Common use of Certain Regulatory Matters Clause in Contracts

Certain Regulatory Matters. (i) The Company has made available to Parent a true and complete copy of all material written communications between the Company or its Subsidiary, on the one hand, and the FDA or any other Governmental Entity on the other hand, and any existing written summaries of material discussions between such parties, that describe matters that are material to assessing compliance of the Company or its Subsidiary with the Federal Food, Drug and Cosmetic Act and its implementing regulations, including copies of (i) all warning letters, notices of adverse findings and similar correspondence, (ii) all audit reports and (iii) any document concerning any significant oral or written communication received from the FDA. The Company has also made available to Parent true and complete copies of all complaints and other information required to be maintained by the Company or its Subsidiary pursuant to the United States Federal Food, Drug and Cosmetic Act and Comprehensive Drug Abuse Prevention and Control Act of 1970 and the corresponding laws of jurisdictions other than the United States. (ii) Section 3.01(x) of the Company Disclosure Schedule hereto contains a true and complete list of all filings made by the Company or its Subsidiary with the FDA and all applicable state, local and foreign regulatory bodies. The Company and its Subsidiary have filed with the FDA and all applicable state, local and foreign regulatory bodies for and received approval of all material registrations, applications, licenses, requests for exemptions, permits and other regulatory authorizations necessary to conduct the businesses of the Company and its Subsidiary as currently conducted. The Company and its Subsidiary and, to the Company's knowledge, any third party which is a manufacturer for the Company or its Subsidiary, are in compliance in all material respects with all such registrations, applications, licenses, requests for exemptions, permits and other regulatory authorizations. Each of the Company, its Subsidiary and, to the Company's knowledge, any such third party manufacturer is in compliance in all material respects with all material FDA, state, local and foreign rules, regulations, guidelines and policies, including, but not limited to, material FDA, state, local and foreign rules, regulations and policies relating to good clinical practice ("GCP"), good manufacturing practice ("GMP"), good laboratory practice ("GLP"), advertising and promotion, pre-and post-marketing adverse drug experience and adverse drug reaction reporting, and all other pre- and post-marketing reporting requirements, as applicable. No party granting any such registration, application, license, request for exemption, permit or other authorization has notified the Company or its Subsidiary in writing that it is considering limiting, suspending or revoking the same, including by enjoining or limiting the production of any product by the Company or its Subsidiary, and to the knowledge of the Company, there is no basis for any such limitation, suspension or revocation.

Certain Regulatory Matters. (ia) The Company COR has made available to Parent Millennium a true and complete copy of all material written communications between the Company COR or any of its SubsidiarySubsidiaries, on the one hand, and the FDA or any other Governmental Entity governmental entity on the other hand, and any existing written summaries of material discussions between such parties, that describe matters that are material to assessing compliance of the Company or its Subsidiary COR with the Federal Food, Drug and Cosmetic Act and its implementing regulations, including copies of (i) all warning letters, notices of adverse findings and similar correspondence, (ii) all audit reports reports, and (iii) any document concerning any significant oral or written communication received from the FDA. The Company COR has also made available to Parent Millennium true and complete copies of all complaints and other information required to be maintained by the Company COR or any of its Subsidiary Subsidiaries pursuant to the United States Federal Food, Drug and Cosmetic Act and Comprehensive Drug Abuse Prevention and Control Act of 1970 and the corresponding laws of jurisdictions other than the United States. (iib) Section 3.01(x) of the Company Disclosure Schedule hereto contains a true and complete list of all filings made by the Company or its Subsidiary with the FDA and all applicable state, local and foreign regulatory bodies. The Company COR and its Subsidiary Subsidiaries have filed with the FDA and all applicable state, local and foreign regulatory bodies for and received approval of all material registrations, applications, licenses, requests for exemptions, permits and other regulatory authorizations necessary to conduct the businesses business of the Company COR and its Subsidiary Subsidiaries as currently conducted. The Company COR and its Subsidiary Subsidiaries and, to the CompanyCOR's knowledge, any third party which is a manufacturer for the Company COR or its SubsidiarySubsidiaries, are in compliance in all material respects with all such registrations, applications, licenses, requests for exemptions, permits and other regulatory authorizations. Each of the CompanyCOR, its Subsidiary Subsidiaries and, to the Company's its knowledge, any such third