Common use of Joint Development Committee Clause in Contracts

Joint Development Committee. 4.1 Within thirty (30) days after the effective date of this Agreement, each Party shall appoint (and notify the other Party of the identity of) an alliance manager. Each Party may, at any time, replace its alliance manager with another suitably qualified individual, on written notice to the other Party. The alliance managers shall be primarily responsible for facilitating communications between the Parties and coordinating the Parties’ activities under this Agreement. 4.2 The Parties shall establish a joint development committee to oversee the development and commercialization activities, including but not limited to discuss and make decisions with respect to the manufacturing of the Licensed Product for clinical supply in accordance with the I-Mab development plan, under this Agreement (the “Joint Development Committee” or “JDC”). The Joint Development Committee shall be composed of four members with the equal number of persons from each Party who are with appropriate seniority and functional expertise. Any decisions of the JDC shall be determined by a majority vote by the JDC members present at a meeting. The minimum quorum for a JDC meeting shall be two-third (2/3) of members who must be present for the entire meeting. If the JDC cannot reach consensus within two (2) weeks on any issue that comes before the JDC, then the Parties shall immediately refer such matter to the Chief Executive Officers at I-Mab and Genexine for resolution. In the event of a dispute between I-Mab and Genexine that cannot be resolved within two (2) weeks by the Chief Executive Officers with respect to matters concerning the research and development of Licensed Product, I-Mab shall have the final decision-making authority. Notwithstanding the foregoing, I-Mab shall have day-to-day operational control over the development, manufacture and commercialization of the Licensed Product, provided that I-Mab conducts such activities in accordance with the terms and conditions of this Agreement. 4.3 The JDC shall hold meetings at such times as it elects to do so, but in no event shall such meetings be held less frequently than once every month. Meetings of the JDC may be held in person, by audio or video teleconference; provided that at least one (1) meeting per year of the JDC shall be held in person. In-person JDC meetings shall be held at locations selected alternatively by the Parties. Each Party shall be responsible for all of its own expenses of participating in the JDC. No action taken at any meeting of the JDC shall be effective unless representatives of both Parties are participating.

Joint Development Committee. 4.1 Within thirty (30) days [***] after the effective date of this AgreementEffective Date, each Party shall appoint (and notify the other Party of the identity of) an alliance manager. Each Party may, at any time, replace its alliance manager with another suitably qualified individual, on written notice to the other Party. The alliance managers shall be primarily responsible for facilitating communications between the Parties and coordinating the Parties’ activities under this Agreement. 4.2 The Parties shall establish a joint development committee to oversee the development and commercialization activities, including but not limited to discuss and make decisions with respect to the manufacturing of the Licensed Product for clinical supply in accordance with the I-Mab development plan, under this Agreement (the “Joint Development Committee” or the “JDC”). The Joint Development Committee shall be , composed of four members with one (1) representative of each Party, to guide the equal number of persons from each Party who are with appropriate seniority and functional expertise. Any decisions collaboration of the JDC shall be determined by a majority vote by Parties under this Agreement and to oversee the JDC members present at a meeting. The minimum quorum for a JDC meeting shall be two-third (2/3) exchange of members who must be present for the entire meeting. If the JDC cannot reach consensus within two (2) weeks on any issue that comes before the JDC, then information between the Parties shall immediately refer such matter to the Chief Executive Officers at I-Mab and Genexine for resolution. In the event of a dispute between I-Mab and Genexine that cannot be resolved within two (2) weeks by the Chief Executive Officers with respect to matters concerning the research Development of Proprietary Drugs and development 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 ProductKnow-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, I-Mab Regulatory approvals, or clinical trials. The JDC shall have the final decision-making authority. Notwithstanding the foregoingonly such powers as are expressly assigned to it in this Agreement, I-Mab and such powers shall have day-to-day operational control over the development, manufacture and commercialization of the Licensed Product, provided that I-Mab conducts such activities in accordance with be subject to the terms and conditions of this Agreement. 4.3 The JDC shall hold meetings at such times as it elects to do so. For clarity, but in no event shall such meetings be held less frequently than once every month. Meetings of the JDC may be held in person, by audio or video teleconference; provided that at least one (1) meeting per year of the JDC shall primarily be held in person. In-person JDC meetings shall advisory and provide a forum for information exchange, with Roivant having ultimate decision making authority to the extent any decisions must be held at locations selected alternatively made by the Parties. Each Party shall be responsible for all JDC; provided, however, that neither the JDC, nor Roivant in the exercise of its own expenses 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 participating in 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. No action taken at any meeting of the JDC shall be effective unless representatives of both Parties are participating.

