FDA Matters. (a) The Corporation has (i) complied in all material respects with all applicable laws, regulations and specifications with respect to the manufacture, design, sale, storing, labeling, testing, distribution, inspection, promotion and marketing of all of the Corporation’s products and product candidates and the operation of manufacturing facilities promulgated by the U.S. Food and Drug Administration (the “FDA”) or any corollary entity in any other jurisdiction and (ii) conducted, and in the case of any clinical trials conducted on its behalf, caused to be conducted, all of its clinical trials with reasonable care and in compliance in all material respects with all applicable laws and the stated protocols for such clinical trials.
(b) All of the Corporation’s submissions to the FDA 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 remain true, accurate and complete in all material respects and do not misstate any of the statements or information included therein, or omit to state a fact necessary to make the statements therein not materially misleading.
(c) The Corporation has not committed any act, made any statement or failed to make any statement that would breach the FDA’s policy with respect to “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any similar laws, rules or regulations, whether under the jurisdiction of the FDA or a corollary entity in any other jurisdiction, and any amendments or other modifications thereto. Neither the Corporation nor, to the Corporation’s Knowledge, any officer, employee or agent of the Corporation 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 state or foreign law or regulation or (ii) exclusion under 42 U.S.C. Section 1320a 7 or any similar state or foreign law or regulation, and neither the Corporation nor, to the Corporation’s Knowledge, any such person has been so debarred or excluded.
(d) The Corporation has not sold or marketed any products prior to receiving any required or necessary approvals or consents from any federal or state governmental authority, including but not limited to the FDA under the Food, Drug & Cosmetics Act of 1976, as amended, and the regulations promulgated the...
FDA Matters. (a) As to each of the product candidates of each of the Company and its Subsidiaries, including compounds currently under research and/or development by the Company and subject to the jurisdiction of the FDA or any equivalent Governmental Authority in any legal jurisdiction other than the U.S. (each such product, a “Company Regulated Product”), such Company Regulated Product is being researched, investigated, developed, manufactured, packaged, labeled, stored, distributed, imported and exported, and tested in compliance in all material respects with all applicable Laws. To the extent that any Company Regulated Product involves the use of a radioisotope, the Company and its Subsidiaries are in compliance in all material respects with respect to the applicable Laws governing such isotopes.
(b) The Company and its Subsidiaries hold, directly or by virtue of its agreements with its vendors, all required Permits to research, investigate, develop, manufacture, package, label, store, distribute, and test each Company Regulated Product and any radioisotope thereof and no such Permit has been revoked, withdrawn, suspended, cancelled or terminated or modified in any adverse manner. To the Knowledge of the Company, there is no basis for believing that any such Permit will not be renewable upon expiration. The Company and its Subsidiaries are, to the extent applicable, in compliance in all material respects with such Permits and have not received any written notice or other written communication, or to the Knowledge of the Company, any other communication from any Governmental Authority regarding (i) any material violation of or failure to comply materially with any term or requirement of any Permit or (ii) any revocation, withdrawal, suspension, cancellation, termination or material modification of any Permit. No Action is pending or, to the Knowledge of the Company, threatened, which seeks to revoke, limit, suspend, or materially modify any such Permit.
(c) There are no Actions pending or, to the Knowledge of the Company, threatened against the Company or any of its Subsidiaries with respect to an alleged material violation of the FDCA or any similar Law administered or promulgated by any FDA-equivalent Governmental Authority in any legal jurisdiction other than the U.S. None of the Company, its Subsidiaries or their respective officers or employees has been or is subject to any enforcement Actions by the FDA or other Governmental Authority and, to the Knowledge of ...
FDA Matters. After due investigation, (i) the TARGET currently ------------ has no reasonable basis to believe that any Governmental Authority, including, but not limited to, the United States Food and Drug Administration (the "FDA"), --- will ultimately prohibit the marketing, sale, license or use in the United States or elsewhere of any product developed, produced or marketed by the TARGET or with third parties (each, a "Product"), (ii) the TARGET knows of no product ------- or process which the FDA has prohibited from being marketed or used in the United States which in function and composition is substantially similar to any Product, (iii) the TARGET has no Product on clinical hold nor any reason to expect that any Product is likely to be placed on clinical hold, (iv) the TARGET has disclosed to the PARENT all submissions to the FDA made by the TARGET and the FDA responses (and other material correspondence received from or submitted to the FDA by the TARGET), including, but not limited to, all FDA warning letters, regulatory letters and notice of adverse finding letters and the relevant responses, received by the TARGET or any agent thereof relative to the development of its Products, (v) none of the TARGET or, to the TARGET's Knowledge, its employees, its Affiliates or its agents, has ever been sanctioned, formally or otherwise, by the FDA, and (vi) there has not been any suspensions or debarments by the FDA or other federal departments and state regulatory bodies against the TARGET or, to the TARGET's Knowledge, any current or former employees of the TARGET.
