Common use of Joint Steering Committee Clause in Contracts

Joint Steering Committee. Promptly after the 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 Agreement concerning the Research Program, Work Plan, and Budget, (i) develop, review, approve, and establish all aspects of the Work Plan and Budget and, once the initial Work Plan and Budget have been established, (ii) monitor and oversee the Parties' progress thereunder, advise the Parties with respect thereto, and develop, review, and approve any changes or amendments to the Work Plan and Budget, such changes and amendments to be effective upon approval thereof by the Joint Steering Committee and agreement by (i) 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 foregoing, the Joint Steering Committee shall have no authority to amend the body of this Agreement. Each party shall indicate in writing within five (5) business days of approval by the Joint Steering Committee whether or not it agrees to its proposed obligations or responsibilities, and, if not agreeing to its proposed obligations or responsibilities, provide its reasonable objections thereto. In the absence of such written notice within such five (5) business day period, a party shall be deemed to have rejected its proposed obligations or responsibilities, and, in the 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 contrary in this Agreement, the Joint Steering Committee shall have no rights or responsibilities, and Cempra shall have no obligations with respect to the Joint Steering Committee, following the Research Term.

Joint Steering Committee. Promptly Within three (3) weeks after the Effective Dateexecution of this Agreement, the Parties parties shall establish form a "Joint Steering Committee" joint steering committee (the “JSC”) comprised of four individuals designated as described in this Section 1A. The Joint Steering Committee set forth below, which JSC shall exist during be responsible for the Research Term. The Joint Steering Committee shallgeneral oversight of the research carried out hereunder, subject to applicable provisions of this Agreement concerning the Research Program, Work Plan, and Budget, including without limitation: (i) developreviewing the goals, reviewstrategy, approveMilestone Events (as defined in Exhibit B), and establish all aspects results of the Work Plan (set forth in Exhibit A) and Budget and, once the initial Work Plan and Budget have been established, activities performed thereunder; (ii) monitor recommending and oversee the Parties' progress thereunder, advise the Parties with respect thereto, and develop, review, and approve any approving changes or amendments to the Work Plan 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 Budget, such changes (vi) resolving any disagreements between the parties concerning the research and amendments to be effective upon approval thereof by the Joint Steering Committee and agreement by (i) 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 foregoing, the Joint Steering Committee shall have no authority to amend the body of development activities carried out under this Agreement. Each party shall indicate 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 writing within five (5) business days the research and development of approval by the Joint Steering Committee whether or not it agrees to its proposed obligations or responsibilities, and, if not agreeing to its proposed obligations or responsibilities, provide its reasonable objections theretopharmaceutical compounds. In the absence of such written notice within such five (5) business day period, a Each party shall be deemed 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 have rejected its proposed obligations or responsibilities, and, in the event Optimer rejects its proposed obligations or responsibilities (whether designate by written notice or to the absence thereof)other Party, Cempra 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 free to pursue alternative solutions therefor. Notwithstanding anything made by unanimous written consent and shall be included in amendments to the contrary Work Plan, if applicable. Where unanimity cannot be achieved in this Agreementrespect of any matter following good faith, commercially reasonable efforts on the Joint Steering Committee part of the members of the JSC, such disputed matter shall have no rights or responsibilities, and Cempra shall have no obligations with respect be referred to the Joint Steering Committeerelevant senior management of the parties who shall promptly meet and endeavor to come to an agreement in a timely manner. The JSC will determine, following subject to the Research Termterms 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.

Joint Steering Committee. Promptly after the 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 Agreement concerning the Research Program, Work Plan, and Budget, (i) develop, review, approve, and establish all aspects of the Work Plan and Budget and, once the initial Work Plan and Budget have been established, (ii) monitor and oversee the Parties' ’ progress thereunder, advise the Parties with respect thereto, and develop, review, and approve any changes or amendments to the Work Plan and Budget, such changes and amendments to be effective upon approval thereof by the Joint Steering Committee and agreement by (i) 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 foregoing, the Joint Steering Committee shall have no authority to amend the body of this Agreement. Each party shall indicate in writing within five (5) business days of approval by the Joint Steering Committee whether or not it agrees to its proposed obligations or responsibilities, and, if not agreeing to its proposed obligations or responsibilities, provide its reasonable objections thereto. In the absence of such written notice within such five (5) business day period, a party shall be deemed to have rejected its proposed obligations or responsibilities, and, in the 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 contrary in this Agreement, the Joint Steering Committee shall have no rights or responsibilities, and Cempra shall have no obligations with respect to the Joint Steering Committee, following the Research Term.

