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 BioLineRx, which shall have responsibility of coordinating all regulatory and other activities under, and pursuant to, this Agreement. 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. Other JDC members will be agreed by both Parties. 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 BioLineRx Project Manager shall provide an update in writing to the Merck Project 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. In addition to a Project Manager, each Party shall designate an alliance 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, reach agreement on such issue, the issue shall be elevated to the Head of Clinical Oncology for Merck and the Vice President of Medical Affairs or Business Development for BioLineRx.

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 BioLineRxAntigen Express, with Antigen Express members having one vote and Merck members having one vote, which shall have responsibility of for coordinating all regulatory and other activities under, and pursuant to, this Agreement. 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 StudyStudy and shall be a member of the JDC. Other JDC members will be agreed by both Parties. 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 BioLineRx Antigen Express Project Manager shall provide an update in writing to the Merck Project 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. In addition to a Project Manager, each Party shall designate an alliance manager (the “Alliance Manager”), who shall endeavor to ensure clear and responsive communication between the Parties and the effective exchange of information, 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, 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 reasonable efforts, reach 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 Head Vice President of Clinical Oncology for Merck and the Vice President of Medical Affairs Chief Operating Officer for Antigen Express. In the event such escalation does not result in resolution or Business Development for BioLineRxconsensus: (a) Merck shall have final decision-making authority with respect to issues related to Merck Compound; and (b) Antigen Express shall have final decision-making authority with respect to issues related to Antigen Express 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 and BioLineRxSyndax, which shall have responsibility of for coordinating all regulatory and other activities under, and pursuant to, this Agreement. JDC members will be agreed by both Parties. Each Party shall designate a project manager (the “Project Manager”) who shall be responsible for whose responsibilities may include, at such Party’s discretion, implementing and coordinating activities, activities and facilitating the exchange of scientific information between the Parties, Parties with respect to the Study. Other JDC members will be agreed by both Parties. The JDC shall meet as soon as practicable after the Effective Date and then no less than twice twicee yearly, and more often as reasonably considered necessary at the request of either Party, to provide an update on the progress of the StudyStudy progress. 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 BioLineRx Syndax Project Manager shall provide an update in writing to the Merck Project 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. In addition to a Project Manager, each Party shall designate an alliance 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 and the Project Managers shall have the right to attend all JDC meetings and may bring to the attention of to 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, reach agreement on such issue, the issue shall be elevated to the Head Chief Executive Officer of Syndax and the head of Clinical or VP of Clinical Oncology for Merck and the Vice President of Medical Affairs or Business Development for BioLineRxMerck.

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 Ideaya and BioLineRxPfizer, which shall have responsibility of for coordinating all regulatory and other activities under, and pursuant to, this Agreement. Each Party shall designate a project manager (the “Project Manager”) who shall be responsible for implementing and coordinating activities, and facilitating the exchange of scientific information between the Parties, Parties with respect to the Study. Other JDC members will be agreed by both Parties. 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 equipmentStudy progress. Prior to any such meeting, the BioLineRx Ideaya Project Manager shall provide an update in writing to the Merck Pfizer Project 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. In addition to a Project Manager, each Party shall designate an alliance 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 [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed. and may bring to the attention of to 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, reach agreement on such issue, the issue shall be elevated to the SVP and CMO, Head of Development for Ideaya and the SVP of Clinical Oncology for Merck Pfizer. Each Party shall also appoint a supply chain representative to hold telephone discussions at a mutually agreed-upon frequency to review the quantities of Pfizer Compound and Ideaya Compound needed for the Vice President of Medical Affairs or Business Development for BioLineRxStudy (in accordance with Article 8 and Appendix B) and any other supply chain issues that may arise during the Study.

