Composition and Purposes. Vertex and CFFT have established a Joint Research Committee (“JRC”) consisting of at least [***] (as may be increased or decreased by the JRC), half of whom shall be designated from time to time by each party. If the JRC chooses to designate a Committee Chair, the Chair will be appointed from among the members of the Committee designated by VERTEX. The JRC shall meet formally no less frequently than once in each three (3) month period during the Research Program, and at such time and location, as may be established by the Committee, for the following purposes: (i) To review reports prepared by Vertex, which shall be submitted to the JRC within fifteen (15) days prior to each meeting, and shall include a thorough summary in written text of progress made during the preceding three month period under the Research Plan (although chemical structures will only be disclosed to CFFT in the context of a publication referenced in Article VII hereof, or as part of the Termination Know-How Package provided to CFFT in connection with an Interruption) and to CFFT’s chemistry advisors in accordance with the following sentence. Chemical Structures will be separately disclosed to CFFT’s chemistry advisors serving on the JRC, who will agree to maintain the confidentiality of the structures, to allow them to fulfill their JRC responsibilities; provided that Vertex shall not be required to disclose structures to any advisors other than CFFT’s chemistry advisors who are currently working with Vertex on CFFT’s behalf, and to any other chemistry advisors approved by Vertex, which approval shall not be unreasonably withheld. (ii) To review and discuss the Research Plan, and the Primary and the Alternate Subplans prepared by Vertex as provided in Section 2.4.3 above, and evaluate any proposed revisions to any of those Plans; (iii) To assist Vertex in determining as soon as possible whether the Potentiator or Corrector approach should be the subject of the Primary Program; and (iv) To review Development Candidates proposed by Vertex and to assess whether a given Development Candidate proposed by Vertex meets the Development Candidate Criteria. Vertex shall prepare and deliver minutes of the meeting to the members of the JRC, within thirty (30) days after the date of each meeting, setting forth, inter alia, all decisions of the JRC, and including as an attachment the report on the progress of work performed required by Section 2.6.1(i).
Appears in 5 contracts
Samples: Research, Development and Commercialization Agreement (Vertex Pharmaceuticals Inc / Ma), Research, Development and Commercialization Agreement (Royalty Pharma PLC), Research, Development and Commercialization Agreement (Royalty Pharma PLC)
Composition and Purposes. Vertex PTI and CFFT have established shall establish a Joint Research Steering Committee (“JRCJSC”) consisting which shall consist of at least an equal number of senior management personnel from each Party with the requisite experience and seniority to enable them to make decisions on behalf of the Parties with respect to the initiation, planning and performance of the activities of the Research CERTAIN CONFIDENTIAL PORTIONS OF THIS EXHIBIT WERE OMITTED AND REPLACED WITH “[***] (]”. 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 406 PROMULGATED UNDER THE SECURITIES ACT OF 1933, AS AMENDED. Plan, as may be increased or decreased agreed by the JRC)Parties from time to time. The JSC shall initially have a total of four (4) members, half two (2) of whom shall be designated from time to time by each partyPTI and two (2) of whom shall be designated by CFFT. If No member shall concomitantly serve on the JRC chooses to designate a Committee Chair, PAG and the JSC. The Chair of the JSC will be appointed from among the members of the Committee JSC designated by VERTEXCFFT. The JRC JSC shall meet formally no less frequently than once in each three (3) month period during be dissolved on the Research ProgramTermination Date, unless the Parties otherwise agree in writing. The JSC shall meet, in person or by means of telephone or other telecommunications device that allows all participants to hear and speak at such meeting simultaneously, semi-annually, or with such other frequency, and at such time and locationlocation or by such means, as may be established by the CommitteeJSC, for the following purposes:
(ia) To to provide general oversight of the Research Program;
(b) to periodically review reports prepared by Vertexthe Budget, which shall be submitted overall goals and strategy of the Research Program;
(c) to determine that the JRC within fifteen (15) days prior to each meeting, and shall include a thorough summary in written text of progress made during the preceding three month period under Award funds were applied solely for the Research Plan (although chemical structures will only be disclosed to CFFT in the context of a publication referenced in Article VII hereof, or as part of the Termination Know-How Package provided to CFFT in connection with an Interruption) and to CFFT’s chemistry advisors in accordance with the following sentence. Chemical Structures will be separately disclosed to CFFT’s chemistry advisors serving on the JRC, who will agree to maintain the confidentiality of the structures, to allow them to fulfill their JRC responsibilities; provided that Vertex shall not be required to disclose structures to any advisors other than CFFT’s chemistry advisors who are currently working with Vertex on CFFT’s behalf, and to any other chemistry advisors approved by Vertex, which approval shall not be unreasonably withheld.
