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 has been obtained and (B) the First Commercial Sale of the Initial Product by Eisai or any of its Affiliates to a Third Party in the Territory, 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 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 7.2 will be made more than once. For the avoidance of doubt, in no event shall Eisai pay more than US$160,000,000 under this Section 7.2 (or US$140,000,000 in accordance with Section 7.2(a) above).
Sample 1

Examples of Commercial Approval in a sentence

  • 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).

  • CVO receivables are expressed in USD and they accrue LIBOR interest at a 5% rate.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.During the nine-month period ended September 30, 2020 and 2019, collections of CVO receivables amounted to 4,306,447 and 8,695,195, respectively.

  • If First Commercial Approval is not obtained by the Performance Deadline, all RSUs in this Award shall be cancelled and forfeited to the Company.

  • If Second Commercial Approval is not obtained by the Performance Deadline, the difference between the maximum number of RSUs and target number of RSUs in this Award shall be cancelled and forfeited to the Company.

  • 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.


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 Confidential 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 any written authorization from a

  • 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:

  • 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, with respect to the Licensed Product in any country or jurisdiction, all approvals (including, where required, pricing and reimbursement approvals), registrations, licenses or authorizations from the relevant regulatory authority in a country or jurisdiction that is specific to the Licensed Product and necessary to market and sell such Licensed Product in such country or jurisdiction.

  • Final Approval Date means the date on which the Court enters its Order and Judgment approving the Settlement.

  • Final Approval Order means the entry of the order and final judgment approving the Settlement Agreement, implementing the terms of this Settlement Agreement, and dismissing the Class Action with prejudice, to be proposed by the Settling Parties for approval by the Court, in substantially the form attached as Exhibit D hereto.

  • 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 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).

  • 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 or use of a Licensed Product as a drug in a regulatory jurisdiction.