Common use of FDA Matters Clause in Contracts

FDA Matters. As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have or reasonably be expected to result in a Material Adverse Effect. There is no pending, completed or, to the Company’s knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiaries, and none of the Company or any of its Subsidiaries has received any notice, warning letter or other communication from the FDA or any other governmental entity, which (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Pharmaceutical Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iv) enjoins production at any facility of the Company or any of its Subsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiaries, and which, either individually or in the aggregate, would have or reasonably be expected to result in a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA. The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.

FDA Matters. As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have or reasonably be expected to result in a Material Adverse Effect. There is no pending, completed or, to the Company’s 's knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiaries, and none of the Company or any of its Subsidiaries has received any notice, warning letter or other communication from the FDA or any other governmental entity, which (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Pharmaceutical Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iv) enjoins production at any facility of the Company or any of its Subsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiaries, and which, either individually or in the aggregate, would have or reasonably be expected to result in a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA. The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company nor nor, to the Company’s knowledge, has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company. .

FDA Matters. As to each product or product candidate subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) and/or the jurisdiction of the non-U.S. counterparts thereof that is manufactured, packaged, labeled, tested, distributed, sold, sold and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and/or and similar laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have or reasonably be expected to result in a Material Adverse EffectChange. The Company currently has no products that have been approved by the FDA or any non-U.S. counterparts thereof to be manufactured, packaged, labeled, distributed, sold and/or marketed. There is no pending, completed or, to the Company’s knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its SubsidiariesCompany, and none of the Company or any of its Subsidiaries has not received any notice, warning letter or other communication from the FDA or any other governmental entityentity or any non-U.S. counterparts thereof, which (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Pharmaceutical Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its SubsidiariesCompany, (iv) enjoins production at any facility of the Company or any of its SubsidiariesCompany, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its SubsidiariesCompany, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its SubsidiariesCompany, and which, either individually or in the aggregate, would have or reasonably be expected to result in a Material Adverse EffectChange. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDAFDA and non-U.S. counterparts thereof. The Company has not been informed by the FDA or any non-U.S. counterparts thereof that the FDA such agency will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company Product nor has the FDA expressed or a non-U.S. counterpart thereof provided any concern as written notice that could reasonably be expected to approving preclude the approval or the clearing for marketing of any product being developed or proposed to be developed by the CompanyProduct.

