Common use of Joint Steering Committee Clause in Contracts

Joint Steering Committee. Within three (3) weeks after the execution of this Agreement, the parties shall form a joint steering committee (the “JSC”) comprised of four individuals designated as set forth below, which JSC shall be responsible for the general oversight of the research carried out hereunder, including without limitation: (i) reviewing the goals, strategy, Milestone Events (as defined in Exhibit B), and results of the Work Plan (set forth in Exhibit A) and the activities performed thereunder; (ii) recommending and approving changes to the Work Plan; (iii) assigning relative priorities in the Work Plan; (iv) terminating any specific activities under the Work Plan; (v) determining whether a Milestone Event has occurred; and (vi) resolving any disagreements between the parties concerning the research and development activities carried out under this Agreement. Each party shall designate two (2) individual representatives as members of the JSC, each of whom shall be authorized to make decisions on behalf of the designating party (subject to the terms and conditions of this Section 2.c.) and shall have significant experience and expertise in the research and development of pharmaceutical compounds. Each party shall CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED. have the right, at any time, to designate by written notice to the other Party, a replacement for any of such party’s representatives on the JSC. The JSC shall endeavor to work by consensus. Decisions of the JSC shall be made by unanimous written consent and shall be included in amendments to the Work Plan, if applicable. Where unanimity cannot be achieved in respect of any matter following good faith, commercially reasonable efforts on the part of the members of the JSC, such disputed matter shall be referred to the relevant senior management of the parties who shall promptly meet and endeavor to come to an agreement in a timely manner. The JSC will determine, subject to the terms and conditions of this Section 2.c., whether any Milestone Event has occurred. The JSC will notify the relevant senior management of each party in writing that any such Milestone Event has occurred no later than [***] after such a determination.

Appears in 3 contracts

Samples: Collaboration Agreement (Morphic Holding, Inc.), Collaboration Agreement (Morphic Holding, Inc.), Collaboration Agreement (Morphic Holding, Inc.)

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Joint Steering Committee. Within three (3) weeks Promptly after the execution Effective Date, the Parties shall establish a "Joint Steering Committee" as described in this Section 1A. The Joint Steering Committee shall exist during the Research Term. The Joint Steering Committee shall, subject to applicable provisions of this AgreementAgreement concerning the Research Program, the parties shall form a joint steering committee (the “JSC”) comprised of four individuals designated as set forth belowWork Plan, which JSC shall be responsible for the general oversight of the research carried out hereunderand Budget, including without limitation: (i) reviewing the goalsdevelop, strategyreview, Milestone Events (as defined in Exhibit B)approve, and results establish all aspects of the Work Plan (set forth in Exhibit A) and Budget and, once the activities performed thereunder; initial Work Plan and Budget have been established, (ii) recommending monitor and approving oversee the Parties' progress thereunder, advise the Parties with respect thereto, and develop, review, and approve any changes or amendments to the Work Plan; Plan and Budget, such changes and amendments to be effective upon approval thereof by the Joint Steering Committee and agreement by (iiii) assigning relative priorities in Optimer with respect to obligations of Optimer (such agreement not to be unreasonably withheld) or (ii) Cempra with respect to responsibilities of Cempra, provided that, notwithstanding the Work Plan; (iv) terminating any specific activities under foregoing, the Work Plan; (v) determining whether a Milestone Event has occurred; and (vi) resolving any disagreements between Joint Steering Committee shall have no authority to amend the parties concerning the research and development activities carried out under body of this Agreement. Each party shall designate two indicate in writing within five (25) individual representatives as members business days of approval by the JSCJoint Steering Committee whether or not it agrees to its proposed obligations or responsibilities, each and, if not agreeing to its proposed obligations or responsibilities, provide its reasonable objections thereto. In the absence of whom such written notice within such five (5) business day period, a party shall be authorized deemed to make decisions on behalf of the designating party (subject to the terms and conditions of this Section 2.c.) and shall have significant experience and expertise rejected its proposed obligations or responsibilities, and, in the research and development of pharmaceutical compounds. Each party shall CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED. have the right, at any time, to designate event Optimer rejects its proposed obligations or responsibilities (whether by written notice or the absence thereof), Cempra shall be free to pursue alternative solutions therefor. Notwithstanding anything to the other Partycontrary in this Agreement, a replacement for any of such party’s representatives on the JSC. The JSC Joint Steering Committee shall endeavor to work by consensus. Decisions of the JSC have no rights or responsibilities, and Cempra shall be made by unanimous written consent and shall be included in amendments have no obligations with respect to the Work PlanJoint Steering Committee, if applicable. Where unanimity cannot be achieved in respect of any matter following good faith, commercially reasonable efforts on the part of the members of the JSC, such disputed matter shall be referred to the relevant senior management of the parties who shall promptly meet and endeavor to come to an agreement in a timely manner. The JSC will determine, subject to the terms and conditions of this Section 2.cResearch Term., whether any Milestone Event has occurred. The JSC will notify the relevant senior management of each party in writing that any such Milestone Event has occurred no later than [***] after such a determination.

