IV Formulation definition

IV Formulation means a formulation of the Product for intravenous administration.
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IV Formulation means the formulation of the Product for intravenous administration. “***” means an application that is filed with the *** to obtain Product Approval for the Product in the ***.
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Examples of IV Formulation in a sentence

  • Except for costs and expenses of the ITP Study related to the treatment of ITP with the IV Formulation, Licensee shall be solely responsible for all costs and expenses incurred by Immunomedics pursuant to the Immunomedics R&D Activities Plan.

  • The Parties anticipate using (but are not obligated to use) a single source of supply for future clinical and commercial supplies of Drug Substance for the Subcutaneous Formulation and the IV Formulation, provided however, that the Parties currently contemplate that each Party shall enter into its own supply agreement with such Third Party manufacturer.

  • For the avoidance of doubt, Otsuka has the right, but not the obligation, to Develop any New IV Formulation in the Otsuka Territory.

  • In addition, at the request of the non-conducting Party, the Party conducting Development of a New IV Formulation in its Territory shall provide to the non-conducting Party all data and information generated from such Development (including Clinical Studies) of the New IV Formulation.

  • If at any time during the term of this Agreement (i) Immunomedics desires a license to the Subcutaneous Formulation to Develop, Commercialize or Manufacture the Product for use in the Oncology Field or (ii) Licensee desires a license to the IV Formulation to Develop, Commercialize or Manufacture the Product for use in the Field, the Parties shall negotiate in good faith with respect to the terms and conditions of such license.

  • If, subsequent to Takeda’s payment of the Regulatory Approval Milestone Payment to TBIL and during the five (5)-year period following First Commercial Sale of an IV Formulation [***], a Regulatory Authority notifies Takeda that a CVOT is required with respect to such IV Formulation [***], TBIL agrees to reimburse Takeda in the amount of [***] of the costs and expenses, including, without limitation, Takeda’s Internal Expenses and Third Party Expenses, of such CVOT up to TBIL having reimbursed Takeda [***].

  • If a Party Develops a New IV Formulation in its Territory, it shall provide an update (by means of a slide presentation or otherwise) summarizing its Development activities for such New IV Formulation, including the results of such activities and the status of each pending and proposed Regulatory Filing for such New IV Formulation, at each regularly scheduled JCC meeting.

  • Each Party will have the right, [***], to Develop any New IV Formulation of any Product in its respective Territory, including conducting Clinical Studies of a Product in any New IV Formulation.

  • If the non-conducting Party wishes to use the data and results generated from the conducting Party’s Development (including Clinical Studies) of the New IV Formulation for the Development, including Regulatory Approval, of such New IV Formulation in the non-conducting Party’s Territory, the non-conducting Party shall (a) so notify the conducting Party, (b) [***].

Related to IV Formulation

  • 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;

  • 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.

  • Pharmaceutical Product shall have the meaning ascribed to such term in Section 3.1(hh).

  • ingredient means any substance, including a food additive used in the manufacture or preparation of food and present in the final product, possibly in a modified form;