Common use of Certification Period Clause in Contracts

Certification Period. 3.1 During the Certification Period, Mylan will exert its continuing best efforts, at its expense, to prosecute the ANDA(s) for the Designated Product (in all CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS the contemplated dosage strengths) filed hereunder successfully to the granting of an FDA approval to market the Designated Product. Penwest will, promptly and throughout the Certification Period, provide to Mylan all necessary information in or coming into Penwest's possession or reasonably available to it for such purpose. Each party understands and agrees that the other does not warrant or commit that the Designated Product will be successfully licensed or certified for marketing by the FDA, and neither party shall have any liability or responsibility to the other or to third parties for any such failure of the certification 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. 3.2 Either party may terminate this Agreement before completion of the Certification Period by delivery of 90 days' written notice to the other if such party reasonably determines that, due to unfavorable action by the FDA, the ANDA is not likely to be approved by the FDA, regardless of any further steps or submissions that could be made. 3.3 Mylan's Project Contact will provide written reports to Penwest's Project Contact at least quarterly throughout the Certification Period, stating in detail all efforts made and in process, and all significant progress achieved and difficulties encountered in the certification effort since the last such report. Mylan's Project Contact will also be available throughout the Certification Period to answer any reasonable questions from Penwest's Project Contact.

Certification Period. (s). ----------------------- 3.1 During the each Certification Period, Mylan each of PPG and Endo will exert its continuing best efforts, at Best Commercial Efforts: (i) to perform the respective Certification Tasks allotted to it; (ii) to do so in accordance with the applicable Certification Budget; and (iii) to assist and to cooperate as requested with the other party's Best Commercial Efforts to do the same as to its expense, to prosecute the ANDA(s) for the Designated Product (in all CONFIDENTIAL MATERIAL OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. ASTERISKS DENOTE SUCH OMISSIONS the contemplated dosage strengths) filed hereunder successfully to the granting of an FDA approval to market the Designated Product. Penwest own Certification Tasks. 3.2 Each party will, promptly and throughout the each Certification Period, provide to Mylan the other party all necessary or useful information in or coming into Penwest's its possession or reasonably available to it for such purpose. Each party understands and agrees that to support the other does not warrant or commit that the Designated Product will be successfully licensed or certified for marketing by the FDA, and neither party shall have any liability or responsibility to the other or to third parties for any such failure of the certification 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. 3.2 Either party may terminate this Agreement before completion achievement of the Certification Period by delivery of 90 days' written notice Tasks. Notwithstanding anything else to the other if contrary contained herein, nothing shall require either party to disclose confidential information for which such party reasonably determines thathas an obligation of confidentiality to a third party, due but each party will exert its Best Commercial Efforts to unfavorable action by bring to the FDA, attention of the ANDA is not likely Alliance Committee any such third party restrictions as may be relevant to be approved by the FDA, regardless of any further steps or submissions that could be madeits role hereunder. 3.3 MylanEach party's Project Contact Contact(s) will provide written reports to Penwestthe other party's Project Contact Contact(s) at least quarterly (and more often upon reasonable request of the other party) throughout the each Certification Period, stating in detail all efforts made and in process, and all significant progress achieved and difficulties encountered in the reporting party's portion of the certification effort since the last such report. Mylan's Each of the Project Contact Contacts will also be available throughout the each Certification Period to answer any reasonable questions from Penwestthe other party's Project ContactContacts, as appropriate. 3.4 During each Certification Period in which it is participating, Endo shall provide *** and related materials reasonably required to support the applicable Certification Tasks, and PPG shall provide all Formulated TIMERx reasonably required therefor, all as shall be more fully described in the applicable Certification Tasks adopted by Committee Action. The costs of such materials will be treated as among the parties' respective expenditures pursuant to the Certification Budget, using for this purpose the Formulated TIMERx Price as to the TIMERx and the *** Price as to the ***. Where, as permitted hereunder, a party is not participating in a Certification Period, it will sell such materials to the participating party pursuant to Section 6.9.5 or Section 7, as applicable, and the price paid therefor shall be treated as part of the buyer's expenditures pursuant to the Certification Budget. 3.5 The parties hereby agree that, unless the Initial Development Period is terminated pursuant to Section 5.2 or Section 5.3, a separate Certification Period will be established directed toward the filing of one or more NDAs with the FDA for the Initial Designated Product(s), and securing an Approval with respect thereto in the United States (the "Initial US Certification Period"). Each party will share equally the total costs of the entire Certification Budget for the Initial US Certification Period regardless of which party is allocated one or more of the relevant Certification Tasks, subject to Section 5.5. In no event shall the aggregate of both parties' expenditures, costs, and other resources to be devoted to the Certification Tasks pursuant to the Certification Budget during the Initial US Certification Period, when added to the aggregate of both parties' expenditures, costs, and other resources devoted to the Initial Development Budget, exceed Fifteen Million Dollars ($15,000,000), unless both parties have consented thereto in writing. If the Certification Tasks for the Initial US Certification Period have not been completed when such $15,000,000 level of aggregate expenditures, costs and other resources has been reached, and one party but not the other desires to spend further sums or to devote further resources to complete such Certification Tasks, then the following shall apply: 3.5.1 The party that does not participate further in the Initial US Certification Period once such point is reached shall not be required to contribute to the reconciliations for the costs of such Certification Period under Section 3.7. Rather, a Certification Excess shall be established with respect to the Initial Designated Product in the US, which shall equal the sums such party would have paid under Section 3.7, had it fully participated in such Certification Period, but did not pay due to its election under this section. 3.5.2 If Endo is the party electing not to participate further in the Initial US Certification Period, this shall have the results stated in Section 6.9 as to the Initial Designated Product in the United States, except that: 3.5.2.1 the relevant Exclusivity Period for the applicable license to PPG in the US will be coterminous with the License Term, and Section 6.9.3 will accordingly not be applicable; and 3.5.2.2 the applicable license to PPG will be royalty- bearing without the relevant Net Realization being reduced as specified in clause (ii) of Section 6.9.4. 3.5.3 If PPG is the party electing not to participate further in the Initial US Certification Period, this shall be treated, for all purposes of the licenses and the parties' rights hereunder, as if PPG had continued to participate in the Initial US Certification Period, except that the Certification Excess described in Section 3.5.1 shall have the results stated in Section 4.5.