party manufacturer is in compliance in all material respects with all material FDA, state, local and foreign rules, regulations, guidelines and policies, including, but not limited to, material FDA, state, local and foreign rules, regulations and policies relating to good clinical practice ("GCP"), good manufacturing practice ("GMP"), good laboratory practice ("GLP"), advertising and promotion, pre-pre- and post-marketing adverse drug experience and adverse drug reaction reporting, and all other pre- and post-marketing reporting requirements, as applicable. No ; (i) no party granting any such registration, application, license, request for exemption, permit or other authorization has notified the Company COR or any of its Subsidiary Subsidiaries in writing that it is considering limiting, suspending or revoking the same, including by enjoining or limiting the production of any product of COR or any of its Subsidiaries manufactured by the Company or its Subsidiarya third party manufacturer, and (ii) to the knowledge of the Company, COR there is no basis for any such limitation, suspension or revocation. (c) The COR Disclosure Schedule sets forth a description of any discussions or negotiations since January 1, 2001 between COR or any of its Subsidiaries or any party marketing, selling or co-promoting Integrilin(R) and the Governmental Entity administering the Medicare program relating to any proposed modification or change of the reimbursement rate or other reimbursement arrangements with respect to Integrilin(R) and lists any written communications relating to such discussions or negotiations.

Certain Regulatory Matters. With respect to the Business: (ia) The Company has made available to Parent Section 3.12(a) of the Seller Disclosure Letter sets forth a true complete and complete copy accurate list of all Regulatory Filings and all material written communications between the Company or its SubsidiarySeller, on the one hand, and the FDA or any other Governmental Entity Entity, on the other hand, and any existing all written summaries of material discussions between any such parties, that describe matters that are material to assessing compliance of the Company or its Subsidiary with the Federal Food, Drug and Cosmetic Act and its implementing regulations, including copies of (i) all warning letters, notices of adverse findings and similar correspondence, (ii) all audit reports and (iii) any document concerning any significant oral or written communication received from the FDA. The Company Seller has also made available to Parent true and complete Purchaser copies of all complaints and other information required to be maintained by the Company or its Subsidiary pursuant to the United States Federal Food, Drug and Cosmetic Act and Comprehensive Drug Abuse Prevention and Control Act of 1970 and the corresponding laws of jurisdictions other than the United Statessuch documents. (iib) Section 3.01(x) of the Company Disclosure Schedule hereto contains a true and complete list of all filings made by the Company or its Subsidiary with the FDA and all applicable state, local and foreign regulatory bodies. The Company and its Subsidiary have Seller has filed with the FDA and all applicable state, local and foreign regulatory bodies for for, and received approval of of, all material Regulatory Filings and all other registrations, applications, licenses, requests for exemptions, permits and other regulatory authorizations necessary to conduct the businesses of the Company and its Subsidiary Business as currently conducted and as currently proposed to be conducted. The Company Seller is and its Subsidiary and, to the Company's knowledge, any third party which is a manufacturer for the Company or its Subsidiary, are has been in compliance in all material respects with all such Regulatory Filings, registrations, applications, licenses, requests for exemptions, permits and other regulatory authorizations. Each of the Company, its Subsidiary and, to the Company's knowledge, any such third party manufacturer Seller is and has been in compliance in all material respects with all material FDA, state, local and foreign rules, regulations, guidelines and policies, including, but not limited to, material FDA, state, local and foreign rules, regulations regulations, guidelines and policies relating to good clinical practice ("GCP"), good manufacturing practice ("GMP"), ) and good laboratory practice ("GLP"), advertising and promotion, pre-and post-marketing adverse drug experience and adverse drug reaction reporting, and all other pre- and post-marketing reporting requirements, as applicable. No Seller has no reason to believe that any party granting any such Regulatory Filing, registration, application, license, request for exemption, permit or other regulatory authorization has notified the Company or its Subsidiary in writing that it is considering terminating, limiting, suspending suspending, revoking, canceling, rescinding, refusing to renew in the ordinary course or revoking modifying the same, including by enjoining or limiting the production same and knows of any product by the Company or its Subsidiary, and to the knowledge of the Company, there is no basis for any such limitationaction. (c) Seller is in compliance in all material respects with all obligations arising under any consent decree, suspension consent agreement, warning letter, Form 483 issued by or