Common use of Joint Development Committee Clause in Contracts

Joint Development Committee. The Parties shall form a joint development committee (the “Joint Development Committee” or “JDC”) made up of an equal number of representatives of Merck and Adaptimmune, which shall have responsibility for coordinating all regulatory and other activities under, and pursuant to, this Agreement. The number of representatives of Merck and Adaptimmune on the JDC will be mutually agreed from time to time during the Term. Each Party shall designate a project manager (the “Project Manager”) who shall be responsible for implementing and coordinating activities and facilitating the exchange of information between the Parties with respect to the Study. Each Party may invite additional members to the JDC where necessary for the coordination of activities pursuant to this Agreement. In particular Adaptimmune will be entitled, *** . The JDC shall meet as soon as practicable after the Effective Date and then no less than twice yearly, and more often as reasonably considered necessary at the request of either Party, to provide an update on the progress of the Study. The JDC may meet in person or by means of teleconference, Internet conference, videoconference or other similar communications equipment. Prior to any such meeting, the Adaptimmune Project Manager shall provide an update in writing to the Merck Project *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. Manager, which update shall contain information about the overall progress of the Study, recruitment status, interim analysis (if results available), final analysis and other information relevant to the conduct of the Study (the “Study Update”). In addition to a Project Manager, each Party shall designate an alliance manager who may be the same individual as the Project Manager (the “Alliance Manager”), who shall endeavor to ensure clear and responsive communication between the Parties and the effective exchange of information and shall serve as the primary point of contact for any issues arising under this Agreement. The Alliance Managers shall have the right to attend all JDC meetings and may bring to the attention of the JDC any matters or issues either of them reasonably believes should be discussed and shall have such other responsibilities as the Parties may mutually agree in writing. In the event that an issue arises and the Alliance Managers cannot or do not, after good faith efforts, facilitate agreement on such issue, or if there is a decision to be made by the JDC on which the members of the JDC cannot unanimously agree, the issue shall be elevated to the Vice President of Clinical Oncology for Merck and the Chief Operating Officer for Adaptimmune. In the event such escalation does not result in resolution or consensus: (a) Merck shall have final decision-making authority with respect to issues related to Merck Compound; and (b) Adaptimmune shall have final decision-making authority with respect to issues related to Adaptimmune Compound.

Joint Development Committee. The Promptly after the Effective Date, the Parties shall form a joint development committee Joint Development Committee (the “Joint Development Committee” or “JDC”) made up of an equal number of representatives of Merck and Adaptimmune, which shall have responsibility for coordinating all regulatory and other activities under, and pursuant to, this Agreement. The number of representatives of Merck and Adaptimmune on the JDC will be mutually agreed from time to time during the Term. Each Party shall designate a project manager (the “Project Manager”) who shall be responsible for implementing and coordinating activities and facilitating the exchange of information between the Parties with respect to the Study. Each Party may invite additional members to the JDC where necessary for the coordination of activities pursuant to this Agreement. In particular Adaptimmune will be entitled, *** ). The JDC shall meet (a) oversee Neuromed’s Development of the Product under the Development Plan, (b) act as soon as practicable after the Effective Date forum for Mallinckrodt to provide its input into Development and then no less than twice yearlyto keep informed about its progress, and more often as reasonably considered necessary at the request of either Party, (c) offer its advice to provide an update on expedite or aid the progress of the StudyDevelopment work. The JDC may meet in person shall be comprised of a total of six (6) appropriately qualified members (or by means such other even number of teleconference, Internet conference, videoconference or other similar communications equipment. Prior members as is agreed to any such meeting, the Adaptimmune Project Manager shall provide an update in writing by the Parties), with each of Neuromed and Mallinckrodt designating one half of the total number of members as its representatives. Either Party may replace any of its respective JDC representatives with an appropriately qualified representative at any time with reasonable prior written notice to the Merck Project *** Portions of other Party. The JDC will meet at least once each month so long as Product is being developed by Neuromed under this page have been omitted pursuant Agreement, provided that the JDC may agree from time-to-time to meet at a request for Confidential