Members; Officers. Within thirty (30) days after the Effective Date, the Parties shall establish a joint product committee (the "Joint Product Committee" or "JPC"), and MYLAN and THERAVANCE shall designate an equal number of representatives, up to a maximum total of eight (8) members on such JPC, with an equal number from each Party. Each of MYLAN and THERAVANCE may replace any or all of its representatives on the JPC at any time upon written notice to the other Party. Such representatives shall be employees of the Parties who have the relevant experience and expertise to complete the activities included in the Development Plan or Commercialization Plan (as the case may be) for the Licensed Product in the Field for the next twelve months. On an occasional basis a Party may designate a substitute employee to temporarily attend and perform the functions of such Party's JPC member at any meeting of the JPC. MYLAN and THERAVANCE each may invite non-member employees representatives of such Party to attend meetings of the JPC. The attendance of members of or any representatives to the JPC who are not employees of the applicable Party shall be subject to the prior written consent of the other Party, not to be unreasonably withheld, refused, conditioned or denied. From the Effective Date until the date that is thirty (30) days after the filing of the first NDA for the Licensed Product in the Field in the U.S. the JPC shall be chaired by a representative of THERAVANCE and MYLAN shall appoint a secretary of the JPC, who shall be a representative of MYLAN. Beginning thirty (30) days after filing of the first NDA for the Licensed Product in the Field in the U.S. the JPC shall be chaired by a representative of MYLAN and ***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. THERAVANCE shall appoint a secretary of the JPC, who shall be a representative of THERAVANCE.
Appears in 1 contract
Samples: Development and Commercialization Agreement (Theravance Biopharma, Inc.)
Members; Officers. Within thirty (30) days after the Effective Date, the Parties shall establish a joint product committee (the "“Joint Product Committee" ” or "“JPC"”), and MYLAN and THERAVANCE shall designate an equal number of representatives, up to a maximum total of eight (8) members on such JPC, with an equal number from each Party. Each of MYLAN and THERAVANCE may replace any or all of its representatives on the JPC at any time upon written notice to the other Party. Such representatives shall be employees of the Parties who have the relevant experience and expertise to complete the activities included in the Development Plan or Commercialization Plan (as the case may be) for the Licensed Product in the Field for the next twelve months. On an occasional basis a Party may designate a substitute employee to temporarily attend and perform the functions of such Party's ’s JPC member at any meeting of the JPC. MYLAN and THERAVANCE each may invite non-member employees representatives of such Party to attend meetings of the JPC. The attendance of members of or any representatives to the JPC who are not employees of the applicable Party shall be subject to the prior written consent of the other Party, not to be unreasonably withheld, refused, conditioned or denied. From the Effective Date until the date that is thirty (30) days after the filing of the first NDA for the Licensed Product in the Field in the U.S. the JPC shall be chaired by a representative of THERAVANCE and MYLAN shall appoint a secretary of the JPC, who shall be a representative of MYLAN. Beginning thirty (30) days after filing of the first NDA for the Licensed Product in the Field in the U.S. the JPC shall be chaired by a representative of MYLAN and ***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. THERAVANCE shall appoint a secretary of the JPC, who shall be a representative of THERAVANCE.
Appears in 1 contract
Samples: Development and Commercialization Agreement (Theravance Biopharma, Inc.)
Members; Officers. Within thirty The JSC shall consist of up to eight (30) days after the Effective Date8) members, the Parties shall establish a joint product committee (the "Joint Product Committee" or "JPC"), and MYLAN and THERAVANCE shall designate an equal number of representatives, up whom shall be designated by each of MYLAN and THERAVANCE and each of whom shall be an employee of the designating Party with appropriate expertise. The initial members of the JSC are set forth on Exhibit C. Each Party's representation on ***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. the JSC will include individuals with responsibility for a broad range of functions important to a maximum total the successful Development and Commercialization of eight (8) members on such JPC, with an equal number from each Partythe Licensed Product in the Field at the applicable stage in the life cycle of the Licensed Products. Each of MYLAN and THERAVANCE may replace any or all of its representatives on the JPC JSC at any time upon written notice to the other Party. Such representatives shall be employees of the Parties who have the relevant experience and expertise to complete the activities included in the Development Plan or Commercialization Plan (as the case may be) for the Licensed Product in the Field for the next twelve months. On an occasional basis a While it is expected that each JSC member attend each JSC meeting, each Party may designate a substitute employee to temporarily attend and perform the functions of one or more of such Party's JPC member JSC members at any meeting of the JPCJSC. MYLAN and THERAVANCE each may may, on advance written notice to the other Party, invite non-member employees employee representatives of such Party to attend meetings of the JPCJSC, which invitees shall not have the right to vote in JSC decisions. The attendance of members of or any representatives to the JPC JSC who are not employees of the applicable Party shall be subject to the prior written consent of the other Party, not to be unreasonably withheld, refused, conditioned or denied. From the Effective Date until the date that is thirty (30) days after the filing of the first NDA for the Licensed Product in the Field in the U.S. the JPC The JSC shall be chaired on an annual rotating basis by a JSC representative of either THERAVANCE and MYLAN or MYLAN, as applicable, with THERAVANCE providing the first such chairperson. The Party that does not appoint the chairperson shall appoint a secretary of the JPCJSC, who shall be a representative of MYLAN. Beginning thirty (30) days after filing of the first NDA such other Party and who shall serve for the Licensed Product in the Field in the U.S. the JPC shall be chaired by a representative of MYLAN and ***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. THERAVANCE shall appoint a secretary of the JPC, who shall be a representative of THERAVANCEsame annual term as such chairperson.