Appears in 3 contracts

Samples: Development and License Agreement (Optimer Pharmaceuticals Inc), Development and License Agreement (Optimer Pharmaceuticals Inc), Stockholders Agreement (Optimer Pharmaceuticals Inc)

Joint Steering Committee. Within three (3) weeks Promptly after the execution Effective Date, the Parties shall establish a “Joint Steering Committee” as described in this Section 1A. The Joint Steering Committee shall exist during the Research Term. The Joint Steering Committee shall, subject to applicable provisions of this AgreementAgreement concerning the Research Program, the parties shall form a joint steering committee (the “JSC”) comprised of four individuals designated as set forth belowWork Plan, which JSC shall be responsible for the general oversight of the research carried out hereunderand Budget, including without limitation: (i) reviewing the goalsdevelop, strategyreview, Milestone Events (as defined in Exhibit B)approve, and results establish all aspects of the Work Plan (set forth in Exhibit A) and Budget and, once the activities performed thereunder; initial Work Plan and Budget have been established, (ii) recommending monitor and approving oversee the Parties’ progress thereunder, advise the Parties with respect thereto, and develop, review, and approve any changes or amendments to the Work Plan; Plan and Budget, such changes and amendments to be effective upon approval thereof by the Joint Steering Committee and agreement by (iiii) assigning relative priorities in Optimer with respect to obligations of Optimer (such agreement not to be unreasonably withheld) or (ii) Cempra with respect to responsibilities of Cempra, provided that, notwithstanding the Work Plan; (iv) terminating any specific activities under foregoing, the Work Plan; (v) determining whether a Milestone Event has occurred; and (vi) resolving any disagreements between Joint Steering Committee shall have no authority to amend the parties concerning the research and development activities carried out under body of this Agreement. Each party shall designate two indicate in writing within five (25) individual representatives as members business days of approval by the JSCJoint Steering Committee whether or not it agrees to its proposed obligations or responsibilities, each and, if not agreeing to its proposed obligations or responsibilities, provide its reasonable objections thereto. In the absence of whom such written notice within such five (5) business day period, a party shall be authorized deemed to make decisions on behalf of the designating party (subject to the terms and conditions of this Section 2.c.) and shall have significant experience and expertise rejected its proposed obligations or responsibilities, and, in the research and development of pharmaceutical compounds. Each party shall CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED. have the right, at any time, to designate event Optimer rejects its proposed obligations or responsibilities (whether by written notice or the absence thereof), Cempra shall be free to pursue alternative solutions therefor. Notwithstanding anything to the other Partycontrary in this Agreement, a replacement for any of such party’s representatives on the JSC. The JSC Joint Steering Committee shall endeavor to work by consensus. Decisions of the JSC have no rights or responsibilities, and Cempra shall be made by unanimous written consent and shall be included in amendments have no obligations with respect to the Work PlanJoint Steering Committee, if applicable. Where unanimity cannot be achieved in respect of any matter following good faith, commercially reasonable efforts on the part of the members of the JSC, such disputed matter shall be referred to the relevant senior management of the parties who shall promptly meet and endeavor to come to an agreement in a timely manner. The JSC will determine, subject to the terms and conditions of this Section 2.cResearch Term., whether any Milestone Event has occurred. The JSC will notify the relevant senior management of each party in writing that any such Milestone Event has occurred no later than [***] after such a determination.

