Key Approval definition

Key Approval means any technical, medical, scientific or other license, registration, authorization or approval of any Agency (including any approval of a New Drug Application or Biologic License Application) necessary for the development, manufacture or commercialization of a pharmaceutical product in any regulatory jurisdiction.
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Examples of Key Approval in a sentence

  • Licensee acknowledges and agrees that it shall be permitted to use any such WHO Prequalification or SRA Approval solely to support any filings to an Agency for Key Approval to Commercialize Licensed Product in the Field in the Territory and shall in no event be permitted to use any such WHO Prequalification or SRA approval as the basis of, or for a reference to, support for any filings to an Agency for Key Approval to Commercialize Licensed Product outside the Field and/or outside the Territory.

  • Licensee will also report to MPP and Pfizer the date of first commercial sale of each Licensed Product, whether such sale is to a Public Purchaser, Governmental Authority or private entity or person and whether such sale is made under an emergency use authorization (“EUA”) or Key Approval within five (5) business days thereafter.

  • Licensee will also report to MPP and Shionogi the date of first commercial sale of each Licensed Product, whether such sale is to a Public Purchaser, Governmental Authority or private entity or person and whether such sale is made under an emergency use authorization (EUA) or Key Approval within five business days thereafter.

  • Licensee acknowledges and agrees that it shall be permitted to use any such WHO Prequalification or SRA approval solely to support any filings to an Agency for Key Approval to Commercialize Licensed Product in the Field in the Territory and shall in no event be permitted to use any such WHO Prequalification or SRA approval as the basis of, or for a reference to, support for any filings to an Agency for Key Approval to Commercialize Licensed Product outside the Field and/or outside the Territory.

  • Any Modification required in connection with a Franchisee Initiated Change to Key Approval will be deemed to be a Modification proposed by the relevant Franchisee under clause 14.2 and clause 14.2 shall apply to such deemed Modification.

  • The financial year is identical with the calendar year (1st of January until 31st of December).Annex A – Approval authorities‌ The UBS Group AG Organizational Regulations, including the Group’s Key Approval Authorities, must be applied by the CS Entities and their governing bodies in addition to this Annex, to the extent that they do not conflict with applicable legal provisions, rules and regulations.The powers contained in this annex must be exercised within the parameters set by the Group.

  • Using the Remember choice checkbox you can save your selection for future messages.If you are using a key for the first time, there are conflicting Encryption Preferences, or if Always show the encryption keys for approval is selected in the Security section of KMail’s configura- tion dialog, the Encryption Key Approval dialog will appear; here, you can select different keys for the recipients and can set the Encryption Preference for each recipient.

  • In the context of deep neural networks, it is typically performed by either 2D-CNNs [25, 51, 12, 53,12, 32, 63] or 3D-CNNs [48, 7, 20, 13].

  • This exception is available only for a transfer to the decreased borrower’s spouse.HB-3-3560 Exhibit 7-1Summary of Key Approval Requirements by Type of Transfer ** The project being transferred must be in compliance or have a Rural Development approved workout plan in place and on schedule.

  • Licensee will also report to MPP and Pfizer the date of first commercial sale of each Licensed Product, whether such sale is to a Public Purchaser, Governmental Authority or private entity or person and whether such sale is made under an emergency use authorization (“EUA”) or Key Approval within five (5) business daysthereafter.

Related to Key Approval

  • 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.

  • 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.

  • 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.

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

  • FCC Approval means the FCC’s grant of the FCC Applications, including any grants by operation of law; provided that the possibility that an appeal, request for stay, or petition for rehearing or review by a court or administrative agency may be filed with respect to such grant, or that the FCC may reconsider or review such grant on its own authority, shall not prevent such grant from constituting FCC Approval for purposes of the Plan.

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

  • 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:

  • 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).

  • 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;

  • 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.

  • 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.

  • Preliminary Approval means the Court’s Order Granting Preliminary Approval of the Settlement.

  • 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;

  • 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.

  • Prior Approval means written ap- proval by an authorized official evi- dencing prior consent.

  • FDA Approval means the approval, license, clearance or authorization of the FDA necessary for the marketing and sale of a product for human use in the United States.

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

  • 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.

  • 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.

  • Works Approval means this Works Approval numbered W5914/2015/1 and issued under the Act; and

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

  • 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.

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

  • Board Approval means the affirmative vote of a majority of the Disinterested Directors of the Company or a unanimous written consent of the Board of Directors of the Company duly obtained in accordance with the applicable provisions of the Company's certificate of incorporation, bylaws and applicable law.

  • FCC Consent means action by the FCC granting its consent to the assignment of the FCC Licenses to Buyer as contemplated by this Agreement.

  • Registry Operator Approval means the receipt of each of the following: (A) the affirmative approval of the Applicable Registry Operators whose payments to ICANN accounted for two-­‐thirds of the total amount of fees (converted to U.S. dollars, if applicable, at the prevailing exchange rate published the prior day in the U.S. Edition of the Wall Street Journal for the date such calculation is made by ICANN) paid to ICANN by all the Applicable Registry Operators during the immediately previous calendar year pursuant to the Applicable Registry Agreements, and (B) the affirmative approval of a majority of the Applicable Registry Operators at the time such approval is obtained. For the avoidance of doubt, with respect to clause (B), each Applicable Registry Operator shall have one vote for each top-­‐level domain operated by such Registry Operator pursuant to an Applicable Registry Agreement.