FPA and accurate list of all material Regulatory Authorizations relating has been authorized by the FERC, pursuant to the Credit Parties FPA, to make such sales at market-based rates. Each of the Company’s Subsidiaries that directly owns generating facilities has obtained an order from the FERC finding it to be, or has self-certified itself to the FERC as, an Exempt Wholesale Generator under the Public Utility Holding Company Act of 2005 (“PUHCA”) and their Subsidiaries, pursuant to Part 366 of the conduct of their business, FERC’s Rules and the Products Regulations (on a per Product basis18 C.F.R. Part 366 (2009)). All such material Regulatory Authorizations There are (i) legally and beneficially owned exclusively by no pending, or to the Credit Parties and their Subsidiariesknowledge of the Company, threatened, judicial or administrative proceedings to revoke a Subsidiary’s market-based rate authorization or Exempt Wholesale Generator status, as applicable. To the knowledge of the Company, free and clear there are no facts that are reasonably likely to cause any of all Liens other than Permitted Liensthe Company’s Subsidiaries that sell electricity at wholesale to lose its market-based rate authorization or any of the Company’s Subsidiaries that directly owns generating facilities to lose its status as an Exempt Wholesale Generator under PUHCA. Neither the Company nor any of its Subsidiaries owns, and (ii) as applicabledirectly or indirectly, validly registered and on file with the applicable Governmental Authority, any interest in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications nuclear generation station or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences manages or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authoritiesoperates any nuclear generation station.
(b) All filings (iother than immaterial filings) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted be made by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act Company or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice during the three years preceding the date hereof, with the FERC under the FPA, the Public Utility Holding Company Act of alleged non-compliance 1935 or adverse findings with respect to any Product PUHCA, the Department of Energy or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to usestate public utility commissions, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, have been made, including all forms, statements, reports, agreements and all documents, exhibits, amendments and supplements appertaining thereto, including all rates, tariffs and related documents, and no consent or other authorization all such filings complied, as of any Governmental Authority is required in connection their respective dates, with the transactions contemplated hereby, including the Liens granted in connection herewith all applicable requirements of applicable statutes and the exercise rules and regulations promulgated thereunder, except for filings the failure of rights which to make or the failure of which to make in compliance with all applicable requirements of applicable statutes and remedies with respect theretothe rules and regulations promulgated thereunder, would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
Appears in 2 contracts
Sources: Merger Agreement (Mirant Corp), Merger Agreement (Rri Energy Inc)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) is a complete At all times during the Term, LL shall maintain the production facility, equipment and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiariesprocesses (including, without limitation, the conduct of their business, process used in producing the Product and the Products (on a per Product basis). All such material Regulatory Authorizations are (iin performing LL’s other obligations under this Agreement) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with this Agreement, the Quality Agreement and all filing and maintenance requirements Applicable Laws (including any fee requirements) thereofincluding, and are in good standingwithout limitation, valid and enforceable with cGMP, the applicable Governmental Authority. All required noticesFDA and, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products extent applicable, the EMA guidelines, employment and labor law requirements, electrical, fire and safety at work codes and regulations and guidelines issued by any applicable Drug Regulatory Authorities in the Territory). LL shall make available for inspection, upon the last five (5) years have been timely filed with the FDA and request of Cadence, all other applicable Governmental Authoritiesdocumentation relating to such compliance.
(b) (i) All regulatory filings required LL shall permit representatives of Cadence to conduct inspections from time to time at all Facilities utilized by any Regulatory Authority or in respect of any Regulatory Authorization with respect LL and its Affiliates hereunder to any Product or any Product Development and Commercialization Activities which representedmanufacture the Product, as agreed between the Parties in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory AuthorityQuality Agreement.
(c) The Credit PartiesIf either Party is notified that the Product manufactured at the Facility or the Facility will be subject to an inspection by FDA or any other Drug Regulatory Authority, their Subsidiaries such Party shall as soon as possible notify the other Party by telephone and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) e-mail of its receipt of such notification. LL shall provide Cadence copies of all applicable Governmental AuthoritiesDrug Regulatory Authority-issued inspection observation reports (including, including the FDA without limitation, Form 483s and all equivalent forms from other Drug Regulatory Authorities) and correspondence, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation purged only of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect confidential information that is unrelated to the Products Product. LL shall permit Cadence’s quality assurance representative to be present at the Facility during any such inspection by FDA or any other Drug Regulatory Authority that relates to the Product or LL’s performance under this Agreement, provided, however, that Cadence shall only have access to or communicate with the inspectors during the facility inspection as permitted under the Quality Agreement. LL will also notify Cadence as soon as possible of LL’s receipt of any other Form 483’s or warning letters or any other significant regulatory action which LL’s quality assurance group determines could impact the regulatory status of the Product. LL and all Cadence will cooperate in resolving any concerns with any Drug Regulatory Authority, and Cadence may review LL’s responses to any such reports and communications. LL will in its reasonable discretion incorporate into such responses any comments received from Cadence. LL will also inform Cadence of any action taken by any Drug Regulatory Authority against LL or any of its officers or employees which may be reasonably expected to adversely affect the Product Development and Commercialization Activities related theretoor LL’s ability to supply the Product hereunder within [***].
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor LL hereby grants Cadence the right to reference any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any drug master file regarding the Product or similar regulatory filing in the Territory that may now exist, or that may exist at any Product Development and Commercialization Activities related thereto which representedtime during the Supply Term or any extension thereof, in the aggregate, 15% any and all regulatory or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has filings made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of Cadence, its Affiliates or sponsored by sublicensees. Upon the Credit Parties and their Subsidiariesrequest of Cadence, or in respect LL shall provide Cadence with a letter evidencing such right of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respectsreference.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.
Appears in 2 contracts
Sources: Supply Agreement (Cadence Pharmaceuticals Inc), Supply Agreement (Cadence Pharmaceuticals Inc)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance 4.1 Company shall comply with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed in relation to the Agent all such regulatory filings manufacturing and all material communications between representatives handling of the Credit Parties (Product in the Territory and their Subsidiaries) and in any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and country outside the agents thereof are in compliance in all material respects Territory where Company manufactures Product or has Product manufactured on its behalf. Distributor shall comply with all applicable statutes, rules regulations and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain laws in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect relation to the Products handling, storage, distribution and all sale of the Product Development in those areas of the Territory where the Product is distributed and Commercialization Activities related theretosold by Distributor.
4.2 Each Party will report to the other all adverse events (d) Except as set forth on Schedule 6.19(dhereinafter called "AE"), no Credit Party nor any of customer complaints, technical or quality-related incidents and/or issues, which come to its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect attention relating to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable yearProduct, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, that come to a Party's attention through publications in journals or other media. Each party shall report any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, serious adverse events relating to any Products which representedProduct, in within 48 hours of receipt, to the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) yearsother.
4.3 Distributor shall be responsible for preparing and submitting medical device reports (e"MDRs") No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required responsible national governmental authorities in the Territory. Company shall review and evaluate all Product complaints forwarded by Distributor. If Distributor believes that an MDR report needs to be disclosed filed, Company shall fully investigate the complaint and shall provide all information necessary to Distributor for Distributor to file the MDR report. With respect to adverse events and the like occurring with the Product outside the [*]CONFIDENTIAL TREATMENT REQUESTED 7 CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION CONFIDENTIAL DOCUMENT Territory, Company shall provide to Distributor all information relating to such complaints that may be or are subject to the FDA's reporting MDR requirements. Distributor shall evaluate this information and shall determine whether an MDR should be submitted. Company shall evaluate such events in relation to the standard operating procedures of Distributor's that will be adopted by Distributor and agreed upon by the parties. Company shall designate Distributor as agent to the FDA for these reporting purposes.
4.4 Within 15 days of the Effective Date of this Agreement, Company shall provide Distributor with copies of all documents relating to or constituting Company's 510(k) filing with the FDA.
4.5 Company agrees that it will not modify the Present Product or any other Regulatory AuthorityProduct whose specifications have been agreed upon by the Parties without prior notification to and approval by Distributor (which approval shall not be unreasonably withheld) so that Distributor can ascertain whether Distributor will need to file any additional Rule 510(k) filings.
4.6 Company will register as the Product manufacturer with the FDA. Distributor will list Product with FDA as approved for marketing.
4.7 Each Party will maintain such records and procedures to ensure that any batch of Products can be effectively and completely recalled from the market in the event that such action is required.
4.8 If, for any reason, it shall become necessary to trace back or recall any particular lot of the Product, or committed to identify the customer or customers to whom units from such lot will have been delivered, each party shall co-operate fully with the other in doing so. In the event that either Party has reason to believe that one or more lots of the Product should be recalled or withdrawn from distribution in the Territory, such Party shall immediately notify the other Party in writing. To the extent permitted by the circumstances, the Parties will confer before initiating any recall, but the decision as to whether or not to initiate a recall of the Product and to notify regulatory authorities in the Territory shall be Distributor's alone. If the recall is required because of a modification or withdrawal of an actapproval from a competent regulatory authority or a failure of the Product to conform to its Specifications, made a statementCompany shall promptly reimburse Distributor for the reasonable costs and expenses of such recall, and, at Distributor's option, Company shall replace the recalled Product free of additional charge, or failed credit or refund the Purchase Price of the recalled Product. If the recall is required because of a negligent act or omission of Distributor in handling, storage or distribution of the Product, then such recall shall be conducted by Distributor at its sole cost and expense and Distributor shall not be entitled to any such credits, replacements or refunds from Company. If such recall is required because of a joint act or omission of the Parties, Distributor shall conduct the recall, the Parties shall divide the cost of such a recall, and any replacement Product required by Distributor shall be provided by the Company to the Distributor at cost.
4.9 Each Party shall furthermore notify the other immediately of any information that it receives regarding any threatened or pending action by any Regulatory Authority which may affect the safety or efficacy claims of the Product within the Territory or the continued marketing of same. Upon receipt of any such information, the Parties shall consult with each other in an effort to arrive at a mutually acceptable procedure for taking appropriate action; provided, however, that nothing contained herein shall be construed as restricting either Party's right to [*]CONFIDENTIAL TREATMENT REQUESTED 8 CONFIDENTIAL PORTION OMITTED AND FILED SEPARATELY WITH THE COMMISSION make a statement that, at timely report of such matter to any Regulatory Authority in the time such disclosure was made (Territory or was not made), could reasonably be expected to take any further action that either Party deems appropriate or is required by applicable law or regulation.
4.10 Distributor will provide a basis for medical information service concerning the FDA or any other Regulatory Authority Products to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery the health professionals and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, patients in the aggregate, 15% or more of Net Sales in any applicable year,Territory.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.
Appears in 2 contracts
Sources: Distribution Agreement (Osi Pharmaceuticals Inc), Distribution Agreement (Cell Pathways Inc /De)
Regulatory Matters. With respect 5. 1Regulatory Activities by PTC. 5.1.1Subject to each Product:
(a) Set forth on Schedule 6.19(a) is a complete this Section 5.1.1 and accurate list of Section 3.5.5, PTC shall have the responsibility to maintain all material Regulatory Authorizations relating INDs necessary to perform the Credit Parties and their Subsidiaries, Ongoing Clinical Trial Activities under the conduct of their businessDevelopment Plan, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file to conduct communications with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to such Regulatory Documentation. All Regulatory Documentation to be submitted to a Regulatory Authority in connection with Ongoing Clinical Trial Activities shall be submitted to Licensee for its review and comment at least [***] (unless an earlier response is required by the Products applicable Regulatory Authority, in which case the Parties shall work in good faith to provide a response within such timeframe) prior to their submission to the applicable Regulatory Authority. PTC shall, and all Product Development shall cause its Affiliates to, consider in good faith and Commercialization Activities related theretoincorporate any such comments of Licensee into such Regulatory Documentation. PTC shall provide Licensee with a copy of such Regulatory Documentation promptly following submission to the applicable Regulatory Authority.
5.1. 2Notwithstanding any other provision of this Agreement, without Licensee’s prior written consent, neither PTC nor its Affiliates shall submit or file any Regulatory Documentation or otherwise communicate with any Regulatory Authority regarding Licensed Compounds or Licensed Products or the Exploitation thereof (dincluding any Clinical Trial) Except other than as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged nonin Section 5.1.1. PTC and Licensee shall jointly prepare the briefing book for the end-compliance or adverse findings of-Phase II Clinical Trial meeting with the FDA in respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, Ongoing Phase 2A Clinical Trial.
5.1. 3PTC shall provide Licensee with: (i) access to or any other similar communication from any Regulatory Authority within copies of all material written or electronic correspondence relating to the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened Ongoing Clinical Trial Activities received by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party PTC or any of its SubsidiariesAffiliates or subcontractors from Regulatory Authorities; and (ii) copies of all meeting minutes and summaries of all meetings, relating to any Products which representedconferences, in the aggregate, 15% and discussions held by PTC or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from Affiliates or subcontractors with the FDA Regulatory Authorities, including copies of all contact reports produced by PTC or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Actits Affiliates, in each case ((i) and (ii)), within [***] of their receipt or production of the foregoing, which representedas applicable. If such written or electronic correspondence received from any such Regulatory Authority relates to the withdrawal, in suspension, or revocation of a Regulatory Approval for a Licensed Compound or Licensed Product, the aggregateprohibition or suspension of the supply of a Licensed Compound or Licensed Product, 15% or more the initiation of Net Sales in any applicable year within investigation, review, or inquiry by such Regulatory Authority concerning the last five (5) yearssafety of a Licensed Compound or Licensed Product, PTC shall notify Licensee and provide Licensee with copies of such written or electronic correspondence as soon as practicable, but not later than [***] after receipt of such correspondence.
5.1. 4PTC shall provide Licensee with prior written notice of any meeting, conference, or discussion (eincluding any advisory committee meeting) No Credit Partywith a Regulatory Authority relating to a Licensed Compound or Licensed Product within [***] after PTC or its Affiliates first receives notice of the scheduling of such meeting, nor any conference, or discussion (or within such shorter period as may be necessary in order to give Licensee a reasonable opportunity to attend such meeting, conference, or discussion). To the extent permitted by the Regulatory Authority, Licensee shall have the right to have up to [***] of its Subsidiariesemployees or agents attend all such meetings, nor conferences or discussions. Licensee shall have the right to replace or temporarily substitute any officer, such employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policysole discretion.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.
Appears in 1 contract
Sources: License and Collaboration Agreement (PTC Therapeutics, Inc.)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) is a complete 2.10.1 The Company and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof Forefront are in compliance in all material respects with all applicable statutes, rules and regulations of the U.S. Food and Drug Administration or similar federal, state or local governmental authority (including all Healthcare Laws the “FDA”) or similar foreign governmental authority (“Foreign Authorities”), the Centers for Disease Control and Regulatory Authorizations) Prevention, the Department of all applicable Governmental Authorities, including Agriculture and the FDA and all other Regulatory Authorities, Department of Commerce with respect to each Product the collection, sale, labeling, storing, testing, distribution, or marketing of the products being distributed or developed by or on behalf of the Company and all Product Development and Commercialization Activities related theretoForefront. The Credit Parties Company has previously delivered or made available to the Buyer an index of all applications, approvals, registrations or licenses obtained by the Company and their Subsidiaries Forefront from the FDA, Foreign Authorities, the Centers for Disease Control and Prevention, the Department of Agriculture or the Department of Commerce or required in connection with the conduct of the business of the Company and Forefront as it is currently conducted and has made all such information available to the Buyer.
2.10.2 All test methods being developed or distributed by the Company and Forefront that are subject to the jurisdiction of the FDA, the Centers for Disease Control and Prevention, or similar federal, state or local government authorities have been and maintain in full force are being developed, tested, labeled, distributed and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are marketed in compliance in all material respects with all applicable registration statutory or regulatory requirements under the Clinical Laboratory Improvement Act of 1988 and listing requirements set forth in its implementing regulations.
2.10.3 The Company has made available to the FD&C Act Buyer all written communications and oral communications to the extent reduced to written form between the Company or equivalent regulation of each Forefront, on the one hand, and the FDA or Foreign Authorities on the other Governmental Authority having jurisdiction over such Person. The Credit Parties hand, dated from August 1, 1998 for the Company, and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities from November 19, 2001, for Forefront, through the date hereof with respect to the Products Company, Forefront or their respective products. The Company shall promptly deliver or make available to the Buyer copies of all written communications and information and records regarding all Product Development oral communications reduced to written form, between the Company or Forefront, on the one hand, and Commercialization Activities related theretothe FDA or Foreign Authorities on the other hand, with respect to the Company, Forefront or any of their products from the date hereof through, and to the extent relevant to the business of the Company and Forefront, after, the Closing. Except as described in Schedule 2.10, neither the Company nor Forefront is in receipt of notice of, and, to the knowledge of the Company and the Shareholder, subject to, any adverse inspection, finding of deficiency, finding of non-compliance, compelled or voluntary recall, investigation, penalty for corrective or remedial action or other compliance or enforcement action, in each case relating to any of its products or to the facilities in which its products are manufactured, collected or handled, by the FDA or Foreign Authorities.
(d) 2.10.4 Except as set forth on Schedule 6.19(d)2.10, there are no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect pending or, to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 knowledge of the FD&C ActCompany and the Shareholder, threatened actions, proceedings or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened complaints by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or Foreign Authorities which would prohibit or impede the conduct of the business of the Company or Forefront as it is currently conducted.
2.10.5 The Company and Forefront have not made any material false statements on, or omissions from, the applications, approvals, reports and other Regulatory Authority submissions to the FDA or Foreign Authorities prepared or maintained to comply with the requirements of the FDA or Foreign Authorities relating to the Company, Forefront or their respective products.
2.10.6 The Company and Forefront have not received any notification, written or oral, that remains unresolved, from Foreign Authorities, the FDA or other authorities indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products Company’s or Forefront’s products is misbranded or adulterated as defined in the FD&C U.S. Food, Drug & Cosmetic Act, in each case 21 U.S.C. 321, et seq., as amended, and the rules and regulations promulgated thereunder.
2.10.7 Except as set forth on Schedule 2.10, no product of the foregoingCompany or Forefront has been recalled, which represented, in the aggregate, 15% suspended or more discontinued as a result of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to action by the FDA or any other Regulatory AuthorityForeign Authority against the Company or Forefront or, failed to disclose a material fact required to be disclosed to the FDA knowledge of the Company and the Shareholder, any licensee, distributor or marketer of any other Regulatory Authorityproduct of the Company or Forefront, in the United States or outside of the United States.
2.10.8 Neither the Company nor Forefront has committed an any act, made a statement, any statement or failed to make a any statement that, at the time such disclosure was made (or was not made), could that would reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting with respect to “Fraud, Untrue Statements of Material Facts, Bribery Bribery, and Illegal Gratuities, ” set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. Neither the Company, Forefront, nor to the knowledge of the Company and the Shareholder, any officer, key employee or agent of the Company or Forefront has been convicted of any crime or engaged in any conduct that would reasonably be expected to result in (i) debarment under 21 U.S.C. Section 335a or any similar policy.
state law or regulation or (fii) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA exclusion under 42 U.S.C. Section 1320a-7 or any other applicable Regulatory Authority has commenced similar state law or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,regulation.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.
Appears in 1 contract
Sources: Stock Purchase Agreement (Inverness Medical Innovations Inc)
Regulatory Matters. With respect to each Product:
(a) Set Section 3.16(a) of the Company Disclosure Letter sets forth on Schedule 6.19(a) is a true and complete list, as of the date of this Agreement, and accurate list of the Company has made available to Parent true and complete copies of, all Regulatory Authorizations from the FDA and the EMA and all material Regulatory Authorizations from any other applicable Regulatory Authorities held by the Company or the Company Subsidiary relating to the Credit Parties and their Subsidiaries, Company Products and/or necessary to conduct the conduct of their business, and the Products (on a per Product basis)Company’s business as presently conducted. All such material Regulatory Authorizations are (i) legally in full force and beneficially owned exclusively by the Credit Parties and their Subsidiarieseffect, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental AuthorityRegulatory Authorities, (iii) in compliance with all formal filing and maintenance requirements and (including any fee requirementsiv) thereof, and are in good standing, valid and enforceable enforceable. Each of the Company and the Company Subsidiary have fulfilled and performed all of its material obligations with respect to such Regulatory Authorizations, and no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof. Except as would not reasonably be expected to, individually or in the aggregate, have a Company Material Adverse Effect, (x) the Company and the Company Subsidiary have filed, maintained or furnished with the applicable Governmental Authority. All Regulatory Authorities all required filings, declarations, listings, registrations, submissions, amendments, modifications, notices and responses to notices, registrations applications and listings, supplemental applications or notificationsapplications, reports (including field alerts, medical device reports (MDRsall adverse event/experience reports) and other reports of adverse experiences or product malfunctionsinformation (collectively, and reports of corrections or removalthe “Health Care Submissions”) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA FDA, EMA and all other applicable Governmental AuthoritiesRegulatory Authorities and (y) all such Health Care Submissions were complete and accurate and in compliance with applicable Health Laws when filed (or were corrected or completed in a subsequent filing).
(b) (i) All regulatory filings required by The Company and the Company Subsidiary are in material compliance with all applicable Health Laws that affect the business, Company Products, properties, assets and activities of the Company, (ii) as of the date of this Agreement, neither the Company nor the Company Subsidiary has received any written notice or other communication from any Regulatory Authority (A) withdrawing or in respect placing any clinical studies of the Company Products on “clinical hold” or requiring the termination or suspension or investigation of any Regulatory Authorization pre-clinical studies or clinical trials of the Company Products or (B) alleging any material violation of any Health Law and (iii) there are no investigations, suits, claims, actions or proceedings pending, or to the knowledge of the Company, threatened against the Company or the Company Subsidiary with respect to any Product of the Company Products or alleging any Product Development and Commercialization Activities which representedviolation by the Company, in the aggregate, 15% Company Subsidiary or more the Company Products of Net Sales in any applicable year, in the last five such Health Law.
(5c) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and All pre-clinical trials, if any, studies and clinical trials conducted or being conducted with respect to the Company Products by or at the direction of investigational Products the Company have been and are being conducted by in material compliance with the Credit Parties required experimental protocols, procedures and their Subsidiaries in accordance with controls, and all applicable laws Laws, including the FDCA and its applicable implementing regulations along with appropriate monitoring at 21 C.F.R. Parts 50, 54, 56, 58 and 312, all applicable requirements of Good Laboratory Practices and Good Clinical Practices and any other applicable regulations that relate to the proper conduct of clinical investigator trial sites for their compliance, studies and (iii) the Credit Parties and their Subsidiaries have disclosed requirements relating to the Agent protection of human subjects and applicable Laws, including applicable Health Laws, governing the privacy of patient medical records and other personal information and data. No clinical trial conducted by or, on behalf of, the Company has been terminated or suspended by any Regulatory Authority. Neither the Company nor the Company Subsidiary has received any written notifications or other written communications from any institutional review board, ethics committee or safety monitoring committee raising any material issues, including from any Regulatory Authority in any jurisdiction that requires or would require the termination or suspension or investigation, or place a clinical hold order on or otherwise delay or restrict, in each case, in any material respect, any clinical studies proposed or currently conducted by, or on behalf of, the Company, or in which the Company or the Company Subsidiary has participated and, to knowledge of the Company, no such action has been threatened against the Company or the Company Subsidiary. With respect to each Company Product, the Company has made available to Parent complete and accurate copies of all such regulatory filings material clinical and preclinical data in the possession of the Company and all material communications between representatives written correspondence that exists as of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries date of this Agreement between the Company and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth All manufacture of the Company Products, including any clinical supplies used in any clinical trials, by or on Schedule 6.19(d)behalf of the Company has been conducted in all material respects in compliance with the applicable specifications and requirements of Good Manufacturing Practices and applicable Law. Neither the Company nor, no Credit Party nor to the knowledge of the Company, any person acting on its behalf has, with respect to any Company Product, (i) been subject to a Regulatory Authority shutdown or import or export prohibition or (ii) received any FDA Form 483, or other Regulatory Authority notice of inspectional observations, “warning letters,” “untitled letters” or written requests or requirements to make any change to any Company Product or any of its Subsidiaries has received the Company’s or the Company Subsidiary’s processes or procedures, or any similar correspondence from any Regulatory Authority in respect of the Company or the Company Subsidiary or their respective business operations alleging or asserting noncompliance with any notice of alleged non-compliance or adverse findings with respect to any Product applicable Law, permit or any Product Development and Commercialization Activities related thereto which representedsuch requests or requirements of a Regulatory Authority and, in to the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 knowledge of the FD&C ActCompany, or any other similar communication from any no Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) yearsconsidering such action.
(e) No Credit PartyNone of the Company, nor the Company Subsidiary or any of its Subsidiariestheir respective officers, nor employees or agents, or, to the knowledge of the Company, any officer, employee or agent thereofclinical investigator acting for the Company, has (i) made an untrue statement of a material fact or fraudulent statements statement to the FDA any Regulatory Authority or any other Regulatory AuthorityGovernmental Entity, including the Centers for Medicare and Medicaid Services, the U.S. Department of Health and Human Services, HHS Office of Inspector General or the Center for Medicare and Medicaid Innovation, (ii) failed to disclose a material fact required to be disclosed to the FDA any Regulatory Authority or any other Regulatory AuthorityGovernmental Entity, including the Centers for Medicare and Medicaid Services, the U.S. Department of Health and Human Services, HHS Office of Inspector General or the Center for Medicare and Medicaid Innovation or (iii) committed an act, made a statement, or failed to make a statement statement, including with respect to any scientific data or information, that, at the time such disclosure was made (or was not made)failure to disclose occurred, could would reasonably be expected to provide a basis for the FDA or any other Regulatory Authority Governmental Entity to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) ), and any amendments thereto, or any similar policypolicy or any other statute or regulation regarding the communication or submission of false information to any applicable Regulatory Authority or Governmental Entity. The Company has not committed or engaged in any fraud or falsification or forgery of any research or development data, report, studies or publications or of any document or statement voluntarily submitted or required to be submitted to any Regulatory Authority or any other Governmental Entity, including the Centers for Medicare and Medicaid Services, the U.S. Department of Health and Human Services, HHS Office of Inspector General or the Center for Medicare and Medicaid Innovation. None of the Company, the Company Subsidiary or any of their respective officers, employees, agents or, to the knowledge of the Company, any clinical investigator acting for the Company, is or has been convicted of any crime or engaged in any conduct that has resulted in, or would reasonably be expected to result in, debarment from participation in any program related to pharmaceutical products pursuant to 21 U.S.C. Section 335a (a) or (b) or exclusion from participation in any federal health care program pursuant to 42 U.S.C. Section 1320a‑7.
(f) Except No Company Product that is or has been manufactured, tested, distributed, held or marketed by or on behalf of the Company has been, recalled, withdrawn or suspended (whether voluntarily or otherwise) or, to the Company’s knowledge, has been adulterated or misbranded. No proceedings (whether complete or pending) seeking the recall, withdrawal, suspension or seizure of any such Company Product or pre-market approvals or marketing authorizations are pending or, to the knowledge of the Company, threatened against the Company or the Company Subsidiary, nor have any such proceedings been pending at any time. The Company has made available to Parent all information about serious adverse events (as set forth such term is defined in 21 C.F.R. 312.32) in the possession of the Company as of the date of this Agreement relating to any Company Product that is or has been manufactured, tested, distributed, held or marketed by or on Schedule 6.19(f), no Credit Party nor behalf of the Company or any of its Subsidiaries licensors or licensees in the possession of the Company (or to which it has received access). In addition, the Company has filed all annual and periodic reports, amendments and safety reports required for any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened Company Product required to commence or initiate, any action be made to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,Authority.
(g) Except as set forth on Schedule 6.19(g), Each of the clinical, preclinical, safety Company and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or Company Subsidiary has complied in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance all material respects with all applicable Regulatory Authorizations security and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness privacy and consumer protection requirements and/or standards regarding protection of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated herebypersonal information, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretohealth information under applicable Laws.
Appears in 1 contract
Sources: Merger Agreement (Dermira, Inc.)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) is a complete and accurate list The business of all material Regulatory Authorizations relating to the Credit Parties and their SubsidiariesParent, the conduct of their businessBorrower and the Subsidiaries has been, and the Products (on a per Product basis). All such currently is, being conducted in material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereofapplicable U.S. federal, state, and are in good standinglocal laws, valid as well as all applicable ordinances, rules, regulations, guidances, judgments, orders, injunctions, decrees, arbitration awards and enforceable with Key Permits (collectively, “Laws”), including, without limitation, the applicable Governmental Authority. All required noticesFD&C Act, registrations and listings, supplemental applications or notifications, reports the Public Health Service Act (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctionsPHSA), and reports Privacy Laws, as well as similar Laws in any foreign jurisdiction. The Products of corrections the Parent, the Borrower and the Subsidiaries are not, and have not been, “adulterated” or removal) and other required filings with respect to “misbranded” within the meaning of the FD&C Act, nor do any such Products for constitute an article prohibited from introduction into interstate commerce under the last five (5) years have been timely filed with the FDA and all other applicable Governmental AuthoritiesFD&C Act.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational The Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their complianceresearched, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Partiesdeveloped, their Subsidiaries and the agents thereof are tested, manufactured, packaged, labeled, distributed, imported, exported, marketed or sold in compliance in all material respects with all applicable statutesrequirements under the FD&C Act and the regulations of the FDA promulgated thereunder and similar Laws in any foreign jurisdiction having authority over the Products, rules including those relating to investigational use, premarket approval or clearance, registration and listing, good manufacturing practices, quality systems regulations and requirements, ISO requirements, good clinical practices, good laboratory practices, labeling, advertising, record keeping and filing of required reports.
(c) The Parent, the Borrower and the Subsidiaries own, free and clear of all Liens, except those permitted pursuant to Section 8.3, all Key Permits, including all Healthcare Laws authorizations under the FD&C Act and Regulatory Authorizations) state Laws, necessary for the research, development and commercialization of all applicable Governmental Authoritiesthe Products and to carry on the Parent’s, including the FDA Borrower’s and all other Regulatory AuthoritiesSubsidiaries’ businesses, with respect to each Product as applicable. All such Key Permits are valid, and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all and the necessary Parent, the Borrower and requisite Regulatory Authorizations. The Credit Parties and their the Subsidiaries are in compliance in all material respects with all applicable registration terms and listing requirements set forth in conditions of such Key Permits. None of the FD&C Act Parent, the Borrower or equivalent regulation of each other any Subsidiary has received any written notice that any Key Permits have been or are being revoked, withdrawn, suspended, limited or challenged, and, to the Parent’s and the Borrower’s knowledge, there is no factual basis for any Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere to initiate a process that might result in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related theretoany Key Permit being revoked, withdrawn, suspended, limited or challenged.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any The Borrower has made available to the Administrative Agent and the Lenders copies of its Subsidiaries has all Key Permits and material correspondence submitted to or received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or other Governmental Authority (including minutes and official contact reports relating to any other Regulatory Authority indicating material communications with any breach Governmental Authority) in the Parent’s, the Borrower’s or violation any Subsidiary’s possession or control as requested by the Administrative Agent or any Lender. There has been no material untrue statement of any applicable Regulatory Authorizationfact and no fraudulent statement made by the Parent, including that the Borrower, any of the Products is misbranded Subsidiaries, or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee their respective agents or agent thereof, has made an untrue statement of a material fact or fraudulent statements representatives to the FDA or any other Regulatory Governmental Authority, failed and there has been no failure to disclose a any material fact required to be disclosed to the FDA or any other Regulatory Governmental Authority. All applications, notifications, product reports, submissions, information, claims, reports and statistics, and other data and conclusions derived therefrom, utilized as the basis for or submitted in connection with any and all requests for Key Permits from any Governmental Authority, were truthful, complete and accurate in all material respects as of the date of submission and as of the date of the grant of such Key Permit. All necessary or committed an actrequired changes, made a statementsupplements, amendments, modifications, updates, or failed corrections to make a statement thatsuch applications, at notifications, submissions, information and data have been submitted to the time such disclosure was made applicable Governmental Authority.
(or was not made)e) None of the Parent, could reasonably be expected to provide a basis for the FDA Borrower or any other Regulatory Subsidiary has had any Product or Product manufacturing site (whether owned by the Parent, the Borrower, a Subsidiary or a contract manufacturer) subject to a Governmental Authority shutdown or import or export prohibition, nor received any notice of inspectional observations, “warning letters,” “untitled letters” or similar correspondence relating to invoke its policy respecting FraudProduct manufacturing processes or procedures and asserting material noncompliance with any applicable Law or Permit and, Untrue Statements to the knowledge of Material Factsthe Parent or Borrower, Bribery and Illegal Gratuitiesno Governmental Authority is considering such action. None of the Parent, set forth in 56 Fed. Reg. 46191 (September 10, 1991) the Borrower or any similar policySubsidiary has had any Product manufacturing site (whether owned by the Parent, the Borrower, a Subsidiary or a contract manufacturer) subject to a material production slowdown or shutdown for reasons other than the order or request of a Governmental Authority.
(f) Except as set forth on Schedule 6.19(fThere are not and have not been any recalls, corrections, removals, field notifications, product replacements, seizures, market withdrawals, warnings, inquiries, “dear doctor” letters, investigator notices, safety alerts, or notices of any action or court order relating to an alleged lack of safety or regulatory compliance of the Products (“Safety Notices”), or (ii) material product complaints associated with the Product. To the knowledge of the Parent or the Borrower, there are no Credit Party nor facts that would be reasonably likely to result in (x) a material Safety Notice with respect to its products, (y) a material change in the labeling of any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiatedproducts, or threatened to commence (z) a termination or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) suspension of developing and testing of any Products or commenced or initiated or threatened of its products. All adverse events and malfunctions have been reported to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, applicable Governmental Authorities in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,accordance with Law.
(g) Except as set forth on Schedule 6.19(g)To the Parent’s and the Borrower’s knowledge, no investigation by any Governmental Authority with respect to the Parent, the clinicalBorrower or any of the Subsidiaries is pending or has been threatened in writing that would reasonably be expected to materially adversely affect the Parent, preclinicalthe Borrower and the Subsidiaries. None of the Parent, safety the Borrower or any Subsidiary has received any written communication from any Person (including any Governmental Authority) of any material noncompliance with any Laws or any written communication from any Governmental Authority or accrediting organization of any material issues, problems, or concerns regarding the quality or performance of the Products, or the practices of the Parent, the Borrower or any of the Subsidiaries with respect to advertising, promoting, or otherwise commercializing the Products, and to the knowledge of the Parent or the Borrower, there is no basis for any adverse and material regulatory action against the Parent, the Borrower or any of the Subsidiaries.
(h) No right of the Parent, the Borrower or any of its Subsidiaries to receive reimbursements pursuant to any government program or private program has ever been terminated or otherwise materially adversely affected as a result of any investigation or enforcement action, whether by any Governmental Authority or other studies Third Party, and none of the Parent, the Borrower or any of the Subsidiaries is the subject of any inspection, investigation, or audit, by any Governmental Authority in connection with any alleged improper activity.
(i) There is no arrangement relating to the Parent, the Borrower or the Subsidiaries providing for any rebates, kickbacks or other forms of compensation that are unlawful to be paid to any Person in return for the purchase or use of any of the Products or for the referral of business or for the arrangement for recommendation of such referrals. All ▇▇▇▇▇▇▇▇ by the Parent, the Borrower and its Subsidiaries for its services, if any, have been true and correct in all material respects (other than any inadvertent errors corrected in the ordinary course of business) and, to the Parent’s and the Borrower’s knowledge, are in compliance in all material respects with all applicable Laws, including the Federal False Claims Act or any applicable state false claim or fraud Law.
(j) None of the Parent, the Borrower or any of the Subsidiaries nor, to the Parent’s or the Borrower’s knowledge, any individual who is an officer, director, manager, employee, stockholder, agent or managing agent of the Parent, the Borrower or any of the Subsidiaries has been convicted of, charged with or, to the Parent’s or the Borrower’s knowledge, investigated for any federal or state health program-related offense or any other offense related to healthcare or been excluded or suspended from participation in any such program; or, to the Parent’s or the Borrower’s knowledge, has been convicted of, charged with or, to the Parent’s or the Borrower’s knowledge, investigated for a violation of Laws related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances, or has been subject to any judgment, stipulation, order or decree of, or criminal or civil fine or penalty imposed by, any Governmental Authority related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances. None of the Parent, the Borrower or any of the Subsidiaries nor, to the Parent’s or the Borrower’s knowledge, any individual who is an officer, director, manager, employee, stockholder, agent or managing agent of the Parent, the Borrower or any of the Subsidiaries has been convicted of any crime or engaged in any conduct that has resulted or would reasonably be expected to result in a debarment or exclusion under (i) 21 U.S.C. Section 335a, (ii) Section 1128 of the Social Security Act or (iii) any similar applicable Law. No debarment proceedings or investigations in respect of the business of the Parent, the Borrower or any of the Subsidiaries, are pending or, to the Parent’s or the Borrower’s knowledge, threatened in writing against the Parent, the Borrower, any of the Subsidiaries or any individual who is an officer, director, manager or employee of, or, to the Parent’s or the Borrower’s knowledge, an agent or managing agent of, the Parent, the Borrower or any of the Subsidiaries.
(k) The Products were researched, developed, designed and validated in compliance in all material respects with all applicable Laws, including the FD&C Act, Privacy Laws and state laws. All studies, tests and preclinical and clinical trials conducted relating to the Products, by or on behalf of the Parent, the Borrower and the Subsidiaries and, to the knowledge of the Parent and the Borrower, their respective licensees, licensors and Third Party services providers and consultants, have been conducted, and are currently being conducted, in compliance in all material respects with all applicable Laws, procedures and controls pursuant to, where applicable, current good clinical practices and current good laboratory practices. All results of such studies, tests and trials, and all other material information related to such studies, tests and trials, have been made available to the Administrative Agent or any Lender as requested by it. To the extent required by applicable Law, the Parent, the Borrower and the Subsidiaries have obtained all necessary Regulatory Authorizations, including an investigational device exemption (IDE) for the conduct of any clinical investigations conducted by or on behalf of the Parent, the Borrower or sponsored by any of the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(hl) The transactions contemplated To the Parent’s and the Borrower’s knowledge, none of the clinical investigators in any clinical trial conducted by or on behalf of the Parent, the Borrower or any Subsidiary has been or is disqualified or otherwise sanctioned by the Loan Documents (FDA, the Department of Health and Human Services, or contemplated by any other Governmental Authority and, to the conditions to effectiveness Parent’s and the Borrower’s knowledge, no such disqualification, or other sanction of any Loan Document) will not impair any Credit Party’s such clinical investigator is pending or threatened in writing. None of the Parent, the Borrower or any of its Subsidiaries’ ownership of or rights under (or the license or Subsidiaries has received from the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent FDA or other authorization applicable Governmental Authority any written notices or correspondence requiring or threatening the termination, suspension, material modification or clinical hold of any Governmental Authority is required in connection with clinical trials conducted by, or on behalf of, the transactions contemplated herebyParent, including the Liens granted in connection herewith and Borrower or any of the exercise of rights and remedies with respect theretoSubsidiaries.
Appears in 1 contract
Regulatory Matters. With respect to each Product:
(a) Set forth Except as disclosed on Schedule 6.19(aSection 5.18(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their SubsidiariesCompany Disclosure Schedule, the conduct of their business, Company has obtained and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are is in compliance in all material respects with all certifications, approvals and clearance from the United States Food and Drug Administration (the "FDA") and all state, local and foreign equivalents (together with the FDA, the "REGULATORY ENTITIES") necessary in order to carry out its business as currently conducted, including without limitation to develop Products in any and all geographic areas in which the Company is currently, or has previously, developed Products.
(b) All nonclinical laboratory studies of Products have been and are being conducted in compliance with all applicable statutesfederal, state, local and foreign laws, rules and regulations (including all Healthcare Laws without limitation, any reporting requirements thereof) and Regulatory Authorizations) with accepted standards of good laboratory practice. All clinical trials of pharmaceutical products have been and are being conducted in compliance with all applicable Governmental Authoritiesfederal, including state, local and foreign laws, rules and regulations (including, without limitation, any reporting requirements thereof) and with accepted standards of good clinical practice.
(c) The Company has provided Parent with copies of any and all notice of inspectional observations, establishment inspection reports and any other documents received from Regulatory Entities, that indicate lack of compliance with the FDA regulatory requirements of Regulatory Entities. The Company has made available to Parent for review all correspondence to or from all Regulatory Entities, minutes of meetings, written reports of phone conversations, visits or other contact with Regulatory Entities, notices of inspectional observations, establishment inspection reports, and all other documents concerning communications to or from Regulatory AuthoritiesEntities, or prepared by or which bear in any way on the Company's compliance with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all regulatory requirements of Regulatory Entities, or on the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation likelihood of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations timing of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related theretoapproval of any Products.
(d) Except as set forth on Schedule 6.19(d)Neither the Company nor, no Credit Party nor any of its Subsidiaries officers, employees or agents has received from committed any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a any statement, or failed to make a statement thatany statement, at the time such disclosure was made (or was not made), could that would be reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting "Fraud, Untrue Statements of Material Facts, Bribery Bribery, and Illegal Gratuities, ," set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto.
