Formation and Composition. Within thirty (30) days after (i) if Acucela exercises the * Opt-In Right, positive top-line data have been obtained as a result of the latest Phase 3 Clinical Trial (other than any Phase 3 Clinical Trial by Adjunctive Use), or (ii) if Acucela does not exercise the * Opt-In Right, Acucela’s exercise of the P3 Opt-In Right, the Parties shall establish a “Joint Commercialization Committee,” or “JCC.” For the avoidance of doubt, if Acucela does not exercise either the * Opt-In Right or the P3 Opt-In Right, the Parties shall not establish a Joint Commercialization Committee. If established, the JCC initially shall be comprised of six (6) members, three (3) of whom shall be representatives appointed by Otsuka and three (3) of whom shall be representatives appointed by Acucela. At least one (1) representative appointed by each Party to the JCC shall have sufficient seniority and authority to make decisions on behalf of such Party and at least two (2) representatives appointed by each Party to the JCC shall have relevant U.S. commercialization expertise. Each Party shall appoint one (1) of its representatives as co-chairperson of the JCC. The JCC may change its size from time to time by mutual consent of its members, provided that the JCC shall include at all times an equal number of representatives of each Party. Each Party may replace its JCC representatives at any time upon written notice to the other Party. Any member of the JCC may designate a substitute to attend and perform the functions of that member at any meeting of the JCC. Each Party may invite non-members to participate in the discussions and meetings of the JCC, provided that such participants shall have no voting authority at the JCC.
Appears in 2 contracts
Samples: Development and Collaboration Agreement (Acucela Inc), Development and Collaboration Agreement (Acucela Inc)
Formation and Composition. Within thirty In the event that a Phase III Clinical Trial for a Therapy utilising a Joint Selected Candidate is initiated, as soon as reasonably practicable after *** , Adaptimmune and Bellicum shall establish a joint commercialisation committee (30) days after (i) if Acucela exercises the * Opt-In Right, positive top-line data have been obtained as a result “JCC”). As of the latest Phase 3 Clinical Trial (other than any Phase 3 Clinical Trial by Adjunctive Use), or (ii) if Acucela does not exercise the * Opt-In Right, Acucela’s exercise of the P3 Opt-In RightEffective Date, the Parties shall establish a “Joint Commercialization Committee,” or “JCC.” For anticipate that the avoidance JCC will monitor and coordinate the communication and activities of doubtboth Parties relating to the further supply, if Acucela does not exercise either the * Opt-In Right or the P3 Opt-In Right, the Parties shall not establish manufacture and commercialisation of such Therapy utilising a Joint Commercialization CommitteeSelected Candidate, and any subsequent Therapies containing a Joint Selected Candidate that enter Phase III Clinical Trials. If establishedUnless otherwise set forth in a Co-Commercialisation Agreement executed by the Parties, the JCC initially shall function in accordance with the remainder of this Clause 2.4 (for clarity, to the extent this Clause 2.4 is inconsistent with the Co-Commercialisation Agreement, the Co-Commercialisation Agreement shall control). The JCC shall be comprised composed of six (6) members, three (3) of whom shall be at least *** but no more than *** representatives appointed by Otsuka and three (3) of whom shall be representatives appointed by Acucela. At least one (1) representative appointed designated by each Party to the JCC shall have sufficient seniority and authority to make decisions on behalf of such Party and at least two (2) representatives appointed by in each Party to the JCC shall have relevant U.S. commercialization expertise. Each Party shall appoint one (1) of its representatives as co-chairperson of the JCC. The JCC may change its size from time to time by mutual consent of its members, provided that the JCC shall include at all times case an equal number of representatives of from each Party. Representatives must be appropriate for the tasks then being undertaken and the stage of development and commercialisation, in terms of their seniority, decision-making authority, availability, function in their respective organisations, training and experience. Each Party may replace its JCC representatives at any from time to time upon written notice to the Alliance Manager of the other Party. Any member of the ; provided, however, if a Party’s JCC representative is unable to attend a JCC meeting, such Party may designate a substitute an alternate to attend such JCC meeting by providing notification in writing to the other Party’s Alliance Manager and following provision of such written notification the alternate will be entitled to perform the functions of that member such JCC representative at such JCC meeting. The Alliance Managers may attend meetings of the JCC but shall have no right to vote on any meeting decisions of the JCC. Each Party may invite non-members to participate in the discussions and meetings of the JCC, provided that such participants shall have no voting authority at the JCC.
