Common use of Formation and Role Clause in Contracts

Formation and Role. Within [*] after the Effective Date, the Parties shall establish a joint steering committee (the "Joint Steering Committee" or "JSC") for the overall coordination and oversight of the Parties' activities under this Agreement. The role of the JSC shall be: (i) to review, discuss and approve the overall strategy for the Development and Drug Approval of the Product in the Field in the Licensed Territory; (ii) to review and discuss the overall performance of the Parties pursuant to this Agreement and to compare such performance to the objectives outlined in the Development Plan and to the diligence obligations set forth in Section 4.6; (iii) to review, discuss and approve any amendments to the Development Plan proposed by the JDC (including the Regulatory Plan to be added to the Development Plan after the Effective Date); (iv) to review and discuss the Commercialization Plan and any amendments to the Commercialization Plan proposed by the JCC; (v) to review and discuss overall strategy for Pricing Approval and Reimbursement Approval of the Product in the Field in the Licensed Territory; (vi) to discuss the Parties' activities with respect to the Product in the Field in the Licensed Territory in conjunction with Allos' and its licensees' activities with respect to the Product in the Field in the Allos Territory; (vii) to review any [*] after receipt of Regulatory Approval; (viii) to direct and oversee the JDC, JCC, JMC and any other operating committee (the "Other Committees") established by the JSC, on all significant issues that fall within the purview of such committees; (ix) to appoint Other Committees, consisting of equal numbers of appropriately qualified members appointed by each Party, from time to time as it deems fit; (x) to attempt to resolve, in a timely manner, issues presented to it by, and disputes within, the JDC, JCC, JMC and Other Committees; and (xi) to perform such other functions as appropriate to further the purposes of this Agreement, as expressly set forth in this Agreement or as mutually determined by the Parties in writing. The JSC shall have only the powers expressly assigned to it in this Section 3.1 and elsewhere in this Agreement. The JSC shall have no power to interpret, amend, modify, or waive compliance with this Agreement.

Formation and Role. Within [*] thirty (30) days after the Effective Date, the Parties shall establish a joint steering committee (the "Joint Steering Committee" or "“JSC"”) for the overall coordination and oversight of the Parties' ’ activities under this Agreement. The role of the JSC shall be: (i) to review, discuss and approve the overall strategy for the Development and Drug Regulatory Approval of the Product in the Field in the Licensed Territory; Confidential Materials Omitted and Filed Separately with the Securities and Exchange Commission Pursuant to a Request for Confidential Treatment under Rule 24b-2 under the Exchange Act of 1934, as amended. Confidential Portions are marked: [***] (ii) to review, discuss and approve the inclusion of Japan in the Licensed Territory based on the business plan presented by Licensee to the JSC; (iiiii) to review and discuss the overall performance of the Parties pursuant to this Agreement and to compare such performance to the objectives outlined in the Development Plan and to the diligence obligations set forth in Section 4.64.4; (iiiiv) to review, discuss and approve the Development Plan (including the Regulatory Plan), and any amendments to the Development Plan proposed by the JDC (including the Regulatory Plan to be added to the Development Plan after the Effective Date)JDC; (ivv) to review, discuss and approve the conduct by Licensee of all country-specific or jurisdiction-specific regulatory activities in the Licensed Territory; (vi) to review and discuss the Commercialization Plan and any amendments to the Commercialization Plan proposed by the JCCeither Party; (vvii) to review and discuss the overall strategy for Pricing Approval and Reimbursement Approval of the Product in the Field in the Licensed Territory, and all country-specific or jurisdiction-specific pricing and reimbursement negotiations in the Licensed Territory, provided global pricing of Product (including pricing floors for referencing countries) will be established collaboratively at the JSC (and in conjunction with other applicable parties, as necessary); (viviii) to discuss the Parties' ’ activities with respect to the Product in the Field in the Licensed Territory in conjunction with Allos' Licensor’s and its other licensees' ’ activities with respect to the Product in the Field in the Allos Licensed Territory or the Licensor Territory; (vii) to review any [*] after receipt of Regulatory Approval; (viiiix) to direct and oversee the JDC, JCC, JMC JCC and any other operating committee (the "“Other Committees"”) established by the JSC, JSC on all significant issues that fall within the purview of such committees; (ixx) to appoint Other Committees, consisting