(e) The Company has not been convicted of any crime or engaged in any conduct that could result in debarment under 21 U.S.C. Section 335a or any similar policystate law or regulation.
(f) Except as set forth on Schedule 6.19(f)There are no proceedings pending with respect to a violation by the Company of the Food, no Credit Party nor any of its Subsidiaries has received any written notice that Drug and Cosmetic Act, FDA regulations adopted thereunder, the FDA Controlled Substance Act or any other applicable Regulatory Authority has commenced legislation or initiated, regulation promulgated by any other United States federal or threatened state Governmental Entity that reasonably might be expected to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, result in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,criminal liability.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.
Appears in 1 contract
Sources: Merger Agreement (Inverness Medical Technology Inc/De)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to To the Credit Parties and their SubsidiariesCompany’s Knowledge, the conduct Exploitation of their businessthe Product is, and at all times since the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their SubsidiariesReference Date has been, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA Act, and all other Regulatory Authoritiesapplicable regulations issued by the FDA, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration reporting requirements under the FDA Act, the Public Health Service Act, as amended, their associated rules and listing requirements set forth in regulations promulgated thereunder.
(b) The post-marketing studies conducted by the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere Company related to the Product were conducted in all material respects to in accordance with all applicable regulations clinical trial protocols, informed consents and applicable requirements of all Regulatory Authorities with respect the FDA, including, as applicable, the FDA’s good clinical practices and good laboratory practices regulations.
(c) Since the Reference Date, the Company has not been subject to any investigation related to the Products Product or the Product Line Operations that is pending and all of which the Company has been notified in writing or, to the Company’s Knowledge, which has been threatened, in each case by any Governmental Entity pursuant to the Federal Healthcare Program Anti-Kickback Statute (42 U.S.C. §1320a-7b(b), the Federal False Claims Act (31 U.S.C. §3729) or any similar anti-kickback statutes applicable to the Company. Since the Reference Date, the Company has not submitted any claim for payment to any government healthcare program in connection with any referrals related to the Product Development and Commercialization Activities that violated in any material respect any applicable self-referral Law. Since the Reference Date, the Company has not submitted any claim for payment to any government healthcare program related theretoto the Product in material violation of any Laws relating to false claim or fraud.
(d) Except as set forth on Schedule 6.19(d)Since the Reference Date, no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect neither the Company nor, to any Product or any Product Development and Commercialization Activities related thereto which representedthe Company’s Knowledge, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, of the Company has (i) made an untrue statement of a material fact or fraudulent statements statement to the FDA or any other Regulatory AuthorityGovernmental Entity, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory AuthorityGovernmental Entity, or committed an act, made a statement, or failed to make a statement statement, including with respect to any scientific data or information, that, at the time such disclosure was made (or was not made)failure to disclose occurred, could would reasonably be expected to provide a basis for the FDA or any other Regulatory Authority Governmental Entity to invoke its the FDA policy respecting “Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, ,” set forth in 56 Fed. Reg. 46191 (September 10, 1991), in each case as related to the Product or the Product Line Operations, (ii) been convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. § 335a(a) or authorized by 21 U.S.C. § 335a(b) or (iii) been convicted of any similar policycrime or engaged in any conduct for which such Person or entity could be excluded from participating in the Federal health care programs under Section 1128 of the Social Security Act of 1935, as amended.
(fe) Except as set forth on Schedule 6.19(f)Since the Reference Date, neither the Company nor its Affiliates have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field alerts, field corrections, market withdrawal, safety alert or warning, “dear doctor” letter, investigator notice or other material notice or action relating to an alleged lack of safety, efficacy or regulatory compliance of the Product. The Company has no Credit Party nor Knowledge of any facts occurring since the Reference Date that are reasonably likely to cause (i) the recall, market withdrawal or replacement of its Subsidiaries the Product, (ii) a material change in the marketing classification or a material change in the labeling of the Product, or (iii) a termination or suspension of the marketing of the Product. Since the Reference Date, the Company has not received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiatedGovernmental Entity has: (1) commenced, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested request the recall of the Product; (whether by correction or removal2) of any Products or commenced or initiated commenced, or threatened to commence or initiate, any action to enjoin the manufacture or distribution of the Product; (3) issued any Product Development and Commercialization Activities demand letter, finding of such Credit Party material deficiency or such Subsidiarynon-compliance or adverse inspection report (including any FDA Form 483s, in each caseFDA Notices of Adverse Findings, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their SubsidiariesUntitled Letters, or Warning Letters) in respect of which the Product; or (4) commenced, or threatened to initiate, any Products action regarding inappropriate advertising or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respectsmarketing of the Product.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.
Appears in 1 contract
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally The businesses of the Borrower has been and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, is being conducted in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws Healthcare Laws, and regulationsall Permits, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted each Product (whether manufactured by the Credit Borrower or any of its Subsidiaries, any of their respective Affiliates or by a third party manufacturer under contract to the Borrower or any of its Subsidiaries) has been, and currently is, being researched, developed, designed, investigated, manufactured, made, assembled, stored, packaged, labeled, marketed and distributed by the Borrower and its Subsidiaries or third parties on their behalf, in compliance with all applicable Requirements of Law, including, without limitation, the Healthcare Laws, all required Permits, cGMP, QSR, the Device Master Record as defined in 21 CFR 820.181 and Document Controls under 21 CFR 820.40 and all Product specifications as established in the Group Members’ documentation, except to the extent any failure to so comply could not reasonably be expected to result in any adverse consequences to the Loan Parties (other than immaterial consequences), (iii) each contract between the Borrower and their any of its Subsidiaries on the one hand, and any third party manufacturer on the other hand contain (and the Borrower and each of its Subsidiaries implement), appropriate quality assurance arrangements in accordance with FDA requirements and comply in all material respects with all applicable laws Healthcare Laws, (iv) the Borrower and regulations along its Subsidiaries are in compliance in all material respects with appropriate monitoring 88 applicable Requirements of clinical investigator trial sites Law governing reporting and recordkeeping of Product modifications, adverse event reporting, reporting of corrections and removals, and recordkeeping for their complianceeach Product, and all manufacturing and release documents and records are true and accurate in all material respects, and (iiiv) neither the Credit Parties Borrower nor any of its Subsidiaries has received or been subject to any written or oral communications from the FDA, the NRC or any other Governmental Authority asserting that the Borrower, any such Subsidiary or any such Product was not in compliance in any material respect with any applicable Requirement of Law or any Permit.
(b) Other than routine surveillance audits and their Subsidiaries have disclosed inspections, no investigation by any Governmental Authority with respect to the Agent all such regulatory filings and all material communications between representatives Borrower or any of its Subsidiary is pending or, to the knowledge of the Credit Parties (and their Subsidiaries) and Loan Parties, threatened. None of the Borrower or any Regulatory Authorityof its Subsidiaries has received any written or oral communication from any Governmental Authority of any noncompliance with any Requirement of Law or any written or oral communication from any Governmental Authority or accrediting organization of any material issues, problems, or concerns regarding the quality or performance of the Products.
(c) The Credit Borrower and its Subsidiaries own, free and clear of all Liens, except Liens securing the Obligations, all Permits, including all authorizations under the FD&C Act, other United States federal laws, and all applicable state and foreign laws, necessary (i) for the research and development and commercialization of the Products, including, without limitation, all Permits necessary in connection with testing, manufacturing, marketing or selling of such Products, as such testing, manufacturing, marketing or selling are currently being conducted, and (ii) to carry on the business of the Borrower and each of its Subsidiaries. All such Permits are valid and in full force and effect and the Borrower and each Subsidiary is in compliance in all material respects with all terms and conditions of such Permits. None of the Borrower or any Subsidiary has received any written notice from any Governmental Authority that any Permit has been or is being revoked, withdrawn, suspended or challenged or that such Governmental Authority is conducting an investigation or review thereof or has issued any order or recommendation stating that the development, testing and/or manufacturing of such Product should cease or that such Product should be withdrawn from the marketplace.
(d) Except as could not reasonably be expected to have a materially adverse impact on the Borrower and its Subsidiaries, there have been no adverse clinical test results and there have been no Product recalls or voluntary Product Market Withdrawals from any market (other than those recalls or Market Withdrawals disclosed on Schedule 4.23(d)).
(e) There has been no material untrue statement of fact and no fraudulent statement made by the Borrower or any of its Subsidiaries or any of their respective agents or representatives to the FDA, NRC, or any other Governmental Authority, and there has been no failure to disclose any material fact required to be disclosed to the FDA, NRC or any other Governmental Authority.
(f) To the best knowledge of the Loan Parties, their no insurance company, managed care organization or Governmental Authority has (i) terminated coverage or reimbursement for procedures and treatments performed using the CyberKnife and TomoTherapy Products, or (ii) reduced the scope of coverage or the rate of reimbursement it provides for procedures and treatments performed using the CyberKnife and TomoTherapy Products, and, in the case of this clause (ii), such reduction could reasonably be expected to have a materially adverse impact on the revenues of the Borrower and its Subsidiaries. None of the Borrower or any of its Subsidiaries has been the subject of any "for cause" inspection, investigation or audit by any Governmental Authority in connection with any alleged improper activity.
(g) There is no arrangement relating to the Borrower or any of its Subsidiaries providing for any rebates, kickbacks or other forms of compensation or remuneration that are unlawful to be paid to any Person to induce, or in return for obtaining or the referral of business or for the arrangement for recommendation of such referrals. All ▇▇▇▇▇▇▇▇ by the Borrower and the agents thereof each of its Subsidiaries for its services have been true and correct in all material respects and are in compliance in all material respects with all applicable statutesHealthcare Laws.
(h) None of the Borrower or any of its Subsidiaries, rules or, to the knowledge of the Loan Parties, any individual who is an officer, director, employee or manager of the Borrower or any of its Subsidiaries has been convicted of, charged with or, to the knowledge of the Loan Parties, investigated for any federal or state health program- related offense or been excluded or suspended from participation in any such program; or, to the knowledge of the Loan Parties, within the past five (5) years, has been convicted of, charged with or, to the knowledge of the Loan Parties, investigated for a violation of any Requirement of Law related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances, or has been subject to any judgment, stipulation, order or decree of, or criminal or civil fine or penalty imposed by, any Governmental Authority related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances. None of the Borrower or any of its Subsidiaries or, to the knowledge of the Loan Parties, any individual who is an officer, director, employee or manager of the Borrower or any of its Subsidiaries has been convicted of any crime or engaged in any conduct including but not limited to any misrepresentation to any Governmental Authority or that has otherwise resulted or would reasonably be expected to result in a debarment or exclusion (i) under 21 U.S.C. Section 335a, or (ii) any similar applicable Requirement of Law. No debarment proceedings or investigations in respect of the business of the Borrower or any of its Subsidiaries are pending or, to the knowledge of the Loan Parties, threatened against the Borrower or any of its Subsidiaries or any individual who is an officer, director, employee or manager of the Borrower or any of its Subsidiaries.
(i) All studies, tests and regulations (including all Healthcare Laws preclinical and Regulatory Authorizations) clinical trials conducted relating to the Products, sponsored by the Borrower or any of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their its Subsidiaries have been conducted, and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance currently being conducted, in all material respects in accordance with all applicable registration Requirement of Law and listing requirements set forth in IDEs, including procedures and controls pursuant to, where applicable, current good clinical practices and current good laboratory practices and other applicable laws, rules regulations. To the FD&C Act extent required by applicable Requirement Law, the Borrower and each of its Subsidiaries has obtained all necessary authorizations from Governmental Authorities and IECs, including an IDE for the conduct of any clinical investigations conducted by or equivalent regulation on behalf of each other Governmental Authority having jurisdiction over the Borrower or such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related theretoSubsidiary, as applicable.
(dj) Except as set forth on Schedule 6.19(d)To the knowledge of the Loan Parties, none of the clinical investigators in any clinical trial sponsored by the Borrower or any of its Subsidiaries has been or is disqualified or otherwise sanctioned by the FDA, the Department of Health and Human Services, or any Governmental Authority and, to the knowledge of the Loan Parties, no Credit Party nor such disqualification, or other sanction of any such clinical investigator is pending or threatened. None of the Borrower or any of its Subsidiaries has received from any Regulatory the FDA or other applicable Governmental Authority any notice notices or correspondence requiring or threatening the termination, suspension, material modification or clinical hold of alleged non-compliance any studies, tests or adverse findings clinical trials with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated herebyProducts.
(k) The Group Members are, to the extent directly applicable to the Group Members, currently conducting its business in material compliance with all regulations promulgated under HIPAA. To the extent the Group Members create any de-identified protected health information, the Group Members do so in compliance with the HIPAA regulations. The Group Members have not failed to notify any individual or required third party, including any appropriate Governmental Authority, of an event that triggered a notification or reporting requirement under any contract to which a Group Member is a party, or any applicable requirement related to the Liens granted in connection herewith and the exercise unauthorized access, use or disclosure of rights and remedies protected health information. The Group Members have no knowledge of any complaints to or investigations by any 90 Governmental Authority with respect theretoto HIPAA compliance by the Group Members, have not received any notice or audit request from the United States Department of Health and Human Services Office for Civil Rights, is currently conducting their businesses in material compliance with all applicable laws governing the privacy, security or confidentiality of protected health information and/or other records generated in the course of providing or paying for health care services, including without limitation, all laws to the extent not preempted by HIPAA, and has conducted its businesses in material compliance with such laws since such laws first became applicable to it.
Appears in 1 contract
Sources: Credit Agreement (Accuray Inc)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to Promptly after the Credit Parties and their SubsidiariesTermination Agreement Date, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements timelines set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties Exhibit A, Takeda shall, in consultation with AMAG and their Subsidiaries adhere in all material respects to all applicable regulations of as further described below, prepare all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification Materials that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required are necessary to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made filed with a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 transfer (September 10, 1991or Withdraw pursuant to Section 5.6 or Exhibit A) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, marketing authorization in each caseTerminated Territory to AMAG. In connection with such activities, which representedTakeda shall provide AMAG with draft submissions of Regulatory Materials, sufficiently in the aggregate[***] INDICATES MATERIAL THAT HAS BEEN OMITTED AND FOR WHICH CONFIDENTIAL TREATMENT HAS BEEN REQUESTED. ALL SUCH OMITTED MATERIAL HAS BEEN FILED WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24b-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, 15% or more AS AMENDED. advance of Net Sales filing to allow AMAG to review and comment on such drafts, and AMAG shall respond in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material a timely manner, and no consent or other authorization shall consider in good faith all reasonable comments of any Governmental AMAG prior to filing the applicable Regulatory Materials. Takeda shall promptly provide AMAG with copies of all communications received from a Regulatory Authority is required in connection with such transfers, and will notify AMAG within one (1) business day of receipt of approval and effectiveness of the transactions contemplated hereby, including the Liens granted transfer or Withdrawal of each marketing authorization. Takeda undertakes not to provide any response to communications from a Regulatory Authority in connection herewith and the exercise relation to transfer or Withdrawal of rights and remedies each marketing authorization without first consulting with respect theretoAMAG for AMAG’s comments concerning such response. Each Party shall bear all expenses it incurs to conduct its activities under this Section 3.1.
Appears in 1 contract
Sources: Termination Agreement
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations There are (i) legally and beneficially owned exclusively no Permits required by the Credit Parties United States Food and their Subsidiaries, Drug Administration (“FDA”) to conduct the Business as applicable, free and clear of all Liens other than Permitted Liens, and it is currently conducted (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the “FDA and all other applicable Governmental AuthoritiesPermits”).
(b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are Company is in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including administered or enforced by the FDA or any other Governmental Authority that regulates the Business.
(c) The Company is and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are has been in compliance in all material respects with all applicable registration and listing Laws requiring the maintenance or submission of reports or records under requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened administered by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of Governmental Authority. Neither the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, Company nor any of its Subsidiaries, nor any officer, employee employees or agent thereof, has agents have made an untrue statement of a material fact or fraudulent statements statement to the FDA or any other Regulatory Authorityapplicable Governmental Authorities, or in any records and documentation prepared or maintained to comply with the applicable Laws, or failed to disclose a material fact required to be disclosed to the FDA or any other similar Governmental Authorities. All material filings, declarations, listings, registrations, reports or submissions, required to be filed by the Company with any Governmental Authority have been filed. All such filings, declarations, listings, registrations, reports or submissions were, when filed, complete and accurate in all material respects and in compliance in all material respects with all applicable Laws, and no material deficiencies have been asserted by any applicable Governmental Authority with respect to any such filings, declarations, listing, registrations, reports or submissions.
(d) The Company has made available to Buyer true and correct copies of all Regulatory AuthorityDocumentation relating to the Phase 1 Products in its possession. No Regulatory Documentation prepared by the Company (if any) contains any material omission or misstatement and all such Regulatory Documentation is maintained in accordance with all applicable Laws.
(e) Neither the Company nor any of the Company’s agents or subcontractors or, to the Knowledge of Company, any of the Company’s Collaborative Partners, has been convicted of any crime or engaged in any conduct that could result or resulted in debarment, exclusion or disqualification by the FDA or any other Governmental Authority (including under the provisions of 21 U.S.C. §§ 335a, 335b, or 335c, 42 U.S.C. § 1320a-7 or any equivalent provisions in any other applicable jurisdiction), and there are no proceedings pending or, to Company’s Knowledge, threatened against the Company or any of its Collaborative Partners that reasonably might be expected to result in criminal or civil Liability or debarment, exclusion or disqualification by the FDA or any other Governmental Authority. The Company has not, and to the Knowledge of Company, none of the Company’s Collaborative Partners have, received written notice of or been subject to any other enforcement action involving the FDA or any other Governmental Authorities, including any suspension, consent decree, notice of criminal investigation, indictment, sentencing memorandum, plea agreement, court order or target or no-target letter, and none of the foregoing are pending or, to Company’s Knowledge, threatened in writing against the Company or any of the Company’s Collaborative Partners. None of the Company or any of its officers, directors or employees has committed an any act, made a statement, any statement or failed to make a any statement that, at the time such disclosure was made (or was not made), could that would reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting with respect to “Fraud, Untrue Statements of Material Facts, Bribery Bribery, and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) ” or for any other Governmental Authority to invoke any similar policy. Neither the Company nor any of its officers, directors or employees: (i) is the subject of any pending or threatened investigation by any Governmental Authority pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” policy, or similar policy; or (ii) has received any notification of any such potential investigation.
(f) Except as set forth on Schedule 6.19(f)The Company is not party to any corporate integrity agreements, no Credit Party nor any of its Subsidiaries has received any written notice that the FDA monitoring agreements, consent decrees, settlement orders or any other applicable Regulatory Authority has commenced similar agreements with or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether imposed by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoAuthority.
Appears in 1 contract
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally The businesses of Borrowers have been and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, are being conducted in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws Law, including the Healthcare Laws, and regulationsall Permits, (ii) each Product (whether manufactured by Accuray or any of its Subsidiaries, any of their respective Affiliates or by a third party manufacturer under contract to Accuray or any of its Subsidiaries) has been, and currently is, being researched, developed, designed, investigated, manufactured, made, assembled, stored, packaged, labeled, marketed and distributed in compliance with all clinical applicable Law, including, without limitation, the Healthcare Laws, all required Permits, cGMP, QSR, the Device Master Record as defined in 21 CFR 820.181 and pre-clinical trialsDocument Controls under 21 CFR 820.40 and all Product specifications as established in company documentation, if any, of investigational Products have been and are being conducted by except to the extent any failure to so comply could not reasonably be expected to result in any adverse consequences to the Credit Parties (other than immaterial consequences), (iii) each contract between Accuray and their any of its Subsidiaries on the one hand, and any third party manufacturer on the other hand contain (and Accuray and each of its Subsidiaries implement), appropriate quality assurance arrangements in accordance with FDA requirements, (iv) Accuray and its Subsidiaries are in compliance in all material respects with applicable Law governing reporting and recordkeeping of Product modifications, adverse event reporting, reporting of corrections and removals, and recordkeeping for each Product, and all manufacturing and release documents and records are true and accurate in all material respects, and (v) neither Accuray nor any of its Subsidiaries has received or been subject to any written or oral communications from the FDA, the NRC or any other Governmental Authority asserting that Accuray, any such Subsidiary or any such Product was not in compliance in any material respect with any applicable Law or any Permit.
2. Other than routine surveillance audits and inspections, no investigation by any Governmental Authority with respect to Accuray or any of its Subsidiary is pending or, to the knowledge of the Credit Parties, threatened. None of Accuray or any of its Subsidiaries has received any written or oral communication from any Governmental Authority of any noncompliance with any Law or any written or oral communication from any Governmental Authority or accrediting organization of any material issues, problems, or concerns regarding the quality or performance of the Products.
3. Accuray and its Subsidiaries own, free and clear of all Liens, except Liens securing the Obligations, all Permits, including all authorizations under the FD&C Act, other United States federal laws, and all applicable state and foreign laws, necessary (i) for the research and development and commercialization of the Products, including, without limitation, all Permits necessary in connection with testing, manufacturing, marketing or selling of such Products, as such testing, manufacturing, marketing or selling are currently being conducted, and (ii) to carry on the business of Accuray and each of its Subsidiaries. All such Permits are valid and in full force and effect and Accuray and each Subsidiary is in compliance in all material respects with all terms and conditions of such Permits. None of Accuray or any Subsidiary has received any written notice from any Governmental Authority that any Permit has been or is being revoked, withdrawn, suspended or challenged or that such Governmental Authority is conducting an investigation or review thereof or has issued any order or recommendation stating that the development, testing and/or manufacturing of such Product should cease or that such Product should be withdrawn from the marketplace.
4. There have been no adverse clinical test results which have or could reasonably be expected to have a materially adverse impact on Accuray or any of its Subsidiaries, and there have been no Product recalls or voluntary Product withdrawals from any market (other than specific and discrete batches or lots not made in conjunction with a larger recall).
5. Neither Accuray nor any of its Subsidiaries have experienced any significant failures in its manufacturing of any Product such that the amount of such Product successfully manufactured by Accuray or any of its Subsidiaries in accordance with all applicable laws specifications thereof and regulations along the required payments related thereto in any twelve (12) month period have decreased by more than twenty percent (20%) with appropriate monitoring respect to the quantities of clinical investigator trial sites for such Product produced in the prior twelve (12) month period.
6. There has been no material untrue statement of fact and no fraudulent statement made by Accuray or any of its Subsidiaries or any of their compliancerespective agents or representatives to the FDA, NRC, or any other Governmental Authority, and (iii) the Credit Parties and their Subsidiaries have there has been no failure to disclose any material fact required to be disclosed to the Agent all such regulatory filings and all material communications between representatives FDA, NRC or any other Governmental Authority.
7. To the best knowledge of the Credit Parties Parties, no insurance company, managed care organization or Governmental Authority has (i) terminated coverage or reimbursement for procedures and their treatments performed using the CyberKnife and TomoTherapy Products, or (ii) reduced the scope of coverage or the rate of reimbursement it provides for procedures and treatments performed using the CyberKnife and TomoTherapy Products, and, in the case of this clause (ii), such reduction could reasonably be expected to have a materially adverse impact on the revenues of Accuray and its Subsidiaries) and . None of Accuray or any Regulatory Authorityof its Subsidiaries has been the subject of any “for cause” inspection, investigation or audit by any Governmental Authority in connection with any alleged improper activity.
(c) The Credit Parties8. There is no arrangement relating to Accuray or any of its Subsidiaries providing for any rebates, their kickbacks or other forms of compensation or remuneration that are unlawful to be paid to any Person to induce, or in return for obtaining or the referral of business or for the arrangement for recommendation of such referrals. All ▇▇▇▇▇▇▇▇ by Accuray and each of its Subsidiaries for its services have been true and the agents thereof correct in all material respects and are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental AuthoritiesLaw, including the FDA Healthcare Laws.
9. None of Accuray or any of its Subsidiaries, or, to the knowledge of the Credit Parties, any individual who is an officer, director, employee or manager of Accuray or any of its Subsidiaries has been convicted of, charged with or, to the knowledge of the Credit Parties, investigated for any federal or state health program-related offense or been excluded or suspended from participation in any such program; or, to the knowledge of the Credit Parties, within the past five (5) years, has been convicted of, charged with or, to the knowledge of the Credit Parties, investigated for a violation of any Law related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances, or has been subject to any judgment, stipulation, order or decree of, or criminal or civil fine or penalty imposed by, any Governmental Authority related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances. None of Accuray or any of its Subsidiaries or, to the knowledge of the Credit Parties, any individual who is an officer, director, employee or manager of Accuray or any of its Subsidiaries has been convicted of any crime or engaged in any conduct including but not limited to any misrepresentation to any Governmental Authority or that has otherwise resulted or would reasonably be expected to result in a debarment or exclusion (i) under 21 U.S.C. Section 335a, or (ii) any similar applicable Law. No debarment proceedings or investigations in respect of the business of Accuray or any of its Subsidiaries are pending or, to the knowledge of the Credit Parties, threatened against Accuray or any of its Subsidiaries or any individual who is an officer, director, employee or manager of Accuray or any of its Subsidiaries.
10. All studies, tests and all other Regulatory Authoritiespreclinical and clinical trials conducted relating to the Products, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their sponsored by Accuray or any of its Subsidiaries have been conducted, and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance currently being conducted, in all material respects in accordance with all applicable registration Law and listing requirements set forth IDEs, including procedures and controls pursuant to, where applicable, current good clinical practices and current good laboratory practices and other applicable laws, rules regulations. To the extent required by applicable Law, Accuray and each of its Subsidiaries has obtained all necessary authorizations from Governmental Authorities and IECs, including an IDE for the conduct of any clinical investigations conducted by or on behalf of Accuray or such Subsidiary, as applicable.
11. To the knowledge of the Credit Parties, none of the clinical investigators in any clinical trial sponsored by Accuray or any of its Subsidiaries has been or is disqualified or otherwise sanctioned by the FD&C Act FDA, the Department of Health and Human Services, or equivalent regulation of each other any Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect and, to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d)knowledge of the Credit Parties, no Credit Party nor such disqualification, or other sanction of any such clinical investigator is pending or threatened. None of Accuray or any of its Subsidiaries has received from any Regulatory the FDA or other applicable Governmental Authority any notice notices or correspondence requiring or threatening the termination, suspension, material modification or clinical hold of alleged non-compliance any studies, tests or adverse findings clinical trials with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoProducts.
Appears in 1 contract
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(aFor the last seven (7) is a complete years, the Company Group Members have obtained all clearances, authorizations, licenses and accurate list of registrations required by any foreign or domestic Governmental Authorities (including, without limitation, the FDA and EMA) to permit the Company Group Members to conduct their business as currently conducted. The Company Group Members have filed with the applicable regulatory authorities (including, without limitation, the FDA, the EMA or any other Governmental Authority performing functions similar to those performed by the FDA and EMA) all material Regulatory Authorizations relating filings, notices, responses to notices, supplemental applications, declarations, listings, registrations, reports or submissions, including but not limited to adverse event reports required to be filed prior to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis)Agreement Date. All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiariesfilings, as applicabledeclarations, free and clear of all Liens other than Permitted Lienslistings, registrations, reports or submissions are, and were since filing (ii) as applicableor were corrected in or supplemented by a subsequent filing), validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with Applicable Laws and all formal filing and maintenance requirements, and no material deficiencies have been asserted by any applicable statutesGovernmental Authority with respect to any such filings, declarations, listing, registrations, reports or submissions that have not been cured.
(b) For the last seven (7) years, all preclinical studies, and Clinical Trials and investigations sponsored or conducted by the Company Group Members have been, and are being, conducted in material compliance with Applicable Laws, and the rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all any applicable Governmental AuthoritiesAuthority, including including, as applicable, Good Laboratory Practices and Good Clinical Practices requirements, and federal and state, national and supranational Applicable Laws, rules, regulations and guidance restricting the use, transfer and disclosure of individually identifiable health information and human subject or patient clinical biological samples. The Company Group Members have not received any written notices or other correspondence from any institutional review board, ethics committee, safety monitoring committee or the FDA and all or any other supranational, foreign, federal, state or local governmental or Regulatory Authorities, Authority performing functions similar to those performed by the FDA with respect to each Product any ongoing Clinical Trials or preclinical studies or tests requiring the termination, suspension or material modification of such studies or tests, and all Product Development and Commercialization Activities related thereto. to the Company’s knowledge, no such action has been threatened.
(c) The Credit Parties and their Subsidiaries Company Group Members have and maintain in full force and effect all the necessary and requisite not received any written notice from any Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act Authority withdrawing or placing any Investigational New Drug application or equivalent regulation application in other countries related to any Company Product or Service, on “clinical hold” or requiring the termination or suspension or investigation of each other Governmental any preclinical studies or Clinical Trials conducted or sponsored by the Company Group, and to the Company’s knowledge there are no pending actions by any Regulatory Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities against or affecting the Company Group with respect to any Company Product or Service or relating to or arising under any Applicable Laws relating to government health care programs, private health care plans or the Products privacy and confidentiality of patient health information. The Company Group Members have made available to Buyer complete and correct copies of all material serious adverse event reports, non-clinical expedited safety reports and periodic adverse event reports, and all material Regulatory Authority communications and documents submitted by the Company Group Members to or received by the Company Group Members from the FDA, the European Commission, the EMA or any other Regulatory Authority, including any material meeting minutes, scientific advice, inspection reports, warning letters and similar documents, relating to the Company Group, the conduct of the business of the Company Group or any Company Product Development and Commercialization Activities related theretoor Service.
(d) Except as set forth on Schedule 6.19(d)For the last seven (7) years, the Company Group Members have not, and to the Company’s knowledge, no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which representedCompany Representative has, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5i) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements statement to the FDA or any other Regulatory Governmental Authority, (ii) failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Governmental Authority, or (iii) committed an any other act, made a statement, any statement or failed to make a statement thatany statement, that (in any such case) establishes, or would have established at the time such disclosure statement was made (or was not made), could reasonably be expected to provide a reasonable basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery Bribery, and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) Gratuities Policy or any Governmental Authority to invoke any similar policyApplicable Law. To the Company’s knowledge, the Company Group Members are not the subject of any pending or threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Policy or any Governmental Authority to invoke any similar Applicable Law.
(e) The Company Group Members are in compliance and have been in compliance in all material respects with all Healthcare Laws applicable to the operation of its business as currently conducted. The Company Group Members are not subject to any enforcement, regulatory or administrative proceedings against or affecting the Company Group relating to or arising under the FDCA or similar Applicable Law, and no such enforcement, regulatory or administrative proceeding has been threatened in writing.
(f) Except as set forth on Schedule 6.19(f)The Company Group Members have never been and none of the Company Representatives (while employed or engaged by the Company Group) has ever been, no Credit Party nor (i) debarred (under the provisions of the Generic Drug Enforcement Act of 1992, 21 U.S.C. §335a) or equivalent foreign law, (ii) convicted of a crime for which a person can be debarred or (iii) indicted for a crime or otherwise engaged in conduct for which a person can be debarred or excluded from participating in any of its Subsidiaries has received any written notice that the FDA U.S. federal health care programs or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,equivalent foreign law.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests Any manufacture of a Company Product or Service used in any Clinical Trials conducted or sponsored by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development Company Group Members have participated, were (and if still pending, are) being been conducted in accordance material compliance with the applicable requirements of current Good Manufacturing Practices and all applicable Regulatory Authorizations and Healthcare Laws in all material respectsother Applicable Laws.
(h) The transactions contemplated Except as disclosed on Section 3.13(h) of the Company Disclosure Schedule, there has not occurred (A) any adverse event(s) in a nonclinical study or Clinical Trial or any other setting that are deemed by the Loan Documents study director or investigator in such nonclinical study or Clinical Trial to be at least possibly related to the Company Product or Service, or (or contemplated by B) the conditions to effectiveness failure of any Loan DocumentClinical Trial for the Company Product or Service to achieve one or more of its primary endpoints in any material respect, or (C) will not impair any Credit Party’s failure of the Company Group or any Third Party service provider acting on behalf of its Subsidiaries’ ownership a Company Group Member to adhere to the requirements under the FDCA, the regulations and guidance documents of or rights under (the FDA promulgated thereunder, the equivalent Applicable Laws and guidance of the EU, or the license EU member states, or any other equivalent foreign authority or any Governmental Permit (including the right failure to usepossess or maintain the validity of any Governmental Permit), as the case may be(x) any Regulatory Authorizations relating to the Products in any material manner, investigational use and no consent clinical trials of the Company Product or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies Service or (y) with respect theretoto the making of untrue or fraudulent statements, the failure to disclose information, or any failure to adhere to clinical protocols or informed consent requirements, which, individually or in the aggregate as to (A), (B) and (C) above would at the time of such of such adverse event or failure, as applicable, reasonably be expected to prevent or materially delay the filing of or require the withdrawal, suspension or termination of an Investigational New Drug application in the United States or equivalent application in other countries covering the Company Product or Service, or prevent or materially delay the Company Product or Service from obtaining Approval.
Appears in 1 contract
Sources: Stock Purchase Agreement (Quince Therapeutics, Inc.)
Regulatory Matters. With respect to each Product:
(a) Set To the extent that they have conducted or been responsible for such activities, whether directly or indirectly (including through any third party other than K-V), FP1096, FemmePharma and their Affiliates have performed all human Clinical Trials with the Initial Danazol Product in accordance with all applicable Laws and all filings with, and approvals, licenses and authorizations by, Regulatory Authorities, including Marketing Authorization Applications and Regulatory Approvals. Except as set forth on Schedule 6.19(a) is a complete and accurate list in Section 3.7 of all material Regulatory Authorizations relating the FP1096 Disclosure Letter, to the Credit Parties extent that they have conducted or been responsible for such activities, whether directly or indirectly (including through any third party other than K-V), FP1096, FemmePharma and their SubsidiariesAffiliates have performed all Development and Manufacturing, use and disposition of the conduct of their businessInitial Danazol Product in accordance with all applicable Laws, including applicable good manufacturing practices, good laboratory practices and other regulations, and the Products (on a per all filings with, and approvals, licenses and authorizations by, Regulatory Authorities, including Marketing Authorization Applications, and Regulatory Approvals. No Initial Danazol Product basis)has been marketed or commercially distributed by FP1096, FemmePharma or their Affiliates. All such material Regulatory Authorizations Authorities with which FP1096 has had any filing, correspondence or other communications concerning the Initial Danazol Product are (ilisted in Section 3.7(a) legally and beneficially owned exclusively by of the Credit Parties FP1096 Disclosure Letter, including a brief description of the nature of each related item of Regulatory Documentation in its possession or control. FP1096 has not had any filing, correspondence or other communications with Regulatory Authorities concerning any K-V Products other than the Initial Danazol Product. As of the Closing Date, FP1096, FemmePharma and their Subsidiaries, as applicable, free and clear of Affiliates have delivered to K-V all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, Regulatory Documentation in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications its possession or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect control related to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental AuthoritiesInitial Danazol Product.
(b) None of FP1096, FemmePharma and their Affiliates have (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authorityfact, (ii) failed to disclose a material fact required fact, or (iii) submitted inaccurate or misleading Regulatory Documentation to be disclosed any Regulatory Authority with respect to the Initial Danazol Product or any component of the Initial Danazol Product.
(c) The FP1096 Disclosure Letter sets forth a list of all Marketing Authorization Applications and Regulatory Approvals sought or received and Clinical Trials that are being or have been conducted prior to the Closing Date by FP1096, FemmePharma and their Affiliates, for the Initial Danazol Product. As of the Closing Date, FP1096 is the exclusive sponsor of all such Clinical Trials and owns all right, title and interest in and to all such Marketing Authorization Applications, Regulatory Approvals, and other Regulatory Documentation. As of the Closing Date, there have been no Marketing Authorization Applications and Regulatory Approvals sought or received or Clinical Trials that are being or have been conducted prior to the Closing Date by FP1096, FemmePharma and their Affiliates, for K-V Products other than the Initial Danazol Product. FP1096 shall give K-V notice and copies (if applicable) of all future correspondence, notices and other communications received from the FDA or any other Regulatory AuthorityAuthorities relating to the Initial Danazol Product and, or committed an actunless requested by K-V in writing, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for will no longer communicate with the FDA or any such other Regulatory Authorities with respect to the Initial Danazol Product.
(d) As of the Closing Date, FP1096 has given the FDA (and any applicable Regulatory Authorities outside the United States) written notice of the change of control of the Marketing Authorization Applications for the Initial Danazol Product, authorizing FP1096, K-V and its Affiliates to communicate with the FDA and such Regulatory Authorities with respect to all matters related thereto. As of the Closing Date, FP1096 has given written notice (to the extent necessary) to all Regulatory Authorities of the transfer to FemmePharma of all human Clinical Trials and any Marketing Authorization Applications for all products other than the K-V Products and has transferred to FemmePharma all Clinical Trials and any Marketing Authorization Applications and all Liabilities associated with such other products under all applicable Laws.
(e) The FP1096 Disclosure Letter lists all significant event(s) and circumstances that, to FP1096's Knowledge, will have a material adverse effect on achieving Regulatory Approval for the Initial Danazol Product, including, but not limited to, adverse drug experiences, clinical holds or suspensions, and governmental inquiries, competitive products, and materials, supply and use factors. Without limiting the foregoing, FemmePharma has disclosed to K-V prior to the date hereof in writing all failures, and allegations by any Regulatory Authority of failure of FP1096, FemmePharma or their Affiliates to invoke comply with the provisions of applicable Laws in any manner which affects or could affect the Manufacture, Development, marketing or other commercialization of the Initial Danazol Product, the performance by FP1096 or FemmePharma of its policy respecting Fraudobligations under this Agreement, Untrue Statements or the use and other exploitation of Material Factsthe Retained Assets or performance of the FP1096 Business by or under authority of Surviving Corporation and K-V, Bribery and Illegal Gratuitiesor otherwise expose Surviving Corporation to Liability that, set forth in 56 Fed. Reg. 46191 (September 10to FP1096's Knowledge, 1991) or any similar policywill have a material adverse effect on achieving Regulatory Approval for the Initial Danazol Product.
(f) Except as set forth on Schedule 6.19(f)Other than with respect to the Initial Danazol Product, no Credit Party FP1096 has not (i) sponsored or conducted any Clinical Trials, nor commenced any of its Subsidiaries has Development or Manufacturing activities relating to any K-V Product or (ii) sought or received any written notice that the FDA or Regulatory Approvals relating to any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any K-V Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted developed by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respectsFP1096.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.
Appears in 1 contract
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) is a complete As between the Parties, CRISPR shall have sole and accurate list of all material Regulatory Authorizations relating exclusive authority to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally prepare and beneficially owned exclusively by the Credit Parties file Regulatory Filings and their Subsidiariesseek Marketing Approvals, as applicable, free each in its own name (or the name of its designee(s)), for all Licensed Products in the Field in the Territory; (ii) conduct all correspondence, meetings, teleconferences and clear other communications with Regulatory Authorities with respect to such Licensed Products in the Field in the Territory, both prior to and following Marketing Approval, including all communications and decisions with respect to (1) labeling of all Liens other than Permitted LiensLicensed Products, and (ii2) as applicablethe negotiation of pricing and reimbursement of the Licensed Products; and (iii) file all INDs, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) NDAs and other reports of adverse experiences filings with Regulatory Authorities for all Licensed Products in the Field in the Territory. Without limiting the foregoing, during the Term, neither Sirius nor its Affiliates will prepare or product malfunctions, and reports of corrections or removal) and other required filings file any Regulatory Filings with any Regulatory Authority with respect to any Licensed Product Candidate or Licensed Product in the Products for Field in the last five (5) years have been timely filed with the FDA and all other applicable Governmental AuthoritiesTerritory.
(b) (i) All regulatory filings required by any As between the Parties, ownership of all right, title and interest in and to all Regulatory Authority or in respect of any Filings and Regulatory Authorization with respect Approvals that are directed to any Licensed Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more Field in each country of Net Sales in any applicable year, the Territory will be held by and in the last five (5) years have been madename of CRISPR, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulationsits Affiliates, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authorityor Sublicensees.
(c) The Credit PartiesUpon CRISPR’s reasonable request, their Subsidiaries Sirius will, and the agents thereof are in compliance in all material respects will cause its Affiliates to, cooperate with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, CRISPR with respect to each all regulatory matters relating to any Licensed Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act Field in the Territory, including without limiting the foregoing, (i) assisting CRISPR in preparing Regulatory Filings for Licensed Products and making all information Controlled by Sirius or equivalent regulation its Affiliates available to CRISPR to the extent necessary or reasonably useful in connection with such Regulatory Filings; and (ii) supporting the Development of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Licensed Products by providing Regulatory Authorities with respect to the Products direct access to, and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to useaudit, as the case may be) any Know-How that are Controlled by Sirius or its Affiliates and are relied on by CRISPR in its Regulatory Authorizations relating to the Filings for Licensed Products in any material mannerthe Field in the Territory. [***]. For the avoidance of doubt, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto[***].
