Common use of FDA and Related Matters Clause in Contracts

FDA and Related Matters. (a) The Company and the Company Subsidiaries are and have been, since January 1, 2010, in compliance in all respects with (i) all Laws (including all rules, regulations and policies) of the FDA, Drug Enforcement Administration (“DEA”), EMEA and other Healthcare Regulatory Authorities and (ii) all Healthcare Regulatory Authorizations, including all requirements of the FDA, DEA, the EMEA and all other Healthcare Regulatory Authorities, that are applicable to the Company and the Company Subsidiaries, or by which any property, product, or other asset of the Company and the Company Subsidiaries (including, without limitation, any Product Candidate (as defined below)) is bound or affected. As of the date of this Agreement, neither the Company nor the Company Subsidiaries has received any written notification of any pending or, to the Knowledge of the Company, threatened, claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any Healthcare Regulatory Authority. (b) Since January 1, 2010, the Company and the Company Subsidiaries have held all Healthcare Regulatory Authorizations required for the conduct of their respective businesses, and all such Healthcare Regulatory Authorizations are in full force and effect. No event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other impairment of the rights of the holder of any such Healthcare Regulatory Authorization. (c) Section 2.16(c) of the Company Disclosure Schedule contains a complete and accurate list of all of the Product Candidates of the Company Entities, listing, where applicable, those Product Candidates for which the Company Entities have applied for or have authorization or clearance through inaction to test the product in human subjects (“Human Testing Authorization”) according to applicable regulations and listing the type of application made. For those Product Candidates listed in Section 2.16(c) of the Company Disclosure Schedule as having Human Testing Authorization, such Human Testing Authorization has not been revoked or rescinded. No notification has been received by any Company Entity from any Regulatory Authority that would reasonably be expected to preclude the Company from continuing to test such Product Candidates. No applications made or other materials submitted by the Company Entities to any Regulatory Authority contained an untrue statement of material fact, or omitted to state a material fact required to be stated therein or necessary in order to make the statements contained therein, in light of the circumstances under which they were made, not misleading on a material matter. For the purposes of this Agreement, “Product Candidates” means biologics, compounds or other products under development, current, active or otherwise, or consideration by the Company or any Company Subsidiary or any of their respective licensees.

FDA and Related Matters. (a) The Company and the Company its Subsidiaries are and and, to the Knowledge of the Company, have been, been since January 1, 2010, in compliance in all respects with (i1) all Laws (including all rules, regulations and policies) of the FDA, Drug Enforcement Administration (“DEA”), EMEA and other Healthcare Regulatory Authorities and (ii2) all Healthcare Regulatory Authorizations, including all requirements of the FDA, DEA, the EMEA and all other Healthcare Regulatory Authorities, that are applicable to the Company and the Company its Subsidiaries, or by which any property, product, or other asset of the Company and the Company its Subsidiaries (including, without limitation, any Product Candidate (as defined below)) is bound or affected, except, in each case, where such noncompliance would not, individually or in the aggregate, have or reasonably be expected to have, a Company Material Adverse Effect. As of the date of this Agreement, neither the Company nor the Company its Subsidiaries has received any written notification of any pending or, to the Knowledge knowledge of the Company, threatened, claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any Healthcare Regulatory Authority, except where such occurrence would not, individually or in the aggregate, have or reasonably be expected to have, a Company Material Adverse Effect. (b) Since January 1, 2010, the Company and the Company its Subsidiaries have held all Healthcare Regulatory Authorizations required for the conduct of their respective businesses, and all such Healthcare Regulatory Authorizations are in full force and effect, except where the failure to hold a Healthcare Regulatory Authorization or the failure to be in full force and effect would not, individually or in the aggregate, have or reasonably be expected to have, a Company Material Adverse Effect. No event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other impairment of the rights of the holder of any such Healthcare Regulatory Authorization, except where such occurrence would not, individually or in the aggregate, have or reasonably be expected to have, a Company Material Adverse Effect. (c) Section 2.16(cNeither the Company nor any of its Subsidiaries has received any material written information since January 1, 2010 from any Healthcare Regulatory Authority with jurisdiction over the marketing, sale, use, handling and control, safety, efficacy, reliability, or manufacturing Company Products which would reasonably be expected to lead to the revocation, withdrawal, or denial or any application for marketing approval before such Healthcare Regulatory Authority, except for any such revocations, withdrawals or denials which, individually or in the aggregate, would not reasonably be expected to have, a Company Material Adverse Effect. (d) All material reports, documents, claims and notices required to be filed, maintained, or furnished to any Healthcare Regulatory Authority by the Company and