Joint Development Committee. 4.1 Within thirty (30) days after the effective date of this Agreement, each Party The JSC shall appoint (and notify the other Party of the identity of) an alliance manager. Each Party may, at any time, replace its alliance manager with another suitably qualified individual, on written notice to the other Party. The alliance managers shall be primarily responsible for facilitating communications between the Parties and coordinating the Parties’ activities under this Agreement. 4.2 The Parties shall promptly establish a joint development committee to oversee the development and commercialization activities, including but not limited to discuss and make decisions with respect to the manufacturing of the Licensed Product for clinical supply in accordance with the I-Mab development plan, under this Agreement (the “Joint Development Committee” or “JDC”), which is subject to the supervision and oversight of the JSC, to review, discuss, coordinate and share information regarding (i) the Development of Licensed Products in the Territory, (ii) the progress of the Regulatory Approvals and Regulatory Submissions for Licensed Products in the Territory, and (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 Joint Development Committee JDC will meet with a frequency and in a manner as determined by the JSC. The JSC shall be composed of four members with the equal number of persons from each Party who are with appropriate seniority and functional expertise. Any decisions of resolve any disputes that arise within the JDC shall be determined by a majority vote by the JDC members present at a meeting. The minimum quorum for a JDC meeting shall be two-third (2/3) of members who must be present for the entire meeting. If the JDC cannot reach consensus within two (2) weeks on [***] days after any issue that comes before the JDC, then the Parties shall immediately refer such matter is brought to the Chief Executive Officers at I-Mab and Genexine JSC for resolution. In the event of a dispute between I-Mab and Genexine that cannot be resolved within two (2) weeks by the Chief Executive Officers with respect to matters concerning the research and development of Licensed Product, I-Mab shall have the final decision-making authority. Notwithstanding the foregoing, I-Mab shall have day-to-day operational control over the development, manufacture and commercialization of the Licensed Product, provided that I-Mab conducts such activities in accordance with the terms and conditions of this Agreement. 4.3 The JDC shall hold meetings at such times as it elects to do so, but in no event shall such meetings be held less frequently than once every month. Meetings the authority of the JDC may be held in person, by audio or video teleconference; provided that at least one (1) meeting per year exceed the authority of the JDC shall be held in person. In-person JDC meetings shall be held at locations selected alternatively by the PartiesJSC. Each Party shall be responsible for all of its own expenses of participating in the JDC. No action taken 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 any each meeting of the JDC 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 (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 keep Zai reasonably informed of NVCR’s Development activity as it relates to Zai’s Development and Commercialization in the Territory. For the avoidance of doubt, NVCR personnel shall not be effective unless representatives obligated to travel to Zai’s facilities, and NVCR’s transfer obligations under this Section 4.1 shall apply solely to the extent the NVCR Know-How is reasonably necessary to support Zai’s Development and Commercialization of both Parties are participatingthe Licensed Product in the Field in the Territory in accordance with this Agreement.