Appears in 1 contract
Sources: Collaboration, Option and License Agreement (CRISPR Therapeutics AG)
Regulatory Matters. With respect to each Product:
(a) Set forth The Regulated Subsidiary is an authorized person and has a Part IV permission to carry on Schedule 6.19(a) regulated activities under the Financial Services and ▇▇▇▇▇▇ ▇▇▇ ▇▇▇▇ (the “FSMA”). Since the Reference Date, no written notice has been received from the FSA that such permission is a complete likely to be revoked. Complete and accurate list details of all material Regulatory Authorizations relating the permission granted to the Credit Parties and their Subsidiaries, Regulated Subsidiary by the conduct FSA under Part IV of their businessthe FSMA are set forth in Schedule 2.21(a), and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear Company has made available to Parent copies of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports scope of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authoritiespermission notices related thereto.
(b) (i) All regulatory filings required Since the Reference Date, all regulated activities carried on by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years Regulated Subsidiary have been madecarried on in compliance with FSMA, all regulations made under FSMA and all such filings above such threshold are complete the provisions of the handbook of rules and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted guidance issued by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their complianceFSA (the “FSA Rules”). Under the FSA rules, and (iii) no Group Company, other than the Credit Parties and their Subsidiaries have disclosed Regulated Subsidiary, is required to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authorityobtain an FSA authorization.
(c) The Credit PartiesAll directors and employees of the Regulated Subsidiary who perform any controlled functions (as defined by section 59 of FSMA) are approved by the FSA in accordance with Part V of FSMA, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutesand, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related theretoCompany’s Knowledge, since the Reference Date no director or employee of the Regulated Subsidiary has at any time performed any controlled function in contravention of Part V of FSMA or the FSA Rules.
(d) Except The internal procedures of each Group Company are, where applicable, in accordance with the requirements of the Money Laundering Regulations 2007, the Proceeds of Crime ▇▇▇ ▇▇▇▇, any FSA anti-money laundering requirements, the Joint Money Laundering Steering Group’s Guidance Notes for the Financial Sector and all other applicable anti-money laundering and terrorist financing obligations and requirements (together, the “Money Laundering Rules”), and, to the Knowledge of the Company, the business of each Group Company has, since the Reference Date, been conducted in accordance with the Money Laundering Rules. No Group Company has, since the Reference Date, received any written notification or indication that it is in breach of the Money Laundering Rules.
(e) Since the Reference Date, no Group Company has, and no director, officer or employee of any Group Company has, been the subject of any known investigation, censure, disciplinary hearing or fine by the FSA, the OFT, or any other financial services regulatory authority in any jurisdiction.
(f) Other than in relation to the transactions contemplated by this Agreement, except as set forth on Schedule 6.19(d2.2l(e), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings since the Reference Date, all required approvals and consents with respect to any Product acquisition, increase or any Product Development and Commercialization Activities related thereto which represented, reduction in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 control of the FD&C Act, or any other similar communication from any Regulatory Authority within Regulated Subsidiary for the last five (5) years. Except as set forth on Schedule 6.19(d), there purposes of Part XII FSMA have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,obtained.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf Copies of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respectscorrespondence between the Regulated Subsidiary and the FSA, and between each other Group Company and the FSA, since the Reference Date have been made available to Parent.
(h) The transactions contemplated by A copy of the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating last annual return submitted to the Products in any material manner, and no consent or other authorization FSA on behalf of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoRegulated Subsidiary has been made available to Parent.
Appears in 1 contract
Sources: Merger Agreement (Bankrate, Inc.)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) Seller and each Subsidiary of Seller is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, has been in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all Laws applicable laws to Seller Products and regulationsSeller’s activities, (ii) including, without limitation, product design, development, testing, manufacture, marketing, distribution, labeling, storage and transport, in all clinical and pre-clinical trials, if any, jurisdictions in which such acts or any of investigational Products them occurred or are reasonably likely to occur or such products or any of them have been and or are being conducted likely to be sold or used (including any Laws administered by the Credit Parties United States Food and their Subsidiaries Drug Administration (“FDA”)). The labeling claims and advertising and promotional claims made by Seller and each Subsidiary of Seller for any Seller Products are and have been consistent with the scope of regulatory clearance, exemption or approval for each such product in accordance with each jurisdiction where it is marketed in all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliancematerial respects, and (iii) the Credit Parties supported by proper research design, testing, analysis and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authoritydisclosure that conforms with Laws.
(cb) The Credit PartiesSeller Products and activities and facilities of Seller and each of Seller’s Subsidiaries, their Subsidiaries as well as, to Seller’s knowledge, its suppliers, distributors, contractors and the agents thereof other intermediaries, are and have been in compliance in all material respects with all applicable statutesrequirements of the Federal Food, rules Drug, and regulations Cosmetic Act (including all Healthcare Laws “FDCA”) and Regulatory Authorizations) of all applicable Governmental Authoritiesimplementing FDA regulations, including the FDA registration, listing, premarket notification, labeling and manufacturing requirements of 21 C.F.R. Parts 807, 809 and 820, all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the extent applicable to any Seller Products and all Product Development and Commercialization Activities related thereto.
(d) Seller’s services. Except as set forth on Schedule 6.19(d)in Section 5.20(b) of the Seller Disclosure Schedule, no Credit Party nor any Seller and each Subsidiary of its Subsidiaries Seller is not and has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect not been subject to any Product obligation or requirement arising under any Product Development and Commercialization Activities related thereto which representedconsent decree, in consent agreement, or warning letter issued by or entered into with the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from Governmental Authority or other notice, response or commitment made to the FDA or any Regulatory Authority other Governmental Authority. Seller has made available to Parent true, correct and complete copies of all customer complaints relating to any Seller Products and all Medical Device Reports, in each case, filed with the FDA within the last five (5) years. Except as set forth on Schedule 6.19(dSeller has made available to Parent true, complete and correct copies of all warning letters, untitled letters, notices of inspectional observations (Form FDA 483s), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requestedsimilar notices, or threatened by other correspondence relating to any Regulatory Authority, Seller Products or (for example in the case of a recall) initiated by Credit Party Seller’s or any of its Seller’s Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved ’ compliance with Laws from the FDA and any other Governmental Authority and all of Seller’s or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year Seller’s Subsidiaries’ responses thereto within the last five (5) years.
(ec) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, Seller has made an untrue statement available to Parent true, correct and complete copies of a material fact (i) all customer complaints relating to any Seller Products and all Medical Device Reports, in each case, filed with the FDA and all MedWatch forms received by the Seller or fraudulent statements to Subsidiary of Seller within the last five (5) years and all comparable adverse event reports from outside the United States; (ii) all warning letters, untitled letters, regulatory letters, notices of inspectional observations (Form FDA 483s), establishment inspection reports (EIRs) or similar notices, or other correspondence, including meeting notes or minutes, from the FDA or any other Regulatory AuthorityGovernmental Authority relating to any Seller Products or Seller’s or any of Seller’s Subsidiaries’ compliance with Laws and all of Seller’s or any of Seller’s Subsidiaries’ responses thereto within the last five (5) years; (iii) a list of all Seller Products marketed within the last five (5) years, failed and for each such product the legal basis for distributing such product in interstate commerce; (iv) all justifications for not filing a 510(k) for a change or modification to disclose a marketed device; (v) all substantially equivalent or not substantially equivalent letters; (vi) all correspondence, meeting notes or minutes, or related documents concerning material fact required communications between the FDA and Seller or a Subsidiary of Seller as they relate to be disclosed 510(k) submissions, including requests for additional information and responses thereto; (vii) all management review reports and management/executive meeting minutes; (viii) all written reports of Good Manufacturing Practices audits of Seller and each Subsidiary of Seller and their suppliers in Seller’s possession or control; and (ix) all product labeling and advertising currently in use, including that posted on Seller’s website and in user manuals.
(d) Except as set forth in Section 5.20(d) of the Seller Disclosure Schedule, since January 1, 2004, no exemptions, clearances or approvals for any Seller Product have been subjected to reevaluation, revocation, rescission, withdrawal, modification, cancellation or suspension by the FDA or other Governmental Authority and no Seller Product has been discontinued (other than for commercial or other business reasons), recalled or subject to a field notification, field correction or removal or safety alert (whether voluntarily or otherwise), nor has the production of such products been enjoined. Except as set forth in Section 5.20(d) of the Seller Disclosure Schedule, since January 1, 2004, no proceedings have occurred (whether completed or pending) seeking to recall, reclassify, re-label, suspend, detain or seize any Seller Product. To Seller’s knowledge, there are no facts which are reasonably likely to cause: (A) the recall, suspension, field notification, field correction or removal, reclassification, re-labeling, detention, seizure or safety alert of any Seller Product or any product intended to be sold by Seller or any Subsidiary of Seller; (B) a change in the marketing classification, clearance or approval or a material change in labeling of any such products; or (C) a termination or suspension of marketing of any such products.
(e) All Seller Products manufactured, distributed, or developed by Seller and each of Seller’s Subsidiaries that are subject to the jurisdiction of the FDA or comparable Governmental Authority are being and have been designed, tested, manufactured, prepared, assembled, packaged, labeled, stored, processed, distributed, and marketed in material compliance with all applicable requirements and implementing regulations thereunder. Seller and each Subsidiary of Seller is, and at all times has been, in compliance with the written procedures, record-keeping, and FDA reporting requirements for Medical Device Reporting set forth in 21 CFR Part 803, and Corrections and Removals set forth in 21 CFR Part 806, and comparable requirements, where applicable, of other Regulatory Governmental Authorities. Seller and Seller’s Subsidiaries have not introduced into commercial distribution any Seller Products which upon their shipment by Seller or Seller’s Subsidiaries were adulterated or misbranded.
(f) All pre-clinical trials and clinical trials conducted by or on behalf of Seller and each of Seller’s Subsidiaries have been, and are being conducted in material compliance with experimental protocols, procedures and controls pursuant to accepted professional scientific standards and all applicable Laws relating thereto, including the FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56 and 812.
(g) Neither Seller, nor any of Seller’s Subsidiaries, nor, to the knowledge of Seller, any of their collective officers, employees or agents has made any false statements on, or material omissions from, any applications, notifications, reports, or other submissions to any Governmental Authority, or committed an act, made a statementany false statements on, or failed to make a statement thatmaterial omissions from, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority records and documentation prepared or maintained to invoke its comply with the requirements of any Governmental Authority. Neither Seller nor any of Seller’s Subsidiaries has ever been or is now subject to FDA’s policy respecting “Fraud, Untrue Statements of Material Facts, Bribery Bribery, and Illegal Gratuities, ,” set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto, or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any comparable policy of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respectsanother Governmental Authority.
(h) The transactions contemplated by Neither Seller, nor any of Seller’s Subsidiaries, nor, to the Loan Documents (knowledge of Seller, any of their collective officers, employees or contemplated by the conditions to effectiveness agents has been convicted of any Loan Documentcrime or engaged in any conduct that could result in a disqualification, debarment under 21 U.S.C. § 335a, or civil penalties or exclusion from state or federal health care programs under 42 U.S.C. §§ 1320a-7, 1320a-7a, 1320a-7b, or 1395nn, or 31 U.S.C. § 3729. No claims, actions, proceedings or investigations that could reasonably be expected to result in such disqualification, debarment, penalty or exclusion are pending or, to the knowledge of Seller, threatened against Seller, each of Seller’s Subsidiaries, or, to the knowledge of Seller, any of their collective officers, employees or agents.
(i) will not impair any Credit Party’s To the knowledge of Seller, there are no investigations, audits, actions, inquiries or other proceedings pending, or threatened, with respect to a violation by Seller or any of its Subsidiaries’ ownership Seller’s Subsidiaries of any Law that reasonably would be expected to result in administrative, civil, or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material mannercriminal liability, and there are no consent facts or circumstances existing that would reasonably be expected to serve as a basis for such an investigation, audit, action, inquiry or other authorization proceeding.
(j) Seller and each of any Governmental Authority Seller’s Subsidiaries is required in connection material compliance with the transactions contemplated herebyall applicable FDA import and export requirements, including the Liens granted in connection herewith including, without limitation, import-for-export requirements, export notifications or authorizations and the exercise of rights and remedies with respect theretorecord keeping requirements.
Appears in 1 contract
Regulatory Matters. With respect All Product, other than Prototypes, supplied to [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] shall be produced under cGMP and in accordance with the Specifications. CIMA shall furnish [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] with a Certificate of Analysis with a cGMP statement to demonstrate that each Product:
(a) Set forth on Schedule 6.19(a) is a complete shipment of Product has been manufactured under cGMP and accurate list other FDA guidelines and in accordance with the Specifications. In addition, [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] reserves the right, at its own expense, to audit the facility of CIMA, including its processes, records and other facets of the operation as may be necessary to assure that all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their businessapplicable regulations have been complied with, and the Products (on Specifications have been met. CIMA shall permit duly authorized representatives of [***CONFIDENTIAL TREATMENT REQUESTED, PORTION OMITTED FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.***] to audit all manufacturing and processing operations at reasonable times with a per Product basis)prior appointment. All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file The right to audit shall commence with the applicable Governmental Authority, in effective date of this Agreement. These audits will be conducted to assure compliance with all filing and maintenance requirements (including any fee requirements) thereofpertinent acts, regulations, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with guidelines promulgated by the FDA and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority or authorities, as well as standards then in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, effect in the aggregate, 15% or more regulatory environment. Such audits will be permitted during normal business hours and will be performed with a minimum of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related theretodisruption. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.EXHIBIT 10.25
Appears in 1 contract
Sources: Master Development, License and Supply Agreement (Cima Labs Inc)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their SubsidiariesExcept as would not reasonably be expected to be, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications individually or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% material to the Company and its Subsidiaries (taken as a whole): (A) the Company and its Subsidiaries hold all Licenses under the Healthcare Laws (as defined below) that are necessary for the lawful operation of the business of the Company and its Subsidiaries in each jurisdiction in which the Company or more any of Net Sales in any applicable yearits Subsidiaries operates, in including the last five FDCA (5including Section 510(k) years have been madethereof), and all Licenses of any applicable Governmental Entity that has regulatory authority over the testing, development, design, quality, identity, safety, efficacy, manufacturing, labeling, marketing, distribution, commercialization, sale, pricing, import or export of the products sold by the Company (“Company Products” and any such filings above such threshold are complete and correct and have complied Governmental Entity, a “Regulatory Agency”), necessary for the lawful operation of the business of the Company or its Subsidiaries in all material respects with all applicable laws and regulations, each jurisdiction in which the Company or any of its Subsidiaries operates (iithe “Regulatory Permits”); (B) all clinical such Regulatory Permits are valid and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all effect; and (C) the necessary Company and requisite Regulatory Authorizations. The Credit Parties and their its Subsidiaries are in compliance with the terms of all Regulatory Permits. There is no Proceeding to which the Company is subject pending or, to the Knowledge of the Company, threatened in all writing that would result in the termination, revocation, suspension or the imposition of a restriction on any such Regulatory Permit or the imposition of any fine, penalty or other sanction for violation of any such Regulatory Permit, in each case, except as would not reasonably be expected to be, individually or in the aggregate, material respects with to the Company and its Subsidiaries (taken as a whole).
(ii) Except as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries (taken as a whole), the business of the Company and its Subsidiaries is being conducted in compliance with: (A) the FDCA (including all applicable registration and listing requirements set forth in Section 510 of the FD&C FDCA (21 U.S.C. § 360) and 21 C.F.R. Part 807); (B) the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010; (C) federal Medicare and Medicaid statutes and related state or local statutes; (D) the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(b)), S▇▇▇▇ Law (42 U.S.C. § 1395nn), the federal False Claims Act (31 U.S.C. § 3729 et seq.), the Health Insurance Portability and Accountability Act of 1996 (42 U.S.C. § 1320d et seq.), as amended by the Health Information Technology for Economic and Clinical Health Act, and any comparable federal, state or local Laws; (E) state testing, manufacturing, distribution, commercialization, marketing, licensing, disclosure, gift ban, code of conduct and reporting requirements, including the Physician Payments Sunshine Act (42 U.S.C. § 1320a-7h) and equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all or related state reporting requirements; (F) applicable regulations of all Regulatory Authorities requirements under Data Protection Laws with respect to the Products protection of Personal Information collected or maintained by or on behalf of the Company; (G) the Federal Trade Commission Act; (H) the rules and regulations promulgated pursuant to all Product Development such applicable Laws with respect to any of the foregoing, each as amended from time to time; (I) any comparable foreign Laws for any of the foregoing; and Commercialization Activities related thereto(J) any other Law that governs the healthcare industry, medical device industry or relationships among healthcare and/or medical device providers, suppliers, distributors, manufacturers and patients, as applicable (collectively, “Healthcare Laws”). Except as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries (taken as a whole), there are no Proceedings or subpoenas against the Company or any of its Subsidiaries or any director, officer or current employee of the foregoing pending by or before any Governmental Entity or, to the Knowledge of the Company, threatened in writing against the Company or any of its Subsidiaries or any director, officer or current employee of the foregoing by any Governmental Entity, in each case with respect to Healthcare Laws.
(diii) Except as set forth on Schedule 6.19(d)As of the date of this Agreement, no Credit Party neither the Company nor any of its Subsidiaries (A) is a party to any corporate integrity agreements, monitoring agreements, deferred prosecution agreements, certificate of compliance, consent decrees, settlement orders or similar material agreements with or imposed by any Governmental Entity, and, to the Knowledge of the Company, no such action is currently proposed to the Company and its Subsidiaries or pending with the Company and its Subsidiaries, (B) has any continuing material reporting obligations pursuant to any agreement contemplated by the foregoing clause (A) of this Section 5.5(e)(iii), (C) is or has been a defendant in any litigation arising out of or relating to the federal False Claims Act (31 U.S.C. § 3729 et seq.) or (D) has been served with or received a search warrant, subpoena or civil investigative demand from any Regulatory Authority any notice of alleged non-compliance Governmental Entity.
(iv) Except as would not reasonably be expected to be, individually or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of material to the FD&C Act, or any other similar communication from any Regulatory Authority within the last five Company and its Subsidiaries (5) years. Except taken as set forth on Schedule 6.19(da whole), there have been no recalls(A) since the Applicable Date, market withdrawalsall reports, field notifications claims, permits, adverse event reports, documents, notices, registrations, applications, responses, submissions, modifications, supplements and amendments required to be filed, maintained or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating furnished to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach Agency by the Company or violation of any applicable Regulatory Authorization, including that any of its Subsidiaries have been so timely filed, maintained or furnished under such applicable legal requirements (“Healthcare Submissions”) and (B) all such Healthcare Submissions were compliant in all respects with applicable legal requirements at the Products is misbranded time of filing (or adulterated were corrected in or supplemented by a subsequent filing).
(v) Except as defined in the FD&C Actwould not reasonably be expected to be, in each case of the foregoing, which represented, individually or in the aggregate, 15% or more material to the Company and its Subsidiaries (taken as a whole), from the Applicable Date to the date of Net Sales in any applicable year within this Agreement, to the last five (5) years.
(e) No Credit PartyKnowledge of the Company, neither the Company nor any of its Subsidiaries, Subsidiaries nor any officer, officer or employee of the Company or agent thereofany of its Subsidiaries, has made an untrue statement of a material fact or a fraudulent statements statement to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory AuthorityFDA, or committed an act, made a statement, statement or failed to make a statement thatstatement, in each case, related to the business and which, at the time such disclosure was made (or was not made), could would reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting the “Fraud, Untrue Statements of Material Facts, Bribery Bribery, and Illegal Gratuities, ” policy of the FDA set forth in 56 Fed. Reg. 46191 (September 10, 1991) ). From the Applicable Date to the date of this Agreement, neither the Company nor any of its Subsidiaries nor, to the Knowledge of the Company, any officer or employee of the Company or any similar policyof its Subsidiaries, has been debarred or convicted of any crime. From the Applicable Date to the date of this Agreement, to the Knowledge of the Company, neither the Company nor any of its Subsidiaries nor any director, officer or employee of the Company or any of its Subsidiaries, has been excluded from participating in any federal health care program or convicted of any crime except, in each case, as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries (taken as a whole).
(fvi) All pre-clinical and clinical studies, tests or investigations conducted or sponsored by or on behalf of the Company or any of its Subsidiaries have been or are being conducted in compliance in all material respects with all applicable Healthcare Laws and other requirements under the Healthcare Laws issued by the applicable Regulatory Agencies, including Good Laboratory Practices, Good Clinical Practices, FDA standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials and the protection of human subjects, including Title 21 parts 11, 50, 54, 56 and 812 of the Code of Federal Regulations and any comparable state and local legal requirements regulating the conduct of pre-clinical and clinical investigations and the protection of human subjects, except, in each case, as would not reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries (taken as a whole).
(vii) Except as set forth on Schedule 6.19(fwould not reasonably be expected to, individually or in the aggregate, have a Material Adverse Effect, neither the Company nor any of its Subsidiaries has received, since the Applicable Date, any FDA Form 483 observations, notice of adverse finding, warning letters, notice of violation, inspection or audit reports from any Regulatory Agency identifying any non-compliances, subpoenas, investigations, actions, demands or notices relating to any alleged non-compliance, which would reasonably be expected to be, individually or in the aggregate, material to the Company and its Subsidiaries (taken as a whole) or to lead to the denial, suspension or revocation of any License or grant for marketing approval with respect to any Company Product currently pending before or previously approved or cleared by the FDA or such other Regulatory Agency.
(viii) Since the Applicable Date, except as would not reasonably be expected to, individually or in the aggregate, have a Material Adverse Effect, neither the Company nor any Subsidiary has voluntarily or involuntarily initiated, conducted or issued, caused to be initiated, conducted or issued, any recall, field corrective action, market withdrawal, seizure, suspension, replacement, safety alert, written warning, “dear doctor” letter, investigator notice to healthcare wholesalers, healthcare distributors, healthcare retailers, healthcare professionals or patients (including any action required to be reported or for which records must be maintained under 21 C.F.R. Part 806) relating to any Company Product (collectively, a “Recall”) or, as of the date hereof, currently intends to initiate, conduct or issue any Recall of any Company Product. Except as would not reasonably be expected to be material to the Company and its Subsidiaries (taken as a whole), no Credit Party neither the Company nor any of its Subsidiaries has received any written notice that from the FDA or any other applicable Regulatory Authority has commenced Agency regarding (x) any Recall of any Company Product or initiated(y) a change in the marketing status or classification, or threatened to commence or initiatea material change in the labeling, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products such Company Product or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, (z) a negative change in the aggregate, 15% or more reimbursement status of Net Sales in any applicable year,a Company Product.
(gix) Except as set forth on Schedule 6.19(g), The Company and its Subsidiaries have instituted and maintain policies and procedures reasonably designed to ensure the clinical, preclinical, safety and integrity of data generated or used in any clinical trials or other studies and tests conducted by or on behalf of or sponsored by related to the Credit Parties and their Subsidiariesdevelopment, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as handling, safety, efficacy, reliability or manufacturing of the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoCompany Products.
Appears in 1 contract
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to The Acquired Corporations have filed with the Credit Parties and their Subsidiariesapplicable regulatory authorities (including the FDA, the conduct of their businessEMA or any other Governmental Body performing functions similar to those performed by the FDA) all required material filings, and declarations, listings, registrations, reports or submissions, including but not limited to Adverse Drug Reaction Reporting, since the Products (on a per Product basis)IPO Date. All such filings, declarations, listings, registrations, reports or submissions were in material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Lienscompliance with applicable Legal Requirements when filed, and (ii) as applicable, validly registered and on file with the no deficiencies have been asserted in writing by any applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings Body with respect to the Products for the last five (5) years any such filings, declarations, listings, registrations, reports or submissions that have not been timely filed with the FDA and all other applicable Governmental Authoritiesremedied.
(b) (i) All regulatory filings The Acquired Corporations hold all material Regulatory Permits required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been madefor their business as currently conducted, and all each such filings above such threshold are complete Regulatory Permit is valid and correct in in full force and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) effect. The Credit Parties, their Subsidiaries and the agents thereof Acquired Corporations are in compliance in all material respects with all the terms and requirements of such Regulatory Permits. Since the IPO Date, no deficiencies have been asserted in writing by any applicable statutesGovernmental Body with respect to any Regulatory Permits of the Acquired Corporations.
(c) Since the IPO Date, the Acquired Corporations have not received any written notice from a Governmental Body that any of their products are misbranded as defined in 21 U.S.C. § 352 or adulterated as defined in 21 U.S.C. § 351, as amended, and the rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authoritiespromulgated thereunder, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain or as defined in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are comparable Legal Requirements in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related theretoany jurisdiction.
(d) Except as set forth on Schedule 6.19(d)in Company Disclosure Schedule, no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance all preclinical and clinical investigations sponsored by the Acquired Corporations (each such preclinical or adverse findings clinical investigation with respect to any Product a material product or any Product Development product candidate of the Acquired Corporations, a “Clinical Study”) have been and Commercialization Activities related thereto which represented, are being conducted in the aggregate, 15% or more of Net Sales in any material compliance with applicable yearLegal Requirements, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) yearsGood Clinical Practice Requirements. No Credit Party nor any of its Subsidiaries Acquired Corporation has received any written notification that remains unresolved notice or other correspondence from the FDA FDA, the EMA or any other Regulatory Authority indicating any breach Governmental Body performing functions similar to those performed by the FDA requiring the termination, suspension or violation material modification of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) yearsongoing Clinical Study.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, Acquired Corporation has (i) made an untrue statement of a material fact or fraudulent statements statement to the FDA FDA, the EMA or any other Regulatory Authoritysimilar Governmental Body, (ii) failed to disclose a material fact required to be disclosed to the FDA FDA, the EMA or any similar Governmental Body or (iii) committed any other Regulatory Authority, or committed an act, made a statement, any statement or failed to make any statement, that (in any such case) establishes a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a reasonable basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery Bribery, and Illegal GratuitiesGratuities Final Policy or for any other Governmental Body to invoke any similar policy. As of the date of this Agreement, set forth no Acquired Corporation is the subject of any pending or, to the knowledge of the Company, threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or by any other Governmental Body under any similar policy. No Acquired Corporation nor, to the knowledge of the Company, any officer, employee or agent of an Acquired Corporation nor any clinical investigator conducting any Clinical Studies has been suspended or debarred or convicted of any crime or engaged in 56 Fed. Reg. 46191 any conduct that would reasonably be expected to result in (September 10, 1991A) debarment under 21 U.S.C. § 335a or any similar policyLegal Requirement or (B) exclusion under 42 U.S.C. § 1320a-7 or any similar Legal Requirement.
(f) Except as set forth on Schedule 6.19(f)Each Acquired Corporation, no Credit Party nor any to the knowledge of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiatedCompany, or threatened to commence or initiateis in compliance and has, any action to withdraw any Regulatory Authorizationsince the IPO Date, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiarybeen in compliance, in each case, which representedin all material respects, with all pharmaceutical- and healthcare-related Legal Requirements applicable to the operation of its business, including (together with their implementing regulations and in each case as amended) (i) the aggregateFDCA; (ii) the Public Health Service Act, 15% (iii) the Health Insurance Portability and Accountability Act of 1996; (iv) the Health Information and Technology for Economic and Clinical Health Act; (v) the federal Medicare and Medicaid statutes; (vi) government program and price reporting Legal Requirements under the Medicaid Drug Rebate Program (42 U.S.C. § 1396r-8), the Medicare program (42 U.S.C. § 1395w-3a), the United States Department of Veterans Affairs Federal Supply Schedule (38 U.S.C. § 8126) including requirements under related contracts and agreements; (vii) the Physician Payments Sunshine Act; (viii) the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(b)); (ix) the federal False Claims Act (42 U.S.C. § 1320a-7b(a)); (x) the Civil Monetary Penalty provisions of the Social Security Act; and (xiii) all applicable foreign Legal Requirements equivalent to any of the foregoing (the “Healthcare Laws”). To the knowledge of the Company, no Acquired Corporation, is subject to any enforcement, regulatory or more of Net Sales administrative proceedings, audit, or investigation against such Acquired Corporation relating to or arising under the Healthcare Laws, and no such enforcement, regulatory or administrative proceeding, or audit or investigation has been threatened in any applicable year,writing.
(g) Except as set forth on Schedule 6.19(g)Since the IPO Date, the clinical, preclinical, safety and other studies and tests there have been no product recalls conducted by the Acquired Corporations and no written requests from any Governmental Body requiring the Acquired Corporations to cease to manufacture, market, distribute or on behalf sell any products of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respectsAcquired Corporations.
(h) The transactions contemplated Acquired Corporations have implemented and have in place a compliance program that satisfies in all material respects the fundamental requirements of the Federal Sentencing Guidelines and the principles established by the Loan Documents Department of Health and Human Services, Office of Inspector General (HHS-OIG).
(i) To the knowledge of the Company, no person has filed against the Company any Legal Proceeding relating to the Company under any federal or state whistleblower statute, including under the False Claims Act of 1863 (31 U.S.C. § 3729 et seq.).
(j) Since the IPO Date, no Acquired Corporation has been notified in writing by any Governmental Body of any failure (or contemplated any investigation with respect thereto) by it or any representative, agent, contract manufacturing organization, contract research organization, clinical investigator or clinical trial site acting on behalf of an Acquired Corporation to comply with any Healthcare Law including those pertaining to the conditions conduct of clinical studies, pharmacovigilance, Good Manufacturing Practice Requirements, Good Laboratory Practice Requirements, Good Clinical Practice Requirements, establishment registration and product listing requirements, requirements applicable to effectiveness the debarment of individuals, requirements applicable to clinical trial sponsors related to financial disclosures for clinical investigators and Adverse Drug Reaction Reporting requirements, in each case with respect to any product or product candidates of any Loan DocumentAcquired Corporation, except for such failures or investigations which would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect.
(k) will not impair Notwithstanding anything to the contrary in this Agreement, none of the representations and warranties in this Section 3.12 are given with respect to any Credit Party’s action (or omission to act) in respect of any research, development, collaboration or similar commercialization activities undertaken jointly between an Acquired Corporation, on the one hand, and Parent or any of its Subsidiaries’ ownership of or rights under , on the other hand, other than any such action (or the license or the right omission to use, as the case may beact) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoby an Acquired Corporation solely on its own behalf.
Appears in 1 contract
Sources: Agreement and Plan of Merger (Akcea Therapeutics, Inc.)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) is a complete The Borrower and accurate list of the Subsidiaries have all material Regulatory Authorizations relating to Permits, including Key Permits and Environmental Permits, necessary or required for the Credit Parties ownership, operation and their Subsidiaries, the conduct of their business, business and ownership of assets and the distribution of the Specified Products and all such Permits are validly held and there are no material breaches, violations or defaults thereunder. No deficiencies have been asserted in writing by any applicable Governmental Authority with respect to any such Permit and to the knowledge of the Borrower no fact, situation, circumstance, condition or other basis exists which, with notice or lapse of time or both, would constitute a material breach, violation or default under such Permit or give any Governmental Authority grounds to suspend, revoke or terminate any such Permit.
(on a per Product basis). b) All such material Regulatory Authorizations Key Permits held by the Borrower and its Subsidiaries are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicableBorrower or such Subsidiary, free and clear of all Liens other than Permitted LiensLiens permitted pursuant to Section 7.01, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in material compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRsof adverse experiences) and other reports filings required to be filed by the Borrower, its Subsidiaries or, to the knowledge of adverse experiences or product malfunctionsthe Borrower, and reports received from any of corrections or removal) and other required filings their respective suppliers with respect to any Specified Products, the Products for business and assets of the last five (5) years have been timely Borrower and each of its Subsidiaries with the applicable Governmental Authorities were duly filed with the FDA and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented. Each such filing was true, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct as of the date of submission, and have complied in all any material respects with all applicable laws and regulationslegally necessary or required updates, (ii) all clinical and pre-clinical trialschanges, if anycorrections, of investigational Products amendments, supplements or modifications to such filings have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed submitted to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory applicable Governmental Authority.
(c) The Credit PartiesTo the knowledge of the Borrower, their Subsidiaries the factual basis for the application to the FDA in respect of, and leading to, the agents thereof are in compliance Wakix ODE was true, correct and complete in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) as of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over date such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect factual basis was represented to the Products FDA, and all Product Development no material misstatements or omissions in such factual basis have been identified or asserted between such dates and Commercialization Activities related theretothe date hereof. None of the Borrower or any of the Subsidiaries has received any written notice that any Key Permits have been or are being revoked, withdrawn, suspended, limited or challenged.
(d) Except Other than as set forth on disclosed in Schedule 6.19(d5.25(d), no Credit Party nor any (i) the Specified Products, as well as the business of the Borrower and its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings Subsidiaries, materially comply with respect to any Product or any Product Development and Commercialization Activities related thereto which represented(A) all applicable material Laws, in the aggregateincluding, 15% or more of Net Sales in any without limitation, all applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 material requirements of the FD&C Act, or any the PHSA and similar applicable state Laws and (B) all Product Authorizations with respect to Specified Products and other similar communication from any Regulatory Authority within Key Permits; (ii) none of the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of Borrower and its Subsidiaries, relating nor, to the knowledge of the Borrower, their respective suppliers, have received any inspection reports, warning letters or untitled letters with respect to any Products which representedSpecified Product of the Borrower and its Subsidiaries, in from any Governmental Authority that assert a lack of compliance with the aggregateFD&C Act, 15% the PHSA and similar applicable state Laws; (iii) none of the Borrower or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from notice of, or otherwise have knowledge of, any pending regulatory enforcement action, investigation or inquiry against the FDA Borrower or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products Subsidiaries, or any of their respective suppliers with respect to the Specified Products, and, to the knowledge of the Borrower, there is misbranded no basis for any adverse regulatory action against the Borrower or adulterated as defined in any of the FD&C ActSubsidiaries or their respective suppliers, in each case of with respect to the Specified Products; and (iv) without limiting the foregoing, (A) (1) there have been no Specified Product recalls, safety alerts, withdrawals, clinical holds, marketing suspensions or removals, undertaken or issued by any Person, whether or not at the request, demand or order of any Governmental Authority or otherwise, with respect to any Specified Product, (2) no such Specified Product recalls, safety alerts, corrections, withdrawals, marketing suspensions or removals have been requested, demanded or ordered by any Governmental Authority, and, to the knowledge of the Borrower, there is no basis for the issuance of any such product recalls, safety alerts, corrections, withdrawals, marketing suspensions or removals by any Person with respect to any Specified Products, and (B) none of the Borrower or any of the Subsidiaries has received any written notice of, and do not otherwise have knowledge of, any criminal, injunctive, seizure, detention or civil penalty actions that have at any time been commenced or threatened in writing by any Governmental Authority with respect to or in connection with any Specified Products, or any consent decrees (including plea agreements) which representedrelate to any Specified Products, in and, to the aggregateknowledge of the Borrower, 15% there is no basis for the commencement for any criminal injunctive, seizure, detention or more civil penalty actions by any Governmental Authority relating to the Specified Products or for the issuance of Net Sales in any applicable year within consent decrees. None of the last five (5) yearsBorrower and its Subsidiaries nor, to the knowledge of the Borrower, any of their respective suppliers is employing or utilizing the services of any individual who has been debarred under any FDA regulations.
(e) No Credit PartyWith respect to Specified Products, nor (i) all design, manufacturing, storage, distribution, packaging, labeling, sale, recordkeeping and other activities by the Borrower or any of its Subsidiaries and, to the knowledge of the Borrower, their respective suppliers relating to the Specified Products have been conducted, and are currently being conducted, in compliance with the applicable requirements of the FD&C Act, the PHSA and other requirements of the FDA and all other applicable Governmental Authorities, including, without limitation, cGMPs and adverse event reporting requirements, and (ii) none of the Borrower or any of its Subsidiaries, nor or, to the knowledge of the Borrower, any officer, employee or agent thereofof their respective suppliers, has received written notice or threat of commencement of action by any Governmental Authority to withdraw its approval of to enjoin production of the Specified Products at any facility, or otherwise to seize any Specified Product. To the knowledge of Borrower, no Specified Product in the inventory of the Borrower or any of its Subsidiaries, or otherwise currently in commercial distribution is adulterated or misbranded. All advertising or other promotion of all Specified Products by the Borrower or any of its Subsidiaries has been conducted in material compliance with applicable FDA requirements for advertising and promotion of pharmaceuticals.
(f) All manufacturing facilities owned or operated by the Borrower or any of the Subsidiaries, or, to the knowledge of the Borrower, used in the production of any Specified Product, are and have been operated in material compliance with cGMPs and all other applicable Laws. The FDA has not issued any written Form 483, Warning Letter, or untitled letter with respect to any such facility, or otherwise alleged in writing any non-compliance with cGMPs.
(g) The Borrower has made an available to the Lenders all written material adverse communications to or from FDA (if any) and other relevant Governmental Authorities of which it has or had a copy, including written inspection reports, warning letters, untitled letters, and material reports and studies, other than opinions of counsel that are attorney-client privileged, with respect to regulatory matters relating to the Borrower and its Subsidiaries, the conduct of their business, the operation of any manufacturing facilities owned or operated by the Borrower or any of its Subsidiaries, and the Specified Products. The Borrower has made available to the Lenders all Key Permits and material written correspondence submitted to or received from FDA, CMS or other Governmental Authority (including minutes and official contact reports relating to any material communications with any Governmental Authority) of which it has or had a copy.
(h) All studies, tests and preclinical and clinical trials conducted relating to the Specified Products by or, to the knowledge of Borrower, on behalf of the Borrower or any of its Subsidiaries and, to the knowledge of the Borrower, their respective licensees, licensors and third party services providers and consultants, have been conducted, and are currently being conducted, in compliance with all applicable Laws in all material respects, including, but not limited to, the FD&C Act, the PHSA, cGCPs and, to the extent required by FDA regulations, cGLPs. Written summaries related to material studies, tests and trials have been made available to the Lenders. To the knowledge of the Borrower, the summaries and descriptions of any of the foregoing provided to the Lenders are accurate in all material respects and contain no material omissions. None of the Borrower and its Subsidiaries, or, to the knowledge of the Borrower, any of their respective licensees, licensors or third party services providers or consultants, has received from the FDA or other applicable Governmental Authority or institutional review board any written notices or correspondence requiring the termination, suspension, material modification or clinical hold of any studies, tests or clinical trials with respect to or in connection with the Specified Products. No clinical trial conducted by or, to the knowledge of the Borrower, on behalf of the Borrower and its Subsidiaries with respect to any Specified Product has used any clinical investigator who has been disqualified under the regulations of the FDA or other applicable Governmental Authority.
(i) There has been no material untrue statement of a fact and no material fact fraudulent statement made by the Borrower or fraudulent statements any of the Subsidiaries, or, to the Borrower’s knowledge, any of their respective agents or representatives to the FDA or any other Regulatory Governmental Authority, failed and there has been no failure to disclose a any material fact required to be disclosed to the FDA or any other Regulatory Governmental Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(fj) Except as set forth on Schedule 6.19(f)There is no arrangement relating to the Borrower or its Subsidiaries providing for any rebates, no Credit Party nor kickbacks or other forms of compensation that are unlawful to be paid to any Person in return for the referral of business or for the arrangement for recommendation of such referrals. None of the Borrower and its Subsidiaries has received any written notice that from the FDA or United States Department of Justice, any other applicable Regulatory Authority has commenced or initiatedU.S. Attorney, any State Attorney General, or threatened to commence or initiateother Governmental Authority alleging any violation of the Federal Anti-kickback Statute, the Federal False Claims Act, the Foreign Corrupt Practices Act, any action to withdraw any Regulatory Authorizationapplicable federal Laws, requested the recall (whether by correction or removal) of any Products similar state or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,foreign Laws.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(hk) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Partythe Borrower’s or any of its the Subsidiaries’ ownership of or rights under (or the license or the other right to use, as the case may be) any Regulatory Authorizations Key Permits relating to the Products in Specified Products.
(l) No right of the Borrower or any material mannerof the Subsidiaries to receive reimbursements pursuant to any government program or private program has ever been terminated or otherwise adversely affected as a result of any investigation or enforcement action, and no consent or other authorization of whether by any Governmental Authority or other Third Party, and none of the Borrower or any Subsidiary has been the subject of any inspection, investigation, or audit, by any Governmental Authority for the purpose of any alleged improper activity or is required aware of any facts which could give rise to such action.
(m) None of the Borrower or any of the Subsidiaries, nor, to the Borrower’s knowledge, any individual who is an officer, director, manager, employee, agent or managing agent of the Borrower or any of the Subsidiaries has been convicted of, or, to the Borrower’s knowledge, charged with or investigated for any federal or state health program-related offense or any other offense related to healthcare or been excluded or suspended from participation in connection any such program; is currently listed on the list of parties excluded from federal procurement programs and non-procurement programs as maintained in the Government Services Administration’s System for Award Management or other federal agencies; or, to the Borrower’s knowledge, within the past five (5) years, has been convicted of, or, to the Borrower’s knowledge, charged with or investigated for a violation of Laws related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances, or has been subject to any judgment, stipulation, order or decree of, or criminal or civil fine or penalty imposed by, any Governmental Authority related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances. None of the Borrower or any of the Subsidiaries, nor, to the Borrower’s knowledge, any individual who is an officer, director, employee, agent or managing agent of the Borrower or any of the Subsidiaries has been convicted of any crime that has resulted or would reasonably be expected to result in a debarment under 21 U.S.C. Section 335a. No debarment proceedings under any FDA regulation in respect of the business of the Borrower or any of the Subsidiaries are pending or, to the Borrower’s knowledge, threatened against the Borrower, any of the Subsidiaries or, to the knowledge of the Borrower, any individual who is an officer, director, manager, employee, agent or managing agent of the Borrower or any of the Subsidiaries. The Borrower and each of its Subsidiaries regularly screens officers, employees, contractors and agents consistent with industry practices for such convictions, exclusions, suspensions, debarments or restrictions.