(ii) To review and discuss the Research Plan, and the Primary and the Alternate Subplans prepared by Vertex as provided in Section 2.4.3 above, and evaluate any proposed revisions to any of those Plans;
(iii) To assist Vertex in determining as soon as possible whether the Potentiator or Corrector approach should be the subject of the Primary ProgramBudget; and
(ivd) To review Development Candidates proposed to discuss and attempt to resolve any deadlocked issues submitted to it by Vertex and to assess whether a given Development Candidate proposed by Vertex meets the Development Candidate Criteria. Vertex shall prepare and deliver minutes of the meeting to the members of the JRC, within thirty (30) days after the date of each meeting, setting forth, inter alia, all decisions of the JRC, and including as an attachment the report on the progress of work performed required by Section 2.6.1(i)PAG.
Appears in 2 contracts
Samples: Research, Development and Commercialization Agreement, Research, Development and Commercialization Agreement (Proteostasis Therapeutics, Inc.)
Composition and Purposes. Vertex and CFFT have established a Joint Research Committee (“JRC”) consisting of at least [***] (as may be increased or decreased by the JRC), half of whom shall be designated from time to time by each party. If the JRC chooses to designate a Committee Chair, the Chair will be appointed from among the members of the Committee designated by VERTEX. The JRC shall meet formally no less frequently than once in each three (3) month period during the Research Program, and at such time and location, as may be established by the Committee, for the following purposes:
(i) To review reports prepared by Vertex, which shall be submitted to the JRC within fifteen (15) days prior to each meeting, and shall include a thorough summary in written text of progress made during the preceding three month period under the Research Plan (although chemical structures will only be disclosed to CFFT in the context of a publication referenced in Article VII hereof, or as part of the Termination Know-How Package provided to CFFT in connection with an Interruption) and to CFFT’s chemistry advisors in accordance with the following sentence. Chemical Structures will be separately disclosed to CFFT’s chemistry advisors serving on the JRC, who will agree to maintain the confidentiality of the structures, to allow them to fulfill their JRC * Information redacted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission. responsibilities; provided that Vertex shall not be required to disclose structures to any advisors other than CFFT’s chemistry advisors who are currently working with Vertex on CFFT’s behalf, and to any other chemistry advisors approved by Vertex, which approval shall not be unreasonably withheld.
(ii) To review and discuss the Research Plan, and the Primary and the Alternate Subplans prepared by Vertex as provided in Section 2.4.3 above, and evaluate any proposed revisions to any of those Plans;
(iii) To assist Vertex in determining as soon as possible whether the Potentiator or Corrector approach should be the subject of the Primary Program; and
(iv) To review Development Candidates proposed by Vertex and to assess whether a given Development Candidate proposed by Vertex meets the Development Candidate Criteria. Vertex shall prepare and deliver minutes of the meeting to the members of the JRC, within thirty (30) days after the date of each meeting, setting forth, inter alia, all decisions of the JRC, and including as an attachment the report on the progress of work performed required by Section 2.6.1(i).
Appears in 1 contract
Samples: Research, Development and Commercialization Agreement (Vertex Pharmaceuticals Inc / Ma)
Composition and Purposes. Vertex and CFFT have established a Joint Research Committee (“JRC”) consisting of at least [***] (as may be increased or decreased by the JRC), half of whom shall be designated from time to time by each party. If the JRC chooses to designate a Committee Chair, the Chair will be appointed from among the members of the Committee designated by VERTEX. The JRC shall meet formally no less frequently than once in each three (3) month period during the Research Program, and at such time and location, as may be established by the Committee, for the following purposes:
(i) To review reports prepared by Vertex, which shall be submitted to the JRC within fifteen (15) days prior to each meeting, and shall include a thorough summary in written text of progress made during the preceding three month period under the Research Plan (although chemical structures will only be disclosed to CFFT in the context of a publication referenced in Article VII hereof, or as part of the Termination Know-How Package provided to CFFT in connection with an Interruption) and to CFFT’s chemistry advisors in accordance with the following sentence. Chemical Structures will be separately disclosed to CFFT’s chemistry advisors serving on the JRC, who will agree to maintain the confidentiality of the structures, to allow them to fulfill their JRC responsibilities; provided that Vertex shall not be required to disclose structures to any advisors other than CFFT’s chemistry advisors who are currently working with Vertex on CFFT’s behalf, and to any other chemistry advisors approved by Vertex, which approval shall not be unreasonably withheld.
(ii) To review and discuss the Research Plan, and the Primary and the Alternate Subplans prepared by Vertex as provided in Section 2.4.3 above, and evaluate any proposed revisions to any of those Plans;
(iii) To assist Vertex in determining as soon as possible whether the Potentiator or Corrector approach should be the subject of the Primary Program; and
(iv) To review Development Candidates proposed by Vertex Xxxxxx and to assess whether a given Development Candidate proposed by Vertex Xxxxxx meets the Development Candidate Criteria. Vertex shall prepare and deliver minutes of the meeting to the members of the JRC, within thirty (30) days after the date of each meeting, setting forth, inter alia, all decisions of the JRC, and including as an attachment the report on the progress of work performed required by Section 2.6.1(i).
