Compliance with Laws; Regulatory Compliance. (a) The Exploitation by Seller and its Affiliates of any Product and the ownership by Seller and its Affiliates of the Purchased Assets have been, at all times, in material compliance with all applicable Law, including applicable Regulatory Laws. Except as set forth in Seller’s Disclosure Schedule, neither Seller nor any Affiliate has received any written communication from a Governmental Entity that alleges that Seller or any Affiliate is not in compliance in any material respect with any Law or Order with respect to its Exploitation of any Product or with respect to ownership of the Purchased Assets, respectively and as applicable. Seller and its Affiliates have, and have had, all Product Registrations necessary for its lawful Exploitation of any Product prior to the Closing Date, and each of such Product Registrations, if any, is valid and in full force and effect. (b) Except as set forth in the Seller Disclosure Schedule, there has not been any claim of which Seller or any Affiliate has received notice of any Action pending or threatened against Seller or an Affiliate relating to any Product or the Purchased Assets. To the Knowledge of Seller, there is no fact or circumstance that would reasonably be expected to serve as a basis for any Action against Seller or any Affiliate relating to any Product or any Purchased Assets or that, if successful, could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreement. There is no Action pending by Seller or any Affiliate, or which Seller intends to initiate against any Third Party relating to any Product or any Purchased Asset. There is no outstanding Order of any Governmental Entity against Seller (i) that relates to the Business, a Product or any Purchased Asset, (ii) that could reasonably be expected to be materially adverse to the Business, any Product or any Purchased Asset, or (iii) that could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreement. (c) There is no Action pending or, to the Knowledge of Seller, threatened against Seller by any Governmental Entity, and there is no claim, investigation or administrative action of any Governmental Entity pending or, to the Knowledge of Seller, threatened, that affects or, if successful, could reasonably be expected to be materially adverse to Seller, the Business, a Product, any Purchased Assets or the Assumed Liabilities or that, if successful, could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreement, nor are there, to the Knowledge of Seller, any facts, circumstances or conditions on which any such Action could be brought in the future. (d) Except as set forth in the Seller Disclosure Schedule, Seller and its Affiliates have timely filed all material reports, statements, documents, registrations, filings, amendments, supplements and submissions required to be filed by it with respect to any Product and the Purchased Assets under applicable Regulatory Laws. Each such filing was, in all material respects, true, complete and correct as of the date of submission, and any necessary or required updates, changes, corrections, amendments, supplements or modifications to such filings have been submitted to the applicable Governmental Entity. (e) Except for notice of the Clinical Hold, neither Seller nor any Affiliate has, with respect to any Product or any Purchased Asset, (i) received or been subject to any action, notice, warning, administrative proceeding, review or investigation by a Regulatory Authority that alleges or asserts that Seller or any Affiliate has violated any applicable Regulatory Laws or (ii) been subject to a corporate integrity agreement, deferred prosecution agreement, consent decree, monitoring agreement, settlement agreement or other similar agreement or Order mandating or prohibiting future or past activities. (f) Except as set forth on Schedule 4.9(f), the Manufacturing and servicing operations conducted by or on behalf of Seller and its Affiliates with respect to any Product are conducted in material compliance with applicable Regulatory Laws, including applicable current good manufacturing practice regulations and similar federal, state, local or foreign requirements for the Manufacture of any Product. (g) Neither Seller, nor any Affiliate, nor any officer, employee or agent of Seller or of any Affiliate, in each case who has been materially involved in the Exploitation of any Product (i) has been convicted of any crime or engaged in any conduct in the operation of Seller’s business for which debarment is mandated or authorized by 21 U.S.C. § 335a or any similar applicable Law, nor has any such Person been so debarred; (ii) has been convicted of any crime or engaged in any conduct which would reasonably be expected to cause Seller to be excluded from participating in federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar applicable Law, nor has any such Person been so excluded; or (iii) to the Knowledge of Seller, is subject to an investigation or proceeding by any Regulatory Authority that could result in such a suspension, exclusion or debarment and there are no facts, to the Knowledge of Seller, that would reasonably be expected to give rise to such suspension, exclusion or debarment. (h) Neither Seller nor any Affiliate has, in connection with its Exploitation of a Product, conducted any business or engaged in any transaction or dealing with any Person with whom transactions were, at the time of such transaction, prohibited as to U.S. Persons by any applicable sanctions Laws administered by the U.S. Treasury Department’s Office of Foreign Assets Control (“OFAC”), including persons appearing on the List of Specially Designated Nationals and Blocked Persons published by OFAC.
Appears in 2 contracts
Samples: Asset Purchase Agreement (Finch Therapeutics Group, Inc.), Asset Purchase Agreement (Finch Therapeutics Group, Inc.)
Compliance with Laws; Regulatory Compliance. (a) The Exploitation Borrower is not an “investment company” or a company “controlled” by Seller an “investment company” under the Investment Company Act of 1940, as amended. Borrower is not engaged as one of its important activities in extending credit for margin stock (under Regulations X, T and its Affiliates of any Product and the ownership by Seller and its Affiliates U of the Purchased Assets Federal Reserve Board of Governors). As of the Effective Date, except as set forth on Schedule B, neither Borrower nor any Subsidiary of Borrower owns any such margin stock. Borrower has complied in all material respects with the Federal Fair Labor Standards Act. Neither Borrower nor any of its Subsidiaries is a “holding company” or an “affiliate” of a “holding company” or a “subsidiary company” of a “holding company” as each term is defined and used in the Public Utility Holding Company Act of 2005. Borrower has not violated any Laws, ordinances or rules, the violation of which could reasonably be expected to have beena Material Adverse Change. None of Borrower’s or any of its Subsidiaries’ properties or assets has been used by Borrower or any Subsidiary or, at all timesto the Borrower’s knowledge, by previous Persons, in disposing, producing, storing, treating, or transporting any hazardous substance other than in material compliance with all applicable Law, including applicable Regulatory Laws. Except as set forth in Seller’s Disclosure Schedule, neither Seller nor any Affiliate has received any written communication from a Governmental Entity that alleges that Seller or any Affiliate is not in compliance in any material respect with any Law or Order with respect to its Exploitation of any Product or with respect to ownership of the Purchased Assets, respectively and as applicable. Seller and its Affiliates have, and have had, all Product Registrations necessary for its lawful Exploitation of any Product prior to the Closing Date, Borrower and each of its Subsidiaries have obtained all consents, approvals and authorizations of, made all declarations or filings with, and given all notices to, all Government Authorities that are necessary to continue their respective businesses as currently conducted, other than such Product Registrationsconsents, if anyapprovals and authorizations, is valid and in full force and effectthe failure of which to obtain could not reasonably be expected to have a Material Adverse Change.
(b) Except as set forth in Neither the Seller Disclosure ScheduleBorrower nor, there has not been to the knowledge of Borrower, any claim of which Seller its Affiliates or any Affiliate has received notice of their respective agents acting or benefiting in any Action pending or threatened against Seller or an Affiliate relating to any Product or the Purchased Assets. To the Knowledge of Seller, there is no fact or circumstance that would reasonably be expected to serve as a basis for any Action against Seller or any Affiliate relating to any Product or any Purchased Assets or that, if successful, could reasonably be expected to result capacity in restraining, enjoining or otherwise preventing the completion by Seller of connection with the transactions contemplated by this Agreement. There Agreement is no Action pending by Seller or any Affiliate, or which Seller intends to initiate against any Third Party relating to any Product or any Purchased Asset. There is no outstanding Order of any Governmental Entity against Seller (i) that relates to the Business, a Product or in violation of any Purchased AssetAnti-Terrorism Law, (ii) engages in or conspires to engage in any transaction that could reasonably be expected evades or avoids, or has the purpose of evading or avoiding or attempts to be materially adverse to the Businessviolate, any Product or of the prohibitions set forth in any Purchased AssetAnti-Terrorism Law, or (iii) that could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreement.
(c) There is no Action pending ora Blocked Person. Neither Borrower nor, to the Knowledge knowledge of Seller, threatened against Seller by any Governmental Entity, and there is no claim, investigation or administrative action of any Governmental Entity pending or, to the Knowledge of Seller, threatened, that affects or, if successful, could reasonably be expected to be materially adverse to Seller, the Business, a ProductBorrower, any Purchased Assets of its Affiliates or the Assumed Liabilities agents acting or that, if successful, could reasonably be expected to result benefiting in restraining, enjoining or otherwise preventing the completion by Seller of any capacity in connection with the transactions contemplated by this Agreement, nor are there, to the Knowledge of Seller, any facts, circumstances or conditions on which any such Action could be brought in the future.
(dx) Except as set forth in the Seller Disclosure Schedule, Seller and its Affiliates have timely filed all material reports, statements, documents, registrations, filings, amendments, supplements and submissions required to be filed by it with respect to any Product and the Purchased Assets under applicable Regulatory Laws. Each such filing was, in all material respects, true, complete and correct as of the date of submission, and any necessary or required updates, changes, corrections, amendments, supplements or modifications to such filings have been submitted to the applicable Governmental Entity.
(e) Except for notice of the Clinical Hold, neither Seller nor any Affiliate has, with respect to any Product or any Purchased Asset, (i) received or been subject to any action, notice, warning, administrative proceeding, review or investigation by a Regulatory Authority that alleges or asserts that Seller or any Affiliate has violated any applicable Regulatory Laws or (ii) been subject to a corporate integrity agreement, deferred prosecution agreement, consent decree, monitoring agreement, settlement agreement or other similar agreement or Order mandating or prohibiting future or past activities.
(f) Except as set forth on Schedule 4.9(f), the Manufacturing and servicing operations conducted by or on behalf of Seller and its Affiliates with respect to any Product are conducted in material compliance with applicable Regulatory Laws, including applicable current good manufacturing practice regulations and similar federal, state, local or foreign requirements for the Manufacture of any Product.
(g) Neither Seller, nor any Affiliate, nor any officer, employee or agent of Seller or of any Affiliate, in each case who has been materially involved in the Exploitation of any Product (i) has been convicted of any crime or engaged in any conduct in the operation of Seller’s business for which debarment is mandated or authorized by 21 U.S.C. § 335a or any similar applicable Law, nor has any such Person been so debarred; (ii) has been convicted of any crime or engaged in any conduct which would reasonably be expected to cause Seller to be excluded from participating in federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar applicable Law, nor has any such Person been so excluded; or (iii) to the Knowledge of Seller, is subject to an investigation or proceeding by any Regulatory Authority that could result in such a suspension, exclusion or debarment and there are no facts, to the Knowledge of Seller, that would reasonably be expected to give rise to such suspension, exclusion or debarment.
(h) Neither Seller nor any Affiliate has, in connection with its Exploitation of a Product, conducted conducts any business or engaged engages in making or receiving any contribution of funds, goods or services to or for the benefit of any Blocked Person, or (y) deals in, or otherwise engages in any transaction relating to, any property or dealing with interest in property blocked pursuant to Executive Order No. 13224, any Person with whom transactions were, at the time of such transaction, prohibited as to U.S. Persons by any applicable sanctions Laws administered by the U.S. Treasury Department’s Office of Foreign Assets Control (“OFAC”), including persons appearing on the List of Specially Designated Nationals and Blocked Persons published by OFACsimilar executive order or other Anti-Terrorism Law.
Appears in 2 contracts
Samples: Loan and Security Agreement (TRIA Beauty, Inc.), Loan and Security Agreement (TRIA Beauty, Inc.)
Compliance with Laws; Regulatory Compliance. (a) The Exploitation by Seller Except as set forth in Section 3.12(a) of the Innovate Schedule of Exceptions, each of Innovate and its Affiliates Subsidiaries, and, to the Knowledge of any Product Innovate, every director, officer, employee, agent, and Representative thereof, is and has been for the ownership by Seller and its Affiliates of the Purchased Assets have been, at all times, past three (3) years in material compliance with all applicable LawLaws (including, but not limited to, FDCA, Health Care Laws, and all trade laws, including applicable Regulatory Lawsimport control and export laws, trade embargos and anti-boycott laws) and Orders. Except as set forth in Seller’s Disclosure ScheduleTo the Knowledge of Innovate and its Subsidiaries, neither Seller nor (i) no investigation by any Affiliate has received any written communication from a Governmental Entity that alleges that Seller or any Affiliate is not in compliance in any material respect with any Law or Order Authority with respect to Innovate or any of its Exploitation of any Product or with respect to ownership of the Purchased Assets, respectively Subsidiaries is active and as applicable. Seller and its Affiliates havepending, and have had(ii) no Governmental Authority has indicated in writing or, all Product Registrations necessary for its lawful Exploitation of any Product prior to the Closing DateKnowledge of Innovate, and each of such Product Registrationsorally, if any, is valid and in full force and effectan intention to conduct an investigation.
(b) Except as set forth in the Seller Disclosure Schedulehas not, there has would not been any claim of which Seller or any Affiliate has received notice of any Action pending or threatened against Seller or an Affiliate relating to any Product or the Purchased Assets. To the Knowledge of Seller, there is no fact or circumstance that and would not reasonably be expected to serve as a basis for any Action against Seller to, individually or any Affiliate relating to any Product or any Purchased Assets or thatin the aggregate, if successfulhave an Innovate Material Adverse Effect, could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller each of the transactions contemplated by this Agreement. There is no Action pending by Seller or any Affiliate, or which Seller intends to initiate against any Third Party relating to any Product or any Purchased Asset. There is no outstanding Order of any Governmental Entity against Seller (i) that relates to the Business, a Product or any Purchased Asset, (ii) that could reasonably be expected to be materially adverse to the Business, any Product or any Purchased Asset, or (iii) that could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreement.
(c) There is no Action pending orInnovate and its Subsidiaries and, to the Knowledge of SellerInnovate, threatened against Seller by any Governmental Entitytheir respective employees and agents, hold all Innovate Permits, including, but not limited to, all authorizations required under the FDCA, and there is no claimthe regulations of the FDA promulgated thereunder as well as the PHSA. Except as has not, investigation or administrative action of any Governmental Entity pending or, to the Knowledge of Seller, threatened, that affects or, if successful, could would not and would not reasonably be expected to, individually or in the aggregate, have an Innovate Material Adverse Effect, all such Innovate Permits are valid, and in full force and effect. Since January 1, 2015, there has not occurred any violation of, default (with or without notice or lapse of time or both) under, or event giving to be materially adverse to Sellerothers any right of termination, the Businessamendment or cancellation of, a Productwith or without notice or lapse of time or both, any Purchased Assets or the Assumed Liabilities or thatInnovate Permit except as has not, if successful, could would not and would not reasonably be expected to result in restrainingto, enjoining individually or otherwise preventing the completion by Seller of the transactions contemplated by this Agreement, nor are there, to the Knowledge of Seller, any facts, circumstances or conditions on which any such Action could be brought in the future.
(d) Except as set forth in the Seller Disclosure Scheduleaggregate, Seller and its Affiliates have timely filed all material reports, statements, documents, registrations, filings, amendments, supplements and submissions required to be filed by it with respect to any Product and the Purchased Assets under applicable Regulatory Lawsan Innovate Material Adverse Effect. Each such filing was, of Innovate and each of its Subsidiaries is in compliance in all material respects, true, complete and correct as of respects with the date of submission, and any necessary or required updates, changes, corrections, amendments, supplements or modifications to such filings have been submitted to the applicable Governmental Entity.
(e) Except for notice of the Clinical Hold, neither Seller nor any Affiliate has, requirements associated with respect to any Product or any Purchased Asset, (i) received or been subject to any action, notice, warning, administrative proceeding, review or investigation by a Regulatory Authority that alleges or asserts that Seller or any Affiliate has violated any applicable Regulatory Laws or (ii) been subject to a corporate integrity agreement, deferred prosecution agreement, consent decree, monitoring agreement, settlement agreement or other similar agreement or Order mandating or prohibiting future or past activities.
(f) Except as set forth on Schedule 4.9(f), the Manufacturing and servicing operations conducted by or on behalf of Seller and its Affiliates with respect to any Product are conducted in material compliance with applicable Regulatory Laws, including applicable current good manufacturing practice regulations and similar federal, state, local or foreign requirements for the Manufacture of any Product.
(g) Neither Seller, nor any Affiliate, nor any officer, employee or agent of Seller or of any Affiliate, in each case who has been materially involved in the Exploitation of any Product (i) has been convicted of any crime or engaged in any conduct in the operation of Seller’s business for which debarment is mandated or authorized by 21 U.S.C. § 335a or any similar applicable Law, nor has any such Person been so debarred; (ii) has been convicted of any crime or engaged in any conduct which would reasonably be expected to cause Seller to be excluded from participating in federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar applicable Law, nor has any such Person been so excluded; or (iii) to the Knowledge of Seller, is subject to an investigation or proceeding by any Regulatory Authority that could result in such a suspension, exclusion or debarment and there are no facts, to the Knowledge of Seller, that would reasonably be expected to give rise to such suspension, exclusion or debarment.
(h) Neither Seller nor any Affiliate has, in connection with its Exploitation of a Product, conducted any business or engaged in any transaction or dealing with any Person with whom transactions were, at the time of such transaction, prohibited as to U.S. Persons by any applicable sanctions Laws administered by the U.S. Treasury Department’s Office of Foreign Assets Control (“OFAC”), including persons appearing on the List of Specially Designated Nationals and Blocked Persons published by OFAC.all Innovate
Appears in 2 contracts
Samples: Merger Agreement (Innovate Biopharmaceuticals, Inc.), Merger Agreement (Innovate Biopharmaceuticals, Inc.)
Compliance with Laws; Regulatory Compliance. (a) The Exploitation by Seller and its Affiliates of any Product and the ownership by Seller and its Affiliates Each of the Purchased Assets have been, at all times, Company and each of its Subsidiaries is in material compliance with all applicable LawLaws or Orders, including applicable Regulatory Laws. Except as set forth in Seller’s Disclosure Schedule, neither Seller nor except where any Affiliate has received any written communication from a Governmental Entity that alleges that Seller or any Affiliate is not such failure to be in compliance in any material respect with any Law or Order with respect to its Exploitation of any Product or with respect to ownership of the Purchased Assets, respectively and as applicable. Seller and its Affiliates have, and have has not had, all Product Registrations necessary for its lawful Exploitation of any Product prior to the Closing Date, and each of such Product Registrations, if any, is valid and in full force and effect.
(b) Except as set forth in the Seller Disclosure Schedule, there has or would not been any claim of which Seller or any Affiliate has received notice of any Action pending or threatened against Seller or an Affiliate relating to any Product or the Purchased Assets. To the Knowledge of Seller, there is no fact or circumstance that would reasonably be expected to serve as have, individually or in the aggregate, a basis for any Action against Seller Company Material Adverse Effect or any Affiliate relating to any Product or any Purchased Assets or that, if successful, could would not reasonably be expected to result in restraining, enjoining prevent or otherwise preventing materially impair the completion by Seller consummation of the transactions contemplated Contemplated Transactions. No investigation, inquiry, proceeding or similar action by this Agreement. There is no Action pending by Seller any Governmental Authority with respect to the Company or any Affiliate, or which Seller intends to initiate against any Third Party relating to any Product or any Purchased Asset. There of its Subsidiaries is no outstanding Order of any Governmental Entity against Seller (i) that relates to the Business, a Product or any Purchased Asset, (ii) that could reasonably be expected to be materially adverse to the Business, any Product or any Purchased Asset, or (iii) that could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreement.
(c) There is no Action pending or, to the Knowledge of Sellerthe Company, threatened against Seller by in writing, nor, to the Knowledge of the Company, has any Governmental EntityAuthority indicated in writing an intention to conduct the same which, in each case, would reasonably be expected to have a Company Material Adverse Effect.
(b) Each of the Company and its Subsidiaries holds all material Permits from the U.S. Food and Drug Administration (the “FDA”) and any other Governmental Authority that is concerned with the quality, identity, strength, purity, safety, efficacy, or manufacturing of Company product candidates (any such Governmental Authority, a “Company Regulatory Agency”), necessary for the operating of the Company’s business in material compliance with applicable Laws (the “Company Permits”), including all Company Permits required under the Federal Food, Drug and Cosmetic Act of 1938, as amended, and there the regulations of the FDA promulgated thereunder (the “FDCA”), the Public Health Service Act of 1944, as amended, and the regulations of the FDA promulgated thereunder (the “PHSA”), and any comparable Laws of other applicable jurisdictions. Except as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, all such Company Permits are valid, and in full force and effect. There has not occurred any violation of, default (with or without notice or lapse of time or both) under, or event giving to others any right of termination, amendment or cancellation of, with or without notice or lapse of time or both, any Company Permit except as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. Each of the Company and its Subsidiaries is in compliance in all material respects with the terms of all Company Permits, and no event has occurred that, to the Knowledge of the Company, would reasonably be expected to result in the revocation, cancellation, non-renewal or adverse modification of any Company Permit, except as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(c) None of the Company or its Subsidiaries nor, to the Knowledge of the Company, any employee or agent thereof, has made any untrue statement of material fact or a fraudulent statement to the FDA or any other Company Regulatory Agency, or failed to disclose a material fact required to be disclosed to the FDA or other such Company Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case related to the Company products candidates, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” as set forth in 56 Fed. Reg. 46191 (Sept. 10, 1991) and any amendments thereto. None of the Company nor, to the Knowledge of the Company, any director, officer, employee or agent thereof, has engaged in any activity prohibited under U.S. federal or state criminal or civil health care Laws, including the U.S. federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), the False Claims Act (31 U.S.C. §§ 3729 et seq.), the Health Insurance Portability and Accountability Act (42 U.S.C. § 1320d et seq.), as amended by the Health Information, Technology for Economic and Clinical Health Act of 2009, the civil monetary penalty laws (42 U.S.C. § 1320a-7a), the FDCA, the PHSA, the regulations promulgated pursuant to such Laws, and any equivalent applicable Laws of other jurisdictions (each, a “Health Care Law”). There is no claimcivil, investigation criminal, administrative or administrative action of any Governmental Entity pending other proceeding, notice or demand pending, received, or, to the Knowledge of Sellerthe Company, threatenedthreatened in writing against the Company that asserts an alleged violation, that affects orin any material respect, if successfulof any Health Care Law. None of the Company or its Subsidiaries or their employees or agents, could reasonably be expected has, under any Health Care Law, been debarred, excluded, suspended, or otherwise determined to be materially adverse ineligible to Sellerparticipate in any health care programs of any Governmental Authority, convicted of any crime, or to the Business, a Product, any Purchased Assets or the Assumed Liabilities or that, if successful, could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller Knowledge of the transactions contemplated Company, engaged in any conduct that has resulted in any such debarment, exclusion, suspension, ineligibility, or conviction, including any debarment mandated by this Agreement, nor 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law. The Company and its Subsidiaries are therenot party to any consent decrees (including plea agreements) or similar actions to which the Company or, to the Knowledge of Sellerthe Company, any factsdirector, circumstances officer, employee or conditions on agent thereof, are bound or which any such Action could be brought in the futurerelate to Company product candidates.
(d) Except as set forth in Each of the Seller Disclosure Schedule, Seller Company and its Affiliates have timely filed Subsidiaries is in compliance in all material reportsrespects with all applicable Laws enforced by, statementsand Orders of, documents, registrations, filings, amendments, supplements the FDA and submissions required to be filed by it any other Company Regulatory Agency with respect to any Product the labeling, storing, testing, development, manufacture, packaging and the Purchased Assets under applicable Regulatory Laws. Each such filing was, in all material respects, true, complete and correct as distribution of the date of submission, and any necessary or Company product candidates. All required updates, changes, corrections, amendments, supplements or modifications to such filings have been submitted to the applicable Governmental Entity.
(e) Except for notice of the Clinical Hold, neither Seller nor any Affiliate has, with respect to any Product or any Purchased Asset, (i) received or been subject to any action, notice, warning, administrative proceeding, review or investigation by a Regulatory Authority that alleges or asserts that Seller or any Affiliate has violated any applicable Regulatory Laws or (ii) been subject to a corporate integrity agreement, deferred prosecution agreement, consent decree, monitoring agreement, settlement agreement or other similar agreement or Order mandating or prohibiting future or past activities.
(f) Except as set forth on Schedule 4.9(f), the Manufacturing and servicing operations pre-clinical toxicology studies conducted by or on behalf of Seller the Company, and all clinical trials sponsored by the Company or any of its Affiliates with respect to any Product Subsidiaries are being conducted in compliance in all material compliance respects with applicable Regulatory Company Permits and applicable Laws, including the applicable current good manufacturing practice requirements of the FDCA and the regulations of the FDA promulgated thereunder, including any applicable requirements of 21 C.F.R. Parts 50, 54, 56, 58, 210, 211, and similar federal, state, local or foreign requirements for the Manufacture 312. The material results of any Product.
(g) Neither Sellersuch studies, nor any Affiliatetests and trials, nor any officerand all other material information related to such studies, employee or agent of Seller or of any Affiliatetests and trials, in each case who has have been materially involved in the Exploitation of any Product (i) has been convicted of any crime or engaged in any conduct in the operation of Seller’s business for which debarment is mandated or authorized made available to Parent. Each clinical trial conducted by 21 U.S.C. § 335a or any similar applicable Law, nor has any such Person been so debarred; (ii) has been convicted of any crime or engaged in any conduct which would reasonably be expected to cause Seller to be excluded from participating in federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar applicable Law, nor has any such Person been so excluded; or (iii) to the Knowledge of Seller, is subject to an investigation or proceeding by any Regulatory Authority that could result in such a suspension, exclusion or debarment and there are no factsor, to the Knowledge of Sellerthe Company, on behalf of the Company or any of its Subsidiaries with respect to Company product candidates has been conducted in compliance in all material respects with all applicable Laws, including FDCA and the regulations of the FDA promulgated thereunder, including any applicable requirements of 21 C.F.R. Parts 50, 54, 56, 58, 210, 211 and 312. The Company has filed with applicable Company Regulatory Agencies all material notices required to be filed (and made available to Parent copies thereof) of adverse drug experiences, injuries or deaths relating to clinical trials conducted by or on behalf of the Company or any of its Subsidiaries with respect to the Company product candidates.
