Pricing Approvals definition

Pricing Approvals means in those countries in the Territory where Regulatory Authorities approve or determine pricing or pricing reimbursement for pharmaceutical products, such approval or determination.

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 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.

Examples of Pricing Approvals in a sentence

• Royalty reductions due to Generic Competition and adverse changes to Pricing Approvals will apply separately from (and potentially additively to) one another.

• 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.

• Pending transfer of such Regulatory Submissions, Regulatory Approvals, and Pricing Approvals, upon the Opt-Out Date, the Opt-Out Party hereby grants to the Continuing Party a right of reference to all such Regulatory Submissions, Regulatory Approvals, and Pricing Approvals, upon the Opt-Out Date for purposes of obtaining Regulatory Approval for the Licensed Compounds and Licensed Products.

• In connection with obtaining or maintaining Regulatory Approvals and Pricing Approvals, interacting with Regulatory Authorities, filing or maintaining Regulatory Documentation, or maintaining regulatory records (in each case in relation to a Party’s System or the Combined Platform), unless required to comply with Applicable Laws or agreed by the Parties, in no instance shall either Party [***] For clarity, in the event Beta Bionics [***], Beta Bionics shall be responsible for [***].

• Elevai has the exclusive right to conduct, and subject to the remainder of this Section 8 (Regulatory), is solely responsible for all aspects of, activities related to (i) setting the regulatory strategy for seeking Regulatory Approvals (including any Pricing Approvals) for Licensed Products in the Field in the Territory and (ii) seeking and obtaining Regulatory Approvals for Licensed Products in the Field in the Territory.

More Definitions of Pricing Approvals

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.

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, 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 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, 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 approval or authorization of any Governmental Authority establishing a pricing scheme and/or health insurance reimbursement scheme for the Products or any of them in any country of the Territory, but excluding Regulatory Approval(s). *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission.

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.