Global Clinical Study Clause Samples
Global Clinical Study. A. Eikon may initiate, suspend, or cease a Global Clinical Study. With respect to any Global Clinical Study that includes clinical sites for a Licensed Compound or Licensed Product in the Impact Territory, Eikon may propose to the JSC a global development plan (the “Global Development Plan”) for JSC’s approval pursuant to Section 6.1.5. As between the Parties for such Global Clinical Study, Eikon shall be responsible for all activities associated with conducting such Global Clinical Study in the Eikon Territory, and Impact shall be responsible for all activities associated with conducting such Global Clinical Study in the Impact Territory, and in each case of Eikon and Impact, in accordance with the Global Development Plan approved by the JSC.
B. As between the Parties, (1) Impact shall, at its sole expense, enroll up to [***] (or such greater amount as is actually required by National Medical Products Administration) of the subjects of such Global Clinical Study in the Impact Territory and Impact shall bear any and all costs and expenses incurred in connection with conducting such Global Clinical Study in the Impact Territory for such [***] (or such greater amount as is actually required by National Medical Products Administration) of the subjects, and (2) Eikon shall bear any and all other costs and expenses incurred in connection with the Global Clinical Study.
C. If Parties agree in writing that Eikon will not Develop the Licensed Compound or Licensed Product with respect to an indication under a Global Clinical Study, then, subject to JSC approval, Impact shall have the right to Develop the Licensed Compound or Licensed Product with respect to such indication in the Impact Territory under the Impact Development Plan approved by the JSC.
Global Clinical Study. If Medgenics conducts a Global Clinical Study in the Field in any country in the Territory, at KHK’s request Medgenics will in good faith discuss with KHK including sites in countries outside of the Territory for such Global Clinical Study in order for KHK to join such Global Clinical Study. In order for Medgenics to include such sites in the Global Clinical Trial, such discussions must result in a mutually satisfactory amendment to this Agreement that addresses all relevant matters including operational matters (such as allocation of responsibilities between the Parties), regulatory matters (such as preparation of any required IND, management of communications with Regulatory Authorities and which Party will be the holder of the IND/sponsor of the trial), risk matters (including KHK indemnifying Medgenics for Losses resulting from Third Party Claims arising from the trial at such sites including product liability and from Medgenics’ performance of its allocated responsibilities) and KHK bearing all costs associated with all of the foregoing. In this Agreement, “Global Clinical Study” means, with respect to Development of Licensed Products, a study with a unique protocol, the results of which are designed to be submitted to Regulatory Authorities of the United States and European Union and other countries as mandatory for obtaining Regulatory Approval of such Licensed Products in the respective countries.