Common use of Diligence Efforts Clause in Contracts

Diligence Efforts. 5.2.1 ViroPharma shall *** to *** and following such approval *** to ***. Subject to Section 5.2.2, ViroPharma shall satisfy the foregoing obligation by *** and to ***. 5.2.2 If, during the term of this Agreement, Halozyme determines in good faith that there exists sufficiently supported, published scientific literature that demonstrates a reasonable scientific basis for application of the ViroPharma Biologic (as it exists as of the Effective Date) for use in an indication other than HAE (an “Expanded Indication”), then it may notify ViroPharma of such Expanded Indication and include a reference to the supporting scientific literature. Within *** (***) days of receipt of such notice, ViroPharma shall determine whether (i) there is reasonable scientific basis for the Expanded Indication, (ii) administration of the Product in such Expanded Indication would be commercially viable as a subcutaneous administration and (iii) pre-clinical and clinical development, manufacturing, seeking regulatory approval and commercialization of the Product for such Expanded Indication would be commercially reasonable when the Product development, manufacturing, regulatory and commercialization strategy is taken as a whole (collectively with (i) and (ii), the “Expanded Indication Criteria”). If the Expanded Indication Criteria are satisfied, ViroPharma shall *** and, following receipt ***. If ViroPharma determines that the Expanded Indication for the Product does not satisfy the Expanded Indication Criteria, then the parties shall attempt to resolve the issue through good faith discussions. If a mutually acceptable resolution is not reached after *** (***) days, then Halozyme shall have the right to seek a declaratory judgment under this Agreement that the Expanded Indication for the Product satisfies the Expanded Indication Criteria. If (a) Halozyme receives a final, non-appealable judgment (or if such judgment is not appealed by ViroPharma within the allotted time) that the Expanded Indication for the Product satisfies the Expanded Indication Criteria and (b) ViroPharma does not commence development or regulatory activities for the Expanded Indication within *** (***) days of such final, non-appealable judgment, as Halozyme’s sole and exclusive remedy therefor, the Expanded Indication shall be automatically removed from the Licensed Field; provided however, that in the event that the foregoing clause (a) is met and ViroPharma notifies Halozyme that it intends to use commercially reasonable efforts to commences development or regulatory activities for the Expanded Indication within *** (***) days of such final, non-appealable judgment, and ViroPhrama does so commence such activities, then ViroPharma shall reimburse Halozyme for its reasonable attorneys’ fees in connection with seeking such declaratory judgment. If Halozyme does not receive such judgment, then no amendment or change shall be made to the Licensed Field. 5.2.3 For purposes of this Section 5.2, *** shall mean those *** as applied to other ***. 5.2.4 If ViroPharma has not notified Halozyme prior to the *** (***) business day following the Regulatory Approval Date that ViroPharma is terminating this Agreement, then, commencing on such *** (***) business day, and except as provided below, neither ViroPharma nor any of its Affiliates shall develop itself, or obtain a license from or otherwise collaborate with a third party to develop a ViroPharma Subcutaneous Product. If, at the time of the Regulatory Approval Date, ViroPharma has received regulatory approval from the applicable regulatory authority in a country outside of the United States for the marketing and sale of a ViroPharma Subcutaneous Product, but ViroPharma has not yet obtained regulatory approval from the applicable regulatory authority in such country for the marketing and sale of the Product, then ViroPharma shall have the right to continue to market and sell such ViroPharma Subcutaneous Product in such country until such time as ViroPharma obtains such regulatory approval for the Product in such country. Following (a) the Regulatory Approval Date with respect to the United States, and (b) receipt of regulatory approval from the applicable regulatory authority for the marketing and sale of the Product in a country outside of the United States on or after the Regulatory Approval Date, then ViroPharma shall commercialize the Product in such country and shall use commercially reasonable efforts to cease the continued development, use or commercialization of any ViroPharma Subcutaneous Product in such country, provided however, that if in such country ViroPharma (i) is then conducting any clinical studies of the ViroPharma Subcutaneous Product, then ViroPharma shall take into account appropriate clinical practices and related regulations and guidelines in winding down or completing any such studies or (ii) received regulatory approval for, and commenced the commercialization of, a ViroPharma Subcutaneous Product prior to the Regulatory Approval Date (with respect to the United States) or the date of such regulatory approval on or after the Regulatory Approval Date (with respect to a country outside of the United States), then ViroPharma shall have the right to take into account appropriate standards of patient care in phasing out the commercialization of such ViroPharma Subcutaneous Product. 5.2.5 If ViroPharma has not initiated a clinical study of an Additional Indication within *** (***) year after the date on which ViroPharma receives written approval from the FDA for a BLA for the Product for HAE in the United States, then Halozyme may remove such Additional Indication from the definition of Exclusive Field. 5.2.6 If (a) ViroPharma permanently abandons, or permanently ceases, development, use or commercialization of, the Product in any Additional Indication, then ViroPharma shall promptly deliver written notice to Halozyme of its decision therefore, or (b) if at any time after the expiration of the *** (***) year period described in Section 5.2.5 ViroPharma unreasonably delays the development or commercialization of the Product in any Additional Indication, then in each case Halozyme shall have the right, at its sole discretion, to remove such Additional Indication from the Exclusive Field, in which case such Additional Indication shall remain in the Licensed Field.