Treatment and filed separately with greater or lesser frequency if appropriate under the Commissioncircumstances. ManagerJDC meetings may be conducted by videoconference, which update shall contain information about the overall progress teleconference or in person, as requested by a Party, except that at least one of the Study, recruitment status, interim analysis (if results available), final analysis meetings per year will be conducted in person. The JDC will agree upon the time and other information relevant to the conduct location of the Study (meetings. A Neuromed representative of the “Study Update”). In addition to a Project Manager, each Party shall designate an alliance manager who may be the same individual JDC will act as the Project Manager chair, and such chair (or a designee) shall coordinate, prepare and circulate an agenda for each JDC meeting reasonably in advance of the “Alliance Manager”)meeting. A reasonable number of additional representatives of a Party may attend meetings of the JDC in a non-voting capacity. The JDC shall seek to reach consensus on matters coming before it, who shall endeavor but will not have any authority to ensure clear and responsive communication between the Parties and the effective exchange of information and shall serve as the primary point of contact for any issues arising decide development matters that are Neuromed’s responsibility under this Agreement. The Alliance Managers Notwithstanding the preceding provisions of this Section 2.2, Mallinckrodt shall have the right to attend all JDC meetings give its prior written approval for those Development activities or actions set forth and may bring to the attention of the JDC any matters or issues either of them reasonably believes should be discussed and shall have described on Appendix C attached hereto, such other responsibilities as the Parties may mutually agree in writing. In the event that an issue arises and the Alliance Managers canapproval not or do not, after good faith efforts, facilitate agreement on such issue, or if there is a decision to be made by the JDC on which the members of the JDC cannot unanimously agree, the issue shall be elevated to the Vice President of Clinical Oncology for Merck and the Chief Operating Officer for Adaptimmune. In the event such escalation does not result in resolution or consensus: (a) Merck shall have final decision-making authority with respect to issues related to Merck Compound; and (b) Adaptimmune shall have final decision-making authority with respect to issues related to Adaptimmune Compoundunreasonably withheld.

Joint Development Committee. The Promptly following CK's exercise of its Co-Funding Option for a Co-Funded Product, or an exercise by GSK of the CK Product Option with respect to a CK Product under Section 4.5 below, the Parties shall form establish a joint development committee (the “Joint Development Committee” or “Committee ("JDC”") made up with respect to such Licensed Product. It is understood that the Project Team for such Licensed Product shall continue after establishment of a JDC and shall report thereto. The JDC shall have responsibility to oversee the Later Stage Development of the Co-Funded Product, and all further development of the Licensed Product for which GSK exercises its CK Product Option under Section 4.5, and to make such decisions as are expressly provided in this Article III. The JDC shall be comprised of an equal number of representatives from each of Merck GSK and AdaptimmuneCK; and unless otherwise agreed, which the JDC shall at all times include CK's head of development and GSK's head of clinical operations for the CEDD or Therapeutic Area Strategic Team ("TAST"), as appropriate, and GSK's CEDD head of biology, unless otherwise agreed, and shall have responsibility for coordinating all regulatory and at least one representative from each Party at the level of Vice President or above. Either Party may replace its respective JDC representatives at any time, with prior written notice to the other activities underParty. From time to time, the JDC may establish subcommittees to oversee particular projects or activities, and pursuant to, this Agreement. The number of representatives of Merck and Adaptimmune on such subcommittees will be constituted as the JDC will be mutually agreed from time to time during the Term. Each Party shall designate a project manager (the “Project Manager”) who shall be responsible for implementing and coordinating activities and facilitating the exchange of information between the Parties with respect to the Study. Each Party may invite additional members to the JDC where necessary for the coordination of activities pursuant to this Agreement. In particular Adaptimmune will be entitled, *** approves. The JDC shall meet as soon as practicable after the Effective Date and then no less than twice yearlyat least quarterly according to an agreed schedule, and more often the Parties shall keep the JDC fully informed as reasonably considered necessary at the request of either Party, to provide an update on the progress all aspects of the StudyLater Stage Development and other ongoing activities pertaining to the Co-Funded Product and all further development of the Licensed Product for which GSK exercises its CK Product Option under Section 4.5. The Decisions of the JDC may meet in