Commercial Approval definition

Commercial Approval has the meaning set forth in Section 7.3.
Sample 1Sample 2
Commercial Approval means the date a Developed Product or a Commercialization Project is approved for commercial-scale manufacturing by MSSG and/or SPWR.
Sample 1Sample 2
Commercial Approval means the date, after the earlier of (A) Regulatory Approval for the Initial Product in the United States has been obtained and (B) the First Commercial Sale in the United States of the Initial Product, that Arena has delivered to Eisai the Launch Quantity of the Initial Product. “Launch Quantity” means the amount of the Initial Product ordered by Eisai under all Purchase Orders submitted no later than five days after such Regulatory Approval in the United States of the Initial Product is obtained, which Purchase Orders shall be submitted in accordance with the agreed Launch Forecast under Section 6.2 and shall not exceed the quantity of the Initial Product specified in the Launch Forecast. No payment under Section 7.3 will be made more than once. For the avoidance of doubt, in no event shall Eisai pay more than US$169,500,000 under this Section 7.3 (or US$149,500,000 in accordance with Section 7.3(b) above).
Sample 1

Examples of Commercial Approval in a sentence

  • If at the end of such period the Selling Member has not completed the Tag-along Sale, the Selling Member may not then effect a Transfer that is subject to this Section 6.04 without again fully complying with the provisions of this Section 6.04.

  • The Buyer does not have a right to demand from the Seller to issue an approval other than a Commercial Approval of the Seller.

  • As a consequence of the Commercial Approval and in accordance with the CVO agreement, the Company collects the CVO receivables converted in US dollars in 120 equal and consecutive installments.

  • A Commercial Approval of the Seller does not contain the data on the manufacturer of the product, which constitutes a trade secret of the Seller.

  • MOFCOM’s local counterparts, i.e. local Commercial Approval Authorities, are in charge of examining and approving establishment and modification of FIEs within their respective competence.

  • Commercial Approval Period: IMPORT: Approval to import a vehicle for Commercial Use will be three (3) months.

  • CVO receivables: The Company accrues interests since the Commercial Approval date and according to the rate agreed in the CVO agreement, as described in Note 1.2.a).

  • For further information please contact: Caithness Chamber of Commerce Naver House Naver Road Thurso Caithness KW14 7QA Telephone No: 00000 000000 E-mail: xxxx@xxxxxxxxxxxxxxxx.xxx Website: xxx.xxxxxxxxxxxxxxxx.xxx Yours faithfully Head of Commercial Approval DSRL ref: Tender No.: CTM Ref: 12454 Tenderer’s Name: Date Response Required: Name: Signature: The purpose of this Framework Agreement is for the provision of Letter of Compliance Support Services.

  • PURPOSE The purpose of this initiative is to develop and implement policies, common processes, and procedures to improve the accuracy and interoperability of health information so that there is a common statewide approach to managing health information that is shared across organizations OUTCOME(S) High quality, trusted health data – across the spectrum of health and social services – that can be readily accessed and used when and where needed.

  • Approvals are defined in a „Commercial Toolkit‟ and given in the Commercial Approval Meeting (CAM).


More Definitions of Commercial Approval

Commercial Approval means the date, after the earlier of (A) Regulatory Approval for the Initial Product in the United States has been obtained and (B) the First Commercial Sale in the United States of the Initial Product, that Arena has delivered to Eisai the Launch Quantity of the Initial Product. “Launch Quantity” means the amount of the Initial Product ordered by Eisai under all Purchase Orders submitted no later than five days after such Regulatory Approval in the United States of the Initial Product is obtained, which Purchase 85 ***Confidential Treatment Requested Orders shall be submitted in accordance with the agreed Launch Forecast under Section 6.2 and shall not exceed the quantity of the Initial Product specified in the Launch Forecast. No payment under Section 7.3 will be made more than once (except as otherwise provided for the milestone events in subsection (n) above). For the avoidance of doubt, in no event shall Eisai pay more than US$292,500,000 under this Section 7.3 (of which US$86,000,000 has been paid by Eisai prior to the 2nd Amendment Effective Date).
Sample 1

Related to Commercial Approval

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

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

  • 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.

  • Initial approval means authorization to admit students and enter into contractual agreements for clinical facilities. It is granted only after an application has been submitted, reviewed and a survey visit made by the Board. No students shall be admitted to the program until the institution has received written notification that initial approval has been granted. Failure to comply will delay initial approval.

  • Conditional approval means a time-limited status that results when an approved nursing education program has failed to maintain requirements as set forth in this chapter.

  • Development approval means a document from a governmental entity which authorizes the commencement of a development.

  • 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.

  • Governmental Approval is any consent, authorization, approval, order, license, franchise, permit, certificate, accreditation, registration, filing or notice, of, issued by, from or to, or other act by or in respect of, any Governmental Authority.

  • 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:

  • Regulatory Approval Application means any application submitted to an appropriate Regulatory Authority seeking any Regulatory Approval.

  • 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.

  • Approval Application means a BLA, NDA or similar application or submission for a Product filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological or pharmaceutical product in that country or group of countries.

  • 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.

  • Commercial applicator means a person who, by contract or for hire, engages in the

  • 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.

  • Regulatory Approval means any and all approvals (including MAA Approval, and Pricing and Reimbursement Approval, if applicable), licenses, registrations, permits, notifications and authorizations (or waivers) of any Regulatory Authority that are necessary for the manufacture, use, storage, import, transport, promotion, marketing, distribution, offer for sale, sale or other commercialization of a Product in any country or jurisdiction.

  • Final Approval Date means the date upon which Final Approval occurs.

  • Final Approval Order means the proposed Order Granting Final Approval to the Settlement, to be entered by the Court with terms to be agreed upon by the Parties and consistent with this Agreement.

  • Final Approval Hearing means the hearing before the Court where the Parties will request the Final Judgment to be entered by the Court approving the Settlement Agreement, the Fee Award, and the incentive award to the Class Representative.

  • Marketing Authorization 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.

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

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

  • Product Approval means the approval of a Governmental Authority necessary for the marketing and sale of the Product in a given country or regulatory jurisdiction, which may include the approval of an MAA (but shall not include any Pricing Approvals).

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

  • Government Approval means any authorization, consent, approval, waiver, exception, variance, order, exemption, publication, filing, declaration, concession, grant, franchise, agreement, permission, permit, or license of, from or with any Governmental Authority, the giving notice to, or registration with, any Governmental Authority or any other action in respect of any Governmental Authority.

  • Drug Approval Application means an application for Regulatory Approval required before commercial sale of a Product as a pharmaceutical product in a regulatory jurisdiction.