Joint Development Committee. 4.1 Within thirty (30) days after the effective date of this Agreement, each Party The JSC shall appoint (and notify the other Party of the identity of) an alliance manager. Each Party may, at any time, replace its alliance manager with another suitably qualified individual, on written notice to the other Party. The alliance managers shall be primarily responsible for facilitating communications between the Parties and coordinating the Parties’ activities under this Agreement. 4.2 The Parties shall promptly establish a joint development committee to oversee the development and commercialization activities, including but not limited to discuss and make decisions with respect to the manufacturing of the Licensed Product for clinical supply in accordance with the I-Mab development plan, under this Agreement (the “Joint Development Committee” or “JDC”), which is subject to the supervision and oversight of the JSC, to review, discuss, coordinate and share information regarding (i) the Development of Licensed Products in the Territory, (ii) the progress of the Regulatory Approvals and Regulatory Submissions for Licensed Products in the Territory, and (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 Joint Development Committee JDC will meet with a frequency and in a manner as determined by the JSC. The JSC shall be composed of four members with the equal number of persons from each Party who are with appropriate seniority and functional expertise. Any decisions of resolve any disputes that arise within the JDC shall be determined by a majority vote by the JDC members present at a meeting. The minimum quorum for a JDC meeting shall be two-third (2/3) of members who must be present for the entire meeting. If the JDC cannot reach consensus within two (2) weeks on [***] days after any issue that comes before the JDC, then the Parties shall immediately refer such matter is brought to the Chief Executive Officers at I-Mab and Genexine JSC for resolution. In the event of a dispute between I-Mab and Genexine that cannot be resolved within two (2) weeks by the Chief Executive Officers with respect to matters concerning the research and development of Licensed Product, I-Mab shall have the final decision-making authority. Notwithstanding the foregoing, I-Mab shall have day-to-day operational control over the development, manufacture and commercialization of the Licensed Product, provided that I-Mab conducts such activities in accordance with the terms and conditions of this Agreement. 4.3 The JDC shall hold meetings at such times as it elects to do so, but in no event shall such meetings be held less frequently than once every month. Meetings the authority of the JDC may be held in person, by audio or video teleconference; provided that at least one (1) meeting per year exceed the authority of the JDC shall be held in person. In-person JDC meetings shall be held at locations selected alternatively by the PartiesJSC. Each Party shall be responsible for all of its own expenses of participating in the JDC. No action taken 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 any each meeting of the JDC 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 (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 keep Zai reasonably informed of NVCR’s Development activity as it relates to Zai’s Development and Commercialization in the Territory. For the avoidance of doubt, NVCR personnel shall not be effective unless representatives obligated to travel to Zai’s facilities, and NVCR’s transfer obligations under this Section 4.1 shall apply solely to the extent the NVCR Know-How is reasonably necessary to support Zai’s Development and Commercialization of both Parties are participatingthe Licensed Product in the Field in the Territory in accordance with this Agreement.

Joint Development Committee. 4.1 (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 date of the first such notice, the Parties will establish a Joint Development Committee; provided, however, that the JDC shall disband, 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 JDC on written notice to the other Party. (c) The JDC will, with respect to Oncology Products: (i) oversee the activities of the Parties under the Development Plan, including monitoring progress and reviewing Development Plans; (ii) to 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 appropriate, establish additional joint subcommittees and delegate responsibilities to such joint subcommittees; and (v) consider and act upon such other matters as specified in this Agreement. Each Party may from time to time invite a reasonable number of participants, in addition to its representatives on the 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 chairperson or as the Parties may otherwise agree. The first meeting of the JDC shall be held as soon as reasonably practicable after the formation thereof, but in no event later than thirty (30) days after the effective date of this Agreement, each Party shall appoint (and notify the other Party of the identity of) an alliance managerformation thereof. Each Party may, at any time, replace its alliance manager with another suitably qualified individual, on written notice to the other Party. The alliance managers Meetings shall be primarily responsible for facilitating communications between the Parties and coordinating the Parties’ activities under this Agreement. 4.2 The Parties shall establish a joint development committee to oversee the development and commercialization activitiesheld at such place or places as are mutually agreed or by teleconference or videoconference; provided, including but not limited to discuss and make decisions with respect to the manufacturing of the Licensed Product for clinical supply in accordance with the I-Mab development planhowever, under this Agreement (the “Joint Development Committee” or “JDC”). The Joint Development Committee that there shall be composed of four members with the equal number of persons from each Party who are with appropriate seniority and functional expertise. Any decisions of the JDC shall be determined by a majority vote by the JDC members present at a meeting. The minimum quorum for a JDC meeting shall be two-third (2/3) of members who must be present for the entire meeting. If the JDC cannot reach consensus within least two (2) weeks on any issue that comes before the JDC, then the Parties shall immediately refer such matter to the Chief Executive Officers at I-Mab and Genexine for resolution. In the event of a dispute between I-Mab and Genexine that cannot be resolved within two (2) weeks by the Chief Executive Officers with respect to matters concerning the research and development of Licensed Product, I-Mab shall have the final decision-making authority. Notwithstanding the foregoing, I-Mab shall have dayface-to-day operational control over the development, manufacture and commercialization of the Licensed Product, provided that I-Mab conducts such activities in accordance with the terms and conditions of this Agreementface meetings per calendar year. 4.3 The JDC shall hold meetings at such times as it elects to do so, but in no event shall such meetings be held less frequently than once every month. Meetings of the JDC may be held in person, by audio or video teleconference; provided that at least one (1) meeting per year of the JDC shall be held in person. In-person JDC meetings shall be held at locations selected alternatively by the Parties. Each Party shall be responsible for all of its own expenses of participating in the JDC. No action taken at any meeting of the JDC shall be effective unless representatives of both Parties are participating.

