THE
PERFORMANCE OF WORK UNDER THIS AGREEMENT.
3.9.4
ISIS WILL NOT PERFORM ANY OF ITS OBLIGATIONS UNDER THE R&D PLAN THROUGH ONE OR
MORE SUBCONTRACTORS OR CONSULTANTS, WITHOUT THE PRIOR WRITTEN APPROVAL OF OMI,
SUCH APPROVAL NOT TO BE UNREASONABLY WITHHELD. OMI WILL PROMPTLY NOTIFY ISIS
REGARDING ANY THIRD PARTY OMI USES TO CONDUCT RESEARCH UNDER THE R&D PLAN OR
THAT OMI TRANSFERS COMPOUNDS OR PRODUCTS TO, INCLUDING IDENTIFYING SUCH THIRD
PARTY.
SECTION
3.10
MATERIALS TRANSFER. IN ORDER TO FACILITATE THE COLLABORATION, EITHER PARTY MAY
PROVIDE TO THE OTHER PARTY CERTAIN MATERIALS FOR USE BY THE OTHER PARTY IN
FURTHERANCE OF THE COLLABORATION. ALL SUCH MATERIALS WILL BE USED BY THE
RECEIVING PARTY IN ACCORDANCE WITH THE TERMS AND CONDITIONS OF THIS AGREEMENT
SOLELY FOR PURPOSES OF PERFORMING ITS RIGHTS AND OBLIGATIONS UNDER THIS
AGREEMENT, AND THE RECEIVING PARTY WILL NOT TRANSFER SUCH MATERIALS TO ANY THIRD
PARTY UNLESS EXPRESSLY CONTEMPLATED BY THIS AGREEMENT OR UPON THE WRITTEN
CONSENT OF THE SUPPLYING PARTY. ANY MATERIALS PROVIDED BY OMI TO ISIS IN SUPPORT
OF THE COLLABORATION, INCLUDING BUT NOT LIMITED TO ANY BIOLOGICAL MATERIALS WITH
RESPECT TO SCREENING ASSAYS, INCLUDING ANY PROGENY, EXPRESSION PRODUCTS,
MUTANTS, REPLICATES, TISSUE SAMPLES, CELLS, DERIVATIVES AND MODIFICATIONS
THEREOF, (SUCH MATERIALS BEING INDIVIDUALLY AND COLLECTIVELY REFERRED TO AS THE
"OMI MATERIALS") WILL BE USED BY ISIS SOLELY FOR PURPOSES OF PERFORMING THE
COLLABORATION AND FOR NO OTHER PURPOSE, AND ANY REMAINING OMI MATERIALS
(INCLUDING, AS APPLICABLE, ANY PROGENY, EXPRESSION PRODUCTS, MUTANTS,
REPLICATES, TISSUE SAMPLES, CELLS, DERIVATIVES AND MODIFICATIONS THEREOF) WILL
BE RETURNED TO OMI (OR DESTROYED AS MAY BE REQUESTED BY OMI IN WRITING) PROMPTLY
FOLLOWING THE END OF THE RESEARCH TERM OR EARLIER UPON REQUEST BY OMI. ALL
INFORMATION RELATED TO SUCH OMI MATERIALS WILL BE OMI CONFIDENTIAL INFORMATION.
ALL SUCH MATERIALS MUST BE USED WITH PRUDENCE AND APPROPRIATE CAUTION IN ANY
EXPERIMENTAL WORK, SINCE ALL OF THEIR CHARACTERISTICS MAY NOT BE KNOWN. ISIS
RECOGNIZES THAT OMI'S OBLIGATIONS UNDER THE R&D PLAN WILL NECESSARILY INVOLVE
THE TRANSFER OF MATERIALS TO THIRD PARTY CONTRACTORS AND THAT IS EXPRESSLY
CONTEMPLATED BY THIS AGREEMENT.
9
SECTION
3.11
SAFETY DATABASE
3.11.1
OMI SHALL ESTABLISH THE GLOBAL SAFETY DATABASE OF ADVERSE
EVENTS AND PREGNANCY REPORTS FOR THE COMPOUND/PRODUCT THAT WILL BE USED FOR
REGULATORY REPORTING AND RESPONSES TO SAFETY QUERIES FROM REGULATORY
AUTHORITIES. ISIS SHALL PROMPTLY TRANSFER ALL CLINICAL ADVERSE EVENT AND DRUG
EXPOSURE DURING PREGNANCY DATA THAT IT HAS REGARDING THE COMPOUNDS OR PRODUCTS
TO OMI FOR ENTRY INTO THE GLOBAL SAFETY DATABASE UPON REQUEST FROM OMI.
3.11.2
[***] A DATABASE THAT INCLUDES INFORMATION REGARDING THE
SAFETY AND TOLERABILITY OF [***] DRUG COMPOUNDS, INDIVIDUALLY AND AS A CLASS,
INCLUDING INFORMATION DISCOVERED DURING PRE-CLINICAL AND CLINICAL DEVELOPMENT
(THE "[***] DATABASE").
(A)
IN AN EFFORT TO MAXIMIZE UNDERSTANDING OF THE [***] WILL COOPERATE IN CONNECTION
WITH POPULATING THE [***] DATABASE. IN ACCORDANCE WITH APPLICABLE LAW AND ANY
APPLICABLE INFORMED CONSENTS OR OTHER THIRD PARTY OBLIGATIONS, [***] WITH COPIES
OF [***] SERIOUS ADVERSE EVENT FINAL REPORTS RELATED TO [***]. IN ADDITION, IN