Document:

Exhibit 10.26

 

LICENSE AGREEMENT BETWEEN CENTRAL
IOWA HEALTH SYSTEM

 

AND NEWLINK GENETICS CORPORATION

 

THIS LICENSE AGREEMENT (the “Agreement”), by and
between CENTRAL IOWA HEALTH SYSTEM, a
not-for-profit corporation, organized and existing under the laws of the state
of Iowa (“CIHS”), and NEWLINK GENETICS
CORPORATION, a Delaware corporation, having a principal place of
business at 2901 S. Loop Drive, Ames, Iowa, 50010 (“NEWLINK”) is effective
as of the 2nd day of August, 2001(the “Effective Date”).  CIHS and NEWLINK are sometimes referred to
herein individually as a “Party” and collectively as the “Parties.”

 

RECITALS

 

WHEREAS, CIHS owns one hundred percent (100%) interest in
the Human Gene Therapy Research Institute located in Des Moines, Iowa (“HGTRI”);

 

WHEREAS, CIHS owns the Inventions, Licensed Patents and
Licensed Technology (as hereinafter defined); and

 

WHEREAS, CIHS has the right to grant, and NEWLINK desires
to acquire, licenses to make use and sell certain products utilizing the
Licensed Patents and Licensed Technology, and to grant sublicenses upon the
terms and conditions hereinafter set forth;

 

NOW, THEREFORE, in consideration of the mutual covenants
and agreements herein contained, the Parties agree as follows:

 

1.                                      DEFINITIONS

 

1.0          “Active Component” shall mean an ingredient in
a Combination Product, which is biologically active and can be used for either
therapeutic or preventative purposes, but does not include diluents, vehicles,
adjuvants, or any other ingredients which does not have any, or which has only
incidental, therapeutic or preventative properties when present alone.

 

1.1          “Affiliate” shall mean an entity which
controls, is controlled by, or is under common control with, a party.  For this purpose, “control” means the
possession of the power to direct or cause the direction of the management and
the policies of an entity, whether through ownership directly or indirectly of
fifty percent (50%) or more of the stock entitled to vote, or where control of
fifty percent (50%) or more of such rights is not permitted in the country
where such entity exists, the maximum permitted in such country.

 

1.2          “Commercially Reasonable Efforts” shall mean the
application of efforts and resources consistent with industry standards for a
product of similar market and profit potential. 
Commercially Reasonable Efforts requires that a Party promptly assign
responsibility for such matter to specific employee(s) who are held
accountable for the progress of such project.

 

1.3          “Control” shall mean the ability to grant
a license, sublicense, or access as

 

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provided for herein without violating the terms of
any agreement or other arrangement with any Third Party.

 

1.4          “Invention” shall mean any invention
covered by one or more Valid Claims within the Licensed Patents.

 

1.5          “Field of Use” shall mean the diagnosis,
prevention, treatment and mitigation of diseases and conditions in humans,
animals, and plants.

 

1.6          “Licensed Patents” shall mean (a) the
patents and patent applications listed in Exhibit A, and (b) all
provisionals, divisionals, substitutions, and continuations of the patents and
patent applications in Section 1.6(a), as well as any claim in a
continuation-in-part patent or application that would be entitled to claim
priority to the filing date of one or more of the patents or patent
applications in Section 1.6(a), and (c) the patent applications from
which the patents listed on Exhibit A issued, excluding those claims
within such patent applications that do not cover the inventions claimed in the
patents and patent applications listed in Exhibit A, and (d) all
reissues, re-examinations, and extensions of any of the preceding patents or of
patents issuing on the preceding patent applications, and all foreign counterparts
thereof.

 

1.7          “Licensed Product(s)” shall mean any product
useful in the Field of Use, (a) the manufacture, use or sale of which is
covered in whole or in part by one or more Valid Claims within the Licensed
Patents or (b) that incorporates any Licensed Technology.

 

1.8          “Licensed Technology” shall mean all proprietary
information, know-how, biological, chemical or physical materials, procedures,
methods, prototypes, designs, technical data, reports, and pre-clinical data
owned or Controlled by HGTRI before and as of the Effective Date that are
necessary for NEWLINK to exercise and practice all Valid Claims of the Licensed
Patents pursuant to this Agreement, as designated by mutual agreement of the
Parties and listed or attached in written format in Exhibit B, after the
earlier of (a) NEWLINK’s completion of its review of the records and
documents at HGTRI relating to such Licensed Technology or (b) six (6) months
after the Effective Date.  It is
understood that NEWLINK’s review of such records and documents at HGTRI shall
be during such times and subject to such restrictions (including, but not
limited to, confidentiality obligations) as the Parties mutually agree.  “Licensed Technology” does not include
Licensed Patents.

 

1.9          “Net Sales” shall mean the total amount
(in United States dollars) invoiced for sales of the Licensed Product, by
NEWLINK, its Affiliates, or Sublicensees to unrelated Third Parties in bona
fide arm’s length transactions, less the following deductions, in each case
related specifically to the Licensed Product in question and actually allowed
and taken and not otherwise recovered by or reimbursed to NEWLINK, its
Affiliates, or Sublicensees: (a) trade, cash and quantity discounts; (b) taxes
on sales (such as sales or use taxes) to the extent added to the sales price
and set forth separately as such in the total amount invoiced; (c) freight,
insurance and other transportation charges to the extent added to the sales
price and set forth separately as such in the total amount invoiced; and (d) amounts
repaid or credited by reason of rejections, defects or returns or because of
the retroactive price reductions, chargebacks, or rebates under any government
programs.

 

1.10        “Phase I”, “Phase II”
and “Phase III” shall mean Phase I, Phase
II and

 

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Phase III clinical trials, respectively, in
each case as prescribed by the U.S. Food and Drug Administration or a
corresponding foreign entity.

 

1.11        “Regulatory Approval” shall mean (a) in the
United States, approval by the FDA of an NDA or equivalent application (such as
a BLA or PMA) and satisfaction of any related applicable FDA registration and
notification requirements (if any); and (b) in any country other than the
United States, approval by regulatory authorities having jurisdiction over such
country of a single application or set of applications comparable to an NDA and
satisfaction of any related applicable regulatory and notification
requirements, if any, together with any other approval necessary to make and
sell Products commercially in such country.

 

1.12        “Sublicensee” shall mean any Third Party (a) to
whom NEWLINK or its Affiliates has granted a license or sublicense under the
Licensed Patents to develop, make, have made, import, use, sell, offer for
sale, or otherwise exploit a Licensed Product in the Field of Use within the
Territory; or (b) to whom NEWLINK or its Affiliates has granted a right to
distribute a Licensed Product in the Field of Use in the Territory pursuant to
an agreement between NEWLINK and such Third Party; provided that such Third
Party has the responsibility for marketing and/or promoting the Licensed
Products within the territory in which such distribution rights are
granted.  For the avoidance of doubt,
wholesalers and retailers who do not take such marketing and/or promotion
responsibility shall not be Sublicensees.

 

1.13        “Term” shall have the meaning set forth in Section 8.0.

 

1.14        “Territory” shall mean worldwide.

 

1.15        “Third Party(ies)” shall mean any entity other
than CIHS, HGTRI or NEWLINK.

 

1.16        “Valid Claim” shall mean either (a) a
claim of an issued and unexpired patent included within the Licensed Patents
which has not been held invalid or unenforceable by a decision of a court or
other governmental agency of competent jurisdiction, unappealable or unappealed
within the time allowed for appeal; or (b) a claim of a pending patent
application included within the Licensed Patents, which claim has not been
abandoned or finally disallowed without the possibility of appeal or refiling
of such application.  Notwithstanding the
foregoing, if a claim of a pending patent application has not issued as a claim
of an issued patent within seven (7) years from the date from which such
claim takes priority, such pending claim shall not be a Valid Claim for
purposes of the Agreement, unless and until the patent is issued including such
claim.

 

2.                                      GRANT

 

2.0          License Grant.  Subject to the reservation of rights set
forth in Section 2.1 below, CIHS hereby grants to NEWLINK, upon the terms
and conditions herein specified, an exclusive  royalty-bearing
license, including the right to grant sublicenses, under the Licensed Patents
and Licensed Technology to develop, make, have made, use, sell, offer for sale,
and import Licensed Products in the Territory and in the Field of Use only.

 

2.1          Reservation of Rights.  The grant in Section 2.0 shall be
subject to and non-exclusive with respect to:

 

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(a)           The right of CIHS to practice the inventions
claimed in the Licensed Patents and to use the Licensed Technology for its own
non-commercial bona fide research.

 

(b)           The right of CIHS to license nonexclusively
other academic or research institutions to practice the inventions claimed in
the Licensed Patents and to use the Licensed Technology for non-commercial
research purposes.

 

(c)           The right of CIHS to publish any information
included in the Licensed Technology and Licensed Patents provided that NEWLINK
shall have the right to review such information prior to publication.  CIHS shall provide NEWLINK with a copy of the
proposed publication at least thirty (30) days prior to submission of such
proposed publication to the publisher. 
NEWLINK will provide comments, if any, within thirty (30) days of receipt
of such proposed publication.  If NEWLINK
determines that such proposed publication contains Confidential Information of
NEWLINK, then NEWLINK may notify CIHS in writing, prior to the expiration of
the thirty (30) day period, specifying the information that NEWLINK considers
its Confidential Information, and may request that such Confidential
Information be deleted from the proposed publication.  If NEWLINK determines that the proposed
publication contains subject matter for which intellectual property protection
should be sought, then NEWLINK may so notify CIHS in writing prior to the
expiration of the thirty (30) day period and CIHS shall then delay publication
of such information for up to a maximum of sixty (60) days from receipt of such
notice solely to enable NEWLINK to file Patent Applications or seek other forms
of intellectual property protection as deemed necessary by NEWLINK.

 

2.2          Government Rights.  This Agreement is subject to all terms and
conditions of Title 35 United States Code Sections 200 through 204, including,
without limitation, an obligation that Licensed Products sold or produced in
the United States be “manufactured substantially in the United States,” and
NEWLINK agrees to take all reasonable action necessary on its part as licensee
to enable CIHS to satisfy its obligation thereunder, relating to the Licensed
Technology and the inventions claimed in the Licensed Patents.

 

2.3          Due Diligence.

 

(a)           NEWLINK agrees to [*],
(2) obtain, at a minimum, the[*] for NEWLINK
(or its Affiliates, and its Sublicensees) to [*] in [*]
in which [*] are projected to provide [*] NEWLINK, its Affiliates and Sublicensees, and (3) following
receipt of the [*] in [*] during
the Term of this Agreement.  As used
herein, “[*]” shall include but is not limited
to, [*].

 

(i)      As part of its Commercially Reasonable Efforts,
NEWLINK shall deliver to CIHS, within ninety (90) days of the Effective Date, a
[*] the [*]
to [*] the [*] and [*] of [*] and [*] and [*] for the [*] of [*] of the [*].  Every half year
thereafter, on or before January 1 and June 1 of each calendar year,
NEWLINK shall provide CIHS with an [*] showing the
[*] commencing upon such half yearly
date.

 

(ii)    Within thirty (30) days after January 1 of each
year, NEWLINK shall make a written annual progress report (“Progress Report”)
to CIHS covering the preceding calendar year ending December 31 and
detailing the progress of NEWLINK toward commercial use of the Licensed
Products.  Such report shall include, at
a minimum, information sufficient to enable CIHS to satisfy reporting
requirements of the U.S. Government and for CIHS to ascertain

 

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progress by NEWLINK toward meeting the diligence
requirements of this Section 2.3.

 

(iii)   The sole purpose of the [*]
and Progress Reports shall be for informational purposes and to enable the
Parties to discuss in good faith NEWLINK’s compliance with its obligation to
use Commercially Reasonable Efforts as set forth in this Section 2.3.  The reporting obligations of NEWLINK under
Sections 2.3(a)(i) and 2.3(a)(ii) shall expire upon the commencement
of NEWLINK’s reporting obligations under Section 2.3(b).

