Carrier Process Development. (a) As part of the Programme, as identified in attached Annex A, Novartis may at its sole discretion be solely responsible for the process research, Development and manufacture of the Programme Carriers, including the final quality of any required salts. Novartis shall be solely responsible for Developing and implementing manufacturing processes, which shall yield materials of appropriate purity, morphology and stability as required by Novartis to commercialize the Product. In the event that Novartis does not elect to be responsible for such activities pursuant to this Article 3.6(a), it shall notify Emisphere within thirty (30) Business Days of taking such a decision and request that Emisphere shall be responsible for all such activities pursuant to this Article 3.6(a). In the event that Emisphere elects to assume responsibility for such activities and provided that Emisphere has received such technical information deemed necessary by both Parties, Emisphere shall provide to Novartis within thirty (30) Business Days of receiving the Novartis request and technical information, a non-binding budget and plan for the conduct of such activities, such budget to be fully paid if agreed to by Novartis on the basis of invoices or reasonable estimates received (the “Emisphere Proposal”). Novartis shall provide all reasonably available information necessary for Emisphere to prepare such budget. Novartis shall have thirty (30) Business Days after receipt of such plan to consider the Emisphere Proposal and in the event that Novartis does not accept the terms of the Emisphere Proposal, Novartis may enter into an agreement with a Third Party for the conduct of such activities.
Carrier Process Development. (a) As part of the Programme, as identified in attached Annex A, Novartis may at its sole discretion be solely responsible for the process research, Development and manufacture of the Development Plan Carriers, including the final quality of any required salts. Novartis shall be solely responsible for Developing and implementing manufacturing processes, which shall yield materials of appropriate purity, morphology and stability as required by Novartis to commercialize the Product. In the event that Novartis does not elect to be responsible for such activities pursuant to this Article 3.6(a), it shall notify Emisphere within thirty (30) Business Days of taking such a decision and request that Emisphere shall be responsible for all such activities pursuant to this Article 3.6(a). In the event that Emisphere elects to assume responsibility for such activities and provided that Emisphere has received such technical information deemed necessary by both Parties, Emisphere shall provide to Novartis within thirty (30) Business Days of receiving the Novartis request and technical information, a non-binding budget and plan for the conduct of such activities, such budget to be fully paid if agreed to by Novartis on the basis of invoices or reasonable estimates received (the “Emisphere Proposal”). Novartis shall provide all *** - indicates material omitted pursuant to a Confidential Treatment Request and filed separately with the Securities and Exchange Commission.
Carrier Process Development. (a) As part of the Programme, as identified in attached Annex A, *** may at its sole discretion be solely responsible for the process research, Development and manufacture of the Programme Carriers, including the final quality of any required salts. *** shall be solely responsible for Developing and implementing manufacturing processes, which shall yield materials of appropriate purity, morphology and stability as required by Novartis to commercialize the Product. In the event that *** does not elect to be responsible for such activities pursuant to this Article 3.6(a), it shall notify *** within thirty (30) Business Days of taking such a decision and request that *** shall be responsible for all such activities pursuant to this Article 3.6(a). In the event that *** elects to assume responsibility for such activities and provided that *** has received such technical information deemed necessary by both Parties, *** shall provide to *** within thirty (30) Business Days of receiving the *** request and technical information, a non-binding budget and plan for the conduct of such activities, such budget to be fully paid if agreed to by *** on the basis of invoices or reasonable estimates received (the “***l”). *** shall provide all reasonably available information necessary for *** to prepare such budget. *** shall have thirty (30) Business Days after receipt of such plan to consider the *** Proposal and in the event that *** does not accept the terms of the *** Proposal, *** may enter into an agreement with a Third Party for the conduct of such activities.
