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 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, with respect to the Licensed Product, the governmental approval, agreement, determination, or decision establishing the price or level of reimbursement for such Licensed Product in a given Region in the Territory prior to the sale of such Licensed Product in such Region in the Field in the Territory.
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.

Examples of Pricing and Reimbursement Approval in a sentence

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

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.

Incyte shall use Commercially Reasonable Efforts (i) to launch at least one (1) Licensed Product in the Hematology/Oncology Field in the Major Markets within one hundred and eighty (180) days after receipt of Regulatory Approval and Pricing and Reimbursement Approval therefor in the applicable country and (ii) thereafter to Commercialize such Licensed Product in such country.

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.

Without limiting the generality of the foregoing, Licensee shall use Angelini Commercially Reasonable Efforts to launch the Product in each country in the Licensee Territory within [***] after receiving Regulatory Approval, or, where required by Applicable Law, after the publication of the Pricing and Reimbursement Approval, of the Product for an Indication from the applicable Regulatory Authority in such country.


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 (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 any approval received from a Regulatory Authority in a country or region relating to (a) the price that may be charged to a third party for the sale of a medical product or (b) the amount to be reimbursed (directly or indirectly) to the seller of such a medical product pursuant to the Applicable Laws in such country or region.
Pricing and Reimbursement Approval means, with respect to a 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 Product in such country or, if earlier, the first commercial sale of a Product in such country for consideration above the cost of goods sold of such 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 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 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.