Global Development. The Product Plan shall set forth commercially reasonable development work (including without limitation clinical studies) to support acceptable regulatory applications for marketing clearance in all Major Countries. The costs associated with these activities shall be deemed "Global Expenses." If either Party fails to pay its share of Global Expenses with respect to a Compound, such Party shall be deemed an Opting Out Party with respect to such Compound in the entire Territory pursuant to Section 3.4(b). Either Party may Opt Out of the commercialization of a Compound on a country-by-country basis provided it funds its share of total Global Expenses, to the extent that funding of any development and/or marketing expenses is solely attributable to one country and is not considered a Global Expense ("Country Expenses"). A Party that does not pay such Country Expenses shall be deemed an Opting Out Party with respect to such Compound in that particular country only pursuant to Section 3.4(b).
Global Development. The Development of Product Candidates in North America and the Territory shall be governed by the Global Development Plan, and the Parties agree that all Development activities relating to Product Candidates shall be conducted in accordance with the Global Development Plan, except for those activities that are specifically included within Additional Development Activities undertaken in accordance with Section 3.5. Each Party will contribute to the operational execution of the Global Development Plan, and will make best use of each Party’s established technological and process excellence for the optimal execution of the Global Development Plan. The JDC shall review the Global Development Plan not less frequently than [***] and shall develop detailed and specific Global Development Plan updates, which shall include annual Development budgets and allocation of responsibilities between the Parties, for each Calendar Year under the Global Development Plan. The JDC shall submit all such updates to the JSC for review and approval such that JSC preliminary approval of the plan and budget for any Calendar Year would occur [***]. Updates with the JSC’s preliminary approval shall be submitted to each Party for its internal budgeting process with a target for final approval by the JSC [***], at which time any updates will be appended to the Global Development Plan.
Global Development. Kiniksa agrees that if Kiniksa or its Affiliates fail to perform one or more Global Clinical Trials as set forth in any Global Development Plan in accordance with the study design set forth in the protocol(s) therefor, then, to the extent that, as a direct result of such failure, Partner is unable to complete its obligations under the Global Development Plan (if Partner is participating as Territory Sponsor) or any Territory Development Plan, Partner will not be in breach of its diligence obligations under Section 5.1 (Development Diligence and Responsibilities) with respect to such failure to perform its obligations under the Global Development Plan or Territory Development Plan, as applicable, as a result of Kiniksa’s failure to perform.
Global Development. If, following Brii Bio’s delivery of a PoC Acceptance Notice for a Licensed Product, AN2 intends to conduct a Global Clinical Trial for a Licensed Product, then AN2 shall notify Brii Bio of such intention within [***] of such determination and Brii Bio shall have [***] following receipt of such notice to determine whether it intends to participate in such Global Clinical Trial. In the event that Brii Bio notifies AN2 that it wishes to participate in such Global Clinical Trial, then the Parties shall, through the JSC, [***]. If Brii Bio elects not to participate in a Global Clinical Trial in accordance with this Section 6.1(d), then [***]. [***] Certain information in this document has been omitted from this exhibit because AN2 Therapeutics, Inc. has determined that it is both (i) not material and (ii) is of the type that would customarily and actually be treated as private or confidential. 22 CONFIDENTIAL EXECUTION VERSION
Global Development. Following the completion of the Collaboration Clinical Study and within ninety (90) days following the provision of a clinical study report to the JSC pursuant to Section 5.2(c), each Party shall determine, in its sole discretion, whether it intends to pursue subsequent development activities in its territory for VBI-2601 or the Novel Composition evaluated in such Collaboration Clinical Study. In the event that the Parties both elect to proceed with further development of VBI-2601 or the Novel Composition, then the Parties shall decide, through the JSC, whether to enter into a Global Development Plan to govern the conduct of Global Clinical Trials with the objective of obtaining clinical trial data to support applications for Marketing Approval in the Field for the applicable product in both the Licensed Territory and countries within the VBI Territory. If the Parties so decide to enter into such Global Development Plan, then the Parties shall mutually agree upon such plan through the JSC, including the allocation of costs between the Parties for such Global Clinical Trials. Notwithstanding the foregoing, the Parties may elect not to jointly conduct a Global Clinical Trial under the Global Development Plan, which election must be made prior to the commencement of any activities relating to such Global Clinical Trial, in which event, neither Party shall thereafter have a right to use any efficacy data resulting from such Clinical Trial to support Marketing Approval in its respective territory.
