Common use of Formation and Role Clause in Contracts

Formation and Role. The Parties hereby establish a Joint Committee that shall monitor and coordinate communication regarding the Parties' performance under this Agreement to Develop and obtain Regulatory Approval for the Product in the Field and in the Licensed Territory. Each Party shall have an equal number of representatives on the Joint Committee, who initially shall be the individuals set forth in Exhibit F. The Joint Committee shall have the membership and authority, and shall operate by the procedures, set forth for it in this Section 2.1 and in Section 2.2. The role of the Joint Committee shall be: (i) to review the overall strategy for seeking Regulatory Approval in the Licensed Territory of the Product for the Initial Indications and any other indications in the Field Collaborator seeks to develop the Product for; (ii) to facilitate the exchange of information between the Parties with respect to the activities hereunder for the Licensed Territory and to establish procedures for the efficient sharing of information and materials necessary for Collaborator's Development of Products hereunder, consistent with this Agreement; (iii) to review, approve, and, if necessary, amend the Development Plan; (iv) to seek to resolve any issues arising under this Agreement; (v) to monitor the Parties' performance against each then-current Development Plan; (vi) to provide a forum to evaluate strategies for obtaining, maintaining and enforcing patent and trademark protection for Products in the Licensed Territory; and (vii) to perform such other functions as appropriate to further the purposes of this Agreement, as determined by the Parties. The Joint Committee shall perform its responsibilities under this Agreement based on the principles of prompt and diligent Development of Products in the Licensed Territory, consistent with good pharmaceutical practices and the maximization of long-term profits derived from the sale of Products in the Licensed Territory. The Joint Committee shall have only the powers assigned expressly to it in this Article 2 and elsewhere in this Agreement, and the Joint Committee shall not have any power to amend, modify or waive compliance with this Agreement.

Formation and Role. The Within [*] after the Effective Date, the Parties hereby shall establish a joint development committee (the "Joint Committee Development Committee" or "JDC") that shall monitor and coordinate communication regarding will be responsible for overseeing the Parties' performance under this Agreement to Develop and obtain Regulatory Approval for Development of the Product in the Field and in the Licensed Territory. Each Party shall have an equal number of representatives on the Joint Committee, who initially shall be the individuals set forth in Exhibit F. The Joint Committee shall have the membership and authority, and shall operate by the procedures, set forth for it in this Section 2.1 and in Section 2.2Field. The role of the Joint Committee JDC shall be: (i) to review oversee the overall strategy for seeking Regulatory Approval in the Licensed Territory Development of the Product for the Initial Indications and any other indications in the Field Collaborator seeks to develop the Product forField; (ii) to prepare amendments to the Development Plan, including the budget for each Development activity and the design of each clinical trial or other study included or proposed to be included in the Development Plan, for review and approval by the JSC, the first amendment of which shall be to add a Regulatory Plan created by the JDC; (iii) to agree on the requirements for Drug Approval in the Licensed Territory; (iv) to establish general guidelines for Investigator-Sponsored Studies with respect to a Product in the Field which, if complied with by a particular ISS, will allow a Party to authorize or facilitate such ISS on prior notice to the JDC but without the need for obtaining the other Party's approval; (v) to review any disputes between the Parties regarding a potential Material Impact of an ISS that does not comply with the general guidelines established by the JDC; (vi) to review, discuss and coordinate the Parties' scientific presentation and publication strategy relating to Products in the Field; (vii) to discuss Development activities in the Field between the Licensed Territory and the Allos Territory; (viii) to facilitate the exchange flow of information Information between the Parties with respect to the activities hereunder for the Licensed Territory Development of, and to establish procedures for the efficient sharing of information and materials necessary for Collaborator's Development of Products hereunderobtaining Drug Approval for, consistent with this Agreement; (iii) to review, approve, and, if necessary, amend the Development Plan; (iv) to seek to resolve any issues arising under this Agreement; (v) to monitor the Parties' performance against each then-current Development Plan; (vi) to provide a forum to evaluate strategies for obtaining, maintaining and enforcing patent and trademark protection for Products in the Licensed TerritoryField; and (viiix) to perform such other functions as may be appropriate to further the purposes of this Agreement, with respect to the Development of the Product in the Field, as determined directed by the Parties. The Joint Committee shall perform its responsibilities under this Agreement based on the principles of prompt and diligent Development of Products in the Licensed Territory, consistent with good pharmaceutical practices and the maximization of long-term profits derived from the sale of Products in the Licensed Territory. The Joint Committee shall have only the powers assigned expressly to it in this Article 2 and elsewhere in this Agreement, and the Joint Committee shall not have any power to amend, modify or waive compliance with this AgreementJSC.