Appears in 1 contract
Samples: Research, Development and Commercialization Agreement (Royalty Pharma PLC)
Composition and Purposes. Vertex CombinatoRx and CFFT have established will establish a Joint Research Committee (“JRC”) consisting initially of at least [***] six (6) members (as may be increased or decreased by the JRC)) with the requisite experience and seniority to enable them to make recommendations on behalf of the Parties with respect to the initiation, planning and performance of the activities of the Research Program, half of whom shall be designated from time to time by each party. If the JRC chooses to designate a Committee Chair, the Chair will be appointed from among the members of the Committee JRC designated by VERTEXCombinatoRx. The JRC shall meet terminate upon the formation of the JDC. The JRC shall meet, in person or by conference telephone, formally no less frequently than once in each three (3) month period during the Research Program, and at such time and locationlocation or by such means, as may be established by the CommitteeJRC, for the following purposes:
(i) To review reports prepared by VertexCombinatoRx, which shall be submitted to the JRC within at least fifteen (15) days prior to each meeting, and shall include a thorough summary in written text of the progress made during the preceding three (3) month period under the Research Plan (although chemical structures will only be disclosed to CFFT in the context of a publication referenced in Article VII hereof, or as part of the Termination Know-How Package provided to CFFT in connection with an Interruption) and to CFFT’s chemistry advisors in accordance with the following sentence. Chemical Structures will be separately disclosed to CFFT’s chemistry advisors serving on the JRC, who will agree to maintain the confidentiality of the structures, to allow them to fulfill their JRC responsibilities; provided that Vertex shall not be required to disclose structures to any advisors other than CFFT’s chemistry advisors who are currently working with Vertex on CFFT’s behalf, and to any other chemistry advisors approved by Vertex, which approval shall not be unreasonably withheld.Plan;
(ii) To review and discuss the Research PlanPlan and to evaluate, consider and make recommendations to the Primary and the Alternate Subplans prepared by Vertex as provided in Section 2.4.3 above, and evaluate JSC regarding any proposed revisions to any of those Plans;the Research Plan; and
(iii) To assist Vertex in determining recommend to the JSC amendments to the Clinical Development Candidate Criteria as soon as possible whether the Potentiator or Corrector approach should be the subject of the Primary Program; andrequired.
(iv) To review the criterion for the selection of Clinical Development Candidates proposed by Vertex CombinatoRx and to assess whether a given Clinical Development Candidate proposed by Vertex CombinatoRx meets the Clinical Development Candidate Criteria. Vertex CombinatoRx shall prepare and deliver minutes of the meeting meetings to the members of the JRC, within thirty (30) days after the adjournment date of each meeting, setting forth, inter alia, all decisions recommendations of the JRC, and including as an attachment the report on the progress of work performed required by Section 2.6.1(i2.4.1(i).
Appears in 1 contract
Samples: Research, Development and Commercialization Agreement (Combinatorx, Inc)
Composition and Purposes. Vertex and CFFT have established a Joint Research Committee (“"JRC”") consisting of at least [***] (as may be increased or decreased by the JRC), half of whom shall be designated from time to time by each party. If the JRC chooses to designate a Committee Chair, the Chair will be appointed from among the members of the Committee designated by VERTEX. The JRC shall meet formally no less frequently than once in each three (3) month period during the Research Program, and at such time and location, as may be established by the Committee, for the following purposes:
(i) To review reports prepared by Vertex, which shall be submitted to the JRC within fifteen (15) days prior to each meeting, and shall include a thorough summary in written text of progress made during the preceding three month period under the Research Plan (although chemical structures will only be disclosed to CFFT in the context of a publication referenced in Article VII hereof, or as part of the Termination Know-How Package provided to CFFT in connection with an Interruption) and to CFFT’s 's chemistry advisors in accordance with the following sentence. Chemical Structures will be separately disclosed to CFFT’s 's chemistry advisors serving on the JRC, who will agree to maintain the confidentiality of the structures, to allow them to fulfill their JRC responsibilities; provided that Vertex shall not be required to disclose structures to any advisors other than CFFT’s 's chemistry advisors who are currently working with Vertex on CFFT’s 's behalf, and to any other chemistry advisors approved by Vertex, which approval shall not be unreasonably withheld.
