Common use of Joint Development Committee Clause in Contracts

Joint Development Committee. Within [***] after the Effective Date, the Parties shall establish a joint development committee (the “Joint Development Committee” or the “JDC”), composed of one (1) representative of each Party, to guide the collaboration of the Parties under this Agreement and to oversee the exchange of information between the Parties with respect to the Development of Proprietary Drugs and Licensed Products until the end of the first Phase 3 Clinical Trial for any Licensed Product. 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 in particular: (a) provide a forum for the discussion of the Development of Proprietary Drugs and Licensed Products until the end of the first Phase 3 Clinical Trial for any Licensed Product; (b) oversee the transfer of Licensed Know-How and materials to Roivant under Section 2.4 (Initial Transfer of Know-How and Materials); and (c) provide a forum for Roivant to keep TheraVida reasonably informed regarding the Development of Licensed Products including the status of any Regulatory Filings, Regulatory approvals, or clinical trials. 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 primarily be advisory and provide a forum for information exchange, with Roivant having ultimate decision making authority to the extent any decisions must be made by the JDC; provided, however, that neither the JDC, nor Roivant in the exercise of its ultimate decision making authority, shall 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. Upon the first approval by the FDA of an NDA for any Licensed Product or the first approval by the EMA of an MAA for any Licensed Product (whichever occurs first), the JDC will cease to exist and the Parties will no longer have any obligations with respect to the JDC.

Joint Development Committee. Within [***] after the Effective Date, the Parties The JSC shall promptly establish a joint development committee (the “Joint Development Committee” or the “JDC”), composed which is subject to the supervision and oversight of one (1) representative of each Partythe JSC, to guide the collaboration of the Parties under this Agreement review, discuss, coordinate and to oversee the exchange of share information between the Parties with respect to the Development of Proprietary Drugs and Licensed Products until the end of the first Phase 3 Clinical Trial for any Licensed Product. 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 in particular: regarding (ai) provide a forum for the discussion of the Development of Proprietary Drugs and Licensed Products until the end of the first Phase 3 Clinical Trial for any Licensed Product; (b) oversee the transfer of Licensed Know-How and materials to Roivant under Section 2.4 (Initial Transfer of Know-How and Materials); and (c) provide a forum for Roivant to keep TheraVida reasonably informed regarding the Development of Licensed Products including in the status Territory, (ii) the progress of any the Regulatory FilingsApprovals and Regulatory Submissions for Licensed Products in the Territory, Regulatory approvals, or clinical trialsand (iii) data generated (for which each Party has the right to reference in regulatory filings) from the other Party’s and their licensees’ ongoing and future Clinical Trials and filings for obtaining Registration Certification for medical devices for all indications for the Licensed Products. The JDC will meet with a frequency and in a manner as determined by the JSC. The JSC shall have only resolve any disputes that arise within the JDC within [***] days after any such powers as are expressly assigned matter is brought to it the JSC for resolution. In no event shall the authority of the JDC exceed the authority of the JSC. Each Party shall be responsible for all of its own expenses of participating in this Agreementthe JDC. ARTICLE 4 TECHNOLOGY TRANSFERS 4.1 Technology Transfer. NVCR shall use good faith efforts to, within [***] days of the Effective Date, provide and transfer to Zai the NVCR Know-How which shall be that exists on the Effective Date and was not previously provided to Zai (the “Initial Technology Transfer”). Thereafter, during the Term, NVCR shall (a) at each meeting of the JSC (and, in any event, on a quarterly basis if any JSC meeting is not held in a particular Calendar Quarter), provide Zai with a summary of additional NVCR Know-How (if any) developed or included in the License and details of any Product Updates and Product Improvements developed [***], (b) transfer any such NVCR Know-How and Product Updates to Zai [***], and such powers (c) provide Zai with reasonable access to NVCR personnel involved in the research and Development of Licensed Products, either in person at NVCR’s facility or by teleconference (the “Continuing Technology Transfer,” and together with the Initial Technology Transfer, the “Technology Transfer”). Thereafter, during the Term, at JSC meetings, NVCR shall be subject keep Zai reasonably informed of NVCR’s Development activity as it relates to Zai’s Development and Commercialization in the terms and conditions of this AgreementTerritory. For claritythe avoidance of doubt, the JDC NVCR personnel shall primarily not be advisory obligated to travel to Zai’s facilities, and provide a forum for information exchange, with Roivant having ultimate decision making authority NVCR’s transfer obligations under this Section 4.1 shall apply solely to the extent any decisions must be made by the JDC; provided, however, that neither NVCR Know-How is reasonably necessary to support Zai’s Development and Commercialization of the JDC, nor Roivant Licensed Product in the exercise of its ultimate decision making authority, shall have any right, power or authority: (i) to determine any issue Field in a manner that would conflict the Territory in accordance with the express terms and conditions of this Agreement; or (ii) to modify or amend the terms and conditions of this Agreement. Upon the first approval by the FDA of an NDA for any Licensed Product or the first approval by the EMA of an MAA for any Licensed Product (whichever occurs first), the JDC will cease to exist and the Parties will no longer have any obligations with respect to the JDC.

