Document:

Exhibit
10.44

 

AGREEMENT AMENDMENT

 

Second Amendment to

Agreement Between

 

NewLink Genetics Corporation

and

Medical College of Georgia Research Institute, Inc.

 

This
second amendment to the agreement is entered into by and between NewLink
Genetics Corporation (hereinafter SPONSOR) and the Medical College of Georgia
Research Institute, Inc. (hereinafter MCGRI).

 

WHEREAS
on November 17, 2006 MCGRI approved and on August 21, 2007 amended,
an agreement with SPONSOR for the term from September 5, 2006 through September 5,
2008 under which MCGRI and the Medical College of Georgia agreed to perform the
study entitled, [*] under the direction of Dr. Andrew
Mellor as Principal Investigator.

 

NOW,
THEREFORE, said agreement is amended as follows:

 

1.                                       Article 1
- RESEARCH PERFORMANCE, subsection 1.4 of agreement is deleted and replaced in
its entirety to read:

 

The
Agreement Period is approximately September 5, 2006 through September 5,
2009 unless earlier terminated pursuant to this Agreement.

 

2.                                       Article 2
- COSTS, BILLINGS, AND OTHER SUPPORT of agreement is amended to include:

 

Sponsor
agrees to pay MCGRI the sum of [*] for the
additional performance period of September 6, 2008 through September 5,
2009. Sponsor shall, at a minimum, pay in four equal installments of [*].

 

3.                                       All other terms
and conditions of agreement not expressly amended herein shall remain in full
force and effect.

 

This
second amendment to the research agreement is signed below and agreed to by the
duly authorized representatives of the parties.

 

	
  MEDICAL COLLEGE OF GEORGIA

  	
   

  	
  NEWLINK
  GENETICS

  	
   

  
	
  RESEARCH INSTITUTE, INC.

  	
   

  	
  CORPORATION

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  /s/Betty
  Aldridge

  	
  3/12/09

  	
   

  	
  /s/Nicholas Vahanian

  	
  1/26/09

  
	
  Betty
  Aldridge

  	
  Date

  	
   

  	
  Nicholas
  N. Vahanian

  	
  Date

  
	
  Executive
  Director

  	
   

  	
   

  	
  Chief
  Medical & Operations OfficerExhibit
10.45

 

RESEARCH AGREEMENT

 

THIS
AGREEMENT, effective this 17th day of Feb 2009, is entered into
by and between NewLink Genetics, Inc. a corporation with its principal
place of business at 2901 South Loop Drive, Suite 3900, Ames, Iowa
50010, hereinafter (“Sponsor”) and the MEDICAL COLLEGE OF GEORGIA RESEARCH
INSTITUTE, INC., (hereinafter “MCGRI”) a non-profit research and
educational corporation, located at the Medical College of Georgia, 1120 15th Street, Augusta, Georgia 30912-4810.

 

WHEREAS,
the research program contemplated by this Agreement is of mutual interest and
benefit to MCGRI and to Sponsor, and will further the instructional and
research objectives of MCGRI in a manner consistent with its status as a
nonprofit, tax-exempt, research and educational institution;

 

WHEREAS,
the research program (hereinafter “Study”) will be performed through a
subcontract to the Medical College of Georgia (hereinafter “MCG”).

 

NOW,
THEREFORE, in consideration of the premises and mutual covenants herein contained,
the parties hereto agree to the following:

 

ARTICLE 1 - RESEARCH PERFORMANCE

 

1.1           The
Study shall be performed as described in the Protocol entitled [*] and attached hereto as EXHIBIT A, under the
direction of David Munn, MD as Principal Investigator. MCGRI and its
subcontractor, MCG, do not represent, warrant or guarantee that any specific
results shall be achieved. In the case of conflict between the terms of this
Agreement and the Protocol or other attachments, the terms of this Agreement
shall control.

