Marketing Authorization Transfer Date definition

Marketing Authorization Transfer Date means, with respect to a Product in an applicable country in the Territory, (a) the effective date approved by the applicable Governmental Authority for the Transfer of the applicable Purchased Marketing Authorization(s) with respect to such Product and such country from Seller or its applicable Affiliate to Buyer or its applicable Affiliate, or (b) the date on which such Transfer is otherwise effected in accordance with applicable Law.
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Examples of Marketing Authorization Transfer Date in a sentence

  • For each country in the Territory, following the Marketing Authorization Transfer Date for such country, except as required by a Party to comply with applicable Law or as contemplated by the terms hereof or any Ancillary Agreement, Purchaser and its Affiliates (including the Transferred Entity) shall have the sole right and responsibility for (and have sole discretion over) regulatory activities with respect to the Product in each applicable country in the Territory.

  • Notwithstanding anything to the contrary in this Section 5.8, nothing in this Section 5.8 shall apply with respect to any Purchased Marketing Authorization held by the Purchased Subsidiary, for which the Marketing Authorization Transfer Date shall be deemed to be the Closing Date.

  • For each country in the Territory, from the Closing Date and until the Marketing Authorization Transfer Date for such country, Seller shall have control, in consultation with Buyer (unless prohibited by applicable Law), over whether to conduct a recall or market withdrawal, as applicable, of any unit of Product sold in the Territory and the manner in which any such recall or market withdrawal shall be conducted.

  • On a country-by-country basis, as promptly after the Closing Date as is reasonably practicable, but in no event later than the applicable Marketing Authorization Transfer Date for each country in the Supply Territory, Recipient shall use commercially reasonable efforts to create and use new marketing and promotional materials for the Product that do not contain any Lilly Retained Names and Marks.

  • If the Marketing Authorization Transfer Date occurs prior to the Distribution End Date for a country in the Supply Territory, Recipient or its applicable Affiliate or other designee shall make any filings with Governmental Authorities in such country required under applicable Law for Lilly or its Affiliate or such other designee to distribute finished Product on behalf of Recipient in such country until the Distribution End Date therefor.

Related to Marketing Authorization Transfer Date

  • Marketing Authorization means all approvals, licenses, registrations or authorizations of any federal, state or local regulatory agency, department, bureau or other governmental entity, necessary for the manufacturing, use, storage, import, transport, marketing and sale of Licensed Products in a country or regulatory jurisdiction.

  • Marketing Authorization Application or “MAA” means an application for Regulatory Approval (but excluding Pricing Approval) in any particular jurisdiction other than the U.S.

  • Required Regulatory Approvals means the Seller Required Regulatory Approvals and the Buyer Required Regulatory Approvals.

  • Requisite Regulatory Approvals has the meaning set forth in Section 7.01(b).

  • UCC Filing Authorization Letter means a letter duly executed by each Loan Party authorizing the Collateral Agent to file appropriate financing statements on Form UCC-1 without the signature of such Loan Party in such office or offices as may be necessary or, in the opinion of the Collateral Agent, desirable to perfect the security interests purported to be created by each Security Agreement and each Mortgage.

  • Initial approval means authorization to admit students and enter into contractual agreements for clinical facilities. It is granted only after an application has been submitted, reviewed and a survey visit made by the Board. No students shall be admitted to the program until the institution has received written notification that initial approval has been granted. Failure to comply will delay initial approval.

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • Cannabis production establishment agent registration card means a registration card that the department issues that:

  • MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the Collaborator Territory, but excluding any Pricing and Reimbursement Approval.

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Marketing Authorisation means, with respect to a country, region or other jurisdiction in the Territory, any and all approvals (including Drug Approval Applications), licenses, registrations, or authorisations of any Regulatory Authority necessary to commercially distribute, sell, or market Product in such country or other jurisdiction, including, where applicable, (a) pre- and post-approval regulatory approvals (including any prerequisite manufacturing approval or authorisation related thereto), and (b) approval of Product labelling.

  • Regulatory Approval means any and all approvals (including MAA Approval, and Pricing and Reimbursement Approval, if applicable), licenses, registrations, permits, notifications and authorizations (or waivers) of any Regulatory Authority that are necessary for the manufacture, use, storage, import, transport, promotion, marketing, distribution, offer for sale, sale or other commercialization of a Product in any country or jurisdiction.

  • Key Regulatory Approvals means those sanctions, rulings, consents, orders, exemptions, permits and other approvals (including the lapse, without objection, of a prescribed time under a statute or regulation that states that a transaction may be implemented if a prescribed time lapses following the giving of notice without an objection being made) of Governmental Entities as set out in Schedule C hereto;

  • Regulatory Approvals means any registrations, licenses, authorizations, permits or approvals issued by any Governmental Authority and applications or submissions related to any of the foregoing.

  • NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.

  • Optional Interconnection Study Agreement means the form of agreement for preparation of an Optional Interconnection Study, as set forth in Tariff, Attachment N-3.

  • Optional Interconnection Study means a sensitivity analysis of an Interconnection Request based on assumptions specified by the Interconnection Customer in the Optional Interconnection Study Agreement.

  • Regulatory Authorizations means all approvals, clearances, authorizations, registrations, certifications, licenses and permits granted by any Regulatory Authority, including all INDs and NDAs.

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale of a Product as a pharmaceutical product in a regulatory jurisdiction.

  • Marketing Approval means all approvals, licenses, registrations or authorizations of the Regulatory Authority in a country, necessary for the manufacture, use, storage, import, marketing and sale of a Product in such country.

  • WTO GPA country end product means an article that—

  • Phase I Clinical Study means a human clinical study of a product, the principal purpose of which is a preliminary determination of safety in healthy individuals or patients, as described in 21 C.F.R. 312.21(a).

  • Required Governmental Approvals means the Company Required Governmental Approvals and the Parent Required Governmental Approvals.

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

  • Product Approvals means any approvals, registrations, permits, licenses, consents, authorizations, and other approvals, and pending applications and requests therefor, required by applicable Agencies related to the research, Development, manufacture, distribution, finishing, packaging, marketing, sale, storage or transport of a Product within the United States of America, and includes, without limitation, all approvals, registrations, licenses or authorizations granted in connection with any Application related to that Product.

  • Pricing Approval means such governmental approval, agreement, determination or decision establishing prices for a Licensed Product that can be charged and/or reimbursed in regulatory jurisdictions where the applicable Governmental Authorities approve or determine the price and/or reimbursement of pharmaceutical products.