(e) The Company and its Subsidiaries have not received any written notice that the FDA or any other Company Regulatory Agency has initiated, or threatened in writing to initiate, any action to suspend any clinical trial, suspend or terminate any Investigational New Drug Application or similar Health Care Permit sponsored by the Company or any of its Subsidiaries, or otherwise materially restrict the pre-clinical research or clinical study of any Company product candidate or any drug product being developed by or on behalf of the Company or any of its Subsidiaries, or to recall, suspend or otherwise materially restrict the development or manufacture of any Company product candidate, except as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. To the Knowledge of the Company, there is no act, omission, event or circumstance that would reasonably be expected to give rise to any such suspension, exclusion action or debarmentevent.
(hf) Neither Seller nor With respect to the Company’s business, the Company has made available to Parent for review copies of any Affiliate hasand all material regulatory applications and submissions (and any supplements or amendments thereto) under applicable Health Care Laws; Company Permits; written notices of inspectional observations and establishment inspection reports of Company Regulatory Agencies; notifications, in connection communications, correspondence, registrations, master files, and/or other filings made to, received from or otherwise conducted with a Company Regulatory Agency, reports or other documents of the Company or any of its Exploitation Subsidiaries that assert or address lack of a Product, conducted any business or engaged in any transaction or dealing material compliance with any Person Health Care Laws, or the likelihood or timing of marketing approval of any Company product candidates; records and other materials maintained to comply with whom transactions wereapplicable Health Care Laws (e.g., at the time of such transactionregarding good laboratory practice, prohibited as good clinical practice, and good manufacturing practice); and records that are necessary or advisable in order to U.S. Persons by any applicable sanctions Laws administered by the U.S. Treasury Department’s Office of Foreign Assets Control (“OFAC”)obtain Company Permits or other approvals from Company Regulatory Agencies. Such books and records are complete and correct in all material respects and have been maintained in accordance with sound business practices, including persons appearing on the List maintenance of Specially Designated Nationals and Blocked Persons published by OFACan adequate system of internal controls.
Appears in 2 contracts
Samples: Merger Agreement (MYnd Analytics, Inc.), Merger Agreement (Emmaus Life Sciences, Inc.)
Compliance with Laws; Regulatory Compliance. (a) The Exploitation by Seller Each of Leap and its Affiliates of any Product and the ownership by Seller and its Affiliates of the Purchased Assets have been, at all times, in material compliance with all applicable Law, including applicable Regulatory Laws. Except as set forth in Seller’s Disclosure Schedule, neither Seller nor any Affiliate has received any written communication from a Governmental Entity that alleges that Seller or any Affiliate Subsidiaries is not in compliance in all material respects, with all Laws. No investigation or review by any material respect with any Law or Order Governmental Entity with respect to its Exploitation of any Product or with respect to ownership of the Purchased Assets, respectively and as applicable. Seller and its Affiliates have, and have had, all Product Registrations necessary for its lawful Exploitation of any Product prior to the Closing Date, and each of such Product Registrations, if any, is valid and in full force and effect.
(b) Except as set forth in the Seller Disclosure Schedule, there has not been any claim of which Seller Leap or any Affiliate has received notice of any Action pending or threatened against Seller or an Affiliate relating to any Product or the Purchased Assets. To the Knowledge of Seller, there its Subsidiaries is no fact or circumstance that would reasonably be expected to serve as a basis for any Action against Seller or any Affiliate relating to any Product or any Purchased Assets or that, if successful, could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreement. There is no Action pending by Seller or any Affiliate, or which Seller intends to initiate against any Third Party relating to any Product or any Purchased Asset. There is no outstanding Order of any Governmental Entity against Seller (i) that relates to the Business, a Product or any Purchased Asset, (ii) that could reasonably be expected to be materially adverse to the Business, any Product or any Purchased Asset, or (iii) that could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreement.
(c) There is no Action pending or, to the Knowledge of SellerLeap, threatened against Seller by threatened, nor has any Governmental Entity indicated an intention to conduct the same.
(b) Each of Leap and its Subsidiaries and their respective employees and agents hold all permits, certificates, licenses, variances, registrations, exemptions, orders, consents and approvals from the U.S. Food and Drug Administration (the “FDA”) and any other Governmental Entity that is concerned with the quality, identity, strength, purity, safety, efficacy or manufacturing of Leap Products (any such Governmental Entity, a “Leap Regulatory Agency”) necessary for the lawful operation of the businesses of Leap and there each of its Subsidiaries as currently conducted (the “Leap Permits”), including all authorizations required under the Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”) and the regulations of the FDA promulgated thereunder, and the Public Health Service Act of 1944, as amended (the “PHSA”). Notwithstanding the foregoing, it is acknowledged that no Leap Product is a marketed product or has received marketing approval and, therefore, that further permits, licenses, variances, registrations, exemptions, orders, consents and/or approvals will be required before any Leap Product may be marketed. Section 3.20(b) of the Leap Disclosure Letter sets forth a list of all Leap Permits as of the date of this Agreement. All such Leap Permits are valid, and in full force and effect. There has not occurred any violation of, default (with or without notice or lapse of time or both) under, or event giving to others any right of termination, amendment or cancellation of, with or without notice or lapse of time or both, any Leap Permit. Each of Leap and each of its Subsidiaries is in compliance in all material respects with the terms of all Leap Permits, and no event has occurred that, would reasonably be expected to result in the revocation, cancellation, non-renewal or adverse modification of any Leap Permit.
(c) None of Leap or its Subsidiaries nor, to the Knowledge of Leap, any director, officer, employee, agent or Representative thereof, has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” as set forth in 56 Fed. Reg. 46191 (Sept. 10, 1991) and any amendments thereto, or for any other Leap Regulatory Agency to invoke a similar policy. None of Leap or its Subsidiaries nor, to the Knowledge of Leap, any director, officer, employee, agent or Representative thereof, has engaged in any activity prohibited under U.S. federal or state criminal or civil health care Laws (including without limitation the U.S. federal Anti-Kickback Statute, Sxxxx Law, False Claims Act, Health Insurance Portability and Accountability Act, in each case, as amended, and any comparable state Laws), or the regulations promulgated pursuant to such Laws (each, a “Health Care Law”). There is no claimcivil, investigation criminal, administrative or administrative action of any Governmental Entity pending other proceeding, notice or demand pending, received or, to the Knowledge of SellerLeap, threatened, threatened against Leap or any of its Subsidiaries that affects or, if successful, could reasonably be expected relates to be materially adverse to Seller, the Business, a Product, an alleged violation of any Purchased Assets Health Care Law. None of Leap or the Assumed Liabilities or that, if successful, could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller any of the transactions contemplated by this Agreement, nor are thereits Subsidiaries nor, to the Knowledge of SellerLeap, any factsdirector, circumstances or conditions on which any such Action could be brought in the future.
(d) Except as set forth in the Seller Disclosure Schedule, Seller and its Affiliates have timely filed all material reports, statements, documents, registrations, filings, amendments, supplements and submissions required to be filed by it with respect to any Product and the Purchased Assets under applicable Regulatory Laws. Each such filing was, in all material respects, true, complete and correct as of the date of submission, and any necessary or required updates, changes, corrections, amendments, supplements or modifications to such filings have been submitted to the applicable Governmental Entity.
(e) Except for notice of the Clinical Hold, neither Seller nor any Affiliate has, with respect to any Product or any Purchased Asset, (i) received or been subject to any action, notice, warning, administrative proceeding, review or investigation by a Regulatory Authority that alleges or asserts that Seller or any Affiliate has violated any applicable Regulatory Laws or (ii) been subject to a corporate integrity agreement, deferred prosecution agreement, consent decree, monitoring agreement, settlement agreement or other similar agreement or Order mandating or prohibiting future or past activities.
(f) Except as set forth on Schedule 4.9(f), the Manufacturing and servicing operations conducted by or on behalf of Seller and its Affiliates with respect to any Product are conducted in material compliance with applicable Regulatory Laws, including applicable current good manufacturing practice regulations and similar federal, state, local or foreign requirements for the Manufacture of any Product.
(g) Neither Seller, nor any Affiliate, nor any officer, employee employee, agent, subcontractor or agent of Seller or of any AffiliateRepresentative thereof, in each case who has been materially involved in the Exploitation of any Product (i) has been convicted of any crime or engaged in any conduct in the operation of Seller’s business for which debarment is or exclusion mandated by 21 U.S.C. sec. 335a(a), 42 U.S.C. sec. 1320a-7(a) or any similar Law, or authorized by 21 U.S.C. § 335a sec. 335a(b), 42 U.S.C. sec. 1320a-7(b) or any similar applicable Law, nor has any such Person been so debarred; (ii) has been convicted of any crime or engaged in any conduct which would reasonably be expected to cause Seller to be excluded from participating in federal health care programs under Section 1128 of the Social Security Act of 1935, as amendedexclusion, or any similar disqualification under applicable Law, nor has any such Person been so excluded; or (iii) to the Knowledge of Seller, is subject to an investigation or proceeding by any Regulatory Authority that could result in such a suspension, exclusion or debarment and there law. There are no factsconsent decrees (including plea agreements) or similar actions to which Leap or any of its Subsidiaries or, to the Knowledge of SellerLeap, any director, officer, employee, agent or Representative thereof, are bound or which relate to Leap Products.
(d) Each of Leap and its Subsidiaries is and has been in compliance in all material respects with all applicable statutes, rules, regulations, decrees, writs and orders of the FDA and any other Leap Regulatory Agency with respect to the labeling, storing, testing, development, manufacture, packaging and distribution of Leap Products. All required pre-clinical studies conducted by or on behalf of Leap or its Subsidiaries (and clinical trials sponsored by Leap or any other Subsidiary) conducted or being conducted with respect thereto, have been and are being conducted in compliance in all material respects with applicable licenses and Laws, including, without limitation, the applicable requirements of the FDA’s current Good Manufacturing Practices, Good Laboratory Practices and Good Clinical Practices, Informed Consent requirements, other applicable requirements contained in 21 CFR Parts 312, 50, 54, 56 and 11, and any applicable clinical trial protocol. The results of any such studies, tests and trials, and all other material information related to such studies, tests and trials, have been made available to M-CO. Each of Leap and its Subsidiaries has filed all required notices (and made available to M-CO copies thereof) of adverse drug experiences, injuries or deaths relating to clinical trials conducted by or on behalf of Leap or any of its Subsidiaries with respect to such Leap Products.
(e) There are no proceedings pending or, to Leap’s Knowledge, threatened with respect to a violation or alleged violation by Leap or any of its Subsidiaries of any rules and regulations of any applicable governmental authorities or regulatory bodies (including without limitation, the FDCA, FDA regulations adopted thereunder, the Controlled Substance Act or any other legislation or regulation promulgated by any other Leap Regulatory Agency). All applications, submissions, information and data utilized by any Leap or any of its Subsidiaries as the basis for, or submitted by or on behalf of Leap or any of its Subsidiaries in connection with any and all requests for a Leap Permit relating to Leap or any of its Subsidiaries, when submitted to the FDA or other Leap Regulatory Agency, were true, correct and complete in all material respects as of the date of submission, and any updates, changes, corrections or modification to such applications, submissions, information and data required under applicable Laws have been submitted to the FDA or other Leap Regulatory Agency. To the Knowledge of Leap, no data generated by Leap or any of its Subsidiaries with respect to Leap Products is the subject of any action, either pending or threatened, by any Leap Regulatory Agency relating to the truthfulness or scientific adequacy of such data.
(f) None of Leap or its Subsidiaries nor, to the Knowledge of Leap, any of the Representatives, licensors, licensees, assignors or assignees thereof has received any notice that the FDA or any other Leap Regulatory Agency or clinical investigator has initiated, or threatened to initiate, any action to suspend any clinical trial, suspend or terminate any Investigational New Drug Application sponsored by Leap or any of its Subsidiaries or otherwise restrict the pre-clinical research or clinical study of any Leap Product or any drug product being developed by any licensee or assignee of Leap Intellectual Property based on such intellectual property, or to recall, suspend or otherwise restrict the development or manufacture of any Leap Product. None of Leap or any of its Subsidiaries is in receipt of written notice of, or is subject to, any adverse inspection, finding of deficiency, finding of non-compliance, investigation, civil or criminal proceeding, hearing, suit, demand, claim, complaint, inquiry, proceeding, or other compliance or enforcement action relating to any Leap Products, including with respect to their development, manufacturing, labeling, storing, or testing, from any Governmental Entity, Leap Regulatory Agency or other third party. To the Knowledge of Leap, there is no act, omission, event or circumstance that would reasonably be expected to give rise to any such suspension, exclusion or debarmentaction.
(hg) Neither Seller nor Leap and its Subsidiaries have made available to M-CO true, correct and complete copies of any Affiliate hasand all applications, in connection approvals, licenses, written notices of inspectional observations, establishment inspection reports and any other documents received from the FDA or other Leap Regulatory Agency, including documents that indicate or suggest lack of compliance with the regulatory requirements of the FDA or other Leap Regulatory Agency. Leap and its Exploitation Subsidiaries have made available to M-CO for review all material correspondence to or from the FDA or other Leap Regulatory Agency, minutes of a Productmeetings, conducted any business written reports of phone conversations, visits or engaged other contact with the FDA or other Leap Regulatory Agency, and all other documents concerning communications to or from the FDA or other Leap Regulatory Agency, or prepared by the FDA or other Leap Regulatory Agency or which bear in any transaction way on Leap’s or dealing any of its Subsidiaries’ compliance with regulatory requirements of the FDA or any Person with whom transactions wereother Leap Regulatory Agency, at the time of such transaction, prohibited as to U.S. Persons by any applicable sanctions Laws administered by the U.S. Treasury Department’s Office of Foreign Assets Control (“OFAC”), including persons appearing or on the List likelihood or timing of Specially Designated Nationals and Blocked Persons published by OFACapproval of any Leap Products.
Appears in 1 contract
Samples: Merger Agreement (Macrocure Ltd.)
Compliance with Laws; Regulatory Compliance. (a) The Exploitation by Seller Each of the Company and its Affiliates of any Product and the ownership by Seller and its Affiliates of the Purchased Assets have been, at all times, Subsidiaries is in material compliance with all applicable LawLaws or Orders, including applicable Regulatory Laws. Except as set forth in Seller’s Disclosure Schedule, neither Seller nor except where any Affiliate has received any written communication from a Governmental Entity that alleges that Seller or any Affiliate is not such failure to be in compliance has not had, or would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. To the Knowledge of Company and its Subsidiaries, (i) no investigation by any material respect with any Law or Order Governmental Authority with respect to the Company or any of its Exploitation of any Product or with respect to ownership of the Purchased Assets, respectively Subsidiaries is active and as applicable. Seller and its Affiliates havepending, and (ii) no Governmental Authority has indicated in writing an intention to conduct an investigation which, in either case, would reasonably be expected to have had, all Product Registrations necessary for a material and adverse impact on the Company or any of its lawful Exploitation of any Product prior to the Closing Date, and each of such Product Registrations, if any, is valid and in full force and effectSubsidiaries.
(b) Except as set forth has not had, and would not reasonably be expected to have, individually or in the Seller Disclosure Scheduleaggregate, a Company Material Adverse Effect, each of the Company and its Subsidiaries and their respective employees and agents hold, to the Knowledge of Company, all permits, licenses, variances, registrations, exemptions, Orders, consents, authorizations and approvals from the U.S. Food and Drug Administration (the “FDA”) and any other Governmental Authority that is concerned with the quality, identity, strength, purity, safety, efficacy or Manufacturing of any of the products or services produced, marketed, licensed, sold, distributed or performed by or on behalf of the Company or any Subsidiary and all products or services currently under development by the Company or any Subsidiary (the “Company Products”) (any such Governmental Authority, a “Company Regulatory Agency”) necessary for the lawful operating of the businesses of the Company and each of its Subsidiaries as currently conducted (the “Company Permits”), including all authorizations required under the Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), and the Public Health Service Act of 1944, as amended (“PHSA”), and the regulations of the FDA promulgated thereunder. Notwithstanding the foregoing, it is acknowledged that no Company Product is a marketed product or has received marketing approval and, therefore, that further permits, licenses, variances, registrations, exemptions, Orders, consents, authorizations and/or approvals will be required before any Company Product may be marketed. Except as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, all such Company Permits are valid, and in full force and effect. Since January 1, 2016, there has not been occurred any claim violation of, default (with or without notice or lapse of which Seller time or both) under, or event giving to others any Affiliate right of termination, amendment or cancellation of, with or without notice or lapse of time or both, any Company Permit except as has received notice not had, and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. Each of any Action pending or threatened against Seller or an Affiliate relating the Company and each of its Subsidiaries is in compliance in all material respects with the terms of all Company Permits. No event has occurred that, to any Product or the Purchased Assets. To the Knowledge of Sellerthe Company, there is no fact would reasonably be expected to result in the revocation, cancellation, non-renewal or circumstance adverse modification of any Company Permit, except as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(c) None of the Company or its Subsidiaries nor, to the Knowledge of the Company, any director, officer, employee, agent or Representative thereof, has committed any act, made any statement or failed to make any statement that would reasonably be expected to serve as provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” as set forth in 56 Fed. Reg. 46191 (Sept. 10, 1991) and any Action against Seller amendments thereto, or a similar policy enforced by any Affiliate relating other Company Regulatory Agency. None of the Company or its Subsidiaries nor, to the Knowledge of the Company, any Product director, officer, employee, agent or Representative thereof, has engaged in any Purchased Assets or that, if successful, could reasonably be expected to activity that would result in restraininga material violation under applicable U.S. federal or state criminal or civil health care Laws (including without limitation the U.S. federal Anti-Kickback Statute, enjoining Xxxxx Law, False Claims Act, Health Insurance Portability and Accountability Act (“HIPAA”), and any comparable state Laws), or otherwise preventing the completion by Seller of the transactions contemplated by this Agreementregulations promulgated pursuant to such Laws (each, a “Health Care Law”). There is no Action pending by Seller civil, criminal, administrative or any Affiliateother proceeding, notice or which Seller intends to initiate against any Third Party relating to any Product or any Purchased Asset. There is no outstanding Order of any Governmental Entity against Seller (i) that relates to the Businessdemand pending, a Product or any Purchased Asset, (ii) that could reasonably be expected to be materially adverse to the Business, any Product or any Purchased Asset, or (iii) that could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreement.
(c) There is no Action pending received or, to the Knowledge of Sellerthe Company, threatened against Seller by the Company or any Governmental Entity, and there is no claim, investigation or administrative action of its Subsidiaries that relates to an alleged violation of any Governmental Entity pending orHealth Care Law. None of the Company or any of its Subsidiaries nor, to the Knowledge of Seller, threatened, that affects or, if successful, could reasonably be expected to be materially adverse to Seller, the Business, a ProductCompany, any Purchased Assets or the Assumed Liabilities or thatdirector, if successful, could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreement, nor are there, to the Knowledge of Seller, any facts, circumstances or conditions on which any such Action could be brought in the future.
(d) Except as set forth in the Seller Disclosure Schedule, Seller and its Affiliates have timely filed all material reports, statements, documents, registrations, filings, amendments, supplements and submissions required to be filed by it with respect to any Product and the Purchased Assets under applicable Regulatory Laws. Each such filing was, in all material respects, true, complete and correct as of the date of submission, and any necessary or required updates, changes, corrections, amendments, supplements or modifications to such filings have been submitted to the applicable Governmental Entity.
(e) Except for notice of the Clinical Hold, neither Seller nor any Affiliate has, with respect to any Product or any Purchased Asset, (i) received or been subject to any action, notice, warning, administrative proceeding, review or investigation by a Regulatory Authority that alleges or asserts that Seller or any Affiliate has violated any applicable Regulatory Laws or (ii) been subject to a corporate integrity agreement, deferred prosecution agreement, consent decree, monitoring agreement, settlement agreement or other similar agreement or Order mandating or prohibiting future or past activities.
(f) Except as set forth on Schedule 4.9(f), the Manufacturing and servicing operations conducted by or on behalf of Seller and its Affiliates with respect to any Product are conducted in material compliance with applicable Regulatory Laws, including applicable current good manufacturing practice regulations and similar federal, state, local or foreign requirements for the Manufacture of any Product.
(g) Neither Seller, nor any Affiliate, nor any officer, employee employee, agent or agent of Seller or of any AffiliateRepresentative thereof, in each case who has been materially involved in the Exploitation of any Product (i) has been convicted of any crime or engaged in any conduct in the operation of Seller’s business for which debarment is mandated by 21 U.S.C. sec. 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a sec. 335a(b) or any similar applicable Law, nor has any such Person been so debarred; (ii) has been convicted of any crime or engaged in any conduct which would reasonably be expected to cause Seller to be excluded from participating in federal health care programs under Section 1128 . None of the Social Security Act of 1935, as amended, Company or any similar applicable Law, nor has any such Person been so excluded; or (iii) to the Knowledge of Seller, is subject to an investigation or proceeding by any Regulatory Authority that could result in such a suspension, exclusion or debarment and there are no factsits Subsidiaries nor, to the Knowledge of Sellerthe Company, any director, officer, employee, agent or Representative thereof: (i) has ever been excluded, suspended, sanctioned or otherwise declared ineligible to participate in any federal health care program under 42 CFR § 1001.601, or any similar Law, nor is any such exclusion, suspension or other sanction threatened; or (ii) has ever been convicted of a criminal offense related to the provision of health care items or services. There are no Orders or similar actions to which the Company or any of its Subsidiaries or, to the Knowledge of the Company, any director, officer, employee, agent or Representative thereof, are bound or which relate to Company Products, or alleged violation of any Health Care Law.
(d) Each of the Company and its Subsidiaries is and has been in compliance in all material respects with all applicable statutes, rules, regulations, decrees, writs and orders of the FDA and any other Company Regulatory Agency with respect to the labeling, storing, testing, development, manufacture, packaging, distribution and promotion of the Company Products. To the Knowledge of the Company, all required pre-clinical toxicology studies conducted by or on behalf of the Company or its Subsidiaries and Company-sponsored clinical trials (or clinical trials sponsored by the Company or any other Subsidiary) conducted or being conducted with respect thereto, have been and are being conducted in compliance in all material respects with applicable licenses and Laws, including, without limitation, the applicable requirements of the FDA’s current Good Manufacturing Practice, Good Laboratory Practice and Good Clinical Practice. The results of any such studies, tests and trials, and all other material information related to such studies, tests and trials, have been made available to Orion. To the Knowledge of the Company, each clinical trial conducted by or on behalf of the Company or any of its Subsidiaries with respect to Company Products has been and is being conducted in accordance with its clinical trial protocol, and in compliance in all material respects with all applicable Laws, including Good Clinical Practice, informed consent and all other applicable requirements contained in 21 CFR Parts 312, 50, 54, 56 and 11. Each of the Company and its Subsidiaries has filed all required notices (and made available to Orion copies thereof) of adverse drug experiences, injuries or deaths arising from clinical trials conducted by or on behalf of the Company or any of its Subsidiaries with respect to such Company Products.
(e) All applications, submissions, information and data utilized by any the Company or any of its Subsidiaries as the basis for, or submitted by or on behalf of the Company or any of its Subsidiaries in connection with any and all requests for a Company Permit relating to the Company or any of its Subsidiaries, when submitted to the FDA or any other Company Regulatory Agency, were true, correct and complete in all material respects as of the date of submission, and any updates, changes, corrections or modification to such applications, submissions, information and data required under applicable Laws have been submitted to the FDA or any other Company Regulatory Agency.
(f) None of the Company or its Subsidiaries nor, to the Knowledge of the Company, any of the Representatives, licensors, licensees, assignors or assignees thereof has received any notice that the FDA or any other Company Regulatory Agency has initiated, or threatened to initiate, any Action to suspend or place restrictions on any clinical trial, suspend or terminate any Investigational New Drug Application or comparable Clinical Trial Application sponsored by the Company or any of its Subsidiaries or otherwise restrict the pre-clinical research related to or clinical study of any Company Product or any drug product being developed by any licensee or assignee of the Company Intellectual Property based on such intellectual property, or to recall, suspend or otherwise restrict the development or manufacture of any Company Product. None of the Company or any of its Subsidiaries is in receipt of written notice of, or is subject to, any adverse inspection, finding of deficiency, finding of non-compliance, investigation, civil or criminal proceeding, hearing, suit, demand, claim, complaint, inquiry, proceeding, or other compliance or enforcement action relating to any Company Products. To the Knowledge of the Company, there is no act, omission, event or circumstance that would reasonably be expected to give rise to any such suspensionaction.
(g) The Company and each of its Subsidiaries are, exclusion and have been for the past six (6) years, in compliance with the requirements of: (i) all applicable privacy and security Laws governing health information; and (ii) all contractual obligations concerning the collection, use, storage and disclosure of health information. To the Knowledge of the Company there has been no unauthorized use, access, modification or debarmentdisclosure of health information, including any Breach of “Unsecured Protected Health Information,” as those terms are defined by HIPAA, by the Company, any of its Subsidiaries, or any of their respective clinical trial sites. The Company and each of its Subsidiaries is not now, and has never been, subject to HIPAA and is not a party to any business associate agreement, as defined by HIPAA.
(h) Neither Seller nor The Company and its Subsidiaries have made available to Orion true, correct and complete copies of any Affiliate hasand all material applications, in connection approvals, licenses, written notices of inspectional observations, establishment inspection reports and any other documents received from the FDA or any other Company Regulatory Agency, including documents that indicate or suggest lack of compliance with the regulatory requirements of the FDA or any other Company Regulatory Agency. The Company and its Exploitation Subsidiaries have made available to Orion for review all material correspondence to or from the FDA or any other Company Regulatory Agency, minutes of a Productmeetings, conducted written reports of phone conversations, visits or other contact with the FDA or any business other Company Regulatory Agency, notices of inspectional observations, establishment inspection reports, and all other documents concerning communications to or engaged from the FDA or any other Company Regulatory Agency, or prepared by the FDA or any other Company Regulatory Agency or which bear in any transaction or dealing with any Person with whom transactions were, at the time of such transaction, prohibited as to U.S. Persons by any applicable sanctions Laws administered by the U.S. Treasury Department’s Office of Foreign Assets Control (“OFAC”), including persons appearing way on the List Company’s or any of Specially Designated Nationals and Blocked Persons published by OFACits Subsidiaries’ compliance with regulatory requirements of the FDA or any other Company Regulatory Agency, or on the likelihood or timing of approval of any Company Products.
