Common use of Working Groups Clause in Contracts

Working Groups. From time to time, a Joint Committee may establish and delegate duties to sub-committees or directed teams (each, a “Working Group”) to oversee particular projects or activities (for example, joint finance group and/or joint intellectual property group), provided that in no event shall a Joint Committee have the right to, and no Joint Committee shall, delegate its respective decision-making authority to any such Working Group. Each such Working Group shall be constituted as the applicable Joint Committee determines and shall establish its own procedures, to the extent that such procedures are not inconsistent with this Agreement; provided that each Working Group shall have adequate functional representation from each Party. Members of a Working Group may also be members of a Joint Committee. Working Groups may be established on an ad hoc basis for purposes of a specific project or on such other basis as the applicable Joint Committee may determine. Each Working Group and its activities shall be subject to the oversight, review, and approval of, and shall report to, the Joint Committee that established such Working Group. In no event shall the authority of a Working Group exceed the authority specified for the Joint Committee that established the Working Group pursuant to this Article 2. All decisions of a Working Group shall be made by unanimous agreement. Any disagreement between the representatives of Takeda and Denali on a Working Group shall be referred to the Joint Committee that established the Working Group for resolution in accordance with Section 2.3.6. Employees of either Party (or a Party’s Affiliate) that are not representatives of such Party on a Working Group may attend meetings of such Working Group; provided, that the Party wishing such persons to participate in a meeting has provided reasonable advance notice to the other Party. Non-employees may only attend meetings of a Working Group if such non-employee is bound by written obligations of confidentiality and non-disclosure substantially equivalent to those set forth in Article 11 and with the prior written approval of the other Party (such approval not to be unreasonably withheld, delayed or conditioned).

Working Groups. From (a) Upon its formation, the PSC shall establish Working Groups which shall be responsible for proposing a detailed development plan (setting forth the different steps and time to timeframes, a Joint Committee may establish and delegate duties to sub-committees or directed teams (each, a “Working Group”as well as the budget for the Parties’ respective activities for the Development of Products) to oversee particular projects or the Project Steering Committee. After approval of the development plan by the Project Steering Committee, which must occur in a timely way so as not to impede the progress of the Working Groups, the Working Groups shall coordinate and implement all day-to-day activities (for exampleof the Parties, joint finance group and/or joint intellectual property group)respectively, provided that in no event under this Agreement. The Working Groups shall a Joint Committee have work openly and cooperatively and shall meet periodically as the right toParties reasonably determine may be necessary, to coordinate research, preclinical and clinical development, process development and production, and no Joint Committee shall, delegate its respective decision-making authority other activities conducted by the Parties according to any the objectives and priorities of the cooperation under this Agreement. The results of such Working Group. Each such Working Group meetings shall be constituted recorded in writing. The minutes shall be approved and signed by both Parties’ project leaders. The minutes shall be marked as the applicable Joint Committee determines “Confidential” and shall establish its own procedures, to the extent that such procedures are not inconsistent with this Agreement; provided that each Working Group shall have adequate functional representation from each Party. Members of a Working Group may also be members of a Joint Committee. Working Groups may be established on an ad hoc basis for purposes of a specific project or on such other basis as the applicable Joint Committee may determine. Each Working Group and its activities shall be subject to the oversight, review, secrecy obligations and approval of, and restrictions on use as per Section 11 hereinafter. (b) The Working Groups shall report to, the Joint Committee include those of its employees that established each Party reasonably determines to be necessary or appropriate (such Working Group. In no event shall the authority of a employees may participate in more than one Working Group exceed the authority specified for the Joint Committee that established which, unless requested by a Party, need not include an equal number of each Party’s expert employees). Decisions of the Working Groups shall be by mutual agreement of the Parties, with any disputes to be resolved by the Project Steering Committee. (c) The Working Groups shall initially include the following and such other Working Groups as may be agreed from time to time by the Project Steering Committee: (i) Clinical Development Group pursuant to this Article 