Price and Reimbursement Approval definition

Price and Reimbursement Approval means any approvals, licenses, registrations or authorizations of any supranational, national, regional, state or local Regulatory Authority or other regulatory agency, department, bureau or governmental entity, necessary to determine or set the pricing of a Product, and/or its reimbursement level by the relevant health authorities, providers or other funding institutions, at supranational, national, regional, state or local level.
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Price and Reimbursement Approval means the approval of the price and the reimbursement category (where relevant) for the Product and/or Optional Product as established from time to time by the relevant Regulatory Authority in the applicable country in the Territory.
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Price and Reimbursement Approval means any governmental price approval or reimbursement approved by the applicable Regulatory Authority of any applicable country of the Territory under the approved national health insurance system. For the sake of clarity, in countries of the Territory where, according to local regulations, prices are formally determined before the application for reimbursement, Price and Reimbursement Approval shall be considered obtained when the final reimbursement price is approved.
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Examples of Price and Reimbursement Approval in a sentence

  • For the avoidance of doubt, Shire or its Affiliates will be solely responsible for all Price and Reimbursement Approval proceedings with respect to GA-EPO in the Territory, and Shire will have complete discretion in setting pricing for GA-EPO in the Territory.

  • On a Subject mAb2-by-Subject mAb2 basis, during the Development and Commercialization Term for any Subject mAb2, Xxxxxxx shall use Commercially Reasonable Efforts to Develop, and obtain Regulatory Approval (and if applicable, Price and Reimbursement Approval) for, [***] containing such Subject mAb2 for [***].

  • Eurofarma may terminate the Agreement effective immediately upon written notice to the other Party within thirty (30) days after Price and Reimbursement Approval is granted by the applicable Regulatory Authorities in [**] for the first Licensed Product if such Price and Reimbursement Approval is not economically viable.

  • Following receipt of Regulatory Approval (and if applicable Price and Reimbursement Approval) for a Product in a Major Market Country, Xxxxxxx shall use Commercially Reasonable Efforts to Commercialize that Product in that Major Market Country.

  • Eurofarma shall use Commercially Reasonable Efforts to promptly notify Summit on the receipt of Price and Reimbursement Approval and to keep Summit updated regarding the entire process, in the Eurofarma Territory.

  • All counties and local jurisdictions shall develop supporting plans or implementing procedures for the implementation of NIMS within their respective jurisdiction as required.

  • ASTRAZENECA shall apply for Price and Reimbursement Approval at such prices as it may determine in its sole discretion subject to all Applicable Laws and Regulations of the Territory and commercial reasonableness for the purpose of this Agreement.


More Definitions of Price and Reimbursement Approval

Price and Reimbursement Approval means any approvals, licenses, registrations or authorizations of any supranational, national, regional, state or local Regulatory Authority or other regulatory agency, department, bureau or governmental entity, necessary to determine or set the pricing of a GVAX Licensed Therapeutic, and/or its reimbursement level by the relevant health authorities, providers or other funding institutions, at supranational, national, regional, state or local level.
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Related to Price and Reimbursement Approval

  • Pricing and Reimbursement Approval means, with respect to a Product, the approval, agreement, determination or decision of any Regulatory 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 country or jurisdiction.

  • 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.

  • Expense Reimbursement has the meaning set forth in Section 8.2(c).

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

  • Final Approval means the Court’s order granting final approval of the Settlement.

  • Special Approval means approval by a majority of the members of the Conflicts Committee.

  • 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.

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

  • CFIUS Approval means that any of the following shall have occurred: (a) the review period under the DPA commencing on the date that a CFIUS Notice is accepted by CFIUS shall have expired and Xxx, on the one hand, and Polaris, on the other hand, shall have received written notice from CFIUS to the effect that such review has been concluded and that either the Contemplated Transactions do not constitute a “covered transaction” under the DPA or there are no unresolved national security concerns, and all action under the DPA is concluded with respect to the Contemplated Transactions, (b) an investigation under the DPA shall have been commenced after such review period and CFIUS shall have determined to conclude all action under the DPA without sending a report to the President of the United States, and Xxx, on the one hand, and Polaris, on the other hand, shall have received written notice from CFIUS that either the Contemplated Transactions do not constitute a “covered transaction” under the DPA or there are no unresolved national security concerns, and all action under the DPA is concluded with respect to the Contemplated Transactions, or (c) CFIUS shall have sent a report to the President of the United States requesting the President’s decision and either (i) the President shall have announced a decision not to take any action to suspend or prohibit the Contemplated Transactions or, (ii) the period under the DPA during which the President may announce his decision to take action to suspend, prohibit or place any limitations on the Contemplated Transactions shall have expired without any such action being threatened, announced or taken.

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

  • Marketing Approval means all approvals, licenses, registrations or authorizations of any federal, state or local regulatory agency, department, bureau or other governmental entity, necessary for the manufacturing, use, storage, import, transport, marketing and sale of Licensed Products in a country or regulatory jurisdiction. For countries where governmental approval is required for pricing or reimbursement for the Licensed Product, “Marketing Approval” shall not be deemed to occur until such pricing or reimbursement approval is obtained.