Existing Formulation definition
Examples of Existing Formulation in a sentence
Nothing in this Agreement shall prevent, restrict or limit ABARIS from developing and commercializing the Existing Formulation or such Drug Product apart from PARI, and PARI shall not acquire any interest or have any claim to the Existing Formulation or such Drug Product by virtue of this Agreement.
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 [* * *].
Each report shall also identify the date of First Commercial Sale of an Existing Formulation Product in each country in the Territory.
ABARIS shall be responsible for pursuing regulatory approval for the Existing Formulation.
PARI shall cooperate with ABARIS in ABARIS’ efforts to pursue regulatory approval of the Existing Formulation, Novel Formulation and Drug Products.
PARI shall perform the Existing Formulation Analysis as set forth in the Test Inhaler Development Plan and in compliance with the Quality Standards.
For clarity, except as provided in Section 2.22.2(d) below, PARI shall not acquire or claim any right, title or interest in the Intellectual Property relating to the Existing Formulation.
Licensee shall pay to Verastem the non-refundable, non-creditable milestone payments set forth in Table 7.2 below (each, a “Regulatory Milestone Payment”) upon the first achievement by Licensee or its Affiliates or Sublicensees of the corresponding regulatory milestone events set forth in Table 7.2 below (each a “Regulatory Milestone Event”) for an Existing Formulation Product [* * *].
The Parties acknowledge that the Test Inhaler Development Plan in Exhibit K sets forth an Approved Budget for the Existing Formulation Analysis, and the Inhaler Development Plan in Exhibit A sets forth an Approved Budget for each of the Inhaler development options.
The Parties shall not implement the Program A Commercialization Strategy until ABARIS determines that the results of the Phase III Clinical Study related to the Existing Formulation are positive.