Common use of Orange Book Listings & Hatch Waxman Litigation Clause in Contracts

Orange Book Listings & Hatch Waxman Litigation. 1. The Parties acknowledge that the owner of an NDA has a non-delegable duty to determine which patents should be listed in the U.S. FDA “Approved Drug Products with Therapeutic Equivalence Evaluations” (sometimes referred to as the “Orange Book”) and any foreign counterparts which require such, including the so-called “Patent Register” listings required in Canada. Prior to such listings and acts, the Parties will meet to evaluate and identify whether any patents falling within Patent Rights sublicensed or co-licensed to the non-NDA holding Party under this Agreement should be included, and the NDA-holding Party shall reach its own decision regarding which patents within such Patent Rights to list in the Orange Book or any foreign counterpart. 2. If an NDA-holding Party lists in the Orange Book or foreign counterpart a patent also licensed to the non-NDA holding Party, it shall give the non-NDA holding Party written notice within [**] Business Days. 3. If the NDA-holding Party receives written notice from a generic company under 21 U.S.C. 355(j)(2)(A)(vii)(IV) (a “Paragraph IV Certification”) that it has filed an Abbreviated New Drug Application to sell a product covered by the NDA, and has certified that a patent listed in the Orange Book that falls within Patent Rights sublicensed or co-licensed to the non-NDA holding Party under this Agreement is either not infringed, invalid, or not enforceable, the NDA-holding Party shall give written notice to the non-NDA holding Party within [**] Business Days, with a copy of the Paragraph IV Certification. The Parties acknowledge that time is of the essence in such matter given the statutory requirement that an NDA-holding Party bring a lawsuit within [**] days of receiving the Paragraph IV Certification. 4. The NDA-holding Party shall promptly discuss with JHU and the non-NDA-holding Party the advisability of filing a lawsuit against the generic company under 21 U.S.C. § 355 (the “Hatch Waxman Act”). If GrayBug is the NDA-holding Party and the Patent Right challenged is a GrayBug Current Patent Right, then GrayBug shall control the litigation, and if it chooses not to litigate, then JHU shall have the secondary right of litigation. If Kala is the NDA-holding Party and the Patent Right challenged is a Kala Current Patent Right or a Kala/JHU Joint Patent Right, then Kala shall control the litigation, and if it chooses not to litigate, then JHU shall have the secondary right of litigation. If GrayBug or Kala is the NDA-holding Party and the Patent Right challenged is a Co-Licensed Other JHU Patent Right or a Future Co-Licensed Patent Right, then GrayBug and Kala shall meet to discuss terms under which the litigation shall take place, which terms shall include that the NDA-holding Party shall pay the cost of the litigation, the Non-NDA holding Party shall have the right of close communication and review of filed litigation documents (except to the extent marked highly business confidential), participation in (but not control over) litigation strategy, and if the NDA-holding Party receives an adverse judgment of invalidity from a court of final jurisdiction, the NDA-holding Party shall compensate the non-NDA-holding Party for all fees and costs it has invested in the litigated patent historically as well as its litigation attorney’s fees.