Joint Development Committee. Within [***] after (i) The JDC will have the responsibility for the overall coordination and oversight of the Development activities for the Licensed Compounds and Licensed Products. As soon as practicable following the Effective Date (but in no event more than ten (10) days following the Effective Date, the Parties shall establish a joint development committee (the “Joint Development Committee” or the “JDC”), composed of one each Party shall designate its initial three (13) representative of each Party, representatives on the JDC. Incyte shall appoint a person from among its representatives on the JDC to guide serve as the collaboration of the Parties under this Agreement and to oversee the exchange of information between the Parties with respect to the Development of Proprietary Drugs and Licensed Products until the end of the first Phase 3 Clinical Trial for any Licensed Product. Each JDC representative shall have appropriate knowledge and expertise and sufficient seniority within the applicable Party to make decisions arising within the scope chairperson of the JDC’s responsibilities. The chairperson shall not have any greater authority than any other representative on the JDC and shall conduct the following activities of the JDC: (A) calling meetings of the JDC; (B) preparing and issuing minutes of each such meeting within thirty (30) days thereafter (which minutes will be deemed approved unless any JDC member objects to the accuracy thereof (provided that any such objection shall have no bearing or effect on the effectiveness of any decisions made by Incyte in accordance with Section 3.5) within ten (10) days after receipt); (C) preparing and circulating an agenda for the upcoming meeting; and (D) ensuring that any decision-making delegated to the JDC is carried out in accordance with Section 3.5, including, as applicable, escalating any dispute to the JSC. The JDC shall in particular:automatically terminate (A) upon the effectiveness of the exercise by Calithera of the Co-Development Opt-Out Right or an Auto Opt-Out Event or (B) if there is no longer at least [ * ] Licensed Compound or Licensed Product being Developed under this Agreement. (aii) provide a forum for the discussion of the Development of Proprietary Drugs and Licensed Products until the end of the first Phase 3 Clinical Trial for any Licensed Product; (b) oversee the transfer of Licensed Know-How and materials to Roivant under Section 2.4 (Initial Transfer of Know-How and Materials); and (c) provide a forum for Roivant to keep TheraVida reasonably informed regarding the Development of Licensed Products including the status of any Regulatory Filings, Regulatory approvals, or clinical trials. The JDC shall have only such powers as are expressly assigned to it responsibility for (A) reviewing and approving the Development Plan and Development Budget and each amendment thereto (in this Agreementeach case, and such powers initial drafts of which shall be subject prepared by Incyte) and presenting them to the terms JSC for resolution of any dispute with respect thereto; (B) overseeing, reviewing and conditions coordinating the conduct of this Agreement. For clarityactivities under the Development Plan; (C) as applicable, overseeing, reviewing and coordinating the work being done under the Development Plan, including reviewing and discussing any reports provided by the Parties; (D) determining the assay for use in measuring the arginase inhibitory activity of any small molecule compound to determine whether such compound is an Arginase Inhibitor; provided that the initial assay shall be determined by the JDC shall primarily within [ * ] of [ * ] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO RULE 24B-2 OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED. the Effective Date and may not thereafter be advisory changed without the Parties’ written consent; (E) determining whether a Phase II Study is a Non-Authorized US Phase II Study; (F) [ * ]; (G) pursuant to Section 5.3(a) and provide a forum for information exchange, with Roivant having ultimate decision making authority to the extent any decisions must be made by the JDC; provided, however, that neither the JDC, nor Roivant in the exercise of its ultimate decision making authority, shall 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. Upon the first approval by the FDA of an NDA for any Licensed Product or the first approval by the EMA of an MAA for any Licensed Product (whichever occurs first5.3(d), the JDC will cease [ * ]; (H) discussing any material regulatory communications with and submissions to exist and the Parties will no longer have any obligations Regulatory Authorities with respect to Licensed Compounds and Licensed Products in the JDCHematology/Oncology Field in the Territory; and (J) reviewing and approving any amendments to the Initial Preclinical Budget and Initial Preclinical Studies and presenting them to the JSC for resolution of any dispute with respect thereto.