Appears in 1 contract
Samples: Merger Agreement (OvaScience, Inc.)
Compliance with Laws; Regulatory Compliance. (a) The Exploitation by Seller Each of CGI and its Affiliates of any Product and the ownership by Seller and its Affiliates of the Purchased Assets have been, at all times, in material compliance with all applicable Law, including applicable Regulatory Laws. Except as set forth in Seller’s Disclosure Schedule, neither Seller nor any Affiliate has received any written communication from a Governmental Entity that alleges that Seller or any Affiliate Subsidiaries is not in compliance in all material respects, with all Laws. No investigation or review by any material respect with any Law or Order Governmental Entity with respect to its Exploitation of any Product or with respect to ownership of the Purchased Assets, respectively and as applicable. Seller and its Affiliates have, and have had, all Product Registrations necessary for its lawful Exploitation of any Product prior to the Closing Date, and each of such Product Registrations, if any, is valid and in full force and effect.
(b) Except as set forth in the Seller Disclosure Schedule, there has not been any claim of which Seller CGI or any Affiliate has received notice of any Action pending or threatened against Seller or an Affiliate relating to any Product or the Purchased Assets. To the Knowledge of Seller, there its Subsidiaries is no fact or circumstance that would reasonably be expected to serve as a basis for any Action against Seller or any Affiliate relating to any Product or any Purchased Assets or that, if successful, could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreement. There is no Action pending by Seller or any Affiliate, or which Seller intends to initiate against any Third Party relating to any Product or any Purchased Asset. There is no outstanding Order of any Governmental Entity against Seller (i) that relates to the Business, a Product or any Purchased Asset, (ii) that could reasonably be expected to be materially adverse to the Business, any Product or any Purchased Asset, or (iii) that could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreement.
(c) There is no Action pending or, to the Knowledge of SellerCGI, threatened against Seller by threatened, nor has any Governmental Entity indicated an intention to conduct the same.
(b) Each of CGI and its Subsidiaries and their respective employees and agents hold all permits, certificates, licenses, variances, registrations, exemptions, orders, consents and approvals from the U.S. Food and Drug Administration (the “FDA”) and any other Governmental Entity that is concerned with the quality, identity, strength, purity, safety, efficacy or manufacturing of CGI products (any such Governmental Entity, a “CGI Regulatory Agency”) necessary for the lawful operation of the businesses of CGI and there each of its Subsidiaries as currently conducted (the “CGI Permits”), including all authorizations required under the Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”) and the regulations of the FDA promulgated thereunder, and the Public Health Service Act of 1944, as amended (the “PHSA”). Section 3.21(b) of the CGI Disclosure Letter sets forth a list of all material CGI Permits as of the date of this Agreement. All such CGI Permits are valid, and in full force and effect. There has not occurred any material violation of, default (with or without notice or lapse of time or both) under, or event giving to others any right of termination, amendment or cancellation of, with or without notice or lapse of time or both, under any CGI Permit. Each of CGI and each of its Subsidiaries is in compliance in all material respects with the terms of all CGI Permits, and no event has occurred that, would reasonably be expected to result in the revocation, cancellation, non-renewal or adverse modification of any CGI Permit.
(c) None of CGI or its Subsidiaries nor, to the Knowledge of CGI, any director, officer, employee, agent or Representative thereof, has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” as set forth in 56 Fed. Reg. 46191 (Sept. 10, 1991) and any amendments thereto, or for any other CGI Regulatory Agency to invoke a similar policy. None of CGI or its Subsidiaries nor, to the Knowledge of CGI, any director, officer, employee, agent or Representative thereof, has engaged in any activity prohibited under U.S. federal or state criminal or civil health care Laws (including without limitation the U.S. federal Anti-Kickback Statute, Sxxxx Law, False Claims Act, Health Insurance Portability and Accountability Act, in each case, as amended, and any comparable state Laws), or the regulations promulgated pursuant to such Laws (each, a “Health Care Law”). There is no claimcivil, investigation criminal, administrative or administrative action of any Governmental Entity pending other proceeding, notice or demand pending, received or, to the Knowledge of SellerCGI, threatened, threatened against CGI or any of its Subsidiaries that affects or, if successful, could reasonably be expected relates to be materially adverse to Seller, the Business, a Product, an alleged violation of any Purchased Assets Health Care Law. None of CGI or the Assumed Liabilities or that, if successful, could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller any of the transactions contemplated by this Agreement, nor are thereits Subsidiaries nor, to the Knowledge of SellerCGI, any factsdirector, circumstances or conditions on which any such Action could be brought in the future.
(d) Except as set forth in the Seller Disclosure Schedule, Seller and its Affiliates have timely filed all material reports, statements, documents, registrations, filings, amendments, supplements and submissions required to be filed by it with respect to any Product and the Purchased Assets under applicable Regulatory Laws. Each such filing was, in all material respects, true, complete and correct as of the date of submission, and any necessary or required updates, changes, corrections, amendments, supplements or modifications to such filings have been submitted to the applicable Governmental Entity.
(e) Except for notice of the Clinical Hold, neither Seller nor any Affiliate has, with respect to any Product or any Purchased Asset, (i) received or been subject to any action, notice, warning, administrative proceeding, review or investigation by a Regulatory Authority that alleges or asserts that Seller or any Affiliate has violated any applicable Regulatory Laws or (ii) been subject to a corporate integrity agreement, deferred prosecution agreement, consent decree, monitoring agreement, settlement agreement or other similar agreement or Order mandating or prohibiting future or past activities.
(f) Except as set forth on Schedule 4.9(f), the Manufacturing and servicing operations conducted by or on behalf of Seller and its Affiliates with respect to any Product are conducted in material compliance with applicable Regulatory Laws, including applicable current good manufacturing practice regulations and similar federal, state, local or foreign requirements for the Manufacture of any Product.
(g) Neither Seller, nor any Affiliate, nor any officer, employee employee, agent, subcontractor or agent of Seller or of any AffiliateRepresentative thereof, in each case who has been materially involved in the Exploitation of any Product (i) has been convicted of any crime or engaged in any conduct in the operation of Seller’s business for which debarment is or exclusion mandated by 21 U.S.C. sec. 335a(a), 42 U.S.C. sec. 1320a-7(a) or any similar Law, or authorized by 21 U.S.C. § 335a sec. 335a(b), 42 U.S.C. sec. 1320a-7(b) or any similar Law, or exclusion, or disqualification under applicable Law, nor has any such Person been so debarred; . There are no consent decrees (iiincluding plea agreements) has been convicted of any crime or engaged in any conduct similar actions to which would reasonably be expected to cause Seller to be excluded from participating in federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, CGI or any similar applicable Law, nor has any such Person been so excluded; or (iii) to the Knowledge of Seller, is subject to an investigation or proceeding by any Regulatory Authority that could result in such a suspension, exclusion or debarment and there are no factsits Subsidiaries or, to the Knowledge of SellerCGI, any director, officer, employee, agent or Representative thereof, are bound or which relate to CGI products or services.
(d) To CGI’s Knowledge, each of CGI and its Subsidiaries is and has been in compliance in all material respects with all applicable statutes, rules, regulations, decrees, writs and orders of the FDA and any other CGI Regulatory Agency with respect to the labeling, advertising, storing, testing, development, manufacture, packaging and distribution of CGI products. To CGI’s Knowledge, all pre-clinical and clinical studies conducted by CGI or its Subsidiaries have been and are being conducted in compliance in all material respects with applicable licenses and Laws, including, without limitation, the applicable requirements of the FDA’s current Good Manufacturing Practices, Good Laboratory Practices and Good Clinical Practices, Informed Consent requirements, other applicable requirements contained in 21 CFR Parts 312, 50, 54, 56 and 11, and any applicable clinical trial protocol.
(e) There are no proceedings pending or, to CGI’s Knowledge, threatened with respect to a violation or alleged violation by CGI or any of its Subsidiaries of any rules and regulations of any applicable Governmental Entities or regulatory bodies (including without limitation, the FDCA, FDA regulations adopted thereunder, the Controlled Substance Act or any other legislation or regulation promulgated by any other CGI Regulatory Agency). To CGI’s Knowledge, all applications, submissions, information and data utilized by CGI or any of its Subsidiaries as the basis for, or submitted by or on behalf of CGI or any of its Subsidiaries in connection with any and all requests for a CGI Permit relating to CGI or any of its Subsidiaries, when submitted to the FDA or other CGI Regulatory Agency, were true, correct and complete in all material respects as of the date of submission, and any updates, changes, corrections or modification to such applications, submissions, information and data required under applicable Laws have been submitted to the FDA or other CGI Regulatory Agency. To the Knowledge of CGI, no data generated by CGI or any of its Subsidiaries with respect to CGI products or services is the subject of any action, either pending or threatened, by any CGI Regulatory Agency relating to the truthfulness or scientific adequacy or integrity of such data.
(f) None of CGI or its Subsidiaries nor, to the Knowledge of CGI, any of the Representatives, licensors, licensees, assignors or assignees thereof has received any notice that the FDA or any other CGI Regulatory Agency or third party has initiated, or threatened to initiate, any action to recall, suspend or otherwise restrict the development or manufacture of any CGI product. None of CGI or any of its Subsidiaries is in receipt of written notice of, or is subject to, any adverse inspection, finding of deficiency, finding of non-compliance, investigation, civil or criminal proceeding, hearing, suit, demand, claim, complaint, inquiry, proceeding, or other compliance or enforcement action relating to any CGI products or services, including with respect to their development, manufacturing, labeling, advertising, storing, or testing, from any Governmental Entity, CGI Regulatory Agency or other third party. To the Knowledge of CGI, there is no act, omission, event or circumstance that would reasonably be expected to give rise to any such suspension, exclusion or debarmentaction.
(hg) Neither Seller nor CGI and its Subsidiaries have made available to NDX true, correct and complete copies of any Affiliate hasand all applications, in connection approvals, licenses, written notices of inspectional observations, establishment inspection reports and any other documents received from the FDA or other CGI Regulatory Agency, including documents that indicate or suggest lack of compliance with the regulatory requirements of the FDA or other CGI Regulatory Agency, other than immaterial items that have been corrected. CGI and its Exploitation Subsidiaries have made available to NDX for review all material correspondence to or from the FDA or other CGI Regulatory Agency, minutes of a Productmeetings, conducted any business written reports of phone conversations, visits or engaged other contact with the FDA or other CGI Regulatory Agency, and all other documents concerning communications to or from the FDA or other CGI Regulatory Agency, or prepared by the FDA or other CGI Regulatory Agency or which bear in any transaction way on CGI’s or dealing any of its Subsidiaries’ compliance with regulatory requirements of the FDA or any Person with whom transactions were, at the time of such transaction, prohibited as to U.S. Persons by any applicable sanctions Laws administered by the U.S. Treasury Department’s Office of Foreign Assets Control (“OFAC”), including persons appearing on the List of Specially Designated Nationals and Blocked Persons published by OFACother CGI Regulatory Agency.
Appears in 1 contract
Compliance with Laws; Regulatory Compliance. (a) The Exploitation by Seller Except as set forth in Section 2.12(a) of the Company Disclosure Schedule, each of the Company and its Affiliates of any Product and Subsidiaries and, to the ownership by Seller and its Affiliates Knowledge of the Purchased Assets have beenCompany, at all timesevery director, officer, employee, agent, and Representative thereof, is and has been for the past three (3) years in material compliance with all applicable LawLaws (including, but not limited to, Health Care Laws and all trade laws, including applicable Regulatory Lawsimport control and export laws, trade embargos and anti-boycott laws) and Orders. Except as set forth in Seller’s Disclosure ScheduleTo the Knowledge of the Company and its Subsidiaries, neither Seller nor (i) no investigation by any Affiliate has received any written communication from a Governmental Entity that alleges that Seller or any Affiliate is not in compliance in any material respect with any Law or Order Authority with respect to the Company or any of its Exploitation of any Product or with respect Subsidiaries is active and pending, and (ii) no Governmental Authority has indicated in writing or, to ownership the Knowledge of the Purchased AssetsCompany, respectively and as applicable. Seller and its Affiliates haveorally, and have had, all Product Registrations necessary for its lawful Exploitation of any Product prior an intention to the Closing Date, and each of such Product Registrations, if any, is valid and in full force and effectconduct an investigation.
(b) Except as set forth has not, would not and would not reasonably be expected to, individually or in the Seller Disclosure Scheduleaggregate, have a Company Material Adverse Effect, each of the Company and its Subsidiaries and, to the Knowledge of the Company, their respective employees and agents, hold all Company Permits, including, but not limited to, all authorizations required under the FDCA, and the regulations of the FDA promulgated thereunder as well as the Public Health Service Act of 1944, as amended (“PHSA”). Except as has not, would not and would not reasonably be expected to, individually or in the aggregate, have a Company Material Adverse Effect, all such Company Permits are valid, and in full force and effect. Since January 1, 2016, there has not been occurred any claim violation of, default (with or without notice or lapse of which Seller time or both) under, or event giving to others any Affiliate right of termination, amendment or cancellation of, with or without notice or lapse of time or both, any Company Permit except as has received notice not, would not and would not reasonably be expected to, individually or in the aggregate, have a Company Material Adverse Effect. Each of any Action pending or threatened against Seller or an Affiliate relating to any Product or the Purchased AssetsCompany and each of its Subsidiaries is in compliance in all material respects with the requirements associated with all Company Permits. To the Knowledge of Seller, there is no fact or circumstance No event has occurred that would reasonably be expected to serve result in the revocation, cancellation, non-renewal or adverse modification of any Company Permit. Table of Contents
(c) Except as a basis for set forth in Section 2.12(c) of the Company Disclosure Schedule, none of the Company or its Subsidiaries, any Action against Seller director, officer, employee nor, to the Knowledge of the Company, agent or Representative thereof, has committed any Affiliate relating act, made any statement or failed to make any Product or any Purchased Assets or that, if successful, could statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” as set forth in 56 Fed. Reg. 46191 (Sept. 10, 1991) and any amendments thereto, or a similar policy enforced by any other Company Regulatory Agency. None of the Company or its Subsidiaries, any director, officer, employee nor, to the Knowledge of the Company, agent or Representative thereof, has engaged in any activity that would result in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreementa material violation under applicable Health Care Laws. There is no Action pending by Seller civil, criminal, administrative or any Affiliateother proceeding, notice or which Seller intends to initiate against any Third Party relating to any Product or any Purchased Asset. There is no outstanding Order of any Governmental Entity against Seller (i) that relates to the Businessdemand pending, a Product or any Purchased Asset, (ii) that could reasonably be expected to be materially adverse to the Business, any Product or any Purchased Asset, or (iii) that could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreement.
(c) There is no Action pending received or, to the Knowledge of Sellerthe Company, threatened against Seller by the Company or any Governmental Entity, and there is no claim, investigation or administrative action of its Subsidiaries that relates to an alleged violation of any Governmental Entity Health Care Law and none of the Company or any of its Subsidiaries is in receipt of written notice of any civil, criminal, administrative or other proceeding, notice or demand pending orthat relates to an alleged violation of any Health Care Law. None of the Company or any of its Subsidiaries, any director, officer, employee nor, to the Knowledge of Sellerthe Company, threatenedagent or Representative thereof, has engaged in any activity that affects or, if successful, could reasonably be expected to be materially adverse to Seller, the Business, a Product, any Purchased Assets or the Assumed Liabilities or that, if successful, could reasonably be expected to would result in restraining, enjoining or otherwise preventing the completion by Seller a material violation of any Health Care Law. None of the transactions contemplated by this Agreement, nor are thereCompany or any of its Subsidiaries nor, to the Knowledge of Sellerthe Company, any factsdirector, circumstances or conditions on which any such Action could be brought in the future.
(d) Except as set forth in the Seller Disclosure Schedule, Seller and its Affiliates have timely filed all material reports, statements, documents, registrations, filings, amendments, supplements and submissions required to be filed by it with respect to any Product and the Purchased Assets under applicable Regulatory Laws. Each such filing was, in all material respects, true, complete and correct as of the date of submission, and any necessary or required updates, changes, corrections, amendments, supplements or modifications to such filings have been submitted to the applicable Governmental Entity.
(e) Except for notice of the Clinical Hold, neither Seller nor any Affiliate has, with respect to any Product or any Purchased Asset, (i) received or been subject to any action, notice, warning, administrative proceeding, review or investigation by a Regulatory Authority that alleges or asserts that Seller or any Affiliate has violated any applicable Regulatory Laws or (ii) been subject to a corporate integrity agreement, deferred prosecution agreement, consent decree, monitoring agreement, settlement agreement or other similar agreement or Order mandating or prohibiting future or past activities.
(f) Except as set forth on Schedule 4.9(f), the Manufacturing and servicing operations conducted by or on behalf of Seller and its Affiliates with respect to any Product are conducted in material compliance with applicable Regulatory Laws, including applicable current good manufacturing practice regulations and similar federal, state, local or foreign requirements for the Manufacture of any Product.
(g) Neither Seller, nor any Affiliate, nor any officer, employee employee, agent or agent of Seller or of any AffiliateRepresentative thereof, in each case who has been materially involved in the Exploitation of any Product (i) has been convicted of any crime or engaged in any conduct in the operation of Seller’s business for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a 335a(b) or any similar applicable Law, nor has any such Person been so debarred; (ii) has been convicted of any crime . There are no Orders or engaged in any conduct similar actions to which would reasonably be expected to cause Seller to be excluded from participating in federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, Company or any similar applicable Lawof its Subsidiaries, nor has any such Person been so excluded; or (iii) to the Knowledge of Sellerdirector, is subject to an investigation or proceeding by any Regulatory Authority that could result in such a suspensionofficer, exclusion or debarment and there are no factsemployee, or, to the Knowledge of Sellerthe Company, that would reasonably be expected agent or Representative thereof, are bound or which relate to give rise Company Products, or alleged violation of any Health Care Law. The Company and its Subsidiaries are currently not, nor have ever been, a party or subject to the terms of a corporate integrity agreement required by the Office of the Inspector General of the United States Department of Health and Human Services or similar agreement or consent order of any other Governmental Authority.
(d) None of the Company or any of its Subsidiaries nor, to the Knowledge of the Company, any director, officer, employee, agent or Representative thereof, has been investigated for, charged with or convicted of a Medicare, Medicaid or federal or state health program related offense, or convicted of, charged with or, to the Knowledge of the Company, investigated for a violation of federal or state Law related to fraud, theft, embezzlement, breach of fiduciary responsibility, financial misconduct, obstruction of an investigation of controlled substances, or has been debarred, excluded or suspended from participation in a Federal Health Care Program (nor is any such suspensiondebarment, exclusion or debarmentsuspension pending), or been subject to any Order or consent decree of, or criminal or civil fine or penalty imposed by, any Governmental Authority. To the Knowledge of the Company, the Company has not arranged or contracted with (by employment or otherwise) any individual or entity that has been convicted of or pled guilty or nolo contendere to any federal or state health care-related criminal offense or is excluded from participation in a Federal Health Care Program for the provision of items or services for which payment may be made under such Federal Health Care Program. No exclusion, suspension, or debarment claims, actions, proceedings or investigations relating to the Company is pending, or to the Knowledge of the Company, is threatened against neither the Company, nor any of the Company’s respective officers, directors, equity holders, employees or agents acting on its behalf or for its benefit.
(e) Except as set forth in Section 2.12(e) of the Company Disclosure Schedule, each of the Company and its Subsidiaries is and has been in compliance in all material respects with all applicable statutes, rules, regulations, decrees, writs and Orders of the FDA and any other Company Regulatory Agency with respect to the labeling, storing, testing, developing, manufacturing, packaging, distributing, marketing, advertising, promoting, and selling of the Company Products. To the Knowledge of the Company, all required pre-clinical toxicology studies conducted by or on behalf of the Company or its Subsidiaries and Company-sponsored clinical trials (or clinical trials sponsored by the Company or any other Subsidiary) conducted or being conducted with respect thereto, have been and are being conducted in compliance in all material respects with applicable licenses and Laws, including, without limitation, the applicable requirements of the FDCA and the FDA’s current Good Manufacturing Practice, as codified in the Quality System Regulation, Good Laboratory Practice and Good Clinical Practice. The results of any such studies, tests and trials, and all other material information related to Table of Contents such studies, tests and trials, have been made available to Radiant. To the Knowledge of the Company, each clinical trial conducted by or on behalf of the Company or any of its Subsidiaries with respect to Company Products has been and is being conducted in all material respects in accordance with its clinical trial protocol, and in compliance in all material respects with all applicable Laws, including Good Clinical Practice, informed consent, Institutional Review Board requirements and all other applicable requirements contained in 21 CFR Parts 312, 812, 50, 54, 56 and 11 and where applicable the Israeli Public Health Regulations (Clinical Trials in Human Subjects), 1980 and the Israeli Procedure for Clinical Trials in Humans, 2016. To the Knowledge of the Company, each of the Company and its Subsidiaries has filed all required notices (and made available to Radiant copies thereof) of design defects, product problems, adverse events, injuries and deaths relating to clinical trials conducted by or on behalf of the Company or any of its Subsidiaries with respect to such Company Products.
(f) Except as set forth in Section 2.12(f) of the Company Disclosure Schedule, all applications, submissions, information and data utilized by the Company or any of its Subsidiaries as the basis for, or submitted by or on behalf of the Company or any of its Subsidiaries in connection with any and all requests for a Company Permit relating to the Company or any of its Subsidiaries, when submitted to the FDA or any other Company Regulatory Agency, were, to the Knowledge of the Company, true, correct and complete in all material respects as of the date of submission, and any updates, changes, corrections or modification to such applications, submissions, information and data required under applicable Laws have been submitted to the FDA or any other Company Regulatory Agency.
(g) Except as set forth in Section 2.12(g) of the Company Disclosure Schedule, (i) the Company and each of its Subsidiaries is in compliance in all material respects with the written procedures, record-keeping and FDA reporting requirements for Reports of Corrections and Removals set forth in 21 C.F.R. Part 806; (ii) neither the Company nor any of its Subsidiaries has voluntarily or involuntarily issued or caused to be issued, or is aware of any facts that would require the Company or any of its Subsidiaries to issue or cause to be issued, any recall notice, market withdrawal notice, safety or Warning Letter, report or other notice or action disclosing an alleged defect or lack of safety or efficacy of any product; (iii) the Company and each of its Subsidiaries is in compliance in all material respects with the regulations for Medical Device Reporting set forth in 21 C.F.R. Part 803, or equivalent requirements issued by any other Governmental Authority; (iv) each product in current commercial distribution in the United States is a Class II medical device as defined under 21 U.S.C. § 360c(a)(1)(A), (B) and applicable rules and regulations thereunder and was first marketed under, and is currently covered by, a premarket notification owned and held exclusively by the Company or one of its Subsidiaries and in compliance with 21 U.S.C. § 360(k) and the applicable rules and regulations thereunder; and (v) the Company and each of its Subsidiaries has always promoted and continues to promote such products for uses that are within the scope of each Permit, and the Company and each of its Subsidiaries have not engaged in any off-label promotion, or promotion of Company Products without Permits, when such medical devices under FDCA must only be marketed with Permits (e.g., 510(k) premarket notification).
(h) Neither Seller nor Except as set forth in Section 2.12(h) of the Company Disclosure Schedule, none of the Company or its Subsidiaries nor, to the Knowledge of the Company, any Affiliate hasof the Representatives, in connection with licensors, licensees, assignors or assignees thereof has received any notice that the FDA or any other Company Regulatory Agency has initiated, or threatened to initiate, any action to suspend or place restrictions on any clinical trial, suspend or terminate any Investigational Device Exemption (“IDE”) or comparable Clinical Trial Application sponsored by the Company or any of its Exploitation Subsidiaries or otherwise restrict the pre-clinical research related to or clinical study of a Product, conducted any business Company Product or engaged in any transaction medical device or dealing with any Person with whom transactions were, at the time of such transaction, prohibited as to U.S. Persons component being developed by any applicable sanctions Laws administered by licensee or assignee of the U.S. Treasury Department’s Office Company Intellectual Property based on such intellectual property, or to recall, suspend or otherwise restrict the development or manufacture of Foreign Assets Control (“OFAC”)any Company Product. To the Knowledge of the Company, including persons appearing on none of the List Company or any of Specially Designated Nationals its Subsidiaries or any supplier of components and Blocked Persons published by OFAC.materials to the Company is in receipt of written notice of, or is subject to, any adverse inspection, finding of deficiency, finding of non-compliance, 483 observation, investigation, civil or criminal proceeding, hearing, suit, demand, claim, complaint, inquiry, proceeding, penalty, Untitled Letter, Warning Letter, seizure, import alert, injunction, prosecution, or other compliance or enforcement action relating to any Company Products or to the Company
Appears in 1 contract
Compliance with Laws; Regulatory Compliance. (a) The Exploitation by Seller Each of Orion and each of its Affiliates of any Product and the ownership by Seller and its Affiliates of the Purchased Assets have been, at all times, Subsidiaries is in material compliance with all applicable LawLaws or Orders, including applicable Regulatory Laws. Except as set forth in Seller’s Disclosure Schedule, neither Seller nor except where any Affiliate has received any written communication from a Governmental Entity that alleges that Seller or any Affiliate is not such failure to be in compliance has not had, or would not reasonably be expected to have, individually or in the aggregate, an Orion Material Adverse Effect. To the Knowledge of Orion and its Subsidiaries, (i) no investigation by any material respect with any Law or Order Governmental Authority with respect to Orion or any of its Exploitation of any Product or with respect to ownership of the Purchased Assets, respectively Subsidiaries is active and as applicable. Seller and its Affiliates havepending, and (ii) no Governmental Authority has indicated in writing an intention to conduct an investigation, which, in either case, would reasonably be expected to have had, all Product Registrations necessary for a material and adverse impact on Orion or any of its lawful Exploitation of any Product prior to the Closing Date, and each of such Product Registrations, if any, is valid and in full force and effectSubsidiaries.
