Fixed Dose definition
Examples of Fixed Dose in a sentence
For clarity, Lilly has the unilateral right to initiate a recall, withdrawal or market notification with respect to a Fixed Dose Combination Product.
Except as set forth in Section 3.2.1, Lilly shall conduct Development Activities in the Reserved Field only for Lilly Product that includes the current Commercialization Compound or with such other Compound as may be necessary or useful to formulate a Fixed Dose Combination Product combining such Compound and the applicable Lilly Target Molecule in final dosage form.
With respect to Fixed Dose Combination Products, on a Fixed Dose Combination Product-by-Fixed Dose Combination Product and country-by-country basis during the Royalty Term applicable to such Fixed Dose Combination Product and such country, Lilly shall pay Licensee a [***] royalty on Net Sales of such Fixed Dose Combination Product.
Novartis agrees to provide reasonable collaborative assistance to resTORbio, at the rates set forth in Article 4, in connection with the regulatory process involving the Fixed Dose Combination as may be required to address aspects of referenced materials to which resTORbio will not have access.
Prior to the 40 Patient Trial Date with Fixed Dose Combination, resTORbio must obtain Novartis’ written consent prior to sublicensing its rights under this Agreement, to the extent that such rights include rights to research, Develop, or Commercialize a Fixed Dose Combination.
Subject to Sections 6.2(c) and 6.2(d), Company shall be solely responsible for and have sole authority Confidential 63 with respect to, at its own expense, all aspects of the Commercialization of the Products in the Company Field in the Company Territory, including all Fixed Dose Combination Products Developed by Company in the Company Field.
Company shall have the right to audit the performance of any Third Party suppliers, contractors and subcontractors used by TESARO in the Manufacturing of Single Agent Products, Compound API or Fixed Dose Combination Products, as applicable, for use by either Party in the Company Field in accordance with this Agreement.
For clarity, (i) Seagen’s right to Develop and Commercialize any RC48 Fixed Dose Combination Product is expressly conditioned on the [ * ] terms for such RC48 Fixed Dose Combination Product having been determined in accordance with this Section 2.7(d), (ii) without limiting the foregoing clause (i), Seagen agrees to [ * ], and (iii) [ * ].
SpringWorks shall only use such BeiGene Compound for the conduct of the Fixed Dose Formulation Work.
Between the Effective Date and the effective date of the API Supply Agreement, TESARO shall use reasonable efforts to Manufacture and supply to Company all of Company’s requirements of Compound API for use (i) in CMC Development activities of Company conducted pursuant to this ARTICLE 7 and (ii) in Manufacturing by Company of Fixed Dose Combination Products for use in Clinical Trials conducted by Company pursuant to this Agreement, as set forth on Exhibit 7.1(a).