Paragraph IV Notices. 5.7.1 Subject to any rights that Daravita Limited may have under the Daravita License Agreement, during the Pre-Closing Period, if Seller or any of its Affiliates receives or is notified in writing of any paragraph IV certification filed pursuant to Section 505(j)(2)(A)(vii)(IV) or 505(b)(2)(A)(iv) of the Act advising Seller or any of its Affiliates of the filing of an ANDA or Section 505(b)(2) NDA that relies on the FDA’s prior finding of safety and effectiveness for the Product (a “Paragraph IV Claim”), then Seller shall provide a copy of such Paragraph IV Claim to Purchaser within five (5) Business Days after its receipt thereof.
5.7.2 Subject to Seller’s obligations to Daravita Limited under the Daravita License Agreement, Seller will, to the extent practicable, consult with Purchaser in exercising any rights it may have under the Daravita License Agreement with respect to any patent infringement litigation for a Paragraph IV Claim (“Product ANDA Litigation”) and consider in good faith Purchaser’s comments with respect to strategic decisions and their implementation with respect to such action.
5.7.3 Subject to any rights that Daravita Limited may have under the Daravita License Agreement, if Daravita Limited does not exercise its right to control any Product ANDA Litigation, Seller shall exercise its step-in rights under the Daravita License Agreement to control such Product ANDA Litigation and shall (a) keep Purchaser reasonably informed regarding Seller’s actions with respect to such action; and (b) to the extent practicable, consult with Purchaser prior to exercising any rights it may have with respect to such Product ANDA Litigation and consider in good faith Purchaser’s comments with respect to strategic decisions and their implementation with respect to such action.
Paragraph IV Notices. Each Party shall immediately give written notice to the other of any certification of which it becomes aware filed pursuant to any statutory or regulatory requirement in any country in the Territory similar to 21 U.S.C. § 355(b)(2)(A)(iv) or § 355(j)(2)(A)(vii)(IV) (or any amendment or successor statute thereto) claiming that any AGTC Patent Right, Joint Patent Right or Biogen Platform Improvement Patent Right Covering any Licensed Product is invalid or that infringement will not arise from the Development, Manufacture, use or Commercialization in the Territory of such Licensed Product by a Third Party. Upon the giving or receipt of such notice, the provisions of Section 13.5 with respect to division of enforcement responsibilities shall apply, mutatis mutandis, with respect to any infringement action against such Third Party. In each case, the Party with the right to bring an infringement action shall notify the other Party at least ten (10) days prior to the date set forth by statute or regulation of its intent to exercise, or not exercise, this right. Any infringement action against a Third Party arising under this Section 13.6.5 shall be governed by the provisions of Section 13.5. Without limiting any provision of Section 13.5, in order to establish standing in connection with any action under this Section 13.6.5, upon the request of the Party bringing the action, the other Party shall reasonably cooperate in any such action at the expense of the Party bring the action and shall timely commence or join in any such action at the request and expense of the Party bringing the action.
Paragraph IV Notices. If any party receives a notice under 21 U.S.C. §355(b)(2)(A)(iv) or 355(j)(2)(A)(vii)(IV), or any notice under any future analogous provisions of United States Law relating to regulation or approval of biological products, concerning a Quark Patent Right, as it relates to a Licensed Product (a “Paragraph IV Claim”), then it shall provide a copy of such notice to the other parties within [ * ] after its receipt thereof. Pfizer shall have the right, but not the obligation, to initiate patent infringement litigation for such Paragraph IV Claim, at its own expense. If Pfizer elects not to assume control over enforcing any Paragraph IV Claim, Pfizer shall notify Quark as soon as practicable but in any event not later than [ * ] before the first action required to enforce or preserve such Paragraph IV Claim so that Quark may, but shall not be required to, assume sole control over enforcing such Paragraph IV Claim using counsel of its own choice. The parties shall cooperate in the prosecution of any Paragraph IV Claim, and share any compensation recovered as a result of such prosecution, as set forth in Section 7.9 above.
Paragraph IV Notices. If either Party receives a notice under 21 U.S.C. §355(b)(2)(A)(iv) or 355(j)(2)(A)(vii)(IV) concerning an ACADIA Patent (a “Paragraph IV Notice”), then it shall provide a copy of such notice to the other Party within […***…] Business Days after its receipt thereof. Patent infringement litigation based on a Paragraph IV Notice concerning an ACADIA Patent shall be brought and controlled as provided in Sections 9.3(b) and 9.3(e). Upon request of BLS, ACADIA agrees to timely join as party-plaintiff in any such litigation, and in any event to cooperate with BLS in connection with such infringement action, including timely filing such action in ACADIA’s name if required.
Paragraph IV Notices. If either party receives a notice under 21 U.S.C. §355(b)(2)(A)(iv) or 355(j)(2)(A)(vii)(IV) directed to a Compound ([***]) or Licensed Product, concerning any Protalix Patent Right (“Paragraph IV Notice”), then it shall provide a copy of such notice to the other party promptly and in any event no later than two (2) Business Days after its receipt thereof. Pfizer shall have the exclusive right, but not the obligation, to initiate patent infringement litigation based on a Paragraph IV Notice directed to a Compound ([***]) or Licensed Product, concerning a Protalix Patent Right, and any expenses incurred by Pfizer with respect to such infringement litigation shall be [***]. Upon request of Pfizer, Protalix agrees to timely join as party−plaintiff in any such litigation, and in any event to cooperate with Pfizer in connection with such infringement action, including timely filing such action in Protalix’s name if required. Pfizer shall promptly notify Protalix of its intention not to initiate patent infringement litigation based on such Paragraph IV Notice. The amount of any recovery from any such infringement suit with respect to activities in the Field in the Territory will be [***].
