Common use of Patent Extensions Orange Book Listings Patent Certifications Clause in Contracts

Patent Extensions Orange Book Listings Patent Certifications. If elections with respect to obtaining patent term extension or supplemental protection certificates or their equivalents in Territory with respect to the Product becomes available, upon NDA Approval for the Product, Pfenex and Alvogen shall mutually agree on the determination of which issued Patent to extend for the Product, and Alvogen shall take such reasonable actions as are necessary to effectuate or assist in such extension. (a) With respect to regulatory exclusivity periods, Pfenex, prior to the transfer of the NDA Approval, and Alvogen or its Affiliate, following such transfer, shall be responsible for seeking and maintaining all such regulatory exclusivity periods that may be available for the Product in the Territory, subject to approval of the Party that is not responsible for seeking and maintaining such exclusivity, such approval not to be unreasonably withheld, delayed or conditioned. The Party that is responsible therefor shall make all filings necessary to list the appropriate exclusivity periods and Pfenex Patents, if any, in the Orange Book with respect to the Product, and the Parties shall mutually agree on which Pfenex Patents, if any, to list in the Orange Book with respect to the Product. (b) Pfenex and Alvogen shall each notify and provide the other Party with copies of any notice of a Paragraph IV Patent Certification (including any associated documents) by a Third Party filing an ANDA or an NDA, or any other similar patent certification by a Third Party in the Territory, in each such case referencing Product. Such notification and copies will [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. be provided to the other Party promptly (but no later than within five (5) Business Days) after receipt of such notification and will be sent to the address set forth in Section 12.2.

Patent Extensions Orange Book Listings Patent Certifications. If elections with respect to obtaining patent term extension or supplemental protection certificates or their equivalents in Territory with respect to the Product becomes available, upon NDA Approval for the Product, Pfenex NRx and Alvogen shall mutually agree on the determination of which issued Patent to extend for the Product, and Alvogen shall take such reasonable actions as are necessary to effectuate or assist in such extension. (a) With respect to regulatory exclusivity periods, Pfenex, prior to the transfer of the NDA Approval, and Alvogen or its Affiliate, following such transfer, Affiliate shall be responsible for seeking and maintaining all such regulatory exclusivity periods that may be available for the Product in the Territory, subject to approval of the Party that is not responsible for seeking and maintaining such exclusivityNRx, such approval not to be unreasonably withheld, delayed or conditioned. The Party that is responsible therefor Alvogen or its Affiliate shall make all filings necessary to list the appropriate exclusivity periods and Pfenex NRx Patents, if any, in the Orange Book with respect to the Product, and the Parties shall mutually agree on which Pfenex NRx Patents, if any, to list in the Orange Book with respect to the Product. (b) Pfenex NRx and Alvogen shall each notify and provide the other Party with copies of any notice of a Paragraph IV Patent Certification (including any associated documents) by a Third Party filing an ANDA or an NDA, or any other similar patent certification by a Third Party in the Territory, in each such case referencing Product. Such notification and copies will [***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions. be provided to the other Party promptly (but no later than within five (5) Business Days) after receipt of such notification and will be sent to the address set forth in Section ‎Section 12.2.