Common use of Joint Development Committee Clause in Contracts

Joint Development Committee. (a) The Parties shall establish a Joint Development Committee (the “Joint Development Committee” or “JDC”), comprised of [**] representatives of Ikaria and [**] representatives of BioLineRx, to oversee the Development of Products. Each Party shall make its initial designation of its representatives not later than [**] days after the Effective Date. Each Party may change any one or more of its representatives to the Joint Development Committee at any time upon notice to the other Party. (b) The JDC shall meet at least [**] during the Development Term or more or less frequently as the JDC may agree. The JDC may meet in person or by means of a telephone or video conference call. One meeting of the JDC per year shall be held in person at Ikaria’s headquarters in Clinton, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs with respect to its participation on the JDC. Prior to every meeting of the JDC, Ikaria will provide to the JDC detailed reports describing Ikaria’s current clinical and development activities and plans. (c) The JDC shall be the vehicle by which BioLineRx may offer insight and guidance to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are set forth in this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteria. (d) The JDC shall only act unanimously, with each Party given one (1) vote regardless of the number of representatives. If, however, the JDC is unable to reach agreement with respect to any matter within [**] days, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer shall have the right to decide the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither Party shall have a unilateral right to resolve any dispute involving the breach or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunder.

Appears in 5 contracts

Samples: License and Commercialization Agreement (Bellerophon Therapeutics, Inc.), License and Commercialization Agreement (Bellerophon Therapeutics LLC), License and Commercialization Agreement (Bellerophon Therapeutics LLC)

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Joint Development Committee. (a) The Parties No later than its initial meeting, the JSC shall establish a Joint joint Development Committee committee (the “Joint Development Committee” or “JDC”)) which shall hold its initial meeting within fifteen (15) days of its establishment. At its first meeting, comprised of the JDC shall: (i) [**] representatives *], and (ii) review, modify as necessary and recommend for approval to the JSC a Development Plan (including the Development Budget). The Illustrative Development Plan/Budget is an illustrative indication of Ikaria the activities and the budget to be considered and addressed in the first Development Plan and shall not be binding on the Parties, the JSC or the JDC. Following its initial meeting, the JDC will meet in person, by teleconference or by video-teleconference at least [***] representatives of BioLineRx, to oversee the Development of Products. Each Party shall make its initial designation of its representatives not later than per [***] days after the Effective Date. Each Party may change any one or more of its representatives to the Joint Development Committee at any time upon notice to the other Party[***]. (b) The Without limiting the foregoing, the JDC shall meet at least be responsible for: (i) reviewing, consulting with the Parties on and modifying (as appropriate) the Development Plan including the Development Budget; (ii) recommending the Development Plan including the Development Budget (as modified) for approval by the JSC; (iii) communicating with the JCC regarding the interrelationship between Development activities and potential Commercialization; (iv) reviewing and monitoring the activities and progress against the Development Plan; (v) reviewing and monitoring the costs and expenses of Development against the Development Budget; (vi) finalizing the Product specifications for inclusion in the Regulatory Filings for the Territory and Regulatory Approvals and Pricing and Reimbursement Approvals for the Territory; and (vii) communicating with the Parties regarding all of the foregoing. For the avoidance of doubt, the CRO used for Clinical Trials shall be selected by Coherus, and such selection shall not be subject to the dispute escalation process under Section 3.1(d) (Decision-Making; Deciding Vote). [***] during Certain information in this document has been omitted and filed separately with the Development Term or more or less frequently as the JDC may agreeSecurities and Exchange Commission. The JDC may meet in person or by means of a telephone or video conference call. One meeting of the JDC per year shall be held in person at Ikaria’s headquarters in Clinton, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs Confidential treatment has been requested with respect to its participation on the JDC. Prior to every meeting of the JDC, Ikaria will provide to the JDC detailed reports describing Ikaria’s current clinical and development activities and plansomitted portions. (c) The JDC shall be the vehicle by which BioLineRx may offer insight and guidance to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are set forth in this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteria. (d) The JDC shall only act unanimously, with each Party given one (1) vote regardless of the number of representatives. If, however, the JDC is unable to reach agreement with respect to any matter within [**] days, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer shall have the right to decide the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither Party shall have a unilateral right to resolve any dispute involving the breach or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunder.

Appears in 3 contracts

Samples: License Agreement (Coherus BioSciences, Inc.), License Agreement (Coherus BioSciences, Inc.), License Agreement (Coherus BioSciences, Inc.)

Joint Development Committee. (a) The Parties shall will establish a Joint Development Committee joint development committee, composed of up to *** representatives from each Party, with equal numbers from each Party (the “Joint Development Committee” or the “JDC”). At each Party’s option, comprised its Alliance Manager may be a member of [the JDC or a non-voting participant at the JDC meetings. Within **] representatives of Ikaria and [**] representatives of BioLineRx, to oversee the Development of Products. Each Party shall make its initial designation of its representatives not later than [**] * days after following the Effective Date, each Party will designate its initial members to serve on the JDC and notify the other Party of the dates of availability for the first meeting of the JDC. Each Party may change any one or more of replace its representatives to on the Joint Development Committee at any time upon JDC on written notice to the other Party. (b) The JDC shall meet at least [**] during oversee the HGS Development Term or more or less frequently as Activities and their related Manufacture activities. In addition, the JDC may agree. The JDC may meet in person or by means of shall serve as a telephone or video conference call. One meeting of the JDC per year shall be held in person at Ikaria’s headquarters in Clinton, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts forum for FivePrime to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs share with HGS information with respect to its participation on FivePrime Development Activities. In accordance with the JDC. Prior to every meeting of foregoing, the JDCJDC shall: (1) Oversee, Ikaria will provide review and discuss activities conducted pursuant to the JDC detailed reports describing IkariaDevelopment Plan and the actual spend of development costs under the Development Plan; (2) review, approve and amend the Development Plan (including the associated budgets) as needed; (3) oversee HGS’ Manufacturing activities under this Agreement; (4) exchange information with respect to FivePrime Development Activities, subject to any of FivePrime’s current clinical confidentiality obligation to any Third Party licensee; (5) monitor the progress and development activities performance of any other joint committee established pursuant to this Agreement, except for the JCC; (6) determine any matter with respect to which an agreement cannot be reached by any other joint committee established pursuant to this Agreement, except for the JCC; and (7) consider and plansact upon such other matters as specified in this Agreement. (c) The JDC shall be not have the vehicle by which BioLineRx may offer insight and guidance to Ikaria with respect to authority to: (i) establishing modify or amend the Development Plan setting forth the Development Program’s objectives terms and the activities to be conducted, conditions of this Agreement; (ii) reviewing waive either Party’s compliance with the terms and updating the Development Plan from time to time, conditions of under this Agreement; or (iii) monitoring the progress and results of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are set forth in this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteria. (d) The JDC shall only act unanimously, with each Party given one (1) vote regardless of the number of representatives. If, however, the JDC is unable to reach agreement with respect to any matter within [**] days, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve determine any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer shall have issue in a manner that would conflict with the right to decide the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither Party shall have a unilateral right to resolve any dispute involving the breach or alleged breach express terms and conditions of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunder.

Appears in 3 contracts

Samples: License and Collaboration Agreement (Five Prime Therapeutics Inc), License and Collaboration Agreement (Five Prime Therapeutics Inc), License and Collaboration Agreement (Five Prime Therapeutics Inc)

Joint Development Committee. (a) The Parties shall establish a Joint Development Committee (the “Joint Development Committee” or “JDC”), comprised of [***] representatives of Ikaria and [***] representatives of BioLineRx, to oversee the Development of Products. Each Party shall make its initial designation of its representatives not later than [***] days after the Effective Date. Each Party may change any one or more of its representatives to the Joint Development Committee at any time upon notice to the other Party. (b) The JDC shall meet at least [***] during the Development Term or more or less frequently as the JDC may agree. The JDC may meet in person or by means of a telephone or video conference call. One meeting of the JDC per year shall be held in person at Ikaria’s headquarters in Clinton, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs with respect to its participation on the JDC. Prior to every meeting of the JDC, Ikaria will provide to the JDC detailed reports describing Ikaria’s current clinical and development activities and plans. (c) The JDC shall be the vehicle by which BioLineRx may offer insight and guidance to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are set forth in this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteria. (d) The JDC shall only act unanimously, with each Party given one (1) vote regardless of the number of representatives. If, however, the JDC is unable to reach agreement with respect to any matter within [***] days, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [***] days following referral, Ikaria’s Executive Officer shall have the right to decide the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither Party shall have a unilateral right to resolve any dispute involving the breach or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunder.

Appears in 3 contracts

Samples: License and Commercialization Agreement (BioLineRx Ltd.), License and Commercialization Agreement (BioLineRx Ltd.), License and Commercialization Agreement (BioLineRx Ltd.)

Joint Development Committee. (a) The Parties shall establish a Joint Development Committee (the “Joint Development Committee” or “JDC”), comprised of [**] representatives of Ikaria and [**] representatives of BioLineRx, to JDC will oversee the Development of ProductsLicensed Products in the Field in the Territory and the European Territory. Each Party shall make its initial designation of its representatives not later As soon as practicable following the Effective Date (but in no event more than [**] thirty (30) days after following the Effective Date. Each ), each Party may change any one or more shall designate its initial three (3) representatives on the JDC, and each of its such representatives will be an employee of such Party and will have sufficient seniority within the applicable Party to make decisions arising within the Joint Development Committee at any time upon notice to scope of the other PartyJDC’s responsibilities. (b) The JDC shall meet at least [**] during the Development Term or more or less frequently as the JDC may agree. The JDC may meet in person or by means of a telephone or video conference call. One meeting of the JDC per year shall be held in person at Ikaria’s headquarters in Clinton, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause appoint a person from among its representatives on the JDC to attend serve as a co-chairperson of the JDC. The co-chairpersons will not have any greater authority than any other representative on the JDC and shall conduct the following activities of the JDC: (i) calling meetings of the JDC. If a representative ; (ii) preparing and issuing minutes of a Party is unable to attend a meeting, such Party may designate an alternate to attend each such meeting in place of within thirty (30) days thereafter; (iii) preparing and circulating an agenda for the absent representative. Each Party shall bear its own costs with respect to its participation on the JDC. Prior to every meeting of the JDC, Ikaria will provide upcoming meeting; and (iv) ensuring that any decision-making delegated to the JDC detailed reports describing Ikaria’s current clinical and development activities and plansis carried out in accordance with Section 3.5. (c) The JDC shall be the vehicle by which BioLineRx may offer insight and guidance to Ikaria with respect to will have responsibility for: (i) establishing overseeing, reviewing and coordinating the Development Plan setting forth of the Licensed Products (including all Clinical Trials and reviewing the protocols, statistical analysis plans and clinical study reports for such Clinical Trials developed by the applicable Lead Development Program’s objectives and Party) in the activities to be conducted, Field; (ii) reviewing developing and updating submitting the Core Development Plan from time Plan, including the budget and proposed amendments or updates thereto, to time, the JSC; and (iii) monitoring as applicable, overseeing, reviewing and coordinating the progress work being done under the Core Development Plan and results of the any Non-Core Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are set forth in this AgreementPlan(s), and determining whether the results of such clinical trials have achieved the applicable success criteria. (d) The JDC UGNX shall only act unanimouslyperiodically, with each Party given one and at least semi-annually, submit comprehensive and complete reports (1i) vote regardless to the JDC, regarding activities previously approved by the JSC and undertaken by or on behalf of the number of representatives. If, however, the JDC is unable to reach agreement UGNX with respect to any matter within [**] daysthe Development of Licensed Products in the Field, including their progress, status and outcome as well as major findings and major decision points, as applicable, so as to keep the matter shall be referred JDC fully advised of UGNX’s Development activities with respect to the Parties’ respective Executive Officers for resolution. If Licensed Products in the Executive Officers are not able Field and (ii) to resolve any such matter the JCC with respect to the Commercialization of Licensed Products in the Field, including Sales, Promotion and Marketing Activities, and the date of the First Commercial Sale in a country (if applicable) in the relevant half year. (e) KHK shall periodically, and at least semi-annually, submit reasonably detailed reports (i) to the JDC, regarding activities undertaken by consensus within [**] days following referral, IkariaKHK with respect to KHK’s Executive Officer shall have Development activities and (ii) to the right JCC with respect to decide the matter taking into account IkariaKHK’s obligation to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither Party shall have a unilateral right to resolve any dispute involving the breach or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunderCommercialization activities.

Appears in 3 contracts

Samples: Collaboration and License Agreement (Ultragenyx Pharmaceutical Inc.), Collaboration and License Agreement (Ultragenyx Pharmaceutical Inc.), Collaboration and License Agreement (Ultragenyx Pharmaceutical Inc.)

Joint Development Committee. (a) The Parties shall establish form a Joint Development Committee joint development committee (the “Joint Development Committee” or “JDC”), comprised made up of [**] an equal number of representatives of Ikaria Merck and [**] representatives of BioLineRx, to oversee the Development which shall have responsibility of Productscoordinating all regulatory and other activities under, and pursuant to, this Agreement. Each Party shall make its initial designation designate a project manager (the “Project Manager”) who shall be responsible for implementing and coordinating activities, and facilitating the exchange of its representatives not later than [**] days after information between the Effective Date. Each Party may change any one or more of its representatives Parties, with respect to the Joint Development Committee at any time upon notice to the other Party. (b) 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 least [**] during the Development Term or more or less frequently as request of either Party, to provide an update on the JDC may agreeprogress of the Study. The JDC may meet in person or by means of a telephone teleconference, Internet conference, videoconference or video conference call. One meeting of the JDC per year shall be held in person at Ikaria’s headquarters in Clinton, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs with respect to its participation on the JDCother similar communications equipment. Prior to every meeting 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 JDCStudy, Ikaria will provide recruitment status, interim analysis (if results available), final analysis and other information relevant to the JDC detailed reports describing Ikaria’s current clinical 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 development activities and plans. (c) The JDC shall be responsive communication between the vehicle by which BioLineRx may offer insight and guidance to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives Parties and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results effective exchange of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Terminformation, and (v) establishing success criteria shall serve as the primary point of contact for the clinical trials (other than those for which success criteria are set forth in any issues arising under this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteria. (d) . The JDC shall only act unanimously, with each Party given one (1) vote regardless of the number of representatives. If, however, the JDC is unable to reach agreement with respect to any matter within [**] days, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer Alliance Managers shall have the right to decide attend all JDC meetings and may bring to the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2attention of the JDC any matters or issues either of them reasonably believes should be discussed, neither Party and shall have a unilateral right 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 resolve any dispute involving the breach Head of Clinical Oncology for Merck and the Vice President of Medical Affairs or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Business Development Plan or the Parties’ respective rights and obligations thereunderfor BioLineRx.

Appears in 3 contracts

Samples: Clinical Trial Collaboration and Supply Agreement (BioLineRx Ltd.), Clinical Trial Collaboration and Supply Agreement (BioLineRx Ltd.), Clinical Trial Collaboration and Supply Agreement (BioLineRx Ltd.)

Joint Development Committee. (a) The Parties shall establish There is hereby created a Joint Development Committee joint development committee (the “Joint Development Committee” or “JDC”), comprised which will consist of [**] 10 representatives designated by the Parties. For the avoidance of Ikaria doubt, the role of the Joint Development Committee shall be only of an advisory capacity to each Party’s management with no authority with respect to the approval of Annual Work Plan and [**] representatives Budgets, AFEs or expenditures of BioLineRx, to oversee the Development of Productsany other nature. Each Party shall make be entitled to designate one representative for each 10% Participating Interest Share of the Joint Interests held by such Party and its initial designation Affiliates on an aggregate basis and rounded to the nearest 10% interest; provided that, solely for the purposes of this Section 5.1(a), if such rounding would cause the number of representatives on the Joint Development Committee to be greater than 10, each Participating Interest Share shall be deemed to be rounded down and the holder of the largest Participating Interest shall be entitled to appoint its representatives not later than [**] days after to fill any vacancies; provided further that any change in the Effective Datenumber of representatives permitted to be designated by a Party to the Joint Development Committee pursuant to this Section 5.1(a) shall be immediate. Each As of the date of this Agreement, Atlas is entitled to designate six representatives with respect to its 60% Participating Interest Share, and Reliance is entitled to designate four representatives with respect to its 40% Participating Interest Share. The Party may change any one or more entitled to appoint the largest number of its representatives to the Joint Development Committee at any time upon notice (or, in the event that there is more than one such Party, the Party entitled to appoint the largest number of representatives to the other PartyJoint Development Committee that shall have last been the JDC Operator) shall be the “JDC Operator”. (b) The JDC shall Joint Development Committee will meet no less than once per calendar month at least [**] during a mutually agreed time and at the Development Term or more or less frequently as the JDC may agree. The JDC may meet in person or by means of a telephone or video conference call. One meeting offices of the JDC per year Operator, which shall be held located in person at Ikaria’s headquarters in Clintonthe Commonwealth of Pennsylvania, NJ unless otherwise mutually agreed to conduct the following activities: (i) review operational activity and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs performance with respect to its participation on the JDC. Prior Joint Interests, including well design, construction, completion, maintenance, lease operating expenses, well potentials and production; (ii) review authorizations for expenditures (each an “AFE”) and any other matter raised by a Party relating to every meeting any aspect of the JDCMulti-Year Plan, Ikaria will provide the Development Plan and Annual Work Plan and Budget then in effect; (iii) review and discuss all geoscience data, data gathering strategies, including seismic and all other relevant data relating to the JDC detailed reports describing Ikaria’s current clinical Multi-Year Plan, the Development Plan and Annual Work Plan and Budget then in effect; and (iv) review annual comparisons between planned and actual well costs, the related root cause analysis, corrective action plans, total unit finding and development activities costs, and plansestimated ultimate recoveries. (c) The At least once every three calendar months the Parties shall meet at a mutually agreed time and at the offices of the JDC shall be Operator unless otherwise mutually agreed to conduct a review of the vehicle by which BioLineRx may offer insight activities under this Agreement, all financial results in connection with Development Operations and guidance to Ikaria with respect to (i) establishing the plans and drilling schedule for activities under the Multi-Year Plan, the Development Plan setting forth or the Development Program’s objectives Annual Work Plan and the activities to be conductedBudget, (ii) reviewing as applicable, and updating the Development Plan from time to time, (iii) monitoring the progress and results of the Development Program, (iv) determining future Development Program activities, including Development other plans or activities relating to Manufacturing, to be conducted during the Development Term, Joint Interests and (v) establishing success criteria the AMI for the clinical trials (other than those for which success criteria are set forth in this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteriafollowing 12 months. (d) The JDC shall only act unanimously, with each Party given one (1) vote regardless Joint Development Committee may establish such subcommittees as the Joint Development Committee may deem appropriate. The functions of the number of representatives. If, however, the JDC is unable to reach agreement with respect to any matter within [**] days, the matter such subcommittees shall be referred to the Parties’ respective Executive Officers for resolutionserve in an advisory capacity only. If the Executive Officers are not able to resolve any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer Each Party shall have the right to decide appoint a number of representatives to each subcommittee on a pro rata basis in accordance with its Participating Interest Share. (e) Each notice of a meeting of the matter taking into account Ikaria’s obligation Joint Development Committee as provided by the JDC Operator shall contain: (i) the date, time and location of the meeting; (ii) a proposed agenda of the matters to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither Party shall have be considered at the meeting and (iii) copies of all proposals to be discussed at a unilateral right meeting (including appropriate supporting information not previously distributed to resolve any dispute involving the breach or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective ); provided the Joint Development Committee will have no approval rights and obligations hereunder oron any such proposals. A Party, except as expressly provided in this Section 3.2by notice to the other Party, which notice may include any Development Plan or additional proposals to be discussed at the meeting (including appropriate supporting information not previously distributed to the Parties’ respective rights ), may add additional matters to the agenda for a meeting. (f) With respect to meetings of the Joint Development Committee and obligations thereundereach subcommittee, JDC Operator’s duties shall include: (i) timely preparation and distribution of the agenda; and (ii) organization and conduct of the meeting. The JDC Operator shall provide each Party with a copy of the minutes of each Joint Development Committee meeting within 15 Business Days after the end of the meeting.

Appears in 3 contracts

Samples: Participation and Development Agreement, Participation and Development Agreement (Atlas Energy, Inc.), Participation and Development Agreement (Atlas Energy Resources, LLC)

Joint Development Committee. Sano and BMS shall establish a joint development committee (the "Joint Development Committee"). (a) The Parties shall establish a Joint Development Committee shall have the following responsibilities: (i) to coordinate all interactions with the FDA or other regulatory authorities regarding the registrational dossier(s) for the Product throughout the Territory, (ii) to review all Phase III and Phase IV studies relating to the Products and any other studies proposed to be performed by BMS in connection with the registration process for the Product, and make amendments to the Clinical Plan, as deemed necessary or desirable, (iii) to coordinate all other regulatory compliance and interactions relating to the Product throughout the Territory, and (v) to provide a mechanism for the exchange of information with regard to the registrational dossier(s) for, and other regulatory filings and communications relating to, the Product throughout the Territory and the Product Registrations to be issued therefrom. (b) Joint Development Committee shall consist of an equal number of representatives appointed by each of the Parties. Within 30 days after the execution of this Agreement by both Parties, Sano and BMS shall determine the number of representatives to be appointed initially to the Joint Development Committee” or “JDC”), comprised of [**] and each shall appoint its representatives to serve on the Committee. Each Party may designate appropriate personnel who shall assist the representatives of Ikaria and [**] representatives of BioLineRx, to oversee the Development of ProductsParty. Each Party shall make be free to change its initial designation of its representatives not later than [**] days after the Effective Date. Each Party may change any one or more of its representatives to the Joint Development Committee at any time upon representatives, on notice to the other Party. (b) . The JDC Joint Development Committee shall meet at least [**] during the Development Term or more or less frequently such times and in such places as the JDC may agree. The JDC may meet in person or agreed upon from time to time by means of a telephone or video conference call. One meeting of the JDC per year shall be held in person at Ikaria’s headquarters in Clinton, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs with respect to its participation on the JDC. Prior to every meeting of the JDC, Ikaria will provide to the JDC detailed reports describing Ikaria’s current clinical and development activities and plans. (c) The JDC shall Joint Development Committee will be chaired by one representative of each Party during each six (6) month period during the vehicle by which BioLineRx may offer insight and guidance to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives term of this Agreement, and the activities to chair shall alternate between the Parties. During the first six (6) months, the Joint Development Committee will be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results chaired by a representative of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are set forth in this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteriaBMS. (d) The JDC Joint Development Committee will meet at least once each calendar quarter during the term of this Agreement, at such dates and times as agreed to by the Parties. Meetings in person shall only act unanimously, with each Party given one (1) vote regardless alternate between the offices of the number Parties or such other place as may be mutually agreed upon. The Joint Development Committee may also convene or be polled or consulted from time to time by means of representativestelecommunications or correspondence. IfAll decisions made or actions taken by the Joint Development Committee will be made unanimously by its members with the Sano members cumulatively having one vote and the BMS members cumulatively having one vote. The Joint Development Committee will prepare written minutes of each meeting and a written record of all decisions, however, whether made at a formal meeting or not. A quorum for a meeting shall require at least one Sano member and at least one BMS member. (e) If there are issues on which the JDC is unable to Joint Development Committee cannot reach agreement because of a deadlock (as here-inafter defined), such matters will be submitted to the President of Sano and the President, BMS Pharmaceutical Group for prompt resolution. For the purpose of this Section 3.2(e), "deadlock)" will mean (i) with respect to any matter within [**] daysconsidered and voted upon by the Joint Development Committee, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any that one Party votes in favor of such matter by consensus within [**] days following referraland the other Party does not vote in favor of such matter, Ikaria’s Executive Officer shall have or (ii) a quorum cannot be established for the right Joint Development Committee to decide the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither Party shall have vote on a unilateral right to resolve any dispute involving the breach or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereundermatter.