revocationentered into with the FDA or other notice, response or commitment made to the FDA or any comparable state, local or foreign Governmental Entity. (d) Seller has disclosed to Purchaser any warning letters or Form 483s or similar notices, or other correspondence relating to Seller's compliance status under applicable legal requirements, from the FDA or any comparable state, local or foreign Governmental Entity within the last three years. (e) Neither Seller nor, to Seller's knowledge, any of its officers, employees, independent contractors or agents has knowingly committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy respecting "Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities," set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. (f) Neither Seller nor, to Seller's knowledge, any of its officers, employees, independent contractors or agents has been convicted of any crime or engaged in any conduct which could result in debarment under 21 U.S.C. ss. 335a or any similar state, local or foreign Law. (g) There are no proceedings pending or, to Seller's knowledge, threatened with respect to a violation by Seller of the Food, Drug and Cosmetic Act, FDA regulations adopted thereunder, the Controlled Substance Act or any other legislation or regulation promulgated by any other Governmental Entity that reasonably might be expected to result in criminal liability.

Certain Regulatory Matters. (ia) The Section 3.16 of the Company has made available to Parent Disclosure Schedule sets forth a true complete and complete copy accurate list of all material any written communications between the Company or its SubsidiaryCompany, on the one hand, and the FDA or any other Governmental Entity Authority on the other hand, and any existing written summaries of material discussions between such parties, hand that describe matters that are could have a material adverse effect on the Company's currently projected sales or revenues attributable to assessing compliance any contemplated compound, product or product line of the Company or its Subsidiary with the Federal Food, Drug and Cosmetic Act and its implementing regulations, including copies of (i) all warning letters, notices of adverse findings and similar correspondence, (ii) all audit reports and (iii) any document concerning any significant oral or written communication received from the FDACompany. The Company has also made available to Parent true and complete both of the other Companies copies of all such documents, as well as copies of all complaints and other information required to be maintained by the Company or its Subsidiary pursuant to the United States Federal Food, Drug and Cosmetic Act and Comprehensive Drug Abuse Prevention and Control Act of 1970 and the corresponding laws of jurisdictions other than the United States. (iib) Section 3.01(x) of the Company Disclosure Schedule hereto contains a true and complete list of all filings made by the Company or its Subsidiary with the FDA and all applicable state, local and foreign regulatory bodies. The Company and its Subsidiary have has filed with the FDA and all applicable state, state and local and foreign regulatory bodies for and received approval of all material registrations, applications, licenses, requests for exemptions, permits and other regulatory authorizations necessary to conduct the businesses business of the Company and its Subsidiary as currently conducted, the absence of which would, individually or in the aggregate, be reasonably likely to have a Company Material Adverse Effect. The Company is, and its Subsidiary andat all relevant times has been, to the Company's knowledge, any third party which is a manufacturer for the Company or its Subsidiary, are in compliance in all material respects with all such registrations, applications, licenses, requests for exemptions, permits and other regulatory authorizations. Each of the Company, its Subsidiary and, to To the Company's knowledgeKnowledge, any such third party which is a manufacturer is for the Company is, and at all relevant times has been, in compliance in all material respects with all such registrations, applications, licenses, requests for exemptions, permits and other regulatory authorizations insofar as the same pertain to the manufacture of products for the Company. The Company is, and at all relevant times has been, in compliance in all material respect with all material FDA, state, state and local and foreign rules, regulations, guidelines and policies, including, but not limited to, material FDA, state, state and local and foreign rules, regulations and policies relating to good clinical practice ("GCP"), good manufacturing practice ("GMP"), ) and good laboratory practice ("GLP"), advertising ; and promotion, pre-and post-marketing adverse drug experience and adverse drug reaction reporting, and all other pre- and post-marketing reporting requirements, as applicable. No the Company has no reason to believe that any party granting any such registration, application, license, request for exemption, permit or other authorization has notified the Company or its Subsidiary in writing that it is considering limiting, suspending or revoking the same, including by enjoining or limiting the production same and knows of any product by the Company or its Subsidiary, and to the knowledge of the Company, there is no basis for any such limitation, suspension or revocation.

