Common use of FDA and Related Matters Clause in Contracts

FDA and Related Matters. The Company and, to the Company’s Knowledge, others who perform services on the Company’s behalf have been and are in compliance with all applicable federal, state, local and foreign laws, rules, regulations, standards, orders and decrees governing their respective businesses, including without limitation, all regulations promulgated by the FDA or any other federal, state, local or foreign agencies or bodies engaged in the regulation of pharmaceuticals or biohazardous substances or materials, except where noncompliance would not, singly or in the aggregate, have a Material Adverse Effect; and the Company has not received any notice citing action or inaction by the Company or others who perform services on the Company’s behalf that would constitute non-compliance with any applicable federal, state, local or foreign laws, rules, regulations or standards excepting, however, such actions that have heretofore been resolved to the satisfaction of such governmental entity. All tests and preclinical and clinical studies conducted by or on behalf of the Company were and, if still pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical and clinical study of new drugs, and laws and regulations; the descriptions of the tests and preclinical and clinical studies, and results thereof, conducted by or on behalf of the Company are accurate in all material respects; except as disclosed in the SEC Reports, the Company has not received any written notice or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring the termination, suspension, material modification or clinical hold of any tests or preclinical or clinical studies being conducted by or on behalf of the Company, which termination, suspension, material modification or clinical hold would reasonably be expected to have a Material Adverse Effect; and the Company has not received any written notices or correspondence from others concerning the termination, suspension, material modification or clinical hold of any tests or preclinical or clinical studies conducted by others on any active ingredient contained in the existing products of the Company or the products described in the SEC Reports as being under development, which termination, suspension, material modification or clinical hold would reasonably be expected to have a Material Adverse Effect.

FDA and Related Matters. The Company and, to the Company’s Knowledge, others who perform services on the Company’s behalf have been and are in compliance with all applicable federal, state, local and foreign laws, rules, regulations, standards, orders and decrees governing their respective businesses, including without limitation, all regulations promulgated by the FDA or any other federal, state, local or foreign agencies or bodies engaged in the regulation of pharmaceuticals or biohazardous substances or materials, except where noncompliance would not, singly individually or in the aggregate, have a Material Adverse Effect; and the Company has not received any notice citing action or inaction by the Company or others who perform services on the Company’s behalf that would constitute non-compliance with any applicable federal, state, local or foreign laws, rules, regulations or standards excepting, however, such actions that have heretofore been resolved to the satisfaction of such governmental entity. All tests and preclinical and clinical studies conducted by or on behalf of the Company were and, if still pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical and clinical study of new drugs, and laws and regulations; the descriptions of the tests and preclinical and clinical studies, and results thereof, conducted by or on behalf of the Company are accurate in all material respects; except as disclosed in the SEC Reports, the Company has not received any written notice or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring the termination, suspension, material modification or clinical hold of any tests or preclinical or clinical studies being conducted by or on behalf of the Company, which termination, suspension, material modification or clinical hold would reasonably be expected to have a Material Adverse Effect; and the Company has not received any written notices or correspondence from others concerning the termination, suspension, material modification or clinical hold of any tests or preclinical or clinical studies conducted by others on any active ingredient contained in the existing products of the Company or the products described in the SEC Reports as being under development, which termination, suspension, material modification or clinical hold would reasonably be expected to have a Material Adverse Effect.

FDA and Related Matters. (i) The Company andhas not failed to file with the relevant regulatory authorities (including, without limitation, the FDA or any foreign, federal, provincial, territorial, state or local governmental or regulatory authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission; (ii) all such filings, declarations, listings, registrations, reports or submissions were in material compliance with applicable laws appropriate for the stage of product development when filed; and (iii) no deficiencies have been asserted by any applicable regulatory authority (including, without limitation, the FDA or any foreign, federal, provincial, territorial, state or local governmental or regulatory authority performing functions similar to those performed by the FDA) with respect to any such filings, declarations, listings, registrations, reports or submissions that remain unresolved. (b) To the Company’s knowledge, with regard to the Company’s products and product candidates, all of the manufacturing facilities and operations of the Company and its U.S. and foreign suppliers are in compliance in all material respects with applicable FDA and comparable regulations, including but not limited to current good manufacturing practices appropriate for the stage of product development and laws and standards related to marketing, promotion, imports and exports, and off-label uses, if applicable. (i) Any preclinical tests and clinical trials associated with the Company’s products were, and if still pending are, to the Company’s Knowledgeknowledge, others who perform services on the Company’s behalf have been and are in compliance with all applicable federal, state, local and foreign laws, rules, regulations, standards, orders and decrees governing their respective businesses, including without limitation, all regulations promulgated by the FDA or any other federal, state, local or foreign agencies or bodies engaged in the regulation of pharmaceuticals or biohazardous substances or materials, except where noncompliance would not, singly or in the aggregate, have a Material Adverse Effect; and the Company has not received any notice citing action or inaction by the Company or others who perform services on the Company’s behalf that would constitute non-compliance with any applicable federal, state, local or foreign laws, rules, regulations or standards excepting, however, such actions that have heretofore been resolved to the satisfaction of such governmental entity. All tests and preclinical and clinical studies conducted by or on behalf of the Company were and, if still pending, are being, being conducted in all material respects in accordance with experimental protocolsprotocols filed with the appropriate regulatory authorities for each such test or trial and in accordance with applicable law, procedures and controls generally used by qualified experts with standard medical and scientific research procedures; (ii) to the Company’s knowledge, the descriptions in the preclinical and clinical study of new drugs, and laws and regulations; the descriptions SEC Reports of the tests and preclinical and clinical studies, and results thereof, conducted by or on behalf of the Company are Company’s clinical studies relating to the Company’s products and product candidates are, as of the dates of such reports, accurate in all material respectsrespects and fairly present the data derived from such studies; and following the date of the SEC Reports containing such descriptions, except as otherwise disclosed in a subsequent SEC Report, the Company has not become aware of any information that is inconsistent with such clinical study results or which would otherwise call into question such clinical study results as described in such SEC Reports, Report; (iii) the Company has not received any written notice notices or other correspondence from the FDA or any foreigncommittee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency or review board requiring or recommending the termination or suspension of any clinical trials related to the Company’s products and product candidates; and (iv) the Company has no knowledge of any studies or tests the results of which call into question the efficacy, state safety, or local governmental body exercising comparable authority approvability by the FDA or its foreign equivalents of the products or product candidates of the Company. (d) There are no current actions by the FDA or any Institutional Review Board other governmental authority to revoke, suspend, cancel, modify or comparable authority requiring withdraw any product approval, clearance, license, clinical trial, investigation, registration, or other material license with respect to any of the terminationCompany’s products and product candidates and, suspensionto the knowledge of the Company, material modification or clinical hold there are no existing circumstances that would furnish the basis of such actions. (e) Neither the Company nor any tests or preclinical or clinical studies being conducted employee of the Company, nor to the knowledge of the Company, any Person retained by or the Company, has made on behalf of the Company any material false statements or material omissions in any application or other submission relating to the Company, which termination, suspension, material modification ’s products and product candidates to the FDA or clinical hold would reasonably be expected to have a Material Adverse Effect; and the other governmental authority. (f) The Company has not received any written available all (i) FDA, or its foreign equivalent, inspection reports, (ii) notices of adverse findings and (iii) warnings, untitled letters, minutes of meetings or other correspondence from others the FDA or other governmental authorities concerning the termination, suspension, material modification Company’s products and product candidates in which the FDA or clinical hold of any tests or preclinical or clinical studies conducted by others on any active ingredient contained in such other governmental authority asserted that the existing products operations of the Company may not be in compliance with applicable laws or that the Company’s products described in the SEC Reports as being under developmentand product candidates may not be safe, which termination, suspension, material modification effective or clinical hold would reasonably be expected to have a Material Adverse Effectapprovable.