(n) None of the Borrower or any of its Subsidiaries or any of their respective owners, directors, officers, employees, contractors or agents is a party or bound by any individual integrity agreement, corporate integrity agreement, corporate compliance agreement, deferred prosecution agreement, or other formal or informal agreement with any Governmental Authority concerning compliance with Health Care Laws, any Government Reimbursement Program or the requirements of any Permit and no such agreement is currently contemplated, proposed or pending with the transactions contemplated herebyforegoing representations limited to the knowledge of the Borrower with respect to contractors and agents only.
(o) There are no material Actions, or, to the Borrower’s knowledge, any Actions threatened in writing, against or affecting Borrower or any of its Subsidiaries relating to or arising under any Health Care Laws. None of the Borrower or any of its Subsidiaries has received notice from any third party, including employees, former employees or competitors alleging that any operation or activity of the Liens granted Borrower or any of its Subsidiaries is in connection herewith violation of any Health Care Laws or other Applicable Law. Without limiting the generality of the foregoing, to the Borrower’s knowledge, no Person has filed or has threatened to file against the Borrower or any of its Subsidiaries any legal action under any federal or state whistleblower statute, including under the civil False Claims Act (31 U.S.C. § 3729 et seq.).
(p) None of the Borrower or its Subsidiaries is a “covered entity” or a “business associate” pursuant to HIPAA (as those terms are defined in 45 C.F.R. §160.103).
(q) Each of the Borrower and its Subsidiaries has an operational healthcare compliance program that: (i) governs all employees and contractors, including sales representatives; (ii) is consistent with the exercise current U.S. Federal Sentencing Guidelines standards for effective compliance programs; (iii) complies with the Pharmaceutical Research and Manufacturers of rights and remedies with respect thereto.America Code on I
Appears in 1 contract
Sources: Credit Agreement (Harmony Biosciences Holdings, Inc.)
Regulatory Matters. With respect to each Product:
(a) Set Schedule 3.12(a) of the Buyer Disclosure Letter sets forth on Schedule 6.19(a) is a true and complete and accurate list as of the date hereof of all material Regulatory Authorizations relating to of the Credit Parties Buyer Products, including the dosage form, active ingredient and their Subsidiariesstrength of each such Buyer Product. In respect of the Buyer Products, Schedule 3.12(a) of the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are Buyer Disclosure Letter sets forth (i) legally and beneficially owned exclusively by a description of the Credit Parties and their Subsidiariesregulatory status thereof (as of the date hereof), as applicableincluding the pending or approved NDAs or ANDAs that any of the Buyer Entities has submitted to the FDA in respect of such Buyer Products (collectively, free and clear of all Liens other than Permitted Liens, “Buyer Filed NDAs”); and (ii) as applicable, validly registered and on file with whether the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect particular regulatory status has been presented to the Products for FDA or any other Governmental Entity under the last five (5) years have been timely filed name of one of the Buyer Entities, or under the name of another Person. Copies of the Buyer Filed NDAs and any other material filings or submissions made by the Buyer Entities with the FDA or any other Governmental Entity (1) were reviewed before filing by an employee or other agent of one of the Buyer Entities who is knowledgeable about the contents of the filing and, were true and accurate in all material respects when filed (subject to correction, amendment or supplementation by subsequent filings as required by the FDA or other applicable Governmental AuthoritiesEntity), and were made in good faith upon the best information reasonably available to the Buyer Entities; and (2) have been made available to the Company upon its request.
(b) (iExcept as set forth in Schedule 3.12(b) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development the Buyer Disclosure Letter, the conduct and Commercialization Activities which represented, in operation of the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been madeBuyer Business is, and at all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulationstimes since the Reference Date has been, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all the FDC Act, and applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including issued by the FDA and all other Regulatory Authoritiesapplicable Laws, including any regulatory Laws of any applicable non-U.S. jurisdiction, and in all material respects with respect to each Product all reporting requirements under the FDC Act, the Controlled Substances Act, as amended, the associated rules and regulations promulgated thereunder and all Product Development other applicable Laws. Without limiting the generality of the foregoing, except as set forth in Schedule 3.12(b) of the Buyer Disclosure Letter, (i) the Buyer Entities have obtained all material clearances, authorizations, licenses and Commercialization Activities related thereto. The Credit Parties registrations required by any Governmental Entity (including, without limitation, the FDA, DEA or any other Governmental Entity, domestic or foreign, performing functions similar to those performed by the FDA or DEA) to permit the conduct of the Buyer Business as currently conducted, (ii) the Buyer Entities have filed with each applicable Governmental Entity (including, without limitation, the FDA, DEA or any other Governmental Entity, domestic or foreign, performing functions similar to those performed by the FDA or DEA) all material, required filings, declarations, listings, registrations, reports or submissions, including but not limited to Adverse Event reports and their Subsidiaries all manufacturing changes to the Buyer Products, (iii) complete and correct copies of all such documents referred to in the immediately preceding clause (ii) have been delivered to the Company and maintain in full force and effect (iv) all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are such filings, declarations, listings, registrations, reports or submissions were in compliance in all material respects with all applicable registration Laws when filed, or subsequently corrected, and listing requirements set forth no deficiencies have been asserted by any applicable Governmental Entity to the Buyer Entities with respect to any such filings, declarations, listing, registrations, reports or submissions.
(c) Each Buyer Product is being, and has been for the past three (3) years, researched, developed, tested, manufactured, supplied, distributed, and stored by or on behalf of the Buyer Entities in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere compliance in all material respects with the FDC Act, the Controlled Substances Act, as amended, and the associated rules and regulations promulgated thereunder, including, as applicable, those requirements relating to the FDA’s current Good Manufacturing Practices, Good Laboratory Practices and Good Clinical Practices, all applicable regulations filings, declarations, listings, registrations, reports or submissions of all Regulatory Authorities the Buyer or its Subsidiaries to Governmental Entities relating to such Buyer Product (including with respect to the Products all Buyer Product specifications), and all Product Development other applicable Laws, including any rules and Commercialization Activities related theretoregulations of any other Governmental Entity, domestic or foreign, performing functions similar to those performed by the FDA or DEA.
(d) Except as set forth on Schedule 6.19(d)All preclinical studies and clinical trials sponsored by the Buyer Entities have been conducted in material compliance with applicable Laws, no Credit Party nor any rules and regulations and Good Clinical Practices, and federal and state Laws, rules and regulations, including, all applicable security laws and privacy standards restricting the use and disclosure of its Subsidiaries has received from any Regulatory Authority any notice individually identifiable health information. Scientific reports of alleged non-compliance such investigations have been, or adverse findings with respect will be, drafted in all material respects according to any Product or any Product Development applicable requirements and Commercialization Activities related thereto which represented, in raw data adequately archived and available for inspection by the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 Governmental Entities. None of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries Buyer Entities has received any written notification that remains unresolved notices or other correspondence from the FDA or any other Regulatory Authority indicating foreign, federal, state or local Governmental Entity performing functions similar to those performed by the FDA with respect to (i) requiring the termination, suspension or material modification of ongoing clinical trials or pre-clinical studies, (ii) adverse inspection reports, (iii) notices of adverse findings, warning letters, untitled letters or (iv) other correspondence asserting that the Buyer Entities may not be in compliance with applicable Laws or that the Buyer Products or any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined compounds contained in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) yearsBuyer Products may not be approvable.
(e) No Credit PartySince the Reference Date, none of the Buyer Entities has been subject to any investigation related to the Buyer Products or the conduct and operation of the Buyer Business that is pending and of which the Buyer Entities has been notified in writing or which (to the Buyer’s Knowledge) has been threatened, in each case by any Governmental Entity pursuant to the Medicaid rebate law (42 U.S.C. § 1396r-8), the Veterans Health Care Act of 1992, the Federal Healthcare Program Anti-Kickback Statute (42 U.S.C. §1320a-7b(b), the Federal False Claims Act (31 U.S.C. §3729) or any similar anti-kickback or false claims statutes applicable to the Buyer Entities. Since the Reference Date, none of the Buyer Entities has submitted any claim for payment to any government healthcare program in connection with any referrals related to the Buyer Products that violated in any material respect any applicable self-referral Law. Since the Reference Date, none of the Buyer Entities has submitted any claim for payment to any government healthcare program related to the Buyer Products in material violation of any Laws relating to false claim or fraud.
(f) Since the Reference Date, neither the Buyer Entities nor, to the Buyer’s Knowledge, any of the Representatives acting on behalf of the Buyer Entities has been under investigation for, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has (i) made an untrue statement of a material fact or fraudulent statements statement to the FDA or any other Regulatory AuthorityGovernmental Entity, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory AuthorityGovernmental Entity, or committed an act, made a statement, or failed to make a statement statement, including with respect to any scientific data or information, that, at the time such disclosure was made (or was not made)failure to disclose occurred, could would reasonably be expected to provide a basis for the FDA or any other Regulatory Authority Governmental Entity to invoke its the FDA policy respecting “Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, ,” set forth in 56 Fed. Reg. 46191 (September 10, 1991), in each case as related to the Buyer Products or the conduct or operation of the Buyer Business, (ii) been convicted of any crime or engaged in any conduct for which disqualification, exclusion or similar action is authorized by a Governmental Entity in relation to the development or approval of any pharmaceutical product, including for which debarment is mandated by 21 U.S.C. § 335a(a) or authorized by 21 U.S.C. § 335a(b) or (iii) been convicted of any similar policycrime or engaged in any conduct for which such Person or entity could be excluded from participating in the Federal health care programs under Section 1128 of the Social Security Act of 1935, as amended.
(fg) Except as set forth on Schedule 6.19(f)Since the Reference Date, no Credit Party nor none of the Buyer Entities have voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field alerts, field corrections, market withdrawal, safety alert or warning, “dear doctor” letter, investigator notice or other material notice or action relating to an alleged lack of its Subsidiaries safety, efficacy or regulatory compliance of the Buyer Products. None of the Buyer Entities has knowledge of any facts that are reasonably likely to cause (i) the recall, market withdrawal or replacement of any Buyer Product, (ii) a material change in the marketing classification or a material change in the labeling of any Buyer Product, or (iii) a termination or suspension of the marketing of any Buyer Product. Since the Reference Date, none of the Buyer Entities has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiatedGovernmental Entity has: (1) commenced, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested request the recall (whether by correction or removal) of any Products or commenced or initiated Buyer Product; (2) commenced, or threatened to commence or initiate, any action to enjoin the manufacture or distribution of any Product Development and Commercialization Activities Buyer Product; (3) issued any demand letter, finding of such Credit Party material deficiency or such Subsidiarynon-compliance or adverse inspection report (including any FDA Form 483s, in each caseFDA Notices of Adverse Findings, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their SubsidiariesUntitled Letters, or Warning Letters) in respect of which any Products Buyer Product; or Product candidates under development have participated(4) commenced, were (and if still pendingor threatened to initiate, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respectsany action regarding inappropriate advertising or marketing of any Buyer Product, nor to the Buyer’s Knowledge do any conditions currently exist that reasonably could be expected to lead to any of the foregoing.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating Buyer has delivered to the Products in Company complete and correct copies of all material scientific, CMC (including any material mannersupply chain risk assessments), preclinical, and no consent or other authorization clinical data of any the Buyer Entities, all material non-clinical and safety risk assessments, and all material written correspondence with all Governmental Authority is required Entities, in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies each case with respect theretoto any Buyer Product.
Appears in 1 contract
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(aCompany (or one of its Affiliates or Sublicensees) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are shall (i) legally be responsible for preparing and beneficially owned exclusively by submit Regulatory Documents for obtaining and maintaining all Regulatory Approvals (including all INDs and ▇▇▇▇) for any Licensed Products in the Credit Parties Field in the Company Territory and, thereafter, maintaining all such Regulatory Approvals for any Licensed Products in the Field in the Company Territory, in each case, in accordance with Law, (ii) be responsible, and their Subsidiariesact as the sole point of contact, for communications with Regulatory Authorities in connection with the Development, Manufacture or Commercialization of any Licensed Products in the Field in the Company Territory, and (iii) have the sole right to determine whether and how to implement a recall or other market withdrawal of its Licensed Products in the Company Territory. In addition, as applicablebetween Biosion and Company, free Company shall own any and clear all Regulatory Documents (including all INDs and ▇▇▇▇) and Regulatory Approvals for any Licensed Products in the Field in the Company Territory.
(b) Following the Effective Date, Biosion shall not initiate (or unless required by Law participate in) (or permit any of all Liens other than Permitted Liensits Affiliates to initiate (or unless required by Law participate in)) any meetings or communications with Regulatory Authorities with respect to any Licensed Product in the Field and in the Company Territory, without Company’s prior consent.
(c) If Biosion or any of its Affiliates receives any written or oral communication from any Regulatory Authority in the Company Territory relating to any Licensed Product, to the extent not prohibited by Law, Biosion shall (i) refer such Regulatory Authority to Company, and (ii) as soon as reasonably practicable, notify Company in writing and provide Company with a copy of any written communication received by Biosion or such Affiliate or, if applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, accurate minutes of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related theretooral communication.
(d) Except Following the Effective Date, the Parties will cooperate with each other with regard to the reporting and handling of safety information involving the Licensed Products in accordance with Law, including applicable regulatory requirements and regulations on pharmacovigilance, clinical safety and data privacy. Without limiting the foregoing, following the Effective Date, (i) Biosion shall transfer a copy of the safety database maintained by Biosion as set forth on Schedule 6.19(d)of the Effective Date to Company (or its Affiliate) and thereafter Company will establish a global safety database for each Licensed Product Developed hereunder and, no Credit Party nor any of its Subsidiaries has received from any as between the Parties, shall own and maintain such global safety database for each such Licensed Product, and (ii) Company shall be responsible for reporting quality complaints, Adverse Events and safety data related to each Licensed Product to the relevant Regulatory Authority any notice of alleged non-compliance or adverse findings with respect in the Company Territory and responding to any Product or any Product Development safety issues and Commercialization Activities related thereto which represented, in the aggregate, 15% or more all relevant requests of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, Authorities relating to any Products which represented, Licensed Product in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such SubsidiaryCompany Territory, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by Law; provided that, upon Biosion’s request, the Loan Documents Parties (or contemplated by the conditions to effectiveness of any Loan Documenttheir respective Affiliates or Sublicensees, as applicable) will not impair any Credit Party’s or any negotiate in good faith and enter into a pharmacovigilance agreement related to Licensed Products in the Company Territory and the Excluded Territory, which will define the pharmacovigilance responsibilities of its Subsidiaries’ ownership of or rights under the Parties (or the license such Affiliate or the right to useSublicensee, as applicable) and include safety data exchange procedures governing the case may beexchange of information affecting the Licensed Products (including Adverse Events, serious Adverse Events and emerging safety issues) any Regulatory Authorizations relating to the enable each Party (or its Affiliate or Third Party sublicensee, as applicable) to comply with all Laws related to such Licensed Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith Company Territory and the exercise of rights and remedies with respect theretoExcluded Territory, as applicable.
Appears in 1 contract
Sources: Exclusive License Agreement (Aclaris Therapeutics, Inc.)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) The Specified Product is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiariesbeing or has been manufactured, the conduct of their businesstested, packaged, distributed, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, sold in compliance in all respects with all filing applicable requirements under the Federal Food, Drug and maintenance requirements Cosmetic Act (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs“FDCA”) and other reports the regulations of adverse experiences or product malfunctions, the Food and reports of corrections or removalDrug Administration (“FDA”) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA promulgated thereunder and all other applicable Governmental AuthoritiesLegal Requirements. The Specified Authorizations are current and in full force and effect. Seller has made available to Purchaser true and complete copies of all material governmental correspondence (including copies of official notices, citations or decisions) in the files of Seller or the Specified Affiliates relating to the Specified Authorizations.
(b) (i) All regulatory filings required by Neither Seller nor any Regulatory Authority or in respect of its Affiliates has received any Regulatory Authorization with respect to any Product communication from FDA or any other Governmental Entity, including without limitation any warning letter or untitled letter or, to the Knowledge of Seller, oral communication that alleges or suggests that the Specified Product Development and Commercialization Activities which represented, is not in the aggregate, 15% or more of Net Sales in compliance with any applicable year, in requirements under the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all FDCA or the FDA regulations promulgated thereunder or under any other applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory AuthorityLegal Requirements.
(c) The Credit PartiesTo the Knowledge of Seller, their Subsidiaries there are no investigations, suits, claims, actions or proceedings against or affecting Seller or any Specified Affiliate relating to the Specified Product, including those relating to or arising under applicable Legal Requirements relating to government health care programs, private health care plans, or the privacy and confidentiality of patient health information.
(d) Seller and the agents thereof Specified Affiliates are in compliance in all material respects with all healthcare Legal Requirements to the extent applicable statutesto the sale of the Specified Product, rules as currently conducted, including any and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authoritiesfederal and state fraud and abuse laws, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.
federal Anti-Kickback Statute (d) Except as set forth on Schedule 6.19(d42 U.S.C. § 1320a-7(b), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were civil False Claims Act (and if still pending, are31 U.S.C. § 3729 et seq.) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoregulations promulgated pursuant to such statutes.
Appears in 1 contract
Sources: Asset Purchase Agreement (Axsome Therapeutics, Inc.)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) is a complete The Company and accurate list of each Company Subsidiary possesses all material approvals, authorizations, certificates, registrations, licenses, exemptions, permits, clearances, and consents (including all investigational new drug applications (as defined in 21 C.F.R. § 312.20 et seq., establishment registrations (as defined in 21 C.F.R. § 207), and product listings (as defined in 21 C.F.R. § 207), all supplements or amendments thereto, and all comparable approvals, authorizations, certificates, registrations, licenses, exemptions, permits, clearances, and consents provided for in other applicable Laws) (“Regulatory Authorizations Authorizations”) from the U.S. Food and Drug Administration (the “FDA”) and all other applicable Regulatory Authorities relating to the Credit Parties Company’s and their Subsidiarieseach Company Product or that are necessary for the Company or any Company Subsidiary to conduct its business in all material respects as presently conducted. Except as would not reasonably be expected to have a Material Adverse Effect, the conduct of their business, and the Products (on a per Product basis). All i) all such material Regulatory Authorizations are (iA) legally in full force and beneficially owned exclusively by the Credit Parties and their Subsidiarieseffect, as applicable, free and clear of all Liens other than Permitted Liens, and (iiB) as applicable, validly registered and on file with the applicable Governmental Authority, Regulatory Authorities and (C) in compliance with all formal filing and maintenance requirements and (including any fee requirementsii) thereofthe Company and each Company Subsidiary has fulfilled and performed all of its material obligations with respect to such Regulatory Authorizations, and are in good standingno event has occurred which allows, valid or after notice or lapse of time would allow, revocation or termination thereof. Except as would not reasonably be expected to be material to the business of the Company and enforceable with the Company Subsidiaries, taken as a whole, (1) the Company and each Company Subsidiary has filed, maintained or furnished to the FDA, Health Canada, or other applicable Governmental Authority. All Bodies or other applicable Regulatory Authorities all required filings, declarations, listings, registrations, submissions, amendments, modifications, notices and responses to notices, registrations applications and listings, supplemental applications or notificationsapplications, reports (including field alerts, medical device reports (MDRsall adverse event/experience reports) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal(2) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are submissions were complete and correct accurate and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutesLaws when filed (or were corrected or completed in a subsequent filing).
(i) The Company and each Company Subsidiary has never marketed, rules and regulations sold, distributed, promoted or advertised any pharmaceutical products (including all Healthcare Laws the Company Products) and Regulatory Authorizations(ii) of all the Company and each Company Subsidiary is, and since January 1, 2018 has been, in material compliance with applicable Governmental AuthoritiesLaws, including the FDA FDCA and its implementing regulations, relating to the development, testing, manufacturing, holding, marketing, selling, distributing, labeling, promoting, advertising, importing or exporting of pharmaceutical products, including without limitation, (i) requirements for obtaining Regulatory Authorizations, (ii) requirements for establishment registration and product listing; (iii) payment of all application and program fees invoiced for the Company Products, (iv) label and labeling requirements and (vi) applicable promotion and advertising requirements.
(c) All non-clinical studies and clinical investigations, preclinical studies or tests sponsored or conducted by or on behalf of the Company or any Company Subsidiary are being conducted in material compliance with applicable Laws, including Good Laboratory Practices, Good Clinical Practices, the FDCA, and all other Laws regarding developing, testing, labeling, manufacturing, storage, marketing, promotion, sale, commercialization, safety, quality, shipment, import, export, or distribution the products of the Company. None of the FDA, Health Canada, any other Regulatory AuthoritiesAuthority, or any institutional review board has sent any written notices or other correspondence with respect to any proposed, ongoing or completed clinical, preclinical or non-clinical studies or tests requiring the termination, suspension or material modification of such studies or tests. With respect to each Product Company Product, the Company has made available to Parent complete and accurate copies of all material clinical, preclinical and nonclinical data in the possession of and reasonably available to the Company or any Company Subsidiary and all Product Development material written correspondence that exists as of the date of this Agreement between the Company and Commercialization Activities related thereto. The Credit Parties any of its subsidiaries and their Subsidiaries have and maintain in full force and effect all the necessary and requisite FDA, Health Canada, or any other Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in Authority performing functions similar to those performed by the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related theretoFDA.
(d) Except as set forth on Schedule 6.19(d), no Credit Party Neither the Company nor any Company Subsidiary nor, to the knowledge of its Subsidiaries has received from the Company, any Regulatory Authority any notice officers, employees or agents of alleged non-compliance or adverse findings with respect to any Product the Company or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereofCompany Subsidiary, has (i) made an untrue statement of a material fact or fraudulent statements statement to the FDA FDA, Health Canada, or any other Regulatory Authority, (ii) failed to disclose a material fact required to be disclosed to the FDA or Health Canada or (iii) committed any other Regulatory Authority, or committed an act, made a statement, any statement or failed to make any statement, that (in any such case) establishes a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a reasonable basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery Bribery, and Illegal GratuitiesGratuities Final Policy. As of the date of this Agreement, set forth neither the Company nor any Company Subsidiary is the subject of any pending or, to the Company’s knowledge, threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the Company nor any Company Subsidiary nor, to the knowledge of the Company, any officers, employees, agents or clinical investigators of the Company or any Company Subsidiary has been suspended or debarred or convicted of any crime or engaged in 56 Fed. Reg. 46191 any conduct that would reasonably be expected to result in (September 10, 1991A) debarment under 21 U.S.C. Section 335a or any similar policyLaw or (B) exclusion under 42 U.S.C. Section 1320a-7 or any similar Law.
(e) Except as would not reasonably be expected to be material to the business of the Company and the Company Subsidiaries, taken as a whole, (i) the Company, each Company Subsidiary and any contractor or other Person acting on their behalf is obtaining and since January 1, 2018, has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company’s ongoing clinical studies; (ii) in using or disclosing patient information received by the Company in connection with the Company’s ongoing clinical studies, the Company, each Company Subsidiary and any contractor or other Person acting on their behalf have complied with all Laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996, the FDCA and the rules and regulations thereunder.
(f) Except as set forth on Schedule 6.19(f)To the extent required by applicable Laws, no Credit Party nor all manufacturing operations conducted with respect to any of its Subsidiaries has received any written notice that Company Product used in human clinical trials have been conducted in accordance with the FDA or any other applicable Regulatory Authority has commenced or initiatedFDCA, or threatened Laws, and Good Manufacturing Practices, except where the failure to commence or initiate, any action comply would not reasonably be expected to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,have a Material Adverse Effect.
(g) Except as set forth on Schedule 6.19(g)Since January 1, the clinical2018, preclinicalno Company Product has been recalled, safety and other withdrawn, suspended or discontinued.
(h) Since January 1, 2018, no preclinical studies and tests sponsored or conducted by or on behalf of the Company for the purpose of supporting a regulatory filing have had any material adverse safety findings that the Company would reasonably expect to have a material adverse impact on clinical studies, and all material preclinical toxicology reports or sponsored preclinical toxicology studies conducted by or on behalf of the Credit Parties Company for the purpose of supporting a regulatory filing have been disclosed to the FDA, Health Canada, and their Subsidiariesall other applicable Regulatory Authorities to the extent required by applicable Laws.
(i) The Company and each Company Subsidiary is, or and since January 1, 2018 has been, in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance material compliance with all applicable Regulatory Authorizations and Healthcare Laws. Neither the Company nor any Company Subsidiary is subject to any enforcement, regulatory or administrative proceedings regarding alleged non-compliance with any Healthcare Laws in all material respectsand, to the knowledge of the Company, no such enforcement, regulatory or administrative proceeding has been threatened.
(hj) The transactions contemplated by Company and the Loan Documents Company Subsidiaries have adopted and maintain a compliance program that is intended to assist the Company and the Company Subsidiaries to be in material compliance with all Law, standards and guidelines relevant to its business, including all Healthcare Laws, and includes each of the following elements: (i) a code of conduct and other applicable policies and procedures; (ii) training on the code of conduct, policies and procedures for all employees; (iii) an auditing and monitoring function; (iv) an anonymous reporting process for potential violations of Law or contemplated by the conditions to compliance program; (v) designation of a compliance officer; and (vi) a mechanism for ensuring the effectiveness of any Loan Document) will not impair any Credit Party’s or the compliance program. None of the Company and its Subsidiaries or, to the Knowledge of the Company, any of its Subsidiaries’ ownership of officers, directors, employees, contractors or rights under (or the license or the right to use, as the case may be) agents has materially violated any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretosuch compliance program.
Appears in 1 contract
Regulatory Matters. With respect to each Product:
(a) Set Except as set forth on Schedule 6.19(ain Section 3.16(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their SubsidiariesCompany Disclosure Letter, the conduct of their business, Company and the Products (on a per Product basis). All such material Regulatory Authorizations are its Subsidiaries (i) legally have filed with all applicable Regulatory Authorities all required applications, filings, declarations, listings, registrations, reports or submissions, (ii) the Company and beneficially owned exclusively by its Subsidiaries own, hold, possess or validly have all Product Registrations required to exploit, commercialize, sell and market the Credit Parties Product in and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liensfor the Territories, and (iiiii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws Legal Requirements related to such Product Registrations. To the Knowledge of the Company, all such applications, filings, declarations, listings, registrations, reports or submissions were in material compliance with applicable Legal Requirements when filed, and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products no material deficiencies have been and are being conducted asserted in writing to the Company or its Subsidiaries by any applicable Regulatory Authority or Governmental Authority with respect to any such applications, filings, declarations, listings, registrations, reports or submissions, except for those deficiencies that have been addressed in full by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory AuthorityCompany.
(cb) The Credit Parties, their Company and its Subsidiaries and the agents thereof are in compliance in hold all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory AuthorizationsPermits as set forth in Section 3.16(b) of the Company Disclosure Letter issued by all relevant Regulatory Authorities required under applicable Governmental AuthoritiesLegal Requirements in each jurisdiction for their businesses as currently conducted, including and, to the FDA Knowledge of the Company and all other its Subsidiaries, each such Regulatory Authorities, with respect to each Product Permit is valid and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizationseffect. The Credit Parties Company and their its Subsidiaries are in compliance in all material respects with all the terms and requirements of such Regulatory Permits. No material deficiencies have been asserted in writing to the Company and its Subsidiaries by any applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Regulatory Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to any material Regulatory Permits of the Products Company and its Subsidiaries.
(c) Except as would not be material to the businesses of the Company and its Subsidiaries, all Product Development preclinical and Commercialization Activities related theretoclinical investigations sponsored by the Company or its Subsidiaries since January 1, 2022, have been and are being conducted in compliance with all applicable Legal Requirements, including Good Clinical Practices requirements for each relevant jurisdiction, and Legal Requirements restricting the use and disclosure of individually identifiable health information. Neither the Company nor its Subsidiaries have received any written notice from a Regulatory Authority with respect to any ongoing clinical or preclinical investigations requiring the termination, suspension or material modification of such studies or tests.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect would not be material to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 businesses of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of Company and its Subsidiaries, relating to any Products which represented, in neither the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party Company nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five have (5i) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements statement to the FDA or any other a Regulatory Authority, (ii) failed to disclose a material fact required to be disclosed to the FDA or any other a Regulatory Authority, or (iii) to the Knowledge of the Company, committed an any other act, made a statement, any statement or failed to make any statement, that (in any such case) establishes a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a reasonable basis for the FDA or any other Regulatory Authority to invoke any policy related to fraud or untrue statements. Neither the Company nor its policy respecting FraudSubsidiaries are the subject of any pending, Untrue Statements or, to the Knowledge of Material Factsthe Company, Bribery threatened investigation by a Regulatory Authority with respect to (i) – (iii). As of the date of this Agreement, to the Knowledge of the Company, no officer, employee, agent or clinical investigator engaged by the Company or its Subsidiaries has been suspended, disqualified, debarred or convicted of any crime by a Regulatory Authority or, to the Knowledge of the Company or its Subsidiaries, engaged in any conduct that could result in debarment, exclusion or the assessment of a civil monetary penalty.
(e) Except as would not be material to the businesses of the Company and Illegal Gratuitiesits Subsidiaries, set forth the Products manufactured or marketed by or on behalf of the Company and its Subsidiaries have, since January 1, 2022, been in 56 Fedcompliance with all Legal Requirements issued by a Regulatory Authority applicable to the Product, pharmaceutical products and to the operation of the Company’s or its Subsidiaries’ business. Reg. 46191 To the Knowledge of the Company, no third party that manufactures or commercializes finished product on behalf of the Company or its Subsidiaries (September 10but only in their capacity as such) has been subject to any enforcement, 1991) regulatory or any similar policyadministrative proceedings initiated by a Regulatory Authority and, to the Knowledge of the Company, no such enforcement, regulatory or administrative proceeding has been threatened.
(f) Except as set forth on Schedule 6.19(f)would not be material to the businesses of the Company and its Subsidiaries, no Credit Party since January 1, 2022, neither the Company nor any of its Subsidiaries has have received any written notice from a Regulatory Authority alleging or asserting (i) any violation applicable to the Product and/or (ii) that the FDA Product is improperly labeled or any other adulterated, pursuant to applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales Legal Requirements in any jurisdiction. The Product has complied in all material respects with all applicable year,Legal Requirements, including without limitation GMP, GDP, and applicable specifications and standards. Since January 1, 2022, neither the Company nor its Subsidiaries have received any written notice of observational inspections or other written warning after inspection of a manufacturing facility, and the observations that have been received have been addressed to the satisfaction of the issuing authorities.
(g) Except as set forth on Schedule 6.19(g)All dossiers for each Product are fully up-to-date, in eCTD format and with all required variations and renewals being filed by the applicable due date.
(h) Since January 1, 2022, the clinicalProduct has not been recalled, preclinicalwithdrawn, safety suspended, seized or discontinued by the Company or its Subsidiaries (whether voluntarily or otherwise) and there have been no written requests from any Governmental Authority or Regulatory Authority requiring the Company or its Subsidiaries to cease manufacturing, marketing, distributing or selling the Products. There are no facts, circumstances or conditions relating to the Products that would reasonably be expected to give rise to any recall, withdrawal, seizure or discontinuation (other studies than for commercial or other business reasons) by the Company or by any of its Subsidiaries of the Products. Up to the date hereof, the Company or any of its Subsidiaries have not received any material written complaints, warnings or notifications of any kind related to nonconformity of the Product, poor product safety, or damages caused by defective Product. Since January 1, 2022, the promotional materials and tests claims made by the Company or its Subsidiaries for the products manufactured or marketed by or on behalf of the Company or its Subsidiaries have complied in all material respects with all applicable Legal Requirements in all jurisdictions.
(i) There are no outstanding, pending, or, to the Knowledge of the Company, threatened claims, disputes, or proceedings, and there are no facts or circumstances that would reasonably be expected to give rise to any such claims, disputes or proceedings, by any third party (including, for the avoidance of doubt, any clinical site, investigator, contract research organization, or patient) seeking payment, compensation, indemnification, reimbursement or any other form of monetary or non-monetary compensation in connection with any preclinical or clinical investigation, study or trial sponsored or conducted by or on behalf of the Company or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.
Appears in 1 contract
Sources: Stock Purchase Agreement (Biocryst Pharmaceuticals Inc)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(dPart 2.6(a) of the Disclosure Schedule, each of the Specified Products is being or has been developed, manufactured, tested, packaged, distributed, and sold in substantial compliance with all applicable requirements under the Federal Food, Drug and Cosmetic Act (“FDCA”), no Credit Party nor the Public Health Service Act (“PHSA”) and the regulations of the Food and Drug Administration (“FDA”) promulgated thereunder and similar applicable foreign Legal Requirements, including those relating to investigational use, good manufacturing practices, good clinical practices, good laboratory practices, registration and listing, record keeping, adverse event reporting, and submission of other required reports. The Specified Authorizations are current and in full force and effect and include all necessary and relevant regulatory filings and governmental registrations made by or issued to Seller or any of its Subsidiaries Affiliates that relate specifically to the Specified Products. Seller has received from any Regulatory Authority any notice made available to Purchaser true and complete copies of alleged non-compliance all governmental correspondence (including copies of official notices, citations or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, decisions) in the aggregate, 15% files of Seller or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within Specified Affiliates relating to the last five Specified Authorizations.
(5b) years. Except as set forth on Schedule 6.19(d)Part 2.6(b) of the Disclosure Schedule, there Seller or the Specified Affiliates have obtained all necessary licenses, permits and registrations required by FDA, any other applicable Governmental Entity, and any applicable foreign regulatory authority to permit the operation of the Specified Business by Seller and the Specified Affiliates as presently conducted and all such licenses, permits and registrations are included in the Specified Authorizations. Neither Seller nor any of its Affiliates have received any communication from any Governmental Entity threatening to withdraw or suspend any such license, permit, or registration. Seller or the Specified Affiliates have filed with the applicable regulatory authorities all required filings, declarations, listings, registrations, reports or submissions, including adverse event reports. All relevant filings, declarations, listings, registrations, reports or submissions were in compliance with applicable Legal Requirements when filed, and no deficiencies have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened asserted by any Regulatory Authorityapplicable regulatory authority with respect to any such filings, declarations, listing, registrations, reports or submissions.
(c) Neither Seller nor any of its Affiliates nor, to the Knowledge of Seller, any of the officers, key employees, agents or clinical investigators acting for example in the case of a recall) initiated by Credit Party Seller or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries Affiliates has received any written notification that remains unresolved communication from the FDA or any other Regulatory Authority indicating Governmental Entity, including without limitation any breach warning letter or violation of untitled letter that alleges or suggests that the Specified Business is not in compliance with any applicable Regulatory Authorizationrequirements under the FDCA, including that the PHSA, FDA regulations promulgated thereunder, or similar applicable foreign Legal Requirements.
(d) Neither Seller or any of the Products is misbranded or adulterated as defined in Specified Affiliates nor, to the FD&C ActKnowledge of Seller, in each case any of the foregoingofficers, which representedkey employees, in agents or clinical investigators acting for Seller or the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereofSpecified Affiliates, has made an untrue statement of a material fact or fraudulent statements to the FDA or committed any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, any statement or failed to make a any statement that, at the time such disclosure was made (or was not made), could commit any act that would reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting with respect to “Fraud, Untrue Statements of Material Facts, Bribery Bribery, and Illegal Gratuities, ” set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. Additionally, neither Seller or the Specified Affiliates, nor to the Knowledge of Seller, any officer, employee or agent of Seller or the Specified Affiliates has been convicted of any crime or engaged in any conduct that would reasonably be expected to result, or has resulted, in (i) debarment under 21 U.S.C. Section 335a or any similar policystate Legal Requirement; or (ii) exclusion under 42 U.S.C. Section 1320a-7 or any similar state Legal Requirement.
(e) Except as set forth in Part 2.6(e) of the Disclosure Schedule, to the Knowledge of Seller, there are no investigations, suits, claims, actions or proceedings against or affecting Seller or any Specified Affiliate relating to the Specified Products, including those relating to or arising under applicable Legal Requirements relating to government health care programs, private health care plans, or the privacy and confidentiality of patient health information.
(f) Except Seller and the Specified Affiliates are in compliance in all material respects with all healthcare Legal Requirements to the extent applicable to the operation of the Specified Business and the sale of the Specified Products, as set forth on Schedule 6.19(fcurrently conducted, including any and all federal, state and local fraud and abuse laws, including the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(b), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinicalcivil False Claims Act (31 U.S.C. § 3729 et seq.) and the regulations promulgated pursuant to such statutes. Neither Seller nor any Specified Affiliate is subject to any enforcement, preclinical, safety and other studies and tests conducted by regulatory or on behalf of administrative proceedings against or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations affecting Seller relating to or arising under the Products in any material mannerFDCA or similar Legal Requirement, and to the Knowledge of Seller no consent such enforcement, regulatory or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoadministrative proceeding has been threatened.
Appears in 1 contract
Sources: Asset Purchase Agreement (Jazz Pharmaceuticals PLC)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority or The businesses of the Borrower has been and is being conducted in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied compliance in all material respects with all applicable laws Healthcare Laws, and regulationsall Permits, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted each Product (whether manufactured by the Credit Borrower or any of its Subsidiaries, any of their respective Affiliates or by a third party manufacturer under contract to the Borrower or any of its Subsidiaries) has been, and currently is, being researched, developed, designed, investigated, manufactured, made, assembled, stored, packaged, labeled, marketed and distributed by the Borrower and its Subsidiaries or third parties on their behalf, in compliance with all applicable Requirements of Law, including, without limitation, the Healthcare Laws, all required Permits, cGMP, QSR, the Device Master Record as defined in 21 CFR 820.181 and Document Controls under 21 CFR 820.40 and all Product specifications as established in the Group Members’ documentation, except to the extent any failure to so comply could not reasonably be expected to result in any adverse consequences to the Loan Parties (other than immaterial consequences), (iii) each contract between the Borrower and their any of its Subsidiaries on the one hand, and any third party manufacturer on the other hand contain (and the Borrower and each of its Subsidiaries implement), appropriate quality assurance arrangements in accordance with FDA requirements and comply in all material respects with all applicable laws Healthcare Laws, (iv) the Borrower and regulations along its Subsidiaries are in compliance in all material respects with appropriate monitoring applicable Requirements of clinical investigator trial sites Law governing reporting and recordkeeping of Product modifications, adverse event reporting, reporting of corrections and removals, and recordkeeping for their complianceeach Product, and all manufacturing and release documents and records are true and accurate in all material respects, and (iiiv) neither the Credit Parties Borrower nor any of its Subsidiaries has received or been subject to any written or oral communications from the FDA, the NRC or any other Governmental Authority asserting that the Borrower, any such Subsidiary or any such Product was not in compliance in any material respect with any applicable Requirement of Law or any Permit.
(b) Other than routine surveillance audits and their Subsidiaries have disclosed inspections, no investigation by any Governmental Authority with respect to the Agent all such regulatory filings and all material communications between representatives Borrower or any of its Subsidiary is pending or, to the knowledge of the Credit Parties (and their Subsidiaries) and Loan Parties, threatened. None of the Borrower or any Regulatory Authorityof its Subsidiaries has received any written or oral communication from any Governmental Authority of any noncompliance with any Requirement of Law or any written or oral communication from any Governmental Authority or accrediting organization of any material issues, problems, or concerns regarding the quality or performance of the Products.
(c) The Credit Borrower and its Subsidiaries own, free and clear of all Liens, except Liens securing the Obligations, all Permits, including all authorizations under the FD&C Act, other United States federal laws, and all applicable state and foreign laws, necessary (i) for the research and development and commercialization of the Products, including, without limitation, all Permits necessary in connection with testing, manufacturing, marketing or selling of such Products, as such testing, manufacturing, marketing or selling are currently being conducted, and (ii) to carry on the business of the Borrower and each of its Subsidiaries. All such Permits are valid and in full force and effect and the Borrower and each Subsidiary is in compliance in all material respects with all terms and conditions of such Permits. None of the Borrower or any Subsidiary has received any written notice from any Governmental Authority that any Permit has been or is being revoked, withdrawn, suspended or challenged or that such Governmental Authority is conducting an investigation or review thereof or has issued any order or recommendation stating that the development, testing and/or manufacturing of such Product should cease or that such Product should be withdrawn from the marketplace.
(d) Except as could not reasonably be expected to have a materially adverse impact on the Borrower and its Subsidiaries, there have been no adverse clinical test results and there have been no Product recalls or voluntary Product Market Withdrawals from any market (other than those recalls or Market Withdrawals disclosed on Schedule 4.23(d)).
(e) There has been no material untrue statement of fact and no fraudulent statement made by the Borrower or any of its Subsidiaries or any of their respective agents or representatives to the FDA, NRC, or any other Governmental Authority, and there has been no failure to disclose any material fact required to be disclosed to the FDA, NRC or any other Governmental Authority.