 

(b)           Commencing ninety (90) days after commercial
launch of a Licensed Product in a country and within sixty (60) days after December 31
of each calendar year thereafter, NEWLINK shall provide written annual reports
to CIHS which shall include but not be limited to: reports of progress on
research and development, Regulatory Approvals received for Licensed Products,
manufacturing, sublicensing, marketing and sales activities by NEWLINK, its
Affiliates or Sublicensees during the preceding twelve (12) months, as well as,
plans of such activities for the coming year. 
NEWLINK shall also deliver to CIHS a copy of its annual report to
stockholders, promptly following the availability of such report.

 

(c)           Without limiting the foregoing, NEWLINK shall
have the specific obligation to achieve the following diligence milestones:

 

(i)      Within [*] after the
Effective Date, either (a) NEWLINK will have expended [*]
for research and development related to the Inventions; or (b) NEWLINK
will have raised [*] in equity capital;

 

(ii)    Within [*] after the
Effective Date, either (a) NEWLINK or its Sublicensee will have developed
a Licensed Product through [*] or (b) NEWLINK
will have expended [*] for
research and development related to the Inventions; or (c) NEWLINK will
have raised an aggregate of [*] in equity
capital, including the equity capital amount set forth in subsection (i) above;

 

(iii)   Within [*] years
after the Effective Date, either (a) NEWLINK or its Sublicensee will have
commenced [*] on a Licensed Product; or (b) NEWLINK
will have expended [*] for
research and development related to the Invention; or (c) NEWLINK will
have raised an aggregate of [*] in equity
capital, including the equity capital amounts of subsections (i) and (ii) above;

 

(d)           In addition, NEWLINK shall use Commercially
Reasonable Efforts to negotiate appropriate sponsored research programs with
researchers at CIHS in connection with the development of Licensed Products or
other product opportunities in the Field of Use, as funds become available to
NEWLINK for basic research.  Funds
provided by NEWLINK for such sponsored research programs may be used to satisfy
the diligence milestones set forth in Section 2.3(c).

 

(e)           NEWLINK shall use Commercially Reasonable
Efforts to grant sublicenses for the development and commercialization of
Licensed Products within the Field of Use that are not otherwise being
diligently developed or commercialized by NEWLINK, its Affiliates or
Sublicensees; provided however, that in no event shall NEWLINK be obligated to
grant to any Third Party a sublicense if such Third Party is a [*] or [*], or if the
grant of such sublicense would reasonably have an adverse effect on NEWLINK’s,
its Affiliate’s or

 

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Sublicensee’s development or commercialization of
Licensed Products in the field of [*].  CIHS recognizes that NEWLINK will initially
focus its development efforts on a few products of strategic importance, and
agrees that NEWLINK’s Commercially Reasonable Efforts hereunder will be
evaluated in view of NEWLINK’s available resources and financing stage.

 

2.4          Failure to Meet Due Diligence Requirements.

 

(a)           In the event that NEWLINK fails to meet the
diligence milestones of Section 2.3(c)(i), the Parties shall in good faith
review for a period of thirty (30) days whether NEWLINK has materially
satisfied its diligence obligations under this Agreement.  If CIHS, in good faith, reasonably concludes
that NEWLINK has failed in this respect, it shall so notify NEWLINK in writing
and NEWLINK shall then have six (6) months to cure such failure.  In the event that NEWLINK fails to meet the
diligence milestones of Sections 2.3(c)(ii) or 2.3(c)(iii), the Parties
shall in good faith review for a period of thirty (30) days whether NEWLINK has
materially satisfied such diligence obligation under this Agreement.  If CIHS, in good faith, concludes that
NEWLINK has failed in this respect, it shall so notify NEWLINK in writing and
NEWLINK shall then have three (3) months to cure such failure.  In each case, if NEWLINK fails to cure its
failure to meet the appropriate milestone within the applicable cure period,
CIHS shall have the right, at its option, to either terminate, or convert to
non-exclusive, the license granted under Section 2.0 of this Agreement.

 

(b)           In addition to Section 2.4(a), if CIHS
determines in its reasonable good faith judgement that NEWLINK has failed to (i) use
Commercially Reasonable Efforts to develop or commercialize the Licensed
Products in a particular field within the Field of Use, and/or (ii) use

 

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Commercially
Reasonable Efforts to grant sublicenses for the development and
commercialization of Licensed Products within the Field of Use that are not
otherwise being diligently developed or commercialized by NEWLINK, its
Affiliates or Sublicensees, pursuant to Section 2.3(e), then CIHS shall so
notify NEWLINK in writing, and following such notice, the Parties shall in good
faith review for a period of thirty (30) days whether NEWLINK has materially
satisfied such diligence obligations.  If
CIHS, in good faith, reasonably concludes that NEWLINK has failed in this
respect, it shall so notify NEWLINK in writing and NEWLINK shall then have six (6) months
to cure such failure.  If NEWLINK fails
to cure such failure within the applicable cure period, CIHS shall have the
right, at its option, to either terminate, or convert to non-exclusive, the
license granted under Section 2.0 of this Agreement with respect to such
particular field.

 

2.5          Sublicenses.

 

(a)           General.  The license granted to NEWLINK under Section 2.0
of this Agreement shall include the right to grant sublicenses.  Any sublicenses granted by NEWLINK under this
Agreement shall be subordinate to the terms and conditions of this
Agreement.  NEWLINK shall promptly notify
CIHS of the identity and address of each Sublicensee with whom it concludes a
sublicense agreement and agrees to provide to CIHS a redacted copy of each such
sublicense agreement sufficient in scope to ensure compliance with the terms of
this Agreement.

 

(b)           Assignment of Sublicenses.  Upon request by a Sublicensee, and at CIHS’s discretion,
a sublicense granted by NEWLINK under the Licensed Patents and Licensed
Technology shall remain in effect and be assigned to CIHS in the event this
Agreement terminates, but only to the extent such sublicense is consistent with
the terms of this Agreement and is not in breach thereof.

 

3.                                      ROYALTIES
AND MILESTONES

 

3.0          License Issue Fee.  In partial consideration of the licenses
granted under Section 2.0, NEWLINK shall enter into a stock purchase
agreement with the Stoddard Cancer Research Institute (a d.b.a. of CIHS) in the
form attached hereto as Exhibit C (the “Stock Purchase Agreement”)
concurrently with the execution of this Agreement, which Stock Purchase
Agreement shall be consistent with the terms set forth in subsections (a) and
(b), as follows:

 

(a)           NEWLINK shall issue, [*]
to the Stoddard Cancer Research Institute, [*] shares of
NEWLINK’s common stock (the “Shares”); and

 

(b)           In addition, the Stock Purchase Agreement
shall provide that CIHS shall have the following rights with respect to such
Shares:

 

(i)      The right to [*];

 

(ii)    [*];

 

(iii)   The right to [*] [*] in [*], to [*]; and

 

(iv)    [*] no later than [*] following
an [*].

 

3.1          Patent Fees and Expenses.  Additionally, NEWLINK shall reimburse CIHS
for

 

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any out-of-pocket patent fees and expenses incurred
by CIHS for filing, prosecuting and maintaining the Licensed Patents [*], subject to the following: (a) if NEWLINK fails or
elects not to pay any such patent fees or expenses with respect to a patent or
patent application within thirty (30) days after an invoice therefor from CIHS,
NEWLINK’s rights and licenses granted to NEWLINK hereunder with respect to such
patent or patent application shall immediately terminate and such patent
application or patent shall no longer be included in Licensed Patents; and (b) if
NEWLINK disputes its obligation to pay any out-of-pocket patent fees and
expenses invoiced by CIHS pursuant to Section 3.1, then the Parties shall
for thirty (30) days in good faith attempt to resolve the dispute, provided
that NEWLINK shall not thereby be relieved of its obligations to make timely
payment of any and all undisputed amounts when due to CIHS.

 

3.2          Royalties.  Subject to the terms and conditions of this
Agreement, commencing on the Effective Date of this Agreement, NEWLINK shall
pay CIHS royalties on Net Sales of Licensed Products by NEWLINK, its Affiliates
and Sublicensees on a country-by-country and Licensed Product-by-Licensed
Product basis as follows:

 

(a)           In countries where the manufacture, use,
sale, offer for sale, or import of Licensed Products would, but for the grant
of the license under the Agreement, infringe a Valid Claim of the Licensed
Patents, NEWLINK shall pay to CIHS a royalty on Net Sales of Licensed Products
in such countries at a rate equal to [*] of annual
Net Sales of Licensed Products.  In the
event that the manufacture, sale or use of any Licensed Product is not covered
by a Valid Claim within the Licensed Patents in a country, then NEWLINK shall pay
to CIHS a royalty with respect to Net Sales in such country of such Licensed
Products by NEWLINK, its Affiliates and Sublicensees at a rate equal to [*].

 

(b)           The royalty obligations of NEWLINK shall
expire on a country-by-country and Licensed Product-by-Licensed Product basis
upon the later of (i) the expiration of the last to expire Valid Claim
within the Licensed Patents covering the Licensed Product in a country (such
expiration to occur only after expiration of extensions of any nature to such
patents which may be obtained under applicable statutes or regulations in the
respective countries of the Territory, such as the Drug Price Competition and
Patent Term Restoration Act of 1984 in the U.S.A., and similar patent extension
laws in other countries), or (ii) until [*] following
the first commercial sale of a Licensed Product in a country.  Following expiration of the royalty
obligations for each Licensed Product in each country, NEWLINK shall retain a
fully-paid, [*] license under the Licensed
Technology to make, have made, use, sell, offer for sale, and import such
Licensed Products in such country.

 

(c)     Combination Products.  Sales of any products that contain one or
more Licensed Products and one or more Active Component(s) that is not a
Licensed Product (“Combination Product”) shall be determined as follows.  Net Sales shall first be calculated in
accordance with the definition of Net Sales set forth in Section 1.10, and
then multiplied by the fraction,  A/A + B, where
A is the invoiced sales price charged for the Licensed Products included in
such Combination Product and B is the invoiced sales price charged for the
other Active Component(s) included in the Combination Product.  If there are no separate sales of such Active
Component(s), Net Sales of the Combination Product shall first be determined in
accordance with the definition of Net Sales set forth in Section 1.10, and
then multiplied by a fraction, A/C, where A shall be the invoiced sales price
of the Licensed Products included  in such
Combination Product and C shall be the invoiced sales price of the Combination
Products.  If neither the Licensed

 

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Product nor the other Active Component(s) included
in such Combination Product are sold separately, then Net Sales of the
Combination Product shall be first determined in accordance with the definition
of Net Sales set forth in Section 1.10, as adjusted by a mechanism to be
agreed upon by the Parties in good faith based upon the respective fair market
values of such Licensed Product and such Active Component(s).  The cost in each case shall be determined in
accordance with generally accepted accounting principles of the United States.

 

(d)           Notwithstanding the foregoing, in no event
shall the royalties owed to CIHS on a given Licensed Product under Section 3.2(a) be
less than [*] of Net Sales (as defined in Section 1.10)
in the case of Licensed Products covered by a Valid Claim, or less than [*] of Net Sales (as defined in Section 1.10) in the
case of Licensed Products not covered by a Valid Claim.

 

3.3          Minimum Royalties.  Following the First Commercial Launch of
Licensed Product, NEWLINK shall pay to CIHS a minimum annual royalty as
follows: Prior to December 31 of the calendar year in which the first Licensed
Product is Commercially Launched, NEWLINK shall pay to CIHS [*] (“Initial Payment”). 
A second payment of [*] shall be
due on the first anniversary of the Initial Payment.  Prior to each of the second and third
anniversaries of the Initial Payment, NEWLINK shall pay CIHS [*], and prior to the fourth and fifth anniversaries of the
Initial Payment, NEWLINK shall pay CIHS [*].  Any royalties resulting from Net Sales of
Licensed Products in a given year may be credited against the minimum royalty
due for that year.  For purposes of this Section 3.3,
“First Commercial Launch” or “Commercially Launched” shall mean, with respect
to each Licensed Product in each country, the first bona fide commercial sale
of a Licensed Product in a country by or under authority of NewLink, its
Affiliates or Sublicensees, including without limitation, any offer for sale or
sale made by NewLink, its Affiliates or Sublicensees to a Third Party pursuant
to a written agreement.