Appears in 3 contracts

Samples: Collaborative Research and Development and License Agreement (Optimer Pharmaceuticals Inc), Stockholders Agreement (Cempra Holdings, LLC), Stockholders Agreement (Optimer Pharmaceuticals Inc)

Joint Steering Committee. Within three (3) weeks [***] after the execution of this Agreement, the parties shall form a joint steering committee (the “JSC”) comprised of four individuals [***] designated as set forth below, which JSC shall be responsible for the general oversight of the research carried out hereunder, including without limitation: (i) reviewing the goals, strategy, Milestone Events (as defined in Exhibit B), and results and deliverables of the Work Plan (as set forth in Exhibit A, the “Work Plan”) or any Research Plan and the activities performed thereunder; (ii) recommending and approving changes to the Work Plan or any Research Plan; (iii) assigning relative priorities in the Work Plan or any Research Plan; (iv) terminating any specific activities under the Work Plan or any Research Plan; (v) determining whether a Milestone Event has occurred; and (vi) resolving any disagreements between the parties concerning the research and development activities carried out under this Agreement. Each party shall designate two (2) [***] individual representatives as members of the JSC, each of whom shall be authorized to make decisions on behalf of the designating party (subject to the terms and conditions of this Section 2.c.) and shall have significant experience and expertise in the research and development of pharmaceutical compounds. Each party shall CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED. have the right, at any time, to designate by written notice to the other Party, a replacement for any of such party’s representatives on the JSC. The JSC shall endeavor to work by consensus. Decisions of the JSC shall be made by unanimous written consent and shall be included in amendments to the Work Plan, if applicable. Where unanimity cannot be achieved in respect of any matter following good faith, commercially reasonable efforts on the part of the members of the JSC, such disputed matter shall be referred CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED. to the relevant senior management of the parties who shall promptly meet and endeavor to come to an agreement in a timely manner. The JSC will determine, subject to the terms and conditions of this Section 2.c., whether any Milestone Event has occurred. The JSC will notify the relevant senior management of each party in writing that any such Milestone Event has occurred no later than [***] after such a determination.

Appears in 2 contracts

Samples: Collaboration Agreement (Morphic Holding, Inc.), Collaboration Agreement (Morphic Holding, Inc.)

Joint Steering Committee. Within three (3) weeks Promptly after the execution of this Agreement, the parties Parties shall form establish a joint steering committee to oversee, review and coordinate the activities of the Parties under this Agreement (the “Joint Steering Committee” or “JSC”) comprised ). Each Party shall name a mutually agreed upon equal number of four individuals designated as set forth below, which JSC shall be responsible representatives for the general oversight of the research carried out hereunder, including without limitation: (i) reviewing the goals, strategy, Milestone Events (as defined in Exhibit B), and results of the Work Plan (set forth in Exhibit A) and the activities performed thereunder; (ii) recommending and approving changes to the Work Plan; (iii) assigning relative priorities in the Work Plan; (iv) terminating any specific activities under the Work Plan; (v) determining whether a Milestone Event has occurred; and (vi) resolving any disagreements between the parties concerning the research and development activities carried out under this Agreement. Each party shall designate two (2) individual representatives as members of the JSCJoint Steering Committee, each of whom shall be authorized to make decisions on behalf a knowledgeable specialist in an appropriate discipline, and at least one level of seniority above the most senior member of the designating party (subject to each Party’s members of the terms and conditions of this Section 2.c.) and shall have significant experience and expertise in Project Team; provided, however, that the research and development of pharmaceutical compounds. Each party shall CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED. have the rightJoint Steering Committee shall, at any timea minimum, to designate by written notice to consist of the other Partyhead of operations for the Walkersville Facility (or, a replacement once it is Validated and Ready, the Singapore Facility), the relevant divisional heads for any of such party’s representatives on each Party and the JSCkey account manager. The Joint Steering Committee shall meet at least once per calendar quarter during the Term of the Agreement, or as otherwise mutually agreed by the Parties. The Joint Steering Committee shall, among other things, (a) review and determine whether to approve the Statements of Work (including subsequent review and determination whether to approve Statements or Work, or modified or amended Statements of Work that have been implemented by the Project Team pending subsequent JSC shall endeavor to work by consensusreview, as set forth in Section 2.1), (b) resolve disputes of the various Project Teams, (c) oversee the progress of the Products through the development and clinical manufacture stages, (d) oversee commercial supply of the Products, and (e) review technology collaboration opportunities in support of the product portfolio. Decisions of the JSC Joint Steering Committee shall be made by unanimous unanimity, with each Party having one vote. In the event that the Joint Steering Committee does not reach unanimity with respect to a particular matter, and the Joint Steering Committee is unable to resolve the dispute after endeavoring for fifteen (15) business days to do so, then (i) either Party may, upon written consent notice, refer such matter the President of each Party’s respective business unit (or their designee having authority to resolve the dispute) (“Senior Executives”), for attempted resolution by good faith negotiations within ten (10) business days after such written notice, and (ii) if the Senior Executives do not reach resolution on such a matter within ten (10) business days after such notice, then CLIENT shall be included in amendments thereafter have final decision-making authority with respect to the Work Plan, if applicable. Where unanimity cannot be achieved in respect of any matter following good faith, commercially reasonable efforts on the part formulation or composition of the members of the JSC, such disputed matter shall be referred to the relevant senior management of the parties who shall promptly meet and endeavor to come to an agreement in a timely mannerTHIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. The JSC will determine, subject to the terms and conditions of this Section 2.c., whether any Milestone Event has occurred. The JSC will notify the relevant senior management of each party in writing that any such Milestone Event has occurred no later than REDACTED MATERIAL IS MARKED WITH [*** * *] after such a determinationAND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