Appears in 2 contracts

Samples: Distribution and Supply Agreement (Sano Corp), Distribution and Supply Agreement (Sano Corp)

Joint Development Committee. (a) The Parties shall establish a Joint Development Committee Within thirty (30) days of the “Joint Development Committee” or “JDC”), comprised of [**] representatives of Ikaria and [**] representatives of BioLineRx, to oversee the Development of Products. Each Party shall make its initial designation of its representatives not later than [**] days after the Original Effective Date. Each Party may change any one or more of its representatives to , the Parties will establish the Joint Development Committee to oversee and control all development of Franchise Products in the Co-Promotion Territory, in the Field, including pre-clinical research, clinical research, manufacturing, regulatory filings and post-approval development studies. The JDC will be composed of three representatives appointed by each of IDEC and Genentech. Each representative will have one vote on all matters within the JDC's purview. Such representatives will include individuals with expertise and responsibilities in the areas of preclinical development, clinical development, process sciences, manufacturing or regulatory affairs. Either Party may replace any or all of its representatives at any time upon written notice to the other Party. The JDC will meet at least once each calendar quarter, or more frequently, as agreed by the JDC. The JDC will operate by consensus, except as expressly set forth herein. If the JDC is unable to resolve a dispute regarding any issue presented to it, such dispute shall be resolved in accordance with Article 17 below. (b) The JDC shall meet at least [**] during coordinate, expedite and guide the development of Franchise Products, including review and approval of Development Term or more or less frequently Plans for New Products, to obtain Regulatory Approvals in the Co-Promotion Territory, and in a manner consistent with maximizing the Operating Profits for all Franchise Products, as the JDC may agreeset forth in Article 4. The JDC may meet in person or by means of a telephone or video conference call. One meeting of will update the JDC per year shall be held in person at Ikaria’s headquarters in Clinton, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts Development Plans from time to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs with respect to its participation on the JDC. Prior to every meeting of the JDC, Ikaria will provide to the JDC detailed reports describing Ikaria’s current clinical and development activities and planstime as it deems necessary. (c) The JDC shall also be the vehicle by which BioLineRx may offer insight and guidance forum for exchange of information on Genentech's substantive development of Franchise Products in the Licensed Territory, unless an IDEC representative is permitted to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results attend meetings of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are a Genentech development committee as set forth in this Agreement)Section 6.4. While the IDEC representatives may comment on such development, and determining whether Genentech shall have the results of such clinical trials have achieved the applicable success criteriafinal say. (d) If any Genentech European development partner so requests, IDEC will consider in good faith allowing a representative of such partner to attend the JDC meetings. (e) The JDC shall only act unanimously, with each Party given one (1) vote regardless term of the number of representatives. If, however, JDC will be determined by the JDC is unable to reach agreement with respect to any matter within [**] days, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer shall have the right to decide the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither Party shall have a unilateral right to resolve any dispute involving the breach or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunderManagement Committee.

Appears in 2 contracts

Samples: Collaboration Agreement (Idec Pharmaceuticals Corp / De), Collaboration Agreement (Genentech Inc)

Joint Development Committee. (a) 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 establish a Joint Development Committee ("JDC") with respect to such Licensed Product. It is understood that the “Joint Development Committee” or “JDC”), comprised Project Team for such Licensed Product shall continue after establishment of [**] representatives of Ikaria a JDC and [**] representatives of BioLineRx, shall report thereto. The JDC shall have responsibility to oversee the Later Stage Development of Productsthe 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. Each 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 shall make its initial designation at the level of its representatives not later than [**] days after the Effective DateVice President or above. Each Either Party may change any one or more of replace its respective JDC representatives to the Joint Development Committee at any time upon time, with prior written notice to the other Party. (b) . 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 [**] during quarterly according to an agreed schedule, and the Development Term or more or less frequently as Parties shall keep the JDC may agreefully 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. The JDC may meet in person or by means of a telephone or video conference call. One meeting Decisions of the JDC per year shall be held in person by majority vote; provided that if there is not an equal number of representatives of each Party present at Ikaria’s headquarters in Clintonsuch meeting, NJ and one meeting then only an equal number of the JDC per year representatives of each Party shall be held in person at BioLineRx’s headquarters in Israel, provided, that entitled to vote. In the Parties’ representatives may participate in person, via telephone, or video conference in their discretionevent the required vote to approve a * Certain information on this page has been omitted and filed separately with the Commission. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs Confidential treatment has been requested with respect to its participation on the JDComitted portions. Prior to every meeting 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 the JDC, Ikaria will provide to the JDC detailed reports describing Ikaria’s current clinical and development activities and plans. (c) The JDC shall be the vehicle by which BioLineRx may offer insight and guidance to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives CK and the activities Chairman, Research and Development for GSK, who shall promptly meet to be conducted, (ii) reviewing and updating resolve the Development Plan from time to time, (iii) monitoring issue. In the progress and results of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria event they are set forth in this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteria. (d) The JDC shall only act unanimously, with each Party given one (1) vote regardless of the number of representatives. If, however, the JDC is unable to reach agreement with respect to any matter within on the matter, the [**] days, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer shall have the right to decide [*] on the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8matter, which [*] shall become the decision of the JDC. Notwithstanding anything in this Section 3.2the foregoing, neither Party [*] shall not have a unilateral the right to resolve any dispute involving the breach or alleged breach of this Agreement, [*] with respect to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereundermatters relating to Licensed Products for which [*].

Appears in 2 contracts

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

Joint Development Committee. (a) The Promptly after the Effective Date, the Parties shall establish form a Joint Development Committee (the “Joint Development Committee” or “JDC”). The JDC shall (a) oversee Neuromed’s Development of the Product 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 (c) offer its advice to expedite or aid the progress of Development work. The JDC shall be comprised of [**] representatives a total of Ikaria six (6) appropriately qualified members (or such other even number of members as is agreed to in writing by the Parties), with each of Neuromed and [**] representatives Mallinckrodt designating one half of BioLineRx, to oversee the Development total number of Productsmembers as its representatives. Each Either Party shall make its initial designation may replace any of its respective JDC representatives not later than [**] days after the Effective Date. Each Party may change any one or more of its representatives to the Joint Development Committee with an appropriately qualified representative at any time upon with reasonable prior written notice to the other Party. . The 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 agree from time-to-time to meet at a greater or lesser 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 chair (bor 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 in a non-voting capacity. The JDC shall meet at least [**] during the Development Term or more or less frequently as the JDC may agree. The JDC may meet in person or by means of a telephone or video conference call. One meeting of the JDC per year shall be held in person at Ikariaseek to reach consensus on matters coming before it, but will not have any authority to decide development matters that are Neuromed’s headquarters in Clinton, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs with respect to its participation on the JDC. Prior to every meeting of the JDC, Ikaria will provide to the JDC detailed reports describing Ikaria’s current clinical and development activities and plans. (c) The JDC shall be the vehicle by which BioLineRx may offer insight and guidance to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are set forth in responsibility under this Agreement). Notwithstanding the preceding provisions of this Section 2.2, and determining whether the results of such clinical trials have achieved the applicable success criteria. (d) The JDC shall only act unanimously, with each Party given one (1) vote regardless of the number of representatives. If, however, the JDC is unable to reach agreement with respect to any matter within [**] days, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer Mallinckrodt shall have the right to decide the matter taking into account Ikaria’s obligation give its prior written approval for those Development activities or actions set forth and described on Appendix C attached hereto, such approval not to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither Party shall have a unilateral right to resolve any dispute involving the breach or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunderbe unreasonably withheld.

Appears in 2 contracts

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

Joint Development Committee. (a) The Parties shall establish form a Joint Development Committee joint development committee (the “Joint Development Committee” or “JDC”), comprised ) made up of [**] an equal number of representatives of Ikaria 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 BioLineRx, Merck and Adaptimmune on the JDC will be mutually agreed from time to oversee time during the Development of ProductsTerm. Each Party shall make its initial designation designate a project manager (the “Project Manager”) who shall be responsible for implementing and coordinating activities and facilitating the exchange of its representatives not later than [**] days after information between the Effective DateParties with respect to the Study. Each Party may change any one or more of its representatives invite additional members to the Joint Development Committee at any time upon notice JDC where necessary for the coordination of activities pursuant to the other Party. (b) 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 least [**] during the Development Term or more or less frequently as request of either Party, to provide an update on the JDC may agreeprogress of the Study. The JDC may meet in person or by means of a telephone teleconference, Internet conference, videoconference or video conference call. One meeting of the JDC per year shall be held in person at Ikaria’s headquarters in Clinton, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs with respect to its participation on the JDCother similar communications equipment. Prior to every meeting 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 JDCStudy, Ikaria will provide recruitment status, interim analysis (if results available), final analysis and other information relevant to the JDC detailed reports describing Ikaria’s current clinical and development activities and plans. conduct of the Study (c) The JDC the “Study Update”). In addition to a Project Manager, each Party shall designate an alliance manager who may be the vehicle by which BioLineRx may offer insight same individual as the Project Manager (the “Alliance Manager”), who shall endeavor to ensure clear and guidance to Ikaria with respect to (i) establishing responsive communication between the Development Plan setting forth the Development Program’s objectives Parties and the activities to be conducted, (ii) reviewing effective exchange of information and updating shall serve as the Development Plan from time to time, (iii) monitoring the progress and results primary point of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria contact for the clinical trials (other than those for which success criteria are set forth in any issues arising under this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteria. (d) . The JDC shall only act unanimously, with each Party given one (1) vote regardless of the number of representatives. If, however, the JDC is unable to reach agreement with respect to any matter within [**] days, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer Alliance Managers shall have the right to decide attend all JDC meetings and may bring to the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither Party 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 unilateral right decision to resolve any dispute involving be made by the breach 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 alleged breach of this Agreement, consensus: (a) Merck shall have final decision-making authority with respect to amend or modify this Agreement or the Parties’ respective rights issues related to Merck Compound; and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunder(b) Adaptimmune shall have final decision-making authority with respect to issues related to Adaptimmune Compound.

Appears in 2 contracts

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

Joint Development Committee. 4.1 Within thirty (a30) days after the effective date of this Agreement, each Party shall appoint (and notify the other Party of the identity of) an alliance manager. Each Party may, at any time, replace its alliance manager with another suitably qualified individual, on written notice to the other Party. The alliance managers shall be primarily responsible for facilitating communications between the Parties and coordinating the Parties’ activities under this Agreement. 4.2 The Parties shall establish a Joint Development Committee joint development committee to oversee the development and commercialization activities, including but not limited to discuss and make decisions with respect to the manufacturing of the Licensed Product for clinical supply in accordance with the I-Mab development plan, under this Agreement (the “Joint Development Committee” or “JDC”). The Joint Development Committee shall be composed of four members with the equal number of persons from each Party who are with appropriate seniority and functional expertise. Any decisions of the JDC shall be determined by a majority vote by the JDC members present at a meeting. The minimum quorum for a JDC meeting shall be two-third (2/3) of members who must be present for the entire meeting. If the JDC cannot reach consensus within two (2) weeks on any issue that comes before the JDC, comprised then the Parties shall immediately refer such matter to the Chief Executive Officers at I-Mab and Genexine for resolution. In the event of [**] representatives a dispute between I-Mab and Genexine that cannot be resolved within two (2) weeks by the Chief Executive Officers with respect to matters concerning the research and development of Ikaria Licensed Product, I-Mab shall have the final decision-making authority. Notwithstanding the foregoing, I-Mab shall have day-to-day operational control over the development, manufacture and [**] representatives commercialization of BioLineRxthe Licensed Product, provided that I-Mab conducts such activities in accordance with the terms and conditions of this Agreement. 4.3 The JDC shall hold meetings at such times as it elects to oversee do so, but in no event shall such meetings be held less frequently than once every month. Meetings of the Development JDC may be held in person, by audio or video teleconference; provided that at least one (1) meeting per year of Productsthe JDC shall be held in person. In-person JDC meetings shall be held at locations selected alternatively by the Parties. Each Party shall make its initial designation be responsible for all of its representatives not later than [**] days after own expenses of participating in the Effective DateJDC. Each Party may change any one or more of its representatives to the Joint Development Committee No action taken at any time upon notice to the other Party. (b) The JDC shall meet at least [**] during the Development Term or more or less frequently as the JDC may agree. The JDC may meet in person or by means of a telephone or video conference call. One meeting of the JDC per year shall be held in person at Ikaria’s headquarters in Clinton, NJ and one meeting effective unless representatives of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs with respect to its participation on the JDC. Prior to every meeting of the JDC, Ikaria will provide to the JDC detailed reports describing Ikaria’s current clinical and development activities and plansboth Parties are participating. (c) The JDC shall be the vehicle by which BioLineRx may offer insight and guidance to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are set forth in this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteria. (d) The JDC shall only act unanimously, with each Party given one (1) vote regardless of the number of representatives. If, however, the JDC is unable to reach agreement with respect to any matter within [**] days, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer shall have the right to decide the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither Party shall have a unilateral right to resolve any dispute involving the breach or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunder.

Appears in 2 contracts

Samples: Intellectual Property License Agreement (I-Mab), Intellectual Property License Agreement (I-Mab)

Joint Development Committee. (a) The Promptly after the Effective Date the Parties shall establish form a Joint Development Committee (the “Joint Development Committee” or “JDC”), comprised . The JDC shall consist of [**] an equal number of representatives of Ikaria and [**] representatives of BioLineRx, to oversee the Development of Productseach Party. Each Party shall make its initial designation be responsible for determining the qualifications and substitutions of its JDC members. It is anticipated that each Party’s representatives not later than [**] days after the Effective Datemay include experts in finance, clinical development, patient safety and regulatory affairs and CMC. Each The JDC shall be co-chaired with one chairperson designated by each Party may change any one or more of its representatives to the Joint Development Committee at any time upon notice to the other Party. (b) each, a “Co-Chair”). The JDC shall meet at least [**] during the Development Term quarterly or more or less frequently at such other frequency as the JDC agrees (and it may agree. The JDC appoint subteams to meet more frequently), provided that either Party through its Co-Chair may meet in person or by means of request a telephone or video conference call. One meeting of the JDC per year shall be held in person at Ikaria’s headquarters in Clintonany time upon five (5) Business Days notice to the other Party, NJ and one meeting of with the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, understanding that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each other Party shall will use reasonable efforts to cause its comply with such request but such other Party will not be in breach of this Agreement in the event that it is unable to comply with such request but is using reasonable efforts to conduct a JDC meeting as promptly as practicable. JDC meetings shall be held by audio or video teleconference, or face-to-face, as agreed upon by the Parties; provided that face-to-face meetings shall alternate between Branford, CT and San Francisco, CA unless otherwise agreed upon by the Parties. There must be a minimum of two (2) representatives to attend the meetings from each Party at any meeting of the JDC. If a representative of a Party is unable No fewer than five (5) Business Days prior to attend a each meeting, such Party may designate an alternate to attend such meeting and in place of the absent representative. Each any event as soon as reasonably practicable, each Party shall bear its own costs use good faith efforts to disclose to the other Party any proposed agenda items together with respect to its participation on the JDCappropriate supporting information. Prior to every The JDC Co-Chairs shall alternate responsibility for preparing and circulating definitive minutes of each meeting of the JDC. Such minutes shall provide a description, Ikaria will in reasonable detail, of the discussions at the meeting, a list of material actions and decisions made by the JDC, a list of action items made by the JDC and a list of material issues not resolved by the JDC. The JDC Co-Chair who drafts the minutes shall provide the other Co-Chair and each Party’s Alliance Managers with the initial draft meeting minutes, who shall return the draft with any proposed changes, and this process shall be repeated until a final version of the meeting minutes is agreed upon and signed (or acknowledged as final via email) by the two Co-Chairs. The Parties shall reasonably cooperate to complete and agree upon a final version of meeting minutes within twenty (20) Business Days from the date of the relevant meeting. The final version of the meeting minutes shall be signed (or acknowledged as final via email) by the two Co-Chairs, and each Party shall be provided with a copy of the final meeting minutes for its safekeeping. A reasonable number of additional representatives of a Party may attend meetings of the JDC in advisory capacity with the prior written consent of the other Party; provided that any JDC meetings that includes representatives of either Party who are not JDC members may, at the request of any JDC member, include a closed session consisting of only JDC members and Alliance Managers. All representatives to the JDC detailed reports describing Ikaria’s current clinical and development activities and plans. (c) The or attending JDC meetings shall be the vehicle by which BioLineRx may offer insight subject to confidentiality and guidance to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than nonuse restrictions at least as restrictive as those for which success criteria are set forth in this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteria. (d) The JDC shall only act unanimously, with each Party given one (1) vote regardless of the number of representativesherein. If, however, the JDC is unable to reach agreement with respect to any matter within CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WHERE OMITTED AND REPLACED WITH “[**] days*]”. A COMPLETE VERSION OF THIS EXHIBIT HAS BEEN FILED SEPARATELY WITH THE SECRETARY OF THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO AN APPLICATION REQUESTING CONFIDENTIAL TREATMENT PURSUANT TO RULE 24B-2 PROMULGATED UNDER THE SECURITIES EXCHANGE ACT OF 1934, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer shall have the right to decide the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither Party shall have a unilateral right to resolve any dispute involving the breach or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunderAS AMENDED.

Appears in 2 contracts

Samples: Clinical Trial Collaboration Agreement, Clinical Trial Collaboration Agreement (BioXcel Therapeutics, Inc.)

Joint Development Committee. (a) 3.1.1 The Parties shall establish a Joint Development Committee joint development committee (the “Joint Development Committee” or “JDC”), comprised which shall have the authority to make decisions within the following areas of [**] representatives of Ikaria and [**] representatives of BioLineRx, to oversee the Development of Products. Each Party shall make its initial designation of its representatives not later than [**] days after the Effective Date. Each Party may change any one or more of its representatives to the Joint Development Committee at any time upon notice to the other Party.responsibilities: (b) The JDC shall meet at least [**] during the Development Term or more or less frequently as the JDC may agree. The JDC may meet in person or by means of a telephone or video conference call. One meeting of the JDC per year shall be held in person at Ikaria’s headquarters in Clinton, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs with respect to its participation on the JDC. Prior to every meeting of the JDC, Ikaria will provide to the JDC detailed reports describing Ikaria’s current clinical and development activities and plans. (c) The JDC shall be the vehicle by which BioLineRx may offer insight and guidance to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives and the activities to be conducted, Approve Co-development Activities; (ii) reviewing Develop and updating maintain an R&D Plan for the Development Plan from time to time, Co-development Activities; (iii) monitoring Allocate development activities, responsibilities and tasks between the Parties as related to each specific Co-development Activity in order to achieve the Purposes; (iv) Prepare agreements/work orders for signature by the Parties on each specific Co-development Activity in relation to the specific project plans (such as a Supply Agreement described in Clause 4.4 - 4.7, specifying inter alia timelines and quantities for iLets to be provided by BB to Zealand); (v) Prepare a quality agreement for signature of the parties as described in Clause 4.3; (vi) Monitor compliance with regulatory requirements relating to the Co-development Activities; (vii) Oversee the overall collaboration and reviewing progress and results of the Development ProgramCo-development Activities; (viii) Discuss and agree on how to initiate, align, manage, use, act upon and share communications with the FDA, EMA and other relevant authorities or ethical committees as related to each specific Co-development Activity and/or in order to achieve the Purposes; (ix) Develop a plan for the publication of the Clinical Data in accordance with Clause 10. 3.1.2 Each Party shall appoint two (2) members to participate in the JDC, which shall have at least two (2) meetings each year either by telephone conference or in a face-to-face meeting, unless otherwise agreed between the Parties. The JDC shall form a quorum when all four (4) members are present or represented by another member by proxy. 3.1.3 The JDC shall be co-chaired by a representative of each Party. A secretary of the JDC will be appointed on an annual, calendar year, rotating basis by either Zealand or BB, with Zealand naming the first secretary. The decisions covered by the decision-making authority of the JDC shall be made by consensus of the representatives of the Parties. In the event that no consensus can be reached, the subject matter shall be escalated by notice from either Party to the [ ] of Zealand and the [ ] of BB for resolution, such senior executives to seek to achieve consensus within fifteen (15) days of such escalation. Should no such consensus be achieved, (iv1) determining future Development Program activities, including Development activities Zealand shall have final decision-making authority with respect to all matters relating primarily to Manufacturing, to be conducted during the Development Termdevelopment of ZP4207 or obtaining regulatory approval for ZP4207 for use inter alia in a dual-hormone artificial pancreas device, and (v2) establishing success criteria BB shall have final decision making authority with respect to all matters relating primarily to development of the iLet as a dual-hormone artificial pancreas device or obtaining regulatory approval for the clinical trials (other than those for which success criteria are set forth in this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteriaiLet. (d) The JDC shall only act unanimously3.1.4 If the performance of a Co-development Activity faces obstacles, with each e.g. the existence of Third Party given one (1) vote regardless of the number of representatives. If, howeverRights, the JDC is unable to reach agreement with respect be informed immediately. Each Party shall be responsible for the enforcement of its Proprietary IP and the defense of any infringement claims arising from the Co-development Activities it performs, provided that, should a Party reasonably request that the other Party take any action to any matter within [**] daysenforce or defend Intellectual Property Rights, the matter other Party shall do so, at the expense of the requesting Party. 3.1.5 The JDC shall on an on-going basis discuss and agree on an overall research and development plan (the “R&D Plan”) for pending and planned Co-development Activities. The R&D Plan shall be referred a non-binding guidance document, unless agreed otherwise in writing in relation to specific Co-development Activities. 3.1.6 The Parties shall initiate the Parties’ respective Executive Officers for resolution. If development of the Executive Officers are not able R&D Plan promptly after the Effective Date with the aim to resolve any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer shall have the right to decide the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither Party shall have a unilateral right to resolve any dispute involving the breach or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except finalise it as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereundersoon as possible.

Appears in 2 contracts

Samples: Co Development Agreement (Zealand Pharma a/S), Co Development Agreement (Zealand Pharma a/S)

Joint Development Committee. (a) The Parties shall establish form a Joint Development Committee joint development team (the “Joint Development Committee” or “JDC”), comprised made up of [**] an equal number of representatives of Ikaria Merck and [**] representatives of BioLineRxSyndax, to oversee the Development of Productswhich shall have responsibility for coordinating all regulatory and other activities under, and pursuant to, this Agreement. JDC members will be agreed by both Parties. Each Party shall make its initial designation designate a project manager (the “Project Manager”) whose responsibilities may include, at such Party’s discretion, implementing and coordinating activities and facilitating the exchange of its representatives not later than [**] days after scientific information between the Effective Date. Each Party may change any one or more of its representatives Parties with respect to the Joint Development Committee at any time upon notice to the other Party. (b) Study. The JDC shall meet as soon as practicable after the Effective Date and then no less than twicee yearly, and more often as reasonably considered necessary at least [**] during the Development Term or more or less frequently as the JDC may agreerequest of either Party, to provide an update on Study progress. The JDC may meet in person or by means of a telephone teleconference, Internet conference, videoconference or video conference call. One meeting of the JDC per year shall be held in person at Ikaria’s headquarters in Clinton, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs with respect to its participation on the JDCother similar communications equipment. Prior to every meeting any such meeting, the Syndax Project Manager shall provide an update in writing to the Merck 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 JDCStudy. In addition to a Project Manager, Ikaria will provide each Party shall designate an alliance manager (the “Alliance Manager”), who shall endeavor to ensure clear and responsive communication between the JDC detailed reports describing Ikaria’s current clinical and development activities and plans. (c) The JDC shall be the vehicle by which BioLineRx may offer insight and guidance to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives Parties and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results effective exchange of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Terminformation, and (v) establishing success criteria shall serve as the primary point of contact for the clinical trials (other than those for which success criteria are set forth in any issues arising under this Agreement), . The Alliance Managers and determining whether the results of such clinical trials have achieved the applicable success criteria. (d) The JDC shall only act unanimously, with each Party given one (1) vote regardless of the number of representatives. If, however, the JDC is unable to reach agreement with respect to any matter within [**] days, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer Project Managers shall have the right to decide attend all JDC meetings and may bring to the matter taking into account Ikaria’s obligation attention to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2the JDC any matters or issues either of them reasonably believes should be discussed, neither Party and shall have a unilateral right 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 resolve any dispute involving the breach Chief Executive Officer of Syndax and the head of Clinical or alleged breach VP of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunderClinical Oncology for Merck.

