Certain Compliance Matters. (a) Each Party will materially comply with all Applicable Laws with respect to its obligations under this Agreement. Notwithstanding anything to the contrary in this Agreement, neither Party shall be required to undertake any activity or obligation under this Agreement which such Party has reason to believe may violate any Applicable Laws; provided however, that a Party which so believes shall promptly inform the other Party of such belief.
(b) Neither Party nor its Affiliates will make any payment, either directly or indirectly, of money or other assets, including the compensation such Party derives from this Agreement (collectively, a “Payment”), to government or political party officials, officials of International Public Organizations, candidates for public office, or representatives of other businesses or persons acting on behalf of any of the foregoing (collectively, “Officials”) or other individuals where such Payment would constitute violation of any Applicable Law, including the FCPA and the UKBA. In addition, regardless of legality, neither Party nor its Affiliates will make any Payment either directly or indirectly to Officials or other individuals if such Payment is for the purpose of improperly influencing decisions or actions to secure a business advantage, including with respect to the subject matter of this Agreement. Each Party shall have necessary procedures in place to prevent bribery and corrupt conduct by itself and each of its Affiliates and subcontractors. All activities will be conducted in compliance with the FCA and the AKA.
Certain Compliance Matters. (a) Neither Seller nor any Affiliate, director, officer or employee, nor, to the knowledge of Seller, any distributor, agent, representative, sales intermediary or other third party acting on behalf of Seller or any of its Affiliates, in any way relating to the Business or the Transferred Assets: (i) has taken any action in violation of any applicable Anticorruption Laws, including the U.S. Foreign Corrupt Practices Act (“FCPA”) (15 U.S.C. § 78 dd-1 et seq.) or (ii) has corruptly offered, paid, given, promised to pay or give or authorized the payment or gift of anything of value, directly or indirectly, to any “Public Official”, as defined in Section 3.19(b), for purposes of (A) influencing any act or decision of any Public Official in his official capacity; (B) inducing such Public Official to do or omit to do any act in violation of his lawful duty; (C) securing any improper advantage; or (D) inducing such Public Official to use his or her influence with a government, Governmental Entity, or commercial enterprise owned or controlled by any government (including state-owned or controlled medical facilities), in order to assist the Business or any Person related in any way to the Business or the Transferred Assets, in obtaining or retaining business or directing any business to any Person except, in each case, as would not, individually or in the aggregate, reasonably be expected to result in material liability to the Business or otherwise materially impair the operation of the Business.
(b) For purposes of this Section 3.19, “Public Official” means: (i) any officer, employee or representative of any regional, federal, state, provincial, county or municipal government or government department, agency, or other division; (ii) any officer, employee or representative of any commercial enterprise that is owned or controlled by a government, including any state- owned or controlled medical facility; (iii) any officer, employee or representative of any public international organization, such as the African Union, the International Monetary Fund, the United Nations or the World Bank; (iv) any person acting in an official capacity for any government or government entity, enterprise or organization identified above; and (v) any political party, party official or candidate for political office.
Certain Compliance Matters. (a) None of the Company nor any of its Subsidiaries or Affiliates, nor any director, manager, officer, agent, employee or other Person acting on behalf of the Company or any of its Subsidiaries has, directly or indirectly, violated any provision of the U.S. Foreign Corrupt Practices Act of 1977, as amended, or any such other applicable anti-bribery Laws, including by: (a) the use of any funds of the Company or its Subsidiaries for unlawful contributions, gifts, entertainment or other expenses; (b) making any unlawful payment to foreign or domestic government officials or employees or to foreign or domestic political parties or campaigns from funds of the Company or its Subsidiaries; or (c) making or receiving any unlawful bribe, rebate, payoff, influence payment, kickback or other similar unlawful payment.
(b) Except as set forth on Section 4.24(b) of the Company Disclosure Letter, during the last three (3) years none of the Company, its Subsidiaries, nor any of the Company’s contract manufacturers, developers, packagers or suppliers has received, nor have they been subject to, any Form 483s, FDA warning letters, adverse inspection, compelled or voluntary recall, market withdrawal or replacement, post-sale warning, investigation, penalty for corrective or remedial action or corrective action plan, in each case relating to the Products or the facility in which the Products were manufactured or stored, by any Regulatory Authority.
(c) For each Product, the Company or its applicable Subsidiary has made available to Parent a complete and correct Regulatory File and such Regulatory Files contain complete and correct copies of all adverse event reports relating to the Products, such adverse event reports were timely and properly reported to Regulatory Authorities as required by Law, for the period and to the extent that such adverse event reports are required by Law to be maintained.
(d) During the last three (3) years the Company and each of its Subsidiaries, contract manufacturers, developers, packagers and suppliers has been in compliance in all material respects with current good manufacturing practices, good laboratory practices and good clinical practices, and all labeling requirements, as regulated or required by the Regulatory Authorities.
(e) Except as set forth in Section 4.24(e) of the Company Disclosure Letter, during the last three (3) years, neither the Company, any Subsidiary, nor any of its contractors has received or been subject to any untitled...
Certain Compliance Matters. The Partnership shall maintain in effect policies and procedures designed to achieve compliance by the Partnership, its Subsidiaries and their respective directors, officers, employees and agents (acting in their capacity as such) with applicable Anti-Corruption Laws and Sanctions. The Partnership and each of its Subsidiaries shall comply with all applicable Anti-Corruption Laws and Sanctions in all material respects.
