Common use of Formation and Role Clause in Contracts

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, obtain Regulatory Approval for and Commercialize the Product in the Field. The role of the 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 and in the Field; (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 each Party's Development and Commercialization of 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 review the plan and the summary budget for the ROW Development to 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 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 the then-current U.S. Development Plan 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 the Product in the Licensed Territory; and (ix) to perform such other functions as appropriate to further the purposes of this Agreement, as determined by the Parties.

Formation and Role. The Parties hereby establish have established a joint manufacturing committee (the “Joint Steering Committee that shall monitor Manufacturing Committee” or “JMC”) for the coordination and coordinate communication regarding oversight of certain of the Parties' performance ’ activities under this Agreement to Develop, obtain Regulatory Approval for and Commercialize the Product in the FieldAgreement. The role of the JSC JMC shall bebe to: (i) to review the overall strategy for Developing coordinate forecasting, ordering and seeking Regulatory Approval for, manufacturing, and Commercializing the Product in the Licensed Territory and in the Fieldother supply-related logistics; (ii) to facilitate the exchange of information between the Parties with respect to the activities hereunder for the Licensed Territory discuss supply-related issues, including shortfalls and to establish procedures for the efficient sharing of information and materials necessary for each Party's Development and Commercialization of the Product hereunder, consistent with this Agreementquality issues; (iii) no later than six months prior to reviewthe First Commercial Sale in any country in the Licensed Territory, approvedevise, andagree upon and begin implementing a strategy for requirements of safety supplies of necessary Raw Materials and/or other materials to be utilized in the manufacture of Bulk Product, if necessary, amend the U.S. Development Plan, the Development Budget and the U.S. Commercialization Plan (including related budget)which strategy will be reviewed on an annual basis; (iv) to review the plan discuss supply-related issues regarding other forms of drug substance or finished product (if any) being pursued jointly by Allos and the summary budget for the ROW Development to the extent customarily generated MMCO or by or available to Takeda from its Affiliates or sublicensees for its internal purposes with respect to the applicable countries in the Royalty 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 faithMMCO independently; (v) to monitor the Parties' performance against the thendiscuss and coordinate manufacturing-current U.S. Development Plan related complaints, recalls and Commercialization Plansany other supply related issues; (vi) review and discuss proposals to create subcommittees as the JSC may find necessary or desirable from time to time for implementation of the Development engage, qualify and Commercialization hereundermaintain Third Party Contractors; (vii) discuss the content and scope of any quality audit undertaken, or to oversee the activities of subcommittees created under this Agreementbe undertaken, and by Allos as it relates to seek to resolve any issues that such subcommittees cannot resolveits Third Party manufacturers; (viii) without reducing Affymax's obligation to obtain review and maintain agree on Allos’ budget amounts (including agreeing on the Affymax Patents applicable FTE rates) for performing the technical assistance contemplated under Section 3.14; (ix) discuss whether Allos can meet the combined MMCO and Allos requirements for Bulk Product (including by increasing batch sizes and/or the capacity or through additional sources) when (A) MMCO’s rolling good faith forecast for required quantities of Bulk Product Trademark provided for herein, to provide a forum to evaluate strategies for obtaining, maintaining and enforcing patent and trademark protection for the Licensed Territory together with Allos’ rolling good faith forecast for required quantities of Bulk Product for the Allos Territory equals or exceeds, in the aggregate, three batches (when converted to batch quantities and based on [***] then current batch size) for a four Calendar Quarter period, as contemplated under Section 3.3(c); or (B) MMCO’s rolling good faith forecast for required quantities of Bulk Product for the Licensed TerritoryTerritory together with Allos’ good faith rolling forecast for required quantities of Bulk Product for the Allos Territory equals or exceeds, in the aggregate, two batches (when converted to batch quantities and based on [***] then current batch size) for any Calendar Quarter, as contemplated under Section 3.3(c); and (ixx) to perform such other functions as may be appropriate to further the purposes of this Agreement, with respect to the manufacture of the Bulk Product or API, as determined directed by the PartiesJPC. The JMC shall have only the powers expressly assigned to it in this Section 3.2 and elsewhere in this Agreement. The JMC shall have no power to interpret, amend, modify, or waive compliance with this Agreement.