person or shall be by means majority vote; provided that if there is not an equal number of teleconference, Internet conference, videoconference or other similar communications equipment. Prior to any representatives of each Party present at such meeting, then only an equal number of representatives of each Party shall be entitled to vote. In the Adaptimmune Project Manager shall provide an update in writing event the required vote to the Merck Project **approve a * Portions of Certain information on this page have has been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. Manager, which update shall contain information about the overall progress of the Study, recruitment status, interim analysis (if results available), final analysis and other information relevant Confidential treatment has been requested with respect to the conduct omitted portions. particular action cannot be obtained, then either Party may request that the issue be referred for resolution through good faith negotiations between the Chief Executive Officer of CK and the Study (the “Study Update”). In addition to a Project ManagerChairman, each Party shall designate an alliance manager who may be the same individual as the Project Manager (the “Alliance Manager”)Research and Development for GSK, who shall endeavor promptly meet to ensure clear and responsive communication between resolve the Parties and issue. In the effective exchange of information and shall serve as event they are unable to reach agreement on the primary point of contact for any issues arising under this Agreement. The Alliance Managers matter, the [*] shall have the right to attend all JDC meetings and may bring to [*] on the attention matter, which [*] shall become the decision of the JDC any matters or issues either of them reasonably believes should be discussed and JDC. Notwithstanding the foregoing, [*] shall not have such other responsibilities as the Parties may mutually agree in writing. In the event that an issue arises and the Alliance Managers cannot or do not, after good faith efforts, facilitate agreement on such issue, or if there is a decision right to be made by the JDC on which the members of the JDC cannot unanimously agree, the issue shall be elevated to the Vice President of Clinical Oncology for Merck and the Chief Operating Officer for Adaptimmune. In the event such escalation does not result in resolution or consensus: (a) Merck shall have final decision-making authority [*] with respect to issues related matters relating to Merck Compound; and (b) Adaptimmune shall have final decision-making authority with respect to issues related to Adaptimmune CompoundLicensed Products for which [*].

Joint Development Committee. 8.1 The Parties shall form a joint development committee (the “Joint Development Committee” or “JDC”), made up of three (3) representatives of each of SpringWorks and GSK unless otherwise agreed (but in any event, the JDC shall be made up of an equal number of representatives of Merck and Adaptimmunefrom each Party), which shall have responsibility for coordinating all regulatory and other activities under, and pursuant to, this Agreement. The number of representatives of Merck and Adaptimmune on the JDC will be mutually agreed from time to time during the Term. Each Party shall designate a project manager (the “Project Manager”) who shall be responsible for implementing and coordinating activities activities, and facilitating the exchange of information between the Parties Parties, with respect to the Sub-Study, and shall notify the other Party in writing regarding the name and contact details of the Project Manager promptly following the Effective Date. Each Party may invite additional Other JDC members will be agreed by the Parties promptly following the Effective Date, but no later than five (5) Business Days prior to the first JDC where necessary for the coordination of activities pursuant to this Agreement. In particular Adaptimmune will be entitled, *** meeting. The JDC shall meet as soon as practicable for the first time after the Effective Date and prior to the Sub-Study initiation, and then no less than twice yearlyquarterly, and or more or less often as reasonably considered necessary at agreed by the request of either PartyJDC, to provide an update on the progress of the StudySub-Study progress. The JDC may meet in person or by means of teleconference, Internet conference, videoconference or other similar communications equipment. Prior Five (5) Business Days prior to any such meeting, the Adaptimmune GSK Project Manager will provide a draft meeting agenda to the SpringWorks Project Manager for review and comment. [***] prior to any such meeting, the GSK Project Manager shall provide provide: (a) a final draft of the meeting agenda (incorporating any comments from the SpringWorks Project Manager) and (b) an update in writing to the Merck SpringWorks Project *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. Manager, which update shall contain information in reasonable detail about [***]. The minutes of each JDC meeting will be drafted by the overall progress meeting’s secretary and shall summarize discussion highlights, actions, and agreements. The draft minutes shall be circulated within three (3) business days of the Study, recruitment status, interim analysis (if results