Recall Objection Notice definition

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

  • With respect to one of the submissions by undertakings from Italy40, analysing Commission v.

  • 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.


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.
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Related to Recall Objection Notice

  • Objection Notice has the meaning set forth in Section 2.3(a) of this Agreement.

  • Rejection Notice has the meaning specified in Section 2.05(b)(v).

  • Allocation Notice shall have the meaning assigned to such term in Section 11.14(i) hereof.

  • Rectification Notice means a notice in writing that identifies a defect in a work and requires rectification of the defect within a specified period of time.

  • Addition Notice With respect to the transfer of Subsequent Mortgage Loans to the Trust Fund pursuant to Section 2.08, a notice of the Depositor's designation of the Subsequent Mortgage Loans to be sold to the Trust Fund and the aggregate principal balance of such Subsequent Mortgage Loans as of the Subsequent Cut-off Date. The Addition Notice shall be given not later than three Business Days prior to the related Subsequent Transfer Date and shall be substantially in the form attached hereto as Exhibit P.

  • Completion Notice means a notice issued by the Developer in accordance with clause 6.1.

  • Selection Notice means a notice substantially in the form set out in Part II of Schedule 3 (Requests) given in accordance with Clause 9 (Interest Periods).

  • Election Notice has the meaning set forth in Section 11.01(b).

  • Material Objection Notice has the meaning set forth in Section 4.2 of this Agreement.

  • Reduction Notice has the meaning set forth in Section 1.3.

  • Closing Notice Has the meaning specified in the NPA. Company: Has the meaning specified in the first paragraph of this Trust Supplement.

  • Seller’s Notice has the meaning set forth in Section 8.5(a).

  • Determination Notice is defined in Section 6.1(b)(i) of the Agreement.

  • Auction Notice has the meaning assigned to such term in the definition of “Dutch Auction”.

  • Response Period has the meaning set forth in Section 9.6(a).

  • Penalty Notice means a written no- tification from the Director informing a respondent that the Director has made a finding of violation and, absent a request for a hearing, will impose a civil monetary penalty.

  • Claim Objection Deadline means the first Business Day that is 180 days after the Effective Date, as may be extended by order of the Bankruptcy Court.

  • Acquisition Notice has the meaning set forth in Section 2.6(a).

  • Objection Period has the meaning set forth in Section 2.4(d).

  • Collection Notice means a notice, in substantially the form of Annex A to Exhibit VI, from the Agent to a Collection Bank.

  • Response Notice is defined in Section 14.3(b)(ii).

  • Plan Objection Deadline means the deadline established by the Bankruptcy Court for filing objections to confirmation of the Plan.

  • Dispute Notice has the meaning set forth in Section 2.7(b).

  • CAFA Notice refers to the notice requirements imposed by 28 U.S.C. § 1715(b).

  • Contribution Notice means a contribution notice issued by the Pensions Regulator under section 38 or section 47 of the Pensions Xxx 0000.

  • Step-Out Notice has the meaning given to it in Section 8.1.