Common use of Development Period Clause in Contracts

Development Period. 2.1 In consideration of Penwest's entering into this Agreement, Mylan shall pay Penwest upon the Effective Date a nonrefundable initial fee of ************. 2.2 As additional inducement to Penwest to enter into this Agreement, Mylan hereby affirms that, other than confidentiality agreements not binding either party to any further agreement, it currently has no agreement or arrangement with any Person other than Penwest for or including the development, design, testing, certification, manufacture or marketing by it or such other Person (or the Affiliate(s) of either) of any controlled-release Nifedipine product that is intended to be essentially bioequivalent to "Procardia XL," and agrees that it will refrain from entering into any such agreement or arrangement (other than such confidentiality agreements) throughout the duration of the Development Period or the period of eighteen months following the date hereof, whichever expires later. 2.3 During the Development Period, each of Penwest and Mylan will exert its continuing best efforts to perform their respective tasks specified in Exhibit , within the estimated time periods there stated, in order to create and produce the Designated Product, and each will cooperate with the other in such efforts. It is understood that the exertion of a party's best efforts will mean that this project will receive a priority at least as high as any of such party's other generic drug development efforts. Each party will, promptly and throughout the Development Period, provide to the other all necessary information in or coming into its possession or reasonably available to it for such purposes. Notwithstanding anything else to the contrary contained herein, nothing shall require either party to disclose confidential information for which such party has an obligation of confidentiality to a third party. Each party understands and agrees that the other does not warrant or commit that the Designated Product will be successfully developed, and neither party shall have any liability or responsibility to the other or to third parties for any such failure of the development process hereunder, except to the extent such failure results from said party's intentional misconduct, negligence, or breach of its duties or obligations as set forth herein. 2.4 Mylan shall be responsible for, and hereby agrees to conduct or arrange for, at Mylan's expense, all testing and studies during the Development Period, CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS including as to bioavailability and bioequivalence, in connection with the development, licensing, manufacture and marketing of the Designated Product, and for substantial compliance with all material and relevant governmental requirements imposed in the Territory with respect to the manufacture, use, and sale of the Designated Product. 2.5 Mylan shall be primarily responsible for the preparation, at its expense, of an ANDA for the Designated Product, to be filed with the FDA at the end of the Development Period. In consideration of Penwest's entering into this Agreement, Mylan agrees to pay Penwest a first milestone fee of *******, payable ********************************************************************* (but only with respect to the ***********************************************, where ********************** are *********************************************** 2.6 Each party's Project Contact will provide written reports to the other party's Project Contact at least monthly throughout the Development Period, stating in detail all efforts made and in process, and all significant progress achieved and difficulties encountered in the development effort since the last such report. Each party's Project Contact will also be available throughout the Development Period to answer any reasonable questions from the other party's Project Contact. The parties will cooperate reasonably during the Development Period such that the sites for meetings among their respective personnel shall be alternated among the parties' facilities to the extent practicable. 2.7 During the Development Period, Mylan will supply, at its own expense, all Nifedipine reasonably required to support the development effort, and Penwest shall provide at its own expense all TIMERx reasonably required for such effort. Each party shall bear its own expenses for all activities during the Development Period, except as otherwise stated in Exhibit . 2.8 Either party may terminate this Agreement before completion of the Development Period by delivery of 90 days' written notice to the other if such party reasonably determines that, due to unfavorable or inconclusive results to that time, no further Development Steps are likely to lead to the successful development of the target Designated Product listed in Exhibit .

Development Period. 2.1 In consideration of Penwest's entering into this Agreement, Mylan shall pay Penwest upon the Effective Date a nonrefundable initial fee of ************. Upon receipt of such sum, Penwest shall conduct a pilot bio-study, the results of which will be supplied to Mylan within 180 days of payment. 2.2 As additional inducement to Penwest to enter into this Agreement, Mylan hereby affirms that, other than confidentiality agreements not binding either party to any further agreement, it currently has no agreement or arrangement with any Person other than Penwest for or including the development, design, testing, certification, manufacture or marketing by it or such other Person (or the Affiliate(s) of either) of any controlled-release Nifedipine product that is intended to be essentially bioequivalent to "Procardia XLAdalat CC," and agrees that it will refrain from entering into any such agreement or arrangement (other than such confidentiality agreements) throughout the duration of the Development Period or the period of eighteen months following the date hereof, whichever expires later. 2.3 During the Development Period, each of Penwest and Mylan will exert its continuing best efforts to perform their respective tasks specified in Exhibit 2.3, within the estimated time periods there stated, in order to create and produce the Designated Product, and each will cooperate with the other in such efforts. It is understood that the exertion of a party's best efforts will mean that this project will receive a priority at least as high as any of such party's other generic drug development efforts. Each party will, promptly and throughout the Development Period, provide to the other all necessary information in or coming into its possession or reasonably available to it for such purposes. Notwithstanding anything else to the contrary contained herein, nothing shall require either party to disclose confidential information for which such party has an obligation of confidentiality to a third party. Each party understands and agrees that the other does not warrant or commit that the Designated Product will be successfully developed, and neither party shall have any liability or responsibility to the other or to third parties for any such failure of the development process hereunder, except to the extent such failure results from said party's intentional misconduct, negligence, or breach of its duties or obligations as set forth herein. 2.4 Mylan shall be responsible for, and hereby agrees to conduct or arrange for, at Mylan's expense, all testing and studies during the Development Period, CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS including as to bioavailability and bioequivalence, in connection with the development, licensing, manufacture and marketing of the Designated Product, and for substantial compliance with all material and relevant governmental requirements imposed in the Territory with respect to the manufacture, use, and sale of the Designated ProductCONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS. 2.5 Mylan shall be primarily responsible for the preparation, at its expense, of an ANDA for the Designated Product, to be filed with the FDA at the end of the Development Period. In consideration of Penwest's entering into this Agreement, Mylan agrees to pay Penwest a first milestone fee of *******, payable ********************************************************************* (but only with respect to the ***********************************************, where ********************** are *********************************************** 2.6 Each party's Project Contact will provide written reports to the other party's Project Contact at least monthly throughout the Development Period, stating in detail all efforts made and in process, and all significant progress achieved and difficulties encountered in the development effort since the last such report. Each party's Project Contact will also be available throughout the Development Period to answer any reasonable questions from the other party's Project Contact. The parties will cooperate reasonably during the Development Period such that the sites for meetings among their respective personnel shall be alternated among the parties' facilities to the extent practicable. 2.7 During the Development Period, Mylan will supply, at its own expense, all Nifedipine reasonably required to support the development effort, and Penwest shall provide at its own expense all TIMERx reasonably required for such effort. Each party shall bear its own expenses for all activities during the Development Period, except as otherwise stated in Exhibit . 2.8 Either party may terminate this Agreement before completion of the Development Period by delivery of 90 days' written notice to the other if such party reasonably determines that, due to unfavorable or inconclusive results to that time, no further Development Steps are likely to lead to the successful development of the target Designated Product listed in Exhibit .