Common use of Joint Development Committee Clause in Contracts

Joint Development Committee. Within [***] days after the Effective Date, the Parties shall establish a joint development committee (the “Joint Development Committee” or the “JDC”), composed of [***] representatives of NPLH (if NPLH elects to participate) and [***] representatives of Everest, to coordinate the Development and Commercialization of the Compound and Licensed Products in the Licensed Field in the Territory. Each JDC representative shall have appropriate knowledge and expertise and sufficient seniority within the applicable Party to make decisions arising within the scope of the JDC’s responsibilities. For the purposes of participation in the JDC, NPLH has the right but not the obligation to participate in the JDC. The JDC shall: (a) serve as a forum for discussing Development of the Compound and Licensed Products in the Licensed Field in the Territory, including by reviewing the Development Plan and coordinating the conduct of the Development activities; (b) serve as a forum for discussing the Commercialization of Licensed Products in the Licensed Field in the Territory, including by reviewing the Commercialization strategy for the Territory, reviewing the Commercialization Plans and coordinating the conduct of the Commercialization activities; (c) serve as a forum for discussing the Manufacture and supply of Compound and Licensed Products in the Licensed Field in the Territory, including by reviewing the Development strategy and Commercialization strategy for the Territory and coordinating the conduct of the Manufacturing and supply activities; (d) serve as a forum for discussing and supervising Development of the Compound and Licensed Products in the Licensed Field in the Territory, including by (i) providing Everest with a forum at each meeting to disclose Everest’s, or its Affiliates’ or Sublicensees’ activities with respect to achieving Regulatory Approvals of Licensed Products in the Territory; material clinical study results; and the Marketing Authorization Applications that Everest or any of its Affiliates reasonably expect to make, seek or attempt to obtain in the Territory; (ii) reviewing the current Development Plan and, with the JDC’s approval, making any amendments or updates to the Development Plan; and (iii) coordinating the conduct of the Development activities; (e) serve as a forum at each meeting for discussing and supervising the Commercialization of Licensed Products in the Licensed Field in the Territory, including by (i) providing Everest with a forum to disclose to Everest’s, or its Affiliates’ or Sublicensees’

Joint Development Committee. Within [***] days after of the Effective DateDate or a period otherwise mutually agreed to by the Parties, the Parties shall establish will form a joint development and regulatory committee (the “Joint Development Committee” or the “JDC”)) to coordinate the overall strategy, composed plans, and responsibilities of the Parties for Development of the Compound and any Licensed Products in the Licensed Territory and outside the Licensed Territory, to facilitate communication between the Parties and provide a forum for the Parties to review Development and regulatory matters pertaining to the Licensed Products in the Licensed Territory and outside the Licensed Territory, and to coordinate such Development activities in the Licensed Territory with Licensed Product development work outside the Licensed Territory. Except as otherwise provided herein, the role and responsibilities of the JDC are: (a) to oversee strategy, progress, and results with respect to the Development of the Licensed Product in the Field in the Licensed Territory; (b) to review and discuss any material Development activities, including any Clinical Trials, with respect to any Licensed Product in the Field both in the Licensed Territory and outside the Licensed Territory; (c) to review and approve the initial Clinical Development Plan and any material amendments or revisions to the Clinical Development Plan; (d) to develop (but not approve): (i) for each Existing Global Study, the [***] representatives of NPLH enrollment allocation (if NPLH elects to participate) and the [***] representatives Enrollment Allocation”) for each [***] in the Enrollment Period, and (ii) for each additional Global Study deemed a Joint Global Study (1) the Minimum Enrollment Threshold, and (2) if the Parties agree to include an obligation for Licensee to meet [***] Enrollment Allocations, the [***] Enrollment Allocation. Each [***] Enrollment Allocation shall be mutually agreed upon or amended in writing by the Parties, and for each additional Global Study deemed a Joint Global Study, the applicable Minimum Enrollment Threshold shall be mutually agreed upon in writing by the Parties; (e) to review and coordinate forecasting and supply of Everest, Licensee’s expected requirements of Licensed Product for Development purposes; (f) to coordinate the Development and Commercialization review all material Clinical Data obtained from Clinical Trials of the Compound and any Licensed Products Product in the Licensed Field Territory; [***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED (g) to review all material Clinical Data for any Joint Global Studies within the Clinical Development Plan; (h) to review all material Reference Data Controlled by a Party and generated or produced in connection with any Development activities conducted for any Licensed Product in the Licensed Territory and outside the Licensed Territory. Each JDC representative shall have appropriate knowledge ; (i) to provide a forum for discussion of and expertise coordinate interactions with Regulatory Authorities in the Licensed Territory and sufficient seniority within outside the applicable Party Licensed Territory; (j) to make decisions arising within review any material Regulatory Filings with respect to the scope Licensed Products to be submitted to any Regulatory Authority in the Licensed Territory; (k) to review and discuss any proposals from Mirati regarding any Additional Global Studies; (l) to discuss and provide a forum for the exchange of pharmacovigilance and safety matters prior to commercial launch of the JDC’s responsibilities. For Licensed Product; (m) to provide a forum for discussion of and coordinate decisions related to research and Development of new Indications, new Licensed Product formulations, and Combined Therapy Development; and (n) to perform such other functions as the Parties may allocate to JDC in writing, where such functions are appropriate to further the purposes of participation in the JDC, NPLH has the right but not the obligation this Agreement with respect to participate in the JDC. The JDC shall: (a) serve as a forum for discussing Development of the Compound and Licensed Products in the Licensed Field in the Territory, including by reviewing the Development Plan and coordinating the conduct of the Development activities; (b) serve as a forum for discussing the Commercialization of Licensed Products in the Licensed Field in the Territory, including by reviewing the Commercialization strategy for the Territory, reviewing the Commercialization Plans and coordinating the conduct of the Commercialization activities; (c) serve as a forum for discussing the Manufacture and supply of Compound and Licensed Products in the Licensed Field in the Territory, including by reviewing the Development strategy and Commercialization strategy for the Territory and coordinating the conduct of the Manufacturing and supply activities; (d) serve as a forum for discussing and supervising Development of the Compound and Licensed Products in the Licensed Field in the Territory, including by (i) providing Everest with a forum at each meeting to disclose Everest’s, or its Affiliates’ or Sublicensees’ activities with respect to achieving Regulatory Approvals of Licensed Products in the Territory; material clinical study results; and the Marketing Authorization Applications that Everest or any of its Affiliates reasonably expect to make, seek or attempt to obtain in the Territory; (ii) reviewing the current Development Plan and, with the JDC’s approval, making any amendments or updates to the Development Plan; and (iii) coordinating the conduct of the Development activities; (e) serve as a forum at each meeting for discussing and supervising the Commercialization of Licensed Products in the Licensed Field in the Territory, including by (i) providing Everest with a forum to disclose to Everest’s, or its Affiliates’ or Sublicensees’.

