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 any MA approved, accepted or issued by a Regulatory Authority and the consequent grant of the right to sell the Licensed Formulation for use in the Licensed Field as a pharmaceutical or medicinal product, and corresponding or related approvals, licenses, registrations, or authorizations granted or issued by any Regulatory Authority. Portions herein identified by [*****] have been omitted pursuant to a request for confidential treatment under Rule 406 of the Securities Act of 1933, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission
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Examples of MA Approval in a sentence

  • TILLOTTS must pay to CPP: (a) [*****] on or before the date thirty days after the date of the MA Approval for the Primary Indication Disease in the EU; and (b) for each EU-5 Country, [*****] on or before the date thirty days after the earliest to occur in that EU-5 Country of the following: (i) the date of First Commercial Sale in that EU-5 Country; (ii) the date on which the applicable Regulatory Authority in that EU-5 Country first approves the pricing and reimbursement schedule for a Licensed Product.

  • In prosecuting each MA, TILLOTTS must exercise its commercially reasonable efforts to maximize the Reimbursed Price for Licensed Products in each dosage form for which MA Approval is received.

  • Upon request of either party, the parties must confer and consult with each other regarding the trademarks, service marks and other branding in the Licensed Territory (collectively, the “Marks”) that will be used for the commercialization, marketing and other promotion of any Licensed Product for which the filing for MA Approval in the Licensed Territory has been made; provided that TILLOTTS may make final decisions with respect to the Marks in the Licensed Territory.

  • Although the Secondary Indication Disease comprises an Indicated Disease, the decision to commence clinical studies directed to obtaining MA Approval for the Licensed Formulation in the Licensed Territory to treat or prevent the Secondary Indication Disease before the issuance or acceptance of an MA Approval of the Licensed Formulation is in TILLOTTS’ sole and absolute discretion subject, however, to Subsection 4.4.2 below.

  • 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.

  • 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.

  • 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.

  • CPP shall conduct and finance studies outside the Primary Indication Disease that are required by the EMA’s Pediatric Committee in the final, approved Pediatric Investigation Plan (as defined and described in the EMA’s pertinent rules and regulations) in order to obtain or maintain an MA Approval in the Primary Indication Disease.

  • 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.

  • 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.

  • 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.

  • 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).

  • 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.

  • FCC Approval means the FCC’s grant of the FCC Applications; 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.

  • 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).

  • 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.

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

  • 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.

  • 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;

  • 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.

  • 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.

  • Pricing Approval means such governmental approval, agreement, determination or decision establishing prices for a Licensed Product that can be charged and/or reimbursed in regulatory jurisdictions where the applicable Governmental Authorities approve or determine the price and/or reimbursement of pharmaceutical products.

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

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

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

  • 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;

  • 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).

  • 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.

  • 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).

  • Reimbursement Approval means an approval, agreement, determination, or other decision by the applicable Governmental Authority that establishes prices charged to end-users for pharmaceutical or biologic products at which a particular pharmaceutical or biologic product will be reimbursed by the Regulatory Authorities or other applicable Governmental Authorities in the Territory.

  • Development approval means any written authorization from a

  • 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.