FOR THE THROMBUS COMPOUND
EP-2104R. FURTHER THROMBUS COMPOUND(S) SHALL ONLY BE DEVELOPED UPON AGREEMENT BY
THE PARTIES. THE COLLABORATION WILL CONSIST OF THE PROVISION OF DATA BY EPIX TO
SCHERING, WHICH ALLOW THE ASSESSMENT OF THE CLINICAL AND COMMERCIAL UTILITY OF
THE THROMBUS COMPOUND BY SCHERING. FOR THIS PURPOSE EPIX SHALL DESIGN, PERFORM
AND MANAGE A PROOF OF CONCEPT DEVELOPMENT PROGRAM FOR THE THROMBUS COMPOUND(S)
WITH THE GOAL TO PROVIDE SCHERING WITH THE DEFINED CLINICAL DATA IN VOLUNTEERS
AND PATIENTS AS DEFINED IN EXHIBIT 2.1 (HEREINAFTER "THE DELIVERABLES").
GENERATED PRECLINICAL AND CHEMICAL DATA WILL BE DISCLOSED TO SCHERING AS WELL.
FOR THE SAKE OF CLARITY, THE PARTIES AGREE THAT THE WORK PERFORMED BY EPIX UNDER
THE PROOF OF CONCEPT PLAN IS NOT SUBJECT TO PRIOR CONSENT BY SCHERING, EXCEPT AS
EXPLICITLY PROVIDED IN THIS AGREEMENT.
2.2.
CONDUCT OF THE PROOF OF CONCEPT DEVELOPMENT
PROGRAM.
THE PROOF OF CONCEPT DEVELOPMENT PROGRAM SHALL CONSIST GENERALLY OF
CHEMICAL AND PRE-CLINICAL DEVELOPMENT WORK NECESSARY TO SUPPORT THE PROPER
CONDUCT OF THE CLINICAL PROOF OF CONCEPT STUDY IN HEALTHY VOLUNTEERS AND
PATIENTS ACCORDING TO THE APPLICABLE INTERNATIONAL REGULATIONS AND QUALITY
STANDARDS (I.E. ICH GCP, GLP ETC.) AND THE APPLICABLE NATIONAL LAWS AND
REGULATIONS. THE GOAL OF THE PROOF OF CONCEPT DEVELOPMENT PROGRAM IS THE
PROVISION OF THE DELIVERABLES. SCHERING WILL BE INFORMED REGULARLY ON THE TIMELY
PROGRESS OF THE PROGRAM AND ON RELEVANT SAFETY AND EFFICACY INFLUENCING
FINDINGS.
2.3.
PROOF OF CONCEPT PLAN.
EPIX IS RESPONSIBLE TO
DEVELOP A PLAN REASONABLY DESCRIBING THE WORK TO BE CONDUCTED BY EPIX RELATED TO
EP-2104R INCLUDING A CLINICAL TRIAL PROTOCOL (HEREINAFTER "PROOF OF CONCEPT
PLAN") TO FULFILL THE OBJECTIVES OF THIS AGREEMENT. THE PROOF OF CONCEPT PLAN
SHALL BE MADE AVAILABLE TO SCHERING FOR INFORMATION. IT IS NOT SUBJECT TO
CONSENT BY SCHERING; PROVIDED, HOWEVER, THAT THE CLINICAL TRIAL PROTOCOL WHICH
IS PART OF THE PROOF OF CONCEPT PLAN SHALL BE SUBJECT TO REVIEW BY SCHERING WITH
REGARD TO SAFETY AND EFFICACY DATA TO BE GAINED TO ASSURE THAT THE OBJECTIVES OF
THIS AGREEMENT WITH REGARD TO THE DELIVERABLES CAN BE ACHIEVED.
8
2.4.
DEVELOPMENT INFORMATION.
IN THE COURSE OF ITS
PERFORMANCE OF THE PROOF OF CONCEPT DEVELOPMENT PROGRAM, EPIX SHALL KEEP
SCHERING REASONABLY INFORMED AS TO ITS PROGRESS UNDER EACH PROOF OF CONCEPT
PLAN.
2.5.
AVAILABILITY TO EMPLOYEES.
SCHERING HEREBY
AGREES TO MAKE ITS EMPLOYEES AND NON-EMPLOYEE CONSULTANTS REASONABLY AVAILABLE,
AT NO COST TO EPIX, TO CONSULT WITH EPIX ON MATTERS RELATING TO THE DEVELOPMENT
OF THE THROMBUS COMPOUND(S), INCLUDING SCIENTIFIC AND TECHNICAL ISSUES ARISING
DURING THE PROOF OF CONCEPT DEVELOPMENT PROGRAM; PROVIDED, HOWEVER, THAT SUCH
ADVICE IS NOT BINDING TO EPIX AND DOES NOT AFFECT EPIX' RESPONSIBILITIES UNDER
THIS AGREEMENT.
ARTICLE 3:
PROOF OF CONCEPT DEVELOPMENT PROGRAM FUNDING
3.1.
FUNDING COMMITMENT.
IN CONSIDERATION OF THE
WORK PERFORMED BY EPIX UNDER THE PROOF OF CONCEPT PLAN, SCHERING SHALL PAY TO
EPIX
AN OVERALL AMOUNT OF US$ 8,972,707 (EIGHT MILLION NINE HUNDRED AND SEVENTY
TWO THOUSAND SEVEN HUNDRED AND SEVEN DOLLARS) CONSISTING OF US$ [*****] FOR THE