Joint Development Committee. Within [****] ([****]) days after the Effective Date, the Parties shall establish a joint development committee (the “Joint Development Committee” or the “JDC”), composed of [****] representatives of NPLH (if NPLH elects to participate) and [***] *]) representatives of Everesteach Party (or such other equal number of representatives from each Party as the Parties may agree in writing from time-to-time), to coordinate the Development and Commercialization of the Compound and Licensed Products and Commercialization Licensed Products in the Licensed Field in the Territory. Each JDC representative shall have appropriate knowledge and expertise and sufficient seniority within the applicable Party to make decisions arising within the scope of the JDC’s responsibilities. For the purposes of participation in the JDC, NPLH has the right but not the obligation to participate in the JDC. The JDC shall: (a) serve as a forum for discussing Development of the Compound and Licensed Products in the Licensed Field in the Territory, including by reviewing the Development Plan and coordinating the conduct of the Development activities; (b) serve as a forum for discussing the Commercialization of Licensed Products in the Licensed Field in the Territory, including by reviewing the Commercialization strategy for the Territory, reviewing the Commercialization Plans and coordinating the conduct of the Commercialization activities; (c) serve as a forum for discussing the Manufacture and supply of Compound and Licensed Products in the Licensed Field in the Territory, including by reviewing the Development strategy and Commercialization strategy for the Territory and coordinating the conduct of the Manufacturing and supply activities; (d) serve as a forum for discussing and supervising Development of the Compound and Licensed Products in the Licensed Field in the Territory, including by (i) providing Everest Sinovant with a forum at each meeting to disclose Everestto Angion Sinovant’s, or its Affiliates’ or Sublicensees’ activities with respect to achieving Regulatory Approvals of Licensed Products in the Territory; material clinical study results; and the Marketing Authorization Applications that Everest Sinovant or any of its Affiliates reasonably expect to make, seek or attempt to obtain in the Territory; (ii) reviewing the current Development Plan andPlan, with the JDC’s approval, making any including approving amendments or and updates to the Development Plan; , and (iii) coordinating the conduct of the Development activities; (eb) serve as a forum at each meeting for discussing and supervising the Commercialization of Licensed Products in the Licensed Field in the Territory, including by (i) providing Everest Sinovant with a forum to disclose to EverestAngion Sinovant’s, or its Affiliates’ or Sublicensees’’ Commercialization activities with respect to Licensed Products in the Territory; (ii) reviewing the Commercialization strategy for the Territory; (iii) reviewing the Commercialization Plan, including approving amendments and updates to the Commercialization Plan, and (iv) coordinating the conduct of the Commercialization activities; (c) discuss intellectual property-related matters affecting, and affected by, the foregoing and other activities under this Agreement; (d) coordinate the Parties’ activities under this Agreement; and (e) perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement unless such provision is first amended in accordance herewith in order to avoid such conflict (including pursuant to such written agreement). The JDC shall have only such powers as are expressly assigned to it in this Agreement, and such powers shall be subject to the terms and conditions of this Agreement. For clarity, The JDC shall not have any right, power or authority: (i) to determine any issue in a manner that would conflict [****] = [CONFIDENTIAL PORTION HAS BEEN OMITTED BECAUSE IT (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED with the express terms and conditions of this Agreement; or (ii) to modify or amend the terms and conditions of this Agreement.