Appears in 2 contracts

Samples: Clinical Trial Collaboration and Supply Agreement (Syndax Pharmaceuticals Inc), Clinical Trial Collaboration and Supply Agreement (Syndax Pharmaceuticals Inc)

Joint Development Committee. (a) The Parties shall establish form a Joint Development Committee joint development committee (the “Joint Development Committee” or “JDC”), comprised ) made up of [**] an equal number of representatives of Ikaria Merck and [**] representatives of BioLineRxAntigen Express, to oversee the Development of Productswith Antigen Express members having one vote and Merck members having one vote, which shall have responsibility for coordinating all regulatory and other activities under, and pursuant to, this Agreement. Each Party shall make its initial designation designate a project manager (the “Project Manager”) who shall be responsible for implementing and coordinating activities and facilitating the exchange of its representatives not later than [**] days after information between the Effective Date. Each Party may change any one or more of its representatives Parties with respect to the Joint Development Committee at any time upon notice to Study and shall be a member of the other Party. (b) 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 least [**] during the Development Term or more or less frequently as request of either Party, to provide an update on the JDC may agreeprogress of the Study. The JDC may meet in person or by means of a telephone teleconference, Internet conference, videoconference or video conference call. One meeting of the JDC per year shall be held in person at Ikaria’s headquarters in Clinton, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs with respect to its participation on the JDCother similar communications equipment. Prior to every meeting any such meeting, the 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 JDCStudy, Ikaria will provide recruitment status, interim analysis (if results available), final analysis and other information relevant to the JDC detailed reports describing Ikaria’s current clinical 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 development activities and plans. (c) The JDC shall be responsive communication between the vehicle by which BioLineRx may offer insight and guidance to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives Parties and the activities to be conducted, (ii) reviewing effective exchange of information and updating shall serve as the Development Plan from time to time, (iii) monitoring the progress and results primary point of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria contact for the clinical trials (other than those for which success criteria are set forth in any issues arising under this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteria. (d) . The JDC shall only act unanimously, with each Party given one (1) vote regardless of the number of representatives. If, however, the JDC is unable to reach agreement with respect to any matter within [**] days, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer Alliance Managers shall have the right to decide attend all JDC meetings and may bring to the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither Party 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 reasonable efforts, reach agreement on such issue, or if there is a unilateral right decision to resolve any dispute involving be made by the breach 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 Antigen Express. In the event such escalation does not result in resolution or alleged breach of this Agreement, consensus: (a) Merck shall have final decision-making authority with respect to amend or modify this Agreement or the Parties’ respective rights issues related to Merck Compound; and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunder(b) Antigen Express shall have final decision-making authority with respect to issues related to Antigen Express Compound.

Appears in 2 contracts

Samples: Clinical Trial Collaboration and Supply Agreement (Nugenerex Immuno-Oncology, Inc.), Clinical Trial Collaboration and Supply Agreement (Generex Biotechnology Corp)

Joint Development Committee. (a) The Parties Within 30 days following the Effective Date, Nerviano and Ignyta shall establish appoint a Joint Development Committee (the “Joint Development Committee” or “JDC”), comprised of [**] representatives of Ikaria and [**] representatives of BioLineRx, ) to oversee exchange information regarding all activities related to the Development of the Products, including to facilitate the transfer from Nerviano to Ignyta of Nerviano Know-How. Each Party The JDC shall make its initial designation continue to be in effect until the receipt of its representatives not later than [**] days after the Effective Date. Each Party may change any one or more of its representatives to the Joint Development Committee at any time upon notice to the other Partyfirst NDA Approval for a Product. (b) The JDC shall meet at least [**] during will consist of four individuals of which two will be designated by Nerviano and two will be designated by Ignyta. Ignyta has the Development Term or more or less frequently as right to designate the JDC may agree. The JDC may meet in person or by means chair of a telephone or video conference callthe JDC. One meeting of the JDC per year representative from each Party shall be held in person at Ikaria’s headquarters in Clintona senior executive from such Party, NJ and one meeting of the JDC per year other representative shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretionproject leader from such Party. Each Party shall use reasonable efforts have the right, at any time, to cause its representatives designate by written notice to attend the meetings other Party, a replacement for any of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs with respect to its participation Party’s members on the JDC. Prior The JDC shall endeavor to every meeting work by consensus. Where consensus cannot be reached, Ignyta shall make the final determination after consultation with Nerviano and considering Nerviano’ position in good faith; provided, however, that Ignyta shall not make any final determination that conflicts with the terms and conditions of this Agreement. As of the time of the establishment of the JDC, Ikaria will provide to each Party shall also designate one of its members of the JDC detailed reports describing Ikaria’s current clinical as the primary contact and development coordinator for such Party, to facilitate communication and coordination of the Parties’ activities and plansunder the Agreement (the “Project Coordinator”). (c) The JDC shall be meet as necessary, but, in any event no less frequently than twice each year. In lieu of in person meetings, meetings of the vehicle JDC may take place by which BioLineRx may offer insight telephonic or video conference. The site for the in-person meetings shall alternate between Nerviano, Italy and guidance San Diego, California, or such other location agreed to Ikaria by the Parties. Other than with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results special meetings of the Development ProgramJDC, which may be called by either Party on not less than ten days prior written notice (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to which notice may be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are set forth in this Agreementby e-mail), the chairperson shall send to the members of the JDC a notice of and determining whether agenda for each meeting at least five business days prior to the results date of such clinical trials have achieved the applicable success criteriameeting. (d) The JDC shall only act unanimously, with Promptly after each Party given one (1) vote regardless meeting of the number of representatives. If, howeverJDC, the JDC is unable chairperson shall (or shall designate another member of the JDC) to reach agreement with respect prepare and distribute, via facsimile or e-mail to any matter within [**] daysall members of the JDC, draft minutes, including action steps and decisions, of the meeting. Promptly after the draft minutes are distributed, the matter members shall be referred either note their approval or provide proposed revisions to the Parties’ respective Executive Officers for resolutiondraft. If Promptly after the Executive Officers are not able receipt of all approvals or proposed revisions to resolve any such matter by consensus within [**] days following referralthe draft, Ikaria’s Executive Officer the chairperson shall have issue the right to decide final minutes of the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither JDC. (e) Each Party shall have a unilateral right to resolve bear its own costs, including travel, lodging, food and telephone or video conference costs, for its personnel serving on the JDC or attending any dispute involving meeting of the breach or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunderJDC.

Appears in 2 contracts

Samples: License Agreement (Ignyta, Inc.), License Agreement (Ignyta, Inc.)

Joint Development Committee. (a) The Parties As soon as practicable after the Effective Date, the parties shall establish form a Joint Development Committee (the “Joint Development Committee” or “JDC”), comprised of [**] representatives of Ikaria ) to focus on and [**] representatives of BioLineRx, to oversee manage the Development of Productsthe Products for the Initial Indications and, if applicable, Additional Indications and/or New Formulations in the Initial Territory. Each The JDC shall be composed of two (2) management representatives appointed by each Party (Such representatives may be management representatives of each Party’s Affiliates.), with a rotating chairman each year; the chairman for the first year shall make its initial designation be from SPI. All decisions of its representatives not later than [**] days after the Effective Date. Each Party may change any one or more of its representatives to the Joint Development Committee at any time upon notice to the other PartyJDC shall be unanimous. (b) The JDC shall meet meet, at least [**] during the Development Term or more or less frequently as a minimum, on a quarterly basis, at a location(s) agreed upon by the JDC may agree. The JDC may meet in person or by means of a telephone or video conference call. One conference, provided that any decision made during a meeting is evidenced in a writing signed by one of the members of the JDC per year shall be held in person at Ikaria’s headquarters in Clinton, NJ and one meeting from each of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear the travel and living expenses of its own costs with respect personnel to its participation on the JDCattend any such meetings. Prior to every meeting of the JDC, Ikaria will provide to the The JDC detailed reports describing Ikaria’s current clinical and development activities and plansshall keep minutes reflecting actions taken at meetings. (c) The JDC responsibilities shall be the vehicle by which BioLineRx may offer insight and guidance to Ikaria with respect to include (i) establishing managing and overseeing Development of the Development Plan setting forth Products for the Development Program’s objectives and Initial Indications and, if applicable, Additional Indications and/or New Formulations in the activities to be conductedInitial Territory, (ii) reviewing developing, approving and updating modifying the Development Plan from time to timefor the Initial Indications and, if applicable, Additional Indications and/or New Formulations in the Initial Territory, (iii) monitoring developing regulatory strategy and protocols for the progress and results of Products for the Development ProgramInitial Indications and, if applicable, Additional Indications and/or New Formulations in the Initial Territory, (iv) determining future managing Development Program activitiesbudgeting for the Initial Indications and, including Development activities relating to Manufacturingif applicable, to be conducted during Additional Indications and/or New Formulations in the Development Term, Initial Territory and (v) establishing success criteria overseeing the approval process for all required Regulatory Approvals for the clinical trials (other than those for which success criteria are set forth Initial Indications and, if applicable, Additional Indications and/or New Formulations in this Agreement), and determining whether the results of such clinical trials have achieved Initial Territory. If the applicable success criteria. (d) The JDC shall only act unanimously, with each Party given one (1) vote regardless of the number of representatives. If, howevercannot resolve an issue within its purview, the JDC is unable JSC shall attempt to reach agreement resolve the conflict; provided, however that if a dispute arises with respect to any matter within [**] daysthe Additional Indications or New Formulations of the Products, the matter JCC shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able entitled to resolve any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer shall have the right to decide the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither Party shall have a unilateral right to resolve any dispute involving the breach or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunderdispute.

Appears in 2 contracts

Samples: Collaboration and License Agreement (Sucampo Pharmaceuticals, Inc.), Collaboration and License Agreement (Sucampo Pharmaceuticals, Inc.)

Joint Development Committee. (a) The Parties shall establish To facilitate the creation, approval and amendment of the Development Plan and each Annual Plan and Budget, to approve or disapprove the other matters set forth in Section 3.1 (h) and to provide (directly or through a Joint subcommittee) advice and recommendations for the conduct of Development Committee Operations and Area-Wide Operations, there is hereby established a joint development committee composed of representatives of CONSOL and Noble (the “Joint Development Committee” or “JDC”), comprised of [**] representatives of Ikaria and [**] representatives of BioLineRx, . CONSOL shall be entitled to oversee the Development of Products. Each Party shall make its initial designation of its representatives not later than [**] days after the Effective Date. Each Party may change any one or more of its appoint three representatives to the Joint Development Committee and Noble shall be entitled to appoint three representatives to the Joint Development Committee. The initial representatives to the Joint Development Committee for CONSOL shall be Xxxxxxx X. Xxxxxx, M. Xxxxxxx Xxxxxxx and Xxxxxxx X. Xxxxxxx and the initial representatives to the Joint Development Committee for Noble shall be Xxxxx Xxxxxxx, Xxxx Xxxxx and Xxxxx Xxxxxxx. Each Party shall have the right to change its representatives at any time upon by giving notice of such change to the other Parties. (b) The Joint Development Committee shall have only the powers and duties expressly ascribed to it in this Agreement. (c) The representatives of a Party shall be authorized to represent and bind such Party with respect to any matter that is within the powers of the Joint Development Committee hereunder and is properly brought before the Joint Development Committee. On all matters coming before the Joint Development Committee, the representatives of each of CONSOL and Noble shall have an aggregate vote equal to the Participating Interest of the Person (and its Affiliates) that appointed such representatives divided by the aggregate Participating Interests of all Persons (and their Affiliates) with representatives on the Joint Development Committee. Any representative of a Party that is present or otherwise available to vote or consent on an action of the Joint Development Committee shall have the authority to cast all of the votes or consents allocated to all of the representatives of such Party. In addition to the representatives, each Party may also send such advisors as it may deem appropriate to any Joint Development Committee meetings. (d) Unless otherwise agreed to by the members of the Joint Development Committee, the Joint Development Committee shall meet once (and no more than once unless otherwise mutually agreed) per calendar month to review and discuss reports concerning the Development Plan, Annual Plan and Budget and the drilling schedule, relevant geoscience and other data relating to Subject Assets and such other matters as may be reasonably proposed by a Party Operator or members of the Joint Development Committee. Meetings of the Joint Development Committee may be called by either CONSOL Operator or NBL Operator by giving notice to the members of the Joint Development Committee at least 5 days in advance of such meeting, along with a proposed agenda for such meeting (which shall include any items that a member of the Joint Development Committee or a Party Operator may request to have included on such agenda). All meetings shall be held during normal business hours at a time and place agreed to by CONSOL Operator and NBL Operator, or failing to reach such agreement, meetings occurring in even numbered months shall be held in a location selected by NBL Operator and meetings held in odd numbered months shall be held in a location selected by CONSOL Operator; provided that members of the Joint Development Committee shall be allowed to participate telephonically (or, to the extent available, by video conference) in any such meeting. (e) All decisions, approvals and other actions of the Joint Development Committee shall be decided by the affirmative vote of members of the Joint Development Committee holding collectively at least two-thirds of the votes eligible to vote on such proposals (which eligible votes, for the avoidance of doubt, shall not include any votes by the representatives of any Defaulting Party in accordance with Section 8.2(a)). The Joint Development Committee shall keep a written record of all meetings and actions taken by the Joint Development Committee or any of its subcommittees. To the fullest extent permitted by Law and notwithstanding any provision of this Agreement or any Associated Agreement to the contrary, no member of the Joint Development Committee, in his or her capacity as a member of the Joint Development Committee, shall have any duty, fiduciary or otherwise, to the Parties that did not appoint such member in connection with any act or omission by such member under this Agreement or any Associated Agreement. Each Party agrees and acknowledges that each member of the Joint Development Committee shall be entitled to determine whether or not to take any action under this Agreement or any Associated Agreement by only considering the interests of the Party that designated such member to the Joint Development Committee and not the interests of the other Party. (bf) In lieu of a meeting, any Party Operator may submit any proposal that is within the Joint Development Committee's powers to approve or disapprove (including any amendment to the then existing Development Plan or Annual Plan and Budget) to the Joint Development Committee for a vote by written notice. Such Party Operator shall provide a copy of any such proposal by written notice to the members of the Joint Development Committee. The members of the Joint Development Committee shall communicate their votes on the proposal by written notice to the submitting Party Operator within 14 days after receipt of the proposal from such Party Operator. If none of the representatives of a Party communicates their collective votes in a timely manner to such Party Operator, such representatives shall be deemed to have voted against such proposal. Promptly following the expiration of the relevant time period, the submitting Party Operator shall give each member of the Joint Development Committee a confirmation notice stating the tabulation and results of the vote on such proposal. (g) The JDC Joint Development Committee may establish such subcommittees as it may deem appropriate, including a technical committee (whose purpose would be to advise the Party Operators with respect to the development of the Subject Assets, the coordination of Development Services, the selection of Third Party contractors, the terms of contracts for Development Operations and such other matters as the Joint Development Committee may direct). The functions of such subcommittees shall be to serve in an advisory capacity only. CONSOL and Noble shall each have the right to appoint an equal number of representatives to each subcommittee. The Joint Development Committee is hereby deemed to have established a HSE Committee (the “HSE Committee”) whose purpose shall be to (A) review violations of applicable health, safety and environmental Law by a Party Operator and (B) collaborate with each Party Operator to develop additional health, safety and environmental policies and programs in its Operated Area. (h) Notwithstanding anything else to the contrary in this Agreement, each of the following actions shall require the approval of the Joint Development Committee: (i) any amendment, modification or supplement to the Development Plan as provided in Section 3.2; (ii) the adoption of any Annual Plan and Budget and any amendment, modification or supplement to any Annual Plan and Budget as provided in Section 3.3; (iii) any allocation of, and any amendment, modification or supplement to the allocation of, Development Services to be provided by the Party Operators as provided in Section 2.11; (iv) any Affiliate Contract or a contract or agreement that contains a confidentiality obligation that would prevent such Party Operator from providing to the other Parties the data and reports required by Section 2.9(a), in each case, to be entered into by a Party Operator as provided in Section 2.12(c); (v) subject to Section 2.11(d), approval or modification to the calculation of Services Costs or the amount of the Marketing Fee as provided in Section 2.11(d); (vi) formation or dissolution of any subcommittee of the Joint Development Committee; (vii) approval of, and any amendment, modification or supplement to any previously approved, operating guidelines to be followed by the Party Operators in conducting Development Operations or Area-Wide Operations; (viii) any amendment, modification or supplement to the insurance standards required to be maintained by each of the Party Operators as provided in Section 2.8 or the reports to be provided by each of the Party Operators as provided in Section 2.9; and (ix) any modification to the number of secondees or the positions of such secondees under either the CONSOL Secondment Agreement or the Noble Secondment Agreement as applicable. (i) Each Party will designate a representative (the “Party Representative”) who will be the primary, but not exclusive, day-to-day point of contact for the other Party with respect to safety, operational, technical, production, financial, land, permitting, marketing and other matters under this Agreement and any Applicable Operating Agreement. Each Party Representative shall meet at least [**] during with the Development Term or more or less frequently as Party Representatives of the JDC may agree. The JDC may meet other Parties on a regular basis in person or by means of a telephone or video conference call. One meeting of the JDC per year shall be held in person at Ikaria’s headquarters in Clinton, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs with respect to its participation on the JDC. Prior to every meeting of the JDC, Ikaria will provide to the JDC detailed reports describing Ikaria’s current clinical and development activities and plans. (c) The JDC shall be the vehicle by which BioLineRx may offer insight and guidance to Ikaria with respect to (i) establishing discuss the Development Plan setting forth the Development Program’s objectives and the activities to be conductedstatus of such matters, (ii) reviewing identify and updating the Development Plan from time seek to timeresolve any issues that may arise with respect to such matters, and (iii) monitoring seek to enhance the progress safety, compliance, continuous improvement, production and results costs of operations under this Agreement and any Applicable Operating Agreement. The initial Party Representative of CONSOL shall be J. Xxxxxxx Xxxxxx and the Development Programinitial Party Representative of Noble shall be Xxxxx Xxxxxxx, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are each of whose contact information is set forth in this Agreement), and determining whether Section 11.2; provided that any Party may change its Party Representative or the results of such clinical trials have achieved the applicable success criteria. (d) The JDC shall only act unanimously, with each contact information for its Party given one (1) vote regardless of the number of representatives. If, however, the JDC is unable to reach agreement with respect to any matter within [**] days, the matter shall be referred Representative by giving notice to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer shall have the right to decide the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under other Parties in accordance with Section 3.8. Notwithstanding anything in this Section 3.2, neither Party shall have a unilateral right to resolve any dispute involving the breach or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunder11.2.

Appears in 1 contract

Samples: Joint Development Agreement (CONSOL Energy Inc)

Joint Development Committee. (a) 3.1 The Parties shall establish hereby establish, as of the Effective Date, a Joint Development Committee joint development committee (the “Joint Development Committee” or “JDC”)) for the purpose of establishing a plan for the development of the Licensed Product in the Territory, comprised monitoring the progress of [**] representatives development activities under such development plan and, as applicable, facilitating the exchange of Ikaria and [**] representatives of BioLineRx, information relating to oversee the Development of Productsdevelopment activities. Each Party shall make its initial designation of its representatives not later than [**] Within 30 days after the Effective Date, each Party shall designate, by written notice to the other Party, [***], representatives to serve on the JDC on behalf of such Party. The Parties’ respective representatives shall be officers, directors, managers or senior level employees with experience and decision-making authority with respect to regulatory affairs, clinical development, and commercial functions. Each Party may change substitute any one or more of its representatives to the Joint Development Committee at any time representatives, in its sole discretion, effective upon notice to the other PartyParty of such change. (b) 3.2 The JDC shall meet at least in accordance with a schedule established by mutual written agreement of the Parties, but no less frequently than [***] during times per year, at a location mutually agreed by the Development Term or more or less frequently as Parties. Alternatively, the JDC may agree. The JDC may meet in person or by means of a telephone teleconference, videoconference or video conference call. One meeting other similar means of the JDC per year shall be held in person at Ikaria’s headquarters in Clinton, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representativecommunication. Each Party shall bear its own costs with respect expenses relating to attendance at such meetings by its participation on the JDC. Prior to every meeting of the JDC, Ikaria will provide to the JDC detailed reports describing Ikaria’s current clinical and development activities and plansrepresentatives. (c) 3.3 The JDC shall be the vehicle endeavor to make decisions by which BioLineRx may offer insight and guidance to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are set forth in this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteria. (d) The JDC shall only act unanimously, with each Party given one (1) vote regardless of the number of representativesconsensus. If, however, If the JDC is unable to reach agreement consensus with respect to a given matter, then the JDC representatives of either Party may submit such matter to the Chief Executive Officers of the Parties, or their designees (any such designee to be a senior member of the designating Chief Executive Officer’s management team) for resolution. If such matter is not resolved within [***] daysfollowing such escalation, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within then [**] days following referral*]. 3.4 Notwithstanding any provision of this Agreement to the contrary, Ikaria’s Executive Officer shall have the right to decide the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither (a) each Party shall have a unilateral right retain the rights, powers and discretion granted to resolve any dispute involving it under this Agreement and no such rights, powers, or discretion shall be delegated to or vested in the breach JDC unless such delegation or alleged breach vesting of this Agreement, to amend or modify rights is expressly provided for in this Agreement or the Parties’ respective rights Parties expressly so agree in writing and obligations hereunder or, except (b) the JDC shall not have the power to amend this Agreement or otherwise modify or waive compliance with this Agreement in any manner. 3.5 The JDC may be dissolved by agreement of the Parties following LICENSEE’s receipt of Marketing Authorization in each of the Priority Countries or as expressly provided otherwise agreed by the Parties in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunderwriting.

Appears in 1 contract

Samples: License Agreement (Vallon Pharmaceuticals, Inc.)

Joint Development Committee. (a) The Members. Promptly after the Execution Date, the Parties shall establish a Joint Development Committee development committee (the “Joint Development Committee” or “JDC”), comprised of [**] . Pfizer and Xxxxx shall each designate three (3) representatives of Ikaria to serve as members on the JDC and [**] representatives of BioLineRx, to oversee the Development of Products. Each each Party shall make its initial designation of its representatives not later than [**] days after the Effective Date. Each Party may change any appoint one or more of its representatives to act as a committee chair and the Joint Development Committee two shall act as co-chairs. Such representatives shall include individuals who have clinical trial and regulatory experience and expertise in pharmaceutical drug development. Each of Pfizer and Lpath may replace any or all of its representatives on the JDC at any time time, in its sole discretion, effective upon written notice to the other Party. A Party may designate a substitute to temporarily attend and perform the functions of such Party’s designee at any JDC Meeting. Additional representatives or consultants may from time to time, by mutual consent of the Parties, attend a JDC Meeting. (b) Responsibilities until License Effective Date. The JDC shall meet at least [**] during the Development Term or more or less frequently as the JDC may agree. The JDC may meet in person or by means of a telephone or video conference call. One meeting of the JDC per year shall be held in person at Ikaria’s headquarters in Clintonplan, NJ implement and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs oversee all development and regulatory activities with respect to its participation on Licensed Products in the JDC. Prior Field in the Territory during the Option Period in accordance with the Development Plan and from time to every meeting of the JDC, Ikaria will provide to the JDC detailed reports describing Ikaria’s current clinical time shall revise and development activities and plansapprove any revised Development Plan as appropriate. (c) The Role after License Effective Date. In the event that Pfizer exercises its Option, then the JDC shall be the vehicle by which BioLineRx may offer insight thereafter serve as a forum for information exchange and guidance to Ikaria discussion concerning material development activities with respect to (i) establishing the Development Plan setting forth Licensed Products in the Development ProgramField in the Territory but shall not have any decision-making authority. Without limiting Lpath’s objectives and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are obligations set forth in this Agreement)Section 5.1, the Parties agree that Xxxxx’s participation in the JDC after the Option Period shall not be mandatory, and determining whether Lpath may in its discretion discontinue its participation in the results of such clinical trials have achieved JDC after the applicable success criteriaOption Period. (d) The JDC shall only act unanimously, with each Party given one (1) vote regardless Decision-making during the Option Period. In spite of the number of representativesPfizer JDC members or Lpath JDC members, each Party shall have one vote and the JDC shall make decisions by consensus with respect to all matters that are the subject of JDC decision-making authority during the Option Period. If, however, If the JDC is unable to reach agreement with respect to consensus on any matter within [**] daysthat is before it, the such matter shall be referred elevated to a member of the Parties’ respective leadership team of Pfizer’s Research and Development organization (or his or her designee who shall have appropriate decision-making authority) and the Chief Executive Officers for resolutionOfficer of Lpath (or his or her designee who shall have appropriate decision-making authority), and such individuals shall attempt in good faith to resolve such matter within fourteen (14) days after it is elevated to them. If the Executive Officers such matter has been discussed by such individuals and they are not able to resolve any reach resolution within such matter by consensus within [**] days following referralfourteen (14) day period, Ikaria’s Executive Officer then Pfizer shall have make the right final decision, provided that in making such decision Pfizer shall not impose on Lpath materially different or greater development obligations or responsibilities (including materially greater financial obligations or responsibilities) as compared to decide those set forth in the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither Party shall have a unilateral right to resolve any dispute involving the breach or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any initial Development Plan or the Parties’ respective rights and obligations thereunderattached hereto in Schedule 1.11.