(b) Except as set forth has not had, and would not reasonably be expected to have, individually or in the Seller Disclosure Scheduleaggregate, an Orion Material Adverse Effect, each of Orion and its Subsidiaries and their respective employees and agents hold, to the Knowledge of Orion, all permits, licenses, variances, registrations, exemptions, Orders, consents, authorizations and approvals from the FDA and any other Governmental Authority that is concerned with the quality, identity, strength, purity, safety, efficacy or Manufacturing of any of the products or services produced, marketed, licensed, sold, distributed or performed by or on behalf of Orion or any of its Subsidiaries and all products or services currently under development by Orion or any of its Subsidiaries (the “Orion Products”) (any such Governmental Authority, a “Orion Regulatory Agency”) necessary for the lawful operating of the businesses of Orion and each of its Subsidiaries as currently conducted (the “Orion Permits”), including all authorizations required under the FDCA, , and the PHSA, and the regulations of the FDA promulgated thereunder. Notwithstanding the foregoing, it is acknowledged that no Orion Product is a marketed product, or has received marketing approval, in the United States and, therefore, that further permits, licenses, variances, registrations, exemptions, Orders, consents and/or approvals will be required before any Orion Product may be marketed. Except as has not had, and would not reasonably be expected to have, individually or in the aggregate, an Orion Material Adverse Effect, all such Orion Permits are valid, and in full force and effect. Since January 1, 2016, there has not been occurred any claim violation of, default (with or without notice or lapse of which Seller time or both) under, or event giving to others any Affiliate right of termination, amendment or cancellation of, with or without notice or lapse of time or both, any Orion Permit except as has received notice not had, and would not reasonably be expected to have, individually or in the aggregate, an Orion Material Adverse Effect. Each of any Action pending or threatened against Seller or an Affiliate relating Orion and each of its Subsidiaries is in compliance in all material respects with the terms of all Orion Permits. No event has occurred that, to any Product or the Purchased Assets. To the Knowledge of SellerOrion, there is no fact would reasonably be expected to result in the revocation, cancellation, non-renewal or circumstance adverse modification of any Orion Permit, except as has not had, and would not reasonably be expected to have, individually or in the aggregate, an Orion Material Adverse Effect.
(c) None of Orion or its Subsidiaries nor, to the Knowledge of Orion, any director, officer, employee, agent or Representative thereof, has committed any act, made any statement or failed to make any statement that would reasonably be expected to serve as provide a basis for any Action against Seller the FDA or any Affiliate relating other Orion Regulatory Agency to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” as set forth in 56 Fed. Reg. 46191 (Sept. 10, 1991) and any Product amendments thereto, or a similar policy enforced by any Purchased Assets or that, if successful, could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreementother Orion Regulatory Agency. There is no Action pending by Seller civil, criminal, administrative or any Affiliateother proceeding, notice or which Seller intends to initiate against any Third Party relating to any Product or any Purchased Asset. There is no outstanding Order of any Governmental Entity against Seller (i) that relates to the Businessdemand, a Product or any Purchased Asset, (ii) that could reasonably be expected to be materially adverse to the Business, any Product or any Purchased Asset, or (iii) that could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreement.
(c) There is no Action pending received or, to the Knowledge of SellerOrion, threatened against Seller by Orion or any Governmental Entity, and there is no claim, investigation or administrative action of its Subsidiaries that relates to an alleged violation of any Governmental Entity Health Care Law and none of Orion or any of its Subsidiaries is in receipt of written notice of any civil, criminal, administrative or other proceeding, notice or demand pending orthat relates to an alleged violation of any Health Care Law. None of Orion or its Subsidiaries nor, to the Knowledge of Seller, threatened, that affects or, if successful, could reasonably be expected to be materially adverse to Seller, the Business, a ProductOrion, any Purchased Assets director, officer, employee, agent or the Assumed Liabilities or thatRepresentative thereof, if successful, could reasonably be expected to has engaged in any activity that would result in restraining, enjoining a material violation of any Health Care Law. None of Orion or otherwise preventing the completion by Seller any of the transactions contemplated by this Agreement, nor are thereits Subsidiaries nor, to the Knowledge of SellerOrion, any factsdirector, circumstances or conditions on which any such Action could be brought in the future.
(d) Except as set forth in the Seller Disclosure Schedule, Seller and its Affiliates have timely filed all material reports, statements, documents, registrations, filings, amendments, supplements and submissions required to be filed by it with respect to any Product and the Purchased Assets under applicable Regulatory Laws. Each such filing was, in all material respects, true, complete and correct as of the date of submission, and any necessary or required updates, changes, corrections, amendments, supplements or modifications to such filings have been submitted to the applicable Governmental Entity.
(e) Except for notice of the Clinical Hold, neither Seller nor any Affiliate has, with respect to any Product or any Purchased Asset, (i) received or been subject to any action, notice, warning, administrative proceeding, review or investigation by a Regulatory Authority that alleges or asserts that Seller or any Affiliate has violated any applicable Regulatory Laws or (ii) been subject to a corporate integrity agreement, deferred prosecution agreement, consent decree, monitoring agreement, settlement agreement or other similar agreement or Order mandating or prohibiting future or past activities.
(f) Except as set forth on Schedule 4.9(f), the Manufacturing and servicing operations conducted by or on behalf of Seller and its Affiliates with respect to any Product are conducted in material compliance with applicable Regulatory Laws, including applicable current good manufacturing practice regulations and similar federal, state, local or foreign requirements for the Manufacture of any Product.
(g) Neither Seller, nor any Affiliate, nor any officer, employee employee, agent or agent of Seller or of any AffiliateRepresentative thereof, in each case who has been materially involved in the Exploitation of any Product (i) has been convicted of any crime or engaged in any conduct in the operation of Seller’s business for which debarment is mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a 335a(b) or any similar applicable Law, nor has any such Person been so debarred; (ii) has been convicted . None of any crime or engaged in any conduct which would reasonably be expected to cause Seller to be excluded from participating in federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, Orion or any similar applicable Law, nor has any such Person been so excluded; or (iii) to the Knowledge of Seller, is subject to an investigation or proceeding by any Regulatory Authority that could result in such a suspension, exclusion or debarment and there are no factsits Subsidiaries nor, to the Knowledge of SellerOrion, any director, officer, employee, agent or Representative thereof: (i) has ever been excluded, suspended, sanctioned or otherwise declared ineligible to participate in any federal health care program under 42 CFR § 1001.601, or any similar Law, nor is any such exclusion, suspension or other sanction threatened; or (ii) has ever been convicted of a criminal offense related to the provision of health care items or services. There are no Orders or similar actions to which Orion or any of its Subsidiaries or, to the Knowledge of Orion, any director, officer or employee thereof, are bound or which relate to Orion Products, or alleged violation of any Health Care Law.
(d) Each of Orion and each of its Subsidiaries is and has been in compliance in all material respects with all applicable statutes, rules, regulations, decrees, writs and Orders of the FDA and any other Orion Regulatory Agency with respect to the labeling, storing, testing, development, manufacture, packaging, distribution and promotion of the Orion Products. To the Knowledge of Orion, all required pre-clinical studies conducted by or on behalf of Orion or its Subsidiaries and Orion-sponsored clinical trials (or clinical trials sponsored by Orion or any other Subsidiary) conducted or being conducted with respect thereto, have been and are being conducted in compliance in all material respects with applicable licenses and Laws. The results of any such studies, tests and trials, and all other material information related to such studies, tests and trials, have been made available to Company. To the Knowledge of Orion, each clinical trial conducted by or on behalf of Orion or any of its Subsidiaries with respect to Orion Products has been and is being conducted in accordance with its clinical trial protocol, and in compliance in all material respects with all applicable Laws. Each of Orion and its Subsidiaries has filed all required notices (and made available to the Company copies thereof) of adverse events, injuries or deaths relating to clinical trials conducted by or on behalf of Orion or any of its Subsidiaries with respect to such Orion Products.
(e) All applications, submissions, information and data utilized by any Orion or any of its Subsidiaries as the basis for, or submitted by or on behalf of Orion or any of its Subsidiaries in connection with any and all requests for an Orion Permit relating to Orion or any of its Subsidiaries, when submitted to the FDA or other Orion Regulatory Agency, were true, correct and complete in all material respects as of the date of submission, and any updates, changes, corrections or modification to such applications, submissions, information and data required under applicable Laws have been submitted to the FDA or other Orion Regulatory Agency.
(f) None of Orion or its Subsidiaries nor, to the Knowledge of Orion, any of the Representatives, licensors, licensees, assignors or assignees thereof has received any notice that the FDA or any other Orion Regulatory Agency has initiated, or threatened to initiate, any Action to suspend or place restrictions on any clinical trial or otherwise restrict the pre-clinical research related to or clinical study of any Orion Product or any product being developed by any licensee or assignee of the Orion Intellectual Property based on such intellectual property, or to recall, suspend or otherwise restrict the development or manufacture of any Orion Product. None of Orion or any of its Subsidiaries is in receipt of written notice of, or is subject to, any adverse inspection, finding of deficiency, finding of non-compliance, investigation, civil or criminal proceeding, hearing, suit, demand, claim, complaint, inquiry, proceeding, or other compliance or enforcement action relating to any Orion Product. To the Knowledge of Orion, there is no act, omission, event or circumstance that would reasonably be expected to give rise to any such suspensionaction.
(g) Orion and each of its Subsidiaries are, exclusion and have been for the past six (6) years, in compliance with the requirements of: (i) all applicable privacy and security Laws governing health information; and (ii) all contractual obligations concerning the collection, use, storage and disclosure of health information. To the Knowledge of Orion, there has been no unauthorized use, access, modification or debarmentdisclosure of health information, including any Breach of “Unsecured Protected Health Information,” as those terms are defined by HIPAA, by Orion, any of its Subsidiaries, or any of their respective clinical trial sites. Orion and each of its Subsidiaries is not now, and has never been, subject to HIPAA and is not a party to any business associate agreement as defined by HIPAA.
(h) Neither Seller nor Orion and its Subsidiaries have made available to the Company true, correct and complete copies of any Affiliate hasand all material applications, in connection approvals, licenses, written notices of inspectional observations, establishment inspection reports and any other documents received from the FDA or any other Orion Regulatory Agency, including documents that indicate or suggest lack of compliance with the regulatory requirements of the FDA or any other Orion Regulatory Agency. Orion and its Exploitation Subsidiaries have made available to the Company for review all material correspondence to or from the FDA or any other Orion Regulatory Agency, minutes of a Productmeetings, conducted written reports of phone conversations, visits or other contact with the FDA or any business other Orion Regulatory Agency, notices of inspectional observations, establishment inspection reports, and all other documents concerning communications to or engaged from the FDA or any other Orion Regulatory Agency, or prepared by the FDA or other any Orion Regulatory Agency or which bear in any transaction way on Orion’s or dealing any of its Subsidiaries’ compliance with regulatory requirements of the FDA or any Person with whom transactions wereother Orion Regulatory Agency, at the time of such transaction, prohibited as to U.S. Persons by any applicable sanctions Laws administered by the U.S. Treasury Department’s Office of Foreign Assets Control (“OFAC”), including persons appearing or on the List likelihood or timing of Specially Designated Nationals and Blocked Persons published by OFACapproval of any Orion Products.
Appears in 1 contract
Samples: Merger Agreement (OvaScience, Inc.)
Compliance with Laws; Regulatory Compliance. (a) The Exploitation FSI and each of its Subsidiaries is in compliance in all material respects with all Laws or Orders. No investigation, inquiry, proceeding or similar action by Seller any Governmental Authority with respect to FSI or any of its Subsidiaries is pending or, to the knowledge of FSI, threatened in writing, nor has any Governmental Authority indicated in writing an intention to conduct the same which, in each case, would reasonably be expected to have a material and adverse impact on FSI or any of its Subsidiaries.
(b) International Trade & Anti-Corruption Laws.
(i) Neither FSI nor its Subsidiaries, or, to the FSI’s Knowledge, any of its Representatives is or has been, since the incorporation of FSI, (A) a Person named on any Sanctions and Export Control Laws-related list of designated Persons maintained by a Governmental Authority; (B) located, organized or resident in a Sanctioned Country; or (C) an entity owned, directly or indirectly, by one or more Persons described in clause (A) or (B). FSI and its Affiliates of any Product Subsidiaries are, and for the ownership by Seller and its Affiliates of the Purchased Assets past five years have been, at all times, in material compliance with applicable Sanctions in all applicable Lawmaterial respects.
(ii) Neither FSI nor, including applicable to FSI’s Knowledge, any of its Subsidiaries or Representatives for the benefit of FSI or its Subsidiaries, has (A) made, offered, promised, paid or received any unlawful bribes, kickbacks or other similar payments to or from any Person, (B) made or paid any improper contributions, directly or indirectly, to a domestic or foreign political party or candidate or (C) otherwise made, offered, received, authorized, promised or paid any improper payment under any Anti-Corruption Laws.
(c) Except as it has not had, and would not reasonably be expected to have, individually or in the aggregate, an FSI Material Adverse Effect, each of FSI and its Subsidiaries and their respective employees and agents hold all permits, licenses, variances, registrations, authorizations, exemptions, Orders, consents and approvals from the U.S. Environmental Protection Agency (“EPA”) and any Governmental Authority with the authority to regulate or supervise the storage, packaging, labeling, product safety, quality, use, manufacturing or distribution of FSI Products (any such Governmental Authority, a “FSI Regulatory LawsAgency”) necessary for the lawful operation of the businesses of FSI and each of its Subsidiaries as currently conducted (the “FSI Permits”). Except as set forth in Seller’s Disclosure Scheduleit has not had, neither Seller nor any Affiliate has received any written communication from a Governmental Entity that alleges that Seller or any Affiliate is and would not in compliance in any material respect with any Law or Order with respect reasonably be expected to its Exploitation of any Product or with respect to ownership of the Purchased Assets, respectively and as applicable. Seller and its Affiliates have, and have hadindividually or in the aggregate, an FSI Material Adverse Effect, all Product Registrations necessary for its lawful Exploitation of any Product prior to the Closing Datesuch FSI Permits are valid, and each of such Product Registrations, if any, is valid and in full force and effect.
. In the past five (b5) Except as set forth in the Seller Disclosure Scheduleyears, there has not been occurred any claim violation of, default (with or without notice or lapse of which Seller time or both) under, or event giving to others any Affiliate right of termination, amendment or cancellation of, with or without notice or lapse of time or both, any FSI Permit except as it has received notice not had, and would not reasonably be expected to have, individually or in the aggregate, an FSI Material Adverse Effect. FSI and each of its Subsidiaries is in compliance in all material respects with the terms of all FSI Permits, and no event has occurred that, to the knowledge of FSI, would reasonably be expected to result in the revocation, cancellation, non-renewal or adverse modification of any Action pending FSI Permit, except as it has not had, and would not reasonably be expected to have, individually or threatened against Seller in the aggregate, an FSI Material Adverse Effect.
(d) None of FSI or an Affiliate relating its Subsidiaries nor, to the knowledge of FSI, any Product Representative thereof, has committed any act, made any statement or the Purchased Assets. To the Knowledge of Seller, there is no fact or circumstance failed to make any statement that would reasonably be expected to serve as provide a basis for any Action against Seller the EPA or any Affiliate relating other FSI Regulatory Agency to any Product investigate it for potential fraud, waste or abuse, illegal gratuity or other prohibited practices. There are no consent decrees (including plea agreements) or similar actions to which FSI or any Purchased Assets or that, if successful, could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreement. There is no Action pending by Seller or any Affiliate, or which Seller intends to initiate against any Third Party relating to any Product or any Purchased Asset. There is no outstanding Order of any Governmental Entity against Seller (i) that relates to the Business, a Product or any Purchased Asset, (ii) that could reasonably be expected to be materially adverse to the Business, any Product or any Purchased Asset, or (iii) that could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreement.
(c) There is no Action pending its Subsidiaries or, to the Knowledge knowledge of Seller, threatened against Seller by any Governmental Entity, and there is no claim, investigation or administrative action of any Governmental Entity pending or, to the Knowledge of Seller, threatened, that affects or, if successful, could reasonably be expected to be materially adverse to Seller, the Business, a ProductFSI, any Purchased Assets Representative thereof, is bound or the Assumed Liabilities or that, if successful, could reasonably be expected which relate to result in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreement, nor are there, to the Knowledge of Seller, any facts, circumstances or conditions on which any such Action could be brought in the futureFSI Products.
(de) Except as set forth FSI and each of its Subsidiaries is and has been in the Seller Disclosure Schedule, Seller and its Affiliates have timely filed compliance in all material reportsrespects with all applicable statutes, statementsrules, documentsregulations, registrationsdecrees, filings, amendments, supplements writs and submissions required to be filed by it orders of any FSI Regulatory Agency with respect to the labeling, packaging, storing, testing, development, manufacture, packaging and distribution of the FSI Products.
(f) All applications, submissions, information and data utilized by FSI or any Product of its Subsidiaries as the basis for, or submitted by or on behalf of FSI or any of its Subsidiaries in connection with any and all requests for a FSI Permit relating to FSI or any of its Subsidiaries, when submitted to the Purchased Assets under applicable EPA or other FSI Regulatory Laws. Each such filing wasAgency, were true, correct and complete in all material respects, true, complete and correct respects as of the date of submission, and any necessary or required updates, changes, corrections, amendments, supplements corrections or modifications modification to such filings have been applications, submissions, information and data required under applicable Laws to be submitted to the applicable Governmental Entity.
(e) Except for notice of the Clinical Hold, neither Seller nor any Affiliate has, with respect to any Product or any Purchased Asset, (i) received or been subject to any action, notice, warning, administrative proceeding, review or investigation by a Regulatory Authority that alleges or asserts that Seller or any Affiliate has violated any applicable Regulatory Laws or (ii) been subject to a corporate integrity agreement, deferred prosecution agreement, consent decree, monitoring agreement, settlement agreement EPA or other similar agreement or Order mandating or prohibiting future or past activities.
(f) Except as set forth on Schedule 4.9(f), the Manufacturing and servicing operations conducted by or on behalf of Seller and its Affiliates with respect to any Product are conducted in material compliance with applicable FSI Regulatory Laws, including applicable current good manufacturing practice regulations and similar federal, state, local or foreign requirements for the Manufacture of any ProductAgency have been submitted.
(g) Neither SellerFSI and its Subsidiaries have made available to the Company true, nor any Affiliate, nor any officer, employee or agent of Seller or correct and complete copies of any Affiliateand all applications, approvals, licenses, written notices of inspectional observations, and establishment inspection reports received from any FSI Regulatory Agency. FSI and its Subsidiaries have made available to the Company for review all correspondence to or from any FSI Regulatory Agency, minutes of meetings, written reports of phone conversations, visits or other contact with any FSI Regulatory Agency, notices of inspectional observations, establishment inspection reports, and all other documents concerning communications to or from any FSI Regulatory Agency, or prepared by any FSI Regulatory Agency or which bear in each case who has been materially involved in any way on FSI’s or any of its Subsidiaries’ compliance with the Exploitation Laws of any Product (i) has been convicted FSI Regulatory Agency, or on the likelihood or timing of approval of any crime or engaged in any conduct in the operation of Seller’s business for which debarment is mandated or authorized by 21 U.S.C. § 335a or any similar applicable Law, nor has any such Person been so debarred; (ii) has been convicted of any crime or engaged in any conduct which would reasonably be expected to cause Seller to be excluded from participating in federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar applicable Law, nor has any such Person been so excluded; or (iii) to the Knowledge of Seller, is subject to an investigation or proceeding by any Regulatory Authority that could result in such a suspension, exclusion or debarment and there are no facts, to the Knowledge of Seller, that would reasonably be expected to give rise to such suspension, exclusion or debarmentFSI Products.
(h) Neither Seller nor any Affiliate has, in connection with its Exploitation of a Product, conducted any business or engaged in any transaction or dealing with any Person with whom transactions were, at the time of such transaction, prohibited as to U.S. Persons by any applicable sanctions Laws administered by the U.S. Treasury Department’s Office of Foreign Assets Control (“OFAC”), including persons appearing on the List of Specially Designated Nationals and Blocked Persons published by OFAC.
Appears in 1 contract
Samples: Merger Agreement (Flexible Solutions International Inc)
Compliance with Laws; Regulatory Compliance. (a) The Exploitation by Seller Each of Parent and each of its Affiliates of any Product Subsidiaries is, and for the ownership by Seller and its Affiliates of the Purchased Assets have past four years has been, at all times, in material compliance with all applicable LawLaws or Orders. No investigation, including applicable Regulatory Laws. Except as set forth in Seller’s Disclosure Scheduleinquiry, neither Seller nor proceeding or similar action by any Affiliate has received any written communication from a Governmental Entity that alleges that Seller or any Affiliate is not in compliance in any material respect with any Law or Order Authority with respect to its Exploitation of any Product or with respect to ownership of the Purchased Assets, respectively and as applicable. Seller and its Affiliates have, and have had, all Product Registrations necessary for its lawful Exploitation of any Product prior to the Closing Date, and each of such Product Registrations, if any, is valid and in full force and effect.
(b) Except as set forth in the Seller Disclosure Schedule, there has not been any claim of which Seller Parent or any Affiliate has received notice of any Action pending or threatened against Seller or an Affiliate relating to any Product or the Purchased Assets. To the Knowledge of Seller, there its Subsidiaries is no fact or circumstance that would reasonably be expected to serve as a basis for any Action against Seller or any Affiliate relating to any Product or any Purchased Assets or that, if successful, could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreement. There is no Action pending by Seller or any Affiliate, or which Seller intends to initiate against any Third Party relating to any Product or any Purchased Asset. There is no outstanding Order of any Governmental Entity against Seller (i) that relates to the Business, a Product or any Purchased Asset, (ii) that could reasonably be expected to be materially adverse to the Business, any Product or any Purchased Asset, or (iii) that could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreement.
(c) There is no Action pending or, to the Knowledge of SellerParent, threatened against Seller by in writing, nor has any Governmental EntityAuthority indicated in writing an intention to conduct the same which, in each case, would reasonably be expected to have a Parent Material Adverse Effect.
(b) Each of Parent and each of its Subsidiaries holds all material Permits from the Food and Drug Administration (the “FDA”) and any other Governmental Authority (any such Governmental Authority, a “Parent Regulatory Agency”) necessary for the operating of the Parent Businesses in material compliance with applicable Laws (the “Parent Permits”), including all Parent Permits required under the Federal Food, Drug and Cosmetic Act of 1938, and there the regulations of the FDA promulgated thereunder (the “FDCA”) and the Public Health Service Act of 1944, as amended, and the regulations of the FDA promulgated thereunder (the “PHSA”) and any comparable Laws of other applicable jurisdictions. All such Parent Permits are valid, and in full force and effect. There has not occurred any violation of, default (with or without notice or lapse of time or both) under, or event giving to others any right of termination, amendment or cancellation of, with or without notice or lapse of time or both, any Parent Permit. Each of Parent and each of its Subsidiaries is in compliance in all material respects with the terms of all Parent Permits, and no event has occurred that, to the Knowledge of Parent, would reasonably be expected to result in the revocation, cancellation, non-renewal or adverse modification of any Parent Permit.
(c) None of Parent or its Subsidiaries nor, to the Knowledge of Parent, any director, officer, employee or agent thereof, has made any untrue statement of material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, or failed to disclose a material fact required to be disclosed to the FDA or other such Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” as set forth in 56 Fed. Reg. 46191 (Sept. 10, 1991) and any amendments thereto. None of Parent or its Subsidiaries nor, to the Knowledge of Parent, any director, officer, employee or agent thereof, has engaged in any activity prohibited under any U.S. federal or state criminal or civil health care Laws, including the U.S. federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), the False Claims Act (31 U.S.C. §§ 3729 et seq.), the Health Insurance Portability and Accountability Act (42 U.S.C. § 1320d et seq.), as amended by the Health Information, Technology for Economic and Clinical Health Act of 2009, the civil monetary penalty laws (42 U.S.C. § 1320a-7a), the FDCA, the PHSA, the regulations promulgated pursuant to such Laws, and any equivalent applicable Laws of other jurisdictions (each a “Health Care Law”). There is no claimcivil, investigation criminal, administrative or administrative action of any Governmental Entity pending other proceeding, notice or demand pending, received, or, to the Knowledge of SellerParent, threatenedthreatened against Parent or any of its Subsidiaries that asserts an alleged violation, that affects in any material respect, of any Health Care Law. None of Parent or any of its Subsidiaries or any employee or agent thereof has, under any Health Care Law, been debarred, excluded, suspended, or otherwise determined to be ineligible to participate in any health care programs of any Governmental Authority, convicted of any crime, or, if successfulto the Knowledge of Parent, could reasonably be expected to be materially adverse to Seller, the Business, a Product, engaged in any Purchased Assets conduct that has resulted or the Assumed Liabilities or that, if successful, could would reasonably be expected to result in restrainingany such debarment, enjoining exclusion, suspension, ineligibility, or otherwise preventing the completion conviction, including any debarment mandated by Seller 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law. Neither Parent nor any of the transactions contemplated by this Agreement, nor are thereits Subsidiaries is a party to any consent decrees (including plea agreements) or similar actions to which Parent or any of its Subsidiaries or, to the Knowledge of SellerParent, any factsdirector, circumstances officer, employee or conditions on which any such Action could be brought in the futureagent thereof, are bound.