 

3.4          Sublicensing Fee.  In addition to the amounts owed by NewLink to
CIHS pursuant to Section 3.0, 3.1, 3.2, and 3.3 above, if NEWLINK grants a
sublicense of its rights hereunder to a Third Party, NEWLINK agrees to pay to
CIHS a sublicensing fee of [*] of any [*] and other consideration (other than [*]
or [*] on [*], and [*]
within [*] of [*])
(collectively, the “Sublicensing Fee”) received by NEWLINK from each
Sublicensee in consideration for the grant of a sublicense of the Licensed
Patents or development of a Licensed Product.

 

3.5          Third Party Royalties.  NEWLINK shall be responsible for all Third
Party payments and/or licenses of Third Party technology necessary to practice
the Licensed Patents and Licensed Technology to make, use or sell Licensed
Products (“Necessary Rights”).  In the
event that NEWLINK pays royalties to Third Parties pursuant to a written
agreement under which it obtains Necessary Rights for a particular Licensed
Product in a particular country(ies) (each a “Third Party Agreement”), NEWLINK
may offset, on a Licensed Product-by-Licensed Product and country-by-country
basis, up to [*] of the royalties due under
such Third Party Agreements against royalties which are due CIHS hereunder for
such Licensed Product in such country(ies), in each case, in such calendar
year.  Notwithstanding the foregoing, the
royalty due to CIHS as set forth in Section 3.2 in each calendar quarter
for any Licensed Product shall not be reduced to less than [*] of
that (or, i.e., [*] of Net Sales for Licensed
Products covered by a Valid Claim in such country, and [*]
of Net Sales for Licensed Products not covered by a Valid Claim in such
country).

 

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3.6          Schedule and Form of Payment/Taxes.

 

(a)           Following the first commercial sale of a
Licensed Product, NEWLINK shall make quarterly written reports to CIHS within
thirty (30) days after the end of each calendar quarter, stating in each such
report the aggregate Net Sales of Products sold by NEWLINK, its Affiliates and
Sublicensees during the calendar quarter. 
Simultaneously with the delivery of each such report, NEWLINK shall pay
to CIHS the total royalties, if any, due to CIHS for the period of such
report.  If no royalties are due, NEWLINK
shall so report.  Neither Party shall
provide to Third Parties any information contained in reports provided to such
Party pursuant to this Section 3.6, except as required by a Party’s
agreements with its licensors.

 

(b)           All amounts payable to CIHS hereunder shall
be payable in United States dollars.  All
amounts payable to CIHS hereunder shall be payable in United States dollars in
Iowa, or at such other place as CIHS may reasonably designate, provided,
however, that if the law of any foreign country prevents any payment payable to
CIHS hereunder to be made in Iowa, or otherwise designated by CIHS or prevents
any such payment to be made in United States dollars, CIHS agrees to accept
such royalty in form and place as permitted, including deposits by NEWLINK in
the applicable foreign currency in a local bank or banks in such country designated
by NEWLINK.  If any currency conversion
is required in connection with any payments to CIHS hereunder, such conversion
shall be made at the buying rate for the transfer of such other currency as
quoted by CITICORP BANK (NEW YORK) on the last business day of the applicable
accounting period, in the case of any payment payable with respect to a
specified accounting period, or in the case of any other payment, the last
business day prior to the date of such payment. 
All such payments shall be paid in United States dollars, originated
from a United States bank located in the United States and made by bank wire
transfer in immediately available funds to such account as the receiving party
shall designate.

 

(c)           Where required to do so by applicable law or
treaty, NEWLINK shall withhold taxes required to be paid to a taxing authority
on account of such income to CIHS, and NEWLINK shall furnish CIHS with
satisfactory evidence of such withholding and payment in order to permit CIHS
to obtain a tax credit or other relief as may be available under the applicable
law or treaty.

 

(d)           Any amounts payable to CIHS hereunder that
are not paid on the date such payments are due under this Agreement shall
accrue interest from the due date until paid, at a rate equal to [*] per month (or the maximum allowed by law, if less).  Said

 

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interest
and the payment and acceptance thereof shall not negate or waive the right of
CIHS to seek any other remedy, legal or equitable, to which it may be entitled
because of the delinquency of any payment.

 

3.7                               Records.  NEWLINK shall maintain complete and accurate
records showing gross sales, deductions and other relevant information
sufficient to enable accurate calculation of royalties on a country-by-country
and Licensed Product-by-Licensed Product basis and other fees payable hereunder
by NEWLINK to CIHS.  NEWLINK shall, at
CIHS’s request and expense, provide certified statements from NEWLINK’s
auditors, concerning royalties and other fees due pursuant to this
Agreement.  Once a calendar year, CIHS
shall have the right to select a certified public accountant to inspect, on
reasonable notice and during regular business hours, the records of NEWLINK to
verify NEWLINK’s statements and royalty payments due pursuant to this
Agreement.  Inspections conducted under
this Section 3.7 shall be at CIHS’s expense, provided, if such an audit
correctly uncovers a deficiency in payment of royalties payable by NEWLINK
hereunder, NEWLINK shall immediately pay to CIHS such deficient amount, and if
the amount of any such deficiency is greater than five percent (5%) of the
total amount due during the audited period, NEWLINK shall bear the reasonable
out of pocket expenses of such accounting firm to conduct such audit.  Records shall be preserved by NEWLINK for
five (5) years for inspection by CIHS.

 

4.                                      PROSECUTION
AND MAINTENANCE OF LICENSED PATENTS

 

4.0                               Prosecution.  CIHS shall, using patent counsel of its
choice, have the initial right to control the preparing, filing, prosecuting
and maintaining patent applications and patents within the Licensed Patents.  CIHS shall provide NEWLINK a reasonable
opportunity to review and comment upon all such filings prior to their
submission to patent authorities.  If
CIHS elects not to pursue any patent application or patent within the Licensed
Patents, CIHS shall notify NEWLINK reasonably in advance of any filing deadline
or material date and NEWLINK shall have the right, but not the obligation, to
assume control of the preparation, filing, protection and maintenance of such
patent or patent application, at its expense.

 

4.1                               Payment
of Costs.  NEWLINK
shall pay all costs incurred in connection with preparing, filing, prosecuting
and maintaining patent applications and patents within the Licensed Patents
that accrue on or after  January 1,
2000.  In the event that NEWLINK decides
not to continue to pay costs related to a particular patent/patent application
within the Licensed Patents in a particular country, NEWLINK shall timely
notify CIHS in writing thereof, and concurrent with such notice, NEWLINK’s
rights under this Agreement to practice the inventions under such patent/patent
application within the Licensed Patents in such country shall immediately
terminate.

 

4.2                               Patent
Enforcement.

 

(a)                                  Each Party
shall notify the other Party in writing of any alleged or threatened
infringement of Licensed Patents of which it becomes aware and which may
adversely impact the rights of the Parties hereunder.

 

(b)                                  NEWLINK shall
have the first right, but not the obligation, to prosecute any infringement of
the Licensed Patents or defend any declaratory judgment with respect to the 

 

11

 

Licensed Patents. 
If NEWLINK elects to commence an action described above, CIHS may, to
the extent permitted by law, elect to join as a party to the action.  Any recovery obtained in such an action shall
be used first to reimburse costs of NEWLINK, then CIHS, in prosecuting such
action (including reasonable attorney’s fees). 
Any remainder of the recovery shall be distributed as follows: [*].  CIHS shall have
the right, but not the obligation, to prosecute any such infringement of the
Licensed Patents if NEWLINK does not elect to do so within one hundred eighty
(180) days after the Parties become aware of allegedly infringing
activities.  Any recovery obtained in
such an action brought by CIHS under the preceding sentence shall be used first
to reimburse costs of CIHS, then NEWLINK, in prosecuting such action (including
reasonable attorney’s fees).  Any
remainder of the recovery shall be distributed as follows: [*].

 

4.3                               Control
of Third Party Enforcement Actions.  During the term of this Agreement, either
Party that brings an action to enforce the Licensed Patent shall prosecute such
action, at its own expense, utilizing counsel of its choice, subject to
reimbursement of costs pursuant to Section 4.2(b).  No settlement, consent judgment or other
voluntary final disposition of any such suit may be entered into without the
written consent of the other Party, which consent shall not unreasonably be
withheld.

 

4.4                               Cooperation.  In any suit to enforce and/or defend the
Licensed Patent pursuant to this Agreement, the Party not in control of such
suit shall, at the request and expense of the controlling Party, cooperate in
all respects and, to the extent reasonably possible, have its employees testify
when requested and make available relevant records, papers, information,
samples, specimens, and the like.  Any
out-of-pocket costs incurred by the Party not in control of such suit shall be
promptly reimbursed by the Party controlling such suit, subject to
reimbursement pursuant to Section 4.2(b).

 

4.5                               Activities
for Licensed Products Infringing Rights of Third Parties.  Each Party shall promptly notify the other if
any legal proceedings are commenced or threatened against either Party alleging
that the manufacture, use, sale or possession of the Licensed Product infringes
a Third Party’s patent or other intellectual property rights.  In such event, the Parties shall meet to
discuss the course of action to be taken with respect to an enforcement action
with respect to such infringement or misappropriation.

 

5.                                      MARKINGS

 

5.1                               Product
Markings.  NEWLINK
shall mark all Licensed Products (or their containers or labels) made, sold, or
otherwise disposed of by NEWLINK, its Affiliates or Sublicensees, under the
license granted in this Agreement, in accordance with all applicable United
States and foreign statutes pertaining to the marking of products with patent
pending, patent number(s), copyrights, or other intellectual property notices
and legends required to maintain the intellectual property rights licensed in
this Agreement.

 

12

 

6.                                      CONFIDENTIALITY

 

6.0                               Confidential
Information.  Except as
expressly provided herein, the Parties agree that, for the term of this
Agreement and for five (5) years thereafter, the receiving Party shall not
publish or otherwise disclose and shall not use for any purpose any
Confidential Information furnished to it by the other Party hereto pursuant to
this Agreement.  For purposes of this
Agreement, “Confidential Information” shall mean all nonpublic technical and/or
business information (whether patentable or copyrightable), including without
limitation, inventions, unpublished and draft patent applications and any information
contained therein, formulae, trade secrets, processes, laboratory notebooks,
reports, technical data and technology, that is owned or possessed by the
disclosing Party and furnished or otherwise made available to the receiving
Party either (a) between January 1, 1999 and the Effective Date (“Pre-Agreement
Period”) or (b) after the Effective Date, provided that such information
is either (i) disclosed in writing and marked “Confidential,” or in a
similar manner, to indicate its confidential nature, or (ii) if disclosed
orally, is confirmed in writing as confidential within forty-five (45) days
following such disclosure. 
Notwithstanding the foregoing, the Parties understand and agree that the
marking and reduction to writing requirements of subsections (i) and (ii) above
shall not apply to Confidential Information disclosed during the Pre-Agreement
Period.

 

6.1                               Confidential
Information Exclusions. 
Notwithstanding the provisions of Section 6.0, the obligation of
confidentiality shall not apply to information that the receiving Party can
demonstrate:

 

(a)                                  is now in the
public domain or which becomes generally available to the public through no
fault of the receiving Party; or

 

(b)                                  is already
known to, or in the possession of, the receiving Party prior to disclosure by
the disclosing party as can be demonstrated by documentary evidence; or

 

(c)                                  is disclosed on
a non-confidential basis from a Third Party having the right to make such a
disclosure; or

 

(d)                                  is
independently developed by the receiving Party (without the use of any
Confidential Information) as can be demonstrated by competent documentary
evidence.