Appears in 1 contract

Samples: Licensing Agreement

Joint Development Committee. 2.3.1. Formation, Composition, Dissolution. No later than [...***...] after the Effective Date the Parties will establish a committee to (a) The oversee the Development of Regional Licensed Antibodies and Regional Licensed Products and Optioned Licensed Antibodies and Optioned Licensed Products in accordance with the applicable Development Plans and to coordinate the Development activities of the Parties shall establish with respect thereto, and (b) facilitate the flow of information between the Parties with respect to, and provide a Joint forum to discuss, the Development Committee of Optioned Licensed Antibodies, Optioned Licensed Products, Global Licensed Antibodies and Global Licensed Products (the “Joint Development Committee” or “JDC”), comprised of . Each Party will initially appoint [...***...] representatives of Ikaria to the JDC, with each representative having knowledge and [**] representatives of BioLineRx, to oversee expertise in the Development of Productscompounds and products similar to the Licensed Antibodies and Licensed Products and having sufficient seniority within the applicable Party to make decisions arising within the scope of the JDC’s responsibilities. Each Party shall make The JDC may change its initial designation size from time to time, provided that the JDC will consist at all times of its an equal number of representatives not later than [**] days after the Effective Dateof each of Xencor and Novartis. Each Party may change any one or more of replace its JDC representatives to the Joint Development Committee at any time upon written notice to the other Party. (b) The JDC shall meet at least [**] during the Development Term or more or less frequently as the JDC may agree. The JDC may meet invite non-members to participate in person or by means of a telephone or video conference call. One meeting the discussions and meetings of the JDC per year shall be held in person JDC, provided that such participants have no voting authority at Ikaria’s headquarters in Clinton, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that and are bound under written obligation of confidentiality no less protective of the Parties’ representatives may participate Confidential Information than those set forth in personthis Agreement. For clarity, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause its representatives to the Alliance Managers should attend the all meetings of the JDC. If a representative The JDC will be co-chaired, with one chairperson designated by Xencor and one chairperson designated by Novartis, whose responsibilities will include conducting meetings, including, when feasible, ensuring that objectives for each meeting are set and achieved. Responsibility for running each meeting of a Party is unable to attend a the JDC will alternate between the chairpersons from meeting-to-meeting, such Party may designate an alternate to attend such meeting in place with Novartis’ chairperson running the first meeting. Upon the later of (a) first commercial sale of the absent representativefinal Regional Licensed Product or Optioned Licensed Product, or (b) removal of any requirement for any Clinical Study established by a Regulatory Authority upon Regulatory Approval for the final Regional Licensed Product or Optioned Licensed Product in any country, the Parties agree that the JDC will be automatically dissolved with no further action required by either Party. 2.3.2. Each Party shall bear its own costs Specific Responsibilities of the JDC. The JDC has the following responsibilities: 2.3.2.1. oversee and review Development responsibilities for each Regional Licensed Antibody, Regional Licensed Product, Optioned Licensed Antibody and Optioned Licensed Product, 2.3.2.2. discuss, prepare and approve for submission to the JSC all RLP Development Plans and OLP Development Plans, and all amendments thereto, 2.3.2.3. oversee and direct the conduct of all RLP Development Plans and OLP Development Plans, 2.3.2.4. create, implement and review the overall strategy for Development, including the design of all Clinical Studies for Regional Licensed Antibodies, Regional Licensed Products, Optioned Licensed Antibodies and Optioned Licensed Products, 2.3.2.5. decide whether and when to initiate or discontinue any Clinical Study under each RLP Development Plan or OLP Development Plan, as applicable, 2.3.2.6. allocate budgeted resources and determine priorities for each Clinical Study included under each RLP Development Plan or OLP Development Plan, 2.3.2.7. oversee and direct the conduct of all Clinical Studies under each RLP Development Plan or OLP Development Plan, 2.3.2.8. facilitate the flow of information between the Parties with respect to its participation on the JDCDevelopment of Licensed Antibodies and Licensed Products, 2.3.2.9. Prior allocate primary responsibility as between the Parties for tasks relating to every meeting the Development of Regional Licensed Antibodies and Optioned Licensed Antibodies where not already specified in the applicable RLP Development Plans or OLP Development Plan, 2.3.2.10. review, discuss, oversee and direct Manufacturing for the Development of Regional Licensed Antibodies, Regional Licensed Products, Optioned Licensed Antibodies and Optioned Licensed Products including the supply chain, 2.3.2.11. determine and oversee the implementation of the JDCoverall strategy regarding, Ikaria will provide to and facilitate the JDC detailed reports describing Ikaria’s current clinical and development activities and plans. (c) The JDC shall be flow of information between the vehicle by which BioLineRx may offer insight and guidance to Ikaria Parties with respect to (i) establishing obtaining, Regulatory Approval of Regional Licensed Products and Optioned Licensed Products, 2.3.2.12. without limitation to Section 2.3.2.1, review the Development Plan setting forth the Development Program’s objectives and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are set forth in this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteria. (d) The JDC shall only act unanimously, with each Party given one (1) vote regardless of the number of representatives. If, however, the JDC is unable to reach agreement regulatory strategy with respect to any matter within [**] daysdiscussions with and commitments to or agreements with Regulatory Authorities (including post-approval commitments) with respect to Regional Licensed Product and Optioned Licensed Product labeling, risk management or Clinical Studies, and 2.3.2.13. perform such other functions as may be appropriate to further the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer shall have the right to decide the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither Party shall have a unilateral right to resolve any dispute involving the breach or alleged breach purposes of this Agreement, to amend as directed by the JSC in accordance with Section 2.2.3 or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunderAgreement.

Appears in 1 contract

Samples: Collaboration and License Agreement (Xencor Inc)

Joint Development Committee. (a) The Parties shall establish form a Joint Development Committee joint development team (the “Joint Development Committee” or “JDC”), comprised made up of [**] an equal number of representatives of Ikaria Merck and [**] representatives Advaxis (not to exceed three (3) each), which shall have responsibility of BioLineRxcoordinating all regulatory and other activities under, to oversee the Development of Productsand pursuant to, this Agreement. Each Party shall make its initial designation designate a project manager (the “Project Manager”) who shall be responsible for implementing and coordinating activities, and facilitating the exchange of its representatives not later than [**] days after information between the Effective Date. Each Party may change any one or more of its representatives Parties, with respect to the Joint Development Committee at any time upon notice to the other Party. (b) 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 once each Calendar Quarter, and more often as reasonably considered necessary at least [**] during the Development Term or more or less frequently as request of either Party, to provide an update on Study progress. Prior to any such meeting, the JDC may agreeAdvaxis Project Manager shall provide an 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 may 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 person or by means of a telephone or video conference callits 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. One meeting of When consensus is not achieved on any matter, the JDC per year shall matter will be held in person at Ikaria’s headquarters in Clinton, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs with respect to its participation on the JDC. Prior to every meeting of the JDC, Ikaria will provide escalated to the JDC detailed reports describing Ikaria’s current clinical and development activities and plans. (c) The JDC shall be the vehicle by which BioLineRx may offer insight and guidance to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives Advaxis CEO and the activities to be conductedhead of Merck Clinical or the VP of Merck Clinical Oncology, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are set forth in this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteria. (d) The JDC shall only act unanimously, with each Party given one provided however that (1) vote regardless of in the number of representatives. If, however, the JDC is unable to reach agreement with respect to any matter within [**] days, event that the matter shall be referred relates to the Parties’ respective Executive Officers 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 (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 resolutionany issues arising under this Agreement. If the Executive Officers are not able to resolve any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer The Alliance Managers shall have the right to decide attend all JDC meetings and may bring to the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither Party attention of the JDC any matters or issues either of them reasonably believes should be discussed and shall have a unilateral right to resolve any dispute involving such other responsibilities as the breach or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided Parties may mutually agree in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunderwriting.

Appears in 1 contract

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

Joint Development Committee. (a) The Parties Within 30 days following the Effective Date, Nerviano and Ignyta shall establish appoint a Joint Development Committee (the “Joint Development Committee” or “JDC”), comprised of [**] representatives of Ikaria and [**] representatives of BioLineRx, ) to oversee exchange information regarding all activities related to the Development of Productsthe Product, including to facilitate the transfer from Nerviano to Ignyta of Nerviano Know-How. Each Party The JDC shall make its initial designation continue to be in effect until the receipt of its representatives not later than [**] days after the Effective Date. Each Party may change any one or more of its representatives to first Regulatory Approval for the Joint Development Committee at any time upon notice to the other PartyProduct. (b) The JDC shall meet at least [**] during will consist of four individuals of which two will be designated by Nerviano and two will be designated by Ignyta. Ignyta has the Development Term or more or less frequently as right to designate the JDC may agree. The JDC may meet in person or by means chair of a telephone or video conference callthe JDC. One meeting of the JDC per year representative from each Party shall be held in person at Ikaria’s headquarters in Clintona senior executive from such Party, NJ and one meeting of the JDC per year other representative shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretionproject leader from such Party. Each Party shall use reasonable efforts have the right, at any time, to cause its representatives designate by written notice to attend the meetings other Party, a replacement for any of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs with respect to its participation Party’s members on the JDC. Prior The JDC shall endeavor to every meeting work by consensus. Where consensus cannot be reached, Ignyta shall make the final determination after consultation with Nerviano and considering Nerviano’ position in good faith; provided, however, that Ignyta shall not make any final determination that conflicts with the terms and conditions of this Agreement. As the time of the establishment of the JDC, Ikaria will provide to each Party shall also designate one of its members of the JDC detailed reports describing Ikaria’s current clinical as the primary contact and development coordinator for such Party, to facilitate communication and coordination of the Parties’ activities and plansunder the Agreement (the “Project Coordinator”). (c) The JDC shall be meet as necessary, but, in any event no less frequently than twice each year. In lieu of in person meetings, meetings of the vehicle JDC may take place by which BioLineRx may offer insight telephonic or video conference. The site for the in-person meetings shall alternate between Nerviano, Italy and guidance San Diego, California, or such other location agreed to Ikaria by the Parties. Other than with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results special meetings of the Development ProgramJDC, which may be called by either Party on not less than ten days prior written notice (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to which notice may be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are set forth in this Agreementby e-mail), the chairperson shall send to the members of the JDC a notice of and determining whether agenda for each meeting at least five business days prior to the results date of such clinical trials have achieved the applicable success criteriameeting. (d) The JDC shall only act unanimously, with Promptly after each Party given one (1) vote regardless meeting of the number of representatives. If, howeverJDC, the JDC is unable chairperson shall (or shall designate another member of the JDC) to reach agreement with respect prepare and distribute, via facsimile or e-mail to any matter within [**] daysall members of the JDC, draft action steps and decisions of the meeting. Promptly after the draft action steps and decisions are distributed, the matter members shall be referred either note their approval or provide proposed revisions to the Parties’ respective Executive Officers for resolutiondraft. If Promptly after the Executive Officers are not able receipt of all approvals or proposed revisions to resolve any such matter by consensus within [**] days following referralthe draft, Ikaria’s Executive Officer the chairperson shall have issue the right to decide final action steps and decisions of the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither JDC. (e) Each Party shall have a unilateral right to resolve bear its own costs, including travel, lodging, food and telephone or video conference costs, for its personnel serving on the JDC or attending any dispute involving meeting of the breach or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunderJDC.

Appears in 1 contract

Samples: License Agreement (Infinity Oil & Gas Co)

Joint Development Committee. (a) The Upon the Effective Date, the Parties shall establish a Joint joint committee dedicated to overseeing Licensee’s Development Committee of the Licensed Products in the Field in the Territory (the “Joint Development Committee” or the “JDC”), comprised of . Each Party shall appoint [***] representatives who possess a general understanding of Ikaria and [**] Development matters to act as its representatives of BioLineRx, to oversee on the Development of ProductsJDC. Each Party shall make its initial designation designate one of its representatives not later than [**] days after as a co-chair of the Effective DateJDC. Each co-chair shall serve as the primary single point of communication within the respective Party’s organization with respect to JDC activities, confer with the co-chair of the other Party regarding JDC logistics and issues and disputes to be raised during JDC meetings, and ensure each Party’s compliance with the rules governing the JDC. Each Party may change any replace one or more of its representatives to (including the Joint Development Committee at any time co-chair), in its sole discretion, effective upon written notice to the other Party of such change. Each Party’s representatives on the JDC, and any replacement for any such representative, shall be bound by the obligations of confidentiality set forth in Article 6. Each Party shall be responsible for all of its own expenses incurred in connection with participating in all such meetings. (b) The JDC shall, consistent with the terms and conditions set forth in this Agreement: i. review and promptly comment on the initial Development Plan for the Second Product for obtaining Regulatory Approval in the Territory (to the extent Licensee exercises the option under Section 2.2 and the Second Product becomes a Licensed Product); ii. review and promptly comment on any material updates or amendments to the Development Plan; iii. keep Lipocine reasonably informed, at each JDC meeting, as to the progress of Licensee’s material Development activities under the Development Plan; iv. review and promptly comment on material Development activities not otherwise included in the Development Plan, including any Phase 4 Trials and other Clinical Trials to be conducted by Licensee to amend the label for a Licensed Product such as to change in dosage forms, strengths, indications or other modifications; v. keep the other Party reasonably informed of any Licensee Improvements, Lipocine Improvements or Joint Improvements; vi. subject to Section 4.5 and solely to the extent necessary to effectuate Section 4.5, keep the other Party reasonably informed of the creation of any new Licensee Data or New Lipocine Data generated by a Party or its Representatives (but for clarity, this Section 4.2(b)(vi) shall not permit any access to any Licensee Data or New Lipocine Data by the non-Data Generating Party, which access shall be subject to the terms and conditions of Section 4.5); review and promptly comment on material Regulatory Documentation and material amendments thereto for the Licensed Products prior to submission by Licensee to FDA; vii. review and approve any material aspects of Clinical Trials in accordance with Section 4.4(b); viii. perform any and all tasks and responsibilities that are otherwise expressly attributed to the JDC under the Agreement; and ix. perform such other functions as the Parties may mutually agree in writing. For the avoidance of doubt, should Licensee determine that JDC review and comment in accordance with this Section 4.2(b) is materially hindering its Development activities hereunder (e.g., review is taking an unreasonably long time) due to Lipocine’s representative(s)’s action, inaction or omission, Licensee may proceed with its planned Development activities prior to receipt of comment from the JDC, provided that Licensee’s decision to proceed is consistent with its obligations to use Commercially Reasonable Efforts with respect to Development hereunder. Notwithstanding the foregoing, nothing in this Section 4.2, shall prevent Licensee from taking action to address a safety concern. (c) To the extent Licensee exercises the option under Section 2.2 and the Second Product becomes a Licensed Product, the JDC shall meet at least (i) [***] per Calendar Quarter until Regulatory Approval of the Second Product and (ii) for the remainder of the Term, at least [***] per Calendar Year. If the First Product is the only Licensed Product, the JDC shall meet at least [***] per Calendar Year during the Development Term or more or less frequently as the JDC may agreeTerm. The location of JDC may meet in person or meetings shall alternate between locations designated by means of a telephone or video conference callLipocine and locations designated by Licensee. One meeting The co-chairs of the JDC per year shall be held in person at Ikaria’s headquarters in Clinton, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretionresponsible for calling meetings on reasonable prior notice. Each Party shall use reasonable efforts to cause make all proposals for agenda items and to provide all appropriate information with respect to such proposed items reasonably in advance of the applicable meeting. The co-chairs may suggest topics for the agenda for JDC meetings and prepare and circulate to the JDC for review and approval of the Parties’ minutes of each meeting within [***] days of a JDC meeting. The Parties shall agree on the minutes of each meeting as promptly as practicable following receipt of the initial draft minutes of such meeting. Representatives of the Parties on the JDC may attend meetings by telephone, videoconference or in person; provided that each participant in any meeting held by telephone or videoconference can hear what is said by, and be heard by, all other participants. Until Regulatory Approval of the Second Product (if applicable), at least [***] (1) JDC meeting per year shall be held in person, unless by reason of a Force Majeure Event, travel or in-person meeting cannot reasonably occur. A quorum of the JDC shall exist whenever there is present at a meeting at least [***] representative appointed by each Party. As appropriate, and upon at least [***]business days’ prior written notice to the other Party, a Party may allow its representatives other employees or a Third Party to attend JDC meetings as observers; provided, however, that a Party shall not allow a Third Party to attend a JDC meeting without the other Party’s prior written consent, not to be unreasonably withheld, conditioned or delayed; and provided further, however, that each such additional attendee (i) shall not participate in the decision-making process of the JDC and (ii) shall agree in writing to be bound by obligations of confidentiality and non-disclosure consistent with those set forth in Article 6. Each Party may also call for special meetings of the JDC with reasonable prior written notice to the other Party (it being agreed that at least [***] business days shall constitute reasonable notice) to resolve particular matters requested by such Party and within the decision-making responsibility of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear be responsible for all of its own costs expenses incurred in connection with respect to its participation on the JDC. Prior to every meeting of the JDC, Ikaria will provide to the JDC detailed reports describing Ikaria’s current clinical and development activities and plans. (c) The JDC shall be the vehicle by which BioLineRx may offer insight and guidance to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are set forth participating in this Agreement), and determining whether the results of all such clinical trials have achieved the applicable success criteriameetings. (d) The JDC Each Party shall only act unanimously, with each Party given one (1) vote regardless of the number of representatives. If, however, provide the JDC is unable such material information as required under this Agreement or as otherwise reasonably requested by the other Party and reasonably available to reach agreement such Party to enable the other Party to perform its material obligations under this Agreement, in each case relating to the progress of material activities under the Development Plan and other agreed upon material activities with respect to any each Licensed Product. (e) If a dispute arises that cannot be resolved by the JDC through good faith discussions, the co-chair of either Party may cause such dispute to be referred to their respect Party’s respective Executives for resolution. Such Executives (or their designees) will in good faith seek to resolve the matter within [**] days, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [**] days following referralafter the matter has been referred to them, Ikaria’s Executive Officer or within such longer time period as the Parties may mutually agree upon. In the event that consensus cannot be reached with respect to a decision after a meeting of the Executives, then Licensee shall have the right to decide the matter taking into account Ikariafinal decision-making authority for all Development activities, provided that Licensee’s obligation decision is consistent with its obligations to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything with respect to Development hereunder. (f) The JDC shall not have any authority beyond the authority with respect to the matters expressly set forth in this Section 3.2Agreement nor any power to amend, neither modify or waive compliance with this Agreement. In furtherance thereof, each Party shall have a unilateral right retain the rights, powers and discretion granted to resolve any dispute involving it under this Agreement and no such rights, powers or discretion shall be delegated or vested in the breach JDC unless such delegation or alleged breach vesting of this Agreement, to amend or modify rights is expressly provided for in this Agreement or the Parties’ respective rights and obligations hereunder or, except as Parties expressly provided so agree in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunderwriting.

Appears in 1 contract

Samples: License Agreement (Lipocine Inc.)

Joint Development Committee. (a) 3.10.1. The Parties shall establish 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 Company, (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), comprised of [**] representatives of Ikaria which shall have responsibility for overseeing all regulatory and [**] representatives of BioLineRxother activities with respect to conducting the Study under, and pursuant to, this Agreement and such other matters to oversee the Development of Productsextent expressly set forth herein. Each Party shall make its initial designation designate a project manager (the “Project Manager”), who shall be responsible for implementing and coordinating activities and facilitating the exchange of its representatives not later than [**] days after information between the Effective DateParties with respect to the Study. Each Party may change any one or more of shall select its representatives respective JDC members; provided that each JDC member shall have appropriate seniority and experience to serve on the Joint Development Committee at any time upon notice to the other Party. (b) 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 least [**] during the Development Term or more or less frequently as reasonable request of either Party, to provide an update on the JDC may agreeprogress 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, Merck’s Project Manager shall provide an update in writing to 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 telephone or video conference call. One meeting Project Manager, each Party shall designate an alliance manager (the “Alliance Manager”), who shall not be a member of the JDC per year and shall be held in person at Ikaria’s headquarters in Clinton, NJ endeavor to ensure clear and one meeting 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 per year any matters or issues either of them reasonably believes should be discussed and shall be held have such other responsibilities as the Parties may mutually agree in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretionwriting. Each Party shall use reasonable efforts to cause may change its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meetingJDC members, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs with respect to its participation on the JDC. Prior to every meeting of the JDC, Ikaria will provide to the JDC detailed reports describing Ikaria’s current clinical Alliance Manager and development activities and plans. (c) The JDC shall be the vehicle by which BioLineRx may offer insight and guidance to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives and the activities to be conducted, (ii) reviewing and updating the Development Plan Project Manager from time to time, ; provided that it provides written notice to the other Party and the selected replacement satisfies those qualifications (iiiif any) monitoring the progress and results of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are set forth in this Agreement)Section. 3.10.2. The Parties’ respective Alliance Managers shall alternate responsibility for preparing and circulating definitive minutes of each JDC meeting, which minutes shall provide a reasonably detailed description of the discussions, including a list of material decisions made, material issues not resolved, and determining whether action items. The Parties shall reasonably cooperate to complete and agree upon a final version of meeting minutes within ten (10) Business Days from the results date of such clinical trials have achieved the applicable success criteriarelevant meeting. (d) 3.10.3. The representatives of the JDC shall only act unanimously, with each Party given one (1) vote regardless of attempt in good faith to reach consensus on all matters properly before the number of representativesJDC. If, however, In the event that the JDC is unable to unanimously agree on such a matter within twenty (20) Business Days of such matter being brought to the JDC’s attention, then either Party may provide written notice referring such issue for resolution to the Vice President of Clinical Oncology for Merck and the Chief Medical Officer for Company (collectively, the “Executive Officers”). In the event that the Executive Officers, after good faith efforts, do not reach agreement consensus within twenty (20) Business Days of written notice referring such issue to the Executive Officers: (a) Merck shall have final decision-making authority with respect to any matter within [**] days, issues to the matter extent exclusively related to Merck Compound; (b) Company shall have final decision-making authority with respect to issues to the extent exclusively related to Company Compound; and (c) all other matters shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer shall have the right to decide the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under resolved in accordance with Section 3.821. Notwithstanding anything in this Section 3.2to the contrary herein, neither Party the JDC shall not have a unilateral right to resolve any dispute involving the breach or alleged breach of this Agreement, ability to amend or modify this Agreement or any of the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunderRelated Agreements.

