Incoming Specifications. The parties will in good faith cooperate with one another to develop the Specifications, which shall be acceptable to both parties. The Specifications shall be agreed upon in writing and shall be attached hereto and incorporated into this Agreement as Exhibit B, and may be amended from time to time by mutual written agreement of the parties. The Specifications shall be considered confidential information pursuant to Section 13 of the Collaboration Agreement and for the purposes of Section 10 hereof.
Incoming Specifications. The parties will in good faith cooperate (via the Joint Steering Committee) with one another to develop the Specifications, which shall be acceptable to both parties and in any event in compliance with cGMP and any and all requirements of the Regulatory Authority in the Territory. The Specifications shall be agreed upon in writing by the parties and attached hereto and incorporated into this Supply Agreement as Exhibit B. To avoid doubt, with respect to any detailed aspects of the manufacturing process for Supply Product that are not explicitly stated in the agreed-upon Specifications, initially such detailed aspects are subject to mutual agreement by the parties (after which such detailed aspects shall be deemed included within the Specifications) and shall only be changed or amended in accordance with the process to amend the Specifications set forth in this Section. The Specifications may be amended from time-to-time by mutual written agreement of the parties and as set forth in this Section with respect to changes required to meet regulatory requirements in the Territory. Each of the parties acknowledges and agrees that it is each of their intentions for the Specifications to be the same in the Territory and in the Retained Territory, and they each agree to work together in good faith toward that intention. Notwithstanding the foregoing, the parties each agree that any change to the Specifications required to meet regulatory requirements in the Territory shall be deemed mutually agreed upon and the Specifications shall be deemed amended to incorporate such required change. ZKC shall notify Theraclone of such required changes and the regulatory requirements requiring them. Any costs of such required change to the Specifications (after the initial Specifications have been mutually agreed by the parties) shall be borne by ZKC. In addition, if ZKC requires (i) that the Specifications for Supply Product (including, without limitation, a combination product) to be used in the Territory are different from the specifications for the corresponding product in the Retained Territory and/or (ii) different Specifications because ZKC requires a Supply Product that is different from the product(s) being developed and/or commercialized in the Retained Territory, then [***] of all costs and expenses associated with developing such different Specifications for the Territory shall be ZKC’s responsibility, including (without limitation) all process development, manufactur...