available), final analysis and other information relevant to JDC meeting by the conduct of the Study (the “Study Update”). In addition to a GSK Project Manager, each Party thereafter, the GSK Project Manager shall designate an alliance manager who may circulate a final version of such minutes to the JDC at least [***] Business Day in advance of the next JDC meeting. The first such secretary shall be the same individual as the GSK Project Manager (and thereafter the “Alliance Manager”), who secretarial appointment shall endeavor to ensure clear and responsive communication alternate between the Parties SpringWorks Project Manager and the effective exchange of GSK Project Manager. [***] Certain information and shall serve as the primary point of contact for any issues arising under in this Agreement. The Alliance Managers shall have the right to attend all JDC meetings and may bring to the attention of the JDC any matters or issues either of them reasonably believes should be discussed and shall have such other responsibilities as the Parties may mutually agree in writing. In the event that an issue arises and the Alliance Managers candocument has been omitted from this exhibit because it is both (i) not or do not, after good faith efforts, facilitate agreement on such issue, or if there is a decision to be made by the JDC on which the members of the JDC cannot unanimously agree, the issue shall be elevated to the Vice President of Clinical Oncology for Merck and the Chief Operating Officer for Adaptimmune. In the event such escalation does not result in resolution or consensus: (a) Merck shall have final decision-making authority with respect to issues related to Merck Compound; material and (bii) Adaptimmune shall have final decision-making authority with respect to issues related to Adaptimmune Compoundwould be competitively harmful if publicly disclosed.

Joint Development Committee. (a) The Parties shall PARTIES agree to form a joint development committee DEVELOPMENT COMMITTEE comprised of senior management of each PARTY (the “Joint Development Committee” or “JDCDEVELOPMENT COMMITTEE”) made up of an equal number of representatives of Merck and Adaptimmune, which shall have responsibility for coordinating all regulatory and other activities under, and pursuant to, this Agreement). The number PARTIES shall use COMMERCIALLY REASONABLE EFFORTS to have a meeting of representatives of Merck the DEVELOPMENT COMMITTEE within forty-five days after the EFFECTIVE DATE and Adaptimmune on the JDC will be thereafter once every CALENDAR QUARTER, or more frequently if mutually agreed from time upon by the PARTIES, (i) to time during discuss and coordinate clinical development plans for PRODUCTS, (ii) to update the Term. Each Party shall designate a project manager other PARTY on and discuss the design, analysis plan, execution plan, timeline of any proposed clinical trial and any related proposal developed in accordance with the clinical development plans (provided however that the “Project Manager”PHASE III CLINICAL TRIAL and any other existing ongoing clinical trials with respect to NUMAX and the liquid formulation of SYNAGIS will not be subject to discussion under this Section 6.6), (iii) who shall be responsible for implementing to review and coordinating activities approve any proposed clinical trials of the PRODUCTS in the TERRITORY consistent with Section 6.8, (iv) to coordinate the strategy of submissions of the REGULATORY FILINGS to REGULATORY AUTHORITIES in the TERRITORY with respect to NUMAX, (v) to review and facilitating approve or reject the exchange publication of data and information between the Parties with respect to the StudyPRODUCTS as set forth in Section 6.11 and (vi) to provide updates of the status of and coordinate completion of the project to remove animal proteins from the working cell banks for the PRODUCT. Each Party may invite additional members The DEVELOPMENT COMMITTEE shall not make the decision to take any action or inaction which conflicts with or fails to conform to the JDC where necessary for applicable laws in any country in the coordination of activities pursuant TERRITORY. A deadlock with respect to this Agreement. In particular Adaptimmune will any matter submitted to the DEVELOPMENT COMMITTEE shall be entitled, *** . The JDC shall meet as soon as practicable after referred to the Effective Date and then no less than twice yearly, and more often as reasonably considered necessary at the request of either Party, to provide an update on the progress respective executive officers of the Study. The JDC may meet in person or by means of teleconference, Internet conference, videoconference or other similar communications equipment. Prior to any such meeting, the Adaptimmune Project Manager shall provide an update in writing to the Merck Project *** Portions of this page have been omitted pursuant to a request PARTIES for Confidential Treatment and filed separately with the Commission. Manager, which update shall contain information about the overall progress of the Study, recruitment status, interim analysis (if results available), final analysis and other information relevant to the conduct of the Study (the “Study Update”). In addition to a Project Manager, each Party shall designate an alliance manager who may be the same individual as the Project Manager (the “Alliance Manager”)resolution, who shall endeavor have ten (10) business days to ensure clear and responsive communication between resolve the Parties and deadlock. If such executive officers are unable to resolve the effective exchange of information and shall serve as the primary point of contact for any issues arising under this Agreement. The Alliance Managers deadlock, MEDIMMUNE shall have the right to attend all JDC meetings and may bring to the attention of the JDC any matters or issues either of them reasonably believes should be discussed and shall have such other responsibilities as the Parties may mutually agree in writing. In the event that an issue arises and the Alliance Managers cannot or do not, after good faith efforts, facilitate agreement on such issue, or if there is a final decision to be made by the JDC on which the members of the JDC cannot unanimously agree, the issue shall be elevated to the Vice President of Clinical Oncology for Merck and the Chief Operating Officer for Adaptimmune. In the event such escalation does not result in resolution or consensus: (a) Merck shall have final decision-making authority with respect to issues related to Merck Compound; and (b) Adaptimmune shall have final decision-making authority with respect to issues related to Adaptimmune Compoundthe deadlock. For clarity, no clinical trials for PRODUCTS will be initiated by XXXXXX without approval of the DEVELOPMENT COMMITTEE.

Joint Development Committee. The Promptly following CK's exercise of its Co-Funding Option for a Co-Funded Product, or an exercise by GSK of the CK Product Option with respect to a CK Product under Section 4.5 below, the Parties shall form establish a joint development committee (the “Joint Development Committee” or “Committee ("JDC”") made up with respect to such Licensed Product. It is understood that the Project Team for such Licensed Product shall continue after establishment of a JDC and shall report thereto. The JDC shall have responsibility to oversee the Later Stage Development of the Co-Funded Product, and all further development of the Licensed Product for which GSK exercises its CK Product Option under Section 4.5, and to make such decisions as are expressly provided in this Article III. The JDC shall be comprised of an equal number of representatives from each of Merck GSK and AdaptimmuneCK; and unless otherwise agreed, which the JDC shall at all times include CK's head of development and GSK's head of clinical operations for the CEDD or Therapeutic Area Strategic Team ("TAST"), as appropriate, and GSK's CEDD head of biology, unless otherwise agreed, and shall have responsibility for coordinating all regulatory and at least one representative from each Party at the level of Vice President or above. Either Party may replace its respective JDC representatives at any time, with prior written notice to the other activities underParty. From time to time, the JDC may establish subcommittees to oversee particular projects or activities, and pursuant to, this Agreement. The number of representatives of Merck and Adaptimmune on such subcommittees will be constituted as the JDC will be mutually agreed from time to time during the Term. Each Party shall designate a project manager (the “Project Manager”) who shall be responsible for implementing and coordinating activities and facilitating the exchange of information between the Parties with respect to the Study. Each Party may invite additional members to the JDC where necessary for the coordination of activities pursuant to this Agreement. In particular Adaptimmune will be entitled, *** approves. The JDC shall meet as soon as practicable after the Effective Date and then no less than twice yearlyat least quarterly according to an agreed schedule, and more often the Parties shall keep the JDC fully informed as reasonably considered necessary at the request of either Party, to provide an update on the progress all aspects of the StudyLater Stage Development and other ongoing activities pertaining to the Co-Funded Product and all further development of the Licensed Product for which GSK exercises its CK Product Option under Section 4.5. The Decisions of the JDC may meet in person or shall be by means majority vote; provided that if there is not an equal number of teleconference, Internet conference, videoconference or other similar communications equipment. Prior to any representatives of each Party present at such meeting, the Adaptimmune Project Manager shall provide then only an update in writing to the Merck Project *** Portions equal number of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. Manager, which update shall contain information about the overall progress representatives of the Study, recruitment status, interim analysis (if results available), final analysis and other information relevant to the conduct of the Study (the “Study Update”). In addition to a Project Manager, each Party shall designate an alliance manager who be entitled to vote. In the event the required vote to approve a particular action cannot be obtained, then either Party may request that the issue be referred for resolution through good faith negotiations between the same individual as Chief Executive Officer of CK and the Project Manager (the “Alliance Manager”)Chairman, Research and Development for GSK, who shall