2. All decisions of a Working - The Clinical Development Group shall be made by unanimous agreementresponsible for proposing the clinical development plans for any Products, including IND-enabling toxicology studies, to the Project Steering Committee, supervising all clinical activities with respect to any Products, and coordinating and implementing the clinical trials and regulatory submissions in connection with those various clinical trial activities. Any disagreement between The Clinical Development Group shall report to the representatives Project Steering Committee from time to time the results of Takeda Development activities for review and Denali for decisions on a Working subsequent activities. (ii) Process Development and Production (PDP) Group—The PDP Group shall be referred responsible, as necessary from time to time, for proposing the process development and production activities with respect to any Products to the Joint Project Steering Committee that established supervising such activities, and coordinating and implementing initial, adaption and scale-up activities. The PDP Group also shall support with its activities the Working clinical development process for any Products. The PDP Group for resolution in accordance with Section 2.3.6. Employees of either Party (or a Party’s Affiliate) that are not representatives of such Party on a Working Group may attend meetings of such Working Group; provided, that the Party wishing such persons to participate in a meeting has provided reasonable advance notice shall report to the other Party. Non-employees may only attend meetings of a Working Group if such non-employee is bound by written obligations of confidentiality and non-disclosure substantially equivalent Project Steering Committee from time to those set forth in Article 11 and with time the prior written approval results of the other Party (such approval not to be unreasonably withheld, delayed or conditioned)work performed for decisions on subsequent activities.

Working Groups. (a) From time to time, a Joint Committee may establish and delegate duties to sub-committees or directed teams (each, a “Working Group”) on an “as-needed” basis to oversee particular projects or activities (for exampleactivities, joint finance group and/or joint intellectual property group), provided which delegation shall be reflected in the minutes of the meetings of the Committee that in no event shall a Joint Committee have the right to, and no Joint Committee shall, delegate its respective decision-making authority to any established such Working Group. Each such Working Group shall be constituted and shall operate as the applicable Joint Committee determines and shall establish its own procedures, to the extent that such procedures are not inconsistent with this Agreement; provided that each establishing it determines. A Working Group shall have adequate functional representation from each Party. Members of a Working Group may also be members of a Joint Committee. Working Groups may be established on an ad hoc basis for purposes of a specific project project, for the life of a Licensed Product, or on such other basis as the applicable Joint Committee may determineestablishing it determines. Each Working Group and its activities shall be subject to the oversight, review, review and approval of, and shall report to, the Joint Committee that established such Working Groupit. In no event shall the authority of a the Working Group exceed the authority that specified for the Joint Committee that established the Working Group pursuant to this Article 2. All decisions of a Working Group shall be made by unanimous agreementit. Any disagreement between the representatives designees of Takeda BMS and Denali Zymo on a Working Group shall be referred to the Joint Alliance Managers and the Committee that established it for resolution. (b) Concurrent with the formation of the initial JDC pursuant to Section 3.2.2, a Manufacturing Working Group for resolution in accordance with Section 2.3.6reporting to the JDC will be formed. Employees of either Party (or a Party’s Affiliate) that are not representatives of such Party on a The Manufacturing Working Group may attend meetings of shall develop a plan and timeline and work with the Finance Contacts to develop a budget for Manufacturing technology transfer and any additional process Development efforts to support the Joint Development Plan, provided that after all Manufacturing-related activities to be conducted by Zymo under the Joint Development Plan have been completed (including all such process transfer), unless otherwise provided by the JDC, the Manufacturing Working Group will dissolve. The Manufacturing Working Group; provided, that the Party wishing such persons to participate in a meeting has provided reasonable advance notice ’s plan will be forwarded to the other Party. Non-employees may only attend meetings of a Working Group if such non-employee is bound by written obligations of confidentiality JDC for comment and non-disclosure substantially equivalent subsequent proposal to those set forth in Article 11 the JEC for review and with approval at the prior written approval first JEC meeting as part of the other Party (such approval not to be unreasonably withheld, delayed or conditioned)Joint Development Plan.