Joint Development Committee. The 3.2.1 To promote the successful development of the Alicaforsen Products, the Parties shall form will establish a joint development committee Joint Development Committee (the “Joint Development Committee” or “JDC”), made up of an equal number of representatives of Merck which will be formed and BioLineRx, which shall have responsibility of coordinating all regulatory and other activities underwill hold its first meeting within 90 days after the Restatement Date, and pursuant to, this Agreementwill be comprised of two Isis representatives and two Atlantic representatives (“Committee Members”). A Party may replace any of its Committee Member(s) by notice to the other Party. Each Party shall designate a project manager (the “Project Manager”) who Committee Member shall be responsible appropriately qualified and experienced in order to make a meaningful contribution to JDC meetings. The purpose of the JDC is to provide a forum for implementing the Parties to share information and coordinating activitiesknowledge on the on-going research and development of the Alicaforsen Products, including sharing scientific direction and data, discussing the current development and regulatory status of the Alicaforsen Products, any Alicaforsen Product sublicensing development plans with Third Parties, discussing regulatory or quality assurance issues in relation to the Alicaforsen API, and facilitating reviewing, providing advice on, and approving the exchange Development Plan. In addition, at JDC meetings, Isis will apprise the JDC of information between the Parties, any development activities undertaken by Isis with respect to any Follow-On Products. The JDC shall conduct its discussions in good faith with a view to operating to the Study. Other JDC members will be agreed by both Partiesmutual benefit of the Parties and in furtherance of the successful marketing of Alicaforsen Products. The JDC shall meet at Isis’ corporate offices located in Carlsbad, California, USA where such meeting is not held by video-conference or telephone conference, as soon often as practicable after the Effective Date and then no Committee Members may determine but in any event not less than twice yearlyonce per calendar quarter. Each JDC meeting shall be chaired by a Committee Member nominated by Atlantic and Atlantic is responsible for coordinating and ensuring that such communication and meetings take place in a timely manner in accordance with this Agreement, and more often as reasonably considered necessary at the request of either Party, to provide an update on the progress of the StudyIsis shall co-operate with Atlantic and will not unreasonably refuse requests for such meetings. The JDC may meet will strive to make decisions by majority vote, and record such decisions in person or by means of teleconference, Internet conference, videoconference or other similar communications equipment. Prior to any such meeting, the BioLineRx Project Manager shall provide an update in writing to the Merck Project Manager, which update shall contain information about the overall progress minutes of the Study, recruitment status, interim analysis (if results available), final analysis and other information relevant to the conduct of the Studyapplicable JDC meeting. In addition to a Project Manager, each Party shall designate an alliance 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 notIf, after good faith efforts, reach agreement on such issuediscussions, the issue shall JDC is unable to decide a particular matter by majority vote, such matter will be elevated referred to the Head Executive Officers for final resolution. If the matter is not resolved by the Executives Officers within 30 days, either Party may seek final resolution of Clinical Oncology for Merck and the Vice President of Medical Affairs or Business Development for BioLineRxmatter in accordance with Section 14.4.

Joint Development Committee. The Within thirty (30) days after the Effective Date, the Parties shall form establish a joint development committee (the “Joint Development Committee” or “JDC”), made up of an equal number of representatives of Merck and BioLineRx, which shall have responsibility consist of coordinating all regulatory and up to six (6) members (or such other activities undernumber as may be agreed by the Parties in writing), three (3) of whom shall be representatives designated by Teijin, and pursuant to, this Agreementthree (3) of whom shall be representatives designated by Radius. Each of Teijin and Radius may replace any or all of its representatives on the JDC at any time upon written notice to the other Party. Such representatives shall include individuals who have clinical trial and regulatory experience and expertise in pharmaceutical drug development. A Party shall may designate a project manager (substitute to temporarily attend and perform the “Project Manager”) who functions of such Party’s designee at any meeting of the JDC. Meetings of the JDC shall commence at a time to be responsible for implementing mutually agreed upon by the Parties and coordinating activitiesthe JDC shall meet in person twice every calendar year, and facilitating in any case more or less frequently as Teijin and Radius deem appropriate or as reasonably requested by either such Party, on such dates and at such places and times as the exchange Parties shall agree. Meetings of information the JDC that are held in person shall alternate between the Partiesoffices of Teijin and Radius, or such other place as the Parties may agree. The members of the JDC also may convene or be polled or consulted from time to time by means of telecommunications, video conferences, electronic mail or correspondence, as deemed necessary or appropriate. Teijin and Radius each may, on advance notice to the other Party, invite non-member employees of such Party to attend meetings of the JDC. The JDC may make decisions with respect to any subject matter that is subject to the StudyJDC’s decision making authority and functions as set forth in this Section 3.8. Other All decisions of the JDC members will shall be agreed made by both Partiesunanimous vote or written consent, with Teijin and Radius each having collectively, among its respective members, one (1) vote in all decisions. If the JDC cannot reach consensus within ten (10) days after it has first met and attempted to reach such consensus, the disputed matter shall be referred on the eleventh (11th) day to the JSC for resolution. The JDC shall meet as soon as practicable after perform 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 BioLineRx Project Manager shall provide an update in writing to the Merck Project 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. In addition to a Project Manager, each Party shall designate an alliance 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, reach agreement on such issue, the issue shall be elevated to the Head of Clinical Oncology for Merck and the Vice President of Medical Affairs or Business Development for BioLineRx.following function:

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 Context and BioLineRxMenarini, which shall initially be set as two (2) representatives from and selected by each Party, which shall have responsibility of for coordinating all regulatory and other activities between the Parties under, and pursuant to, this Agreement. Each Party shall designate a project manager (the “Project Manager”) who may or may not be part of the JDC and who shall be responsible for implementing and coordinating activities, activities and facilitating the exchange of scientific information between the Parties, Parties with respect to the Study. Other JDC members will be agreed by both Parties. 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 equipmentStudy progress. Prior to any such meeting, the BioLineRx Context Project Manager shall provide an update in writing to the Merck Menarini Project Manager, which update shall contain ACTIVE/117982251.1 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. In addition to a Project Manager, each Party shall designate an alliance manager (the “Alliance Manager”), who may or may not be the Project Manager and/or a member of the JDC, and who shall endeavor to ensure clear and responsive communication between the Parties and the effective exchange of information, 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 to the JDC any matters or issues either of them reasonably believes should be discussed, discussed and shall have such other responsibilities as the Parties may mutually agree in writing. In the event that an issue arises arises, and the Alliance Managers cannot or do not, after good faith efforts, reach agreement on such issue, the issue shall be elevated to the Head of Clinical Oncology Chief Medical Officer for Merck Context and the Vice President Chief Medical Officer for Menarini. If the Parties cannot agree, Context shall have final decision making rights on all operational issues and regulatory strategies relating to the Study, except that Context may not make changes to the Study which may materially impact the Menarini Compound without the written consent of Medical Affairs Menarini, which shall not be unreasonably withheld, conditioned or Business Development delayed; provided that, in all cases, such consent or written explanation for BioLineRxwhy such consent is being withheld, conditioned or delayed shall be provided within [***] days of Context's request for Menarini's consent; and provided further that if Menarini fails to provide such written explanation within such fifteen [***] day period, then Menarini shall be deemed to have provided its consent.

Joint Development Committee. 3.10.1. 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 BioLineRxCompany, (each Party’s representatives shall collectively have one (1) vote for all matters to be considered by the JDC pursuant to the terms hereof, which matters shall require unanimity), which shall have responsibility of coordinating for overseeing all regulatory and other activities with respect to conducting the Study under, and pursuant to, this AgreementAgreement and such other matters to the extent expressly set forth herein. 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. Other Each Party shall select its respective JDC members will be agreed by both Partiesmembers; provided that each JDC member shall have appropriate seniority and experience to serve on the JDC. 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 reasonable 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 BioLineRx Merck’s Project Manager shall provide an update in writing to the Merck Company’s Project 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. In addition to a Project Manager, each Party shall designate an alliance manager (the “Alliance Manager”), who shall not be a member of the JDC and shall endeavor to ensure clear and responsive communication between the Parties and the effective exchange of information, 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, discussed and shall have such other responsibilities as the Parties may mutually agree in writing. In Each Party may change its JDC members, Alliance Manager and Project Manager from time to time; provided that it provides written notice to the event that an issue arises other Party and the Alliance Managers cannot or do not, after good faith efforts, reach agreement on such issue, the issue shall be elevated to the Head of Clinical Oncology for Merck and the Vice President of Medical Affairs or Business Development for BioLineRxselected replacement satisfies those qualifications (if any) set forth in this Section.

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 Ideaya and BioLineRxPfizer, which shall have responsibility of for coordinating all regulatory and other activities under, and pursuant to, this Agreement. Each Party shall designate a project manager (the “Project Manager”) who shall be responsible for implementing and coordinating activities, and facilitating the exchange of scientific information between the Parties, Parties with respect to the Study. Other JDC members will be agreed by both Parties. 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 equipmentStudy progress. Prior to any such meeting, the BioLineRx Ideaya Project Manager shall provide an update in writing to the Merck Pfizer Project 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. In addition to a Project Manager, each Party shall designate an alliance 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 [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed. Agreement. The Alliance Managers shall have the right to attend all JDC meetings and may bring to the attention of to 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, reach agreement on such issue, the issue shall be elevated to the SVP and CMO, Head of Development for Ideaya and the SVP of Clinical Oncology for Merck Pfizer. Each Party shall also appoint a supply chain representative to hold telephone discussions at a mutually agreed-upon frequency to review the quantities of Pfizer Compound and Ideaya Compound needed for the Vice President of Medical Affairs or Business Development for BioLineRxStudy (in accordance with Article 8 and Appendix B) and any other supply chain issues that may arise during the Study.

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 Ideaya and BioLineRxPfizer, which shall have responsibility of for coordinating all regulatory and other activities under, and pursuant to, this Agreement. Each Party shall designate a project manager (the “Project Manager”) who shall be responsible for implementing and coordinating activities, and facilitating the exchange of scientific information between the Parties, Parties with respect to the Study. Other JDC members will be agreed by both Parties. 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 equipmentStudy progress. Prior to any such meeting, the BioLineRx Ideaya Project Manager shall provide an update in writing to the Merck Pfizer Project 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. In addition to a Project Manager, each Party shall designate an alliance 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 to the JDC any matters or issues either of them reasonably believes should be discussed, and shall have such other responsibilities as the Parties may [***] Certain information in this document has been excluded pursuant to Regulation S-K, Item 601(b)(10). Such excluded information is not material and would likely cause competitive harm to the registrant if publicly disclosed. mutually agree in writing. In the event that an issue arises and the Alliance Managers cannot or do not, after good faith efforts, reach agreement on such issue, the issue shall be elevated to the SVP and CMO, Head of Development for Ideaya and the SVP of Clinical Oncology for Merck Pfizer. Each Party shall also appoint a supply chain representative to hold telephone discussions at a mutually agreed-upon frequency to review the quantities of Pfizer Compound and Ideaya Compound needed for the Vice President of Medical Affairs or Business Development for BioLineRxStudy (in accordance with Article 8 and Appendix B) and any other supply chain issues that may arise during the Study.