(ii) To review and discuss the Research Plan, and the Primary and the Alternate Subplans prepared by Vertex as provided in Section 2.4.3 above, and evaluate any proposed revisions to any of those Plans;
(iii) To assist Vertex in determining as soon as possible whether the Potentiator or Corrector approach should be the subject of the Primary Program; and
(iv) To review Development Candidates proposed by Vertex and to assess whether a given Development Candidate proposed by Vertex meets the Development Candidate Criteria. Vertex shall prepare and deliver minutes of the meeting to the members of the JRC, within thirty (30) days after the date of each meeting, setting forth, inter alia, all decisions of the JRC, and including as an attachment the report on the progress of work performed required by Section 2.6.1(i).
Appears in 1 contract
Samples: Research, Development and Commercialization Agreement (Vertex Pharmaceuticals Inc / Ma)
Composition and Purposes. Vertex VERTEX and CFFT have established SERONO will establish within thirty (30) days of the Effective Date a Joint Research Committee (“"JRC”") consisting which shall consist of at least [***] six (6) representatives (as may be increased or decreased by the JRC), half of whom shall be designated from time to time by each party. If Meetings of the JRC chooses other than regularly scheduled quarterly meetings may be held only if a quorum of at least two (2) representatives of each party participates; except that lack of a quorum shall not prevent the scheduling and conduct of a meeting by either party after that party has made good faith but unsuccessful attempts for more than ninety (90) days to designate a Committee Chair, schedule and convene the Chair will be appointed from among the members of the Committee designated by VERTEXmeeting. The JRC shall meet formally no less frequently than once in each three (3) month period during the Research Programat least quarterly, or with such other frequency, and at such time and location, as may be established by the CommitteeJRC, for the following purposes:
(i) To receive and review reports prepared by VertexVERTEX and its project teams, and by SERONO if it is conducting research under the Research Plan, which shall be prepared and submitted to the other party and to the JRC on a quarterly basis within fifteen (15) days prior to after the end of each meetingcalendar quarter (commencing with the calendar quarter ending December 31, 2000), summarizing data and shall include a thorough summary in written text of progress made during the preceding three month period information generated under the Research Plan (although chemical structures and other progress with respect thereto. The first such report provided by VERTEX will only be disclosed provide information regarding all Compounds invented, discovered or developed by VERTEX prior to CFFT the Effective Date in the context course of a publication referenced research program directed toward the discovery of Compounds, and that data will be updated in Article VII hereofsubsequent reports to reflect new Compounds invented, discovered or as part developed by VERTEX since the date of the Termination Know-How Package provided to CFFT in connection with an Interruption) and to CFFT’s chemistry advisors in accordance with the following sentence. Chemical Structures will be separately disclosed to CFFT’s chemistry advisors serving on the JRC, who will agree to maintain the confidentiality of the structures, to allow them to fulfill their JRC responsibilities; provided that Vertex shall not be required to disclose structures to any advisors other than CFFT’s chemistry advisors who are currently working with Vertex on CFFT’s behalf, and to any other chemistry advisors approved by Vertex, which approval shall not be unreasonably withheld.last report;
(ii) To coordinate and review research activity and discuss the Research Plan, interactions between VERTEX and the Primary and the Alternate Subplans prepared by Vertex as provided in Section 2.4.3 above, and evaluate any proposed revisions to any of those PlansSERONO;
(iii) To assist Vertex in determining as soon as possible whether the Potentiator or Corrector approach should be the subject of the Primary Program; andreview any Compounds proposed by either party for development;
(iv) To review, consider and approve revisions to the Research Plan;
(v) To periodically review Development Candidates proposed by Vertex the overall goals and strategy of the Research Program and to assess consider whether a given Development Candidate proposed by Vertex meets the Development Candidate Criteria. Vertex shall prepare and deliver minutes redirection or termination of the Research Program should be recommended under Section 2.9 hereof; and
(vi) To discuss matters relating to Patents claiming Program Technology. VERTEX will prepare the initial draft of an agenda for each JRC meeting and will submit the draft to SERONO for comments a reasonable period before the members of the JRC, within thirty (30) days after the date of each scheduled meeting, setting forth, inter alia, all decisions of the JRC, and including as an attachment the report on the progress of work performed required by Section 2.6.1(i).
