Common use of Compliance of Products Clause in Contracts

Compliance of Products. (a) Each Credit Party: (i) has obtained all Required Permits, or has contracted with third parties holding Required Permits, necessary for compliance with all Laws and all such Required Permits are current, except where the failure to do so could not reasonably be expected to have a Material Adverse Effect; (ii) has not, to its knowledge, used the services of any Person debarred under the provisions of the Generic Drug Enforcement Act of 1992, 21 U.S.C. Section 335a (a) or (b); (iii) warrants and represents that to its knowledge none of its officers, directors, employees, their agents or affiliates has been convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. Section 335a (a) or authorized by 00 X.X. Xxxxxxx 000x (b); (iv) warrants and represents that to its knowledge none of its officers, directors, employees, their agents or affiliates has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Regulation 46191 (September 10, 1991); (v) has not received any written notice that any Governmental Authority, including without limitation the FDA, the DEA, the Office of the Inspector General of HHS or the United States Department of Justice has commenced or threatened to initiate any action against a Credit Party, any action to enjoin a Credit Party, their officers, directors, or to its knowledge, employees, or their agents and Affiliates, from conducting their businesses at any facility owned or used by them or for any material civil penalty, injunction, seizure or criminal action; (vi) except as set forth on Schedule 3.11, has not received from the FDA or the DEA, at any time since January 1, 2003, a Warning Letter, Form FDA-483, “Untitled Letter,” other correspondence or notice setting forth alleged violations of laws and regulations enforced by the FDA or the DEA, or any comparable correspondence from any state or local authority responsible for regulating drug products and establishments, or any comparable correspondence from any foreign counterpart of the FDA or DEA, or any comparable correspondence from any foreign counterpart of any state or local authority with regard to any Product or the manufacture, processing, packing, or holding thereof; and (vii) except as set forth on Schedule 3.11, has not engaged in any Recalls or other forms of product retrieval from the marketplace of any Products since January 1, 2003. (b) None of the Credit Parties, their Affiliates or any of their respective agents acting or benefiting in any capacity in connection with the transactions contemplated by this Agreement is (i) in violation of any Anti-Terrorism Law, (ii) engages in or conspires to engage in any transaction that evades or avoids, or has the purpose of evading or avoiding, or attempts to violate, any of the prohibitions set forth in any Anti-Terrorism Law, or (iii) is a Blocked Person. No Credit Party nor, to the knowledge of any Credit Party, any of its Affiliates or agents acting or benefiting in any capacity in connection with the transactions contemplated by this Agreement, (x) conducts any business or 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 interest in property blocked pursuant to Executive Order No. 13224, any similar executive order or other Anti-Terrorism Law. (c) With respect to Products: (i) All Products are listed on Exhibit F; provided, however, that, if after the Closing Date, any Borrower wishes to sell or market any new Product, Borrowers shall give prior written notice to Administrative Agent of such intention (which shall include a brief description of such Product), along with a copy of an amended and restated Exhibit F; and provided, further that Borrowers shall promptly (but, in any event within 30 days) provide Administrative Agent with a copy of the FDA’s approval letter for any Product approved after the date hereof; (ii) Each Product is not adulterated or misbranded within the meaning of the FDCA; (iii) Each Product is not an article prohibited from introduction into interstate commerce under the provisions of Sections 404, 505 or 512 of the FDCA; (iv) Each Product that is sold pursuant to a Credit Party’s belief that it is not a “new drug”, as that term is defined in 21 U.S.C. Section 321(p), is generally recognized by qualified experts as safe and effective for its intended uses as those terms have been interpreted by FDA and the United States Supreme Court, and has been used for a material extent and for a material time for such uses; (v) Each Product for which a Drug Efficacy Study Implementation (DESI) Notice has been published in the Federal Register and each Product that is identical to, related to, or similar to such a drug conforms with the requirements set forth in such DESI Notice; (vi) Each Product has been and/or shall be manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed in accordance in all material respects with all applicable Permits and Laws; (vii) Each Product has been and/or shall be manufactured in accordance with Good Manufacturing Practices; (viii) Without limiting the generality of Section 3.11(a)(i) above, with respect