8.5
NOTIFICATION OF PATENT CERTIFICATION.
ISIS SHALL NOTIFY
AND PROVIDE BMS WITH COPIES OF ANY ALLEGATIONS OF ALLEGED PATENT INVALIDITY,
UNENFORCEABILITY OR NON-INFRINGEMENT
31
OF AN ISIS PATENT RIGHT COVERING A COMPOUND OR PRODUCT (INCLUDING METHODS OF USE
THEREOF) PURSUANT TO A PARAGRAPH IV PATENT CERTIFICATION BY A THIRD PARTY FILING
AN ABBREVIATED NEW DRUG APPLICATION, AN APPLICATION UNDER §505(B)(2) OR OTHER
SIMILAR PATENT CERTIFICATION BY A THIRD PARTY, AND ANY FOREIGN EQUIVALENT
THEREOF FOR A GENERIC PRODUCT.
SUCH NOTIFICATION AND COPIES SHALL BE PROVIDED
TO BMS BY ISIS AS SOON AS PRACTICABLE AND AT LEAST WITHIN FIVE (5) DAYS AFTER
ISIS RECEIVES SUCH CERTIFICATION, AND SHALL BE SENT BY FACSIMILE AND OVERNIGHT
COURIER TO THE ADDRESS SET FORTH BELOW:
Bristol-Myers Squibb Company
P.O. Box 4000
Route 206 & Province Line Road
Princeton, New Jersey 08543-4000
Attention:
Vice President and Chief Intellectual Property Counsel
Telephone:
609-252-4825
Facsimile:
609-252-7884
SECTION 8.6
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), BMS SHALL 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 BMS 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 BMS, ISIS SHALL PROVIDE REASONABLE COOPERATION TO BMS IN
FILING AND MAINTAINING ANY SUCH LISTING AND FILINGS.
BMS SHALL NOT LIST ISIS
CORE TECHNOLOGY PATENTS IN THE FDA ORANGE BOOK WITHOUT ISIS' PRIOR WRITTEN
CONSENT, SUCH CONSENT NOT TO BE UNREASONABLY WITHHELD OR DELAYED.
IN NO EVENT
SHALL ISIS SHALL WITHHOLD OR DELAY SUCH CONSENT WHERE THE LISTING OF SUCH ISIS
CORE TECHNOLOGY PATENT IS REQUIRED UNDER APPLICABLE LAW.
SECTION 8.7
FURTHER ACTIONS.
EACH PARTY SHALL, UPON THE REASONABLE
REQUEST OF THE OTHER PARTY, PROVIDE SUCH ASSISTANCE AND EXECUTE SUCH DOCUMENTS
AS ARE REASONABLY NECESSARY FOR SUCH PARTY TO EXERCISE ITS RIGHTS AND/OR PERFORM
ITS OBLIGATIONS PURSUANT TO THIS ARTICLE 8; PROVIDED HOWEVER, THAT NEITHER PARTY
SHALL BE REQUIRED TO TAKE ANY ACTION PURSUANT TO ARTICLE 8 THAT SUCH PARTY
REASONABLY DETERMINES IN ITS SOLE JUDGMENT AND DISCRETION CONFLICTS WITH OR
VIOLATES ANY APPLICABLE COURT OR GOVERNMENT ORDER OR DECREE.
SECTION 8.8
INFRINGEMENT CLAIMS; OPPOSITIONS.
BMS AND ISIS SHALL
PROMPTLY INFORM THE OTHER IN WRITING OF ANY WRITTEN NOTICE TO IT OF ALLEGED
INFRINGEMENT OR MISAPPROPRIATION, BASED ON THE RESEARCH, DEVELOPMENT, MAKING,
USING, IMPORTING, EXPORTING OR SELLING OF A COMPOUND OR PRODUCT, OF A THIRD
PARTY'S INTELLECTUAL PROPERTY RIGHTS OF WHICH IT SHALL BECOME AWARE.
THE
PARTIES SHALL CONFER ON THE HANDLING OF SUCH MATTER.
ISIS SHALL NOT ACKNOWLEDGE
TO A THIRD PARTY THE VALIDITY OF