FDA and Related Matters. The (a) In connection with the Company andProducts: (i) the Company and its Subsidiaries have not failed to file with the applicable regulatory authorities (including, to the Company’s Knowledge, others who perform services on the Company’s behalf have been and are in compliance with all applicable federal, state, local and foreign laws, rules, regulations, standards, orders and decrees governing their respective businesses, including without limitation, FDA or any foreign, federal, state or local governmental or regulatory authority performing functions similar to those performed by the FDA) any required filing, declaration, listing, registration, report or submission; (ii) all regulations promulgated such filings, declarations, listings, registrations, reports or submissions were in material compliance with applicable laws when filed; and (iii) no deficiencies have been asserted by any applicable regulatory authority (including, without limitation, the FDA or any other foreign, federal, state, state or local governmental or foreign agencies or bodies engaged in the regulation of pharmaceuticals or biohazardous substances or materials, except where noncompliance would not, singly or in the aggregate, have a Material Adverse Effect; and the Company has not received any notice citing action or inaction regulatory authority performing functions similar to those performed by the Company FDA) with respect to any such filings, declarations, listings, registrations, reports or others who perform services on submissions that remain unresolved. (b) To the Company’s behalf that would constitute non-compliance knowledge, with any applicable federal, state, local or foreign laws, rules, regulations or standards excepting, however, such actions that have heretofore been resolved regard to the satisfaction Company Products, all of such governmental entity. All tests the manufacturing facilities and preclinical and clinical studies conducted by or on behalf operations of the Company and its United States and foreign suppliers are in compliance in all material respects with applicable FDA and comparable regulations, including current Good Manufacturing Practices. (i) Any preclinical tests and clinical trials associated with the Company Products were and, if still pending, are being, to the Company’s knowledge being conducted in all material respects in accordance with experimental protocolsprotocols filed with the appropriate regulatory authorities for each such test or trial and in accordance with all statutes, procedures laws, rules and controls generally used by qualified experts regulations, as the case may be, and with standard medical and scientific research procedures; (ii) to the Company’s knowledge, the descriptions in the preclinical and clinical study of new drugs, and laws and regulations; the descriptions Company SEC Reports of the tests and preclinical and clinical studies, and results thereof, conducted by or on behalf of the Company’s clinical studies relating to the Company are Products are, as of the dates of such reports, accurate in all material respectsrespects and fairly present the data derived from such studies; and following the date of the Company SEC Reports containing such descriptions, except as otherwise disclosed in the a subsequent Company SEC ReportsReport, the Company has not become aware of any information that is inconsistent with such clinical study results or which would otherwise call into question such clinical study results as described in such Company SEC Report; and (iii) neither the Company nor its Subsidiaries has received any written notice notices or other correspondence from the FDA or any foreigncommittee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency or review board requiring or recommending the termination or suspension of any clinical trials related to the Company Products. (d) To the Company’s knowledge, state or local governmental body exercising comparable authority there are no existing circumstances which would furnish a basis for an action by FDA or any Institutional Review Board other Governmental Authority to revoke, suspend, cancel, modify or comparable authority requiring withdraw any product approval, clearance, license, clinical trial, investigation, registration, or other Material License with respect to any of the termination, suspension, material modification or clinical hold Company Products and the Company is not aware of any tests of the foregoing having occurred. (e) Neither the Company nor its Subsidiaries, nor any employee of the Company or preclinical its Subsidiaries, nor to the knowledge of the Company, any Person retained by the Company or clinical studies being conducted by or its Subsidiaries, has made on behalf of the Company, which termination, suspension, Company or its Subsidiaries any material modification false statements or clinical hold would reasonably be expected material omissions in any application or other submission relating to have a Material Adverse Effect; and the Company has not received any written Products to the FDA or other Governmental Authority. (f) The Company and its Subsidiaries have provided or otherwise made available to Purchasers a copy of all (i) FDA or its foreign equivalent inspection reports, (ii) notices of adverse findings, (iii) warning, untitled letters, minutes of meetings or other correspondence from others the FDA or other Governmental Authorities concerning the termination, suspension, material modification Company Products in which FDA or clinical hold of any tests or preclinical or clinical studies conducted by others on any active ingredient contained in such other Governmental Authority asserted that the existing products operations of the Company or its Subsidiaries may not be in compliance with applicable laws or that the products described in the SEC Reports as being under developmentCompany Products may not be safe, which terminationeffective, suspension, material modification or clinical hold would reasonably be expected to have a Material Adverse Effectapprovable.