its Subsidiaries since January 1, 2010 have been so filed, maintained or furnished and, to the knowledge of the Company, were complete and correct in all material respects on the date filed (or were corrected in or supplemented by a subsequent filing). (e) The Company and its Subsidiaries have not since January 1, 2010 voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recalls, field notifications, field corrections, market withdrawals or replacements, warnings, “dear doctor” letters, investigator notices, safety alerts or other notice of action relating to an alleged lack of safety, efficacy, or regulatory compliance of any product manufactured, distributed or marketed by or on behalf of the Company Disclosure Schedule contains and its Subsidiaries. Neither the Company nor any of its Subsidiaries has received any written notice since January 1, 2010 that the FDA or any other Governmental Authority has (i) commenced, or threatened to initiate, any action to revoke or withdraw a complete and accurate list product approval, or request the recall of all any product or product candidate, (ii) commenced, or threatened to initiate, any action to enjoin manufacture or distribution of any product or product candidate or (iii) commenced, or threatened to initiate, any action to enjoin the manufacture or distribution of any product or product candidate produced at any facility where any product or product candidate is manufactured, tested, processed, packaged or held for sale, except in each case where such action would not, individually or in the aggregate, have or reasonably be expected to have, a Company Material Adverse Effect. (f) To the Knowledge of the Product Candidates Company, all clinical and pre-clinical studies conducted by or on behalf of or sponsored by the Company or its Subsidiaries, or in which the Company and its Subsidiaries or their products or product candidates have participated were and, if still pending, are being conducted in accordance with standard medical and scientific research procedures and all applicable Laws, except where such noncompliance would not, individually or in the aggregate, have or reasonably be expected to have, a Company Material Adverse Effect. The Company and its Subsidiaries have not received since January 1, 2010 any written notices, correspondence or other communication from any Healthcare Regulatory Authority requiring the termination or suspension of any clinical trials conducted by, or on behalf of, the Company or any of its Subsidiaries, or in which the Company or the any of its Subsidiaries have participated. (g) Neither the Company nor any of its Subsidiaries has received any FDA Form 483, notice of adverse finding, warning letters, untitled letters or other notices alleging a lack of safety from any Healthcare Regulatory Authority, and there is no action or proceeding pending or, to the Knowledge of the Company, threatened by any such Authority, contesting the approval of, the uses of, or the labeling or promotion of, or otherwise alleging any violation of law with respect to, any product manufactured, distributed or marketed by or on behalf of the Company Entitiesor its Subsidiaries, listingexcept where such occurrence would not, where applicableindividually or in the aggregate, those Product Candidates for which have or reasonably be expected to have, a Company Material Adverse Effect. (h) Neither the Company Entities have applied for nor any of its Subsidiaries is the subject of any pending or, to the Knowledge of the Company, threatened investigation regarding the Company, its Subsidiaries, or have authorization their products, by the FDA pursuant to its “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” Final Policy set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto, or clearance through inaction otherwise. Neither the Company nor any of its Subsidiaries, nor, to test the product in human subjects (“Human Testing Authorization”) according to applicable regulations and listing Knowledge of the type of application made. For those Product Candidates listed in Section 2.16(c) Company, any officer, employee, agent or distributor of the Company Disclosure Schedule as having Human Testing Authorizationor any of its Subsidiaries, such Human Testing Authorization has not committed or been revoked convicted of any crime or rescindedengaged in any conduct for which debarment is 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. No notification Neither the Company nor any of its Subsidiaries, nor, to the Knowledge of the Company, any officer, employee, agent or distributor of the Company or any of its Subsidiaries, has been received by convicted of any Company Entity crime or engaged in any conduct for which such Person could be excluded from participating in the federal health care programs under Section 1128 of the Social Security Act of 1935, as amended, or any Regulatory Authority similar Law. As of the date hereof, no claims, actions, proceedings or investigations that would reasonably be expected to preclude result in a material debarment or exclusion are pending or, to the Knowledge of the Company, threatened, against the Company from continuing or, to test such Product Candidates. No applications made or other materials submitted by the Company Entities to any Regulatory Authority contained an untrue statement of material fact, or omitted to state a material fact required to be stated therein or necessary in order to make the statements contained therein, in light Knowledge of the circumstances under which they were madeCompany, not misleading on a material matter. For the purposes of this Agreement, “Product Candidates” means biologics, compounds or other products under development, current, active or otherwise, or consideration by the Company or any Company Subsidiary or any of their respective licenseesits directors, officers, employees or agents.