Joint Development Committee. Within [***] after the Effective Date, the Parties The JSC shall promptly establish a joint development committee (the “Joint Development Committee” or the “JDC”), composed which is subject to the supervision and oversight of one (1) representative of each Partythe JSC, to guide the collaboration of the Parties under this Agreement review, discuss, coordinate and to oversee the exchange of share information between the Parties with respect to the Development of Proprietary Drugs and Licensed Products until the end of the first Phase 3 Clinical Trial for any Licensed Product. 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 in particular: regarding (ai) provide a forum for the discussion of the Development of Proprietary Drugs and Licensed Products until the end of the first Phase 3 Clinical Trial for any Licensed Product; (b) oversee the transfer of Licensed Know-How and materials to Roivant under Section 2.4 (Initial Transfer of Know-How and Materials); and (c) provide a forum for Roivant to keep TheraVida reasonably informed regarding the Development of Licensed Products including in the status Territory, (ii) the progress of any the Regulatory FilingsApprovals and Regulatory Submissions for Licensed Products in the Territory, Regulatory approvals, or clinical trialsand (iii) data generated (for which each Party has the right to reference in regulatory filings) from the other Party’s and their licensees’ ongoing and future Clinical Trials and filings for obtaining Registration Certification for medical devices for all indications for the Licensed Products. The JDC will meet with a frequency and in a manner as determined by the JSC. The JSC shall have only resolve any disputes that arise within the JDC within [***] days after any such powers as are expressly assigned matter is brought to it the JSC for resolution. In no event shall the authority of the JDC exceed the authority of the JSC. Each Party shall be responsible for all of its own expenses of participating in this Agreementthe JDC. THIS EXHIBIT HAS BEEN REDACTED AND IS THE SUBJECT OF A CONFIDENTIAL TREATMENT REQUEST. REDACTED MATERIAL IS MARKED WITH [***] AND HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. 17 ARTICLE 4 TECHNOLOGY TRANSFERS 4.1 Technology Transfer. NVCR shall use good faith efforts to, within [***] days of the Effective Date, provide and transfer to Zai the NVCR Know-How which shall be that exists on the Effective Date and was not previously provided to Zai (the “Initial Technology Transfer”). Thereafter, during the Term, NVCR shall (a) at each meeting of the JSC (and, in any event, on a quarterly basis if any JSC meeting is not held in a particular Calendar Quarter), provide Zai with a summary of additional NVCR Know-How (if any) developed or included in the License and details of any Product Updates and Product Improvements developed [***], (b) transfer any such NVCR Know-How and Product Updates to Zai [***], and such powers (c) provide Zai with reasonable access to NVCR personnel involved in the research and Development of Licensed Products, either in person at NVCR’s facility or by teleconference (the “Continuing Technology Transfer,” and together with the Initial Technology Transfer, the “Technology Transfer”). Thereafter, during the Term, at JSC meetings, NVCR shall be subject keep Zai reasonably informed of NVCR’s Development activity as it relates to Zai’s Development and Commercialization in the terms and conditions of this AgreementTerritory. For claritythe avoidance of doubt, the JDC NVCR personnel shall primarily not be advisory obligated to travel to Zai’s facilities, and provide a forum for information exchange, with Roivant having ultimate decision making authority NVCR’s transfer obligations under this Section 4.1 shall apply solely to the extent any decisions must be made by the JDC; provided, however, that neither NVCR Know-How is reasonably necessary to support Zai’s Development and Commercialization of the JDC, nor Roivant Licensed Product in the exercise of its ultimate decision making authority, shall have any right, power or authority: (i) to determine any issue Field in a manner that would conflict the Territory in accordance with the express terms and conditions of this Agreement; or (ii) to modify or amend the terms and conditions of this Agreement. Upon the first approval by the FDA of an NDA for any Licensed Product or the first approval by the EMA of an MAA for any Licensed Product (whichever occurs first), the JDC will cease to exist and the Parties will no longer have any obligations with respect to the JDC.