Joint Development Committee. Within [***] days after following the Effective Date, the Parties shall establish a joint development committee (the “Joint Development Committee” or the “JDC”), composed of [***] representatives of NPLH (if NPLH elects to participate) and [***] representatives of Everest, to coordinate the Development and Commercialization of the Compound and Licensed Products in the Licensed Field in the Territory. Each JDC representative shall have appropriate knowledge and expertise and sufficient seniority within the applicable Party to make decisions arising within the scope of the JDC’s responsibilities. For the purposes of participation in the JDC, NPLH has the right but not the obligation to participate in the JDC. The JDC shall: (a) serve as a forum for discussing Development of the Compound discuss and Licensed Products in the Licensed Field approve any Additional Indication or Combination Therapy to be Developed in the Territory, including by reviewing or any clinical trial to be performed in whole or in part in the Territory, in each case, that is not set forth in the then-current Clinical Development Plan and coordinating is proposed by a Party in accordance with Section 4.3. If Hutchmed proposes a Local Trial to be added to the conduct of Clinical Development Plan, the Development activitiesJDC may approve converting such Local Trial into a Joint Global Trial; (b) serve as a forum for discussing discuss the Commercialization current Clinical Development Plan and approve any updates or amendments to the Clinical Development Plan, including the addition of any Additional Indication, Combination Therapy or Local Trial or Joint Global Trial not set forth in the then-current Clinical Development Plan, and discuss the use of any relevant diagnostic in the Territory; (c) monitor and discuss the alignment of Hutchmed Entities’ Development of Licensed Products in the Territory with Epizyme’s Development of the Licensed Products outside of the Territory, and discuss and provide strategic guidance on the Development of the Licensed Products in the Field in the Territory, including by reviewing the Commercialization strategy for the Territory, reviewing the Commercialization Plans and coordinating the conduct of the Commercialization activities; (c) serve as a forum for discussing the Manufacture and supply of Compound and Licensed Products in the Licensed Field in the Territory, including by reviewing the Development strategy and Commercialization strategy for the Territory and coordinating the conduct of the Manufacturing and supply activities; (d) serve as discuss whether Hutchmed shall participate in a forum global trial for discussing and supervising Development of the Compound and Licensed Products Product presented by Epizyme, which would include clinical sites both in the Licensed Field in Territory and outside the Territory, including by (i) providing Everest with a forum at each meeting to disclose Everest’s, or its Affiliates’ or Sublicensees’ activities with respect to achieving Regulatory Approvals of Licensed Products in the Territory; material clinical study results; and the Marketing Authorization Applications that Everest or any of its Affiliates reasonably expect to make, seek or attempt to obtain in the Territory; (ii) reviewing the current Development Plan and, with the JDC’s approval, making any amendments or updates to the Development Plan; and (iii) coordinating the conduct of the Development activities; (e) serve as discuss the clinical sites in the Territory to be included in each Local Trial and each Joint Global Trial; (f) discuss the protocols for each Local Trial and Joint Global Trial and discuss the status and progress thereof; (g) coordinate the operations of the Hutchmed Entities and Epizyme Entities with respect to Joint Global Trials; (h) discuss the budget for the Joint Global Trials (and approve the budget for costs under Section 9.3(c)(iii)) to be conducted under this Agreement; provided that each Party shall solely determine the budget for its activities in its respective territory; ​ (i) discuss and approve the Permitted Subcontractors defined in Section 1.145(a), if any, that may be used for Joint Global Trials by Hutchmed in the Territory; (j) discuss Pre-Clinical Research activities with respect to the Licensed Products that any Hutchmed Entity wishes to conduct in the Territory, and discuss the status and progress of such activities; (k) provide a forum at each meeting for discussing and supervising the Commercialization Parties to share information with respect to the Development of the Licensed Products in the Field, including reasonably detailed updates on progress and status of Local Trials and Joint Global Trials in the Territory and updates regarding interactions with Regulatory Authorities; (l) coordinate plans and provide updates regarding attendance at conferences and congresses and interactions with key opinion leaders by the Parties, subject to Section 4.9; (m) discuss the plans for any publication or presentation proposed by Hutchmed and related to the Development of Licensed Field Products, subject to Section 10.5(a); (n) discuss the Hutchmed Entities’ Medical Affairs strategy for the Licensed Products in the Territory and take into account Epizyme’s Global Medical Affairs Strategy; (o) discuss the Hutchmed Entities’ regulatory strategy for the Licensed Products in the Territory in the Field, including regulatory strategy for meetings with the Regulatory Authorities and the clinical and preclinical portions of the Drug Approval Application for the Licensed Product in the Territory; (p) review and discuss the content of any IND or Drug Approval Application for any Licensed Product in the Territory (other than the chemistry, including manufacturing and controls (“CMC”) module of such IND or Drug Approval Application, which shall be reviewed by the JMC); (iq) providing Everest with discuss the status and progress of any LCM Epizyme Trial being performed by Epizyme or other Epizyme Entities, for which Epizyme will provide regular updates to the JDC; (r) establish, within [**] after the establishment of the JDC, a forum Subcommittee to disclose oversee and coordinate activities related to Everest’sthe ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇, or its Affiliates’ or Sublicensees’which Subcommittee shall meet [**] unless otherwise agreed; and (s) determine whether to create any other Subcommittee, and perform such other duties as are specifically assigned to the JDC under this Agreement.

