Common use of Joint Development Committee Clause in Contracts

Joint Development Committee. 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 establish a Joint Development Committee ("JDC") 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 GSK and CK; and unless otherwise agreed, 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 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 Party. From time to time, the JDC may establish subcommittees to oversee particular projects or activities, and such subcommittees will be constituted as the JDC approves. The JDC shall meet at least quarterly according to an agreed schedule, and the Parties shall keep the JDC fully informed as to all aspects of the Later 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. Decisions of the JDC shall be by majority vote; provided that if there is not an equal number of 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 event the required vote to approve a * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the 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 Chairman, Research and Development for GSK, who shall promptly meet to resolve the issue. In the event they are unable to reach agreement on the matter, the [*] shall have the right to [*] on the matter, which [*] shall become the decision of the JDC. Notwithstanding the foregoing, [*] shall not have the right to [*] with respect to matters relating to Licensed Products for which [*].

Appears in 2 contracts

Samples: Collaboration and License Agreement (Cytokinetics Inc), Collaboration and License Agreement (Cytokinetics Inc)

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Joint Development Committee. Promptly following CK's exercise of its Co-Funding Option for a Co-Funded Product, or an exercise by GSK of after the CK Product Option with respect to a CK Product under Section 4.5 belowEffective Date, the Parties shall establish form a Joint Development Committee ("the “JDC") 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 (a) oversee the Later Stage Neuromed’s Development of the Co-Funded ProductProduct under the Development Plan, (b) act as the forum for Mallinckrodt to provide its input into Development and to keep informed about its progress, and all further development (c) offer its advice to expedite or aid the progress 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 IIIDevelopment work. The JDC shall be comprised of an equal a total of six (6) appropriately qualified members (or such other even number of representatives from members as is agreed to in writing by the Parties), with each of GSK Neuromed and CK; and unless otherwise agreed, Mallinckrodt designating one half of the JDC shall at all times include CK's head total number of development and GSK's head of clinical operations for the CEDD or Therapeutic Area Strategic Team ("TAST"), members as appropriate, and GSK's CEDD head of biology, unless otherwise agreed, and shall have at least one representative from each Party at the level of Vice President or aboveits representatives. Either Party may replace any of its respective JDC representatives with an appropriately qualified representative at any time, time with reasonable prior written notice to the other Party. From time to timeThe JDC will meet at least once each month so long as Product is being developed by Neuromed under this Agreement, provided that the JDC may establish subcommittees agree from time-to-time to oversee particular projects meet at a greater or activitieslesser frequency if appropriate under the circumstances. JDC meetings may be conducted by videoconference, teleconference or in person, as requested by a Party, except that at least one of the meetings per year will be conducted in person. The JDC will agree upon the time and location of the meetings. A Neuromed representative of the JDC will act as the chair, and such subcommittees will be constituted as chair (or a designee) shall coordinate, prepare and circulate an agenda for each JDC meeting reasonably in advance of the meeting. A reasonable number of additional representatives of a Party may attend meetings of the JDC approvesin a non-voting capacity. The JDC shall meet at least quarterly according to an agreed schedule, and the Parties shall keep the JDC fully informed as to all aspects of the Later 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. Decisions of the JDC shall be by majority vote; provided that if there is not an equal number of 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 event the required vote to approve a * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the 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 Chairman, Research and Development for GSK, who shall promptly meet to resolve the issue. In the event they are unable seek to reach agreement consensus on matters coming before it, but will not have any authority to decide development matters that are Neuromed’s responsibility under this Agreement. Notwithstanding the matterpreceding provisions of this Section 2.2, the [*] Mallinckrodt shall have the right to [*] give its prior written approval for those Development activities or actions set forth and described on the matterAppendix C attached hereto, which [*] shall become the decision of the JDC. Notwithstanding the foregoing, [*] shall such approval not have the right to [*] with respect to matters relating to Licensed Products for which [*]be unreasonably withheld.

Appears in 2 contracts

Samples: Development and Transition Services Agreement (Combinatorx, Inc), Development and Transition Services Agreement (Combinatorx, Inc)