Working Groups. From time to time, a Joint Committee may establish and delegate duties to sub-committees or directed teams (each, a “Working Group”) to oversee particular projects or activities (for example, joint finance group and/or joint intellectual property groupthe Finance Working Group and CMC Working Group), provided that in no event shall a Joint Committee have the right to, and no Joint Committee shall, delegate its respective decision-making authority to any such Working Group. Each such Working Group shall be constituted as the applicable Joint Committee determines and shall establish its own procedures, to the extent that such procedures are not inconsistent consistent with this Definitive LRRK2 Agreement; provided that each Working Group shall have adequate functional representation from each Party. Members of a Working Group may also be members of a Joint Committee. Working Groups may be established as a standing subcommittee or on an ad hoc basis for purposes of a specific project or on such other basis as the applicable Joint Committee may determine. Each Working Group and its activities shall be subject to the oversight, review, review and approval of, and shall report to, the Joint Committee that established such Working Group. In no event shall the authority of a Working Group exceed the authority specified for the Joint Committee that established the Working Group pursuant to this Article 22 (Collaboration Management). All decisions of a Working Group shall be made by unanimous agreement. Any disagreement between the representatives of Takeda Biogen and Denali on a Working Group shall be referred to the Joint Committee that established the Working Group for resolution in accordance with Section 2.3.62.4.5 (Joint Committee Decision-Making). Employees Personnel of either Party (or a Party’s Affiliate) that are not representatives of such Party on a Working Group may attend meetings of such Working Group; provided, provided that the Party wishing such persons to participate in a meeting has provided reasonable advance notice to the other Party. NonParty and non-employees may only attend meetings of a Working Group if such non-employee is bound by written obligations of confidentiality and non-disclosure substantially equivalent to those set forth in Article 11 10 (Confidentiality and with Non-Disclosure) or is otherwise bound by professional ethical obligations. Unless the prior written approval Parties otherwise agree, draft minutes of the other Party meetings of any Working Group will be generated and circulated to its members within [***] following the meeting. The responsibility for generating and circulating any such minutes will alternate between the Alliance Managers (or their designees). The Working Groups will use diligent efforts to review and finalize any such approval not to be unreasonably withheldminutes within [***] after their circulation and, delayed or conditioned)in all circumstances, no later than the next meeting of the same Working Group.

Working Groups. From A working group will be established immediately after the formation of the JRC (the “Working Group”). The Working Group will have three chairpersons: a chemistry chairperson from AMRI, a chemistry chairperson from BMS and a biology chairperson from BMS. The key responsibility of the Working Group will be the day-to-day execution of the Research Plan. The Working Group will report directly to the JRC and will present its progress against the Research Plan to the JRC once per Calendar Quarter during the term of the Research Program. The chairpersons of the Working Group will designate employees from BMS and AMRI to be members of the Working Group as needed to get proper representation on the Working Group for all expertise needed to execute the Research Plan. In addition, from time to time, a Joint Committee the JRC may establish and delegate duties to sub-committees or directed teams (each, a on an “Working Group”) as-needed” basis to oversee particular projects or activities (for example, joint finance group and/or joint intellectual property group), provided that in no event shall a Joint Committee have the right to, and no Joint Committee shall, delegate its respective decision-making authority to any such Working Groupactivities. Each such Working Group sub-committee shall be constituted and shall operate as the applicable Joint Committee determines and shall establish its own procedures, to the extent that such procedures are not inconsistent with this Agreement; provided that each Working Group shall have adequate functional representation from each PartyJRC determines. Members of a Working Group may also be members of a Joint Committee. Working Groups Sub-committees may be established on an ad hoc basis for purposes of a specific project or on such other basis as the applicable Joint Committee JRC may determine. Each The Working Group and its each sub-committee and their activities shall be subject to the oversight, review, review and approval of, and shall report to, the Joint Committee that established such JRC. Decisions of the Working Group and each sub-committee shall be reached by consensus between the Parties, and in no case shall either Party have a casting vote in decisions of the Working Group, or any sub-committee of the JRC. In the case of a non-concurrence in the Working Group, or in a sub-committee, the issue shall be referred for a decision to the JRC. In no event shall the authority of a the Working Group exceed the authority that specified for the Joint Committee that established the Working Group pursuant to JRC in this Article 2. All decisions of a Working Group shall be made by unanimous agreement. Any disagreement between the representatives of Takeda and Denali on a Working Group shall be referred to the Joint Committee that established the Working Group for resolution in accordance with Section 2.3.6. Employees of either Party (or a Party’s Affiliate) that are not representatives of such Party on a Working Group may attend meetings of such Working Group; provided, that the Party wishing such persons to participate in a meeting has provided reasonable advance notice to the other Party. Non-employees may only attend meetings of a Working Group if such non-employee is bound by written obligations of confidentiality and non-disclosure substantially equivalent to those set forth in Article 11 and with the prior written approval of the other Party (such approval not to be unreasonably withheld, delayed or conditioned).

