Common use of Joint Development Committee Clause in Contracts

Joint Development Committee. […***…] after the Effective Date, the Parties will form a joint development and regulatory committee (the “JDC”) to coordinate the overall strategy, 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 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. Except as otherwise provided herein, the role and responsibilities of the JDC are: (a) to oversee strategy, progress, and results with respect to Licensed Product Development in the Field […***…]; (b) 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 discussion of and coordinate interactions with Regulatory Authorities […***…]; (g) to review any material Regulatory Filings with respect to the 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 Territory.

Joint Development Committee. Within […***…] after of the Effective DateDate or a period otherwise mutually agreed to by the Parties, the Parties will form a joint development and regulatory committee (the “JDC”) to coordinate the overall strategy, 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 Product 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 Development in the Field […***…]in the Licensed Territory; (b) to review and approve the conduct by Mirati of discuss any material Development activities activities, including any Clinical Trials, with respect to any Licensed Product in the Field both in the Licensed Territory solely for use or sale and outside the Licensed Territory, other than […***…]; (c) to review and approve the Development Plan, with the understanding that the Initial initial Clinical Development Plan has been approved by the Parties, and any material amendments or revisions theretoto the Clinical Development Plan; (d) to develop (but not approve): (i) for each Existing Global Study, the [***] enrollment allocation (the [***] 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 BeiGeneLicensee’s expected requirements of Drug Substance and Drug Licensed Product for Development purposes; 15 *** Confidential Treatment Requested (e) to review all material […***…]; (f) to provide a forum for discussion review all material Clinical Data obtained from Clinical Trials of the Compound and coordinate interactions with Regulatory Authorities […***…]; any Licensed Product in the Licensed Territory; (g) to review all material Clinical Data for any material Regulatory Filings with respect to the 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 Joint Global Studies within 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 Territory.Plan;

Joint Development Committee. Within […***…] days after the Effective Date, the Parties will form shall establish a joint development and regulatory committee (the “Joint Development Committee” or the “JDC”), composed of [***] representatives of S▇▇▇▇ (if S▇▇▇▇ elects to participate) and [***] representatives of Everest, to coordinate the overall strategy, plans, Development and responsibilities Commercialization of the Parties 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, 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 any Licensed Products in the Licensed Territory and outside Field in the Licensed Territory, to facilitate communication between including by reviewing the Parties Development Plan and provide a forum for coordinating 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. Except as otherwise provided herein, the role and responsibilities conduct of the JDC are: (a) to oversee strategy, progress, and results with respect to Licensed Product Development in the Field […***…]activities; (b) 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 serve as a forum for discussion of and coordinate interactions with Regulatory Authorities […***…]; (g) to review any material Regulatory Filings with respect to discussing the 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 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. […***…] after the Effective Date, the 8.2.1 The Parties will form hereby establish a joint development and regulatory committee (the “JDC”) with the responsibility to oversee, review and coordinate the overall strategyDevelopment of the Licensed Antibodies and Licensed Products in the Field in the Territory. Subject to the oversight of the JSC, plansthe JDC shall perform the following functions, subject to the final decision-making authority of the respective Parties as set forth in Section 8.7.4: (a) in consultation with the JMC (with respect to supply of Licensed Antibodies and Licensed Products), discussing, preparing and submitting to the JSC for approval material amendments to the Joint Development Plan (including the budget therein), on at least an annual basis, and responsibilities reviewing, discussing and approving all other amendments to the Joint Development Plan (including the budget therein); provided that if either Party’s representative(s) on the JDC believes that an amendment is material, then such amendment shall be submitted to the JSC for approval; (b) overseeing and monitoring all Development activities for the Territory, including the implementation of the Parties Joint Development Plan and the costs incurred; (c) creating, implementing and reviewing the overall strategy for Development of the Compound Licensed Antibodies and Licensed Products (including the Global Regulatory Strategy) and the design and objectives of all Clinical Trials and non-clinical studies conducted under the Joint Development Plan; (d) preparing the Global Regulatory Strategy for inclusion within the Joint Development Plan; (e) facilitating the exchange of all regulatory information and data between the Parties and ensuring all regulatory reviews by and between the Parties are conducted in parallel (not sequentially) and on a timely basis; (f) reviewing and approving all Regulatory Documentation for the Licensed Antibody or any Licensed Products in the Licensed Territory (other than (i) Pricing and outside the Licensed Territory, to facilitate communication between the Parties Reimbursement Approvals 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. Except as otherwise provided herein, the role and responsibilities of the JDC are: (aii) to oversee strategy, progress, and results with respect to Licensed Product Clinical Trials under the Independent Development in Plan), including for consistency with the Field […***…]; Global Regulatory Strategy; (bg) to review and approve reviewing the conduct by Mirati of any Development activities regulatory documentation on Schedule 4.2.5 with respect to any Licensed Product in activities under the Licensed Territory solely for use or sale outside the Licensed Territory, other than […***…]; (c) to review and approve the Independent 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 discussion of and coordinate interactions with Regulatory Authorities […***…]; (g) to review any material Regulatory Filings with respect to the 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 Territory.