Appears in 1 contract
Samples: Development and Commercialization Agreement (Theravance Biopharma, Inc.)
Members; Officers. Within thirty (30) [* * *] days after of the Effective Date, the Parties shall will establish a joint product steering committee (the "“Joint Product Steering Committee" ” or "JPC"“JSC”), and MYLAN and THERAVANCE which shall designate consist of an equal number of representativesrepresentatives from each of Durect and Hospira, up to a maximum total of eight (8) [* * *] members from each Party on such JPCCommittee unless otherwise agreed to by the Parties in writing. The representatives on the JSC shall be set forth on Schedule 2.2, with an equal number as may be amended by the designating Party from each Partytime to time. Each of MYLAN Durect and THERAVANCE Hospira may replace any or all of its representatives on the JPC JSC at any time upon written notice to the other Party. Such representatives shall be employees of each such Party, and those representatives of each such Party shall, individually or collectively, have expertise in pharmaceutical drug development, Confidential treatment has been sought for portions of this Agreement. The copy filed herewith omits the Parties who have information subject to the relevant experience confidential treatment request. Omissions are designated as * * *. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. regulatory matters, Clinical Trials, and/or other expertise to complete the activities included in extent relevant. Any member of the Development Plan or Commercialization Plan (as the case may be) for the Licensed Product in the Field for the next twelve months. On an occasional basis a Party JSC may designate a substitute employee with due authority to temporarily attend and perform the functions of such Party's JPC that member at any meeting of the JPCJSC. MYLAN Durect and THERAVANCE Hospira each may may, in its discretion, invite non-member representatives that are employees representatives of such Party or external consultants retained by either Hospira or Durect (and non-employee agents and consultants if agreed to in writing by the Parties) to attend meetings of the JPCJSC, provided that such non-employee agents and consultants have signed customary confidentiality agreements. The attendance of members of or any representatives to the JPC who are not employees of the applicable Party shall be subject to the prior written consent of the other Party, not to be unreasonably withheld, refused, conditioned or denied. From the Effective Date until the date that is thirty (30) days after the filing of the first NDA for the Licensed Product in the Field in the U.S. the JPC JSC shall be chaired by a representative of THERAVANCE each of Durect and MYLAN shall appoint a Hospira, as such representative may be changed by the designating Party at any time. The secretary of the JPC, who JSC shall alternate between a representative of Durect and a representative of Hospira. The first secretary of the JSC shall be a representative of MYLAN. Beginning thirty (30) days after filing of the first NDA for the Licensed Product in the Field in the U.S. the JPC shall be chaired by a representative of MYLAN and ***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. THERAVANCE shall appoint a secretary of the JPC, who shall be a representative of THERAVANCEDurect representative.