Formation and Role. The Within [ * ] after the Effective Date, the Parties hereby shall establish a joint manufacturing committee (the “Joint Steering Committee that shall monitor Manufacturing Committee” or “JMC”) for the coordination and coordinate communication regarding oversight of certain of the Parties' performance ’ activities under this Agreement to Develop, obtain Regulatory Approval for and Commercialize the Product in the FieldAgreement. The role of the JSC JMC shall be:be to: [ * ] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. (i) to review the overall strategy for Developing coordinate forecasting, ordering and seeking Regulatory Approval for, manufacturing, and Commercializing the Product in the Licensed Territory and in the Fieldother supply-related logistics; (ii) to facilitate the exchange of information between the Parties with respect to the activities hereunder for the Licensed Territory discuss supply-related issues, including shortfalls and to establish procedures for the efficient sharing of information and materials necessary for each Party's Development and Commercialization of the Product hereunder, consistent with this Agreementquality issues; (iii) no later than six months prior to reviewthe First Commercial Sale in any country in the Licensed Territory, approvedevise, andagree upon and begin implementing a strategy for requirements of safety supplies of necessary Raw Materials and/or other materials to be utilized in the manufacture of Bulk Product, if necessary, amend the U.S. Development Plan, the Development Budget and the U.S. Commercialization Plan (including related budget)which strategy will be reviewed on an annual basis; (iv) to review the plan discuss supply-related issues regarding other forms of drug substance or finished product (if any) being pursued jointly by Allos and the summary budget for the ROW Development to the extent customarily generated MMCO or by or available to Takeda from its Affiliates or sublicensees for its internal purposes with respect to the applicable countries in the Royalty 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 faithMMCO independently; (v) to monitor the Parties' performance against the thendiscuss and coordinate manufacturing-current U.S. Development Plan related complaints, recalls and Commercialization Plansany other supply related issues; (vi) review and discuss proposals to create subcommittees as the JSC may find necessary or desirable from time to time for implementation of the Development engage, qualify and Commercialization hereundermaintain Third Party Contractors; (vii) discuss the content and scope of any quality audit undertaken, or to oversee the activities of subcommittees created under this Agreementbe undertaken, and by Allos as it relates to seek to resolve any issues that such subcommittees cannot resolveits Third Party manufacturers; (viii) without reducing Affymax's obligation to obtain review and maintain agree on Allos’ budget amounts (including agreeing on the Affymax Patents applicable FTE rates) for performing the technical assistance contemplated under Section 3.14; (ix) discuss whether Allos can meet the combined MMCO and Allos requirements for Bulk Product (including by increasing batch sizes and/or the capacity or through additional sources) when (A) MMCO’s rolling good faith forecast for required quantities of Bulk Product Trademark provided for herein, to provide a forum to evaluate strategies for obtaining, maintaining and enforcing patent and trademark protection for the Licensed Territory together with Allos’ rolling good faith forecast for required quantities of Bulk Product for the Allos Territory equals or exceeds, in the aggregate, three batches (when converted to batch quantities and based on [ * ] then current batch size) for a four Calendar Quarter period, as contemplated under Section 3.3(c); or (B) MMCO’s rolling good faith forecast for required quantities of Bulk Product for the Licensed TerritoryTerritory together with Allos’ good faith rolling forecast for required quantities of Bulk Product for the Allos Territory equals or exceeds, in the aggregate, two batches (when converted to batch quantities and based on [ * ] then current batch size) for any Calendar Quarter, as contemplated under Section 3.3(c); and (ixx) to perform such other functions as may be appropriate to further the purposes of this Agreement, with respect to the manufacture of the Bulk Product or API, as determined directed by the PartiesJSC. [ * ] = Certain confidential information contained in this document, marked by brackets, is filed with the Securities and Exchange Commission pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. The JMC shall have only the powers expressly assigned to it in this Section 3.2 and elsewhere in this Agreement. The JMC shall have no power to interpret, amend, modify, or waive compliance with this Agreement.