FDA Matters. As (a) The Company and each of its Subsidiaries has obtained or, to each product subject Seller’s Knowledge, reasonably believes that Company will be able to obtain through commercially reasonable means and efforts, in all material respects and to the jurisdiction extent applicable, all necessary approvals, clearances, authorizations, licenses and registrations required by the United States Federal government and its agencies and approvals, clearances, authorizations, licenses and registrations required by all other governmental authorities, to permit the activities, including, without limitation, pre-clinical testing, currently undertaken by the Company or each such Subsidiary, respectively, to date (the “Activities to Date”) in jurisdictions where the Company or such Subsidiaries currently conduct such activities (collectively, the “Regulatory Licenses”). To Seller’s Knowledge, the Company and each of its Subsidiaries is substantially in compliance with all material terms and conditions of each applicable Regulatory License and with all applicable and material laws, rules and regulations pertaining to the Activities to Date, including, without limitation, (i) requirements governing investigational drugs and devices under the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act and regulations issued thereunder, (ii) regulations related to good laboratory practices and good clinical practices issued by the United States Food and Drug Administration (the “FDA”) and (iii) the U.S. Animal Welfare Act, as amendedthe regulations issued thereunder, and the regulations thereunder (“FDCA”) that any similar federal, state, and foreign statutes and regulations. The Company is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company substantially in compliance with all applicable and material reporting requirements under FDCA and similar lawsfor all Regulatory Licenses. (b) None of Seller, rules and regulations relating to registrationthe Company, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have or reasonably be expected to result in a Material Adverse Effect. There is no pending, completed Company’s Subsidiaries or, to the CompanySeller’s knowledgeKnowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiaries, and none of the Company or any of its Subsidiaries has their respective Affiliates have received any notice, warning letter written notice or other written communication (or to Seller’s Knowledge, any oral notice or other oral communication) from the FDA or any other governmental entity, which Governmental Authority (i) contests contesting the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, of or the labeling and promotion of any Pharmaceutical Productproduct including, (ii) withdraws its approval ofwithout limitation, requests the recall, suspension, those products currently under research or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation development by the Company or its Subsidiaries, or (ii) otherwise alleging any violation by the Company or its Subsidiaries of any law, regulation or other legal provision applicable to any such product. (c) Neither the Company nor any of its SubsidiariesSubsidiaries nor, to Seller’s Knowledge, any officer, employee or Affiliate of the Company or any such Subsidiary has made an untrue statement of a material fact or fraudulent statement to the FDA or any other governmental authority performing similar functions or failed to disclose a material fact required to be disclosed to the FDA or such other governmental authority. (ivd) enjoins production at any facility No clinical trials involving third party human subjects has been conducted by or on behalf of the Company or any of its Subsidiaries, except in government-approved trials in the jurisdictions where such trials would require approval. (ve) enters The preclinical trials conducted by, on behalf of, or proposes to enter into a consent decree of permanent injunction with sponsored by, the Company or any of its Subsidiaries (or, to the extent conducted in connection with the Business, the Company’s or its Subsidiaries’ respective Affiliates) were and, or (vi) otherwise alleges any violation of any lawsto the extent still pending, rules or regulations by the Company or any of its Subsidiariesare being, and which, either individually or in the aggregate, would have or reasonably be expected to result in a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, FDA rules and regulations of the FDAin all material respects. The Company has not been informed by the FDA that the FDA will prohibit the marketingTo Seller’s Knowledge, sale, license or use in the United States of any product proposed to be developed, produced or marketed by neither the Company nor any of its Subsidiaries has received any written notices or correspondence, or oral communications, from the FDA expressed or any concern as to approving other governmental authority exercising comparable authority requiring or clearing for marketing requesting the termination, suspension or material modification of any product being developed such study, test or proposed to be developed by the Companytrial.

FDA Matters. As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“"FDA”") under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“"FDCA”") that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries subsidiaries (each such product, a “"Pharmaceutical Product”"), to the knowledge of the Company, such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, reports except where the failure to be in compliance would not have or reasonably be expected to result in a Material Adverse Effect. There is no pending, completed or, to the Company’s 's knowledge, threatened, threatened action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiariessubsidiaries, and none of the Company or any of its Subsidiaries subsidiaries has received any notice, warning letter or other communication from the FDA or any other governmental entity, which (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Pharmaceutical Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiariessubsidiaries, (iv) enjoins production at any facility of the Company or any of its Subsidiariessubsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiariessubsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiariessubsidiaries, and which, either individually or in the aggregate, would have or reasonably be expected to result in a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA. The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.

FDA Matters. As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) FDA under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries Company, including, without limitation, the Prestalia Products (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have or reasonably be expected to result in a Material Adverse Effect. There is no pending, completed or, to the Company’s knowledgeKnowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its SubsidiariesCompany, and none of the Company or any of its Subsidiaries has not received any notice, warning letter or other communication from the FDA or any other governmental entity, which (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Pharmaceutical Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its SubsidiariesCompany, (iv) enjoins production at any facility of the Company or any of its SubsidiariesCompany, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its SubsidiariesCompany, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its SubsidiariesCompany, and which, either individually or in the aggregate, would have or reasonably be expected to result in a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA. The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.

FDA Matters. As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries subsidiaries (each such product, a “Pharmaceutical Product”), to the knowledge of the Company, such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, reports except where the failure to be in compliance would not have or reasonably be expected to result in a Material Adverse Effect. There is no pending, completed or, to the Company’s knowledge, threatened, threatened action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiariessubsidiaries, and none of the Company or any of its Subsidiaries subsidiaries has received any notice, warning letter or other communication from the FDA or any other governmental entity, which (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Pharmaceutical Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiariessubsidiaries, (iv) enjoins production at any facility of the Company or any of its Subsidiariessubsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiariessubsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiariessubsidiaries, and which, either individually or in the aggregate, would have or reasonably be expected to result in a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA. The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.