FDA Matters. Notify and consult with Parent promptly (A) after receipt of any material communication between the Company and the FDA (or any similar foreign Governmental Entity) or inspections of any manufacturing facility or clinical trial site and before giving any material submission to the FDA (or any similar foreign Governmental Entity), and (B) prior to making any material change to a study protocol, adding any new trials, making any material change to a manufacturing plan or process, or making a material change to the development timeline for any of its product candidates or programs.
FDA Matters. (a) The Company and each of its Subsidiaries has obtained or, to 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 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. 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, the regulations issued thereunder, and any similar federal, state, and foreign statutes and regulations. The Company is substantially in compliance with all applicable and material reporting requirements for all Regulatory Licenses.
(b) None of Seller, the Company, the Company’s Subsidiaries or, to Seller’s Knowledge, any of their respective Affiliates have received any 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 Authority (i) contesting the premarket approval of, the uses of or the labeling and promotion of any product including, without limitation, those products currently under research or 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 Subsidiaries nor, to Seller’s Knowledge, any officer, employee or Af...
FDA Matters. The FDA or any other Governmental Authority initiates enforcement action including but not limited to any inspection against any Credit Party or any of its Subsidiaries, or any suppliers that causes such Credit Party or Subsidiary to recall, withdraw, remove or discontinue manufacturing, shipping or marketing any of its Products the result of which could reasonably be expected to result in aggregate liability and expense to the Credit Parties and their Subsidiaries of the FDA Trigger Amount or more or would reasonably be expected to have a Material Adverse Effect; (ii) the FDA requires Credit Party or its Subsidiaries to modify the label or labeling of any Product as a result of a safety or compliance risk, or seeks to restrict in any way, the distribution of any of Credit Party’s or its Subsidiaries’ Products, which would reasonably be expected, in the aggregate to have a Material Adverse Effect; (iii) the FDA or any other Governmental Authority issues a warning letter or other communication to any Credit Party or any of its Subsidiaries with respect to any Regulatory Matter which if not promptly resolved would reasonably be expected, in the aggregate, to have a Material Adverse Effect; (iv) any Credit Party or any of its Subsidiaries conducts a mandated or voluntary recall or market withdrawal which could reasonably be expected to result in aggregate liability and expense to the Credit Parties and their Subsidiaries of the FDA Trigger Amount or more; or (v) any Credit Party or any of its Subsidiaries enters into a settlement agreement with the FDA or any other Governmental Authority that results in aggregate liability as to any single or related series of transactions, incidents or conditions, of the FDA Trigger Amount or more, or that would reasonably be expected to have a Material Adverse Effect.
FDA Matters. (a) Except as noted in paragraph (b), Borrowers, their Subsidiaries and the operation of their respective food facilities in the United States are in compliance with and are not in violation of all applicable Requirements of Law (including the FDC Act), regulations, rules, standards, guidelines, policies, and orders administered or issued by the FDA or any comparable Governmental Authority (including, without limitation, as applicable, the Bioterrorism Act (21 CFR 1.326-1.368), prohibited cattle materials (21 CFR 189.5) and import notification requirements (21 CFR 1.276-1.285)), except for failures to comply or violations that, individually or in the aggregate, could not reasonably be expected to result in a Material Adverse Effect.
(b) Since December 29, 2017, no Governmental Authority has served notice on any Loan Party or its Subsidiaries that the business or the assets of the Loan Parties or their Subsidiaries, may be, or are in material violation of any Requirement of Law or the subject of any material investigation, except for violations or investigations that, individually or in the aggregate, could not reasonably be expected to result in a Material Adverse Effect.
(c) Since December 29, 2017, no Loan Party or its Subsidiaries has received notice from any Governmental Authority nor does any Loan Party have any knowledge that there are any circumstances currently existing which would be reasonably likely to lead to any loss of or refusal to renew any material governmental licenses, permits, registrations, product registrations, Governmental Permits, approvals, authorizations related to the business and that the terms of all such licenses, permits, registrations, product registrations, governmental permits, approvals, and authorizations currently in force, except for any notice or circumstance that, individually or in the aggregate, could not reasonably be expected to result in a Material Adverse Effect.