Global Development. If either Party desires to conduct a Global Clinical Trial, then: (a) such Party shall so notify the other Party in writing; and (b) the Parties shall promptly meet to discuss in good faith the terms and conditions of a Global Clinical Trial over a period of thirty (30) days. In the event that the Parties both elect to proceed with such Global Clinical Trial, then the JSC will govern the conduct of Global Clinical Trials with the objective of obtaining clinical trial data to support applications for Marketing Approval in the Field for the Licensed Product in both the Licensed Territory and countries within the VBI Territory. If the Parties so decide to enter into such Global Clinical Trial, then the Parties shall mutually agree upon a Global Development Plan through the JSC, except that each Party shall bear its costs for the conduct of such Global Clinical Trial. Notwithstanding the foregoing: (x) the Parties may elect not to jointly conduct a Global Clinical Trial, in which event, neither Party shall thereafter have a right to conduct a Clinical Trial in the other Party’s respective territory; and (y) each Party may conduct Clinical Trials of the Licensed Product in its respective territory without needing to obtain any consent from the other Party, subject to Section 4.1(e).
Global Development. The Parties acknowledge that it may be in their mutual interests to integrate Licensee’s development of a Licensed Product within the Territory into Amgen’s global development plan for such Licensed Product for a particular Licensee Indication. The Parties agree to discuss in good faith where it may be appropriate to so integrate such development, and the relevant cost-sharing that will be applicable thereto. The Parties further acknowledge the mutual desire to progress Licensed Products in an effort to provide meaningful therapies to patients. While each Party acknowledges that the Licensed Products are of a developmental nature and that there is no guarantee that any or all Licensed Products will ultimately provide such benefits, the Parties express their current desire to seek to progress the Licensed Products as is reasonably prudent, in accordance with this Agreement, to provide data that can inform the Parties of the development potential of the Licensed Products.
Global Development. During the Term, the Parties may agree, through the JSC, to conduct any global Development activities, including one or more Global Clinical Trials, for the Licensed Products of each Licensed Antibody, which shall be conducted pursuant to a written plan with respect to such Licensed Antibody (each, a “Global Development Plan”) approved by the JSC. Each Global Development Plan will include [***]
Global Development. Except as expressly set forth in this letter, nothing in this letter is intended to modify or otherwise alter the provisions of the Collaboration Agreement with respect to ongoing and / or future global clinical development of the Collaboration Compounds.
Global Development. The Parties acknowledge that it may be in their mutual interests to integrate Collaborator’s development of Dmab within the Territory into Amgen’s global development plan for Dmab for a particular Collaborator Indication. The Parties agree to discuss in good faith where it may be appropriate to so include such development, and the relevant cost-sharing that will be applicable thereto. As requested by either Party, the Parties shall meet and confer in good faith as to the feasibility and potential efficiency gains of cooperating to integrate Collaborator’s development of Dmab for [*] in the Territory into Amgen’s global development plan for such indication. The Parties acknowledge that one ongoing study within Oncology, a study of [*], the “Ongoing Oncology Study”), currently includes sites both inside and outside the Territory. The Ongoing Oncology Study is a global registration trial intended to support a filing for approval in the United States and Europe, as well as in the Territory. After the Effective Date, the management of those sites shall be addressed as provided in Section 4.18 (Transition in Oncology Development), and shall be conducted strictly in accordance with Amgen’s global procedures and protocol for such trial, as in effect at the relevant time, as communicated by Amgen to Collaborator (and/or any relevant contract research organization). If Amgen elects to [*] that would be likely to [*] in the Territory, the Parties will discuss [*] and will discuss [*] in the Territory.