Joint Development Committee. 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 The Parties shall establish form a joint development committee (the “Joint Development Committee ("Committee” or “JDC") 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 made up of an equal number of representatives from each of GSK Merck and CK; Adaptimmune, which shall have responsibility for coordinating all regulatory and unless otherwise agreedother 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 at all times include CK's head designate a project manager (the “Project Manager”) who shall be responsible for implementing and coordinating activities and facilitating the exchange of development and GSK's head of clinical operations information between the Parties with respect to the Study. Each Party may invite additional members to the JDC where necessary for the CEDD or Therapeutic Area Strategic Team ("TAST"), as appropriate, and GSK's CEDD head coordination of biology, unless otherwise agreed, and shall have at least one representative from each Party at the level of Vice President or aboveactivities pursuant to this Agreement. Either Party may replace its respective JDC representatives at any time, with prior written notice to the other Party. From time to time, the JDC may establish subcommittees to oversee In particular projects or activities, and such subcommittees Adaptimmune will be constituted as the JDC approvesentitled, *** . The JDC shall meet at least quarterly according to an agreed scheduleas soon as practicable after the Effective Date and then no less than twice yearly, and more often as reasonably considered necessary at the Parties shall keep request of either Party, to provide an update on the JDC fully informed as to all aspects progress of the Later Stage Development and Study. The JDC may meet in person or by means of teleconference, Internet conference, videoconference or other ongoing activities pertaining similar communications equipment. Prior 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. Decisions of the JDC shall be by majority vote; provided that if there is not an equal number of representatives of each Party present at any such meeting, then only the Adaptimmune Project Manager shall provide an equal number update in writing to the Merck Project *** Portions of representatives of each Party shall be entitled to vote. In the event the required vote to approve a * Certain information on this page has have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. Confidential treatment has been requested with respect 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 omitted portionsconduct of the Study (the “Study Update”). particular action cannot In addition to a Project Manager, each Party shall designate an alliance manager who may be obtained, then either Party may request that the issue be referred for resolution through good faith negotiations between same individual as the Chief Executive Officer of CK and Project Manager (the Chairman, Research and Development for GSK“Alliance Manager”), who shall promptly meet endeavor to resolve ensure clear and responsive communication between the issueParties and the effective exchange of information and shall serve as the primary point of contact for any issues arising under this Agreement. In the event they are unable to reach agreement on the matter, the [*] The Alliance Managers shall have the right to [*] on attend all JDC meetings and may bring to the matter, which [*] shall become the decision attention of the JDCJDC 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. Notwithstanding In the foregoingevent 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 the right to [*] final decision-making authority with respect to matters relating issues related to Licensed Products for which [*]Merck Compound; and (b) Adaptimmune shall have final decision-making authority with respect to issues related to Adaptimmune Compound.

Appears in 2 contracts

Samples: Trial Collaboration and Supply Agreement (Adaptimmune Therapeutics PLC), Trial Collaboration and Supply Agreement (Adaptimmune Therapeutics PLC)

Joint Development Committee. 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 The Parties shall establish form a joint development team (the “Joint Development Committee ("Committee” or “JDC") 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 made up of an equal number of representatives from each of GSK Merck and CK; and unless otherwise agreed, 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 Advaxis ("TAST"not to exceed three (3) each), as appropriatewhich shall have responsibility of coordinating all regulatory and other activities under, and GSK's CEDD head of biologypursuant to, unless otherwise agreed, this Agreement. Each Party shall designate a project manager (the “Project Manager”) who shall be responsible for implementing and shall have 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 Party. From time to time, the JDC may establish subcommittees to oversee particular projects or coordinating activities, and such subcommittees facilitating the exchange of information between the Parties, with respect to the Study. Other JDC members will be constituted as the JDC approvesagreed by both Parties. The JDC shall meet at least quarterly according to an agreed scheduleas soon as practicable after the Effective Date and then no less than once each Calendar Quarter, and more often as reasonably considered necessary at the Parties shall keep the JDC fully informed as request of either Party, to all aspects of the Later Stage Development and other ongoing activities pertaining provide an update on Study progress. Prior 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. Decisions of the JDC shall be by majority vote; provided that if there is not an equal number of representatives of each Party present at any such meeting, then only the Advaxis Project Manager shall provide an equal number update in writing to the Merck Project Manager, which update shall contain information about overall Study progress, recruitment status, interim analysis (if results available), final analysis and other information relevant to the conduct of the 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 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 be entitled designate an alliance manager (the “Alliance Manager”) who shall endeavor to vote. In the event the required vote to approve a * Certain information on this page has been omitted ensure clear and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. particular action cannot be obtained, then either Party may request that the issue be referred for resolution through good faith negotiations responsive communication between the Chief Executive Officer of CK Parties and the Chairman, Research effective exchange of information and Development shall serve as the primary point of contact for GSK, who shall promptly meet to resolve the issueany issues arising under this Agreement. In the event they are unable to reach agreement on the matter, the [*] The Alliance Managers shall have the right to [*] on attend all JDC meetings and may bring to the matter, which [*] shall become the decision attention of the JDC. Notwithstanding JDC any matters or issues either of them reasonably believes should be discussed and shall have such other responsibilities as the foregoing, [*] shall not have the right to [*] with respect to matters relating to Licensed Products for which [*]Parties may mutually agree in writing.

Appears in 1 contract

Samples: Clinical Trial Collaboration and Supply Agreement (Advaxis, Inc.)