Joint Development Committee. 4.1 Within thirty (30a) days after the effective date of this Agreement, each Party shall appoint (and notify the other Party Effective as of the identity of) an alliance manager. Each Party mayEffective Date, at any time, replace its alliance manager with another suitably qualified individual, on written notice to the other Party. The alliance managers shall be primarily responsible for facilitating communications between the Parties and coordinating the Parties’ activities under this Agreement. 4.2 The Parties shall establish a joint development committee to oversee the development and commercialization activities, including but not limited to discuss and make decisions with respect to the manufacturing of the Licensed Product for clinical supply in accordance with the I-Mab development plan, under this Agreement (the “Joint Development Committee” or “JDC”). The Joint Development Committee Members of the JDC as of the Effective Date shall be composed as set forth on Exhibit 3.3. The voting Members of four members the ***Certain confidential information contained in this document, marked with 3 asterisks, has been omitted and filed separately with the equal number Securities and Exchange Commission pursuant to Rule 24b-2 of persons the Securities Act of 1934, as amended. JDC shall include representation from each Party who are with appropriate seniority Party’s global drug development, clinical development, and/or regulatory affairs departments, and functional expertise. Any decisions the non-voting Members of the JDC shall include representation from each Party’s global drug development project management and U.S. medical affairs departments and/or such other departments as the JDC may 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 determined by a majority vote briefed by the JDC members present at a meetingParties regarding the content, execution, and results thereunder. The minimum quorum for a JDC meeting JDC’s sole role shall be two-third to (2/3i) of members who must be present assist in *** for the entire meeting. If Development of, Clinical Studies for, and preparation and submission of Regulatory Filings for obtaining Regulatory Approval for the JDC cannot reach consensus within two 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 (2ii) weeks on provide a forum for sharing advice, progress, and results and documents, including without limitation the PNE Development Plan, Clinical Study designs, protocols, study reports, and any issue that comes before the JDC, then the Parties shall immediately refer such matter to the Chief Executive Officers at I-Mab and Genexine for resolution. In the event of a dispute between I-Mab and Genexine that cannot be resolved within two (2) weeks by the Chief Executive Officers other material information with respect to matters concerning Development of the research and development of Licensed Product, I-Mab shall have including without limitation for the final decision-making authority. Notwithstanding PNE Indication, and reviewing the foregoingforegoing (“JDC Role”). (b) In performing the JDC Role, I-Mab shall have day-to-day operational control over the development, manufacture powers and commercialization responsibilities of the Licensed ProductJDC 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 that I-Mab conducts such activities for in accordance with this Agreement or the terms and conditions of this Agreement. 4.3 Parties expressly so agree in writing. The JDC shall hold meetings at 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 times activities and activities. The JDC shall attempt to facilitate the resolution of any disputes between the Parties, as it elects described in Section 3.5. In particular and Subject to do soSection 3.5, but in no event shall such meetings be held less frequently than once every month. Meetings of the JDC may be held in person, by audio or video teleconference; provided that at least one (1) meeting per year of the JDC shall be held in person. In-person JDC meetings shall be held at locations selected alternatively by the Parties. Each Party shall be responsible for all 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 its own expenses of participating 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 JDC. No action taken at Field; (ii) clinical data go/no-go decisions through the Development and registration process as described in any meeting 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 Rule 24b-2 of the JDC shall be effective Securities Act of 1934, as amended. unless representatives Allergan is Developing and Commercializing Product for the PNE Indication for compliance with Applicable Laws, including without limitation regulatory requirements for Regulatory Approval; (iv) review quality control procedures and 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 (v) other Development of both Parties are participatingthe Product, other than Product for the PNE Indication unless Allergan is Developing and Commercializing Product for the PNE Indication, in the Field in the United States as described in any Development and Supply Plan.