Common use of Failure to Develop Clause in Contracts

Failure to Develop. Should KDP fail to proceed with development of the Product in accordance with the Development Plan, and/or if KDP has not submitted a Regulatory Filing for Marketing Authorization of the Product in the Field in the Territory within twelve (12) months after the date specified for such filing in the Development Plan (as it may be amended from time to time), other than for good faith reasons, such as but not limited to force majeure (as described in Section 16.1), Can-Fxxx will have the right (either itself or through a Third Party), exercisable upon written notice to KDP following the expiration of a ninety (90)-day cure period (or, if it is not practicable to complete the cure of such failure within such 90-day period, following the expiration of an extended period of time to be determined upon mutual written agreement of the Parties), to develop the Product (either itself or through a Third Party) in the Territory, and thereafter all rights to develop and commercialize the Product in the Territory shall revert to Can-Fxxx. This Section 5.3 shall not limit any other remedies Can-Fxxx may have under this Agreement or applicable law. Notwithstanding the foregoing provisions of this Section 5.3, Can-Fxxx is not entitled to forward the aforementioned notice to KDP, or, if forwarded by Can-Fxxx, such notice shall have no effect and force as specified above, in the following instances:

Failure to Develop. Should KDP CKD fail to proceed with development of the Product in accordance with the Development Plan, and/or if KDP CKD has not submitted a Regulatory Filing for Marketing Authorization of the Product in the Field in the Territory within twelve (12) months after the date specified for such filing in the Development Plan (as it may be amended from time to time), other than for good faith reasons, such as but not limited to force majeure (as described in Section 16.1), Can-Fxxx Xxxx will have the right (either itself or through a Third Party), exercisable upon written notice to KDP CKD following the expiration of a ninety (90)-day cure period (or, if it is not practicable to complete the cure of such failure within such 90-day period, following the expiration of an extended period of time to be determined upon mutual written agreement of the Parties), to develop the Product (either itself or through a Third Party) in the Territory, and thereafter all rights to develop and commercialize the Product in the Territory shall revert to Can-FxxxXxxx. Notwithstanding the foregoing, a negative result in the pre-examination application for orphan drug designation shall not be deemed to constitute a “failure to develop” which triggers the rights of Can-Xxxx under this Section 5.5. This Section 5.3 5.5 shall not limit any other remedies Can-Fxxx Xxxx may have under this Agreement or applicable law. Notwithstanding the foregoing provisions of this Section 5.35.5, Can-Fxxx Xxxx is not entitled to forward the aforementioned notice to KDPCKD, or, if forwarded by Can-FxxxXxxx, such notice shall have no effect and force as specified above, in the following instances: (i) If such failure was significantly attributable (more than 75%) to an act or omission of Can-Xxxx or a Third Party contracted or designated by Can-Xxxx in connection with this Agreement; (ii) If such failure was noticed by CKD to Can-Xxxx in writing in a timely manner, together with a written plan for CKD’s practicably prompt cure or recovery, and such plan is accepted by Can-Xxxx in writing; provided that such acceptance of such plan by Can-Xxxx shall not be unreasonably withheld; and provided further that if CKD fails to achieve such cure or recovery in accordance with such plan, Can-Xxxx may deliver the aforementioned notice to CKD; (iii) If such failure was reasonably attributed to a lack of clinical efficacy and/or safety with respect to a Product, and CKD provides a written plan for continued development of such Product; or (iv) If such failure was caused by or resulted from events beyond the reasonable control of CKD, including but not limited to enactment, revision or repeal of a law, regulation, rule, guideline or the like, and/or a decree, order, instruction, guidance, warning or the like of the relevant Regulatory Authority or a court having jurisdiction, wherein such event precludes CKD from developing or obtaining Marketing Authorization for the Product in the Territory as it is then configured; provided that CKD will prepare and provide to Can-Xxxx, CKD’s written plan regarding other, lawful means whereby CKD would be likely to obtain Marketing Authorization for the Product in the Territory within reasonable time.

Failure to Develop. Should KDP SKK fail to proceed with development of the Product in accordance with the Development Plan, and/or if KDP SKK has not submitted a Regulatory Filing for Marketing Authorization of the Product in the Field in the Territory within twelve (12) months after the date specified for such filing in the Development Plan (as it may be amended from time to time), other than for good faith reasons, such as but not limited to force majeure (as described in Section 16.1), Can-Fxxx will have the right (either itself or through a Third Party), exercisable upon written notice to KDP SKK following the expiration of a ninety (90)-day cure period (or, if it is not practicable to complete the cure of such failure within such 90-day period, following the expiration of an extended period of time to be determined upon mutual written agreement of the Parties), to develop the Product (either itself or through a Third Party) in the Territory, and thereafter all rights to develop and commercialize the Product in the Territory shall revert to Can-Fxxx. This Section 5.3 5.5 shall not limit any other remedies Can-Fxxx may have under this Agreement or applicable law. Notwithstanding the foregoing provisions of this Section 5.35.5, Can-Fxxx is not entitled to forward the aforementioned notice to KDPSKK, or, if forwarded by Can-Fxxx, such notice shall have no effect and force as specified above, in the following instances: (i) If such failure was caused solely by an act or omission of Can-Fxxx or a Third Party contracted or designated by Can-Fxxx in connection with this Agreement; (ii) If such failure was noticed by SKK to Can-Fxxx in writing in a timely manner, together with a written plan for SKK’s practicably prompt cure or recovery, and such plan is accepted by Can-Fxxx in writing; provided that such acceptance of such plan by Can-Fxxx shall not be unreasonably withheld; and provided further that if SKK fails to achieve such cure or recovery in accordance with such plan, Can-Fxxx may deliver the aforementioned notice to SKK; (iii) If such failure was reasonably attributed to a lack of clinical efficacy and/or safety with respect to a Product, and SKK provides a written plan for continued development of such Product; or (iv) If such failure was caused by or resulted from events beyond the reasonable control of SKK, including but not limited to enactment, revision or repeal of a law, regulation, rule, guideline or the like, and/or a decree, order, instruction, guidance, warning or the like of the relevant Regulatory Authority or a court having jurisdiction, wherein such event precludes SKK from developing or obtaining Marketing Authorization for the Product as it is then configured; provided that SKK will prepare and provide to Can-Fxxx SKK’s written plan regarding other, lawful means whereby SKK would be likely to obtain Marketing Authorization for the Product within reasonable time.