Common use of Joint Development Committee Clause in Contracts

Joint Development Committee. Within [***] ([***]) days following the Effective Date, the Parties shall establish the JDC. The JDC shall: (a) discuss the Preclinical Development Plan and Clinical Development Plan and any proposed updates or amendments to the same (including the addition of indications), and propose revisions to such plans in accordance with Section 4.01 (Joint Development in the Field in the Territory); (b) secure alignment of the Astellas Entities’ Development of 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 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 registrant 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 such Joint Study; (f) discuss the contract research organizations in the Territory to be used for each Joint Study; (g) provide a forum for 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 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. (a) Within [***] ([***]) days following the Effective Date, the Parties shall establish the JDC. The JDC shall: (ai) discuss and approve the Preclinical Development Plan and Clinical Development Plan and any proposed updates or amendments to the same Development Plan (including the addition of indicationsindications not set forth in the then-current Development Plan), and propose revisions to such plans the Development Plan in accordance with Section 4.01 (Joint Development in the Field in the Territory); (bii) secure alignment of the Astellas Licensee Entities’ Development of Licensed Products in the Astellas Territory with Frequency’s Agios’ Development of the Licensed Products in outside of the Frequency Territory; (ciii) discussdiscuss and determine, with respect to each clinical study Global Study and on an indication-by-indication basis, whether to include clinical sites in both Parties’ respective portions of the Territory in such Global Study and whether such study Global Study shall be a Joint Study or a Regional Global 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 registrant if publicly disclosed.; (div) 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; (evii) for each Joint Global Study, coordinate the operations of the Frequency Agios Entities and Astellas Licensee Entities with respect to such Joint Global Study; (fviii) discuss and determine the contract research organizations in the Territory to be used for each Joint Global Study; (gix) 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 share information with respect to the Development of the Licensed Products in the Field, including reasonably detailed updates on progress and status of Regional 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; (hxii) discuss and approve publications and publication plans as to the Development and Commercialization of Licensed Products in the Territory; (ixiii) discuss, coordinate and provide strategic guidance on the Development of the Licensed Products in the Field in the Territory; (jxiv) discuss and approve 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 (nxv) perform such other duties as are specifically assigned to the JDC under this Agreement.

Joint Development Committee. Within [***] ([***]) days following the Effective Date, the Parties shall establish the JDC. The JDC shall: (a) discuss and approve any Additional Indication or Combination Therapy to be Developed in the Preclinical Development Plan and 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 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 approve any proposed updates or amendments to the same (Clinical Development Plan, including the addition of indications)any Additional Indication, Combination Therapy or Local Trial or Joint Global Trial not set forth in the then-current Clinical Development Plan, and propose revisions to such plans in accordance with Section 4.01 (Joint Development in discuss the Field use of any relevant diagnostic in the Territory); (bc) secure monitor and discuss the alignment of the Astellas Hutchmed Entities’ Development of Licensed Products in the Astellas Territory with FrequencyEpizyme’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 Frequency Field in the Territory; (cd) discussdiscuss whether Hutchmed shall participate in a global trial for the Licensed Product presented by Epizyme, with respect to each clinical study and on an indication-by-indication basis, whether to which would include clinical sites both in both Parties’ respective portions of the Territory and 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 outside the registrant if publicly disclosed.Territory; (de) discuss the clinical sites in the Territory to be included in each Joint Study; (e) for Local Trial and each Joint Study, coordinate the operations of the Frequency Entities and Astellas Entities with respect to such Joint StudyGlobal Trial; (f) discuss the contract research organizations in the Territory to be used protocols for each Local Trial and Joint StudyGlobal 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 for 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 Regional Studies Local Trials and Joint Studies Global Trials in the Territory and updates regarding interactions with Regulatory Authorities; (hl) 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 publications the plans for any publication or presentation proposed by Hutchmed and publication plans as related to the Development and Commercialization 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; (ip) discuss, coordinate review 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 TerritoryTerritory (other than the chemistry, manufacturing and