Diligence Efforts. 5.2.1 ViroPharma shall *** to *** and following such approval *** to ***. Subject to Section 5.2.2, ViroPharma shall satisfy the foregoing obligation by *** and to ***. 5.2.2 If, during the term of this Agreement, Halozyme determines in good faith that there exists sufficiently supported, published scientific literature that demonstrates a reasonable scientific basis for application of the ViroPharma Biologic (as it exists as of the Effective Date) for use in an indication other than HAE (an “Expanded Indication”), then it may notify ViroPharma of such Expanded Indication and include a reference to the supporting scientific literature. Within *** (***) days of receipt of such notice, ViroPharma shall determine whether (i) there is reasonable scientific basis for the Expanded Indication, (ii) administration of the Product in such Expanded Indication would be commercially viable as a subcutaneous administration and (iii) pre-clinical and clinical development, manufacturing, seeking regulatory approval and commercialization of the Product for such Expanded Indication would be commercially reasonable when the Product development, manufacturing, regulatory and commercialization strategy is taken as a whole (collectively with (i) and (ii), the “Expanded Indication Criteria”). If the Expanded Indication Criteria are satisfied, ViroPharma shall *** and, following receipt ***. If ViroPharma determines that the Expanded Indication for the Product does not satisfy the Expanded Indication Criteria, then the parties shall attempt to resolve the issue through good faith discussions. If a mutually acceptable resolution is not reached after *** (***) days, then Halozyme shall have the right to seek a declaratory judgment under this Agreement that the Expanded Indication for the Product satisfies the Expanded Indication Criteria. If (a) Halozyme receives a final, non-appealable judgment (or if such judgment is not appealed by ViroPharma ▇▇▇▇▇▇▇▇▇▇ within the allotted time) that the Expanded Indication for the Product satisfies the Expanded Indication Criteria and (b) ViroPharma does not commence development or regulatory activities for the Expanded Indication within *** (***) days of such final, non-appealable judgment, as Halozyme’s sole and exclusive remedy therefor, the Expanded Indication shall be automatically removed from the Licensed Field; provided however, that in the event that the foregoing clause (a) is met and ViroPharma notifies Halozyme that it intends to use commercially reasonable efforts to commences development or regulatory activities for the Expanded Indication within *** (***) days of such final, non-appealable judgment, and ViroPhrama does so commence such activities, then ViroPharma shall reimburse Halozyme for its reasonable attorneys’ fees in connection with seeking such declaratory judgment. If Halozyme does not receive such judgment, then no amendment or change shall be made to the Licensed Field. 5.2.3 For purposes of this Section 5.2, *** shall mean those *** as applied to other ***. 5.2.4 If ViroPharma has not notified Halozyme prior to the *** (***) business day following the Regulatory Approval Date that ViroPharma is terminating this Agreement, then, commencing on such *** (***) business day, and except as provided below, neither ViroPharma nor any of its Affiliates shall develop itself, or obtain a license from or otherwise collaborate with a third party to develop a ViroPharma Subcutaneous Product. If, at the time of the Regulatory Approval Date, ViroPharma has received regulatory approval from the applicable regulatory authority in a country outside of the United States for the marketing and sale of a ViroPharma Subcutaneous Product, but ViroPharma has not yet obtained 15 regulatory approval from the applicable regulatory authority in such country for the marketing and sale of the Product, then ViroPharma shall have the right to continue to market and sell such ViroPharma Subcutaneous Product in such country until such time as ViroPharma obtains such regulatory approval for the Product in such country. Following (a) the Regulatory Approval Date with respect to the United States, and (b) receipt of regulatory approval from the applicable regulatory authority for the marketing and sale of the Product in a country outside of the United States on or after the Regulatory Approval Date, then ViroPharma shall commercialize the Product in such country and shall use commercially reasonable efforts to cease the continued development, use or commercialization of any ViroPharma Subcutaneous Product in such country, provided however, that if in such country ViroPharma (i) is then conducting any clinical studies of the ViroPharma Subcutaneous Product, then ViroPharma shall take into account appropriate clinical practices and related regulations and guidelines in winding down or completing any such studies or (ii) received regulatory approval for, and commenced the commercialization of, a ViroPharma Subcutaneous Product prior to the Regulatory Approval Date (with respect to the United States) or the date of such regulatory approval on or after the Regulatory Approval Date (with respect to a country outside of the United States), then ViroPharma shall have the right to take into account appropriate standards of patient care in phasing out the commercialization of such ViroPharma Subcutaneous Product. 5.2.5 If ViroPharma has not initiated a clinical study of an Additional Indication within *** (***) year after the date on which ViroPharma receives written approval from the FDA for a BLA for the Product for HAE in the United States, then Halozyme may remove such Additional Indication from the definition of Exclusive Field. 5.2.6 If (a) ViroPharma permanently abandons, or permanently ceases, development, use or commercialization of, the Product in any Additional Indication, then ViroPharma shall promptly deliver written notice to Halozyme of its decision therefore, or (b) if at any time after the expiration of the *** (***) year period described in Section 5.2.5 ViroPharma unreasonably delays the development or commercialization of the Product in any Additional Indication, then in each case Halozyme shall have the right, at its sole discretion, to remove such Additional Indication from the Exclusive Field, in which case such Additional Indication shall remain in the Licensed Field.