Original Products definition
Examples of Original Products in a sentence
Medicis desires to collaborate with Impax regarding the research and development of (a) the next generation derivative of the Original Products, and (b) certain generic drugs in exchange for a share of the Gross Profit (as defined below), all on the terms and conditions of this Agreement.
The parties acknowledge and agree that Impax will obtain access to Confidential Information of Medicis with respect to the Original Products and any development work relating to the New Product, all of which may provide Impax with a competitive advantage.
If requested by a Party, the other terms under which a Party will manufacture Degronimids, Original Products and Phase I Completed Original Products will be set forth in one or more manufacturing and supply agreements to be entered into between the Parties (each a “Supply Agreement”).
Prior to Roche’s exercise of the Roche Option Right for a Target, C4T has responsibility for the manufacture of Degronimids, Original Products and Phase I Completed Original Products, subject to the oversight of the JRC or JDC, in accordance with the applicable Research Plan and Phase I Plan for such Target.
The Parties will share equally the Development Costs of the Phase I Studies (i.e. fifty percent (50%) will be paid by C4T and fifty percent (50%) will be paid by Roche) for Phase I Completed Original Products.
The Parties shall establish committees to oversee activities under this Agreement, a JRC to oversee the Research Plan activities under this Agreement, a JDC to oversee all activities of any Phase I Plans for a Phase I Completed Original Products and clinical development of any C4T Co-Dev Products, and a JCC to oversee co-Detailing activities for C4T Co-Dev Products for which C4T has exercised its C4T Co-Detail Option.
C4T shall have the right and responsibility for all regulatory affairs related to Phase I Completed Original Products, including filing the IND in the US for each such Phase I Completed Original Product.
Each Party will maintain scientific records, in sufficient detail and in sound scientific manner appropriate for Patent and regulatory purposes and in compliance with cGCP with respect to activities intended to be submitted in regulatory filings (including INDs and BLAs), which will fully and accurately reflect all work done and results achieved in the performance of the Development activities, Clinical Studies with respect to Original Products, Roche Products, C4T Co-Dev Products by such Party.
C4T, at its sole cost, shall report to appropriate Regulatory Authorities in accordance with local requirements all adverse events related to use of the Phase I Completed Original Products, as well as any Reversion Product.
C4T shall periodically provide to the JDC an update regarding development activities conducted by or on behalf of C4T with respect to Phase I Completed Original Products.