Collaboration Program Sample Clauses
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Collaboration Program. The Parties shall conduct their collaboration pursuant to the Collaboration Program that sets forth specific activities to be pursued by each Party, divided up in several work packages, with pre-agreed criteria specified in the Collaboration Program which is attached to this Agreement as Exhibit B. The initial Exhibit B, as attached hereto, shall be supplemented with an expanded document detailing the specific activities, reporting, and success criteria for the Parties, encompassed within the work packages for ▇▇▇▇▇ ▇ (▇▇▇, ▇▇▇, and WP 3) of the Collaboration Program as are set out in the Exhibit B and in accordance with the budgets set out for each; this expanded Exhibit B shall be designed and approved by the JSC in accordance with section 2.1 (d)(iv), and it is expected that the JSC shall complete such Exhibit B at the first meeting noted in section 2.1 (b) or as soon thereafter as is practicable. Each work package must be met in full prior to initiating a subsequent work package, and budgets and timelines associated with such activities. As of the Effective Date, the Parties have agreed upon the initial Collaboration Program and associated budget under Exhibit B. From time to time (at least on an annual basis), the JSC shall review, and as may be needed, and approve amendments to the then-current Collaboration Program and associated budget, provided that any increase of the budget in excess of one hundred and ten percent (110%) of the budgeted Collaboration Funding (as defined below) will also require an amendment to this Agreement to be signed by the Parties. Once approved by the JSC, such revised Collaboration Program and budget shall replace the prior applicable Collaboration Program and budget. If the terms of a Collaboration Program contradict, or create inconsistencies or ambiguities with, the terms of this Agreement, then the terms of this Agreement shall govern and control.
Collaboration Program. (a) [***] Program Before Opt-In and MGNX Option Program within the Collaboration Territory
(i) Regulatory Submissions. With respect to (1) the [***] Program before the Opt-In and (2) the MGNX Option Program, as between the Parties, subject to this Section 6.1(a)(i), Zai shall be solely responsible for, at [***], preparing, translating (to the extent required by the applicable Regulatory Authority in the applicable Collaboration Territory) and filing all Regulatory Submissions, and obtaining and maintaining Regulatory Approvals, for the Collaboration 40 Products in the applicable Collaboration Territory, in compliance with all Applicable Laws and Regulations. MacroGenics shall have the right, but not the obligation, to review and comment on all Regulatory Submissions for any Collaboration Product to any Regulatory Authority in the applicable Collaboration Territory, and Zai shall reasonably consider any such comments in such Regulatory Submissions prior to filing thereof and shall promptly provide copies of any Regulatory Submissions (including all updates thereof) to MacroGenics. MacroGenics shall cooperate with Zai in all material respects and be actively involved in Zai’s efforts with respect to such Regulatory Submissions, including without limitation providing to Zai any revisions to the investigator’s brochure and CMC information required for Regulatory Submissions to Regulatory Authorities in the applicable Collaboration Territory.
(ii) Interactions with Regulatory Authorities. With respect to (1) the [***] Program before the Opt-In and (2) the MGNX Option Program, as between the Parties, subject to this Section 6.1(a)(ii), Zai shall be responsible for, at [***], responding to inquiries and correspondence from the applicable Regulatory Authorities with respect to Collaboration Products in the applicable Collaboration Territory. MacroGenics (or its designee) shall have a right to be present at (but not participate in, unless otherwise requested by Zai or the applicable Regulatory Authority) meetings with the Regulatory Authorities if (1) it is reasonably likely that there would be discussions on the agenda about the Collaboration Product beyond the scope of Zai’s Development of the Collaboration Product in the applicable Collaboration Territory (e.g., CMC matters, Clinical Data generated by MacroGenics),
Collaboration Program. 2.1 OBJECTIVE. PACKARD and AURORA hereby commit to undertake and pursue a collaboration program with the primary objective to develop and commercialize ***CONFIDENTIAL TREATMENT REQUESTED
Collaboration Program. The Collaboration Program Working Group shall be chaired by a project leader from [***], whose appointment shall be subject to the reasonable approval by [***]. The Collaboration Program Working Group will create the initial Research Plan and Research Budget, the planned content of an Option Exercise Data Package, and, to the extent practicable, the specific criteria for acceptance of the Option Exercise Data Package for the applicable Collaboration Program. The Collaboration Program Working Group will also oversee and coordinate the performance of activities under the Research Plan for such Collaboration Program and perform such other activities as the JRC may delegate to the Collaboration Program Working Group from time to time. Any disputes arising out of the Collaboration Program Working Group will be escalated to the JRC for resolution.