(f) To the best knowledge of the Loan Parties, their no insurance company, managed care organization or Governmental Authority has (i) terminated coverage or reimbursement for procedures and treatments performed using the CyberKnife and TomoTherapy Products, or (ii) reduced the scope of coverage or the rate of reimbursement it provides for procedures and treatments performed using the CyberKnife and TomoTherapy Products, and, in the case of this clause (ii), such reduction could reasonably be expected to have a materially adverse impact on the revenues of the Borrower and its Subsidiaries. None of the Borrower or any of its Subsidiaries has been the subject of any "for cause" inspection, investigation or audit by any Governmental Authority in connection with any alleged improper activity.
(g) There is no arrangement relating to the Borrower or any of its Subsidiaries providing for any rebates, kickbacks or other forms of compensation or remuneration that are unlawful to be paid to any Person to induce, or in return for obtaining or the referral of business or for the arrangement for recommendation of such referrals. All ▇▇▇▇▇▇▇▇ by the Borrower and the agents thereof each of its Subsidiaries for its services have been true and correct in all material respects and are in compliance in all material respects with all applicable statutesHealthcare Laws.
(h) None of the Borrower or any of its Subsidiaries, rules or, to the knowledge of the Loan Parties, any individual who is an officer, director, employee or manager of the Borrower or any of its Subsidiaries has been convicted of, charged with or, to the knowledge of the Loan Parties, investigated for any federal or state health program- related offense or been excluded or suspended from participation in any such program; or, to the knowledge of the Loan Parties, within the past five (5) years, has been convicted of, charged with or, to the knowledge of the Loan Parties, investigated for a violation of any Requirement of Law related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances, or has been subject to any judgment, stipulation, order or decree of, or criminal or civil fine or penalty imposed by, any Governmental Authority related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances. None of the Borrower or any of its Subsidiaries or, to the knowledge of the Loan Parties, any individual who is an officer, director, employee or manager of the Borrower or any of its Subsidiaries has been convicted of any crime or engaged in any conduct including but not limited to any misrepresentation to any Governmental Authority or that has otherwise resulted or would reasonably be expected to result in a debarment or exclusion (i) under 21 U.S.C. Section 335a, or (ii) any similar applicable Requirement of Law. No debarment proceedings or investigations in respect of the business of the Borrower or any of its Subsidiaries are pending or, to the knowledge of the Loan Parties, threatened against the Borrower or any of its Subsidiaries or any individual who is an officer, director, employee or manager of the Borrower or any of its Subsidiaries.
(i) All studies, tests and regulations (including all Healthcare Laws preclinical and Regulatory Authorizations) clinical trials conducted relating to the Products, sponsored by the Borrower or any of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their its Subsidiaries have been conducted, and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance currently being conducted, in all material respects in accordance with all applicable registration Requirement of Law and listing requirements set forth in IDEs, including procedures and controls pursuant to, where applicable, current good clinical practices and current good laboratory practices and other applicable laws, rules regulations. To the FD&C Act extent required by applicable Requirement Law, the Borrower and each of its Subsidiaries has obtained all necessary authorizations from Governmental Authorities and IECs, including an IDE for the conduct of any clinical investigations conducted by or equivalent regulation on behalf of each other Governmental Authority having jurisdiction over the Borrower or such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related theretoSubsidiary, as applicable.
(dj) Except as set forth on Schedule 6.19(d)To the knowledge of the Loan Parties, none of the clinical investigators in any clinical trial sponsored by the Borrower or any of its Subsidiaries has been or is disqualified or otherwise sanctioned by the FDA, the Department of Health and Human Services, or any Governmental Authority and, to the knowledge of the Loan Parties, no Credit Party nor such disqualification, or other sanction of any such clinical investigator is pending or threatened. None of the Borrower or any of its Subsidiaries has received from any Regulatory the FDA or other applicable Governmental Authority any notice notices or correspondence requiring or threatening the termination, suspension, material modification or clinical hold of alleged non-compliance any studies, tests or adverse findings clinical trials with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated herebyProducts.
(k) The Group Members are, to the extent directly applicable to the Group Members, currently conducting its business in material compliance with all regulations promulgated under HIPAA. To the extent the Group Members create any de-identified protected health information, the Group Members do so in compliance with the HIPAA regulations. The Group Members have not failed to notify any individual or required third party, including any appropriate Governmental Authority, of an event that triggered a notification or reporting requirement under any contract to which a Group Member is a party, or any applicable requirement related to the Liens granted in connection herewith and the exercise unauthorized access, use or disclosure of rights and remedies protected health information. The Group Members have no knowledge of any complaints to or investigations by any Governmental Authority with respect theretoto HIPAA compliance by the Group Members, have not received any notice or audit request from the United States Department of Health and Human Services Office for Civil Rights, is currently conducting their businesses in material compliance with all applicable laws governing the privacy, security or confidentiality of protected health information and/or other records generated in the course of providing or paying for health care services, including without limitation, all laws to the extent not preempted by HIPAA, and has conducted its businesses in material compliance with such laws since such laws first became applicable to it.
Appears in 1 contract
Sources: Credit Agreement (Accuray Inc)
Regulatory Matters. With respect to each Product:
The studies, tests and preclinical or clinical trials conducted by or on behalf of the Company that are described in the General Disclosure Package and the Prospectus (athe “Company Studies and Trials”) Set forth on Schedule 6.19(a) is a complete and accurate list of were and, if still pending, are being, conducted in all material Regulatory Authorizations relating to respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards; the Credit Parties descriptions of the results of the Company Studies and their SubsidiariesTrials contained in the General Disclosure Package and Prospectus are accurate in all material respects; the Company has no knowledge after reasonable investigation and due diligence inquiry (“Knowledge”) of any other studies or trials not described in the General Disclosure Package and the Prospectus, the conduct results of their business, which are inconsistent with or call in question the results described or referred to in the General Disclosure Package and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally Prospectus; and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including Company has not received any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications notices or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed correspondence with the FDA and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by or any Regulatory Authority foreign, state or in respect local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Regulatory Authorization with respect Company Studies or Trials that termination, suspension or material modification would reasonably be expected to any Product have a material adverse effect and, to the Company’s Knowledge, there are no reasonable grounds for the same. The Company has obtained (or any Product Development and Commercialization Activities which represented, caused to be obtained) informed consent by or on behalf of each human subject who participated in the aggregateCompany Studies and Trials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have Company has complied in all material respects with all applicable laws and regulationsregulatory rules or requirements, (ii) all including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical and pre-clinical trials, if any, of investigational Products have investigator or has been and are being conducted found by the Credit Parties FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring operations of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof its suppliers are operated in compliance in all material respects with all applicable statutes, rules rules, regulations and regulations (including all Healthcare Laws and Regulatory Authorizations) policies of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 comparable regulatory agencies outside of the FD&C Act, or any other similar communication from any Regulatory Authority within United States to which the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products Company is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) yearssubject.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.
Appears in 1 contract
Regulatory Matters. With respect At all times after the Effective Date, Metabolex shall own and maintain, at its own cost, all regulatory filings and Regulatory Approvals for PPAR-d Products that Metabolex is developing or commercializing pursuant to each Product:
(a) Set forth on Schedule 6.19(a) is a complete this Agreement, including all INDs, CTAs, NDAs, and accurate list of statistical analyses. As such, Metabolex shall be responsible for reporting all material Regulatory Authorizations relating adverse drug reactions related to PPAR-d Products to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities.
(b) (i) All appropriate regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, authorities in the aggregaterelevant countries, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all the applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliancesuch countries. As soon as practicable, but not more than thirty (30) days after the Effective Date, ▇▇▇▇▇▇▇ shall transfer ownership of, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such files relating to, its regulatory filings and all material communications between representatives associated with PPAR-d Products to Metabolex (including, but not limited to, any INDs Controlled by ▇▇▇▇▇▇▇ or its Affiliates). Metabolex shall provide ▇▇▇▇▇▇▇ with copies of the Credit Parties (draft [*] = Certain confidential information contained in this document, marked by brackets, has been omitted and their Subsidiaries) filed separately with the Securities and any Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. registration submissions in connection with obtaining Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Approval for a PPAR-d Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties Major Markets, prior to their submission, and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there ▇▇▇▇▇▇▇ shall have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to usereview such draft submission and provide comments thereon to Metabolex, as the case may be) which Metabolex agrees to reasonably consider. ▇▇▇▇▇▇▇ also agrees to discuss and answer any Regulatory Authorizations questions relating to PPAR-d Know-How that Metabolex may have regarding regulatory matters for PPAR-d Products. Metabolex shall also be responsible for all meetings with regulatory authorities and all post-approval commitments. Notwithstanding the Products in any material mannerabove, ▇▇▇▇▇▇▇ shall prepare and file a FDA regulatory submission covering the [*]. ▇▇▇▇▇▇▇ shall provide Metabolex with a copy of the draft submission prior to its submission, and no consent or other authorization of any Governmental Authority is required Metabolex shall review such draft submission and provide comments thereon to ▇▇▇▇▇▇▇, which ▇▇▇▇▇▇▇ agrees to consider and incorporate into the submission if in connection with the transactions contemplated hereby, including the Liens granted in connection herewith ▇▇▇▇▇▇▇’▇ reasonable judgment such suggestions are justified and the exercise of rights and remedies with respect theretoproper.
Appears in 1 contract
Regulatory Matters. With Following the transfer of the Regulatory Documentation, including INDs to MedImmune pursuant to Section 3.9, subject to the terms set forth below, MedImmune shall be solely responsible for all regulatory filings and communications with each Regulatory Health Authority with respect to each that Regulatory Documentation including any INDs relating to the Licensed Product:
, and MedImmune shall be solely responsible for any and all subsequent filings and communications with the Regulatory Health Authority including, without limitation, for the preparation and filing of all additional INDs relating to the Licensed Product and for providing, in the format required by Regulatory Health Authorities, the data and information required to be submitted to such Regulatory Health Authorities for Regulatory Approval of Licensed Products, including without limitation data from all Clinical Trials and all Manufacturing and controls information required for Regulatory Approval of such Licensed Product by the Regulatory Health Authorities. Notwithstanding the foregoing, MedImmune shall (ai) Set forth on Schedule 6.19(a) is a complete and accurate list provide Innate with copies of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Documentation received from Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Health Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) provide Innate with advance copies of all clinical material Regulatory Documentation for submission to Regulatory Health Authorities in the Major Markets, with sufficient time for Innate to review and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their complianceprovide comment, and give reasonable, good faith consideration to Innate’s suggestions therefor, (iii) permit at least one Innate representative to be present at all discussions and meetings with the Credit Parties EMA and their Subsidiaries have disclosed the FDA relating to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) Licensed Products subject to Applicable Law and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened restrictions imposed by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other EMA and (iv) generate true and accurate minutes of all discussions and meetings with Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Health Authorities relating to Licensed Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to Major Markets and provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities copies of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in minutes to Innate as promptly as possible following any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.such
Appears in 1 contract
Sources: Co Development and License Agreement (Innate Pharma SA)
Regulatory Matters. With respect The nonclinical studies and clinical trials conducted by or to each Product:
the Company’s Knowledge on behalf of the Company that are described in the Registration Statement and the Prospectus (athe “Company Studies and Trials”) Set forth on Schedule 6.19(a) is a complete and accurate list of were and, if still pending, are being, conducted in all material Regulatory Authorizations relating respects in accordance with experimental protocols, procedures and controls pursuant to, where applicable, accepted professional scientific standards, except as described in the Registration Statement or the Prospectus; the descriptions of the results of the Company Studies and Trials contained in the Registration Statement and Prospectus are accurate in all material respects; the Company has no Knowledge of any other studies or trials not described in the Registration Statement and the Prospectus, the results of which are inconsistent with or reasonably call into question the results described or referred to in the Registration Statement and the Prospectus; and the Company has not received any written notices or other correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority requiring the termination, suspension or material modification of any Company Studies or Trials except where such termination, suspension or material modification would not reasonably be expected to have a Material Adverse Effect, and to the Credit Parties Company’s Knowledge, there are no reasonable grounds for the same. The Company has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company Studies and their SubsidiariesTrials. In using or disclosing patient information received by the Company in connection with the Company Studies and Trials, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have Company has complied in all material respects with all applicable laws and regulationsregulatory rules or requirements, (ii) all including, without limitation, the Health Insurance Portability and Accountability Act of 1996 and the rules and regulations thereunder. To the Company’s Knowledge, none of the Company Studies and Trials involved any investigator who has been disqualified as a clinical and pre-clinical trials, if any, of investigational Products have investigator or has been and are being conducted found by the Credit Parties FDA to have engaged in scientific misconduct. To the Company’s Knowledge, the manufacturing facilities and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring operations of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof its suppliers are operated in compliance in all material respects with all applicable statutes, rules rules, and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 comparable regulatory agencies outside of the FD&C Act, or any other similar communication from any Regulatory Authority within United States to which the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products Company is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) yearssubject.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.
Appears in 1 contract
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(aThe Company and Company Subsidiaries have filed with the applicable regulatory authorities (including the FDA or any other Governmental Authority performing functions similar to those performed by the FDA) is a complete and accurate list of all required material Regulatory Authorizations relating to the Credit Parties and their Subsidiariesfilings, the conduct of their businessdeclarations, and the Products (on a per Product basis)listings, registrations, reports or submissions. All such filings, declarations, listings, registrations, reports or submissions were in material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Lienscompliance with applicable Law when filed, and (ii) as applicable, validly registered no material deficiencies have been asserted in writing to any of the Company and on file with the Company Subsidiaries by any applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings Authority with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authoritiesany such filings, declarations, listings, registrations, reports or submissions.
(b) Except as would not reasonably be expected to have a Company Material Adverse Effect, since January 1, 2020, (i) All regulatory filings the Company and the Company Subsidiaries have and have had in effect all necessary and applicable Regulatory Permits required by any Regulatory Health Authority or in respect to permit the conduct of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulationstheir respective businesses as currently conducted, (ii) all clinical of such Regulatory Permits are in full force and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, effect and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives each of the Credit Parties (Company and their Subsidiaries) applicable Company Subsidiary is in compliance with, and any is not in default under, each such Regulatory AuthorityPermit.
(c) The Credit PartiesExcept as would not reasonably be expected to have a Company Material Adverse Effect, their Subsidiaries since January 1, 2020, the Company, the Company Products, and the agents thereof facilities in which the Company Products are developed, tested, made, processed, labeled, packaged, handled or stored are in compliance in all material respects with all applicable statutesrequirements under applicable Health Laws, rules any comparable applicable foreign Laws, and regulations (including all Healthcare Laws terms and Regulatory Authorizations) conditions of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related theretoPermits.
(d) Except Set forth on Section 4.13(c) of the Company Disclosure Letter is a list and description of all Regulatory Permits. Other than the Regulatory Permits in Section 4.13(c) of the Company Disclosure Letter and except as set forth on Schedule 6.19(d)in Section 4.13(c) of the Company Disclosure Letter, there are no Credit Party nor additional Regulatory Permits required by any Health Authority to permit the conduct of its Subsidiaries has received from any their respective businesses as currently conducted, except where the failure to have such Regulatory Authority any notice of alleged non-compliance Permits would not reasonably be expected to have a Company Material Adverse Effect, individually or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit PartyExcept as would not reasonably be expected to have a Company Material Adverse Effect, nor since January 1, 2020, none of the Company, any of its Subsidiariesthe Company Subsidiaries or, nor to the Knowledge of the Company, any officerof their respective directors, employee officers, employees or agent thereof, agents has (i) made an untrue statement of a material fact or fraudulent statements statement to the FDA or any other Regulatory Authority, Health Authority or (ii) failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Health Authority. None of the Company, any of the Company Subsidiaries or any of their respective directors, officers, employees or agents is the subject of any pending or, to the Knowledge of the Company, threatened investigation by the FDA, or the subject of any investigation by any other Health Authority or Governmental Authority, or committed an act, made a statement, or failed to make a statement that, at the time assuming such disclosure was made (investigations were determined or was not made)resolved adversely, could would be reasonably be expected to provide have a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Company Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policyAdverse Effect.
(f) Except as set forth on Schedule 6.19(f)would not reasonably be expected to have a Company Material Adverse Effect, no Credit Party neither the Company nor any of its the Company Subsidiaries (i) has received any material written notice that from any Health Authority or Governmental Authority (including a warning, untitled, or notice of violation letter or Form FDA 483) alleging any violation of, or non-compliance with, any Health Law, (ii) is subject to any material enforcement, regulatory or administrative proceedings against or affecting the FDA Company or any other applicable Regulatory Authority Company Subsidiary relating to or arising under any Health Law and, to the Knowledge of the Company, no such enforcement, regulatory or administrative proceeding has commenced or initiatedbeen threatened, or threatened (iii) is a party to commence any corporate integrity agreement, monitoring agreement, deferred prosecution agreement, consent decree, settlement order, or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiaryother similar agreement, in each case, which representedentered into with or imposed by any Governmental Authority, in and no such action is pending as of the aggregate, 15% or more of Net Sales in any applicable year,date hereof.
(g) Since January 1, 2020, except as would not reasonably be expected to have a Company Material Adverse Effect, neither any the Company, Company Subsidiaries, nor any of their officers, directors, managers, employees, or agents are or have been: (i) excluded, suspended or debarred from participation, or are otherwise determined to be or identified as ineligible to participate, in any Governmental Health Program, (ii) subject to a civil monetary penalty assessed under Section 1128A of the Social Security Act, sanctioned, indicted or convicted of a crime, or pled nolo contendere or to sufficient facts, in connection with any allegation of violation of any Governmental Health Program requirement or Law, (iii) to the Knowledge of the Company, the target or subject of any investigation relating to any offense of any Governmental Health Program, (iv) party to any individual integrity agreement, corporate integrity agreement or other formal or informal agreement (e.g., deferred prosecution agreement) with any Governmental Authority concerning any Health Law, (v) listed on the Office of Inspector General’s List of Excluded Individuals and Entities, (vi) listed on the General Services Administration’s published list of parties excluded from federal procurement programs and non-procurement programs, or (vii) subjected to any other debarment, exclusion or sanction list or database.
(h) Except as set forth on Schedule 6.19(g)Section 4.13(h) of the Company Disclosure Letter, the clinical, preclinical, safety and other studies and tests all manufacturing operations conducted by or on behalf for the benefit of or sponsored by the Credit Parties Company and their Subsidiaries, or in respect of which any Products or Product candidates under development the Company Subsidiaries have participated, were (and if still pending, are) being been conducted in accordance compliance in all material respects with all applicable Regulatory Authorizations Health Laws, including good manufacturing practices regulations, and Healthcare Laws no Company Product has been recalled, withdrawn or suspended (whether voluntarily or otherwise) or has been adulterated or misbranded by the Company or a Company Subsidiary in all material respectsa manner that would reasonably be expected to result in action by a Governmental Authority. No proceedings seeking the recall, withdrawal, suspension or seizure of any such Company Product or pre-market approvals or marketing authorizations are pending or, to the Knowledge of the Company, threatened against the Company, nor have any such proceedings been pending at any time.
(hi) The transactions contemplated by Neither the Loan Documents Company nor the Company Subsidiaries are considered to be Covered Entities or a Business Associate pursuant to HIPAA.
(or contemplated by the conditions j) This Section 4.13 does not apply to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to useCompany Plans, as the case may be) any Regulatory Authorizations relating to the Products which are covered in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoSection 4.9.
Appears in 1 contract
Regulatory Matters. With respect to each Product:
(a) Set forth on Other than as disclosed in Section 3.8 of the Disclosure Schedule, the Group Companies have obtained necessary Approvals with respect to their respective operations and the Principal Business and all such Approvals are in full force and effect. The absence, or failure of renewal or maintaining, of such Approvals as disclosed in Section 3.8 of the Disclosure Schedule 6.19(a) is a complete and accurate list has not resulted in, would not be expected to result in, any Material Adverse Effect. None of all the Group Companies has engaged in any insurance or banking business or any financial services, telecommunication, utilities or other regulated business outside the scope of business as currently conducted by such Group Company. No Warrantor has reason to believe that any material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, Approval required for the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively Principal Business or any part thereof which is subject to periodic renewal will not be granted or renewed by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable relevant Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority Each registered holder or in respect beneficial owner of any Regulatory Authorization Equity Securities in the Company other than the Investors (each, a “Company Security Holder”) who is a Domestic Resident and subject to any of the registration or reporting requirements of Circular 37 or any other applicable SAFE rules and regulations (collectively, the “SAFE Rules and Regulations”) has complied with such registration and/or reporting requirements under the SAFE Rules and Regulations with respect to its investment in the Group Companies. None of the Warrantors, nor, to the Knowledge of the Warrantors, the other Company Security Holders has received any oral or written inquiries, notifications, orders or any other forms of official correspondence from SAFE or any of its local branches with respect to any Product actual or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development the SAFE Rules and Commercialization Activities related thereto which representedRegulations and the Company and the Company Security Holders have made all oral and written filings, in the aggregateregistrations, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or reporting and any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened communications required by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party SAFE or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any local branches applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory AuthorityGroup Companies. The WFOE and each Domestic Company has obtained all Approvals necessary under PRC Laws to conduct foreign exchange transactions as now being conducted by it, failed and has no reason to disclose a material fact required believe that it cannot obtain all Approvals for the conduct of foreign exchange transactions as now being conducted and planned to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policyconducted.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.
Appears in 1 contract
Sources: Series C Preferred Shares Purchase Agreement (Cango Inc.)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(aWithin thirty (30) is a days after the Closing Date, Seller shall provide Buyer with complete and accurate list copies of all material Sellers Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and Approvals for the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA Territory and all correspondence or other applicable Governmental Authoritiesdocuments reasonably related to such Regulatory Approvals.
(b) (i) All regulatory filings required by Buyer irrevocably grants to Seller and its Affiliates the right to reference and quote the Regulatory Approvals and all portions thereof to support Seller's Product related activities outside of the Territory and to support any Regulatory Authority veterinary pharmaceutical products, which Seller currently markets or in respect of any Regulatory Authorization with respect to any Product sells or any Product Development and Commercialization Activities which representedmay, in the aggregatefuture, 15% market or more sell. Buyer shall not amend the Regulatory Approvals for the Bicillin(R) and Wycillin(R) Products during the respective term of Net Sales in any applicable yearthe Supply Agreement for each such Product without the prior written consent of Seller, in the last five (5) years have been madesuch consent not to be unreasonably withheld, and all Seller shall respond to Buyer's request for consent within thirty (30) days from such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authorityrequest.
(c) The Credit PartiesUpon transfer and assignment of each of the Regulatory Approvals to Buyer, their Subsidiaries as provided in Section 2.5 and Section 6.8(d), and thereafter Buyer shall be solely responsible for conducting all activities in connection with such Regulatory Approvals for the agents thereof are Bicillin(R), Wycillin(R), and Nordette(R) Products, as applicable, including, without limitation, communicating, and preparing and filing all reports (including, without limitation, adverse drug experience reports) with the appropriate Governmental Authorities in compliance in all material respects the Territory and interacting with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, any third parties with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth Products sold or distributed in the FD&C Act or equivalent regulation Territory; provided, however, that for up to sixty (60) days after such transfer, Seller shall assist and cooperate in the transition of each other Governmental Authority having jurisdiction over such Personactivities to Buyer. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect Additionally, to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d)extent that Buyer is obligated, no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect under Applicable Laws, to any Product or any Product Development and Commercialization Activities related thereto which represented, report to Governmental Authorities in the aggregateTerritory, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any adverse drug experiences associated with Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted sold by or on behalf of or sponsored by Seller outside of the Credit Parties and their SubsidiariesTerritory, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted Seller shall provide Buyer with information about such adverse drug experiences in accordance with all applicable Regulatory Authorizations the provisions of this Section, and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the extent that Seller is obligated under Applicable Laws to report adverse drug experiences associated with Products in any material mannersold by or on behalf of Buyer inside the Territory, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.Buyer shall
Appears in 1 contract
Sources: Asset Purchase Agreement (King Pharmaceuticals Inc)
Regulatory Matters. With respect to each Product:
(a) Set forth on Each of the products under development by the Company is identified in Section 4.15(a) of the Company Disclosure Schedule 6.19(a) (the “Company Products”). The Company is a complete and accurate list of not currently marketing any product. The Company holds all material Regulatory Authorizations relating to the Credit Parties licenses, permits, franchises, variances, registrations, exemptions, orders and their Subsidiariesother governmental authorizations, the conduct of their businessconsents, approvals and clearances, and have submitted all material notices to, all Government Authorities, including all required authorizations under the FDCA, PHSA and the regulations of the FDA promulgated thereunder, and any other Government Authority that regulates the quality, identity strength, purity, safety, efficacy or manufacturing of the Company Products (any such Government Authority a “Company Regulatory Agency”) required for the lawful operation of the business of the Company (the “Company Permits”), except, in each case, as would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect on a per Product basis)the Company. All such material Regulatory Authorizations Company Permits are (i) legally valid and beneficially owned exclusively by the Credit Parties in full force and their Subsidiarieseffect. None of such Company Permit will be terminated or impaired or become terminable, in whole or in part, as applicablea result of the transactions contemplated by this Agreement. The Company is the sole and exclusive owner of Company Permit and the associated filings and applications with the FDA, including any biologics license application, new drug application, abbreviated new drug application, drug master files, biologics master files, master files for devices, 510(k) submission, premarket approval, investigational new drug or investigational device exemption application, comparable regulatory application or filing made or held by or issued to the Company (collectively, the “Company Regulatory Filings”) and hold all right, title and interest in and to all Company Regulatory Filings free and clear of all Liens other than Permitted Liensany encumbrance. The Company has not granted any third party any right or license to use, and (ii) as applicableaccess or reference any of the Company Regulatory Filings, validly registered and on file with including any of the applicable Governmental Authority, know-how contained in compliance with all filing and maintenance requirements any of the Company Regulatory Filings or rights (including any fee requirementsregulatory exclusivities) thereof, and are in good standing, valid and enforceable associated with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authoritieseach such Company Regulatory Filing.
(b) Since January 1, 2010, there has not occurred any breach or violation of, default (iwith or without notice or lapse of time or both) All regulatory filings required by any Regulatory Authority under or in respect of any Regulatory Authorization with respect event giving rise to any Product right of termination, amendment or cancellation of (with or without notice or lapse of time or both), any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) Company Permit. The Credit Parties, their Subsidiaries and the agents thereof are Company is in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) the terms of all applicable Governmental AuthoritiesCompany Permit, including and no event has occurred and no facts or circumstances exist that, to the knowledge of the Company, would reasonably be expected to result in the revocation, cancellation, non-renewal or adverse modification of any the Company Permit.
(c) Since January 1, 2010, all material applications, submissions, information and data used by the Company as the basis for, or submitted by or, to the knowledge of the Company, on behalf of the Company in connection with, any and all requests for Company Permit when submitted to the FDA or other Company Regulatory Agency, were, to the Company’s knowledge, accurate and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance complete in all material respects with all applicable registration as of the date of submission, and listing requirements set forth in the FD&C Act any updates, changes, corrections or equivalent regulation of each other Governmental Authority having jurisdiction over modifications to such Person. The Credit Parties applications, submissions, information and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect data required under Applicable Law have been submitted to the Products and all Product Development and Commercialization Activities related theretoFDA or other Company Regulatory Agency.
(d) Except as set forth on Schedule 6.19(d)Since January 1, no Credit Party nor 2010, the Company has not committed any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, any statement or failed to make a any statement that, at the time such disclosure was made (or was not made), could that would reasonably be expected to provide a basis for the FDA or any other Company Regulatory Authority Agency to invoke its policy respecting with respect to “Fraud, Untrue Statements of Material Facts, Bribery Bribery, and Illegal Gratuities” or similar policies under Applicable Law. Neither the Company nor, to the knowledge of the Company, any agent, subcontractor, director, officer, employee or other Person associated with or acting on behalf of the Company has been convicted of any crime or engaged in any conduct which has resulted or could result in debarment or disqualification by the FDA or any other Government Authority, and there are no proceedings pending or threatened that reasonably might be expected to result in criminal or civil liability or debarment or disqualification by the FDA or any other Government Authority.
(e) The Company nor, to the knowledge of the Company, any director, officer, agent, employee or other Person associated with or acting on behalf of the Company, has: (i) used any corporate funds for any unlawful contribution, gift, entertainment or other unlawful expense relating to political activity; (ii) made any direct or indirect unlawful payment to any foreign or domestic government official or employee from corporate funds; (iii) violated or is in violation of any provision of the FCPA or any similar Applicable Law; or (iv) made any bribe, rebate, payoff, influence payment, kickback or other unlawful payment. There are no pending or, to the knowledge of the Company, threatened filings against the Company of an action relating to the federal Anti-kickback Statute (42 U.S.C. § 1320a-7b(b)).
(f) Since January 1, 2010, there has not been any voluntarily or involuntarily initiated, conducted, or issued recall, field notification, field correction, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, market correction, or investigator notice relating to an alleged material lack of safety or efficacy of any Company Product.
(g) The Company is in compliance in all material respects with all Applicable Laws and any other letters, notices or guidance issued by the FDA or any Government Authority which regulate the clinical investigation, manufacture, sale, promotion, sampling and distribution of pharmaceutical products or biological, or device products in any jurisdiction. The Company has at all times and is currently distributing, marketing, promoting, labeling and selling its products in accordance with the FDCA and Prescription Drug Marketing Act of 1987. There are no pending or, to the knowledge of the Company, threatened regulatory Actions (other than non-material routine or periodic inspections or reviews) against the Company. Since January 1, 2010 there have been no written notices, reports, FDA Form 483 observations that have not been disclosed by the Company warning letters, or untitled letters alleging or asserting noncompliance in any material respect with any Applicable Law relating to the Company or any Company Product or any subpoenas or investigative demands or other written inquiries that would reasonably be interpreted as raising a compliance concern sent or delivered by any Government Authority with regard to any Company Product.
(h) The manufacture of Company Products is being conducted in compliance in all material respects with current “good manufacturing practices,” as defined by the FDA. The Company has been in material compliance with FDA’s registration and listing requirements to the extent required by FDA.
(i) The Company is and has been in compliance in all material respects with all Applicable Laws requiring the maintenance or submission of reports or records under requirements administered by the FDA or any other Government Authority, including Adverse Experiences, Serious Adverse Events, and Serious Injuries. There have been no Serious Adverse Events or Serious Injuries associated with the use (including in clinical trials) of any Company Products that have not been reported to the FDA in accordance with Applicable Law.
(j) To the knowledge of the Company, all studies, tests, and preclinical and clinical research being conducted by the Company, and to the knowledge of the Company, on behalf of the Company, are being, and at all times have been, conducted incompliance in all material respects with all Applicable Laws, including, as applicable, good laboratory practice regulations set forth in 21 C.F.R. Part 58, good clinical practices, as defined or recognized by the FDA, including the ICH Tripartite Guideline for Good Clinical Practice, other applicable provisions of the FDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58, 312 and 812, and comparable laws of any other Government Authority. No clinical trial conducted by the Company or, to the knowledge of the Company, on behalf of the Company, has been terminated or suspended prior to completion for safety or non-compliance reasons, and neither the FDA nor any other Government Authority, clinical investigator or institutional review board that has or had jurisdiction over or participated in any such clinical trial has initiated, or, to the knowledge of the Company, threatened to initiate, any action to place a clinical hold order on, or otherwise terminate, materially delay or suspend, any such ongoing clinical trial, or to disqualify, restrict or debar any clinical investigator or other Person or entity involved in any such clinical trial.
(k) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company is a party to, or bound by, any order, individual integrity agreement, corporate integrity agreement, monitoring agreement, consent decree, settlement order, deferred prosecution agreement or other formal or informal agreement with any Government Authority concerning compliance with the laws governing any Federal Health Care Program. The Company meets all the requirements of participation and payment of Medicare, Medicaid, and any Programs to the extent in which it participates. There is no action pending, received or, to the Company’s knowledge, threatened against the Company which relates in any way to a violation of any health care laws or which could result in the imposition penalties against or the exclusion of the Company from participation in any Programs. Neither the Company nor any officer, director or managing employee has engaged in any activities which are cause for civil penalties or mandatory or permissive exclusion from any Program. To the Company’s knowledge, there is no pending, proposed or final Medicare national or local coverage determination that, if finalized, would restrict coverage for the Company’s products. The Company has not established any reimbursement support program, such that payment for the Company product is contingent upon a purchaser’s receipt of payment from a third party payer. The Company does not furnish any coverage, coding or billing advice to any health care professionals regarding off-label indications of the Company products.
(l) Neither the Company nor any officer, director, managing employee (as those terms are defined in 42 C.F.R. § 1001.1001) of the Company, nor, to the knowledge of the Company, any agent (as such term is defined in 42 C.F.R. § 1001.1001(a)(1)(ii)) of the Company: (i) has been debarred, excluded or suspended under 21 U.S.C. § 335a, or (ii) any similar law, from participation in any Federal Health Care Program; (ii) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act; (iii) is currently listed on the General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs; (iv) to the knowledge of the Company, is the target or subject of any current investigation by a Government Authority relating to any Federal Health Care Program related offense; or (v) is currently charged with or convicted of any criminal offense relating to the delivery of an item or service under any Federal Health Care Program; or (vi) is the subject of any pending or threatened investigation by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) or and any similar policyamendments thereto.
(fm) Except as set forth on Schedule 6.19(fThere are no pending or, to the knowledge of the Company, threatened filings against the Company of an action relating to the Company under any federal or state whistleblower statute, including under the civil False Claims Act of 1863 (31 U.S.C. § 3729 et seq.), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA administrative False Claims Law (42 U.S.C. § 1320a-7b(a)) or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall Anti-Inducement Law (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,42 U.S.C. § 1320a-7a(a)(5)).
(gn) Except as set forth on Schedule 6.19(g)To the knowledge of the Company, the clinical, preclinical, safety and other studies and tests conducted Company is not under investigation by or on behalf any Government Authority for a violation of or sponsored by the Credit Parties and their SubsidiariesHIPAA, or the regulations contained in respect 45 C.F.R. Parts 160 and 164, including receiving any notices from the United States Department of which the Company and Human Services Office of Civil Rights relating to any Products such violations, or Product candidates under development have participated, were (and if still pending, are) being conducted any comparable state or local laws. The Company is not a “covered entity” as that term is defined in accordance with all applicable Regulatory Authorizations and Healthcare Laws HIPAA. The Company has been in compliance in all material respectsrespects with federal and state data breach laws.
(ho) The Company is and has been in compliance in all material respects with all Applicable Laws requiring state registration, state reporting of applicable sales and marketing expenditures and transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material mannerhealth care professionals, and no consent or other authorization state compliance program requirements, which may include (depending on the state) but is not limited to adoption of any Governmental Authority is required in connection with the transactions contemplated herebyOIG Office of Inspector General’s Compliance Program Guidance for Pharmaceutical Manufacturers, including the Liens granted in connection herewith and AdvaMed Code, and/or the exercise of rights and remedies with respect thereto.PhRMA Code. See Cal. Health & Safety Code §§ 119400 — 119402; Connecticut, Subst. Senate ▇▇▇▇ ▇▇. ▇▇▇, ▇▇▇▇ ▇▇. ▇▇▇, ▇▇▇. ▇▇. ▇▇▇; D.C., D.C. Code ▇▇▇. §§ 48-833.01—48-833.09; Maine, Maine Rev.
Appears in 1 contract
Sources: Agreement and Plan of Merger (Biosante Pharmaceuticals Inc)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(aThe Acquired Corporations have filed with the applicable regulatory authorities (including the FDA or any other Governmental Body performing functions similar to those performed by the FDA) is a complete and accurate list of all required material Regulatory Authorizations relating to the Credit Parties and their Subsidiariesfilings, the conduct of their businessdeclarations, and the Products (on a per Product basis)listings, registrations, reports or submissions. All such filings, declarations, listings, registrations, reports or submissions were in material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Lienscompliance with applicable Legal Requirements when filed, and (ii) as applicable, validly registered and on file with no material deficiencies have been asserted in writing to any of the Acquired Corporations by any applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings Body with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authoritiesany such filings, declarations, listings, registrations, reports or submissions.
(b) (i) All regulatory filings The Acquired Corporations hold all material Regulatory Permits required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been madefor their business as currently conducted, and all each such filings above such threshold are complete Regulatory Permit is valid and correct in in full force and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) effect. The Credit Parties, their Subsidiaries and the agents thereof Acquired Corporations are in compliance in all material respects with all applicable statutes, rules the terms and regulations (including all Healthcare Laws and requirements of such Regulatory Authorizations) Permits. No material deficiencies have been asserted in writing to any of all the Acquired Corporations by any applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, Body with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all any material Regulatory Permits of the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related theretoAcquired Corporations.
(dc) Except as set forth on Schedule 6.19(d)in documents either delivered or made available to Parent prior to the date of this Agreement, no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-all preclinical and clinical investigations sponsored by the Acquired Corporations have been and are being conducted in material compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable yearLegal Requirements, including any FDA Form 483 inspectional observationsGood Clinical Practices requirements and federal and state laws, notices rules and regulations restricting the use and disclosure of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) yearsindividually identifiable health information. No Credit Party nor any of its Subsidiaries Acquired Corporation has received any written notification that remains unresolved notice from the FDA or any other Regulatory Authority indicating Governmental Body performing functions similar to those performed by the FDA with respect to any breach ongoing clinical or violation preclinical investigations requiring the termination, suspension or material modification of any applicable Regulatory Authorization, including that any of the Products is misbranded such studies or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) yearstests.
(ed) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, Acquired Corporation has (i) made an untrue statement of a material fact or fraudulent statements statement to the FDA or any other Regulatory AuthorityGovernmental Body, (ii) failed to disclose a material fact required to be disclosed to the FDA or (iii) committed any other Regulatory Authority, or committed an act, made a statement, any statement or failed to make any statement, that (in any such case) establishes a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a reasonable basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery Bribery, and Illegal GratuitiesGratuities Final Policy. No Acquired Corporation is the subject of any pending or, set forth to the knowledge of the Company, threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. No Acquired Corporation nor any officers, employees, agents or clinical investigators has been suspended or debarred or convicted of any crime or, to the knowledge of the Company, engaged in 56 Fed. Reg. 46191 any conduct that would reasonably be expected to result in (September 10, 1991A) debarment under 21 U.S.C. § 335a or any similar policyLegal Requirement or (B) exclusion under 42 U.S.C. § 1320a-7 or any similar Legal Requirement.
(e) Each Acquired Corporation is in compliance and has been in compliance in all material respects with all related Legal Requirements applicable to pharmaceutical companies and to the operation of its business, including the FDCA and the regulations promulgated thereunder. No Acquired Corporation has been subject to any enforcement, regulatory or administrative proceedings against or affecting such Acquired Corporation relating to or arising under the FDCA or similar Legal Requirements and no such enforcement, regulatory or administrative proceeding has been threatened in writing.
(f) Except as set forth on Schedule 6.19(f)Each Acquired Corporation has operated its business in compliance in all material respects with all applicable Legal Requirements, no Credit Party nor any clinical trial protocols, and contractual or other requirements that regulate or limit the maintenance, use, disclosure or transmission of its Subsidiaries has received any written notice that the FDA medical records, clinical trial data, patient information or any other applicable Regulatory Authority has commenced Personal Information made available to or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted collected by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required Acquired Corporations in connection with the transactions contemplated herebyoperation of the Acquired Corporations’ businesses, including the Liens granted U.S. Health Insurance Portability and Accountability Act of 1996, as amended by the U.S. Health Information Technology for Economic and Clinical Health Act of 2009, including the regulations promulgated thereunder (collectively “HIPAA”), the U.S. Health Information Technology for Economic and Clinical Health Act (Pub. L. No. 111-5) (“HITECH”) and HITECH implementing regulations, Directive 95/46/EC and all comparable Legal Requirements relating to any of the foregoing (the “Health Care Data Requirements”). In conducting the Acquired Corporations’ businesses, each Acquired Corporation has been in connection herewith compliance in all material respects with all applicable confidentiality, security and other measures required by the exercise Health Care Data Requirements and all applicable privacy and security requirements of rights HIPAA and remedies HITECH. No Acquired Corporation has suffered any accidental, unauthorized, or unlawful destruction, loss, alteration, or disclosure of, or access to, Personal Information or suffered any security breach in relation to any other data which it holds. No breach has occurred with respect theretoto any unsecured Protected Health Information, as that term is defined in 45 C.F.R. §160.103, maintained by or for any Acquired Corporation that is subject to the notification requirements of 45 C.F.R. Part 164, Subpart D, and, no information security or privacy breach event has occurred that would require notification under any Health Care Data Requirement.
Appears in 1 contract
Regulatory Matters. With respect to each Product:
(a) Set Except as specifically provided in this Article 4, the Parties' roles and responsibilities in regulatory matters for the Licensed Compound and any of the Licensed Products in the Licensed Territory (including but not limited to CMA submissions, ▇▇▇▇, orphan designation(s) and PIPs) shall be set forth on Schedule 6.19(ain a regulatory strategy document to be negotiated in good faith and presented to the JSC for final approval by no later than forty-five (45) is a complete days of the Effective Date (the Regulatory Strategy). The Regulatory Strategy shall also set forth the clinical, non-clinical and accurate list of all material Regulatory Authorizations CMC data relating to the Credit Licensed Compound and Licensed Products to be shared between the Parties under Article 4(g).