Joint Development Committee. Within [****] after the Effective Date, the Parties shall establish a joint development committee (the “Joint Development Committee” or the “JDC”)) with the responsibility to oversee, composed review and coordinate the Development, including regulatory activities, of one Licensed Products in the Field in the Territory (1) representative of each Party, other than any Development activity that is solely and specifically intended to guide support or maintain Regulatory Approval in [****]. Subject to the collaboration oversight of the Parties under this Agreement JSC, the JDC shall perform the following functions: 2.2.1 oversee and monitor the regulatory and other Development activities (including with respect to oversee Manufacturing) in support of obtaining Regulatory Approval for the exchange of information between Licensed Products in the Parties Field in [****]; 2.2.2 discuss any additional clinical studies or other Development activities to be conducted with respect to the Development of Proprietary Drugs and Licensed Compounds or Licensed Products until in the end Field in [****]; 2.2.3 develop and approve the initial Development Plan (if any) and review and approve any amendments thereto; 2.2.4 oversee and monitor the implementation of the first Phase 3 Clinical Trial for Development Plan and the cost incurred with respect thereto; 2.2.5 determine whether to designate any Licensed Product. Each JDC representative shall have appropriate knowledge and expertise and sufficient seniority within country other than the applicable Party to make decisions arising within the scope of the JDC’s responsibilities. The JDC shall countries in particular: clause (a) provide of the definition of Designated Country as a forum Designated Country; 2.2.6 review and approve any Product Labeling with the FDA for the discussion of the Development of Proprietary Drugs and Licensed Products until the end of the first Phase 3 Clinical Trial for any Initial Licensed Product; (b) oversee 2.2.7 [****]; 2.2.8 determine which Party should hold and maintain the transfer of global safety database for the Licensed Know-How Products; 2.2.9 develop and materials to Roivant under Section 2.4 (Initial Transfer of Know-How and Materials)approve the Publication Policies; and (c) provide a forum for Roivant to keep TheraVida reasonably informed regarding the Development of Licensed Products including the status of any Regulatory Filings, Regulatory approvals, or clinical trials. The JDC shall have only 2.2.10 perform such powers as other functions that are expressly assigned to it the JDC under this Agreement or by the JSC or as the Parties may mutually agree in this Agreementwriting, and such powers shall be subject to the terms and conditions except where in conflict with any provision of this Agreement. For clarity, the JDC shall primarily be advisory and provide a forum for information exchange, with Roivant having ultimate decision making authority to the extent any decisions must be made by the JDC; provided, however, that neither the JDC, nor Roivant in the exercise of its ultimate decision making authority, shall not have any rightauthority beyond the specific matters set forth in this Section 2.2, and in particular shall not have any power to (a) amend or authority: modify the terms of this Agreement (ib) waive a Party’s compliance with this Agreement, (c) decide or resolve any issues other than those specifically subject to JDC approval in this Section 2.2, (d) determine any issue in a manner that would conflict with the express terms and conditions of this Agreement; Agreement or (iie) to modify or amend impose any other obligations on either Party without the terms and conditions prior written consent of this Agreement. Upon the first approval by the FDA of an NDA for any Licensed Product or the first approval by the EMA of an MAA for any Licensed Product (whichever occurs first), the JDC will cease to exist and the Parties will no longer have any obligations with respect to the JDCsuch Party.