FDA and Related Matters. The Company and(a) Neither the Company, nor, to the Company’s Knowledge, others who perform services on Knowledge of the Company’s behalf have been , Biogen Idec, has knowingly committed or permitted to exist any violation of the rules and are in compliance with all applicable federal, state, local and foreign laws, rules, regulations, standards, orders and decrees governing their respective businesses, including without limitation, all regulations promulgated by of the FDA or any other federal, state, local or foreign agencies or bodies engaged governmental entity in the regulation Territory that is concerned with the safety, efficacy, reliability or manufacturing of pharmaceuticals or biohazardous substances or materialsdrug products (each, except where noncompliance would not, singly or in a “Drug Regulatory Agency”). (b) All preclinical and other developmental studies of the aggregate, have a Material Adverse Effect; and the Company has not received any notice citing action or inaction Product by the Company or others who perform services on and, to the Company’s behalf that would constitute non-Knowledge, Biogen Idec were conducted in compliance with any Applicable Law, including the applicable federal, state, local requirements of Good Laboratory Practices or foreign laws, rules, regulations or standards excepting, however, such actions that have heretofore been resolved to the satisfaction of such governmental entity. All tests and preclinical and clinical studies conducted by or on behalf Good Clinical Practices. (c) None of the Company were andor, if still pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls generally used by qualified experts in to the preclinical and clinical study of new drugs, and laws and regulations; the descriptions of the tests and preclinical and clinical studies, and results thereof, conducted by or on behalf of the Company are accurate in all material respects; except as disclosed in the SEC Reports, the Company has not received any written notice or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring the termination, suspension, material modification or clinical hold of any tests or preclinical or clinical studies being conducted by or on behalf Knowledge of the Company, any of its respective agents or subcontractors, has been convicted of any crime or engaged in any conduct which termination, suspension, material modification or clinical hold would reasonably be expected to have a Material Adverse Effect; result in debarment or disqualification by the FDA or any Drug Regulatory Agency, and there are no proceedings pending or, to the Knowledge of the Company, threatened in writing to the Company that reasonably might be expected to result in criminal liability or debarment or disqualification by the FDA or any Drug Regulatory Agency. (d) Except as set forth on Schedule 4.25(d), the Company has not received any written notices or correspondence from others concerning requested all methods, know-how and other information pertaining to the terminationProduct that it is entitled to receive pursuant to the terms of the Biogen Idec License Agreement and the Biogen Idec Supply Agreement. The Company has provided to Parent all methods, suspension, material modification or clinical hold of any tests or preclinical or clinical studies conducted by others on any active ingredient contained know-how and other information pertaining to the Product in the existing products possession of the Company or any of its Representatives, including (i) the products described in hard drive on which Biogen Idec delivered to the SEC Reports as being under developmentCompany certain methods, which terminationknow-how and other information pertaining to the Product (ii) all other data, suspensionmethods, material modification information and reports that relate to the Product to the extent such data, methods, information and reports would be reasonably likely to be necessary or clinical hold would reasonably be expected useful to have a Material Adverse Effectthe development of such Product, and (iii) all written correspondence (or summaries of other communications) to or from any Governmental Authorities (including any Drug Regulatory Agency). To the Knowledge of the Company, no methods, know-how or other information that the Company was entitled to receive pursuant to the Biogen Idec License Agreement and the Biogen Idec Supply Agreement and pertaining to the Product was omitted from the information delivered to the Company by Biogen Idec.

FDA and Related Matters. The Company and, to the Company’s Knowledgeknowledge, others who perform services on the Company’s behalf have been and are in compliance with all applicable federal, state, local and foreign laws, rules, regulations, standards, orders and decrees governing their respective businesses, including without limitation, all regulations promulgated by the FDA or any other federal, state, local or foreign agencies or bodies engaged in the regulation of pharmaceuticals or biohazardous substances or materials, except where noncompliance would not, singly or in the aggregate, have a Material Adverse Effect; and the Company has not received any notice citing action or inaction by the Company or others who perform services on the Company’s behalf that would constitute non-compliance with any applicable federal, state, local or foreign laws, rules, regulations or standards excepting, however, such actions that have heretofore been resolved to the satisfaction of such governmental entity. All The tests and preclinical and clinical studies conducted by or on behalf of the Company that are described in the SEC Reports were and, if still pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical and clinical study of new drugs, and laws and regulations; the descriptions of the tests and preclinical and clinical studies, and results thereof, conducted by or on behalf of the Company contained in the SEC Reports are accurate in all material respects; except as disclosed in the SEC Reports, the Company has not received any written notice or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring the termination, suspension, material modification or clinical hold of any tests or preclinical or clinical studies being conducted by or on behalf of the Company, which termination, suspension, material modification or clinical hold would reasonably be expected to have a Material Adverse Effect; and the Company has not received any written notices or correspondence from others concerning the termination, suspension, material modification or clinical hold of any tests or preclinical or clinical studies conducted by others on any active ingredient contained in the existing products of the Company or the products described in the SEC Reports as being under development, which termination, suspension, material modification or clinical hold would reasonably be expected to have a Material Adverse Effect.

FDA and Related Matters. The Company and the Subsidiaries and, to the Company’s Knowledge, others who perform services on the Company’s or a Subsidiary’s behalf have been and are in compliance with all applicable federal, state, local and foreign laws, rules, regulations, standards, orders and decrees governing their respective businesses, including without limitation, all regulations promulgated by the FDA or any other federal, state, local or foreign agencies or bodies engaged in the regulation of pharmaceuticals or biohazardous substances or materials, except where noncompliance would not, singly or in the aggregate, have a Material Adverse Effect; and neither the Company has not nor any Subsidiary received any notice citing action or inaction by the Company Company, any Subsidiary or others who perform services on the Company’s or any Subsidiary’s behalf that would constitute non-compliance with any applicable federal, state, local or foreign laws, rules, regulations or standards excepting, however, such actions that have heretofore been resolved to the satisfaction of such governmental entity. All tests and preclinical and clinical studies conducted by or on behalf of the Company or any Subsidiary were and, if still pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical and clinical study of new drugs, and laws and regulations; the descriptions of the tests and preclinical and clinical studies, and results thereof, conducted by or on behalf of the Company are accurate in all material respects; except as disclosed in the SEC Reports, neither the Company nor any Subsidiary has not received any written notice or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring the termination, suspension, material modification or clinical hold of any tests or preclinical or clinical studies being conducted by or on behalf of the CompanyCompany or any Subsidiary, which termination, suspension, material modification or clinical hold would reasonably be expected to have a Material Adverse Effect; and neither the Company nor any Subsidiary has not received any written notices or correspondence from others concerning the termination, suspension, material modification or clinical hold of any tests or preclinical or clinical studies conducted by others on any active ingredient contained in the existing products of the Company or any Subsidiary or the products described in the SEC Reports as being under development, which termination, suspension, material modification or clinical hold would reasonably be expected to have a Material Adverse Effect.