Certain Regulatory Matters. With respect to the Business: (ia) The Company has made available to Parent Section 3.12(a) of the Seller Disclosure Letter sets forth a true complete and complete copy accurate list of all Regulatory Filings and all material written communications between the Company or its SubsidiarySeller, on the one hand, and the FDA or any other Governmental Entity Entity, on the other hand, and any existing all written summaries of material discussions between any such parties, that describe matters that are material to assessing compliance of the Company or its Subsidiary with the Federal Food, Drug and Cosmetic Act and its implementing regulations, including copies of (i) all warning letters, notices of adverse findings and similar correspondence, (ii) all audit reports and (iii) any document concerning any significant oral or written communication received from the FDA. The Company Seller has also made available to Parent true and complete Purchaser copies of all complaints and other information required to be maintained by the Company or its Subsidiary pursuant to the United States Federal Food, Drug and Cosmetic Act and Comprehensive Drug Abuse Prevention and Control Act of 1970 and the corresponding laws of jurisdictions other than the United Statessuch documents. (iib) Section 3.01(x) of the Company Disclosure Schedule hereto contains a true and complete list of all filings made by the Company or its Subsidiary with the FDA and all applicable state, local and foreign regulatory bodies. The Company and its Subsidiary have Seller has filed with the FDA and all applicable state, local and foreign regulatory bodies for for, and received approval of of, all material Regulatory Filings and all other registrations, applications, licenses, requests for exemptions, permits and other regulatory authorizations necessary to conduct the businesses of the Company and its Subsidiary Business as currently conducted and as currently proposed to be conducted. The Company Seller is and its Subsidiary and, to the Company's knowledge, any third party which is a manufacturer for the Company or its Subsidiary, are has been in compliance in all material respects with all such Regulatory Filings, registrations, applications, licenses, requests for exemptions, permits and other regulatory authorizations. Each of the Company, its Subsidiary and, to the Company's knowledge, any such third party manufacturer Seller is and has been in compliance in all material respects with all material FDA, state, local and foreign rules, regulations, guidelines and policies, including, but not limited to, material FDA, state, local and foreign rules, regulations regulations, guidelines and policies relating to good clinical practice ("GCP"), good manufacturing practice ("“GMP"), ”) and good laboratory practice ("“GLP"”), advertising and promotion, pre-and post-marketing adverse drug experience and adverse drug reaction reporting, and all other pre- and post-marketing reporting requirements, as applicable. No Seller has no reason to believe that any party granting any such Regulatory Filing, registration, application, license, request for exemption, permit or other regulatory authorization has notified the Company or its Subsidiary in writing that it is considering terminating, limiting, suspending suspending, revoking, canceling, rescinding, refusing to renew in the ordinary course or revoking modifying the same, including by enjoining or limiting the production same and knows of any product by the Company or its Subsidiary, and to the knowledge of the Company, there is no basis for any such limitationaction. (c) Seller is in compliance in all material respects with all obligations arising under any consent decree, suspension consent agreement, warning letter, Form 483 issued by or revocationentered into with the FDA or other notice, response or commitment made to the FDA or any comparable state, local or foreign Governmental Entity. (d) Seller has disclosed to Purchaser any warning letters or Form 483s or similar notices, or other correspondence relating to Seller’s compliance status under applicable legal requirements, from the FDA or any comparable state, local or foreign Governmental Entity within the last three years. (e) Neither Seller nor, to Seller’s knowledge, any of its officers, employees, independent contractors or agents has knowingly committed any act, made any statement or failed to make any statement that would reasonably be expected to provide a basis for the FDA to invoke its policy respecting “Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities,” set forth in 56 Fed. Reg. 46191 (September 10, 1991) and any amendments thereto. (f) Neither Seller nor, to Seller’s knowledge, any of its officers, employees, independent contractors or agents has been convicted of any crime or engaged in any conduct which could result in debarment under 21 U.S.C. § 335a or any similar state, local or foreign Law. (g) There are no proceedings pending or, to Seller’s knowledge, threatened with respect to a violation by Seller of the Food, Drug and Cosmetic Act, FDA regulations adopted thereunder, the Controlled Substance Act or any other legislation or regulation promulgated by any other Governmental Entity that reasonably might be expected to result in criminal liability.