 

1.2           MCGRI
and MCG shall use reasonable efforts to perform such Study substantially in
accordance with the terms and conditions of this Agreement. By signing below,
the Principal Investigator agrees to undertake the obligations of the
Investigator as set forth in the Protocol.

 

1.3           In
the event that the Principal Investigator becomes unable or unwilling to
continue the Study, and a mutually acceptable substitute is not available,
MCGRI or Sponsor shall have the option to terminate said Study on thirty days
written notice.

 

1.4           The
Agreement Period is approximately January 1, 2008 through December 31,
2008, unless earlier terminated pursuant to this Agreement.

 

ARTICLE 2 - COSTS,
BILLINGS AND OTHER SUPPORT

 

2.1           Sponsor
agrees to pay MCGRI the sum of [*] for the
entire Study. Sponsor shall pay the total cost of the Study, in three equal

 

 

installments.
The first payment will be made upon final execution of this agreement, and
subsequent payments will follow in March and April 2009.

 

A
final payment that includes all outstanding payments due will be sent within
thirty (30) days after all data has been received by Sponsor and all queries
have been resolved.

 

	
   

  	
  Checks should be made payable to:

  	
  MCG Research Institute

  
	
   

  	
   

  	
   

  
	
   

  	
  Mailing address for payments:

  	
  MCG Research Institute, Inc.

  
	
   

  	
   

  	
  P.O. Box 945552

  
	
   

  	
   

  	
  Atlanta, GA 30394-5552

  
	
   

  	
   

  	
  Attn: Seq. No. 22751A

  

 

The
MCGRI tax identification number is [*].

 

2.2           Sponsor
acknowledges and agrees that payments made payable or sent to any individual or
corporation other than as specified, shall not be credited towards fulfillment
of Sponsor’s obligations under this Article.

 

2.3           MCG
shall retain title to any equipment purchased with funds provided by Sponsor
under this Agreement.

 

2.4           In
the event of early termination of this Agreement by Sponsor pursuant to this
Agreement, Sponsor shall pay all costs accrued by MCGRI as of the date of
termination, including non-cancelable obligations, incurred prior to the
effective date of termination.

 

ARTICLE 3 - DATA,
REPORTS AND CONFERENCES

 

3.1           MCGRI
agrees to complete case report forms under the Study promptly and to deliver
these forms and any other necessary data related to the Study to
representatives of Sponsor at periodic monitoring visits. All such information
and material will become the property of Sponsor and may be freely utilized by
Sponsor in any manner desired. MCGRI further agrees to assist Sponsor’s
representatives in resolving any discrepancies or errors in case report forms
and in performing random audits of original case records, laboratory reports
and/or other raw data sources underlying data recorded on the case report
forms. Sponsor will send copies of the final corrected case report forms to the
Principal Investigator when complete.

 

3.2           MCGRI
shall retain copies of all documentation relating to this Study as required by
federal, state or local laws or regulations or by the Protocol, until all
obligations of all persons associated with the Study have been completed.

 

3.3           During
the term of this Agreement, representatives of MCGRI may meet with
representatives of Sponsor at times and places mutually agreed upon to discuss
the progress and results as well as ongoing plans, or changes therein, of the
Study to be performed hereunder.

 

 

3.4           Sponsor
will notify MCGRI prior to or concurrent with any monitoring visits.

 

ARTICLE 4 - ARTICLE 4
- CONFIDENTIALITY

 

4.1           MCGRI
and MCG shall use that care which they use to protect their own confidential
information not to disclose to any third party any information or data provided
by Sponsor to MCGRI in connection with the Study and the Protocol which is
marked by Sponsor as confidential or with a similar legend, or which is reduced
to writing within 30 days after disclosure and designated as confidential (“Confidential
Information”). Such confidentiality obligation shall be observed during the
performance of the Study and for a period of three years following the
termination or expiration date of this Agreement. Confidential Information
shall be returned to Sponsor to the extent possible upon completion by MCGRI of
its obligations under this agreement or upon demand.