FDA and Related Matters. (a) The Company and the Company its Subsidiaries are and and, to the Knowledge of the Company, have been, been since January 1, 2010, in compliance in all respects with (i1) all Laws (including all rules, regulations and policies) of the FDA, Drug Enforcement Administration (“DEA”), EMEA and other Healthcare Regulatory Authorities and (ii2) all Healthcare Regulatory Authorizations, including all requirements of the FDA, DEA, the EMEA and all other Healthcare Regulatory Authorities, that are applicable to the Company and the Company its Subsidiaries, or by which any property, product, or other asset of the Company and the Company its Subsidiaries (including, without limitation, any Product Candidate (as defined below)) is bound or affected, except, in each case, where such noncompliance would not, individually or in the aggregate, have or reasonably be expected to have, a Company Material Adverse Effect. As of the date of this Agreement, neither the Company nor the Company its Subsidiaries has received any written notification of any pending or, to the Knowledge knowledge of the Company, threatened, claim, suit, proceeding, hearing, enforcement, audit, investigation, arbitration or other action from any Healthcare Regulatory Authority, except where such occurrence would not, individually or in the aggregate, have or reasonably be expected to have, a Company Material Adverse Effect. (b) Since January 1, 2010, the Company and the Company its Subsidiaries have held all Healthcare Regulatory Authorizations required for the conduct of their respective businesses, and all such Healthcare Regulatory Authorizations are in full force and effect, except where the failure to hold a Healthcare Regulatory Authorization or the failure to be in full force and effect would not, individually or in the aggregate, have or reasonably be expected to have, a Company Material Adverse Effect. No event has occurred which allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other impairment of the rights of the holder of any such Healthcare Regulatory Authorization, except where such occurrence would not, individually or in the aggregate, have or reasonably be expected to have, a Company Material Adverse Effect. (c) Section 2.16(c) of Neither the Company Disclosure Schedule contains a complete and accurate list nor any of all of the Product Candidates of the Company Entitiesits Subsidiaries has received any material written information since January 1, listing, where applicable, those Product Candidates for which the Company Entities have applied for or have authorization or clearance through inaction to test the product in human subjects (“Human Testing Authorization”) according to applicable regulations and listing the type of application made. For those Product Candidates listed in Section 2.16(c) of the Company Disclosure Schedule as having Human Testing Authorization, such Human Testing Authorization has not been revoked or rescinded. No notification has been received by any Company Entity 2010 from any Healthcare Regulatory Authority that with jurisdiction over the marketing, sale, use, handling and control, safety, efficacy, reliability, or manufacturing Company Products which would reasonably be expected to preclude lead to the revocation, withdrawal, or denial or any application for marketing approval before such Healthcare Regulatory Authority, except for any such revocations, withdrawals or denials which, individually or in the aggregate, would not reasonably be expected to have, a Company from continuing Material Adverse Effect. (d) All material reports, documents, claims and notices required to test such Product Candidates. No applications made be filed, maintained, or other materials submitted furnished to any Healthcare Regulatory Authority by the Company Entities and its Subsidiaries since January 1, 2010 have been so filed, maintained or furnished and, to any Regulatory Authority contained an untrue statement the knowledge of the Company, were complete and correct in all material factrespects on the date filed (or were corrected in or supplemented by a subsequent filing). (e) The Company and its Subsidiaries have not since January 1, 2010 voluntarily or involuntarily initiated, conducted or issued, or omitted to state a material fact required caused to be stated therein initiated, conducted or necessary in order issued, any recalls, field notifications, field corrections, market withdrawals or replacements, warnings, “dear doctor” letters, investigator notices, safety alerts or other notice of action relating to make the statements contained thereinan alleged lack of safety, in light efficacy, or regulatory compliance of any product manufactured, distributed or marketed by or on behalf of the circumstances under which they were madeCompany and its Subsidiaries. Neither the Company nor any of its Subsidiaries has received any written notice since January 1, not misleading on a material matter. For 2010 that the purposes of this Agreement, “Product Candidates” means biologics, compounds FDA or any other products under development, current, active or otherwiseGovernmental Authority has (i) commenced, or consideration threatened to initiate, any action to revoke or withdraw a product approval, or request the recall of any product or product candidate, (ii) commenced, or threatened to initiate, any action to enjoin manufacture or distribution of any product or product candidate or (iii) commenced, or threatened to initiate, any action to enjoin the manufacture or distribution of any product or product candidate produced at any facility where any product or product candidate is manufactured, tested, processed, packaged or held for sale, except in each case where such action would not, individually or in the aggregate, have or reasonably be expected to have, a Company Material Adverse Effect. (f) To the Knowledge of the Company, all clinical and pre-clinical studies conducted by or on behalf of or sponsored by the Company or any its Subsidiaries, or in which the Company Subsidiary and its Subsidiaries or any of their respective licensees.products or product candidates have participated were and, if still pending, are being conducted in accordance with standard medical and scientific research procedures and all applicable Laws, except where such noncompliance would not, individually or in the aggregate, have or reasonably be expected to have, a Company Material

