Scope of Committee Oversight. The Committee shall be responsible for overseeing the Research Program, including to (i) review and amend the Research Program activities set forth in the Work Plan from time to time, (ii) review and coordinate the Parties’ activities under the Research Program, (iii) confer regarding the status of the Research Program and the progress under the Research Program and to make determinations and decisions in connection with the activities under the Work Plan (including issues of priority), (iv) review relevant data and results under the Research Program, (v) consider and advise on any technical issues that arise under the Research Program, (vi) assigning Response Outcomes, as per the criteria and decision tree outlined in Schedule 1.54, (vii) agree on a specific, single percentage between [***] and [***] that will be applied (in accordance with the processes set forth in Sections 5.3 and 5.4.2, as applicable) to all future upfront payments (as set forth in Section 5.3), development and regulatory milestone payments, and sales milestones payments associated with each of the three (3) individual programs to be undertaken under the Work Plan which may be assigned a Response Outcome 2 as per the process outlined in Schedule 1.54, (viii) and to determine such other matters as allocated to the Committee hereunder and (ix) agreeing on which of the LBPs will be deselected and discontinued from further work during the performance of the Work Plan, including establishing a reasonable process for formally documenting same. The Committee shall not have the authority to: (w) modify or amend the terms and conditions of this Agreement; (x) waive either Party’s compliance with the terms and conditions of this Agreement; (y) determine any issue in a manner that would conflict with the express terms and conditions of this Agreement or (z) amend the Work Plan in a manner that would result in an increase in a Party’s obligations, costs or expenses under the Research Program or this Agreement. For clarity, other than amendments outlined above, all other changes to the Work Plan may only be amended upon mutual written agreement by authorized representative(s) of the Parties.
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Samples: Research Collaboration and Option to License Agreement (4D Pharma PLC), Research Collaboration and Option to License Agreement (4D Pharma PLC)
Scope of Committee Oversight. The Committee shall be responsible for overseeing the Research Program, including to (i) review and amend the Research Program activities set forth in the Work Plan from time to time, (ii) review and coordinate the Parties’ activities under the Research Program, (iii) confer regarding the status of the Research Program and the progress under the Research Program and to make determinations and decisions in connection with the activities under the Work Plan Research Program (including issues of priority), (iv) review relevant data and results under the Research Program, (v) consider and advise on any technical issues that arise under the Research Program, and (vi) assigning Response Outcomes, as per the criteria and decision tree outlined in Schedule 1.54, (vii) agree on a specific, single percentage between [***] and [***] that will be applied (in accordance with the processes set forth in Sections 5.3 and 5.4.2, as applicable) to all future upfront payments (as set forth in Section 5.3), development and regulatory milestone payments, and sales milestones payments associated with each of the three (3) individual programs to be undertaken under the Work Plan which may be assigned a Response Outcome 2 as per the process outlined in Schedule 1.54, (viii) and to determine such other matters as allocated to the Committee hereunder and (ix) agreeing on which of the LBPs will be deselected and discontinued from further work during the performance of the Work Plan, including establishing a reasonable process for formally documenting samehereunder. The Committee shall not have the authority to: (w) modify or amend the terms and conditions of this Agreement; (x) waive either Party’s compliance with the terms and conditions of this Agreement; (y) determine any issue in a manner that would conflict with the express terms and conditions of this Agreement or (z) amend the Work Research Plan in a manner that would result in an increase in a Party’s the financial or other resource (i.e., FTEs) obligations imposed on Cocrystal or Merck beyond the scope of those required under the then current planned activities, and if such amendment would increase such financial or other resource (i.e., FTEs) obligations, costs or expenses under then such amendment must be mutually agreed to by the Parties in writing (including mutual agreement on the number of additional FTEs of Cocrystal needed to perform such work and to be funded by Merck in accordance with Section 5.1); provided that, for the avoidance of doubt if the work proposed in the amendment to the Research Program or this Agreement. For clarityactivities could be performed by the FTEs then currently being funded by Merck and such work would not impose additional financial obligations on Cocrystal beyond the then current Research Program activities, other than amendments outlined above, all other changes Cocrystal shall perform such work at no additional charge and the Research Program activities shall automatically be deemed to the Work Plan may only be amended upon mutual written agreement to include such work as proposed by authorized representative(s) of the PartiesCommittee.
Appears in 1 contract
Samples: Exclusive License and Research Collaboration Agreement (Cocrystal Pharma, Inc.)