 

4.2           The
obligation to protect Sponsor’s Confidential Information shall not apply to any
information that:

 

(1)                                  is already in
the possession of, or is independently developed by, MCGRI as evidenced by
written record,

(2)                                  is or becomes
publicly available other than through breach of MCGRI’s confidentiality
obligations,

(3)                                  is received by
MCGRI from a third party without either knowledge of origination in Sponsor or
obligation of confidence,

(4)                                  is released for
disclosure by Sponsor with its written consent, or

(5)                                  is required to
be disclosed by law, regulation or court order, including but not limited to
the Georgia Open Records Act (providing that MCGRI has taken all reasonable
efforts to keep information confidential to the extent permitted by such Act).

 

ARTICLE 5 -
PUBLICATIONS

 

5.1           Sponsor
recognizes that under MCGRI and MCG policy, the results of the Study must be
publishable and agrees that researchers engaged in the Study shall be permitted
to present at symposia, national or regional professional meetings, and to
publish in journals, theses or dissertations, or otherwise of their own
choosing, methods and results of the Study, provided, however, that Sponsor
shall have been furnished copies of any proposed publication or presentation at
least one month in advance of the submission of such proposed publication or
presentation to a journal, editor, or other third party. Sponsor shall have 30
days after receipt of said copies, to object to such proposed presentation or
proposed publication because there is patentable subject matter which needs
protection. In the event that Sponsor makes such objection, said researcher(s) shall
refrain from making such publication or presentation for a maximum of four
months from date of receipt of such objection in order for MCGRI to file patent
application(s) with the United States Patent and Trademark Office or
foreign patent office(s) directed to the patentable subject matter
contained in the proposed publication or presentation.

 

 

ARTICLE 6 -
INTELLECTUAL PROPERTY

 

6.1           All
rights and title to MCGRI Intellectual Property under the Study shall belong to
MCGRI, subject to the right of Sponsor to take an exclusive, or non-exclusive,
royalty-bearing license to MCGRI Intellectual Property, as set forth in Article 7,
below and shall be subject to the terms and conditions of this Agreement. “MCGRI
Intellectual Property” shall mean individually and collectively all inventions,
improvements or discoveries which are conceived or made by one or more
employees of MCG in performance of the Study during Agreement Period.

 

6.2           MCGRI
will promptly notify Sponsor of any MCGRI Intellectual Property. If Sponsor
directs or MCGRI determines that a patent application or application for other
intellectual property protection should be filed, MCGRI shall promptly prepare,
file and prosecute such U. S. or foreign application in MCGRI’s name. If
Sponsor directs MCGRI to file a patent application hereunder or desires to
maintain its right to exercise either option (a) or (b) of Section 7.2,
below, Sponsor shall bear all costs incurred in connection with such
preparation, filing, prosecution and maintenance of U. S. and foreign
application(s). Sponsor shall cooperate with MCGRI to assure that such
application(s) will cover, to the best of Sponsor’s knowledge, all items
of commercial interest and importance. While MCGRI shall be responsible for
making decisions regarding scope and content of application(s) to be filed
and prosecution thereof, Sponsor shall be given an opportunity to review and
provide input thereto. MCGRI shall inform Sponsor of all developments with
respect to such application(s) and shall promptly supply to Sponsor copies
of all papers received and filed in connection with the prosecution thereof in
sufficient time for Sponsor to comment thereon.