Joint Development Committee. Within 2.3.1. Formation, Composition, Dissolution. No later than [...***...] days after the Effective DateDate the Parties will establish a committee to (a) oversee the Development of Regional Licensed Antibodies and Regional Licensed Products and Optioned Licensed Antibodies and Optioned Licensed Products in accordance with the applicable Development Plans and to coordinate the Development activities of the Parties with respect thereto, and (b) facilitate the flow of information between the Parties with respect to, and provide a forum to discuss, the Parties shall establish a joint development committee Development of Optioned Licensed Antibodies, Optioned Licensed Products, Global Licensed Antibodies and Global Licensed Products (the “Joint Development Committee” or the “JDC”), composed of . Each Party will initially appoint [...***...] representatives of NPLH (if NPLH elects to participate) the JDC, with each representative having knowledge and [***] representatives of Everest, to coordinate expertise in the Development of compounds and Commercialization of products similar to the Compound Licensed Antibodies and Licensed Products in the Licensed Field in the Territory. Each JDC representative shall have appropriate knowledge and expertise and having sufficient seniority within the applicable Party to make decisions arising within the scope of the JDC’s responsibilities. For The JDC may change its size from time to time, provided that the purposes JDC will consist at all times of participation an equal number of representatives of each of Xencor and Novartis. Each Party may replace its JDC representatives at any time upon written notice to the other Party. The JDC may invite non-members to participate in the discussions and meetings of the JDC, NPLH has provided that such participants have no voting authority at the right but not JDC and are bound under written obligation of confidentiality no less protective of the obligation to participate Parties’ Confidential Information than those set forth in this Agreement. For clarity, the Alliance Managers should attend all meetings of the JDC. The JDC shall: will be co-chaired, with one chairperson designated by Xencor and one chairperson designated by Novartis, whose responsibilities will include conducting meetings, including, when feasible, ensuring that objectives for each meeting are set and achieved. Responsibility for running each meeting of the JDC will alternate between the chairpersons from meeting-to-meeting, with Novartis’ chairperson running the first meeting. Upon the later of (a) serve as a forum for discussing Development first commercial sale of the Compound final Regional Licensed Product or Optioned Licensed Product, or (b) removal of any requirement for any Clinical Study established by a Regulatory Authority upon Regulatory Approval for the final Regional Licensed Product or Optioned Licensed Product in any country, the Parties agree that the JDC will be automatically dissolved with no further action required by either Party. 2.3.2. Specific Responsibilities of the JDC. The JDC has the following responsibilities: 2.3.2.1. oversee and review Development responsibilities for each Regional Licensed Products in Antibody, Regional Licensed Product, Optioned Licensed Antibody and Optioned Licensed Product, 2.3.2.2. discuss, prepare and approve for submission to the Licensed Field in the TerritoryJSC all RLP Development Plans and OLP Development Plans, including by reviewing the Development Plan and coordinating all amendments thereto, 2.3.2.3. oversee and direct the conduct of all RLP Development Plans and OLP Development Plans, 2.3.2.4. create, implement and review the Development activities; (b) serve as a forum overall strategy for discussing the Commercialization of Licensed Products in the Licensed Field in the TerritoryDevelopment, including by reviewing the Commercialization strategy design of all Clinical Studies for the TerritoryRegional Licensed Antibodies, reviewing the Commercialization Plans Regional Licensed Products, Optioned Licensed Antibodies and coordinating Optioned Licensed Products, 2.3.2.5. decide whether and when to initiate or discontinue any Clinical Study under each RLP Development Plan or OLP Development Plan, as applicable, 2.3.2.6. allocate budgeted resources and determine priorities for each Clinical Study included under each RLP Development Plan or OLP Development Plan, 2.3.2.7. oversee and direct the conduct of all Clinical Studies under each RLP Development Plan or OLP Development Plan, 2.3.2.8. facilitate the Commercialization activities; (c) serve as a forum for discussing flow of information between the Manufacture and supply of Compound and Licensed Products in the Licensed Field in the Territory, including by reviewing the Development strategy and Commercialization strategy for the Territory and coordinating the conduct of the Manufacturing and supply activities; (d) serve as a forum for discussing and supervising Development of the Compound and Licensed Products in the Licensed Field in the Territory, including by (i) providing Everest with a forum at each meeting to disclose Everest’s, or its Affiliates’ or Sublicensees’ activities Parties with respect to achieving Regulatory Approvals the Development of Licensed Products in Antibodies and Licensed Products, 2.3.2.9. allocate primary responsibility as between the Territory; material clinical study results; and the Marketing Authorization Applications that Everest or any of its Affiliates reasonably expect to make, seek or attempt to obtain in the Territory; (ii) reviewing the current Development Plan and, with the JDC’s approval, making any amendments or updates Parties for tasks relating to the Development of Regional Licensed Antibodies and Optioned Licensed Antibodies where not already specified in the applicable RLP Development Plans or OLP Development Plan; , 2.3.2.10. review, discuss, oversee and (iii) coordinating direct Manufacturing for the conduct Development of Regional Licensed Antibodies, Regional Licensed Products, Optioned Licensed Antibodies and Optioned Licensed Products including the supply chain, 2.3.2.11. determine and oversee the implementation of the Development activities; (e) serve as a forum at each meeting for discussing overall strategy regarding, and supervising facilitate the Commercialization flow of information between the Parties with respect to obtaining, Regulatory Approval of Regional Licensed Products and Optioned Licensed Products, 2.3.2.12. without limitation to Section 2.3.2.1, review the regulatory strategy with respect to discussions with and commitments to or agreements with Regulatory Authorities (including post-approval commitments) with respect to Regional Licensed Product and Optioned Licensed Product labeling, risk management or Clinical Studies, and 2.3.2.13. perform such other functions as may be appropriate to further the purposes of this Agreement, as directed by the JSC in the Licensed Field accordance with Section 2.2.3 or as expressly provided in the Territory, including by (i) providing Everest with a forum to disclose to Everest’s, or its Affiliates’ or Sublicensees’this Agreement.