FDA and Related Matters. The Company and, (a) Each product or product candidate subject to the Company’s KnowledgeFederal Food, others who perform services on Drug and Cosmetic Act (including the Company’s behalf have been rules and are in compliance with all applicable federal, state, local and foreign laws, rules, regulations, standards, orders and decrees governing their respective businesses, including without limitation, all regulations promulgated by of the FDA promulgated thereunder, the “FDCA”) or comparable Laws in any other federal, state, local or foreign agencies or bodies engaged in the regulation of pharmaceuticals or biohazardous substances or materials, except where noncompliance would not, singly or in the aggregate, have a Material Adverse Effect; and the Company has not received any notice citing action or inaction by the Company or others who perform services on the Company’s behalf that would constitute non-compliance with any applicable federalU.S. jurisdiction that has been developed, statemanufactured, local tested, distributed, promoted or foreign laws, rules, regulations or standards excepting, however, such actions that have heretofore been resolved to the satisfaction of such governmental entity. All tests and preclinical and clinical studies conducted marketed by or on behalf of the Company were andor any of its Subsidiaries (each such product or product candidate, if still pendinga “Company Product”), is being or has been developed, manufactured, tested, distributed, promoted and marketed in material compliance with all applicable requirements under the FDCA and comparable laws in any applicable non-U.S. jurisdiction, including those relating to investigational use, premarket clearance or approval, registration and listing, good manufacturing practices, good clinical practices, good laboratory practices, labeling, advertising, data protection and data transfer, record keeping and filing of required reports. The Company maintains accurate and complete documentation showing that components supplied to the Company are being, conducted in all material respects manufactured in accordance with experimental protocolsthe Company’s specifications therefor. (b) In connection with the Company Products: (i) the Company and its Subsidiaries and, procedures and controls generally used by qualified experts in to the preclinical and clinical study of new drugs, and laws and regulations; the descriptions knowledge of the tests and preclinical and clinical studies, and results thereof, conducted by or on behalf of the Company are accurate in all material respects; except as disclosed in the SEC ReportsCompany, the Company has Partners have not received failed to file with the applicable regulatory authorities (including, without limitation, FDA or any written notice foreign, federal, state or correspondence from local governmental or regulatory authority performing functions similar to those performed by the FDA) any required material filing, declaration, listing, registration, report or submission; (ii) all such material filings, declarations, listings, registrations, reports or submissions were in material compliance with applicable laws when filed; and (iii) no deficiencies have been asserted by any applicable regulatory authority (including, without limitation, the FDA or any foreign, federal, state or local governmental body exercising comparable or regulatory authority performing functions similar to those performed by the FDA) with respect to any such filings, declarations, listings, registrations, reports or submissions that remain unresolved. Neither the Company or its Subsidiaries, nor any Institutional Review Board employee of the Company or comparable authority requiring its Subsidiaries, nor to the terminationknowledge of the Company, suspensionany Person retained by the Company or its Subsidiaries, material modification or clinical hold of any tests or preclinical or clinical studies being conducted by or has made on behalf of the Company or its Subsidiaries any material false statements or material omissions in any application or other submission relating to the products or product candidates to the FDA or other Governmental Entity. (c) To the Company’s knowledge, with regard to the Company Products, all of the manufacturing facilities and operations of the Company are in compliance in all material respects with applicable FDA and comparable regulations, including current Good Manufacturing Practices. (d) To the Company’s knowledge, there are no existing circumstances which terminationwould furnish a basis for an action by FDA or any other Governmental Authority to revoke, suspensionsuspend, material modification cancel, modify or withdraw any product approval, clearance, license, clinical hold would reasonably be expected trial, investigation, registration, or other Material License with respect to have a Material Adverse Effect; any of the Company Products and the Company is not aware of any of the foregoing having occurred. (e) Neither the Company nor any of its Subsidiaries has not received any written notices notice that the FDA or correspondence from others concerning any other Governmental Authority has commenced, or threatened to initiate, any action that remains unresolved to (i) withdraw its investigational device exemption, premarket clearance or premarket approval or request the termination, suspension, material modification or clinical hold recall of any tests Company Product, (ii) enjoin manufacture or preclinical distribution of any Company Product, or clinical studies restrict the promotion of any Company Product in the manner currently conducted by others on the Company and its Subsidiaries, (iii) enjoin the manufacture or distribution of any active ingredient contained Company Product produced at any facility where any Company Product is manufactured, tested, processed, packaged or held for sale, or (iv) investigate the Company or its products or its practices related thereto. (f) The Company and its Subsidiaries have not either voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, any recall, field notifications, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, safety alert or other notice or action relating to an alleged lack of safety, efficacy or regulatory compliance of any product that remains unresolved. The Company and its Subsidiaries are not aware of any facts which are reasonably likely to cause (1) the recall, market withdrawal or replacement of any product currently sold or intended to be sold by the Company or its Subsidiaries; (2) a change in the existing products marketing classification or a material change in the labeling of any such products, or (3) a termination or suspension of the marketing of such products. (g) Neither the Company nor its Subsidiaries, nor any employee of the Company or its Subsidiaries, nor to the products described knowledge of the Company, any Person retained by the Company or its Subsidiaries has made on behalf of the Company or its Subsidiaries any material false statements or material omissions in any application or other submission relating to the SEC Reports as being under developmentCompany Products to the FDA or other Governmental Authority. (h) The Company and its Subsidiaries have provided or otherwise made available to Purchasers a copy of all of the following since December 31, 2008 (i) FDA or its foreign equivalent inspection reports, (ii) notices of adverse findings, (iii) warning, untitled letters, minutes of meetings or other correspondence from the FDA or other Governmental Authorities concerning the Company Products in which terminationFDA or such other Governmental Authority asserted that the operations of the Company or its Subsidiaries or any Company Partner may not be in compliance with applicable laws, suspensionthat the Company Products may not be safe, material modification effective, or clinical hold would reasonably be expected to have a Material Adverse Effectapprovable or contesting the investigational device exemption, premarket clearance or approval of, the uses of or the labeling or promotion of any Company Products.

FDA and Related Matters. (i) The businesses of the Company and each of its Subsidiaries and, to the Company’s Knowledgeknowledge of the Seller, others who perform services on their authorized distributors are being conducted in compliance in all material respects with any applicable provisions of the Company’s behalf have Federal Food, Drug and Cosmetic Act of 1938, as amended (the “FDCA”), including the rules and regulations promulgated thereunder, the Healthcare Legal Requirements and state licensing, registration, disclosure and reporting requirements. (ii) As to each product or product candidate subject to the FDCA and the regulations of the FDA promulgated thereunder, that is manufactured by the Company or any of its Subsidiaries (each such product or product candidate, a “Medical Device”), such Medical Device has been and are is being designed, developed, manufactured, labeled and promoted in compliance in all material respects with all applicable federalrequirements under the FDCA and the regulations of the FDA promulgated thereunder and all other applicable Healthcare Legal Requirements. Except as set forth on Schedule 4.18(d), statenone of the Seller, local and the Company or any of its Subsidiaries or (to the knowledge of the Seller) foreign lawsdistributors has, rulessince January 1, regulations2008, standardsreceived any FDA Form 483, orders and decrees governing their respective businessesnotice of adverse finding, including without limitationnotices, all regulations promulgated by untitled or warning letters or other correspondence or notice from the FDA or any other federal, state, local or foreign agencies or bodies engaged in the regulation of pharmaceuticals or biohazardous substances or materials, except where noncompliance would not, singly or in the aggregate, have a Material Adverse Effect; Governmental Authority and the Company has not received any notice citing there is no action or inaction proceeding pending or, to the knowledge of the Seller, threatened (including any prosecution, injunction, seizure, civil fine, debarment, suspension or recall), in each case (A) contesting the investigational device exemption, premarket clearance or approval of, the uses of or the labeling or promotion of any Medical Device or (B) otherwise alleging any violation applicable to any Medical Device by the Company or others who perform services any of its Subsidiaries of any applicable Law. (iii) Except as set forth on Schedule 4.18(d), since January 1, 2008, the Company’s behalf that would constitute non-Company and its Subsidiaries and authorized distributors have not either voluntarily or involuntarily initiated, conducted or issued, or caused to be initiated, conducted or issued, with respect to any Medical Device, any recall, field notifications, field corrections, market withdrawal or replacement, safety alert, warning, “dear doctor” letter, investigator notice, safety alert or other notice or action relating to an alleged lack of safety, efficacy or regulatory compliance of any product. (iv) During the past three years, (A) no Governmental Authority has commenced or threatened in writing to initiate any Proceeding to withdraw any Medical Device or request the recall of any Medical Device, or commenced or threatened in writing to initiate any Action to enjoin production of any Medical Device, nor (B) have the Seller, the Company or any of its Subsidiaries, or to the knowledge of Seller, any of its authorized distributors or suppliers received any notice to such effect. (v) All applications, submissions, information, claims, reports and statistics, and other data derived therefrom submitted in connection with any applicable federaland all requests for a Permit of the FDA or other Governmental Authority relating to any Medical Device, state, local or foreign laws, rules, regulations or standards excepting, however, such actions that have heretofore been resolved when submitted to the satisfaction of such governmental entity. All tests FDA or other Governmental Authority, were true, complete and preclinical and clinical studies conducted by or on behalf of the Company were and, if still pending, are being, conducted correct in all material respects in accordance with experimental protocolsas of the date of submission and any updates, procedures changes, corrections or modifications to such applications, submissions, information, claims, reports or statistics required by Law to be made have been submitted to FDA and controls generally used by qualified experts in other Governmental Authority. (vi) To the preclinical knowledge of the Seller, all pre-clinical and clinical study of new drugs, and laws and regulations; the descriptions of the tests and preclinical and clinical studies, and results thereof, trials conducted by or on behalf of the Company are accurate and its Subsidiaries with respect to any Medical Device have been conducted in all material respects; except as disclosed in the SEC Reports, the Company has not received any written notice or correspondence from compliance with applicable Laws promulgated by the FDA or any foreignrelating thereto, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring including the terminationFDCA and its applicable implementing regulations at 21 C.F.R. Parts 50, suspension54, material modification or clinical hold of any tests or preclinical or clinical studies being conducted by or on behalf of the Company56 and 312, which termination, suspension, material modification or clinical hold would reasonably be expected to have a Material Adverse Effect; and the Company has not received any written notices or correspondence from others concerning the termination, suspension, material modification or clinical hold of any tests or preclinical or clinical studies conducted by others on any active ingredient contained in the existing products of the Company or the products described in the SEC Reports as being under development, which termination, suspension, material modification or clinical hold would reasonably be expected to have a Material Adverse Effectamended.