Appears in 1 contract
Members; Officers. Within thirty ten (3010) days after the Effective Date, the Parties shall establish a joint product commercialization committee (the "“Joint Product Commercial Committee" ” or "JPC"“JCC”), and MYLAN Cephalon and THERAVANCE XxXxxx shall designate an equal number of representatives, up to a maximum **Portions of the Exhibit have been omitted and have been filed separately pursuant to an application for confidential treatment filed with the Securities and Exchange Commission pursuant to Rule 24b-2 under the Securities Exchange Act of 1934, as amended. total of eight (8) [**] members on such JPC, with an equal number the JCC. The Chair of the JCC shall be selected by Cephalon from each Partyamong Cephalon’s JCC members. Each of MYLAN Cephalon and THERAVANCE XxXxxx may replace any or all of its representatives on the JPC JCC at any time upon written notice to the other Partyother. Such representatives shall be employees include individuals who have experience and expertise in pharmaceutical product marketing, sales and regulatory matters. At least [**] percent ([**]%) of the JCC members from each of the Parties who have shall hold positions of reasonable seniority in their respective organizations, as reasonably determined by the relevant experience and expertise to complete the activities included in the Development Plan or Commercialization Plan (as the case may be) for the Licensed Product in the Field for the next twelve monthsParty designating its own JCC members. On an occasional basis a A Party may designate a substitute employee to temporarily attend and perform the functions of such Party's JPC member ’s designee at any meeting of the JPCJCC. MYLAN Cephalon and THERAVANCE XxXxxx each may may, upon prior written notice to the other Party, invite non-member employees representatives of such Party to attend meetings of the JPCJCC. The attendance Chair shall prepare the agenda for each meeting of members of or any representatives the JCC (which agenda shall be distributed to the JPC who are not employees of the applicable Party shall be subject to the prior written consent of the other PartyJCC members at least five (5) days, not to be unreasonably withheld, refused, conditioned or denied. From the Effective Date until the date that is thirty such shorter period if five (305) days after is not practical as may be mutually agreed upon by the filing of the first NDA for the Licensed Product in the Field in the U.S. the JPC shall be chaired by a representative of THERAVANCE Parties from time to time, prior to any scheduled meeting) and MYLAN shall appoint a secretary of the JPCJCC for such meeting, who shall be a representative of MYLAN. Beginning thirty (30) days after filing of the first NDA for the Licensed Product in the Field in the U.S. the JPC shall be chaired by a representative of MYLAN and ***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. THERAVANCE shall appoint a secretary of the JPC, who shall be a representative of THERAVANCEXxXxxx.
Appears in 1 contract
Members; Officers. Within thirty The JSC shall consist of up to eight (30) days after the Effective Date8) members, the Parties shall establish a joint product committee (the "Joint Product Committee" or "JPC"), and MYLAN and THERAVANCE shall designate an equal number of representatives, up whom shall be designated by each of MYLAN and THERAVANCE and each of whom shall be an employee of the designating Party with appropriate expertise. The initial members of the JSC are set forth on Exhibit C. Each Party’s representation on ***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. the JSC will include individuals with responsibility for a broad range of functions important to a maximum total the successful Development and Commercialization of eight (8) members on such JPC, with an equal number from each Partythe Licensed Product in the Field at the applicable stage in the life cycle of the Licensed Products. Each of MYLAN and THERAVANCE may replace any or all of its representatives on the JPC JSC at any time upon written notice to the other Party. Such representatives shall be employees of the Parties who have the relevant experience and expertise to complete the activities included in the Development Plan or Commercialization Plan (as the case may be) for the Licensed Product in the Field for the next twelve months. On an occasional basis a While it is expected that each JSC member attend each JSC meeting, each Party may designate a substitute employee to temporarily attend and perform the functions of one or more of such Party's JPC member ’s JSC members at any meeting of the JPCJSC. MYLAN and THERAVANCE each may may, on advance written notice to the other Party, invite non-member employees employee representatives of such Party to attend meetings of the JPCJSC, which invitees shall not have the right to vote in JSC decisions. The attendance of members of or any representatives to the JPC JSC who are not employees of the applicable Party shall be subject to the prior written consent of the other Party, not to be unreasonably withheld, refused, conditioned or denied. From the Effective Date until the date that is thirty (30) days after the filing of the first NDA for the Licensed Product in the Field in the U.S. the JPC The JSC shall be chaired on an annual rotating basis by a JSC representative of either THERAVANCE and MYLAN or MYLAN, as applicable, with THERAVANCE providing the first such chairperson. The Party that does not appoint the chairperson shall appoint a secretary of the JPCJSC, who shall be a representative of MYLAN. Beginning thirty (30) days after filing of the first NDA such other Party and who shall serve for the Licensed Product in the Field in the U.S. the JPC shall be chaired by a representative of MYLAN and ***CERTAIN INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE COMMISSION. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. THERAVANCE shall appoint a secretary of the JPC, who shall be a representative of THERAVANCEsame annual term as such chairperson.
Appears in 1 contract
Samples: Development and Commercialization Agreement (Theravance Biopharma, Inc.)