Existing Formulation definition

Existing Formulation means the formulation of the Product with Regulatory Approval from the FDA as of the Execution Date.
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Existing Formulation has the meaning ascribed thereto in Section 3.1(b)(iv).
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Existing Formulation means any Cream Formulation for Compound or Product that is claimed or covered by an Existing Patent or a Patent that claims priority thereto or shares a priority claim therewith.
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Examples of Existing Formulation in a sentence

  • ABARIS shall be responsible for pursuing regulatory approval for the Existing Formulation.

  • Specifically, PARI shall develop and verify the Test Inhaler for use in conjunction with the Existing Formulation so as to meet all or substantially all of the Inhaler Specifications in compliance with the Test Inhaler Development Plan and the Quality Standards.

  • PARI acknowledges that ABARIS has the right to proceed with the development and commercialization of the Existing Formulation instead of the Novel Formulation, and that in such case, ABARIS shall not be in breach of the Agreement for its failure to develop, test, pursue regulatory approval for or make any commercial sales of the Drug Product produced with the Novel Formulation.

  • PARI acknowledges that ABARIS has the right to proceed with the development and commercialization of the Novel Formulation instead of the Existing Formulation, and that in such case, ABARIS shall not be in breach of the Agreement for its failure to develop, test, pursue regulatory approval for or make any commercial sales of the Drug Product produced with the Existing Formulation.

  • Within [* * *], commencing with [* * *], Licensee shall provide Verastem with a report that contains the following information for the applicable [* * *], on an Existing Formulation Product-by-Existing Formulation Product and country-by-country basis: [* * *].

  • Each report shall also identify the date of First Commercial Sale of an Existing Formulation Product in each country in the Territory.

  • In no event shall any such announcement or release disclose any description of the novel, proprietary or technical aspects of this Agreement, the Development Activities, the results thereof, or the functional design, elements or components of the Existing Formulation, Novel Formulation, Drug Product, Test Inhaler or Inhaler without the prior written consent of the other Party.

  • PARI acknowledges that: (a) the development, manufacture, verification and delivery of the Test Inhalers according to the Test Inhaler Delivery Schedule is critical to the Phase II Clinical Study for the Existing Formulation; and (b) in setting the Test Inhaler Delivery Schedule, ABARIS has taken into account certain risks, some of which cannot be fully foreseen as of the Effective Date.

  • In such event, upon the request of either Party, the Parties shall negotiate in good faith an amendment to this Agreement to allow PARI to continue certain development activities for ABARIS’ Phase III Clinical Study related to the Existing Formulation.

  • With respect to an Existing Formulation Product in the Territory, in no event shall a deduction or deductions under Section 7.4(c)(i) and Section 7.4(c)(ii) reduce the royalty payment made by Licensee in respect of Net Sales of such Existing Formulation Product in the Territory in any Calendar Quarter to [* * *].


More Definitions of Existing Formulation

Existing Formulation means the one or more formulations for the Drug Product which are known or otherwise exist as of the Effective Date, including, without limitation, compositions, chemical structures, molecules, compounds, ingredients, formulas, recipes, chemical reactions, mixtures, technical information and know-how of the Drug Product which are necessary for producing, manufacturing or packaging the Drug Product.
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