(b) Unless provided otherwise in the Regulatory Strategy, LICENSEE will have ultimate responsibility for and their Subsidiariescontrol over marketing authorizations, orphan designation, PIP submissions and/or modifications and related processes within the Licensed Territory, it being understood and agreed that LICENSOR shall contribute to such tasks as detailed in the Regulatory Strategy.
(c) Subject to LICENSEE's roles and responsibilities set forth in the Regulatory Strategy, LICENSOR shall be responsible at its own cost for preparing the dossiers for registration of the Existing Product for FSGS and lgAN in the Licensed Territory for so long as LICENSOR is the sole applicant thereunder and, thereafter, the conduct Parties shall agree on a cost sharing taking into due account their roles and responsibilities. Unless provided otherwise in the Regulatory Strategy, the Party that applies for regulatory approval of their businessa Licensed Product shall be responsible for the filing costs of such application.
(d) Irrespective of the allocation of roles and responsibilities in this Article 4 and in the Regulatory Strategy, LICENSOR shall, at any time, use Commercially Reasonable Efforts to support all tasks of the Regulatory Strategy by contributing its expertise, Know-How and documentation available with regards to the Licensed Compound and the Existing Product in a timely manner as required for submissions and meeting of any deadlines in the regulatory processes. LICENSEE shall contribute its Know-How relating to regulatory matters accordingly and at its own cost.
(e) As soon as reasonably practicable and taking into account the details set forth in the Regulatory Strategy, registrations and marketing authorizations shall, subject to applicable local legislation, be applied for and maintained in the name and at the cost of LICENSEE, its Affiliates or admitted sub-licensees. Where LICENSOR has applied for or obtained product registrations and marketing authorizations within the Licensed Territory in its own name, it shall assign and transfer them to LICENSEE or to LICENSEE's Affiliates or admitted sub-licensees upon first request after regulatory approval.
(f) The maintenance of registrations and marketing authorizations and the related contacts with the regulatory authorities for Licensed Products in the Licensed Territory shall be the responsibility of LICENSEE (or its determined Affiliates or sub-licensees) at its own cost, and, for clarity, LICENSEE shall use Commercially Reasonable Efforts to perform and complete its obligations as detailed in the Regulatory Strategy and as otherwise necessary to obtain and maintain regulatory approvals of the Licensed Products in the Licensed Territory, and if required under applicable laws, rules or regulations, pricing and reimbursement approvals for the Licensed Products in the Licensed Territory. If requested by LICENSEE, LICENSOR shall use Commercially Reasonable Efforts to support such tasks by contributing its Licensed Compound and the Existing Product related expertise, Know-How and documentation.
(on a per Product basisg) To the extent permitted under applicable laws, regulations and guidance from regulatory authorities, and in accordance with Annex 4(g). All such material Regulatory Authorizations are , (i) legally and beneficially owned exclusively by within a reasonably prompt period following the Credit Parties and their SubsidiariesEffective Date, as applicable, free and clear LICENSOR shall make available to LICENSEE electronic copies of all Liens other than Permitted Liensexisting Regulatory Documentation for the Licensed Products in LICENSOR’s possession and Control as of the Effective Date, and (ii) as applicable, validly registered thereafter each Party will make available to the other Party electronic copies of all Regulatory Documentation for the Licensed Products in the possession and on file Controlled by such Party in accordance with the applicable Governmental Authority, timelines set forth in compliance with all filing and maintenance requirements (including any fee requirements) thereofthe Regulatory Strategy, and are in good standingeach Party grants to the other Party the right to cross-reference to such Regulatory Documentation (and the data and information contained therein) as necessary to support a clinical trial for the Licensed Products, valid and enforceable with to support regulatory approvals of the applicable Governmental AuthorityLicensed Products, to support a label expansion for the Licensed Products, or to support any New Indications agreed to by LICENSOR or as otherwise expressly permitted or required under this Agreement to enable a Party to exercise its rights or perform its obligations hereunder. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRsAnnex 4(g) and other reports sets forth the scope of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings information that is to be provided to LICENSEE by LICENSOR with respect to the Products for PROTECT Study and DUPLEX Study that is subject to a limited group of reviewers and identifies the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority roles or in respect positions of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries reviewers and the agents thereof are in compliance in all material respects with all applicable statutes, rules time and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto conditions under which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to information shall be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respectsprovided.
(h) The transactions contemplated by Subject to the Loan Documents (or contemplated by Regulatory Strategy and Annex 4(g), each Party agrees to inform the conditions to effectiveness other Party duly in advance of any Loan Document) will not impair any Credit Party’s scheduled health authority meetings, which are intended to seek advice on activities listed in the Clinical Development Plan, and the Parties shall share all documents, correspondences and/or meeting minutes upon request and to the extent permitted under applicable laws, regulations and guidance from regulatory authorities. LICENSEE shall make available to LICENSOR copies of all regulatory correspondence pertaining to the Existing Product in general or any of its Subsidiaries’ ownership the Licensed Products in the Licensed Territory. LICENSOR shall make available to LICENSEE copies of or rights under (or all regulatory correspondence with the license or the right to use, as the case may be) any Regulatory Authorizations relating FDA pertaining to the Products Existing Product in general or any material mannerof the Licensed Products, subject to the Regulatory Strategy, Annex 4(g) and no consent or to the extent permitted under applicable laws, regulations and guidance from regulatory authorities.
(i) This Article 4 shall apply mutatis mutandis with regard to applications for and maintenance of health technology assessments (HTAs) and any other authorization activities in support of any Governmental Authority is required in connection with reimbursement by local healthcare insurance schemes, being the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise main responsibility of rights and remedies with respect theretoLICENSEE.
Appears in 1 contract
Sources: License and Collaboration Agreement (Travere Therapeutics, Inc.)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) is a complete and accurate list Clinical Trials. None of all material the Company’s product candidates have received marketing approval from any Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required noticesclinical and preclinical studies and trials conducted by or on behalf of or sponsored by the Company or its subsidiaries, registrations and listingsor in which the Company or its subsidiaries participated, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products Company’s product candidates, including any such studies and trials that are described in the Registration Statement, the General Disclosure Package and the Prospectus, or the results of which are referred to in the Registration Statement, the General Disclosure Package and the Prospectus, as applicable (collectively, “Company Trials”), were, and if still pending are, being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with all applicable statutes, rules, regulations and policies of the Regulatory Authorities and current good clinical practices and good laboratory practices, standard medical and scientific research procedures and any applicable rules, regulations and policies of the jurisdiction in which such trials and studies are being conducted; the descriptions in the Registration Statement, the General Disclosure Package and the Prospectus of the results of any Company Trials are accurate and complete descriptions in all material respects and fairly present the data derived therefrom; the Company and its subsidiaries have no knowledge of any other studies or trials not described in the Registration Statement, the General Disclosure Package and the Prospectus, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement, the General Disclosure Package and the Prospectus; the Company and its subsidiaries have operated at all times and are currently in compliance in all material respects with all applicable statutes, rules, regulations and policies of the Regulatory Authorities; neither the Company nor its subsidiaries have received, nor does the Company or its subsidiaries have knowledge after due inquiry that any of its collaboration partners has received, any written notices, correspondence or other communications from the Regulatory Authorities or any other governmental agency requiring or threatening the termination, material modification or suspension of Company Trials, and, to the Company’s and its subsidiaries’ knowledge, there are no reasonable grounds for the last five same. The Company and its subsidiaries have obtained (5or caused to be obtained) years have been timely filed informed consent by or on behalf of each human subject who participated in a Company Trial. In using or disclosing patient information received by the Company or its subsidiaries in connection with a Company Trial, the FDA Company and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and its subsidiaries have complied in all material respects with all applicable laws and regulationsregulatory rules or requirements, (ii) all clinical including, without limitation, the Health Insurance Portability and pre-clinical trials, if any, Accountability Act of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries 1996 and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) thereunder. To the Company’s knowledge, none of all applicable Governmental Authorities, including the Company Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain engaged in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related theretoscientific misconduct.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.
Appears in 1 contract
Sources: Atm Equity Offering Sales Agreement (Neoleukin Therapeutics, Inc.)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(aThe Acquired Companies have filed with the applicable regulatory authorities (including the Food and Drug Administration (the “FDA”) is a complete or any other Governmental Body performing functions similar to those performed by the FDA in any jurisdiction) all required material filings, declarations, listings, registrations, reports or submissions, including but not limited to adverse event reports and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis)investigational new drug safety reports. All such filings, declarations, listings, registrations, reports or submissions were in material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Lienscompliance with applicable Legal Requirements when filed, and (ii) as applicable, validly registered and on file with the no deficiencies that have been asserted by any applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings Body with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authoritiesany such filings, declarations, listing, registrations, reports or submissions remain outstanding.
(b) (i) All nonclinical and clinical investigations sponsored by or on behalf of the Acquired Companies have been conducted and are being conducted in material compliance with applicable Legal Requirements and guidances, including good clinical practices requirements and applicable Legal Requirements restricting the use and disclosure of individually identifiable health information. As of the date of this Agreement, neither the FDA, nor any other foreign, federal, state or local governmental or regulatory filings required authority performing functions similar to those performed by the FDA, nor any Regulatory Authority institutional review board or in respect of independent ethics committee, has sent any Regulatory Authorization written notices or other correspondence to any Acquired Company or an investigator with respect to any Product clinical or nonclinical studies or tests sponsored by or on behalf of any Product Development and Commercialization Activities which represented, in the aggregate, 15% Acquired Company alleging or more of Net Sales in asserting material noncompliance with any applicable yearLegal Requirements or Governmental Authorizations with respect to any such study or test, in or recommending or requiring the last five (5) years termination, suspension or material modification of such studies or tests, which modification would reasonably be expected to have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authoritya Material Adverse Effect.
(c) The Credit PartiesAll animal studies or other preclinical tests performed in connection with or as the basis for any regulatory approval or clearance required for a product or product candidate of the Acquired Companies either (i) have been conducted in accordance, their Subsidiaries in all material respects, with applicable Good Laboratory Practice requirements contained in 21 C.F.R. Part 58 (“GLPs”) or (ii) involved experimental research techniques that could not be performed by a registered GLP testing laboratory (with appropriate notice being given to the FDA) and the agents thereof are in compliance have employed in all material respects with all applicable statutes, rules the procedures and regulations (including all Healthcare Laws and Regulatory Authorizations) controls generally used by qualified experts in animal or preclinical study of all applicable Governmental Authorities, including products comparable to those being developed by the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related theretoAcquired Companies.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any None of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product the Acquired Companies or any Product Development and Commercialization Activities related thereto which representedofficer, in the aggregate, 15% director or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 managing employee of the FD&C ActAcquired Companies or, or any other similar communication from any Regulatory Authority within to the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations knowledge of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, Company and to the extent relating to any Products which represented, in the aggregate, 15% product or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any product candidate of the Products is misbranded or adulterated as defined in the FD&C ActAcquired Companies, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five Collaboration Partner (5i) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements statement to the FDA or any other Regulatory AuthorityGovernmental Body, (ii) has failed to disclose a material fact required to be disclosed to the FDA or any Governmental Body, (iii) has committed any other Regulatory Authority, or committed an act, made a statement, any statement or failed to make any statement, that (in any such case) establishes a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a reasonable basis for the FDA or any other Regulatory Authority Governmental Body to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery Bribery, and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) Gratuities Final Policy or any similar policy, (iv) has had a civil monetary penalty assessed against it, him or her under Section 1128A of the Social Security Act, codified at Title ▇▇, ▇▇▇▇▇▇▇ ▇, ▇▇ ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇▇ Code, or (v) is currently listed on the United States General Services Administration published list of parties excluded from federal procurement programs and non-procurement programs. As of the date of this Agreement, no Acquired Company is the subject of any pending or, to the Company’s knowledge, threatened investigation in writing by the FDA or any other Governmental Body pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy or any similar policy. None of the Acquired Companies or any officers or employees of any Acquired Company or, to the knowledge of the Company, any agents or clinical investigators of the Acquired Companies has been suspended or debarred or charged with or convicted of any crime or engaged in any conduct that would reasonably be expected to result in (a) debarment under 21 U.S.C. Section 335a or any similar Legal Requirement or (b) exclusion under 42 U.S.C. Section 1320a-7 or any similar Legal Requirement.
(e) Each Acquired Company is and, to the knowledge of the Company and to the extent relating to any product or product candidate of the Acquired Companies, each Collaboration Partner is, in material compliance and since January 1, 2020, has been in material compliance with all healthcare laws to the extent applicable to the operation of its business as currently conducted, including (i) any and all federal, state and local fraud and abuse laws, including the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7(b)), the civil False Claims Act (31 U.S.C. § 3729 et seq.) and the regulations promulgated pursuant to such statutes; (ii) the Federal Food, Drug and Cosmetic Act (“FDCA”), (iii) the Health Insurance Portability and Accountability Act of 1996, the Health Information and Technology for Economic and Clinical Health Act, and the regulations promulgated pursuant thereto; (iv) the Public Health Service Act (“PHSA”); and (v) Legal Requirements which are cause for exclusion from any federal health care program. The Acquired Companies are not and have not been subject to and, to the knowledge of the Company and to the extent relating to any product or product candidate of the Acquired Companies, no Collaboration Partner is or has been subject to, any civil or criminal enforcement, regulatory or administrative proceedings against or affecting the Acquired Companies relating to or arising under the FDCA, the Anti-Kickback Statute, or similar Legal Requirements, and, to the knowledge of the Company, no such enforcement, regulatory or administrative proceeding has been threatened in writing. None of the Acquired Companies or any officers or employees of any Acquired Company or, to the knowledge of the Company, no agent or clinical investigator of the Acquired Companies, is a party to any corporate integrity agreement, monitoring agreement, consent decree, settlement order or similar agreement with or imposed by any Governmental Body.
(f) Except as set forth on Schedule 6.19(f)All manufacturing operations conducted for the benefit of the Acquired Companies with respect to any product candidate being used in human clinical trials have been conducted in all material respects in accordance with all applicable Legal Requirements including GMP. No manufacturing site that has conducted or is conducting manufacturing operations of product candidates for the benefit of the Acquired Companies is or has been, no Credit Party nor with respect to such product candidates being used in human clinical trials, subject to a shutdown or import or export prohibition imposed or requested by FDA or another Governmental Body. None of the Acquired Companies or, to the knowledge of the Company, any contract manufacturer for a product candidate manufactured for the benefit of its Subsidiaries the Acquired Companies that has been or is being used in human clinical trials, has, with respect to such product candidate, received any (i) FDA Form 483, (ii) warning letter, (iii) untitled letter, (iv) requests or requirements to make changes to its products, manufacturing processes or procedures, or (v) other similar correspondence or written notice that from the FDA or any other Governmental Body alleging or asserting material noncompliance with any applicable Regulatory Authority Legal Requirements or Governmental Authorizations. To the knowledge of the Company, no event has commenced occurred which would reasonably be expected to lead to any material claim, suit, proceeding, investigation, enforcement, inspection or initiatedother action by any Governmental Body or any FDA Form 483, warning letter, untitled letter or request or requirement to make changes to such product candidates or the manner in which such product candidates are manufactured, distributed, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,marketed.
(g) Except The Company has made available to Parent and Parent’s Representatives true, and correct copies of the following materials in the possession of the Acquired Companies as set forth on Schedule 6.19(g)of the date of this Agreement: (i) Investigational New Drug Applications; (ii) all material correspondence to or from the FDA and any other Governmental Body, and all other documents concerning material communications to or from the clinicalFDA and any other Governmental Body, preclinicalin each case held by the Acquired Companies or any of their Collaboration Partners concerning (A) any product or product candidate of the Acquired Companies, safety (B) the compliance of the Acquired Companies and their Collaboration Partners with applicable Legal Requirements regarding any product or product candidate of the Acquired Companies, and (C) the likelihood or timing of, or requirements for, regulatory approval of any product or product candidate of the Acquired Companies; (iii) nonclinical, clinical and other studies data contained in or relied upon in any of the foregoing; and tests conducted by or on behalf of or sponsored by (iv) all material information concerning the Credit Parties and their Subsidiariessafety, efficacy, side effects, toxicity, or in respect manufacturing quality and controls of which any Products product or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respectsproduct candidate of the Acquired Companies.
(h) The transactions contemplated Each Acquired Company holds and has, since January 1, 2020, held all material Governmental Authorizations and has submitted notices to the applicable regulatory authorities, including all authorizations under the FDCA, the PHSA, and the regulations of the FDA promulgated thereunder, necessary for the lawful operation of such Acquired Company’s business as is currently conducted or has been conducted, and all such Governmental Authorizations are valid and in full force and effect. There has not occurred any material violation of or default (with or without notice or lapse of time or both) under any such Governmental Authorization. Each Acquired Company is in compliance in all material respects with the terms of all such Governmental Authorizations. Since January 1, 2020, the Acquired Companies have not received written notice of any pending or threatened claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any Governmental Body alleging that any operation or activity of any Acquired Company is in material violation of any law that applies to such a Governmental Authorization.
(i) As of the date of this Agreement, the Company has no knowledge of (i) any adverse events that should have been reported but were not yet reported to FDA or other Governmental Body or institutional review board or independent ethics committee with respect to the safety or efficacy of any product or product candidate of the Acquired Companies, (ii) any scientific or technical fact or circumstance in existence as of the date of this Agreement that has had or would reasonably be expected to have, individually or in the aggregate, a material adverse effect on the scientific, therapeutic or commercial viability of any product or product candidate of the Acquired Companies in light of the particular stage of development of the product or product candidate of the Acquired Companies and taking into account all relevant facts and circumstances in existence as of the date of this Agreement at the time such facts or circumstances arose, including medical and clinical considerations, the regulatory environment and competitive market conditions, or (iii) any circumstance in existence as of the date of this Agreement that would reasonably be expected to lead to any refusal by any Governmental Body to accept or approve any filing, application or request for regulatory approval of the products or product candidates of the Acquired Companies in the United States or any other applicable jurisdiction.
(j) Part 3.13(j) of the Company Disclosure Schedule sets forth a true and complete list of all drug and biologic products that are being researched or under development by the Loan Documents (Acquired Companies as of the date of this Agreement. All such products are in compliance in all material respects with all applicable requirements under the FDCA, the PHSA and all comparable state or contemplated by foreign laws, including all requirements relating to research, development, manufacture, storing, testing, record-keeping, reporting, import, export, labeling, marketing, promotion, advertising, and distributing. The Acquired Companies have not received any written notice or other written communication from the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s FDA or any other Governmental Body alleging any violation of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretosuch requirements.
Appears in 1 contract
Regulatory Matters. With respect to each Product:
(a) Set Section 4.14(a) of the Company Disclosure Letter sets forth on Schedule 6.19(a) is a true and complete list, as of the Agreement Date, and accurate list of the Company has made available to Parent true and complete copies of, all Regulatory Authorizations from the FDA and all material Regulatory Authorizations from any other applicable Regulatory Authorities held by the Company relating to the Credit Parties and their SubsidiariesCompany Products. Except as would not reasonably be expected to, individually or in the conduct of their businessaggregate, and result in a Company Material Adverse Effect: (x) the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their SubsidiariesCompany has filed, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file maintained or furnished with the applicable Governmental AuthorityRegulatory Authorities all required filings, in compliance with all filing declarations, listings, registrations, submissions, amendments, modifications, notices and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required responses to notices, registrations applications and listings, supplemental applications or notificationsapplications, reports (including field alerts, medical device reports (MDRsall required adverse event reports) and other reports of adverse experiences information (collectively, the “Health Care Submissions”); and (y) all such Health Care Submissions were complete and accurate and in compliance in all material respects with applicable Health Laws when filed (or product malfunctions, and reports of corrections were corrected or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authoritiescompleted in a subsequent filing).
(b) (i) All regulatory filings required by Since January 1, 2022, the Company and its subsidiaries have been in material compliance with all Health Laws applicable to the Company’s business and Company Products; (ii) as of the Agreement Date, neither the Company nor its subsidiaries have received any written notice or other communication from any Regulatory Authority or in respect alleging any material violation of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, Health Law; and (iii) the Credit Parties and their Subsidiaries have disclosed there are no investigations, suits, claims, actions or proceedings pending, or to the Agent all such regulatory filings and all material communications between representatives knowledge of the Credit Parties (and their Subsidiaries) and Company, threatened against the Company or its subsidiaries alleging any Regulatory Authorityviolation by the Company, its subsidiaries or the Company Products of any such Health Law.
(c) The Credit PartiesSince January 1, their Subsidiaries 2022, to the Company’s knowledge, all pre-clinical studies and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities clinical trials conducted with respect to the Company Products by or at the direction of the Company have been conducted in material compliance with all applicable Laws, including the FDCA and all Product Development its applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and Commercialization Activities related thereto312, and any other applicable regulations that relate to the proper conduct of clinical studies. No clinical trial conducted by or, on behalf of, the Company has been terminated or suspended by any Regulatory Authority. As of the Agreement Date, neither the Company nor its subsidiaries have outstanding written notifications or other written communications from any institutional review board, ethics committee or safety monitoring committee raising any material issues, including from any Regulatory Authority in any jurisdiction, that requires or would require the termination or suspension or investigation of, or place a clinical hold order on or otherwise materially restrict, any clinical studies in which the Company or its subsidiaries have participated and, to the knowledge of the Company, no such action has been threatened against the Company or its subsidiaries. Nothing in this Section 4.14(c) will apply to the Company’s compliance with Data Privacy and Security Requirements.
(d) Except as set forth Since January 1, 2022, to the Company’s knowledge, all manufacture of the Company Product, including any clinical supplies used in any clinical trials, by or on Schedule 6.19(d)behalf of the Company has been conducted in material compliance with the applicable specifications and requirements of applicable Health Laws. As of the Agreement Date, no Credit Party nor neither the Company nor, to the knowledge of the Company, any of person acting on its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings behalf has, with respect to the Company Product: (i) been subject to a Regulatory Authority shutdown or import or export prohibition; or (ii) received any FDA Form 483, or other Regulatory Authority written notice of inspectional observations, “warning letters,” “untitled letters” or written requests or requirements to make any material adverse changes to the Company Product or any Product Development and Commercialization Activities related thereto which represented, in of the aggregate, 15% or more of Net Sales in Company’s business operations due to noncompliance with any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, Health Law or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit PartyNone of the Company, nor its subsidiaries, or, to the knowledge of the Company, its officers, employees, or any of its Subsidiaries, nor any officer, employee or agent thereof, has clinical investigator acting for the Company has: (i) made an untrue statement of a material fact or fraudulent statements statement to the FDA any Regulatory Authority or any other Regulatory Authority, Governmental Entity; (ii) failed to disclose a material fact required to be disclosed to the FDA any Regulatory Authority or any other Regulatory Authority, Governmental Entity; or (iii) committed an act, made a statementstatement of material fact, or failed to make a statement of material fact require to be disclosed, including with respect to any scientific data or information, that, at the time such disclosure was made (or was not made)failure to disclose occurred, could would reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery Bribery, and Illegal Gratuities, ,” set forth in 56 Fed. Reg. 46191 (September 10, 1991), and any amendments thereto, or for any Regulatory Authority to invoke any similar policy or any other statute or regulation regarding the communication or submission of false information to any applicable Regulatory Authority or Governmental Entity. The Company has not committed or engaged in any fraud or falsification or forgery of any research or development data, report, studies or publications of any document or statement voluntarily submitted or required to be submitted to any Regulatory Authority or any other Governmental Entity. None of the Company, its subsidiaries, or, to the knowledge of the Company, its officers, employees, or any clinical investigator acting for the Company, is currently or has been convicted of any crime that has resulted in, or would reasonably be expected to result in, debarment pursuant to 21 U.S.C. Section 335a (a) or (b) or exclusion from participation in any similar policyfederal health care program pursuant to 42 U.S.C. Section 1320a-7.
(f) Except as set forth No Company Product that is or has been manufactured, tested, distributed, held or marketed by or on Schedule 6.19(f)behalf of the Company has been recalled, no Credit Party nor withdrawn or suspended (whether voluntarily or otherwise) due to material noncompliance with the FDCA or, to the Company’s knowledge, has been adulterated or misbranded in material violation of the FDCA. No Proceedings (whether complete or pending) seeking the recall, withdrawal, suspension or seizure of any such Company Product or pre-market approvals or marketing authorizations are pending or, to the knowledge of its Subsidiaries the Company, threatened against the Company. The Company has received any written notice that filed all annual and periodic reports, amendments and safety reports required for the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened Company Product required to commence or initiate, any action be made to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,Authority.
(g) Except as set forth on Schedule 6.19(g)Neither the Company nor its subsidiaries are a party to any corporate integrity agreement, the clinicalmonitoring agreement, preclinicalconsent decree, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiariessettlement order, or in respect of which similar agreement with or imposed by any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s Authority or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoEntity.
Appears in 1 contract
Sources: Merger Agreement (Allakos Inc.)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) is a complete The Lead Product Candidate of the Company Group has been developed, tested, manufactured, stored, distributed, dispensed and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiariesadministered, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with applicable law including Healthcare Laws, Privacy Laws, including without limitation, those requirements of any Regulatory Authority governing current good manufacturing practices, good laboratory practices, good clinical practices, the conduct of clinical trials, and the protection of human subjects enrolled in clinical trials as required of clinical trial sponsors.
(b) Complete and accurate copies of all Regulatory Permits, and all material correspondence with the FDA or other applicable Regulatory Authorities with respect to the Regulatory Permits, have been made available to the Purchaser. The Company Group have never imported for sale, exported for sale, marketed for sale, sold, offered for sale, distributed for sale, processed for sale or packaged for sale any product, except for those products that are sold as a supplement and not as a drug.
(c) To the knowledge of the Company, the clinical trials conducted or otherwise sponsored by the Company Group with respect to the Lead Product Candidate of the Company and its Subsidiaries were conducted and are being conducted in all material respects in accordance with all applicable statutesclinical trial protocols, rules informed consents, the terms and regulations (including all Healthcare Laws and Regulatory Authorizations) conditions of all applicable Governmental AuthoritiesRegulatory Permits, requirements imposed by applicable Institutional Review Boards (IRB), and applicable requirements of Law. The Company Group owns or has the right to use all data collected in the course of such clinical trials, including the FDA right to use such data in submissions to the FDA, the EMA or other Governmental Entities. The Company has the right to transfer (including transfer of the right to use) all data collected in the course of such clinical trials to the Purchaser.
(d) The Company Group has made available to Purchaser complete, true and correct copies of all other substantive correspondence (including letters, memoranda, emails and formal summaries of meetings, phone calls, conversations and teleconferences whether written or electronic) (“Correspondence”) to or from any Regulatory AuthoritiesAuthority and the Company Group or its Subsidiaries or any Person acting for or on behalf of the Company Group or its Subsidiaries including relating to clinical trials or proposed clinical trials of the Lead Product Candidate, data from such trials, preclinical testing of the Lead Product Candidate, testing required or recommended for approval of the Lead Product Candidate, the manufacture of the Lead Product Candidate, inspection of facilities, audit reports or the pricing of or reimbursement for the Lead Product Candidate (whether for commercial sale or compassionate or similar use).
(e) Except as disclosed on Schedule 5.28, and made available to the Purchaser, as of the date of this Agreement, neither the Company Group, its Subsidiaries, nor, to the Knowledge of the Company Group, any Person acting for or on behalf of the Company Group or its Subsidiaries has had any substantive communication, whether orally, electronically, telephonically, in writing or otherwise, with respect a Regulatory Authority relating to the Lead Product Candidate potentially being available in any compassionate use.
(f) Except as made available to the Purchaser, as of the date of this Agreement, to the knowledge of the Company, no Regulatory Authority or IRB currently places a clinical hold (whether full or partial), or has taken any other material action currently in effect to delay, suspend, terminate, or modify any clinical trial conducted or otherwise sponsored by the Company Group of the Lead Product Candidate.
(g) To the knowledge of the Company, the Company Group are not subject to any investigation that is pending and of which the Company Group has been notified in writing or, to the Company Group’s Knowledge, which has been threatened, in each Product case by (i) the FDA, (ii) the Department of Health and all Product Development Human Services Office of Inspector General, (iii) the Department of Justice, or (iv) any other Governmental Entity pursuant to the Anti-Kickback Statute, the Federal False Claims Act (31 U.S.C. §3729) or other similar state or foreign law.
(h) The Company and Commercialization Activities related thereto. The Credit Parties and their its Subsidiaries have complied and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects respects, with all applicable registration Healthcare Laws and listing requirements set forth in Privacy Laws. To the FD&C Act knowledge of the Company, neither the Company Group, its Subsidiaries, nor any of their Affiliates, officers, directors, employees, agents, or equivalent regulation contractors has: (i) been debarred, excluded or received notice of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations action or threat of all Regulatory Authorities action with respect to debarment, exclusion or other action under the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d)provisions of 21 U.S.C. §§ 335a, no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance 335b, or adverse findings with respect to any Product 335c, 42 U.S.C. § 1320a-7 or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales equivalent provisions in any other applicable yearjurisdiction; (ii) made or offered any payment, including any FDA Form 483 inspectional observations, notices gratuity or other thing of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened value that is prohibited by any Regulatory Authority, or (for example in the case law to personnel of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five Governmental Entity; (5iii) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements statement to the FDA or any other Governmental Authority or Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Governmental Authority or Regulatory Authority, or in any records and documentation prepared or maintained to comply with the applicable laws, or committed an any act, made a any statement, or failed to make a any statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Governmental Authority or Regulatory Authority to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery Bribery, and Illegal Gratuities, ” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
, (fiv) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that of or been subject to any other material enforcement action involving the FDA or any other applicable Regulatory Authority has commenced similar Governmental Entity, including any suspension, consent decree, notice of criminal investigation, indictment, sentencing memorandum, plea agreement, court order or initiated, target or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material mannerno-target letter, and no consent or other authorization none of any Governmental Authority is required the foregoing are pending or, to Company Group’s Knowledge, threatened in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretowriting.
Appears in 1 contract
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file The Acquired Corporations have filed with the applicable regulatory authorities (including the FDA or any other Governmental AuthorityBody performing functions similar to those performed by the FDA in other applicable jurisdictions) all required material filings, declarations, listings, registrations, reports or submissions. To the knowledge of the Company, all such filings, declarations, listings, registrations, reports or submissions were in material compliance with all filing and maintenance requirements (including any fee requirements) thereofapplicable Legal Requirements when filed, and are no material deficiencies have been asserted in good standing, valid and enforceable with writing to any of the Acquired Corporations by any applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings Body with respect to the Products any such filings, declarations, listings, registrations, reports or submissions, except for the last five (5) years those deficiencies that have been timely filed with addressed in full by the FDA and all other applicable Governmental AuthoritiesCompany.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in The Acquired Corporations hold all material respects with all Regulatory Permits required under applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites Legal Requirements for their compliancebusiness as currently conducted, and (iii) the Credit Parties and their Subsidiaries have disclosed and, to the Agent all such regulatory filings and all material communications between representatives knowledge of the Credit Parties (Acquired Corporations, each such Regulatory Permit is valid and their Subsidiaries) in in full force and any Regulatory Authority.
(c) effect. The Credit Parties, their Subsidiaries and the agents thereof Acquired Corporations are in compliance in all material respects with the terms and requirements of such Regulatory Permits. No material deficiencies have been asserted in writing to any of the Acquired Corporations by any applicable Governmental Body with respect to any material Regulatory Permits of the Acquired Corporations.
(c) All preclinical and clinical investigations sponsored by the Acquired Corporations since January 1, 2019 have been and are being conducted in material compliance with all applicable statutesLegal Requirements, including Good Clinical Practices requirements, requirements relating to ▇▇▇▇▇▇▇▇▇▇▇▇▇▇.▇▇▇, and federal and state laws, rules and regulations (including all Healthcare Laws restricting the use and Regulatory Authorizations) disclosure of all applicable Governmental Authoritiesindividually identifiable health information, including those similar requirements as applicable in jurisdictions outside the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) yearsUnited States. No Credit Party nor any of its Subsidiaries Acquired Corporation has received any written notification that remains unresolved notice from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined Governmental Body in the FD&C ActUnited States or elsewhere performing functions similar to those performed by the FDA with respect to any ongoing clinical or preclinical investigations requiring the termination, in each case suspension or material modification of the foregoing, which represented, in the aggregate, 15% such studies or more of Net Sales in any applicable year within the last five (5) yearstests.
(ed) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, Acquired Corporation has (i) made an untrue statement of a material fact or fraudulent statements statement to the FDA or any other Regulatory AuthorityGovernmental Body, (ii) failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory AuthorityGovernmental Body, or (iii) to the knowledge of the Company, committed an any other act, made a statement, any statement or failed to make any statement, that (in any such case) establishes a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a reasonable basis for the FDA or any other Regulatory Authority Governmental Body to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery Bribery, and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) Gratuities Final Policy or any similar policypolicy administered in any other applicable jurisdiction. No Acquired Corporation is the subject of any pending, or, to the knowledge of the Company, threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy, or by any Governmental Body pursuant to any similar Legal Requirement. As of the date of this Agreement, no Acquired Corporation nor, to the knowledge of the Company, any officers, employees, agents or clinical investigators has been suspended, disqualified, debarred or convicted of any crime or, to the knowledge of the Company, engaged in any conduct that would reasonably be expected to result in (A) debarment under 21 U.S.C. § 335a or any similar Legal Requirement or (B) exclusion under 42 U.S.C. § 1320a-7 or any similar Legal Requirement.
(e) Each Acquired Corporation and the products manufactured or marketed by or on behalf of such Acquired Corporation have, since January 1, 2019, been in compliance in all material respects with all Legal Requirements applicable to ophthalmic pharmaceutical companies and to the operation of such Acquired Corporation’s business, including the FDCA, its foreign equivalents and the regulations promulgated thereunder. No Acquired Corporation or, to the knowledge of the Company, third party that manufactures or commercializes finished product on behalf of the Acquired Corporations (but only in their capacity as such) has been subject to any enforcement, regulatory or administrative proceedings against or affecting such Acquired Corporation or such third party relating to or arising under the FDCA or similar Legal Requirements and no such enforcement, regulatory or administrative proceeding has been threatened in writing. No Acquired Corporation or to the knowledge of the Company third party that manufactures or commercializes finished product on behalf of any Acquired Corporation (but only in their capacity as such) is party to or has any ongoing obligations pursuant to or under any corporate integrity agreements, deferred prosecution agreements, monitoring agreements, consent decrees, settlement orders, plans of correction or similar agreements with or imposed by any Governmental Body.
(f) Except Each Acquired Corporation has operated its business in compliance in all material respects with all applicable Legal Requirements, clinical trial protocols, and contractual or other requirements that regulate or limit the maintenance, use, disclosure or transmission of medical records, clinical trial data, patient information or other Personal Information made available to or collected by or on behalf of any of the Acquired Corporations in connection with the operation of the Acquired Corporations’ businesses, including the U.S. Health Insurance Portability and Accountability Act of 1996, as set forth on Schedule 6.19(famended by the U.S. Health Information Technology for Economic and Clinical Health Act of 2009, including the regulations promulgated thereunder (collectively “HIPAA”), no Credit Party nor the U.S. Health Information Technology for Economic and Clinical Health Act (Pub. L. No. 111-5) (“HITECH”) and HITECH implementing regulations, Directive 95/46/EC and all comparable Legal Requirements relating to any of its Subsidiaries the foregoing, as well as applicable similar requirements in any applicable regime (the “Health Care Data Requirements”). In conducting the Acquired Corporations’ businesses, each Acquired Corporation has been in compliance in all material respects with applicable confidentiality, security and other measures required by the Health Care Data Requirements and all applicable privacy and security requirements of HIPAA and HITECH. As of the date of this Agreement, no Acquired Corporation has suffered any accidental, unauthorized, or unlawful destruction, loss, alteration, or disclosure of, or access to, Personal Information or suffered any security breach in relation to any other data which it holds. As of the date of this Agreement, no breach has occurred with respect to any unsecured Protected Health Information, as that term is defined in 45 C.F.R. §160.103, maintained by or for any Acquired Corporation that is subject to the notification requirements of 45 C.F.R. Part 164, Subpart D, and, no information security or privacy breach event has occurred that would require notification under any Health Care Data Requirement.
(g) Since January 1, 2019, none of the Acquired Corporations has received any written notice from a Governmental Body alleging or asserting that any of their products are misbranded as defined in 21 U.S.C. § 352 or adulterated as defined in 21 U.S.C. § 351, as amended, and the FDA or any other applicable Regulatory Authority has commenced or initiatedrules and regulations promulgated thereunder, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, as defined in each case, which represented, in the aggregate, 15% or more of Net Sales comparable Legal Requirements in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted jurisdiction. The products manufactured or marketed by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or Acquired Corporations have complied in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance all material respects with all applicable Regulatory Authorizations Legal Requirements, including cGMP, and, since January 1, 2019, the promotional materials and Healthcare Laws claims made by the Acquired Corporations for the products manufactured or marketed by or on behalf of the Acquired Corporations have complied in all material respectsrespects with all applicable Legal Requirements.
(h) The transactions contemplated Since January 1, 2019, there have been no product recalls conducted by the Loan Documents Acquired Corporations, no product recalls of product manufactured by or on behalf of the Acquired Corporations, and no written requests from any Governmental Body requiring any Acquired Corporation to cease manufacturing, marketing, distributing or selling any products of the Acquired Corporations. Since January 1, 2019, no Governmental Body (including the FDA or contemplated similar entities) has initiated an injunction, seizure, or import or export prohibition against any Acquired Corporation, any product manufactured or marketed by the conditions to effectiveness or on behalf of any Loan DocumentAcquired Corporation, or any third party establishment that manufactures or tests product on behalf of any Acquired Corporation (but only in their capacity as such). Since January 1, 2019, the Acquired Corporations have not received a “warning letter” or “untitled letter” or similar correspondence or written notice from any Governmental Body (including the FDA or similar entities), nor has any Acquired Corporation been asked or directed by any Governmental Body (including the FDA or similar entities) will not impair any Credit Party’s or to make material changes to any of its Subsidiaries’ ownership products or product candidates. No Acquired Corporation has received an FDA Form 483 or similar list of regulatory observations from any Governmental Body (including the FDA or rights under similar entities), and, to the knowledge of the Company, the observations that have been received have been addressed to the satisfaction of the issuing authorities.
(or i) To the license or knowledge of the right to useCompany, as since January 1, 2019, no Person has filed against the case may be) any Regulatory Authorizations Company a Legal Proceeding relating to the Products in any material mannerFalse Claims Act of 1863 (31 U.S.C. § 3729 et seq.) or equivalent state statute, and no consent or other authorization of any Governmental Authority is required in connection with which was disclosed to the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoCompany.
Appears in 1 contract
Sources: Merger Agreement (Alcon Inc)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, The Key Holders and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally Group Companies have obtained any and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the Approvals from applicable Governmental Authority, in compliance Authorities and have fulfilled any and all filings and registration requirements with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings Authorities necessary with respect to the Products Founders and their investment in the Group Companies, and with respect to the Group Companies and their operations. The Schools have obtained any and all Approvals from applicable Governmental Authorities and have fulfilled any and all filings and registration requirements with applicable Governmental Authorities necessary with respect to their establishment and operations. All filings and registrations with applicable Governmental Authorities required with respect to the Group Companies, the Founders and the Schools have been duly completed in accordance with applicable Law. Neither any Founder nor any Group Company has received any letter or notice from any applicable Governmental Authorities notifying it of the revocation of any Approval issued to it or any Schools or the need for compliance or remedial actions with respect to the activities carried out directly or indirectly by any Founder or any Group Company or any School. Each Group Company and each School has been conducting its business activities within the permitted scope of business or is otherwise operating its Businesses in full compliance with all relevant Laws and Governmental Orders, including providing products and/or services with all requisite licenses, permits and approvals granted by the competent Governmental Authorities. Neither any Founder nor any Group Company has reason to believe that any authorization of any Governmental Authority, license or permit required for the last five (5) years have been timely filed with conduct of any part of its Business and/or for the FDA and all other applicable operation of any School which is subject to periodic renewal will not be granted or renewed by the relevant Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect Each holder of any Regulatory Authorization Equity Securities of the Company (each, a “Company Security Holder”), who is a Domestic Resident and subject to any of the registration or reporting requirements of Circular 75 or any other applicable SAFE rules and regulations (collectively, the “SAFE Rules and Regulations”), has complied with such reporting and/or registration requirements under the SAFE Rules and Regulations. Neither the Warrantors nor any of the Company Security Holders has received any oral or written inquiries, notifications, orders or any other forms of official correspondence from SAFE or any of its local branches with respect to any Product actual or alleged non-compliance with the SAFE Rules and Regulations and the Company and the Company Security Holders have made all oral or written filings, registrations, reporting or any Product Development other communications required by SAFE or any of its local branches. Each Group Company has obtained all certificates, approvals, permits, licenses, registration receipts and Commercialization Activities which represented, in any similar authority necessary under the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are PRC Law to conduct foreign exchange transactions as now being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authorityit.