Joint Development Committee. Within […***…] after following the Effective Date, the Parties will form shall establish the JDC. The JDC shall: (a) discuss and approve any Additional Indication or Combination Therapy to be Developed in the Territory, 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 is proposed by a joint development Party in accordance with Section 4.3. If Hutchmed proposes a Local Trial to be added to the Clinical Development Plan, the JDC may approve converting such Local Trial into a Joint Global Trial; (b) discuss the current Clinical Development Plan and regulatory committee (approve any updates or amendments to the “JDC”) to coordinate Clinical Development Plan, including the overall strategyaddition of any Additional Indication, plansCombination Therapy or Local Trial or Joint Global Trial not set forth in the then-current Clinical Development Plan, and responsibilities discuss the use of any relevant diagnostic in the Parties for Territory; (c) monitor and discuss the alignment of Hutchmed Entities’ Development of the Compound and any 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; (d) discuss whether Hutchmed shall participate in a global trial for the Licensed Product presented by Epizyme, which would include clinical sites both in the Territory and outside the Territory; (e) 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, to facilitate communication between and discuss the Parties status and progress of such activities; (k) 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. Except as otherwise provided herein, the role and responsibilities of the JDC are: (a) to oversee strategy, progress, and results with respect to Licensed Product Development in the Field […***…]; (b) 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 discussion of and coordinate interactions with Regulatory Authorities […***…]; (g) to review any material Regulatory Filings with respect to the 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 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 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, manufacturing and controls (“CMC”) module of such IND or Drug Approval Application, which shall be reviewed by the JMC); (q) 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 Subcommittee to oversee and coordinate activities related to the 3▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇, 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 […***…] after ([***]) days following the Effective Date, the Parties will form a joint development shall establish the JDC. The JDC shall: (a) discuss the Preclinical Development Plan and regulatory committee Clinical Development Plan and any proposed updates or amendments to the same (including the “JDC”) to coordinate the overall strategy, plansaddition of indications), and responsibilities propose revisions to such plans in accordance with Section 4.01 (Joint Development in the Field in the Territory); (b) secure alignment of the Parties for Astellas Entities’ Development of the Compound and any Licensed Products in the Astellas Territory with Frequency’s Development of the Licensed Products in the Frequency Territory; (c) discuss, with respect to each clinical study and on an indication-by-indication basis, whether to include clinical sites in both Parties’ respective portions of the Territory and outside whether such study shall be a Joint Study or a Regional Study; [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the Licensed Territoryregistrant if publicly disclosed. (d) discuss the clinical sites in the Territory to be included in each Joint Study; (e) for each Joint Study, coordinate the operations of the Frequency Entities and Astellas Entities with respect to facilitate communication between such Joint Study; (f) discuss the Parties and contract research organizations in the Territory to be used for each Joint Study; (g) 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. Except as otherwise provided herein, the role and responsibilities of the JDC are: (a) to oversee strategy, progress, and results with respect to Licensed Product Development in the Field […***…]; (b) 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 discussion of and coordinate interactions with Regulatory Authorities […***…]; (g) to review any material Regulatory Filings with respect to the 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 share information with respect to the Development of the Licensed Products in the Field, including reasonably detailed updates on progress and status of Regional Studies and Joint Studies in the Territory and updates regarding interactions with Regulatory Authorities; (h) discuss publications and publication plans as to the Development and Commercialization of Licensed Products in the Territory; (i) discuss, coordinate and provide strategic guidance on the Development of the Licensed Products in the Field in the Territory; (j) discuss the content of any IND or Drug Approval Application for any Licensed Product in the Territory; (k) provide a forum for the Parties to share and discuss GCP quality information with respect to each Party’s Development activities; (l) discuss and establish a GCP Quality Plan within [***] ([***]) days following the Effective Date; (m) submit recommendations to the JSC regarding the matters set forth above; and (n) perform such other duties as are specifically assigned to the JDC under this Agreement.