(d) Except as set forth Parent and each of its Subsidiaries is in the Seller Disclosure Schedule, Seller and its Affiliates have timely filed compliance in all material reportsrespects with all applicable Laws enforced by, statementsand Orders of, documentsthe FDA and any other Parent Regulatory Agency with respect to the labeling, registrationsstoring, filingstesting, amendmentsdevelopment, supplements manufacture, packaging, distribution and submissions promotion of its products. All required pre-clinical toxicology studies conducted by or, to the Knowledge of Parent, on behalf of Parent or any of its Subsidiaries and all clinical trials sponsored by Parent or any of its Subsidiaries are being conducted in compliance in all material respects with applicable Parent Permits and applicable Laws, including, the applicable requirements of the FDCA and the regulations of the FDA promulgated thereunder, including, any applicable requirements of 21 C.F.R. Parts 50, 54, 56, 58, 210, 211, and 312. The material results of any such studies, tests and trials, and all other material information related to such studies, tests and trials, have been made available to the Company. Each clinical trial conducted by or, to the Knowledge of Parent, on behalf of Parent or any of its Subsidiaries has been conducted in compliance in all material respects with all applicable Laws, including the FDCA and the regulations of the FDA promulgated thereunder, including, any applicable requirements of 21 C.F.R. Parts 50, 54, 56, 58, 210, 211, and 312. Parent and each of its Subsidiaries has filed with applicable Parent Regulatory Agencies all material notices required to be filed by it with respect to any Product (and the Purchased Assets under applicable Regulatory Laws. Each such filing was, in all material respects, true, complete and correct as of the date of submission, and any necessary or required updates, changes, corrections, amendments, supplements or modifications to such filings have been submitted made available to the applicable Governmental Entity.
(eCompany copies thereof) Except for notice of the Clinical Holdadverse drug experiences, neither Seller nor any Affiliate has, with respect injuries or deaths relating to any Product or any Purchased Asset, (i) received or been subject to any action, notice, warning, administrative proceeding, review or investigation by a Regulatory Authority that alleges or asserts that Seller or any Affiliate has violated any applicable Regulatory Laws or (ii) been subject to a corporate integrity agreement, deferred prosecution agreement, consent decree, monitoring agreement, settlement agreement or other similar agreement or Order mandating or prohibiting future or past activities.
(f) Except as set forth on Schedule 4.9(f), the Manufacturing and servicing operations clinical trials conducted by or on behalf of Seller and Parent or any of its Affiliates with respect to any Product are conducted in material compliance with applicable Regulatory Laws, including applicable current good manufacturing practice regulations and similar federal, state, local or foreign requirements for the Manufacture of any ProductSubsidiaries.
(ge) Neither SellerNone of Parent or its Subsidiaries has received any written notice that the FDA or any other Parent Regulatory Agency has initiated, nor or threatened in writing to initiate, any Affiliateaction to suspend any clinical trial, nor suspend or terminate any officer, employee Investigational New Drug Application or agent similar Health Care Law permit sponsored by Parent or any of Seller its Subsidiaries or otherwise materially restrict the pre-clinical research or clinical study of any Affiliatedrug product being developed by or on behalf of Parent or any of its Subsidiaries, in each case who has been or to recall, suspend or otherwise materially involved in restrict the Exploitation development or manufacture of any Product (i) drug product, except as has been convicted of any crime or engaged in any conduct in the operation of Seller’s business for which debarment is mandated or authorized by 21 U.S.C. § 335a or any similar applicable Lawnot had, nor has any such Person been so debarred; (ii) has been convicted of any crime or engaged in any conduct which and would not reasonably be expected to cause Seller to be excluded from participating have, individually or in federal health care programs under Section 1128 of the Social Security Act of 1935aggregate, as amended, or any similar applicable Law, nor has any such Person been so excluded; or (iii) to a Parent Material Adverse Effect. To the Knowledge of SellerParent, there is subject to an investigation no act, omission, event or proceeding by any Regulatory Authority that could result in such a suspension, exclusion or debarment and there are no facts, to the Knowledge of Seller, circumstance that would reasonably be expected to give rise to any such suspension, exclusion or debarmentaction.
(hf) Neither Seller nor With respect to the Parent Business, Parent and its Subsidiaries have made available to the Company for review copies of any Affiliate hasand all material regulatory applications and submissions (and any supplements or amendments thereto) under applicable Health Care Laws, in connection Parent Permits, written notices of inspectional observations, and establishment inspection reports of Parent Regulatory Agencies, notifications, communications, correspondence, registrations, master files, and/or other filings made to, received from or otherwise conducted with a Parent Regulatory Agency, reports or other documents of Parent or its Exploitation Subsidiaries that assert or address lack of a Product, conducted any business or engaged in any transaction or dealing material compliance with any Person Health Care Laws, or the likelihood or timing of marketing approval of any drug product, records and other materials maintained to comply with whom transactions wereapplicable Health Care Laws (e.g., at the time of such transactionregarding good laboratory practice, prohibited as to U.S. Persons by any applicable sanctions Laws administered by the U.S. Treasury Department’s Office of Foreign Assets Control (“OFAC”good clinical practice, and good manufacturing practice), and records that are necessary or advisable in order to obtain Parent Permits or other approvals from Parent Regulatory Agencies. Such books and records are complete and correct in all material respects and have been maintained in accordance with sound business practices, including persons appearing on the List maintenance of Specially Designated Nationals and Blocked Persons published by OFACan adequate system of internal controls.
Appears in 1 contract
Compliance with Laws; Regulatory Compliance. (a) The Exploitation by Seller Each of Talos and each of its Affiliates of any Product and the ownership by Seller and its Affiliates of the Purchased Assets have been, at all times, Subsidiaries is in material compliance with all applicable LawLaws or Orders, including applicable Regulatory Laws. Except as set forth in Seller’s Disclosure Schedule, neither Seller nor except where any Affiliate has received any written communication from a Governmental Entity that alleges that Seller or any Affiliate is not such failure to be in compliance has not had, or would not reasonably be expected to have, individually or in the aggregate, a Talos Material Adverse Effect. No investigation or review by any material respect with any Law or Order Governmental Authority with respect to Talos or any of its Exploitation of any Product or with respect to ownership of the Purchased AssetsSubsidiaries is pending or, respectively and as applicable. Seller and its Affiliates have, and have had, all Product Registrations necessary for its lawful Exploitation of any Product prior to the Closing DateKnowledge of Talos, threatened, nor has any Governmental Authority indicated an intention to conduct the same which, in each case, would reasonably be expected to have a material and each adverse impact on Talos or any of such Product Registrations, if any, is valid and in full force and effectits Subsidiaries.
(b) Except as set forth has not had, and would not reasonably be expected to have, individually or in the Seller Disclosure Scheduleaggregate, a Talos Material Adverse Effect, each of Talos and its Subsidiaries and their respective employees and agents hold all permits, licenses, variances, registrations, exemptions, Orders, consents and approvals from the FDA and any other Governmental Authority that is concerned with the quality, identity, strength, purity, safety, efficacy or manufacturing of Talos Products (any such Governmental Authority, a “Talos Regulatory Agency”) necessary for the lawful operating of the businesses of Talos and each of its Subsidiaries as currently conducted (the “Talos Permits”), including all authorizations required under the FDCA and the regulations of the FDA promulgated thereunder, and the PHSA. Notwithstanding the foregoing, it is acknowledged that no Talos Product is a marketed product or has received marketing approval (with the exception of Inversine, which was approved in the United States for the management of moderately severe to severe essential hypertension and uncomplicated cases of malignant hypertension) and, therefore, that further permits, licenses, variances, registrations, exemptions, Orders, consents and/or approvals will be required before any Talos Product may be marketed. Except as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Talos Material Adverse Effect, all such Talos Permits are valid, and in full force and effect. Since January 1, 2013, there has not been occurred any claim violation of, default (with or without notice or lapse of which Seller time or both) under, or event giving to others any Affiliate right of termination, amendment or cancellation of, with or without notice or lapse of time or both, any Talos Permit except as has received notice not had, and would not reasonably be expected to have, individually or in the aggregate, a Talos Material Adverse Effect. Each of any Action pending or threatened against Seller or an Affiliate relating Talos and each of its Subsidiaries is in compliance in all material respects with the terms of all Talos Permits, and no event has occurred that, to any Product or the Purchased Assets. To the Knowledge of SellerTalos, there is no fact would reasonably be expected to result in the revocation, cancellation, non-renewal or circumstance adverse modification of any Talos Permit, except as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Talos Material Adverse Effect.
(c) None of Talos or its Subsidiaries nor, to the Knowledge of Talos, any director, officer, employee, agent or Representative thereof, has committed any act, made any statement or failed to make any statement that would reasonably be expected to serve as provide a basis for any Action against Seller the FDA or any Affiliate relating other Talos Regulatory Agency to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” as set forth in 56 Fed. Reg. 46191 (Sept. 10, 1991) and any Product amendments thereto. None of Talos or its Subsidiaries nor, to the Knowledge of Talos, any Purchased Assets director, officer, employee, agent or thatRepresentative thereof, if successful, could reasonably be expected to result has engaged in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreementany activity prohibited under any Health Care Law. There is no Action pending by Seller civil, criminal, administrative or any Affiliateother proceeding, notice or which Seller intends to initiate against any Third Party relating to any Product or any Purchased Asset. There is no outstanding Order of any Governmental Entity against Seller (i) that relates to the Businessdemand pending, a Product or any Purchased Asset, (ii) that could reasonably be expected to be materially adverse to the Business, any Product or any Purchased Asset, or (iii) that could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreement.
(c) There is no Action pending received or, to the Knowledge of SellerTalos, threatened against Seller by Talos or any Governmental Entity, and there is no claim, investigation or administrative action of its Subsidiaries that relates to an alleged violation of any Governmental Entity pending orHealth Care Law. None of Talos or any of its Subsidiaries nor, to the Knowledge of Seller, threatened, that affects or, if successful, could reasonably be expected to be materially adverse to Seller, the Business, a ProductTalos, any Purchased Assets or the Assumed Liabilities or thatdirector, if successful, could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreement, nor are there, to the Knowledge of Seller, any facts, circumstances or conditions on which any such Action could be brought in the future.
(d) Except as set forth in the Seller Disclosure Schedule, Seller and its Affiliates have timely filed all material reports, statements, documents, registrations, filings, amendments, supplements and submissions required to be filed by it with respect to any Product and the Purchased Assets under applicable Regulatory Laws. Each such filing was, in all material respects, true, complete and correct as of the date of submission, and any necessary or required updates, changes, corrections, amendments, supplements or modifications to such filings have been submitted to the applicable Governmental Entity.
(e) Except for notice of the Clinical Hold, neither Seller nor any Affiliate has, with respect to any Product or any Purchased Asset, (i) received or been subject to any action, notice, warning, administrative proceeding, review or investigation by a Regulatory Authority that alleges or asserts that Seller or any Affiliate has violated any applicable Regulatory Laws or (ii) been subject to a corporate integrity agreement, deferred prosecution agreement, consent decree, monitoring agreement, settlement agreement or other similar agreement or Order mandating or prohibiting future or past activities.
(f) Except as set forth on Schedule 4.9(f), the Manufacturing and servicing operations conducted by or on behalf of Seller and its Affiliates with respect to any Product are conducted in material compliance with applicable Regulatory Laws, including applicable current good manufacturing practice regulations and similar federal, state, local or foreign requirements for the Manufacture of any Product.
(g) Neither Seller, nor any Affiliate, nor any officer, employee employee, agent or agent of Seller or of any AffiliateRepresentative thereof, in each case who has been materially involved in the Exploitation of any Product (i) has been convicted of any crime or engaged in any conduct in the operation of Seller’s business for which debarment is mandated by 21 U.S.C. sec. 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a sec. 335a(b) or any similar applicable Law, nor has any such Person been so debarred; . There are no consent decrees (iiincluding plea agreements) has been convicted of any crime or engaged in any conduct similar actions to which would reasonably be expected to cause Seller to be excluded from participating in federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, Talos or any similar applicable Law, nor has any such Person been so excluded; or (iii) to the Knowledge of Seller, is subject to an investigation or proceeding by any Regulatory Authority that could result in such a suspension, exclusion or debarment and there are no factsits Subsidiaries or, to the Knowledge of SellerTalos, any director, officer, employee, agent or Representative thereof, are bound or which relate to Talos Products.
(d) Each of Talos and each of its Subsidiaries is and has been in compliance in all material respects with all applicable statutes, rules, regulations, decrees, writs and orders of the FDA and any other Talos Regulatory Agency with respect to the labeling, storing, testing, development, manufacture, packaging and distribution of the Talos Products. All required pre-clinical toxicology studies conducted by or on behalf of Talos or its Subsidiaries and Talos-sponsored clinical trials (or clinical trials sponsored by Talos or any other Subsidiary) conducted or being conducted with respect thereto, have been and are being conducted in compliance in all material respects with applicable licenses and Laws, including, without limitation, the applicable requirements of the FDA’s current Good Manufacturing Practices, Good Laboratory Practices and Good Clinical Practices. The results of any such studies, tests and trials, and all other material information related to such studies, tests and trials, have been made available to the Company. Each clinical trial conducted by or on behalf of Talos or any of its Subsidiaries with respect to Talos Products has been conducted in accordance with its clinical trial protocol, and in compliance in all material respects with all applicable Laws, including Good Clinical Practices, Informed Consent and all other applicable requirements contained in 21 CFR Parts 312, 50, 54, 56 and 11. Each of Talos and its Subsidiaries has filed all required notices (and made available to the Company copies thereof) of adverse drug experiences, injuries or deaths relating to clinical trials conducted by or on behalf of Talos or any of its Subsidiaries with respect to such Talos Products.
(e) All applications, submissions, information and data utilized by any Talos or any of its Subsidiaries as the basis for, or submitted by or on behalf of Talos or any of its Subsidiaries in connection with any and all requests for a Talos Permit relating to Talos or any of its Subsidiaries, when submitted to the FDA or other Talos Regulatory Agency, were true, correct and complete in all material respects as of the date of submission, and any updates, changes, corrections or modification to such applications, submissions, information and data required under applicable Laws have been submitted to the FDA or other Talos Regulatory Agency.
(f) None of Talos or its Subsidiaries nor, to the Knowledge of Talos, any of the Representatives, licensors, licensees, assignors or assignees thereof has received any notice that the FDA or any other Talos Regulatory Agency has initiated, or threatened to initiate, any Action to suspend any clinical trial, suspend or terminate any Investigational New Drug Application sponsored by Talos or any of its Subsidiaries or otherwise restrict the pre-clinical research or clinical study of any Talos Product or any drug product being developed by any licensee or assignee of the Talos Intellectual Property based on such intellectual property, or to recall, suspend or otherwise restrict the development or manufacture of any Talos Product. None of Talos or any of its Subsidiaries is in receipt of written notice of, or is subject to, any adverse inspection, finding of deficiency, finding of non-compliance, investigation, civil or criminal proceeding, hearing, suit, demand, claim, complaint, inquiry, proceeding, or other compliance or enforcement action relating to any Talos Products. To the Knowledge of Talos, there is no act, omission, event or circumstance that would reasonably be expected to give rise to any such suspension, exclusion or debarmentaction.
(hg) Neither Seller nor Talos and its Subsidiaries have made available to the Company true, correct and complete copies of any Affiliate hasand all applications, in connection approvals, licenses, written notices of inspectional observations, establishment inspection reports and any other documents received from the FDA or other Talos Regulatory Agency, including documents that indicate or suggest lack of compliance with the regulatory requirements of the FDA or other Talos Regulatory Agency. Talos and its Exploitation Subsidiaries have made available to the Company for review all correspondence to or from the FDA or other Talos Regulatory Agency, minutes of a Productmeetings, conducted any business written reports of phone conversations, visits or engaged other contact with the FDA or other Talos Regulatory Agency, notices of inspectional observations, establishment inspection reports, and all other documents concerning communications to or from the FDA or other Talos Regulatory Agency, or prepared by the FDA or other Talos Regulatory Agency or which bear in any transaction way on Talos’ or dealing any of its Subsidiaries’ compliance with regulatory requirements of the FDA or any Person with whom transactions wereother Talos Regulatory Agency, at the time of such transaction, prohibited as to U.S. Persons by any applicable sanctions Laws administered by the U.S. Treasury Department’s Office of Foreign Assets Control (“OFAC”), including persons appearing or on the List likelihood or timing of Specially Designated Nationals and Blocked Persons published by OFACapproval of any Talos Products.
Appears in 1 contract
Samples: Merger Agreement (Targacept Inc)
Compliance with Laws; Regulatory Compliance. (a) The Exploitation by Seller and its Affiliates of any Product and the ownership by Seller and its Affiliates of the Purchased Assets have been, at all times, SSMP is in material compliance with all applicable LawLaws or Orders, including applicable Regulatory Laws. Except as set forth in Seller’s Disclosure Schedule, neither Seller nor except where any Affiliate has received any written communication from a Governmental Entity that alleges that Seller or any Affiliate is not such failure to be in compliance would not reasonably be expected to result in material Liability to SSMP or otherwise materially interfere with the conduct of the business of SSMP in substantially the manner currently conducted. No investigation, inquiry, proceeding or similar action by any material respect with any Law or Order Governmental Authority with respect to its Exploitation SSMP is pending or, to the Knowledge of SSMP, threatened, nor has any Product Governmental Authority indicated in writing an intention to conduct the same which, in each case, would not reasonably be expected to result in material Liability to SSMP or otherwise materially interfere with respect to ownership the conduct of the Purchased Assets, respectively and as applicable. Seller and its Affiliates have, and have had, all Product Registrations necessary for its lawful Exploitation business of any Product prior to SSMP in substantially the Closing Date, and each of such Product Registrations, if any, is valid and in full force and effectmanner currently conducted.
(b) Except as set forth would not reasonably be expected to result in material Liability to SSMP or otherwise materially interfere with the Seller Disclosure Scheduleconduct of the business of SSMP in substantially the manner currently conducted, (i) SSMP and its employees and agents hold all permits, licenses, variances, registrations, authorizations, exemptions, Orders, consents and approvals from the FDA and any other Governmental Authority that is concerned with the quality, identity, strength, purity, safety, efficacy or manufacturing of SSMP Products (any such Governmental Authority, a “SSMP Regulatory Agency”) necessary for the lawful operating of the business of SSMP as currently conducted (the “SSMP Permits”), including all authorizations required under the FDCA, and the regulations of the FDA promulgated thereunder, and the PHSA, and the regulations of the FDA promulgated thereunder (it is acknowledged that any SSMP Product that is not a marketed product or has not received marketing approval will require further permits, licenses, variances, registrations, authorizations, exemptions, Orders, consents and/or approvals before such SSMP Product may be marketed), (ii) all such SSMP Permits are valid, and in full force and effect, (iii) since January 1, 2020, there has not been occurred any claim violation of, default (with or without notice or lapse of which Seller time or both) under, or event giving to others any Affiliate right of termination, amendment or cancellation of, with or without notice or lapse of time or both, any SSMP Permit, and (iv) SSMP is in compliance with the terms of all SSMP Permits, and no event has received notice of any Action pending or threatened against Seller or an Affiliate relating occurred that, to any Product or the Purchased Assets. To the Knowledge of SellerSSMP, there is no fact would reasonably be expected to result in the revocation, cancellation, non-renewal or circumstance adverse modification of any SSMP Permit.
(c) Neither SSMP nor, to the Knowledge of SSMP, any of its directors, officers, employees, agents or Representatives, has (i) committed any act, made any statement or failed to make any statement that would reasonably be expected to serve as provide a basis for any Action against Seller the FDA or any Affiliate relating other SSMP Regulatory Agency to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” as set forth in 56 Fed. Reg. 46191 (Sept. 10, 1991) and any Product amendments thereto or (ii) engaged in any Purchased Assets activity prohibited under U.S. federal or thatstate criminal or civil health care Laws (including without limitation the U.S. federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), if successfulthe Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), could reasonably be expected False Claims Act (31 U.S.C. §§ 3729 et seq.), Health Insurance Portability and Accountability Act (42 U.S.C. § 1320d et seq.), as amended by the Health Information, Technology for Economic and Clinical Health Act of 2009, the civil monetary penalty laws (42 U.S.C. § 1320a-7a), the FDCA, the PHSA and any comparable state or foreign Laws), or the regulations promulgated pursuant to result in restrainingsuch Laws (each, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreementa “Health Care Law”). There is no Action pending by Seller civil, criminal, administrative or any Affiliateother proceeding, notice or which Seller intends to initiate against any Third Party relating to any Product or any Purchased Asset. There is no outstanding Order of any Governmental Entity against Seller (i) that relates to the Businessdemand pending, a Product or any Purchased Asset, (ii) that could reasonably be expected to be materially adverse to the Business, any Product or any Purchased Asset, or (iii) that could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreement.
(c) There is no Action pending received or, to the Knowledge of SellerSSMP, threatened against Seller by any Governmental Entity, and there is no claim, investigation or administrative action SSMP that relates to an alleged violation of any Governmental Entity pending orHealth Care Law. Neither SSMP nor, to the Knowledge of Seller, threatened, that affects or, if successful, could reasonably be expected to be materially adverse to Seller, the Business, a ProductSSMP, any Purchased Assets of its directors, officers, employees, agents or the Assumed Liabilities or thatRepresentatives, if successful, could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreement, nor are there, to the Knowledge of Seller, any facts, circumstances or conditions on which any such Action could be brought in the future.
(d) Except as set forth in the Seller Disclosure Schedule, Seller and its Affiliates have timely filed all material reports, statements, documents, registrations, filings, amendments, supplements and submissions required to be filed by it with respect to any Product and the Purchased Assets under applicable Regulatory Laws. Each such filing was, in all material respects, true, complete and correct as of the date of submission, and any necessary or required updates, changes, corrections, amendments, supplements or modifications to such filings have been submitted to the applicable Governmental Entity.
(e) Except for notice of the Clinical Hold, neither Seller nor any Affiliate has, with respect to any Product or any Purchased Asset, (i) received or been subject to any action, notice, warning, administrative proceeding, review or investigation by a Regulatory Authority that alleges or asserts that Seller or any Affiliate has violated any applicable Regulatory Laws or (ii) been subject to a corporate integrity agreement, deferred prosecution agreement, consent decree, monitoring agreement, settlement agreement or other similar agreement or Order mandating or prohibiting future or past activities.
(f) Except as set forth on Schedule 4.9(f), the Manufacturing and servicing operations conducted by or on behalf of Seller and its Affiliates with respect to any Product are conducted in material compliance with applicable Regulatory Laws, including applicable current good manufacturing practice regulations and similar federal, state, local or foreign requirements for the Manufacture of any Product.
(g) Neither Seller, nor any Affiliate, nor any officer, employee or agent of Seller or of any Affiliate, in each case who has been materially involved in the Exploitation of any Product (i) has been convicted of any crime or engaged in any conduct in the operation of Seller’s business for which debarment is mandated by 21 U.S.C. sec. 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a sec. 335a(b) or any similar applicable Law, nor has any such Person been so debarred; (ii) has been convicted of any crime or engaged in any conduct which would reasonably be expected to cause Seller to be excluded from participating in federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar applicable Law, nor has any such Person been so excluded; or (iii) to the Knowledge of Seller, is subject to an investigation or proceeding by any Regulatory Authority that could result in such a suspension, exclusion or debarment and there . There are no factsconsent decrees (including plea agreements) or similar actions to which SSMP is or, to the Knowledge of SellerSSMP, any of its directors, officers, employees, agents or Representatives are, bound or which relate to SSMP Products.
(d) SSMP is and has been in compliance in all material respects with all applicable statutes, rules, regulations, decrees, writs and orders of the FDA and any other SSMP Regulatory Agency with respect to the labeling, storing, testing, development, manufacture, packaging and distribution of SSMP Products. All required pre-clinical studies conducted by or, to the Knowledge of SSMP, on behalf of SSMP and Company-sponsored clinical trials (or clinical trials sponsored by SSMP) conducted or, to the Knowledge of SSMP, being conducted with respect thereto, have been and are being conducted in compliance in all material respects with applicable licenses and Laws, including, without limitation, the applicable requirements of the FDCA and the regulations of the FDA promulgated thereunder, including, but not limited to, 21 C.F.R. Parts 50, 54, 56, 58, 210, 211, and 312. SSMP has been provided with the opportunity to inspect the results of any such studies, tests and trials and all material information related thereto. Each clinical trial conducted by or, to the Knowledge of SSMP, on behalf of SSMP with respect to SSMP Products has been conducted in accordance with its clinical trial protocol, and in compliance in all material respects with all applicable Laws, including FDCA and the regulations of the FDA promulgated thereunder, including, but not limited to, 21 C.F.R. Parts 50, 54, 56, 58, 210, 211 and 312. SSMP has filed all required notices of adverse experiences, injuries or deaths relating to clinical trials conducted by or on behalf of SSMP with respect to such SSMP Products.
(e) All applications, submissions, information and data utilized by SSMP as the basis for, or submitted by or on behalf of SSMP in connection with, any and all requests for a SSMP Permit relating to SSMP, when submitted to the FDA or other SSMP Regulatory Agency, were true, correct and complete in all material respects as of the date of submission, and any updates, changes, corrections or modification to such applications, submissions, information and data required under applicable Laws have been submitted to the FDA or other SSMP Regulatory Agency.
(f) Neither SSMP nor, to the Knowledge of SSMP, any of its Representatives, licensors, licensees, assignors or assignees has received any written notice that the FDA or any other SSMP Regulatory Agency has initiated, or threatened to initiate, any action to suspend any clinical trial, suspend or terminate any investigational new drug application sponsored by SSMP or otherwise restrict the pre-clinical research or clinical study of any SSMP Product being developed by any licensee or assignee of SSMP Intellectual Property based on such intellectual property, or to recall, suspend or otherwise materially restrict the development or manufacture of any SSMP Product. SSMP is not in receipt of written notice of, and is not subject to, any adverse inspection, finding of deficiency, finding of non-compliance, investigation, civil or criminal proceeding, hearing, suit, demand, claim, complaint, inquiry, proceeding, or other compliance or enforcement action relating to any SSMP Products. To the Knowledge of SSMP, there is no act, omission, event or circumstance that would reasonably be expected to give rise to any such suspension, exclusion or debarmentaction.