Joint Steering Committee. Promptly Within [***] after the Effective Dateexecution of this Agreement, the Parties parties shall establish form a "Joint Steering Committee" joint steering committee (the “JSC”) comprised of [***] designated as described in this Section 1A. The Joint Steering Committee set forth below, which JSC shall exist during be responsible for the Research Term. The Joint Steering Committee shallgeneral oversight of the research carried out hereunder, subject to applicable provisions of this Agreement concerning the Research Program, Work Plan, and Budget, including without limitation: (i) developreviewing the goals, reviewstrategy, approveMilestone Events (as defined in Exhibit B), and establish all aspects results and deliverables of the Work Plan and Budget and(as set forth in Exhibit A, once the initial “Work Plan”) or any Research Plan and Budget have been established, the activities performed thereunder; (ii) monitor recommending and oversee the Parties' progress thereunder, advise the Parties with respect thereto, and develop, review, and approve any approving changes or amendments 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 Budget, such changes (vi) resolving any disagreements between the parties concerning the research and amendments to be effective upon approval thereof by the Joint Steering Committee and agreement by (i) 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 foregoing, the Joint Steering Committee shall have no authority to amend the body of development activities carried out under this Agreement. Each party shall indicate designate [***] 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 writing within five (5) business days the research and development of approval by the Joint Steering Committee whether or not it agrees to its proposed obligations or responsibilities, and, if not agreeing to its proposed obligations or responsibilities, provide its reasonable objections theretopharmaceutical compounds. In the absence of such written notice within such five (5) business day period, a Each party shall be deemed have the right, at any time, to have rejected its proposed obligations or responsibilities, and, in the event Optimer rejects its proposed obligations or responsibilities (whether designate by written notice or to the absence thereof)other Party, Cempra 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 free to pursue alternative solutions therefor. Notwithstanding anything made by unanimous written consent and shall be included in amendments to the contrary Work Plan, if applicable. Where unanimity cannot be achieved in this Agreementrespect of any matter following good faith, commercially reasonable efforts on the Joint Steering Committee part of the members of the JSC, such disputed matter shall have no rights or responsibilitiesbe referred CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, and Cempra shall have no obligations with respect MARKED BY [***], HAS BEEN OMITTED BECAUSE IT IS NOT MATERIAL AND WOULD LIKELY CAUSE COMPETITIVE HARM TO THE COMPANY IF PUBLICLY DISCLOSED. to the Joint Steering Committeerelevant senior management of the parties who shall promptly meet and endeavor to come to an agreement in a timely manner. The JSC will determine, following subject to the Research Termterms 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.