Joint Development Committee. Within […***…] after following the Effective Date, the Parties will form shall establish the JDC. The JDC shall: (a) discuss and approve any Additional Indication or Combination Therapy to be Developed in the Territory, 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 is proposed by a joint development Party in accordance with Section 4.3. If Hutchmed proposes a Local Trial to be added to the Clinical Development Plan, the JDC may approve converting such Local Trial into a Joint Global Trial; (b) discuss the current Clinical Development Plan and regulatory committee (approve any updates or amendments to the “JDC”) to coordinate Clinical Development Plan, including the overall strategyaddition of any Additional Indication, plansCombination Therapy or Local Trial or Joint Global Trial not set forth in the then-current Clinical Development Plan, and responsibilities discuss the use of any relevant diagnostic in the Parties for Territory; (c) monitor and discuss the alignment of Hutchmed Entities’ Development of the Compound and any 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; (d) discuss whether Hutchmed shall participate in a global trial for the Licensed Product presented by Epizyme, which would include clinical sites both in the Territory and outside the Territory; (e) 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, to facilitate communication between and discuss the Parties status and progress of such activities; (k) 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. Except as otherwise provided herein, the role and responsibilities of the JDC are: (a) to oversee strategy, progress, and results with respect to Licensed Product Development in the Field […***…]; (b) 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 discussion of and coordinate interactions with Regulatory Authorities […***…]; (g) to review any material Regulatory Filings with respect to the 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 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 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, manufacturing and controls (“CMC”) module of such IND or Drug Approval Application, which shall be reviewed by the JMC); (q) 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 Subcommittee to oversee and coordinate activities related to the ▇▇▇ ▇▇▇▇▇▇ ▇▇▇▇▇, 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 […***…] after following the Effective Date, the Parties will form a joint development shall establish the JDC. The JDC shall: (i) discuss and regulatory committee approve the Development Plan and any proposed updates or amendments to the Development Plan (including the “JDC”) to coordinate addition of indications not set forth in the overall strategy, plansthen-current Development Plan), and responsibilities propose revisions to the Development Plan in accordance with Section 4.01 (Development in the Field in the Territory); (ii) secure alignment of the Parties for Licensee Entities’ Development of the Compound and any Licensed Products in the Licensed Territory and outside with Agios’ Development of the Licensed Products outside of the Territory; (iii) discuss and determine, with respect to facilitate communication between each Global Study and on an indication-by-indication basis, whether to include clinical sites in the Parties 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; (xi) 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. Except as otherwise provided herein, the role and responsibilities of the JDC are: (a) to oversee strategy, progress, and results with respect to Licensed Product Development in the Field […***…]; (b) 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 discussion of and coordinate interactions with Regulatory Authorities […***…]; (g) to review any material Regulatory Filings with respect to the 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 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; (xiv) discuss and approve the content of any IND or Drug Approval Application for any Licensed Product in the Territory; and (xv) perform such other duties as are specifically assigned to the JDC under this Agreement.