Appears in 1 contract
Samples: Co Development and Co Commercialisation Agreement (Adaptimmune Therapeutics PLC)
Formation and Composition. Within thirty In the event that a Phase III Clinical Trial for a Therapy utilising a Joint Selected Candidate is initiated, as soon as reasonably practicable after […***…], Adaptimmune and Bellicum shall establish a joint commercialisation committee (30) days after (i) if Acucela exercises the * Opt-In Right, positive top-line data have been obtained as a result “JCC”). As of the latest Phase 3 Clinical Trial (other than any Phase 3 Clinical Trial by Adjunctive Use), or (ii) if Acucela does not exercise the * Opt-In Right, Acucela’s exercise of the P3 Opt-In RightEffective Date, the Parties shall establish a “Joint Commercialization Committee,” or “JCC.” For anticipate that the avoidance JCC will monitor and coordinate the communication and activities of doubtboth Parties relating to the further supply, if Acucela does not exercise either the * Opt-In Right or the P3 Opt-In Right, the Parties shall not establish manufacture and commercialisation of such Therapy utilising a Joint Commercialization CommitteeSelected Candidate, and any subsequent Therapies containing a Joint Selected Candidate that enter Phase III Clinical Trials. If establishedUnless otherwise set forth in a Co-Commercialisation Agreement executed by the Parties, the JCC initially shall function in accordance with the remainder of this Clause 2.4 (for clarity, to the extent this Clause 2.4 is inconsistent with the Co-Commercialisation Agreement, the Co-Commercialisation Agreement shall control). The JCC shall be comprised composed of six (6) members, three (3) of whom shall be at least […***…] but no more than […***…] representatives appointed by Otsuka and three (3) of whom shall be representatives appointed by Acucela. At least one (1) representative appointed designated by each Party to the JCC shall have sufficient seniority and authority to make decisions on behalf of such Party and at least two (2) representatives appointed by in each Party to the JCC shall have relevant U.S. commercialization expertise. Each Party shall appoint one (1) of its representatives as co-chairperson of the JCC. The JCC may change its size from time to time by mutual consent of its members, provided that the JCC shall include at all times case an equal number of representatives of from each Party. Representatives must be appropriate for the tasks then being undertaken and the stage of development and commercialisation, in terms of their seniority, decision-making authority, availability, function in their respective organisations, training and experience. Each Party may replace its JCC representatives at any from time to time upon written notice to the Alliance Manager of the other Party. Any member of the ; provided, however, if a Party’s JCC representative is unable to attend a JCC meeting, such Party may designate a substitute an alternate to attend such JCC meeting by providing notification in writing to the other Party’s Alliance Manager and following provision of such written notification the alternate will be entitled to perform the functions of that member such JCC representative at such JCC meeting. The Alliance Managers may attend meetings of the JCC but shall have no right to vote on any meeting decisions of the JCC. Each Party may invite non-members to participate in the discussions and meetings of the JCC, provided that such participants shall have no voting authority at the JCC.