endeavor promptly meet to ensure clear and responsive communication between resolve the Parties and issue. In the effective exchange of information and shall serve as event they are unable to reach agreement on the primary point of contact for any issues arising under this Agreement. The Alliance Managers matter, the [*] shall have the right to attend all JDC meetings and may bring to [*] on the attention matter, which [*] shall become the decision of the JDC any matters or issues either of them reasonably believes should be discussed and JDC. Notwithstanding the foregoing, [*] shall not have such other responsibilities as the Parties may mutually agree in writing. In the event that an issue arises and the Alliance Managers cannot or do not, after good faith efforts, facilitate agreement on such issue, or if there is a decision right to be made by the JDC on which the members of the JDC cannot unanimously agree, the issue shall be elevated to the Vice President of Clinical Oncology for Merck and the Chief Operating Officer for Adaptimmune. In the event such escalation does not result in resolution or consensus: (a) Merck shall have final decision-making authority [*] with respect to issues related matters relating to Merck Compound; and (b) Adaptimmune shall have final decision-making authority with respect to issues related to Adaptimmune CompoundLicensed Products for which [*].

Joint Development Committee. The Parties shall form a joint development committee team (the “Joint Development Committee” or “JDC”) ), made up of an equal number of representatives of Merck and AdaptimmuneAdvaxis (not to exceed three (3) each), which shall have responsibility for of coordinating all regulatory and other activities under, and pursuant to, this Agreement. The number of representatives of Merck and Adaptimmune on the JDC will be mutually agreed from time to time during the Term. Each Party shall designate a project manager (the “Project Manager”) who shall be responsible for implementing and coordinating activities activities, and facilitating the exchange of information between the Parties Parties, with respect to the Study. Each Party may invite additional Other JDC members to the JDC where necessary for the coordination of activities pursuant to this Agreement. In particular Adaptimmune will be entitled, *** agreed by both Parties. The JDC shall meet as soon as practicable after the Effective Date and then no less than twice yearlyonce each Calendar Quarter, and more often as reasonably considered necessary at the request of either Party, to provide an update on the progress of the Study. The JDC may meet in person or by means of teleconference, Internet conference, videoconference or other similar communications equipmentStudy progress. Prior to any such meeting, the Adaptimmune Advaxis Project Manager shall provide an update in writing to the Merck Project *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. Manager, which update shall contain information about the overall progress of the StudyStudy progress, recruitment status, interim analysis (if results available), final analysis and other information relevant to the conduct of the Study Study. The JDC will meet quarterly and attempt to reach decisions by consensus with the Advaxis representatives having collectively one vote and the Merck representatives having collectively one vote, except that Merck will determine in its sole discretion the dose and dosing regimen for the Merck Compound and Advaxis will determine in its sole discretion the dose and dosing regimen for the Advaxis Compound. When consensus is not achieved on any matter, the matter will be escalated to the Advaxis CEO and the head of Merck Clinical or the VP of Merck Clinical Oncology, provided however that (1) in the “Study Update”)event that the matter relates to the Merck Compound, Merck shall have final decision-making authority and (2) in the event that the matter relates to the Advaxis Compound, Advaxis shall have final decision-making authority. In addition to a Project Manager, each Party shall designate an alliance manager who may be the same individual as the Project Manager (the “Alliance Manager”), ) who shall endeavor to ensure clear and responsive communication between the Parties and the effective exchange of information and shall serve as the primary point of contact for any issues arising under this Agreement. The Alliance Managers shall have the right to attend all JDC meetings and may bring to the attention of the JDC any matters or issues either of them reasonably believes should be discussed and shall have such other responsibilities as the Parties may mutually agree in writing. In the event that an issue arises and the Alliance Managers cannot or do not, after good faith efforts, facilitate agreement on such issue, or if there is a decision to be made by the JDC on which the members of the JDC cannot unanimously agree, the issue shall be elevated to the Vice President of Clinical Oncology for Merck and the Chief Operating Officer for Adaptimmune. In the event such escalation does not result in resolution or consensus: (a) Merck shall have final decision-making authority with respect to issues related to Merck Compound; and (b) Adaptimmune shall have final decision-making authority with respect to issues related to Adaptimmune Compound.