Working Groups. From time to time, a Joint the Parties or any Committee may establish and delegate duties to sub-committees or directed teams a working group (each, a “Working Group”) to oversee particular projects or activities activities. Within thirty (for example30) days after the Effective Date, joint Infinity and AbbVie shall designate their representatives to a finance working group and/or joint (the “Finance Working Group”), which shall initially report to the JSC; a medical affairs working group (the “IST/IIS Working Group”), which shall initially report to the JMAC; a regulatory working group (the “Regulatory Working Group”), a pharmacovigilance working group (the “Pharmacovigilance Working Group”), an intellectual property groupworking group (the “IP Working Group”), provided and a translational medicine working group (the “Translational Medicine Working Group”), each of which shall initially report to the JDC; a co-promotion working group (the “Co-Promotion Working Group”), which shall report to the JCC; and a manufacturing working group (the “Manufacturing Working Group”), which shall report to the JDC for Development-related Manufacturing matters and shall report to the JCC for all matters involving Commercialization-related Manufacturing matters. The Committee to which any Working Group reports may be reassigned upon approval of the JSC. Each Working Group shall undertake the activities allocated to it herein or delegated to it by the Committee to which it reports. During the process of establishing each Working Group, such Working Group and the Committee to which it reports shall agree regarding which matters such Working Group will resolve on its own and which matters such Working Group will advise the Committee regarding (and with respect to which such advice-specific matters the Committee will resolve); provided, that in no event shall Committee or any other Person designated with authority hereunder may delegate to a Joint Committee have the right to, and no Joint Committee shall, delegate its respective Working Group any decision-making authority over any matter that has been expressly allocated to any a Committee or such Working Group. Each such Working Group shall be constituted as Person in Section 2.9, and provided further, that the applicable Joint Committee determines Parties acknowledge and shall establish its own procedures, to the extent that such procedures are not inconsistent with this Agreement; provided agree that each Working Group shall have adequate functional representation from is intended to function primarily in a supporting role providing advice to the Committee to which it reports, but that each Party. Members of a Working Group may also will be members of a Joint Committee. Working Groups may be established on an ad hoc basis for purposes of a specific project or on such other basis best positioned to provide expedited guidance regarding certain operational matters as the applicable Joint Committee may determine. Each Working Group determined by and its activities shall be subject to the oversight, review, and approval of, and shall report to, jurisdiction of the Joint Committee that established to which such Working Group. In no event shall the authority of a Working Group exceed the authority specified for the Joint Committee that established the Working Group pursuant to this Article 2. All decisions of a Working Group shall be made by unanimous agreementreports. Any disagreement between the representatives of Takeda and Denali on dispute arising within a Working Group shall be referred to the Joint Committee that established the Working Group to which it reports for resolution in accordance with Section 2.3.6. Employees of either Party (or a Party’s Affiliate) that are not representatives of such Party on a Working Group may attend meetings of such Working Group; provided, that the Party wishing such persons to participate in a meeting has provided reasonable advance notice to the other Party. Non-employees may only attend meetings of a Working Group if such non-employee is bound by written obligations of confidentiality and non-disclosure substantially equivalent to those set forth in Article 11 and with the prior written approval of the other Party (such approval not to be unreasonably withheld, delayed or conditioned)resolution.