Global Studies. 5.7.1 If, after the Effective Date, either Party proposes to undertake a Global Study, then it shall provide the JSC with the (i) proposed detailed budget, protocol and clinical trial design, details of the sites and the key investigators, (ii) a detailed breakdown and budget of the proposed Development Costs and (iii) any other relevant information and plans relating to such study, including template patient consent forms that are reasonably requested by the other Party.
Global Studies. The milestones in the table immediately below in this Section 5.2(a) shall be due upon Achievement (i.e., by TAIHO or its Sublicensee) of such milestones so long as TAIHO or its Sublicensee would be able (in TAIHO’s opinion, acting in good faith) and intends to obtain Marketing Approval based solely on Arcus Know-How and clinical data from Global Studies conducted by or under authority of Arcus or its Affiliates (“Global Study Pathway”). For avoidance of doubt, the milestones in the table immediately below shall not be due if TAIHO determines (in its opinion, acting in good faith) not to pursue the Global Study Pathway for the particular Licensed Product, and TAIHO or its Sublicensee conducts a Clinical Trial for such Licensed Product that is not a part of the Global Studies. [***]
Global Studies. Minimum qualifications shall be those of the discipline(s) being taught in these special topics courses. For example, if the course combines global topics in History and Biology, then the faculty member teaching the History portion shall have the minimum qualifications to teach history and the faculty member teaching the Biology portion shall have the minimum qualifications in biology.
Global Studies. (i) Licensor may, from time to time, propose a Global Study by providing all relevant information about such proposed Global Study to Licensee through the JSC. Licensee may determine, in its sole discretion, whether it wishes to participate in such Global Study in the Territory. The Parties will discuss Licensor’s proposal in good faith and Licensee will reasonably consider participating in such Global Study in the Territory. - 25 - of - 75 -
(ii) If Licensee determines that it wishes to participate in such Global Study in the Territory, then Licensee shall conduct such Global Study as sponsor in the Territory in coordination with Licensor, who shall be responsible for such Global Study outside the Territory, and the Parties shall discuss coordination of efforts and cost-sharing for such Global Study.
(iii) If Licensee determines that it does not wish to participate in such Global Study performed in the Territory and Licensor continues to wish to conduct such Global Study in the Territory without Licensee’s participation, then Licensor may request that Licensee permit Licensor to so conduct such Global Study in the Territory. Licensee will consider such proposal in good faith and will not arbitrarily refuse Licensor’s proposal, always understood that Licensee shall have the final decision-making power with no veto right for Licensor. If Licensee elects to accept such proposal, (a) Licensee will cooperate in good faith with Licensor to execute such documents that are reasonably required for Licensor to conduct the Global Study in the Territory, with reasonable and documented costs for the execution of such documents as well as applicable out-of-pocket expenses to be reimbursed by Licensor, and (b) Licensor will share the Development Data arising from such Global Study pursuant to Section 4.7 to the same extent as for any other Clinical Trial conducted under this Agreement. If Licensee elects not to accept such proposal, then such Global Study will not be conducted in the Territory.
Global Studies. Minimum qualifications shall be those of the discipline(s) being taught in these special topics
Global Studies. (a) Global Development Strategy. [***].
Global Studies. If, after the Effective Date, ARIAD is interested in undertaking any global development of the Product for any New Indication or in any New Formulation (i.e., any global clinical trial of the Product that includes clinical trial sites in (x) the US and/or the European Economic Area and (y) Japan and the data from which, if such trial is successful, could be used to obtain marketing authorization for the Product in the US, the European Economic Area and Japan under a protocol that PMDA has indicated is sufficient to support an application for Marketing Authorization in Japan, or, with respect to a New Formulation, any non-clinical study or research for the benefit of the US, the European Economic Area and Japan (each a “Global Study”)), ARIAD shall inform Otsuka of such interest and shall provide Otsuka with information and plans relating to such Global Study, including budgets for out-of-pocket costs and, as applicable, proposed protocols and clinical trial designs. Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended.
Global Studies. If AbbVie desires to perform a Global Study for a Licensed Product, AbbVie shall [Redacted].
Global Studies. The Parties acknowledge that the Development of Licensed Antibodies and Products on a global basis is desirable for maximizing the value of the Products. As such, in addition to each Party’s Development rights in their respective Territories as set forth in Sections 4.1 and 4.2, each Party may participate, at its sole cost and subject to the remainder of this Section 4.3, in one or more Clinical Study(ies) planned by the other Party or its Affiliates or Sublicensees to be conducted in such other Party’s Territory by participating in such Clinical Study(ies) in its own Territory, provided that such Clinical Study includes a sufficient number of study subjects in each Party’s Territory to achieve Regulatory Approval in such Territory for the relevant indication (with respect to each Territory and Clinical Study, the “Enrollment Threshold”). Each such Clinical Study in which both Parties will participate in accordance with this Section 4.3 shall be deemed a “Global Study”.
Global Studies
