Price and Reimbursement Approvals definition

Price and Reimbursement Approvals means the approval of the price and the reimbursement category (where relevant) for the Product as established from time to time by the relevant Regulatory Authority in the Territory.
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Price and Reimbursement Approvals means the approvals of the price and the reimbursement category (where relevant) for GA-EPO as established from time to time by the relevant Pricing and Reimbursement Authority in the applicable country in the Territory. Price and Reimbursement Approvals will not include Registration Approval.
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Price and Reimbursement Approvals means any approvals, licenses, registrations or authorisations of any supranational, national, regional, state or local Regulatory Authority or other regulatory agency, department, bureau or governmental entity, necessary to determine or set the pricing of a Licensed Product, and/or its reimbursement level by the relevant health authorities, providers or other funding institutions, at supranational, national, regional, state or local level.
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Examples of Price and Reimbursement Approvals in a sentence

  • In addition, and without limitation of the foregoing, Licensee shall, as soon as possible following each MAA Approval(s), subject to Section 6.4(b), launch the Product for such indication and obtain all necessary Price and Reimbursement Approvals at least in [ * ] (subject to the business judgment to delay or not to launch a particular Product in a particular country of the EU because of adverse pricing or other business considerations).

Related to Price and Reimbursement Approvals

  • Pricing and Reimbursement Approval means the approval, agreement, determination or decision from a Regulatory Authority establishing the price and/or reimbursement for Licensed Product for sale in a given country or regulatory jurisdiction of the Territory, as required by Law in such country or other regulatory jurisdiction prior to or subsequent to the marketing and sale of Licensed Product in such country or regulatory jurisdiction of the Territory.

  • Reimbursement Approval means an approval, agreement, determination, or other decision by the applicable Governmental Authority that establishes prices charged to end-users for pharmaceutical or biologic products at which a particular pharmaceutical or biologic product will be reimbursed by the Regulatory Authorities or other applicable Governmental Authorities in the Territory.

  • Project Approvals means all approvals, consents, waivers, orders, agreements, authorizations, permits and licenses required under Applicable Laws or under the terms of any restriction, covenant, easement or agreement affecting all or any applicable Phase of the Project, or otherwise necessary or desirable for the ownership, acquisition, construction, development, equipping, use or operation of the Project.

  • Regulatory Approvals with respect to the Warrantholder, means, to the extent applicable and required to permit the Warrantholder to exercise this Warrant for shares of Common Stock and to own such Common Stock without the Warrantholder being in violation of applicable law, rule or regulation, the receipt of any necessary approvals and authorizations of, filings and registrations with, notifications to, or expiration or termination of any applicable waiting period under, the Xxxx-Xxxxx-Xxxxxx Antitrust Improvements Act of 1976, as amended, and the rules and regulations thereunder.

  • Approvals means the permits, clearances, licenses and consents as are listed in Schedule 3 hereto and any other statutory approvals.

  • Government Approvals means all permits, licenses, authorisations, consents, clearances, decrees, waivers, privileges, approvals from and filing with government instrumentalities necessary for the development, construction and operation of the Work.

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

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

  • Licenses means any approvals, authorizations, consents, licenses, registrations, permits or certificates of a Governmental Authority.

  • Third Party Consents shall have the meaning set forth in Section 8.3.

  • CPUC Approval means a final and non-appealable order of the CPUC, without conditions or modifications unacceptable to the Parties, or either of them, which contains the following terms:

  • Required Consents shall have the meaning set forth in Section 4.5.

  • Supply Contracts means contracts having as their object the purchase, lease, rental or hire-purchase, with or without an option to buy, of products. A supply contract may include, as an incidental matter, siting and installation operations;

  • Consents, Clearances and Permits means all authorizations, licenses, approvals, registrations, permits, waivers, privileges, acknowledgements, agreements, or concessions required to be obtained from or provided by any concerned authority for the purpose of setting up of the generation facilities and/or supply of power;

  • Conditional approval means a time-limited status that results when an approved nursing education program has failed to maintain requirements as set forth in this chapter.