Common use of CMC Activities Clause in Contracts

CMC Activities. (i) Damora may request that Paragon perform CMC Activities for a particular Project Antibody in furtherance of a Research Program by selecting one (1) Project Antibody from such Research Program (the “CMC Project Antibody”) and a CMC Activities package from the options set forth on Exhibit D (the “CMC Activities Package”) and delivering written notice thereof to Paragon during the applicable Research Term. Paragon may update Exhibit D on a bi-annual basis by providing written notice thereof to Damora at least [***] prior to the end of the [***], and such updated Exhibit D shall only apply to new CMC Activities (i.e., CMC Activities for a Research Program that has not previously been the subject of CMC Activities, or CMC Activities for a CMC Substitution Project Antibody). Following receipt of such notice, if Paragon, in its sole discretion, agrees in writing to perform such CMC Activities for the CMC Project Antibody, then the Parties shall, through the JDC, mutually agree on an amendment to the Research Plan for such Research Program that shall include (1) the CMC Activities to be performed by Paragon for such CMC Project Antibody, (2) an updated Budget that includes the total fee corresponding to the mutually agreed CMC Activities Package set forth on Exhibit D (the “CMC Fee”) and any estimated Third Party Costs to be incurred by Paragon in the performance of the CMC Activities as part of the Development Fees, and (3) the estimated number of months until the completion of the CMC Activities corresponding to the mutually agreed CMC Activities Package as set forth on Exhibit D (the “CMC Estimated Timeline”). If CMC Activities are completed prior to the end of the CMC Estimated Timeline, the total CMC Fee related to the CMC Activities will still be payable to Paragon. Any portion of the CMC Fee that was not billed prior to completion of the CMC Activities shall be invoiced to Damora upon completion of the CMC Activities. If Damora requests any material changes to the scope of the CMC Activities, and Paragon, in its sole discretion, agrees to such changes, or if the Parties otherwise agree to changes to the scope of any CMC Activities, then the Parties shall, through the JDC, mutually agree on any amendment to the applicable Research Plan, which shall include such changes, and any adjustments to the CMC Fee (and corresponding CMC Monthly Fee) to account for the impact of such changes on Paragon’s costs. (ii) The JDC shall oversee the performance of the CMC Activities and shall have the authority to determine whether, based on the progress of such CMC Activities, the CMC Activities should be performed with respect to a different Project Antibody. If the JDC makes such determination, Damora shall have the one-time right, exercisable upon written notice within [***] of the JDC’s determination, to substitute the CMC Project Antibody with a different Project Antibody (such Project Antibody, the “CMC Substitution Project Antibody”). If ▇▇▇▇▇▇▇ agrees, in its sole discretion, to perform the CMC Activities for the CMC Substitution Project Antibody, the Parties shall update the applicable Research Plan, a new CMC Fee and CMC Estimated Timeline shall apply to such CMC Activities, and any unpaid portion of the CMC Fee for the CMC Activities for the original CMC Project Antibody shall be waived. If Paragon does not agree to proceed with CMC Activities for the CMC Substitution Project Antibody, the Parties shall amend the applicable Research Plan so that it does not require the performance of any CMC Activities or further payment of the CMC Fee.