Existing Clinical Studies Sample Clauses

Existing Clinical Studies. There are no Clinical Studies or other development activities being conducted by or on behalf of Kiniksa (or any of its Affiliates) relating to Licensed Antibodies or Licensed Products other than the In Progress PN Study; and all Clinical Studies conducted by or on behalf of ▇▇▇▇▇▇▇ (or any of its Affiliates) relating to Licensed Antibodies or Licensed Products have been conducted in accordance with Applicable Law, including good laboratory practices, good clinical practices, good manufacturing practices (and each of their foreign equivalents), and applicable privacy, data protection and informed consent requirements.

Existing Clinical Studies. Without limiting the generality of Section 3.9, upon assignment of the IND No. [*] to Company according to Section 2.5(b) until completion or termination of the Existing Clinical Studies, Company will maintain the IND No. [*] and will take all actions necessary to enable the Existing Licensee to complete the Existing Clinical Studies based on the existing cross-reference to the IND No. [*], including by providing IB updates to the Regulatory Authority and the Existing Licensee as applicable, and maintaining the CMC-related information (e.g. module 3) comprised in IND No. [*] in such a way that MRKDG’s ability to supply its reserved inventory of Pimasertib to Existing Licensee or the use of such Compound Inventory by Existing Licensee for purpose of the Existing Clinical Studies is not negatively affected. If Existing Licensee requires any additional quantities of Pimasertib (i.e. in excess of the amount reserved by MRKDG) for conducting the Existing Clinical Studies or continued treatment of patients who participated in the Existing Clinical Studies after completion or termination of the Existing Clinical Studies, Company shall supply such quantities to Existing Licensee, and shall negotiate in good faith with Existing Licensee regarding a respective supply agreement between Company and Existing Licensee. MRKDG shall use Commercially Reasonable Efforts to cause the Existing Licensee to enter into good faith negotiations with Company regarding necessary agreements, e.g. pharmacovigilance with respect to the Existing Clinical Studies, if required by Applicable Laws. Company acknowledges and agrees that it will not use any data that Company may receive from Existing Licensee under such pharmacovigilance agreement or otherwise, that relates to any compound or product other than Compounds and Products (in particular, Company will not process, edit, analyze or publish any such data relating to any compound or product other than Compounds and Products), without MRKDG’s prior written consent.

Existing Clinical Studies. (a) ▇▇▇▇▇ shall, as soon as reasonably practicable following the Effective Date, (i) wind-down all remaining activities with respect to those certain clinical studies set forth on Schedule 4.1.2(a) (the “Wind-Down Existing Clinical Studies”) and (ii) conduct any post-completion obligations with respect thereto as required by Applicable Law, in accordance with the timelines set forth on such schedule. (b) ▇▇▇▇▇ shall conduct those certain clinical studies set forth on Schedule 4.1.2(b) (the “Continued Existing Clinical Studies”; collectively, with the Wind-Down Existing Clinical Studies, the “Existing Clinical Studies”) in accordance with the protocols therefor and Applicable Law, at Licensee’s expense, until such time as responsibility for performing such studies, has been transferred to Licensee pursuant to the plan therefor set forth on Schedule 4.1.2(b) (the “Study Transfer Plan”), provided that, notwithstanding anything to the contrary, (i) ▇▇▇▇▇ shall not amend, modify or deviate from any existing protocol with respect to the Continued Existing Clinical Studies, as such protocol exists as of the Effective Date, or suspend or terminate the Continued Existing Clinical Studies, in each case without Licensee’s prior written consent (not to be unreasonably withheld or delayed) except solely to the extent required by any Regulatory Authority, Applicable Law, or investigational review board or similar body and (ii) ▇▇▇▇▇ shall not be obligated under this Agreement to enroll any additional patients or subjects in the Continued Existing Clinical Studies. The Parties shall perform and complete the Study Transfer Plan (including but not limited to assignment to Licensee of any applicable Regulatory Documentation owned or controlled by ▇▇▇▇▇ or any Affiliate thereof or, to the extent permitted by the terms thereof or consent to assignment is obtained, agreements between ▇▇▇▇▇ and any Third Parties solely relating to the Continued Existing Clinical Studies, each as set forth in the Study Transfer Plan) in accordance with the timelines set forth therein. Licensee shall reimburse ▇▇▇▇▇ for all internal and external costs incurred by ▇▇▇▇▇ or any Affiliate thereof following the Effective Date with respect to the performance of its obligations under this Section 4.1.2(b) within thirty (30) days of the receipt of any invoice with respect thereto. For clarity, neither Licensee nor its Affiliates will be responsible for any costs or liabilities accrued by ▇▇▇▇▇ or its Af...

Existing Clinical Studies. Notwithstanding anything herein to the contrary, MRKDG (itself or through its Affiliates or through any Third Party under contract with MRKDG as of the Effective Date with respect to the Existing Clinical Studies) shall have the right to complete the Existing Clinical Studies. For clarity, MRKDG (itself or through its Affiliates or through any Third Party) may not initiate any new Clinical Trial for Pimasertib during the Term. MRKDG shall not and shall ensure that its Affiliates and Existing Sublicensee do not use any Excluded Know-How for the further Development or Commercialization of Pimasertib or any Product containing or comprising Pimasertib.