Research Commitment. During the Formulation-Development Term, Emisphere shall use commercially reasonable efforts to conduct its responsibilities under the Formulation-Development Program in accordance with the Formulation-Development Plan and Formulation-Development Budget, as revised from time to time by the TLC. Without limiting the generality of the foregoing, Emisphere shall devote to the Formulation-Development Program such personnel as is reasonably necessary to conduct all of Emisphere’s responsibilities required under the Formulation-Development Plan, it being understood that Genta is and will be responsible (a) under the Formulation-Development Plan only for the supply of cGMP quantities of Gallium Salt API (in the form of gallium nitrate or such Gallium Salt(s) as may be mutually agreed by the parties) to Emisphere in connection with formulation development, and (b) for the conduct of the Clinical Program (as set forth in greater detail in Article 4). Emisphere acknowledges that while the Formulation-Development Plan describes the principal activities that Emisphere is to perform under the Formulation-Development Program, Emisphere’s responsibilities under the Formulation-Development Program (and the reimbursement provided under Section 6.1) include all such activities that would normally be performed to perform such principal activities, including the analysis and compilation of results from such activities in a form appropriate for submission in an IND filing. Subject to the foregoing Genta acknowledges that Emisphere’s responsibilities under the Formulation-Development Program may not constitute all activities that are necessary to develop a Product for the * Field to the point of supporting the filing of an IND. In addition, Emisphere shall promptly provide written reports of the status of its activities under the Formulation-Development Plan and the results from its performance of such activities, in accordance with a schedule agreed upon by the parties, which shall be in any event at least monthly. Each party shall be solely responsible for the costs and expenses incurred in connection with its performance of Development Plan activities, subject to Section 6.1. Genta shall be responsible for the conduct of toxicology studies of Products that it deems appropriate, to the extent such studies are not otherwise covered by the Formulation-Development Plan. To the extent Genta conducts any toxicology studies of Products, Emisphere shall have no right to utilize the data generated from such studies without the prior written consent of Genta, unless required by law; provided, however, that, at Emisphere’s option, Emisphere shall have the right to purchase such data solely for use in accordance with Section 5.3, and Genta agrees, subject to Genta’s consent not to be unreasonably withheld, to sell such data to Emisphere solely for such purpose and as Confidential Information of Genta subject to the confidentiality restrictions of this Agreement, upon payment by Emisphere to Genta of an amount equal to Genta’s cost of conducting the applicable toxicology study(ies). * denotes material omitted pursuant to a Confidential Treatment Request and filed separately with the Securities and Exchange Commission.
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Sources: Development and License Agreement (Emisphere Technologies Inc)
Research Commitment. During the Formulation-Development Term, Emisphere shall use commercially reasonable efforts to conduct its responsibilities under the Formulation-Development Program in accordance with the Formulation-Development Plan and Formulation-Development Budget, as revised from time to time by the TLC. Without limiting the generality of the foregoing, Emisphere shall devote to the Formulation-Development Program such personnel as is reasonably necessary to conduct all of Emisphere’s responsibilities required under the Formulation-Development Plan, it being understood that Genta is and will be responsible (a) under the Formulation-Development Plan only for the supply of cGMP quantities of Gallium Salt API (in the form of gallium nitrate or such Gallium Salt(s) as may be mutually agreed by the parties) to Emisphere in connection with formulation development, and (b) for the conduct of the Clinical Program (as set forth in greater detail in Article 4). Emisphere acknowledges that while the Formulation-Development Plan describes the principal activities that Emisphere is to perform under the Formulation-Development Program, Emisphere’s responsibilities under the Formulation-Development Program (and the reimbursement provided under Section 6.1) include all such activities that would normally be performed to perform such principal activities, including the analysis and compilation of results from such activities in a form appropriate for submission in an IND filing. Subject to the foregoing Genta acknowledges that Emisphere’s responsibilities under the Formulation-Development Program may not constitute all activities that are necessary to develop a Product for the * Field to the point of supporting the filing of an IND. In addition, Emisphere shall promptly provide written reports of the status of its activities under the Formulation-Development Plan and the results from its performance of such activities, in accordance with a schedule agreed upon by the parties, which shall be in any event at least monthly. Each party shall be solely responsible for the costs and expenses incurred in connection with its performance of Development Plan activities, subject to Section 6.1. Genta shall be responsible for the conduct of toxicology studies of Products that it deems appropriate, to the extent such studies are not otherwise covered by the Formulation-Development Plan. To the extent Genta conducts any toxicology studies of Products, Emisphere shall have no right to utilize the data generated from such studies without the prior written consent of Genta, unless required by law; provided, however, that, at Emisphere’s option, Emisphere shall have the right to purchase such data solely for use in accordance with Section 5.3, and Genta agrees, subject to Genta’s consent not to be unreasonably withheld, to sell such data to Emisphere solely for such purpose and as Confidential Information of Genta subject to the confidentiality restrictions of this Agreement, upon payment by Emisphere to Genta of an amount equal to Genta’s cost of conducting the applicable toxicology study(ies). * denotes material omitted pursuant to a Confidential Treatment Request and filed separately with the Securities and Exchange Commission.its
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