Price Approval Country definition

Price Approval Country means any country in the Territory that requires pricing or reimbursement approval to be obtained from a Regulatory Authority in order for the Combination Product to be sold in such country, including any country in the Territory for which the applicable Regulatory Authority sets any such price or grants reimbursement approval for the
Sample 1
Price Approval Country shall have the meaning set forth in Section 4.1(c)(ii).
Sample 1
Price Approval Country means any country in the Territory that requires pricing or reimbursement approval to be obtained from a Regulatory Authority in order for the Combination Product to be sold in such country, including any country in the Territory for which the applicable Regulatory Authority sets any such price or grants reimbursement approval for the [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. CONFIDENTIAL TREATMENT REQUESTED UNDER 17 C.F.R. §§ 200.80 (b)(4) AND 230.406 Combination Product by reference to the price (or reimbursement price) of the Combination Product in one or more other countries.
Sample 1

Examples of Price Approval Country in a sentence

  • Except as otherwise agreed by the Parties in writing, with respect to any Price Approval Country, the Selling Party shall be responsible for managing the negotiation with the applicable authority(ies) in each such country in the Territory to obtain and maintain pricing approval.

  • For purposes of a Price Approval Country, a Discounted Price shall mean any price that is lower than the Approved Price for the Territory Combination Product.

  • Further, in the event that the Parties cannot (x) reach agreement on a Country Price with respect to a country other than a Price Approval Country or Reference Price Country, or (y) obtain any initial pricing approval required by a national pricing authority in a Price Approval Country [*] (as defined in Annex C), the Combination Product shall not be Launched in such country.

  • Notwithstanding any other provision of this Agreement, in the event that, following the Launch of the Combination Product in a given Price Approval Country, [*].

  • Section 7.4(a)(i) is hereby amended by inserting the following sentence at the end of such Section: If the Approved Price for the Territory Combination Product is different than the Base Price in a Price Approval Country, then notwithstanding the other provisions of this Section 7.4(a)(i), the Selling Party shall sell at such Approved Price, unless a discount is permitted pursuant to this Agreement or an Ancillary Agreement.

  • In the event that an initial Approved Price is obtained in a Price Approval Country, [*].

  • The minimum acceptable Approved Price (the “Minimum Target Price”) to be obtained in connection with any negotiations by the Selling Party (or its applicable Affiliate) with the applicable pricing authority for the purpose of obtaining any initial Approved Price for the Combination Product in any Price Approval Country shall equal the then current 1+1 Approved Price in such country or such other price as the Parties may agree in writing.

Related to Price Approval Country

  • Price Approval means, in any country where a Governmental Authority authorizes reimbursement for, or approves or determines pricing for, pharmaceutical products, 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).

  • MAA Approval means approval by the EMEA of a marketing authorization application (“MAA”) filed with the EMEA for the applicable Licensed Product under the centralized European procedure. If the centralized EMEA filing procedure is not used, MAA Approval shall be achieved upon the first Approval for the applicable Licensed Product in any two of the following countries: France, Germany, Italy, Spain or the United Kingdom.

  • NDA Approval means the Approval of an NDA by the FDA for a Product in the U.S.

  • IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and federal requirements.

  • Marketing Approval means all approvals, licenses, registrations or authorizations of the Regulatory Authority in a country, necessary for the manufacture, use, storage, import, marketing and sale of a Product in such country.

  • FDA Approval means with respect to the Product, a Regulatory Approval by the FDA for the commercial use of the Product in the United States.

  • Marketing Authorization Application or “MAA” means an application to the appropriate Regulatory Authority for approval to sell the Product (but excluding Pricing Approval) in any particular country or regulatory jurisdiction.

  • Requisite Regulatory Approvals has the meaning set forth in Section 7.01(b).

  • Marketing Approval Application or “MAA” means a New Drug Application (or its equivalent), as defined in the U.S. Food, Drug and Cosmetic Act and the regulations promulgated thereunder, or any corresponding or similar application, registration or certification in any country.