Formation and Role. The Within [ * ] after the Effective Date, the Parties hereby shall establish a joint development committee (the “Joint Committee Development Committee” or “JDC”) that shall monitor and coordinate communication regarding will be responsible for overseeing the Parties' performance under this Agreement to Develop and obtain Regulatory Approval for Development of the Product in the Field and in the Licensed Territory. Each Party shall have an equal number of representatives on the Joint Committee, who initially shall be the individuals set forth in Exhibit F. The Joint Committee shall have the membership and authority, and shall operate by the procedures, set forth for it in this Section 2.1 and in Section 2.2Field. The role of the Joint Committee JDC shall be: (i) to review oversee the overall strategy for seeking Regulatory Approval in the Licensed Territory Development of the Product for the Initial Indications and any other indications in the Field Collaborator seeks to develop the Product forField; (ii) to prepare amendments to the Development Plan, including the budget for each Development activity and the design of each clinical trial or other study included or proposed to be included in the Development Plan, for review and approval by the JSC, the first amendment of which shall be to add a Regulatory Plan created by the JDC; (iii) to agree on the requirements for Drug Approval in the Licensed Territory; (iv) to establish general guidelines for Investigator-Sponsored Studies with respect to a Product in the Field which, if complied with by a particular ISS, will allow a Party to authorize or facilitate such ISS on prior notice to the JDC but without the need for obtaining the other Party’s approval; (v) to review any disputes between the Parties regarding a potential Material Impact of an ISS that does not comply with the general guidelines established by the JDC; (vi) to review, discuss and coordinate the Parties’ scientific presentation and publication strategy relating to Products in the Field; (vii) to discuss Development activities in the Field between the Licensed Territory and the Allos Territory; (viii) to facilitate the exchange flow of information Information between the Parties with respect to the activities hereunder for the Licensed Territory Development of, and to establish procedures for the efficient sharing of information and materials necessary for Collaborator's Development of Products hereunderobtaining Drug Approval for, consistent with this Agreement; (iii) to review, approve, and, if necessary, amend the Development Plan; (iv) to seek to resolve any issues arising under this Agreement; (v) to monitor the Parties' performance against each then-current Development Plan; (vi) to provide a forum to evaluate strategies for obtaining, maintaining and enforcing patent and trademark protection for Products in the Licensed TerritoryField; and (viiix) to perform such other functions as may be appropriate to further the purposes of this Agreement, with respect to the Development of the Product in the Field, as determined directed by the Parties. The Joint Committee shall perform its responsibilities under this Agreement based on the principles of prompt and diligent Development of Products in the Licensed Territory, consistent with good pharmaceutical practices and the maximization of long-term profits derived from the sale of Products in the Licensed Territory. The Joint Committee shall have only the powers assigned expressly to it in this Article 2 and elsewhere in this Agreement, and the Joint Committee shall not have any power to amend, modify or waive compliance with this AgreementJSC.