Joint Development Committee. (a) If Infinity intends that the first Phase II Study for a Product be in an oncology Indication, Infinity will provide Intellikine with written notice of Infinity’s intent to conduct such Phase II Study at least ninety (90) days before the expected date of first patient, first visit in such Phase II Study, and, subject to Sections 7.1(e) and 7.3, such Product shall thereafter be deemed an Oncology Product. Within [***] ten (10) days after the Effective Datedate of the first such notice, the Parties shall will establish a joint development committee (the “Joint Development Committee” or the “JDC”), composed of one (1) representative of each Party, to guide the collaboration of the Parties under this Agreement and to oversee the exchange of information between the Parties with respect to the Development of Proprietary Drugs and Licensed Products until the end of the first Phase 3 Clinical Trial for any Licensed Product. 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 in particular: (a) provide a forum for the discussion of the Development of Proprietary Drugs and Licensed Products until the end of the first Phase 3 Clinical Trial for any Licensed Product; (b) oversee the transfer of Licensed Know-How and materials to Roivant under Section 2.4 (Initial Transfer of Know-How and Materials); and (c) provide a forum for Roivant to keep TheraVida reasonably informed regarding the Development of Licensed Products including the status of any Regulatory Filings, Regulatory approvals, or clinical trials. 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 primarily be advisory and provide a forum for information exchange, with Roivant having ultimate decision making authority to the extent any decisions must be made by the JDC; provided, however, that neither the JDCJDC shall disband, nor Roivant and the relevant Product shall no longer be considered an Oncology Product, upon written notice from Infinity to Intellikine that Infinity does not intend to conduct such Phase II Study. (b) The JDC shall be composed of three (3) representatives from Intellikine and three (3) representatives from Infinity. The JDC members shall be appropriately qualified and experienced in order to make a meaningful contribution to committee meetings. Each Party may replace its representatives on the exercise of its ultimate decision making authorityJDC on written notice to the other Party. (c) The JDC will, shall have any right, power or authoritywith respect to Oncology Products: (i) to determine any issue in a manner that would conflict with oversee the express terms activities of the Parties under the Development Plan, including monitoring progress and conditions of this Agreementreviewing Development Plans; or (ii) to modify the extent Intellikine has exercised its Oncology Product Option and has not terminated its Oncology Participation Rights with respect to an Oncology Product, approving (subject to Section 1.2 of Exhibit 5) the Development Plans (including budgets) and any amendment thereto for any Shared Product; (iii) coordinating activities to the extent that Intellikine is conducting a clinical trial with respect to an Oncology Product in accordance with Section 5.8; (iv) as necessary or amend the terms appropriate, establish additional joint subcommittees and conditions of delegate responsibilities to such joint subcommittees; and (v) consider and act upon such other matters as specified in this Agreement. Upon Each Party may from time to time invite a reasonable number of participants, in addition to its representatives on the first approval JDC, to attend JDC meetings in a non-voting capacity, provided such participants are subject to the confidentiality provisions set forth in Article 12. The JDC will be chaired by a representative of Infinity. The chairperson shall set agendas for JDC meetings in advance, provided that the agendas will include any matter requested by either Party. The chairperson shall be responsible for recording, preparing and, within a reasonable time, issuing draft minutes of each JDC meeting. (d) The JDC will also be responsible for resolving disputes that may arise between the Parties with regard to matters pertaining to the development program for an Oncology Product. Decisions of the JDC shall be made by unanimous vote, with Infinity’s representatives to the JDC collectively having one (1) vote and Intellikine’s representatives to the JDC collectively having one (1) vote. If the JDC fails to reach unanimous agreement on a matter before it for decision for a period in excess of thirty (30) days, such matter shall be resolved in accordance with Section 4.7. (e) The JDC shall meet at least quarterly and at such other times as requested by the FDA chairperson or as the Parties may otherwise agree. The first meeting of an NDA for any Licensed Product or the first approval by the EMA of an MAA for any Licensed Product (whichever occurs first), the JDC will cease to exist and shall be held as soon as reasonably practicable after the Parties will formation thereof, but in no longer have any obligations with respect to event later than thirty (30) days after the JDCformation thereof. Meetings shall be held at such place or places as are mutually agreed or by teleconference or videoconference; provided, however, that there shall be at least two (2) face-to-face meetings per calendar year.

