AMENDMENT #1 COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT # 1901
Exhibit 10.28
AMENDMENT #1
COOPERATIVE RESEARCH AND DEVELOPMENT AGREEMENT # 1901
[*]
The purpose of this amendment is to change certain terms of the above-referenced Cooperative Research and Development Agreement (CRADA). These changes are reflected below and except for these changes all other provisions of the original CRADA remain in full force and effect. Two originals of this amendment are provided for execution; one is to remain with the National Cancer Institute and the other copy is to remain with the Collaborator.
1. The NCI
Staffing commitment section of Appendix B is changed to read as follows, where underline
shows additions and strikethrough shows deletions:
For NCI:
Staffing
Personnel paid with CRADA
funds will dedicate the majority of their time to work under the Research
Plan. NCI shall, in addition to its
Principal Investigators, provide sufficient staffing to execute and fulfill the
obligations of the CRADA. The NCI estimates that its Principal Investigator
shall contribute up to 25% of his time to the this collaboration. The NCI estimates that, in total, it will
commit the efforts of up to 0.75 1.25 full-time equivalent staff per
year, including the contribution of its Principal Investigator. The level of commitment to the various phases
of the CRADA Research Plan will be established and agreed to by NewLink
Genetics Corporation and NCI.
NCI will provide no funding to NewLink Genetics Corporation for collaborative research and development pursuant to this CRADA, inasmuch as financial contributions by the U.S. Government to non-Federal parties under CRADA is prohibited under the Federal Technology Transfer Act of 1986 [(15 U.S.C. 3710a(d)(1)].”
2. The
funding commitment of the Collaborator is changed to read as follows, where underline
shows additions and strikethrough shows deletions:
Funding
Within thirty (30) days of
the execution date of this CRADA, NewLink Genetics Corporation will make an
initial payment of [*] to NCI with
a thirty (30) day grace period for payment.
These CRADA funds shall be used for protocol development and for patient
recruitment and treatment during the initial six months of the CRADA project. Within thirty (30) days of the six month
anniversary of the execution date of this CRADA, NewLink Genetics
Corporation will thereafter pay NCI [*].
On the one year anniversary of the CRADA NewLink Genetics Corporation shall pay [*] to NCI and will thereafter pay [*] every six months [*] for the remainder of the CRADA. Financial contribution may be renegotiated depending upon patient load and work scope. NewLink Genetics Corporation and the NCI must mutually agree to the use of funds to pay for activities that are appropriate under this Agreement. Personnel paid with CRADA funds will dedicate the majority of their time to work under the Research Plan; however, both parties acknowledge that personnel paid with CRADA funds are free to participate in other projects and interactions typically found within the laboratory. No funds provided under this CRADA by NewLink Genetics Corporation will be used by NCI to pay the salary of full-time tenured Federal employees.
Travel costs are limited by the Federal travel rules and regulations for all Government staff whether paid for by Government funds or private Collaborators. Collaborator may provide direct support under the 348 travel mechanism for travel and lodging costs for attendance of NCI staff at selected scientific or developmental meetings. Both Collaborator and NCI must agree that the activities would be appropriate under this Agreement, and acceptance of Collaborator support of NCI’s participation in the activities will be contingent upon appropriate NCI approval. Travel costs for such travel are also limited by the Federal Travel Rules and Regulations for all Government staff whether paid for by Government funds or private Collaborators.”
ACCEPTED AND AGREED TO:
For the National Cancer Institute:
/s/ Xxxx Xxxxxx |
|
10/20/04 |
Xxxx Xxxxxx, Ph.D. |
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Date |
Deputy Director for Advanced Technologies |
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And Strategic Partnerships |
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|
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For NewLink Genetics Corporation: |
|
|
|
|
|
|
|
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/s/ Xxxxxxxx Xxxxxxxx |
|
10/25/04 |
Xxxxxxxx Xxxxxxxx, M.D. |
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Date |
Chief Medical Officer |
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|