Appears in 1 contract

Samples: Clinical Trial Collaboration and Supply Agreement (Array Biopharma Inc)

Joint Development Committee. (a) The Members. Promptly after the Execution Date, the Parties shall establish a Joint Development Committee development committee (the “Joint Development Committee” or “JDC”), comprised of [**] . Pfizer and Lpath shall each designate three (3) representatives of Ikaria to serve as members on the JDC and [**] representatives of BioLineRx, to oversee the Development of Products. Each each Party shall make its initial designation of its representatives not later than [**] days after the Effective Date. Each Party may change any appoint one or more of its representatives to act as a committee chair and the Joint Development Committee two shall act as co-chairs. Such representatives shall include individuals who have clinical trial and regulatory experience and expertise in pharmaceutical drug development. Each of Pfizer and Lpath may replace any or all of its representatives on the JDC at any time time, in its sole discretion, effective upon written notice to the other Party. A Party may designate a substitute to temporarily attend and perform the functions of such Party’s designee at any JDC Meeting. Additional representatives or consultants may from time to time, by mutual consent of the Parties, attend a JDC Meeting. (b) Responsibilities until License Effective Date. The JDC shall meet at least [**] during the Development Term or more or less frequently as the JDC may agree. The JDC may meet in person or by means of a telephone or video conference call. One meeting of the JDC per year shall be held in person at Ikaria’s headquarters in Clintonplan, NJ implement and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs oversee all development and regulatory activities with respect to its participation on Licensed Products in the JDC. Prior Field in the Territory during the Option Period in accordance with the Development Plan and from time to every meeting of the JDC, Ikaria will provide to the JDC detailed reports describing Ikaria’s current clinical time shall revise and development activities and plansapprove any revised Development Plan as appropriate. (c) The Role after License Effective Date. In the event that Pfizer exercises its Option, then the JDC shall be the vehicle by which BioLineRx may offer insight thereafter serve as a forum for information exchange and guidance to Ikaria discussion concerning material development activities with respect to (i) establishing the Development Plan setting forth Licensed Products in the Development ProgramField in the Territory but shall not have any decision-making authority. Without limiting Lpath’s objectives and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are obligations set forth in this Agreement)Section 5.1, the Parties agree that Lpath’s participation in the JDC after the Option Period shall not be mandatory, and determining whether Lpath may in its discretion discontinue its participation in the results of such clinical trials have achieved JDC after the applicable success criteriaOption Period. (d) The JDC shall only act unanimously, with each Party given one (1) vote regardless Decision-making during the Option Period. In spite of the number of representativesPfizer JDC members or Lpath JDC members, each Party shall have one vote and the JDC shall make decisions by consensus with respect to all matters that are the subject of JDC decision-making authority during the Option Period. If, however, If the JDC is unable to reach agreement with respect to consensus on any matter within [**] daysthat is before it, the such matter shall be referred elevated to a member of the Parties’ respective leadership team of Pfizer’s Research and Development organization (or his or her designee who shall have appropriate decision-making authority) and the Chief Executive Officers for resolutionOfficer of Lpath (or his or her designee who shall have appropriate decision-making authority), and such individuals shall attempt in good faith to resolve such matter within fourteen (14) days after it is elevated to them. If the Executive Officers such matter has been discussed by such individuals and they are not able to resolve any reach resolution within such matter by consensus within [**] days following referralfourteen (14) day period, Ikaria’s Executive Officer then Pfizer shall have make the right final decision, provided that in making such decision Pfizer shall not impose on Lpath materially different or greater development obligations or responsibilities (including materially greater financial obligations or responsibilities) as compared to decide those set forth in the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither Party shall have a unilateral right to resolve any dispute involving the breach or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any initial Development Plan or the Parties’ respective rights and obligations thereunderattached hereto in Schedule 1.11.

Appears in 1 contract

Samples: Option, License and Development Agreement (Lpath, Inc)

Joint Development Committee. (a) The 3.2.1 To promote the successful development of the Alicaforsen Products, the Parties shall will establish a Joint Development Committee (the “Joint Development Committee” or “JDC”), comprised of [**] representatives of Ikaria which will be formed and [**] representatives of BioLineRx, to oversee the Development of Products. Each Party shall make will hold its initial designation of its representatives not later than [**] first meeting within 90 days after the Effective Restatement Date, and will be comprised of two Isis representatives and two Atlantic representatives (“Committee Members”). Each A Party may change replace any one or more of its representatives to the Joint Development Committee at any time upon Member(s) by notice to the other Party. (b) . Each Committee Member shall be 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 the Parties to share information and knowledge 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 reviewing, providing advice on, and approving the Development Plan. In addition, at JDC meetings, Isis will apprise the JDC of 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 mutual benefit of the Parties and in furtherance of the successful marketing of Alicaforsen Products. The JDC shall meet at least [**] during the Development Term Isis’ corporate offices located in Carlsbad, California, USA where such meeting is not held by video-conference or more or less frequently telephone conference, as often as the Committee Members may determine but in any event not less than once per calendar quarter. Each JDC may agreemeeting 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 Isis 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 a telephone or video conference call. One meeting the minutes of the applicable JDC per year shall be held in person at Ikaria’s headquarters in Clinton, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs with respect to its participation on the JDC. Prior to every meeting of the JDC, Ikaria will provide to the JDC detailed reports describing Ikaria’s current clinical and development activities and plans. (c) The JDC shall be the vehicle by which BioLineRx may offer insight and guidance to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are set forth in this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteria. (d) The JDC shall only act unanimously, with each Party given one (1) vote regardless of the number of representatives. If, howeverafter good faith discussions, the JDC is unable to reach agreement with respect to any decide a particular matter within [**] daysby majority vote, the such matter shall will be referred to the Parties’ respective Executive Officers for final resolution. If the Executive matter is not resolved by the Executives Officers are not able to resolve any such matter by consensus within [**] days following referral30 days, Ikaria’s Executive Officer shall have the right to decide either Party may seek final resolution of the matter taking into account Ikaria’s obligation in accordance with Section 14.4. 3.2.2 The JDC will continue in existence for three years after the Restatement Date, subject to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither Party shall have a unilateral right to resolve any dispute involving the breach or alleged breach extension by mutual agreement of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunder.

Appears in 1 contract

Samples: License Agreement (Isis Pharmaceuticals Inc)

Joint Development Committee. (a) The Promptly after the Effective Date, the Parties shall establish form a Joint Development Committee (the “Joint Development Committee” or “JDC”), comprised ) to oversee the Combined Therapy Studies conducted under this Agreement. The JDC shall consist of [**] representatives of Ikaria and [**] representatives of BioLineRx, to oversee the Development of Products]. Each Party shall make its initial designation be responsible for determining the qualifications and substitutions of its JDC members. It is anticipated that each Party’s representatives not later than [**] days after the Effective Datemay include experts in clinical development, patient safety and regulatory affairs. Each The JDC shall be co-chaired with one co-chairperson designated by each Party may change any one or more of its representatives to the Joint Development Committee at any time upon notice to the other Party. (b) each, a “Co-Chair”). The JDC shall meet at least [**] during the Development Term on a Quarterly basis, or more or less frequently as the JDC agrees (and it may agree. The JDC appoint subteams to meet more frequently), provided that either Party through its Co-Chair may meet in person or by means of request a telephone or video conference call. One meeting of the JDC per year shall be held in person (or the Co-Chairs only) at Ikaria’s headquarters in Clintonany time upon [*] notice to the other Party, NJ and one meeting of with the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, understanding that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each other Party shall will use reasonable efforts to cause its representatives to attend comply with such request but such other Party will not be in breach of this Agreement in the meetings of the JDC. If a representative of a Party event that it is unable to attend comply with such request but is using reasonable efforts to conduct a JDC meeting as promptly as practicable. Upon request by either Party, such meetings will be held by audio or video teleconference, provided that face-to-face meetings shall occur at least semi-annually. No fewer than [*] prior to each meeting, such Party may designate an alternate to attend such meeting and in place of the absent representative. Each any event as soon as reasonably practicable, each Party shall bear its own costs use good faith efforts to disclose to the other Party any proposed agenda items together with respect to its participation on appropriate supporting information. The Co-Chairs shall alternate responsibility for preparing and circulating the JDC. Prior to every final agendas for, and the definitive minutes of each meeting of the JDC, Ikaria will and may conduct such activities through their designees. Such minutes shall provide a description, in reasonable detail, of the discussions at the meeting, a list of material actions and decisions made by the JDC, a list of action items made by the JDC and a list of material issues not resolved by the JDC. The JDC Co-Chair who drafts the minutes (or his or her designee) shall provide the other Co-Chair and each Party’s Alliance Managers with the initial draft meeting minutes, who shall return the draft with any proposed changes, and this process shall be repeated until a final version of the meeting minutes is agreed upon and signed (or acknowledged as final via email) by each of the Co-Chairs. The Parties shall reasonably cooperate to complete and agree upon a final version of meeting minutes within [*] from the date of the relevant meeting. The final version of the meeting minutes shall be signed (or acknowledged as final via email) by the two Co-Chairs, and each Party shall be provided with a copy of the final version of the meeting minutes for its safekeeping. To the extent relevant to the agenda, a reasonable number of additional representatives of a Party may attend meetings of the JDC in advisory capacity with the prior written consent of the other Party. All representatives to the JDC detailed reports describing Ikaria’s current clinical and development activities and plans. (c) The or attending JDC meetings shall be the vehicle by which BioLineRx may offer insight subject to confidentiality and guidance to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than nonuse restrictions at least as restrictive as those for which success criteria are set forth in this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteriaherein. (d) The JDC shall only act unanimously, with each Party given one (1) vote regardless of the number of representatives. If, however, the JDC is unable to reach agreement with respect to any matter within [**] days, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer shall have the right to decide the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither Party shall have a unilateral right to resolve any dispute involving the breach or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunder.

Appears in 1 contract

Samples: Master Clinical Trial Collaboration Agreement (Compugen LTD)

Joint Development Committee. (a) 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 establish a Joint Development Committee ("JDC") with respect to such Licensed Product. It is understood that the “Joint Development Committee” or “JDC”), comprised Project Team for such Licensed Product shall continue after establishment of [**] representatives of Ikaria a JDC and [**] representatives of BioLineRx, shall report thereto. The JDC shall have responsibility to oversee the Later Stage Development of Productsthe 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. Each 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 shall make its initial designation at the level of its representatives not later than [**] days after the Effective DateVice President or above. Each Either Party may change any one or more of replace its respective JDC representatives to the Joint Development Committee at any time upon time, with prior written notice to the other Party. (b) . 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 [**] during quarterly according to an agreed schedule, and the Development Term or more or less frequently as Parties shall keep the JDC may agreefully 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. The JDC may meet in person or by means of a telephone or video conference call. One meeting Decisions of the JDC per year shall be held in person by majority vote; provided that if there is not an equal number of representatives of each Party present at Ikaria’s headquarters in Clintonsuch meeting, NJ and one meeting then only an equal number of the JDC per year representatives of each Party shall be held in person at BioLineRx’s headquarters in Israelentitled to vote. In the event the required vote to approve a particular action cannot be obtained, provided, then either Party may request that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause its representatives to attend issue be referred for resolution through good faith negotiations between the meetings Chief Executive Officer of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs with respect to its participation on the JDC. Prior to every meeting of the JDC, Ikaria will provide to the JDC detailed reports describing Ikaria’s current clinical and development activities and plans. (c) The JDC shall be the vehicle by which BioLineRx may offer insight and guidance to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives CK and the activities Chairman, Research and Development for GSK, who shall promptly meet to be conducted, (ii) reviewing and updating resolve the Development Plan from time to time, (iii) monitoring issue. In the progress and results of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria event they are set forth in this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteria. (d) The JDC shall only act unanimously, with each Party given one (1) vote regardless of the number of representatives. If, however, the JDC is unable to reach agreement with respect to any matter within on the matter, the [**] days, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer shall have the right to decide [*] on the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8matter, which [*] shall become the decision of the JDC. Notwithstanding anything in this Section 3.2the foregoing, neither Party [*] shall not have a unilateral the right to resolve any dispute involving the breach or alleged breach of this Agreement, [*] with respect to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereundermatters relating to Licensed Products for which [*].

Appears in 1 contract

Samples: Collaboration and License Agreement (Cytokinetics Inc)

Joint Development Committee. (a) The Promptly after the Effective Date, the Parties shall establish form a Joint Development Committee (the “Joint Development Committee” or “JDC”), comprised . The JDC shall consist of [**] * of representatives of Ikaria and [**] representatives of BioLineRx, to oversee the Development of Productsfrom each Party. Each Party shall make its initial designation be responsible for determining the qualifications and substitutions of its JDC members. It is anticipated that each Party’s representatives not later than [**] days after the Effective Datemay include experts in clinical development, project management, patient safety and regulatory affairs and CMC. Each Party may change invite representatives of such Party who are not JDC members to attend JDC meetings, provided that any JDC meeting that includes representatives of either Party who are not JDC members may, at the request of any JDC member, include a closed session consisting of only JDC members and Alliance Managers. The JDC shall be co-chaired with one or more of its representatives to the Joint Development Committee at any time upon notice to the other Party. chairperson designated by each Party (b) each, a “Co-Chair”). The JDC shall meet at least [**] during the Development Term *, or more or less frequently at such other frequency as the JDC agrees (and it may agree. The JDC appoint subteams to meet more frequently), provided that either Party through its Co-Chair may meet in person or by means of request a telephone or video conference call. One meeting of the JDC per year shall be held in person at Ikaria’s headquarters in Clintonany time upon *** notice to the other Party, NJ and one meeting of with the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, understanding that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each other Party shall will use reasonable efforts to cause its comply with such request but such other Party will not be in breach of this Agreement in the event that it is unable to comply with such request but is using reasonable efforts to conduct a JDC meeting as promptly as practicable. Upon request by either Party, such meetings will be held by audio or video teleconference; provided that face-to-face meetings shall occur at least ***, the location of which shall alternate between South San Francisco, California and Princeton, New Jersey. There must be a minimum of *** JDC representatives to attend the meetings from each Party at any meeting of the JDC. If a representative of a Party is unable No fewer than *** prior to attend a each meeting, such Party may designate an alternate to attend such meeting and in place of the absent representative. Each any event as soon as reasonably practicable, each Party shall bear its own costs use good faith efforts to disclose to the other Party any proposed agenda items together with respect to its participation on the JDCappropriate supporting information. Prior to every The JDC Co-Chairs shall alternate responsibility for preparing and circulating definitive minutes of each meeting of the JDC. Such minutes shall provide a description, Ikaria will in reasonable detail, of the discussions at the meeting, a list of material actions and decisions made by the JDC, a list of action items made by the JDC and a list of material issues not resolved by the JDC. The JDC Co-Chair who drafts the minutes shall provide the other Co-Chair and each Party’s Alliance Managers with the initial draft meeting minutes, who shall return the draft with any proposed changes, and this process shall be repeated until a final version of the meeting minutes is agreed upon and signed (or acknowledged as final via email) by the two Co-Chairs. The Parties shall reasonably cooperate to complete and agree upon a final version of meeting minutes within *** from the date of the relevant meeting. The final version of the meeting minutes shall be signed (or acknowledged as final via email) by the two Co-Chairs, and each Party shall be provided with a copy of the final meeting minutes for its safekeeping. A reasonable number of additional representatives of a Party may attend meetings of the JDC in advisory capacity with the prior written consent of the other Party. All representatives to the JDC detailed reports describing Ikaria’s current clinical and development activities and plans. (c) The or attending JDC meetings shall be the vehicle by which BioLineRx may offer insight subject to confidentiality and guidance to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than nonuse restrictions at least as restrictive as those for which success criteria are set forth in this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteriaherein. (d) The JDC shall only act unanimously, with each Party given one (1) vote regardless of the number of representatives. If, however, the JDC is unable to reach agreement with respect to any matter within [**] days, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer shall have the right to decide the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither Party shall have a unilateral right to resolve any dispute involving the breach or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunder.

Appears in 1 contract

Samples: Clinical Trial Collaboration Agreement (Five Prime Therapeutics Inc)

Joint Development Committee. (a) The Parties shall establish form a Joint Development Committee joint development team (the “Joint Development Committee” or “JDC”), comprised made up of [**] an equal number of representatives of Ikaria Ideaya and [**] representatives of BioLineRxPfizer, to oversee the Development of Productswhich shall have responsibility for coordinating all regulatory and other activities under, and pursuant to, this Agreement. Each Party shall make its initial designation designate a project manager (the “Project Manager”) who shall be responsible for implementing and coordinating activities, and facilitating the exchange of its representatives not later than [**] days after scientific information between the Effective Date. Each Party may change any one or more of its representatives Parties with respect to the Joint Development Committee at any time upon notice to the other Party. (b) 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 least the request of either Party, to provide an update on Study progress. Prior to any such meeting, the Ideaya Project Manager shall provide an update in writing to the Pfizer 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. 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 [***] during 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 Development Term or more or less frequently as the JDC may agreeregistrant if publicly disclosed. Agreement. The JDC may meet in person or by means of a telephone or video conference call. One meeting of the JDC per year shall be held in person at Ikaria’s headquarters in Clinton, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs with respect to its participation on the JDC. Prior to every meeting of the JDC, Ikaria will provide to the JDC detailed reports describing Ikaria’s current clinical and development activities and plans. (c) The JDC shall be the vehicle by which BioLineRx may offer insight and guidance to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are set forth in this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteria. (d) The JDC shall only act unanimously, with each Party given one (1) vote regardless of the number of representatives. If, however, the JDC is unable to reach agreement with respect to any matter within [**] days, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer Alliance Managers shall have the right to decide attend all JDC meetings and may bring to the matter taking into account Ikaria’s obligation attention to use Commercially Reasonable Efforts under Section 3.8the 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. Notwithstanding anything in this Section 3.2In the event that an issue arises and the Alliance Managers cannot or do not, neither 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 Pfizer. Each Party shall have also appoint a unilateral right supply chain representative to resolve hold telephone discussions at a mutually agreed-upon frequency to review the quantities of Pfizer Compound and Ideaya Compound needed for the Study (in accordance with Article 8 and Appendix B) and any dispute involving other supply chain issues that may arise during the breach or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunderStudy.

Appears in 1 contract

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

Joint Development Committee. (a) The Parties shall establish a Joint Development Committee Within thirty (30) days of the “Joint Development Committee” or “JDC”), comprised of [**] representatives of Ikaria and [**] representatives of BioLineRx, to oversee the Development of Products. Each Party shall make its initial designation of its representatives not later than [**] days after the Original Effective Date. Each Party may change any one or more of its representatives to , the Parties will establish the Joint Development Committee to oversee and control all development of Franchise Products in the Co-Promotion Territory, in the Field, including pre-clinical research, clinical research, manufacturing, regulatory filings and post-approval development studies. The JDC will be composed of three representatives appointed by each of IDEC and Genentech. Each representative will have one vote on all matters within the JDC’s purview. Such representatives will include individuals with expertise and responsibilities in the areas of preclinical development, clinical development, process sciences, manufacturing or regulatory affairs. Either Party may replace any or all of its representatives at any time upon written notice to the other Party. The JDC will meet at least once each calendar quarter, or more frequently, as agreed by the JDC. The JDC will operate by consensus, except as expressly set forth herein. If the JDC is unable to resolve a dispute regarding any issue presented to it, such dispute shall be resolved in accordance with Article 17 below. (b) The JDC shall meet at least [**] during coordinate, expedite and guide the development of Franchise Products, including review and approval of Development Term or more or less frequently as Plans for New Products, to obtain Regulatory Approvals in the JDC may agreeCo-Promotion Territory, and in a manner consistent with maximizing the Operating Profits for all Franchise Products subject to and in accordance with Section 4.1. The JDC may meet in person or by means of a telephone or video conference call. One meeting of will update the JDC per year shall be held in person at Ikaria’s headquarters in Clinton, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts Development Plans from time to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs with respect to its participation on the JDC. Prior to every meeting of the JDC, Ikaria will provide to the JDC detailed reports describing Ikaria’s current clinical and development activities and planstime as it deems necessary. (c) The JDC shall also be the vehicle by which BioLineRx may offer insight and guidance forum for exchange of information on Genentech’s substantive development of Franchise Products in the Licensed Territory, unless an IDEC representative is permitted to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results attend meetings of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are a Genentech development committee as set forth in this Agreement)Section 6.4. While the IDEC representatives may comment on such development, and determining whether Genentech shall have the results of such clinical trials have achieved the applicable success criteriafinal say. (d) The JDC shall only act unanimouslyIf any Genentech European development partner so requests, with each Party given one (1) vote regardless IDEC will consider in good faith allowing a representative of the number of representatives. If, however, such partner to attend the JDC is unable to reach agreement with respect to any matter within meetings. [**] days= Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. (e) The term of the JDC will be determined by the Management Committee. (f) For clarity, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer JDC shall have no oversight of, involvement in or control over any aspect of the right to decide development of OCR, which shall reside solely with and in the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither Party shall have a unilateral right to resolve any dispute involving the breach or alleged breach discretion of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunderGenentech.

Appears in 1 contract

Samples: Collaboration Agreement (Biogen Idec Inc.)