(c) The Credit Parties, their Subsidiaries Beijing Company has obtained any and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all Approvals from applicable Governmental Authorities, including the FDA Authorities and has fulfilled any and all other Regulatory Authorities, filings and registration requirements with applicable Governmental Authorities necessary with respect to each Product its franchising agreements entered into with any and all Product Development franchisees for Firstleap Education and Commercialization Activities related theretothe relevant businesses conducted thereunder. The Credit Parties Beijing Company has not violated any of such franchising agreements in any material aspect and, to the best knowledge of the Warrantors, each of the training centres of Beijing Company is duly established under PRC Law and their Subsidiaries have and maintain has been operating in full force and effect all compliance with PRC Law. To the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 best knowledge of the FD&C ActWarrantors, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any each of the Products franchised schools and training centres of Beijing Company (the “Franchised Schools”) is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery duly established and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted operated in accordance with all applicable Regulatory Authorizations the Law of the People’s Republic of China on the Promotion of Privately-run Schools (《中华人民共和国民办教育促进法》) and Healthcare Laws in all material respectsrelevant regulations.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.
Appears in 1 contract
Sources: Series a Preferred Shares Purchase Agreement (Xueda Education Group)
Regulatory Matters. With respect 6.1 Regulatory Responsibilities in the Territory. (a)Other than AST-005, Licensee is responsible for all regulatory submissions and will control all development and regulatory activities after Stage 4 of each Development Candidate and Product, including safety reporting, analysis and strategy. After Option exercise of AST-005, Licensee is responsible for all regulatory submissions and will control all development and regulatory activities for AST-005, including safety reporting, analysis and strategy. Licensor will provide non-financial, timely support to each Product:
(a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings Licensee with respect to such regulatory activities and transfer all Information related to such Development Candidate or Product to Licensee at such time that Licensee has the Products foregoing responsibilities. In addition, for each Exercised Development Candidate and Product, Licensor shall transfer all Information related to such Development Candidate or Product to Licensee and at Licensee’s request use Commercially Reasonable Efforts to transfer any agreements related to such Development Candidate or Product, including all contract research organization agreements, to Licensee. Further, as of the last five (5) years have been timely filed with Trigger Date, Licensor shall transfer to Licensee the FDA AST-005 IND and all other applicable Governmental AuthoritiesInformation related to AST-005 and, as of the date of Licensee’s selection of a Collaboration Target, Licensor shall transfer to Licensee all Regulatory Materials relating to such Collaboration Target.
(b) Licensee will be the primary interface with and will otherwise handle all correspondence, meetings and other interactions with the relevant Regulatory Authorities concerning regulatory activities related to each Product in the Field in the Territory, and Licensee will prepare and file any and all Regulatory Materials for each Product in the Field in the Territory at its sole expense in accordance with the Collaboration Research Plan. Licensor will assist and cooperate at its own expense with Licensee in connection with the preparation and filing of such Regulatory Materials, as reasonably requested by Licensee, including preparation of ongoing clinical trials, study reports and Periodic Safety Update Reports (“PSURs”). Such cooperation will include promptly responding within procedural timelines set by Regulatory Authorities to any reasonable request from Licensee for Licensor Know-How needed for the Regulatory Materials. 31 THE COMPANY HAS REQUESTED AN ORDER FROM THE SECURITIES AND EXCHANGE COMMISSION (THE “COMMISSION”) PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED, GRANTING CONFIDENTIAL TREATMENT TO SELECTED PORTIONS. ACCORDINGLY, THE CONFIDENTIAL PORTIONS HAVE BEEN OMITTED FROM THIS EXHIBIT, AND HAVE BEEN FILED SEPARATELY WITH THE COMMISSION. OMITTED PORTIONS ARE INDICATED IN THIS EXHIBIT WITH “*****”.
(c) Unless the Parties otherwise agree in writing: (i) All regulatory filings required except as expressly contemplated by any Regulatory Authority or in respect of any Regulatory Authorization this Section 6.1, Licensor will not communicate with respect to any Product or in the Field with any Product Development and Commercialization Activities which representedRegulatory Authority having jurisdiction in the Territory, unless so ordered by such Regulatory Authority, in the aggregate, 15% or more which case Licensor will provide immediate notice to Licensee of Net Sales in any applicable year, in the last five (5) years have been made, such order; and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trialsexcept as expressly contemplated by this Section 6.1, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and Licensor will not submit any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Materials or seek Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Approvals for Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, Field in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) yearsTerritory. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.6.2
Appears in 1 contract
Sources: Research Collaboration, Option and License Agreement
Regulatory Matters. With respect to each Product:[CONFIDENTIAL TREATMENT REQUESTED BY AVADEL PHARMACEUTICALS PLC]
(a) Set Schedule 3.10(a) sets forth on Schedule 6.19(a) is a true and complete and accurate list of (i) all material Regulatory Authorizations held by each Seller or under which any Seller conducts business, or that have been submitted by or on behalf of any Seller, in each case, relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on Business or a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted LiensProduct, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences notifications or product malfunctions, and reports of corrections submissions for Regulatory Authorizations pending in relation thereto. Sellers possess all material Regulatory Authorizations that are required for or removal) and other required filings with respect relate to the Products for Business. Sellers are the last five sole and exclusive owner(s) of the Regulatory Authorizations and none of the Regulatory Authorizations has been sold, conveyed, delivered, transferred or assigned to another party. Each such Regulatory Authorization (5A) years have has, to Sellers’ Knowledge, been timely filed with validly issued or acknowledged by the FDA appropriate Regulatory Authority and all other applicable Governmental Authoritiesis in full force and effect and (B) is transferable to Buyer. To Sellers’ Knowledge, there are no facts, circumstances or conditions that would prevent the transfer of any Regulatory Authorization to Buyer on or after the Closing Date.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which representedExcept as set forth on Schedule 3.10(b), in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trialsand clinical studies, if any, of investigational Products have been trials and investigations conducted or sponsored in relation to the Business are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliancebeing, and (iii) the Credit Parties and their Subsidiaries at all times have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Partiesbeen, their Subsidiaries and the agents thereof are conducted in compliance in all material respects with all applicable statutesclinical protocols, rules informed consents and regulations (including all Healthcare applicable Laws and administered or issued by applicable Regulatory Authorizations) of all applicable Governmental Authorities, including (to the extent applicable) (i) the U.S. Food and Drug Administration (“FDA”) or other health authority standards for conducting non-clinical laboratory studies contained in Title 21 part 58 of the Code of Federal Regulations and associated regulatory guidance, (ii) investigational new drug requirements and associated regulatory guidance, (iii) FDA or other health authority standards for the design, conduct, performance, monitoring, auditing, recording, analysis and all reporting of clinical trials contained in Title 21 parts 50, 54, 56, 312, 314, and 320 of the Code of Federal Regulations and associated regulatory guidance, (iv) federal and state laws or other Regulatory Authoritiesregulatory authority standards for restricting the use and disclosure of individually identifiable health information, with respect to each Product (v) the International Council for Harmonisation Guideline on Good Clinical Practice (ICH Topic E6) and all Product Development associated regulatory guidance and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act (vi) communications or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all notices from Regulatory Authorities with respect to regarding the Products conduct of such studies, trials and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) yearsinvestigations. Except as set forth on Schedule 6.19(d3.10(b), there have been no recallsdrug-related adverse event or events in patients in a clinical trial conducted or sponsored in relation to the Business, the effect of which would reasonably be expected to (x) prevent Buyer from obtaining approval from a Regulatory Authority to market withdrawalsa Product in the United States or (y) delay such approval to such an extent that the delay (taking into account the expected length of such delay and the basis or reasons therefor) would materially impair the aggregate financial value to be derived by Buyer from a Product. All clinical trial adverse events in patients in a clinical trial conducted or sponsored in relation to the Business within the knowledge of any Seller have been disclosed to Buyer and all associated correspondence, field notifications including actual or correctionspotential claims for recompense, detentionshave been made available to Buyer.
(c) No Regulatory Authority has commenced, seizuresor, notifications or allegations of misbranding or adulteration or safety alerts conductedto Sellers’ Knowledge, requestedthreatened to initiate, any Action to place a clinical hold order on, or threatened by otherwise terminate, delay or suspend any proposed or ongoing pre-clinical or clinical studies, trials, investigational new drug application or investigations conducted or proposed to be conducted in connection with the Business.
(d) No Seller has directly or indirectly received any written communication (including any warning letter, untitled letter, Form 483 or similar notice) from any Regulatory Authority, and to Sellers’ Knowledge there are no material Actions related to the Business pending or threatened (for example including any prosecution, injunction, seizure, civil fine, suspension or recall), in the each case of a recall(i) initiated by Credit Party relating to, arising under or alleging that any Seller or any of its Subsidiariesofficers, relating to employees or agents is not currently in compliance with, any Products which represented, Law administered or issued by any Regulatory Authority or (ii) regarding any debarment action or investigation in the aggregate, 15% respect of any Seller or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA officers, employees or agents undertaken pursuant to 21 U.S.C. Sections 335(a), (b) and (c), or any similar regulation of a Regulatory Authority. There are no pending voluntary or involuntary destruction orders, seizures or other regulatory enforcement actions related to the Business and, to Sellers’ Knowledge, no Data relating to a Product or the Compound that has been made public is the subject of any regulatory or other Action, either pending or threatened, by any Regulatory Authority indicating any breach relating to the truthfulness or violation scientific adequacy of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) yearssuch Data.
(e) No Credit PartySince the Measurement Date, nor neither any of its SubsidiariesSeller nor, nor to Sellers’ Knowledge, any officer, employee employee, agent or agent thereofdistributor of any Seller, has made an untrue statement of a material fact or fraudulent statements statement to the FDA or any other Regulatory Governmental Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Governmental Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could would reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for any other Governmental Authority to invoke any similar policy. Neither any Seller nor, to Sellers’ Knowledge, any officer, employee or agent of any Seller has been convicted of any crime or engaged in any conduct for which debarment is mandated by or authorized by 21 U.S.C. Sections 335(a), (b) and (c) or any similar Laws. Neither Seller nor, to Sellers’ Knowledge, any officer, employee or agent of any Seller has been convicted of any crime or engaged in any conduct for which such Person would be excluded from participating in the Federal health care programs under Section 1128 of the Social Security Act of 1935, as amended (the “Social Security Act”), or any similar Laws.
(f) Except as set forth on Schedule 6.19(fEach Seller is, and, since the Measurement Date, has been, in compliance with: (i) laws, regulations and guidance pertaining to state and federal Anti-Kickback Statutes (42 U.S.C. §§ 1320a-7b(b), no Credit Party nor any et seq. and their implementing regulations) and the related Safe Harbor Statutes; (ii) laws, regulations and guidance pertaining to submission of false claims to governmental or private health care payors (31 U.S.C. §§ 3729, et seq. and its Subsidiaries has received any written notice that the FDA implementing regulations); and (iii) state laws and federal laws and regulations relating to providing and reporting of payments to health care professionals or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,health care entities.
(g) Except No Seller is a “covered entity” or a “business associate” pursuant to the Health Insurance Portability and Accountability Act of 1996 (as set forth on Schedule 6.19(gthose terms are defined in 45 §160.103), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws each Seller has complied in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations respects with all other applicable Laws relating to the Products in any material manner, privacy and no consent or other authorization security of any Governmental Authority is required in connection with the transactions contemplated herebyindividually identifiable information, including the Liens granted Federal Trade Commission Act, the Children’s Online Privacy Protection Act (COPPA), and similar applicable Laws in connection herewith and any foreign jurisdiction in which the exercise of rights and remedies with respect theretoapplicable Seller does business.
Appears in 1 contract
Sources: Asset Purchase Agreement (Avadel Pharmaceuticals PLC)
Regulatory Matters. With respect to each Product:
(a) Set Except as set forth on Schedule 6.19(aSection 3.7(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their SubsidiariesSeller Disclosure Letter, each of the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are Transferred Entities (i) legally has implemented policies and beneficially owned exclusively by procedures that are reasonably designed to comply in all material respects with all Applicable Local Laws including those relating to anti-money laundering, advertising, employee personal trading, ▇▇▇▇▇▇▇ ▇▇▇▇▇▇▇, licensing and registration, supervision, communications with the Credit Parties public, sales practices, market conduct, maintenance of net capital, risk assessment, continuing education, books and their Subsidiariesrecords and the rules of the CFTC, as applicableSEC and any other Government Entity or any Self-Regulatory Organization having jurisdiction over such Transferred Entity, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have has complied in all material respects with all applicable laws the policies and regulationsprocedures described in the immediately preceding clause (i).
(b) Except as set forth on Section 3.7(b) of the Seller Disclosure Letter, the “associated persons” (as defined in the Advisers Act, the CEA, the rules and regulations of the CFTC, the Exchange Act, the rules and regulations of the SEC, or the rules of any Self-Regulatory Organization, as applicable) of the Transferred Entities are registered or licensed to act in their respective capacities in each such jurisdiction where such registration or licensing is required by Applicable Local Law. Section 3.7(b) of the Seller Disclosure Letter sets forth a list for each Transferred Entity of the jurisdictions in which it or its associated persons: (i) are registered as broker/dealers, investment advisers, futures commission merchants or commodity trading advisors or equivalent under Applicable Local Law; or (ii) all clinical and pre-clinical trialsare required to give notice that they are acting as broker/dealers, if anyinvestment advisers, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliancefutures commission merchants or commodity trading advisors. Each such registration or license is, and (iii) the Credit Parties when required by Applicable Local Law has been, in full force and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authorityeffect.
(c) The Credit PartiesExcept as set forth on Section 3.7(c) of the Seller Disclosure Letter, as of their Subsidiaries and respective dates, the agents thereof are in compliance Regulatory Documents of each of the Transferred Entities complied in all material respects with Applicable Local Laws. Each of the Transferred Entities has timely filed all applicable statutesRegulatory Documents, rules and regulations (including has timely paid in full all Healthcare Laws fees and assessments due and payable in connection therewith. None of such Regulatory AuthorizationsDocuments contained any untrue statement of a material fact or omitted to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading and no relevant Government Entity or Self-Regulatory Organization has raised any questions in relation to the Regulatory Documents that remain unanswered. Seller has previously delivered or made available to Buyer a correct and complete copy of each Regulatory Document set forth on Section 3.7(c) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related theretoSeller Disclosure Letter.
(d) Except as set forth on Schedule 6.19(d)Section 3.7(d) of the Seller Disclosure Letter, no Credit Party nor since January 1, 2008, Seller has not received any of its Subsidiaries has received material complaints relating to the Commodities Business from any Self-Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product Organization or any Product Development and Commercialization Activities related thereto which represented, in customer or Client that could be material to the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five Commodities Business.
(5e) years. Except as set forth on Schedule 6.19(d)Section 3.7(e) of the Seller Disclosure Letter, there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations none of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party Transferred Entities or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five “associated person” (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Advisers Act, in each case the CEA, the rules and regulations of the foregoingCFTC, the Exchange Act, the rules and regulations of the SEC, or the rules of any Self-Regulatory Organization, as applicable) thereof, as applicable, is ineligible pursuant to any Applicable Local Law to act as a broker/dealer, investment adviser, futures commission merchant, commodity trading advisor if such Person is currently acting in such capacity, or, with respect to such associated person, as an associated person of such Person or any substantially equivalent pursuant to non-U.S. Applicable Local Law (including being subject to any “statutory disqualification” as defined in Section 3(a)(39) of the Exchange Act or as set forth in Section 8a(2) or 8a(3) of the CEA) and no such Persons or Persons performing “controlled functions” (as defined in Section 59(3) of the FSMA) are subject to, or have since January 1, 2008, been subject to, any (i) disciplinary proceedings of any Government Entity or Self-Regulatory Organization arising under Applicable Local Laws, (ii) expulsion or suspension from membership, (iii) bar or suspension from association, (iv) denial of trading privileges, (v) Order denying, suspending, or revoking registration or barring or suspending association or (vi) finding with respect to causing any such effective suspension, expulsion or Order (for purposes of clauses (i) through (vi), all with respect to such applicable Government Entity or Self-Regulatory Organization). No Legal Proceeding is pending or, to the Knowledge of Seller, threatened by any Government Entity or Self-Regulatory Organization which represented, would reasonably be expected to result in any of the actions set forth in the aggregate, 15% immediately preceding clauses (i) through (vi) or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could which would reasonably be expected to provide a basis for any of the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, actions set forth in 56 Fed. Reg. 46191 the immediately preceding clauses (September 10, 1991i) or any similar policythrough (vi).
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removalSection 3.7(f) of any Products the Seller Disclosure Letter, all the Employees and Persons performing “controlled functions” (as defined in Section 59(3) of the FSMA) who are required to be licensed or commenced registered to conduct the business as currently conducted of the Transferred Entities are duly licensed or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, registered in each case, jurisdiction and with each Government Entity and Self-Regulatory Organization in which represented, or with which such licensing or registration is so required and all such registrations are in the aggregate, 15% or more of Net Sales in any applicable year,full force and effect.
(g) Except as set forth on Schedule 6.19(g), None of the clinical, preclinical, safety and other studies and tests conducted by or on behalf activities of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or Transferred Entities requires any of its Subsidiaries’ ownership of such Transferred Entities to register as an exchange, alternative trading system, transfer agent, clearing agency or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretocommodity pool operator.
Appears in 1 contract
Sources: Stock and Asset Purchase Agreement (Jefferies Group Inc /De/)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) Carv▇▇ ▇▇▇eral Savings Bank is a complete the only "insured depository institution" within the meaning of the FDIA that is, directly or indirectly, "controlled" by the Issuer within the meaning of the FDIA and accurate list is the only federal savings bank of which 5% or more of any class of voting securities are directly or indirectly owned or controlled by the Issuer, all material Regulatory Authorizations relating within the meaning of the HOLA. Carv▇▇ ▇▇▇eral Savings Bank maintains in full force and effect deposit insurance with the FDIC through the Bank Insurance Fund or Savings Association Insurance Fund, and has fully paid to the Credit Parties FDIC as and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of when due all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings assessments with respect to its deposits as are required to maintain such deposit insurance in full force and effect. As of the Products for date hereof, Carv▇▇ ▇▇▇eral Savings Bank is rated Satisfactory under the last five (5) years have been timely filed with the FDA and all other applicable Governmental AuthoritiesCommunity Reinvestment Act.
(b) (i) All Carv▇▇ ▇▇▇eral Savings Bank has paid, as and when due, all fees, charges, assessments, or the like, to each and every governmental or regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization agency having jurisdiction with respect to it as required by law, regulation, or rule, other than any Product such items the failure of which to pay would not, individually or any Product Development and Commercialization Activities which represented, in the aggregate, 15% have a Material Adverse Effect.
(c) Since January 1, 1997, the Issuer and its Subsidiaries have filed all material reports, registrations, applications and statements, together with any amendments required to be made with respect thereto, that are required to be filed with (A) the Office of Thrift Supervision, (B) the FDIC, and (C) any other applicable federal or more of Net Sales in any applicable year, in the last five state banking authorities (5) years have been made, all such authorities referred to collectively as "REGULATORY AUTHORITIES," and all such filings above such threshold are complete and correct and have reports referred to collectively as the "REGULATORY REPORTS"). As of its filing date, each Regulatory Report complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws enforced or promulgated by the Regulatory Authority with which they were filed. Except for examinations conducted by a Regulatory Authority in the regular course of the business of the Issuer and its Subsidiaries since January 1, 1997, no Regulatory Authorizations) Authority has initiated any proceeding, or, to the knowledge of all applicable Governmental Authoritiesthe Issuer or its Subsidiaries, including any investigation, into the FDA and all other business or operations of the Issuer or its Subsidiaries. There is no unresolved violation, criticism or exception by any Regulatory Authorities, Authority with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries any report or statement relating to any examination or the Issuer or its Subsidiaries, except as to such matters which would not have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related theretoa Material Adverse Effect.
(d) Except as set forth on Schedule 6.19(d), no Credit Party Neither the Issuer nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect is a party to any Product commitment letter or similar undertaking to, cease-and-desist order or written agreement or memorandum of understanding with, or subject to any Product Development and Commercialization Activities related thereto which representedwritten order or directive from, or is a recipient of any extraordinary supervisory letter from, or has adopted any board resolutions at the request of, any federal or state governmental authority charged with the supervision or regulation of banks or engaged in the aggregateinsurance of bank deposits, 15% nor has the Issuer or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received been advised that any written notification that remains unresolved from the FDA such governmental authority is contemplating issuing or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that requesting any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.
Appears in 1 contract
Regulatory Matters. With respect to each Product:
(a) Set Schedule 3.11(a) sets forth on Schedule 6.19(a) is as of the date hereof a true and complete and accurate list of all Seller Regulatory Authorizations. The Seller Regulatory Authorizations include all material Regulatory Authorizations relating that are required for or relate to the Credit Parties Business or the Purchased Assets. Seller or one of its Affiliates is the sole and their Subsidiaries, exclusive owner of all of the conduct of their business, and the Products (on a per Product basis). All such material Seller Regulatory Authorizations are and none of the Seller Regulatory Authorizations have been sold, conveyed, delivered, transferred or assigned to another party. Each such Seller Regulatory Authorization (iA) legally and beneficially owned exclusively has, to Seller’s Knowledge, been validly issued or acknowledged by the Credit Parties appropriate Governmental Authority and their Subsidiaries, as applicable, free is in full force and clear of all Liens other than Permitted Liens, effect and (iiB) as applicableis transferable to Buyer. To Seller’s Knowledge, validly registered and there are no facts, circumstances or conditions that could prevent the transfer of any Seller Regulatory Authorization to Buyer on file with or after the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental AuthoritiesClosing Date.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trialsand clinical studies, if any, of investigational Products have been trials and investigations conducted or sponsored in relation to the Business are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliancebeing, and (iii) the Credit Parties and their Subsidiaries at all times have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Partiesbeen, their Subsidiaries and the agents thereof are conducted in compliance in all material respects with all applicable statutesclinical protocols, rules informed consents and regulations (including all Healthcare applicable Laws and Regulatory Authorizations) of all administered or issued by applicable Governmental Authorities, including (to the extent applicable) (i) the U.S. Food and Drug Administration (“FDA”) or other health authority standards for conducting non-clinical laboratory studies, including those contained in Title 21, part 58 of the Code of Federal Regulations, (ii) investigational new drug requirements, (iii) FDA or other health authority standards for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trials, including those contained in Title 21, parts 50, 54, 56, 312, 314, and 320 of the Code of Federal Regulations, (iv) federal and state laws or other regulatory authority standards for restricting the use and disclosure of individually identifiable health information, (v) the International Council for Harmonisation’s Guideline on Good Clinical Practice (ICH Topic E6) and (vi) communications or notices from Governmental Authorities regarding the conduct of such studies, trials and investigations. Except as included in the Seller Regulatory Documentation that has been made available to Buyer prior to the date hereof, there have been no adverse events, adverse drug reactions or other safety events in patients in a clinical trial conducted or sponsored in relation to the Business, the effect of which would reasonably be expected to (x) prevent Buyer from obtaining approval from a Governmental Authority to market a Product in the United States or (y) delay such approval to such an extent that the delay (taking into account the expected length of such delay and the basis or reasons therefor) would materially impair the aggregate financial value to be derived by Buyer from a Product. All clinical trial adverse events in patients in a clinical trial conducted or sponsored in relation to the Business, to Seller’s Knowledge, have been disclosed to Buyer and all other Regulatory Authoritiesassociated correspondence, with respect including actual or potential claims for recompense, have been made available to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain Buyer.
(c) Except as otherwise disclosed in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Schedule 3.11(c), no Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere has commenced, or, to Seller’s Knowledge, threatened to initiate, any Action to place a clinical hold order on, or otherwise terminate, delay or suspend any proposed or ongoing pre-clinical or clinical studies, trials, IND or investigations conducted or proposed to be conducted in all material respects to all applicable regulations of all Regulatory Authorities connection with respect to the Products and all Product Development and Commercialization Activities related theretoBusiness.
(d) Except as set forth on Schedule 6.19(dSince January 1, 2019, Seller and its Affiliates have not directly or indirectly received any oral or written communication (including any warning letter, untitled letter, Form FDA 483 or similar notice) from any Governmental Authority, and to Seller’s Knowledge there are no material Actions related to the Business or the Purchased Assets pending or threatened (including any prosecution, injunction, seizure, civil fine, suspension or recall), no Credit Party nor in each case (i) relating to, arising under or alleging that Seller, any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party Affiliates or any of its Subsidiariesor their officers, employees or agents is not currently in compliance with, any Law administered or issued by any Governmental Authority or (ii) regarding any debarment action or investigation in respect of Seller, any of its Affiliates or any of its or their officers, employees or agents undertaken pursuant to 21 U.S.C. Section 335a, or any similar regulation of a Governmental Authority. There are no pending voluntary or involuntary destruction orders, seizures or other regulatory enforcement actions related to the Business or the Purchased Assets and, to Seller’s Knowledge, no Seller Data relating to the Compounds that has been made public is the subject of any regulatory or other Action, either pending or threatened, by any Governmental Authority relating to the truthfulness or scientific adequacy of such Seller Data. Seller has made available to Buyer prior to the date hereof unredacted copies of all material correspondence between the Seller and its Affiliates, on the one hand, and the FDA, EMA or any other Governmental Authority, on the other hand, including minutes and contact reports relating to any Products which represented, in the aggregate, 15% or more of Net Sales in communications with any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) yearsGovernmental Authority.
(e) No Credit PartySince January 1, nor any 2019, none of Seller, its SubsidiariesAffiliates nor, nor to Seller’s Knowledge, any officer, employee employee, or agent thereofof Seller or its Affiliates, has made an untrue statement of a material fact or fraudulent statements statement to the FDA or any other Regulatory Governmental Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Governmental Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could would reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery Bribery, and Illegal Gratuities”, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or for any other Governmental Authority to invoke any similar policy. None of Seller, its Affiliates nor, to Seller’s Knowledge, any officer, employee or agent of Seller or its Affiliates has been convicted of any crime or engaged in any conduct for which debarment is mandated by or authorized by 21 U.S.C. Section 335a or any similar Laws. None of Seller, its Affiliates nor, to Seller’s Knowledge, any officer, employee or agent of Seller or its Affiliates has been convicted of any crime or engaged in any conduct for which such Person could be excluded from participating in the Federal health care programs under Section 1128 of the Social Security Act of 1935, as amended (the “Social Security Act”), or any similar Laws.
(f) Except as set forth on Schedule 6.19(fSeller and its Affiliates are, and, since January 1, 2019, have been, in compliance with: (i) laws, regulations and guidance pertaining to state and federal Anti-Kickback Statutes (42 U.S.C. §§ 1320a-7b(b), no Credit Party nor any et seq. and their implementing regulations) and the related Safe Harbor Statutes; (ii) laws, regulations and guidance pertaining to submission of false claims to governmental or private health care payors (31 U.S.C. §§ 3729, et seq. and its Subsidiaries has received any written notice that the FDA implementing regulations); and (iii) state laws and federal laws and regulations relating to providing and reporting of payments to health care professionals or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,health care entities.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf None of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s Seller or any of its Subsidiaries’ ownership Affiliates is a “covered entity” or a “business associate” pursuant to the Health Insurance Portability and Accountability Act of or rights under 1996 (or the license or the right to use, as the case may be) any Regulatory Authorizations those terms are defined in 45 C.F.R. §160.103). Seller and its Affiliates have complied in all material respects with all other applicable Laws relating to the Products in any material manner, privacy and no consent or other authorization security of any Governmental Authority is required in connection with the transactions contemplated herebyindividually identifiable information, including the Liens granted Federal Trade Commission Act, the Children’s Online Privacy Protection Act (COPPA), and similar Laws in connection herewith and the exercise any foreign jurisdiction in which Seller or any of rights and remedies with respect theretoits Affiliates does business.
Appears in 1 contract
Sources: Asset Purchase Agreement (Yumanity Therapeutics, Inc.)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) The Company is a complete legally, financially and accurate list of all material Regulatory Authorizations otherwise qualified under the Communications Act to perform its obligations hereunder, to be the licensee of, and to own and operate the Station. To Seller’s Knowledge, no fact or circumstance exists relating to the Credit Parties and their Subsidiaries, FCC qualifications of the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are Company that (i) legally and beneficially owned exclusively by could reasonably be expected to prevent or delay the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and FCC from granting the Assignment Application or (ii) would otherwise disqualify the Company as applicablethe licensee, validly registered and on file with owner, operator or transferee of the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental AuthoritiesStation.
(b) (i) All regulatory filings required The Disclosure Schedule sets forth a true and complete list of all FCC Licenses, all pending applications filed with the FCC by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, Company and all such filings above such threshold are complete and correct and have complied Permits held by Company in all material respects connection with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, the conduct of investigational Products have been and are being the Station Business as conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed immediately prior to the Agent all such regulatory filings and all material communications between representatives Closing, including any registrations of the Credit Parties Transmission Structures (and their Subsidiaries) and any Regulatory Authoritycopies of which are attached thereto).
(c) The Credit PartiesNo application, their Subsidiaries and action or proceeding is pending for the agents thereof are in compliance in all material respects with all applicable statutesrenewal of any FCC License as to which any petition to deny or objection has been filed and, rules and regulations to Seller’s Knowledge, there is not before the FCC any investigation, proceeding, notice of violation, or order of forfeiture relating to the Company. There is not now pending and, to Seller’s Knowledge, there is not threatened, any action by or before the FCC to revoke, suspend, cancel, rescind or modify any of the FCC Licenses (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including other than proceedings to amend the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Communications Act or equivalent regulation proceedings of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect general applicability to the Products and all Product Development and Commercialization Activities related theretobroadcast radio industry).
(d) Except The Station is owned and operated by the Company in compliance with (i) the terms of the FCC Licenses and (ii) the Communications Act. The Company has filed or made all applications, reports, and other disclosures required by the FCC to be made in respect of the Station and have or will have timely paid all FCC regulatory fees in respect thereof. No licenses, authorizations, permits or other rights other than the Permits and the FCC Licenses are required to own and operate the Station in substantially the same manner as set forth on Schedule 6.19(d), no Credit Party nor any it is being operated as of its Subsidiaries has received from any Regulatory Authority any notice the date hereof and as of alleged non-compliance or adverse findings with respect the Closing Date. The FCC Licenses are in full force and effect; and are not subject to any Product condition except conditions applicable to broadcast radio licenses generally, or as otherwise disclosed on the face of the FCC Licenses. Seller has no reason to believe that the FCC will not renew any Product Development and Commercialization Activities related thereto which represented, FCC Licenses in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) yearsordinary course.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements The Transmission Structures are registered to the FDA or any other Regulatory Authorityextent required by Law and all such Transmission Structures have been constructed, failed to disclose a material fact required to be disclosed and are operated and maintained, in compliance with the FCC Licenses and all applicable Laws, including the Communications Act and those promulgated by the FAA (and including, to the FDA or any other Regulatory Authorityextent applicable, or committed an actall such Laws concerning the marking, made a statementpainting, or failed to make a statement thatlighting, at height and registration of the time such disclosure was made (or was not madeTransmission Structures), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f)All transmission and related equipment will be, no Credit Party nor any (i) in good operating condition and adequate repair (ordinary wear and tear excepted) and (ii) operated and maintained in accordance with good engineering practices and in full compliance with all applicable Laws, including the Communications Act and the FCC Licenses. The Company has conducted or obtained engineering studies (including studies in respect of its Subsidiaries has received any written notice wind load) that demonstrate, using good engineering practices, that the FDA or any other applicable Regulatory Authority Tower has commenced or initiatedbeen constructed in a manner sufficient to hold and support the structures currently mounted, or threatened contemplated to commence or initiatebe mounted, thereon (including the Station’s antennae) by the Station pursuant to the FCC Licenses, any action to withdraw any Regulatory Authorization, requested the recall Contract (whether by correction including this Agreement) or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,otherwise.
(g) Except as set forth on Schedule 6.19(g), The Station is operating at the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by effective radiated power authorized under the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respectsFCC Licenses.
(h) The transactions contemplated by To Seller’s Knowledge, the Loan Documents (Station does not cause or contemplated by receive any interference that is in violation of the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s Communications Act or any of its Subsidiaries’ ownership of or rights under other applicable Laws.
(or i) All returns, reports and statements that the license or the right Company is currently required to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection file with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoFCC or FAA have been filed.
Appears in 1 contract
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect The businesses of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have Borrower has been and are is being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutesHealthcare Laws, rules and regulations all Permits, (including all Healthcare Laws ii) each Product (whether manufactured by the Borrower or any of its Subsidiaries, any of their respective Affiliates or by a third party manufacturer under contract to the Borrower or any of its Subsidiaries) has been, and Regulatory Authorizations) of currently is, being researched, developed, designed, investigated, manufactured, made, assembled, stored, packaged, labeled, marketed and distributed by the Borrower and its Subsidiaries or third parties on their behalf, in compliance with all applicable Governmental AuthoritiesRequirements of Law, including including, without limitation, the FDA Healthcare Laws, all required Permits, cGMP, QSR, the Device Master Record as defined in 21 CFR 820.181 and all other Regulatory Authorities, with respect to each Product Document Controls under 21 CFR 820.40 and all Product Development specifications as established in the Group Members’ documentation, except to the extent any failure to so comply could not reasonably be expected to result in any adverse consequences to the Loan Parties (other than immaterial consequences), (iii) each contract between the Borrower and Commercialization Activities related thereto. The Credit Parties any of its Subsidiaries on the one hand, and their any third party manufacturer on the other hand contain (and the Borrower and each of its Subsidiaries have implement), appropriate quality assurance arrangements in accordance with FDA requirements and maintain comply in full force all material respects with all applicable Healthcare Laws, (iv) the Borrower and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their its Subsidiaries are in compliance in all material respects with applicable Requirements of Law governing reporting and recordkeeping of Product modifications, adverse event reporting, reporting of corrections and removals, and recordkeeping for each Product, and all applicable registration manufacturing and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties release documents and their Subsidiaries adhere records are true and accurate in all material respects to all applicable regulations of all Regulatory Authorities with respect to respects, and (v) neither the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d), no Credit Party Borrower nor any of its Subsidiaries has received or been subject to any written or oral communications from the FDA or any Regulatory other Governmental Authority asserting that the Borrower, any notice such Subsidiary or any such Product was not in compliance in any material respect with any applicable Requirement of alleged non-compliance Law or adverse findings any Permit.
(b) Other than routine surveillance audits and inspections, no investigation by any Governmental Authority with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party Borrower or any of its SubsidiariesSubsidiary is pending or, relating to any Products which representedthe knowledge of the Loan Parties, in threatened. None of the aggregate, 15% Borrower or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved or oral communication from the FDA any Governmental Authority of any noncompliance with any Requirement of Law or any other Regulatory written or oral communication from any Governmental Authority indicating any breach or violation accrediting organization of any applicable Regulatory Authorizationmaterial issues, problems, or concerns regarding the quality or performance of the Products.
(c) The Borrower and its Subsidiaries own, free and clear of all Liens, except Liens securing the Obligations, all Permits, including that any of the Products is misbranded or adulterated as defined in all authorizations under the FD&C Act, in each case other United States federal laws, and all applicable state and foreign laws, necessary (i) for the research and development and commercialization of the foregoingProducts, which representedincluding, without limitation, all Permits necessary in connection with testing, manufacturing, marketing or selling of such Products, as such testing, manufacturing, marketing or selling are currently being conducted, and (ii) to carry on the aggregatebusiness of the Borrower and each of its Subsidiaries. All such Permits are valid and in full force and effect and the Borrower and each Subsidiary is in compliance in all material respects with all terms and conditions of such Permits. None of the Borrower or any Subsidiary has received any written notice from any Governmental Authority that any Permit has been or is being revoked, 15% withdrawn, suspended or more challenged or that such Governmental Authority is conducting an investigation or review thereof or has issued any order or recommendation stating that the development, testing and/or manufacturing of Net Sales in such Product should cease or that such Product should be withdrawn from the marketplace.
(d) Except as could not reasonably be expected to have a materially adverse impact on the Borrower and its Subsidiaries, there have been no adverse clinical test results and there have been no Product recalls or voluntary Product Market Withdrawals from any applicable year within the last five market (5) yearsother than those recalls or Market Withdrawals disclosed on Schedule 4.23(d)).
(e) No Credit Party, nor There has been no material untrue statement of fact and no fraudulent statement made by the Borrower or any of its Subsidiaries, nor Subsidiaries or any officer, employee of their respective agents or agent thereof, has made an untrue statement of a material fact or fraudulent statements representatives to the FDA or any other Regulatory Governmental Authority, failed and there has been no failure to disclose a any material fact required to be disclosed to the FDA or any other Regulatory Governmental Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except None of the Borrower or any of its Subsidiaries has been the subject of any “for cause” inspection, investigation or audit by any Governmental Authority in connection with any alleged improper activity.
(g) There is no arrangement relating to the Borrower or any of its Subsidiaries providing for any rebates, kickbacks or other forms of compensation or remuneration that are unlawful to be paid to any Person to induce, or in return for obtaining or the referral of business or for the arrangement for recommendation of such referrals. All ▇▇▇▇▇▇▇▇ by the Borrower and each of its Subsidiaries for its services have been true and correct in all material respects and are in compliance in all material respects with all applicable Healthcare Laws.
(h) None of the Borrower or any of its Subsidiaries, or, to the knowledge of the Loan Parties, any individual who is an officer, director, employee or manager of the Borrower or any of its Subsidiaries has been convicted of, charged with or, to the knowledge of the Loan Parties, investigated for any federal or state health program- related offense or been excluded or suspended from participation in any such program; or, to the knowledge of the Loan Parties, within the past five (5) years, has been convicted of, charged with or, to the knowledge of the Loan Parties, investigated for a violation of any Requirement of Law related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances, or has been subject to any judgment, stipulation, order or decree of, or criminal or civil fine or penalty imposed by, any Governmental Authority related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation or controlled substances. None of the Borrower or any of its Subsidiaries or, to the knowledge of the Loan Parties, any individual who is an officer, director, employee or manager of the Borrower or any of its Subsidiaries has been convicted of any crime or engaged in any conduct including but not limited to any misrepresentation to any Governmental Authority or that has otherwise resulted or would reasonably be expected to result in a debarment or exclusion (i) under 21 U.S.C. Section 335a, or (ii) any similar applicable Requirement of Law. No debarment proceedings or investigations in respect of the business of the Borrower or any of its Subsidiaries are pending or, to the knowledge of the Loan Parties, threatened against the Borrower or any of its Subsidiaries or any individual who is an officer, director, employee or manager of the Borrower or any of its Subsidiaries.
(i) All studies, tests and preclinical and clinical trials conducted relating to the Products, sponsored by the Borrower or any of its Subsidiaries have been conducted, and are currently being conducted, in all material respects in accordance with all applicable Requirement of Law and IDEs, including procedures and controls pursuant to, where applicable, current good clinical practices and current good laboratory practices and other applicable laws, rules regulations. To the extent required by applicable Requirement Law, the Borrower and each of its Subsidiaries has obtained all necessary authorizations from Governmental Authorities and IECs, including an IDE for the conduct of any clinical investigations conducted by or on behalf of the Borrower or such Subsidiary, as set forth on Schedule 6.19(f)applicable.
(j) To the knowledge of the Loan Parties, none of the clinical investigators in any clinical trial sponsored by the Borrower or any of its Subsidiaries has been or is disqualified or otherwise sanctioned by the FDA, the Department of Health and Human Services, or any Governmental Authority and, to the knowledge of the Loan Parties, no Credit Party nor such disqualification, or other sanction of any such clinical investigator is pending or threatened. None of the Borrower or any of its Subsidiaries has received any written notice that from the FDA or any other applicable Regulatory Governmental Authority has commenced any notices or initiatedcorrespondence requiring or threatening the termination, suspension, material modification or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) clinical hold of any Products studies, tests or commenced clinical trials with respect to or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated herebyProducts.
(k) The Group Members are, to the extent directly applicable to the Group Members, currently conducting its business in material compliance with all regulations promulgated under HIPAA. To the extent the Group Members create any de-identified protected health information, the Group Members do so in compliance with the HIPAA regulations. The Group Members have not failed to notify any individual or required third party, including any appropriate Governmental Authority, of an event that triggered a notification or reporting requirement under any contract to which a Group Member is a party, or any applicable requirement related to the Liens granted in connection herewith and the exercise unauthorized access, use or disclosure of rights and remedies protected health information. The Group Members have no knowledge of any complaints to or investigations by any Governmental Authority with respect theretoto HIPAA compliance by the Group Members, have not received any notice or audit request from the United States Department of Health and Human Services Office for Civil Rights, is currently conducting their businesses in material compliance with all applicable laws governing the privacy, security or confidentiality of protected health information and/or other records generated in the course of providing or paying for health care services, including without limitation, all laws to the extent not preempted by HIPAA, and has conducted its businesses in material compliance with such laws since such laws first became applicable to it.
