Common use of Feasibility Study Clause in Contracts

Feasibility Study. 3.1 KRYPTON shall initiate the development program contemplated hereunder as soon as technically feasible and within the time limits set forth in the mutually accepted development program by giving written notice to that effect to GENTA JAGO. Not later than two (2) months after receipt of (i) such notice, (ii) a * and (iii) the Active Ingredient, GENTA JAGO shall commence the feasibility study under this Article 3. and shall use its commercially reasonable efforts to develop the Prototype Formulations. Up to three (3) of the developed Prototype Formulations shall be chosen by mutual agreement by the Parties for further study and development. ----------------- * Confidential treatment requested. The redacted material has been separately filed with the Commission. The Parties recognize that the Specifications mutually agreed upon eventually will need to be updated with more detailed specifications for the Final Product in the course of the development, and in such case the Parties agree to mutually agree on any reasonable amendment of the Specifications. 3.2 The development of the Prototype Formulations shall include, but not necessarily be limited to, the following elements: (a) Development and establishment of analytical methodology specific to the characterization of such Prototype Formulations; (b) Qualitative and quantitative characterization of such Prototype Formulation; (c) In-vitro release profile characterization of such Prototype Formulations and the Originator by using appropriate methodology mutually agreed to by the Parties; (d) Elaboration of pre-scale up procedures and the production of samples (2000 units +/- 10%) of the chosen Prototype Formulations for evaluation by KRYPTON, and for use in the Pilot Pharmacokinetic Study under Article 4. below; and (e) Accelerated stability testing of Prototype Formulations to provide *. 3.3 GENTA JAGO will ensure the use of generally accepted standards of Good Laboratory and Manufacturing Practices during the performance of the feasibility study. 3.4 Within thirty (30) days of the completion of the feasibility study, GENTA JAGO shall supply KRYPTON with a report (the "Feasibility Study Report") reasonably detailing the development of the Prototype Formulation(s) and containing one (1) month accelerated stability data only. A supplement to the Feasibility Study Report containing the * accelerated stability data will be forwarded sixty (60) days later. 3.5 Prior to the commencement of the Feasibility Study GENTA JAGO shall submit to KRYPTON * for the entire Feasibility Study which * shall be reasonably acceptable to KRYPTON. KRYPTON shall reimburse GENTA JAGO's *, reasonably incurred by GENTA JAGO during the Feasibility Study, including but not limited to costs, expenses and fees paid to Jago Pharma and third party contractors, by the payment of non-refundable development fees. Such development costs shall be refunded by KRYPTON to GENTA JAGO * upon receipt by KRYPTON of an invoice from GENTA JAGO or Jago Pharma AG. 3.6 In the event that the results of the feasibility study conclusively demonstrate that no Prototype Formulation has been developed which reasonably meets the Specifications to ----------------- * Confidential treatment requested. The redacted material has been separately filed with the Commission. the good faith mutual satisfaction of KRYPTON and GENTA JAGO, the Parties agree to enter into good faith negotiations in order to determine an appropriate course of action, including, but not limited to, that the Parties may mutually agree to abandon the development program under this Agreement, and terminate this Agreement with immediate effect.

Appears in 1 contract

Samples: Development & Sub License Agreement (Genta Incorporated /De/)