Joint Steering Committee. Promptly after Within ninety (90) days of the Effective Date, the Parties shall establish a "Joint 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 “Steering Committee" as described in this Section 1A. ” or “SC”). The Joint Steering Committee shall exist during be run and act in accordance with the Research Term. The Joint provisions of Exhibit E Without prejudice to the provisions of Exhibit E the Steering Committee shall, subject shall act as a forum to applicable provisions of this Agreement concerning the Research Program, Work Plan, discuss and Budget, (i) develop, review, approve, and establish coordinate all aspects of the Work Plan Development, manufacture and Budget andCommercialization of the Products in or for the 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 Steering Committee in accordance with Exhibit E to ensure both Parties are kept up to date on relevant issues. For the avoidance of doubt, once except as provided otherwise in this Agreement, Licensee shall have the initial Work Plan sole and Budget have been establishedfinal discretion or decision-making power in relation to Development, (ii) monitor manufacture, and oversee Commercialization of the Parties' progress thereunderProducts in the Territory For the avoidance of doubt, advise 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 with respect thereto, and develop, review, and approve any changes or amendments mutually agreeing in writing to disband the Work Plan and Budget, such changes and amendments to be effective upon approval thereof by the Joint Steering Committee and agreement by (i) Optimer either in entirety or with respect to obligations of Optimer (such agreement not to be unreasonably withhelda particular Product or Products) or (ii) Cempra on termination of this Agreement in its entirety with respect to responsibilities all Products. On discontinuance of Cemprathe Steering Committee, provided that, notwithstanding but in the foregoingevent that this Agreement continues in effect, the Joint Steering Committee shall have no authority further responsibilities under this Agreement and any requirement of a Party to amend provide information, reports or other materials to the body of this Agreement. Each party shall indicate in writing within five (5) business days of approval by the Joint Steering Committee whether or not it agrees to its proposed obligations or responsibilities, and, if not agreeing to its proposed obligations or responsibilities, provide its reasonable objections thereto. In the absence of such written notice within such five (5) business day period, a party shall be deemed a requirement to have rejected its proposed obligations provide such information, reports or responsibilities, and, in the 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 other materials to the contrary in this Agreement, the Joint Steering Committee shall have no rights or responsibilities, and Cempra shall have no obligations with respect to the Joint Steering Committee, following the Research Term.other Party. DEVELOPMENT

Joint Steering Committee. Promptly after the Effective Date, the Parties shall establish a "Joint Steering Committee" as described in this Section 1A. The A Joint Steering Committee (“JSC”) comprising representatives of GSK and Innoviva shall exist during meet once per Calendar Year before the Research Termend 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) representatives attend each JSC meeting. The JSC’s purpose and responsibility will be to review at such meeting the sales performance, and one-year sales forecasts for each Retained Product in each Major Market Country and in all other countries in the world as a group (and the material related assumptions used in developing such forecasts). Through its representative on the JSC, GSK will also provide an annual update on major developments (if any) in the patent protection for the Retained Products.” For the avoidance of doubt, there will be no representation of TRC on the JSC and the JSC will not discuss matters pertaining to the Assigned Collaboration Products. All other references in the Collaboration Agreement to the Joint Steering Committee shall, subject to applicable provisions of this Agreement concerning the Research Program, Work Plan, and Budget, (iother than in Section 1.4.8) develop, review, approve, and establish all aspects of the Work Plan and Budget and, once the initial Work Plan and Budget have been established, (ii) monitor and oversee the Parties' progress thereunder, advise the Parties with respect thereto, and develop, review, and approve any changes or amendments to the Work Plan and Budgetshall hereafter be deemed deleted, such changes that the JSC shall have no rights, powers or obligations (other than those set out in Section 3.1) and amendments to be effective upon approval thereof GSK alone shall assume all such rights, powers, obligations and roles previously held by the Joint Steering Committee Committee. ii. Section 3.2 of the Collaboration Agreement is hereby deleted in its entirety and agreement by (i) Optimer replaced with respect the following “[Reserved.]”, and all other references in the Collaboration Agreement to obligations of Optimer (such agreement not to be unreasonably withheld) or (ii) Cempra with respect to responsibilities of Cempra, provided that, notwithstanding the foregoing, the Joint Steering Project Committee shall hereafter be deemed deleted, such that the Joint Project Committee shall have no authority to amend the body of this Agreement. Each party rights, powers or obligations and GSK alone shall indicate in writing within five (5) business days of approval assume all such rights, powers, obligations and roles previously held by the Joint Steering Committee whether 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 not it agrees effect and shall be deemed deleted and null and void for all purposes. iv. Section 7.1.1 of the Collaboration Agreement is hereby deleted in its entirety and replaced with the following “[Reserved.]” v. Section 13.1.3 of the Collaboration Agreement shall be amended by the deletion of the following sentence: “GSK shall regularly advise Theravance of the status of all pending applications, including with respect to its proposed obligations any hearings or responsibilitiesother proceedings before any Governmental Authority, and, if not agreeing at Theravance’s request, shall provide Theravance with copies of documentation relating to its proposed obligations or responsibilitiessuch applications, provide its reasonable objections thereto. In the absence of such written notice within such five (5) business day period, a party shall be deemed including all correspondence to have rejected its proposed obligations or responsibilities, and, in the 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 contrary in this Agreement, the Joint Steering Committee shall have no rights or responsibilities, and Cempra shall have no obligations with respect to the Joint Steering Committee, following the Research Termfrom any Governmental Authority.”