Formation and Role. The Parties hereby establish a Joint Steering Committee (sometimes referred to hereinafter as “JSC”) that shall monitor and coordinate communication regarding the Parties' ’ performance under this Agreement to Develop and Develop, obtain Regulatory Approval for and Commercialize the Product in the Field and in the Licensed Territory. Each Party shall have an equal number of representatives on the Joint Committee, who initially shall be the individuals set forth in Exhibit F. The Joint Committee shall have the membership and authority, and shall operate by the procedures, set forth for it in this Section 2.1 and in Section 2.2Product. The role of the Joint Committee JSC shall be: (i) to discuss and agree upon the Development Plan and Commercialization Plan, and any proposed changes or amendments thereto that are not inconsistent with this Agreement; (ii) to review the overall strategy for Developing and seeking Regulatory Approval for, manufacturing of, and Commercializing the Product in the Licensed Territory of the Product for the Initial Indications and any other indications in the Field Collaborator seeks to develop the Product forTerritory; (iiiii) to facilitate the exchange of information between the Parties with respect to the activities hereunder for the Licensed Territory and to establish procedures for the efficient sharing of information and materials necessary for Collaborator's each Party’s Development, Product Development and Commercialization of Products the Product hereunder, consistent with this Agreement; (iii) to review, approve, and, if necessary, amend the Development Plan; (iv) to seek review the plan and the summary budget for the Development with respect to resolve any issues arising under this Agreementthe applicable countries in the Territory and provide comments regarding the content and implementation of such plans; (v) to monitor the Parties' ’ performance against each the then-current Development PlanPlan and Commercialization Plans; (vi) to inform the other party of up-coming material internal events and decisions related to each such party’s obligations hereunder and communicate to the other party on the results of such events and decisions taken; (vii) to discuss material submissions to FDA and other Regulatory Authorities; (viii) to create subcommittees as the JSC may find necessary or desirable from time to time for implementation of the Development and Commercialization hereunder; (ix) to oversee the activities of subcommittees created under this Agreement, and to seek to resolve any issues that such subcommittees cannot resolve; (x) to provide a forum to evaluate strategies for obtaining, maintaining and enforcing patent and trademark protection for Products the Product in the Licensed Territory; and (viixi) to perform such other functions as appropriate to further the purposes of this Agreement, as determined by the Parties. The Joint Committee shall perform its responsibilities under this Agreement based on the principles of prompt and diligent Development of Products in the Licensed Territory, consistent with good pharmaceutical practices and the maximization of long-term profits derived from the sale of Products in the Licensed Territory. The Joint Committee shall have only the powers assigned expressly to it in this Article 2 and elsewhere in this Agreement, and the Joint Committee shall not have any power to amend, modify or waive compliance with this Agreement.

Formation and Role. The Parties hereby agree to establish a Joint Steering Committee that shall monitor (or “JSC”) for the overall coordination and coordinate communication regarding oversight of the Parties' performance ’ activities under this Agreement to Develop and obtain Regulatory Approval for Agreement, promptly after the Product in the Field and in the Licensed Territory. Each Party shall have an equal number of representatives on the Joint Committee, who initially shall be the individuals set forth in Exhibit F. The Joint Committee shall have the membership and authority, and shall operate by the procedures, set forth for it in this Section 2.1 and in Section 2.2Effective Date. The role of the Joint Steering Committee shall be: (i) to review (A) review, coordinate, discuss and approve the overall strategy for conducting Development of and seeking Regulatory Approval for Products in the Licensed Territory of the Product for the Initial Indications and any other indications Retained Territory in the Field Collaborator seeks to develop and (B) review and discuss Commercializing Products in the Product forLicensed Territory in the Field; (ii) to review, discuss and approve the Development Plan and/or associated budget, any proposed amendments or revisions to the Development Plan and any corresponding change to the associated budget; (iii) to facilitate the exchange of information between the Parties with respect to under this Agreement regarding the strategy for implementing the joint Development activities hereunder for the Licensed Territory and to establish procedures discuss those activities that a Party may conduct independently for the efficient sharing of information and materials necessary for Collaborator's Development of Products hereunder, consistent with this Agreementits Territory; (iiiiv) to oversee the activities performed by the JDC; (v) to review, approvediscuss and approve the Commercialization Plan, and, if necessary, amend the Development Planand any proposed amendments or revisions to such plan; (ivvi) to seek to resolve any issues arising under this Agreement; (vvii) to monitor establish such additional joint subcommittees as it deems necessary to achieve the Parties' performance against each then-current Development Planobjectives and intent of this Agreement; (viviii) to provide a forum review, discuss and approve publications pursuant to evaluate strategies for obtaining, maintaining and enforcing patent and trademark protection for Products in the Licensed Territorythis Agreement; and (viiix) to perform such other functions as appropriate to further the purposes of this Agreement, as determined by the Parties. The Joint Committee shall perform its responsibilities under this Agreement based on the principles of prompt and diligent Development of Products Parties in the Licensed Territory, consistent with good pharmaceutical practices and the maximization of long-term profits derived from the sale of Products in the Licensed Territory. The Joint Committee shall have only the powers assigned expressly to it in this Article 2 and elsewhere in this Agreement, and the Joint Committee shall not have any power to amend, modify or waive compliance with this Agreementwriting.