Scope of Committee Oversight. (a) The Committee shall be responsible for overseeing the Research Program, including including, without limitation, to (i) review and amend the Research Program activities set forth in the Work Plan from time to time, including to amend the Research Plan to require additional FTEs or reduce the number of FTEs, (ii) review and coordinate the Parties’ activities under the Research Program, (iii) confer regarding the status of the Research Program and the progress under the Research Program and to make determinations and decisions in connection with the activities under the Work Plan Research Program (including issues of priority), (iv) review relevant data and results generated under the Research Program, (v) consider and advise on any technical issues that arise under the Research Program, (vi) assigning Response Outcomesreview and amend the Initial Research Budget as necessary and propose and agree upon additional Research Budgets in accordance with Section 6.2.1, as per the criteria and decision tree outlined in Schedule 1.54, (vii) agree on a specific, single percentage between [***] and [***] that will be applied (in accordance with the processes set forth in Sections 5.3 and 5.4.2, as applicable) to all future upfront payments (as set forth in Section 5.3), development and regulatory milestone payments, and sales milestones payments associated with each of the three (3) individual programs to be undertaken under the Work Plan which may be assigned a Response Outcome 2 as per the process outlined in Schedule 1.54, (viii) and to determine such other matters as allocated to the Committee hereunder (including the formation or disbandment of subcommittees), subject in each case (i)-(vii) to Section 2.3.2(c).
(b) The Committee is empowered to establish, from time to time, one or more subcommittees to oversee particular activities under the Research Program, and (ix) agreeing on which of the LBPs such subcommittees will be deselected constituted as the Committee agrees. The subcommittees shall oversee activities within areas delegated to them by the Committee and discontinued from further work during to make decisions regarding matters within each of their purviews. The Parties may replace their respective subcommittee representatives at any time, with prior written notice to the performance other Party. Any issue within the purview of such a subcommittee that is not settled or determined unanimously by the Work Planapplicable subcommittee shall be submitted to the Committee for resolution. The chairperson of each subcommittee shall report on subcommittee efforts at each Committee meeting, including establishing a reasonable process for formally documenting same. and either Party may invite its own representatives on such subcommittee to also report on such efforts.
(c) The Committee shall not have the authority to: (wi) modify or amend the terms and conditions of this Agreement; (xii) waive either Party’s compliance with the terms and conditions of this Agreement; (yiii) determine any issue in a manner that would conflict with the express terms and conditions of this Agreement or Agreement; (ziv) amend the Work Research Plan in a manner that would result in an increase in a Party’s obligations, require Company to incur costs or expenses under the Research Program Plan that would not be funded by Merck or this Agreementto increase the scope of activities or resource obligations imposed on the Company beyond the scope of those required under the then current planned activities, and if such amendment would increase such scope of activities or resource obligations, then such amendment must be mutually agreed to by the Parties (i.e., without escalation as described in Section 2.3.1(b)) in writing (including mutual agreement on the number of additional FTEs of Company needed to perform such work and to be funded by Merck in accordance with Section 6.2.2(b)); or (v) require the Company to violate any applicable law or regulation, clinical or non-clinical research ethical requirement, or any agreement the Company may have with any Third Party. For clarityCERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, other than amendments outlined aboveMARKED BY [***], all other changes to the Work Plan may only be amended upon mutual written agreement by authorized representative(sHAS BEEN OMITTED BECAUSE IT IS BOTH (I) of the Parties.NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED
Appears in 1 contract
Samples: Research Collaboration and Exclusive License Agreement (Janux Therapeutics, Inc.)