FDA Matters. As to each product (a) All Company Products that are subject to the jurisdiction of the U.S. United States Food and Drug Administration (“FDA”the "FD ') under the Federal Foodare being developed, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packagedused, processed, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeledstored, tested, distributed, sold and/or marketed by the Company and imported or exported in compliance in all material respects with all Applicable Laws, including all applicable requirements under FDCA the federal Food and similar lawsDrug and Cosmetic Act ("FDC '), rules the Public Health Service Act and regulations relating their applicable implementing regulations. All Company Products that are subject to registrationthe jurisdiction of any other Governmental Entity are being developed, investigational usemanufactured, premarket clearanceused, licensureprocessed, labeled, stored, tested, imported, and exported in compliance in all material respects with all comparable Applicable Laws of such Governmental Entity. (b) Neither the Company nor any representative of the Company nor, to the knowledge of the Company, any licensees or assignees of any Company Intellectual Property has received any written notice that the FDA or any other Governmental Entity has initiated, or application approvalthreatened to initiate, good manufacturing practicesany action to (i) suspend any clinical trial, good laboratory practices(ii) withdraw approval of, good or suspend or terminate, any Investigational New Drug Application, or any comparable foreign regulatory application, in each case sponsored by the Company with respect to any Company Product, or otherwise prevent or prohibit the preclinical research on or clinical practicesstudy of any Company Products by or on behalf of the Company, product listingor (ill) recall, quotasor order to suspend the manufacture of, labelingany Company Product. (c) Neither the Company nor, advertisingto the knowledge of the Company, record keeping any of its officers, employees, or agents or clinical investigators acting for the Company, 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, ▇▇▇▇▇▇▇, and filing Illegal Gratuities" set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. Additionally, neither the Company nor, to the knowledge of reportsthe Company, except where any officer, employee, or agent of the failure to be Company has been convicted of any crime or engaged in compliance any conduct that would not have or reasonably be expected to result in a Material Adverse Effect. There is no pending, completed or, to the Company’s knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiaries, and none of the Company or any of its Subsidiaries has received any notice, warning letter or other communication from the FDA or any other governmental entity, which (i) contests the premarket clearance, licensure, registration, debarment under 21 U.S.C. Section 335a or approval of, the uses of, the distribution of, the manufacturing any similar applicable state or packaging of, the testing of, the sale of, foreign Applicable Law or the labeling and promotion of any Pharmaceutical Product, (ii) withdraws its approval of, requests the recall, suspension, exclusion under 42 U.S.C. Section 1320a- 7 or seizure of, any similar applicable state or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, foreign Applicable Law. (iiid) imposes a clinical hold on any clinical investigation by Except as is not material to the Company or in any of its Subsidiaries, (iv) enjoins production at any facility of the Company or any of its Subsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiaries, and which, either individually case or in the aggregate, would all animal studies or other preclinical tests performed by the Company, or by third-party vendors on the Company's behalf, in connection with or as the basis for any regulatory approval required for the Company Products either have been conducted in accordance, in all material respects, with applicable Law, including applicable Good Laboratory Practice regulations as described in 21 CPR Part 58 or reasonably be expected comparable foreign Applicable Laws. (e) The Company has delivered to result the Acquirer copies of any and all written notices of inspectional observations, establishment inspection reports, and any other documents received by the Company from any Governmental Entity, including the FDA or any comparable foreign Governmental Entities, that identify lack of compliance by the Company \with Applicable Laws, including Applicable Laws of the FDA or comparable foreign Governmental Entities. (f) True, complete, and correct copies of any and all of the Company's submissions to, or material correspondence with, the FDA or its comparable foreign Governmental Entity have been provided to the Acquirer by the Company. (g) There is no Legal Proceeding pending or, to the knowledge of the Company, threatened, with respect to a violation by the Company of any Applicable Law, including the FDCA, FDA regulations adopted thereunder, or the Controlled Substance Act. (h) The Company has not received from any Governmental Entity any (i) inspection reports, (ii) notices of adverse :findings, warning or untitled letters, or minutes of meetings, or (iii) other correspondence concerning the Company Products, in a Material Adverse Effect. The properties, business and each case in which any Governmental Entity asserted in writing that the operations of the Company have been and are being conducted may not be in all material respects in accordance compliance with all applicable laws, rules and regulations of the FDA. Applicable Laws. (i) The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States received written notice from any of its suppliers of any product proposed to be developedmaterial interruption of supply or manufacturing capacity, produced shortage of raw materials, components, or marketed by other manufacturing problems that would have a material adverse effect on the subsequent development of the Company nor has Products, nor, to the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by knowledge of the Company, do any conditions exist that reasonably would be expected to lead to such manufacturing problems.

