Additional Formulation definition

Additional Formulation means any formulation of the Wakix Product other than its initial formulation under the LCA, [***], which the Parties may agree from time to Develop under this Agreement.
Additional Formulation means any formulation (other than a Product) directed to the treatment of PH1 using the LNP Technology and the Dicerna Materials necessary or useful to support Dicerna’s preclinical studies and clinical trials that is Manufactured by Protiva.
Additional Formulation means [***]

Examples of Additional Formulation in a sentence

  • For such purpose, RTU shall grant to such Back-Up Supplier a non-exclusive, royalty-free, license under the patent rights and know-how owned by RTU to manufacture Drug Substance and Drug Product, Authorized Generic or Additional Formulation solely as the Back-Up Supplier pursuant to the terms of this Agreement.

  • In the event the Parties cannot agree upon the Clinical Supply Price and the Commercial Supply Price for the Additional Formulation, SAG may use a qualified Back-Up Supplier for the manufacture of the Additional Formulation in accordance with Article 2.14.

  • Notwithstanding Article 2.2, SAG may elect to qualify a back-up supplier ("Back-Up Supplier") reasonably acceptable to RTU for any Authorized Generic, Additional Formulation or the supply of Drug Substance and Drug Product which acceptance shall not be unreasonably withheld, conditioned or delayed in the event that RTU is unable, or determines that it will be unable, to produce Drug Substance or Drug Product in accordance with SAG's Orders or Specifications, Authorized Generic or Additional Formulation.

  • Article 1.1. "Additional Formulation" means any and all formulations other than the Initial Formulation.

  • The Development timetable for the Development program of any replacement or substituted Additional Formulation shall, if applicable, acknowledge the impact of any delay or failure(s) in the Development of the terminated Product.

  • At any time after the Execution Date and during the Collaboration Term, either Party may propose the Development of an Additional Indication or Additional Formulation within the Territory for a Collaboration Compound under this Agreement.

  • Upon development of an Additional Formulation, the Developing Party shall promptly, and in any event within *** after ***, provide the Negotiating Party of notice of the development of the Additional Formulation, setting forth in reasonable detail the Additional Formulation (the “Formulation Notice”).

  • In the event of the Parties agree to Develop an Additional Indication or Additional Formulation, the CFDT or the applicable ROC shall promptly prepare and propose an amendment to the Long‑Term Commercialization [*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request.

  • Except as described in Sections 3.6(a), 3.6(b) and 3.6(c), with respect to the Licensed Formulations, an Additional Formulation and the Option Indications, as of the Second Restated Effective Date, neither Party shall be obligated to conduct any further technology transfer of the Licensed Technology.

  • At any time during the Term Ono may submit a written request to Progenics requesting the right to engage in research activities in the Territory with respect to any Additional Formulation.


More Definitions of Additional Formulation

Additional Formulation means any and all formulations other than the Initial Formulation.
Additional Formulation shall have the meaning set forth in Section 2.11(b).

Related to Additional Formulation

  • Additional Product means any Product identified as such in the Product Terms and chosen by Enrolled Affiliate under this Enrollment.

  • Formulation means the combination of various ingredients designed to render the product useful and effective for the purpose claimed, or the form of pesticide as purchased by users;

  • Additional Products means products, services and applications that are not part of the Services but that may be accessible, via the Admin Console or otherwise, for use with the Services.

  • Biological product means a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood

  • Biological Samples means any physical samples obtained from Study Participants in accordance with the Protocol for the purposes of the Study.