RESEARCH GOALS SHALL NOT BECOME EFFECTIVE UNTIL APPROVED BY THE STEERING
COMMITTEE.
THE STEERING COMMITTEE SHALL REVIEW AND CONSIDER ANY SUCH PROPOSED
UPDATES OR AMENDMENTS OR REVISED RESEARCH GOALS ON A REASONABLY EXPEDITIOUS
BASIS.
ONCE THE STEERING COMMITTEE DECIDES THAT THE SADR STUDY HAS BEEN
COMPLETED AND NO ADDITIONAL WORK IS TO BE SCHEDULED, THE PARTIES SHALL EXECUTE
THE FINAL DATA TRANSFER ACCORDING TO SECTION 2.1.2(F) AND PREPARE THE
PRELIMINARY SADR STUDY REPORT IN ACCORDANCE WITH SECTION 2.1.2(G).
2.1.2
SADR STUDY OBJECTIVES AND RESPONSIBILITIES.
(A)
GENERAL.
THE OBJECTIVES OF THE SADR STUDY
ARE TO (I) CONFIRM GNSC SADR HAPTM MARKER ASSOCIATIONS; (II) EXPAND THE BAYER
SADR POLYMORPHISM
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ASSOCIATIONS TO COLLABORATION SADR HAPLOTYPE ASSOCIATIONS; AND (III) DISCOVER
COLLABORATION SADR HAPLOTYPE ASSOCIATIONS FOR CANDIDATE GENES.
EACH PARTY
AGREES TO USE COMMERCIALLY REASONABLE EFFORTS TO (A) UNDERTAKE THE
RESPONSIBILITIES ASSIGNED TO SUCH PARTY IN THIS ARTICLE II AND THE SADR PLAN,
INCLUDING, BUT NOT LIMITED TO, THE DEDICATION OF LABORATORY FACILITIES,
EQUIPMENT AND PERSONNEL APPROPRIATE TO SUCH EFFORTS, (B) PERFORM ITS OBLIGATIONS
HEREUNDER IN GOOD FAITH IN A SCIENTIFIC AND WORKMANLIKE MANNER, (C) AS
APPROPRIATE, MAKE AVAILABLE TO THE OTHER PARTY THOSE RESOURCES SET FORTH IN
ARTICLE II AND THE SADR PLAN, AND (D) CARRY OUT ALL WORK DONE IN THE COURSE OF
THE SADR STUDY IN MATERIAL COMPLIANCE WITH ALL APPLICABLE FEDERAL, STATE OR
LOCAL LAWS, REGULATIONS AND GUIDELINES GOVERNING THE CONDUCT OF SUCH WORK.
(B)
CONFIRMATION OF GNSC SADR HAPTM MARKER
ASSOCIATIONS.
AS PART OF THE SADR STUDY, THE PARTIES SHALL UNDERTAKE A
CASE/CONTROL STUDY TO CONFIRM GNSC SADR HAPTM MARKER ASSOCIATIONS BY ANALYZING
SADR CONFIRMATION GENES IN DNA SAMPLES FROM APPROPRIATE PATIENTS FROM THE [**]
TRIAL SELECTED BY THE STEERING COMMITTEE.
BAYER SHALL DELIVER TO GENAISSANCE
THE DNA SAMPLES FOR EACH PATIENT TO BE ANALYZED BY GENAISSANCE TO DETERMINE THE
SUITABILITY OF EACH SUCH SAMPLE FOR USE IN ONE OF GENAISSANCE'S STANDARD HAPTM
TYPING PROCESSES THAT IS CHOSEN BY GENAISSANCE IN CONSULTATION WITH THE STEERING
COMMITTEE FOR EACH SADR CONFIRMATION GENE.
IF GENAISSANCE REASONABLY DETERMINES
THAT ANY SUCH DNA SAMPLE IS UNSUITABLE FOR USE IN SUCH PROCESSES, GENAISSANCE
SHALL PROVIDE WRITTEN NOTICE TO BAYER OF SUCH DETERMINATION AND THE STEERING
COMMITTEE SHALL DETERMINE IN GOOD FAITH A PROPER COURSE OF ACTION.
ALL HAPTM
TYPING PROCESSES AND EXPENSES INCURRED BY GENAISSANCE PURSUANT TO THIS
SUBSECTION (B) SHALL BE BORNE BY GENAISSANCE.
(C)
EXPANSION OF BAYER SADR POLYMORPHISM
ASSOCIATIONS TO COLLABORATION SADR HAPLOTYPE ASSOCIATIONS.
AS PART OF THE SADR
STUDY, THE PARTIES SHALL UNDERTAKE A CASE/CONTROL STUDY OF SADR EXPANSION GENES
IN ACCORDANCE WITH THIS SUBSECTION (C).
EACH SADR EXPANSION GENE SHALL
PREFERABLY HAVE A KNOWN GENOMIC STRUCTURE; HOWEVER, IF AN SADR EXPANSION GENE
DOES NOT HAVE A KNOWN GENOMIC STRUCTURE, THE STEERING COMMITTEE SHALL DECIDE
WHETHER TO PROCEED WITH A HAPTM MARKER DISCOVERY EFFORT FOR SUCH GENE OR WHETHER
ADDITIONAL MEASURES, SUCH AS CLONING, SHOULD BE UNDERTAKEN TO ACQUIRE THE
GENOMIC SEQUENCE INFORMATION.
THE COSTS OF ACQUIRING SUCH INFORMATION SHALL BE
BORNE BY BAYER.
(I)
PATIENT SELECTION.
THE STEERING