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 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 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, 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 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, to the Company’s knowledge, 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 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 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 ’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 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 nor, to the Company’s knowledge, 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 Company. Product.

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 a Material Adverse Effect. There is no pending, completed Company’s Subsidiaries or, to the Company's knowledgeSeller’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 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 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 in all material respects. To Seller’s Knowledge, neither the Company nor any of the FDA. The Company its Subsidiaries has not been informed by received any written notices or correspondence, or oral communications, from the FDA that or any other governmental authority exercising comparable authority requiring or requesting the FDA will prohibit the marketingtermination, sale, license suspension or use in the United States material modification of any product proposed to be developedsuch study, produced test or marketed by the Company 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. trial.

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 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 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, 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 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 reasonably be expected to have 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 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 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, to the Company’s knowledge, 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 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 reasonably be expected to have a Material Adverse Effect. There is no pending, completed or, to the Company's knowledge’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 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 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, to the Company’s knowledge, 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 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 a Material Adverse Effect. There is no pending, completed ornor, to the Company's knowledge’s Knowledge, 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 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, 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 (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 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 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, 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. statements therein not misleading.

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 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 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, 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 (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, or application approvallabeled, good manufacturing practicesstored, good laboratory practicestested, good clinical practicesimported, product listing, quotas, labeling, advertising, record keeping and filing of reports, except where the failure to be exported in compliance would not 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 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 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 comparable Applicable Laws of such Governmental Entity. (b) Neither 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 nor any representative of any product proposed to be developed, produced or marketed by the Company nor, to the knowledge of the Company’s knowledge, 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 threatened to initiate, any action to (i) suspend any clinical trial, (ii) withdraw approval of, 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 study of any Company Products by or on behalf of the Company, or (ill) recall, or order to suspend the manufacture of, any Company Product. (c) Neither the Company nor, to the knowledge of the Company, 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 expressed to invoke its policy with respect to "Fraud, Untrue Statements of Material Facts, ▇▇▇▇▇▇▇, and Illegal Gratuities" set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any concern amendments thereto. Additionally, neither the Company nor, to the knowledge of the Company, any officer, employee, or agent of the Company has been convicted of any crime or engaged in any conduct that would reasonably be expected to result in (i) debarment under 21 U.S.C. Section 335a or any similar applicable state or foreign Applicable Law or (ii) exclusion under 42 U.S.C. Section 1320a- 7 or any similar applicable state or foreign Applicable Law. (d) Except as is not material to approving the Company in any case or clearing for marketing any product being developed in the aggregate, all animal studies or proposed to be developed 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 comparable foreign Applicable Laws. (e) The Company has delivered to 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 each case in which any Governmental Entity asserted in writing that the operations of the Company may not be in compliance with Applicable Laws. (i) The Company has not received written notice from any of its suppliers of any material interruption of supply or manufacturing capacity, shortage of raw materials, components, or other manufacturing problems that would have a material adverse effect on the subsequent development of the Company Products, nor, to the knowledge of the Company, do any conditions exist that reasonably would be expected to lead to such manufacturing problems.

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 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 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, to the Company’s knowledge, 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 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 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, 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 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 reportsmandatory reports to FDA that could reasonably be expected to require or lead to investigation, except where the failure corrective action or enforcement, regulatory or administrative action or proceedings relating to be in compliance would not have a Material Adverse Effect. There is no pendingSeller, completed ornor has there been any such violation. (d) No Product has been seized, to the Company's knowledgewithdrawn, threatenedrecalled, action (including any lawsuit, arbitrationdetained, 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 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 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 principles set forth in the United States of any product proposed to be developedInternational Conference on Harmonisation (ICH) Guideline for Good Clinical Practice (E6) and FDA GCP requirements, produced including institutional research board-approved study protocols, valid informed consent, monitoring and auditing plans, adverse event reporting proper documentation, and valid data collection and reporting procedures. (f) No officer or marketed by the Company noremployee or, to the CompanySeller’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 FDA expressed any concern as to approving or clearing for marketing any product being developed 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 be developed by 48 C.F.R. Subpart 9.4; or (i) subject to a civil monetary penalty assessed under Section 1128A of the Company. Social Security Act.