(hg) Neither Seller nor SSMP has been provided with the opportunity to inspect true, correct and complete copies of any Affiliate hasand all applications, in connection approvals, licenses, written notices of inspectional observations, establishment inspection reports and any other documents received from the FDA or other SSMP Regulatory Agency, including documents that indicate or suggest lack of compliance with its Exploitation the Laws of a Productthe FDA or other SSMP Regulatory Agency. SSMP has been provided with the opportunity to inspect all correspondence to or from the FDA or other SSMP Regulatory Agency, conducted any business minutes of meetings, written reports of phone conversations, visits or engaged other contact with the FDA or other SSMP Regulatory Agency, notices of inspectional observations, establishment inspection reports, and all other documents concerning communications to or from the FDA or other SSMP Regulatory Agency, or prepared by the FDA or other SSMP Regulatory Agency or which bear in any transaction or dealing with any Person with whom transactions were, at the time of such transaction, prohibited as to U.S. Persons by any applicable sanctions Laws administered by the U.S. Treasury Department’s Office of Foreign Assets Control (“OFAC”), including persons appearing way on the List compliance by SSMP with the Laws of Specially Designated Nationals and Blocked Persons published by OFACthe FDA or any other SSMP Regulatory Agency, or on the likelihood or timing of approval of any SSMP Products.
Appears in 1 contract
Samples: Merger Agreement (Second Sight Medical Products Inc)
Compliance with Laws; Regulatory Compliance. (a) The Exploitation by Seller Each of Saffron and each of its Affiliates of any Product and the ownership by Seller and its Affiliates of the Purchased Assets have been, at all times, Subsidiaries is in material compliance with all applicable LawLaws or Orders, including applicable Regulatory Laws. Except as set forth in Seller’s Disclosure Schedule, neither Seller nor except where any Affiliate has received any written communication from a Governmental Entity that alleges that Seller or any Affiliate is not such failure to be in compliance has not had, or would not reasonably be expected to have, individually or in the aggregate, a Saffron Material Adverse Effect. No investigation, inquiry, proceeding or similar action by any material respect with any Law or Order Governmental Authority with respect to Saffron or any of its Exploitation of any Product or with respect to ownership of the Purchased AssetsSubsidiaries is pending or, respectively and as applicable. Seller and its Affiliates have, and have had, all Product Registrations necessary for its lawful Exploitation of any Product prior to the Closing DateKnowledge of Saffron, threatened in writing, nor has any Governmental Authority indicated in writing an intention to conduct the same which, in each case, would reasonably be expected to have a material and each adverse impact on Saffron or any of such Product Registrations, if any, is valid and in full force and effectits Subsidiaries.
(b) Except as set forth has not had, and would not reasonably be expected to have, individually or in the Seller Disclosure Scheduleaggregate, a Saffron Material Adverse Effect, each of Saffron and its Subsidiaries and their respective employees and agents hold all permits, licenses, variances, registrations, authorizations, exemptions, Orders, consents and approvals from the FDA and any other Governmental Authority that is concerned with the quality, identity, strength, purity, safety, efficacy or manufacturing of Saffron Products (any such Governmental Authority, a “Saffron Regulatory Agency”) necessary for the lawful operating of the businesses of Saffron and each of its Subsidiaries as currently conducted (the “Saffron Permits”), including all authorizations required under the FDCA and the regulations of the FDA promulgated thereunder, and the PHSA and the regulations of the FDA promulgated thereunder. Notwithstanding the foregoing, it is acknowledged that no Saffron Product is a marketed product or has received marketing approval and, therefore, that further permits, licenses, variances, registrations, authorizations, exemptions, Orders, consents and/or approvals will be required before any Saffron Product may be marketed. Except as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Saffron Material Adverse Effect, all such Saffron Permits are valid, and in full force and effect. Since January 1, 2015, there has not been occurred any claim violation of, default (with or without notice or lapse of which Seller time or both) under, or event giving to others any Affiliate right of termination, amendment or cancellation of, with or without notice or lapse of time or both, any Saffron Permit except as has received notice not had, and would not reasonably be expected to have, individually or in the aggregate, a Saffron Material Adverse Effect. Each of any Action pending or threatened against Seller or an Affiliate relating Saffron and each of its Subsidiaries is in compliance in all material respects with the terms of all Saffron Permits, and no event has occurred that, to any Product or the Purchased Assets. To the Knowledge of SellerSaffron, there is no fact would reasonably be expected to result in the revocation, cancellation, non-renewal or circumstance adverse modification of any Saffron Permit, except as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Saffron Material Adverse Effect.
(c) None of Saffron or its Subsidiaries nor, to the Knowledge of Saffron, any director, officer, employee, agent or Representative thereof, has committed any act, made any statement or failed to make any statement that would reasonably be expected to serve as provide a basis for any Action against Seller the FDA or any Affiliate relating other Saffron Regulatory Agency to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” as set forth in 56 Fed. Reg. 46191 (Sept. 10, 1991) and any Product amendments thereto. None of Saffron or its Subsidiaries nor, to the Knowledge of Saffron, any Purchased Assets director, officer, employee, agent or thatRepresentative thereof, if successful, could reasonably be expected to result has engaged in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreementany activity prohibited under any Health Care Law. There is no Action pending by Seller civil, criminal, administrative or any Affiliateother proceeding, notice or which Seller intends to initiate against any Third Party relating to any Product or any Purchased Asset. There is no outstanding Order of any Governmental Entity against Seller (i) that relates to the Businessdemand pending, a Product or any Purchased Asset, (ii) that could reasonably be expected to be materially adverse to the Business, any Product or any Purchased Asset, or (iii) that could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreement.
(c) There is no Action pending received or, to the Knowledge of SellerSaffron, threatened in writing against Seller by Saffron or any Governmental Entity, and there is no claim, investigation or administrative action of its Subsidiaries that relates to an alleged violation of any Governmental Entity pending orHealth Care Law. None of Saffron or any of its Subsidiaries nor, to the Knowledge of Seller, threatened, that affects or, if successful, could reasonably be expected to be materially adverse to Seller, the Business, a ProductSaffron, any Purchased Assets or the Assumed Liabilities or thatdirector, if successful, could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreement, nor are there, to the Knowledge of Seller, any facts, circumstances or conditions on which any such Action could be brought in the future.
(d) Except as set forth in the Seller Disclosure Schedule, Seller and its Affiliates have timely filed all material reports, statements, documents, registrations, filings, amendments, supplements and submissions required to be filed by it with respect to any Product and the Purchased Assets under applicable Regulatory Laws. Each such filing was, in all material respects, true, complete and correct as of the date of submission, and any necessary or required updates, changes, corrections, amendments, supplements or modifications to such filings have been submitted to the applicable Governmental Entity.
(e) Except for notice of the Clinical Hold, neither Seller nor any Affiliate has, with respect to any Product or any Purchased Asset, (i) received or been subject to any action, notice, warning, administrative proceeding, review or investigation by a Regulatory Authority that alleges or asserts that Seller or any Affiliate has violated any applicable Regulatory Laws or (ii) been subject to a corporate integrity agreement, deferred prosecution agreement, consent decree, monitoring agreement, settlement agreement or other similar agreement or Order mandating or prohibiting future or past activities.
(f) Except as set forth on Schedule 4.9(f), the Manufacturing and servicing operations conducted by or on behalf of Seller and its Affiliates with respect to any Product are conducted in material compliance with applicable Regulatory Laws, including applicable current good manufacturing practice regulations and similar federal, state, local or foreign requirements for the Manufacture of any Product.
(g) Neither Seller, nor any Affiliate, nor any officer, employee employee, agent or agent of Seller or of any AffiliateRepresentative thereof, in each case who has been materially involved in the Exploitation of any Product (i) has been convicted of any crime or engaged in any conduct in the operation of Seller’s business for which debarment is mandated by 21 U.S.C. sec. 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a sec. 335a(b) or any similar applicable Law, nor has any such Person been so debarred; . There are no consent decrees (iiincluding plea agreements) has been convicted of any crime or engaged in any conduct similar actions to which would reasonably be expected to cause Seller to be excluded from participating in federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, Saffron or any similar applicable Law, nor has any such Person been so excluded; or (iii) to the Knowledge of Seller, is subject to an investigation or proceeding by any Regulatory Authority that could result in such a suspension, exclusion or debarment and there are no factsits Subsidiaries or, to the Knowledge of SellerSaffron, any director, officer, employee, agent or Representative thereof, are bound or which relate to Saffron Products.
(d) Each of Saffron and each of its Subsidiaries is and has been in compliance in all material respects with all applicable statutes, rules, regulations, decrees, writs and orders of the FDA and any other Saffron Regulatory Agency with respect to the labeling, storing, testing, development, manufacture, packaging and distribution of the Saffron Products. All required pre-clinical toxicology studies conducted by or, to the Knowledge of Saffron, on behalf of Saffron or its Subsidiaries and Saffron-sponsored clinical trials (or clinical trials sponsored by Saffron or any other Subsidiary) conducted or, to the Knowledge of Saffron, being conducted with respect thereto, have been and are being conducted in compliance in all material respects with applicable licenses and Laws, including, without limitation, the applicable requirements of the FDCA and the regulations of the FDA promulgated thereunder, including, but not limited to, 21 C.F.R. Parts 50, 54, 56, 58, 210, 211, and 312. The results of any such studies, tests and trials, and all other material information related to such studies, tests and trials, have been made available to the Company. Each clinical trial conducted by or, to the Knowledge of Saffron, on behalf of Saffron or any of its Subsidiaries with respect to Saffron Products has been conducted in accordance with its clinical trial protocol, and in compliance in all material respects with all applicable Laws, including FDCA and the regulations of the FDA promulgated thereunder, including, but not limited to, 21 C.F.R. Parts 50, 54, 56, 58, 210, 211, and 312. Each of Saffron and its Subsidiaries has filed all required notices (and made available to the Company copies thereof) of serious adverse drug experiences, injuries or deaths relating to clinical trials conducted by or on behalf of Saffron or any of its Subsidiaries with respect to such Saffron Products.
(e) All applications, submissions, information and data utilized by any Saffron or any of its Subsidiaries as the basis for, or submitted by or on behalf of Saffron or any of its Subsidiaries in connection with any and all requests for a Saffron Permit relating to Saffron or any of its Subsidiaries, when submitted to the FDA or other Saffron Regulatory Agency, were true, correct and complete in all material respects as of the date of submission, and any updates, changes, corrections or modification to such applications, submissions, information and data required under applicable Laws have been submitted to the FDA or other Saffron Regulatory Agency.
(f) None of Saffron or its Subsidiaries nor, to the Knowledge of Saffron, any of the Representatives, licensors, licensees, assignors or assignees thereof has received any written notice that the FDA or any other Saffron Regulatory Agency has initiated, or threatened to initiate, any action to suspend any clinical trial, suspend or terminate any Investigational New Drug Application sponsored by Saffron or any of its Subsidiaries or otherwise restrict the pre-clinical research or clinical study of any Saffron Product or any drug product being developed by any licensee or assignee of the Saffron Intellectual Property based on such intellectual property, or to recall, suspend or otherwise materially restrict the development or manufacture of any Saffron Product. None of Saffron or any of its Subsidiaries is in receipt of written notice of, or is subject to, any adverse inspection, finding of deficiency, finding of non-compliance, investigation, civil or criminal proceeding, hearing, suit, demand, claim, complaint, inquiry, proceeding, or other compliance or enforcement action relating to any Saffron Products. To the Knowledge of Saffron, there is no act, omission, event or circumstance that would reasonably be expected to give rise to any such suspension, exclusion or debarmentaction.
(hg) Neither Seller nor Saffron and its Subsidiaries have made available to the Company true, correct and complete copies of any Affiliate hasand all applications, in connection approvals, licenses, written notices of inspectional observations, establishment inspection reports and any other documents received from the FDA or other Saffron Regulatory Agency, including documents that indicate or suggest lack of compliance with the Laws of the FDA or other Saffron Regulatory Agency. Saffron and its Exploitation Subsidiaries have made available to the Company for review all correspondence to or from the FDA or other Saffron Regulatory Agency, minutes of a Productmeetings, conducted any business written reports of phone conversations, visits or engaged other contact with the FDA or other Saffron Regulatory Agency, notices of inspectional observations, establishment inspection reports, and all other documents concerning communications to or from the FDA or other Saffron Regulatory Agency, or prepared by the FDA or other Saffron Regulatory Agency or which bear in any transaction way on Saffron’s or dealing any of its Subsidiaries’ compliance with the Laws of the FDA or any Person with whom transactions wereother Saffron Regulatory Agency, at the time of such transaction, prohibited as to U.S. Persons by any applicable sanctions Laws administered by the U.S. Treasury Department’s Office of Foreign Assets Control (“OFAC”), including persons appearing or on the List likelihood or timing of Specially Designated Nationals and Blocked Persons published by OFACapproval of any Saffron Products.
Appears in 1 contract
Compliance with Laws; Regulatory Compliance. (a) The Exploitation by Seller Each of Parent and each of its Affiliates of any Product and the ownership by Seller and its Affiliates of the Purchased Assets have been, at all times, Subsidiaries is in material compliance with all applicable LawLaws or Orders, including applicable Regulatory Laws. Except as set forth in Seller’s Disclosure Schedule, neither Seller nor except where any Affiliate has received any written communication from a Governmental Entity that alleges that Seller or any Affiliate is not such failure to be in compliance in any material respect with any Law or Order with respect to its Exploitation of any Product or with respect to ownership of the Purchased Assets, respectively and as applicable. Seller and its Affiliates have, and have has not had, all Product Registrations necessary for its lawful Exploitation of any Product prior to the Closing Date, and each of such Product Registrations, if any, is valid and in full force and effect.
(b) Except as set forth in the Seller Disclosure Schedule, there has or would not been any claim of which Seller or any Affiliate has received notice of any Action pending or threatened against Seller or an Affiliate relating to any Product or the Purchased Assets. To the Knowledge of Seller, there is no fact or circumstance that would reasonably be expected to serve as have, individually or in the aggregate, a basis for any Action against Seller Parent Material Adverse Effect or any Affiliate relating to any Product or any Purchased Assets or that, if successful, could would not reasonably be expected to result in restraining, enjoining prevent or otherwise preventing materially impair the completion by Seller consummation of the transactions contemplated Contemplated Transactions. No investigation, inquiry, proceeding or similar action by this Agreement. There is no Action pending by Seller any Governmental Authority with respect to Parent or any Affiliate, or which Seller intends to initiate against any Third Party relating to any Product or any Purchased Asset. There of its Subsidiaries is no outstanding Order of any Governmental Entity against Seller (i) that relates to the Business, a Product or any Purchased Asset, (ii) that could reasonably be expected to be materially adverse to the Business, any Product or any Purchased Asset, or (iii) that could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreement.
(c) There is no Action pending or, to the Knowledge of SellerParent, threatened against Seller by in writing, nor has any Governmental EntityAuthority indicated in writing an intention to conduct the same which, in each case, would reasonably be expected to have a Parent Material Adverse Effect.
(b) Each of Parent and each of its Subsidiaries holds all material Permits from the U.S. Food and Drug Administration (the “FDA”) and any other Governmental Authority that is concerned with the quality, identity, strength, purity, safety, efficacy or manufacturing of Parent Product Candidates (any such Governmental Authority, a “Parent Regulatory Agency”) necessary for the operating of the Parent Businesses in material compliance with applicable Laws (the “Parent Permits”), including all Parent Permits required under the Federal Food, Drug and Cosmetic Act of 1938, as amended, and there the regulations of the FDA promulgated thereunder (the “FDCA”), the Public Health Service Act of 1944, as amended, and the regulations of the FDA promulgated thereunder (the “PHSA”), and any comparable Laws of other applicable jurisdictions. Except as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect, all such Parent Permits are valid, and in full force and effect. There has not occurred any violation of, default (with or without notice or lapse of time or both) under, or event giving to others any right of termination, amendment or cancellation of, with or without notice or lapse of time or both, any Parent Permit except as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. Each of Parent and each of its Subsidiaries is in compliance in all material respects with the terms of all Parent Permits, and no event has occurred that, to the Knowledge of Parent, would reasonably be expected to result in the revocation, cancellation, non-renewal or adverse modification of any Parent Permit, except as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect.
(c) None of Parent or its Subsidiaries nor, to the Knowledge of Parent, any employee or agent thereof, has made any untrue statement of material fact or a fraudulent statement to the FDA or any other Parent Regulatory Agency, or failed to disclose a material fact required to be disclosed to the FDA or other such Parent Regulatory Agency, or committed an act, made a statement, or failed to make a statement, in each such case related to the Parent Product Candidates, that, at the time such disclosure was made, would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” as set forth in 56 Fed. Reg. 46191 (Sept. 10, 1991) and any amendments thereto. None of Parent nor, to the Knowledge of Parent, any director, officer, employee or agent thereof, has engaged in any activity prohibited under U.S. federal or state criminal or civil health care Laws, including the U.S. federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), the Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), the False Claims Act (31 U.S.C. §§ 3729 et seq.), the Health Insurance Portability and Accountability Act (42 U.S.C. § 1320d et seq.), as amended by the Health Information, Technology for Economic and Clinical Health Act of 2009, the civil monetary penalty laws (42 U.S.C. § 1320a-7a), the FDCA, the PHSA, the regulations promulgated pursuant to such Laws, and any equivalent applicable Laws of other jurisdictions (each, a “Health Care Law”). There is no claimcivil, investigation criminal, administrative or administrative action of any Governmental Entity pending other proceeding, notice or demand pending, received, or, to the Knowledge of SellerParent, threatenedthreatened in writing against Parent or any of its Subsidiaries that asserts an alleged violation, that affects orin any material respect, if successfulof any Health Care Law. None of Parent or any of its Subsidiaries or any employee or agent thereof, could reasonably be expected has under any Health Care Law, been debarred, excluded, suspended, or otherwise determined to be materially adverse ineligible to Sellerparticipate in any health care programs of any Governmental Authority, the Businessconvicted of any crime, a Product, any Purchased Assets or the Assumed Liabilities or that, if successful, could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreement, nor are thereor, to the Knowledge of SellerParent, engaged in any conduct that has resulted in any such debarment, exclusion, suspension, ineligibility, or conviction, including any debarment mandated by 21 U.S.C. § 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a(b) or any similar Law. Neither Parent nor any of its Subsidiaries is a party to any consent decrees (including plea agreements) or similar actions to which Parent or any of its Subsidiaries or, to the Knowledge of Parent, any factsdirector, circumstances officer, employee or conditions on agent thereof, are bound or which any such Action could be brought in the futurerelate to Parent Product Candidates.
(d) Except as set forth Each of Parent and each of its Subsidiaries is in the Seller Disclosure Schedule, Seller and its Affiliates have timely filed compliance in all material reportsrespects with all applicable Laws enforced by, statementsand Orders of, documents, registrations, filings, amendments, supplements the FDA and submissions required to be filed by it any other Parent Regulatory Agency with respect to any Product the labeling, storing, testing, development, manufacture, packaging and the Purchased Assets under applicable Regulatory Laws. Each such filing was, in all material respects, true, complete and correct as distribution of the date Parent Product Candidates. To the Knowledge of submissionParent, and any necessary or all required updates, changes, corrections, amendments, supplements or modifications to such filings have been submitted to the applicable Governmental Entity.
(e) Except for notice of the Clinical Hold, neither Seller nor any Affiliate has, with respect to any Product or any Purchased Asset, (i) received or been subject to any action, notice, warning, administrative proceeding, review or investigation by a Regulatory Authority that alleges or asserts that Seller or any Affiliate has violated any applicable Regulatory Laws or (ii) been subject to a corporate integrity agreement, deferred prosecution agreement, consent decree, monitoring agreement, settlement agreement or other similar agreement or Order mandating or prohibiting future or past activities.
(f) Except as set forth on Schedule 4.9(f), the Manufacturing and servicing operations pre-clinical toxicology studies conducted by or on behalf of Seller Parent or its Subsidiaries and its Affiliates with respect to all clinical trials sponsored by Parent or any Product other Subsidiary are being conducted in compliance in all material compliance respects with applicable Regulatory Parent Permits and applicable Laws, including including, the applicable current good manufacturing practice requirements of the FDCA and the regulations of the FDA promulgated thereunder, including, any applicable requirements of 21 C.F.R. Parts 50, 54, 56, 58, 210, 211, and similar federal, state, local or foreign requirements for the Manufacture 312. The material results of any Product.
(g) Neither Sellersuch studies, nor any Affiliatetests and trials, nor any officerand all other material information related to such studies, employee or agent of Seller or of any Affiliatetests and trials, in each case who has have been materially involved in the Exploitation of any Product (i) has been convicted of any crime or engaged in any conduct in the operation of Seller’s business for which debarment is mandated or authorized by 21 U.S.C. § 335a or any similar applicable Law, nor has any such Person been so debarred; (ii) has been convicted of any crime or engaged in any conduct which would reasonably be expected to cause Seller to be excluded from participating in federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar applicable Law, nor has any such Person been so excluded; or (iii) made available to the Knowledge of Seller, is subject to an investigation or proceeding Company. Each clinical trial conducted by any Regulatory Authority that could result in such a suspension, exclusion or debarment and there are no factsor, to the Knowledge of SellerParent, on behalf of Parent or any of its Subsidiaries with respect to Parent Product Candidates has been conducted in compliance in all material respects with all applicable Laws, including FDCA and the regulations of the FDA promulgated thereunder, including, any applicable requirements of 21 C.F.R. Parts 50, 54, 56, 58, 210, 211, and 312. Each of Parent and its Subsidiaries has filed with applicable Parent Regulatory Agencies all material notices required to be filed (and made available to the Company copies thereof) of adverse drug experiences, injuries or deaths relating to clinical trials conducted by or on behalf of Parent or any of its Subsidiaries with respect to the Parent Product Candidates.
(e) None of Parent or its Subsidiaries has received any written notice that the FDA or any other Parent Regulatory Agency has initiated, or threatened in writing to initiate, any action to suspend any clinical trial, suspend or terminate any investigational new drug application or similar health care Permit sponsored by Parent or any of its Subsidiaries or otherwise materially restrict the pre-clinical research or clinical study of any Parent Product Candidate or any drug product being developed by or on behalf of Parent or any of its Subsidiaries, or to recall, suspend or otherwise materially restrict the development or manufacture of any Parent Product Candidate, except as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Parent Material Adverse Effect. To the Knowledge of Parent, there is no act, omission, event or circumstance that would reasonably be expected to give rise to any such suspension, exclusion or debarmentaction.
(hf) Neither Seller nor With respect to the Parent Business and the Parent Product Candidates, Parent and its Subsidiaries have made available to the Company for review copies of any Affiliate hasand all material regulatory applications and submissions (and any supplements or amendments thereto) under applicable Health Care Laws, in connection Parent Permits, written notices of inspectional observations, and establishment inspection reports of Parent Regulatory Agencies, notifications, communications, correspondence, registrations, master files, and/or other filings made to, received from or otherwise conducted with a Parent Regulatory Agency, reports or other documents of Parent or its Exploitation Subsidiaries that assert or address lack of a Product, conducted any business or engaged in any transaction or dealing material compliance with any Person Health Care Laws, or the likelihood or timing of marketing approval of any Parent Product Candidates, records and other materials maintained to comply with whom transactions wereapplicable Health Care Laws (e.g. regarding good laboratory practice, at the time of such transactiongood clinical practice, prohibited as to U.S. Persons by any applicable sanctions Laws administered by the U.S. Treasury Department’s Office of Foreign Assets Control (“OFAC”and good manufacturing practice), and records that are necessary or advisable in order to obtain Parent Permits or other approvals from Parent Regulatory Agencies. Such books and records are complete and correct in all material respects and have been maintained in accordance with sound business practices, including persons appearing on the List maintenance of Specially Designated Nationals and Blocked Persons published by OFACan adequate system of internal controls.
Appears in 1 contract
Samples: Merger Agreement (Skinvisible Inc)
Compliance with Laws; Regulatory Compliance. (a) The Exploitation by Seller Each of the Company and its Affiliates of any Product and the ownership by Seller and its Affiliates of the Purchased Assets have been, at all times, Subsidiaries is in material compliance with all applicable LawLaws or Orders, including applicable Regulatory Laws. Except as set forth in Seller’s Disclosure Schedule, neither Seller nor except where any Affiliate has received any written communication from a Governmental Entity that alleges that Seller or any Affiliate is not such failure to be in compliance has not had, or would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. No investigation or review by any material respect with any Law or Order Governmental Authority with respect to the Company or any of its Exploitation of any Product or with respect Subsidiaries is pending or, to ownership the Knowledge of the Purchased AssetsCompany, respectively threatened, nor has any Governmental Authority indicated an intention to conduct the same which, in each case, would reasonably be expected to have a material and as applicable. Seller and adverse impact on the Company or any of its Affiliates have, and have had, all Product Registrations necessary for its lawful Exploitation of any Product prior to the Closing Date, and each of such Product Registrations, if any, is valid and in full force and effectSubsidiaries.