of equal numbers of appropriately qualified members appointed by each Party, from time to time as it deems fit; (xxi) to attempt to resolve, in a timely manner, issues presented to it by, and disputes within, the JDC, JCC, JMC JCC and Other Committees; and (xixii) to perform such other functions as appropriate to further the purposes of this Agreement, as expressly set forth in this Agreement or as mutually determined by the Parties in writing. Confidential Materials Omitted and Filed Separately with the Securities and Exchange Commission Pursuant to a Request for Confidential Treatment under Rule 24b-2 under the Exchange Act of 1934, as amended. Confidential Portions are marked: [***] The JSC shall have has only the powers expressly assigned to it in this Section 3.1 and elsewhere in this Agreement. The JSC shall have has no power to interpret, amend, modify, or waive compliance with this Agreement.

Formation and Role. Within [*] after the Effective Date, the The Parties shall desire to establish a joint steering committee Joint Steering Committee (the "Joint Steering Committee" or "“JSC"”) for the overall coordination that will monitor and oversight of coordinate communication regarding the Parties' activities ’ efforts under this AgreementAgreement to Develop, obtain Regulatory Approval for, and Commercialize the Product in the Field in the Licensed Territory. The JSC shall have the membership and authority, and shall operate by the procedures, set forth for it in this Section 2.2. The role of the JSC shall be: (i) to review, discuss and approve facilitate the overall strategy for exchange of information between the Parties with respect to the Development and Drug Approval Commercialization activities hereunder for the Licensed Territory and to establish procedures for the efficient sharing of information and materials necessary for the Parties’ Development and Commercialization of the Product in the Field in the Licensed Territoryhereunder, consistent with this Agreement; (ii) to review and discuss the overall performance of the Parties pursuant to this Agreement and to compare such performance to the objectives outlined in the approve each Development Plan and to the diligence obligations set forth in Section 4.6any amendments thereto; (iii) to review, discuss review and approve in advance the overall budget (each, a “Budget”) associated with each Development Plan, and any amendments amendment to a Budget that increases by twenty-five percent (25%) or more the Development Plan proposed by the JDC (including the Regulatory Plan to be added to the Development Plan after the Effective Date)total expenditures under such previously-approved Budget; (iv) to review and discuss the Commercialization Plan and approve any amendments clinical studies (including related protocols) to the Commercialization Plan proposed be conducted by the JCCParties for the Initial Indication and each Co-Developed Indication; (v) for the Initial Indication and each Co-Developed Indication, to review and discuss overall strategy approve all Regulatory Materials and Product Labeling for Pricing Approval and Reimbursement Approval of the Product in the Field in the Licensed Territory; (vi) to discuss review and approve each Marketing Plan, promotional strategy, and Promotional Materials for the Parties' activities with respect to the Product in the Field in the Licensed Territory in conjunction with Allos' Product, and its licensees' activities with respect to the Product in the Field in the Allos Territoryany updates and amendments thereto; (vii) to review any [*] after receipt establish such additional joint subcommittees or committees as the JSC deems necessary to achieve the objectives and intent of Regulatory Approval; (viii) to direct and oversee the JDC, JCC, JMC and any other operating committee (the "Other Committees") established by the JSC, on all significant issues that fall within the purview of such committees; (ix) to appoint Other Committees, consisting of equal numbers of appropriately qualified members appointed by each Party, from time to time as it deems fit; (x) to attempt to resolve, in a timely manner, issues presented to it by, and disputes within, the JDC, JCC, JMC and Other Committeesthis Agreement; and (xiviii) to perform such other functions as appropriate to further the purposes of this Agreement, as expressly set forth in this Agreement or as mutually determined by the Parties Parties. The JSC shall perform its responsibilities under this Agreement based on the principles of prompt and diligent Development and Commercialization of the Product in writingthe Licensed Territory, consistent with good pharmaceutical practices and the maximization of long-term profits derived from the sale of the Product in the Licensed Territory. The JSC shall have only the powers assigned expressly assigned to it in this Section 3.1 Article 2 and elsewhere in this Agreement. The , and the JSC shall not have no any power to interpret, amend, modify, modify or waive compliance with this Agreement.