Formation and Role. The Parties hereby establish a Joint Steering Committee that shall monitor and coordinate communication regarding the Parties' ’ performance under this Agreement to Develop and Develop, obtain Regulatory Approval for and Commercialize the Product in the Field and in the Licensed Territory. Each Party shall have an equal number of representatives on the Joint Committee, who initially shall be the individuals set forth in Exhibit F. The Joint Committee shall have the membership and authority, and shall operate by the procedures, set forth for it in this Section 2.1 and in Section 2.2Field. The role of the Joint Committee JSC shall be: (i) to review the overall strategy for Developing and seeking Regulatory Approval for, manufacturing, and Commercializing the Product in the Licensed Territory of the Product for the Initial Indications and any other indications in the Field Collaborator seeks to develop the Product forField; (ii) to facilitate the exchange of information between the Parties with respect to the activities hereunder for the Licensed Territory and to establish procedures for the efficient sharing of information and materials necessary for Collaborator's each Party’s Development and Commercialization of Products the Product hereunder, consistent with this Agreement; (iii) to review, approve, and, if necessary, amend the U.S. Development Plan, the Development Budget and the U.S. Commercialization Plan (including related budget); (iv) to seek review the plan and the summary budget for the ROW Development to resolve any issues arising under the extent customarily generated by or available to Takeda from its Affiliates or sublicensees for its internal purposes with respect to the applicable countries in the Royalty [ * ] = Certain confidential information contained in this Agreementdocument, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. Territory (all Xxxxx 0 Xxxxxxx xxx Xxxxx 0 Xxxxxxx wherein Takeda decides to Develop the Product, as described in further detail in Section 3.5) and the ROW Commercialization Plan and provide comments regarding the content and implementation of such plans, which comments shall not be controlling but shall be considered by Takeda in good faith; (v) to monitor the Parties' ’ performance against each the then-current U.S. Development PlanPlan and Commercialization Plans; (vi) to create subcommittees as the JSC may find necessary or desirable from time to time for implementation of the Development and Commercialization hereunder; (vii) to oversee the activities of subcommittees created under this Agreement, and to seek to resolve any issues that such subcommittees cannot resolve; (viii) without reducing Affymax’s obligation to obtain and maintain the Affymax Patents and/or the Product Trademark provided for herein, to provide a forum to evaluate strategies for obtaining, maintaining and enforcing patent and trademark protection for Products the Product in the Licensed Territory; and (viiix) to perform such other functions as appropriate to further the purposes of this Agreement, as determined by the Parties. The Joint Committee shall perform its responsibilities under this Agreement based on the principles of prompt and diligent Development of Products in the Licensed Territory, consistent with good pharmaceutical practices and the maximization of long-term profits derived from the sale of Products in the Licensed Territory. The Joint Committee shall have only the powers assigned expressly to it in this Article 2 and elsewhere in this Agreement, and the Joint Committee shall not have any power to amend, modify or waive compliance with this Agreement.

