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.
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 that establishes prices charged to end-users for pharmaceutical or biologic products at which a particular pharmaceutical or biologic product shall be reimbursed by the Regulatory Authorities or other applicable Governmental Authorities in the Territory.
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.
More Definitions of Pricing and Reimbursement Approval
Pricing and Reimbursement Approval means any official, final, binding and non-appealable determination of the reimbursable price of the Product in accordance with Applicable Laws and approval by relevant Regulatory Authorities pertaining to the reimbursement of the Product, as applicable in each country in the Territory in which a Regulatory Authority approves or determines the price and/or reimbursement of 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, in any country where a Regulatory Authority authorizes reimbursement for, or approves or determines pricing or level of reimbursement for, pharmaceutical products, receipt (or, if required to make such authorization, approval or determination effective, publication) of such reimbursement authorization and/or pricing approval or determination (as the case may be).
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 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 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 the approvals, agreements, determinations, or governmental decisions establishing (a) a price for the applicable Product or LB-001, as applicable, that can be legally charged to consumers and (b) the level of reimbursement for the applicable Product or LB-001, as applicable, that will be reimbursed by Governmental Authorities, in each case ((a) and (b)) if required in a given jurisdiction or country in connection with Commercialization of such Product or LB-001, as applicable, in such jurisdiction or country.