Appears in 1 contract
Samples: Research Agreement (Vertex Pharmaceuticals Inc / Ma)
Composition and Purposes. Vertex Predix and CFFT have established shall establish a Joint Research Committee (“"JRC”") consisting of at least [***] six (6) representatives (as may be increased or decreased by the JRC), half of whom shall be designated from time to time by each party. If the Each party shall choose a Program Coordinator who may be changed from time to time by designation of each party. The Program Coordinator for Predix shall be Oren Becker, PhD. The Program Coordinator for CFFT shall be Diana Wetxxxx. Xx xxe JRC chooses to designate a Committee Chair, the Chair will be appointed from among the members of the Committee designated by VERTEXXxxxx xxxx xe Predix's Program Coordinator. The JRC shall meet formally no less frequently than once in each three (3) month period during the Research Program, and at such time and location, as may be established by the Committee. However, the JRC will make its schedule flexible in order to foster the successful completion of the Research Programs. The JRC shxxx xxet for the following purposes:
(iI) To review reports prepared by Vertex, which shall be submitted to the JRC within fifteen (15) days prior to each meeting, and shall include a thorough summary in written text of progress made during the preceding three month period under the Research Plan (although chemical structures will only be disclosed to CFFT in the context of a publication referenced in Article VII hereof, or as part of the Termination Know-How Package provided to CFFT in connection with an Interruption) and to CFFT’s chemistry advisors in accordance with the following sentence. Chemical Structures will be separately disclosed to CFFT’s chemistry advisors serving on the JRC, who will agree to maintain the confidentiality of the structures, to allow them to fulfill their JRC responsibilities; provided that Vertex shall not be required to disclose structures to any advisors other than CFFT’s chemistry advisors who are currently working with Vertex on CFFT’s behalf, and to any other chemistry advisors approved by Vertex, which approval shall not be unreasonably withheld.
(ii) To review and discuss the Research Plan, and the Primary and the Alternate Subplans prepared by Vertex as provided in Section 2.4.3 above, Plan and evaluate any proposed revisions to any of those Plansplans;
(iiiII) To assist Vertex in determining as soon as possible to determine whether the Potentiator or Corrector approach should be the subject of the Primary Programmilestones have been achieved; and
(ivIII) To review Development Candidates proposed by Vertex and to assess whether provide guidance to the research team if such guidance is needed on next steps to implement the Research Programs. PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 24b-2 OF THE EXCHANGE ACT; [*] DENOTES OMISSIONS. EXECUTION COPY At least five (5) working days prior to each JRC meeting, Predix will send a given Development Candidate proposed by Vertex meets written report to CFFT detailing the Development Candidate Criteriaprogress made in the respective Research Programs during the preceding quarter. Vertex Within thirty (30) days after the date of each meeting, Predix shall prepare and deliver minutes of the meeting to the members of the JRC, within thirty (30) days after the date of each meeting, setting forth, inter alia, all decisions of the JRC, and including as an attachment the report on the progress of work performed required by this Section 2.6.1(i)2.5.1.
Appears in 1 contract
Samples: Research, Development and Commercialization Agreement (EPIX Pharmaceuticals, Inc.)
Composition and Purposes. Vertex Predix and CFFT have established shall establish a Joint Research Committee (“"JRC”") consisting of at least [***] six (6) representatives (as may be increased or decreased by the JRC), half of whom shall be designated from time to time by each party. Each party shall choose a Program Coordinator who may be changed from time to time by designation of each party. The Program Coordinator for Predix shall be [*********]. The Program Coordinator for CFFT shall be [******************]. If the JRC chooses to designate a Committee Chair, the Chair will be appointed from among the members of the Committee designated by VERTEX[******************]. The JRC shall meet formally no less frequently than once in each three (3) month period during the Research Program, and at such time and location, as may be established by the Committee. However, the JRC will make its schedule flexible in order to xxxxxx the successful completion of the Research Programs. The JRC shall meet for the following purposes:
(i) To review reports prepared by Vertex, which shall be submitted to the JRC within fifteen (15) days prior to each meeting, and shall include a thorough summary in written text of progress made during the preceding three month period under the Research Plan (although chemical structures will only be disclosed to CFFT in the context of a publication referenced in Article VII hereof, or as part of the Termination Know-How Package provided to CFFT in connection with an Interruption) and to CFFT’s chemistry advisors in accordance with the following sentence. Chemical Structures will be separately disclosed to CFFT’s chemistry advisors serving on the JRC, who will agree to maintain the confidentiality of the structures, to allow them to fulfill their JRC responsibilities; provided that Vertex shall not be required to disclose structures to any advisors other than CFFT’s chemistry advisors who are currently working with Vertex on CFFT’s behalf, and to any other chemistry advisors approved by Vertex, which approval shall not be unreasonably withheld.
(ii) To review and discuss the Research Plan, and the Primary and the Alternate Subplans prepared by Vertex as provided in Section 2.4.3 above, Plan and evaluate any proposed revisions to any of those Plansplans;
(ii) to determine whether milestones have been achieved; and
(iii) To assist Vertex to provide guidance to the research team if such guidance is needed on next steps to implement the Research Programs. PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT; [*] DENOTES OMISSIONS. At least [**********] working days prior to each JRC meeting, Predix will send a written report to CFFT detailing the progress made in determining as soon as possible whether the Potentiator or Corrector approach should be respective Research Programs during the subject preceding quarter. Within [**************] days after the date of the Primary Program; and
(iv) To review Development Candidates proposed by Vertex and to assess whether a given Development Candidate proposed by Vertex meets the Development Candidate Criteria. Vertex each meeting, Predix shall prepare and deliver minutes of the meeting to the members of the JRC, within thirty (30) days after the date of each meeting, setting forth, inter alia, all decisions of the JRC, and including as an attachment the report on the progress of work performed required by this Section 2.6.1(i)2.5.1.