 

6.2                               Permitted
Usage.  Notwithstanding the provisions
of Section 6.0 above, the receiving Party may use or disclose Confidential
Information of the disclosing Party to the extent necessary to exercise the
rights granted to it hereunder (provided it uses reasonable efforts to protect
such information commensurate with the efforts used to protect its own
information) in prosecuting or defending litigation, complying with applicable
governmental regulations and/or submitting information to tax or other
governmental authorities; provided that if the receiving Party is required by
law to make any public disclosures of Confidential Information of the disclosing
Party, to the extent it may legally do so, it will give reasonable advance
notice to the disclosing Party of such disclosure and will use its reasonable
efforts to secure confidential treatment of Confidential Information prior to
its disclosure (whether through protective orders or otherwise).

 

13

 

7.                                      WARRANTIES
AND INDEMNITIES

 

7.0                               Representations
and Warranties.

 

(a)                                  NEWLINK hereby
represents and warrants that (i) it has the authority and right to enter into
and perform this Agreement, and has taken all necessary corporate or other
action and obtained all necessary approvals to do so, and (ii) its
execution, delivery and performance of this Agreement does not and will not
conflict with any other agreement to which it is or becomes a party or by which
it is or becomes bound.

 

(b)                                  CIHS hereby
represents and warrants that to the best of its knowledge as of the Effective
Date, all rights, interest, and title in and to the Invention has been properly
assigned by all inventors thereof to HGTRI.

 

7.1                               CIHS MAKES NO
REPRESENTATIONS AND EXTENDS NO WARRANTIES OF ANY KIND EXPRESS OR IMPLIED.  THERE ARE NO EXPRESS OR IMPLIED WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR THAT USE OF A LICENSED
PRODUCT OR A PRODUCT MADE USING A LICENSED PROCESS WILL NOT INFRINGE ANY
PATENT, COPYRIGHT, TRADEMARK, OR OTHER RIGHTS OF THIRD PARTIES.

 

7.2                               Indemnities.

 

(a)                                  NEWLINK agrees
to indemnify, hold harmless and defend CIHS, HGTRI, and their respective
trustees, officers, employees, students, and agents from and against all
losses, liabilities, damages, costs and expenses (including without limitation,
reasonable attorney’s fees and other expenses of litigation) (“Liabilities”)
arising from any claims, demands, actions or other proceedings (“Claims”) by
any and all Third Parties for [*] arising
out of (i) [*], under this Agreement and (ii) [*]; provided however, that NEWLINK shall not be obligated
to indemnify, hold harmless and defend CIHS, HGTRI, and their respective
trustees, officers, employees, students, and agents from and against any
Liabilities arising from any Claims arising out of the [*]
of CIHS, HGTRI, and their respective trustees, officers, employees, students,
and agents.

 

(b)                                  NEITHER PARTY
SHALL BE LIABLE TO THE OTHER FOR ANY INDIRECT, SPECIAL OR CONSEQUENTIAL
DAMAGES, WHATSOEVER, WHETHER GROUNDED IN TORT (INCLUDING NEGLIGENCE), STRICT
LIABILITY, CONTRACT OR OTHERWISE.  CIHS
SHALL NOT HAVE [*] WITH RESPECT TO LICENSED
PRODUCT(S).

 

(c)                                  NEWLINK shall
at all times comply, through insurance or self-insurance, with all statutory
workers’ compensation and employers’ liability requirements covering any and
all employees with respect to activities performed under this Agreement.

 

14

 

7.3                               Insurance.  In addition to the foregoing, NEWLINK shall
maintain during the term of this Agreement, Comprehensive General Liability
Insurance, including Products Liability Insurance, with reputable and
financially secure insurance carrier(s) to cover the indemnity granted in Section 7.2.  NEWLINK shall maintain an insurance policy
that provides minimum limits of liability as follows: beginning on the
Effective Date to the commencement of the first clinical trial of any Licensed
Product, the minimum limit shall be two million dollars ($2,000,000); beginning
on the commencement of the first clinical trial of any Licensed Product to the
commencement of the first Phase III clinical trial of any Licensed Product, the
minimum limit shall increase to ten million dollars ($10,000,000); and
beginning on the first Phase III clinical trial of any Licensed Product to the
termination or expiration of this Agreement, the minimum limit shall increase
to twenty million dollars ($20,000,000). 
Such insurance shall include CIHS, HGTRI, and their respective trustees,
officers, employees, students, and agents as additional insureds.  Such insurance shall be written to cover
claims incurred, discovered, manifested, or made during or after the expiration
of this Agreement and should be placed with carriers with ratings of at least
A- as rated by A.M. Best.  Within
fifteen (15) days of the Effective Date of this Agreement, NEWLINK shall
furnish a Certificate of Insurance evidencing primary coverage and additional
insured requirements and requiring thirty (30) days prior notice of
cancellation or material change to CIHS. 
NEWLINK shall advise CIHS, in writing, that it maintains excess
liability coverage (following form) over primary insurance for at least the minimum
limit set forth above.  All such
insurance of NEWLINK shall be primary coverage.

 

8.                                      TERM
AND TERMINATION

 

8.0                               Term.  Unless previously terminated as herein
provided, the term of this Agreement shall commence upon the Effective Date and
expire on the date when NEWLINK has no further royalty obligations hereunder.

 

8.1                               Termination.

 

(a)                                  This Agreement
may be terminated prior to its expiration under Section 8.0 under the
following circumstances:

 

(i)                 If a Party commits material
breach of this Agreement, the non-breaching Party at its option, may terminate
this Agreement by giving the breaching Party written notice of its election to
terminate as of a stated date, not less than forty-five (45) days from the date
of the notice.  Such notice shall state
the nature of the defaults claimed by the non-breaching Party.  The breaching Party may, during such
forty-five (45) day period, or such longer period as may be specified in such
notice, correct any default stated in such notice and if such default is
corrected, this Agreement shall continue in full fame and effect as if such
notice had not been given.

 

(ii)             This Agreement may be
terminated by NEWLINK, at will, at any time upon not less than sixty (60) days
prior written notice to CIHS.

 

(b)                                  NEWLINK may
terminate its license with respect to a specific patent or patent application
within the Licensed Patents, at will, at any time upon not less than ninety
(90) days prior written notice to CIHS. 
In such event, the specified patent application or patent shall no

 

15

 

longer
be a Licensed Patent and NEWLINK shall retain an exclusive license to the
remaining patents and patent applications within the Licensed Patents.

 

8.2                               Effect
of Termination.

 

(a)                                  Accrued
Obligations.  Termination
of this Agreement for any reason shall not release either Party hereto from any
liability which, at the time of such termination, has already accrued to the
other Party or which is attributable to a period prior to such termination nor
preclude either Party from pursuing any rights and remedies it may have
hereunder or at law or in equity with respect to any breach of this Agreement.

 

(b)                                  Termination
of Agreement.  In the
event of any early termination of this Agreement, whether by CIHS pursuant to Section 2.4(a) due
to NEWLINK’s failure to meet one or more of its diligence obligations, or by
CIHS pursuant to Section 8.1(a)(i) due to NEWLINK’s material breach,
or by NEWLINK pursuant to Section 8.1(a)(ii), in each case:

 

(i)                 NEWLINK, its Affiliates and
Sublicensees shall immediately cease all development and commercialization of
Licensed Products, and all practice or use of the Licensed Patents and Licensed
Technology; provided, however, that NEWLINK, its Affiliates, Sublicensees and
distributors shall have the right to sell or otherwise distribute Licensed
Products in their inventories or otherwise in their control as of such
termination of this Agreement for a period not to exceed three (3) months
from such termination.

 

(ii)             NEWLINK shall return, or
destroy, at CIHS’s option, all Confidential Information of CIHS, including any
copies of any Licensed Technology.

 

(c)                                  Termination
of a patent within the Licensed Patents.  In the event of any early termination of
NEWLINK’s license to a particular patent and/or patent application within the
Licensed Patents, whether by NEWLINK pursuant to Section 8.1(b), or by
CIHS pursuant to Section 4.1, in each case:

 

(i)                 NEWLINK, its Affiliates and
Sublicensees shall immediately cease all development and commercialization of
Licensed Products relating to such patent or patent application, and all
practice or use of such patent or patent application; provided, however, that
NEWLINK, its Affiliates, Sublicensees and distributors shall have the right to
sell or otherwise distribute Licensed Products relating to such patent or
patent application that is in their inventories or otherwise in their control
as of such termination of this Agreement for a period not to exceed three (3) months
from such termination.

 

(ii)             NEWLINK shall return, or
destroy, at CIHS’s option, all Confidential Information of CIHS, including any
copies of any Licensed Technology relating to such patent or patent
application, unless such Confidential Information or Licensed Technology also
relates to patents or patent applications with respect to which NEWLINK still
retains a license under this Agreement.

 

(d)                                  Termination
of a field within the Field.  In the event of any termination of NEWLINK’s
license to a particular field within the Field, by CIHS pursuant to Section 2.4(b):

 

16

 

(i)                 NEWLINK, its Affiliates and
Sublicensees shall immediately cease all development and commercialization of
Licensed Products in such field, and all practice or use of Licensed Patents
and Licensed Technology in such field; provided, however, that NEWLINK, its
Affiliates, Sublicensees and distributors shall have the right to sell or
otherwise distribute Licensed Products in such field that is in their
inventories or otherwise in their control as of such termination of this
Agreement for a period not to exceed three (3) months from such
termination.

 

(ii)             NEWLINK shall return, or
destroy, at CIHS’s option, all Confidential Information of CIHS, including any
copies of any Licensed Technology relating to field, unless such Confidential
Information or Licensed Technology also relates to Licensed Patents, Licensed
Technology or Licensed Products in a field with respect to which NEWLINK
retains a license under this Agreement.

 

8.3                               Survival.  Articles 1, 5, 6, and 9, and Sections 2.5(b),
3.2-3.7, 4.5, 7.1, 7.2, 8.2 and 8.3 of this Agreement shall survive expiration
or termination of this Agreement.

 

9.                                      MISCELLANEOUS

 

9.0                               Notices.  All notices, requests and other
communications hereunder shall be in writing and shall be personally delivered,
sent by courier, sent by registered or certified mail, return receipt
requested, postage prepaid, or sent via facsimile in each case to the
respective address specified below, or such other address as may be specified
in writing to the other Party hereto:

 

	
  CIHS:

  	
  Central
  Iowa Health System

  
	
   

  	
  1200 Pleasant Street

  
	
   

  	
  Des Moines, Iowa 50309

  
	
   

  	
  Attn: President

  
	
   

  	
  Fax: 515-241-5994

  
	
   

  	
   

  
	
  with
  copies to:

  	
  Wilson
  Sonsini Goodrich & Rosati

  
	
   

  	
  Professional
  Corporation

  
	
   

  	
  650
  Page Mill Road

  
	
   

  	
  Palo
  Alto, California 94304-1050

  
	
   

  	
  Attn:
  Kenneth A. Clark, Esq.

  
	
   

  	
  Fax:
  (650) 493-6811

  
	
   

  	
   

  
	
   

  	
  Iowa
  Health System

  
	
   

  	
  1200
  Pleasant Street

  
	
   

  	
  Des
  Moines, Iowa 50309

  
	
   

  	
  Attn:
  General Counsel

  
	
   

  	
  Fax:
  515-241-4656

  
	
   

  	
   

  
	
  NEWLINK:

  	
  NEWLINK
  Genetics Corporation

  
	
   

  	
  2901
  S. Loop Drive

  
	
   

  	
  Ames, Iowa
  50010

  
	
   

  	
  Attn:
  Chairman

  

 

17

 

	
   

  	
  Fax:
  515-296-5557

  
	
   

  	
   

  
	
  with
  a copy to:

  	
  Cooley
  Godward, L.L.P.

  
	
   

  	
  380
  Interlocken Crescent

  
	
   

  	
  Suite 900

  
	
   

  	
  Broomfield,
  CO 80021-8023

  
	
   

  	
  Attn:
  James C. Linfield, Esq.

