Company Regulatory Agency definition

Company Regulatory Agency has the meaning set forth in Section 2.12(b).

Company Regulatory Agency shall have the meaning set forth in Section 3.19(a).

Company Regulatory Agency means any Governmental Entity that regulates the quality, identity, strength, purity, safety, pricing, reimbursement, efficacy or manufacturing of the Company’s products, including, without limitation, the FDA, the EMA and the Japanese Ministry of Health.

Examples of Company Regulatory Agency in a sentence

• Except for normal examinations conducted by a Holding Company Regulatory Agency in the ordinary course of Holding Company’s and each of the Holding Company Subsidiaries’ business, there is no pending proceeding before, or, to its Knowledge, examination or investigation by, any Holding Company Regulatory Agency into the business or operations of Holding Company or any of the Holding Company Subsidiaries.

• Any such Bank Report regarding Holding Company or any of the Holding Company Subsidiaries filed with or otherwise submitted to any Holding Company Regulatory Agency complied in all material respects with relevant legal requirements, including as to content.

• There is no unresolved violation, criticism, or exception by any Company Regulatory Agency with respect to any report or statement relating to any examinations of the Company or any of its Subsidiaries.

• No Company Regulatory Agency, clinical investigator, institutional review board or independent monitoring committee has provided notice that it has initiated or, to the knowledge of the Company, threatened to initiate any action to place a hold order on, or otherwise terminate, delay, suspend or modify any such ongoing testing, and, to the knowledge of the Company, there are no facts that would reasonably be expected to give rise to such a determination.

• Neither the Company nor any of the Company Subsidiaries have received any written notice from any Governmental Entity (including any Company Regulatory Agency) threatening any, and there is no pending, Proceeding alleging any material violation applicable to any Company Product by the Company or any of the Company Subsidiaries of any applicable Law, including any Healthcare Law.

More Definitions of Company Regulatory Agency

Company Regulatory Agency means the FDA, Health Canada, the European Medicines Agency and any other Governmental Entity that regulates the quality, identity, strength, purity, safety, efficacy, manufacturing, distribution, sale, import or export of the Company Products.

Company Regulatory Agency has the meaning set forth in Section 4.9(a)(i)(B).

Company Regulatory Agency means any applicable Governmental Entity that has regulatory authority over the development, design, testing, quality, identity, safety, efficacy, manufacturing, labeling, marketing, distribution, commercialization, sale, pricing, import or export of any Company Products, including the FDA.

Company Regulatory Agency. Section 3.13(a)

Company Regulatory Agency means the FDA and any other Governmental Authority that is concerned with the quality, identity, strength, purity, safety, efficacy, Manufacturing, supply or distribution of any of the Company Products necessary for the lawful operating of the businesses of the Company and each of its Subsidiaries as currently conducted.

Company Regulatory Agency is defined in Section 3.12(a) of the Agreement.

Company Regulatory Agency means any Governmental Entity that regulates the business of the Company or its facilities, including, without limitation, the Centers for Medicare and Medicaid Services.