controls (“CMC”) module of such IND or Drug Approval Application, which shall be reviewed by the JMC); (kq) discuss the status and progress of any LCM Epizyme Trial being performed by Epizyme or other Epizyme Entities, for which Epizyme will provide a forum for regular updates to the Parties to share and discuss GCP quality information with respect to each Party’s Development activitiesJDC; (lr) discuss and establish a GCP Quality Plan establish, within [***] (after the establishment of the JDC, a Subcommittee to oversee and coordinate activities related to the 000 Xxxxxx Xxxxx, which Subcommittee shall meet [***]) days following the Effective Date; (m) submit recommendations to the JSC regarding the matters set forth above] unless otherwise agreed; and (ns) 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 [***] ([***]) days following 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) discuss serve as a forum for discussing Development of the Preclinical Development Plan Compound and Clinical Development Plan and any proposed updates or amendments to the same (including the addition of indications), and propose revisions to such plans in accordance with Section 4.01 (Joint Development Licensed Products in the Licensed Field in the Territory), including by reviewing the Development Plan and coordinating the conduct of the Development activities; (b) secure alignment of the Astellas Entities’ Development of 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 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 registrant 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 such Joint Study; (f) discuss the contract research organizations in the Territory to be used for each Joint Study; (g) provide serve as 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 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 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; (ic) discuss, coordinate serve as a forum for discussing the Manufacture and provide strategic guidance on the Development supply of the 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; (jd) discuss serve as a forum for discussing and supervising Development of the content of any IND or Drug Approval Application for any Compound and Licensed Product Products in the Licensed Field in the Territory; , including by (ki) provide providing Everest with a forum for the Parties at each meeting to share and discuss GCP quality information disclose Everest’s, or its Affiliates’ or Sublicensees’ activities with respect to each Partyachieving 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; (le) discuss serve as a forum at each meeting for discussing and establish supervising the Commercialization of Licensed Products in the Licensed Field in the Territory, including by (i) providing Everest with a GCP Quality Plan within [***] ([***]) days following the Effective Date; (m) submit recommendations forum to the JSC regarding the matters set forth above; and (n) perform such other duties as are specifically assigned disclose to the JDC under this Agreement.Everest’s, or its Affiliates’ or Sublicensees’

Joint Development Committee. Within [****] ([****]) days following after the Effective Date, the Parties shall establish a joint development 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 Development 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. The JDC shall: (a) discuss serve as a forum for discussing and supervising Development of the Preclinical Development Plan Compound and Clinical Development Plan and any proposed updates or amendments to the same (including the addition of indications), and propose revisions to such plans in accordance with Section 4.01 (Joint Development 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’ activities with respect to achieving Regulatory Approvals of Licensed Products in the 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) secure alignment of the Astellas Entities’ Development of 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 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 registrant 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 such Joint Study; (f) discuss the contract research organizations in the Territory to be used for each Joint Study; (g) provide serve as a forum for discussing and supervising 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 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 Licensed Field in the Territory; , including by (i) discussproviding Sinovant with a forum to disclose to Angion Sinovant’s, coordinate and provide strategic guidance on the Development of the or its Affiliates’ or Sublicensees’ Commercialization activities with respect to Licensed Products in the Field in Territory; (ii) reviewing the Commercialization strategy for the Territory; ; (jiii) discuss reviewing the content Commercialization Plan, including approving amendments and updates to the Commercialization Plan, and (iv) coordinating the conduct 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 Commercialization activities; (lc) discuss intellectual property-related matters affecting, and establish 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 GCP Quality Plan within manner that would conflict [****] = [CONFIDENTIAL PORTION HAS BEEN OMITTED BECAUSE IT ([***]I) days following IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED with the Effective Date; express terms and conditions of this Agreement; or (mii) submit recommendations to modify or amend the JSC regarding the matters set forth above; and (n) perform such other duties as are specifically assigned to the JDC under terms and conditions of this Agreement.