  
	
   

  	
  Fax:
  (650) 493-6811

  

 

Any
such notice mailed by registered or certified mail or air express shall be
deemed to have been given when mailed, as evidenced by the date on the receipt
retained by the sender.  Either Party may
change the address to which notices to it are to be given by notice as provided
herein.

 

9.1                               Force
Majeure.  Neither Party to this
Agreement shall be liable for delay or failure in the performance of any of its
obligations hereunder if such delay or failure is due to causes beyond its
reasonable control, including, without limitation, acts of God, fires,
earthquakes, strikes and labor disputes, acts of war, civil unrest, or
intervention of any governmental authority, provided that the affected Party
shall use reasonable efforts to remedy any such delay or failure.

 

9.2                               Assignments.  Except as provided in this Section 9.2,
this Agreement may not be assigned by NEWLINK without the written prior consent
of CIHS, which consent shall not be unreasonably withheld, provided that
NEWLINK may assign this Agreement without CIHS’ prior consent to an Affiliate
or in connection with the sale or transfer of all or substantially all the
assets of NEWLINK relating to the Agreement. 
CIHS may assign this Agreement at its discretion.

 

9.3                               Injunctive
Relief.  The Parties acknowledges that
the terms hereunder are necessary and reasonable to protect the Parties, and
expressly agree that monetary damages may not be a sufficient remedy for any
breach of this Agreement, and therefore the breaching Party will not oppose the
non-breaching Party’s requests for injunctive relief as a remedy for any such
breach.  In addition, the Parties agrees
that they shall be entitled to seek temporary and permanent injunctive relief
against any threatened violation of the terms of this Agreement or the
continuation of any such violation in any court of competent jurisdiction,
without the necessity of proving actual damages or the posting of any
bond.  For avoidance of doubt, any such
equitable remedies shall be cumulative and not exclusive and are in addition to
any other remedies, which either Party may have under this Agreement or
applicable law.

 

9.4                               Severability.  In the event that any provisions of this
Agreement are determined to be invalid or unenforceable by a court of competent
jurisdiction, the remainder of the Agreement shall remain in full force and
effect without said provision.  In such
event, the parties shall in good faith negotiate an amendment providing a
substitute clause for any provision declared invalid or unenforceable, which
shall most nearly approximate the intent of the Parties in entering this
Agreement.

 

9.5                               Waivers
and Modifications.  The failure
of any Party to insist on the performance of any obligation hereunder shall not
act as a waiver of such obligation.  No
waiver, modification,

 

18

 

release, or amendment of any obligation under this
Agreement shall be valid or effective unless in writing and signed by both
Parties hereto.

 

9.6                               Successors
in Interest.  This
Agreement shall inure to the benefit of and be binding on the Parties’
permitted assigns, successors in interest, and subsidiaries.

 

9.7                               Independent
Contractors.  The Parties
hereto agree that each is acting as an independent contractor and not as an
agent of the other or as joint venturers.

 

9.8                               Choice
of Law and Jurisdiction.  This
Agreement is subject to and shall be construed and enforced in accordance with
the laws of the U.S.A. and the State of Iowa.

 

9.9                               Entire
Agreement.  This
Agreement together with the Exhibits attached hereto, constitute the entire
agreement between the Parties as to the subject matter hereof, and all prior
negotiations, representations, agreements and understandings are merged into,
extinguished by and completely expressed by this Agreement.

 

9.10                        Headings.  The captions to the several Sections and
Articles hereof are not a part of this Agreement, but are included merely for
convenience of reference only and shall not affect its meaning or interpretation.

 

9.11                        Counterparts.  This Agreement may be executed in two
counterparts, each of which shall be deemed an original and which together
shall constitute one instrument.

 

IN
WITNESS WHEREOF, the Parties have duly executed this Agreement effective as of
the Effective Date.

 

	
  NEWLINK
  GENETICS CORPORATION

  	
  CENTRAL
  IOWA HEALTH SYSTEM

  
	
   

  	
   

  
	
   

  	
   

  
	
  By:

  	
  /s/

  	
   

  	
  By:

  	
  /s/

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Title:

  	
  Chairman

  	
   

  	
  Title:

  	
  President

  

 

19

 

	
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Inventions
and know how

 

1.              [*]

 

2.              [*]

 

3.              [*]

 

4.              [*]

 

5.              [*]

 

 

EXHIBIT “C”

 

Stock Purchase Agreement
with the Stoddard Cancer Research Institute

 

 

NEWLINK GENETICS CORPORATION

 

STOCK PURCHASE AGREEMENT

 

This
Stock Purchase Agreement (the “Agreement”) is made this 2nd day of August, 2001, between Newlink Genetics
Corporation, a Delaware corporation (the “Company”), and Stoddard Cancer
Research Institute, a d.b.a. of Central Iowa Health System, an Iowa non-profit
corporation, (the “Purchaser”).

 

1.                                       Sale of Stock.  The Company hereby agrees to sell to the
Purchaser and the Purchaser hereby agrees to purchase an aggregate of [*] shares of the Company’s Common Stock (the “Shares”).

 

2.                                       Payment of
Purchase Price.  The
purchase price for the Shares shall be deemed paid by Purchaser’s grant of
licenses to the Company pursuant to Section 2.0 of the License Agreement
dated August 2, 2001 between Purchaser and the Company.

 

3.                                       Representations
and Warranties of the Company.  The Company represents and warrants to the
Purchaser as follows:

 

(a)          Organization and Standing.  The Company is a corporation duly organized
and validly existing under, and by virtue of, the laws of the State of Delaware
and is in good standing under such laws. 
The Company has requisite corporate power and authority to own and
operate its properties and assets, and to carry on its business as presently
conducted.  The Company is duly qualified
to do business as a foreign corporation in each jurisdiction in which the
failure to be so qualified will have a material adverse affect on the Company’s
business.

 

(b)         Corporate Power;
Authorization.  The Company
has all requisite legal and corporate power and authority to execute and
deliver this Agreement and to issue the Common Stock sold under this
Agreement.  All corporate action on the
part of the Company, its officers, directors and stockholders necessary for the
authorization, execution, delivery and performance of this Agreement and the
performance of all of the Company’s obligations under this Agreement has been
taken.  The Shares, when issued in
compliance with the provisions of this Agreement will be validly issued, fully
paid and nonassessable.

 

(c)          Capitalization.  The authorized capital stock of the Company
consists or will, upon the execution of the Agreement, consist of 12,000,000
shares of Common Stock and 3,000,000 shares of Preferred Stock, 1,600,000 of
which is designated Series A Preferred Stock.  Immediately prior to the execution of this
Agreement, 5,198,200 shares of Common Stock and 420,000 shares of Series A
Preferred Stock will be issued and outstanding. 
No other shares of capital stock will be outstanding.  All of the issued and outstanding shares of
Common Stock and Series A Preferred Stock are duly authorized, validly
issued, fully paid and nonassessable, and were issued in compliance with
applicable federal and state securities laws. 
Except for (i) the conversion privileges of the Series A
Preferred Stock, (ii) 188,000 shares of Common Stock subject to issued
options issued under the Company’s 2000 Equity Incentive Plan, and (iii) 1,500,000
shares of Common Stock reserved for future issuance pursuant to the Company’s
Equity Incentive Plan and (iv) the rights provided in the Company’s
Investors’ Rights Agreement, there are no other outstanding shares of capital
stock or outstanding rights of first refusal, preemptive rights or other
rights, options, warrants, conversion rights, or other

 

 

agreements either directly or indirectly for the
purchase or acquisition from the Company of any shares of its capital stock.

 

4.                                       Representations
and Warranties of the Purchaser.  Purchaser represents and warrants to the Company
as follows:

 

(a)          Restricted Securities.  Purchaser is aware that the Shares to be
issued to Purchaser by the Company pursuant to this Agreement have not been
registered under the Securities Act of 1933, as amended (the “Act”), and that
the Shares are deemed to constitute “restricted securities” under Rule 144
promulgated under the Act.

 

(b)         Accredited Investor.  Purchaser is an accredited investor within
the meaning of Regulation D prescribed by the Securities and Exchange
Commission pursuant to the Act.

 

(c)          Investment Experience.  By virtue of such Purchaser’s experience in
evaluating and investing in private placement transactions of securities in
companies similar to the Company, Purchaser has sufficient knowledge and
experience in business and financial matters to evaluate the Company, its
proposed activities and is capable of evaluating the merits and risks of such
Purchaser’s investment in the Company, Purchaser has the capacity to protect
such Purchaser’s own interests in connection with the purchaser of the Shares
by virtue of the business or financial expertise of any professional advisors
to Purchaser who are unaffiliated with and who are not compensated by the
Company or any of its affiliates, directly or indirectly.  Purchaser has the ability to accept the high
risk and lack of liquidity inherent in this type of investment.

 

(d)         Investment Intent. Purchaser is
acquiring the Securities for investment for such Purchaser’s own account and
not with a view to, or for resale in connection with, any distribution
thereof.  Purchaser understands that the
Securities have not been registered under the Act by reason of a specific
exemption from the registration provisions of the Act that depends upon, among
other things, the bona fide nature of the investment intent as expressed
herein.

 

(e)          Rule 144.  Purchaser understands that the exemption from
registration under Rule 144 will not be available for at least two years
from the date of receipt of the Shares unless at least one year from the date
of receipt (i) a public trading market then exists for the Common Stock of
the Company, (ii) adequate information concerning the Company is then
available to the public, and (iii) other terms and conditions of Rule 144
are complied with; and that any sale of the Shares may be made only in limited
amounts in accordance with such terms and conditions and that after ninety days
after the Company becomes subject to the reporting requirements of Section 13
or 15(d) of the Securities Exchange Act of 1934, the Shares may be resold
by persons other than affiliates in reliance on Rule 144 without
compliance with paragraphs (c), (d), (e) and (h) thereof, and by
affiliates without compliance with paragraph (d) thereof.

 

(f)            Knowledge of Company,
Company Information.  Purchaser
is familiar with the Company, the nature of its business, its financial
prospects and the merits and risks of an investment in the Company, and has the
capacity to protect its own interests. 
Purchaser has had an opportunity to discuss the Company’s business,
management and financial affairs with directors, officers and management of the
Company.  Purchaser has also had the
opportunity to ask questions of, and receive answers from, the Company and its
management regarding the terms and conditions of this investment.

 

2

 

(g)         Additional Capital.  Purchaser understands that the Company may
need to raise additional financing to support expansion, develop new or
enhanced applications and services, respond to competitive pressures, acquire
complementary business or technologies or take advantage of unanticipated
opportunities.  Purchaser understands
that the Company may need to raise additional funds by selling debt or equity securities,
by entering into strategic relationships or through other arrangements.  Purchaser understands that such financing may
be dilutive to existing stockholders.

 

5.                                       [*].

 

(a)          [*]  The Company hereby [*], on the terms set
forth in this Section 5, [*] to [*] or [*] of [*] of the [*] which the [*]
to [*] to [*] and [*].  The Purchaser may
[*] on the [*] and [*] the [*] to [*]. 
For the purposes of [*] of the [*] is a [*] the [*] is the [*] of [*]
and the [*] is the [*] of the [*] of [*] of or [*] of, as the case may be, [*]
or [*] to the [*] of the [*].

 

(b)         [*] of
the [*] or [*] and [*] or [*] to [*] and [*] of [*] or [*] into [*] that [*]
does [*] to a [*] or [*] or [*] to [*] or [*] of the [*] to [*] or [*] by the
[*] of the [*] to [*] to [*] by the [*] of the [*] or [*] or [*] or [*] from [*]
or [*] or [*] by the [*] of the [*] of [*] in [*] with [*] or [*] by the [*]
and [*] the [*] and other [*] or [*] or [*] or [*].

 

(c)          [*]  In the event [*] to [*] of [*], it [*] to the
[*] of its [*] the [*] of [*] the [*] the [*] to [*] the [*] the [*] of the [*]
and [*] to the [*] of [*] of [*] to [*]. 
The [*] from the [*] of the [*] to [*] of [*] of the [*] for the [*] and
[*] the [*] in the [*] to the [*] the [*] of [*] to be [*] and [*] for [*] to
the [*] if [*] or in [*] the [*] of the [*] in the [*]

 

(d)         [*]  The [*] be [*] the [*] to [*] any [*] or [*]
of [*] to any [*] or [*] or [*] of the [*].

