Common use of FDA Approval Clause in Contracts

FDA Approval. (a) To the Company’s knowledge, all clinical trials conducted by or for the benefit of the Company have been, and are being, conducted in material compliance with the applicable requirements of “Good Clinical Practice”, informed consent, and all applicable requirements relating to protection of human subjects contained in 21 C.F.R.; (b) Except as set forth in Section 3.29 of the Disclosure Schedule, to the Company’s knowledge, all manufacturing operations currently conducted by or for the benefit of the Company relating to drugs for human use have been and are being conducted in material compliance with the FDA’s applicable current “Good Manufacturing Practice” regulations; (c) To the Company’s knowledge, no product (co-)promoted by the Company has been recalled, suspended or discontinued in the United States as a result of any action by the FDA; (d) The Company has not received any notice, and to its knowledge Allergan has not received any notice, that the FDA has commenced, or threatened to initiate, any action to withdraw approval, place marketing or sale restrictions, or request the recall of any product (co-)promoted by the Company, or commenced, or threatened to initiate, any action to enjoin or place restrictions on the production, sale, or marketing of any such products; (e) The Company has no product on clinical hold nor has the Company received written notice indicating that any product is reasonably likely to be placed on clinical hold; (f) Neither the Company nor any officer or employee of the Company has been convicted of any crime or engaged in any conduct that would reasonably be expected to result in (A) debarment under 21 U.S.C. Section 335a or any similar state law or regulation or (B) exclusion under 42 U.S.C. Section 1320a-7 or any similar state law or regulation; and (g) The Company has made available to the Investor all submissions to the FDA and the FDA responses (and other material correspondence received from or submitted to the FDA), including, but not limited to, all FDA warning letters, regulatory letters and notice of adverse finding letters and the relevant responses, received by the Company or any agent thereof relative to the development of the Company’s products and in the possession of the Company.

FDA Approval. (a) To the Company’s knowledge, all clinical trials conducted by or for the benefit of the Company have been, and are being, conducted in material compliance with the applicable requirements of “Good Clinical Practice”, informed consent, and all applicable requirements relating to protection of human subjects contained in 21 C.F.R.; (b) Except as expressly set forth in Section 3.29 of the Disclosure ScheduleSchedule 4.16, to the Company’s knowledge's Knowledge, all manufacturing operations currently conducted by or for the benefit of the Company relating to drugs for human use have been and are being conducted in material compliance with (i) no Governmental Authority, including, but not limited to, the FDA’s applicable current “Good Manufacturing Practice” regulations; (c) To , will ultimately prohibit the Company’s knowledgemarketing, no product (co-)promoted by the Company has been recalledsale, suspended distribution, license or discontinued use in the United States as a result or elsewhere of any action product that is produced or marketed, or is proposed to be developed, produced or marketed by the FDA; Company or its Subsidiaries or with third parties (deach, a "Product"), (ii) The Company the FDA has not received prohibited any noticeproduct or process from being marketed or used in the United States which product or process is substantially similar to any Product in function or composition, and (iii) neither the Company nor any Subsidiary has reason to its knowledge Allergan has not received any notice, believe that the FDA has commenced, or threatened to initiate, any action to withdraw approval, place marketing or sale restrictions, or request will ultimately restrict the recall current intended use of any product Product. Except as expressly set forth in Schedule 4.16, (co-)promoted by i) neither the Company, or commenced, or threatened to initiate, Company nor any action to enjoin or place restrictions on the production, sale, or marketing of Subsidiary has any such products; (e) The Company has no product Product on clinical hold nor or for which the FDA or an institutional review board ("IRB") has withdrawn approval for a clinical investigation or, to the Company received written notice indicating Company's Knowledge, any reason to expect that any product Product is reasonably likely to be placed on clinical hold; hold or have approval for an investigation be withdrawn or suspended by the FDA or IRB, (fii) Neither none of the Company nor or its Subsidiaries or, to the Company's Knowledge, its employees or agents, has ever been sanctioned, formally or otherwise, by the FDA, including, but not limited to, implementation of the FDA integrity policy, (iii) there has not been any officer suspensions or debarments by the FDA or other federal departments and state regulatory bodies against the Company or its Subsidiaries, or to the Company's Knowledge, any current or former employee of the Company has been convicted Company, or to Company's Knowledge, any current or former clinical investigator participating in clinical investigations of any crime Product of the Company or engaged in any conduct that would reasonably be expected to result in its Subsidiaries, and (Aiv) debarment under 21 U.S.C. Section 335a or any similar state law or regulation or (B) exclusion under 42 U.S.C. Section 1320a-7 or any similar state law or regulation; and (g) The the Company has made available to the Investor Purchasers all submissions to the FDA and the FDA responses (and other material correspondence received from or submitted to the FDA), including, but not limited to, all FDA warning letters, regulatory letters and letters, notice of adverse finding letters, and untitled compliance letters and the relevant responses, received by the Company Company, any Subsidiary or any agent thereof relative to the development development, marketing or distribution of the Company’s products and in the possession of the Company.its Products