Appears in 1 contract

Samples: Manufacturing Services Agreement (Mesoblast LTD)

Joint Steering Committee. Within A Joint Steering Committee (“JSC”) comprising representatives of GSK and Innoviva shall meet once per Calendar Year before the end of February, either in person or by videoconference. GSK shall not be required to have more than one (1) representative attend each JSC meeting provided that such representative is reasonably knowledgeable and informed regarding the commercialization and intellectual property protection of the Retained Products. Innoviva may have up to three (3) weeks after representatives attend each JSC meeting. The JSC’s purpose and responsibility will be to review at such meeting the execution of this Agreement, the parties shall form a joint steering committee (the “JSC”) comprised of four individuals designated as set forth below, which JSC shall be responsible for the general oversight of the research carried out hereunder, including without limitation: (i) reviewing the goals, strategy, Milestone Events (as defined in Exhibit B)sales performance, and results of one-year sales forecasts for each Retained Product in each Major Market Country and in all other countries in the Work Plan world as a group (set forth in Exhibit A) and the activities performed thereunder; (ii) recommending and approving changes to the Work Plan; (iii) assigning relative priorities material related assumptions used in the Work Plan; (iv) terminating any specific activities under the Work Plan; (v) determining whether a Milestone Event has occurred; and (vi) resolving any disagreements between the parties concerning the research and development activities carried out under this Agreementdeveloping such forecasts). Each party shall designate two (2) individual representatives as members of Through its representative on the JSC, each GSK will also provide an annual update on major developments (if any) in the patent protection for the Retained Products.” For the avoidance of whom shall doubt, there will be authorized to make decisions no representation of TRC on behalf of the designating party (subject JSC and the JSC will not discuss matters pertaining to the terms and conditions of this Section 2.c.) and shall have significant experience and expertise Assigned Collaboration Products. All other references in the research and development of pharmaceutical compounds. Each party shall CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED. have the right, at any time, to designate by written notice Collaboration Agreement to the Joint Steering Committee (other Partythan in Section 1.4.8) shall hereafter be deemed deleted, a replacement for any of such party’s representatives on the JSC. The JSC shall endeavor to work by consensus. Decisions of that the JSC shall have no rights, powers or obligations (other than those set out in Section 3.1) and GSK alone shall assume all such rights, powers, obligations and roles previously held by the Joint Steering Committee. ii. Section 3.2 of the Collaboration Agreement is hereby deleted in its entirety and replaced with the following “[Reserved.]”, and all other references in the Collaboration Agreement to the Joint Project Committee shall hereafter be made deemed deleted, such that the Joint Project Committee shall have no rights, powers or obligations and GSK alone shall assume all such rights, powers, obligations and roles previously held by unanimous written consent the Joint Project Committee. iii. Section 5.1 of the Collaboration Agreement is hereby deleted in its entirety and replaced with the following “[Reserved.]”, and all other references in the Collaboration Agreement to “Marketing Plan(s)” shall hereafter have no further force or effect and shall be included in amendments to the Work Plan, if applicabledeemed deleted and null and void for all purposes. Where unanimity cannot be achieved in respect of any matter following good faith, commercially reasonable efforts on the part iv. Section 7.1.1 of the members Collaboration Agreement is hereby deleted in its entirety and replaced with the following “[Reserved.]” v. Section 13.1.3 of the JSC, such disputed matter Collaboration Agreement shall be referred to amended by the relevant senior management deletion of the parties who following sentence: “GSK shall promptly meet regularly advise Theravance of the status of all pending applications, including with respect to any hearings or other proceedings before any Governmental Authority, and, at Theravance’s request, shall provide Theravance with copies of documentation relating to such applications, including all correspondence to and endeavor to come to an agreement in a timely manner. The JSC will determine, subject to the terms and conditions of this Section 2.cfrom any Governmental Authority., whether any Milestone Event has occurred. The JSC will notify the relevant senior management of each party in writing that any such Milestone Event has occurred no later than [***] after such a determination.