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Joint Development Committee. (a) The Within ***** days after the Effective Date, the Parties shall establish appoint a Joint Development Committee joint development committee (the “Joint Development Committee” or “JDC”), comprised consisting of [an equal number of members appointed by each Party, which number of members shall not exceed **] representatives of Ikaria and [**] representatives of BioLineRx* from each Party, to oversee the performance of the Services and the Development and Manufacturing by Protiva of Productsthe Manufactured Product, subject to the terms set forth herein. Each member of the JDC shall have the appropriate expertise to oversee the Parties’ performance of their respective obligations under this Supply Agreement. Each Party shall make its initial designation of its representatives not later than [**] days after have the Effective Date. Each Party may change any one or more of its representatives to the Joint Development Committee right, at any time upon notice and from time to time, to designate a replacement, on a permanent or temporary basis, for any or all of its previously designated members of the other PartyJDC. After the JDC has been formed, it shall remain in existence until the earlier of the First Commercial Sale of the Manufactured Product or the successful completion of Technical Transfer. (b) The JDC shall meet at least [**] during the Development Term or more or less frequently *** per ***** on such dates and times as the JDC Parties may agree. The JDC may meet Parties shall agree in person or by means of advance on a telephone or video conference call. One written agenda for each meeting of the JDC per year shall be held in person at Ikaria’s headquarters in Clinton, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting The regularly scheduled JDC meetings shall take place in place person or telephonically as determined by the Parties. The members of the absent representativeJDC may also convene or be polled or consulted from time to time by means of telephone conference, video conference, electronic mail or correspondence and the like, as the Parties deem necessary. Each Party shall bear its own costs with respect to its participation on The Parties will alternate (every other meeting) responsibility for drafting the JDC. Prior to every minutes of the meeting of the JDC, Ikaria will provide which shall be promptly (and in any event within ***** days of the meeting) issued to the JDC detailed reports describing Ikaria’s current clinical and development activities and plansParties following each meeting. The Parties shall use Commercially Reasonable Efforts to agree as to the specific text of such minutes within ***** days after receipt. (c) The principal purposes of the JDC shall be to oversee and provide guidance and direction on the vehicle overall strategy for the Development and Manufacturing by which BioLineRx may offer insight and guidance Protiva of the Manufactured Product. Subject to Ikaria with respect to the express rights of the Parties as set forth herein, the functions of the JDC shall include: (i) establishing reviewing the Development Plan setting forth overall strategy regarding clinical and regulatory matters pertaining to the Development Program’s objectives and the activities to be conductedManufactured Product; THE COMPANY HAS REQUESTED AN ORDER FROM THE COMMISSION PURSUANT TO RULE 406 UNDER THE SECURITIES ACT OF 1933, AS AMENDED, GRANTING CONFIDENTIAL TREATMENT TO SELECTED PORTIONS. ACCORDINGLY, THE CONFIDENTIAL PORTIONS HAVE BEEN OMITTED FROM THIS EXHIBIT, AND HAVE BEEN FILED SEPARATELY WITH THE COMMISSION. OMITTED PORTIONS ARE INDICATED IN THIS EXHIBIT WITH “*****”. (ii) acting as liaison between the Parties to ensure that they are informed of the ongoing progress of the Development of the Manufactured Product; (iii) overseeing creation of annual and long-range plans for Development of the Manufactured Product; (iv) reviewing and updating approving Specifications and SOPs; (v) agreeing to non-binding written Batch Forecasts and non-binding written Services Forecasts of anticipated Manufacturing and Service requirements during the Development Plan applicable *****-month period covered by each such forecast, in accordance with Section 3.1 below; and (vi) performing such other responsibilities as may be mutually agreed upon by the Parties from time to time, (iii) monitoring the progress and results of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are set forth in this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteria. (d) The JDC Parties shall only act unanimouslyuse Commercially Reasonable Efforts to make all decisions in good faith by unanimous vote or unanimous written consent of both Parties, with each Party given having, collectively among its respective designees, one (1) vote regardless of the number of representatives. Ifin all decisions; provided, however, that if the issue in question requires resolution prior to the date Dicerna could reasonably expect the issue to be resolved pursuant to this Supply Agreement, then subject to the other provisions in, and obligations under, this Agreement (i) Protiva has final decision making authority (including regarding the implementation thereof), on: ***** (ii) the JDC is unable shall continue to reach agreement with respect to any matter within [discuss the following items in good faith, which may only be resolved by the unanimous vote or unanimous written consent of the JDC: **] days, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer shall have the right to decide the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither Party shall have a unilateral right to resolve any dispute involving the breach or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunder.*

Appears in 1 contract

Samples: Development and Supply Agreement (Dicerna Pharmaceuticals Inc)

Joint Development Committee. Within thirty (a30) The days after the Effective Date, the Parties shall establish a Joint Development Committee joint development committee (the “Joint Development Committee” or “JDC”), comprised which shall consist of [**] up to six (6) members (or such other number as may be agreed by the Parties in writing), three (3) of whom shall be representatives designated by Teijin, and three (3) of Ikaria and [**] whom shall be representatives of BioLineRx, to oversee the Development of Productsdesignated by Radius. Each Party shall make its initial designation of Teijin and Radius may replace any or all of its representatives not later than [**] days after on the Effective Date. Each Party may change any one or more of its representatives to the Joint Development Committee JDC at any time upon written notice to the other Party. (b) The . Such representatives shall include individuals who have clinical trial and regulatory experience and expertise in pharmaceutical drug development. A Party may designate a substitute to temporarily attend and perform the functions of such Party’s designee at any meeting of the JDC. Meetings of the JDC shall commence at a time to be mutually agreed upon by the Parties and the JDC shall meet at least [**] during the Development Term or in person twice every calendar year, and 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 Parties shall agree. Meetings of the JDC that are held in person shall alternate between the offices of Teijin and Radius, or such other place as the Parties may agree. The members of the JDC also may meet in person convene or be polled or consulted from time to time by means of a telephone telecommunications, video conferences, electronic mail or video conference callcorrespondence, as deemed necessary or appropriate. One meeting Teijin and Radius each may, on advance notice to the other Party, invite non-member employees of the JDC per year shall be held in person at Ikaria’s headquarters in Clinton, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each such Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party The JDC may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs make decisions with respect to its participation on any subject matter that is subject to the JDC. Prior to every meeting of the JDC, Ikaria will provide to the JDC detailed reports describing Ikaria’s current clinical decision making authority and development activities and plans. (c) The JDC shall be the vehicle by which BioLineRx may offer insight and guidance to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are functions as set forth in this Agreement), and determining whether Section 3.8. All decisions of the results of such clinical trials have achieved the applicable success criteria. (d) The JDC shall only act unanimouslybe made by unanimous vote or written consent, with Teijin and Radius each Party given having collectively, among its respective members, one (1) vote regardless of in all decisions. If the number of representatives. If, howeverJDC cannot reach consensus within ten (10) days after it has first met and attempted to reach such consensus, the JDC is unable to reach agreement with respect to any matter within [**] days, the disputed matter shall be referred on the eleventh (11th) day to the Parties’ respective Executive Officers JSC for resolution. If The JDC shall perform the Executive Officers are not able following function: 3.8.1 Discuss and approve any changes to resolve any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer shall have the right to decide the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither Party shall have a unilateral right to resolve any dispute involving the breach or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Japanese Development Plan and any amendments thereto; and 3.8.2 Establish a forum for the Parties to discuss any proposals for the co-Development of a new Indication for Xxxxx-SC in Japan or the Parties’ respective rights and obligations thereunderoutside Japan in accordance with Section 4.1.

Appears in 1 contract

Samples: License and Development Agreement (Radius Health, Inc.)

Joint Development Committee. (a) The Parties shall will also establish a Joint Development Committee (the “Joint Development Committee” or “JDC”), comprised composed of [**] three representatives of Ikaria each Party selected by the Parties that have knowledge and [**] representatives expertise in the development of BioLineRx, products similar to Product to oversee the Development of Productsthe Product hereunder and to coordinate the global development of Product. Each Party The initial JDC chairperson shall make its initial designation be appointed by Norgine and shall serve in such capacity for one (1) year. Thereafter, the member of its representatives not later than [**] days after the Effective DateJDC who shall serve as the JDC chairperson shall be designated alternately by each Party, with each chairperson serving for a period of one (1) year. Each Party may change any one or more of replace its JDC representatives to the Joint Development Committee at any time upon by written notice to the other Party. The role of the JDC shall be: (i) to facilitate the exchange of Information between the Parties under this Agreement with respect to their Product-related activities (including activities conducted in the Licensed Territory and the Retained Territory), including as and to the extent necessary for each Party to perform its obligations under this Agreement; (ii) to develop, review and comment on the Development Plan (and associated budget) and all amendments and updates thereto, and to submit such plan (and associated budget) to the JSC for approval (it being understood that the JDC shall submit such plan (and associated budget) with sufficient time for the JSC to review and approve such plan); and (iii) to establish such working teams or subcommittees and to perform such other functions as appropriate to further the purposes of this Agreement, as determined by the Parties in writing. (b) The JDC shall meet at least [**] during once per quarter, unless otherwise specified by the Development Term JSC, at times mutually agreed upon by the Parties. At least two (2) such meetings per calendar year must be held in person, and all other such meetings may be held by teleconference or more or less frequently as videoconference. The location of the JDC may agree. The JDC may meet in person or meetings shall alternate between sites designated by means of a telephone or video conference call. One each Party, with the first such meeting of the JDC per year shall to be held in person to be at IkariaTranzyme’s headquarters in Clinton, NJ and one meeting offices. A unanimous vote of all the members of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that is required to make decisions. In the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If a representative event of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs with respect to its participation on the JDC. Prior to every meeting disagreement among members of the JDC, Ikaria will provide the committee members shall use good PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT TO AN APPICATION FOR CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT; [***] DENOTES OMISSIONS. faith efforts to discuss and resolve expeditiously such disagreement. If a disagreement among members of the JDC remains unresolved for more than thirty (30) days after the committee first addresses such matter (or such longer period as the Parties may mutually agree upon), such disagreement shall be submitted to the JDC detailed reports describing Ikaria’s current clinical and development activities and plans. (c) JSC for resolution under Section 3.2. The JDC shall be the vehicle by which BioLineRx may offer insight and guidance to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are set forth in this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteria. (d) The JDC shall only act unanimously, with each Party given one (1) vote regardless of the number of representatives. If, however, the JDC is unable to reach agreement with respect to any matter within [**] days, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer shall have the right to decide the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither Party shall have a unilateral right to resolve any dispute involving the breach or alleged breach of this Agreement, no power to amend or modify waive compliance with this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunderAgreement.

Appears in 1 contract

Samples: License Agreement (Tranzyme Inc)

Joint Development Committee. (a) The Parties shall establish To facilitate the creation, approval and amendment of the Development Plan and each Annual Plan and Budget, to approve or disapprove the other matters set forth in Section 3.1(h) and to provide (directly or through a Joint subcommittee) advice and recommendations for the conduct of Development Committee Operations and Area-Wide Operations, there is hereby established a joint development committee composed of representatives of CONSOL and Noble (the “Joint Development Committee” or “JDC”), comprised of [**] representatives of Ikaria and [**] representatives of BioLineRx, . CONSOL shall be entitled to oversee the Development of Products. Each Party shall make its initial designation of its representatives not later than [**] days after the Effective Date. Each Party may change any one or more of its appoint three representatives to the Joint Development Committee and Noble shall be entitled to appoint three representatives to the Joint Development Committee. The initial representatives to the Joint Development Committee for CONSOL shall be Xxxxxxx X. Xxxxxx, M. Xxxxxxx Xxxxxxx and Xxxxxxx X. Xxxxxxx and the initial representatives to the Joint Development Committee for Noble shall be Xxxxx Xxxxxxx, Xxxx Xxxxx and Xxxxx Xxxxxxx. Each Party shall have the right to change its representatives at any time upon by giving notice of such change to the other Parties. (b) The Joint Development Committee shall have only the powers and duties expressly ascribed to it in this Agreement. (c) The representatives of a Party shall be authorized to represent and bind such Party with respect to any matter that is within the powers of the Joint Development Committee hereunder and is properly brought before the Joint Development Committee. On all matters coming before the Joint Development Committee, the representatives of each of CONSOL and Noble shall have an aggregate vote equal to the Participating Interest of the Person (and its Affiliates) that appointed such representatives divided by the aggregate Participating Interests of all Persons (and their Affiliates) with representatives on the Joint Development Committee. Any representative of a Party that is present or otherwise available to vote or consent on an action of the Joint Development Committee shall have the authority to cast all of the votes or consents allocated to all of the representatives of such Party. In addition to the representatives, each Party may also send such advisors as it may deem appropriate to any Joint Development Committee meetings. (d) Unless otherwise agreed to by the members of the Joint Development Committee, the Joint Development Committee shall meet once (and no more than once unless otherwise mutually agreed) per calendar month to review and discuss reports concerning the Development Plan, Annual Plan and Budget and the drilling schedule, relevant geoscience and other data relating to Subject Assets and such other matters as may be reasonably proposed by a Party Operator or members of the Joint Development Committee. Meetings of the Joint Development Committee may be called by either CONSOL Operator or NBL Operator by giving notice to the members of the Joint Development Committee at least 5 days in advance of such meeting, along with a proposed agenda for such meeting (which shall include any items that a member of the Joint Development Committee or a Party Operator may request to have included on such agenda). All meetings shall be held during normal business hours at a time and place agreed to by CONSOL Operator and NBL Operator, or failing to reach such agreement, meetings occurring in even numbered months shall be held in a location selected by NBL Operator and meetings held in odd numbered months shall be held in a location selected by CONSOL Operator; provided that members of the Joint Development Committee shall be allowed to participate telephonically (or, to the extent available, by video conference) in any such meeting. (e) All decisions, approvals and other actions of the Joint Development Committee shall be decided by the affirmative vote of members of the Joint Development Committee holding collectively at least two-thirds of the votes eligible to vote on such proposals (which eligible votes, for the avoidance of doubt, shall not include any votes by the representatives of any Defaulting Party in accordance with Section 8.2(a)). The Joint Development Committee shall keep a written record of all meetings and actions taken by the Joint Development Committee or any of its subcommittees. To the fullest extent permitted by Law and notwithstanding any provision of this Agreement or any Associated Agreement to the contrary, no member of the Joint Development Committee, in his or her capacity as a member of the Joint Development Committee, shall have any duty, fiduciary or otherwise, to the Parties that did not appoint such member in connection with any act or omission by such member under this Agreement or any Associated Agreement. Each Party agrees and acknowledges that each member of the Joint Development Committee shall be entitled to determine whether or not to take any action under this Agreement or any Associated Agreement by only considering the interests of the Party that designated such member to the Joint Development Committee and not the interests of the other Party. (bf) In lieu of a meeting, any Party Operator may submit any proposal that is within the Joint Development Committee’s powers to approve or disapprove (including any amendment to the then existing Development Plan or Annual Plan and Budget) to the Joint Development Committee for a vote by written notice. Such Party Operator shall provide a copy of any such proposal by written notice to the members of the Joint Development Committee. The members of the Joint Development Committee shall communicate their votes on the proposal by written notice to the submitting Party Operator within 14 days after receipt of the proposal from such Party Operator. If none of the representatives of a Party communicates their collective votes in a timely manner to such Party Operator, such representatives shall be deemed to have voted against such proposal. Promptly following the expiration of the relevant time period, the submitting Party Operator shall give each member of the Joint Development Committee a confirmation notice stating the tabulation and results of the vote on such proposal. (g) The JDC Joint Development Committee may establish such subcommittees as it may deem appropriate, including a technical committee (whose purpose would be to advise the Party Operators with respect to the development of the Subject Assets, the coordination of Development Services, the selection of Third Party contractors, the terms of contracts for Development Operations and such other matters as the Joint Development Committee may direct). The functions of such subcommittees shall be to serve in an advisory capacity only. CONSOL and Noble shall each have the right to appoint an equal number of representatives to each subcommittee. The Joint Development Committee is hereby deemed to have established a HSE Committee (the “HSE Committee”) whose purpose shall be to (A) review violations of applicable health, safety and environmental Law by a Party Operator and (B) collaborate with each Party Operator to develop additional health, safety and environmental policies and programs in its Operated Area. (h) Notwithstanding anything else to the contrary in this Agreement, each of the following actions shall require the approval of the Joint Development Committee: (i) any amendment, modification or supplement to the Development Plan as provided in Section 3.2; (ii) the adoption of any Annual Plan and Budget and any amendment, modification or supplement to any Annual Plan and Budget as provided in Section 3.3; (iii) any allocation of, and any amendment, modification or supplement to the allocation of, Development Services to be provided by the Party Operators as provided in Section 2.11; (iv) any Affiliate Contract or a contract or agreement that contains a confidentiality obligation that would prevent such Party Operator from providing to the other Parties the data and reports required by Section 2.9(a), in each case, to be entered into by a Party Operator as provided in Section 2.12(c); (v) subject to Section 2.11(d), approval or modification to the calculation of Services Costs or the amount of the Marketing Fee as provided in Section 2.11(d); (vi) formation or dissolution of any subcommittee of the Joint Development Committee; (vii) approval of, and any amendment, modification or supplement to any previously approved, operating guidelines to be followed by the Party Operators in conducting Development Operations or Area-Wide Operations; (viii) any amendment, modification or supplement to the insurance standards required to be maintained by each of the Party Operators as provided in Section 2.8 or the reports to be provided by each of the Party Operators as provided in Section 2.9; and (ix) any modification to the number of secondees or the positions of such secondees under either the CONSOL Secondment Agreement or the Noble Secondment Agreement as applicable. (i) Each Party will designate a representative (the “Party Representative”) who will be the primary, but not exclusive, day-to-day point of contact for the other Party with respect to safety, operational, technical, production, financial, land, permitting, marketing and other matters under this Agreement and any Applicable Operating Agreement. Each Party Representative shall meet at least [**] during with the Development Term or more or less frequently as Party Representatives of the JDC may agree. The JDC may meet other Parties on a regular basis in person or by means of a telephone or video conference call. One meeting of the JDC per year shall be held in person at Ikaria’s headquarters in Clinton, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs with respect to its participation on the JDC. Prior to every meeting of the JDC, Ikaria will provide to the JDC detailed reports describing Ikaria’s current clinical and development activities and plans. (c) The JDC shall be the vehicle by which BioLineRx may offer insight and guidance to Ikaria with respect to (i) establishing discuss the Development Plan setting forth the Development Program’s objectives and the activities to be conductedstatus of such matters, (ii) reviewing identify and updating the Development Plan from time seek to timeresolve any issues that may arise with respect to such matters, and (iii) monitoring seek to enhance the progress safety, compliance, continuous improvement, production and results costs of operations under this Agreement and any Applicable Operating Agreement. The initial Party Representative of CONSOL shall be J. Xxxxxxx Xxxxxx and the Development Programinitial Party Representative of Noble shall be Xxxxx Xxxxxxx, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are each of whose contact information is set forth in this Agreement), and determining whether Section 11.2; provided that any Party may change its Party Representative or the results of such clinical trials have achieved the applicable success criteria. (d) The JDC shall only act unanimously, with each contact information for its Party given one (1) vote regardless of the number of representatives. If, however, the JDC is unable to reach agreement with respect to any matter within [**] days, the matter shall be referred Representative by giving notice to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer shall have the right to decide the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under other Parties in accordance with Section 3.8. Notwithstanding anything in this Section 3.2, neither Party shall have a unilateral right to resolve any dispute involving the breach or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunder11.2.

Appears in 1 contract

Samples: Joint Development Agreement (Noble Energy Inc)

Joint Development Committee. (a) 8.1 The Parties shall establish form a Joint Development Committee joint development committee (the “Joint Development Committee” or “JDC”), comprised made up of [**] three (3) representatives of Ikaria 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 BioLineRxfrom each Party), to oversee the Development of Productswhich shall have responsibility for coordinating all regulatory and other activities under, and pursuant to, this Agreement. Each Party shall make its initial designation designate a project manager (the “Project Manager”) who shall be responsible for implementing and coordinating activities, and facilitating the exchange of its representatives not later than [**] days after information between the 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 change any one or more of its representatives 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 Joint Development Committee at any time upon notice to the other Party. (b) first JDC meeting. The JDC shall meet for the first time after the Effective Date and prior to the Sub-Study initiation, and then no less than quarterly, or more or less often as agreed by the 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 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 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 shall summarize discussion highlights, actions, and agreements. 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 [***] during Business Day in advance of the Development Term or more or less frequently as the next JDC may agreemeeting. The JDC may meet in person or by means of a telephone or video conference call. One meeting of the JDC per year shall be held in person at Ikaria’s headquarters in Clinton, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, first such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs with respect to its participation on the JDC. Prior to every meeting of the JDC, Ikaria will provide to the JDC detailed reports describing Ikaria’s current clinical and development activities and plans. (c) The JDC secretary shall be the vehicle by which BioLineRx may offer insight GSK Project Manager and guidance to Ikaria with respect to (i) establishing thereafter the Development Plan setting forth secretarial appointment shall alternate between the Development Program’s objectives SpringWorks Project Manager and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are set forth in this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteriaGSK Project Manager. (d) The JDC shall only act unanimously, with each Party given one (1) vote regardless of the number of representatives. If, however, the JDC is unable to reach agreement with respect to any matter within [**] days, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer shall have the right to decide the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither Party shall have a unilateral right to resolve any dispute involving the breach or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunder.

Appears in 1 contract

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

Joint Development Committee. (a) The Parties 8.1 Calliditas and Licensee shall establish form a Joint Development Committee joint development committee (the “Joint Development Committee” or “JDC”), which will be comprised of [**] an equal number of representatives of Ikaria from Calliditas and [**] representatives of BioLineRx, to oversee the Development of ProductsLicensee. Each Party shall make its initial designation identify one of its representatives to act as co-chair, representing that Party. In addition, each Party shall designate a project leader or alliance manager to act as the primary day-to-day contact for that Party in relation to the development, who shall not later than [**] days after be a JDC representative but may attend the Effective DateJDC meetings and bring issues to the JDC’s attention. Each Party may from time to time change any one or more its representatives on the JDC by notifying the other Party with the name of its representatives new representative. 8.2 The JDC shall be responsible for overseeing the development of the Licensed Product in the Field in the Territory and shall serve as a forum for information exchange for the development of the Licensed Product outside the Territory. The JDC’s responsibilities include the following: a) prepare the initial Development Plan and decide whether or not to make modifications and variations to the Joint Development Committee at any time upon notice Plan, proposed or requested by either Party; b) coordinating the activities of the Parties pursuant to the other PartyDevelopment Plan and this Agreement; and c) monitoring the progress of the activities carried out in accordance with the Development Plan. (b) 8.3 The JDC shall meet at least [**] during the Development Term or more or less frequently as the JDC may agree. The JDC may meet (either in person or by means of telephone conference) on a telephone or video conference call. One meeting of the JDC per year shall be held in person regular basis and at Ikaria’s headquarters in Clinton, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representativeleast once each calendar quarter. Each Party shall bear all travel and related costs for its own costs with respect to its participation on representatives’ attendance at the JDC. Prior to every ’s meetings. 8.4 The quorum for a meeting of the JDCJDC shall be two individuals, Ikaria will provide to one representing each Party. No valid meeting of the JDC detailed reports describing Ikaria’s current clinical may be held unless a quorum is present and development activities and plansall Parties have received not less than 14 days’ notice of the meeting. (c) 8.5 Minutes shall be kept at all meetings of the JDC and such minutes shall be circulated for approval within ten business days after the meeting. 8.6 The JDC shall be the vehicle endeavor to make decisions by which BioLineRx may offer insight and guidance to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are set forth in this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteria. (d) The JDC shall only act unanimously, with each Party given one (1) vote regardless of the number of representativesconsensus. If, however, If the JDC is unable to does not reach a consensus agreement with respect to any matter material decision within [**] days10 business days following a vote on such decision, the matter shall may, at the request of either Party, be referred to the Parties’ respective Executive Officers Senior Executives for resolution. The Senior Executives shall meet within 15 business days and attempt to resolve the matter in good faith. If the Executive Officers are Senior Executives do not able to resolve any reach agreement on such matter by consensus within [**] 30 business days following referralafter the date on which the matter is referred to them, Ikaria’s Executive Officer then such matter shall be resolved in accordance with the following: a) Changes to the Development Plan require mutual agreement; provided however that Licensee shall have the right to make changes to the Development Plan required by Competent Authority in the Territory and/or necessary to comply with applicable laws and regulations in the Territory, provided that (i) Calliditas shall have the ultimate right to reject any proposed change for the ongoing clinical Trial if the proposed change in its sole opinion adversely affects the ongoing Trial, and (ii) for other future global trials, Calliditas shall have the ultimate right to decide not to include (or not to fully include) the matter taking into account Ikaria’s obligation Development of the Licensed Product in the Territory as part of any future global Trial if such inclusion in its reasonable opinion would materially adversely affect the global Trial, and Licensee shall have the right to use Commercially Reasonable Efforts conduct separate development activities in the Territory to satisfy the requirement of Competent Authority in the Territory to the extent such activities are not included as part of the global Trial; b) Calliditas shall have the final decision-making authority relating to matters outside the Territory; and c) Licensee shall have the final decision-making authority relating to matters in the Territory, subject to Section 8.6(a). 8.7 Neither Party may exercise its decision-making authority under Section 3.88.6 in a manner that would require the other Party to perform an act that would violate any applicable laws. Notwithstanding anything Further, Licensee may not exercise its decision-making authority or withhold consent on matters requiring mutual agreement under Section 8.6 in this Section 3.2a manner that can be reasonably expected to have an adverse and material effect on (i) the development or regulatory approval process for the Licensed Product outside the Territory, neither Party or (ii) the Trial and any other clinical trials conducted under the Development Plan and/or the regulatory approval of such Trial and/or such other clinical trials. 8.8 For the avoidance of doubt, the JDC shall not have a unilateral right the power to resolve make any dispute involving changes to the breach or alleged breach provisions of this AgreementAgreement other than the Development Plan, to amend or modify this which may be amended as stated above. Any amendments of the Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided shall be made in this accordance with Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunder27.7 below.

Appears in 1 contract

Samples: License Agreement (Calliditas Therapeutics AB)

Joint Development Committee. (a) The Parties shall establish form a Joint Development Committee joint development team (the “Joint Development Committee” or “JDC”), comprised made up of [**] an equal number of representatives of Ikaria Ideaya and [**] representatives of BioLineRxPfizer, to oversee the Development of Productswhich shall have responsibility for coordinating all regulatory and other activities under, and pursuant to, this Agreement. Each Party shall make its initial designation designate a project manager (the “Project Manager”) who shall be responsible for implementing and coordinating activities, and facilitating the exchange of its representatives not later than [**] days after scientific information between the Effective Date. Each Party may change any one or more of its representatives Parties with respect to the Joint Development Committee at any time upon notice to the other Party. (b) 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 least [**] during the Development Term or more or less frequently as the JDC may agree. The JDC may meet in person or by means request of a telephone or video conference call. One meeting of the JDC per year shall be held in person at Ikaria’s headquarters in Clintoneither Party, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate provide an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs with respect to its participation update on the JDCStudy progress. Prior to every meeting any such meeting, the Ideaya Project Manager shall provide an update in writing to the Pfizer 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 JDCStudy. In addition to a Project Manager, Ikaria will provide each Party shall designate an alliance manager (the “Alliance Manager”), who shall endeavor to ensure clear and responsive communication between the JDC detailed reports describing Ikaria’s current clinical and development activities and plans. (c) The JDC shall be the vehicle by which BioLineRx may offer insight and guidance to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives Parties and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results effective exchange of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Terminformation, and (v) establishing success criteria shall serve as the primary point of contact for the clinical trials (other than those for which success criteria are set forth in any issues arising under this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteria. (d) . The JDC shall only act unanimously, with each Party given one (1) vote regardless of the number of representatives. If, however, the JDC is unable to reach agreement with respect to any matter within [**] days, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer Alliance Managers shall have the right to decide attend all JDC meetings and may bring to the matter taking into account Ikaria’s obligation attention to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything 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 Section 3.2document has been excluded pursuant to Regulation S-K, neither 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 Pfizer. Each Party shall have also appoint a unilateral right supply chain representative to resolve hold telephone discussions at a mutually agreed-upon frequency to review the quantities of Pfizer Compound and Ideaya Compound needed for the Study (in accordance with Article 8 and Appendix B) and any dispute involving other supply chain issues that may arise during the breach or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunderStudy.