Appears in 1 contract
Samples: Co Development and Co Commercialisation Agreement (Bellicum Pharmaceuticals, Inc)
Formation and Composition. Within thirty (30) [***] days after (i) if Acucela exercises the * Opt-In Right, positive top-line data have been obtained as a result of the latest Phase 3 Clinical Trial (other than any Phase 3 Clinical Trial by Adjunctive Use), or (ii) if Acucela does not exercise the * Opt-In Right, Acucela’s exercise of the P3 Opt-In RightEffective Date, the Parties shall establish a joint research committee (a “Joint Commercialization Committee,” or JRC”) for the Neuro Field (the “JCC.” For Neuro JRC”) and a JRC for the avoidance [***] Field (the “[***] JRC”). The Neuro JRC shall be composed of doubt, if Acucela does not exercise either up to [***] representatives designated by each of Recursion and Roche and the * Opt-In Right or the P3 Opt-In Right, [***] JRC shall be composed of up to [***] representatives designated by each of Recursion and Roche (though the Parties shall need not establish have the same number of representatives on a Joint Commercialization CommitteeJRC), each appropriate for the tasks then being undertaken and the stage of research, in terms of their seniority, function in their respective organizations (including decision-making authority), training and experience. If establishedFor each JRC, the JCC initially shall be comprised of six (6) members, three (3) of whom shall be representatives appointed by Otsuka and three (3) of whom shall be representatives appointed by Acucela. At least one (1) representative appointed by each Party to the JCC shall have sufficient seniority and authority to make decisions on behalf of such Party and at least two (2) representatives appointed by each Party to the JCC shall have relevant U.S. commercialization expertise. Each Party shall appoint designate one (1) of its representatives as coits primary contact for JRC matters (such Party’s “JRC Co-chairperson of Chair”). Subject to the JCC. The JCC may change its size from time to time by mutual consent of its membersforegoing, provided that the JCC shall include at all times an equal number of representatives of each Party. Each Party may replace any or all of its JCC JRC representatives (and designated JRC Co-Chair) at any time upon by informing the other Party in advance, in writing (which may be by email). Each JRC shall meet at least [***] each Calendar Quarter, or as otherwise agreed to by the Parties, and shall meet at such other times as deemed appropriate by the JRC. Either Party may invite a reasonable number of other employees, consultants, research contractors, or scientific advisors to attend a JRC meeting in a non-voting capacity with prior written notice to the other Party. Any member of the JCC may designate a substitute to attend and perform the functions of that member at any meeting of the JCC. Each Party may invite non-members to participate in the discussions and meetings of the JCC, ; provided that such participants invitees are bound by appropriate confidentiality and invention assignment obligations consistent with the terms of this Agreement. Unless otherwise agreed by the Parties, each JRC shall have meet and operate during the period commencing upon its formation until the end of its applicable Exclusivity Period [***] in the applicable Exclusive Field. Thereafter, such JRC shall cease operations and perform no voting authority at further functions under this Agreement. Notwithstanding the JCCforegoing, following dissolution of a JRC, the Parties upon mutual agreement may re-establish such JRC as needed [***].
Appears in 1 contract
Samples: Collaboration and License Agreement (Recursion Pharmaceuticals, Inc.)
Formation and Composition. Within thirty (30) days after (i) if Acucela exercises the * Opt-In Right, positive top-line data have been obtained as a result of the latest Phase 3 Clinical Trial (other than any Phase 3 Clinical Trial by Adjunctive Use), or (ii) if Acucela does not exercise the * Opt-In Right, Acucela’s exercise of the P3 Opt-In Right, the Parties shall establish a “Joint Commercialization Committee,” or “JCC.” For the avoidance * Confidential Treatment Requested. of doubt, if Acucela does not exercise either the * Opt-In Right or the P3 Opt-In Right, the Parties shall not establish a Joint Commercialization Committee. If established, the JCC initially shall be comprised of six (6) members, three (3) of whom shall be representatives appointed by Otsuka and three (3) of whom shall be representatives appointed by Acucela. At least one (1) representative appointed by each Party to the JCC shall have sufficient seniority and authority to make decisions on behalf of such Party and at least two (2) representatives appointed by each Party to the JCC shall have relevant U.S. commercialization expertise. Each Party shall appoint one (1) of its representatives as co-chairperson of the JCC. The JCC may change its size from time to time by mutual consent of its members, provided that the JCC shall include at all times an equal number of representatives of each Party. Each Party may replace its JCC representatives at any time upon written notice to the other Party. Any member of the JCC may designate a substitute to attend and perform the functions of that member at any meeting of the JCC. Each Party may invite non-members to participate in the discussions and meetings of the JCC, provided that such participants shall have no voting authority at the JCC.
Appears in 1 contract