Appears in 1 contract

Samples: Collaboration Agreement (Innoviva, Inc.)

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Joint Steering Committee. Within three (3) weeks Promptly after the execution of this Agreement, the parties Parties shall form establish a joint steering committee to oversee, review and coordinate the activities of the Parties under this Agreement (the “Joint Steering Committee” or “JSC”) comprised ). Each Party shall name a mutually agreed upon equal number of four individuals designated as set forth below, which JSC shall be responsible representatives for the general oversight of the research carried out hereunder, including without limitation: (i) reviewing the goals, strategy, Milestone Events (as defined in Exhibit B), and results of the Work Plan (set forth in Exhibit A) and the activities performed thereunder; (ii) recommending and approving changes to the Work Plan; (iii) assigning relative priorities in the Work Plan; (iv) terminating any specific activities under the Work Plan; (v) determining whether a Milestone Event has occurred; and (vi) resolving any disagreements between the parties concerning the research and development activities carried out under this Agreement. Each party shall designate two (2) individual representatives as members of the JSCJoint Steering Committee, each of whom shall be authorized to make decisions on behalf a knowledgeable specialist in an appropriate discipline, and at least one level of seniority above the most senior member of the designating party (subject to each Party’s members of the terms and conditions of this Section 2.c.) and shall have significant experience and expertise in Project Team; provided, however, that the research and development of pharmaceutical compounds. Each party shall CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED. have the rightJoint Steering Committee shall, at any timea minimum, to designate by written notice to consist of the other Partyhead of operations for the Walkersville Facility (or, a replacement once it is Validated and Ready, the Singapore Facility), the relevant divisional heads for any of such party’s representatives on each Party and the JSCkey account manager. The Joint Steering Committee shall meet at least once per calendar quarter during the Term of the Agreement, or as otherwise mutually agreed by the Parties. The Joint Steering Committee shall, among other things, (a) review and determine whether to approve the Statements of Work (including subsequent review and determination whether to approve Statements or Work, or modified or amended Statements of Work that have been implemented by the Project Team pending subsequent JSC shall endeavor to work by consensusreview, as set forth in Section 2.1), (b) resolve disputes of the various Project Teams, (c) oversee the progress of the Products through the development and clinical manufacture stages, (d) oversee commercial supply of the Products, and (e) review technology collaboration opportunities in support of the product portfolio. Decisions of the JSC Joint Steering Committee shall be made by unanimous unanimity, with each Party having one vote. In the event that the Joint Steering Committee does not reach unanimity with respect to a particular matter, and the Joint Steering Committee is unable to resolve the dispute after endeavoring for fifteen (15) business days to do so, then (i) either Party may, upon written consent and shall be included in amendments to notice, refer such matter the Work Plan, if applicable. Where unanimity cannot be achieved in respect of any matter following good faith, commercially reasonable efforts on the part of the members of the JSC, such disputed matter shall be referred to the relevant senior management of the parties who shall promptly meet and endeavor to come to an agreement in a timely manner. The JSC will determine, subject to the terms and conditions of this Section 2.c., whether any Milestone Event has occurred. The JSC will notify the relevant senior management President of each party in writing that any such Milestone Event has occurred no later than [***] Party’s respective business unit (or their designee having authority to resolve the dispute) (“Senior Executives”), for attempted resolution by good faith negotiations within ten (10) business days after such written notice, and (ii) if the Senior Executives do not reach resolution on such a determination.matter within ten (10) business days after such notice, then CLIENT shall thereafter have final decision-making authority with respect to formulation or composition of the