  • Regulatory Approval Application means an application to seek regular or expedited Regulatory Approval of the Licensed Product for sale or marketing in any country(ies) or Region(s) in the Territory, as defined in the applicable Laws and filed with the Regulatory Authority of such country(ies) or Region(s).

  • Marketing Authorization means all approvals from the relevant Regulatory Authority necessary to market and sell a Product in any country (including without limitation all applicable pricing and governmental reimbursement approvals even if not legally required to sell Product in a country).

  • Regulatory Approvals with respect to the Warrantholder, means, to the extent applicable and required to permit the Warrantholder to exercise this Warrant for shares of Common Stock and to own such Common Stock without the Warrantholder being in violation of applicable law, rule or regulation, the receipt of any necessary approvals and authorizations of, filings and registrations with, notifications to, or expiration or termination of any applicable waiting period under, the Xxxx-Xxxxx-Xxxxxx Antitrust Improvements Act of 1976, as amended, and the rules and regulations thereunder.

  • Regulatory Approval means, with respect to a Product in any country or jurisdiction, any approval (including where required, pricing and reimbursement approvals), registration, license or authorization from a Regulatory Authority in a country or other jurisdiction that is necessary to market and sell such Product in such country or jurisdiction.

  • Drug Approval Application means, with respect to a Licensed Product in the Territory, an application for Regulatory Approval for such product in a country in the Territory. For purposes of clarity, Drug Approval Application shall include, without limitation, (a) an NDA or BLA (for U.S.) or MAA (for Europe); (b) a counterpart of an NDA, BLA or MAA in any country or region in the Territory; and (c) all supplements (including supplemental applications such as sNDAs) and amendments to the foregoing.

  • Approval Authority means the authority of a Member State with competence for all aspects of the approval of a type of vehicle, system, component or separate technical unit or of the individual approval of a vehicle; for the authorisation process, for issuing and, if appropriate, withdrawing approval certificates; for acting as the contact point for the approval authorities of other Member States; for designating the technical services and for ensuring that the manufacturer meets his obligations regarding the conformity of production;

  • Key Regulatory Approvals means those sanctions, rulings, consents, orders, exemptions, permits and other approvals (including the lapse, without objection, of a prescribed time under a statute or regulation that states that a transaction may be implemented if a prescribed time lapses following the giving of notice without an objection being made) of Governmental Entities set out in Schedule C hereto;

  • Major EU Country means one or more of the following countries within the European Union: France, Germany, Italy, Spain and the United Kingdom.

  • Pre-approval means written notification via a pre-approval letter to Customer that Ameren Illinois has reviewed Customer's Application and determined that the project meets the program eligibility requirements for a maximum pre-approved incentive amount if the project is completed by the estimated completion date and all final application paperwork is submitted and approved.

  • Non-Approval Event means, in respect of the Benchmark:

  • type-approval means the procedure whereby an approval authority certifies that a type of vehicle, system, component or separate technical unit satisfies the relevant administrative provisions and technical requirements;

  • Development approval means any written authorization from a

  • Required Regulatory Approvals means the Seller Required Regulatory Approvals and the Buyer Required Regulatory Approvals.

  • Requisite Approval means the affirmative vote of the holders of at least a majority of the shares of outstanding Company Common Stock and outstanding Company Preferred Stock voting as a single class.

  • Pricing Approval means such mandatory governmental approval, agreement, determination or decision establishing prices for the Product that can be charged and/or reimbursed in regulatory jurisdictions where the applicable Governmental Authorities approve or determine the price and/or reimbursement of pharmaceutical products.

  • Application Approval Date means the date that the Application is approved by the Board of Trustees of the District and as further identified in Section 2.3.B of this Agreement.

  • Major Market Country means each of the United States, Japan, France, Germany, Italy, Spain and the United Kingdom.