Price Approvals definition

Price Approvals means, in those countries in the Territory where Regulatory Authorities may approve or determine pricing and/or pricing reimbursement for pharmaceutical products, such pricing and/or pricing reimbursement approval or determination.
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Price Approvals means in those countries in the Territory where Governmental Authorities may approve or determine pricing and/or pricing reimbursement for pharmaceutical products, such approval or determination.
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Price Approvals means, in any country outside of the United States where an applicable Governmental Entity authorizes reimbursement for, or approves and determines pricing for, pharmaceutical products, receipt (or, if required to make such authorization, approval or determination effective, publication including in appropriate official journal) of such authorization, approval or determination as required by applicable Law prior to marketing and sale of the Product in such country.
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Examples of Price Approvals in a sentence

  • Ownership of all right, title and interest in and to any and all Regulatory Filings, Regulatory Approvals and Price Approvals directed to any Licensed Agent or any Product directed to each Collaboration Target in each country of the Territory will be held in the name of Vertex, its Affiliate, designee or Sublicensee.

  • Ownership of all right, title and interest in and to all Regulatory Filings, Regulatory Approvals and Price Approvals directed to any Licensed Agent or Product in the Field in each country of the Territory will be held by and in the name of Vertex, its Affiliate, designee or Sublicensee.

  • Sanofi will book all sales of Products in the Territory and will control all Price Approvals.

  • Regulatory Authority means any national (e.g., the FDA), supra-national (e.g., the European Commission, the Council of the European Union, or the EMA), regional, state or local regulatory agency, department, bureau, commission, council or other governmental authority involved in the granting of Regulatory Approvals or Price Approvals for pharmaceutical products in such country or countries.

  • For all Licensed Products, Sanofi will exclusively control without coordination by the JCC (a) all Price Approvals and (b) all decisions with respect to Commercialization of such Licensed Products as Combination Products.

  • Ownership of all rights in and to all Regulatory Filings, Regulatory Approvals and Price Approvals directed to any Capsids or Product in the Field in each country of the Territory will be held in the name of Vertex, its Affiliate, designee or Sublicensee.

  • The Regulatory Lead will own all INDs, NDAs, Marketing Approvals, Regulatory Filings, Price Approvals and related regulatory documents in the Territory with respect to such Collaboration Candidates and Licensed Products Directed Against such Collaboration Target, including any drug master files maintained by such Regulatory Lead solely with respect thereto in the Territory.

  • Ownership of all right, title and interest in and to any and all Regulatory Filings, Regulatory Approvals and Price Approvals directed to any Product in each country of the Territory will be held in the name of Vertex, its Affiliate, designee or Sublicensee.

  • Solely as used in Section 8.2, “MAA” shall mean the application for Regulatory Approval (but excluding Price Approvals) required for marketing of the first Product in the EU.

  • For the sake of clarity, Regulatory Approval shall not be achieved for a Licensed Product in a country or jurisdiction until all applicable Price Approvals, if any, have also been obtained by Pfizer or its Affiliate, sublicensee or other designee for such Licensed Product in such country or jurisdiction.


More Definitions of Price Approvals

Price Approvals means, with respect to a Licensed Product, pricing or pricing reimbursement approval granted in each country in the Territory by the applicable Regulatory Authorities necessary for the commercial sale of such Licensed Product in such regulatory jurisdiction.
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Price Approvals means, in PRC where Regulatory Authorities may approve or determine pricing and/or pricing reimbursement for pharmaceutical products, such pricing and/or pricing reimbursement approval or determination.
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Price Approvals means, in any jurisdiction where Regulatory Agencies may approve or determine pricing and/or pricing reimbursement for pharmaceutical products, such pricing and/or pricing reimbursement approval or determination.
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Related to Price Approvals

  • 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).

  • Regulatory Approvals means any registrations, licenses, authorizations, permits or approvals issued by any Governmental Authority and applications or submissions related to any of the foregoing.

  • Export Approvals has the meaning specified in Section 4.26(a).

  • Project Approvals means all approvals, consents, waivers, orders, agreements, authorizations, permits and licenses required under Applicable Laws or under the terms of any restriction, covenant, easement or agreement affecting all or any applicable Phase of the Project, or otherwise necessary or desirable for the ownership, acquisition, construction, development, equipping, use or operation of the Project.

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

  • Government Approvals means all permits, licenses, authorisations, consents, clearances, decrees, waivers, privileges, approvals from and filing with government instrumentalities necessary for the development, construction and operation of the Work.

  • 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 as set out in Schedule C hereto;

  • Approvals means all approvals, consents, authorisations, permissions, licences, resolutions, exemptions, registrations, filings, permits and rights from all government, regulatory and statutory entities and authorities;

  • Company Approvals has the meaning set forth in Section 3.5(b).

  • Product Approvals means any approvals, registrations, permits, licenses, consents, authorizations, and other approvals, and pending applications and requests therefor, required by applicable Agencies related to the research, Development, manufacture, distribution, finishing, packaging, marketing, sale, storage or transport of a Product within the United States of America, and includes, without limitation, all approvals, registrations, licenses or authorizations granted in connection with any Application related to that Product.

  • Necessary Consents means all planning permissions and all other consents, licences, permissions, certificates, authorisations and approvals whether of a public or private nature which shall be required by any Competent Authority for the Permitted Use;

  • 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.

  • Development Approvals means all permits and other entitlements for use subject to approval or issuance by CITY in connection with development of the Property including, but not limited to: (a) general plan, general plan amendments, specific plans and specific plan amendments; (b) tentative and final subdivision and parcel maps; (c) conditional use permits and master plans; (d) zoning, zoning map amendments, and zoning text amendments; and, (e) grading and building permits.

  • HSR Approval means expiration of all applicable waiting periods under the HSR Act (including any voluntary agreed extensions) or earlier termination thereof.

  • Required Consents shall have the meaning set forth in Section 4.5.

  • MAA Approval means approval of an MAA by the applicable Regulatory Authority for marketing and sale of a Product in the Collaborator Territory, but excluding any Pricing and Reimbursement Approval.

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

  • Gaming Approvals means with respect to any action by a particular Person, any consent, finding of suitability, license, approval or other authorization required for such action by such Person from a Gaming Authority or under Gaming Laws.

  • CPUC Approval means a final and non-appealable order of the CPUC, without conditions or modifications unacceptable to the Parties, or either of them, which contains the following terms:

  • Governmental Approvals means all authorizations, consents, approvals, licenses and exemptions of, registrations and filings with, and reports to, all Governmental Authorities.

  • Necessary preconstruction approvals or permits means those permits or approvals required under federal air quality control laws and regulations and those air quality control laws and regulations which are part of the applicable State Implementation Plan.

  • 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.

  • Authorizations means all filings, recordings, and registrations with, and all validations or exemptions, approvals, orders, authorizations, consents, franchises, licenses, certificates, and permits from, any Governmental Authority.

  • Necessary Authorizations means all approvals and licenses from, and all filings and registrations with, any governmental or other regulatory authority, including, without limiting the foregoing, the Licenses and all approvals, licenses, filings and registrations under the Communications Act, necessary in order to enable the Borrower and its Subsidiaries to own, construct, maintain, and operate communications tower facilities and to invest in other Persons who own, construct, maintain, manage and operate communications tower facilities.

  • 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;

  • Required Governmental Approvals means the Company Required Governmental Approvals and the Parent Required Governmental Approvals.