Collaboration Program. Subject to the terms and conditions of this Agreement, the Parties shall collaborate on a research and pre-clinical program to construct, optimize and develop one or more Gene Editing Therapy(ies) made using the ARCUS Technology that targets the HBV Target (the “Collaboration Program”) and conduct the Development activities set forth in the collaboration research and development plan described in Section 3.2.1 (such plan, as amended from time to time, the “Collaboration R&D Plan”). The Collaboration Program shall commence on the Effective Date and will, unless otherwise mutually agreed by the Parties in writing, continue until the third anniversary of the Effective Date or, if earlier, the later of (a) acceptance by the FDA or other competent foreign Regulatory Authority of [***] of the first IND filing for the first Licensed Product and (b) the satisfactory [***] Confidential treatment requested pursuant to a request for confidential treatment filed with the Securities and Exchange Commission. Omitted portions have been filed separately with the Commission. completion (as mutually agreed upon by the Parties) of all tasks and activities required under the Collaboration R&D Plan (“Initial Term”); provided that, if either (a) or (b) has not occurred by the third anniversary of the Effective Date, Gilead, at its option, may extend the Initial Term (or then-current term, as the case may be) for one or more additional six (6) month periods until such time as the later of (a) and (b) has occurred, by serving a written notice(s) to Precision; provided that, Gilead pays to Precision the funding payment for such additional period(s) in accordance with Section 5.1 (the Initial Term together with any such extensions, the “Collaboration Term”).
Collaboration Program. […***…]. Senomyx hereby grants to Firmenich a non-exclusive, non-sublicensable and non-transferable (except as permitted under Sections 8.2.1 and 17.12) license under the Collaboration Program IP to […***…] under the Collaborative Program (but only to the extent […***…] as reflected in the Research Plan […***…]. Notwithstanding the foregoing, it is understood and agreed that Firmenich may not exercise or use any of the rights granted under the […***…] unless and until such time as […***…], and Firmenich has exercised its right to effect […***…] as set forth below. It is further understood and agreed that Firmenich shall be prohibited from exercising or using any of the rights granted under […***…] (i) during any period if it is in material breach of this Agreement, or (ii) if […***…] occurs after the end of the […***…] under the Agreement. Any use by Firmenich of the […***…] prior to Firmenich’s proper exercise of […***…] shall invalidate this Section 8.1.3 ab initio. […***…] following Firmenich’s written notice of […***…] subsequent to […***…] Senomyx shall promptly use […***…] from the aforementioned […***…] in order to give Firmenich the full benefits and rights of the […***…] but only to the extent that it would not cause Senomyx to incur out-of-pocket expenses […***…] Nevertheless, Firmenich acknowledges and agrees that this Section 8.1.3 shall not obligate Senomyx to maintain […***…] or to continue to perform any obligations under […***…] either during or following the Term of this Agreement. Similarly, this Section 8.1.3 does not impose on Senomyx any obligation to […***…] prior to or following […***…] In addition to […***…] set forth in the paragraph above, following Firmenich’s written notice to Senomyx of a […***…], (i) Senomyx shall provide Firmenich with […***…] and […***…], such as information regarding […***…] to the extent necessary to evaluate […***…] or to support […***…] of any […***…] and […***…] but only to the extent that such […***…]; and (ii) Senomyx shall provide Firmenich with […***…] and a copy of […***…] if any, but only to the extent that […***…]. In the event of the first occurrence of an event under subsection (A) under the definition of a […***…] (as defined on Appendix A) during the Collaborative Period, Senomyx shall promptly notify Firmenich of such occurrence. In the event that […***…] occurs during the Collaborative Period, Firmenich shall have the option, in its sole discretion, within […***…] thereafter to […***…] To e...
Collaboration Program. If the proposed gene target is rejected, GSK may request another gene target in accordance with the terms of this Section 1.5.
Collaboration Program. 11 Section 2.1 General.............................................................. 11 Section 2.2 JRDC................................................................. 11 Section 2.3 Management of Collaboration Program.................................. 12 Section 2.4 Decisionmaking....................................................... 16 Section 2.5 Term of Collaboration Program........................................ 17 Section 2.6 Exclusivity and Diligence Obligations..............................
Collaboration Program. Each Partnership Party may subcontract the performance of any activities undertaken by such Partnership Party in accordance with the Global Development Plan, Global Manufacturing Plan, Global Medical Affairs Plan, Global Commercialization Plans or Regional Commercialization Plans to one or more Subcontractor pursuant to a Subcontract. Notwithstanding the foregoing, if either Partnership Party desires to subcontract any such activities, it will first discuss the matter with the other Partnership Party and reasonably consider using the other Partnership Party for such subcontracted activities, taking into account the capabilities of the other Partnership Party and potential impact on costs, as a potential alternative to subcontracting such activities to a Third Party. If, following such discussion a Partnership Party still desires to subcontract the performance of any such activity to one or more Third Parties, it may proceed to do so; provided, that prior to entering into any Subcontract which the subcontracting Partnership Party reasonably anticipates will entail payments to the Subcontractor in excess of [***] Dollars ($[***]) with respect to subcontracted activities under this Agreement that would be Collaboration Program Expenses, the subcontracting Partnership Party will obtain the applicable Committee’s approval, not to be unreasonably withheld, delayed or conditioned to the extent within the scope of an agreed budget for such activities, of use of the proposed Subcontractor to conduct the activities proposed to be subcontracted prior to execution of the applicable Subcontract. For clarity, the foregoing shall not apply to any Subcontractor already engaged by Sirius-US or its Affiliates prior to the Effective Date and set forth on Schedule 3.1.2(c)(ii) or Schedule 3.4.5(a) attached hereto.
Collaboration Program