Appears in 1 contract

Samples: Manufacturing Services Agreement (Mesoblast LTD)

Joint Steering Committee. Within three ninety (390) weeks after days of the execution of this AgreementEffective Date, the parties Parties shall form establish a joint steering committee to oversee the performance of the Agreement which shall consist of two appointees of the Licensor and two appointees of Licensee (the “JSCSteering Committee” or “SC) comprised of four individuals designated as set forth below, which JSC ). The Steering Committee shall be responsible run and act in accordance with the provisions of Exhibit E Without prejudice to the provisions of Exhibit E the Steering Committee shall act as a forum to discuss and coordinate all aspects of the Development, manufacture and Commercialization of the Products in or for the general oversight Territory for the purpose of coordinating and maximizing the research carried out hereunder, including without limitation: (i) reviewing the goals, strategy, Milestone Events (as defined commercial interests of both Parties and any key decisions and updates on progress in Exhibit B), and results of the Work Plan (set forth in Exhibit A) and the activities performed thereunder; (ii) recommending and approving changes to the Work Plan; (iii) assigning relative priorities in the Work Plan; (iv) terminating any specific activities under the Work Plan; (v) determining whether a Milestone Event has occurred; and (vi) resolving any disagreements between the parties concerning the research and development activities carried out under this Agreement. Each party shall designate two (2) individual representatives as relation thereto will be shared among members of the JSCSteering Committee in accordance with Exhibit E to ensure both Parties are kept up to date on relevant issues. For the avoidance of doubt, each except as provided otherwise in this Agreement, Licensee shall have the sole and final discretion or decision-making power in relation to Development, manufacture, and Commercialization of whom the Products in the Territory For the avoidance of doubt, such discretion or decision-making power shall only apply to the extent that such activity concerns only the Territory. Licensee may not, and shall procure that its Affiliates and sublicensees do not, perform or conduct any such activity in a manner that has, or is reasonably likely to have, a detrimental impact on the legal title, right and benefit as enjoyed by the Licensor in the Products. The Steering Committee shall continue to exist until the earlier of the Parties mutually agreeing in writing to disband the Steering Committee (either in entirety or with respect to a particular Product or Products) or on termination of this Agreement in its entirety with respect to all Products. On discontinuance of the Steering Committee, but in the event that this Agreement continues in effect, the Steering Committee shall have no further responsibilities under this Agreement and any requirement of a Party to provide information, reports or other materials to the Steering Committee shall be authorized deemed a requirement to make decisions on behalf of the designating party (subject to the terms and conditions of this Section 2.c.) and shall have significant experience and expertise in the research and development of pharmaceutical compounds. Each party shall CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENTprovide such information, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED. have the right, at any time, to designate by written notice reports or other materials to the other Party, a replacement for any of such party’s representatives on the JSC. The JSC shall endeavor to work by consensus. Decisions of the JSC shall be made by unanimous written consent and shall be included in amendments to the Work Plan, if applicable. Where unanimity cannot be achieved in respect of any matter following good faith, commercially reasonable efforts on the part of the members of the JSC, such disputed matter shall be referred to the relevant senior management of the parties who shall promptly meet and endeavor to come to an agreement in a timely manner. The JSC will determine, subject to the terms and conditions of this Section 2.c., whether any Milestone Event has occurred. The JSC will notify the relevant senior management of each party in writing that any such Milestone Event has occurred no later than [***] after such a determination.DEVELOPMENT