Certain Regulatory Matters. (ia) All products and product candidates that are included in the Assets and that have been developed, tested, manufactured, marketed, distributed or sold by or on behalf of the Seller (the “Products”) are described in the Seller Disclosure Schedule, which schedule also indicates each such product currently developed, manufactured, marketed, distributed or sold by or on behalf of the Seller. (b) The Company has made available to Parent Seller Disclosure Schedule sets forth a true and complete copy list of all material any written communications relating to the Assets between the Company or its SubsidiarySeller, on the one hand, and the FDA or any other Governmental Entity governmental entity on the other hand, and any existing written summaries of material discussions between such parties, that describe matters that are material to assessing compliance of the Company or its Subsidiary Seller with the Federal Food, Drug and Cosmetic Act and its implementing regulations, including copies of (i) all warning letters, notices of adverse findings and similar correspondence, (ii) all audit reports reports, and (iii) any document concerning any significant oral or written communication received from the FDA. The Company Seller has also delivered or made available to Parent the Purchaser true and complete copies of all such documents, as well as copies of all complaints and other information required to be maintained by the Company or its Subsidiary Seller pursuant to the United States Federal Food, Drug and Cosmetic Act and Comprehensive Drug Abuse Prevention and Control Act of 1970 and the corresponding laws of jurisdictions other than the United States. (iic) Section 3.01(x) of the Company Disclosure Schedule hereto contains a true and complete list of all filings made by the Company or its Subsidiary with the FDA and all applicable state, local and foreign regulatory bodies. The Company and its Subsidiary have Seller has filed with the FDA and all applicable state, local and foreign regulatory bodies for and received approval of all material registrations, applications, licenses, requests for exemptions, permits and other regulatory authorizations necessary (i) to conduct the businesses business of the Company Seller as previously conducted by the Seller and its Subsidiary as (ii) to own and use the Assets in the manner in which they are currently conductedowned and used. The Company and its Subsidiary Seller and, to the Company's knowledgebest of the knowledge of the Seller, any third party which is a manufacturer for the Company or its SubsidiarySeller, are is in compliance in all material respects with all such registrations, applications, licenses, requests for exemptions, permits and other regulatory authorizations. Each of the Company, its Subsidiary Seller and, to the Company's knowledgebest of the knowledge of the Seller, any such third party manufacturer manufacturer, is in compliance in all material respects with all material FDA, state, local and foreign rules, regulations, guidelines and policies, including, but not limited to, material including FDA, state, local and foreign rules, regulations and policies relating to good clinical practice ("GCP"), good manufacturing practice ("GMP"), and good laboratory practice ("GLP"), advertising practice; and promotion, pre-and post-marketing adverse drug experience and adverse drug reaction reporting, and all other pre- and post-marketing reporting requirements, as applicable. No the Seller does not believe that any party granting any such registration, application, license, request for exemption, permit or other authorization has notified the Company or its Subsidiary in writing that it is considering limiting, suspending or revoking the same, including by enjoining or limiting same and knows of no facts that would reasonably be likely to be the production of any product by the Company or its Subsidiary, and to the knowledge of the Company, there is no basis for any such limitation, suspension or revocation.