FDA Matters. As to each of the Company’s product candidates subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal U.S. Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries subsidiaries (each such productproduct candidate, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar other federal or state laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have or reasonably be expected to result in have a Material Adverse Effect. There is no pending, completed or, to the Company’s knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiariessubsidiaries, and none of the Company or any of its Subsidiaries subsidiaries has received any notice, warning letter or other communication from the FDA or any other governmental entity, which (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Pharmaceutical Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiariessubsidiaries, (iv) enjoins production at any facility of the Company or any of its Subsidiariessubsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiariessubsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiariessubsidiaries, and which, either individually or in the aggregate, would have or reasonably be expected to result in have a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA. The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.

FDA Matters. As (a) Neither the Company nor the Subsidiary has sold any products anywhere in the world prior to each product subject receiving any required or necessary approvals or consents from any Governmental Authority, including but not limited to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) FDA under the Federal Food, Drug and Cosmetic Act& Cosmetics Act of 1976, as amended, and the regulations thereunder (“FDCA”) that is manufacturedpromulgated thereunder, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (corollary entity in any other jurisdiction. Except as set forth on Schedule 3.20(a) hereto, each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have or reasonably be expected to result in a Material Adverse Effect. There is no pending, completed or, to the Company’s knowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiaries, and none of the Company and each Subsidiary has obtained in the United States and in all countries where it is currently marketing its products, all applicable licenses, registrations, approvals, consents, clearances and authorizations required by local, state or any federal agencies in such countries regulating the safety, effectiveness and market clearance of its Subsidiaries such products to sell, promote and market such products. Neither the Company nor the Subsidiary has received any noticenotice of, and the Company is not aware of, any outstanding, pending or threatened actions, citations, decisions, product recalls, medical device reports, information requests, warning letter letters or other communication Section 305 notices from the FDA or similar issues or notifications from any corollary entity in any other governmental entityjurisdiction. (b) Except as set forth on Schedule 3.20(b) hereto, which each of the Company and each Subsidiary has (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Pharmaceutical Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iv) enjoins production at any facility of the Company or any of its Subsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiaries, and which, either individually or in the aggregate, would have or reasonably be expected to result in a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted complied in all material respects with all applicable laws, regulations and specifications with respect to the design, manufacture, labeling, testing and inspection of all of its products and the operation of manufacturing facilities promulgated by the FDA or any corollary entity in any other jurisdiction, and (ii) conducted all of its clinical trials with reasonable care and in accordance with all applicable laws, rules laws in all material respects and regulations in accordance with the stated protocols for such clinical trials. (c) All of the FDA. The Company has not been informed by Company's submissions to the FDA that and any corollary entity in any other jurisdiction whether oral, written or electronically delivered were true, accurate and complete in all material respects as of the date made, and together with any amendments to such submissions or supplemental information provided to the FDA will prohibit or such other corollary entity, remain true, accurate and complete in all material respects as of the marketingdate hereof, saleand do not materially misstate any of the statements or information included therein, license or use in omit to state a material fact necessary to make the United States of any product proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Companystatements therein not misleading.