Joint Development Committee. Within [***] after (a) Effective as of the Effective Date, the Parties shall establish a joint development committee (the “Joint Development Committee” or the “JDC”). The Members of the JDC as of the Effective Date shall be as set forth on Exhibit 3.3. The voting Members of the ***Certain confidential information contained in this document, composed marked with 3 asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Rule 24b-2 of one (1) representative the Securities Act of 1934, as amended. JDC shall include representation from each Party’s global drug development, to guide clinical development, and/or regulatory affairs departments, and the collaboration non-voting Members of the Parties under this Agreement JDC shall include representation from each Party’s global drug development project management and to oversee U.S. medical affairs departments and/or such other departments as the exchange of information between the Parties with respect to the Development of Proprietary Drugs and Licensed Products until the end of the first Phase 3 Clinical Trial for any Licensed Product. 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 responsibilitiesmay deem appropriate. The JDC shall review and provide comments relating to each Development and Supply Plan and the PNE Development Plan, as applicable, and any modifications thereof, and shall be briefed by the Parties regarding the content, execution, and results thereunder. The JDC’s sole role shall be to (i) assist in particular: *** for the Development of, Clinical Studies for, and preparation and submission of Regulatory Filings for obtaining Regulatory Approval for the Product in the Field, other than Products for the PNE Indication unless Allergan is Developing and Commercializing Product for the PNE Indication, for the United States, including without limitation review of any relevant documents necessary or useful to perform the foregoing role, and (aii) provide a forum for sharing advice, progress, and results and documents, including without limitation the discussion PNE Development Plan, Clinical Study designs, protocols, study reports, and any other material information with respect to Development of the Development of Proprietary Drugs Product, including without limitation for the PNE Indication, and Licensed Products until reviewing the end of the first Phase 3 Clinical Trial for any Licensed Product;foregoing (“JDC Role”). (b) oversee In performing the transfer JDC Role, the powers and responsibilities of Licensed Knowthe JDC are limited to the matters set forth in this Section 3.3. Each Party shall retain the rights, powers and discretion granted to it under this Agreement and no such rights, powers, or discretion shall be delegated to or vested in the JDC unless such delegation or vesting of rights is expressly provided for in this Agreement or the Parties expressly so agree in writing. The JDC shall not have the power to amend, modify or waive compliance with this Agreement, including without limitation any Development and Supply Plan or the PNE Development Plan. The JDC shall coordinate with the respective Party to meet its responsibilities hereunder. The JDC shall also provide a forum for sharing advice, progress, and results and documents for review relating to such activities and activities. The JDC shall attempt to facilitate the resolution of any disputes between the Parties, as described in Section 3.5. In particular and Subject to Section 3.5, the JDC shall be responsible for overseeing and making decisions regarding: (i) preclinical activities and Clinical Studies, including but not limited to clinical and registration strategy, Clinical Study designs, review of essential documents (such as clinical study protocols, Clinical Study reports, statistical analysis plans, and CTD documents) for such Clinical Studies, as described in any Development and Supply Plan, to support the NDA for the Product in the Field; (ii) clinical data go/no-How go decisions through the Development and registration process as described in any Development and Supply Plan; (iii) review all materials that will be included in the eCTD (as defined in Section 5.1(a)(iii)) for Product other than Product for the PNE Indication ***Certain confidential information contained in this document, marked with 3 asterisks, has been omitted and filed separately with the Securities and Exchange Commission pursuant to Roivant under Section 2.4 Rule 24b-2 of the Securities Act of 1934, as amended. unless Allergan is Developing and Commercializing Product for the PNE Indication for compliance with Applicable Laws, including without limitation regulatory requirements for Regulatory Approval; (Initial Transfer of Know-How iv) review quality control procedures and Materials)plans with respect to all Clinical Trials for Product other than Product for the PNE Indication unless Allergan is Developing and Commercializing Product for the PNE Indication for compliance with Applicable Laws, including without limitation regulatory requirements for Regulatory Approval; and (cv) provide a forum for Roivant to keep TheraVida reasonably informed regarding the other Development of Licensed Products including the status of any Regulatory FilingsProduct, Regulatory approvalsother than Product for the PNE Indication unless Allergan is Developing and Commercializing Product for the PNE Indication, or clinical trials. 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 primarily be advisory and provide a forum for information exchange, with Roivant having ultimate decision making authority to the extent any decisions must be made by the JDC; provided, however, that neither the JDC, nor Roivant in the exercise of its ultimate decision making authority, shall have Field in the United States as described in any right, power or authority: (i) to determine any issue in a manner that would conflict with the express terms Development and conditions of this Agreement; or (ii) to modify or amend the terms and conditions of this Agreement. Upon the first approval by the FDA of an NDA for any Licensed Product or the first approval by the EMA of an MAA for any Licensed Product (whichever occurs first), the JDC will cease to exist and the Parties will no longer have any obligations with respect to the JDCSupply Plan.