Pricing Approvals definition

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

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Pricing Approvals means, with respect to a Product in any country or jurisdiction in the Licensed Territory, all pricing and reimbursement approvals for the Product from Government Authorities required by applicable Law or Governmental Authorities.

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

Examples of Pricing Approvals in a sentence

The right of reference granted to SGI herein shall be solely for the purpose of SGI, its Affiliates or any Third Party sublicensees of SGI (i) obtaining Regulatory Approvals or Pricing Approvals in the SGI Territory for the Licensed Product, (ii) conducting activities (including conducting clinical trials) assigned to SGI under the Global Product Development Plan or (iii) conducting SGI Independent Activity.
The right of reference granted to MPI herein shall be solely for the purpose of MPI, its Affiliates or any Third Party sublicensees of MPI (A) obtaining Regulatory Approvals or Pricing Approvals in the Licensed Territory for the Licensed Product, (B) conducting activities (including conducting clinical trials) assigned to MPI under the Global Product Development Plan or (C) conducting MPI Independent Activity.
Each Party shall keep the other Party reasonably and regularly informed of the preparation of all Regulatory Materials, Regulatory Authority review of Regulatory Materials, meetings with Regulatory Authorities, and Regulatory Approvals and Pricing Approvals for the Licensed Products, in each case in such Party’s territory, pursuant to procedures to be developed by the JSC.
MPI shall use Commercially Reasonable Efforts to prepare and submit the appropriate Regulatory Materials for Licensed Products in the Licensed Territory, as determined on a country-by-country basis, and to seek to obtain Regulatory Approvals (and, if applicable, Pricing Approvals) for Licensed Products in the Licensed Territory, as determined on a country-by-country basis.
For all Licensed Products, following the Effective Date, Company will exclusively control (a) all Pricing Approvals, (b) all decisions related to market access and (c) all decisions with respect to Commercialization of such Licensed Products as Combination Products.

More Definitions of Pricing Approvals

Pricing Approvals means the pricing and third party reimbursement approvals that are required by any national, supra-national (e.g., the European Commission or the Council of the European Union), regional, state, provincial or local Regulatory Authority in the Territory, for the distribution, use or sale of a pharmaceutical product in the Territory, as amended or supplemented from time to time.

Pricing Approvals means such approval, agreement, determination or governmental decision establishing prices (i.e., Yakka) for the Product that can be charged to consumers and will be reimbursed by Governmental Authorities in Japan.

Pricing Approvals means, in any country where a Government Authority, as a required condition precedent to the launch of Licensed Product or in order to continue the marketing or sale of the Licensed Product following launch under provisional pricing or reimbursement, authorizes reimbursement for, or approves or determines pricing for, pharmaceutical products or medical devices, receipt (or, if required to make such authorization, approval or determination effective, publication) of such reimbursement authorization or pricing approval or determination (as the case may be).

Pricing Approvals means any approval or authorization of any Governmental Authority establishing a pricing scheme and/or health insurance reimbursement scheme for the Product or any of them in the Territory, but excluding Marketing Authorization. 1.25 “Product” means the product manufactured by or on behalf of SUPPLIER for the indication(s) and application(s) specified in the approved Summary of Product Characteristics, listed in ANNEX A. 1.26 “Product Intellectual Property Rights” means all Intellectual Property Rights which SUPPLIER may at any time own, control, adopt, use, license or register with respect to the Product. 1.27 “Promotional Material(s)” means any sales literature, product descriptions, sales aids and advertising and promotional materials used for the marketing, promotion and/or sales of the Product. 1.28 "Quality Agreement" means the document(s) together with its exhibits and appendices referenced in ANNEX E, as may be amended by agreement of the Parties from time to time, laying down each Party’s and/or its Affiliates’ responsibilities with respect to the quality assurance of Product supplied and purchased under this Agreement, as provided for in accordance with the Quality Agreement. [***] 4 (65)

Pricing Approvals means, with respect to the Product in any country or jurisdiction, all pricing and reimbursement approvals or decisions granted or decided for the Product from Governmental Authorities or from any other private or public body entitled to decide if the Product can be totally or partially reimbursed by the corresponding national health system or private health systems and, if applicable, the ex-factory price at which the Product will be reimbursed in a certain country of the Territory. 1. 101 “Product” means any product, including without limitation any Combination Product, containing Lebrikizumab as pharmaceutically active agent, regardless of their finished forms or formulations or dosages. For clarity, different formulations or finished forms or dosages containing Lebrikizumab are considered the same Product.

Pricing Approvals means any pricing and reimbursement approvals which must be obtained before placing a Licensed Product on the market in a particular jurisdiction.