Document:

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)].”

 

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.”

 

2

 

ACCEPTED AND AGREED TO:

 

For the National Cancer Institute:

 

 

	
  /s/ Anna Barker

  	
   

  	
  10/20/04

  
	
  Anna Barker, Ph.D.

  	
   

  	
  Date

  
	
  Deputy Director for Advanced Technologies

  	
   

  	
   

  
	
  And Strategic Partnerships

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  For NewLink Genetics Corporation:

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  /s/ Nicholas Vahanian

  	
   

  	
  10/25/04

  
	
  Nicholas Vahanian, M.D.

  	
   

  	
  Date

  
	
  Chief Medical Officer

  	
   

  	
   

  

 

 

3Exhibit 10.29

 

AMENDMENT #2

 

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 and as
amended on October 25, 2004 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 term of the CRADA is
hereby extended for twenty-four (24) months, such that the CRADA will expire on
January 1, 2010.  This Amendment is
retroactively effective to January 1, 2008.

 

2.               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 1.25  1.0 full-time equivalent staff
per year, including the contribution of its Principal Investigator.  The level of commitment to the various phases
of the CO )A 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.

 

1

 

3710a(d)(1)].

 

3.               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 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  through and including the payment due six
months after the third anniversary of the CRADA.  NewLink Genetics Corporation will
thereafter make payments to the NCI on the following dates in the amounts
indicated:

 

	
  Date

  	
   

  	
  Payment

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Within 30 days of
  July 1, 2008

  	
   

  	
  [*]

  	
   

  
	
  Within 30 days of November 1,
  2008

  	
   

  	
  [*]

  	
   

  
	
  Within 30 days of
  July 1, 2009

  	
   

  	
  [*]

  	
   

  
	
  Within 30 days of
  November 1, 2009

  	
   

  	
  [*]

  	
   

  

 

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.”

 

4.               Appendix C “Exceptions or Modifications
to this CA” is amended to reflect a modification of the noted CRADA Articles as
follows (additions shown by underlining; deletions shown with strikethrough):

 

“7.2  Exercise of License Option.  The option of Article 7.1 must be
exercised by written notice mailed within three (3) months after either (i) Collaborator
receives written notice from 

 

2

 

PHS that the patent or other IP application has been
filed; or (ii) the date Collaborator files such IP application.  The written notice exercising this option
will include a completed “Application for License to Public Health Service
Inventions” and will initiate a negotiation period that expires nine (9) months
after the exercise of the option.  Exercise of this option by the
Collaborator initiates a negotiation period that expires nine (9) months
after the exercise of the options. 
If the last proposal by the Collaborator has not been responded to in
writing by PHS within this nine (9) month period, the negotiation
period shall be extended to expire one (1) month after PHS so responds,
during which month the Collaborator may accept in writing the final license
proposal of PHS.  In the absence of Collaborator’s
exercise of the option  such acceptance, or upon election of a
nonexclusive license, an extension of the time limits by PHS, PHS
will be free to license the CRADA Subject Invention  such IP
rights to others.  These time periods may
be extended at the sole discretion of PHS upon good cause shown in writing by
Collaborator.  In the event that the
Collaborator elects the option for an exclusive license, but no such license is
executed during the negotiation period, PHS agrees not to make an offer for an
exclusive license on more favorable terms to a third party for a period of six (6) months
without first offering Collaborator those more favorable terms.  These times may be extended at the sole
discretion of PHS upon good cause shown in writing by the Collaborator.

 

ACCEPTED AND AGREED TO:

 

For the National Cancer Institute:

 

	
  /s/ Anna Barker

  	
   

  	
  05/28/08

  
	
  Anna Barker, Ph.D.

  	
   

  	
  Date

  
	
  Deputy Director for Advanced Technologies

  	
   

  	
   

  
	
  And Strategic Partnerships

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  For NewLink Genetics Corporation:

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  /s/ Nicholas Vahanian

  	
   

  	
  8/5/08

  
	
  Nicholas Vahanian, M.D.

  	
   

  	
  Date

  
	
  Chief Medical Officer

  	
   

  	
   

  

 

3

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