Formation and Role. Within [*] after the Effective Date, the The Parties shall hereby establish a joint steering committee (the "Joint Steering Committee" or "Committee (sometimes referred to hereinafter as “JSC"”) for the overall coordination that shall monitor and oversight of coordinate communication regarding the Parties' activities ’ performance under this AgreementAgreement to Develop, obtain Regulatory Approval for and Commercialize the Product. The role of the JSC shall be: (i) to review, discuss and approve the overall strategy for agree upon the Development Plan and Drug Approval of the Product in the Field in the Licensed TerritoryCommercialization Plan, and any proposed changes or amendments thereto that are not inconsistent with this Agreement; (ii) to review and discuss the overall performance of strategy for Developing and seeking Regulatory Approval for, manufacturing of, and Commercializing the Parties pursuant to this Agreement and to compare such performance to the objectives outlined Product in the Development Plan and to the diligence obligations set forth in Section 4.6Territory; (iii) to review, discuss and approve any amendments facilitate the exchange of information between the Parties with respect to the activities hereunder for the Territory and to establish procedures for the efficient sharing of information and materials necessary for each Party’s Development, Product Development Plan proposed by and Commercialization of the JDC (including the Regulatory Plan to be added to the Development Plan after the Effective Date)Product hereunder, consistent with this Agreement; (iv) to review the plan and discuss the Commercialization Plan and any amendments summary budget for the Development with respect to the Commercialization Plan proposed by applicable countries in the JCCTerritory and provide comments regarding the content and implementation of such plans; (v) to review monitor the Parties’ performance against the then-current Development Plan and discuss overall strategy for Pricing Approval and Reimbursement Approval of the Product in the Field in the Licensed TerritoryCommercialization Plans; (vi) to discuss inform the Parties' activities with respect other Party of up-coming material internal events and decisions related to the Product in the Field in the Licensed Territory in conjunction with Allos' and its licensees' activities with respect to the Product in the Field in the Allos TerritoryDevelopment; (vii) to review discuss material submissions to FDA and any [*] after receipt of other Regulatory ApprovalAuthorities; (viii) to direct create subcommittees as the JSC may find necessary or desirable from time to time for implementation of the Development and oversee the JDC, JCC, JMC and any other operating committee (the "Other Committees") established by the JSC, on all significant issues that fall within the purview of such committeesCommercialization hereunder; (ix) to appoint Other Committeesoversee the activities of subcommittees created under this Agreement, consisting of equal numbers of appropriately qualified members appointed by each Party, from time and to time as it deems fitseek to resolve any issues that such subcommittees cannot resolve; (x) to attempt provide a forum to resolveevaluate strategies for obtaining, maintaining and enforcing patent and trademark protection for the Product in a timely manner, issues presented to it by, and disputes within, the JDC, JCC, JMC and Other CommitteesTerritory; and (xi) to perform such other functions as appropriate to further the purposes of this Agreement, as expressly set forth in this Agreement or as mutually determined by the Parties in writing. The JSC shall have only the powers expressly assigned to it in this Section 3.1 and elsewhere in this Agreement. The JSC shall have no power to interpret, amend, modify, or waive compliance with this AgreementParties.