Joint Steering Committee. Promptly after the Effective Dateexecution of this Agreement, the Parties shall establish a "steering committee to oversee, review and coordinate the activities of the Parties under this Agreement (the “Joint Steering Committee" as described ” or “JSC”). Each Party shall name a mutually agreed upon equal number of representatives for the Joint Steering Committee, each of whom shall be a knowledgeable specialist in this Section 1A. an appropriate discipline, and at least one level of seniority above the most senior member of the each Party’s members of the Project Team; provided, however, that the Joint Steering Committee shall, at a minimum, consist of the head of operations for the Walkersville Facility (or, once it is Validated and Ready, the Singapore Facility), the relevant divisional heads for each Party and the key account manager. The Joint Steering Committee shall exist meet at least once per calendar quarter during the Research TermTerm of the Agreement, or as otherwise mutually agreed by the Parties. The Joint Steering Committee shall, subject among other things, (a) review and determine whether to applicable provisions approve the Statements of this Agreement concerning 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 Research ProgramProject Team pending subsequent JSC review, Work Planas 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 Budget, (ie) develop, review, approve, and establish all aspects review technology collaboration opportunities in support of the Work Plan and Budget and, once the initial Work Plan and Budget have been established, (ii) monitor and oversee the Parties' progress thereunder, advise the Parties with respect thereto, and develop, review, and approve any changes or amendments to the Work Plan and Budget, such changes and amendments to be effective upon approval thereof by the Joint Steering Committee and agreement by (i) Optimer with respect to obligations product portfolio. Decisions of Optimer (such agreement not to be unreasonably withheld) or (ii) Cempra with respect to responsibilities of Cempra, provided that, notwithstanding the foregoing, the Joint Steering Committee shall have no authority to amend be made by unanimity, with each Party having one vote. In the body of this Agreement. Each party shall indicate in writing within five (5) business days of approval by event that the Joint Steering Committee whether or does not it agrees reach unanimity with respect to its proposed obligations or responsibilitiesa particular matter, and, if not agreeing to its proposed obligations or responsibilities, provide its reasonable objections thereto. In the absence of such written notice within such five (5) business day period, a party shall be deemed to have rejected its proposed obligations or responsibilities, and, in the 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 contrary in this Agreement, and the Joint Steering Committee shall have no rights is unable to resolve the dispute after endeavoring for fifteen (15) business days to do so, then (i) either Party may, upon written notice, refer such matter the President of each Party’s respective business unit (or responsibilitiestheir 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 Cempra (ii) if the Senior Executives do not reach resolution on such a matter within ten (10) business days after such notice, then CLIENT shall thereafter have no obligations final decision-making authority with respect to formulation or composition of the Joint Steering Committee, following the Research TermTHIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [* * *] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION.