 

(e)          [*]  The [*] under this Section 5 [*] the [*]
of the [*] to [*] by the [*]

 

6.                                       [*]

 

(a)          [*]  If the [*] to [*] of [*] for [*] or [*] of
[*] other [*] to [*] or [*] to [*] to [*] or [*] on [*] or [*] the [*] to be
[*] the [* ]of the [*] the [*] the [*] and [*] and [*] the [*] of [*] in [*]
the [*] of [*] the [*] in [*].

 

(b)         [*]  If the [*] for [*] the ]*] is for [*] the [*]
to [*] be [*] the [*] in[*] and the [*] of [*] in the [*] to [*] in [*] with
the [*] or [*] by the [*]. 
Notwithstanding any other provision of this Section, if the [*] that [*]
on the [*] of [*] to be [*] and [*] may [*] of the [*] with the [*] that may be
[*] in the [*] and [*] the [*] and all other [*] to have [*] in [*] in [*] as
nearly as [*], to the [*] of [*] which they [*] to be [*] in [*].

 

(c)          [*] of
the [*] of [*] for the [*] shall be [*] by the [*] to the [*] of [*] and [*] of
the [*] in the [*] by [*] which [*] by the [*] and [*] on the [*] of the [*].

 

(d)         [*]  The [*] under this Section 6 [*] to a
[*] of [*] to [*] or [*]. ‘

 

(e)          [*]  The [*] under this Section 6 [*] as to
the [*] or a [*] when [*] is [*] under this Agreement [*] in [*]

 

3

 

7.                                       Financial
Information.  The Company
will provide the Purchaser with reports and provide access for Purchaser as set
forth below.

 

(a)          As soon as practicable after
the end of each fiscal year, and in any event within one hundred twenty (120)
days thereafter, consolidated balance sheets of the Company and its
subsidiaries, if any, as of the end of such fiscal year, and unaudited
consolidated statements of income and consolidated statements of changes in
financial position of the Company and its subsidiaries, if any, for such year,
prepared in accordance with generally accepted accounting principles and
setting forth in each case in comparative form the figures for the previous
fiscal year (or, at the election of the Company, setting forth in comparative
form the budgeted figures for the fiscal year then reported), all in reasonable
detail.

 

(b)         As soon as practicable after
the end of each quarter, and in any event within sixty (60) days after each
quarterly accounting period, an unaudited quarterly report including a balance
sheet, profit and loss statement and cash flow analysis (prepared in accordance
with generally accepted accounting principles other than for accompanying notes
and subject to changes resulting from year-end audit adjustments).

 

(c)          The Company shall permit
each Purchaser, at such Purchaser’s expense, to visit and inspect the Company’s
properties, to examine its books of account and records and to discuss the
Company’s affairs, finances and accounts with its officers, all at such
reasonable times as may be requested by the Investor.

 

(d)         Anything in Section 7(c) to
the contrary notwithstanding, the Purchaser or transferee of the Purchaser by
reason of this Agreement shall not have access to any trade secrets or
classified information of the Company. 
The Purchaser hereby agrees to hold in confidence and trust and not to
misuse or disclose any confidential information provided pursuant to Section 7(c) and
any transferee of must agree, in writing, to the same.  The Company shall not be required to comply
with this Section 7(c)in respect of the Purchaser or transferee of the
Purchaser whom the Company reasonably determines to be a competitor or an
officer, employee, director or greater than 5% shareholder of a competitor or
to the extent compliance would result in disclosure of trade secrets.

 

(e)          Termination of Covenants.  The covenants set forth in this Section 7
shall terminate and be of no further force or effect upon the closing of the
Company’s initial underwritten public offering pursuant to an effective
registration statement filed by the Company under the Act.

 

8.                                       Legends.  The share certificate evidencing the Shares
issued hereunder shall be endorsed with the following legends (in addition to
any legend required under applicable state securities laws):

 

(a)                                  THE SHARES
REPRESENTED BY THIS CERTIFICATE HAVE BEEN ACQUIRED FOR INVESTMENT AND NOT WITH
A VIEW TO, OR IN CONNECTION WITH, THE SALE OR DISTRIBUTION THEREOF. NO SUCH
SALE OR DISPOSITION MAY BE EFFECTED WITHOUT AN EFFECTIVE REGISTRATION
STATEMENT RELATED THERETO OR AN OPINION OF COUNSEL SATISFACTORY

 

4

 

TO THE COMPANY THAT SUCH
REGISTRATION IS NOT REQUIRED UNDER THE SECURITIES ACT OF 1933.

 

(b)                                 THE SHARES OF
STOCK REPRESENTED BY THIS CERTIFICATE ARE SUBJECT TO RESTRICTIONS PURSUANT TO
THE COMPANY’S BYLAWS.  SUCH BYLAW, AMONG
OTHER THINGS, RESTRICTS CERTAIN RIGHTS WITH RESPECT TO THE SALE AND TRANSFER OF
THE SHARES AND OTHERWISE ENCUMBERS THE SHARES REPRESENTED HEREBY. COPIES OF THE
BYLAWS MAY BE OBTAINED UPON WRITTEN REQUEST TO THE SECRETARY OF THE
COMPANY.

 

(c)                                  Any legend
required to be placed thereon by the Delaware Commissioner of Corporations or
any other applicable state securities laws.

 

9.                                       Restrictions on
Transfer.

 

(a)          Without in any way limiting
the foregoing, Purchaser further agrees that Purchaser shall in no event make
any disposition of all or any portion of the Shares which Purchaser is being
issued unless and until:  (i) there
is then in effect a registration statement under the Act covering such proposed
disposition and such disposition is made in accordance with said registration
statement; or (ii) (A) The transferee has agreed in writing to be
bound by the terms of this Agreement, (B) Purchaser shall have notified
the Company of the proposed disposition and shall have furnished the Company
with a detailed statement of the circumstances surrounding the proposed
disposition, and (C) if reasonably requested by the Company, Purchaser
shall have furnished the Company with an opinion of counsel, reasonably
satisfactory to the Company, that such disposition will not require
registration of the Shares under the Act. In addition, Purchaser agrees that
any such disposition shall be made in accordance with the provisions of the
Company’s Bylaws, provided however that the Company hereby waives any right of
first refusal pursuant to Article XIV of the Company’s Bylaws with respect
to any transfer of the Shares by Purchaser to any parent corporation or entity,
subsidiary or affiliate of Purchaser.

 

(b)         The Company shall not be
required (i) to transfer on its books any Shares which shall have been
sold or transferred in violation of any of the provisions set forth in the Section 9(a) or
(ii) to treat as owner of such Shares or to accord the right to vote as
such owner or to pay dividends to any transferee to whom such Shares shall have
been so transferred.

 

(c)          Purchaser hereby agrees that
for a period of not less than 180 days following the effective date of the
first registration statement of the Company covering Common Stock (or other
securities) to be sold on its behalf in an underwritten public offering,
Purchaser shall not, to the extent requested by the Company or any underwriter,
sell or otherwise transfer or dispose of (other than to donees who agree to be
similarly bound) any Common Stock of the Company held by Purchaser at any time
during such period except Common Stock included in such registration.

 

(d)         In order to enforce the
foregoing covenant, the Company may impose stop-transfer instructions with
respect to the Common Stock held by Purchaser (and the shares or securities of
every other person subject to the foregoing restriction) until the end of such
period.

 

5

 

10.                                 Adjustment for
Stock Split.  All
references to the number of Shares and the purchase price of the Shares in this
Agreement shall be appropriately adjusted to reflect any stock split, stock
dividend or other change in the Shares which may be made by the Company after
the date of this Agreement.

 

11.                                 Tax
Consequences.  The
Purchaser has reviewed with the Purchaser’s own tax advisors the federal,
state, local and foreign tax consequences of this investment and the
transactions contemplated by this Agreement.  The Purchaser is relying solely on such
advisors and not on any statements or representations of the Company or any of
its agents.  The Purchaser understands
that the Purchaser (and not the Company) shall be responsible for the Purchaser’s
own tax liability that may arise as a result of this investment or the
transactions contemplated by this Agreement.

 

12.                                 General
Provisions.

 

(a)          This Agreement shall be
governed by the laws of the State of Delaware. 
This Agreement represents the entire agreement between the parties with
respect to the purchase of Common Stock by the Purchaser and may only be
modified, amended or waived in writing signed by both parties.

 

(b)         Any notice, demand or
request required or permitted to be given by either the Company or the Purchaser
pursuant to the terms of this Agreement shall be in writing and shall be deemed
given when delivered personally or deposited in the U.S. Mail, First Class with
postage prepaid, and addressed to the parties at the addresses of the parties
set forth at the end of this Agreement or such other address as a party may
request by notifying the other in writing.

 

(c)          Except as otherwise provided
herein, the provisions hereof shall inure to the benefit of, and be binding
upon, the successors and assigns of the parties, hereto.

 

(d)         Either party’s failure to
enforce any provision or provisions of this Agreement shall not in any way be
construed as a waiver of any such provision or provisions, nor prevent that
party thereafter from enforcing each and every other provision of this
Agreement.  The rights granted both
parties herein are cumulative and shall not constitute a waiver of either party’s
right to assert all other legal remedies available to it under the
circumstances.

 

(e)          The Purchaser agrees upon
request to execute any further documents or instruments necessary or desirable
to carry out the purposes or intent of this Agreement.

 

6

 

IN
WITNESS WHEREOF, the parties have duly executed this Agreement as of the day
and year first set forth above.

 

 

	
  COMPANY

  	
   

  	
  PURCHASER

  
	
   

  	
   

  	
   

  
	
  NEWLINK
  GENETICS CORPORATION

  	
   

  	
  STODDARD
  CANCER RESEARCH INST.

  
	
  a
  Delaware corporation

  	
   

  	
  a
  d.b.a. of Central Iowa Health System

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  /s/Charles
  Link, Jr.

  	
   

  	
  /s/
  Eric Crowell

  
	
  (Signature)

  	
   

  	
  (Signature)

  
	
   

  	
   

  	
   

  
	
  Charles
  Link, Jr.

  	
   

  	
  Eric
  Crowell

  
	
  (Print
  Name)

  	
   

  	
  (Print
  Name)

  
	
   

  	
   

  	
   

  
	
  Chairman

  	
   

  	
  President

  
	
  (Title)

  	
   

  	
  (Include
  Title if signing on behalf of an entity)

  
	
   

  	
   

  	
   

  
	
  2901
  S. Loop Drive

  	
   

  	
  1200
  Pleasant St.

  
	
  (Address)

  	
   

  	
  (Address)

  
	
   

  	
   

  	
   

  
	
  Ames, IA
  50010

  	
   

  	
  Des
  Moines, IA 50309

  
	
  (City,
  State Zip)

  	
   

  	
  (City,
  State Zip)

  

 

7Exhibit 10.27

 

Cooperative Research and

Development Agreement

 

(CRADA #1901)

 

[*]

 

NCI Principal Investigator

 

John C. Morris, M.D.

Metabolism Branch, CCR, NCI

 

Collaborator Principal
Investigator

 

Nicholas Vahanian, M.D.

NewLink Genetics Corporation

 

Term of CRADA

Four (4) years from date of
the final CRADA signature

 

Prepared by

Technology Transfer Branch

National Cancer Institute

 

 

PUBLIC HEALTH SERVICE

 

COOPERATIVE RESEARCH AND
DEVELOPMENT AGREEMENT

 

This
Cooperative Research and Development Agreement, hereinafter referred to as the “CRADA,”
consists of this Cover Page, an attached Agreement, and various Appendices
referenced in the Agreement.  This Cover Page serves
to identify the Parties to this CRADA:

 

(1)                                  the following
Bureau(s), Institute(s), Center(s) or Division(s) of the
National Institutes of Health (“NIH”), the Food and Drug Administration (“FDA”),
and the Centers for Disease Control and Prevention (“CDC”): National Cancer
Institute, hereinafter singly or collectively referred to as the Public Health
Service (“PHS”); and

 

(2)                                  NewLink
Genetics Corporation, which has offices at 2901 South Loop Drive, Suite 3900,
Ames, Iowa 50010; hereinafter referred to as the “Collaborator.”

