AND THE OTHER PARTY WILL RECEIVE
[***]% OF THE AMOUNT OF SUCH SPECIAL OR PUNITIVE DAMAGES.
9.4.7
ENFORCEMENT OF ISIS CORE TECHNOLOGY PATENTS AND ISIS
MANUFACTURING AND ANALYTICAL PATENTS BY OMI. IN THE EVENT THAT ISIS OR OMI
BECOMES AWARE OF A SUSPECTED INFRINGEMENT OF ANY ISIS CORE TECHNOLOGY PATENTS
AND ISIS MANUFACTURING AND ANALYTICAL PATENTS BY A THIRD PARTY WHERE SUCH
INFRINGEMENT INVOLVES THE MANUFACTURE, USE OR SALE OF AN ASO TARGETING A
COLLABORATION GENE TARGET (INCLUDING BUT NOT LIMITED TO INFRINGEMENT WHICH IS
THE SUBJECT OF A NOTICE UNDER SECTION 9.5), THE PARTIES WILL CONFER AND DISCUSS
IN GOOD FAITH AN ENFORCEMENT STRATEGY WITH RESPECT TO SUCH ISIS CORE TECHNOLOGY
PATENTS AND ISIS MANUFACTURING AND ANALYTICAL PATENTS AGAINST SUCH THIRD PARTY,
AND ISIS WILL CONSIDER IN GOOD FAITH AND NOT UNREASONABLY DENY OR DELAY OMI'S
REQUEST TO ENFORCE SUCH ISIS CORE TECHNOLOGY PATENTS AND ISIS MANUFACTURING AND
ANALYTICAL PATENTS IN THE SAME MANNER AS A PRODUCT SPECIFIC PATENT AS SET FORTH
ABOVE IN THIS ARTICLE 9.
SECTION
9.5
NOTIFICATION OF PATENT CERTIFICATION. ISIS WILL NOTIFY AND PROVIDE OMI WITH
COPIES OF ANY ALLEGATIONS OF ALLEGED PATENT INVALIDITY, UNENFORCEABILITY OR
NON-INFRINGEMENT 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 WILL BE
29
PROVIDED TO OMI BY ISIS AS SOON AS PRACTICABLE AND AT LEAST WITHIN FIVE (5) DAYS
AFTER ISIS RECEIVES SUCH CERTIFICATION, AND WILL BE SENT BY FACSIMILE AND
OVERNIGHT COURIER TO THE ADDRESS SET FORTH BELOW:
ORTHO MCNEIL, INC.
1000 US ROUTE 202
RARITAN, NEW JERSEY, 08869
Attention:
President
Facsimile:
908-707-9757
With copy to:
Johnson & Johnson Chief Patent Counsel
Johnson & Johnson
1 Johnson & Johnson Plaza
New Brunswick, NJ 08933
Facsimile:
732-524-5575
SECTION
9.6
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),
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 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 OMI,
ISIS WILL PROVIDE REASONABLE COOPERATION TO OMI IN FILING AND MAINTAINING ANY
SUCH LISTING AND FILINGS. ALL LISTING AND FILING DECISIONS SHALL BE AT THE SOLE
DISCRETION OF OMI; PROVIDED ,HOWEVER THAT OMI WILL NOT LIST ISIS CORE TECHNOLOGY
PATENTS IN THE FDA ORANGE BOOK WITHOUT