Paragraph IV Notices. If either Party receives a notice under 21 U.S.C. §355(b)(2)(A)(iv) or 355(j)(2)(A)(vii)(IV) concerning an Arena Patent or a Program Patent, or any similar notice under the Applicable Laws of a country in the Additional Territory, (a “Paragraph IV Notice”), then it shall provide a copy of such notice to the other Party within five days after its receipt thereof. Patent infringement litigation based on a Paragraph IV Notice concerning an Arena Patent or Program Patent shall be brought as provided in Section 9.3(b), with such Paragraph IV Notice being deemed a Field Infringement.
Paragraph IV Notices. If either Party receives a notice under 21 U.S.C. §355(b)(2)(A)(iv) or 355(j)(2)(A)(vii)(IV) (“Paragraph IV Notice”) concerning an Erytech Patent Right, then it shall provide a copy of such notice to the other Party within [***] after its receipt thereof. Any infringement actions or other actions shall be governed by the terms of Section 6.5
Paragraph IV Notices. If either Party receives a notice under 21 U.S.C. §355(b)(2)(A)(iv) or 355(j)(2)(A)(vii)(IV) (“Paragraph IV Notice”) concerning an Incyte Product Patent Right, Incyte Program Patent Right or Incyte Patent Right or a Program Patent Right, Pfizer Patent Right, Pfizer Process Patent Claim or Pfizer Use Patent Claim, then it shall use reasonable efforts to provide a copy of such notice to the other Party within two (2) Business Days after its receipt thereof and best efforts to provide such copy as promptly as practicable thereafter. Pfizer shall have the only right, but no obligation, to initiate patent infringement litigation based on a Paragraph IV Notice concerning a Pfizer Patent Right, Pfizer Process Patent Claim or Pfizer Use Patent Claim, at its own expense. Pfizer shall have the first right, but no obligation, to initiate patent infringement litigation based on a Paragraph IV Notice concerning an Incyte Patent Right or a Program Patent Right, at its own expense. If Pfizer fails to initiate such litigation within thirty (30) days of its receipt of the applicable Paragraph IV Notice, then Incyte shall have the right, but no obligation, to initiate such litigation, at Incyte’s expense, but only if such litigation (x) involves an Incyte Compound or Incyte Product and (y) does not involve a Pfizer Product or a Compound that Pfizer has selected for development. Incyte shall have the only right, but no obligation, to initiate patent infringement litigation based on a Paragraph IV Notice concerning an Incyte Product Patent Right or Incyte Program Patent Right. Each Party, upon request of the other Party, shall reasonably cooperate with the requesting Party in any such litigation at the requesting Party’s expense.
Paragraph IV Notices. (a) If either party receives a notice under 21 U.S.C. §355(b)(2)(A)(iv) or 355(j)(2)(A)(vii)(IV) directed to a Compound (other than [***]) or Licensed Product, concerning any Protalix Patent Right (“Paragraph IV Notice”), then it shall provide a copy of such notice to the other party promptly and in any event no later than two (2) Business Days after its receipt thereof. Pfizer shall have the exclusive right, but not the obligation, to initiate patent infringement litigation based on a Paragraph IV Notice directed to a Compound (other than [***]) or Licensed Product, concerning a Protalix Patent Right, and any expenses incurred by Pfizer with respect to such infringement litigation shall constitute [***]. Upon request of Pfizer, Protalix agrees to timely join as party-plaintiff in any such litigation, and in any event to cooperate with Pfizer in connection with such infringement action, including timely filing such action in Protalix’s name if required. Pfizer shall promptly notify Protalix of its intention not to initiate patent infringement litigation based on such Paragraph IV Notice. The amount of any recovery from any such infringement suit with respect to activities in the Field in the Territory will be deemed [***].
(b) Notwithstanding anything to the contrary in Section 8.9(a), following receipt by Protalix of a Section 14.2(c) Notice, Protalix shall have the sole right during the remainder of the Section 14.2(c) Termination Notice Period, but not the obligation, to initiate patent infringement litigation based on a Paragraph IV Notice directed to a Compound or Licensed Product, concerning a Protalix Patent Right. Upon request of Protalix, Pfizer agrees to timely join as party-plaintiff in any such litigation, [***], and in any event to cooperate with Protalix [***] in connection with such infringement action, including timely filing such action in Pfizer’s name if required. Protalix shall retain [***] received by Protalix as a result of its enforcement of Protalix Patent Rights under this Section 8.9(b).
(c) [***].
Paragraph IV Notices. If either Party receives a notice under 21 U.S.C. §355(b)(2)(A)(iv) or 355(j)(2)(A)(vii)(IV) concerning an Arena Patent or a Program Patent, or any similar notice under the Applicable *** This portion has been redacted pursuant to a confidential treatment request under Rule 24b-2 of the Securities Exchange Act of 1934, as amended. A complete copy of this document has been filed separately with the Securities and Exchange Commission. Laws of a particular country (each, a “Paragraph IV Notice”), then it shall provide a copy of such notice to the other Party within [***] days after its receipt thereof. Patent infringement litigation based on a Paragraph IV Notice concerning an Arena Patent or Program Patent shall be brought as provided in Section 9.3(b), with such Paragraph IV Notice being deemed a Field Infringement.