 

 

COOPERATIVE RESEARCH AND
DEVELOPMENT AGREEMENT

 

Article 1.                                            Introduction

 

This
Cooperative Research and Development Agreement (CRADA) between PHS and the
Collaborator will be effective when signed by all Parties.  The research and development activities which
will be undertaken by each of the Parties in the course of this CRADA are
detailed in the Research Plan (RP) which is attached as Appendix A.  The funding and staffing commitments of the
Parties are set forth in Appendix B. Any exceptions or changes to the CRADA are
set forth in Appendix C.  This CRADA is
made under the authority of the Federal Technology Transfer Act, 15 U.S.C.
§3710a and is governed by its terms.

 

Article 2.                                            Definitions

 

As
used in this CRADA, the following terms shall have the indicated meanings:

 

2.1                                 “Affiliate” means any corporation or other business entity
controlled by, controlling, or under common control with Collaborator.  For this purpose, A “control” means direct or
indirect beneficial ownership of at least fifty (50) percent of the voting
stock or at least fifty (50) percent interest in the income of such corporation
or other business.

 

2.2                                 “Cooperative Research and Development Agreement” or “CRADA” means this Agreement, entered into by PHS pursuant to
the Federal Technology Transfer Act of 1986, as amended, 15 U.S.C. 3710a et
seq. and Executive Order 12591 of October 10, 1987.

 

2.3                                 “Government” means the Government of the United States as
represented through the PHS agency that is a Party to this agreement.

 

2.4                                 “IP” means intellectual property.

 

2.5                                 “Invention” means any invention or discovery which is or may
be patentable or otherwise protected under title 35, United States Code, or any
novel variety or plant which is or may be protectable under the Plant Variety
Protection Act (7 U.S.C. 2321 et seq.).

 

2.6                                 “Principal Investigator(s)” or “PIs”
means the persons designated respectively by the Parties to this CRADA who will
be responsible for the scientific and technical conduct of the RP.

 

2.7                                 “Proprietary/Confidential Information” means confidential
scientific, business, or financial information provided that such information
does not include:

 

2.7.1                        information
that is publicly known or available from other sources who are not under a
confidentiality obligation to the source of the information;

 

2.7.2                        information
which has been made available by its owners to others without a confidentiality
obligation;

 

2.7.3                        information
which is already known by or available to the receiving Party without a
confidentiality obligation; or

 

 

2.7.4                        information
which relates to potential hazards or cautionary warnings associated with the
production, handling or use of the subject matter of the Research Plan of this
CRADA.

 

2.8                                 “Research Materials” means all tangible materials other than
Subject Data first produced in the performance of this CRADA.

 

2.9                                 “Research Plan” or “RP” means the
statement in Appendix A of the respective research and development commitments
of the Parties to this CRADA.

 

2.10                           “Subject Invention” means any Invention of the Parties,
conceived or first actually reduced to practice in the performance of the
Research Plan of this CRADA.

 

2.11                           “Subject Data” means all recorded information first produced
in the performance of this CRADA by the Parties.

 

Article 3.                                            Cooperative
Research

 

3.1                                 Principal
Investigators.  PHS research
work under this CRADA will be performed by the PHS laboratory identified in the
RP, and the PHS Principal Investigator (PI) designated in the RP will be
responsible for the scientific and technical conduct of this project on behalf
of PHS. Also designated in the RP is the Collaborator PI who will be
responsible for the scientific and technical conduct of this project on behalf
of the Collaborator.

 

3.2                                 Research
Plan Change.  The RP may be
modified by mutual written consent of the Principal Investigators.  Substantial changes in the scope of the RP
will be treated as amendments under Article 13.6.

 

Article 4.                                            Reports

 

4.1                                 Interim
Reports.  The Parties
shall exchange formal written interim progress reports on a schedule agreed to
by the PIs, but at least within twelve (12) months after this CRADA becomes
effective and at least within every twelve (12) months thereafter.  Such reports shall set forth the technical
progress made, identifying such problems as may have been encountered and establishing
goals and objectives requiring further effort, any modifications to the
Research Plan pursuant to Article 3.2, and identify Subject Inventions
pursuant to Article 6.1.

 

4.2                                 Final
Reports.  The Parties
shall exchange final reports of their results within four (4) months  after completing the projects described in the RP or after
the expiration or termination of this CRADA.

 

Article 5.                                            Financial
and Staffing Obligations

 

5.1                                 PHS and
Collaborator Contributions.  The
contributions of the Parties, including payment schedules, if applicable, are
set forth in Appendix B.  PHS shall not
be obligated to perform any of the research specified herein or to take any
other action required by this CRADA if the funding is not provided as set forth
in Appendix B.  PHS shall return excess
funds to the Collaborator when it sends its final fiscal report pursuant to Article 5.2,
except for staffing support pursuant to Article 10.3.  Collaborator acknowledges that the U.S.
Government will have the authority to retain and expend any excess funds for up
to one (1) year  subsequent to
the expiration or termination of the CRADA to cover any costs incurred during
the term of the CRADA in undertaking the work set forth in the RP.

 

 

5.2                                 Accounting
Records.  PHS shall maintain separate
and distinct current accounts, records, and other evidence supporting all its
obligations under this CRADA, and shall provide the Collaborator a final fiscal
report pursuant to Article 4.2.

 

5.3                                 Capital
Equipment.  Equipment
purchased by PHS with funds provided by the Collaborator shall be the property
of PHS. All capital equipment provided under this CRADA by one party for the
use of another Party remains the property of the providing Party unless other
disposition is mutually agreed upon by in writing by the Parties.  If title to this equipment remains with the
providing Parry, that Party is responsible for maintenance of the equipment and
the costs of its transportation to and from the site where it will be used.

 

Article 6.                                            Patent
Applications

 

6.1                                 Reporting.
 The Parties shall promptly
report to each other in writing each Subject Invention and any patent
applications filed thereon resulting from the research conducted under this
CRADA that is reported to them by their respective employees.  Each Party shall report all Subject
Inventions to the other Party in sufficient detail to determine
inventorship.  Such reports shall be
treated as Proprietary/Confidential Information in accordance with Article 8.4.

 

6.2                                 Filing
of Patent Applications.  [*] shall be
responsible for filing patent or other IP applications in a timely manner and [*] and after consultation with [*].  The Parties will consult and mutually
determine a filing strategy for [*] subject
inventions.

 

6.3                                 Patent
Expenses.  The expenses
attendant to the filing of patent or other IP applications generally shall be
paid by the Party filing such application. 
If an exclusive license to any Subject Invention is granted to the
Collaborator, the Collaborator shall be responsible for all past and future
out-of-pocket expenses in connection with the preparation, filing, prosecution
and maintenance of any applications claiming such exclusively-licensed
inventions and any patents or other IP grants that may issue on such
applications.  The Collaborator may waive
its exclusive license rights on any application, patent or other IP grant at
any time, and incur no subsequent compensation obligation for that application,
patent or IP grant.

 

6.4                                 Prosecution
of Intellectual Property Applications.  Within  one month of
receipt or filing, each Party shall provide the other Party with copies of the
applications and all documents received from or filed with the relevant patent
or other IP office in connection with the prosecution of such
applications.  Each Party shall also
provide the other Party with the power to inspect and make copies of all
documents retained in the patent or other IP application files by the
applicable patent or other IP office. 
Where licensing is contemplated by Collaborator, the Parties agree to
consult with each other with respect to the prosecution of applications for PHS
Subject Inventions and joint Subject Inventions.  If the Parties agree that Collaborator shall
file and prosecute IP applications on joint Subject Inventions, then Collaborator
agrees to grant PHS an associate power of attorney (or its equivalent) on such
IP applications.

 

Article 7.                                            Licensing

 

7.1                                 Option
for Commercialization License.  With respect to Government IP rights to any
Subject Invention not made solely by the Collaborator’s employees for which a
patent or other IP application is filed, PHS hereby grants to the Collaborator
an exclusive option to elect an exclusive or nonexclusive commercialization
license, which is substantially in the form of the appropriate model PHS
license agreement.  This option does not
apply to Subject Inventions [*] that are [*], if [*], PHS has [*]

 

 

[*] and has [*] or [*].  The terms of the license will fairly reflect
the nature of the invention, the relative contributions of the Parties to the
invention and the CRADA, the risks incurred by the Collaborator and the costs
of subsequent research and development needed to bring the invention to the
marketplace.  The field of use of the
license will be [*].

 

7.2                                 Exercise
of License Option.  The option of
Article 7.1 must be exercised by written notice mailed within [*] after either (i) Collaborator receives written
notice from PHS that the patent or other IP application has been filed; or (ii) the
date Collaborator files such IP application. 
Exercise of this option by the Collaborator initiates a negotiation
period that expires [*] after the
exercise of the option.  If the last
proposal by the Collaborator has not been responded to in writing by PHS within
this [*] period, the negotiation period
shall be extended to expire [*] after PHS
so responds, during which [*] the
Collaborator may accept in writing the final license proposal of PHS. In the
absence of such acceptance, or an extension of the time limits by PHS, PHS will
be free to license such IP rights to others. 
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 [*] 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.

 

7.3                                 License
for [*] Inventions.  Pursuant to 15 U.S.C. §
3710a(b)(l)(A), for Subject Inventions made under this CRADA [*] and licensed pursuant to the option of Article 7.1,
the Collaborator grants to the Government a nonexclusive, nontransferable,
irrevocable, paid-up license to practice the invention or have the invention
practiced throughout the world by or on behalf of the Government.  In the exercise of such license, the
Government shall not publicly disclose trade secrets or commercial or financial
information that is privileged or confidential within the meaning of 5 U.S.C.
552(b)(4) or which would be considered as such if it had been obtained
from a non-Federal party.

 

7.4                                 License
in [*] Inventions.  Pursuant to
15 U.S.C. § 3710a(b)(2), for Subject Inventions made [*]
under this CRADA, the Collaborator grants to the Government  a
nonexclusive, nontransferable, irrevocable, paid-up license to practice the
invention or have the invention practiced throughout the world by or on behalf
of the Government for research or other Government purposes.

 

7.5                                 Third
Party License.  Pursuant to
15 U.S.C. § 3710a(b)(1)(B), if PHS grants  an exclusive
license  to a Subject Invention made [*] under this CRADA, the Government shall retain the right
to require the Collaborator to grant to a responsible applicant  a nonexclusive, partially exclusive, or exclusive
sublicense to use the invention in Collaborator’s licensed field of use on
terms that are reasonable under the circumstances; or if the Collaborator fails
to grant such a license, to grant the license itself.  The exercise of such rights by the Government
shall only be in exceptional circumstances and only if the Government
determines (1) the action is necessary to meet health or safety needs that
are not reasonably satisfied by Collaborator, (ii) the action is necessary
to meet requirements for public use specified by Federal regulations, and such
requirements are not reasonably satisfied by the Collaborator; or (iii) the
Collaborator has failed to comply with an agreement containing provisions
described in 15 U.S.C. 3710a(c)(4)(B). 
The determination made by the Government under this Article is
subject to administrative appeal and judicial review under 35 U.S.C. 203(2).

 

7.6                                 Joint
Inventions Not Exclusively Licensed.  In the event that the Collaborator does not
acquire  an exclusive commercialization license
to IP rights in all fields in joint Subject Inventions then each Party

 

 

shall have the right to use the joint Subject
Invention and to license its use to others in all fields not exclusively
licensed to Collaborator.  The Parties
may agree to a joint licensing approach for such IP rights.

