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 Product pursuant to an NDA, (2) a person owning or controlling the ability to enforce the patent(s) listed in the FDA Publication “Approved Drug Products with Therapeutic Equivalence Evaluations” (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 licenses, licensors, successors, and assigns of each of the foregoing.
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Examples of NDA Holder in a sentence

  • This remedy, in addition to facilitating the court’s access to information about the Commission’s views, may also make the process more public and thereby may prompt other generic drug manufacturers (or other interested parties) to participate.Paragraph IV addresses privateagreements in which an ANDA First Filer agrees with the NDA Holder not to enter the market.

  • So, the percentage welfare impact (direct) resulting from fuel price change is almost the same.

  • Paragraph II.A. bars agreements in which the first company to file an ANDA agrees with the NDA Holder not to relinquish its right to the 180-day exclusivity period (as interpreted by the courts at the time of the agreement).

  • In particular substantial competitive concerns could arise from an agreement in which a generic company (other than the ANDA First Filer) agrees with the NDA Holder to refrain from marketing a non-infringing product.

  • An NDA Holder can also submit a patent for listing in the Orange Book following the approval of its NDA as long as the submission for listing is made to the FDA within thirty (30) days of the patent being issued by the USPTO.

  • In such cases, tank gauging and corresponding generation of documentation can often be performed in a hurried fashion and the onus is always on the ship’s officers to ensure errors are not made.

  • Thus, the order requires that themarket, its 180-day exclusivity right is not extended, and the Commission is provided notice.Paragraph II’s focus on agreementsbetween an NDA Holder and the ANDA First Filer does not mean that the Commission believes that there is no risk of competitive harm in other types of agreements.

  • In addition, for method of use patents, the NDA Holder must submit to the FDA a description of each indication covered by the patent.

  • What is/are the date(s) on the registered mail receipt(s) (i.e., the date(s) the NDA holder and patent owner(s) received notification):Date(s): Paragraph IV notification to the NDA Holder was received by Pfizer, Inc.


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 (3) the predecessors, subsidiaries, divisions, groups and affiliates controlled by, controlling, or under common control with any of
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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

  • 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 forth in Section 5.2(a).

  • 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.

  • 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(a)(i) or 3(a)(ii) 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, collectively, (i) the Sponsor and (ii) any affiliate or successor of a person referenced in clauses (i) and (ii) of this definition.

  • 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, except that, solely for the purpose of giving any consent, request or waiver pursuant to this Agreement, the interest evidenced by any Class A Certificate registered in the name of the Transferor, Servicer, or any Person actually known to an Authorized Officer of Trustee to be an Affiliate, the Transferor, or Servicer, shall not be taken into account in determining whether the requisite percentage necessary to effect any such consent, request or waiver shall have been obtained.

  • 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;