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 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 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, 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. Transaction Documents.

FDA Matters. As to (a) Such Company and each product subject to of its subsidiaries is, and the jurisdiction products sold by such Company and each of its subsidiaries are, in compliance in all material respects with all current applicable laws, statutes, rules, regulations, standards, guides or orders administered or issued by the U.S. Federal Food and Drug Administration or any other federal, foreign, state or local agency or governmental body (“"GOVERNMENTAL AUTHORITY") having regulatory authority over the products of such Company and its subsidiaries (the "FDA”"). (b) under The manufacturing operations of such Company and each of its subsidiaries is in compliance in all material respects with all applicable laws, statutes, rules, 15 regulations, standards, guides or orders administered or issued by the Federal Food, Drug FDA or Governmental Authority relating to the methods and Cosmetic Act, as amendedmaterials used in, and the regulations thereunder facilities and controls used for, the manufacture, processing, packaging, labeling, storage and distribution of the products manufactured by such Company, including current Good Manufacturing Practice requirements. Further, no governmental action has been taken or is in the process of being taken that could halt or enjoin the manufacturing operations of such Company or subject the manufacturing operations of such Company to regulatory enforcement action. (“FDCA”c) that is manufacturedSuch Company or its subsidiaries have not received from the FDA, packagedand none of them has knowledge of any facts which would furnish any reasonable basis for, labeledany notice of adverse findings, testedForm 483 inspectional observations, distributedregulatory letters, soldwarning letters, and/or marketed Section 305 notices or other similar communications from the FDA or other Governmental Authority, and there have been no seizures conducted or threatened by the FDA or other Governmental Authority, and no recalls, market withdraws, field notifications, notifications of misbranding or adulteration, or alerts conducted, requested or threatened by the FDA or other Governmental Authority relating to the products sold by such Company or any of its Subsidiaries subsidiaries. (d) Each premarket approval ("PMA") and premarket notification ("510(K)") submission and related documents and information for each of the products of such productCompany and its subsidiaries is in compliance in all material respects with the applicable federal statutes, a “Pharmaceutical Product”)rules, such Pharmaceutical Product is being manufacturedregulations, packagedstandards, labeled, tested, distributed, sold and/or marketed guides or orders administered or promulgated by the FDA or other Governmental Authority and all preclinical and clinical studies have been conducted with current Good Clinical and Good Laboratory Practices in all material respects. Such Company has disclosed 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 a Material Adverse Effect. There is no pending, completed or, writing to the Company's knowledgeother Company a complete and accurate list of all products of such Company and its subsidiaries indicating (i) which products are marketed under an approved or cleared FDA authority (e.g., threatenedPMA, action PMA supplement, 510(k) or IDE) and identifying such authority, and (including any lawsuitii) which products are not marketed under an approved or cleared FDA authority, arbitrationand indicating why such products are being marketed without such authority. Such listing also contains a complete and accurate list of all PMA applications, or legal or administrative or regulatory proceedingPMA supplements, charge, complaint, or investigation510(k) against the submissions and IDE submissions of such Company or any of its Subsidiariessubsidiaries currently pending with the FDA. (e) Such Company and its subsidiaries are not aware of any facts which are reasonably likely to cause (i) the denial, and none withdrawal, recall or suspension of the any products sold or intended to be sold by such 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, registrationsubsidiaries, 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 a change in the recall, suspensionmarketing classification or labeling of any such products, 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 termination or suspension of marketing of any clinical investigation such products. (f) None of the products manufactured, marketed or sold by the such Company or any of its Subsidiaries, subsidiaries has been recalled or subject to a field notification (iv) enjoins production at any facility of the Company whether voluntarily 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 Subsidiariesotherwise), and which, either individually or in the aggregate, would such Company and its subsidiaries 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, 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. .received notice

