NDA Holder definition

NDA Holder means a party to a Brand/Generic Settlement that controls the NDA for the Subject Drug Product or has the exclusive right to distribute the Branded subject Drug Product in the United States.
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NDA Holder means the party to a Branded/Generic Agreement or a Branded/Generic Supply Agreement that controls the NDA for the Subject Drug Product, or has the exclusive right to distribute branded Subject Drug Product.
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NDA Holder means: (1) the person that received FDA approval to market a Drug Product pursuant to an NDA, (2) a person owning or controlling the ability to enforce the patent(s) listed in the Orange Book in connection with the NDA, or (3) the predecessors, subsidiaries, divisions, groups and affiliates controlled by, controlling, or under common control with any of the entities described in subparagraphs (1) and (2) above (such control to be presumed by direct or indirect share ownership of 50% or greater), as well as the licensees, licensors, successors, and assigns of each of the foregoing.
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Examples of NDA Holder in a sentence

  • If, during its ownership of the NDA, the NDA Holder (defined above in Section 8.02(b)) receives any information that would lead a Party to reasonably conclude that a recall is required or warranted, the NDA Holder shall, within twenty-four (24) hours, notify the other Party of that information in sufficient detail to allow the Parties to comply with any and all applicable Laws.

  • The NDA Holder shall also keep the JSC apprised on a regular basis of drug safety matters.

  • Recognizing that THERAVANCE shall be the NDA Holder for a period after First Commercial Sale, until the time of NDA transfer to ASTELLAS, THERAVANCE agrees to fulfill all responsibilites and obligations of an NDA holder or to execute and file with FDA appropriate instuments delegating some or all of such responsibitiles and obligations to ASTELLAS.

  • The Party controlling a Defensive Action agrees to keep the other Party reasonably and periodically informed of all material developments in connection with any such Defensive Action in the Mylan Territory (including the filing of any related declaratory judgment action that the Product does not infringe the applicable Patent(s) of the NDA Holder), and Revance agrees to keep Mylan informed of any similar actions or proceedings in the Revance Territory.

  • The NDA Holder shall promptly notify the other Party of any material actions to be taken by the NDA Holder with respect to any recall or market withdrawal or other corrective action related to the Licensed Product and, where feasible given statutory or regulatory timelines for taking such action, shall permit the other Party a reasonable opportunity to consult with the NDA Holder with respect thereto prior to such action.


More Definitions of NDA Holder

NDA Holder is defined as: An "Applicant" as defined in 21 CFR Part 314.3(b), for regulatory approval of the Product in any regulatory jurisdiction, including a holder of a foreign equivalent thereto.
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NDA Holder means: (1) the party that received FDA approval to market a Drug Product pursuant to an NDA, (2) a party owning or controlling enforcement of the patent(s) listed in the Approved Drug Products With Therapeutic Equivalence Evaluations (commonly known as the “FDA Orange Book”) in connection with the NDA, or
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NDA Holder means the party to a Branded/Generic Supply Agreement or a Branded/Generic Agreement who Controls the branded version of the Subject Drug Product.
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NDA Holder shall have the meaning set forth in Section 8.02(b).
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Related to NDA 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.

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

  • 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).

  • 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.

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

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

  • Major Stockholder means any such Person.

  • 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;

  • 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.

  • 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.

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

  • or "Holder The Person in whose name a Certificate is registered in the Certificate Register, except that a Disqualified Organization or a Non-United States Person shall not be a Holder of a Residual Certificate for any purposes hereof and, solely for the purposes of giving any consent pursuant to this Agreement, any Certificate registered in the name of the Depositor or the Master Servicer or any Affiliate thereof shall be deemed not to be outstanding and the Voting Rights to which it is entitled shall not be taken into account in determining whether the requisite percentage of Voting Rights necessary to effect any such consent has been obtained, except as otherwise provided in Section 11.01. The Trustee and the NIMS Insurer may conclusively rely upon a certificate of the Depositor or the Master Servicer in determining whether a Certificate is held by an Affiliate thereof. All references herein to "Holders" or "Certificateholders" shall reflect the rights of Certificate Owners as they may indirectly exercise such rights through the Depository and participating members thereof, except as otherwise specified herein; provided, however, that the Trustee and the NIMS Insurer shall be required to recognize as a "Holder" or "Certificateholder" only the Person in whose name a Certificate is registered in the Certificate Register.

  • Major Shareholder means a shareholder who directly or indirectly holds 10% or more of the voting rights.

  • 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.

  • 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.

  • Controlling Shareholder means any shareholder owning more than fifty

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

  • Initiating Holder has the meaning set forth in Section 2.01(a).

  • 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.

  • Significant Stockholder means Allied Irish Banks, p.l.c., a limited liability company incorporated under the laws of Ireland having its registered office at Bankcentre, Ballsbridge, Dublin 4, Ireland, and any successor thereto.

  • ² Shareholder means a person who owns shares in the company and is actively involved in the management of the company or business and exercises control over the company.

  • U.S. Holder means a beneficial owner of units, Class A ordinary shares or warrants that is for U.S. federal income tax purposes (i) an individual citizen or resident of the United States, (ii) a corporation (or other entity treated as a corporation for U.S. federal income tax purposes) that is created or organized (or treated as created or organized) in or under the laws of the United States, any state thereof or the District of Columbia, (iii) an estate the income of which is subject to U.S. federal income taxation regardless of its source, or (iv) a trust if (A) a court within the United States is able to exercise primary supervision over the administration of the trust and one or more U.S. persons have the authority to control all substantial decisions of the trust, or (B) it has in effect under applicable U.S. Treasury regulations a valid election to be treated as a U.S. person; and

  • 10% Shareholder means a person who owns, directly or indirectly, stock possessing more than 10% of the total combined voting power of all classes of stock of the Company or any Parent or Subsidiary of the Company. Indirect ownership of stock shall be determined in accordance with Code Section 424(d).

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

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