Formation and Role. Within [*] after thirty (30) days upon the Effective Dateearlier of the Trigger Date or the date of Development of any TNF-α Development Candidate other than AST-005 pursuant to Section 2.10, the Parties shall will establish a joint steering research committee (the "Joint Steering Committee" or "JSC"“JRC”) for to govern the overall coordination and oversight pre-clinical stages of the Parties' activities under this Agreementresearch and collaboration by the Parties on the Collaboration Development Candidates and Collaboration Products. The role of the JSC shall beJRC is: (i) to review, discuss and approve the overall strategy for the research and collaboration by the Parties on the Collaboration Development Candidates and Drug Approval of the Product Collaboration Products in the Field in the Licensed Territory; (ii) to review and discuss the overall performance of the research and collaboration by the Parties pursuant to this Agreement on the Collaboration Development Candidates and Collaboration Products and to compare such performance to the objectives outlined in the Development Collaboration Research Plan and to the diligence obligations set forth in Section 4.62.5; (iii) to develop, review, discuss and approve any amendments to the Development Plan proposed by the JDC (including the Regulatory Plan to be added to the Development Plan after the Effective Date); (iv) to review and discuss the Commercialization Collaboration Research Plan and any amendments to the Commercialization Plan proposed by the JCC; (v) to review and discuss overall strategy for Pricing Approval and Reimbursement Approval of the Product in the Field in the Licensed Territory; (vi) to discuss the Parties' activities with respect to the Product in the Field in the Licensed Territory in conjunction with Allos' and its licensees' activities with respect to the Product in the Field in the Allos Territory; (vii) to review any [*] after receipt of Regulatory Approval; (viii) to direct and oversee the JDC, JCC, JMC and any other operating committee (the "Other Committees") established by the JSC, on all significant issues that fall within the purview of such committees; (ix) to appoint Other Committees, consisting of equal numbers of appropriately qualified members appointed by each Party, from time to time as it deems fit; (x) to attempt to resolve, in a timely manner, issues presented to it by, and disputes within, the JDC, JCC, JMC and Other Committeesthereto; and (xiiv) to perform such other functions as appropriate to further the purposes of this Agreement, Agreement as expressly set forth in this Agreement (including as set forth in Section 2.10) or as mutually determined by the Parties in writing. The JSC shall have JRC has only the powers expressly assigned to it in this Section 3.1 5.1 and elsewhere in this Agreement. For the avoidance of doubt, the JRC will not have input into Development after Stage 5. The JSC shall have JRC has no power to interpret, amend, modify, or waive compliance with this Agreement. THE COMPANY HAS REQUESTED AN ORDER FROM THE SECURITIES AND EXCHANGE COMMISSION (THE “COMMISSION”) PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED, GRANTING CONFIDENTIAL TREATMENT TO SELECTED PORTIONS. ACCORDINGLY, THE CONFIDENTIAL PORTIONS HAVE BEEN OMITTED FROM THIS EXHIBIT, AND HAVE BEEN FILED SEPARATELY WITH THE COMMISSION. OMITTED PORTIONS ARE INDICATED IN THIS EXHIBIT WITH “*****”.