FDA Matters. As to Except as would not, individually or in the aggregate, result in a Material Adverse Effect: (i) the Company and each product subject of its Subsidiaries is and has been in compliance with statutes, laws, ordinances, rules and regulations applicable to the jurisdiction Company or its Subsidiaries for the ownership, testing, development, manufacture, packaging, processing, use, labeling, storage, or disposal of any product manufactured by or on behalf of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed Company or any of its Subsidiaries or out-licensed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Company Product”), including without limitation, the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq., the Public Health Service Act, 42 U.S.C. § 262, similar laws of other governmental entities and the regulations promulgated pursuant to such Pharmaceutical laws (collectively, “Applicable Laws”); (ii) the Company and each of its Subsidiaries possesses all licenses, certificates, approvals, authorizations, permits and supplements or amendments thereto required by any such Applicable Laws and/or for the ownership of its properties or the conduct of its business as it relates to a Company Product and as described in the SEC Filings (collectively, “Authorizations”) and such Authorizations are valid and in full force and effect and the Company and each of its Subsidiaries is not in violation of any term of any such Authorizations; (iii) neither the Company nor any of its Subsidiaries has received any written notice of adverse finding, warning letter or other written correspondence or notice from the U.S. Food and Drug Administration (the “FDA”) or any other governmental entity alleging or asserting noncompliance with any Applicable Laws or Authorizations relating to a Company Product; (iv) neither the Company nor any of its Subsidiaries has received written notice of any ongoing claim, action, suit, proceeding, hearing, enforcement, investigation, arbitration or other action from any governmental entity or third party alleging that any Company Product, operation or activity related to a Company Product is being manufacturedin violation of any Applicable Laws or Authorizations or has any knowledge that any such governmental entity or third party is considering any such claim, packagedlitigation, labeledarbitration, testedaction, distributedsuit, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar lawsinvestigation or proceeding, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have or reasonably be expected to result in a Material Adverse Effect. There is no pending, completed ornor, to the Company’s knowledgeKnowledge, threatened, action (including has there been any lawsuit, arbitration, noncompliance with or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or violation of any of its Subsidiaries, and none of Applicable Laws by the Company or any of its Subsidiaries that would reasonably be expected to require the issuance of any such written notice or result in an investigation, corrective action, or enforcement action by the FDA or similar governmental entity with respect to a Company Product; (v) neither the Company nor any of its Subsidiaries has received written notice that any noticegovernmental entity has taken, warning letter is taking or intends to take action to limit, suspend, modify or revoke any Authorizations or has any knowledge that any such governmental entity has threatened or is considering such action with respect to a Company Product; and (vi) the Company and each of its Subsidiaries has filed, obtained, maintained or submitted all reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments as required by any Applicable Laws or Authorizations and that all such reports, documents, forms, notices, applications, records, claims, submissions and supplements or amendments were complete, correct and not misleading on the date filed (or were corrected or supplemented by a subsequent submission). To the Company’s Knowledge, neither the Company nor any of Subsidiaries nor any of its or their directors, officers, employees or agents, has made, or caused the making of, any false statements on, or material omissions from, any other communication from records or documentation prepared or maintained to comply with the requirements of the FDA or any other governmental entity, which (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Pharmaceutical Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iv) enjoins production at any facility of the Company or any of its Subsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiaries, and which, either individually or in the aggregate, would have or reasonably be expected to result in a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA. The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.