FDA and Related Matters. The Company and(i) has not received any FDA Form 483, to written notice of adverse finding, warning letter, untitled letter or other written notice from the Company’s Knowledge, others who perform services on the Company’s behalf have been and are in compliance with all applicable FDA or any other similar federal, state, local or foreign governmental or regulatory authority alleging or asserting material noncompliance with any Health Care Laws (defined below) or with respect to any licenses, certificates approvals, clearances, authorizations, exemptions, permits or supplements or amendments thereto required by any Health Care Laws to conduct the business of the Company as described in the 2022 SEC Reports (collectively, “Authorizations”); (ii) possesses all applicable Authorizations and foreign lawssuch Authorizations are valid and in full force and effect and the Company is not in violation of any such Authorizations except where such violation would not have a Material Adverse Effect; (iii) has not received written notice of any pending or completed claim, rulesaction, regulationssuit, standardsproceeding, orders and decrees governing their respective businesseshearing, including without limitationenforcement, all regulations promulgated by investigation, arbitration or other action from the FDA or any other federal, state, local or foreign agencies governmental or bodies engaged regulatory authority or third party alleging that any product, operation, or activity of the Company is in the regulation material violation of pharmaceuticals any Health Care Laws or biohazardous substances or materials, except where noncompliance would not, singly or in the aggregate, have a Material Adverse Effect; Authorizations and the Company has does not received have any notice citing action knowledge that the FDA or inaction by the Company or others who perform services on the Company’s behalf that would constitute non-compliance with any applicable other federal, state, local or foreign lawsgovernmental or regulatory authority or third party is considering any such claim, ruleslitigation, regulations arbitration, action, suit, investigation or standards excepting, however, such actions that have heretofore been resolved to the satisfaction of such governmental entity. All tests and preclinical and clinical studies conducted by or on behalf of the Company were and, if still pending, are being, conducted in all material respects in accordance with experimental protocols, procedures and controls generally used by qualified experts in the preclinical and clinical study of new drugs, and laws and regulationsproceeding; the descriptions of the tests and preclinical and clinical studies, and results thereof, conducted by or on behalf of the Company are accurate in all material respects; except as disclosed in the SEC Reports, the Company (iv) has not received any written notice or correspondence from that the FDA or any foreignother federal, state state, local or local foreign governmental body exercising comparable or regulatory authority has taken, is taking or intends to take action to suspend, or revoke any material Authorizations and has no knowledge that the FDA or any Institutional Review Board other federal, state, local or comparable foreign governmental or regulatory authority requiring the termination, suspension, material modification or clinical hold of any tests or preclinical or clinical studies being conducted by or on behalf of the Company, which termination, suspension, material modification or clinical hold would reasonably be expected to have a Material Adverse Effectis considering such action; and (v) has filed, obtained, maintained or submitted all material reports, documents, forms, notices, applications, records, claims, submissions, information and supplements or amendments as required by any Health Care Laws or Authorizations and all such reports, documents, forms, notices, applications, records, claims, submissions, information and supplements or amendments were materially true, complete and correct on the Company has not received any written notices date filed (or correspondence from others concerning the termination, suspension, material modification were corrected or clinical hold of any tests or preclinical or clinical studies conducted supplemented by others on any active ingredient contained in the existing products of the Company or the products described in the SEC Reports as being under development, which termination, suspension, material modification or clinical hold would reasonably be expected to have a Material Adverse Effectsubsequent submission).

