Common use of Development and Commercialization Committee Clause in Contracts

Development and Commercialization Committee. Within thirty (30) days of the Effective Date, Schering and Exhale will establish a Development and Commercialization Committee. The Development and Commercialization Committee will be composed of six (6) members, three (3) representatives appointed by Schering and three (3) representatives appointed by Exhale. Such representatives will include individuals with expertise in areas such as clinical development, regulatory affairs and marketing. The Development and Commercialization Committee will meet (in person, telephonically or via videoconference). Upon reasonable request of either Party, employees of the Parties who have expertise in certain other areas may attend meetings of the Development and Commercialization Committee as guests. Unless otherwise agreed between the Parties, meetings of the Development and Commercialization Committee shall take place quarterly. One of the Exhale members of the Development and Commercialization Committee, chosen at the sole discretion of Exhale, along with one of the Schering members of the Development and Commercialization Committee, chosen at the sole discretion of Schering, shall serve as co-chairs of the Development and Commercialization Committee. Either Party may replace any or all of its representatives at any time upon written notice to the other Party. If any issues or disputes cannot be resolved unanimously within the Development * CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION and Commercialization Committee, these issues shall be referred to Exhale’s CEO and the President of the Strategic Business Unit (“SBU”) Specialized Therapeutics at Schering’s Affiliate Berlipharm, Inc., Montville, New Jersey, U.S.A., for resolution. If Exhale’s CEO and the President of the SBU Specialized Therapeutics cannot resolve the issue unanimously, Exhale’s CEO shall discuss this issue with the board member of Schering who is responsible for the SBU Specialized Therapeutics. Should Exhale’s CEO and Schering’s board member not come to an unanimous resolution (i) with respect to an issue that could be reasonably expected to have an adverse effect on Schering’s Product business outside the Territory, then Schering shall have the final decision, and (ii) with respect to any other issue, Exhale shall have the final decision, provided that Exhale agrees to solely bear its increased cost or expense resulting from such decision. Each Party will disclose to the other proposed agenda items reasonably in advance of each meeting of the Development and Commercialization Committee. Each Party shall bear its own costs for participation in the Development and Commercialization Committee.

Appears in 3 contracts

Samples: Development and License Agreement (Cotherix Inc), Development and License Agreement (Cotherix Inc), Development and License Agreement (Cotherix Inc)

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Development and Commercialization Committee. Within thirty (30) days of the Effective Date, Schering and Exhale will 3.1.1 The Parties hereby establish a committee which shall provide a forum for open communication between the Parties regarding Product Development and Commercialization Committeeactivities, and which shall be responsible for such matters related to Development and Commercialization of the Products in the Territory as may be described below. The Development and Commercialization Committee will shall consist of such even number of individuals as shall be composed agreed by the Parties, fifty percent (50%) of whom shall be Galena designees and fifty percent (50%) of whom shall be MSRx designees (the “Committee”). Each Party shall have the right at any time 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 Committee. MSRx shall appoint one of its designees to serve as the Chair of the Committee. The initial Committee shall consist of six (6) membersmembers (including the Chair of such Committee), three (3) representatives appointed of whom shall be designated by Schering and three each Party within ten (310) representatives appointed by Exhale. Such representatives will include individuals with expertise in areas such as clinical development, regulatory affairs and marketingbusiness days after the Effective Date. The Development Committee shall meet at least once per Calendar Quarter, and Commercialization Committee will meet (in person, telephonically or via videoconference). Upon reasonable request of either Party, employees of the Parties who have expertise in certain other areas may attend meetings of the Development and Commercialization Committee more frequently as guests. Unless otherwise mutually agreed between by the Parties, meetings on such dates, and at such places and times, as the Parties shall agree; provided, however, that the Parties shall use their Commercially Reasonable Efforts to cause the first meeting of the Development Committee to occur within thirty (30) days after the Effective Date. The Chair shall send a notice and Commercialization Committee shall take place quarterly. One agenda for each meeting of the Exhale Committee to all members of the Development and Commercialization Committee, chosen at the sole discretion of Exhale, along with one of the Schering members of the Development and Commercialization Committee, chosen at the sole discretion of Schering, shall serve as co-chairs of the Development and Commercialization Committee. Either Party may replace any or all of its representatives at any time upon written notice to the other Party. If any issues or disputes cannot be resolved unanimously within the Development * CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION and Commercialization Committee, these issues shall be referred to Exhale’s CEO and the President of the Strategic Business Unit (“SBU”) Specialized Therapeutics at Schering’s Affiliate Berlipharm, Inc., Montville, New Jersey, U.S.A., for resolution. If Exhale’s CEO and the President of the SBU Specialized Therapeutics cannot resolve the issue unanimously, Exhale’s CEO shall discuss this issue with the board member of Schering who is responsible for the SBU Specialized Therapeutics. Should Exhale’s CEO and Schering’s board member not come to an unanimous resolution (i) with respect to an issue that could be reasonably expected to have an adverse effect on Schering’s Product business outside the Territory, then Schering shall have the final decision, and (ii) with respect to any other issue, Exhale shall have the final decision, provided that Exhale agrees to solely bear its increased cost or expense resulting from such decision. Each Party will disclose to the other proposed agenda items Committee reasonably in advance of each the meeting. The Party hosting any Committee meeting shall appoint one person (who need not be a member of the Development Committee) to attend the meeting and Commercialization record the minutes of the meeting in writing. Such minutes shall be circulated to the members of the Committee in a time frame to be agreed upon by the Committee after the meeting and the members agree to review and comment on such minutes in a time frame to be agreed upon by the Committee. Each Party shall bear its own costs for participation in the Development and Commercialization CommitteeThe Parties agree to use Commercially Reasonable Efforts to promptly finalize any dispute regarding minutes of any meeting.

