Biologics Price Competition and Innovation Act Sample Clauses

Biologics Price Competition and Innovation Act. To the extent permissible under the BPCIA or as may be agreed between Roche and an applicant submitting a Section 351(k) application under the BPCIA relating to a Licensed Product (a “Section 351(k) applicant”), Roche shall promptly notify Prothena upon the receipt of a copy of a Section 351(k) application under the BPCIA relating to a Licensed Product. Subject to the preceding sentence, provided that (i) Prothena has informed the Section 351(k) applicant of Prothena’s agreement to be subject to the confidentiality provisions set forth in Section 351(l)(1) of the BPCIA and (ii) Prothena has obtained the Section 351(k) applicant’s agreement that the confidential information (as defined in the BPCIA) provided to Roche by such applicant may be shared with Prothena and has so notified Roche, the Parties shall cooperate to exercise any rights that may be exercisable by Roche as the reference product sponsor under the BPCIA, including: (i) engaging in the information exchange provisions of the BPCIA, including providing a list of patents that relate to the relevant Licensed Compound and/or Licensed Product incorporating such Licensed Compound, (ii) engaging in the patent resolution provisions of the BPCIA, and (iii) determining which patents will be the subject of immediate patent infringement action under Section 351(l)(6) of the BPCIA. In the event that the Parties do not agree with respect to the exercise of any such rights, Roche shall make the determination with respect thereto, including without limitation with respect to (i), (ii) and (iii), above. Roche shall have the first right, but not the obligation, to bring an action for patent infringement under Section 351(l) of the BPCIA against a Section 351(k) applicant relating to a Licensed Product. If Roche elects not to bring an action for patent infringement against a Section 351(k) applicant, Roche shall notify Prothena of such as soon as reasonably practicable but in any event no later than [*] after agreement on the patents in suit in accordance with Section 351(l)(4)(A) of the BPCIA or the exchange of lists pursuant to Section 351(l)(5)(B) of the BPCIA. Upon receipt of such notice or absent an action for patent infringement within such [*], then to the extent permitted under Applicable Law, Prothena shall have the right at its sole discretion to institute an action for patent infringement against the Section 351(k) applicant in its own name and, unless expressly agreed otherwise by Roche, Prothena may...
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Biologics Price Competition and Innovation Act. To the extent permissible under the BPCIA or as may be agreed between Roche and an applicant submitting a Section 351(k) application under the BPCIA relating to a Licensed Product (a “Section 351(k) applicant”), Roche shall promptly notify Prothena upon the receipt of a copy of a Section 351(k) application under the BPCIA relating to a Licensed Product. Subject to the preceding sentence, provided that (i) Prothena has informed the Section 351(k) applicant of Prothena’s agreement to be subject to the confidentiality provisions set forth in Section 351(l)(1) of the BPCIA and (ii) Prothena has obtained the Section 351(k) applicant’s agreement that the confidential information (as defined in the BPCIA) provided to Roche by such applicant may be shared with Prothena and has so notified Roche, the Parties shall cooperate to exercise any rights that may be exercisable by Roche as the reference product sponsor under the BPCIA, including: (i) engaging in the information exchange provisions of the BPCIA, including providing a list of patents that relate to the relevant Licensed Compound and/or Licensed Product incorporating such Licensed Compound, (ii) engaging in the patent resolution provisions of the BPCIA, and (iii) determining which patents will be the subject of immediate patent infringement action under Section 351(l)(6)
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Related to Biologics Price Competition and Innovation Act

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  • Proprietary Information and Inventions Agreements The Company shall require all employees and consultants with access to confidential information to execute and deliver a Proprietary Information and Inventions Agreement in substantially the form approved by the Company’s Board of Directors.

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