Certain Regulatory Matters. (ia) The Group Companies have obtained any and all Government Approvals required to be obtained on or prior to the Closing and have fulfilled any and all filings and registration requirements with applicable Governmental Authorities necessary in respect the Group Companies and their operations. All such filings and registrations with applicable Governmental Authorities required in respect of the Group Companies, including but not limited to the registrations with the Ministry of Commerce (or any predecessors), the State Administration of Industry and Commerce, SAFE, the Ministry of Industry and Information Technology, the Ministry of Culture, the General Administration for Press and Publication, the State Administration for Radio, Film and Television, tax bureau, customs authorities and the local counterparts of each of such Governmental Authorities, as applicable, have been duly completed in accordance with applicable Law. No Group Company has made available received any letter or notice from any applicable Governmental Authorities notifying it of the revocation of any Government Approval issued to Parent it or the need for compliance or remedial actions in respect of the activities carried out directly or indirectly by any Group Company. Each Group Company has been conducting its business activities within the permitted scope of business or is otherwise operating its businesses in full compliance with all relevant Laws and Governmental Orders. No Group Company has reason to believe that any authorization of any Governmental Authority, license or permit requisite for the conduct of any part of its business which is subject to periodic renewal will not be granted or renewed by the relevant Governmental Authorities. (b) Except as set forth in Section 3.8(b) of the Disclosure Schedule, each of the PRC Subsidiary and Sogou Information upon its formation has obtained any certificates, approvals, permits, licenses, registration receipts and any similar authority necessary under PRC Laws to conduct foreign exchange transactions (collectively, the “Foreign Exchange Authorization”) as now being conducted by it, the lack of which could cause a true Material Adverse Effect, and complete copy believes it can obtain, without undue burden or expense, any such Foreign Exchange Authorization for the conduct of all material written communications between foreign exchange transactions as planned to be conducted. All existing Foreign Exchange Authorization held by the Company or PRC Subsidiary and Sogou Information upon its Subsidiary, on the one handformation are valid, and the FDA or PRC Subsidiary and Sogou Information upon its formation is not in default in any other Governmental Entity on the other hand, and material respect under any existing written summaries of material discussions between such parties, that describe matters that are material to assessing compliance of the Company or its Subsidiary with the Federal Food, Drug and Cosmetic Act and its implementing regulations, including copies of (i) all warning letters, notices of adverse findings and similar correspondence, (ii) all audit reports and (iii) any document concerning any significant oral or written communication received from the FDA. The Company has also made available to Parent true and complete copies of all complaints and other information required to be maintained by the Company or its Subsidiary pursuant to the United States Federal Food, Drug and Cosmetic Act and Comprehensive Drug Abuse Prevention and Control Act of 1970 and the corresponding laws of jurisdictions other than the United StatesForeign Exchange Authorization. (ii) Section 3.01(x) of the Company Disclosure Schedule hereto contains a true and complete list of all filings made by the Company or its Subsidiary with the FDA and all applicable state, local and foreign regulatory bodies. The Company and its Subsidiary have filed with the FDA and all applicable state, local and foreign regulatory bodies for and received approval of all material registrations, applications, licenses, requests for exemptions, permits and other regulatory authorizations necessary to conduct the businesses of the Company and its Subsidiary as currently conducted. The Company and its Subsidiary and, to the Company's knowledge, any third party which is a manufacturer for the Company or its Subsidiary, are in compliance in all material respects with all such registrations, applications, licenses, requests for exemptions, permits and other regulatory authorizations. Each of the Company, its Subsidiary and, to the Company's knowledge, any such third party manufacturer is in compliance in all material respects with all material FDA, state, local and foreign rules, regulations, guidelines and policies, including, but not limited to, material FDA, state, local and foreign rules, regulations and policies relating to good clinical practice ("GCP"), good manufacturing practice ("GMP"), good laboratory practice ("GLP"), advertising and promotion, pre-and post-marketing adverse drug experience and adverse drug reaction reporting, and all other pre- and post-marketing reporting requirements, as applicable. No party granting any such registration, application, license, request for exemption, permit or other authorization has notified the Company or its Subsidiary in writing that it is considering limiting, suspending or revoking the same, including by enjoining or limiting the production of any product by the Company or its Subsidiary, and to the knowledge of the Company, there is no basis for any such limitation, suspension or revocation.