Formation and Role. The Parties hereby agree to establish and convene a Joint Executive Steering Committee that shall monitor (or “ESC”) for the overall coordination and coordinate communication regarding oversight of the Parties' performance ’ activities under this Agreement to Develop and obtain Regulatory Approval for Agreement, promptly after the Product in the Field and in the Licensed TerritoryEffective Date. Each Party shall have an equal number of representatives on the Joint Committee, who initially shall be the individuals set forth in Exhibit F. ESC. The Joint Committee shall have the membership and authority, and ESC shall operate by the procedures, procedures set forth for it in this Section 2.1 and in Section 2.23.3. The Except as otherwise provided in Section 14.3(b) and subject to Section 14.2(b), the role of the Joint Executive Steering Committee shall be:: ** Indicates that certain information contained herein has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. **** Indicates that the amount of information omitted was a page or more in length, and such information has been filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. (i) For the Licensed Territory and the ROW Territory, to review and discuss the overall strategy for seeking the Development, Manufacture, Regulatory Approval in (including the Licensed Territory initial approval and any supplements and expansions thereof) and Commercialization of the Product for the Initial Indications and any other indications in the Field Collaborator seeks to develop the Product forProduct; (ii) to facilitate review, discuss and approve the exchange Development Plans (including the Development Budget) on or before March 1 of information between the Parties with respect to the activities hereunder for the Licensed Territory and to establish procedures for the efficient sharing of information and materials necessary for Collaborator's Development of Products hereunder, consistent with this Agreementeach calendar year; (iii) to review, approve, and, if necessary, amend discuss and approve any changes or revisions to the Development PlanPlan (including the Development Budget); (iv) to seek review and discuss the Sales and Marketing Plan, and any proposed amendments or revisions to resolve any issues arising under this Agreementsuch plan; (v) to monitor resolve any disputes arising within the Parties' performance against each then-current Development Plan;JDC; and (vi) to provide a forum to evaluate strategies for obtainingestablish such subcommittees, maintaining including without limitation the regulatory working group as provided in Section 5.3 and enforcing patent the Publication Team as provided in Section 6.7, and trademark protection for Products in the Licensed Territory; and (vii) to perform such other functions as appropriate to further the purposes of this Agreement, as determined mutually agreed by the Parties. The Joint Committee shall perform its responsibilities under this Agreement based on the principles of prompt and diligent Development of Products Parties in the Licensed Territory, consistent with good pharmaceutical practices and the maximization of long-term profits derived from the sale of Products in the Licensed Territory. The Joint Committee shall have only the powers assigned expressly to it in this Article 2 and elsewhere in this Agreement, and the Joint Committee shall not have any power to amend, modify or waive compliance with this Agreementwriting.

Formation and Role. The Parties hereby establish a Joint Committee that shall monitor and coordinate communication regarding the Parties' ’ performance under this Agreement to Develop and obtain Regulatory Approval for the Product in the Field and in the Licensed Territory. Each Party shall have an equal number of representatives on the Joint Committee, who initially shall be the individuals set forth in Exhibit F. The Joint Committee shall have the membership and authority, and shall operate by the procedures, set forth for it in this Section 2.1 and in Section 2.2. The role of the Joint Committee shall be: (i) to review the overall strategy for seeking Regulatory Approval in the Licensed Territory of the Product for the Initial Indications and any other indications in the Field Collaborator seeks to develop the Product for; (ii) to facilitate the exchange of information between the Parties with respect to the activities hereunder for the Licensed Territory and to establish procedures for the efficient sharing of information and materials necessary for Collaborator's ’s Development of Products hereunder, consistent with this Agreement; (iii) to review, approve, and, if necessary, amend the Development Plan; (iv) to seek to resolve any issues arising under this Agreement; (v) to monitor the Parties' ’ performance against each then-current Development Plan; (vi) to provide a forum to evaluate strategies for obtaining, maintaining and enforcing patent and trademark protection for Products in the Licensed Territory; and (vii) to perform such other functions as appropriate to further the purposes of this Agreement, as determined by the Parties. [ * ] = Certain confidential information contained in this document, marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 406 of the Securities Act of 1933, as amended. The Joint Committee shall perform its responsibilities under this Agreement based on the principles of prompt and diligent Development of Products in the Licensed Territory, consistent with good pharmaceutical practices and the maximization of long-term profits derived from the sale of Products in the Licensed Territory. The Joint Committee shall have only the powers assigned expressly to it in this Article 2 and elsewhere in this Agreement, and the Joint Committee shall not have any power to amend, modify or waive compliance with this Agreement.