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Feasibility Study. 3.1 KRYPTON shall initiate the development program contemplated hereunder as soon as technically feasible and within the time limits set forth in the mutually accepted development program by giving written notice to that effect to GENTA JAGO. Not later than two (2) months after receipt of (i) such notice, (ii) a * and (iii) the Active Ingredient, GENTA JAGO shall commence the feasibility study under this Article 3. and shall use its commercially reasonable efforts to develop the Prototype Formulations. Up to three (3) of the developed Prototype Formulations shall be chosen by mutual agreement by the Parties for further study and development. ----------------- ------------------ * Confidential treatment requested. The redacted material has been separately filed with the Commission. The Parties recognize that the Specifications mutually agreed upon uopn eventually will need to be updated with more detailed specifications for the Final Product in the course of the development, and in such case the Parties agree to mutually agree on any reasonable amendment of the Specifications. 3.2 The development of the Prototype Formulations shall include, but not necessarily be limited to, the following elements: (a) Development and establishment of analytical methodology specific to the characterization of such Prototype Formulations; (b) Qualitative and quantitative characterization of such Prototype Formulation; (c) In-vitro release profile characterization of such Prototype Formulations and the Originator by using appropriate methodology mutually agreed to by the Parties; (d) Elaboration of pre-scale up procedures and the production of samples (2000 units +/- 10%) of the chosen Prototype Formulations for evaluation by KRYPTON, and for use in the Pilot Pharmacokinetic Study under Article 4. below; and (e) Accelerated stability testing of Prototype Formulations to provide *. 3.3 GENTA JAGO will ensure the use of generally accepted standards of Good Laboratory and Manufacturing Practices during the performance of the feasibility study. 3.4 Within thirty (30) days of the completion of the feasibility study, GENTA JAGO shall supply KRYPTON with a report (the "Feasibility Study Report") reasonably detailing the development of the Prototype Formulation(s) and containing one (1) month accelerated stability data only. A supplement to the Feasibility Study Report containing the * accelerated stability data will be forwarded sixty (60) days later. 3.5 Prior to the commencement of the Feasibility Study GENTA JAGO shall submit to KRYPTON * for the entire Feasibility Study which * shall be reasonably acceptable to KRYPTON. KRYPTON shall reimburse GENTA JAGO's *, reasonably incurred by GENTA JAGO during the Feasibility Study, including but not limited to costs, expenses and fees paid to Jago Pharma and third party contractors, by the payment of non-refundable development fees. Such development costs shall be refunded by KRYPTON to GENTA JAGO * at the end of each quarter upon receipt by KRYPTON of an invoice from GENTA JAGO or Jago Pharma AG. 3.6 In the event that the results of the feasibility study conclusively demonstrate that no Prototype Formulation has been developed which reasonably meets the Specifications to ----------------- * Confidential treatment requested. The redacted material has been separately filed with the Commission. the good faith mutual satisfaction of KRYPTON and GENTA JAGO, the Parties agree to enter into good faith negotiations in order to determine an appropriate course of action, ------------------ * Confidential treatment requested. The redacted material has been separately filed with the Commission. including, but not limited to, that the Parties may mutually agree to abandon the development program under this Agreement, and terminate this Agreement with immediate effect.

Appears in 1 contract

Samples: Development & Sub License Agreement (Genta Incorporated /De/)