 

6.3           If
Sponsor elects not to exercise its option as described below or decides to
discontinue the financial support of the prosecution or maintenance of the protection,
MCGRI shall be free to file or continue prosecution or maintain any such
application(s), and to maintain any protection issuing thereon in the U.S. and
in any foreign country at MCGRI’s sole expense. MCGRI hereby grants Sponsor a
royalty-free, non-exclusive license to use MCGRI Intellectual Property within
its own organization for any noncommercial purpose.  MCGRI hereby grants the first option, at
Sponsor’s sole selection, for either (a) a non-exclusive, royalty-bearing
license to use MCGRI Intellectual Property for any purpose except sublicensing,
or (b) an exclusive royalty-bearing license with a right to sublicense.
Terms and conditions of these licenses are to be negotiated in good faith and
agreed upon between MCGRI and Sponsor. Provided Sponsor has participated in
bearing patent expenses as described above, this option shall extend for a
period of sixty days from the termination date of this Agreement. In the event
that Sponsor acquires an exclusive license or right under this Agreement, Sponsor
hereby grants to MCGRI the right to continue to use MCGRI Intellectual Property
for any noncommercial purpose.

 

ARTICLE 7
- GRANT OF RIGHTS

 

Not
applicable

 

 

ARTICLE 8 - TERM AND
TERMINATION

 

8.1           This
Agreement shall become effective upon the date first written above and shall
continue in effect for the full duration of the Agreement Period, as specified
in Article 1.5. The parties hereto may, however, extend the term of this
Agreement for additional periods as desired under mutually agreeable terms and
conditions which the parties reduce to writing and sign.

 

8.2           This
Study may be terminated at any time by MCGRI for any valid cause or if required
to protect patient safety (e.g., due to the occurrence of serious or unexpected
adverse reactions) or by Sponsor for any valid cause, by either party’s giving
thirty (30) days written notice to the other party. If this Study is terminated
prior to completion, MCGRI shall furnish to Sponsor all case report forms,
either completed or uncompleted, up to the date of termination, as well as all
other Study materials, including but not limited to the Study Product.

 

8.3           No
termination of this Agreement, however effectuated, shall release the parties
from their rights and obligations accrued prior to the effective date of
termination.

 

ARTICLE 9
- INDEMNIFICATION AND INSURANCE

 

9.1           Sponsor
agrees to indemnify and hold harmless MCGRI and its duly authorized agents,
servants and employees from all claims, demands, actions, causes of action and
suites of whatever kind or nature and to indemnify MCGRI and its duly
authorized agents, servants and employees from all damages, losses, judgments,
costs and fees, including attorneys’ fees, [*], provided
that:

 

(1)                                  MCGRI, and its
agents, servants and employees have followed the Protocol described herein as Exhibit A
and [*]; and

 

(2)                                  MCGRI promptly
gives SPONSOR notice of, and the right to defend against, any claim or suit as
well as the unconditional right to settlement of such suits in the sole
discretion of SPONSOR; and

 

(3)                                  MCGRI agrees to
cooperate fully with SPONSOR in its defense of any claim or suit.

 

9.2           MCGRI
warrants and represents that MCG has adequate liability insurance, such
protection being applicable to officers, employees, and agents while acting
within the scope of their employment by MCG. MCG has no liability insurance
policy as such that can extend protection to any other person.

 

9.3           Sponsor
acknowledges that this Agreement does not confer upon Sponsor any right of
claim of indemnification by the MCGRI or MCG, either express or implied.

 

ARTICLE 10 -
INDEPENDENT CONTRACTOR

 

10.1         MCGRI
shall be deemed to be and shall be an independent contractor and as such MCGRI
shall not be entitled to any benefits applicable to employees of Sponsor.

 

10.2         Neither
party is authorized or empowered to act as agent for the other for any purpose

 

 

and
shall not on behalf of the other enter into any contract, warranty or
representation as to any matter. Neither shall be bound by the acts or conduct
of the other.

 

ARTICLE 11 - USE OF NAME

 

11.1         Sponsor
agrees that it will not use the name of MCGRI, MCG or the Principal
Investigator or sub-investigators in any advertising or publicity material, or
make any form of representation or statement in relation to the work conducted
under the terms of this Agreement which would constitute an express or implied
endorsement by MCGRI, MCG or the Principal Investigator or sub-investigators of
any commercial product or service, and that it will not authorize others to do
so, without first having obtained written approval from MCGRI.