Joint Development Committee. Promptly following CK's exercise 8.1 The Parties shall form a joint development committee (the “Joint Development Committee” or “JDC”), made up of its Co-Funding Option for a Co-Funded Product, or an exercise by three (3) representatives of each of SpringWorks and GSK of the CK Product Option with respect to a CK Product under Section 4.5 belowunless otherwise agreed (but in any event, the Parties shall establish a Joint Development Committee ("JDC") 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 made up of an equal number of representatives from each of GSK and CK; and unless otherwise agreed, 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"Party), as appropriatewhich shall have responsibility for coordinating all regulatory and other activities under, and GSK's CEDD head 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 biologyinformation between the Parties, unless otherwise agreedwith respect to the Sub-Study, and shall have at least one representative from each notify the other Party at in writing regarding the level name and contact details of Vice President or abovethe Project Manager promptly following the Effective Date. Either Party may replace its respective Other JDC representatives at any timemembers will be agreed by the Parties promptly following the Effective Date, with but no later than five (5) Business Days prior written notice to the other Party. From time to time, the first JDC may establish subcommittees to oversee particular projects or activities, and such subcommittees will be constituted as the JDC approvesmeeting. The JDC shall meet at least quarterly according for the first time after the Effective Date and prior to an agreed schedulethe Sub-Study initiation, and then no less than quarterly, or more or less often as agreed by the Parties JDC, to provide an update on Sub-Study progress. Five (5) Business Days prior to any such meeting, the 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 keep the JDC fully informed as to all aspects provide: (a) a final draft of the Later Stage Development meeting agenda (incorporating any comments from the SpringWorks Project Manager) and other ongoing activities pertaining (b) an update in writing to the Co-Funded Product SpringWorks Project Manager, which update shall contain information in reasonable detail about [***]. The minutes of each JDC meeting will be drafted by the meeting’s secretary and all further development of the Licensed Product for which GSK exercises its CK Product Option under Section 4.5shall summarize discussion highlights, actions, and agreements. Decisions The draft minutes shall be circulated within three (3) business days of the JDC meeting by the GSK Project Manager, thereafter, the GSK Project Manager shall 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 by majority vote; provided that if there is not an equal number of representatives of each Party present at such meeting, then only an equal number of representatives of each Party the GSK Project Manager and thereafter the secretarial appointment shall be entitled to votealternate between the SpringWorks Project Manager and the GSK Project Manager. In the event the required vote to approve a * [***] Certain information on in this page document has been omitted from this exhibit because it is both (i) not material and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions. particular action cannot (ii) would 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 Chairman, Research and Development for GSK, who shall promptly meet to resolve the issue. In the event they are unable to reach agreement on the matter, the [*] shall have the right to [*] on the matter, which [*] shall become the decision of the JDC. Notwithstanding the foregoing, [*] shall not have the right to [*] with respect to matters relating to Licensed Products for which [*]competitively harmful if publicly disclosed.

Appears in 1 contract

Samples: Clinical Trial Collaboration and Supply Agreement (SpringWorks Therapeutics, Inc.)

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Joint Development Committee. 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 The Parties shall establish form a joint development team (the “Joint Development Committee ("Committee” or “JDC") 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 made up of an equal number of representatives from each of GSK Advaxis and CK; and unless otherwise agreed, 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 Incyte ("TAST"not to exceed three (3) each), as appropriatewhich shall have responsibility for coordinating all regulatory and other activities under, and GSK's CEDD head pursuant to, this Agreement. 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 biologyinformation, unless otherwise agreedserving as the primary point of contact for any issues arising under this Agreement, implementing and shall have 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 Party. From time to time, the JDC may establish subcommittees to oversee particular projects or coordinating activities, and such subcommittees facilitating the exchange of information between the Parties, with respect to the Study. Other JDC members will be constituted as the JDC approvesagreed by both Parties. The JDC shall meet at least quarterly according to an agreed scheduleas soon as practicable after the Effective Date and then no less than once each Calendar Quarter, and more often as reasonably considered necessary at the Parties shall keep the JDC fully informed as request of either Party with reasonable notice, to all aspects provide an update on progress of the Later Stage Development Study and other ongoing activities pertaining make decisions regarding the conduct of the Study and any modifications to the Co-Funded Product Protocol and all further development of the Licensed Product for which GSK exercises its CK Product Option under Section 4.5Budget. Decisions of the JDC shall be by majority vote; provided that if there is not an equal number of representatives of each Party present at Five (5) business days prior to any such meeting, then only the Incyte Project Manager shall provide an equal number of representatives of each Party shall be entitled to vote. In the event the required vote to approve a * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect update in writing to the omitted portionsAdvaxis Project Manager, which update shall contain information about overall Study progress, recruitment status, interim analysis (if results are available), final analysis and other information relevant to the conduct of the Study. 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 Chairman, Research and Development for GSK, who shall promptly meet to resolve the issue. In the event they are unable The JDC will attempt to reach agreement decisions by consensus, except that Advaxis will determine in its sole discretion the 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. When consensus is not achieved on the any matter, the [*] matter will be escalated to the Incyte CEO and the EVP CMO Advaxis or his/her nominee for resolution, provided however that (1) in the event that the matter relates solely to the Advaxis Compound, Advaxis shall have final decision-making authority and (2) in the right event that the matter relates solely to [*] on the matterIncyte Compound, which [*] Incyte shall become the decision of the JDC. Notwithstanding the foregoing, [*] shall not have the right to [*] with respect to matters relating to Licensed Products for which [*]final decision-making authority.