Feasibility Study. 3.1 By the notice of exercise of the option granted in Section 2.1 above from KRYPTON shall initiate the development program contemplated hereunder as soon as technically feasible and within the time limits set forth in the mutually accepted development program by giving written notice to that effect to GENTA JAGOshall be initiated. Not later than two (2) months after as of the receipt of (i) such notice, (ii) a * and (iii) the Active Ingredient, GENTA JAGO shall commence the feasibility study under this Article 3. and shall use its commercially reasonable efforts to develop the Prototype Formulations. Up to three (3) of the developed Prototype Formulations shall be chosen by mutual agreement by the Parties for further study and development. ----------------- * Confidential treatment requested. The redacted material has been separately filed with the Commission. The Parties recognize that the Specifications mutually agreed upon eventually will need to be updated with more detailed specifications for the Final Product in the course of the development, and in such case the Parties agree to mutually agree on any reasonable amendment of the Specifications. 3.2 The development of the Prototype Formulations shall include, but not necessarily be limited to, the following elements: (a) Development and establishment of analytical methodology specific to the characterization of such Prototype Formulations; (b) Qualitative and quantitative characterization of such Prototype Formulation; (c) In-vitro release profile characterization of such Prototype Formulations and the Originator by using appropriate methodology mutually agreed to by the Parties; (d) Elaboration of pre-scale up procedures and the production of samples (2000 units +/- 10%) of the chosen Prototype Formulations for evaluation by KRYPTON, and for use in the Pilot Pharmacokinetic Study under Article 4. below; and (e) Accelerated stability testing of Prototype Formulations to provide *. 3.3 GENTA JAGO will ensure the use of generally accepted standards of Good Laboratory and Manufacturing Practices during the performance of the feasibility study. 3.4 Within thirty (30) days of the completion of the feasibility study, GENTA JAGO shall supply KRYPTON with a report (the "Feasibility Study Report") reasonably detailing the development of the Prototype Formulation(s) and containing one (1) month accelerated stability data only. A supplement to the Feasibility Study Report containing the * accelerated stability data will be forwarded sixty (60) days later. ------------------ * Confidential treatment requested. The redacted material has been separately filed with the Commission. 3.5 Prior to the commencement of the Feasibility Study GENTA JAGO shall submit to KRYPTON a * for the entire Feasibility Study which * shall be reasonably acceptable to KRYPTON. KRYPTON shall reimburse GENTA JAGO's *, reasonably incurred by GENTA JAGO during the Feasibility Study, including but not limited to costs, expenses and fees paid to Jago Pharma and third party contractors, by the payment of non-refundable development fees. Such development costs shall be refunded by KRYPTON to GENTA JAGO * upon receipt by KRYPTON of an invoice from GENTA JAGO or Jago Pharma AG. 3.6 In the event that the results of the feasibility study conclusively demonstrate that no Prototype Formulation has been developed which reasonably meets the Specifications to ----------------- * Confidential treatment requested. The redacted material has been separately filed with the Commission. the good faith mutual satisfaction of KRYPTON and GENTA JAGO, the Parties agree to enter into good faith negotiations in order to determine an appropriate course of action, including, but not limited to, that the Parties may mutually agree to abandon the development program under this Agreement, and terminate this Agreement with immediate effect.

Appears in 1 contract

Samples: Option, Development & Sub License Agreement (Genta Incorporated /De/)

Feasibility Study. 3.1 KRYPTON shall initiate the development program contemplated hereunder as soon as technically feasible and within the time limits set forth in the mutually accepted development program by giving written notice to that effect to GENTA JAGO. Not later than two (2) months after receipt of (i) such notice, (ii) a * and (iii) the Active Ingredient, GENTA JAGO shall commence the feasibility study under this Article 3. and shall use its commercially reasonable efforts to develop the Prototype Formulations. Up to three (3) of the developed Prototype Formulations shall be chosen by mutual agreement by the Parties for further study and development. ----------------- ------------- * Confidential treatment requested. The redacted material has been separately filed with the Commission. The Parties recognize that the Specifications mutually agreed upon eventually will need to be updated with more detailed specifications for the Final Product in the course of the development, and in such case the Parties agree to mutually agree on any reasonable amendment of the Specifications. 3.2 The development of the Prototype Formulations shall include, but not necessarily be limited to, the following elements: (a) Development and establishment of analytical methodology specific to the characterization of such Prototype Formulations; (b) Qualitative and quantitative characterization of such Prototype Formulation; (c) In-vitro release profile characterization of such Prototype Formulations and the Originator by using appropriate methodology mutually agreed to by the Parties; (d) Elaboration of pre-scale up procedures and the production of samples (2000 units +/- 10%) of the chosen Prototype Formulations for evaluation by KRYPTON, and for use in the Pilot Pharmacokinetic Study under Article 4. below; and (e) Accelerated stability testing of Prototype Formulations to provide *. 3.3 GENTA JAGO will ensure the use of generally accepted standards of Good Laboratory and Manufacturing Practices during the performance of the feasibility study. 3.4 Within thirty (30) days of the completion of the feasibility study, GENTA JAGO shall supply KRYPTON with a report (the ",,Feasibility Study Report") reasonably detailing the development of the Prototype Formulation(s) and containing one (1) month accelerated stability data only. A supplement to the Feasibility Study Report containing the * accelerated stability data will be forwarded sixty (60) days later. 3.5 Prior to the commencement of the Feasibility Study GENTA JAGO shall submit to KRYPTON * for the entire Feasibility Study which * shall be reasonably acceptable to KRYPTON. KRYPTON shall reimburse GENTA JAGO's *, reasonably incurred by GENTA JAGO during the Feasibility Study, including but not limited to costs, expenses and fees paid to Jago Pharma and third party contractors, by the payment of non-refundable development fees. Such development costs shall be refunded by KRYPTON to GENTA JAGO * upon receipt by KRYPTON of an invoice from GENTA JAGO or Jago Pharma AG. 3.6 In the event that the results of the feasibility study conclusively demonstrate that no Prototype Formulation has been developed which reasonably meets the Specifications to ----------------- * Confidential treatment requested. The redacted material has been separately filed with the Commission. the good faith mutual satisfaction of KRYPTON and GENTA JAGO, the Parties agree to enter into good faith negotiations in order to determine an appropriate course of action, including, but not limited to, that the Parties may mutually agree to abandon the ------------- * Confidential treatment requested. The redacted material has been separately filed with the Commission. development program under this Agreement, and terminate this Agreement with immediate effect.