FDA Matters. As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amendedSeller is, and the regulations thereunder (“FDCA”) that is manufacturedat all times has been, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in material compliance with all applicable requirements under FDCA FDA Laws and similar lawsRegulations including but not limited to (i) the requirement for and the terms of all necessary Governmental Approvals, rules including, without limitation, approvals, clearances, exemptions, licenses and regulations relating to registrationother authorizations, investigational use(ii) current Good Manufacturing Practices (“cGMP”), premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, (iii) establishment registration and product listing, quotas(iv) labeling, promotion, and advertising, (v) Good Clinical Practices (“GCP”) and Good Laboratory Practices (“GLP”), (vi) payment of all application, product and establishment fees, and (vii) recordkeeping and reporting requirements other than those applicable to cGMP, GCP, and GLP. Without limiting the generality of the foregoing, in each case, with respect to the Business and Transferred Assets: (a) Seller has not received any written notice or communication from any Governmental Authority of any actual or threatened investigation, inquiry, or administrative or regulatory action, hearing, or enforcement proceeding against Seller regarding any material violation of FDA Laws and Regulations. Seller is not subject to any material obligation arising under an investigation, inquiry, or administrative, regulatory or judicial action, hearing, or enforcement proceeding by or on behalf of the FDA, warning letter, untitled letter, Form FDA-483, notice of violation letter, consent decree, request for information or other notice, response, or commitment made to or with any Governmental Authority with respect to FDA Laws and Regulations, and no such material obligation has been threatened. (b) There is no product liability, civil, or criminal action, suit, proceeding, demand, claim, complaint, hearing, investigation, demand letter, warning letter, proceeding or request for information pending against or relating to Seller or to any of their employees that involves or arises from a material violation of FDA Laws and Regulations, and Seller has no material liability for failure to comply with any FDA Laws and Regulations. To Seller’s knowledge, there is no act, omission, event, or circumstance that would reasonably be expected to give rise to or lead to any such action, suit, demand, claim, complaint, hearing, investigation, notice, demand letter, warning letter, proceeding or request for information or any such material liability. (c) There has not been any violation of any FDA Laws and Regulations by Seller in the product development efforts, submissions, production, marketing, distribution, labeling, advertising, record keeping and filing of reports, except where the failure mandatory reports to be in compliance would not have or FDA that could reasonably be expected to result in a Material Adverse Effect. There is no pendingrequire or lead to investigation, completed orcorrective action or enforcement, regulatory or administrative action or proceedings relating to the Company’s knowledgeSeller, threatenednor has there been any such violation. (d) No Product has been seized, action (including any lawsuitwithdrawn, arbitrationrecalled, detained, or legal or administrative or regulatory proceedingsubject to a suspension of research, charge, complaintmanufacturing, or investigation) against distribution, activity by a Governmental Authority. No Action in the Company or any of its Subsidiaries, and none of the Company or any of its Subsidiaries has received any notice, warning letter or other communication from the FDA United States or any other governmental entityjurisdiction seeking the withdrawal, which (i) contests the premarket clearancerecall, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Pharmaceutical Product, (ii) withdraws its approval of, requests the recallrevocation, suspension, import refusal, or seizure ofof any Product are pending or threatened against Seller. (e) Seller conducts and has conducted, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, (iii) imposes engaged with a third party to conduct clinical hold on any clinical investigation by the Company or any of its Subsidiaries, (iv) enjoins production at any facility of the Company or any of its Subsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiaries, and which, either individually or in the aggregate, would have or reasonably be expected to result in a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted trials in all material respects in accordance with all the applicable lawsprinciples set forth in the International Conference on Harmonisation (ICH) Guideline for Good Clinical Practice (E6) and FDA GCP requirements, rules including institutional research board-approved study protocols, valid informed consent, monitoring and regulations auditing plans, adverse event reporting proper documentation, and valid data collection and reporting procedures. (f) No officer or employee or, to Seller’s knowledge, agent of Seller is, has been, or has been threatened to be: (a) debarred under FDA proceedings under 21 U.S.C. § 335a; (b) disqualified under FDA investigator disqualification proceedings; (c) subject to FDA’s Application Integrity Policy; (d) subject to any enforcement proceeding arising from material false statements to FDA pursuant to 18 U.S.C. § 1001; (e) debarred, excluded or suspended from participating in any “federal health care program” as defined in 42 U.S.C. § 1320a-7b(f); (f) subject to a civil monetary penalty assessed under 42 U.S.C. § 1320a-7a, sanctioned, indicted or convicted of a crime, or pled nolo contendere or to sufficient facts, in connection with any allegation of violation of any “federal health care program” requirement or Applicable Law; (g) listed on the General Services Administrative published list of parties excluded from federal procurement programs and non-procurement programs; (h) debarred, excluded, suspended, or proposed in writing for debarment from receiving government contracts in any country, including the U.S. pursuant to 48 C.F.R. Subpart 9.4; or (i) subject to a civil monetary penalty assessed under Section 1128A of the FDA. The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the CompanySocial Security Act.