Joint Development Committee. Within [***] days after following the Effective Date, the Parties shall establish a joint development committee (the “Joint Development Committee” or the “JDC”), composed of [***] representatives of NPLH (if NPLH elects to participate) and [***] representatives of Everest, to coordinate the Development and Commercialization of the Compound and Licensed Products in the Licensed Field in the Territory. Each JDC representative shall have appropriate knowledge and expertise and sufficient seniority within the applicable Party to make decisions arising within the scope of the JDC’s responsibilities. For the purposes of participation in the JDC, NPLH has the right but not the obligation to participate in the JDC. The JDC shall: (a) serve as a forum for discussing Development of the Compound discuss and Licensed Products in the Licensed Field approve any Additional Indication or Combination Therapy to be Developed in the Territory, including by reviewing or any clinical trial to be performed in whole or in part in the Territory, in each case, that is not set forth in the then-current Clinical Development Plan and coordinating is proposed by a Party in accordance with Section 4.3. If Hutchmed proposes a Local Trial to be added to the conduct of Clinical Development Plan, the Development activitiesJDC may approve converting such Local Trial into a Joint Global Trial; (b) serve as a forum for discussing discuss the Commercialization current Clinical Development Plan and approve any updates or amendments to the Clinical Development Plan, including the addition of any Additional Indication, Combination Therapy or Local Trial or Joint Global Trial not set forth in the then-current Clinical Development Plan, and discuss the use of any relevant diagnostic in the Territory; (c) monitor and discuss the alignment of Hutchmed Entities’ Development of Licensed Products in the Territory with Epizyme’s Development of the Licensed Products outside of the Territory, and discuss and provide strategic guidance on the Development of the Licensed Products in the Field in the Territory, including by reviewing the Commercialization strategy for the Territory, reviewing the Commercialization Plans and coordinating the conduct of the Commercialization activities; (c) serve as a forum for discussing the Manufacture and supply of Compound and Licensed Products in the Licensed Field in the Territory, including by reviewing the Development strategy and Commercialization strategy for the Territory and coordinating the conduct of the Manufacturing and supply activities; (d) serve as discuss whether Hutchmed shall participate in a forum global trial for discussing and supervising Development of the Compound and Licensed Products Product presented by Epizyme, which would include clinical sites both in the Licensed Field in Territory and outside the Territory, including by (i) providing Everest with a forum at each meeting to disclose Everest’s, or its Affiliates’ or Sublicensees’ activities with respect to achieving Regulatory Approvals of Licensed Products in the Territory; material clinical study results; and the Marketing Authorization Applications that Everest or any of its Affiliates reasonably expect to make, seek or attempt to obtain in the Territory; (ii) reviewing the current Development Plan and, with the JDC’s approval, making any amendments or updates to the Development Plan; and (iii) coordinating the conduct of the Development activities; (e) serve as discuss the clinical sites in the Territory to be included in each Local Trial and each Joint Global Trial; (f) discuss the protocols for each Local Trial and Joint Global Trial and discuss the status and progress thereof; (g) coordinate the operations of the Hutchmed Entities and Epizyme Entities with respect to Joint Global Trials; (h) discuss the budget for the Joint Global Trials (and approve the budget for costs under Section 9.3(c)(iii)) to be conducted under this Agreement; provided that each Party shall solely determine the budget for its activities in its respective territory; (i) discuss and approve the Permitted Subcontractors defined in Section 1.145(a), if any, that may be used for Joint Global Trials by Hutchmed in the Territory; (j) discuss Pre-Clinical Research activities with respect to the Licensed Products that any Hutchmed Entity wishes to conduct in the Territory, and discuss the status and progress of such activities; (k) provide a forum at each meeting for discussing and supervising the Commercialization Parties to share information with respect to the Development of the Licensed Products in the Field, including reasonably detailed updates on progress and status of Local Trials and Joint Global Trials in the Territory and updates regarding interactions with Regulatory Authorities; (l) coordinate plans and provide updates regarding attendance at conferences and congresses and interactions with key opinion leaders by the Parties, subject to Section 4.9; (m) discuss the plans for any publication or presentation proposed by Hutchmed and related to the Development of Licensed Field Products, subject to Section 10.5(a); (n) discuss the Hutchmed Entities’ Medical Affairs strategy for the Licensed Products in the Territory and take into account Epizyme’s Global Medical Affairs Strategy; (o) discuss the Hutchmed Entities’ regulatory strategy for the Licensed Products in the Territory in the Field, including regulatory strategy for meetings with the Regulatory Authorities and the clinical and preclinical portions of the Drug Approval Application for the Licensed Product in the Territory; (p) review and discuss the content of any IND or Drug Approval Application for any Licensed Product in the Territory (other than the chemistry, including manufacturing and controls (“CMC”) module of such IND or Drug Approval Application, which shall be reviewed by the JMC); (iq) providing Everest with discuss the status and progress of any LCM Epizyme Trial being performed by Epizyme or other Epizyme Entities, for which Epizyme will provide regular updates to the JDC; (r) establish, within [**] after the establishment of the JDC, a forum Subcommittee to disclose oversee and coordinate activities related to Everest’sthe 3▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇, or its Affiliates’ or Sublicensees’which Subcommittee shall meet [**] unless otherwise agreed; and (s) determine whether to create any other Subcommittee, and perform such other duties as are specifically assigned to the JDC under this Agreement.