Appears in 1 contract

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

Joint Development Committee. (a) The Parties shall establish a Joint Development Committee Within thirty (the “Joint Development Committee” or “JDC”), comprised of [**] representatives of Ikaria and [**] representatives of BioLineRx, to oversee the Development of Products. Each Party shall make its initial designation of its representatives not later than [**] 30) calendar days after the Effective Date, Licensor and Licensee shall form a joint development committee ("JDC") consisting of two representatives designated by each party hereto. Each Party party may change any one or more of replace its JDC representatives to the Joint Development Committee at any time upon prior written notice to the other Partyparty. (b) The Subject to the terms of this Agreement including the provisions of sub-Section 7.1.4(e) below, the JDC shall meet at least [**] during have the responsibility and authority to: (i) exchange information related to the worldwide development and Registration of Products, including information related to licensing or sublicensing rights to make or sell Products in the Territory and the SK Territory; (ii) review and discuss any amendments or updates to the Development Term or more or less frequently Plan and Licensor's plans to develop Product in the SK Territory; (iii) serve as forum for discussions related to coordinating development of Products in the Territory and the SK Territory; (iv) authorize Licensee to conduct research and/or development activities under the Licensed IP in the SK Territory and/or make (but not sell) Products in the SK Territory; (v) authorize Licensor to conduct research and/or development activities under the Licensed IP in the Territory and/or make (but not sell) Products in the Territory; (vi) review and discuss prosecution and maintenance of Patent Rights; and (vii) perform such other functions as the JDC parties may agree. The JDC may meet agree in person or by means of a telephone or video conference call. One meeting of the JDC per year shall be held in person at Ikaria’s headquarters in Clinton, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs with respect to its participation on the JDC. Prior to every meeting of the JDC, Ikaria will provide to the JDC detailed reports describing Ikaria’s current clinical and development activities and planswriting. (c) The JDC shall be meet at least two times every calendar year, at such location, on such dates and at such times as mutually agreed by the vehicle parties. JDC members may attend meetings in person or, as long as each attendee is able to hear the others, by which BioLineRx telephone or video conference. Each party may offer insight and guidance permit visitors to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results attend meetings of the Development ProgramJDC as Certain portions of this Exhibit have been omitted pursuant to a request for confidentiality. Such omitted portions, (iv) determining future Development Program activitieswhich are marked with brackets [ ] and an asterisk*, including Development activities relating to Manufacturing, to have been separately filed with the Commission. the JDC determines. Each party shall be conducted during responsible for its own expenses and those of its visitors for participating in the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are set forth in this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteriaJDC. (d) The JDC shall only act unanimouslydecide all matters by consensus, with each Party given party having one (1) vote regardless collective vote. The members of the number of representatives. If, however, the JDC is unable shall act in good faith to cooperate with one another and to reach agreement with respect to issues to be decided by the JDC. Action that may be taken at a meeting of the JDC also may be taken without a meeting if a written consent setting forth the action so taken is signed by the committee members. In the event that the members of the JDC cannot come to consensus within fifteen (15) days with respect to any matter within over which the JDC has authority and responsibility, the JDC shall submit the respective positions of the parties with respect to such matter for discussion in good faith by the parties' respective senior executive officers. (e) The JDC shall have no authority other than that expressly set forth in sub-Section 7.1.4(b). It is the expectation of the parties that the JDC will set forth the general principles and strategies upon which the parties will perform their activities under the Development Plan. The JDC will use commercially reasonable efforts to decide important matters by consensus, but [***] daysNotwithstanding the foregoing, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [**] *]. Each party shall provide the JDC with at least ninety (90) days following referral, Ikaria’s Executive Officer shall have the right advance written notice of any plan to decide the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither Party shall have a unilateral right to resolve commence human clinical testing of any dispute involving the breach or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunderProduct.

Appears in 1 contract

Samples: License Agreement (Acorda Therapeutics Inc)

Joint Development Committee. (a) The Parties shall hereby establish a Joint the JDC to oversee and coordinate the Parties’ activities with respect to the Development Committee of the Memantine-Donepezil FDC Product in the Field in the Territory as follows: (i) Composition of the Joint Development Committee” or “JDC”), ; Decision Making. The Development Plan activities shall be conducted under the oversight of the JDC comprised of [**] three (3) named senior representatives of Ikaria Forest and [**] three (3) named senior representatives of BioLineRx, to oversee the Development of ProductsXxxxxx. Each Party shall make its initial designation notify the other within [*] after the Effective Date of the appointment of its representatives not later than [**] days after to the Effective DateJDC. Each Party may change any one or more of its representatives to the Joint Development Committee at any JDC from time to time in its sole discretion, effective upon notice to the other Party. (b) The JDC Party of such change. These representatives shall meet at least [**] during the have appropriate technical credentials, experience and knowledge, and ongoing familiarity with Development Term or more or less frequently Plan activities as the JDC may agree. The JDC may meet in person or by means of a telephone or video conference call. One meeting of the JDC per year shall be held in person at Ikaria’s headquarters in Clinton, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts well as sufficient authority to cause its representatives to attend the meetings of the JDC. If a representative take actions on behalf of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs with respect to its participation on the JDC. Prior to every meeting of the JDC, Ikaria will provide to the JDC detailed reports describing Ikaria’s current clinical and development activities and plans. (c) The JDC shall be the vehicle by which BioLineRx extent permitted under this Agreement. Additional representatives or consultants may offer insight and guidance to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results by mutual consent of the Development ProgramParties, (iv) determining future Development Program activities, including Development activities relating be invited to Manufacturing, attend JDC meetings. Alliance Managers shall be invited to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are set forth in this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteria. (d) attend all JDC meetings. The JDC shall only act unanimously, with each be chaired [*]. Each Party given shall have collectively one (1) vote regardless of in all decisions and the number of representativesParties shall attempt to make decisions by consensus. If, however, In the event the JDC is unable to cannot reach agreement with respect to consensus on any matter within [**] daysthe scope of its oversight, the matter disputes shall be referred to the Parties’ respective Executive Officers for resolutionSenior Executives. If the Executive Officers are Senior Executives cannot able to resolve any such matter by consensus the dispute within [**] days following referralafter the dispute has been referred to them, Ikaria’s Executive Officer then Forest shall have the right final decision-making authority with respect to decide the matter taking into account Ikaria’s obligation such dispute, except that Forest shall not have any final decision-making authority with respect to use Commercially Reasonable Efforts under Section 3.8[*] or [*], any dispute with respect to which shall be [*]. Notwithstanding anything the foregoing, Forest shall not exercise such final decision-making authority in any manner that (A) [*] unless [*] and [*], or (B) is inconsistent with this Agreement. Each Party shall bear its own expenses related to the attendance of such meetings by its representatives. [*] = Certain confidential information contained in this Section 3.2document, neither Party shall have a unilateral right marked by brackets, has been omitted and filed separately with the Securities and Exchange Commission pursuant to resolve any dispute involving Rule 406 of the breach or alleged breach Securities Act of this Agreement1933, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunderamended.

Appears in 1 contract

Samples: Development, Licensing and Marketing Agreement

Joint Development Committee. (a) The Parties shall recognize that it is in both of their interests to (i) xxxxxx the development of the Licensed Product in the Territory, including regulatory submissions; (ii) minimize the time to First Commercial Sale of the Licensed Product in the Territory during the term of this Agreement; and (iii) coordinate the activities of both Parties with respect to the development and time to First Commercial Sale of the Licensed Product in the Territory. 3.2.1 Accordingly, the Parties hereby establish a Joint Development Committee development committee made up of an equal number of representatives of each Party set forth in Schedule B hereto (the “Joint Development Committee” or “JDC”). Both Parties shall have the right from time to time to substitute individuals, comprised on a permanent or temporary basis, for any of [**] representatives its previously designated members of Ikaria and [**] representatives of BioLineRx, to oversee the Development of ProductsJDC. Each The members appointed by each Party shall make its initial designation be vested with appropriate decision-making authority and power by such Party. Either Party shall have the right to engage Third Parties to assist as members of its representatives the JDC, provided, however, (i) said Third Party agrees to protect the confidential information of both Parties consistent with the terms and provisions of Section 10; and (ii) the applicable Party obtains the prior written approval of the other Party of said Third Party, such approval not later than [**] days after to be unreasonably withheld or delayed. 3.2.2 The JDC shall meet: (i) once every six months prior to the Effective Date. Each Party may change any one First Commercial Sale, or more of its representatives often as needed, on a date and at a location to be agreed to by the Joint Development Committee at any time JDC, and (ii) upon written notice by either Party to the other Party. that a meeting is required or requested, in which case a meeting will be held within fourteen (b14) The calendar days of such notice on a date and at a location to be agreed to by the Parties. After the First Commercial Sale the JDC shall meet at least [**] during on an as needed basis. Notice requesting a meeting shall include adequate information describing the Development Term or more or less frequently as activity to be reviewed. Any meetings of the JDC may agree. The JDC may meet in person or by means of a telephone or video conference call. One meeting of the JDC per year shall be held in person at Ikaria’s headquarters in Clintona location to be agreed to by the Parties, NJ and one meeting or by videoconference or teleconference. Other representatives of the Parties may attend JDC per year meetings as participants. The Parties shall be held in person agree, at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs with respect to its participation on the JDC. Prior to every first meeting of the JDC, Ikaria will provide upon procedures for maintaining meeting minutes. 3.2.3 The purpose of the JDC is to serve as an advisory committee and to make recommendations and to coordinate the development and clinical study efforts of the Parties with respect to the development effort of the Licensed Product in the Territory and to minimize the time to First Commercial Sale thereof. Accordingly, the JDC detailed reports describing Ikariashall discuss and resolve, to the extent possible, any issues that arise under this Agreement including, without limitation, the following: (a) Review of the Licensee’s current development plan for the Licensed Product, including clinical study requirements and development activities protocol needed for FDA approval ; (b) Determining the analytical methods, validation, and plans.stability of Licensed Product to be provided by Licensee for use in the Territory; and (c) The JDC shall be Determining the vehicle by which BioLineRx may offer insight optimal concentration of Licensed Product and guidance to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results packaging of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria Licensed Product in preparation for the clinical trials (other than those for which success criteria are set forth in this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteriaFirst Commercial Sale. (d) The 3.2.4 In the event of a JDC shall only act unanimouslydispute that cannot be otherwise resolved, with each Party given one (1) vote regardless of the number of representatives. If, however, the JDC is unable to reach agreement with respect to any matter within [**] days, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [**] days following referral, IkariaLicensee’s Executive Officer President shall have final authority. That authority may be exercised in Licensee’s President’s discretion, provided it is consistent with the right to decide the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither Party shall have a unilateral right to resolve any dispute involving the breach or alleged breach terms of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunder.

Appears in 1 contract

Samples: License Agreement (Ventrus Biosciences Inc)

Joint Development Committee. (a) The Parties shall establish form a Joint Development Committee joint development team (the “Joint Development Committee” or “JDC”), comprised ) made up of [**] an equal number of representatives of Ikaria Context and [**] Menarini, which shall initially be set as two (2) representatives of BioLineRxfrom and selected by each Party, to oversee which shall have responsibility for coordinating all activities between the Development of ProductsParties under, and pursuant to, this Agreement. Each Party shall make its initial designation designate a project manager (the “Project Manager”) who may or may not be part of its representatives not later than [**] days after the Effective Date. Each Party may change any one or more JDC and who shall be responsible for implementing and coordinating activities and facilitating the exchange of its representatives scientific information between the Parties with respect to the Joint Development Committee at any time upon notice to the other Party. (b) Study. 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 least [**] during the Development Term or more or less frequently as the JDC may agree. The JDC may meet in person or by means request of a telephone or video conference call. One meeting of the JDC per year shall be held in person at Ikaria’s headquarters in Clintoneither Party, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate provide an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs with respect to its participation update on the JDCStudy progress. Prior to every meeting any such meeting, the Context Project Manager shall provide an update in writing to the Menarini Project Manager, which update shall contain ACTIVE/117982251.1 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. 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, Ikaria will provide and who shall endeavor to ensure clear and responsive communication between the JDC detailed reports describing Ikaria’s current clinical and development activities and plans. (c) The JDC shall be the vehicle by which BioLineRx may offer insight and guidance to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives Parties and the activities to be conducted, (ii) reviewing effective exchange of information and updating shall serve as the Development Plan from time to time, (iii) monitoring the progress and results primary point of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria contact for the clinical trials (other than those for which success criteria are set forth in any issues arising under this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteria. (d) . The JDC shall only act unanimously, with each Party given one (1) vote regardless of the number of representatives. If, however, the JDC is unable to reach agreement with respect to any matter within [**] days, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer Alliance Managers shall have the right to decide attend all JDC meetings and may bring to the matter taking into account Ikaria’s obligation attention to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither Party the JDC any matters or issues either of them reasonably believes should be discussed and shall have a unilateral right 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 resolve any dispute involving the breach or alleged breach of this AgreementChief Medical Officer for Context and the 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 amend or modify this Agreement or the Parties’ respective rights and obligations hereunder orStudy, except as expressly that Context may not make changes to the Study which may materially impact the Menarini Compound without the written consent of Menarini, which shall not be unreasonably withheld, conditioned or delayed; provided that, in this Section 3.2all cases, any Development Plan such consent or the Parties’ respective rights written explanation for why such consent is being withheld, conditioned or delayed shall be provided within [***] days of Context's request for Menarini's consent; and obligations thereunderprovided 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.

Appears in 1 contract

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

Joint Development Committee. (a) The Parties shall establish a Joint Development Committee Within thirty (30) days of the “Joint Development Committee” or “JDC”), comprised of [**] representatives of Ikaria and [**] representatives of BioLineRx, to oversee the Development of Products. Each Party shall make its initial designation of its representatives not later than [**] days after the Original Effective Date. Each Party may change any one or more of its representatives to , the Parties will establish the Joint Development Committee to oversee and control all development of Franchise Products in the Co-Promotion Territory, in the Field, including pre-clinical research, clinical research, manufacturing, regulatory filings and post-approval development studies. The JDC will be composed of three representatives appointed by each of IDEC and Genentech. Each representative will have one vote on all matters within the JDC’s purview. Such representatives will include individuals with expertise and responsibilities in the areas of preclinical development, clinical development, process sciences, manufacturing or regulatory affairs. Either Party may replace any or all of its representatives at any time upon written notice to the other Party. The JDC will meet at least once each calendar quarter, or more frequently, as agreed by the JDC. The JDC will operate by consensus, except as expressly set forth herein. If the JDC is unable to resolve a dispute regarding any issue presented to it, such dispute shall be resolved in accordance with Article 17 below. (b) The JDC shall meet at least [**] during coordinate, expedite and guide the development of Franchise Products, including review and approval of Development Term or more or less frequently Plans for New Products, to obtain Regulatory Approvals in the Co-Promotion Territory, and in a manner consistent with maximizing the Operating Profits for all Franchise Products, as the JDC may agreeset forth in Article 4. The JDC may meet in person or by means of a telephone or video conference call. One meeting of will update the JDC per year shall be held in person at Ikaria’s headquarters in Clinton, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts Development Plans from time to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs with respect to its participation on the JDC. Prior to every meeting of the JDC, Ikaria will provide to the JDC detailed reports describing Ikaria’s current clinical and development activities and planstime as it deems necessary. (c) The JDC shall also be the vehicle by which BioLineRx may offer insight and guidance forum for exchange of information on Genentech’s substantive development of Franchise Products in the Licensed Territory, unless an IDEC representative is permitted to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results attend meetings of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are a Genentech development committee as set forth in this Agreement)Section 6.4. While the IDEC representatives may comment on such development, and determining whether Genentech shall have the results of such clinical trials have achieved the applicable success criteriafinal say. (d) If any Genentech European development partner so requests, IDEC will consider in good faith allowing a representative of such partner to attend the JDC meetings. (e) The JDC shall only act unanimously, with each Party given one (1) vote regardless term of the number of representatives. If, however, JDC will be determined by the JDC is unable to reach agreement with respect to any matter within [**] days, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer shall have the right to decide the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither Party shall have a unilateral right to resolve any dispute involving the breach or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunderManagement Committee.

Appears in 1 contract

Samples: Collaboration Agreement (Idec Pharmaceuticals Corp / De)

Joint Development Committee. (a) The Parties shall establish PARTIES agree to form a Joint Development Committee joint DEVELOPMENT COMMITTEE comprised of senior management of each PARTY (the Joint Development Committee” or “JDCDEVELOPMENT COMMITTEE”), comprised . The PARTIES shall use COMMERCIALLY REASONABLE EFFORTS to have a meeting of [**] representatives of Ikaria and [**] representatives of BioLineRx, to oversee the Development of Products. Each Party shall make its initial designation of its representatives not later than [**] DEVELOPMENT COMMITTEE within forty-five days after the Effective Date. Each Party may change any one EFFECTIVE DATE and thereafter once every CALENDAR QUARTER, or more frequently if mutually agreed upon by 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 its representatives any proposed clinical trial and any related proposal developed in accordance with the clinical development plans (provided however that the 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) to review and 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 approve or reject the publication of data and information with respect to the Joint Development Committee at PRODUCTS 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. The DEVELOPMENT COMMITTEE shall not make the decision to take any time upon notice action or inaction which conflicts with or fails to conform to the other Partyapplicable 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, who shall have ten (10) business days to resolve the deadlock. If such executive officers are unable to resolve the deadlock, MEDIMMUNE shall have the final decision with respect to the deadlock. For clarity, no clinical trials for PRODUCTS will be initiated by XXXXXX without approval of the DEVELOPMENT COMMITTEE. (b) The JDC MEDIMMUNE shall meet periodically, and at least [**] during semi-annually, submit comprehensive and complete reports to the Development Term DEVELOPMENT COMMITTEE, in MEDIMMUNE’s format, regarding activities undertaken by or more or less frequently as the JDC may agree. The JDC may meet in person or by means on behalf of a telephone or video conference call. One meeting of the JDC per year shall be held in person at Ikaria’s headquarters in Clinton, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs MEDIMMUNE with respect to its participation the development of NUMAX, and specifically on activities and studies/trials undertaken by MEDIMMUNE pursuant to MEDIMMUNE’s development plan for NUMAX, including their progress, status and outcome as well as major findings and major decision points, as applicable, so as to keep the JDC. Prior to every meeting DEVELOPMENT COMMITTEE fully advised of the JDC, Ikaria will provide to the JDC detailed reports describing IkariaMEDIMMUNE’s current clinical and development activities and planswith respect to NUMAX. (c) The JDC XXXXXX shall be periodically, and at least semi-annually, submit comprehensive and complete reports to the vehicle DEVELOPMENT COMMITTEE, in XXXXXX’x format, regarding activities previously approved by which BioLineRx may offer insight the DEVELOPMENT COMMITTEE and guidance to Ikaria undertaken by or on behalf of XXXXXX with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results development of the Development Program, (iv) determining future Development Program activitiesNUMAX, including Development their progress, status and outcome as well as major findings and major decision points, as applicable, so as to keep the DEVELOPMENT COMMITTEE fully advised of XXXXXX’x development activities relating with respect to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are set forth in this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteriaNUMAX. (d) The JDC shall only act unanimously, with each Party given one (1) vote regardless of the number of representatives. If, however, the JDC is unable to reach agreement with respect to any matter within [**] days, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer shall have the right to decide the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.26.6 to the contrary, neither Party following approval of NUMAX by the REGULATORY AUTHORITIES in the MAJOR MARKETS the PARTIES shall have a unilateral right meet from time to resolve time to review and revise as necessary the obligations of the DEVELOPMENT COMMITTEE to meet regularly and to receive regular reports (but any dispute involving such changes will not, in any event, affect the breach or alleged breach responsibilities of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided DEVELOPMENT COMMITTEE set forth in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunderAGREEMENT).

Appears in 1 contract

Samples: Distribution Agreement (Medimmune Inc /De)

Joint Development Committee. (a) The Promptly after the Effective Date, the Parties shall establish form a Joint Development Committee (the “Joint Development Committee” or “JDC”), comprised of [**] representatives of Ikaria and [**] representatives of BioLineRx, ) to oversee the Development Combined Therapy Studies conducted under this Agreement. The JDC shall consist of Productsan equal number of appropriate employee representatives from each Party. Each Party shall make its initial designation be responsible for determining the qualifications and substitutions of its JDC members. It is anticipated that each Party’s representatives not later than [**] days after the Effective Datemay include experts in clinical development, patient safety and regulatory affairs. Each The JDC shall be co-chaired with one co-chairperson designated by each Party may change any one or more of its representatives to the Joint Development Committee at any time upon notice to the other Party. (b) each, a “Co-Chair”). The JDC shall meet at least [**] during the Development Term on a Quarterly basis, or more or less frequently as the JDC agrees (and it may agree. The JDC appoint subteams to meet more frequently), provided that either Party through its Co-Chair may meet in person or by means of request a telephone or video conference call. One meeting of the JDC per year shall be held in person (or the Co-Chairs only) at Ikaria’s headquarters in Clintonany time upon five (5) Business Days’ notice to the other Party, NJ and one meeting of with the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, understanding that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each other Party shall will use reasonable efforts to cause its representatives comply with such request but such other Party will not be in breach of this Agreement in the event that it is unable to attend comply with such request but is using reasonable efforts to conduct a JDC meeting as promptly as practicable. Upon request by either Party, such meetings will be held by audio or video teleconference, provided that face-to-face meetings shall occur at least semi-annually except during a declared state of emergency due to pandemic in Massachusetts, New York, or New Jersey. No fewer than five (5) Business Days prior to each meeting, and in any event as soon as reasonably practicable, each Party shall use good faith efforts to disclose to the meetings other Party any proposed agenda items together with appropriate supporting information. The Co-Chairs shall alternate responsibility for preparing and circulating the final agendas for, and the definitive minutes of each meeting of the JDC. If Such minutes shall provide a representative description, in reasonable detail, of the discussions at the meeting, a list of material actions and decisions made by the JDC, a list of action items made by the JDC and a list of material issues not resolved by the JDC. The JDC Co-Chair who drafts the minutes shall provide the other Co-Chair and each Party’s Alliance Managers with the initial draft meeting minutes, who shall return the draft with any proposed changes, and this process shall be repeated until a final version of the meeting minutes is agreed upon and signed (or acknowledged as final via email) by each of the Co-Chairs. The Parties shall reasonably cooperate to complete and agree upon a final version of meeting minutes within twenty (20) Business Days from the date of the relevant meeting. The final version of the meeting minutes shall be signed (or acknowledged as final via email) by the two Co-Chairs, and each Party shall be provided with a copy of the final version of the meeting minutes for its safekeeping. A reasonable number of additional representatives of a Party is unable to may attend a meeting, such Party may designate an alternate to attend such meeting in place meetings of the absent representative. Each Party shall bear its own costs JDC in an advisory capacity with respect to its participation on the JDC. Prior to every meeting prior written consent of the JDC, Ikaria will provide other Party. All representatives to the JDC detailed reports describing Ikaria’s current clinical and development activities and plans. (c) The or attending JDC meetings shall be the vehicle by which BioLineRx may offer insight subject to confidentiality and guidance to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than nonuse restrictions at least as restrictive as those for which success criteria are set forth in this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteriaherein. (d) The JDC shall only act unanimously, with each Party given one (1) vote regardless of the number of representatives. If, however, the JDC is unable to reach agreement with respect to any matter within [**] days, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer shall have the right to decide the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither Party shall have a unilateral right to resolve any dispute involving the breach or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunder.