Joint Development Committee. Within […***…*] ([****]) days after the Effective Date, the Parties will form shall establish a joint development and regulatory committee (the “Joint Development Committee” or the “JDC”), composed of [****] ([****]) representatives of each 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 overall strategy, plans, and responsibilities of the Parties for Development of the Compound and any Licensed Products and Commercialization 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 Product Field 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, Each JDC representative shall have appropriate knowledge and expertise and sufficient seniority within the role and responsibilities applicable Party to make decisions arising within the scope of the JDC’s responsibilities. The JDC areshall: (a) 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 Sinovant with a forum to oversee strategydisclose to Angion Sinovant’s, progress, and results or its Affiliates’ or Sublicensees’ activities with respect to achieving Regulatory Approvals of Licensed Product Development Products in the Field […***…]Territory; material clinical study results; and the Marketing Authorization Applications that Sinovant or any of its Affiliates reasonably expect to make, seek or attempt to obtain in the Territory; (ii) reviewing the Development Plan, including approving amendments and updates to the Development Plan, and (iii) coordinating the conduct of the Development activities; (b) 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 serve as a forum for discussion of discussing and coordinate interactions with Regulatory Authorities […***…]; (g) to review any material Regulatory Filings with respect to supervising the 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 Commercialization of Licensed Products in the Licensed Field in the Territory, including by (i) providing Sinovant with a forum to disclose to Angion 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. […***…] after the Effective Date, the Parties will form a joint development and regulatory committee (the “JDC”) to coordinate the overall strategy, 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 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. Except as otherwise provided herein, the role and responsibilities of the JDC are: (a) to oversee strategy, progress, and results with respect to Licensed Product Development in the Field […***…]; (b) 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 16 *** Confidential Treatment Requested (e) to review all material […***…]; (f) to provide a forum for discussion of and coordinate interactions with Regulatory Authorities […***…]; (g) to review any material Regulatory Filings with respect to the 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 Territory.

Joint Development Committee. Within […***…] after of the Effective DateDate or a period otherwise mutually agreed to by the Parties, the Parties will form a joint development and regulatory committee (the “JDC”) to coordinate the overall strategy, 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 Product 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 Development in the Field […***…]in the Licensed Territory; (b) to review and approve the conduct by Mirati of discuss any material Development activities activities, including any Clinical Trials, with respect to any Licensed Product in the Field both in the Licensed Territory solely for use or sale and outside the Licensed Territory, other than […***…]; (c) to review and approve the Development Plan, with the understanding that the Initial initial Clinical Development Plan has been approved by the Parties, and any material amendments or revisions theretoto the Clinical Development Plan; (d) to develop (but not approve): (i) for each Existing Global Study, the [***] enrollment allocation (the [***] 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 BeiGeneLicensee’s expected requirements of Drug Substance and Drug Licensed Product for Development purposes; 15 *** Confidential Treatment Requested; (ef) to review all material Clinical Data obtained from Clinical Trials of the Compound and any Licensed Product in the Licensed Territory; […***…]] = CERTAIN CONFIDENTIAL INFORMATION OMITTED (g) to review all material Clinical Data for any Joint Global Studies within the Clinical Development Plan; (fh) 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; (i) to provide a forum for discussion of and coordinate interactions with Regulatory Authorities […***…]in the Licensed Territory and outside the Licensed Territory; (gj) to review any material Regulatory Filings with respect to the Licensed Product Products to be submitted to any Regulatory Authority […***…]in the Licensed Territory; (hk) to review and discuss […***…]any proposals from Mirati regarding any Additional Global Studies; (il) to discuss and provide a forum for the exchange of pharmacovigilance and safety mattersmatters prior to commercial launch of the Licensed Product; (jm) 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 (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 (ln) 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 Territory.

Joint Development Committee. Within […***…] days after the Effective Date, the Parties will form shall establish 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, Development and responsibilities Commercialization of the Parties 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 any Licensed Products in the Licensed Territory and outside Field in the Licensed Territory, to facilitate communication between including by reviewing the Parties Development Plan and provide a forum for coordinating 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. Except as otherwise provided herein, the role and responsibilities conduct of the JDC are: (a) to oversee strategy, progress, and results with respect to Licensed Product Development in the Field […***…]activities; (b) 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 serve as a forum for discussion of and coordinate interactions with Regulatory Authorities […***…]; (g) to review any material Regulatory Filings with respect to discussing the 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 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’