Joint Development Committee. Within […***…] ([***]) days following after the Effective Date, the Parties shall establish will form a joint development and regulatory committee (the “JDC. The JDC shall: (a”) discuss to coordinate the Preclinical overall strategy, plans, and responsibilities of the Parties for Development Plan and Clinical Development Plan of the Compound and any proposed updates or amendments to the same (including the addition of indications), and propose revisions to such plans in accordance with Section 4.01 (Joint Development in the Field in the Territory); (b) secure alignment of the Astellas Entities’ Development of Licensed Products in the Astellas Licensed Territory with Frequency’s Development of and outside the Licensed Products in Territory, to facilitate communication between the Frequency Territory; (c) discuss, with respect to each clinical study Parties and on an indication-by-indication basis, whether to include clinical sites in both Parties’ respective portions of the Territory and 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 registrant 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 such Joint Study; (f) discuss the contract research organizations in the Territory to be used for each Joint Study; (g) provide a forum for the Parties to share information 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 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 [***] ([***]) days following 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 “JDC. The JDC shall: (a”) discuss to coordinate the Preclinical overall strategy, plans, and responsibilities of the Parties for Development Plan and Clinical Development Plan of the Compound and any proposed updates or amendments to the same (including the addition of indications), and propose revisions to such plans in accordance with Section 4.01 (Joint Development in the Field in the Territory); (b) secure alignment of the Astellas Entities’ Development of Licensed Products in the Astellas Licensed Territory with Frequency’s Development of and outside the Licensed Products in Territory, to facilitate communication between the Frequency Territory; (c) discuss, with respect to each clinical study Parties and on an indication-by-indication basis, whether to include clinical sites in both Parties’ respective portions of the Territory and 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 registrant 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 such Joint Study; (f) discuss the contract research organizations in the Territory to be used for each Joint Study; (g) provide a forum for the Parties to share information 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 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 Product in the Field in the Licensed Territory; (jb) to review and discuss the content of any IND or Drug Approval Application for 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; (kc) provide a forum for to review and approve the Parties initial Clinical Development Plan and any material amendments or revisions to share and discuss GCP quality information with respect to each Party’s the Clinical Development activitiesPlan; (ld) discuss and establish a GCP Quality Plan within to develop (but not approve): (i) for each Existing Global Study, the [***] enrollment allocation (the [***]] Enrollment Allocation”) days following for each [***] in the Effective DateEnrollment 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; (me) submit recommendations to the JSC regarding the matters set forth above; andreview and coordinate forecasting and supply of Licensee’s expected requirements of Licensed Product for Development purposes; (nf) perform such other duties as are specifically assigned to review all material Clinical Data obtained from Clinical Trials of the JDC under this Agreement.Compound and any Licensed Product in the Licensed Territory; (g) to review all material Clinical Data for any Joint Global Studies within the Clinical Development Plan;

Joint Development Committee. Within [***] ([***]) days following after the Effective Date, the Parties shall establish a joint development committee (the “Joint Development Committee” or the “JDC”), composed of [***] representatives of Sxxxx (if Sxxxx 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, Sxxxx has the right but not the obligation to participate in the JDC. The JDC shall: (a) discuss serve as a forum for discussing Development of the Preclinical Development Plan Compound and Clinical Development Plan and any proposed updates or amendments to the same (including the addition of indications), and propose revisions to such plans in accordance with Section 4.01 (Joint Development Licensed Products in the Licensed Field in the Territory), including by reviewing the Development Plan and coordinating the conduct of the Development activities; (b) secure alignment of the Astellas Entities’ Development of 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 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 registrant 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 such Joint Study; (f) discuss the contract research organizations in the Territory to be used for each Joint Study; (g) provide serve as 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 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 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; (ic) discuss, coordinate serve as a forum for discussing the Manufacture and provide strategic guidance on the Development supply of the 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; (jd) discuss serve as a forum for discussing and supervising Development of the content of any IND or Drug Approval Application for any Compound and Licensed Product Products in the Licensed Field in the Territory; , including by (ki) provide providing Everest with a forum for the Parties at each meeting to share and discuss GCP quality information disclose Everest’s, or its Affiliates’ or Sublicensees’ activities with respect to each Partyachieving 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; (le) discuss serve as a forum at each meeting for discussing and establish supervising the Commercialization of Licensed Products in the Licensed Field in the Territory, including by (i) providing Everest with a GCP Quality 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 within [***] and, with the JDC’s approval, making any amendments or updates to the Commercialization Plan; and ([***]iv) days following coordinating the Effective Dateconduct of the Commercialization activities; (mf) submit recommendations to coordinate the JSC regarding the matters set forth aboveactivities of Sxxxx and Everest under this Agreement; and (ng) perform such other duties functions as are specifically 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 under 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 following the Effective Date, the Parties shall establish the JDC. The JDC shall: (a) discuss and approve any Additional Indication or Combination Therapy to be Developed in the Preclinical Development Plan and 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 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 approve any proposed updates or amendments to the same (Clinical Development Plan, including the addition of indications)any Additional Indication, Combination Therapy or Local Trial or Joint Global Trial not set forth in the then-current Clinical Development Plan, and propose revisions to such plans in