Appears in 1 contract

Samples: Master Clinical Trial Collaboration Agreement (Checkmate Pharmaceuticals, Inc.)

Joint Development Committee. (a) The Parties shall establish a Joint Development Committee (the “Joint Development Committee” or “JDC”), comprised of [**] representatives of Ikaria and [**] representatives of BioLineRx, to oversee the Development of Products. Each Party shall make its initial designation of its representatives not later than Within [**] days after the Effective Date, the Parties shall form a Joint Development Committee (the “JDC”). The JDC shall consist of no more than [**] representatives and shall consist of an equal number of representatives from each Party, with one representative from each Party appointed as co-chairpersons. The Parties hereby agree that neither Executive Officer shall be a member of the JDC. Each Party may change any one or more shall be responsible for determining the qualifications and substitutions of its JDC members. It is anticipated that each Party’s representatives to may include experts in clinical development, patient safety and regulatory affairs. The JDC shall meet [**] or at such other frequency as the Joint Development Committee JDC agrees, provided that either Party may call a meeting of the JDC at any time upon [**] business days’ notice to the other Party. (b) The JDC shall meet at least [**] during the Development Term or more or less frequently as the JDC . Upon request by a Party, such meetings may agree. The JDC may meet in person or be held by means of a telephone audio or video conference call. One meeting of the JDC per year shall be held in person at Ikaria’s headquarters in Clinton, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretionteleconference. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If have a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting single vote in place of the absent representative. Each Party shall bear its own costs with respect to its participation on the JDC. Prior to every meeting of the JDC, Ikaria will provide to the JDC detailed reports describing Ikaria’s current clinical and development activities and plans. (c) The JDC shall be the vehicle by which BioLineRx may offer insight and guidance to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are set forth in this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteria. (d) The JDC shall only act unanimously, with each Party given one (1) vote regardless of the number of representativesrepresentatives appointed to the JDC. IfThere must be a minimum of [**] representatives from each Party at any meeting of the JDC. All decisions of the JDC shall be unanimous. Any decision required or permitted to be taken by the JDC may be taken without a meeting in person or by an audio or video teleconference taking place, provided that a consent in writing, setting forth the decision so taken, is signed by the JDC co-chairperson of each Party. No fewer than [**] business days prior to each meeting, and in any event as soon as reasonably practicable, each Party shall use good faith efforts to disclose to the other Party any proposed agenda items together with appropriate supporting information. The JDC co-chairpersons shall alternate responsibility for preparing definitive minutes of each meeting of the JDC. Such minutes shall provide a description, in reasonable detail, of the discussions at the meeting, a list of material actions and decisions made by the JDC, a list of action items made by the JDC and a list of material issues not resolved by the JDC, provided, however, that the portions of the meeting minutes addressing any Patents or documenting any decisions thereon shall be initially drafted by a legal representative of the Party who has responsibility for preparing the initial draft of the minutes for that meeting. The JDC co-chairperson of the drafting Party shall provide the counterpart JDC co-chairperson of the other Party with the initial draft meeting minutes, who shall return the draft with any proposed changes, and this process shall be repeated until a final version of the meeting minutes is unable agreed upon and signed by both JDC co-chairpersons. The Parties shall reasonably cooperate to reach agreement with respect to any matter complete and agree upon a final version of meeting minutes within [**] days, business days from the matter date of the relevant meeting. The final version of the meeting minutes shall be referred signed by the JDC co-chairperson of each Party, and each Party shall be provided with a copy of the signed meeting minutes for its safekeeping. A reasonable number of additional representatives of a Party may attend meetings of the JDC in a non-voting capacity with the prior written consent of the other Party. All representatives to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able JDC or attending JDC meetings shall be subject to resolve any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer shall have the right to decide the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither Party shall have a unilateral right to resolve any dispute involving the breach or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective rights confidentiality and obligations hereunder or, except nonuse restrictions at least as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunderrestrictive as those set forth herein.

Appears in 1 contract

Samples: Clinical Trial Collaboration Agreement (Idenix Pharmaceuticals Inc)

Joint Development Committee. (a) The Parties Within thirty (30) days following the Effective Date, Nerviano and Trovagene shall establish appoint a Joint Development Committee (the “Joint Development Committee” or “JDC”), comprised of [**] representatives of Ikaria and [**] representatives of BioLineRx, ) to oversee exchange information regarding all activities related to the Development of Productsthe Product, including to facilitate the transfer from Nerviano to Trovagene of Nerviano Know-How. Each Party The JDC shall make its initial designation continue to be in effect until the receipt of its representatives not later than [**] days after the Effective Date. Each Party may change any one or more of its representatives to first Regulatory Approval for the Joint Development Committee at any time upon notice to the other PartyProduct. (b) The JDC shall meet at least [**] during will consist of four individuals of which two will be designated by Nerviano and two will be designated by Trovagene. Trovagene has the Development Term or more or less frequently as right to designate the JDC may agree. The JDC may meet in person or by means chair of a telephone or video conference callthe JDC. One meeting of the JDC per year representative from each Party shall be held in person at Ikaria’s headquarters in Clinton, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretiona senior executive from such Party. Each Party shall use reasonable efforts have the right, at any time, to cause its representatives designate by written notice to attend the meetings other Party, a replacement for any of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs with respect to its participation Party’s members on the JDC. Prior The JDC shall endeavor to every meeting work by consensus. Where consensus cannot be reached, Trovagene shall make the final determination after consultation with Nerviano and considering Nerviano’ position in good faith; provided, however, that Trovagene shall not make any final determination that conflicts with the terms and conditions of this Agreement. As the time of the establishment of the JDC, Ikaria will provide to each Party shall also designate one of its members of the JDC detailed reports describing Ikaria’s current clinical as the primary contact and development coordinator for such Party, to facilitate communication and coordination of the Parties’ activities and plansunder the Agreement (the “Project Coordinator”). (c) The JDC shall be meet as necessary, but, in any event no less frequently than twice each year. In lieu of in person meetings, meetings of the vehicle JDC may take place by which BioLineRx may offer insight telephonic or video conference. The site for the in-person meetings shall alternate between Nerviano, Italy and guidance San Diego, California, or such other location agreed to Ikaria by the Parties. Other than with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results special meetings of the Development ProgramJDC, which may be called by either Party on not less than ten days prior written notice (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to which notice may be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are set forth in this Agreementby e-mail), the chairperson shall send to the members of the JDC a notice of and determining whether agenda for each meeting at least five business days prior to the results date of such clinical trials have achieved the applicable success criteriameeting. (d) The JDC shall only act unanimously, with Promptly after each Party given one (1) vote regardless meeting of the number of representatives. If, howeverJDC, the JDC is unable chairperson shall (or shall designate another member of the JDC) to reach agreement with respect prepare and distribute, via facsimile or e-mail to any matter within [**] daysall members of the JDC, draft action steps and decisions of the meeting. Promptly after the draft action steps and decisions are distributed, the matter members shall be referred either note their approval or provide proposed revisions to the Parties’ respective Executive Officers for resolutiondraft. If Promptly after the Executive Officers are not able receipt of all approvals or proposed revisions to resolve any such matter by consensus within [**] days following referralthe draft, Ikaria’s Executive Officer the chairperson shall have issue the right to decide final action steps and decisions of the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither JDC. (e) Each Party shall have a unilateral right to resolve bear its own costs, including travel, lodging, food and telephone or video conference costs, for its personnel serving on the JDC or attending any dispute involving meeting of the breach or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunderJDC.

Appears in 1 contract

Samples: License Agreement (Trovagene, Inc.)

Joint Development Committee. (a) The Within sixty (60) days after the First Amendment Effective Date, the Parties shall establish create a Joint Development Committee (the “Joint Development Committee” or “JDC”), comprised of [**] representatives of Ikaria and [**] representatives of BioLineRx, ) to oversee the Development Plan of Productsthe Product. The JDC shall develop the strategies for and oversee the Development of the Product in the Territory. (b) Each Party shall make its initial designation designate representatives who are employees of its representatives such Party or an Affiliate of such Party (not later than [**] days after to exceed six (6) for each Party) with appropriate expertise to serve as members of the Effective DateJDC. Each Party may change replace any one or more all of its representatives to the Joint Development Committee at any time upon prior written notice to the other Party. (b) The JDC shall meet at least [**] during the Development Term or more or less frequently as the JDC may agree. The JDC may meet in person or by means of a telephone or video conference call. One meeting of the JDC per year shall be held in person at Ikaria’s headquarters in Clinton, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause designate one of its representatives to attend as a co-chair of the JDC. The duties of each co-chair of the JDC shall be (i) scheduling meetings of the JDC. If a representative of a Party is unable to attend a , (ii) preparing an agenda for each meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs with respect to its participation on the JDC. Prior to every meeting of the JDC, Ikaria will provide to (iii) leading the JDC detailed reports describing Ikaria’s current clinical in each meeting, and development activities and plans(iv) preparing the minutes from each meeting. (c) The JDC shall be the vehicle by which BioLineRx may offer insight and guidance to Ikaria with respect to among other things (i) establishing develop, within sixty (60) days of formation of the JDC, a comprehensive revised Development Plan setting forth the Development Program’s objectives and the activities to be conducted, for each Product; (ii) reviewing and updating periodically (no less often than biannually) review the Development Plan from time to timePlan, and review and approve amendments thereto for approval by the JSC; (iii) monitoring the progress and results of the serve as a forum for discussing proposed Development Program, activities for each respective Party; (iv) determining future resolve any disputes regarding Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and ; (v) establishing success criteria oversee and ensure the conduct of Development activities under the Development Plan; (vi) serve as a forum for discussing and coordinating strategies (including prioritization and timelines) for obtaining Marketing Authorization for the clinical trials Product in the Territory; and (vii) perform such other than those for which success criteria functions as are set forth herein or as the Parties may mutually agree in this writing, except where in conflict with any provision of the Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteria. (d) No later than April 30, 2013, the JDC shall approve the Paccal Vet Second Source Manufacturer Plan. (e) In the event of a dispute between the Parties in the JDC that cannot be resolved in the JDC, the dispute will be raised to the JSC for resolution. (f) The JDC shall only act unanimously, with each Party given one (1) vote regardless meet as frequently as members of the number of representatives. IfJDC determine is required (but in no event, howeverless frequently than every other month during the first calendar year following the First Amendment Effective Date and once every calendar quarter thereafter), the JDC is unable to reach agreement with respect to any matter within [**] days, the matter shall be referred on such dates and at such times as agreed to the Parties, with all scheduled in-person meetings to alternate between sites as designated by the respective Party prior to such meeting, or at other locations as determined by the JDC, or be held by teleconference or other suitable remote meeting system, if agreed by the Parties. In addition, either Party may convene a special meeting of the JDC by no less than ten (10) daysrespective Executive Officers for resolutionprior written notice. If Meetings may be held by audio or video conference with the Executive Officers are not able to resolve any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer shall have the right to decide the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8consent of each Party. Notwithstanding anything in this Section 3.2, neither Each Party shall have a unilateral right to resolve any dispute involving be responsible for its own expenses for participating in each JDC meeting. Meetings of the breach JDC shall be effective only if more than one-half of the total representatives of each Party are present or alleged breach of this Agreement, to amend or modify this Agreement or participating. Decisions by the Parties’ respective rights JDC shall be minuted and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or formally signed by representatives from both Parties within ten (10) days from the Parties’ respective rights and obligations thereundermeeting.

Appears in 1 contract

Samples: Distribution Agreement (Oasmia Pharmaceutical AB)

Joint Development Committee. (a) The Parties shall establish Within ten (10) days after the Effective Date, a Joint Development Committee (the “Joint Development Committee” or “JDC”)) shall be established with the responsibilities and authority set forth in this Section 3.4. The JDC shall consist of six (6) members, comprised three (3) members to be appointed by each of [**] representatives of Ikaria Premas and [**] representatives of BioLineRx, to oversee the Development of ProductsLicensee. Each Party shall make its initial designation of its representatives not later than [**] days after the Effective Date. Each Party may change any one or more of its representatives to the Joint Development Committee at any time upon may, with notice to the other Partyother, substitute any of its members serving on the JDC and may invite ad hoc non-voting members as desired. The Parties may also, by mutual agreement, increase or decrease the number of members serving on the JDC; provided that the number of members representing each Party remains equal. Licensee will have the right to appoint one of its members to be the chairperson of the JDC. The JDC will be in place until the earlier of (i) expiration and/or termination of the Development Period or (ii) there is a written agreement between the Parties to disband the JDC. (b) The JDC shall meet at least [**] during have the responsibility and authority to: (i) provide a forum for exchange of information related to the development of Products in the Field in the Territory; (ii) review and discuss any proposed material amendments or updates to the Development Term or more or less frequently Plan; (iii) oversee the implementation of the Development Plan; (iv) monitor the progress of the Development Plan against the metrics agreed to by the Parties (such as timeline and costs); and (iv) perform any other functions as the JDC Parties may agree. The JDC may meet agree in person or by means of a telephone or video conference call. One meeting of the JDC per year shall be held in person at Ikaria’s headquarters in Clinton, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs with respect to its participation on the JDC. Prior to every meeting of the JDC, Ikaria will provide to the JDC detailed reports describing Ikaria’s current clinical and development activities and planswriting. (c) The JDC shall be hold meetings as mutually agreed by the vehicle by Parties, but in no event less than quarterly unless Licensee and Premas mutually agree in writing (which BioLineRx may offer insight and guidance to Ikaria with respect to include email), no later than thirty (i30) establishing days in advance of any meeting following the Development Plan setting forth the Development Program’s objectives and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results initial meeting of the Development ProgramJDC, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to that no new business has transpired that would require a meeting of the JDC. Meetings may be conducted during held by telephone or video conference as agreed by the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are set forth in this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteriaParties. (d) The quorum for JDC meetings shall be four (4) members, provided there are at least two (2) members from each of Licensee and Premas present. The JDC will render decisions by unanimous vote. The members of the JDC shall only act unanimously, in good faith to cooperate with each Party given one (1) vote regardless of the number of representatives. If, however, the JDC is unable another and to reach agreement with respect to any matter issues to be decided by the JDC. (e) Disagreements among the JDC will be resolved via good-faith discussions; provided, that in the event of a disagreement that cannot be resolved within [**] daysthirty (30) days after the date on which the disagreement arose, the matter shall be referred resolved as requested by Licensee. (f) At each JDC meeting, Premas will keep the JDC informed regarding the progress and results of development activities with respect to Products in the Parties’ respective Executive Officers for resolution. If Territory in the Executive Officers are not able to resolve any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer shall have the right to decide the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither Party shall have a unilateral right to resolve any dispute involving the breach or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunderField.

Appears in 1 contract

Samples: License and Development Agreement (Akers Biosciences, Inc.)

Joint Development Committee. (a) The Parties shall establish form a Joint Development Committee joint development team (the “Joint Development Committee” or “JDC”), comprised made up of [**] an equal number of representatives of Ikaria Ideaya and [**] representatives of BioLineRxPfizer, to oversee the Development of Productswhich shall have responsibility for coordinating all regulatory and other activities under, and pursuant to, this Agreement. Each Party shall make its initial designation designate a project manager (the “Project Manager”) who shall be responsible for implementing and coordinating activities, and facilitating the exchange of its representatives not later than [**] days after scientific information between the Effective Date. Each Party may change any one or more of its representatives Parties with respect to the Joint Development Committee at any time upon notice to the other Party. (b) 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 least [**] during the Development Term or more or less frequently as the JDC may agree. The JDC may meet in person or by means request of a telephone or video conference call. One meeting of the JDC per year shall be held in person at Ikaria’s headquarters in Clintoneither Party, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate provide an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs with respect to its participation update on the JDCStudy progress. Prior to every meeting any such meeting, the Ideaya Project Manager shall provide an update in writing to the Pfizer 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 JDCStudy. In addition to a Project Manager, Ikaria will provide each Party shall designate an alliance manager (the “Alliance Manager”), who shall endeavor to ensure clear and responsive communication between the JDC detailed reports describing Ikaria’s current clinical and development activities and plans. (c) The JDC shall be the vehicle by which BioLineRx may offer insight and guidance to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives Parties and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results effective exchange of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Terminformation, and (v) establishing success criteria shall serve as the primary point of contact for the clinical trials (other than those for which success criteria are set forth in any issues arising under this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteria. (d) . The JDC shall only act unanimously, with each Party given one (1) vote regardless of the number of representatives. If, however, the JDC is unable to reach agreement with respect to any matter within [**] days, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer Alliance Managers shall have the right to decide the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything attend all JDC meetings [***] Certain information in this Section 3.2document has been excluded pursuant to Regulation S-K, neither 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 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 Pfizer. Each Party shall have also appoint a unilateral right supply chain representative to resolve hold telephone discussions at a mutually agreed-upon frequency to review the quantities of Pfizer Compound and Ideaya Compound needed for the Study (in accordance with Article 8 and Appendix B) and any dispute involving other supply chain issues that may arise during the breach or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunderStudy.

Appears in 1 contract

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

Joint Development Committee. (a) The Parties Within 30 days of the date CoCensys exercises the Re-engagement Option in accordance with Section 5.3 to co-develop a Collaboration Lead Compound, Warner shall establish appoint 4 representatives and CoCensys shall appoint 2 representatives to a Joint Development Committee (the "Joint Development Committee" or "JDC"). Such representatives will include individuals with expertise and responsibilities in the areas of preclinical development, comprised clinical development, or regulatory affairs. The JDC will oversee all aspects of [**] representatives the Preclinical Development and Development of Ikaria each Collaboration Lead Compound for which CoCensys has exercised the Re-engagement Option through the filing of an NDA or its foreign equivalent on a Collaboration Product arising from such Collaboration Lead Compound. With respect to each Collaboration Lead Compound in Preclinical Development and [**] representatives each Collaboration Product in Development, the Executive Committee will, upon nomination from each party, select one Warner JDC representative as a "Project Team Leader" with respect to such Collaboration Lead Compound or Collaboration Product. The Project Team Leader will be responsible for overseeing the operational aspects of BioLineRx, to oversee the Preclinical Development and the Development of Productsthe applicable Collaboration Lead Compound or Collaboration Product, as directed by the JDC, and will prepare and submit to the JDC issues and problems to be decided by the JDC. The JDC will meet on a quarterly basis, alternating between Ann Arbor, Michigan and Irvine, California and will otherwise communicate regularly by telephone, facsimile and video conference. Each Party shall make its initial designation party recognizes the importance of the Joint Development Committee in the success of the Collaboration and will use diligent efforts to cause all of its representatives not later than [**] days after the Effective Dateto such committee to attend all meetings of such committee. Each Party A party may change any one or more of its representatives appointments to the Joint Development Committee at any time upon giving written notice to the other Partyparty. (b) The JDC shall meet at least [**] during the Development Term or more or less frequently as the JDC may agree. The JDC may meet in person or by means of a telephone or video conference call. One meeting of the JDC per year shall be held in person at Ikaria’s headquarters in Clinton, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs with respect to its participation on the JDC. Prior to every meeting of the JDC, Ikaria will provide to the JDC detailed reports describing Ikaria’s current clinical and development activities and plans. (c) The JDC shall be the vehicle by which BioLineRx may offer insight and guidance to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are set forth in this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteria. (d) The JDC shall only act unanimously, with each Party given one (1) vote regardless of the number of representatives. If, however, the JDC is unable to reach agreement with respect to any matter within [**] days, the matter shall be referred to the Parties’ respective Executive Officers for resolution. If the Executive Officers are not able to resolve any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer shall have the right to decide the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither Party shall have a unilateral right to resolve any dispute involving the breach or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunder.

Appears in 1 contract

Samples: Research, Development and Marketing Collaboration Agreement (Cocensys Inc)

Joint Development Committee. (a) The Parties shall establish For so long as ISIS is performing work pursuant to the Development Plan, the Development Program will be conducted under the overall oversight of a Joint Development Committee joint development committee (the “Joint Development Committee” or “"JDC”), ") comprised of [**] 2 representatives of Ikaria each from LILLY and [**] representatives of BioLineRx, to oversee the Development of ProductsISIS. Each Party shall make its initial designation party will designate a representative as a project leader to serve as the contact person for that party. The parties may agree to add additional members to the JDC, as long as equal representation is maintained. LILLY will designate one of its representatives not later than [**] days after as chairman of the Effective DateJDC. Each Party may change any one or more In the event of its representatives to a tied vote, the Joint Development Committee at any time upon notice to the other PartyJDC chairman will have final decision-making authority. (b) The JDC shall will be responsible for overseeing the parties' performance of the Development Program and for making strategic decisions related to that program. The JDC will be responsible for approving or disapproving any amendments to the Development Plan proposed by either party. The JDC will provide to the parties copies of the amended Development Plan promptly after approval by the JDC. (c) During the term of ISIS's participation in the Development Program, the JDC will meet on a regular basis, and at least [**] during the Development Term quarterly, either in person, or more or less frequently as the JDC parties otherwise may agree. The JDC may meet in person will review the progress of the activities carried out under the Development Program and will consider proposed modifications to the strategy and goals of that program. The frequency, dates and times of all meetings will be mutually agreed upon by the parties, as will the location for face-to-face meetings, alternating between Indianapolis, Indiana and Carlsbad, California, or by means of a telephone or video conference call. One meeting such other location as members of the JDC per year shall be held in person at Ikaria’s headquarters in Clintonwill agree. At its first meeting, NJ and one meeting of the JDC per year shall be held in person at BioLineRx’s headquarters in Israel, provided, that will decide upon the Parties’ representatives may participate in person, via telephone, or video conference in their discretion. Each Party shall use reasonable efforts to cause its representatives to attend the meetings of the JDC. If a representative of a Party is unable to attend a meeting, such Party may designate an alternate to attend such meeting in place of the absent representative. Each Party shall bear its own costs with respect to its participation on the JDC. Prior to every meeting of the JDC, Ikaria organizational rules under which it will provide to the JDC detailed reports describing Ikaria’s current clinical and development activities and plans. (c) The JDC shall be the vehicle by which BioLineRx may offer insight and guidance to Ikaria with respect to (i) establishing the Development Plan setting forth the Development Program’s objectives and the activities to be conducted, (ii) reviewing and updating the Development Plan from time to time, (iii) monitoring the progress and results of the Development Program, (iv) determining future Development Program activities, including Development activities relating to Manufacturing, to be conducted operate during the Development Term, and (v) establishing success criteria for the clinical trials (other than those for which success criteria are set forth in term of this Agreement), and determining whether the results of such clinical trials have achieved the applicable success criteria. (d) The JDC shall only act unanimously, with each Party given one (1) vote regardless Upon completion of the number of representatives. If, howeveractivities required to be performed by ISIS under the Development Plan, the JDC is unable will be disbanded, and LILLY will assume full control over the conduct of the Development Program. However, ISIS and LILLY will meet to reach agreement discuss the plans for and the progress of development of the Product on a semi-annual basis for the duration of the clinical development of the Product. Such meetings may be held in conjunction with respect to the meetings of LILLY's Therapeutic Area Steering Committee for Oncology (or any matter within [**] days, successor committee or group charged with the matter shall be referred to oversight of the Parties’ respective Executive Officers for resolution. If development of the Executive Officers are not able to resolve any such matter by consensus within [**] days following referral, Ikaria’s Executive Officer shall have the right to decide the matter taking into account Ikaria’s obligation to use Commercially Reasonable Efforts under Section 3.8. Notwithstanding anything in this Section 3.2, neither Party shall have a unilateral right to resolve any dispute involving the breach or alleged breach of this Agreement, to amend or modify this Agreement or the Parties’ respective rights and obligations hereunder or, except as expressly provided in this Section 3.2, any Development Plan or the Parties’ respective rights and obligations thereunderProduct).

Appears in 1 contract

Samples: Development and License Agreement (Isis Pharmaceuticals Inc)

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