Appears in 1 contract

Samples: Development & Sub License Agreement (Genta Incorporated /De/)

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Feasibility Study. 3.1 KRYPTON shall initiate the development program contemplated hereunder as soon as technically feasible and within the time limits set forth in the mutually accepted development program by giving written notice to that effect to GENTA JAGO. Not later than two (2) months after receipt of (i) such notice, (ii) a * and (iii) the Active Ingredient, GENTA JAGO shall commence the feasibility study under ------------- * Confidential treatment requested. The redacted material has been separately filed wit the Commission. this Article 3. and shall use its commercially reasonable efforts to develop the Prototype Formulations. Up to three (3) of the developed Prototype Formulations shall be chosen by mutual agreement by the Parties for further study and development. ----------------- * Confidential treatment requested. The redacted material has been separately filed with the Commission. The Parties recognize that the Specifications mutually agreed upon eventually will need to be updated with more detailed specifications for the Final Product in the course of the development, and in such case the Parties agree to mutually agree on any reasonable amendment of the Specifications. 3.2 The development of the Prototype Formulations shall include, but not necessarily be limited to, the following elements: (a) Development and establishment of analytical methodology specific to the characterization of such Prototype Formulations; (b) Qualitative and quantitative characterization of such Prototype Formulation; (c) In-vitro release profile characterization of such Prototype Formulations and the Originator by using appropriate methodology mutually agreed to by the Parties; (d) Elaboration of pre-scale up procedures and the production of samples (2000 units +/- 10%) of the chosen Prototype Formulations for evaluation by KRYPTON, and for use in the Pilot Pharmacokinetic Study under Article 4. below; and (e) Accelerated stability testing of Prototype Formulations to provide *. 3.3 GENTA JAGO will ensure the use of generally accepted standards of Good Laboratory and Manufacturing Practices during the performance of the feasibility study. 3.4 Within thirty (30) days of the completion of the feasibility study, GENTA JAGO shall supply KRYPTON with a report (the "Feasibility Study Report") reasonably detailing the development of the Prototype Formulation(s) and containing one (1) month accelerated stability data only. A supplement to the Feasibility Study Report containing the * accelerated stability data will be forwarded sixty (60) days later. 3.5 Prior to the commencement of the Feasibility Study GENTA JAGO shall submit to KRYPTON * for the entire Feasibility Study which * shall be reasonably acceptable to KRYPTON. KRYPTON shall reimburse GENTA JAGO's *, reasonably incurred by GENTA JAGO during the Feasibility Study, including but not limited to costs, expenses and fees paid to Jago Pharma and third party contractors, by the payment of non-refundable development fees. Such development costs shall be refunded by KRYPTON to GENTA JAGO * upon receipt by KRYPTON of an invoice from GENTA JAGO or Jago Pharma AG. ------------- * Confidential treatment requested. The redacted material has been separately filed wit the Commission. 3.6 In the event that the results of the feasibility study conclusively demonstrate that no Prototype Formulation has been developed which reasonably meets the Specifications to ----------------- * Confidential treatment requested. The redacted material has been separately filed with the Commission. the good faith mutual satisfaction of KRYPTON and GENTA JAGO, the Parties agree to enter into good faith negotiations in order to determine an appropriate course of action, including, but not limited to, that the Parties may mutually agree to abandon the development program under this Agreement, and terminate this Agreement with immediate effect.