FDA and Related Matters. The (a) To the Knowledge of the Sellers, the Company possesses all Registrations required to conduct its Business as currently conducted. Each such Registration is valid and subsisting in full force and effect. To the Knowledge of the Sellers, as of the date hereof, neither the United States Food and Drug Administration (the “FDA”) nor any comparable Regulatory Authority or Governmental Authority is considering limiting, suspending or revoking any such Registration or changing the marketing classification or labeling of the Products of the Company. To the Knowledge of the Sellers, there is no false or misleading information or material omission in any product application or other submission to the FDA or any comparable Regulatory Authority or Governmental Authority. Except as set forth on Schedule 2.27(a), the Company is in compliance with, and have fulfilled and performed in all material respects their respective obligations under, each such Registration, and, as of the date hereof, to the Company’s KnowledgeKnowledge of the Sellers, others who perform services on no event has occurred or condition or state of facts exists which would constitute a breach or default or would cause revocation or termination of any such Registration. To the Knowledge of the Sellers, any third Person that is a manufacturer or contractor for the Company is in compliance with all Registrations insofar as they pertain to the manufacture of product components or Products for the Company’s . (b) To the Knowledge of the Sellers, all Products developed, tested, investigated, produced, manufactured, labeled, distributed, marketed, stored, sold, imported or exported by or on behalf of the Company that are subject to the jurisdiction of the FDA or any comparable Regulatory Authority have been and are being developed, tested, investigated, produced, manufactured, labeled, distributed, marketed, stored, sold, imported and exported, as applicable, in all material respects, in compliance with FDA Laws, and any comparable Laws enforced by any other Regulatory Authority that has jurisdiction over the operations of the Company, including, to the Knowledge of the Sellers, those regarding non-clinical research, clinical research, establishment registration, device listing, pre-market notification, good manufacturing practices, labeling, advertising, record-keeping, device importation and exportation, adverse event reporting and reporting of corrections and removals, except where the failure to be in compliance would not have a Material Adverse Effect. Except as set forth on Schedule 2.27(b), to the Knowledge of the Sellers, except as would not have a Material Adverse Effect, taken as a whole, any third Person that is a manufacturer or Contractor for the Company is in compliance with all FDA Laws or any other applicable federalLaw insofar as they pertain to the manufacture of product components or Products for the Company. (c) As of the date hereof, statethere are no Proceedings pending or, local and foreign lawsto the Knowledge of the Sellers, rulesthreatened by or on behalf of any Regulatory Authority that has jurisdiction over the operations of the Company. Except as set forth in Schedule 2.27(c), regulationsas of the date hereof, standardsthe Company has not received any Form FDA-483, orders and decrees governing their respective businessesnotice of adverse finding, including without limitationFDA warning letter, all regulations promulgated by notice of violation or “untitled letter,” notice of FDA action for import detention or refusal, or any other notice from the FDA or any other federalGovernmental Authority alleging or asserting noncompliance with any applicable Laws or Registrations. Except as set forth in Schedule 2.27(c), statethe Company is not subject to any obligation arising under an administrative or regulatory action, local FDA inspection, FDA warning letter, FDA notice of violation letter or foreign agencies other notice, response or bodies engaged commitment made to or with the FDA or any comparable Regulatory Authority. The Company has made all notifications, submissions, responses and reports required by FDA Laws, including any such obligation arising under any administrative or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation letter, or other notice, response, or commitment made to or with the FDA or any comparable Regulatory Authority or Governmental Authority and all such notifications, submissions, responses and reports were true, complete and correct in all material respects as of the date of submission to the FDA or any comparable Regulatory Authority or Governmental Authority. To the Knowledge of the Sellers, as of the date hereof, no basis for liability exists with respect to any such notification, submission, or report. (d) Except as set forth on Schedule 2.27(d), no Product distributed or sold by or on behalf of the Company has been seized, withdrawn, recalled, detained or subject to a suspension of manufacturing, and as of the date hereof, to the Knowledge of the Sellers, there are no facts or circumstances reasonably likely to cause (i) the seizure, denial, withdrawal, recall, detention, field notification, field correction, safety alert or suspension of manufacturing relating to any such Product; (ii) a change in the regulation labeling of pharmaceuticals any such Product; or biohazardous substances (iii) a termination, seizure, limitation, restriction, modification or materialssuspension of the marketing or distribution (including for commercial, except where noncompliance would notinvestigational or any other use) of any such Product. As of the date hereof, singly or no Proceedings in the aggregateUnited States or any other jurisdiction seeking the withdrawal, have a Material Adverse Effect; and recall, correction, suspension, import detention, seizure or similar action of any such Product are pending or, to the Knowledge of the Sellers, threatened against the Company. As of the date hereof, the Company has not received any notice citing action from a Regulatory Authority or inaction other Governmental Authority that any Product distributed or sold by or on behalf of the Company or others who perform services any of its Affiliates cannot be developed, tested, investigated, produced, manufactured, labeled, distributed, marketed, stored, sold, imported or exported substantially in the manner presently performed or contemplated by or on behalf of the Company’s behalf that would constitute non-compliance with any applicable federal, state, local or foreign laws, rules, regulations or standards excepting, however, such actions that have heretofore been resolved to the satisfaction of such governmental entity. . (e) All tests and preclinical and clinical studies investigations sponsored or conducted by or on behalf of the Company were and, if still pending, have been and are being, being conducted in material compliance with all material respects in accordance with experimental applicable Laws and other requirements, including good clinical practices requirements, other FDA Laws, applicable research protocols, procedures and controls generally used by qualified experts in the preclinical and clinical study of new drugscorrective action plans, and laws federal and regulations; state laws, rules, regulations relating to patient privacy requirements or restricting the descriptions use and disclosure of the tests and preclinical and individually identifiable health information. No clinical studies, and results thereof, trial sponsored or conducted by or on behalf of the Company are accurate in all material respects; except as disclosed in has been terminated, materially delayed, limited or suspended prior to completion by the SEC ReportsFDA, the Company any other applicable Regulatory Authority, or any institutional review board that has not received any written notice or correspondence from has had jurisdiction over such clinical trial, and neither the FDA nor any other applicable Regulatory Authority, nor any institutional review board that has or has had jurisdiction over a clinical trial conducted or sponsored by or on behalf of the Company, has ordered or commenced, or, to the Knowledge of the Sellers, threatened to initiate, any foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring the termination, suspension, material modification or action to place a clinical hold of order on, or otherwise terminate, materially delay, limit, modify or suspend, any tests proposed or preclinical ongoing clinical trial conducted or clinical studies being proposed to be conducted by or on behalf of the Company, which terminationor, suspensionto the Knowledge of the Sellers, material modification or clinical hold would reasonably be expected to have a Material Adverse Effect; and the Company has not received alleged any written notices or correspondence from others concerning the termination, suspension, material modification or clinical hold violation of any tests or preclinical or FDA Law in connection with any such clinical studies conducted by others on any active ingredient contained in the existing products of the Company or the products described in the SEC Reports as being under development, which termination, suspension, material modification or clinical hold would reasonably be expected to have a Material Adverse Effecttrial.