Appears in 1 contract
Samples: Research, Development and Commercialization Agreement (Predix Pharmaceuticals Holdings Inc)
Composition and Purposes. Vertex VERTEX and CFFT NOVARTIS have established and will continue to participate in a Joint Research Committee (“"JRC”") consisting of at least [***] eight (8) representatives (as may be increased or decreased by the JRC), half of whom shall be designated from time to time by each party. If the JRC chooses to designate a Committee Chair, the Chair will be appointed from among the members of the Committee designated by VERTEX. The JRC shall meet formally no less frequently than once in each three (3) month period during the Research Programat least quarterly, or with such other frequency, and at such time and location, as may be established by the Committee, for the following purposes:
(i) To receive and review reports prepared by VertexVERTEX and its project teams, which shall be prepared and submitted to the JRC on a quarterly basis within fifteen (15) days prior to after the end of each meetingcalendar quarter, and shall include a thorough summary in written text of such reports summarizing progress made during the preceding three month period quarter under the Research Plan Plan; and to review information with respect to the Compounds under investigation (although chemical structures will only be disclosed to CFFT which VERTEX shall provide in the context of a publication referenced in Article VII hereof, or form and content at least as part of the Termination Know-How Package extensive as customarily provided to CFFT in connection with an Interruption) and to CFFT’s chemistry advisors in accordance with the following sentence. Chemical Structures will be separately disclosed to CFFT’s chemistry advisors serving on JRC under the JRC, who will agree to maintain the confidentiality of the structures, to allow them to fulfill their JRC responsibilities; provided that Vertex shall not be required to disclose structures to any advisors other than CFFT’s chemistry advisors who are currently working with Vertex on CFFT’s behalf, and to any other chemistry advisors approved by Vertex, which approval shall not be unreasonably withheld.Original Agreement);
(ii) To review and discuss a proposal by either party that specified Excluded Compounds or Excluded Kinases be included in the Research PlanProgram, or that a Kinase be added to the list of Excluded Kinases; provided that the JRC shall have no authority to include or exclude any Compound or Kinase from the Research Program, and that any such action must be the Primary and the Alternate Subplans prepared by Vertex as provided in Section 2.4.3 above, and evaluate any proposed revisions subject of a formally adopted amendment to any of those Plansthis Research Agreement;
(iii) To assist Vertex in determining define as soon as possible whether the Potentiator further, more specific Development Criteria (x) for ongoing projects, after the signature of this Research Agreement, or Corrector approach should be (y) for new projects, after the subject start of the Primary Program; andsuch new research project;
(iv) To review Development Candidates proposed by Vertex VERTEX and to assess whether a given Development Candidate proposed by Vertex VERTEX meets the Development Candidate Criteria;
(v) To review the Research Plan and any proposed revisions thereto;
(vi) [This subsection has been intentionally left blank.]; and
(vii) To discuss matters relating to Patents, as may be presented to the JRC by VERTEX or NOVARTIS. Vertex The party hosting a particular JRC meeting shall prepare and deliver minutes of the meeting to the members of the JRC, within thirty (30) days after the date of each meeting, minutes of such meeting setting forth, inter alia, all decisions of the JRC, and including as an attachment the a report on the progress of work performed required performed. In case the JRC meets by Section 2.6.1(i)means of telephone or video conferences, this responsibility shall lie with VERTEX.
Appears in 1 contract
Samples: Research and Early Development Agreement (Vertex Pharmaceuticals Inc / Ma)
Composition and Purposes. Vertex Predix and CFFT have established shall establish a Joint Research Committee (“"JRC”") consisting of at least [***] six (6) representatives (as may be increased or decreased by the JRC), half of whom shall be designated from time to time by each party. If the Each party shall choose a Program Coordinator who may be changed from time to time by designation of each party. The Program Coordinator for Predix shall be Oren Becker, PhD. The Program Coordinator for CFFT shall be Diana Wexxxxx. Xx xhe JRC chooses to designate a Committee Chair, the Chair will thx Xxxxx xxxx be appointed from among the members of the Committee designated by VERTEXPredix's Program Coordinator. The JRC shall meet formally no less frequently than once in each three (3) month period during the Research Program, and at such time and location, as may be established by the Committee. However, the JRC will make its schedule flexible in order to foster the successful completion of the Research Programs. The JRC sxxxx xeet for the following purposes:
(iI) To review reports prepared by Vertex, which shall be submitted to the JRC within fifteen (15) days prior to each meeting, and shall include a thorough summary in written text of progress made during the preceding three month period under the Research Plan (although chemical structures will only be disclosed to CFFT in the context of a publication referenced in Article VII hereof, or as part of the Termination Know-How Package provided to CFFT in connection with an Interruption) and to CFFT’s chemistry advisors in accordance with the following sentence. Chemical Structures will be separately disclosed to CFFT’s chemistry advisors serving on the JRC, who will agree to maintain the confidentiality of the structures, to allow them to fulfill their JRC responsibilities; provided that Vertex shall not be required to disclose structures to any advisors other than CFFT’s chemistry advisors who are currently working with Vertex on CFFT’s behalf, and to any other chemistry advisors approved by Vertex, which approval shall not be unreasonably withheld.
