CMC Activities Clause Samples

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 A...

CMC Activities. Notwithstanding anything herein to the contrary (but subject to the last two sentences of this Section 4.4), with respect to CMC responsibilities, (i) Loxo shall be responsible for ongoing CMC Activities related to the capsule or liquid formulation of a Licensed Product pursuant to the applicable Development Plan, (ii) Bayer shall be responsible for CMC Activities related to a tablet formulation of any LOXO-101 Product pursuant to the applicable Development Plan and, (iii) following the transition of Manufacturing and CMC Activities to Bayer as set forth in Section 10.1, Bayer shall be solely responsible for CMC Activities for Licensed Compounds and Licensed Products pursuant to the applicable Development Plan. For clarity, the provisions of Section 3.6.3 with respect to Loxo’s final decision-making authority shall not apply to CMC Activities following the transition of such activities to Bayer as set forth in Section 10.1. [***] Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Confidential treatment has been requested with respect to this information. [***]

CMC Activities. (a) The first sentence of Section 4.2 of the Agreement shall be deleted in its entirety and replaced with the following: “NN shall pay ZGEN the milestone fees set forth in Sections 4.2(a) through 4.2(d) and 4.2(i), subject to utilization of any credits provided in Sections 4.5(b) and 5.5.” (b) A new Section 3.12 shall be added to the Agreement as follows:

CMC Activities. As part of winding-down the Studies and the manufacturing activities related thereto, Merck will discontinue all activities related to drug substance-, formulation- and analytical development of all Compounds and Follow-on Compounds. Discontinuing formulation development includes Merck’s short term stability studies after 9-months stability data become available from Alphalytik. Upon Idera´s request, and subject to Idera´s willingness to take on all subsequent costs and duties associated with such stability studies, Merck is willing to provide reasonable assistance to Idera to enable continuation of the ongoing stability studies beyond the 9-month timepoint. Idera will inform Merck within [**] days after the Effective Date if it wants to assume the responsibility of conducting the stability studies beyond 9 months. In any event, Merck shall not be liable to Idera for any failure of Idera to enter into a contract with Alphalytik. Furthermore, Merck´s assistance will be limited to reasonable efforts to establish contact and mediate a handover within [**] months following the Effective Date, but shall not include any continuation of technical activities such as laboratory work.

CMC Activities. XOMA shall be responsible for the performance of CMC Activities for Bulk Drug Substance, including associated regulatory activities, in accordance with the Manufacturing Plan. Prior to XOMA’s exercise of the Cardiometabolic Indications Option and thereafter if XOMA does not exercise such option, Servier shall reimburse XOMA for all documented costs incurred by XOMA in performing such activities in accordance with the Manufacturing Plan and the budget contained therein, as provided in Article 3. If XOMA exercises the Cardiometabolic Indications Option, XOMA shall reimburse certain of these costs as provided in Section 8.5, and the Parties shall thereafter share such costs for the Cardiometabolic Field as provided in Section 3.4(d).

CMC Activities. NN shall use commercially reasonable efforts to perform the process development, implementation, qualification, validation, and process scale-up to clinical and commercial scale and any other activities required to develop and commercialize a Licensed Product, including, without limitation, production of the drug product (“Drug Product”) at anticipated commercial scale of, at least, [ * ] liters (“Commercial Scale Production”) and [ * ] stability studies of a new formulation of the Licensed Products produced at a lab scale under research (non-GMP) conditions (“New Formulation Stability Study”). (c) A new Section 4.2(i) shall be added to the Agreement as follows: (i) The milestone fees for CMC activities shall be as follows: U.S. $[ * ] First successful completion of the Commercial Scale Production. A Commercial Scale Production will be considered successful if it meets the success criteria outlined in the attached Exhibit J. U.S. $[ * ] First successful completion of New Formulation Stability Study. A New Formulation Stability Study will be considered successful if it meets the success criteria outlined in the attached Exhibit K. U.S. $[ * ] Due on [ * ] (not subject to Section 4.2(e)(iv)) For the avoidance of doubt, the Time Milestone in the table in Section 4.2(i) shall terminate if NN terminate the License Agreement for Recombinant Factor XIII. (d) A new Exhibit J shall be added to the Agreement in the form attached as Schedule 1. (e) A new Exhibit K shall be added to the Agreement in the form attached as Schedule 2.

CMC Activities. As of the Effective Date and during the first [***] years this Agreement is in effect, ISIS will support ATL's efforts to timely file an IND application for each Collaboration Compound with respect to the CMC activities described in Exhibit 9.1 for Collaboration Compounds for which ISIS supplied API.