Novel Formulation definition

Novel Formulation means any new, novel or proposed formulation which: (a) is different than the Existing Formulation; and (b) results from the activities conducted under this Agreement by PARI or ABARIS, individually or jointly with one another or third parties.
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Examples of Novel Formulation in a sentence

  • In the event that ABARIS conducts a Phase III Clinical Study related to the Novel Formulation of the Drug Product, the Parties shall discuss and develop a written Program B Commercialization Strategy for the commercialization of the Drug Product made using the Novel Formulation and the Inhaler adapted to deliver such Drug Product.

  • 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.

  • Subject to agreement between PARI and ABARIS on the supply of the Drug Product for such Phase III Study and Commercial supply under Section 3.7.2, PARI shall use the Novel Formulation to produce a commercially reasonable quantity of samples of the Drug Product in order to fully meet the Novel Formulation Specifications and the applicable Quality Standards.

  • 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 shall complete the portion of the Feasibility Assessment set forth in Section 3.2(a) above within [*] after ABARIS’ written notice under Section 3.1 to begin the Novel Formulation Development Activities.

  • Upon the written request of ABARIS, and in accordance with a reasonable delivery schedule to be agreed upon by ABARIS and PARI, PARI shall deliver to ABARIS a requested quantity of Drug Product made using the Novel Formulation for ABARIS’ Phase III Clinical Study for the Novel Formulation.

  • PARI shall provide written documentation relating to the details of the Novel Formulation, its development and selection, methods, assays, and other pertinent documentation for ABARIS’ use in furtherance of the development of the program.

  • Upon ABARIS’ request, in accordance with Section 3.4, PARI shall continue with the Novel Formulation Development Activities pursuant to the terms and conditions of this Agreement.

  • Subject to the terms and conditions of this Agreement, [*] hereby grants to [*] a transferable, sub-licensable, worldwide, exclusive license, under the Novel Formulation Intellectual Property for purposes outside the Field which do not compete, directly or indirectly, with [*] worldwide commercialization of any drug in the Field which includes an anesthetic within the same pharmacological family or category as lidocaine.