(b) Except as set forth has not had, and would not reasonably be expected to have, individually or in the Seller Disclosure Scheduleaggregate, a Company Material Adverse Effect, each of the Company and its Subsidiaries and their respective employees and agents hold all permits, licenses, variances, registrations, exemptions, Orders, consents and approvals from the U.S. Food and Drug Administration (the “FDA”) and any other Governmental Authority that is concerned with the quality, identity, strength, purity, safety, efficacy or manufacturing of Company Products (any such Governmental Authority, a “Company Regulatory Agency”) necessary for the lawful operating of the businesses of the Company and each of its Subsidiaries as currently conducted (the “Company Permits”), including all authorizations required under the Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”) and the regulations of the FDA promulgated thereunder, and the Public Health Service Act of 1944, as amended (the “PHSA”). Notwithstanding the foregoing, it is acknowledged that no Company Product is a marketed product or has received marketing approval and, therefore, that further permits, licenses, variances, registrations, exemptions, Orders, consents and/or approvals will be required before any Company Product may be marketed. Except as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, all such Company Permits are valid, and in full force and effect. Since January 1, 2013, there has not been occurred any claim violation of, default (with or without notice or lapse of which Seller time or both) under, or event giving to others any Affiliate right of termination, amendment or cancellation of, with or without notice or lapse of time or both, any Company Permit except as has received notice not had, and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect. Each of any Action pending or threatened against Seller or an Affiliate relating the Company and each of its Subsidiaries is in compliance in all material respects with the terms of all Company Permits, and no event has occurred that, to any Product or the Purchased Assets. To the Knowledge of Sellerthe Company, there is no fact would reasonably be expected to result in the revocation, cancellation, non-renewal or circumstance adverse modification of any Company Permit, except as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect.
(c) None of the Company or its Subsidiaries nor, to the Knowledge of the Company, any director, officer, employee, agent or Representative thereof, has committed any act, made any statement or failed to make any statement that would reasonably be expected to serve as provide a basis for any Action against Seller the FDA or any Affiliate relating other Company Regulatory Agency to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” as set forth in 56 Fed. Reg. 46191 (Sept. 10, 1991) and any Product or any Purchased Assets or that, if successful, could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller amendments thereto. None of the transactions contemplated by this AgreementCompany or its Subsidiaries nor, to the Knowledge of the Company, any director, officer, employee, agent or Representative thereof, has engaged in any activity prohibited under U.S. federal or state criminal or civil health care Laws (including without limitation the U.S. federal Anti-Kickback Statute, Xxxxx Law, False Claims Act, Health Insurance Portability and Accountability Act, and any comparable state Laws), or the regulations promulgated pursuant to such Laws (each, a “Health Care Law”). There is no Action pending by Seller civil, criminal, administrative or any Affiliateother proceeding, notice or which Seller intends to initiate against any Third Party relating to any Product or any Purchased Asset. There is no outstanding Order of any Governmental Entity against Seller (i) that relates to the Businessdemand pending, a Product or any Purchased Asset, (ii) that could reasonably be expected to be materially adverse to the Business, any Product or any Purchased Asset, or (iii) that could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreement.
(c) There is no Action pending received or, to the Knowledge of Sellerthe Company, threatened against Seller by the Company or any Governmental Entity, and there is no claim, investigation or administrative action of its Subsidiaries that relates to an alleged violation of any Governmental Entity pending orHealth Care Law. None of the Company or any of its Subsidiaries nor, to the Knowledge of Seller, threatened, that affects or, if successful, could reasonably be expected to be materially adverse to Seller, the Business, a ProductCompany, any Purchased Assets or the Assumed Liabilities or thatdirector, if successful, could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreement, nor are there, to the Knowledge of Seller, any facts, circumstances or conditions on which any such Action could be brought in the future.
(d) Except as set forth in the Seller Disclosure Schedule, Seller and its Affiliates have timely filed all material reports, statements, documents, registrations, filings, amendments, supplements and submissions required to be filed by it with respect to any Product and the Purchased Assets under applicable Regulatory Laws. Each such filing was, in all material respects, true, complete and correct as of the date of submission, and any necessary or required updates, changes, corrections, amendments, supplements or modifications to such filings have been submitted to the applicable Governmental Entity.
(e) Except for notice of the Clinical Hold, neither Seller nor any Affiliate has, with respect to any Product or any Purchased Asset, (i) received or been subject to any action, notice, warning, administrative proceeding, review or investigation by a Regulatory Authority that alleges or asserts that Seller or any Affiliate has violated any applicable Regulatory Laws or (ii) been subject to a corporate integrity agreement, deferred prosecution agreement, consent decree, monitoring agreement, settlement agreement or other similar agreement or Order mandating or prohibiting future or past activities.
(f) Except as set forth on Schedule 4.9(f), the Manufacturing and servicing operations conducted by or on behalf of Seller and its Affiliates with respect to any Product are conducted in material compliance with applicable Regulatory Laws, including applicable current good manufacturing practice regulations and similar federal, state, local or foreign requirements for the Manufacture of any Product.
(g) Neither Seller, nor any Affiliate, nor any officer, employee employee, agent or agent of Seller or of any AffiliateRepresentative thereof, in each case who has been materially involved in the Exploitation of any Product (i) has been convicted of any crime or engaged in any conduct in the operation of Seller’s business for which debarment is mandated by 21 U.S.C. sec. 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a sec. 335a(b) or any similar applicable Law, nor has any such Person been so debarred; . There are no consent decrees (iiincluding plea agreements) has been convicted of any crime or engaged in any conduct similar actions to which would reasonably be expected to cause Seller to be excluded from participating in federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, Company or any similar applicable Law, nor has any such Person been so excluded; or (iii) to the Knowledge of Seller, is subject to an investigation or proceeding by any Regulatory Authority that could result in such a suspension, exclusion or debarment and there are no factsits Subsidiaries or, to the Knowledge of Sellerthe Company, any director, officer, employee, agent or Representative thereof, are bound or which relate to Company Products.
(d) Each of the Company and its Subsidiaries is and has been in compliance in all material respects with all applicable statutes, rules, regulations, decrees, writs and orders of the FDA and any other Company Regulatory Agency with respect to the labeling, storing, testing, development, manufacture, packaging and distribution of the Company Products. All required pre-clinical toxicology studies conducted by or on behalf of the Company or its Subsidiaries and Company-sponsored clinical trials (or clinical trials sponsored by the Company or any other Subsidiary) conducted or being conducted with respect thereto, have been and are being conducted in compliance in all material respects with applicable licenses and Laws, including, without limitation, the applicable requirements of the FDA’s current Good Manufacturing Practices, Good Laboratory Practices and Good Clinical Practices. The results of any such studies, tests and trials, and all other material information related to such studies, tests and trials, have been made available to Phoenix. Each clinical trial conducted by or on behalf of the Company or any of its Subsidiaries with respect to Company Products has been conducted in accordance with its clinical trial protocol, and in compliance in all material respects with all applicable Laws, including Good Clinical Practices, Informed Consent and all other applicable requirements contained in 21 CFR Parts 312, 50, 54, 56 and 11. Each of the Company and its Subsidiaries has filed all required notices (and made available to Phoenix copies thereof) of adverse drug experiences, injuries or deaths relating to clinical trials conducted by or on behalf of the Company or any of its Subsidiaries with respect to such Company Products.
(e) All applications, submissions, information and data utilized by any the Company or any of its Subsidiaries as the basis for, or submitted by or on behalf of the Company or any of its Subsidiaries in connection with any and all requests for a Company Permit relating to the Company or any of its Subsidiaries, when submitted to the FDA or other Company Regulatory Agency, were true, correct and complete in all material respects as of the date of submission, and any updates, changes, corrections or modification to such applications, submissions, information and data required under applicable Laws have been submitted to the FDA or other Company Regulatory Agency.
(f) None of the Company or its Subsidiaries nor, to the Knowledge of the Company, any of the Representatives, licensors, licensees, assignors or assignees thereof has received any notice that the FDA or any other Company Regulatory Agency has initiated, or threatened to initiate, any Action to suspend any clinical trial, suspend or terminate any Investigational New Drug Application sponsored by the Company or any of its Subsidiaries or otherwise restrict the pre-clinical research or clinical study of any Company Product or any drug product being developed by any licensee or assignee of the Company Intellectual Property based on such intellectual property, or to recall, suspend or otherwise restrict the development or manufacture of any Company Product. None of the Company or any of its Subsidiaries is in receipt of written notice of, or is subject to, any adverse inspection, finding of deficiency, finding of non-compliance, investigation, civil or criminal proceeding, hearing, suit, demand, claim, complaint, inquiry, proceeding, or other compliance or enforcement action relating to any Company Products. To the Knowledge of the Company, there is no act, omission, event or circumstance that would reasonably be expected to give rise to any such suspension, exclusion or debarmentaction.
(hg) Neither Seller nor The Company and its Subsidiaries have made available to Phoenix true, correct and complete copies of any Affiliate hasand all applications, in connection approvals, licenses, written notices of inspectional observations, establishment inspection reports and any other documents received from the FDA or other Company Regulatory Agency, including documents that indicate or suggest lack of compliance with the regulatory requirements of the FDA or other Company Regulatory Agency. The Company and its Exploitation Subsidiaries have made available to Phoenix for review all correspondence to or from the FDA or other Company Regulatory Agency, minutes of a Productmeetings, conducted any business written reports of phone conversations, visits or engaged other contact with the FDA or other Company Regulatory Agency, notices of inspectional observations, establishment inspection reports, and all other documents concerning communications to or from the FDA or other Company Regulatory Agency, or prepared by the FDA or other Company Regulatory Agency or which bear in any transaction or dealing with any Person with whom transactions were, at the time of such transaction, prohibited as to U.S. Persons by any applicable sanctions Laws administered by the U.S. Treasury Department’s Office of Foreign Assets Control (“OFAC”), including persons appearing way on the List Company’s or any of Specially Designated Nationals and Blocked Persons published by OFACits Subsidiaries’ compliance with regulatory requirements of the FDA or any other Company Regulatory Agency, or on the likelihood or timing of approval of any Company Products.
Appears in 1 contract
Samples: Merger Agreement (Zalicus Inc.)
Compliance with Laws; Regulatory Compliance. (a) The Exploitation by Seller and its Affiliates Each of any Product the Company and the ownership by Seller and its Affiliates of the Purchased Assets have been, at all times, Company Subsidiaries is in material compliance with all applicable LawLaws or Orders, including applicable Regulatory Lawsexcept where any such failure to be in compliance has not had, or would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect. Except as set forth in Seller’s Disclosure ScheduleTo the knowledge of Company, neither Seller nor (i) no investigation by any Affiliate has received any written communication from a Governmental Entity that alleges that Seller or any Affiliate is not in compliance in any material respect with any Law or Order with respect to its Exploitation of the Company or any Product or with respect to ownership of the Purchased Assets, respectively Company Subsidiaries is active and as applicable. Seller and its Affiliates havepending, and have had, all Product Registrations necessary for its lawful Exploitation (ii) no Governmental Entity has indicated orally or in writing an intention to conduct any investigation into the Company or any of any Product prior to the Closing Date, and each of such Product Registrations, if any, is valid and in full force and effectCompany Subsidiaries.
(b) Except as set forth has not had, and would not reasonably be expected to have, individually or in the Seller Disclosure Scheduleaggregate, a Material Adverse Effect, each of the Company and the Company Subsidiaries and their respective employees and agents holds all permits, licenses, variances, registrations, exemptions, Orders, consents, authorizations and approvals from the U.S. Food and Drug Administration (the “FDA”) and any other Governmental Entity that is concerned with the quality, identity, strength, purity, safety, efficacy or Manufacturing of any of the products or services produced, marketed, licensed, sold, distributed or performed by or on behalf of the Company or any Subsidiary and all products or services currently under development by the Company or any Subsidiary (the “Company Products”) (any such Governmental Entity, a “Company Regulatory Agency”) necessary for the lawful operation of the businesses of the Company and each of the Company Subsidiaries as currently conducted (the “Company Permits”), including all authorizations required under the Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), and the Public Health Service Act of 1944, as amended (“PHSA”), and the regulations of the FDA promulgated thereunder. Notwithstanding the foregoing, it is acknowledged that no Company Product is a marketed product or has received marketing approval and, therefore, that further permits, licenses, variances, registrations, exemptions, Orders, consents, authorizations and/or approvals will be required before any Company Product may be marketed. Except as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect, all such Company Permits are valid, and in full force and effect. Since December 31, 2016, there has not been occurred any claim violation of, default (with or without notice or lapse of which Seller time or both) under, or event giving to others any Affiliate right of termination, amendment or cancellation of, with or without notice or lapse of time or both, any Company Permit except as has received notice not had, and would not reasonably be expected to have, individually or in the aggregate, a Material Adverse Effect. Each of any Action pending or threatened against Seller or an Affiliate relating to any Product or the Purchased AssetsCompany and the Company Subsidiaries is in compliance in all material respects with the terms of all Company Permits. To the Knowledge of Seller, there is no fact or circumstance No event has occurred that would reasonably be expected to serve as a basis for any Action against Seller or any Affiliate relating to any Product or any Purchased Assets or that, if successful, could reasonably be expected to result in restrainingthe revocation, enjoining cancellation, non-renewal or otherwise preventing the completion by Seller of the transactions contemplated by this Agreement. There is no Action pending by Seller or any Affiliate, or which Seller intends to initiate against any Third Party relating to any Product or any Purchased Asset. There is no outstanding Order adverse modification of any Governmental Entity against Seller (i) that relates to the Business, a Product or any Purchased Asset, (ii) that could reasonably be expected to be materially adverse to the Business, any Product or any Purchased Asset, or (iii) that could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this AgreementCompany Permit.
(c) None of the Company or the Company Subsidiaries nor, to the knowledge of the Company, any director, officer, employee, agent or Representative thereof, has committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” as set forth in 56 Fed. Reg. 46191 (Sept. 10, 1991) and any amendments thereto, or a similar policy enforced by any other Company Regulatory Agency. None of the Company or the Company Subsidiaries nor, to the knowledge of the Company, any director, officer, employee, agent or Representative thereof, has engaged in any activity that would result in a material violation under applicable U.S. federal or state criminal or civil health care Laws (including without limitation the U.S. federal Anti-Kickback Statute, Xxxxx Law, False Claims Act, Health Insurance Portability and Accountability Act (“HIPAA”), and any comparable state Laws), or the regulations promulgated pursuant to such Laws (each, a “Health Care Law”). There is no Action pending civil, criminal, administrative or other proceeding, notice or demand pending, received or, to the Knowledge knowledge of Sellerthe Company, threatened against Seller by the Company or any Governmental Entity, and there is no claim, investigation or administrative action of the Company Subsidiaries that relates to an alleged violation of any Governmental Entity pending orHealth Care Law. None of the Company or any of the Company Subsidiaries nor, to the Knowledge knowledge of Seller, threatened, that affects or, if successful, could reasonably be expected to be materially adverse to Seller, the Business, a ProductCompany, any Purchased Assets or the Assumed Liabilities or thatdirector, if successful, could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreement, nor are there, to the Knowledge of Seller, any facts, circumstances or conditions on which any such Action could be brought in the future.
(d) Except as set forth in the Seller Disclosure Schedule, Seller and its Affiliates have timely filed all material reports, statements, documents, registrations, filings, amendments, supplements and submissions required to be filed by it with respect to any Product and the Purchased Assets under applicable Regulatory Laws. Each such filing was, in all material respects, true, complete and correct as of the date of submission, and any necessary or required updates, changes, corrections, amendments, supplements or modifications to such filings have been submitted to the applicable Governmental Entity.
(e) Except for notice of the Clinical Hold, neither Seller nor any Affiliate has, with respect to any Product or any Purchased Asset, (i) received or been subject to any action, notice, warning, administrative proceeding, review or investigation by a Regulatory Authority that alleges or asserts that Seller or any Affiliate has violated any applicable Regulatory Laws or (ii) been subject to a corporate integrity agreement, deferred prosecution agreement, consent decree, monitoring agreement, settlement agreement or other similar agreement or Order mandating or prohibiting future or past activities.
(f) Except as set forth on Schedule 4.9(f), the Manufacturing and servicing operations conducted by or on behalf of Seller and its Affiliates with respect to any Product are conducted in material compliance with applicable Regulatory Laws, including applicable current good manufacturing practice regulations and similar federal, state, local or foreign requirements for the Manufacture of any Product.
(g) Neither Seller, nor any Affiliate, nor any officer, employee employee, agent or agent of Seller or of any AffiliateRepresentative thereof, in each case who has been materially involved in the Exploitation of any Product (i) has been convicted of any crime or engaged in any conduct in the operation of Seller’s business for which debarment is mandated by 21 U.S.C. sec. 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a sec. 335a(b) or any similar applicable Law. None of the Company or any of the Company Subsidiaries nor, to the knowledge of the Company, any director, officer, employee, agent or Representative thereof: (i) has ever been excluded, suspended, sanctioned or otherwise declared ineligible to participate in any federal health care program under 42 CFR § 1001.601, or any similar Law, nor has is any such Person been so debarredexclusion, suspension or other sanction threatened; or (ii) has ever been convicted of any crime or engaged in any conduct which would reasonably be expected a criminal offense related to cause Seller to be excluded from participating in federal the provision of health care programs under Section 1128 items or services. There are no Orders or similar actions to which the Company or any of the Social Security Act of 1935, as amended, or any similar applicable Law, nor has any such Person been so excluded; or (iii) to the Knowledge of Seller, is subject to an investigation or proceeding by any Regulatory Authority that could result in such a suspension, exclusion or debarment and there are no factsCompany Subsidiaries or, to the Knowledge knowledge of Sellerthe Company, any director, officer, employee, agent or Representative thereof, are bound or which relate to Company Products, or alleged violation of any Health Care Law.
(d) Each of the Company and the Company Subsidiaries is and has been in compliance in all material respects with all applicable statutes, rules, regulations, decrees, writs and orders of the FDA and any other Company Regulatory Agency with respect to the labeling, storing, testing, development, manufacture, packaging, distribution and promotion of the Company Products. To the knowledge of the Company, all required pre-clinical toxicology studies conducted by or on behalf of the Company or the Company Subsidiaries and Company-sponsored clinical trials (or clinical trials sponsored by the Company or any other Subsidiary) conducted or being conducted with respect thereto, have been and are being conducted in compliance in all material respects with applicable licenses and Laws, including, without limitation, the applicable requirements of the FDA’s current Good Manufacturing Practice, Good Laboratory Practice and Good Clinical Practice. The results of any such studies, tests and trials, and all other material information related to such studies, tests and trials, have been made available to KBL. To the knowledge of the Company, each clinical trial conducted by or on behalf of the Company or any of the Company Subsidiaries with respect to Company Products has been and is being conducted in accordance with its clinical trial protocol, and in compliance in all material respects with all applicable Laws, including Good Clinical Practice, informed consent and all other applicable requirements contained in 21 CFR Parts 312, 50, 54, 56 and 11. Each of the Company and the Company Subsidiaries has filed all required notices (and made available to KBL copies thereof) of adverse drug experiences, injuries or deaths arising from clinical trials conducted by or on behalf of the Company or any of the Company Subsidiaries with respect to such Company Products.
(e) All applications, submissions, information and data utilized by the Company or any of the Company Subsidiaries as the basis for, or submitted by or on behalf of the Company or any of the Company Subsidiaries in connection with any and all requests for a Company Permit relating to the Company or any of the Company Subsidiaries, when submitted to the FDA or any other Company Regulatory Agency, were true, correct and complete in all material respects as of the date of submission, and any updates, changes, corrections or modification to such applications, submissions, information and data required under applicable Laws have been submitted to the FDA or any other Company Regulatory Agency.
(f) None of the Company or the Company Subsidiaries nor, to the knowledge of the Company, any of the Representatives, licensors, licensees, assignors or assignees thereof, has received any notice that the FDA or any other Company Regulatory Agency has initiated, or threatened to initiate, any Action to suspend or place restrictions on any clinical trial, suspend or terminate any Investigational New Drug Application or comparable Clinical Trial Application sponsored by the Company or any of the Company Subsidiaries or otherwise restrict the pre-clinical research related to or clinical study of any Company Product or any drug product being developed by any licensee or assignee of the Company Intellectual Property based on such intellectual property, or to recall, suspend or otherwise restrict the development or manufacture of any Company Product. None of the Company or any of the Company Subsidiaries is in receipt of written notice of, or is subject to, any adverse inspection, finding of deficiency, finding of non-compliance, investigation, civil or criminal proceeding, hearing, suit, demand, claim, complaint, inquiry, proceeding, or other compliance or enforcement action relating to any Company Products. To the knowledge of the Company, there is no act, omission, event or circumstance that would reasonably be expected to give rise to any such suspensionaction.
(g) The Company and each of the Company Subsidiaries are, exclusion and have been for the past six (6) years, in compliance with the requirements of: (i) all applicable privacy and security Laws governing health information; and (ii) all contractual obligations concerning the collection, use, storage and disclosure of health information. To the knowledge of the Company there has been no unauthorized use, access, modification or debarmentdisclosure of health information, including any Breach of “Unsecured Protected Health Information,” as those terms are defined by HIPAA, by the Company, any of the Company Subsidiaries, or any of their respective clinical trial sites. The Company and each of the Company Subsidiaries is not now, and has never been, subject to HIPAA and is not a party to any business associate agreement, as defined by HIPAA. Additionally, except as would not reasonably be expected to be, individually or in the aggregate, material to the Company or the Company Subsidiaries, taken as a whole, each of the Company and the Company Subsidiaries is, and at all times since December 31, 2016, has been, in compliance with (i) all federal, state, local and foreign laws, rules and regulations pertaining to (A) data security, cyber security, and e-commerce, and (B) the collection, storage, use, access, disclosure, processing, security, and transfer of personal information (collectively, “Data Activities”). Except as would not reasonably be expected to be, individually or in the aggregate, material to the Company or the Company Subsidiaries, taken as a whole, each of the Company and the Company Subsidiaries has implemented written policies relating to Data Activities as and to the extent required by applicable Law, and at all times since December 31, 2016, each of the Company and the Company Subsidiaries, as applicable, has been in compliance with such policies.
(h) Neither Seller nor The Company and the Company Subsidiaries have made available to KBL true, correct and complete copies of any Affiliate hasand all material applications, in connection approvals, licenses, written notices of inspectional observations, establishment inspection reports and any other documents received from the FDA or any other Company Regulatory Agency, including documents that indicate or suggest lack of compliance with its Exploitation the regulatory requirements of a Productthe FDA or any other Company Regulatory Agency. The Company and the Company Subsidiaries have made available to KBL for review all material correspondence to or from the FDA or any other Company Regulatory Agency, conducted minutes of meetings, written reports of phone conversations, visits or other contact with the FDA or any business other Company Regulatory Agency, notices of inspectional observations, establishment inspection reports, and all other documents concerning communications to or engaged from the FDA or any other Company Regulatory Agency, or prepared by the FDA or any other Company Regulatory Agency or which bear in any transaction or dealing with any Person with whom transactions were, at the time of such transaction, prohibited as to U.S. Persons by any applicable sanctions Laws administered by the U.S. Treasury Department’s Office of Foreign Assets Control (“OFAC”), including persons appearing way on the List Company’s or any of Specially Designated Nationals and Blocked Persons published by OFACthe Company Subsidiaries’ compliance with regulatory requirements of the FDA or any other Company Regulatory Agency, or on the likelihood or timing of approval of any Company Products.
Appears in 1 contract
Samples: Business Combination Agreement (KBL Merger Corp. Iv)
Compliance with Laws; Regulatory Compliance. (a) The Exploitation by Seller and its Affiliates of any Product and the ownership by Seller and its Affiliates of the Purchased Assets have been, at all times, Company is in material compliance with all applicable LawLaws or Orders, including applicable Regulatory Laws. Except as set forth in Seller’s Disclosure Schedule, neither Seller nor except where any Affiliate has received any written communication from a Governmental Entity that alleges that Seller or any Affiliate is not such failure to be in compliance would not reasonably be expected to result in material Liability to the Company or otherwise materially interfere with the conduct of the business of the Company in substantially the manner currently conducted. No investigation, inquiry, proceeding or similar action by any material respect with any Law or Order Governmental Authority with respect to its Exploitation of any Product or with respect the Company is pending or, to ownership the Knowledge of the Purchased AssetsCompany, respectively and as applicable. Seller and its Affiliates havethreatened, and have hadnor has any Governmental Authority indicated in writing an intention to conduct the same which, all Product Registrations necessary for its lawful Exploitation of any Product prior in each case, would not reasonably be expected to result in material Liability to the Closing Date, and each Company or otherwise materially interfere with the conduct of such Product Registrations, if any, is valid and the business of the Company in full force and effectsubstantially the manner currently conducted.
(b) Except as set forth would not reasonably be expected to result in material Liability to the Seller Disclosure ScheduleCompany or otherwise materially interfere with the conduct of the business of the Company in substantially the manner currently conducted, (i) the Company and its employees and agents hold all permits, licenses, variances, registrations, authorizations, exemptions, Orders, consents and approvals from the U.S. Food and Drug Administration (the “FDA”) and any other Governmental Authority that is concerned with the quality, identity, strength, purity, safety, efficacy or manufacturing of Company Products (any such Governmental Authority, a “Company Regulatory Agency”) necessary for the lawful operating of the business of the Company as currently conducted (the “Company Permits”), including all authorizations required under the Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), and the regulations of the FDA promulgated thereunder, and the Public Health Service Act of 1944, as amended (the “PHSA”), and the regulations of the FDA promulgated thereunder (it is acknowledged that any Company Product that is not a marketed product or has not received marketing approval will require further permits, licenses, variances, registrations, authorizations, exemptions, Orders, consents and/or approvals before such Company Product may be marketed), (ii) all such Company Permits are valid, and in full force and effect, (iii) since January 1, 2020, there has not been occurred any claim violation of, default (with or without notice or lapse of which Seller time or both) under, or event giving to others any Affiliate right of termination, amendment or cancellation of, with or without notice or lapse of time or both, any Company Permit, and (iv) the Company is in compliance with the terms of all Company Permits, and no event has received notice of any Action pending or threatened against Seller or an Affiliate relating occurred that, to any Product or the Purchased Assets. To the Knowledge of Sellerthe Company, there is no fact would reasonably be expected to result in the revocation, cancellation, non-renewal or circumstance adverse modification of any Company Permit.
