Reports and Information Exchange. As between the Parties -------------------------------- hereto, BioMarin/Genzyme LLC shall own all clinical trial data accumulated from all clinical trials of Collaboration Products conducted as part of the Program or otherwise funded or partially funded by BioMarin/Genzyme LLC. Each of BioMarin and Genzyme shall use commercially reasonable and diligent efforts to disclose to BioMarin/Genzyme LLC and to the other Party all material information relating to any Collaboration Product promptly after it is learned or its materiality is appreciated. The Party performing or supervising clinical trials of Collaboration Products in accordance with the Development Plan shall, on behalf and in the name of BioMarin/Genzyme LLC, maintain the database of clinical trial data accumulated from all clinical trials of Collaboration Products and of adverse reaction information for all such Collaboration Products. Each Party shall also keep the Program Management Team informed as to its progress in the Development Plan. All protocols for clinical trials to be conducted, and all product registration plans, for Collaboration Products for applications within the Field in the Territory shall be submitted to the Program Management Team for review and comment by the Program Management Team prior to filing of such protocols or registrations with any regulatory agency. Within sixty (60) days following the end of each calendar quarter during the Development Program, each of BioMarin and Genzyme shall provide the other Parties with a reasonably detailed written report describing the progress to date of all activities for which such Party was allocated responsibility during such quarter under the Development Plan.
Appears in 2 contracts
Sources: Collaboration Agreement (Biomarin Pharmaceutical Inc), Collaboration Agreement (Biomarin Pharmaceutical Inc)
Reports and Information Exchange. As between the Parties -------------------------------- hereto, BioMarin/Genzyme LLC shall own all clinical trial data accumulated from all clinical trials of Collaboration Products conducted as part of the Program or otherwise funded or partially funded by BioMarin/Genzyme LLCthe Parties. Each of BioMarin Party shall use, and Genzyme shall use cause its Permitted Subcontractors to use, commercially reasonable and diligent efforts to disclose to BioMarin/Genzyme LLC and to the other Party all material information relating to any Collaboration Product promptly after it is learned or its materiality is appreciated. The Party performing or supervising clinical trials of Collaboration Products in accordance with the Development Plan shallshall maintain, on behalf and in the name of BioMarin/Genzyme LLCshall cause its Permitted Subcontractors to maintain, maintain the database of clinical trial data accumulated from all clinical trials of Collaboration Products and of adverse reaction information for all such Collaboration Products. Such database shall be maintained in accordance with the Medical Dictionary for Regulatory Activities standard, as in effect from time to time. Each Party shall also keep the Program Management Team informed as to its or its Permitted Subcontractors’ progress in the Development Plan. All protocols for clinical trials to be conducted, and all product registration plans, plans for Collaboration Products for applications within the Field in the Territory shall be submitted to the Program Management Team for review and comment by the Program Management Team prior to filing of such protocols or registrations with any regulatory agency. Within sixty (60) days following the end of each calendar quarter during the Development Program, each of BioMarin and Genzyme Party shall provide the other Parties Party with a reasonably detailed written report describing which shall describe the progress to date of all activities for which such Party was and its Affiliates were allocated responsibility during such quarter under the Development Plan.
Appears in 2 contracts
Sources: License and Collaboration Agreement, License and Collaboration Agreement (Cambridge Antibody Technology Group PLC)
Reports and Information Exchange. As between the Parties -------------------------------- hereto, BioMarin/Genzyme LLC shall own all -------------------------------- clinical trial data accumulated from all clinical trials of Collaboration Products conducted as part of the Program or otherwise funded or partially funded by BioMarin/Genzyme LLCthe Parties. Each of BioMarin Party shall use, and Genzyme shall use cause its Permitted Subcontractors to use, commercially reasonable and diligent efforts to disclose to BioMarin/Genzyme LLC and to the other Party all material information relating to any Collaboration Product promptly after it is learned or its materiality is appreciated. The Party performing or supervising clinical trials of Collaboration Products in accordance with the Development Plan shallshall maintain, on behalf and in the name of BioMarin/Genzyme LLCshall cause its Permitted Subcontractors to maintain, maintain the database of clinical trial data accumulated from all clinical trials of Collaboration Products and of adverse reaction information for all such Collaboration Products. Such database shall be maintained in accordance with the Medical Dictionary for Regulatory Activities standard, as in effect from time to time. Each Party shall also keep the Program Management Team informed as to or its or its Permitted Subcontractors' progress in the Development Plan. All protocols for clinical trials to be conducted, and all product registration plans, plans for Collaboration Products for applications within the Field in the Territory shall be submitted to the Program Management Team for review and comment by the Program Management Team prior to filing of such protocols or registrations with any regulatory agency. Within sixty (60) days following the end of each calendar quarter during the Development Program, each of BioMarin and Genzyme Party shall provide the other Parties Party with a reasonably detailed written report describing which shall describe the progress to date of all activities for which such Party was and its Affiliates were allocated responsibility during such quarter under the Development Plan.
Appears in 1 contract
Sources: License and Collaboration Agreement (Cambridge Antibody Technology Group PLC)