Recall Objection Notice definition

Recall Objection Notice has the meaning set forth in Section 12.4.1.

Split View

AI-Powered Contracts

Draft, Review & Redline at the Speed of AI

Get StartedBook a Demo

Recall Objection Notice has the meaning set forth in Section 13.5.1. 1.86 “Receiving Party” has the meaning set forth in Section 10.1. 1.87 “Registration Batches” has the meaning set forth in Section 5.1. 1.88 “Regulatory Approval” means any approvals (including applications therefore, supplements and amendments thereto and pricing and reimbursement approvals), licenses, registrations, or authorizations of any Regulatory Authority, necessary for the Development, Commercialization, Supply, manufacture, testing, labeling, packaging, or shipping of the Product in the Territory, including the approval for clinical trials and the Marketing Authorization(s) for the Product. 1.89 “Regulatory Approval Application” means any filings submitted to a Regulatory Authority in the Territory, in each case, with all additions, deletion or supplements thereto, for Regulatory Approval of the Product in the Territory. 1.90 “Regulatory Authority” means any national, regional, state, provincial or local regulatory agency, department, bureau, commission, council or other governmental authority in the Territory involved in the granting of approvals (including pricing and reimbursement approvals), licenses, registrations or authorizations for the marketing, sale, manufacturing, testing, labeling, storage, handling, packaging, shipping or supply the Product, including the NMPA, and any other body or any health regulatory authority(ies) in the Territory that is equivalent to the United States Food and Drug Administration (and its successor agencies or departments) and holds responsibility for granting Regulatory Approval for the Product, and any successor(s) thereto having substantially the same functions.

Recall Objection Notice. Supplier" Introductory paragraph Introductory paragraph Section 2.1 Section 8.2 Section 8.2 Section 2.1 Section 7.4 Section 8.1 Section 3.3(a) Section 2.2(d) Section 6.1 Section 4.7 Section 4.4(b) Introductory paragraph

Examples of Recall Objection Notice in a sentence

• If Galena and MSRx fail within ten (10) days after delivery of the Recall Objection Notice to agree as to the Party that is the cause of such Recall, the issue, and as applicable, any representative samples of the Product, shall be submitted to a mutually acceptable independent laboratory or consultant (if not a laboratory analysis issue) for analysis or review.

• The Parties agree to attempt to resolve such dispute within ten (10) days after receipt of the Recall Objection Notice.

• If CPI and GEL fail within ten (10) days after delivery of the Recall Objection Notice to agree as to the Party that is the cause of such Recall, the issue, and as applicable, any representative samples of the Product, shall be submitted to a mutually acceptable independent laboratory or consultant (if not a laboratory analysis issue) for analysis or review.

• If Pharmanovia and Aquestive fail within ten (10) days after receipt of the Recall Objection Notice to agree as to the Party that is the cause of such Recall, the issue, and as applicable, any representative samples of the Product, shall be submitted to a mutually and reasonably acceptable independent Third Party laboratory of national reputation, or consultant (if not a laboratory analysis issue), as evidenced by written agreement of the Parties, for analysis or review.

More Definitions of Recall Objection Notice

Recall Objection Notice has the meaning set forth in Section 4.8.3. 1.85 “Receiving Party” has the meaning set forth in Section 10.1. 1.86 “Regulatory Approval” means authorization from the relevant Regulatory Authorities within the Territory for approval to Commercialize the Product in the Field in the Territory, including the Marketing Authorization for the Product. 1.87 “Regulatory Approval Application” means any filings submitted to a Regulatory Authority in the Territory, in each case, with all additions, deletion or supplements thereto, for Regulatory Approval of the Product in the Field in the Territory. 1.88 “Regulatory Authority” means any national, international, federal, regional, state, provincial or local government, or political subdivision thereof, or any multinational organization or any authority, regulatory agency, department, bureau, commission, council or other regulatory or taxing authority entitled to exercise any administrative, executive, judicial, legislative, police, regulatory or taxing authority or power, including with respect to the granting of approvals (including pricing and reimbursement approvals), licenses, registrations, or authorizations for the marketing, sale, manufacturing, testing, labeling, storage, handling, packaging, shipping or supply of the Product or granting Regulatory Approval for the Product, including the FDA, any other regulatory authority(ies) equivalent to the FDA including the EMA and the MHRA, and any successor(s) thereto having substantially the same functions, or any court or tribunal (or any department, bureau or division thereof, or any governmental arbitrator or arbitral body). 1.89 “Regulatory Notification” shall have the meaning given to it in Section 4.6.2.