Joint Development Committee. (a) Within [***] days after following the Effective Date, the Parties shall establish a joint development committee (the “Joint Development Committee” or the “JDC”), composed of [***] representatives of NPLH (if NPLH elects to participate) and [***] representatives of Everest, to coordinate the Development and Commercialization of the Compound and Licensed Products in the Licensed Field in the Territory. Each JDC representative shall have appropriate knowledge and expertise and sufficient seniority within the applicable Party to make decisions arising within the scope of the JDC’s responsibilities. For the purposes of participation in the JDC, NPLH has the right but not the obligation to participate in the JDC. The JDC shall: (ai) serve as a forum for discussing discuss and approve the Development Plan and any proposed updates or amendments to the Development Plan (including the addition of indications not set forth in the then-current Development Plan), and propose revisions to the Development Plan in accordance with Section 4.01 (Development in the Field in the Territory); (ii) secure alignment of the Licensee Entities’ Development of the Compound and Licensed Products in the Territory with Agios’ Development of the Licensed Field Products outside of the Territory; (iii) discuss and determine, with respect to each Global Study and on an indication-by-indication basis, whether to include clinical sites in the Territory in such Global Study and whether such Global Study shall be a Joint Global Study; (iv) discuss and determine the clinical sites in the Territory to be included in each Local Study; (v) discuss and approve the protocols for each Local Study and Joint Global Study; (vi) discuss and determine the clinical sites in the Territory to be included in each Joint Global Study; (vii) for each Joint Global Study, coordinate the operations of the Agios Entities and Licensee Entities with respect to such Joint Global Study; (viii) discuss and determine the contract research organizations in the Territory to be used for each Joint Global Study; (ix) discuss and approve the Licensee Entities’ regulatory strategy for the Licensed Products in the Territory based on the then-current Development Plan; (x) discuss and approve Pre-Clinical Research activities with respect to the Licensed Products that any Licensee Entity wishes to conduct in the Territory, including by reviewing the Development Plan and coordinating the conduct of the Development activities; (bxi) serve as provide a forum for discussing the Parties to share information with respect to the Development of the Licensed Products in the Field, including reasonably detailed updates on progress and status of Local Studies and Joint Global Studies in the Territory and commenting on Development activities outside of the Territory and updates regarding interactions with Regulatory Authorities; (xii) discuss and approve publications and publication plans as to the Development and Commercialization of Licensed Products in the Territory; (xiii) discuss, coordinate and provide strategic guidance on the Development of the Licensed Products in the Field in the Territory, including by reviewing the Commercialization strategy for the Territory, reviewing the Commercialization Plans and coordinating the conduct of the Commercialization activities; (cxiv) serve as a forum discuss and approve the content of any IND or Drug Approval Application for discussing the Manufacture and supply of Compound and any Licensed Products in the Licensed Field in the Territory, including by reviewing the Development strategy and Commercialization strategy for the Territory and coordinating the conduct of the Manufacturing and supply activities; (d) serve as a forum for discussing and supervising Development of the Compound and Licensed Products in the Licensed Field in the Territory, including by (i) providing Everest with a forum at each meeting to disclose Everest’s, or its Affiliates’ or Sublicensees’ activities with respect to achieving Regulatory Approvals of Licensed Products Product in the Territory; material clinical study results; and the Marketing Authorization Applications that Everest or any of its Affiliates reasonably expect to make, seek or attempt to obtain in the Territory; and (iixv) reviewing the current Development Plan and, with the JDC’s approval, making any amendments or updates perform such other duties as are specifically assigned to the Development Plan; and (iii) coordinating the conduct of the Development activities; (e) serve as a forum at each meeting for discussing and supervising the Commercialization of Licensed Products in the Licensed Field in the Territory, including by (i) providing Everest with a forum to disclose to Everest’s, or its Affiliates’ or Sublicensees’JDC under this Agreement.

Joint Development Committee. Within [***] days after the Effective Date, the Parties shall establish a joint development committee (the “Joint Development Committee” or the “JDC”), composed of [***] representatives of NPLH S▇▇▇▇ (if NPLH S▇▇▇▇ elects to participate) and [***] representatives of Everest, to coordinate the Development and Commercialization of the Compound and Licensed Products in the Licensed Field in the Territory. Each JDC representative shall have appropriate knowledge and expertise and sufficient seniority within the applicable Party to make decisions arising within the scope of the JDC’s responsibilities. For the purposes of participation in the JDC, NPLH S▇▇▇▇ has the right but not the obligation to participate in the JDC. The JDC shall: (a) serve as a forum for discussing Development of the Compound and Licensed Products in the Licensed Field in the Territory, including by reviewing the Development Plan and coordinating the conduct of the Development activities; (b) serve as a forum for discussing the Commercialization of Licensed Products in the Licensed Field in the Territory, including by reviewing the Commercialization strategy for the Territory, reviewing the Commercialization Plans and coordinating the conduct of the Commercialization activities; (c) serve as a forum for discussing the Manufacture and supply of Compound and Licensed Products in the Licensed Field in the Territory, including by reviewing the Development strategy and Commercialization strategy for the Territory and coordinating the conduct of the Manufacturing and supply activities; (d) serve as a forum for discussing and supervising Development of the Compound and Licensed Products in the Licensed Field in the Territory, including by (i) providing Everest with a forum at each meeting to disclose Everest’s, or its Affiliates’ or Sublicensees’ activities with respect to achieving Regulatory Approvals of Licensed Products in the Territory; material clinical study results; and the Marketing Authorization Applications that Everest or any of its Affiliates reasonably expect to make, seek or attempt to obtain in the Territory; (ii) reviewing the current Development Plan and, with the JDC’s approval, making any amendments or updates to the Development Plan; and (iii) coordinating the conduct of the Development activities; (e) serve as a forum at each meeting for discussing and supervising the Commercialization of Licensed Products in the Licensed Field in the Territory, including by (i) providing Everest with a forum to disclose to Everest’s, or its Affiliates’ or Sublicensees’’ Commercialization activities with respect to Licensed Products in the Territory; (ii) reviewing the Commercialization strategy for the Territory; (iii) reviewing the Commercialization Plan and, with the JDC’s approval, making any amendments or updates to the Commercialization Plan; and (iv) coordinating the conduct of the Commercialization activities; (f) coordinate the activities of S▇▇▇▇ and Everest under this Agreement; and (g) perform such other functions as are set forth herein or as the Parties may mutually agree in writing, except where in conflict with any provision of this Agreement. The JDC shall have only such powers as are expressly assigned to it in this Agreement, and such powers shall be subject to the terms and conditions of this Agreement. For clarity, the JDC shall not have any right, power or authority: (i) to determine any issue in a manner that would conflict with the express terms and conditions of this Agreement; or (ii) to modify or amend the terms and conditions of this Agreement.