Orange Book Listings & Hatch Waxman Litigation. 1. The Parties acknowledge that the owner of an NDA has a non-delegable duty to determine which patents should be listed in the U.S. FDA “Approved Drug Products with Therapeutic Equivalence Evaluations” (sometimes referred to as the “Orange Book”) and any foreign counterparts which require such, including the so-called “Patent Register” listings required in Canada. Prior to such listings and acts, the Parties will meet to evaluate and identify whether any patents falling within Patent Rights sublicensed or co-licensed to the non-NDA holding Party under this Agreement should be included, and the NDA-holding Party shall reach its own decision regarding which patents within such Patent Rights to list in the Orange Book or any foreign counterpart. 2. If an NDA-holding Party lists in the Orange Book or foreign counterpart a patent also licensed to the non-NDA NOA holding Party, it shall give the non-NDA holding Party written notice within [**] Business Days. 3. If the NDA-holding Party receives written notice from a generic company under 21 U.S.C. 355(j)(2)(A)(vii)(IV) (a “Paragraph IV Certification”) that it has filed an Abbreviated New Drug Application to sell a product covered by the NDA, and has certified that a patent listed in the Orange Book that falls within Patent Rights sublicensed or co-licensed to the non-NDA NOA holding Party under this Agreement is either not infringed, invalid, or not enforceable, the NDA-holding Party shall give written notice to the non-NDA NOA holding Party within [**] Business Days, with a copy of the Paragraph IV Certification. The Parties acknowledge that time is of the essence in such matter given the statutory requirement that an NDA-holding Party bring a lawsuit within [**] days of receiving the Paragraph IV Certification. 4. The NDA-holding Party shall promptly discuss with JHU and the non-NDA-holding Party the advisability of filing a lawsuit against the generic company under 21 U.S.C. § 355 (the “Hatch Waxman Act”). If GrayBug is the NDA-holding Party and the Patent Right challenged is a GrayBug Current Patent Right, then GrayBug shall control the litigation, and if it chooses not to litigate, then JHU shall have the secondary right of litigation. If Kala is the NDA-holding Party and the Patent Right challenged is a Kala Current Patent Right or a Kala/JHU Joint Patent Right, then Kala shall control the litigation, and if it chooses not to litigate, then JHU shall have the secondary right of litigation. If GrayBug or Kala is the NDA-holding Party and the Patent Right challenged is a Co-Licensed Other JHU Patent Right or a Future Co-Licensed Patent Right, then GrayBug and Kala shall meet to discuss terms under which the litigation shall take place, which terms shall include that the NDA-holding Party shall pay the cost of the litigation, the Non-NDA NOA holding Party shall have the right of close communication and review of filed litigation documents (except to the extent marked highly business confidential), participation in (but not control over) litigation strategy, and if the NDA-holding Party receives an adverse judgment of invalidity from a court of final jurisdiction, the NDA-holding Party shall compensate the non-NDANOA-holding Party for all fees and costs it has invested in the litigated patent historically as well as its litigation attorney’s fees.

Orange Book Listings & Hatch Waxman Litigation. ​ 1. The Parties acknowledge that the owner of an NDA has a non-delegable duty to determine which patents should be listed in the U.S. FDA “Approved Drug Products with Therapeutic Equivalence Evaluations” (sometimes referred to as the “Orange Book”) and any foreign counterparts which require such, including the so-called “Patent Register” listings required in Canada. Prior to such listings and acts, the Parties will meet to evaluate and identify whether any patents falling within Patent Rights sublicensed or co-licensed to the non-NDA holding Party under this Agreement should be included, and the NDA-holding Party shall reach its own decision regarding which patents within such Patent Rights to list in the Orange Book or any foreign counterpart.. ​ 2. If an NDA-holding Party lists in the Orange Book or foreign counterpart a patent also licensed to the non-NDA holding Party, it shall give the non-NDA holding Party written notice within [**] Business Days.. ​ ​ ​ 3. If the NDA-holding Party receives written notice from a generic company under 21 U.S.C. 355(j)(2)(A)(vii)(IV) (a “Paragraph IV Certification”) that it has filed an Abbreviated New Drug Application to sell a product covered by the NDA, and has certified that a patent listed in the Orange Book that falls within Patent Rights sublicensed or co-licensed to the non-NDA holding Party under this Agreement is either not infringed, invalid, or not enforceable, the NDA-holding Party shall give written notice to the non-NDA holding Party within [**] Business Days, with a copy of the Paragraph IV Certification. The Parties acknowledge that time is of the essence in such matter given the statutory requirement that an NDA-holding Party bring a lawsuit within [**] days of receiving the Paragraph IV Certification.. ​ 4. The NDA-holding Party shall promptly discuss with JHU and the non-NDA-holding Party the advisability of filing a lawsuit against the generic company under 21 U.S.C. § 355 (the “Hatch Waxman Act”). If GrayBug is the NDA-holding Party and the Patent Right challenged is a GrayBug Current Patent Right, then GrayBug shall control the litigation, and if it chooses not to litigate, then JHU shall have the secondary right of litigation. If Kala is the NDA-holding Party and the Patent Right challenged is a Kala Current Patent Right or a Kala/JHU Joint Patent Right, then Kala shall control the litigation, and if it chooses not to litigate, then JHU shall have the secondary right of litigation. If GrayBug or Kala is the NDA-holding Party and the Patent Right challenged is a Co-Licensed Other JHU Patent Right or a Future Co-Licensed Patent Right, then GrayBug and Kala shall meet to discuss terms under which the litigation shall take place, which terms shall include that the NDA-holding Party shall pay the cost of the litigation, the Non-NDA holding Party shall have the right of close communication and review of filed litigation documents (except to the extent marked highly business confidential), participation in (but not control over) litigation strategy, and if the NDA-holding Party receives an adverse judgment of invalidity from a court of final jurisdiction, the NDA-holding Party shall compensate the non-NDA-holding Party for all fees and costs it has invested in the litigated patent historically as well as its litigation attorney’s fees.. ​ ​ ​