MA Approval definition

MA Approval means approval, licenses, registrations, or authorizations of Regulatory Authorities in the applicable regulatory jurisdiction for the use, storage, import, transport and/or sale of a pharmaceutical, therapeutic and medical device product in such regulatory jurisdiction.
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MA Approval means each of the Governmental Approvals set forth at items 1, 3 and 4 on Schedule E-1, and all of the items set forth on Schedule E-2 and the Financial Regulatory Approval set forth in clause (i) of the definition of the UAE VARA Approval.
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Examples of MA Approval in a sentence

  • Subject to TILLOTTS’ timely payment of the payments and fees required under ARTICLE V, CPP will cause a Phase III clinical trial to be conducted at trial sites in Europe and North America directed to MA Approval by the EMA for the Primary Indication Disease in accordance with the protocol attached hereto as Exhibit B (the “Phase III Trial”).

  • If a Secondary Disease Development Plan is mutually agreed, then TILLOTTS must exercise Reasonable Diligence, at its sole expense, to implement and conduct the Secondary Disease Development Plan and obtain MA Approval for the Use of the Licensed Formulation to treat or prevent the Secondary Indication Disease.

  • The Interim MA Approval order shall have been entered within 30 days after the Petition Date, the Final MA Approval Order shall have been entered within 25 days after entry of the Interim MA Approval Order, the Overbid Procedures Order shall have been entered within 30 days after the Petition Date and the Approval Order shall been entered within 25 days after the Interim MA Approval Order.

  • To that end, on or before the date three months after the date on which MA Approval is obtained, TILLOTTS must make any necessary filings and requests for pricing and reimbursement approval in each country within the jurisdiction of that MA Approval.

  • If MA Approval is obtained based on those filings, then CPP will, at TILLOTTS’ expense, assign any resultant MA Approvals to TILLOTTS, at TILLOTTS’ expense, and TILLOTTS must reimburse CPP the cost of those submissions and filings promptly after TILLOTTS receives CPP’s statement, with supporting documentation, for the expenses thereof.

  • Notwithstanding the foregoing, in the event that OBIO or its designated Third Party holds the MA Approval in accordance with Section 5.1(b)(viii)(c), the Parties agree to reallocate the roles set forth in this Section 5.2 with respect to reporting of adverse events in compliance with the Applicable Laws separately in writing.

  • Such M&A Approval Request shall include the identity of the proposed acquiring or merging entity or entities, the expected relationship (if any) between Company and its Affiliates, Company’s shareholders, and Company’s management following such PTC Corporate Change, and the expected impact of such PTC Corporate Change on Company’s obligations under the Agreement.

  • TILLOTTS may elect not to submit an MA for the Licensed Formulation in the Licensed Territory if the JSC opines that the results of the Phase III Trial do not suggest that MA Approval is reasonably possible.

  • As MA Approval for the Licensed Formulation for Use in the Primary Indication Disease is received in each country of the Licensed Territory, TILLOTTS must diligently seek, file for and obtain pricing and reimbursement approval in each country of the EU-5 if within the jurisdiction of the MA Approval.

  • The foregoing license includes the limited right of TILLOTTS to refer to, and incorporate in, its filings in the Licensed Territory the Regulatory Dossier, as is necessary for TILLOTTS to obtain in the countries of the Licensed Territory MA Approval of the Licensed Formulation in the Licensed Field in accordance with the terms of ARTICLE IV below.

Related to MA Approval

  • 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.

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

  • FDA Approval means the approval of the United States Food and Drug Administration necessary for the marketing, distribution in interstate commerce and sale of the Initial Product (as defined in the Collaboration and License Agreement) in the United States.

  • 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:

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