(ii) To review and discuss the Research Plan, and the Primary and the Alternate Subplans prepared by Vertex as provided in Section 2.4.3 above, Plan and evaluate any proposed revisions to any of those Plansplans;
(iiiII) To assist Vertex in determining as soon as possible to determine whether the Potentiator or Corrector approach should be the subject of the Primary Programmilestones have been achieved; and
(ivIII) To review Development Candidates proposed by Vertex and to assess whether provide guidance to the research team if such guidance is needed on next steps to implement the Research Programs. PORTIONS OF THIS EXHIBIT WERE OMITTED AND HAVE BEEN FILED SEPARATELY WITH THE SECRETARY OF THE COMMISSION PURSUANT TO THE COMPANY'S APPLICATION REQUESTING CONFIDENTIAL TREATMENT UNDER RULE 406 OF THE SECURITIES ACT; [*] DENOTES OMISSIONS. At least five (5) working days prior to each JRC meeting, Predix will send a given Development Candidate proposed by Vertex meets written report to CFFT detailing the Development Candidate Criteriaprogress made in the respective Research Programs during the preceding quarter. Vertex Within thirty (30) days after the date of each meeting, Predix shall prepare and deliver minutes of the meeting to the members of the JRC, within thirty (30) days after the date of each meeting, setting forth, inter alia, all decisions of the JRC, and including as an attachment the report on the progress of work performed required by this Section 2.6.1(i)2.5.1.
Appears in 1 contract
Samples: Research, Development and Commercialization Agreement (Predix Pharmaceuticals Holdings Inc)
Composition and Purposes. Vertex and CFFT have established During the term of the Research Project, a Joint Research Committee (“JRC”) consisting shall facilitate communication between the Parties, and make recommendations, with respect to the Research Project. The JRC shall consist of at least [***] four (as may be increased or decreased by the JRC)4) members, half two (2) of whom shall be designated by EPIX (the “EPIX Designees”), and two (2) of whom shall be designated by CFFT (the “CFFT Designees”). Each Party shall select a Project Coordinator from among its designees to the JRC or may designate a Project Coordinator as an additional non-voting member of the JRC who shall be allowed to participate in JRC meetings. Each Party may change any such designees to the JRC at any time to or from time-to-time by each partywritten notice to the other Party. If EPIX shall nominate the JRC chooses to designate a Committee Chair, the Chair will be appointed from among the members Chairperson of the Committee designated by VERTEXJRC. In addition to JRC members, CFFT and EPIX shall be entitled to bring to JRC meetings employees or advisors, provided such advisors have executed appropriate confidential agreements. The JRC shall meet formally no less frequently than once in each three terminate upon the earliest of (3i) month period during completion of the Research ProgramProject, (ii) on the Research Termination Date and (iii) the termination of this Agreement. The JRC’s authority shall devolve from, and at such time be subordinate to, the authority of the JSC, and locationas such, shall be subject to the limitations on the JSC’s authority as may be established by set forth in Section 2.7.1. Without limiting the Committeegenerality of the foregoing, for the following purposesJRC shall:
(i) To Annually review reports prepared by Vertexand prepare updated Research Plans and, which shall be submitted to during the JRC within fifteen (15) days prior to each meetingyear, consider, review, and shall include a thorough summary in written text of progress made during the preceding three month period under reevaluate the Research Plan (although chemical structures will only be disclosed Plan, evaluate any proposed revisions to CFFT in the context of a publication referenced in Article VII hereof, or as part of the Termination Know-How Package provided to CFFT in connection with an Interruption) and to CFFT’s chemistry advisors in accordance with the following sentence. Chemical Structures will be separately disclosed to CFFT’s chemistry advisors serving on the JRC, who will agree to maintain the confidentiality of the structures, to allow them to fulfill their JRC responsibilities; provided that Vertex shall not be required to disclose structures to any advisors other than CFFT’s chemistry advisors who are currently working with Vertex on CFFT’s behalf, and to any other chemistry advisors approved by Vertex, which approval shall not be unreasonably withheld.