Joint Development Committee. Within [***] days after of the Effective DateDate or a period otherwise mutually agreed to by the Parties, the Parties shall establish will form a joint development and regulatory committee (the “Joint Development Committee” or the “JDC”)) to coordinate the overall strategy, composed plans, and responsibilities of the Parties for Development of the Compound and any Licensed Products in the Licensed Territory and outside the Licensed Territory, to facilitate communication between the Parties and provide a forum for the Parties to review Development and regulatory matters pertaining to the Licensed Products in the Licensed Territory and outside the Licensed Territory, and to coordinate such Development activities in the Licensed Territory with Licensed Product development work outside the Licensed Territory. Except as otherwise provided herein, the role and responsibilities of the JDC are: (a) to oversee strategy, progress, and results with respect to the Development of the Licensed Product in the Field in the Licensed Territory; (b) to review and discuss any material Development activities, including any Clinical Trials, with respect to any Licensed Product in the Field both in the Licensed Territory and outside the Licensed Territory; (c) to review and approve the initial Clinical Development Plan and any material amendments or revisions to the Clinical Development Plan; (d) to develop (but not approve): (i) for each Existing Global Study, the [***] representatives of NPLH enrollment allocation (if NPLH elects to participate) and the [***] representatives of Everest, to coordinate the Development and Commercialization of the Compound and Licensed Products Enrollment Allocation”) for each [***] in the Licensed Field in the Territory. Each JDC representative shall have appropriate knowledge Enrollment Period, and expertise and sufficient seniority within the applicable Party to make decisions arising within the scope of the JDC’s responsibilities. For the purposes of participation in the JDC, NPLH has the right but not the obligation to participate in the JDC. The JDC shall: (a) serve as a forum for discussing Development of the Compound and Licensed Products in the Licensed Field in the Territory, including by reviewing the Development Plan and coordinating the conduct of the Development activities; (b) serve as a forum for discussing the Commercialization of Licensed Products in the Licensed Field in the Territory, including by reviewing the Commercialization strategy for the Territory, reviewing the Commercialization Plans and coordinating the conduct of the Commercialization activities; (c) serve as a forum for discussing the Manufacture and supply of Compound and Licensed Products in the Licensed Field in the Territory, including by reviewing the Development strategy and Commercialization strategy for the Territory and coordinating the conduct of the Manufacturing and supply activities; (d) serve as a forum for discussing and supervising Development of the Compound and Licensed Products in the Licensed Field in the Territory, including by (i) providing Everest with a forum at each meeting to disclose Everest’s, or its Affiliates’ or Sublicensees’ activities with respect to achieving Regulatory Approvals of Licensed Products in the Territory; material clinical study results; and the Marketing Authorization Applications that Everest or any of its Affiliates reasonably expect to make, seek or attempt to obtain in the Territory; (ii) reviewing for each additional Global Study deemed a Joint Global Study (1) the current Development Plan andMinimum Enrollment Threshold, with the JDC’s approval, making any amendments or updates to the Development Plan; and (iii2) coordinating if the conduct of Parties agree to include an obligation for Licensee to meet [***] Enrollment Allocations, the Development activities[***] Enrollment Allocation. Each [***] Enrollment Allocation shall be mutually agreed upon or amended in writing by the Parties, and for each additional Global Study deemed a Joint Global Study, the applicable Minimum Enrollment Threshold shall be mutually agreed upon in writing by the Parties; (e) serve as a forum at each meeting for discussing to review and supervising the Commercialization coordinate forecasting and supply of Licensee’s expected requirements of Licensed Products Product for Development purposes; (f) to review all material Clinical Data obtained from Clinical Trials of the Compound and any Licensed Product in the Licensed Field in Territory; (g) to review all material Clinical Data for any Joint Global Studies within the Territory, including by (i) providing Everest with a forum to disclose to Everest’s, or its Affiliates’ or Sublicensees’Clinical Development Plan;

Joint Development Committee. Within […***…] days after the Effective Date, the Parties shall establish will form a joint development and regulatory committee (the “Joint Development Committee” or the “JDC”), composed of [***] representatives of NPLH (if NPLH elects to participate) and [***] representatives of Everest, to coordinate the overall strategy, plans, and responsibilities of the Parties for Development and Commercialization of the Compound and any Licensed Products in the Licensed Field Territory and outside the Licensed Territory, to facilitate communication between the Parties and provide a forum for the Parties to review Development and regulatory matters pertaining to the Licensed Product in the Licensed Territory and outside the Licensed Territory, and to coordinate such Development activities in the Licensed Territory with Licensed Product development work outside the Licensed Territory. Each JDC representative shall have appropriate knowledge Except as otherwise provided herein, the role and expertise and sufficient seniority within the applicable Party to make decisions arising within the scope responsibilities of the JDC’s responsibilities. For the purposes of participation in the JDC, NPLH has the right but not the obligation to participate in the JDC. The JDC shallare: (a) serve as a forum for discussing to oversee strategy, progress, and results with respect to Licensed Product Development of the Compound and Licensed Products in the Licensed Field in the Territory, including by reviewing the Development Plan and coordinating the conduct of the Development activities[…***…]; (b) serve as to review and approve the conduct by Mirati of any Development activities with respect to any Licensed Product in the Licensed Territory solely for use or sale outside the Licensed Territory, other than […***…]; (c) to review and approve the Development Plan, with the understanding that the Initial Development Plan has been approved by the Parties, and any material amendments or revisions thereto; (d) to review and coordinate forecasting and supply of BeiGene’s expected requirements of Drug Substance and Drug Product for Development purposes; 15 *** Confidential Treatment Requested (e) to review all material […***…]; (f) to provide a forum for discussing discussion of and coordinate interactions with Regulatory Authorities […***…]; (g) to review any material Regulatory Filings with respect to