Joint Steering Committee. Promptly after the Effective Dateexecution of this Agreement, the Parties shall establish a "steering committee to oversee, review and coordinate the activities of the Parties under this Agreement (the “Joint Steering Committee" as described ” or “JSC”). Each Party shall name a mutually agreed upon equal number of representatives for the Joint Steering Committee, each of whom shall be a knowledgeable specialist in this Section 1A. an appropriate discipline, and at least one level of seniority above the most senior member of the each Party’s members of the Project Team; provided, however, that the Joint Steering Committee shall, at a minimum, consist of the head of operations for the Walkersville Facility (or, once it is Validated and Ready, the Singapore Facility), the relevant divisional heads for each Party and the key account manager. The Joint Steering Committee shall exist meet at least once per calendar quarter during the Research TermTerm of the Agreement, or as otherwise mutually agreed by the Parties. The Joint Steering Committee shall, subject among other things, (a) review and determine whether to applicable provisions approve the Statements of this Agreement concerning 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 Research ProgramProject Team pending subsequent JSC review, Work Planas 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 Budget, (ie) develop, review, approve, and establish all aspects review technology collaboration opportunities in support of the Work Plan and Budget and, once the initial Work Plan and Budget have been established, (ii) monitor and oversee the Parties' progress thereunder, advise the Parties with respect thereto, and develop, review, and approve any changes or amendments to the Work Plan and Budget, such changes and amendments to be effective upon approval thereof by the Joint Steering Committee and agreement by (i) Optimer with respect to obligations product portfolio. Decisions of Optimer (such agreement not to be unreasonably withheld) or (ii) Cempra with respect to responsibilities of Cempra, provided that, notwithstanding the foregoing, the Joint Steering Committee shall have no authority to amend be made by unanimity, with each Party having one vote. In the body of this Agreement. Each party shall indicate in writing within five (5) business days of approval by event that the Joint Steering Committee whether or does not it agrees reach unanimity with respect to its proposed obligations or responsibilitiesa particular matter, and, if not agreeing to its proposed obligations or responsibilities, provide its reasonable objections thereto. In the absence of such written notice within such five (5) business day period, a party shall be deemed to have rejected its proposed obligations or responsibilities, and, in the 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 contrary in this Agreement, and the Joint Steering Committee shall have no rights is unable to resolve the dispute after endeavoring for fifteen (15) business days to do so, then (i) either Party may, upon written notice, refer such matter the President of each Party’s respective business unit (or responsibilitiestheir 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 Cempra (ii) if the Senior Executives do not reach resolution on such a matter within ten (10) business days after such notice, then CLIENT shall thereafter have no obligations final decision-making authority with respect to the Joint Steering Committee, following the Research Term.formulation or composition of the

Joint Steering Committee. Promptly after Within thirty (30) days of the Effective Date, the Parties shall establish a "Joint 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 “Steering Committee" as described in this Section 1A. ” or “SC”). The Joint Steering Committee shall exist during be run and act in accordance with the Research Term. The Joint provisions of Exhibit E. Without prejudice to the provisions of Exhibit E the Steering Committee shall, subject shall act as a forum to applicable provisions of this Agreement concerning the Research Program, Work Plan, discuss and Budget, (i) develop, review, approve, and establish coordinate all aspects of the Work Plan Development, Manufacture and Budget andCommercialization of the Products in the Field in and for the 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 Steering 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 clause (3) in Exhibit E), Licensee shall have the sole and final discretion or decision-making power in relation to Manufacture and Commercialization of the Products in the Field in the Territory, provided 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, 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 long as such indication, once approved, will be automatically included in the initial Work Plan Field and Budget the rights or benefits granted to Licensee under this License will be accordingly extended to such indication), for which Licensor shall have been establishedthe final decision making power. Licensor shall have the final decision making authority in relation to the Development of the Product (including the local regulatory strategies or solutions for the Territory) and the Global 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 (ii) monitor including 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 oversee the Parties' progress thereunder, advise 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 with respect thereto, and develop, review, and approve any changes or amendments mutually agreeing in writing to disband the Work Plan and Budget, such changes and amendments to be effective upon approval thereof by the Joint Steering Committee and agreement by (i) Optimer either in entirety or with respect to obligations of Optimer (such agreement not to be unreasonably withhelda particular Product or Products) or (ii) Cempra on termination of this Agreement in its entirety with respect to responsibilities all Products. On discontinuance of Cemprathe Steering Committee, provided that, notwithstanding but in the foregoingevent that this Agreement continues in effect, the Joint Steering Committee shall have no authority further responsibilities under this Agreement and any requirement of a Party to amend provide information, reports or other materials to the body of this Agreement. Each party shall indicate in writing within five (5) business days of approval by the Joint Steering Committee whether or not it agrees to its proposed obligations or responsibilities, and, if not agreeing to its proposed obligations or responsibilities, provide its reasonable objections thereto. In the absence of such written notice within such five (5) business day period, a party shall be deemed a requirement to have rejected its proposed obligations provide such information, reports or responsibilities, and, in the 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 other materials to the contrary in this Agreement, the Joint Steering Committee shall have no rights or responsibilities, and Cempra shall have no obligations with respect to the Joint Steering Committee, following the Research Termother Party.