however, in no circumstance shall IDEC be required
to amend a PROTOCOL to incorporate the comments or suggestions submitted
by SK
CORPORATION.
(C)
IN CONSIDERATION OF IDEC'S EXPERTISE IN THE FIELD OF CLINICAL
TRIAL DESIGN, THE PARTIES WISH TO CLARIFY IDEC'S RIGHTS WITH RESPECT TO BUSINESS
AND SCIENTIFIC DECISIONS RELATING TO DEVELOPMENT ACTIVITIES APPLICABLE TO THE
IDEC TERRITORY AND HEREBY AMEND SECTION 3.03 OF THE CDA TO DELETE THE LAST
SENTENCE THEREOF AND REPLACE SAME WITH THE FOLLOWING PROVISION:
"Notwithstanding the foregoing, in the event the Steering Committee is unable to
unanimously agree on a decision regarding CDA DEVELOPMENT applicable to
development and regulatory approval of a Product in the IDEC TERRITORY,
[CONFIDENTIAL TREATMENT REQUESTED].
(D)
IT IS UNDERSTOOD THAT THE PARTIES REQUIRE REASONABLE FLEXIBILITY
IN CONDUCTING DEVELOPMENT ACTIVITIES AND COMMITTING THEIR RESPECTIVE RESOURCES
THERETO.
THE PARTIES DESIRE TO PROVIDE FOR CERTAIN RIGHTS TO DISCONTINUE THE
CLINICAL STUDIES DESCRIBED IN PART II OF APPENDIX C WITHOUT TERMINATING ALL
RIGHTS AND LICENSES GRANTED UNDER ARTICLE 2 OF THE LICENSE AGREEMENT.
THE
PARTIES DESIRE TO FURTHER AMEND ARTICLE 3 OF THE CDA BY ADDING THE FOLLOWING NEW
SECTIONS 3.12 AND 3.13:
"3.12.
IDEC may elect at any time and for any reason to discontinue CDA
DEVELOPMENT relating to a CLINICAL TRIAL in the IDEC TERRITORY.
IDEC shall give
SK CORPORATION not less than thirty (30) days written notice of its intent to
discontinue a clinical study and will use reasonable efforts
4
to wind down such studies in an orderly fashion.
Discontinuation of a CLINICAL
TRIAL by IDEC pursuant to this Section 3.12 shall not be deemed a breach of the
CDA and shall not give SK CORPORATION the right to terminate the CDA pursuant to
Section 9.03 of the CDA.
3.13.
SK CORPORATION may elect to discontinue further funding of CDA
DEVELOPMENT relating to CLINICAL TRIALS in the IDEC TERRITORY only if the
election is made in writing within thirty (30) days following (i) Steering
Committee approval of a CLINICAL TRIAL in addition to those set forth in
Appendix C as amended herewith or (ii) Steering Committee approval of a MATERIAL
PROTOCOL AMENDMENT relating to a clinical study.
For purposes of this Section
3.13, "MATERIAL PROTOCOL AMENDMENT" shall mean an increase of more than
twenty-five percent (25%) over the total patient enrollment
currently set forth
in Part 2 of Appendix C.
Notwithstanding other provisions of the CDA to the
contrary, in the event SK CORPORATION elects under Section 3.13(i) or 3.13(ii)
to discontinue funding a clinical study in the IDEC TERRITORY, SK CORPORATION
shall pay [CONFIDENTIAL TREATMENT REQUESTED
([CONFIDENTIAL TREATMENT
REQUESTED])
CLINICAL TRIAL COSTS actually incurred by IDEC up to the date of
election by SK CORPORATION to discontinue funding of such CLINICAL TRIAL, and
IDEC shall have no obligation to provide SK CORPORATION data, information or
results from any clinical study, including any applications filed with the FDA,
generated after the discontinuance of funding by SK CORPORATION.
3.
Development Milestones and Funding.
(A)
AS OF THE EFFECTIVE DATE ,