Common use of Data Exclusivity and Orange Book Listings Clause in Contracts

Data Exclusivity and Orange Book Listings. With respect to data exclusivity periods (such as those periods listed in the FDA’s Orange Book (including without limitation any available pediatric extensions) or periods under national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83, and all international equivalents), ITI shall use Commercially Reasonable Efforts consistent with its obligations under applicable Law to seek, maintain and enforce all such data exclusivity periods available for the Licensed Products. With respect to Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. filings in the FDA Orange Book (and foreign equivalents) for issued patents for a Licensed Product, ITI shall, consistent with its obligations under applicable Law, list in a timely manner and maintain all applicable BMS Patent Rights and other patents Controlled by ITI required to be filed by it, or that it is permitted to file, under applicable Law. At least sixty (60) days prior to an anticipated deadline for the filing of patent listing information for BMS Patent Rights, ITI shall consult with BMS regarding the content of such filing. In the event of a dispute between the Parties as to whether a BMS Patent Right can be filed and/or the content of such filing, the Parties shall take expedited steps to resolve the dispute as promptly as possible, including seeking advice of an independent legal counsel to guide their decision. BMS shall provide, consistent with its obligations under applicable Law, reasonable cooperation to ITI in filing and maintaining such Orange Book (and foreign equivalent) listings.

Data Exclusivity and Orange Book Listings. With Subject to applicable terms of the Pharmatop License Agreement: (i) with respect to data exclusivity periods in the Territory (such as those periods listed in the FDA’s Orange Book (including without limitation any available pediatric extensions)) or periods under national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83Cadence, and all international equivalents)as appropriate, ITI shall use Commercially Reasonable Efforts commercially reasonable efforts consistent with its obligations under applicable Applicable Law in the Territory to seek, maintain and enforce all such data exclusivity periods available for the Licensed Products. With , and (ii) with respect to Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. filings in the FDA Orange Book (and foreign equivalents) for issued patents for a Licensed Product, ITI the appropriate Party shall, consistent with its obligations under applicable LawApplicable Law in the Territory, list (and update as appropriate) in a timely manner and maintain all applicable BMS Patent Rights and other patents Controlled by ITI Patents required to be filed by it, or that it is permitted to file, under applicable Lawsuch Applicable Law in connection with such Product. At least sixty [***] (60) days [***])[***] prior to an anticipated deadline for the filing of patent listing information for BMS Patent Rightssuch Patents, ITI the Party making such filing shall notify in writing and consult with BMS the other Party regarding the content of such filing. In the event of a dispute between the Parties as to whether a BMS particular Patent Right can be filed listed and/or the content of the filing for such filinglisting, the Parties shall take expedited steps to resolve the dispute as promptly as possible, including seeking advice of an independent legal counsel to guide their decision. BMS The other Party shall provide, consistent with its obligations under applicable LawApplicable Law in the Territory, reasonable cooperation to ITI the Party making such listing in filing and maintaining such Orange Book (and foreign equivalent) listings.

Data Exclusivity and Orange Book Listings. 14.6.1 With respect to data exclusivity periods (such as those periods listed in the FDA’s Orange Book (including without limitation any available pediatric extensions) or periods under national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83, and all international equivalents), ITI BMS and AMRI, as appropriate shall use Commercially Reasonable Efforts consistent with its obligations under applicable Law law to seek, maintain and enforce all such data exclusivity periods available for the 122 Licensed Products. With respect to Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. filings in the FDA Orange Book (and foreign equivalents) for issued patents for a Licensed Product, ITI the appropriate Party shall, consistent with its obligations under applicable Lawlaw, list in a timely manner and maintain all applicable BMS AMRI Patent Rights and other patents Controlled by ITI or BMS Licensed Patent Rights required to be filed by it, or that it is permitted to file, under applicable Lawlaw in connection with such Licensed Product. At least sixty (60) days prior to an anticipated deadline for the filing of patent listing information for AMRI Patent Rights or BMS Licensed Patent Rights, ITI the Party making such filing shall notify in writing and consult with BMS the other Party regarding the content of such filing. In the event of a dispute between the Parties as to whether a an AMRI Patent Right or BMS Licensed Patent Right can be filed listed and/or the content of the filing for such filinglisting, the Parties shall take expedited steps to resolve the dispute as promptly as possible, including seeking advice of an independent legal counsel to guide their decision. BMS The other Party shall provide, consistent with its obligations under applicable Lawlaw, reasonable cooperation to ITI the Party making such listing in filing and maintaining such Orange Book (and foreign equivalent) listings.

Data Exclusivity and Orange Book Listings. 10.6.1 With respect to data exclusivity periods (such as those periods listed in the FDA’s Orange Book (including without limitation any available pediatric extensions) or periods under national implementations of Article 10.1(a)(iii) of Directive 2001/EC/83, as amended, and all international equivalents), ITI Pharmacopeia shall use Commercially Reasonable Efforts commercially reasonable efforts consistent with its obligations under applicable Law to seek, maintain and enforce all such data exclusivity periods available for the Licensed Products. With respect to Portions of this Exhibit, indicated by the xxxx “[***],” were omitted and have been filed separately with the Securities and Exchange Commission pursuant to the Registrant’s application requesting confidential treatment pursuant to Rule 24b-2 of the Securities Exchange Act of 1934, as amended. filings in the FDA Orange Book (and foreign equivalents) for issued patents for a Licensed Product, ITI Pharmacopeia shall, consistent with its obligations under applicable Law, list in a timely manner and maintain all applicable BMS Patent Rights and other patents Controlled by ITI Pharmacopeia required to be filed by it, or that it is permitted to file, under applicable Law. At least sixty *** (60***) days prior to an anticipated deadline for the filing of patent listing information for BMS Patent Rights, ITI shall Pharmacopeia will consult with BMS regarding the content of such filing. In the event of a dispute between the Parties as to whether a BMS Patent Right or BMS Other Patent Right can be filed and/or the content of such filing, the Parties shall will take expedited steps to resolve the dispute as promptly as possible, including seeking advice of an independent legal counsel to guide their decision. BMS shall provide, use commercially reasonable efforts consistent with its obligations under applicable Law, including to provide reasonable cooperation to ITI Pharmacopeia in filing and maintaining such Orange Book (and foreign equivalent) listings.