Appears in 1 contract

Samples: License and Supply Agreement (Galena Biopharma, Inc.)

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Development and Commercialization Committee. Within thirty (30) days of the Effective Date, Schering and Exhale will 3.1.1 The Parties hereby establish a committee which shall provide a forum for open communication between the Parties regarding Product Development and Commercialization Committeeactivities, and which shall be responsible for such matters related to Development and Commercialization of the Products in the Territory as may be described below. The Development and Commercialization Committee will shall consist of such even number of individuals as shall be composed agreed by the Parties, fifty percent (50%) of whom shall be Galena designees and fifty percent (50%) of whom shall be MSRx designees (the “Committee”). Each Party shall have the right at any time 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 Committee. MSRx shall appoint one of its designees to serve as the Chair of the Committee. The initial Committee shall consist of six (6) membersmembers (including the Chair of such Committee), three (3) representatives appointed of whom shall be designated by Schering and three each Party within ten (310) representatives appointed by Exhale. Such representatives will include individuals with expertise in areas such as clinical development, regulatory affairs and marketingbusiness days after the Effective Date. The Development Committee shall meet at least once per Calendar Quarter, and Commercialization Committee will meet (in person, telephonically or via videoconference). Upon reasonable request of either Party, employees of the Parties who have expertise in certain other areas may attend meetings of the Development and Commercialization Committee more frequently as guests. Unless otherwise mutually agreed between by the Parties, meetings on such dates, and at such places and times, as the Parties shall agree; provided, however, that the Parties shall use their Commercially Reasonable Efforts to cause the first meeting of the Development Committee to occur within thirty (30) days after the Effective Date. The Chair shall send a notice and Commercialization Committee shall take place quarterly. One agenda for each meeting of the Exhale Committee to all members of the Development and Commercialization Committee, chosen at the sole discretion of Exhale, along with one of the Schering members of the Development and Commercialization Committee, chosen at the sole discretion of Schering, shall serve as co-chairs of the Development and Commercialization Committee. Either Party may replace any or all of its representatives at any time upon written notice to the other Party. If any issues or disputes cannot be resolved unanimously within the Development * CONFIDENTIAL MATERIAL REDACTED AND FILED SEPARATELY WITH THE COMMISSION and Commercialization Committee, these issues shall be referred to Exhale’s CEO and the President of the Strategic Business Unit (“SBU”) Specialized Therapeutics at Schering’s Affiliate Berlipharm, Inc., Montville, New Jersey, U.S.A., for resolution. If Exhale’s CEO and the President of the SBU Specialized Therapeutics cannot resolve the issue unanimously, Exhale’s CEO shall discuss this issue with the board member of Schering who is responsible for the SBU Specialized Therapeutics. Should Exhale’s CEO and Schering’s board member not come to an unanimous resolution (i) with respect to an issue that could be reasonably expected to have an adverse effect on Schering’s Product business outside the Territory, then Schering shall have the final decision, and (ii) with respect to any other issue, Exhale shall have the final decision, provided that Exhale agrees to solely bear its increased cost or expense resulting from such decision. Each Party will disclose to the other proposed agenda items Committee reasonably in advance of each the meeting. The Party hosting any Committee meeting shall appoint one person (who need not be a member of the Development Committee) to attend the meeting and Commercialization record the minutes of the meeting in writing. Such minutes shall be circulated to the members of the Committee in a time frame to be agreed upon by the Committee after the meeting and the members agree to review and comment on such minutes in a time frame to be agreed upon by the Committee. Each Party shall bear its own costs for participation in the Development and Commercialization CommitteeThe Parties agree to use Commercially Reasonable Efforts to promptly finalize any dispute regarding minutes of any meeting. SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS ([***]) DENOTE SUCH OMISSIONS. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THIS OMITTED INFORMATION.

Appears in 1 contract

Samples: License and Supply Agreement (Midatech Pharma PLC)

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