THROUGH COMPLETION OF PHASE IIB TRIALS, WHICH
COST SHALL NOT EXCEED $[***] PER GRAM.
ALL SUCH API MANUFACTURE WILL BE
PERFORMED AT ISIS' FACILITIES.
ISIS SHALL NOT USE A THIRD PARTY (SUB)CONTRACTOR
FOR THE MANUFACTURE OF SUCH API WITHOUT THE PRIOR WRITTEN APPROVAL OF BMS.
SECTION 3.6
RESEARCH PROGRAM RECORDS.
ISIS WILL MAINTAIN COMPLETE
AND ACCURATE RECORDS OF ALL WORK CONDUCTED IN THE PERFORMANCE OF THE RESEARCH
PROGRAM AND ALL RESULTS, DATA, INVENTIONS AND DEVELOPMENTS MADE IN THE
PERFORMANCE OF THE RESEARCH PROGRAM.
SUCH RECORDS WILL BE IN SUFFICIENT DETAIL
AND IN GOOD SCIENTIFIC MANNER APPROPRIATE FOR PATENT AND REGULATORY PURPOSES.
ISIS SHALL MAINTAIN APPROPRIATE RECORDS SUFFICIENT TO DOCUMENT THE WORK
PERFORMED BY EACH OF THE INDIVIDUALS COMPRISING THE FTES WORKING IN SUPPORT OF
THE RESEARCH PROGRAM AND THE TIME SUCH INDIVIDUALS SPENT WORKING IN SUPPORT OF
THE RESEARCH PROGRAM.
ISIS SHALL PROVIDE BMS THE RIGHT TO INSPECT SUCH RECORDS,
AND SHALL PROVIDE COPIES OF ALL REQUESTED RECORDS, TO THE EXTENT REASONABLY
REQUIRED FOR THE PERFORMANCE OF BMS' RIGHTS AND OBLIGATIONS UNDER THIS
AGREEMENT; PROVIDED HOWEVER, THAT BMS SHALL MAINTAIN SUCH RECORDS AND THE
INFORMATION OF ISIS IN CONFIDENCE IN ACCORDANCE WITH ARTICLE 7 HEREOF AND SHALL
NOT USE SUCH RECORDS OR INFORMATION EXCEPT TO THE EXTENT OTHERWISE PERMITTED BY
THIS AGREEMENT.
6
IN ORDER TO PROTECT THE PARTIES' PATENT RIGHTS UNDER U.S. LAW IN ANY INVENTIONS
CONCEIVED OR REDUCED TO PRACTICE DURING OR AS A RESULT OF THE RESEARCH PROGRAM,
EACH PARTY AGREES TO MAINTAIN A POLICY THAT REQUIRES ITS EMPLOYEES TO RECORD AND
MAINTAIN ALL DATA AND INFORMATION DEVELOPED DURING THE RESEARCH PROGRAM IN SUCH
A MANNER AS TO ENABLE THE PARTIES TO USE SUCH RECORDS TO ESTABLISH THE EARLIEST
DATE OF INVENTION AND/OR DILIGENCE TO REDUCTION TO PRACTICE.
AT A MINIMUM, THE
POLICY SHALL REQUIRE SUCH INDIVIDUALS TO RECORD ALL INVENTIONS GENERATED BY THEM
IN STANDARD LABORATORY NOTEBOOKS OR OTHER SUITABLE MEANS THAT ARE DATED AND
CORROBORATED BY NON-INVENTORS ON A REGULAR, CONTEMPORANEOUS BASIS.
SECTION 3.7
DISCLOSURE OF RESULTS OF RESEARCH PROGRAM.
THE RESULTS OF ALL WORK PERFORMED BY THE PARTIES AS PART OF THE RESEARCH PROGRAM
SHALL BE PROMPTLY DISCLOSED TO THE OTHER PARTY IN A REASONABLE MANNER AS SUCH
RESULTS ARE OBTAINED.
ISIS SHALL PERIODICALLY PROVIDE BMS WITH WRITTEN REPORTS
OF THE WORK PERFORMED UNDER THE RESEARCH PROGRAM AND THE RESULTS ACHIEVED BY
ISIS.
ISIS AND BMS WILL PROVIDE REPORTS AND ANALYSES AT EACH JRC MEETING, AND
MORE FREQUENTLY ON REASONABLE REQUEST BY THE JRC, DETAILING THE CURRENT STATUS
OF THE RESEARCH PROGRAM, INCLUDING BUT NOT LIMITED TO THE UTILIZATION OF THE
ISIS FTE RESOURCES.
WITHIN 30 DAYS FOLLOWING THE END OF EACH CALENDAR QUARTER,
ISIS AND BMS SHALL EACH EXCHANGE AND PROVIDE TO THE JRC A WRITTEN REPORT
SUMMARIZING IN REASONABLE DETAIL THE WORK PERFORMED BY IT UNDER THE RESEARCH
PROGRAM AND RESULTS ACHIEVED DURING THE PRECEDING CALENDAR QUARTER.
IN
ADDITION, ON REASONABLE REQUEST BY A PARTY, THE OTHER PARTY WILL MAKE
PRESENTATIONS OF ITS ACTIVITIES IN THE PERFORMANCE OF THE RESEARCH PROGRAM