Appears in 1 contract

Samples: Development & Sub License Agreement (Genta Incorporated /De/)

Feasibility Study. 3.1 KRYPTON shall initiate the development program contemplated hereunder as soon as technically feasible and within the time limits set forth in the mutually accepted development program by giving written notice to that effect to GENTA JAGO. Not later than two (2) months after receipt of (i) such notice, (ii) a * and (iii) the Active Ingredient, GENTA JAGO shall commence the feasibility study under this Article 3. and shall use its commercially reasonable efforts to develop the Prototype Formulations. Up to three (3) of the developed Prototype Formulations shall be chosen by mutual agreement by the Parties for further study and development. ----------------- * Confidential treatment requested. The redacted material has been separately filed with the Commission. The Parties recognize that the Specifications mutually agreed upon uopn eventually will need to be updated with more detailed specifications for the Final Product in the course of the development, and in such case the Parties agree to mutually agree on any reasonable amendment of the Specifications. 3.2 The development of the Prototype Formulations shall include, but not necessarily be limited to, the following elements: (a) Development and establishment of analytical methodology specific to the --------------- * Confidential treatment requested. The redacted material has been separately filed with the Commission. characterization of such Prototype Formulations; (b) Qualitative and quantitative characterization of such Prototype Formulation; (c) In-vitro release profile characterization of such Prototype Formulations and the Originator by using appropriate methodology mutually agreed to by the Parties; (d) Elaboration of pre-scale up procedures and the production of samples (2000 units +/- 10%) of the chosen Prototype Formulations for evaluation by KRYPTON, and for use in the Pilot Pharmacokinetic Study under Article 4. below; and (e) Accelerated stability testing of Prototype Formulations to provide *. 3.3 GENTA JAGO will ensure the use of generally accepted standards of Good Laboratory and Manufacturing Practices during the performance of the feasibility study. 3.4 Within thirty (30) days of the completion of the feasibility study, GENTA JAGO shall supply KRYPTON with a report (the "Feasibility Study Report") reasonably detailing the development of the Prototype Formulation(s) and containing one (1) month accelerated stability data only. A supplement to the Feasibility Study Report containing the * accelerated stability data will be forwarded sixty (60) days later. 3.5 Prior to the commencement of the Feasibility Study GENTA JAGO shall submit to KRYPTON * for the entire Feasibility Study which * shall be reasonably acceptable to KRYPTON. KRYPTON shall reimburse GENTA JAGO's *, reasonably incurred by GENTA JAGO during the Feasibility Study, including but not limited to costs, expenses and fees paid to Jago Pharma and third party contractors, by the payment of non-refundable development fees. Such development costs shall be refunded by KRYPTON to GENTA JAGO * upon receipt by KRYPTON of an invoice from GENTA JAGO or Jago Pharma AG. 3.6 In the event that the results of the feasibility study conclusively demonstrate that no Prototype Formulation has been developed which reasonably meets the Specifications to ----------------- * Confidential treatment requested. The redacted material has been separately filed with the Commission. the good faith mutual satisfaction of KRYPTON and GENTA JAGO, the Parties agree to enter into good faith negotiations in order to determine an appropriate course of action, including, but not limited to, that the Parties may mutually agree to abandon the development program under this Agreement, and terminate this Agreement with immediate effect.

Appears in 1 contract

Samples: Development & Sub License Agreement (Genta Incorporated /De/)

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