Formation and Role. The Parties hereby wish to establish a Joint Committee that shall monitor and coordinate communication regarding (the Parties' performance under this Agreement “Joint Committee”) to Develop and obtain Regulatory Approval provide a forum for the Product in Parties to share and discuss their respective plans relating to the Field Development and in Commercialization of Compound(s) and Products and to coordinate activities to be taken by the Licensed TerritoryParties with respect to the Development and Commercialization of such Compound(s) and Products. Each Party shall have an equal number of representatives on the Joint Committee, who initially shall be the individuals set forth in Exhibit F. The Joint Committee shall have the membership and authority, and shall operate by the procedures, procedures set forth for it in this Section 2.1 and in Section 2.22.2 and shall have only the powers described in this Article 2 and elsewhere in this Agreement. The role of the Joint Committee shall bewill be to: (i) to review and discuss the overall strategy Parties’ respective strategies for seeking Regulatory Approval of Products for treatment of HIV infection, and such Other Indications for which a Party wishes to seek Regulatory Approval, within the Parties’ Territories (for clarification, the Parties may meet with Regulatory Authorities in their respective Territory with respect to Products for the Licensed Territory Indication without the approval of the Product for the Initial Indications and any other indications in the Field Collaborator seeks Joint Committee), subject to develop the Product fortheir obligations under this Agreement; (ii) to facilitate the exchange of information between the Parties with respect to the Gilead’s activities hereunder for the Licensed Gilead Territory and JT’s activities hereunder for the JT Territory; (iii) review and discuss the Gilead Development Plan, the Gilead Commercialization Plan and updates thereof; (iv) review and discuss the JT Development Plan, the JT Commercialization Plan and updates thereof; (v) review, discuss and facilitate resolution of matters discussed in the Joint Committee, including other agenda items submitted in accordance with Section 3.4 and Section 5.4; (vi) in conjunction with the IP Subcommittee, provide a forum for updates on strategies for obtaining, maintaining and enforcing Patent and Trademark protection for Products in the Gilead Territory; (vii) establish such working groups or sub-committees, in addition to the IP Subcommittee, as it may choose from time to time to accomplish its purposes, and such groups or subcommittees may include those not members of the Joint Committee; (viii) work with the Alliance Managers to facilitate communication, interaction and coordination of the activities under this Agreement; (ix) establish procedures for the efficient sharing of information Regulatory Information, Know-How and materials necessary for Collaborator's each Party’s preclinical, non-clinical, clinical and regulatory Development of Products hereunder, consistent with this Agreement; (iiix) review and discuss actions taken by either Party with respect to reviewProducts that would conflict with a Party’s efforts to achieve Regulatory Approval of a Product or to maximize global Commercialization of a Product for the treatment of HIV infection, approveand such Other Indications for which a Party wishes to seek Regulatory Approval, and, if necessary, amend and that could reasonably be expected to have a material adverse impact upon the Development Planregulatory status or potential sales of Products in the other Party’s Territory; (ivxi) to seek to resolve review and discuss any issues unresolved conflict arising under this Agreement; (v) to monitor the Parties' performance against each then-current Development Plan; (vi) to provide a forum to evaluate strategies for obtaining, maintaining and enforcing patent and trademark protection for Products in the Licensed TerritorySection 6.7; and (viixii) to perform such other functions as appropriate to further the purposes of this Agreement, as determined by the Parties. The Joint Committee shall perform its responsibilities under this Agreement based on the principles of prompt and diligent Development of Products in the Licensed Territory, consistent with good pharmaceutical practices and the maximization of long-term profits derived from the sale of Products in the Licensed Territory. The Joint Committee shall have only the powers assigned expressly to it in this Article 2 and elsewhere in this Agreement, and the Joint Committee shall not have any power to amend, modify or waive compliance with this Agreement.