FDA Matters. As to each product subject to The properties, business and operations of the jurisdiction Company have been and are being conducted in accordance with all applicable laws, rules and regulations of the U.S. Food and Drug Administration (the “FDA”) including without limitation under the Federal U.S. Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company and other federal or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar state laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be in compliance would not have or reasonably be expected to result in have a Material Adverse Effect. There is no pending, completed or, to the Company’s knowledgeKnowledge, threatened, action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiariessubsidiaries, and none of the Company or any of its Subsidiaries subsidiaries has received any notice, warning letter or other communication from the FDA or any other governmental entity, which (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any of the Company’s product candidates subject to the jurisdiction of the FDA that is manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company or any of its Subsidiaries (each such product candidate, a “Pharmaceutical Product”), (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiariessubsidiaries, (iv) enjoins production at any facility of the Company or any of its Subsidiariessubsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiariessubsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiariessubsidiaries, and which, either individually or in the aggregate, would have or reasonably be expected to result in have a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA. The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use in the United States of any product proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the Company.

FDA Matters. As to each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amended, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed by the Company or any of its Subsidiaries (each such product, a “Pharmaceutical Product”), to the knowledge of the Company, such Pharmaceutical Product is being manufactured, packaged, labeled, tested, distributed, sold and/or marketed by the Company in compliance with all applicable requirements under FDCA and similar laws, rules and regulations relating to registration, investigational use, premarket clearance, licensure, or application approval, good manufacturing practices, good laboratory practices, good clinical practices, product listing, quotas, labeling, advertising, record keeping and filing of reports, reports except where the failure to be in compliance would not have or reasonably be expected to result in a Material Adverse Effect. There is no pending, completed or, to the Company’s knowledge, threatened, threatened action (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigation) against the Company or any of its Subsidiariessubsidiaries, and none of the Company or any of its Subsidiaries subsidiaries has received any notice, warning letter or other communication from the FDA or any other governmental entity, which (i) contests the premarket clearance, licensure, registration, or approval of, the uses of, the distribution of, the manufacturing or packaging of, the testing of, the sale of, or the labeling and promotion of any Pharmaceutical Product, (ii) withdraws its approval of, requests the recall, suspension, or seizure of, or withdraws or orders the withdrawal of advertising or sales promotional materials relating to, any Pharmaceutical Product, (iii) imposes a clinical hold on any clinical investigation by the Company or any of its Subsidiariessubsidiaries, (iv) enjoins production at any facility of the Company or any of its Subsidiariessubsidiaries, (v) enters or proposes to enter into a consent decree of permanent injunction with the Company or any of its Subsidiariessubsidiaries, or (vi) otherwise alleges any violation of any laws, rules or regulations by the Company or any of its Subsidiariessubsidiaries, and which, either individually or in the aggregate, would have or reasonably be expected to result in a Material Adverse Effect. The properties, business Company acknowledges and operations of agrees that no Buyer makes or has made any representations or warranties with respect to the Company have been and are being conducted in all material respects in accordance with all applicable laws, rules and regulations of the FDA. The Company has not been informed by the FDA that the FDA will prohibit the marketing, sale, license or use transactions contemplated hereby other than those specifically set forth in the United States of any product proposed to be developed, produced or marketed by the Company nor has the FDA expressed any concern as to approving or clearing for marketing any product being developed or proposed to be developed by the CompanyTransaction Documents.