CDA or the License Agreement,
whichever is relevant.
The following definitions shall also apply to this
ADDENDUM.
CLINICAL TRIAL shall mean clinical study(ies) designed to support an application
to the FDA for marketing approval of a PRODUCT in the FIELD to be conducted by
IDEC in accordance herewith, which shall comprise a part of CDA DEVELOPMENT.
CLINICAL TRIAL COSTS shall mean all costs [CONFIDENTIAL TREATMENT REQUESTED].
BLA PREPARATION COSTS shall mean those FULLY BURDENED COSTS actually incurred by
IDEC in preparing, submitting, reviewing, or developing data or information for
the purpose of filing of any Biologics License Application (BLA) directed to the
use of PRODUCT in the FIELD including, without limitation, FULLY BURDENED COSTS
incurred in the preparation of the Integrated Summaries and in the conduct of
the Functional Activities set forth in Appendix F.
FULLY BURDENED COSTS shall mean, with respect to a particular item (e.g.,
PRODUCT, PRODUCT manufacturing, BLA PREPARATION COSTS), the costs [CONFIDENTIAL
TREATMENT REQUESTED].
2.
CDA DEVELOPMENT AND APPENDIX C.
(A)
THE CDA PROVIDES THAT THE PRECLINICAL AND CLINICAL DEVELOPMENT
PROGRAM ON A PRODUCT WITHIN THE FIELD CONDUCTED DURING THE TERM OF THE CDA SHALL
BE CARRIED OUT IN ACCORDANCE WITH ARTICLE 3 OF THE CDA AND APPENDIX C TO THE
CDA.
THE PARTIES DESIRE TO EXPAND THE CLINICAL DEVELOPMENT TO BE CARRIED OUT
UNDER THE CDA TO INCLUDE ADDITIONAL CLINICAL STUDIES.
TO APPENDIX C TO THE CDA
APPENDIX C ATTACHED TO THIS ADDENDUM SHALL BE ADDED.
APPENDIX C, AS REVISED
PURSUANT TO THIS ADDENDUM, IS DIVIDED INTO TWO PARTS.
PART I DESCRIBES THE
PRECLINICAL AND PHASE I CLINICAL DEVELOPMENT WHICH SK CORPORATION HAS FUNDED AND
WILL CONTINUE TO FUND PURSUANT TO SECTION 4.02 OF THE CDA.
PART II DESCRIBES
THE CURRENT AND PRESENTLY ANTICIPATED FUTURE CLINICAL DEVELOPMENT PROGRAM TO BE
MANAGED BY IDEC, FUNDING FOR WHICH IS DESCRIBED IN PARAGRAPH 3 BELOW.
EXCEPT AS
OTHERWISE AGREED TO IN WRITING BY THE PARTIES, IDEC SHALL NOT HAVE
RESPONSIBILITY FOR ANY DEVELOPMENT ACTIVITIES IN THE SK
3
CORPORATION TERRITORY.
The Steering Committee shall retain the right to amend
Appendix C when appropriate, subject to the provisions of Section 3.03 of the
CDA, as amended by this Addendum.
(B)
IN PARTIAL CONSIDERATION OF THE FUNDING PROVIDED BY SK
CORPORATION, IDEC SHALL CONSIDER THE INPUT OF SK CORPORATION IN DESIGNING
CLINICAL TRIALS.
ACCORDINGLY, SECTION 3.02 OF THE CDA IS AMENDED BY ADDING AT
THE END THEREOF THE FOLLOWING:
"IDEC shall forward to SK CORPORATION a draft clinical study protocol, which
defines the designs, population and procedures of any CLINICAL TRIAL to be
conducted in accordance with
Part 2 of Appendix C and under which such CLINICAL
TRIAL shall be operated ("PROTOCOL"), promptly after its preparation.
SK
CORPORATION shall submit any comments or suggestions concerning the draft
clinical study protocol to IDEC within two weeks of receipt by SK CORPORATION of
such draft clinical study protocol. IDEC will consider in good faith any
comments or suggestions timely submitted
by SK CORPORATION in accordance with
this Section 3.02 as amended,