Price Approvals definition

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Price Approvals means in those countries in the Territory where Governmental Authorities may approve or determine pricing and/or pricing reimbursement for pharmaceutical products, such approval or determination.

Price Approvals means, in any country outside of the United States where an applicable Governmental Entity authorizes reimbursement for, or approves and determines pricing for, pharmaceutical products, receipt (or, if required to make such authorization, approval or determination effective, publication including in appropriate official journal) of such authorization, approval or determination as required by applicable Law prior to marketing and sale of the Product in such country.

Examples of Price Approvals in a sentence

Ownership of all right, title and interest in and to any and all Regulatory Filings, Regulatory Approvals and Price Approvals directed to any Licensed Agent or any Product directed to each Collaboration Target in each country of the Territory will be held in the name of Vertex, its Affiliate, designee or Sublicensee.
Ownership of all right, title and interest in and to all Regulatory Filings, Regulatory Approvals and Price Approvals directed to any Licensed Agent or Product in the Field in each country of the Territory will be held by and in the name of Vertex, its Affiliate, designee or Sublicensee.
For all Licensed Products, Sanofi will exclusively control without coordination by the JCC (a) all Price Approvals and (b) all decisions with respect to Commercialization of such Licensed Products as Combination Products.
The Regulatory Lead will own all INDs, NDAs, Marketing Approvals, Regulatory Filings, Price Approvals and related regulatory documents in the Territory with respect to such Collaboration Candidates and Licensed Products Directed Against such Collaboration Target, including any drug master files maintained by such Regulatory Lead solely with respect thereto in the Territory.
Regulatory Authority means any national (e.g., the FDA), supra-national (e.g., the European Commission, the Council of the European Union, or the EMA), regional, state or local regulatory agency, department, bureau, commission, council or other governmental authority involved in the granting of Regulatory Approvals or Price Approvals for pharmaceutical products in such country or countries.
Sanofi will book all sales of Products in the Territory and will control all Price Approvals.
Pfizer shall have the sole authority and exclusive right to Commercialize, and shall be responsible for paying all costs and expenses (except as otherwise expressly set forth in this Agreement) associated with the Commercialization of, the Licensed Product in the Field in the Territory, including marketing, promoting, selling, distributing and [***] for the Licensed Product and obtaining any necessary Price Approvals.
Ownership of all rights in and to all Regulatory Filings, Regulatory Approvals and Price Approvals directed to any Capsids or Product in the Field in each country of the Territory will be held in the name of Vertex, its Affiliate, designee or Sublicensee.
On and following the Marketed Products Closing, Hyperion shall have the sole authority for: (a) determining the overall pricing strategy for all Transferred Marketed Products; (b) obtaining Price Approvals for the Transferred Marketed Products as may be required; and (c) managing distribution of each Transferred Marketed Product in each applicable country.
For the sake of clarity, Regulatory Approval shall not be achieved for a Licensed Product in a country or jurisdiction until all applicable Price Approvals, if any, have also been obtained by Pfizer or its Affiliate, sublicensee or other designee for such Licensed Product in such country or jurisdiction.

More Definitions of Price Approvals

Price Approvals means, in those countries in the Territory where Regulatory Authorities may approve or determine pricing and/or pricing reimbursement for pharmaceutical products and such pricing or pricing reimbursement is required (or is reasonably commercially necessary) for the marketing and sale of a pharmaceutical product in such country, such pricing and/or pricing reimbursement approval or determination.

Price Approvals means, with respect to a Licensed Product, pricing or pricing reimbursement approval granted in each country in the Territory by the applicable Regulatory Authorities necessary for the commercial sale of such Licensed Product in such regulatory jurisdiction.

Price Approvals means, in PRC where Regulatory Authorities may approve or determine pricing and/or pricing reimbursement for pharmaceutical products, such pricing and/or pricing reimbursement approval or determination.