Formation and Role. Within [*] after the Effective Date, the The Parties shall also agree to establish a joint steering committee Joint Development Committee (or “JDC”) which will monitor and coordinate communication and operations regarding the "Joint Steering Committee" or "JSC") for Parties’ efforts with respect to the overall coordination Development, Manufacture, and oversight Regulatory Approval of the Parties' activities under this AgreementProduct in the Field and in the Licensed Territory and the ROW Territory. Each Party shall have an equal number of representatives on the Joint Development Committee. The Joint Development Committee shall operate by the procedures set forth in Section 3.3. The role of the JSC Joint Development Committee shall be: (i) to review, discuss and approve facilitate the overall strategy for exchange of Information between the Development and Drug Approval of the Product in the Field Parties under this Agreement with respect to their Product-related activities (including activities conducted in the Licensed Territory and the ROW Territory;), including as and to the extent necessary for each Party to perform its obligations under this Agreement; ** 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. (ii) to review and discuss comment on the overall performance of the Parties pursuant to this Agreement and to compare such performance to the objectives outlined in the Initial Development Plan and all updates thereto, and to submit such plan to the diligence obligations set forth in Section 4.6ESC for approval (it being understood that the JDC shall submit such plan with sufficient time for the ESC to review and approve such plan on or before March 1 of each calendar year); (iii) to review, discuss review and approve comment on any amendments proposed changes or revisions to the Development Plan proposed by the JDC (including the Regulatory Plan to be added to the Development Plan after the Effective DateBudget); (iv) to review and discuss comment on the Sales and Marketing Plans, and CTI’s Commercialization Plan activities for the Product in the Licensed Territory and any amendments to Chroma’s Commercialization activities for the Commercialization Plan proposed by Product in the JCCROW Territory; (v) to review and discuss overall establish a global branding strategy for Pricing Approval and Reimbursement Approval of the Product in the Field at least twelve (12) months prior to any Product launch in the Licensed Territory or the ROW Territory;, including the determination of ownership rights related to Product Marks and related trademark registrations. (vi) to discuss the Parties' activities with respect to the Product in the Field in the Licensed Territory in conjunction with Allos' establish such working teams or subcommittees and its licensees' activities with respect to the Product in the Field in the Allos Territory; (vii) to review any [*] after receipt of Regulatory Approval; (viii) to direct and oversee the JDC, JCC, JMC and any other operating committee (the "Other Committees") established by the JSC, on all significant issues that fall within the purview of such committees; (ix) to appoint Other Committees, consisting of equal numbers of appropriately qualified members appointed by each Party, from time to time as it deems fit; (x) to attempt to resolve, in a timely manner, issues presented to it by, and disputes within, the JDC, JCC, JMC and Other Committees; and (xi) to perform such other functions as appropriate to further the purposes of this Agreement, as expressly set forth in this Agreement or as mutually determined by the Parties in writing. The JSC shall have only the powers expressly assigned to it in this Section 3.1 and elsewhere in this Agreement. The JSC shall have no power to interpret, amend, modify, or waive compliance with this Agreement.

Formation and Role. Within [***] after the Effective Date, the Parties shall establish a joint steering committee (the "Joint Steering Committee" or "“JSC"”) for the overall coordination to coordinate, review and oversight of discuss the Parties' ’ activities under this Agreementwith respect to the Development and Commercialization of Licensed Products. The role of For that purpose and to the extent reasonably necessary, the JSC shall be:(by itself or through discharging its responsibilities through one (1) or more subcommittees): (ia) discuss the status, progress, and results of all Development activities conducted by or on behalf of either Party with respect to Licensed Products, both in and outside the Collaborative Territory; (b) facilitate communications and discussions between the Parties with respect to the Development Plan (as defined in Section 8.2 (Development Plan)); (c) review, discuss discuss, and approve the overall strategy for initial Development Plan and any proposed, major amendments or revisions to the Development Plan and Drug Approval oversee the implementation of the Product Development Plan; (d) review and discuss significant correspondence to or from a Regulatory Authority (including submissions of Regulatory Submissions) that are relevant to Licensed Products in the Field, both inside and outside the Collaborative Territory; (e) discuss and review