FDA Matters. As to (a) Holdings and each product subject to the jurisdiction of the U.S. Food and Drug Administration (“FDA”) under the Federal Food, Drug and Cosmetic Act, as amendedits Subsidiaries is, and the regulations thereunder (“FDCA”) that is manufactured, packaged, labeled, tested, distributed, sold, and/or marketed products sold by the Company or any Holdings and each of its Subsidiaries (each such productare, a “Pharmaceutical Product”)in compliance in all material respects with all current applicable statutes, such Pharmaceutical Product is being manufacturedrules, packagedregulations, labeledstandards, testedguides, distributed, sold and/or marketed policies or orders administered or issued 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 a Material Adverse Effect. There is no pending, completed or, to the Company's knowledge, threatened, action FDA. (including any lawsuit, arbitration, or legal or administrative or regulatory proceeding, charge, complaint, or investigationb) against the Company or any of its Subsidiaries, and none of the Company or Neither Holdings nor any of its Subsidiaries has received received, or has knowledge of any noticefacts which furnish any reasonable basis for, warning letter any Notice of Adverse Findings, Warning Letters, Regulatory Letters, Section 305 Notices, or other communication from similar communications, and there have been no recalls, field notifications, alerts or seizures requested or threatened relating to the products sold by Borrower and each of its Subsidiaries. (c) The premarket approval ("PMA") and premarket notification ("510(k)") documents and related documents and information for each of the products of Holdings and each of its Subsidiaries are in compliance in all material respects with the applicable federal statutes, rules, regulations, standards, guides, policies or orders administered or promulgated by the FDA and Holdings has no reason to believe that the FDA is considering limiting, suspending or revoking any other governmental entity, such approvals or clearances. All preclinical and clinical studies have been conducted with recognized good clinical and good laboratory practices in all material respects. (d) Neither Holdings nor any of its Subsidiaries is aware of any facts which are reasonably likely to cause (i) contests the premarket clearancedenial, licensurewithdrawal, registration, recall 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 suspension of any Pharmaceutical Product, (ii) withdraws its approval of, requests the recall, suspension, product sold 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 intended to be sold 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 Holdings or any of its Subsidiaries, or (viii) otherwise alleges any violation a change in the marketing classification or labeling of any lawssuch products, rules or regulations (iii) a termination or suspension of marketing of any such products. (e) Annex IX hereto contains an accurate and complete list of (i) all products currently manufactured, marketed or sold by the Company Holdings and each of its Subsidiaries which have been recalled or subject to a field notification (whether voluntarily or otherwise); and (ii) all proceedings of which Holdings or any of its Subsidiaries has received notice (whether completed or pending) at any time seeking recall, suspension or seizure of any product sold or proposed to be sold by Holdings or any of its Subsidiaries. (f) Holdings has conducted all internal audits, has prepared all internal audit reports, has conducted all management reviews of such audit reports and has taken all such follow up corrective action indicated by such audit reports as are required by 21 C.F.R. Section 820.20. (g) Holdings and each of its Subsidiaries has timely filed all medical device reports (the "Medical Device Report Policy") required to be filed by 21 C.F.R. Section 803.24. Annex X hereto sets forth Holdings' and each of its Subsidiary's corporate policy for filing such reports. (h) Holdings has obtained all necessary regulatory approvals from any foreign regulatory agencies related to the products distributed and sold by Holdings or any of its Subsidiaries. (i) Holdings reasonably believes that it will be able to obtain authorization from the FDA to market all products proposed as of the Initial Borrowing Date to be introduced by it under a 510(k) clearance, and which, either individually or in the aggregate, would have will not be required to file a Material Adverse Effect. The properties, business and operations of the Company have been and are being conducted in all material respects in accordance PMA application 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 with respect to any product proposed to be developed, produced or marketed by the Company 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. such products.