FDA and Related Matters. (a) Section 4.9 of the Company Disclosure Letter sets forth a true and complete list of all Regulatory Authorizations from the FDA, EMEA and all other Regulatory Authorities owned by the Company or the Company Subsidiaries or held by Company Partners (as defined in Section 4.9(b) hereof) and relating to the Core Products (as defined in Section 9.14(g)) and used in the conduct of the Company's business, and there are no other Regulatory Authorizations required for the Company, the Company Subsidiaries or the Core Products in connection with the conduct of the Company's business as currently conducted. All such Regulatory Authorizations owned by the Company or a Company Subsidiary are, and to the knowledge of the Company all other Regulatory Authorizations are, in all material respects, (i) in full force and effect, (ii) validly registered and on file with applicable Regulatory Authorities, (iii) in compliance with all formal filing and maintenance requirements, and (iv) in good standing, valid and enforceable. The Company and the Company Subsidiaries are have filed all required notices and have beenresponses to notices, since January 1supplemental applications, 2010reports (including adverse experience reports) and other information with the FDA, EMEA and all other applicable Regulatory Authorities. (b) Without limiting the generality of any other representations and warranties made by the Company under this Agreement, to the knowledge of the Company, the conduct of the business of the Company and the Company Subsidiaries as currently conducted is in compliance in all material respects with (i1) all written communications, requirements and applicable Laws (including all rules, regulations and policies) Orders of the FDA, Drug Enforcement Administration (“DEA”), EMEA and other Healthcare Regulatory Authorities and (ii2) all Healthcare Regulatory Authorizations, including all requirements of the FDA, DEA, the EMEA and all other Healthcare Regulatory Authorities in warning letters, notices of adverse findings and Section 305 notices and similar letters or notices, and in connection with all product recalls, notifications and safety alerts, and any request from the FDA, the EMEA or any Regulatory Authority requesting the Company or any Company Subsidiary to cease to investigate, test or market any product, and all consent decrees (including plea agreements) issued with respect to the Company or any Company Subsidiary. There are no, and have not been, any inspection reports, warning letters, notices of adverse findings, Section 305 notices or similar written documents received by the Company or, to the knowledge of the Company, by any Company Partner, that assert a lack of compliance with any applicable Laws, Orders, or regulatory requirements that have not been fully resolved to the satisfaction of the FDA, the EMEA or any other Regulatory Authorities, as applicable. None of the Company or any of the Company Subsidiaries has knowledge (or has been notified by a third party) of any pending regulatory action, investigation or inquiry of any sort by the FDA, EMEA or any other Regulatory Authority (other than non-material routine or periodic inspections or reviews) against any of the Company, a Company Subsidiary, the Core Products or any Person that are applicable manufactures, develops or distributes the Core Products pursuant to a development, commercialization, manufacturing, supply or other collaboration arrangement with the Company or any Company Subsidiary (each, a "Company Partner"), and, to the knowledge of the Company, there is no basis for any adverse regulatory action. Without limiting the foregoing, (i) to the knowledge of the Company, there have been no product recalls, warnings, notifications or safety alerts conducted or issued by the Company or Company Subsidiaries, the FDA, the EMEA or any other Regulatory Authorities with respect to the Company's and the Company Subsidiaries' Products, or by which any property, product, or other asset none of the Company foregoing has been requested or demanded by the FDA, the EMEA or any other Regulatory Authorities, and to the Company's knowledge, and there is no reasonable basis for any of the foregoing; (ii) none of the Company, the Company Subsidiaries (includingor, without limitationto the knowledge of the Company, any Product Candidate of their respective agents or subcontractors, has been convicted of any crime or engaged in any conduct which would reasonably be expected to result in criminal liability, debarment or disqualification by the FDA, the EMEA or any other Regulatory Authority, and (as defined below)iii) no criminal, injunctive, seizure or civil penalty actions have at any time been commenced or threatened by any Regulatory Authority against the Company or any Company Subsidiary or, to the knowledge of the Company, any of their respective agents or subcontractors, and there are no consent decrees (including plea agreements) or