accordance with Section 4.01 (Joint Development in discuss the Field use of any relevant diagnostic in the Territory); (bc) secure monitor and discuss the alignment of the Astellas Hutchmed Entities’ Development of Licensed Products in the Astellas Territory with FrequencyEpizyme’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 Frequency Field in the Territory; (cd) discussdiscuss whether Hutchmed shall participate in a global trial for the Licensed Product presented by Epizyme, with respect to each clinical study and on an indication-by-indication basis, whether to which would include clinical sites both in both Parties’ respective portions of the Territory and 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 outside the registrant if publicly disclosed.Territory; (de) discuss the clinical sites in the Territory to be included in each Joint Study; (e) for Local Trial and each Joint Study, coordinate the operations of the Frequency Entities and Astellas Entities with respect to such Joint StudyGlobal Trial; (f) discuss the contract research organizations in the Territory to be used protocols for each Local Trial and Joint StudyGlobal 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 for 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 Regional Studies Local Trials and Joint Studies Global Trials in the Territory and updates regarding interactions with Regulatory Authorities; (hl) 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 publications the plans for any publication or presentation proposed by Hutchmed and publication plans as related to the Development and Commercialization 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; (ip) discuss, coordinate review 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 TerritoryTerritory (other than the chemistry, manufacturing and controls (“CMC”) module of such IND or Drug Approval Application, which shall be reviewed by the JMC); (kq) discuss the status and progress of any LCM Epizyme Trial being performed by Epizyme or other Epizyme Entities, for which Epizyme will provide a forum for regular updates to the Parties to share and discuss GCP quality information with respect to each Party’s Development activitiesJDC; (lr) discuss and establish a GCP Quality Plan establish, within [***] (after the establishment of the JDC, a Subcommittee to oversee and coordinate activities related to the 300 Xxxxxx Xxxxx, which Subcommittee shall meet [***]) days following the Effective Date; (m) submit recommendations to the JSC regarding the matters set forth above] unless otherwise agreed; and (ns) 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 [***] ([***]) days following 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 “JDC. The JDC shall: (a”) discuss to coordinate the Preclinical overall strategy, plans, and responsibilities of the Parties for Development Plan and Clinical Development Plan of the Compound and any proposed updates or amendments to the same (including the addition of indications), and propose revisions to such plans in accordance with Section 4.01 (Joint Development in the Field in the Territory); (b) secure alignment of the Astellas Entities’ Development of Licensed Products in the Astellas Licensed Territory with Frequency’s Development of and outside the Licensed Products in Territory, to facilitate communication between the Frequency Territory; (c) discuss, with respect to each clinical study Parties and on an indication-by-indication basis, whether to include clinical sites in both Parties’ respective portions of the Territory and 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 registrant 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 such Joint Study; (f) discuss the contract research organizations in the Territory to be used for each Joint Study; (g) provide a forum for the Parties to share information 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 Products Product in the FieldField in the Licensed Territory; (b) to review and discuss any material Development activities, including reasonably detailed updates on progress and status of Regional Studies and Joint Studies any Clinical Trials, with respect to any Licensed Product in the Field both in the Licensed Territory and updates regarding interactions with Regulatory Authoritiesoutside 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 [***] 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 Licensee’s expected requirements of Licensed 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 Territory; [***] = CERTAIN CONFIDENTIAL INFORMATION OMITTED (g) to review all material Clinical Data for any Joint Global Studies within the Clinical Development Plan; (h) discuss publications to review all material Reference Data Controlled by a Party and publication plans as to the generated or produced in connection with any Development and Commercialization of activities conducted for any Licensed Products Product in the Licensed Territory and outside the Licensed Territory; (i) discuss, to provide a forum for discussion of and coordinate and provide strategic guidance on the Development of interactions with Regulatory Authorities in the Licensed Products in Territory and outside the Field in the Licensed Territory; (j) discuss to review any material Regulatory Filings with respect to the content of Licensed Products to be submitted to any IND or Drug Approval Application for any Licensed Product 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 Parties exchange of pharmacovigilance and safety matters prior 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 commercial launch of the Effective DateLicensed Product; (m) submit recommendations to the JSC regarding the matters set forth aboveprovide 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 duties functions as the Parties may allocate to JDC in writing, where such functions are specifically assigned appropriate to further the purposes of this Agreement with respect to the JDC under this AgreementDevelopment of Licensed Products in the Licensed Territory.

Joint Development Committee. Within […***…] ([***]) days following after the Effective Date, the Parties shall establish will form a joint development and regulatory committee (the “JDC. The JDC shall: (a”) discuss to coordinate the Preclinical overall strategy, plans, and responsibilities of the Parties for Development Plan and Clinical Development Plan of the Compound and any proposed updates or amendments to the same (including the addition of indications), and propose revisions to such plans in accordance with Section 4.01 (Joint Development in the Field in the Territory); (b) secure alignment of the Astellas Entities’ Development of Licensed Products in the Astellas Licensed Territory with Frequency’s Development of and outside the Licensed Products in Territory, to facilitate communication between the Frequency Territory; (c) discuss, with respect to each clinical study Parties and on an indication-by-indication basis, whether to include clinical sites in both Parties’ respective portions of the Territory and 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 registrant 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 such Joint Study; (f) discuss the contract research organizations in the Territory to be used for each Joint Study; (g) provide a forum for the Parties to share information 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; 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 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.