(d) The Loan Parties have no knowledge of any acts with respect to their food business or products that furnish a reasonable basis for a warning letter, untitled letter, Section 305 notice, or other similar communication from FDA or any Governmental Authority, except for any acts that, individually or in the aggregate, could not reasonably be expected to result in a Material Adverse Effect.
(e) The Loan Parties have no knowledge of any existing obligation of a Loan Party arising under any administrative or regulatory action, FDA inspection, FDA warnin...
FDA Matters. There are no applications or other proceedings presently pending before the United States Food and Drug Administration ("FDA"). The FDA has not delivered a letter of nonapproval, or threatened to deliver such a letter, with respect to any product manufactured, marketed, licensed or developed by the Company, or any product which the Company intends to manufacture, market, license or develop.
FDA Matters. Without limiting the generality of Section 5.10 or Section 5.23:
(a) The Company is, and since January 1, 2019 at all times has been, in compliance in all material respects with the United States Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq., and applicable regulations, as amended (collectively, the “FDCA”), including the rules and regulations of the U.S. Food and Drug Administration (the “FDA”) promulgated thereunder, and comparable Laws in any non-U.S. jurisdiction.
(b) As to each product subject to the FDCA or similar Law in any non-U.S. jurisdiction that is developed, manufactured, manufactured for, tested, distributed, and/or marketed by the Company (a “Company Product”), each such Company Product is being, and since January 1, 2019 has been, developed, manufactured, manufactured for, labeled, tested, distributed, and/or marketed in material compliance with all applicable requirements under the FDCA and similar laws, including those relating to investigational use, approval, or premarket clearance to market any Company Product, current good manufacturing practices, labeling, and Quality System Regulation, as defined in 21 C.F.R. Parts 4, 211, and 820 (as applicable), advertising, promotion, continuing medical education, recordkeeping, training, medical device reporting, adverse event reporting, and filing of other reports and security.
(c) The Company has not received any communication from FDA or any other Governmental Authority (i) contesting the investigational use of, premarket clearance or approval of, the uses of, or the labeling and promotion of any Company Product, or (ii) otherwise alleging any violation of the FDCA or any similar Law as applicable to any Company Product.
(d) No Company Product (i) is currently under consideration by the Company for recall, withdrawal, suspension, seizure, or discontinuance, or (ii) has been recalled, subjected to a product advisory notice, withdrawn, suspended, seized, or discontinued (other than for commercial or other business reasons) by the Company, whether voluntarily or otherwise.
(e) The Company has not received any communication that the FDA or any similar Governmental Authority (i) intends to withhold or materially condition its approval or clearance of any Company Product; (ii) has commenced, or has threatened to initiate, any action to withdraw its approval or clearance of any Company Product; (iii) has requested the recall, withdrawal, suspension, seizure, or discontinuance of any...
FDA Matters. (a) All Drug Authorizations are current and in full force and effect, have been duly and validly issued, contain no material error or omission, and are owned exclusively by Bioglan. All regulatory approvals or authorizations owned by Sellers and relating to the Products are set forth on Section 2.1(a)(i) of the Disclosure Letter. Sellers have complied in all material respects with their respective obligations to report adverse drug experiences and are in compliance in all material respects with all other obligations applicable to the Products pursuant to the FFDCA and other applicable Legal Requirements. There is no Proceeding pending or, to the Knowledge of Sellers, threatened seeking the recall of any Products or the revocation or suspension of any Drug Authorization. Sellers have made available to Buyer true and correct copies of all Drug Authorizations, and there are no material changes, amendments or other circumstances in connection with or relating to any of the Products that would require the filing of any material amendment or supplement to a Drug Authorization or the filing of any new Drug Authorization.
(b) To Sellers’ Knowledge, the ANDA relating to Adoxa® is current and in full force and effect, has been duly and validly issued and contains no material error or omission. To Sellers’ Knowledge, there is no Proceeding pending or threatened seeking the recall of Adoxa® or the revocation or suspension of the ANDA relating to Adoxa®. To Sellers’ Knowledge, there are no material changes, amendments or other circumstances in connection with or relating to Adoxa® that would require the filing of any material amendment or supplement to the ANDA relating to Adoxa®.
(c) Except as set forth in Section 3.17(c) of the Disclosure Letter, Sellers have not received or been subject to: (i) any FDA Form 483’s concerning the Products; (ii) any FDA Notices of Adverse Findings concerning the Products; or (iii) warning letters or other correspondence from the FDA or any other Governmental Body concerning (1) the Products in which the FDA or other such Governmental Body asserted that the operations of any Seller or the Products were not in compliance with applicable Legal Requirements in any material respect, (2) issues arising from any pricing issues concerning the Products, including “best pricing” issues and Medicaid rebates,
