MA Holder definition

MA Holder means the entity that holds the marketing authorization for the Combination Product in a given country.
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MA Holder means, on a country by country basis within the Territory, the Party (or its Affiliate or designee under its control) that holds the Regulatory Approval required for the Commercialization of the Product in such country.
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MA Holder means an entity holding one or more of the Marketing Authorizations listed in Schedule 2 and MA Holders means several or all of such persons;
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Examples of MA Holder in a sentence

  • The NHS pharmacy can dispense any brand of Candesartan or Carvedilol currently in stock.An example of a Candesartan MA Holder is Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, BN22 9AG and the MA number is PL 00289/1176.An example of a Carvedilol MA Holder is Teva UK Limited, Brampton Road, Hampden Park, Eastbourne, BN22 9AG and the MA number is PL 00289/0548.

  • In the case of a Product approved in the United States under the PHS Act (or, in the case of a country in the Territory other than the United States, any similar Law), to the extent permitted by applicable Law, the MA Holder, as the sponsor of the application for the Product, will be the “reference product sponsor” under the PHS Act.

  • The MA Holder will give written notice to the other Party of receipt of a Biosimilar Notice received by MA Holder with respect to a Product, and MA Holder will consult with the other Party with respect to the selection of any Patent Rights to be submitted pursuant to 42 U.S.C. § 262(l) (or any similar law in any country of the Territory outside the United States); provided that the MA Holder will have final say on such selection of Patent Rights.

  • It defines the individual responsibilities of the MA Holder, the Contract Giver and the Contract Acceptor, and in particular defines who is responsible for the GMP aspects of manufacturing and specifies the way in which the Qualified Person releases product batches for the market in agreement with the FDA Marketing Authorization.

  • In connection with any action brought by such other Party under this Section 10.4.6, such other Party, upon the MA Holder’s request, will reasonably cooperate and will cause its Affiliates and use Commercially Reasonable Efforts to cause all Third Party Licensors to reasonably cooperate with MA Holder in any such action, including timely commencing or joining in any action brought by MA Holder under this Section 10.4.6.

  • NAME OF THE MARKETING AUTHORISATION HOLDER Pfizer Europe MA EEIG (as MA Holder logo) 3.

  • By the fifteenth calendar day of the month following the end of each quarter, the MA Holder shall submit (5) copies of a quarterly technical report.

  • The Non-MA Holder Party shall support the MA Holder, as may be [****] requested by the MA Holder, in obtaining and maintaining Regulatory Approvals for the Licensed Products in such country and supporting activities, including providing all documents or other materials as may be necessary or reasonably useful for the MA Holder to obtain and maintain Regulatory Approvals for the Licensed Products in such country and attending meetings with Regulatory Authorities with respect thereto in such country.

  • The MA Holder shall be solely responsible for preparing and making all reports, submissions and responses to Regulatory Authorities concerning the Initial Product, any Elected Additional Product and any New Presentation, including price reporting with respect to any of the foregoing required by applicable Law, each in conformance with applicable Law.

  • Without limitation to the foregoing, the MA Holder shall immediately inform the Non-MA Holder in the event that the MA Holder receives any notice from a Regulatory Authority relating to any finding of deficiency, finding of non-compliance, investigation, penalty for corrective or remedial action or of any other compliance or enforcement action related to a Product or any New Presentation.


More Definitions of MA Holder

MA Holder means, (a) with respect to the United States, [****] and (b) with respect to each country in the OUS Territory, [****].
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MA Holder has the meaning set forth in Section 3.5.
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Related to MA Holder

  • data holder means a legal person or data subject who, in accordance with applicable Union or national law, has the right to grant access to or to share certain personal or non-personal data under its control;

  • FTR Holder means the PJM Member that has acquired and possesses an FTR.

  • Note A Holder means with regards to any A Note, the related Initial Note Holder or any subsequent holder of such A Note, as applicable.

  • Series A Holder means a Record Holder of the Series A Preferred Units.

  • Transferring Stockholder has the meaning assigned to such term in Section 3.4(a).

  • Participating Stockholder means a “Participating Stockholder” under the HBB Stockholders’ Agreement, HY Stockholders’ Agreement and NACCO Stockholders’ Agreement, to the extent the Partnership owns HBB Class B Shares, HY Class B Shares or NACCO Class B Shares. A Partner shall cease to be a Participating Stockholder under this Agreement and shall be deemed to be a Former Partner immediately prior to any event or lapse of time that causes such Partner to no longer be a “Participating Stockholder” under such applicable stockholders’ agreements.

  • 10% Stockholder means the owner of stock (as determined under Code Section 424(d)) possessing more than ten percent (10%) of the total combined voting power of all classes of stock of the Corporation (or any Parent or Subsidiary).

  • Class A Holder means the Person in whose name a Class A Certificate is registered in the Certificate Register.

  • Transferring Shareholder has the meaning set out in Section 6.1; and

  • Class B Stockholder means (i) the registered holder of a share of Class B Common Stock at the Effective Time and (ii) the initial registered holder of any shares of Class B Common Stock that are originally issued by the Corporation after the Effective Time.

  • Ticket Holder means any individual possessing, holding or using a Ticket, including (without limitation) the Ticket Purchaser or any person to whom the Ticket was issued or transferred;

  • Existing Holder means a Broker-Dealer or any such other Person as may be permitted by the Corporation that is listed as the holder of record of shares of AMPS in the Stock Books.

  • Eligible Shareholder means an existing or new investor of the Company that is eligible at the ACD’s discretion to invest in the Class X Shares upon entering into an agreement with the ACD and fulfilling the eligibility conditions set by the ACD from time to time.

  • Octopus Holder means a user of an Octopus who may be an AAVS Account Holder or who has linked his/her Octopus to an AAVS Account in the name of one of his/her family members or friends;

  • Major Stockholder means any such Person.

  • Electing Holder means any holder of Registrable Securities that has returned a completed and signed Notice and Questionnaire to the Company in accordance with Section 3(d)(ii) or 3(d)(iii) hereof.

  • Majority Stockholder means, collectively or individually as the context requires, TPG Capital, L.P., Apollo Global Management, LLC and/or their respective affiliates.

  • Deceased Holder Not applicable.

  • Designated Holder means the Holder of Note A-1.

  • Participating Holder means any Holder of Registrable Securities that has returned a completed and signed Notice and Questionnaire to the Company in accordance with Section 2(b) hereof.

  • Qualifying Holder shall have the meaning ascribed thereto in Section 12 hereof.

  • Majority Shareholder means a holder of more than fifty percent (50%) of the outstanding stock of the Company, or if no person holds more than fifty percent (50%) of the outstanding stock of the Company, the holder of a plurality of the outstanding stock of the Company.

  • Principal Stockholder means any person who individually or in concert with his spouse and

  • Major Holder means with respect to any registration the Holder that, together with its Affiliates, includes the largest number of Registrable Securities in such registration.

  • Selling Stockholder means any Stockholder owning Registrable Shares included in a Registration Statement.

  • Eligible Stockholder means a person who has either (1) been a record holder of the shares of common stock of the Corporation used to satisfy the eligibility requirements in Section 3.2(d) continuously for the required three-year period or (2) provides to the Secretary of the Corporation, within the time period referred to in Section 3.2(e), evidence of continuous Ownership of such shares for such three-year period from one or more securities intermediaries.