Appears in 1 contract
Regulatory Matters. With respect to each ProductFrom and after the Effective Date, Licensee shall:
(a) Set forth on Schedule 6.19(a) is a complete Have sole authority and accurate list responsibility for the timely preparation, filing and prosecution of all material filings, submissions, authorizations or approvals with Regulatory Authorizations relating to Authorities in the Credit Parties and their Subsidiaries, the conduct of their businessTerritory, and shall own and control all such filings, submissions, authorizations and approvals, including any Investigational Drug Application or New Drug Application in the Products (on a per Product basis)Territory. All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear Licensee shall provide copies of all Liens other than Permitted Lienssuch filings, submissions, authorizations and (ii) as applicableapprovals to Licensor upon Licensor’s reasonable request, validly registered at Licensor’s sole cost and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authoritiesexpense.
(b) (i) All regulatory filings required by Be the primary contact with each Regulatory Authority in the Territory and be solely responsible for all communications with each Regulatory Authority that relate to any Investigational Drug Application or New Drug Application in the Territory, provided, however, that upon the reasonable request of Licensee, Licensor shall provide appropriate personnel to participate in discussions with any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregateTerritory and/or to assist and consult with Licensee in its applications for Regulatory Approval, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, at Licensee’s cost and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authorityexpense.
(c) The Credit PartiesFrom and after receipt of each Regulatory Approval, their Subsidiaries have exclusive authority and responsibility to submit all reports, amendments and/or other requirements of applicable Law necessary to maintain such Regulatory Approvals and to seek revisions of the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and conditions of each such Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth Approval in the FD&C Act or equivalent regulation Territory as appropriate. Licensee shall have sole authority and responsibility to seek and/or obtain any required approvals of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere any labeling, prescribing information, package inserts, monographs and/or packaging used in all material respects to all applicable regulations of all Regulatory Authorities connection with respect to the Products and all Product Development and Commercialization Activities related theretoa Licensed Product.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, Have the authority in the aggregateTerritory concerning (i) the protocols for Clinical Trials of Licensed Products, 15% or more (ii) indications sought for any Licensed Products, (iii) approval of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, all contracts relating to any Products which representedthe Development of Licensed Products, in (iv) the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or formulation used in respect of which any Products or Product candidates under development have participateda Licensed Product, were and (and if still pending, arev) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations contracts relating to the Products in any material manner, and no consent or other authorization Commercialization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoLicensed Product.
Appears in 1 contract
Sources: License Agreement (Athenex, Inc.)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) is a complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally Notwithstanding anything in this Agreement to the contrary, none of the Company Securityholders or the Representative (on behalf of any Seller Indemnifying Party), shall have the right to control the defense, or consent to any compromise, settlement or consent to entry of any judgment in respect of, any claim pursuant to which indemnification is sought under Section 8.1(g) (a “Regulatory Claim”); provided, however, that, the Representative shall have the right, but not the obligation, together with legal counsel to the Representative, to consult (at reasonable times) with and beneficially owned exclusively by receive information from Parent and the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings Company with respect to all Regulatory Claims, strategy for addressing the Products for the last five (5) years have been timely filed with the FDA claims and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by material decisions concerning any Regulatory Authority Claim and the Parent will give due consideration to any recommendations or in respect of any Regulatory Authorization comments from the Representative or its counsel, provided that the Representative shall have no consent right with respect to any Product or any Product Development such decisions and Commercialization Activities which represented, in Parent and the aggregate, 15% or more of Net Sales in any applicable year, in Company shall have the last five (5) years have been made, exclusive right to make all such decisions and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings final determination with respect to any Product Regulatory Claim, and the Representative shall sign an appropriate confidentiality and/or joint defense agreement with the Company as a condition to exercising the consultation right set forth in this paragraph (it being understood that Parent and the Company shall not be required to provide any information to which the Company has been advised by counsel may not be shared with the Representative without risk of loss of applicable privilege)
(ii) For avoidance of doubt, all reasonable costs related to the Company's defense of any Regulatory Claim, including all reasonable investigation expenses, court and other filings fees and costs, reasonable attorneys' and expert fees, and all other reasonable costs and fees to the extent reasonably attributable to the investigation, defense or settlement or other resolution of any Product Development Regulatory Claim (the “Regulatory Defense Costs”), whether of Company counsel or otherwise, shall be considered Damages indemnifiable pursuant to Section 8.1(g); provided, however, that Regulatory Defense Costs and Commercialization Activities Regulatory Damages (as defined below) shall not include allocation of employee salaries or Company overhead other than any overtime expenses of employees demonstrably related thereto which representedthereto.. Notwithstanding the forgoing, the Parent shall use commercially reasonable efforts (consistent with prudent industry practice) to minimize the Regulatory Defense Costs and Regulatory Damages. Further, the Representative shall have the right to challenge any Regulatory Defense Costs and Regulatory Damages to the extent it believes they are unreasonable.
(iii) The parties hereto agree that, from and after the Closing, the Company is authorized (without the separate consent of the Representative) to direct the Escrow Agent to make payments to the Company from the Regulatory Escrow Funds in the aggregateamount of any documented Damages incurred or suffered by the Parent Indemnified Parties as a result of, 15% arising out of or more of Net Sales in relating to, directly or indirectly, any applicable yearRegulatory Claim, including any FDA Form 483 inspectional observationsRegulatory Defense Cost (“Regulatory Damages”), notices as and when such Regulatory Damages are suffered, sustained or incurred, including, without limitation, upon (x) the invoice of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within Defense Costs, (y) the last five (5) years. Except as set forth on Schedule 6.19(d)imposition of any fine, there have been no recallsfee, market withdrawals, field notifications penalty or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened other payment requirement by any Regulatory AuthorityGovernmental Entity or the entry of a judgment or order of a court of competent jurisdiction with respect thereto, or (for example in z) a final, binding settlement by the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in Company with any applicable year within Governmental Entity resolving any such Regulatory Claim; provided, however, the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation Company shall provide a copy of any applicable such request for Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five Damages (5together with reasonable supporting documentation) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policyRepresentative.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.
Appears in 1 contract
Sources: Merger Agreement (Aspect Software Group Holdings Ltd.)
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) is a complete The Company and accurate list of each Company Subsidiary possesses all material approvals, authorizations, certificates, registrations, licenses, exemptions, permits, clearances, and consents (including all investigational new drug applications (as defined in 21 C.F.R. § 312.20 et seq., establishment registrations (as defined in 21 C.F.R. § 207), and product listings (as defined in 21 C.F.R. § 207), all supplements or amendments thereto, and all comparable approvals, authorizations, certificates, registrations, licenses, exemptions, permits, clearances, and consents provided for in other applicable Laws) (“Regulatory Authorizations Authorizations”) from the United States Food and Drug Administration (the “FDA”) and all other applicable Regulatory Authorities relating to any Product or that are necessary for the Credit Parties and their Subsidiaries, the Company or any Company Subsidiary to conduct of their business, and the Products its business in all material respects as presently conducted.
(on a per Product basis). i) All such material Regulatory Authorizations are materially (iA) legally in full force and beneficially owned exclusively by the Credit Parties and their Subsidiarieseffect, as applicable, free and clear of all Liens other than Permitted Liens, and (iiB) as applicable, validly registered and on file with the applicable Governmental Authority, Regulatory Authorities and (C) in compliance with all formal filing and maintenance requirements and (including any fee requirementsii) thereofthe Company and each Company Subsidiary has fulfilled and performed all of its material obligations with respect to such Regulatory Authorizations, and are in good standingno event has occurred which allows, valid or after notice or lapse of time would allow, revocation or termination thereof. Except as would not reasonably be expected to be material to the business of the Company and enforceable with the Company Subsidiaries, taken as a whole, (1) the Company and each Company Subsidiary has filed, maintained or furnished to the FDA or other applicable Governmental Authority. All Bodies or other applicable Regulatory Authorities all required filings, declarations, listings, registrations, submissions, amendments, modifications, notices and responses to notices, registrations applications and listings, supplemental applications or notificationsapplications, reports (including field alerts, medical device reports (MDRsall adverse event/experience reports) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal(2) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are submissions were complete and correct accurate and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutesLaws when filed (or were corrected or completed in a subsequent filing).
(i) The Company and each Company Subsidiary has never marketed, rules and regulations sold, distributed, promoted or advertised any pharmaceutical products (including all Healthcare Laws the Products) and Regulatory Authorizations(ii) of all the Company and each Company Subsidiary is, and since January 1, 2020 has been, in material compliance with applicable Governmental AuthoritiesLaws, including the FDA FDCA and its implementing regulations, relating to the development, testing, manufacturing, holding, marketing, selling, distributing, labeling, promoting, advertising, importing or exporting of pharmaceutical products, in each case as applicable, including without limitation, (i) requirements for obtaining Regulatory Authorizations, (ii) requirements for establishment registration and product listing; (iii) payment of all application and program fees invoiced for the Products, (iv) label and labeling requirements and (v) applicable promotion and advertising requirements.
(c) All non-clinical studies and clinical investigations, preclinical studies or tests sponsored or conducted by or on behalf of the Company or any Company Subsidiary are being conducted in material compliance with applicable Laws, including Good Laboratory Practices, Good Clinical Practices, the FDCA, and all other Laws regarding developing, testing, labeling, manufacturing, storage, marketing, promotion, sale, commercialization, safety, quality, shipment, import, export, or distribution of the products of the Company. None of the FDA, any other Regulatory AuthoritiesAuthority, or any institutional review board has sent any written notices or other correspondence with respect to any proposed, ongoing or completed clinical, preclinical or non-clinical studies or tests requiring the termination, suspension or material modification of such studies or tests. With respect to each Product Product, the Company has made available to Parent complete and accurate copies of all material clinical, preclinical and nonclinical data in the possession of and reasonably available to the Company or any Company Subsidiary and all Product Development material written correspondence that exists as of the date of this Agreement between the Company and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of performing functions similar to those performed by the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) yearsFDA.
(ed) No Credit Party, Neither the Company nor any Company Subsidiary nor, to the knowledge of its Subsidiariesthe Company, nor any officerofficers, employee employees or agent thereofagents of the Company or any Company Subsidiary, has (i) made an untrue statement of a material fact or fraudulent statements statement to the FDA or any other Regulatory Authority, (ii) failed to disclose a material fact required to be disclosed to the FDA or (iii) committed any other Regulatory Authority, or committed an act, made a statement, any statement or failed to make any statement, that (in any such case) establishes a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a reasonable basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery Bribery, and Illegal GratuitiesGratuities Final Policy. As of the date of this Agreement, set forth neither the Company nor any Company Subsidiary is the subject of any pending or, to the Company’s knowledge, threatened investigation by the FDA pursuant to its Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities Final Policy. Neither the Company nor any Company Subsidiary nor, to the knowledge of the Company, any officers, employees, agents or clinical investigators of the Company or any Company Subsidiary has been suspended or debarred or convicted of any crime or engaged in 56 Fed. Reg. 46191 any conduct that would reasonably be expected to result in (September 10, 1991A) debarment under 21 U.S.C. Section 335a or any similar policyLaw or (B) exclusion under 42 U.S.C. Section 1320a-7 or any similar Law.
(e) Except as would not reasonably be expected to be material to the business of the Company and the Company Subsidiaries, taken as a whole, (i) the Company, each Company Subsidiary and any contractor or other Person acting on their behalf is obtaining and since January 1, 2020, has obtained (or caused to be obtained) informed consent by or on behalf of each human subject who participated in the Company’s ongoing clinical studies; (ii) in using or disclosing patient information received by the Company in connection with the Company’s ongoing clinical studies, the Company, each Company Subsidiary and any contractor or other Person acting on their behalf have complied with all Laws and regulatory rules or requirements, in each case to the extent applicable, including, without limitation, the Health Insurance Portability and Accountability Act of 1996, the FDCA and the rules and regulations thereunder.
(f) Except as set forth on Schedule 6.19(f)To the extent required by applicable Laws, no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened all manufacturing operations conducted with respect to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development used in human clinical trials have been conducted in material accordance with the FDCA, Laws, and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,Good Manufacturing Practices.
(g) Except as set forth on Schedule 6.19(g)Since January 1, the clinical2021, preclinicalno Product has been recalled, safety and other withdrawn, suspended or discontinued.
(h) Since January 1, 2021, no preclinical studies and tests sponsored or conducted by or on behalf of the Company for the purpose of supporting a regulatory filing have had any material adverse safety findings that the Company would reasonably expect to have a material adverse impact on clinical studies, and all material preclinical toxicology reports or sponsored preclinical toxicology studies conducted by or on behalf of the Credit Parties Company for the purpose of supporting a regulatory filing have been disclosed to the FDA and their Subsidiariesall other applicable Regulatory Authorities to the extent required by applicable Laws.
(i) The Company and each Company Subsidiary is, or and since January 1, 2021 has been, in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance material compliance with all applicable Regulatory Authorizations and Healthcare Laws. Neither the Company nor any Company Subsidiary is subject to any enforcement, regulatory or administrative proceedings regarding alleged non-compliance with any Healthcare Laws in all material respectsand, to the knowledge of the Company, no such enforcement, regulatory or administrative proceeding has been threatened.
(hj) The transactions contemplated by Company and the Loan Documents Company Subsidiaries have adopted and maintain a compliance program that is intended to assist the Company and the Company Subsidiaries to be in material compliance with all Law, standards and guidelines relevant to its business, including all Healthcare Laws, and includes each of the following elements: (i) a code of conduct and other applicable policies and procedures; (ii) training on the code of conduct, policies and procedures for all employees; (iii) an auditing and monitoring function; (iv) an anonymous reporting process for potential violations of Law or contemplated by the conditions to compliance program; (v) designation of a compliance officer; and (vi) a mechanism for ensuring the effectiveness of any Loan Document) will not impair any Credit Party’s or the compliance program. None of the Company and its Subsidiaries or, to the knowledge of the Company, any of its Subsidiaries’ ownership of officers, directors, employees, contractors or rights under (or the license or the right to use, as the case may be) agents has materially violated any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretosuch compliance program.
Appears in 1 contract
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) is a complete and accurate list The Borrower, each of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their its Subsidiaries and the Borrower’s agents thereof and the agents of each of the Borrower’s Subsidiaries are in compliance in all material respects with all applicable statutes, rules laws and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties Borrower and their each of its Subsidiaries have and maintain maintains in full force and effect all the necessary and requisite material Regulatory Authorizations. The Credit Parties Borrower and their each of its Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act FDCA or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties Borrower and their each of its Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities Activities, labeling, advertising, promotion, Product descriptions and claims for the Products related thereto.
(db) All notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical reports or other reports of adverse experiences) and other filings required by any Regulatory Authority with respect to the Products have been filed with the FDA and any other applicable Governmental Authority.
(c) Neither the Borrower nor any of its Subsidiaries has introduced into commercial distribution any Products manufactured by or on behalf of the Borrower or its Subsidiaries that were upon their shipment by the Borrower or any of its Subsidiaries adulterated or misbranded and all Products are and have been labeled, promoted, and advertised in accordance with their Registrations and approved labeling or within the scope of an exemption from obtaining such Registration.
(i) The Borrower and its Subsidiaries and, to their knowledge, their respective suppliers are, and have been in material compliance with, and each Product in current commercial distribution is designed, manufactured, prepared, assembled, packaged, labeled, stored, installed, serviced, and processed in material compliance with, the applicable Regulatory Authority manufacturing requirements; and (ii) the Borrower and its Subsidiaries are in material compliance with the written procedures, record-keeping and reporting requirements required by the FDA or any other applicable Governmental Authority pertaining to the reporting of adverse events involving the Products, including, as the case may be, the FDA’s Safety Reporting Portal, the FDA’s MedWatch, or the FDA’s Center for Food Safety and Applied Nutrition Adverse Event Reporting System (CAERS).
(e) Except as set forth on provided in Schedule 6.19(d3.30(e), no Credit Party neither the Borrower nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable yearthereto, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled warning letters, criminal proceeding notices under Section 305 of the FD&C ActFDCA, or any other similar communication from any Regulatory Authority within the last five (5) yearsAuthority. Except as set forth on Schedule 6.19(d), there There have been no seizures conducted or threatened by any Regulatory Authority with respect to any Product, and no recalls, market withdrawals, field notifications or corrections, detentions, seizuresnotifications, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, requested or threatened by any Regulatory AuthorityAuthority with respect to any Product, and no recalls, market withdrawals, field notifications, notifications of misbranding or (for example in the case of a recall) initiated adulteration or safety alerts have been conducted requested or threatened by Credit Party or any of its Subsidiaries, Regulatory Authority relating to any Products which represented, in Products. Neither the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party Borrower nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of FDCA or the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) yearsrules and regulations promulgated thereunder.
(ef) No Credit Party, Neither the Borrower nor any of its Subsidiaries, Subsidiaries nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Partythe Borrower’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect thereto.
Appears in 1 contract
Regulatory Matters. With respect to each Product:
(a) Set Section 4.16(a) of the Company Disclosure Letter sets forth on Schedule 6.19(a) is a true and complete list, as of the Agreement Date, and accurate list the Company has made available to Parent true and complete copies of, all Regulatory Authorizations from the FDA, other than immaterial portions of such authorizations, and all material Regulatory Authorizations from any other applicable Regulatory Authorities, other than immaterial portions of such authorizations, held by the Company or any Company Subsidiary relating to the Credit Parties and their Subsidiaries, Company Product and/or necessary to conduct the conduct of their business, and the Products (on a per Product basis)Company’s business as presently conducted. All such material Regulatory Authorizations are (i) legally in full force and beneficially owned exclusively by the Credit Parties and their Subsidiarieseffect, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental AuthorityRegulatory Authorities, (iii) in compliance with all formal filing and maintenance requirements and (including any fee requirementsiv) thereof, and are in good standing, valid and enforceable enforceable. The Company and the Company Subsidiaries have fulfilled and performed all of their material obligations with respect to such Regulatory Authorizations, and no event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof. Except as would not reasonably be expected to, individually or in the aggregate, result in a material liability to the Company and the Company Subsidiaries (taken as a whole), (x) the Company and the Company Subsidiaries have filed, maintained or furnished with the applicable Governmental Authority. All Regulatory Authorities all required filings, declarations, listings, registrations, submissions, amendments, modifications, notices and responses to notices, registrations applications and listings, supplemental applications or notificationsapplications, reports (including field alerts, medical device reports (MDRsall adverse event/experience reports) and other reports of adverse experiences or product malfunctionsinformation (collectively, and reports of corrections or removalthe “Health Care Submissions”) and other required filings (y) all such Health Care Submissions were complete and accurate and in compliance with applicable Health Laws when filed (or were corrected or completed in a subsequent filing). Since January 1, 2021, there has been no Proceeding pending, or to the knowledge of the Company, threatened, with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authoritiesany Health Care Submission.
(b) Since January 1, 2021, (i) All regulatory filings required by the Company and the Company Subsidiaries have been in material compliance with all applicable Health Laws that affect the business, Company Product, properties, assets and activities of the Company and the Company Subsidiaries, (ii) as of the Agreement Date, neither the Company nor any Company Subsidiary has ever received any written notice or other written communication from any Regulatory Authority (A) withdrawing or in respect placing any clinical studies of the Company Product on “clinical hold” or requiring the termination or suspension, material modification, material evaluation, or investigation of any Regulatory Authorization non-clinical, pre-clinical studies or clinical trials, clinical investigations, material performance evaluations trials and other investigations, or material evaluations of or related to the Company Product or (B) alleging any material violation of any Health Law and (iii) there have been no investigations, suits, claims, actions or proceedings pending, or to the knowledge of the Company, threatened against the Company or any Company Subsidiary with respect to any of the Company Product or alleging any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted violation by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring Company or any Company Subsidiary or the Company Product of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all any such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory AuthorityHealth Law.
(c) The Credit PartiesSince January 1, their Subsidiaries 2021, all non-clinical studies, pre-clinical studies, clinical trials, clinical investigations, performance evaluations trials, and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act investigations or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities evaluations conducted or being conducted with respect to the Products Company Product by or at the direction of the Company have been and are currently being conducted in material compliance with the required experimental protocols, procedures and controls, and all Product Development applicable Health Laws, including the FDCA and Commercialization Activities related theretoits applicable implementing regulations at 21 C.F.R. Parts 50, 54, 56, 58 and 312, all applicable requirements of Good Laboratory Practices and Good Clinical Practices and any other applicable regulations that relate to the proper conduct of clinical studies and requirements relating to the protection of human subjects and applicable Laws, including applicable Health Laws, governing the privacy of patient medical records and other personal information and data. No clinical trial conducted by or, on behalf of, the Company has been terminated or suspended by any Regulatory Authority. As of the Agreement Date, neither the Company nor any Company Subsidiary has received any written notifications or other written communications from any institutional review board, ethics committee or safety monitoring committee raising any material issues, including from any Regulatory Authority in any jurisdiction that requires or would require the termination or suspension or investigation of, or place a clinical hold order on or otherwise materially delay or restrict, any clinical studies proposed or currently conducted by, or on behalf of, the Company, or in which the Company or any Company Subsidiary has participated and, to knowledge of the Company, no such action has been threatened against the Company or any Company Subsidiary. With respect to the Company Product, to the knowledge of the Company, the Company has made available to Parent complete and accurate copies of all material clinical and preclinical data and all material written correspondence that exists as of the Agreement Date between the Company and the applicable Regulatory Authorities, in each case, in the possession of the Company as of the Agreement Date (it being understood that data and correspondence in the possession of a contract research organization or similar third party acting on behalf of the Company shall not be deemed to be in possession of the Company solely by reason of its being in the possession of such third party).
(d) Except as set forth Since January 1, 2021, all manufacture of the Company Product, including any clinical supplies used in any clinical trials, by or on Schedule 6.19(d)behalf of the Company has been conducted in material compliance with the applicable specifications and requirements of Good Manufacturing Practices and Health Laws. As of the Agreement Date, no Credit Party nor neither the Company nor, to the knowledge of the Company, any person acting on its behalf has, with respect to the Company Product, (i) been subject to a Regulatory Authority shutdown or import or export prohibition or (ii) received any FDA Form 483, or other Regulatory Authority written notice of inspectional observations, “warning letters,” “untitled letters” or written requests or requirements to make any material change to the Company Product or any of its Subsidiaries has received the Company’s or any Company Subsidiary’s manufacturing or clinical trial processes or procedures or any similar written correspondence from any Regulatory Authority any notice in respect of alleged non-compliance the Company or adverse findings the Company Subsidiary or their manufacturing or clinical trial operations alleging or asserting noncompliance with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable yearHealth Law or Regulatory Authorization and, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 to the knowledge of the FD&C ActCompany, or any other similar communication from any no Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) yearsconsidering such action.
(e) No Credit Party, None of the Company nor any of its Subsidiariesthe Company Subsidiaries or any of their respective officers or employees, nor nor, to the knowledge of the Company, agents or any officer, employee or agent thereof, clinical investigator acting for the Company has (i) made an untrue statement of a material fact or fraudulent statements statement to the FDA any Regulatory Authority or any other Regulatory AuthorityGovernmental Entity, (ii) failed to disclose a material fact required to be disclosed to the FDA any Regulatory Authority or any other Regulatory Authority, Governmental Entity or (iii) committed an act, made a statement, or failed to make a statement statement, including with respect to any scientific data or information, that, at the time such disclosure was made (or was not made)failure to disclose occurred, could would reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery Bribery, and Illegal Gratuities, ,” set forth in 56 Fed. Reg. 46191 (September 10, 1991), and any amendments thereto, or for any Regulatory Authority to invoke any similar policy or any other statute or regulation regarding the communication or submission of false information to any applicable Regulatory Authority or Governmental Entity. None of the Company nor any of the Company Subsidiaries or any of their respective officers or employees, nor, to the knowledge of the Company, agents or any clinical investigator acting for the Company has committed or engaged in any fraud or falsification or forgery of any research or development data, report, studies or publications of any document or statement voluntarily submitted or required to be submitted to any Regulatory Authority or any other Governmental Entity. None of the Company, any Company Subsidiary or any of their respective officers or employees or, to the knowledge of the Company, agents or any clinical investigator acting for the Company, is currently or has been convicted of any crime or engaged in any conduct that has resulted in, or would reasonably be expected to result in, debarment from participation in any program related to pharmaceutical products pursuant to 21 U.S.C. Section 335a (a) or (b) or exclusion from participation in any similar policyfederal health care program pursuant to 42 U.S.C. Section 1320a-7.
(f) Except No Company Product that is or has been manufactured, tested, distributed, held or marketed by or on behalf of the Company has been recalled, withdrawn or suspended (whether voluntarily or otherwise) or, to the Company’s knowledge, has been adulterated or misbranded. No proceedings (whether complete or pending) seeking the recall, withdrawal, suspension or seizure of any such Company Product or pre-market approvals or marketing authorizations are pending or, to the knowledge of the Company, threatened against the Company or the Company Subsidiary, nor have any such proceedings been pending at any time. The Company has made available to Parent all material information about serious adverse events (as set forth such term is defined in 21 C.F.R. 312.32) in the possession of the Company as of the Agreement Date relating to any Company Product that is or has been manufactured, tested, distributed, held or marketed by or on Schedule 6.19(f), no Credit Party nor behalf of the Company or any of its Subsidiaries licensors or licensees. The Company has received filed all annual and periodic reports, amendments and safety reports required for any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened Company Product required to commence or initiate, any action be made to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,Authority.
(g) Except as set forth on Schedule 6.19(g)Neither the Company nor any Company Subsidiary is a party to any corporate integrity agreement, the clinicalmonitoring agreement, preclinicalconsent decree, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiariessettlement order, or in respect of which similar agreement with or imposed by any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions to effectiveness of any Loan Document) will not impair any Credit Party’s Authority or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoEntity.
Appears in 1 contract
Regulatory Matters. With respect to each Product:
(a) Set forth on Schedule 6.19(a) is a complete and accurate list Clinical Trials. None of all material the Company’s or its subsidiaries’ product candidates have received marketing approval from any Applicable Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental Authorities, including the FDA and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) years. Except as set forth on Schedule 6.19(d), there have been no recalls, market withdrawals, field notifications or corrections, detentions, seizures, notifications or allegations of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example in the case of a recall) initiated by Credit Party or any of its Subsidiaries, relating to any Products which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years. No Credit Party nor any of its Subsidiaries has received any written notification that remains unresolved from the FDA or any other Regulatory Authority indicating any breach or violation of any applicable Regulatory Authorization, including that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) years.
(e) No Credit Party, nor any of its Subsidiaries, nor any officer, employee or agent thereof, has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Authority, failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Authority, or committed an act, made a statement, or failed to make a statement that, at the time such disclosure was made (or was not made), could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority to invoke its policy respecting Fraud, Untrue Statements of Material Facts, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar policy.
(f) Except as set forth on Schedule 6.19(f), no Credit Party nor any of its Subsidiaries has received any written notice that the FDA or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development and Commercialization Activities of such Credit Party or such Subsidiary, in each case, which represented, in the aggregate, 15% or more of Net Sales in any applicable year,.
(g) Except as set forth on Schedule 6.19(g), the clinical, preclinical, safety and other studies and tests trials conducted by or on behalf of or sponsored by the Credit Parties and their SubsidiariesCompany or its subsidiaries, or in respect of which any Products the Company or Product candidates under development its subsidiaries have participated, were with respect to the Company’s or its subsidiaries’ product candidates, including any such studies and trials that are described in the Registration Statement and the Prospectus, or the results of which are referred to in the Registration Statement and the Prospectus, as applicable (collectively, “Company Trials”), were, and if still pending, are) pending are being conducted in all material respects in accordance with all applicable Health Care Laws of the Applicable Regulatory Authorizations Authorities and Healthcare current good clinical practices and good laboratory practices, standard medical and scientific research procedures and any applicable rules, regulations and policies of the jurisdiction in which such trials and studies are being conducted; the descriptions in the Registration Statement and the Prospectus of the results of any Company Trials are accurate and complete descriptions in all material respects and fairly present the data derived therefrom; the Company has no knowledge of any other studies or trials not described in the Registration Statement and the Prospectus, the results of which are inconsistent with or call into question the results described or referred to in the Registration Statement and the Prospectus; the Company and each of its subsidiaries have operated at all times and are currently in compliance in all material respects with all applicable Health Care Laws of the Applicable Regulatory Authorities; neither the Company nor any of its subsidiaries have received, nor does the Company have knowledge after due inquiry that any of its or its subsidiaries’ collaboration partners have received any written notices, correspondence or other communications from the Applicable Regulatory Authorities or any other Governmental Entity requiring or threatening the termination, material modification or suspension of Company Trials, other than ordinary course communications with respect to modifications in connection with the design and implementation of such studies or trials, and, to the Company’s knowledge, there are no reasonable grounds for the same. The Company Trials have been designed to ensure that informed consent from each human subject participating in the Company Trials is obtained. In using or disclosing patient information received by the Company or a subsidiary in connection with a Company Trial, the Company or such subsidiary has complied in all material respects.
(h) The transactions contemplated , to the extent applicable, with all applicable laws and regulatory rules or requirements, including, without limitation, HIPAA and the rules and regulations thereunder. To the Company’s knowledge, none of the Company Trials involved any investigator who has been disqualified as a clinical investigator or has been found by the Loan Documents (or contemplated by the conditions FDA to effectiveness of any Loan Document) will not impair any Credit Party’s or any of its Subsidiaries’ ownership of or rights under (or the license or the right to use, as the case may be) any Regulatory Authorizations relating to the Products have engaged in any material manner, and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith and the exercise of rights and remedies with respect theretoscientific misconduct.
Appears in 1 contract
Sources: Underwriting and Placement Agency Agreement (ObsEva SA)
Regulatory Matters. With respect to each Product:
(a) Set Schedule 5.16 sets forth on Schedule 6.19(a) is a true, correct and complete and accurate list of all material Regulatory Authorizations relating to the Credit Parties and their Subsidiaries, the conduct of their business, and the Products (on a per Product basis). All such material Regulatory Authorizations are (i) legally and beneficially owned exclusively by the Credit Parties and their Subsidiaries, as applicable, free and clear of all Liens other than Permitted Liens, and (ii) as applicable, validly registered and on file with the applicable Governmental Authority, in compliance with all filing and maintenance requirements (including any fee requirements) thereof, and are in good standing, valid and enforceable with the applicable Governmental Authority. All required notices, registrations and listings, supplemental applications or notifications, reports (including field alerts, medical device reports (MDRs) and other reports of adverse experiences or product malfunctions, and reports of corrections or removal) and other required filings with respect to the Products for the last five (5) years have been timely filed with the FDA and all other applicable Governmental Authorities.
(b) (i) All regulatory filings required by any Regulatory Authority or in respect of any Regulatory Authorization with respect to any Product or any Product Development and Commercialization Activities which represented, in the aggregate, 15% or more of Net Sales in any applicable year, in the last five (5) years have been made, and all such filings above such threshold are complete and correct and have complied in all material respects with all applicable laws and regulations, (ii) all clinical and pre-clinical trials, if any, of investigational Products have been and are being conducted by the Credit Parties and their Subsidiaries in accordance with all applicable laws and regulations along with appropriate monitoring of clinical investigator trial sites for their compliance, and (iii) the Credit Parties and their Subsidiaries have disclosed to the Agent all such regulatory filings and all material communications between representatives of the Credit Parties (and their Subsidiaries) and any Regulatory Authority.
(c) The Credit Parties, their Subsidiaries and the agents thereof are in compliance in all material respects with all applicable statutes, rules and regulations (including all Healthcare Laws and Regulatory Authorizations) of all applicable Governmental AuthoritiesADMA Registrations, including the FDA ADMA BLAs and all other Regulatory Authorities, with respect to each Product and all Product Development and Commercialization Activities related thereto. The Credit Parties and their Subsidiaries have and maintain in full force and effect all the necessary and requisite Regulatory Authorizations. The Credit Parties and their Subsidiaries are in compliance in all material respects with all applicable registration and listing requirements set forth in the FD&C Act or equivalent regulation of each other Governmental Authority having jurisdiction over such Person. The Credit Parties and their Subsidiaries adhere in all material respects to all applicable regulations of all Regulatory Authorities with respect to the Products and all Product Development and Commercialization Activities related thereto.
(d) Except as set forth on Schedule 6.19(d), no Credit Party nor any of its Subsidiaries has received from any Regulatory Authority any notice of alleged non-compliance or adverse findings with respect to any Product or any Product Development and Commercialization Activities related thereto which represented, in the aggregate, 15% or more of Net Sales in any applicable year, including any FDA Form 483 inspectional observations, notices of violations, Warning Letters, untitled letters, criminal proceeding notices under Section 305 of the FD&C Act, or any other similar communication from any Regulatory Authority within the last five (5) yearsADMA INDs. Except as set forth on Schedule 6.19(d)5.16:
(a) ADMA is the sole and exclusive owner of the ADMA Registrations and is the sole and exclusive holder of the ADMA BLAs and ADMA INDs. The ADMA Registrations, there have been no recallsADMA BLAs and ADMA INDs are in full force and effect and ADMA is in compliance with the ADMA Registrations, market withdrawalsADMA BLAs and ADMA INDs, field notifications or correctionsexcept where noncompliance would not be material to the continued operation of the ADMA Business. To ADMA’s Knowledge, detentionsthe ADMA Registrations, seizuresincluding the ADMA BLAs and ADMA INDs, notifications or allegations are the only ADMA Registrations necessary to own, lease and operate the business of misbranding or adulteration or safety alerts conducted, requested, or threatened by any Regulatory Authority, or (for example the ADMA Business in the case Ordinary Course of a recallBusiness (the “ADMA Required Registrations”).
(b) initiated by Credit Party or To ADMA’s Knowledge, ADMA is in possession of all ADMA Required Registrations. ADMA has not received written notice from any of its Subsidiaries, relating Governmental Authority that there are circumstances currently existing which could reasonably be likely to lead to any Products which representedloss or revocation of any ADMA Required Registration or refusal to renew any ADMA Required Registration on terms no less advantageous to ADMA than the terms of those ADMA Required Registrations currently in force.
(c) All equipment that is used in the operation of the ADMA Business that is required by applicable Laws to be cGMP compliant is, in all material respects, cGMP compliant, the aggregateprocesses that are used in the manufacturing of ADMA’s products are, 15% or more of Net Sales in any applicable year within all material respects, validated, and the last establishment at which such products are manufactured is operated, in all material respects, in compliance with cGMP.
(d) ADMA has, since the date that is five (5) yearsyears prior to the Effective Time, conducted the ADMA Business in compliance, in all material respects, with all applicable Laws enforced or administered by the FDA, including, without limitation, the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act and their implementing regulations, or any other Governmental Authority prior to the Effective Time with respect to the collection, manufacture, processing, holding, storing, testing, labeling, distribution, marketing, and advertising of the ADMA products, including, without limitation, (i) cGMP, (ii) payment of all application, product, and establishment fees relating to the ADMA products or the establishment at which the ADMA products are manufactured, (iii) recordkeeping and reporting requirements, and (iv) label, labeling, promotional, and advertising requirements. No Credit Party nor any To ADMA’s Knowledge, ADMA has filed with the FDA all required notices, supplemental applications and annual or other reports, including adverse experience reports, as applicable, with respect to the products which are material to the ADMA Business or the further clinical development of its Subsidiaries the ADMA products.
(e) ADMA has not, since the date that is five (5) years prior to the Effective Time, received any written notification that remains unresolved FDA Form 483, notice of inspectional observations, notice of adverse findings, warning letters, untitled letters or other notices alleging a lack of safety or compliance or violation of any Law from the FDA or any other Regulatory Authority indicating Governmental Authority. ADMA has not received any breach or violation of any applicable Regulatory Authorizationnotice, including since the date that any of the Products is misbranded or adulterated as defined in the FD&C Act, in each case of the foregoing, which represented, in the aggregate, 15% or more of Net Sales in any applicable year within the last five (5) yearsyears prior to the Effective Time, that the FDA or any similar Governmental Authority has commenced, or threatened to initiate, any action to enjoin manufacture or distribution of any ADMA product.
(ef) No Credit PartyADMA has not, since the date that is five (5) years prior to the Effective Time, voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recalls, field notifications, field corrections, market withdrawals or replacements, warnings, “dear doctor” letters, investigator notices, safety alerts or other notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance of any product manufactured, distributed or marketed by or on behalf of the ADMA Business. ADMA has made available to Seller copies of all (i) reports of inspection observations, (ii) establishment inspection reports, (iii) warning letters, as well as any other documents received by ADMA from the FDA or any other Governmental Authority relating to the ADMA products that assert ongoing lack of compliance with any Laws (including regulations promulgated by the FDA and any other Governmental Authority) by ADMA.
(g) Neither ADMA nor any of its Subsidiariesofficers, nor any officerdirectors, employee employees or agent thereof, agents has made an untrue statement of a material fact or fraudulent statements to the FDA or any other Regulatory Governmental Authority, with respect to the products or activities of the ADMA Business (whether in any submission to such Governmental Authority or otherwise), or failed to disclose a material fact required to be disclosed to the FDA or any other Regulatory Governmental Authority, with respect to the products or committed an actactivities of the ADMA Business.
(h) ADMA has not been and is not currently the subject of any Action whereby the activities of the ADMA Business could lead to a debarment, made a statementunder 21 U.S.C. § 335a or any similar state Law or regulation; exclusion under 42 U.S.C. § 1320a-7 or any similar state Law or regulation; imposition of the Application Integrity Policy by the FDA; or any Action for violation of Laws related to any Federal Health Care Program.
(i) All studies, tests and non-clinical and clinical trials conducted by, or failed on behalf of, ADMA with respect to make a statement thatthe ADMA products are being and have been conducted in material compliance with the protocols and controls pursuant to accepted professional scientific standards and all applicable Laws, at including the time such disclosure was made FDC Act, all regulations promulgated by the FDA relating thereto, including 21 C.F.R. Parts 50, 54, 56, 58 and 312, as amended, and all applicable guidance, including the ICH E6 Guidance, Good Clinical Practice: Consolidated Guidance. Since the date that is five (5) years prior to the Effective Time, ADMA has not received any written notices, correspondence or was not made)other communication from any institutional review board, could reasonably be expected to provide a basis for the FDA or any other Regulatory Authority Governmental Authority, recommending or requiring the termination, suspension or material modification of any ongoing or planned clinical trials related to invoke its policy respecting Fraudany ADMA product conducted by, Untrue Statements of Material Factsor on behalf of, Bribery and Illegal Gratuities, set forth in 56 Fed. Reg. 46191 (September 10, 1991) ADMA or any similar policythe ADMA Business.
(fj) Except Each of ADMA and its Affiliates has a privacy policy (an “ADMA Privacy Policy”) regarding the collection, use and protection of Personal Data that is in material compliance with all applicable Laws and has, prior to the date hereof, provided Seller with true, correct and complete copies of such ADMA Privacy Policies as set forth on Schedule 6.19(f)they currently exist. Since January 1, no Credit Party 2014, neither ADMA nor any of its Subsidiaries Affiliates has received in the past violated or currently is in violation of its ADMA Privacy Policy. There has not been any written notice that the FDA unauthorized access or any other applicable Regulatory Authority has commenced or initiated, or threatened to commence or initiate, any action to withdraw any Regulatory Authorization, requested the recall (whether by correction or removal) disclosure of any Products or commenced or initiated or threatened to commence or initiate, any action to enjoin any Product Development Personal Data in connection with the operation of the business of ADMA and Commercialization Activities its Affiliates. The execution and delivery of such Credit Party or such Subsidiary, in each case, which represented, in this Agreement and the aggregate, 15% or more consummation of Net Sales in any applicable year,the Transactions do not violate the ADMA Privacy Policies.
(gk) Except as Notwithstanding anything to the contrary herein, (i) no representation or warranty is made in this Agreement about the matters set forth on Schedule 6.19(g)in the Complete Response Letter received by ADMA in July 2016 from the FDA, the clinical, preclinical, safety and other studies and tests conducted by or on behalf of or sponsored by the Credit Parties and their Subsidiaries, or in respect of which any Products or Product candidates under development have participated, were (and if still pending, are) being conducted in accordance with all applicable Regulatory Authorizations and Healthcare Laws in all material respects.
(h) The transactions contemplated by the Loan Documents (or contemplated by the conditions there shall be no Liability to effectiveness of any Loan Document) will not impair any Credit Party’s Seller or any of its Subsidiaries’ ownership Affiliates hereunder by ADMA, Buyer or any of their respective Affiliates with respect to such matters, and (ii) the representation and warranties made in this Agreement about the matters set forth in Section 5.16 are solely for disclosure purposes and there shall be no Liability to Seller or rights under (any of its Affiliates hereunder by ADMA, Buyer or the license or the right any of their respective Affiliates with respect to use, as such matters except in the case may beof fraud, intentional misrepresentation or intentional misconduct by ADMA or Buyer.
(l) Notwithstanding any Regulatory Authorizations relating to the Products in any material mannerother provisions of this Agreement, this Section 5.16 sets forth ADMA’s and no consent or other authorization of any Governmental Authority is required in connection with the transactions contemplated hereby, including the Liens granted in connection herewith Buyer’s sole and the exercise of rights exclusive representations and remedies warranties with respect theretoto healthcare regulatory matters.
Appears in 1 contract
Sources: Master Purchase and Sale Agreement (Adma Biologics, Inc.)