Appears in 1 contract

Samples: Clinical Study Collaboration Agreement (Advaxis, Inc.)

Joint Development Committee. 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 establish a Joint Development Committee ("JDC") 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 GSK and CK; and unless otherwise agreed, 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 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 Party. From time to time, the JDC may establish subcommittees to oversee particular projects or activities, and such subcommittees will be constituted as the JDC approves. The JDC shall meet at least quarterly according to an agreed schedule, and the Parties shall keep the JDC fully informed as to all aspects of the Later 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. Decisions of the JDC shall be by majority vote; provided that if there is not an equal number of 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 event the required vote to approve a * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the 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 Chairman, Research and Development for GSK, who shall promptly meet to resolve the issue. In the event they are unable to reach agreement on the matter, the [*] shall have the right to [*] on the matter, which [*] shall become the decision of the JDC. Notwithstanding the foregoing, [*] shall not have the right to [*] with respect to matters relating to Licensed Products for which [*].

Appears in 1 contract

Samples: Collaboration and License Agreement (Cytokinetics Inc)

Joint Development Committee. Promptly following CK's exercise (a) The PARTIES agree to form a joint DEVELOPMENT COMMITTEE comprised of its Cosenior management of each PARTY (“DEVELOPMENT COMMITTEE”). The PARTIES shall use COMMERCIALLY REASONABLE EFFORTS to have a meeting of the DEVELOPMENT COMMITTEE within forty-Funding Option for a Co-Funded Productfive days after the EFFECTIVE DATE and thereafter once every CALENDAR QUARTER, or an exercise more frequently if mutually agreed upon by GSK the PARTIES, (i) to discuss and coordinate clinical development plans for PRODUCTS, (ii) to update the 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 CK Product Option clinical development plans (provided however that the PHASE III CLINICAL TRIAL and any other existing ongoing clinical trials with respect to a CK Product NUMAX and the liquid formulation of SYNAGIS will not be subject to discussion under this Section 4.5 below6.6), (iii) to review and approve any proposed clinical trials of the Parties shall establish a Joint Development Committee PRODUCTS in the TERRITORY consistent with Section 6.8, ("JDC"iv) to coordinate the strategy of submissions of the REGULATORY FILINGS to REGULATORY AUTHORITIES in the TERRITORY with respect to such Licensed Product. It is understood that NUMAX, (v) to review and approve or reject the Project Team for such Licensed Product shall continue after establishment publication of a JDC data 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 GSK and CK; and unless otherwise agreed, 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 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 Party. From time to time, the JDC may establish subcommittees to oversee particular projects or activities, and such subcommittees will be constituted as the JDC approves. The JDC shall meet at least quarterly according to an agreed schedule, and the Parties shall keep the JDC fully informed as to all aspects of the Later 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. Decisions of the JDC shall be by majority vote; provided that if there is not an equal number of 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 event the required vote to approve a * Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portionsPRODUCTS 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. particular The DEVELOPMENT COMMITTEE shall not make the decision to take any action cannot be obtained, then either Party may request that or inaction which conflicts with or fails to conform to the issue applicable laws in any country in the TERRITORY. A deadlock with respect to any matter submitted to the DEVELOPMENT COMMITTEE shall be referred to the respective executive officers of the PARTIES for resolution through good faith negotiations between the Chief Executive Officer of CK and the Chairman, Research and Development for GSKresolution, who shall promptly meet have ten (10) business days to resolve the issuedeadlock. In the event they If such executive officers are unable to reach agreement on resolve the matterdeadlock, the [*] MEDIMMUNE shall have the right to [*] on the matter, which [*] shall become the final decision of the JDC. Notwithstanding the foregoing, [*] shall not have the right to [*] with respect to matters relating to Licensed Products the deadlock. For clarity, no clinical trials for which [*]PRODUCTS will be initiated by XXXXXX without approval of the DEVELOPMENT COMMITTEE.

Appears in 1 contract

Samples: Distribution Agreement (Medimmune Inc /De)

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