Scope of Committee Oversight. The Until the Committee is transitioned to an advisory committee in accordance with Section 2.3.6, the Committee shall be responsible for overseeing the Research Program, including to (ia) review review, amend and amend approve the Research Program activities set forth in the Work Plan from time to time, ; (iib) review and coordinate the Parties’ activities under the Research ProgramPlan, including, for example, ModeX’s use of subcontractors to perform Research Program activities; (iiic) confer regarding the status of the Research Program and Program, confer regarding the progress under the Research Program Plan, and to make determinations and decisions in connection with the activities under the Work Plan thereunder (including issues of priority), ; (ivd) review relevant data and results under the Research Program, ; (ve) consider and advise on any technical issues that arise under the Research Program; (f) oversee the CMC Development and Manufacturing activities of the CDMO engaged by the Manufacturing Party under Section 2.12; (g) oversee the initial manufacturing technology transfer contemplated under Section 2.5; (h) conduct and oversee developability and preclinical immunogenicity studies, ensure technology transfer, and provide strategic oversight; (vii) assigning Response Outcomes, as per review written progress reports to be provided by each Party in advance of each meeting describing the criteria and decision tree outlined in Schedule 1.54, work performed by or on behalf of such Party (vii) agree on a specific, single percentage between [***] and [***] that will be applied (in accordance with the processes set forth in Sections 5.3 and 5.4.2, as applicableor its sublicensees) to all future upfront payments (date on the Research Program and such other information as set forth in Section 5.3), development and regulatory milestone payments, and sales milestones payments associated with each of the three (3) individual programs to be undertaken under the Work Plan which may be assigned a Response Outcome 2 as per required by the process outlined in Schedule 1.54, Research Plan; and (viiij) and to determine such other matters as allocated to the Committee hereunder and (ix) agreeing on which hereunder. Within *** after each meeting of the LBPs will be deselected and discontinued from further work during the performance Committee, *** shall provide to *** a written summary of the Work Plan, including establishing a reasonable process for formally documenting same. The Committee shall not have the authority to: (w) modify or amend the terms and conditions of this Agreement; (x) waive either Party’s compliance with the terms and conditions of this Agreement; (y) determine any issue in a manner that would conflict with the express terms and conditions of this Agreement or (z) amend the Work Plan in a manner that would result in an increase in a Party’s obligations, costs or expenses Parties’ progress under the Research Program or this Agreement. For claritysince the previous Committee meeting, other than amendments outlined above, all other changes which report may be *** to the Work Plan may only extent required by ***, it being understood that any such reports from *** shall be amended upon mutual written agreement the confidential Information of *** (with respect to *** Information) and *** (with respect to *** Information, even though such report is prepared by authorized representative(s) ***), and shall be *** subject to obligations of the Parties.confidentiality substantially similar to those contained herein. Confidential
Appears in 1 contract
Samples: License and Research Collaboration Agreement (Opko Health, Inc.)
Scope of Committee Oversight. (a) The Committee shall be responsible for overseeing the Research ProgramProgram during the Initial Research Program Term, including to (i) review and amend the Research Program activities set forth in the Work Research Plan from time to time, (ii) review and coordinate the Parties’ activities under the Research Program, (iii) confer regarding the status of the Research Program and the progress under the Research Program and to make determinations and decisions in connection with the activities under the Work Plan Research Program (including issues of priority), (iv) review relevant data and results under the Research Program, including reviewing and discussing data included in a Final Research Objective Notice and [**] intention regarding making a Go Decision, (v) determine whether any compound or peptide that is identified or designed as a result of activities under the Research Program has demonstrated activity in one or more relevant Program Target functional assay(s), (vi) determine the criteria for selecting [**] Compounds, (vii) consider and advise on any technical issues that arise under the Research Program, (viviii) assigning Response Outcomes, as per the criteria and decision tree outlined in Schedule 1.54, (vii) agree on make a specific, single percentage between [***] and [***] that will be applied (in accordance with the processes set forth in Sections 5.3 and 5.4.2, as applicable) to all future upfront payments (as set forth in No Go Decision under Section 5.32.2.2(a), development and regulatory milestone payments, and sales milestones payments associated with each of the three (3ix) individual programs to be undertaken under the Work Plan which may be assigned a Response Outcome 2 as per the process outlined in Schedule 1.54, (viii) and to determine such other matters as allocated to the Committee hereunder and hereunder.
(ixb) agreeing on which of the LBPs will be deselected and discontinued from further work during the performance of the Work Plan, including establishing a reasonable process for formally documenting same. The Committee shall not have the power or authority to: (wi) modify or amend the terms and conditions of this Agreement; (xii) waive either Party’s compliance with the terms and conditions of this Agreement; (yiii) determine any issue in a manner that would conflict with the express terms and conditions of this Agreement Agreement; or (ziv) amend impose any requirement on a Party to perform any act that such Party reasonably believes (A) to be inconsistent with applicable laws, rules or regulations, or (B) would cause such Party to infringe or misappropriate any Third Party intellectual property rights.
(c) Notwithstanding anything to the Work contrary in this Agreement, during the Late Research Program Term, Merck shall be responsible for overseeing the [**] activities set forth in the Research Plan in a manner that would result in an increase in a Party’s obligations, costs or expenses and the role of the Committee shall be limited to (i) reviewing relevant data under the Research Program Program, and (ii) considering and advising on any technical issues that arise under the Research Program. [**] and shall make its employees or this Agreement. For clarity, other than amendments outlined above, all other changes subcontractors available to respond to reasonable inquiries from Merck and/or the Work Plan may only be amended upon mutual written agreement by authorized representative(s) of Committee regarding Company’s activities under the PartiesResearch Plan.
Appears in 1 contract
Samples: Research Collaboration and Exclusive License Agreement (Foghorn Therapeutics Inc.)