(c) Neither the Company nor, to the Knowledge of the Company, any of its directors, officers, employees, agents or Representatives, has (i) committed any act, made any statement or failed to make any statement that would reasonably be expected to serve as provide a basis for any Action against Seller the FDA or any Affiliate relating other Company Regulatory Agency to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” as set forth in 56 Fed. Reg. 46191 (Sept. 10, 1991) and any Product amendments thereto or (ii) engaged in any Purchased Assets activity prohibited under U.S. federal or thatstate criminal or civil health care Laws (including without limitation the U.S. federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b(b)), if successfulthe Anti-Inducement Law (42 U.S.C. § 1320a-7a(a)(5)), could reasonably be expected False Claims Act (31 U.S.C. §§ 3729 et seq.), Health Insurance Portability and Accountability Act (42 U.S.C. § 1320d et seq.), as amended by the Health Information, Technology for Economic and Clinical Health Act of 2009, the civil monetary penalty laws (42 U.S.C. § 1320a-7a), the FDCA, the PHSA and any comparable state or foreign Laws), or the regulations promulgated pursuant to result in restrainingsuch Laws (each, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreementa “Health Care Law”). There is no Action pending by Seller civil, criminal, administrative or any Affiliateother proceeding, notice or which Seller intends to initiate against any Third Party relating to any Product or any Purchased Asset. There is no outstanding Order of any Governmental Entity against Seller (i) that relates to the Businessdemand pending, a Product or any Purchased Asset, (ii) that could reasonably be expected to be materially adverse to the Business, any Product or any Purchased Asset, or (iii) that could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreement.
(c) There is no Action pending received or, to the Knowledge of Sellerthe Company, threatened against Seller by any Governmental Entity, and there is no claim, investigation or administrative action the Company that relates to an alleged violation of any Governmental Entity pending orHealth Care Law. Neither the Company nor, to the Knowledge of Seller, threatened, that affects or, if successful, could reasonably be expected to be materially adverse to Seller, the Business, a ProductCompany, any Purchased Assets of its directors, officers, employees, agents or the Assumed Liabilities or thatRepresentatives, if successful, could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreement, nor are there, to the Knowledge of Seller, any facts, circumstances or conditions on which any such Action could be brought in the future.
(d) Except as set forth in the Seller Disclosure Schedule, Seller and its Affiliates have timely filed all material reports, statements, documents, registrations, filings, amendments, supplements and submissions required to be filed by it with respect to any Product and the Purchased Assets under applicable Regulatory Laws. Each such filing was, in all material respects, true, complete and correct as of the date of submission, and any necessary or required updates, changes, corrections, amendments, supplements or modifications to such filings have been submitted to the applicable Governmental Entity.
(e) Except for notice of the Clinical Hold, neither Seller nor any Affiliate has, with respect to any Product or any Purchased Asset, (i) received or been subject to any action, notice, warning, administrative proceeding, review or investigation by a Regulatory Authority that alleges or asserts that Seller or any Affiliate has violated any applicable Regulatory Laws or (ii) been subject to a corporate integrity agreement, deferred prosecution agreement, consent decree, monitoring agreement, settlement agreement or other similar agreement or Order mandating or prohibiting future or past activities.
(f) Except as set forth on Schedule 4.9(f), the Manufacturing and servicing operations conducted by or on behalf of Seller and its Affiliates with respect to any Product are conducted in material compliance with applicable Regulatory Laws, including applicable current good manufacturing practice regulations and similar federal, state, local or foreign requirements for the Manufacture of any Product.
(g) Neither Seller, nor any Affiliate, nor any officer, employee or agent of Seller or of any Affiliate, in each case who has been materially involved in the Exploitation of any Product (i) has been convicted of any crime or engaged in any conduct in the operation of Seller’s business for which debarment is mandated by 21 U.S.C. sec. 335a(a) or any similar Law or authorized by 21 U.S.C. § 335a sec. 335a(b) or any similar applicable Law, nor has any such Person been so debarred; (ii) has been convicted of any crime or engaged in any conduct which would reasonably be expected to cause Seller to be excluded from participating in federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar applicable Law, nor has any such Person been so excluded; or (iii) to the Knowledge of Seller, is subject to an investigation or proceeding by any Regulatory Authority that could result in such a suspension, exclusion or debarment and there . There are no factsconsent decrees (including plea agreements) or similar actions to which the Company is or, to the Knowledge of Sellerthe Company, any of its directors, officers, employees, agents or Representatives are, bound or which relate to Company Products.
(d) The Company is and has been in compliance in all material respects with all applicable statutes, rules, regulations, decrees, writs and orders of the FDA and any other Company Regulatory Agency with respect to the labeling, storing, testing, development, manufacture, packaging and distribution of the Company Products. All required pre-clinical studies conducted by or, to the Knowledge of the Company, on behalf of the Company and Company-sponsored clinical trials (or clinical trials sponsored by the Company) conducted or, to the Knowledge of the Company, being conducted with respect thereto, have been and are being conducted in compliance in all material respects with applicable licenses and Laws, including, without limitation, the applicable requirements of the FDCA and the regulations of the FDA promulgated thereunder, including, but not limited to, 21 C.F.R. Parts 50, 54, 56, 58, 210, 211, and 312. SSMP has been provided with the opportunity to inspect the results of any such studies, tests and trials and all material information related thereto. Each clinical trial conducted by or, to the Knowledge of the Company, on behalf of the Company with respect to Company Products has been conducted in accordance with its clinical trial protocol, and in compliance in all material respects with all applicable Laws, including FDCA and the regulations of the FDA promulgated thereunder, including, but not limited to, 21 C.F.R. Parts 50, 54, 56, 58, 210, 211 and 312. The Company has filed all required notices of adverse experiences, injuries or deaths relating to clinical trials conducted by or on behalf of the Company with respect to such Company Products.
(e) All applications, submissions, information and data utilized by the Company as the basis for, or submitted by or on behalf of the Company in connection with, any and all requests for a Company Permit relating to the Company, when submitted to the FDA or other Company Regulatory Agency, were true, correct and complete in all material respects as of the date of submission, and any updates, changes, corrections or modification to such applications, submissions, information and data required under applicable Laws have been submitted to the FDA or other Company Regulatory Agency.
(f) Neither the Company nor, to the Knowledge of the Company, any of its Representatives, licensors, licensees, assignors or assignees has received any written notice that the FDA or any other Company Regulatory Agency has initiated, or threatened to initiate, any action to suspend any clinical trial, suspend or terminate any investigational new drug application sponsored by the Company or otherwise restrict the pre-clinical research or clinical study of any Company Product being developed by any licensee or assignee of the Company Intellectual Property based on such intellectual property, or to recall, suspend or otherwise materially restrict the development or manufacture of any Company Product. The Company is not in receipt of written notice of, and is not subject to, any adverse inspection, finding of deficiency, finding of non-compliance, investigation, civil or criminal proceeding, hearing, suit, demand, claim, complaint, inquiry, proceeding, or other compliance or enforcement action relating to any Company Products. To the Knowledge of the Company, there is no act, omission, event or circumstance that would reasonably be expected to give rise to any such suspension, exclusion or debarmentaction.
(hg) Neither Seller nor SSMP has been provided with the opportunity to inspect true, correct and complete copies of any Affiliate hasand all applications, in connection approvals, licenses, written notices of inspectional observations, establishment inspection reports and any other documents received from the FDA or other Company Regulatory Agency, including documents that indicate or suggest lack of compliance with its Exploitation the Laws of a Productthe FDA or other Company Regulatory Agency. SSMP has been provided with the opportunity to inspect all correspondence to or from the FDA or other Company Regulatory Agency, conducted any business minutes of meetings, written reports of phone conversations, visits or engaged other contact with the FDA or other Company Regulatory Agency, notices of inspectional observations, establishment inspection reports, and all other documents concerning communications to or from the FDA or other Company Regulatory Agency, or prepared by the FDA or other Company Regulatory Agency or which bear in any transaction or dealing with any Person with whom transactions were, at way on the time of such transaction, prohibited as to U.S. Persons by any applicable sanctions Laws administered compliance by the U.S. Treasury Department’s Office Company with the Laws of Foreign Assets Control (“OFAC”)the FDA or any other Company Regulatory Agency, including persons appearing or on the List likelihood or timing of Specially Designated Nationals and Blocked Persons published by OFACapproval of any Company Products.
Appears in 1 contract
Samples: Merger Agreement (Second Sight Medical Products Inc)
Compliance with Laws; Regulatory Compliance. (ai) The Exploitation by Seller and its Affiliates of any Product and the ownership by Seller and its Affiliates of the Purchased Assets have been, at all times, Parent is in material compliance with all applicable LawLaws (as defined in the Merger Agreement) or Orders (as defined in the Merger Agreement), including applicable Regulatory Laws. Except as set forth in Seller’s Disclosure Schedule, neither Seller nor except where any Affiliate has received any written communication from a Governmental Entity that alleges that Seller or any Affiliate is not such failure to be in compliance in any material respect with any Law or Order with respect to its Exploitation of any Product or with respect to ownership of the Purchased Assets, respectively and as applicable. Seller and its Affiliates have, and have has not had, all Product Registrations necessary for its lawful Exploitation of any Product prior to the Closing Date, and each of such Product Registrations, if any, is valid and in full force and effect.
(b) Except as set forth in the Seller Disclosure Schedule, there has or would not been any claim of which Seller or any Affiliate has received notice of any Action pending or threatened against Seller or an Affiliate relating to any Product or the Purchased Assets. To the Knowledge of Seller, there is no fact or circumstance that would reasonably be expected to serve have, individually or in the aggregate, a Parent Material Adverse Effect (as a basis for any Action against Seller defined in the Merger Agreement). No investigation or any Affiliate relating to any Product or any Purchased Assets or that, if successful, could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion review by Seller of the transactions contemplated by this Agreement. There is no Action pending by Seller or any Affiliate, or which Seller intends to initiate against any Third Party relating to any Product or any Purchased Asset. There is no outstanding Order of any Governmental Entity against Seller Authority (ias defined in the Merger Agreement) that relates with respect to the Business, a Product or any Purchased Asset, (ii) that could reasonably be expected to be materially adverse to the Business, any Product or any Purchased Asset, or (iii) that could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreement.
(c) There Parent is no Action pending or, to the Knowledge (as defined in the Merger Agreement) of Sellerthe Parent, threatened against Seller by threatened, nor has any Governmental EntityAuthority (as defined in the Merger Agreement) indicated an intention to conduct the same which, in each case, would reasonably be expected to have a material and adverse impact on Parent.
(ii) Parent has not committed nor, to the Knowledge (as defined in the Merger Agreement) of Parent, has any director, officer or employee of Parent, committed any act, made any statement or failed to make any statement that would provide a basis for the FDA (as defined in the Merger Agreement) or any other Parent Regulatory Agency (as defined in the Merger Agreement) to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and there Illegal Gratuities,” as set forth in 56 Fed. Reg. 46191 (Sept. 10, 1991) and any amendments thereto. Neither Parent nor, to the Knowledge (as defined in the Merger Agreement) of Parent, has any director, officer or employee of Parent, violated any Health Care Law (as defined in the Merger Agreement). There is no claimcivil, investigation criminal, administrative or administrative action of any Governmental Entity pending other proceeding, notice or demand pending, received or, to the Knowledge (as defined in the Merger Agreement) of SellerParent, threatened, threatened against Parent that affects or, if successful, could reasonably be expected relates to be materially adverse to Seller, an alleged violation of any Health Care Law (as defined in the Business, a Product, any Purchased Assets or the Assumed Liabilities or that, if successful, could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Merger Agreement, nor are there). Parent has not nor, to the Knowledge (as defined in the Merger Agreement) of SellerParent, has any director, officer or employee of Parent, has been debarred pursuant to 21 U.S.C. sec. 335a(a) or any similar Law or authorized by 21 U.S.C. sec. 335a(b) or any similar Law (as defined in the Merger Agreement). There are no consent decrees (including plea agreements) or similar actions to which Parent or, to the Knowledge (as defined in the Merger Agreement) of Parent, any factsdirector, circumstances officer or conditions on employee of Parent, are bound or which any such Action could be brought relate to Parent Products (as defined in the futureMerger Agreement).
(diii) Except To the Knowledge (as set forth defined in the Seller Disclosure ScheduleMerger Agreement) of Parent, Seller all applications, submissions, information and its Affiliates have timely filed data utilized by Parent as the basis for, or submitted by or on behalf of Parent in connection with any and all material reportsrequests for a Parent Permit (as defined in the Merger Agreement) relating to Parent, statementswhen submitted to the FDA (as defined in the Merger Agreement) or other Parent Regulatory Agency (as defined in the Merger Agreement), documentswere true, registrations, filings, amendments, supplements correct and submissions required to be filed by it with respect to any Product and the Purchased Assets under applicable Regulatory Laws. Each such filing was, complete in all material respects, true, complete and correct respects as of the date of submission, and any necessary or required updates, changes, corrections, amendments, supplements corrections or modifications modification to such filings applications, submissions, information and data required under applicable Laws (as defined in the Merger Agreement) have been submitted to the applicable Governmental EntityFDA (as defined in the Merger Agreement) or other Parent Regulatory Agency (as defined in the Merger Agreement).
(e) Except for notice of the Clinical Hold, neither Seller nor any Affiliate has, with respect to any Product or any Purchased Asset, (i) received or been subject to any action, notice, warning, administrative proceeding, review or investigation by a Regulatory Authority that alleges or asserts that Seller or any Affiliate has violated any applicable Regulatory Laws or (ii) been subject to a corporate integrity agreement, deferred prosecution agreement, consent decree, monitoring agreement, settlement agreement or other similar agreement or Order mandating or prohibiting future or past activities.
(f) Except as set forth on Schedule 4.9(f), the Manufacturing and servicing operations conducted by or on behalf of Seller and its Affiliates with respect to any Product are conducted in material compliance with applicable Regulatory Laws, including applicable current good manufacturing practice regulations and similar federal, state, local or foreign requirements for the Manufacture of any Product.
(giv) Neither Seller, nor any Affiliate, nor any officer, employee or agent of Seller or of any Affiliate, in each case who has been materially involved in the Exploitation of any Product (i) has been convicted of any crime or engaged in any conduct in the operation of Seller’s business for which debarment is mandated or authorized by 21 U.S.C. § 335a or any similar applicable Law, nor has any such Person been so debarred; (ii) has been convicted of any crime or engaged in any conduct which would reasonably be expected to cause Seller to be excluded from participating in federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, or any similar applicable Law, nor has any such Person been so excluded; or (iii) to the Knowledge of Seller, is subject to an investigation or proceeding by any Regulatory Authority that could result in such a suspension, exclusion or debarment and there are no factsParent nor, to the Knowledge (as defined in the Merger Agreement) of SellerParent, any of the Representatives (as defined in the Merger Agreement), licensors, licensees, assignors or assignees thereof has received any notice that would reasonably be expected the FDA (as defined in the Merger Agreement) or any other Parent Regulatory Agency (as defined in the Merger Agreement) has initiated, or threatened to give rise initiate, any Action (as defined in the Merger Agreement) to such suspensionsuspend any clinical trial, exclusion suspend or debarment.
terminate any Investigational New Drug Application (has defined in the Merger Agreement) Neither Seller nor sponsored by Parent or otherwise restrict the pre-clinical research or clinical study of any Affiliate has, in connection with its Exploitation of a Product, conducted Parent Product or any business or engaged in any transaction or dealing with any Person with whom transactions were, at the time of such transaction, prohibited as to U.S. Persons drug product being developed by any applicable sanctions Laws administered by licensee or assignee of the U.S. Treasury Department’s Office Parent Intellectual Property (as defined in the Merger Agreement) based on such intellectual property, or to recall, suspend or otherwise restrict the development or manufacture of Foreign Assets Control any Parent Product (“OFAC”as defined in the Merger Agreement). Parent is not in receipt of any written notice of, including persons appearing on the List or subject to, any adverse inspection, finding of Specially Designated Nationals and Blocked Persons published by OFAC.deficiency, finding of non-compliance, investigation, civil or criminal proceeding, hearing, suit, demand, claim, complaint, inquiry, proceeding, or other compliance or enforcement action relating to any Parent Products
Appears in 1 contract
Compliance with Laws; Regulatory Compliance. (a) The Exploitation by Seller and its Affiliates of any Product and the ownership by Seller and its Affiliates of the Purchased Assets have been, at all times, in material compliance with all applicable Law, including applicable Regulatory Laws. Except as set forth in Seller’s Disclosure Schedule, neither Seller nor any Affiliate has received any written communication from a Governmental Entity that alleges that Seller or any Affiliate NDX is not in compliance in any all material respect respects with all Laws, and NDX has no material liability for failure to comply with any Law Law. No investigation or Order review by any Governmental Entity with respect to its Exploitation of any Product or with respect to ownership of the Purchased Assets, respectively and as applicable. Seller and its Affiliates have, and have had, all Product Registrations necessary for its lawful Exploitation of any Product prior to the Closing Date, and each of such Product Registrations, if any, NDX is valid and in full force and effect.
(b) Except as set forth in the Seller Disclosure Schedule, there has not been any claim of which Seller or any Affiliate has received notice of any Action pending or threatened against Seller or an Affiliate relating to any Product or the Purchased Assets. To the Knowledge of Seller, there is no fact or circumstance that would reasonably be expected to serve as a basis for any Action against Seller or any Affiliate relating to any Product or any Purchased Assets or that, if successful, could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreement. There is no Action pending by Seller or any Affiliate, or which Seller intends to initiate against any Third Party relating to any Product or any Purchased Asset. There is no outstanding Order of any Governmental Entity against Seller (i) that relates to the Business, a Product or any Purchased Asset, (ii) that could reasonably be expected to be materially adverse to the Business, any Product or any Purchased Asset, or (iii) that could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreement.
(c) There is no Action pending or, to the Knowledge of SellerNDX, threatened against Seller by threatened, nor has any Governmental Entity indicated an intention to conduct the same.
(b) NDX and its respective employees and agents hold all permits, certificates, licenses, variances, registrations, exemption, orders, consents and approvals from any Governmental Entity that is concerned with the quality, identity, strength, purity, safety, efficacy or manufacturing of NDX products (any such Governmental Entity, an “NDX Regulatory Agency”) necessary for the lawful operation of the businesses of NDX as currently conducted (the “NDX Permits”). Section 4.22(b) of the NDX Disclosure Letter sets forth a list of all material NDX Permits as of the date of this Agreement. All such NDX Permits are valid, in full force and there effect. There has not occurred any material violation of, default (with or without notice or lapse of time or both) under, or event giving to others any right of termination, amendment or cancellation of, with or without notice or lapse of time or both, under any NDX Permit. NDX is in compliance in all material respects with the terms of all NDX Permits, and no event has occurred that, would reasonably be expected to result in the revocation, cancellation, non-renewal or adverse modification of any NDX Permit.
(c) NDX has not nor, to the Knowledge of NDX, has any director, officer, employee, agent or Representative thereof, committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” as set forth in 56 Fed. Reg. 46191 (Sept. 10, 1991) and any amendments thereto, or for any other NDX Regulatory Agency to invoke any similar policy. To the Knowledge of NDX, no director, officer, employee, agent or Representative thereof, has engaged in any activity prohibited under any Health Care Law. There is no claimcivil, investigation criminal, administrative or administrative action of any Governmental Entity pending other proceeding, notice or demand pending, received or, to the Knowledge of SellerNDX, threatened, threatened against NDX that affects or, if successful, could reasonably be expected relates to be materially adverse to Seller, the Business, a Product, an alleged violation of any Purchased Assets or the Assumed Liabilities or that, if successful, could reasonably be expected to result in restraining, enjoining or otherwise preventing the completion by Seller of the transactions contemplated by this Agreement, nor are there, to Health Care Law. To the Knowledge of SellerNDX, any factsno director, circumstances or conditions on which any such Action could be brought in the future.
(d) Except as set forth in the Seller Disclosure Schedule, Seller and its Affiliates have timely filed all material reports, statements, documents, registrations, filings, amendments, supplements and submissions required to be filed by it with respect to any Product and the Purchased Assets under applicable Regulatory Laws. Each such filing was, in all material respects, true, complete and correct as of the date of submission, and any necessary or required updates, changes, corrections, amendments, supplements or modifications to such filings have been submitted to the applicable Governmental Entity.
(e) Except for notice of the Clinical Hold, neither Seller nor any Affiliate has, with respect to any Product or any Purchased Asset, (i) received or been subject to any action, notice, warning, administrative proceeding, review or investigation by a Regulatory Authority that alleges or asserts that Seller or any Affiliate has violated any applicable Regulatory Laws or (ii) been subject to a corporate integrity agreement, deferred prosecution agreement, consent decree, monitoring agreement, settlement agreement or other similar agreement or Order mandating or prohibiting future or past activities.
(f) Except as set forth on Schedule 4.9(f), the Manufacturing and servicing operations conducted by or on behalf of Seller and its Affiliates with respect to any Product are conducted in material compliance with applicable Regulatory Laws, including applicable current good manufacturing practice regulations and similar federal, state, local or foreign requirements for the Manufacture of any Product.
(g) Neither Seller, nor any Affiliate, nor any officer, employee employee, agent or agent of Seller or of any AffiliateRepresentative thereof, in each case who has been materially involved in the Exploitation of any Product (i) has been convicted of any crime or engaged in any conduct in the operation of Seller’s business for which debarment or exclusion is mandated by 21 U.S.C. sec. 335a(a), 42 U.S.C. sec. 1320a-7(a) or any similar Law or authorized by 21 U.S.C. § 335a sec. 335a(b), 42 U.S.C. sec. 1320a-7(b) or any similar Law, or exclusion or disqualification under applicable Law, nor has any such Person been so debarred; . There are no consent decrees (iiincluding plea agreements) has been convicted of any crime or engaged in any conduct similar actions to which would reasonably be expected to cause Seller to be excluded from participating in federal health care programs under Section 1128 of the Social Security Act of 1935, as amendedNDX, or any similar applicable Law, nor has any such Person been so excluded; or (iii) to the Knowledge of SellerNDX, any director, officer, employee, agent or Representative thereof, are bound or which relate to NDX products or services.
(d) To NDX’s Knowledge, NDX has complied in all material respects with all applicable statutes, rules, regulations, decrees, writs and orders of the FDA and any other NDX Regulatory Agency with respect to the labeling, advertising, storing, testing, development, manufacture, packaging and distribution of NDX products. To the Knowledge of NDX, all pre-clinical studies conducted by NDX have been and are being conducted in compliance in all material respects with applicable licenses and Laws, including, without limitation, the applicable requirements of the FDA’s current Good Manufacturing Practices, Good Laboratory Practices and Good Clinical Practices. Each clinical trial conducted by NDX has been and is subject being conducted in accordance with its clinical trial protocol, and in compliance in all material respects with all applicable Laws, including Good Clinical Practices, Informed Consent and all other applicable requirements contained in 21 CFR Parts 312, 50, 54, 56 and 11.
(e) There are no proceedings pending or, to an investigation NDX’s Knowledge, threatened with respect to a violation or proceeding alleged violation by NDX of any rules and regulations of any applicable Governmental Entities or regulatory bodies (including without limitation, the FDCA, FDA regulations adopted thereunder, the Controlled Substance Act or any other legislation or regulation promulgated by any other NDX Regulatory Authority that could result Agency). To the Knowledge of NDX, all applications, submissions, information and data utilized by NDX as the basis for, or submitted by or on behalf of NDX in connection with an NDX Permit relating to any NDX products or services, relating to NDX, when submitted to the FDA or other NDX Regulatory Agency, were true, correct and complete in all material respects as of the date of submission, and any updates, changes, corrections or modification to such a suspensionapplications, exclusion submissions, information and data required under applicable Laws were submitted to the FDA or debarment and there are other NDX Regulatory Agency. To the Knowledge of NDX, no factsdata generated by NDX with respect to NDX products or services is the subject of any action, either pending or threatened, by any NDX Regulatory Agency relating to the truthfulness or scientific adequacy or integrity of such data.
(f) Neither NDX nor, to the Knowledge of SellerNDX, any of its Representatives, licensors, licensees, assignors or assignees thereof has received any notice that the FDA or any other NDX Regulatory Agency or third party has initiated, or threatened to initiate, any action to recall, suspend or otherwise restrict the development or manufacture of any NDX product. NDX has not received written notice of, or is subject to, any adverse inspection, finding of deficiency, finding of non-compliance, investigation, civil or criminal proceeding, hearing, suit, demand, claim, complaint, inquiry, proceeding, or other compliance or enforcement action relating to any NDX products or services, including with respect to their development, manufacturing, labeling, advertising, storing, or testing, from any Governmental Entity, NDX Regulatory Agency, or other third party. To the Knowledge of NDX, there is no act, omission, event or circumstance that would reasonably be expected to give rise to any such suspension, exclusion or debarmentaction.
(hg) Neither Seller nor NDX has made available to CGI true, correct and complete copies of any Affiliate hasand all applications, in connection approvals, licenses, written notices of inspectional observations, establishment inspection reports and any other documents received from the FDA or other NDX Regulatory Agency that indicate or suggest lack of compliance with its Exploitation the regulatory requirements of a Productthe FDA or other NDX Regulatory Agency, conducted any business other than immaterial items that have been corrected. NDX has made available to CGI for review all material correspondence to or engaged from the FDA or other NDX Regulatory Agency, minutes of meetings, written reports of phone conversations, visits or other contact with the FDA or other NDX Regulatory Agency, and all other documents concerning communications to or from the FDA or other NDX Regulatory Agency, or prepared by the FDA or other NDX Regulatory Agency or which bear in any transaction way on NDX’s compliance with regulatory requirements of the FDA or dealing with any Person with whom transactions were, at the time of such transaction, prohibited as to U.S. Persons by any applicable sanctions Laws administered by the U.S. Treasury Department’s Office of Foreign Assets Control (“OFAC”), including persons appearing on the List of Specially Designated Nationals and Blocked Persons published by OFACother NDX Regulatory Agency.
Appears in 1 contract
