Pricing and Reimbursement Approval definition

Pricing and Reimbursement Approval means, with respect to a Product, the approval, agreement, determination, or decision of any Governmental Authority establishing the list price or level of reimbursement for such Product, as required in a given country or jurisdiction prior to sale of such Product in such jurisdiction.

Pricing and Reimbursement Approval means an approval, agreement, determination or other decision by the applicable Governmental Authority of a country or jurisdiction 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 Authority or other applicable Governmental Authority in such country or jurisdiction.

Pricing and Reimbursement Approval means, with respect to a Product, the approval, agreement, determination or decision of any Governmental Authority establishing the price or level of reimbursement for such Product, as required in a given country or jurisdiction prior to sale of such Product in such jurisdiction.

Examples of Pricing and Reimbursement Approval in a sentence

• Licensee shall keep Exelixis timely informed on the status of any application for Pricing and Reimbursement Approval or material updates to an existing Pricing and Reimbursement Approval in the Licensee Territory, including any discussion with a Regulatory Authority with respect thereto.

• In addition, Licensee shall also use Commercially Reasonable Efforts to Develop Licensee Only Development Work and any Licensee Independent Work, file XXXx and seek and maintain Regulatory Approval (including Pricing and Reimbursement Approval, as applicable) for the Products throughout the Licensee Territory.

• UCB shall notify Dermira promptly after, and in any event within [*] Business Days after, each of (1) receipt of Pricing and Reimbursement Approval and (2) first commercial sale, in each case (1) and (2) in each of the countries listed below.

• Collaborator shall keep Exelixis timely informed on the status of any application for Pricing and Reimbursement Approval or material updates to an existing Pricing and Reimbursement Approval in the Collaborator Territory, including any discussion with a Regulatory Authority with respect thereto, via the JCC.

• In addition, consistent with the GDP, Collaborator shall use Commercially Reasonable Efforts to perform Collaborator Local Development Work and any Collaborator Independent Work, file XXXx and seek and maintain Regulatory Approval (including Pricing and Reimbursement Approval, as applicable) for the Products in the Collaborator Territory.

More Definitions of Pricing and Reimbursement Approval

Pricing and Reimbursement Approval means (a) the governmental approval, agreement, determination or decision establishing prices for a Product that can be charged in regulatory jurisdictions where the applicable Governmental Authorities approve or determine the price of pharmaceutical products, and (b) the approval, agreement, determination or decision recommending or approving a Product for use or establishing the prices for a Product that can be reimbursed in regulatory jurisdictions where the applicable Governmental Authority or Non-Governmental Authority approves, determines or recommends the reimbursement or use of pharmaceutical products; provided, that in all cases Pricing and Reimbursement Approval shall only be deemed obtained after Drug Approval has been obtained in the applicable jurisdiction.

Pricing and Reimbursement Approval means, with respect to any country or jurisdiction in the Territory in which Governmental Authorities determine the pricing at which a Licensed Product will be reimbursed, the approval, agreement, determination or decision by the applicable Governmental Authorities establishing the pricing and reimbursement status for such Licensed Product.

Pricing and Reimbursement Approval 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 of or reimbursement for pharmaceutical products.

Pricing and Reimbursement Approval means, with respect to a Licensed Product, the governmental approval, agreement, determination or decision establishing the price or level of reimbursement for such Licensed Product, in a given country in the Territory prior to the sale of such Licensed Product in such jurisdiction in the Territory.

Pricing and Reimbursement Approval means, with respect to an MRT Product in a country, the approval, license, registration or authorization of a Governmental Entity or relevant health authority to determine or set the price or reimbursement level of such MRT Product in such country.

Pricing and Reimbursement Approval means, for each country or region within the Promotion Territory where Pricing and Reimbursement Authorities, Regulatory Authorities or other competent public or private bodies and authorities must approve or determine gross and/or net pricing or pricing reimbursement or formulary coverage for pharmaceutical products that are distributed and sold in such country or region, such approvals or determinations.

Pricing and Reimbursement Approval means, with respect to a 2 mg vial of the Product in a given country, following Regulatory Approval of such 2 mg vial of the Product for the treatment of Arginase-1 Deficiency in such country by the applicable Regulatory Authority in such country, the later of (A) the approval, agreement, determination or decision by (1) the Ministries of Health and Social Security in France as published in the Journal Officiel, (2) the National Institute for Health and Care Excellence in the United Kingdom as set forth in the applicable commercial access agreement and (3) Spitzenverband der Gesetzlichen Krankenkassen (GKV-Spitzenverband) in Germany as published in the Xxxxx Taxe establishing a price for such 2 mg vial of the Product that can be legally charged to consumers, if required or desirable, in such country in connection with the broad commercialization of such 2 mg vial of the Product for the treatment of Arginase-1 Deficiency in such country; and (B) the approval, agreement, determination or decision by the foregoing applicable Governmental Authority establishing the level of reimbursement for such 2 mg vial of the Product that will be reimbursed by such Governmental Authority, if required or desirable, in such country in connection with the broad commercialization of such 2 mg vial of the Product for the treatment of Arginase-1 Deficiency in such country.