similar actions to which the Company or any Company Subsidiary is bound or affectedwhich relate to the Core Products. As Neither the Company nor any Company Subsidiary is, to the knowledge of the date Company, employing or utilizing the services of this Agreementany individual who has been debarred, temporarily denied approval or suspended under any applicable Law or Order. To the knowledge of the Company, neither the Company nor the any Company Subsidiaries Subsidiary has received made any written notification untrue statement of any pending or, fact or fraudulent statement to the Knowledge FDA, the EMEA or any other Regulatory Authority nor have they failed to disclose any fact required to be disclosed to the FDA, the EMEA or any other Regulatory Authority, and to the knowledge of the Company, threatenedno Company Partner (as defined below) has made any untrue statement of fact or fraudulent statement to the FDA, claimthe EMEA or any other Regulatory Authority relating to the Products, suitnor to the knowledge of the Company, proceedinghas any Company Partner failed to disclose any facts required to be disclosed to the FDA, hearing, enforcement, audit, investigation, arbitration the EMEA or any other action from any Healthcare Regulatory AuthorityAuthority relating to the Products. (bc) Since January 1, 2010, the The Company and the Company Subsidiaries have held made available to Parent complete and accurate copies of all Healthcare Regulatory Authorizations required for and regulatory dossiers relating thereto, all serious adverse event reports, periodic adverse event reports and other pharmacoviligence reports and data, and all other material Regulatory Authority communications, documents and other information submitted by the Company to or received by the Company from the FDA, the EMEA or any equivalent Regulatory Authority, including inspection reports, warning letters and similar documents, relating to the Company or any Company Subsidiary, the conduct of their respective businesses, and all such Healthcare Regulatory Authorizations are in full force and effect. No event has occurred which allowsbusiness, or after notice or lapse of time would allow, revocation or termination thereof or results in any other impairment of the rights of the holder of any such Healthcare Regulatory AuthorizationCore Products. (cd) Section 2.16(c) of All preclinical studies and clinical trials conducted or being conducted with respect to the Company's and the Company Disclosure Schedule contains a complete and accurate list Subsidiaries' Products by or at the direction of all of the Product Candidates of the Company Entities, listing, where applicable, those Product Candidates for which the Company Entities have applied for or have authorization or clearance through inaction to test the product in human subjects (“Human Testing Authorization”) according to applicable regulations and listing the type of application made. For those Product Candidates listed in Section 2.16(c) of the Company Disclosure Schedule as having Human Testing Authorization, such Human Testing Authorization has not been revoked or rescinded. No notification has been received by any Company Entity from any Regulatory Authority that would reasonably be expected to preclude the Company from continuing to test such Product Candidates. No applications made or other materials submitted by the Company Entities to any Regulatory Authority contained an untrue statement of material fact, or omitted to state a material fact required to be stated therein or necessary in order to make the statements contained therein, in light of the circumstances under which they were made, not misleading on a material matter. For the purposes of this Agreement, “Product Candidates” means biologics, compounds or other products under development, current, active or otherwise, or consideration by the Company or any Company Subsidiary have been and are being conducted in material compliance with the applicable requirements of Good Laboratory Practices and Good Clinical Practices and applicable regulations and guidances that relate to the conduct of clinical studies, and, the Company (1) is not aware of any failure by any Company Partner to conduct clinical studies in compliance with such applicable requirements, regulations and guidances and (2) has not received any notifications from any institutional review board (IRB) raising any issues. All results of studies, tests and trials related to the Core Products and conducted by or at the direction of the Company, and all other material information related to such studies, tests and trials, have been made available to Parent. (e) The manufacture of products by the Company and any Company Subsidiary is, or, in the case of any products manufactured by a Company Partner, to the knowledge of the Company is, being conducted in material compliance with the applicable requirements of Current Good Manufacturing Practices. In addition, the Company and each Company Subsidiary and, to the knowledge of the Company, their respective licenseesCompany Partners, are in material compliance with all applicable registration and listing requirements, including, for example, those set forth in 21 U.S.C. Section 360 and 21 C.F.R. Parts 207 and 807 and all similar applicable Laws and Orders. To the knowledge of the Company, no Product sold by the Company or held in inventory by the Company has been adulterated or misbranded. All labeling is in compliance with FDA, EMEA and other Regulatory Authority requirements, and all advertising and promotional materials of the Company and each Company Subsidiary are in material compliance with FDA, EMEA and other applicable Regulatory Authority requirements.