to any Product being tested or manufactured by any Borrower, Borrowers have received, and such Product shall be the subject of, all Required Permits needed in connection with the testing or manufacture of such Product as such testing is currently being conducted by or on behalf of Borrower, and Borrowers have not received any notice from any applicable Government Authority, specifically including the FDA, that such Government Authority is conducting an investigation or review of (A) Borrowers’ manufacturing facilities and processes for such Product which have disclosed any material deficiencies or violations of Laws (including Healthcare laws) and/or the Required Permits related to the manufacture of such Product, or (B) any such Required Permit or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing and/or manufacturing of such Product by Borrower should cease; (ix) Without limiting the generality of Section 3.11(a)(i) above, with respect to any Product marketed or sold by any Borrower, Borrowers shall have received, and such Product shall be the subject of, all Required Permits needed in connection with the marketing and sales of such Product as currently being marketed or sold by Borrower, and Borrowers have not received any notice from any applicable Governmental Authority, specifically including the FDA, that such Governmental Authority is conducting an investigation or review of any such Required Permit or approval or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that such marketing or sales of such Product cease or that such Product be withdrawn from the marketplace; and (x) Borrowers have not (since the Closing Date) experienced any significant failures in their manufacturing of any Product such that the amount of such Product successfully manufactured by Borrowers in accordance with all specifications thereof and the Required Payments related thereto in any month shall decrease significantly with respect to the quantities of such Product produced in the prior month.

Compliance of Products. (a) Each Credit Party: (i) has obtained all Required Permits, or has contracted with third parties holding Required Permits, necessary for compliance with all Laws Laws, including the FDCA, and all such Required Permits are current, except where the failure to do so could not reasonably be expected to have a Material Adverse Effect; (ii) has notbeen operating in compliance with the FDCA, including but not limited to, reporting to its knowledge, used the services FDA of any Person debarred under the provisions device malfunctions and/or device-related serious injuries or deaths pursuant to 21 C.F.R. 803 and reporting to FDA of the Generic Drug Enforcement Act of 1992, corrections or removals pursuant to 21 U.S.C. Section 335a (a) or (b)C.F.R. 806; (iii) warrants and represents that to its knowledge none of its officers, directors, employees, their agents or affiliates has been convicted of any crime or engaged in any conduct for which debarment is mandated by 21 U.S.C. Section 335a (a) or authorized by 00 X.X. Xxxxxxx 000x (b); (iv) warrants and represents that to its knowledge none of its officers, directors, employeesshareholders, their agents or affiliates has made an untrue statement of material fact or fraudulent statement to the FDA or failed to disclose a material fact required to be disclosed to the FDA, committed an act, made a statement, or failed to make a statement that could reasonably be expected to provide a basis for the FDA to invoke its policy respecting “"Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” " set forth in 56 Fed. Regulation 46191 (September 10, 1991);; and (viv) has not received any written notice that any Governmental Authority, including without limitation the FDA, the DEA, the Office of the Inspector General of HHS or the United States Department of Justice has commenced or threatened to initiate any action against a Credit Party, any action to enjoin a Credit Party, their officers, directors, or to its knowledge, employees, shareholders or their agents and Affiliates, from conducting their businesses at any facility owned or used by them or for to seek any material civil penalty, injunction, seizure or criminal action; (vi) except as set forth on Schedule 3.11, has not received from the FDA or the DEA, at any time since January 1, 2003, a Warning Letter, Form FDA-483, “Untitled Letter,” other correspondence or notice setting forth alleged violations of laws and regulations enforced by the FDA or the DEA, or any comparable correspondence from any state or local authority responsible for regulating drug products and establishments, or any comparable correspondence from any foreign counterpart of the FDA or DEA, or any comparable correspondence from any foreign counterpart of any state or local authority with regard to any Product or the manufacture, processing, packing, or holding thereof; and (vii) except as set forth on Schedule 3.11, has not engaged in any Recalls or other forms of product retrieval from the marketplace of any Products since January 1, 2003. (b) None of the Credit Parties, their Affiliates or any of their