the Commercialization Licensed Product to be submitted to any Regulatory Authority […***…]; (h) to review and discuss […***…]; (i) to discuss and provide a forum for the exchange of pharmacovigilance and safety matters; (j) to provide a forum for discussion of and coordinate decisions related to […***…]; and (k) to discuss, review and approve any proposed publications and presentations by Mirati that includes the Clinical Data of BeiGene and to discuss and review any […***…], with the objective of protecting each Party’s Confidential Information and providing a reasonable opportunity for patent prosecution as appropriate prior to publication; and (l) to perform such other functions as the Parties may allocate to JDC in writing, where such functions are appropriate to further the purposes of this Agreement with respect to the Development of Licensed Products in the Licensed Field in the Territory, including by reviewing the Commercialization strategy for the Territory, reviewing the Commercialization Plans and coordinating the conduct of the Commercialization activities; (c) serve as a forum for discussing the Manufacture and supply of Compound and Licensed Products in the Licensed Field in the Territory, including by reviewing the Development strategy and Commercialization strategy for the Territory and coordinating the conduct of the Manufacturing and supply activities; (d) serve as a forum for discussing and supervising Development of the Compound and Licensed Products in the Licensed Field in the Territory, including by (i) providing Everest with a forum at each meeting to disclose Everest’s, or its Affiliates’ or Sublicensees’ activities with respect to achieving Regulatory Approvals of Licensed Products in the Territory; material clinical study results; and the Marketing Authorization Applications that Everest or any of its Affiliates reasonably expect to make, seek or attempt to obtain in the Territory; (ii) reviewing the current Development Plan and, with the JDC’s approval, making any amendments or updates to the Development Plan; and (iii) coordinating the conduct of the Development activities; (e) serve as a forum at each meeting for discussing and supervising the Commercialization of Licensed Products in the Licensed Field in the Territory, including by (i) providing Everest with a forum to disclose to Everest’s, or its Affiliates’ or Sublicensees’.

Joint Development Committee. Within […***…] days after the Effective Date, the Parties shall establish will form a joint development and regulatory committee (the “Joint Development Committee” or the “JDC”), composed of [***] representatives of NPLH (if NPLH elects to participate) and [***] representatives of Everest, to coordinate the overall strategy, plans, and responsibilities of the Parties for Development and Commercialization of the Compound and any Licensed Products in the Licensed Field Territory and outside the Licensed Territory, to facilitate communication between the Parties and provide a forum for the Parties to review Development and regulatory matters pertaining to the Licensed Product in the Licensed Territory and outside the Licensed Territory, and to coordinate such Development activities in the Licensed Territory with Licensed Product development work outside the Licensed Territory. Each JDC representative shall have appropriate knowledge Except as otherwise provided herein, the role and expertise and sufficient seniority within the applicable Party to make decisions arising within the scope responsibilities of the JDC’s responsibilities. For the purposes of participation in the JDC, NPLH has the right but not the obligation to participate in the JDC. The JDC shallare: (a) serve as a forum for discussing to oversee strategy, progress, and results with respect to Licensed Product Development of the Compound and Licensed Products in the Licensed Field in the Territory, including by reviewing the Development Plan and coordinating the conduct of the Development activities[…***…]; (b) serve as to review and approve the conduct by Mirati of any Development activities with respect to any Licensed Product in the Licensed Territory solely for use or sale outside the Licensed Territory, other than […***…]; (c) to review and approve the Development Plan, with the understanding that the Initial Development Plan has been approved by the Parties, and any material amendments or revisions thereto; (d) to review and coordinate forecasting and supply of BeiGene’s expected requirements of Drug Substance and Drug Product for Development purposes; 16 *** Confidential Treatment Requested (e) to review all material […***…]; (f) to provide a forum for discussing discussion of and coordinate interactions with Regulatory Authorities […***…]; (g) to review any material Regulatory Filings with respect to the Commercialization Licensed Product to be submitted to any Regulatory Authority […***…]; (h) to review and discuss […***…]; (i) to discuss and provide a forum for the exchange of pharmacovigilance and safety matters; (j) to provide a forum for discussion of and coordinate decisions related to […***…]; and (k) to discuss, review and approve any proposed publications and presentations by Mirati that includes the Clinical Data of BeiGene and to discuss and review any […***…], with the objective of protecting each Party’s Confidential Information and providing a reasonable opportunity for patent prosecution as appropriate prior to publication; and (l) to perform such other functions as the Parties may allocate to JDC in writing, where such functions are appropriate to further the purposes of this Agreement with respect to the Development of Licensed Products in the Licensed Field in the Territory, including by reviewing the Commercialization strategy for the Territory, reviewing the Commercialization Plans and coordinating the conduct of the Commercialization activities; (c) serve as a forum for discussing the Manufacture and supply of Compound and Licensed Products in the Licensed Field in the Territory, including by reviewing the Development strategy and Commercialization strategy for the Territory and coordinating the conduct of the Manufacturing and supply activities; (d) serve as a forum for discussing and supervising Development of the Compound and Licensed Products in the Licensed Field in the Territory, including by (i) providing Everest with a forum at each meeting to disclose Everest’s, or its Affiliates’ or Sublicensees’ activities with respect to achieving Regulatory Approvals of Licensed Products in the Territory; material clinical study results; and the Marketing Authorization Applications that Everest or any of its Affiliates reasonably expect to make, seek or attempt to obtain in the Territory; (ii) reviewing the current Development Plan and, with the JDC’s approval, making any amendments or updates to the Development Plan; and (iii) coordinating the conduct of the Development activities; (e) serve as a forum at each meeting for discussing and supervising the Commercialization of Licensed Products in the Licensed Field in the Territory, including by (i) providing Everest with a forum to disclose to Everest’s, or its Affiliates’ or Sublicensees’.