Common use of Certification Period Clause in Contracts

Certification Period. 3.1 During the Certification Period with respect to the United States, Schw▇▇▇ ▇▇▇rma will exert its continuing best efforts, at its expense, to prepare and file an ANDA or ANDAs for the Designated Products with the FDA and to prosecute the same successfully to the granting of an FDA license to market the Designated Product in both of the dosage strengths. TIMERx Technologies will, promptly and throughout the Certification Period, provide to Schw▇▇▇ ▇▇▇rma all necessary information in or coming into TIMERx Technologies' possession or reasonably available to it for such purpose. Also, during the Certification Period, ********************************************************* ************************. 3.2 Schw▇▇▇ ▇▇▇rma shall exert its continuing best efforts to conduct or arrange for, at Schw▇▇▇ ▇▇▇rma's expense, all further testing and studies during the Certification Period, including as to efficacy, bioavailability, bioequivalence, and safety and toxicology, in connection with the development, licensing, manufacture and marketing of the Designated Product, and for compliance with all requirements imposed by the government of the United States with respect to the Designated Products, and, if there is a Certification Period for Canada and/or Mexico pursuant to Section 3.3, also as imposed by the government of such nation(s). TIMERx Technologies will, promptly and throughout the Certification Period, provide to Schw▇▇▇ ▇▇▇rma all necessary information in or coming into TIMERx Technologies' possession or reasonably available to it for such purpose. 3.3 If, at any time or times during the License Period, TIMERx Technologies reasonably demonstrates to Schw▇▇▇ ▇▇▇rma that (i) Covera-HS or an AB bioequivalent to it has been approved for marketing in Canada or Mexico, or such approval has been applied for and is reasonably likely to be granted; and (ii) TIMERx Technologies or a third party is interested in good faith in undertaking to market the Designated Product in such nation pursuant to the equivalent of an ANDA in such nation, then TIMERx Technologies shall afford Schw▇▇▇ ▇▇▇rma a period of 60 days in which to agree that a Certification Period with respect to such nation, and governed by this Section 3, shall commence hereunder, during which Schw▇▇▇ ▇▇▇rma will exert its continuing best efforts, at its expense, to prepare and file such ANDA-equivalent applications for the Designated Products with the regulatory authorities in such nation, and to prosecute the same successfully to the granting of marketing approvals from such authorities for the Designated Product in both of the dosage strengths. It is understood that Schw▇▇▇ ▇▇▇rma may meet such obligations with respect to such nation through the efforts of its sublicensee, which may be TIMERx or the third party (if any) identified by TIMERx Technologies and referenced in clause (ii) above, to whom Schw▇▇▇ ▇▇▇rma may sublicense its rights as set forth in this Agreement. (If TIMERx Technologies is the sublicensee, the same terms and conditions of this Agreement shall apply to the sublicense.) If Schw▇▇▇ ▇▇▇rma fails to agree in writing within such period to prepare, file and prosecute an ANDA equivalent, either directly or through sublicensing as described herein, such nation and its territories and possessions shall thereupon be removed from the Territory.