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 11.1(a)(iii) of Directive 2001/EC/83, or similar periods as may be applicable to a biologic, and all international equivalents), Sanofi will use Commercially Reasonable Efforts consistent with its obligations under applicable law (including any applicable consent order) to seek, maintain and enforce all such data exclusivity periods available for the Products exclusively licensed by Sanofi hereunder. With respect to filings in the FDA Orange Book or other similar filings or listings as may be applicable (and foreign equivalents) for issued patents for a Product, upon reasonable request by Sanofi, Regulus will provide reasonable cooperation to Sanofi in filing and maintaining any such listing and filings. All listing and filing decisions will be at the sole discretion of Sanofi; provided, however that Sanofi will not list Regulus Core Technology Patents in the FDA Orange Book without Regulus’ prior written consent, such consent not to be unreasonably withheld or delayed. In no event will Regulus withhold or delay such consent where the listing of such Regulus Core Technology Patent is required under applicable law.

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 11.1(a)(iii) of Directive 2001/EC/83, or similar periods as may be applicable to a biologic, and all international equivalents), Sanofi AstraZeneca will use Commercially Reasonable Efforts consistent with its obligations under applicable law (including any applicable consent order) to seek, maintain and enforce all such data exclusivity periods available for the Lead Compounds and Products exclusively licensed by Sanofi AstraZeneca hereunder. With respect to filings in the FDA Orange Book or other similar filings or listings as may be applicable (and foreign equivalents) for issued patents for a Lead Compound or Product, upon reasonable request by SanofiAstraZeneca, Regulus will provide reasonable cooperation to Sanofi AstraZeneca in filing and maintaining any such listing and filings. All listing and filing decisions will be at the sole discretion of SanofiAstraZeneca except for Regulus Core Technology Patents; provided, however that Sanofi will not AstraZeneca may list Regulus Core Technology Patents and Other Joint Patents in the FDA Orange Book without with Regulus’ prior written consent, such consent not to be unreasonably withheld or delayed. In no event will Regulus withhold or delay such consent where the listing of such Regulus Core Technology Patent or Other Joint Patent is required under applicable law.

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 11.1(a)(iii) of Directive 2001/EC/83, or similar periods as may be applicable to a biologic, and all international equivalents), Sanofi OMI will use Commercially Reasonable Efforts consistent with its obligations under applicable law (including any applicable consent order) to seek, maintain and enforce all such data exclusivity periods available for the Products exclusively licensed by Sanofi OMI hereunder. With respect to filings in the FDA Orange Book or other similar filings or listings as may be applicable (and foreign equivalents) for issued patents for a Product, upon reasonable request by SanofiOMI, Regulus Isis will provide reasonable cooperation to Sanofi OMI in filing and maintaining any such listing and filings. All listing and filing decisions will shall be at the sole discretion of SanofiOMI; provided, provided ,however that Sanofi OMI will not list Regulus Isis Core Technology Patents in the FDA Orange Book without RegulusIsis’ prior written consent, such consent not to be unreasonably withheld or delayed. In no event will Regulus Isis withhold or delay such consent where the listing of such Regulus Isis Core Technology Patent is required under applicable law.