 

ARTICLE 12 - CONFLICT
OF INTEREST

 

12.1         MCG
institutional policy requires that persons engaged in Sponsored research must
disclose potential financial conflicts of interest with such research,
including certain consulting, stock ownership, or other relationships with a
company which Sponsors such research, and that MCG must take measures to
eliminate or minimize any effects of such potential conflicts on the
objectivity of such research. By signing below, Principal Investigator agrees
to comply with MCG institutional policy and requirements governing conflict of
interest.

 

ARTICLE 13 -
NON-DISCRIMINATION

 

13.1         Neither
MCGRI nor Sponsor shall discriminate against any person on the basis of race,
national origin, religion, creed, sex, sexual orientation, age or handicaps in
the performance of this Agreement.

 

ARTICLE 14 -
GOVERNING LAW

 

14.1         This
Agreement shall be governed and construed in accordance with the laws of the
State of Georgia.

 

ARTICLE 15 -
ASSIGNMENT

 

15.1         This
Agreement shall not be assigned by either party without the prior written
consent of the parties hereto, except that the parties hereby consent to the
subcontracting of the research to the Medical College of Georgia.

 

15.2         This
Agreement is assignable to any division of Sponsor, any majority stockholder of
Sponsor, or any subsidiary of Sponsor in which fifty-one percent of the
outstanding stock is owned by Sponsor.

 

 

ARTICLE 16 - COMPLETE
AGREEMENT AND MODIFICATION

 

16.1         This
writing contains the complete agreement of MCGRI and Sponsor, which stipulate
that they have made no representation with respect to the subject matter of
this Agreement including the execution and delivery hereof except such
representations as are specifically set forth herein.

 

ARTICLE 17 - NOTICES

 

17.1         Notices
hereunder shall be deemed made if given by registered or certified mail,
postage prepaid, and addressed to the party to receive such notice at the
address given below, or such other address as may hereafter be designated by
notice in writing:

 

	
  If to Sponsor:

  	
   

  	
  If to MCGRI:

  
	
  Sandra Carroll

  	
   

  	
  Betty Aldridge

  
	
  NewLink Genetics

  	
   

  	
  Executive Director

  
	
  2901 South Loop Drive

  	
   

  	
  MCG Research Institute, Inc.

  
	
  Ames, IA 50010

  	
   

  	
  Medical College of Georgia

  
	
   

  	
   

  	
  CJ-3301, 1120 15th Street,

  
	
   

  	
   

  	
  Augusta, GA 30912-4810

  

 

ARTICLE 18 - AUDIT
EXPENSES

 

18.1         In
the event of an FDA or Sponsor-initiated audit, the Sponsor agrees to pay all
actual costs incurred by MCGRI and the Medical College of Georgia as a direct
result of the audit.

 

ARTICLE 19 - RECORDS
RETENTION

 

19.1         In
the event that the Sponsor wants study documents stored beyond  2 years after the close of the study, the Sponsor will be
responsible for all study documents storage fees after that time.

 

AGREED TO:

 

 

	
  NEWLINK
  GENETICS, INC.

  	
   

  	
  MEDICAL
  COLLEGE OF GEORGIA RESEARCH INSTITUTE, INC.

  
	
   

  	
   

  	
   

  
	
  /s/Nicholas
  N. Vahanian

  	
   

  	
  /s/Betty
  Aldridge

  
	
  Name:

  	
   

  	
  Betty
  Aldridge

  
	
  Title:
  COO

  	
   

  	
  Executive
  Director

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  2/17/09

  

 

 

	
  Date

  	
   

  	
  Date

  

 

ACCEPTED
BY:

 

	
   

  	
  /s/ David
  Munn                                          2-16-09

  	
   

  
	
   

  	
  Principal Investigator (Signature)                               Date

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