Commercialization of Licensed Products in the Field in the Collaborative Territory, including the tracking of sales of Licensed TerritoryProducts; (iif) to review and discuss the overall performance of the Parties pursuant to this Agreement and to compare such performance to the objectives outlined in the Development Plan and to the diligence obligations set forth in Section 4.6; (iii) to discuss, review, discuss and approve any amendments to the Development Plan proposed by the JDC (including the Regulatory Plan to be added to the Development Plan after the Effective Date); (iv) to review and discuss the Commercialization Plan and any amendments to oversee the implementation of the Commercialization Plan (as defined in Section 10.3 (Commercialization Plan)), and discuss review and approve any proposed by the JCCamendments or revisions thereof; (vg) establish procedures regarding the collection, sharing, and reporting of Adverse Event information related to review and discuss overall strategy for Pricing Approval and Reimbursement Approval of the Product Licensed Products in the Field inside and outside the Collaborative Territory, consistent with the Pharmacovigilance Agreement (as defined in the Licensed Territory; Section 9.7 (viAdverse Events)) to discuss the Parties' activities be entered into in accordance with respect to the Product in the Field in the Licensed Territory in conjunction with Allos' and its licensees' activities with respect to the Product in the Field in the Allos Territory; Section 9.7 (vii) to review any [*] after receipt of Regulatory Approval; (viii) to direct and oversee the JDC, JCC, JMC and any other operating committee (the "Other Committees") established by the JSC, on all significant issues that fall within the purview of such committees; (ix) to appoint Other Committees, consisting of equal numbers of appropriately qualified members appointed by each Party, from time to time as it deems fit; (x) to attempt to resolve, in a timely manner, issues presented to it by, and disputes within, the JDC, JCC, JMC and Other CommitteesAdverse Events); and (xih) to perform such other functions as appropriate to further the purposes of this Agreement, as expressly set forth in this Agreement or as mutually determined by the Parties in writing. The Notwithstanding the foregoing, in no event shall the JSC shall or any subcommittee of the JSC have only the any powers that are not expressly assigned to it in this Section 3.1 7.1.1 (Formation and Role) and elsewhere in this Agreement. The In no event shall the JSC shall or any subcommittee of the JSC have no power to interpret, any authority to: (a) amend, modify, or waive compliance with this Agreement; (b) determine that a breach has occurred under this Agreement; or (c) make any decision that is specified elsewhere in this Agreement as being made by one (1) or both Parties.

Formation and Role. Within [*[ * ] after the Effective Date, the Parties shall establish a joint steering committee (the "“Joint Steering Committee" ” or "“JSC"”) for the overall coordination and oversight of the Parties' ’ activities under this Agreement. The role of the JSC shall be: (i) to review, discuss and approve the overall strategy for the Development and Drug Approval of the Product in the Field in the Licensed Territory; (ii) to review and discuss the overall performance of the Parties pursuant to this Agreement and to compare such performance to the objectives outlined in the Development Plan and to the diligence obligations set forth in Section 4.6; (iii) to review, discuss and approve any amendments to the Development Plan proposed by the JDC (including the Regulatory Plan to be added to the Development Plan after the Effective Date); (iv) to review and discuss the Commercialization Plan and any amendments to the Commercialization Plan proposed by the JCC; (v) to review and discuss overall strategy for Pricing Approval and Reimbursement Approval of the Product in the Field in the Licensed Territory; (vi) to discuss the Parties' ’ activities with respect to the Product in the Field in the Licensed Territory in conjunction with Allos' ’ and its licensees' ’ activities with respect to the Product in the Field in the Allos Territory; (vii) to review any [*[ * ] after receipt of Regulatory Approval; (viii) to direct and oversee the JDC, JCC, JMC and any other operating committee (the "“Other Committees"”) established by the JSC, on all significant issues that fall within the purview of such committees; (ix) to appoint Other Committees, consisting of equal numbers of appropriately qualified members appointed by each Party, from time to time as it deems fit; (x) to attempt to resolve, in a timely manner, issues presented to it by, and disputes within, the JDC, JCC, JMC and Other Committees; and (xi) to perform such other functions as appropriate to further the purposes of this Agreement, as expressly set forth in this Agreement or as mutually determined by the Parties in writing. [ * ] = 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 JSC shall have only the powers expressly assigned to it in this Section 3.1 and elsewhere in this Agreement. The JSC shall have no power to interpret, amend, modify, or waive compliance with this Agreement.