FDA and Related Matters. The Company (i) Novadaq and its Subsidiaries have all Registrations from the United States Food and Drug Administration (the “FDA”) and comparable Regulatory Authorities or Governmental Entities required to conduct its business as currently conducted, and Section 3.1(ee)(i) of the Novadaq Disclosure Letter sets forth a true, complete and correct list as of the date of this Agreement of such Registrations. Each of the Registrations is valid and subsisting in full force and effect. Novadaq or one of its Subsidiaries is the sole and exclusive owner of the Registrations and none of the Registrations has been sold, conveyed, delivered, transferred or assigned to another party. Each such Registration (A) has been validly issued or acknowledged by the appropriate Regulatory Authority or Governmental Entity and is in full force and effect, and (B) is transferable to Stryker. To the knowledge of Novadaq, as of the date hereof, neither the FDA nor any comparable Regulatory Authority or Governmental Entity is considering limiting, suspending, cancelling or revoking any such Registration or changing the marketing classification or labeling of the products of Novadaq and its Subsidiaries. Novadaq and its Subsidiaries have fulfilled and performed in all material respects their obligations under each Registration, and, as of the date hereof, to the Company’s Knowledgeknowledge of Novadaq, others who perform services no event has occurred or condition or state of facts exists which would constitute a breach or default or would cause suspension, cancellation, revocation or termination of any such Registration. To the knowledge of Novadaq, any third party that is a manufacturer or contractor for Novadaq or any of its Subsidiaries is in compliance with all Registrations insofar as they pertain to the manufacture of product components or products for Novadaq or such Subsidiary. (ii) Since January 1, 2012, all products developed, tested, investigated, manufactured, distributed, marketed or sold by or on behalf of Novadaq or one of its Subsidiaries that are subject to the Company’s behalf jurisdiction of the FDA or any comparable Regulatory Authority or Governmental Entity have been and are being developed, tested, investigated, manufactured, distributed, marketed and sold in all material respects in compliance with FDA Laws, any comparable Laws enforced by any other Regulatory Authority or Governmental Entity that has jurisdiction over the operations of Novadaq or any of its Subsidiaries, any other applicable Law, including those regarding non-clinical research, clinical research, establishment registration, device or drug listing, pre-market notification, good clinical practice, good laboratory practice, good manufacturing practices, quality management systems, labeling, advertising, record-keeping, device or drug importation and exportation, adverse event reporting and reporting of corrections and removals, and with all applicable federal, state, local preclinical and foreign laws, rules, regulations, standards, orders and decrees governing their respective businesses, including without limitation, all regulations promulgated by the FDA or any other federal, state, local or foreign agencies or bodies engaged in the regulation of pharmaceuticals or biohazardous substances or materialsclinical trial protocols, except where noncompliance would notas set forth in Section 3.1(ee)(ii) of the Novadaq Disclosure Letter. To the knowledge of Novadaq, singly except as otherwise, individually or in the aggregate, have has not had, or would not reasonably be expected to have, a Novadaq Material Adverse Effect; and the Company has not received , any notice citing action third party that is a manufacturer or inaction by the Company contractor for Novadaq or others who perform services on the Company’s behalf that would constitute non-any of its Subsidiaries is in compliance with all FDA Laws or any other applicable federal, state, local or foreign laws, rules, regulations or standards excepting, however, such actions that have heretofore been resolved Law insofar as they pertain to the satisfaction manufacture of such governmental entity. All tests and preclinical and clinical studies conducted product components or products for Novadaq or any of its Subsidiaries. (iii) There are no enforcement actions (including any administrative proceeding, prosecution, injunction, seizure, civil penalty, criminal penalty or debarment action) against Novadaq or any of its Subsidiaries or, to the knowledge of Novadaq, any of their officers, employees, or agents, pending or threatened by or on behalf of FDA or any other Regulatory Authority or Governmental Entity that has jurisdiction over the Company operations of Novadaq or any of its Subsidiaries, and there are no facts, circumstances or conditions that could reasonably form the basis of any such action. Except as set forth on Section 3.1(ee)(iii) of the Novadaq Disclosure Letter, since January 1, 2012, Novadaq and its Subsidiaries have not received any Form FDA-483, notice of adverse finding, FDA warning letter, notice of violation or “untitled letter,” notice of FDA action for import detention or refusal, or any other notice, warning, letter or report from the FDA or other Governmental Entity alleging or asserting noncompliance with any applicable Laws or Registrations. Novadaq and its Subsidiaries are not subject to any obligation arising under an administrative or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation letter or other notice, response or commitment made to or with the FDA or any comparable Regulatory Authority or Governmental Entity, except those related to actions set forth in Section 3.1(ee)(iii) of the Novadaq Disclosure Letter. Novadaq and its Subsidiaries have made all notifications, submissions and reports required by FDA Laws or any other applicable Law, including any such obligation arising under any administrative or regulatory action, FDA inspection, FDA warning letter, FDA notice of violation letter, or other notice, response, or commitment made to or with the FDA or any comparable Regulatory Authority or Governmental Entity and all such notifications, submissions and reports were andtrue, if still pendingcomplete and correct in all material respects as of the date of submission to the FDA or any comparable Regulatory Authority or Governmental Entity. To the knowledge of Novadaq, as of the date hereof, no basis for liability exists with respect to any such notification, submission, or report. (iv) Except as set forth on Section 3.1(ee)(iv) of the Novadaq Disclosure Letter, since January 1, 2012, no product distributed or sold by or on behalf of Novadaq or any of its Subsidiaries has been seized, withdrawn, recalled, detained or subject to a suspension of manufacturing, and as of the date hereof, there are beingno facts or circumstances reasonably likely to cause (A) the seizure, conducted denial, withdrawal, recall, detention, field notification, field correction, safety alert or suspension of manufacturing relating to any such product; (B) a change in the labeling of any such product; or (C) a termination, seizure or suspension of the marketing or distribution (including for commercial, investigational or any other use) of any such product. No proceedings in Canada, the United States or any other jurisdiction in which Novadaq currently markets its products seeking the withdrawal, recall, correction, suspension, import detention or seizure of any such product are pending or, to the knowledge of Novadaq, threatened against Novadaq or any of its Subsidiaries. (v) Neither Novadaq nor any of its Subsidiaries, nor any officer or employee of Novadaq or any of its Subsidiaries, nor, to the knowledge of Novadaq, any agent of Novadaq or any of its Subsidiaries, has been convicted of a crime or engaged in any conduct that has resulted, or would reasonably be expected to result, in debarment under applicable Laws, including 21 U.S.C. Section 335a. (vi) Complete and accurate copies of the following information have been disclosed in the Data Room: (i) all material filings with the FDA or any comparable Regulatory Authority or Governmental Entity relating to products developed, tested, investigated, manufactured, distributed, marketed or sold by or on behalf of Novadaq or its Subsidiaries, (ii) all material correspondence with the FDA or any comparable Regulatory Authority or Governmental Entity relating to products developed, tested, investigated, manufactured, distributed, marketed or sold by or on behalf of Novadaq or its Subsidiaries, and (iii) all material data, information, results, analyses, publications, and reports relating to products developed, tested, investigated, manufactured, distributed, marketed or sold by or on behalf of Novadaq or its Subsidiaries, including all clinical trial protocols, trial statistical analysis plans and published trial results (collectively, the “Material Product and Trial Information”). The Material Product and Trial Information is a true and correct representation in all material respects of the matters reflected therein. (vii) The Registrations and regulatory files, dossiers, and supporting materials of Novadaq and its Subsidiaries with respect to products developed, tested, investigated, manufactured, distributed, marketed or sold by or on behalf of Novadaq or its Subsidiaries have been maintained in all material respects in accordance with experimental protocolsapplicable Laws, procedures and controls generally used by qualified experts in the preclinical and clinical study of new drugsreasonable industry standards, and laws and regulations; the descriptions standard operating procedures of Novadaq or its Subsidiaries. None of the tests and preclinical and clinical