Appears in 1 contract

Samples: License, Collaboration and Distribution Agreement

Joint Steering Committee. Within three thirty (330) weeks after days of the execution of this AgreementEffective Date, the parties Parties shall form establish a joint steering committee to oversee the performance of the Agreement and the Exclusive Trademark License, which shall consist of two appointees of the Licensor and two appointees of Licensee (the “JSCSteering Committee” or “SC) comprised of four individuals designated as set forth below, which JSC ). The Steering Committee shall be responsible run and act in accordance with the provisions of Exhibit E. Without prejudice to the provisions of Exhibit E the Steering Committee shall act as a forum to discuss and coordinate all aspects of the Development, Manufacture and Commercialization of the Products in the Field in and for the general oversight Territory for the purpose of coordinating and maximizing the commercial interests of both Parties and any key decisions and updates on progress in relation thereto will be shared among members of the research carried out hereunderSteering Committee in accordance with Exhibit E to ensure both Parties are kept up to date on relevant issues. For the avoidance of doubt, except as provided otherwise in this Agreement (including without limitation: clause (i3) reviewing in Exhibit E), Licensee shall have the goalssole and final discretion or decision-making power in relation to Manufacture and Commercialization of the Products in the Field in the Territory, strategyprovided that Licensee must exercise its final decision-making power consistent with Licensor’s Global Branding Strategy and strictly in accordance with the terms of the Exclusive Trademark License. For the avoidance of doubt, Milestone Events such discretion or decision-making power shall only apply to the extent that such activity concerns only in the Field in the Territory, and Licensee shall not have the final discretion or decision making power over matters that affects the Development, Manufacture or Commercialization of the Product outside the Territory, or the Development of any indication outside the Field in the Territory (as defined long as such indication, once approved, will be automatically included in Exhibit Bthe Field and the rights or benefits granted to Licensee under this License will be accordingly extended to such indication), and results for which Licensor shall have the final decision making power. Licensor shall have the final decision making authority in relation to the Development of the Work Plan Product (set forth in Exhibit Aincluding the local regulatory strategies or solutions for the Territory) and the activities performed thereunderGlobal Branding Strategy for the Product; provided that Licensor’s decision is consistent with the guidance or requirements of local Regulatory Authorities and provides its decision promptly within a period officially requested by the Regulatory Authority or otherwise reasonably requested by Licensee. Licensee may not, and shall procure that its Affiliates and Designated Parties do not, exercise its discretion or final decision making power or perform or conduct any such activity in a manner that has, or is reasonably likely to have, a detrimental impact on the Development, manufacture or Commercialization of the Product outside the Territory or the legal title, right and benefit as enjoyed by the Licensor in the Licensor IP or Products (iiincluding Development of any indication outside the Field in the Territory, as long as such indication, once approved, will be automatically included in the Field and the rights or benefits granted to Licensee under this License will be accordingly extended to such indication). The Steering Committee shall continue to exist until the earlier of the Parties mutually agreeing in writing to disband the Steering Committee (either in entirety or with respect to a particular Product or Products) recommending or on termination of this Agreement in its entirety with respect to all Products. On discontinuance of the Steering Committee, but in the event that this Agreement continues in effect, the Steering Committee shall have no further responsibilities under this Agreement and approving changes any requirement of a Party to provide information, reports or other materials to the Work Plan; (iii) assigning relative priorities in the Work Plan; (iv) terminating any specific activities under the Work Plan; (v) determining whether a Milestone Event has occurred; and (vi) resolving any disagreements between the parties concerning the research and development activities carried out under this Agreement. Each party shall designate two (2) individual representatives as members of the JSC, each of whom Steering Committee shall be authorized deemed a requirement to make decisions on behalf of the designating party (subject to the terms and conditions of this Section 2.c.) and shall have significant experience and expertise in the research and development of pharmaceutical compounds. Each party shall CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENTprovide such information, MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED. have the right, at any time, to designate by written notice reports or other materials to the other Party, a replacement for any of such party’s representatives on the JSC. The JSC shall endeavor to work by consensus. Decisions of the JSC shall be made by unanimous written consent and shall be included in amendments to the Work Plan, if applicable. Where unanimity cannot be achieved in respect of any matter following good faith, commercially reasonable efforts on the part of the members of the JSC, such disputed matter shall be referred to the relevant senior management of the parties who shall promptly meet and endeavor to come to an agreement in a timely manner. The JSC will determine, subject to the terms and conditions of this Section 2.c., whether any Milestone Event has occurred. The JSC will notify the relevant senior management of each party in writing that any such Milestone Event has occurred no later than [***] after such a determination.

Appears in 1 contract

Samples: License, Collaboration and Supply Agreement (Capstar Special Purpose Acquisition Corp.)

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