Evaluation of Milestone Criteria. (a) In the event that a Vector achieves all or substantially all of the Milestone Criteria after TELETHON-HSR has completed the activities required to make such an assessment, TELETHON-HSR shall promptly notify GSK in writing of such event and shall provide to the JSC a completed data package containing a set of the analyses, results, raw data, reports and any related correspondence and information received from or sent to any Regulatory Authority from the Collaboration Program for such Lead Vector (the “Milestone Report”). Unless otherwise agreed to by the Parties, the JSC will schedule an ad hoc meeting as soon as reasonably possible, but in any event not more than [***] after receipt by GSK of such complete Milestone Criteria Report, to review such Milestone Report and to confirm whether or not such Vector meets all or substantially all of the applicable Milestone Criteria. In the event that the JSC agrees that all or substantially all of the applicable Milestone Criteria have been met, subject to payment of the milestone as outlined in Section 6.2, TELETHON-HSR shall use its Commercially Reasonable Efforts to continue to progress the Collaboration Program through to completion of the Proof of Concept Study. (b) If all or substantially all of the applicable Milestone Criteria have not been met, then TELETHON-HSR shall complete any additional studies as are required by the JSC to determine if all or substantially all of the applicable Milestone Criteria have been met and if they have, subject to payment of the applicable milestone, progress such Vector through completion of the Proof of Concept Study under the relevant provisions of Articles 2 and 3. If the Parties via the JSC (with neither Party having final say) disagree as to whether or not the relevant Milestone Criteria have been met or can reasonably be achieved for any particular Vector, such dispute will be referred to expert determination in accordance with Section 13.1(b), other than for the achievement of PoC Criteria, for which GSK shall have the final say under Section 3.2(d)(ii).
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)
Evaluation of Milestone Criteria. (a) In the event that a Vector Compound achieves all or substantially all of the Milestone Criteria after TELETHON-HSR PROSENSA has completed the activities required to make such an assessment, TELETHON-HSR PROSENSA shall promptly notify GSK in writing of such event and shall provide to the JSC a completed data package containing a set of the analyses, results, raw data, reports and any related correspondence and information received from or sent to any Regulatory Authority from the PROSENSA Collaboration Program for such Lead Vector Compound (the “Milestone Report”). Unless otherwise agreed to by the Parties, the JSC will schedule an ad hoc meeting as soon as reasonably possible, but in any event not more than [***] * * * * * after receipt by GSK of such complete Milestone Criteria Report, to review such Milestone Report and to confirm whether or not such Vector Compound meets all or substantially all of the applicable Milestone Criteria. In the event that the JSC agrees that all or substantially all of the applicable Milestone Criteria have been met, subject to payment of the milestone as outlined in Section 6.2, TELETHON-HSR PROSENSA shall use its Commercially Reasonable Efforts to continue to progress the PROSENSA Collaboration Program through to completion of the Proof of Concept Study.
(b) If all or substantially all of the applicable Milestone Criteria have not been met, then TELETHON-HSR PROSENSA shall complete any additional studies as are required by the JSC to determine if all or substantially all of the applicable Milestone Criteria have been met and if they have, subject to payment of the applicable milestone, progress such Vector Compound through completion of the Proof of Concept Study under the relevant provisions of Articles 2 and 3. If the Parties via the JSC (with neither Party having final say) disagree as to whether or not the relevant Milestone Criteria have been met or can reasonably be achieved for any particular VectorCompound, such dispute will be referred to expert determination in accordance with Section 13.1(b), other than for the achievement of PoC Criteria, for which GSK shall have the final say under Section 3.2(d)(ii).
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.)