studiesmaterial filings made by Novadaq or its Subsidiaries with the FDA or any comparable Regulatory Authority or Governmental Entity, and results thereofor with any Review Board, conducted relating to any product developed, tested, investigated, manufactured, distributed, marketed or sold by or on behalf of Novadaq or its Subsidiaries contained any untrue statement of a material fact or fraudulent statement or omitted to state any material fact necessary to make the Company are accurate in all material respects; except as disclosed in the SEC Reportsstatements therein not misleading, the Company and neither Novadaq or its Subsidiaries, nor any officer, employee, or agent of Novadaq or its Subsidiaries, has not received committed any written notice other act, or correspondence from made a statement, or failed to make a statement that could reasonably be expected to provide a basis for the FDA or any foreigncomparable Regulatory Authority or Governmental Entity to invoke its policy respecting “Fraud, state or local governmental body exercising comparable authority Untrue Statements of Material Facts, Bribery, and Illegal Gratuities” set forth in 56 Fed. Reg. 46191 (September 10, 1991) or any Institutional Review Board similar policy. (viii) To the knowledge of Novadaq, Novadaq and its Subsidiaries have in their possession copies of all of the material documentation in existence on or prior to the date hereof and required to be filed with the FDA or any comparable authority requiring Regulatory Authority or Governmental Entity for the termination, suspension, material modification regulatory approval or clinical hold registration of any tests product developed, tested, investigated, manufactured, distributed, marketed or preclinical or clinical studies being conducted sold by or on behalf of Novadaq or its Subsidiaries. (ix) All clinical trials conducted or sponsored by Novadaq or its Subsidiaries which are Applicable Clinical Trials and are required to be registered on xxxxxxxxxxxxxx.xxx have been properly and duly registered on xxxxxxxxxxxxxx.xxx. (x) All clinical trial results information for clinical trials conducted or sponsored by Novadaq or its Subsidiaries which are Applicable Clinical Trials for which clinical trial results information must be submitted has been properly and duly submitted for posting on xxxxxxxxxxxxxx.xxx. (xi) To the Companyknowledge of Novadaq, which terminationall material information as to the safety and efficacy of all products developed, suspensiontested, material modification investigated, manufactured, distributed, marketed or clinical hold sold by or on behalf of Novadaq or its Subsidiaries has been disclosed in the Data Room. (xii) Novadaq and its Subsidiaries are not aware of any information, condition, event, occurrence or circumstance that, to the knowledge of Novadaq, would reasonably be expected to have a Material Adverse Effect; and adversely affect, in any material respect, the Company has not received any written notices acceptance, or correspondence from others concerning the terminationsubsequent approval, suspension, material modification or clinical hold of any tests filing, application or preclinical request for approval of any product developed, tested, investigated, manufactured, distributed, marketed or clinical studies conducted sold by others or on any active ingredient contained in the existing products behalf of the Company Novadaq or the products described in the SEC Reports as being under development, which termination, suspension, material modification or clinical hold would reasonably be expected to have a Material Adverse Effectits Subsidiaries.

FDA and Related Matters. (a) The Company has all licenses, permits, consents, approvals, authorizations, registrations, qualifications and certifications or other action of, or any filing, registration or qualification required by, the United States Food and Drug Administration (the “FDA”) and comparable foreign regulatory and governmental entities (collectively, “FDA Permits”), as are necessary under applicable law to own or lease its property and conduct its business as currently conducted, except for any of the foregoing that could not, in the aggregate, reasonably be expected to have a Company Material Adverse Effect; the Company has satisfied all of the requirements of and fulfilled and performed all of its obligations with respect to the FDA Permits, and, to the Company’s Knowledgeknowledge, others who perform services on no event has occurred that allows, or after notice or lapse of time would allow, revocation or termination thereof or results in any other impairment of the rights of the holder or any such FDA Permits, except for any of the foregoing that could not reasonably be expected to have a Company Material Adverse Effect. (b) Except as disclosed in Section 3.28 of the Company’s behalf have been and are in compliance with all applicable federal, state, local and foreign laws, rules, regulations, standards, orders and decrees governing their respective businesses, including without limitation, all regulations promulgated by the FDA Disclosure Schedule or any other federal, state, local or foreign agencies or bodies engaged in the regulation of pharmaceuticals or biohazardous substances or materials, except where noncompliance would as otherwise could not, singly or in the aggregate, reasonably be expected to have a Company Material Adverse Effect; and , (i) the Company has not received any notice citing action failed to submit to the FDA an Investigational New Drug Application for each clinical trial it is conducting or inaction sponsoring within the United States and (ii) all such submissions were in material compliance with applicable laws when submitted and no material deficiencies have been asserted by the Company or others who perform services on the Company’s behalf that would constitute non-compliance FDA with respect to any applicable federalsuch submissions. (c) The tests, state, local or foreign laws, rules, regulations or standards excepting, however, such actions that have heretofore been resolved to the satisfaction of such governmental entity. All tests and preclinical nonclinical studies and clinical studies trials conducted by or on behalf of the Company were andwere, and if still pending, are being, being conducted in all material respects in accordance with applicable regulations, guidelines and generally accepted standards of good clinical practice, experimental protocols, requirements of a duly-constituted institutional review board (“IRB”) or animal care and use committee as appropriate, procedures and controls generally used pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by qualified experts in the preclinical and clinical study of new drugs, and laws and regulations; the descriptions of the tests and preclinical and clinical studies, and results thereof, conducted by or on behalf of the Company are accurate in all material respects; except as disclosed in the SEC Reports, the Company. The Company has not received any written notice notices or correspondence from the FDA or any foreign, state or local governmental body exercising comparable authority or any Institutional Review Board IRB or comparable authority requiring the termination, suspension, suspension or material modification or clinical hold of any tests tests, studies or preclinical or clinical studies being trials conducted by or on behalf of the Company, Company which termination, suspension, suspension or material modification or clinical hold would reasonably be expected to have a Company Material Adverse Effect; . (d) The Company (i) is not and the Company has not received been debarred from participation in any written notices program related to pharmaceutical products pursuant to 21 U.S.C. Section 335a (a) or correspondence from others concerning (b) (“Debarred”), (ii) does not employ or use the termination, suspension, material modification or clinical hold services of any tests person or preclinical entity that is Debarred and (iii) to the knowledge of the Company, has not employed or clinical studies conducted used the services of any person or entity that is or, during the time when such person or entity was employed by others on any active ingredient contained or providing services to the Company, was Debarred, except in the existing products case of the Company or the products described in the SEC Reports this clause (iii) as being under development, which termination, suspension, material modification or clinical hold would not reasonably be expected to have a Company Material Adverse Effect. The Company does not employ or use the services of and, to the Company’s Knowledge, has not employed or used the services of, any investigator who has been disqualified under 21 C.F.R. Section 312.70. (e) The Company has provided to Parent with true, correct and complete copies of each annual report filed by the Company with the FDA and any similar state or foreign regulatory or governmental entity with respect to any products and product candidates of the Company. (f) The Company has provided Parent with (i) true, correct and complete copies of each New Drug Application (“NDA”) and each Investigational New Drug application (“IND”), and each similar state or foreign regulatory filing made on behalf of any of the Company, including all supplements and amendments thereto, (ii) all correspondence sent to and received from the FDA and similar state and foreign Governmental Authorities that concerns or would reasonably be expected to impact a product or product candidate of the Company, and (iii) all existing written records relating to all material discussions and all meetings between the Company and the FDA or similar foreign regulatory or governmental entities.