FAITH WITH RESPECT TO AN
AGREEMENT FOR ISIS TO MANUFACTURE AND SUPPLY THE API FOR BMS' COMMERCIAL
REQUIREMENTS OF THE PRODUCT.
IF THE PARTIES DO NOT REACH AGREEMENT WITHIN [***]
DAYS OF SUCH NOTICE BY BMS TO ISIS, BMS SHALL BE FREE AT ITS DISCRETION (AND
SUBJECT TO SECTION 4.5.3(B)) TO ENTER INTO AN AGREEMENT WITH ANY THIRD PARTY
WITH RESPECT TO SUCH COMMERCIAL SUPPLY ON TERMS AND OTHER CONSIDERATIONS
11
(SUCH OTHER CONSIDERATIONS INCLUDING NON-FINANCIAL CONSIDERATIONS INCLUDING BUT
NOT LIMITED TO QUALITY, CAPACITY, LEAD TIME, CONTINGENCY PLANNING, RELIABILITY
AND REGULATORY COMPLIANCE) THAT WHEN TAKEN AS A WHOLE AS REASONABLY DETERMINED
BY BMS ARE NO LESS FAVORABLE TO BMS THAN THE TERMS AND OTHER CONSIDERATIONS LAST
PRESENTED TO BMS BY ISIS.
(C)
IN ADVANCE OF ANY NEGOTIATIONS BETWEEN THE PARTIES UNDER SECTION
4.5.2(A) OR (B), UPON REQUEST BY BMS, ISIS SHALL PROVIDE TO BMS A SUMMARY OF THE
MANUFACTURING TECHNOLOGY PROPOSED TO BE USED BY OR FOR ISIS FOR THE
MANUFACTURING OF API, AND OTHER RELATED INFORMATION AS REASONABLY REQUESTED BY
BMS.
4.5.3
TRANSFER OF MANUFACTURING TECHNOLOGY.
(A)
UPON REQUEST BY BMS, SOLELY FOR PURPOSES OF THE MANUFACTURE AND
SUPPLY OF BMS' REQUIREMENTS OF API FOR [***] AND/OR COMMERCIAL SUPPLY OF
COMPOUND AND/OR PRODUCT PURSUANT TO THE EXERCISE OF BMS' RIGHTS UNDER THIS
AGREEMENT, ISIS SHALL TRANSFER ANY ISIS MANUFACTURING TECHNOLOGY TO BMS, AND/OR
ANY ISIS PERMITTED MANUFACTURING TECHNOLOGY TO A THIRD PARTY MANUFACTURER
SELECTED BY BMS.
AS SOON AS IS PRACTICABLE AFTER ITS RECEIPT OF SUCH REQUEST,
ISIS SHALL TRANSFER TO BMS THE ISIS MANUFACTURING TECHNOLOGY, OR THE ISIS
PERMITTED MANUFACTURING TECHNOLOGY TO SUCH THIRD PARTY MANUFACTURER.
FOR SUCH
PURPOSE ISIS SHALL TRANSFER TO BMS ALL DOCUMENTATION AND INFORMATION, AND PERMIT
BMS TO REFERENCE AND USE ANY REGULATORY FILINGS, AND OTHERWISE FULLY COOPERATE
WITH BMS TO ENABLE BMS TO MAKE OR HAVE MADE API FOR USE BY BMS IN ACCORDANCE
WITH THIS AGREEMENT.
ALL DOCUMENTED OUT-OF-POCKET COSTS AND EXPENSES INCURRED
BY ISIS IN CARRYING OUT SUCH TRANSFER SHALL BE REIMBURSED BY BMS UPON SUCCESSFUL
COMPLETION AND CONFIRMATION OF SUCH TRANSFER.
IN ADDITION, UPON REQUEST BY BMS,
ISIS SHALL PROVIDE BMS WITH A REASONABLE LEVEL OF TECHNICAL ASSISTANCE AND
CONSULTATION IN CONNECTION WITH THE TRANSFER OF SUCH MANUFACTURING TECHNOLOGY TO
HELP ENABLE BMS OR SUCH THIRD PARTY MANUFACTURER (AS APPLICABLE) TO MANUFACTURE
SUCH API.
FOR SUCH PURPOSE ISIS SHALL PROVIDE BMS WITH REASONABLE ACCESS BY
TELECONFERENCE OR IN-PERSON AT ISIS' FACILITIES TO ISIS PERSONNEL INVOLVED IN
THE MANUFACTURING OF API, PROVIDED THAT IF BMS REQUESTS SUCH TECHNICAL
ASSISTANCE IN EXCESS OF [***] AGGREGATE HOURS OF TECHNICAL ASSISTANCE, BMS SHALL
REIMBURSE ISIS FOR ITS TIME INCURRED IN PROVIDING SUCH ASSISTANCE IN EXCESS OF
SUCH [***] HOUR LIMIT AT THE THEN-APPLICABLE ISIS FTE RATE PER HOUR, PLUS ANY
REASONABLE OUT-OF-POCKET EXPENSES INCURRED BY ISIS IN PROVIDING SUCH TECHNICAL
ASSISTANCE REQUESTED BY BMS.
SUCH PAYMENT SHALL BE MADE TO ISIS WITHIN 30 DAYS
AFTER SUBMISSION OF AN INVOICE BY ISIS REASONABLY DETAILING ISIS' TIME EXPENDED,
TOGETHER WITH REASONABLE SUBSTANTIATION OF ANY OUT-OF-POCKET