(ii) To review and discuss the Research Plan, and make recommendations to the Primary and JSC regarding same, provided that amendments that would increase the Alternate Subplans Budget must be approved by the Parties;
(ii) review reports prepared by Vertex EPIX and otherwise monitor the progress of the Research Project and make recommendations to EPIX’ research team as provided in Section 2.4.3 above, and evaluate any proposed revisions needed on next steps to any of those Plansimplement the Research Project;
(iii) To assist Vertex in determining as soon as possible gives its recommendation to the JSC on the choice of EDCs and Back-Up Compounds;
(iv) give its recommendations to the JSC on whether the Potentiator or Corrector approach should be the subject of the Primary ProgramMilestones have been satisfied and achieved; and
(ivv) To review Development Candidates proposed by Vertex and to assess whether a given Development Candidate proposed by Vertex meets the Development Candidate Criteria. Vertex shall prepare and deliver minutes of the meeting recommend to the members of JSC any revisions to the JRC, within thirty (30) days after the date of each meeting, setting forth, inter alia, all decisions of the JRC, EDC and including as an attachment the report on the progress of work performed required by Section 2.6.1(i).Clinical Development criteria set forth in Exhibit B.
Appears in 1 contract
Samples: Research, Development and Commercialization Agreement (EPIX Pharmaceuticals, Inc.)
Composition and Purposes. Vertex Upon the execution of this Agreement, VERTEX and CFFT have established NOVARTIS will establish a Joint Research Committee (“"JRC”") consisting which shall consist of at least [***] eight (8) representatives (as may be increased or decreased by the JRC), half of whom shall be designated from time to time by each party. If the JRC chooses to designate a Committee Chair, the Chair will be appointed from among the members of the Committee designated by VERTEX. The JRC shall meet formally no less frequently than once in each three (3) month period during the Research Programat least quarterly, or with such other frequency, and at such time and location, as may be established by the Committee, for the following purposes:
(i) To receive and review reports prepared by VertexVERTEX and its project teams, and by NOVARTIS if it is involved in research and early development activities in the Field, which shall be prepared and submitted to the JRC on a quarterly basis within fifteen (15) days prior to after the end of each meetingcalendar quarter (commencing with the first full quarter after the execution of this Agreement), summarizing progress under the Research Plan, and shall include a thorough summary any Early Development Plan then in written text of progress made effect, during the preceding three month period under the Research Plan (although chemical structures will only be disclosed to CFFT in the context of a publication referenced in Article VII hereof, or as part of the Termination Know-How Package provided to CFFT in connection with an Interruption) and to CFFT’s chemistry advisors in accordance with the following sentence. Chemical Structures will be separately disclosed to CFFT’s chemistry advisors serving on the JRC, who will agree to maintain the confidentiality of the structures, to allow them to fulfill their JRC responsibilities; provided that Vertex shall not be required to disclose structures to any advisors other than CFFT’s chemistry advisors who are currently working with Vertex on CFFT’s behalf, and to any other chemistry advisors approved by Vertex, which approval shall not be unreasonably withheld.quarter;
(ii) To review and discuss a proposal by either party that specified Excluded Compounds or Excluded Kinases be included in the Research PlanProgram, and or that an included Kinase be added to the Primary and list of Excluded Kinases; provided that the Alternate Subplans prepared by Vertex as provided in Section 2.4.3 above, and evaluate JRC shall have no authority to include or exclude any proposed revisions to any of those PlansCompound or Kinase from the Research Program;
(iii) To assist Vertex in determining as soon as possible whether the Potentiator or Corrector approach should be the subject review Development Candidates selected by VERTEX, to discuss recommended product profiles for those Candidates and to review Proof of the Primary Program; andConcept Study requirements;
(iv) To review the Research Plan, any Early Development Candidates Plan, and any proposed revisions to either;
(v) To consider whether redirection or termination of the Research Program should be recommended under Section 2.8 hereof; and
(vi) To discuss matters relating to Patents, as may be presented to the JRC by Vertex and to assess whether VERTEX or NOVARTIS. The party hosting a given Development Candidate proposed by Vertex meets the Development Candidate Criteria. Vertex particular JRC meeting shall prepare and deliver minutes of the meeting to the members of the JRC, within thirty (30) days after the date of each meeting, minutes of such meeting setting forth, inter alia, all decisions of the JRC, and including as an attachment the a report on the progress of work performed required performed. In case the JRC meets by Section 2.6.1(i)means of telephone or video conferences, this responsibility shall lie with VERTEX. VERTEX also expects to provide NOVARTIS with reports from its early development project teams if and when they become available and are appropriate for distribution.
Appears in 1 contract
Samples: Research and Early Development Agreement (Vertex Pharmaceuticals Inc / Ma)