Safety Data Exchange. The Parties shall negotiate in good faith a safety data exchange agreement with respect to GSK Products within sixty (60) Calendar Days of GSK’s exercise of an Option. The safety data exchange agreement shall facilitate management of safety for all GSK Products covered under such agreement in accordance with standards that are no less stringent than in the ICH guidelines, such that the Parties would be able to comply with all regulatory and legal requirements regarding the management of safety data, by providing for the exchange of relevant information in appropriate format within applicable timeframes.
Appears in 2 contracts
Samples: Research and Development Collaboration and License Agreement (Prosensa Holding B.V.), Research and Development Collaboration and License Agreement (Prosensa Holding B.V.)
Safety Data Exchange. The Parties shall negotiate in good faith a safety data exchange agreement with respect to GSK Products within sixty (60) Calendar Days [***] of GSK’s exercise of an Option. The safety data exchange agreement shall facilitate management of safety for all GSK Products covered under such agreement in accordance with standards that are no less stringent than in the ICH guidelines, such that the Parties would be able to comply with all regulatory and legal requirements regarding the management of safety data, by providing for the exchange of relevant information in appropriate format within applicable timeframes.
Appears in 2 contracts
Samples: Research and Development Collaboration and License Agreement (Orchard Rx LTD), Research and Development Collaboration and License Agreement (Orchard Rx LTD)
Safety Data Exchange. The Parties shall negotiate in good faith a safety data exchange agreement with respect to GSK Products within sixty (60) Calendar Days [ * ] days of GSK’s exercise of an Option. The safety data exchange agreement shall facilitate management of safety for all GSK Products covered under such agreement in accordance with standards that are no less stringent than in the ICH guidelines, such that the Parties would be able to comply with all regulatory and legal requirements regarding the management of safety data, by providing for the exchange of relevant information in appropriate format within applicable timeframes.
Appears in 2 contracts
Samples: Research and Development Collaboration and License Agreement (Dynavax Technologies Corp), Research and Development Collaboration and License Agreement (Dynavax Technologies Corp)