Joint Development Committee. The Parties shall form a joint development committee team (the “Joint Development Committee” or “JDC”) ), made up of an equal number of representatives of Merck Advaxis and AdaptimmuneIncyte (not to exceed three (3) each), which shall have responsibility for coordinating all regulatory and other activities under, and pursuant to, this Agreement. The number of representatives of Merck and Adaptimmune on the JDC will be mutually agreed from time to time during the Term. Each Party shall designate a project manager (the “Project Manager”) who shall be responsible for ensuring clear and responsive communication between the Parties and the effective exchange of information, serving as the primary point of contact for any issues arising under this Agreement, implementing and coordinating activities activities, and facilitating the exchange of information between the Parties Parties, with respect to the Study. Each Party may invite additional Other JDC members to the JDC where necessary for the coordination of activities pursuant to this Agreement. In particular Adaptimmune will be entitled, *** agreed by both Parties. The JDC shall meet as soon as practicable after the Effective Date and then no less than twice yearlyonce each Calendar Quarter, and more often as reasonably considered necessary at the request of either PartyParty with reasonable notice, to provide an update on the progress of the StudyStudy and make decisions regarding the conduct of the Study and any modifications to the Protocol and Budget. The JDC may meet in person or by means of teleconference, Internet conference, videoconference or other similar communications equipment. Prior Five (5) business days prior to any such meeting, the Adaptimmune Incyte Project Manager shall provide an update in writing to the Merck Advaxis Project *** Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. Manager, which update shall contain information about the overall progress of the StudyStudy progress, recruitment status, interim analysis (if results are available), final analysis and other information relevant to the conduct of the Study (Study. The JDC will attempt to reach decisions by consensus, except that Advaxis will determine in its sole discretion the “Study Update”)dose and dosing regimen for the Advaxis Compound and Incyte will determine in its sole discretion the dose and dosing regimen for the Incyte Compound. In addition When consensus is not achieved on any matter, the matter will be escalated to a Project Manager, each Party shall designate an alliance manager who may be the same individual as the Project Manager (the “Alliance Manager”), who shall endeavor to ensure clear and responsive communication between the Parties Incyte CEO and the effective exchange of information and shall serve as the primary point of contact EVP CMO Advaxis or his/her nominee for any issues arising under this Agreement. The Alliance Managers shall have the right to attend all JDC meetings and may bring to the attention of the JDC any matters or issues either of them reasonably believes should be discussed and shall have such other responsibilities as the Parties may mutually agree resolution, provided however that (1) in writing. In the event that an issue arises and the Alliance Managers cannot or do not, after good faith efforts, facilitate agreement on such issue, or if there is a decision to be made by the JDC on which the members of the JDC cannot unanimously agree, the issue shall be elevated matter relates solely to the Vice President of Clinical Oncology for Merck and the Chief Operating Officer for Adaptimmune. In the event such escalation does not result in resolution or consensus: (a) Merck Advaxis Compound, Advaxis shall have final decision-making authority with respect to issues related to Merck Compound; and (b2) Adaptimmune in the event that the matter relates solely to the Incyte Compound, Incyte shall have final decision-making authority with respect to issues related to Adaptimmune Compoundauthority.