respective agents acting or benefiting in any capacity in connection with the transactions contemplated by this Agreement is (i) in violation of any Anti-Terrorism Law, (ii) engages in or conspires to engage in any transaction that evades or avoids, or has the purpose of evading or avoiding, or attempts to violate, any of the prohibitions set forth in any Anti-Terrorism Law, or (iii) is a Blocked Person. No Credit Party nor, to the knowledge of any Credit Party, any of its Affiliates or agents acting or benefiting in any capacity in connection with the transactions contemplated by this Agreement, (x) conducts any business or 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 interest in property blocked pursuant to Executive Order No. 13224, any similar executive order or other Anti-Terrorism AntiTerrorism Law. (c) With respect to Products: (i) All Products are listed on Exhibit F; provided, however, that, if after the Closing Date, any Borrower wishes to sell or market any new Product, Borrowers shall give prior written notice to Administrative Agent of such intention (which shall include a brief description of such Product), along with a copy of an amended and restated Exhibit F; and provided, further that Borrowers shall promptly (but, in any event within 30 days) provide Administrative Agent with a copy of the FDA’s approval letter for any Product approved after the date hereof; (ii) Each Product is not adulterated or misbranded within the meaning of the FDCA; (iiiii) Each Product is not an article prohibited from introduction into interstate commerce under the provisions of Sections 404, 505 510(k) or 512 515 of the FDCA; (iv) Each Product that is sold pursuant to a Credit Party’s belief that it is not a “new drug”, as that term is defined in 21 U.S.C. Section 321(p), is generally recognized by qualified experts as safe and effective for its intended uses as those terms have been interpreted by FDA and the United States Supreme Court, and has been used for a material extent and for a material time for such uses; (v) Each Product for which a Drug Efficacy Study Implementation (DESI) Notice has been published in the Federal Register and each Product that is identical to, related to, or similar to such a drug conforms with the requirements set forth in such DESI Notice; (viiii) Each Product has been and/or shall be manufactured, imported, possessed, owned, warehoused, marketed, promoted, sold, labeled, furnished, distributed and marketed in accordance in all material respects with all applicable Permits and Laws, including but not limited to the FDCA; (viiiv) Each Product has been and/or shall be designed and manufactured in accordance with Good Manufacturing PracticesPractices as defined in the Quality System Regulation (21 C.F.R. Part 820); (viiiv) Without limiting the generality of Section 3.11(a)(i3.25(a)(i) above, with respect to any Product being tested or manufactured by any Borrower, Borrowers have Borrower has received, and such Product shall be the subject of, all Required Permits needed in connection with the testing or manufacture of such Product as such testing is currently being conducted by or on behalf of Borrower, and Borrowers have not received any notice from any applicable Government Authority, specifically including the FDA, that such Government Authority is conducting an investigation has commenced any action seeking to revoke or review of (A) Borrowers’ manufacturing facilities and processes for such Product which have disclosed any material deficiencies or violations of Laws (including Healthcare laws) and/or the Required Permits related to the manufacture of such Product, or (B) withdraw any such Required Permit or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that the development, testing and/or manufacturing of such Product by Borrower should cease;; and (ixvi) Without limiting the generality of Section 3.11(a)(i3.25(a)(i) above, with respect to any Product marketed or sold by any Borrower, Borrowers Borrower shall have received, and such Product shall be the subject of, all Required Permits needed in connection with the marketing and sales of such Product as currently being marketed or sold by Borrower, and Borrowers have not received any notice from any applicable Governmental Authority, specifically including the FDA, that such Governmental Authority is conducting an investigation has commenced any action seeking to revoke or review of withdraw any such Required Permit or approval or that any such Required Permit has been revoked or withdrawn, nor has any such Governmental Authority issued any order or recommendation stating that such marketing or sales of such Product cease or that such Product be withdrawn from the marketplace; and (x) Borrowers have not (since the Closing Date) experienced any significant failures in their manufacturing of any Product such that the amount of such Product successfully manufactured by Borrowers in accordance with all specifications thereof and the Required Payments related thereto in any month shall decrease significantly with respect to the quantities of such Product produced in the prior month.