Certain Compliance Matters. The Trading Advisor shall use its reasonable best efforts to cooperate with instructions given to the Trading Advisor by the Trading Entity to satisfy any compliance requirements that arise under any applicable governmental, regulatory and self-regulatory laws, rules or regulations, including any that may arise because the Registered Fund is registered under the 1940 Act and has elected to be a “regulated investment company” under the Code.
Certain Compliance Matters. (a) Notwithstanding any other provision of this Agreement, neither Party shall be required to undertake any activity or obligation under this Agreement which it has reason to believe may violate any Applicable Laws; provided, however, a Party which so believes shall promptly inform the other Party of such belief.
(b) Neither Party nor its Affiliates will make any payment, either directly or indirectly, of money or other assets, including the compensation such Party derives from this Agreement (collectively, a “Payment”), to government or political party officials, officials of International Public Organizations, candidates for public office, or representatives of other businesses or persons acting on behalf of any of the foregoing (collectively, “Officials”) or other individuals where such Payment would constitute violation of any Applicable Law, including the Foreign Corrupt Practices Act of 1977, 15 U.S.C. §§ 78dd-1, et seq., and the United Kingdom Bribery Act. In addition regardless of legality, neither Party nor Confidential 106 its Affiliates will make any Payment either directly or indirectly to Officials or other individuals if such Payment is for the purpose of improperly influencing decisions or actions to secure a business advantage, including with respect to the subject matter of this Agreement. Each Party shall have necessary procedures in place to prevent bribery and corrupt conduct by itself and each of its Affiliates and subcontractors. All activities will be conducted in compliance with the U.S. False Claims Act and the U.S. Anti-Kickback Statute. Each Party and each of its Affiliates and subcontractors shall conduct its activities hereunder in accordance with the provisions of Exhibit 10.5 to this Agreement.
Certain Compliance Matters. Except as disclosed by the Party to the other Party prior to the Effective Date pursuant to the Collaboration and License Agreement, each Party represents and warrants to the other Party with respect to itself that as of the Effective Date:
11.6.1 Except as disclosed to the other Party prior to the Effective Date or made publicly available prior to the Effective Date, there is no material Action pending against, or to the knowledge of the Party, threatened against or affecting the Party by, before or with any of the FDA, Department of Health and Human Services, the Drug Enforcement Administration, state Medicaid agencies, or any other federal or state Governmental Authority with jurisdiction over the marketing of pharmaceutical products in the Co-Promotion Territory;
11.6.2 Except as disclosed publicly prior to the Effective Date, the Party (a) has not been excluded from participation in any Federal Health Care Program, (b) is not a party to a corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services, (c) has not been convicted of any criminal offense relating to the delivery of any item or service reimbursable under a Federal Health Care Program or relating to the manufacture, distribution, wholesaling, labeling, packaging or marketing of prescription drugs in the Co-Promotion Territory, and (d) is not, to the knowledge of the Party, a party to or subject to any Action concerning any of the matters described in clauses (a) through (c); and
11.6.3 Within the last [**] years, the Party has not received any warning letters, untitled letters or similar correspondence from FDA relating to the Product.
Certain Compliance Matters. To the extent any such business exists, the Company shall use reasonable best efforts to cause the cessation or disposition, by no later than the Effective Time, by the Company and its Subsidiaries of any Contract, transaction or other business, direct or indirect, with any OFAC Prohibited Party.
Certain Compliance Matters. Neither the Seller, nor any of its directors, managers, officers or employees, nor, to the knowledge of the Seller, any agent, Affiliate, joint venture partner or other Person associated with or acting on behalf of the Seller, is an individual or entity, or controlled by an individual or entity (within the meaning of the applicable Law), that is currently or has been (i) the subject or the target of any sanctions (including, without limitation, any enabling legislation, executive orders, or regulations) administered or enforced by the United States government (including, without limitation, sanctions administered or enforced by the Office of Foreign Assets Control of the U.S. Department of the Treasury or any other relevant governmental authority (collectively, “Sanctions”), including Persons that are the subject or the target of the designations “specially designated national,” “blocked person,” “foreign sanctions evader,” or any individual on the “Sectoral Sanctions Identification List,” or any similar list maintained by any
Certain Compliance Matters. (i) The Company is in compliance in all material respects with the applicable provisions of the Sxxxxxxx-Xxxxx Act. Each of the principal executive officer of the Company and the principal financial officer of the Company has made all certifications required by Rule 15d-14 under the Exchange Act with respect to the SEC Filings. For purposes of this Agreement, “principal executive officer” and “principal financial officer” have the meanings given to such terms in the Sxxxxxxx-Xxxxx Act.
(ii) The Company’s system of “internal control over financial reporting” (as defined in Rule 15d-15(f) under the Exchange Act) is reasonably sufficient in all material respects to provide reasonable assurance (x) that transactions are recorded as necessary to permit preparation of financial statements in accordance with GAAP, (y) that receipts and expenditures are being made only in accordance with the authorization of management of the Company and (z) regarding prevention or timely detection of unauthorized acquisition, use or disposition of the Company’s assets that could have a material effect on the Company’s financial statements.
(iii) The Company’s “disclosure controls and procedures” (as defined in Rule 15d-15(e) under the Exchange Act) are reasonably designed in all material respects to ensure that (x) information required to be disclosed by the Company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC and (y) all such information is accumulated and communicated to the Company’s management as appropriate to allow timely decisions regarding required disclosure and to make the certifications of the principal executive officer and principal financial officer of the Company required under the Exchange Act with respect to such reports.