 

Article 8.                                            Proprietary
Rights and Publication

 

8.1                                 Right
of Access.  PHS and the
Collaborator agree to exchange all Subject Data produced in the course of
research under this CRADA. Research Materials will be shared equally by the
Parties to the CRADA unless other disposition is agreed to by the Parties.  All Parties to this CRADA will be free to
utilize Subject Data and Research Materials for their own purposes, consistent
with their obligations under this CRADA.

 

8.2                                 Ownership
of Subject Data and Research Materials.  Subject to the
sharing requirements of Paragraph 8.1 and the regulatory filing requirements of
Paragraph 8.3, [*] will [*]
ownership of and title to all Subject Inventions, all Subject Data and all
Research Materials [*]].  [*] Subject
Inventions, Subject Data and Research Materials will be [*].

 

8.3                                 Dissemination
of Subject Data and Research Materials.  To the extent
permitted by law, the Collaborator and PHS agree to use reasonable efforts to
keep Subject Data and Research Materials confidential until published or until
corresponding patent applications are filed. 
Any information that would identify human subjects of research or
patients will always be maintained confidentially.  To the extent permitted by law, the
Collaborator shall have the exclusive right to use any and all CRADA Subject
Data in and for any regulatory filing by or on behalf of Collaborator, except
that PHS shall have the exclusive right to use Subject Data for that purpose,
and authorize others to do so, if the CRADA is terminated or if Collaborator
abandons its commercialization efforts. 
Collaborator acknowledges the basic research mission of the PHS, and
agrees that after publication, PHS may make unpatented research materials arising
out of this CRADA available to third parties for further research.

 

8.4                                 Proprietary/Confidential
Information.  Each Party
agrees to limit its disclosure of Proprietary/Confidential Information to the
amount necessary to carry out the Research Plan of this CRADA, and shall place
a confidentiality notice on all such information.  Confidential oral communications shall be
reduced to writing within 30 days by the disclosing Party.  Each Party receiving Proprietary/Confidential
Information agrees that any information so designated shall be used by it only
for the purposes described in the attached Research Plan.  Any Party may object to the designation of
information as Proprietary/Confidential Information by another Party.  Subject Data and Research Materials developed
[*] may be designated as
Proprietary/Confidential Information when they are [*],
and [*]. 
The exchange of other confidential information, e.g.,
patient-identifying data, should be similarly limited and treated.  [*] Subject Data and
Research Material  derived from the Research Plan
may be disclosed by Collaborator to a third party under a confidentiality
agreement for the purpose of possible sublicensing pursuant to the Licensing
Agreement and subject to Article 8.7.

 

8.5                                 Protection
of Proprietary/Confidential Information.  Proprietary/Confidential Information shall not
be disclosed, copied, reproduced or otherwise made available to any other
person or entity without the consent of the owning Party except as required
under court order or the Freedom of Information Act (5 U.S.C. 552).  Each Party agrees to use its best efforts to
maintain the confidentiality of Proprietary/Confidential Information.  Each Party agrees that the other Party is not
liable for the disclosure of Proprietary/Confidential Information which, after
notice to and consultation with the concerned Party, the

 

 

other Party in possession of the
Proprietary/Confidential Information determines may not be lawfully withheld,
provided the concerned Party has been given an opportunity to seek a court
order to enjoin disclosure.

 

8.6                                 Duration
of Confidentiality Obligation.  The obligation to maintain the confidentiality
of Proprietary/Confidential Information shall expire at the  earlier
of the date when the information is no longer Proprietary Information as
defined in Article 2.7 or three (3) years after the expiration or
termination date of this CRADA. The Collaborator may request an extension to
this term when necessary to protect Proprietary/Confidential Information
relating to products not yet commercialized.

 

8.7                                 Publication.  The Parties are encouraged
to make publicly available the results of their research.  Before either Party submits a paper or
abstract for publication or otherwise intends to publicly disclose information
about a Subject Invention, Subject Data or Research Materials, the other Party
shall be provided thirty (30) days to review the proposed publication or
disclosure to assure that Proprietary/Confidential Information is
protected.  The publication or other
disclosure shall be delayed for up to thirty (30) additional days upon written
request by any Party as necessary to preserve U.S. or foreign patent or other
IP rights.

 

Article 9.  Representations
and Warranties

 

9.1                                 Representations
and Warranties of PHS.  PHS hereby
represents and warrants to the Collaborator that the official signing this
CRADA has authority to do so.

 

9.2                                 Representations
and Warranties of the Collaborator.

 

(a)                                  The Collaborator hereby
represents and warrants to PHS that the Collaborator has the requisite power
and authority to enter into this CRADA and to perform according to its terms,
and that the Collaborator’s official signing this CRADA has authority to do
so.  The Collaborator further represents
that it is financially able to satisfy any funding commitments made in Appendix
B.

 

(b)                                 The Collaborator certifies
that the statements herein are true, complete, and accurate to the best of its
knowledge.  The Collaborator is aware
that any false, fictitious, or fraudulent statements or claims may subject it
to criminal, civil, or administrative penalties.

 

Article 10.  Termination

 

10.1                           Termination
By Mutual Consent.  PHS and the
Collaborator may terminate this CRADA, or portions thereof, at any time by
mutual written consent.  In such event
the Parties shall specify the disposition of all property, inventions, patent
or other IP applications and other results of work accomplished or in progress,
arising from or performed under this CRADA, all in accordance with the rights
granted to the Parties under the terms of this Agreement.

 

10.2                           Unilateral
Termination.  Either PHS or
the Collaborator may unilaterally terminate this entire CRADA at any time by
giving written notice at least thirty (30) days prior to the desired
termination date, and any rights accrued in property, patents or other IP
rights shall be disposed of as provided in paragraph 10.1, except that PHS may,
at its option, retain funds transferred to PHS prior to unilateral termination
by Collaborator for use in completing the Research Plan solely or with another
partner.

 

10.3                           Staffing.  If this CRADA is mutually or
unilaterally terminated prior to its expiration, funds will

 

 

nevertheless remain available to PHS for continuing
any staffing commitment made by the Collaborator pursuant to Article 5.1
above and Appendix B, if applicable, for a period of six (6) months after
such termination.  If there are
insufficient funds to cover this expense, the Collaborator agrees to pay the
difference.

 

10.4                           New
Commitments.  No Party
shall make new commitments related to this CRADA after a mutual termination or
notice of a unilateral termination and shall, to the extent feasible, cancel
all outstanding commitments and contracts by the termination date.

 

10.5                           Termination
Costs.  Concurrently with the exchange
of final reports pursuant to Articles 4.2 and 52, PHS shall submit to the
Collaborator for payment a statement of all costs incurred prior to the date of
termination and for all reasonable termination costs including the cost of
returning Collaborator property or removal of abandoned property, for which
Collaborator shall be responsible.

 

Article 11.                                     Disputes

 

11.1                           Settlement.
 Any dispute arising under this
CRADA which is not disposed of by agreement of the 

Principal Investigators shall be submitted jointly to the signatories of this
CRADA. If the signatories are unable to jointly resolve the dispute within
thirty (30) days after notification thereof, the Assistant Secretary for Health
(or his/her designee or successor) shall propose a resolution.  Nothing in this Article shall prevent
any Party from pursuing any additional administrative remedies that may be
available and, after exhaustion of such administrative remedies, pursuing all
available judicial remedies.

 

11.2                           Continuation
of Work.  Pending the
resolution of any dispute or claim pursuant to this Article, the Parties agree
that performance of all obligations shall be pursued diligently in accordance
with the direction of the PHS signatory.

 

Article 12.  Liability

 

12.1                           Property.
 The U.S. Government shall not be
responsible for damages to any Collaborator property provided to PHS, where
Collaborator retains title to the property, or any property acquired by
Collaborator for its own use pursuant to this CRADA.

 

12.2                           NO
WARRANTIES. EXCEPT AS SPECIFICALLY STATED IN ARTICLE 9, THE
PARTIES MAKE NO EXPRESS OR IMPLIED WARRANTY AS TO ANY MATTER WHATSOEVER, INCLUDING
THE CONDITIONS OF THE RESEARCH OR ANY INVENTION OR PRODUCT, WHETHER TANGIBLE OR
INTANGIBLE, MADE, OR DEVELOPED UNDER THIS CRADA, OR THE OWNERSHIP,
MERCHANTABILITY, OR FITNESS FOR A PARTICULAR PURPOSE OF THE RESEARCH OR ANY
INVENTION OR PRODUCT.

 

12.3                           Indemnification.  The Collaborator agrees to
hold the U.S. Government harmless and to indemnify the Government for all
liabilities, demands, damages, expenses and losses arising out of the use by
the Collaborator for any purpose of the Subject Data, Research Materials and/or
Subject Inventions produced in whole or part by PHS employees under this CRADA,
unless due to the negligence or willful misconduct of PHS, its employees, or
agents.  The Collaborator shall be liable
for any claims or damages it incurs in connection with this CRADA.  PHS has no authority to indemnify the
Collaborator.

 

12.4                           Force
Majeure.  Neither Party shall be
liable for any unforeseeable event beyond its reasonable control not caused by
the fault or negligence of such Party, which causes such Party to be unable to
perform its

 

 

obligations under this CRADA, and which it has been
unable to overcome by the exercise of due diligence.  In the event of the occurrence of such a force majeure event, the Party unable to perform shall
promptly notify the other Party.  It
shall further use its best efforts to resume performance as quickly as possible
and shall suspend performance only for such period of time as is necessary as a
result of the force majeure event.

 

Article 13.                                     Miscellaneous

 

13.1                           Governing
Law.  The construction, validity,
performance and effect of this CRADA shall be governed by Federal law, as
applied by the Federal Courts in the District of Columbia.  Federal law and regulations will preempt any
conflicting or inconsistent provisions in this CRADA.

 

13.2                           Entire
Agreement.  This CRADA
constitutes the entire agreement between the Parties concerning the subject
matter of this CRADA and supersedes any prior understanding or written or oral
agreement.

 

13.3                           Headings.
 Titles and headings of the
articles and subarticles of this CRADA are for convenient reference only, do
not form a part of this CRADA, and shall in no way affect its
interpretation.  The PHS component that
is the Party for all purposes of this CRADA is the Bureau(s), Institute(s),
Center(s) or Division(s) listed on the Cover Page herein.

 

13.4                           Waivers.
 None of the provisions of this
CRADA shall be considered waived by any Parry unless such waiver is given in
writing to the other Party.  The failure
of a Party to insist upon strict performance of any of the terms and conditions
hereof, or failure or delay to exercise any rights provided herein or by law,
shall not be deemed a waiver of any rights of any Party.

 

13.5                           Severability.  The illegality or invalidity
of any provisions of this CRADA shall not impair, affect, or invalidate the
other provisions of this CRADA.

 

13.6                           Amendments.
 If either Party desires a modification
to this CRADA, the Parties shall, upon reasonable notice of the proposed
modification or extension by the Party desiring the change, confer in good
faith to determine the desirability of such modification or extension.  Such modification shall not be effective
until a written amendment is signed by the signatories to this CRADA or by
their representatives duly authorized to execute such amendment.

 

13.7                           Assignment.
 Neither this CRADA nor any
rights or obligations of any Party hereunder shall be assigned or otherwise
transferred  by either Party without the prior
written consent of the other Party.

 

13.8                           Notices.  All notices pertaining to or
required by this CRADA shall be in writing and shall be signed by an authorized
representative and shall be delivered by hand or sent by certified mail, return
receipt requested, with postage prepaid, to the addresses indicated on the
signature page for each Party. 
Notices regarding the exercise of license options shall be made pursuant
to Article 7.2.  Any Party may
change such address by notice given to the other Party in the manner set forth
above.

 

13.9                           Independent
Contractors.  The
relationship of the Parties to this CRADA is that of independent contractors
and not agents of each other or joint venturers or partners.  Each Party shall maintain sole and exclusive
control over its personnel and operations. 
Collaborator employees who will be working at PHS facilities may be
asked to sign a Guest Researcher or Special Volunteer Agreement appropriately
modified in view of the terms of this CRADA.

 

 

13.10                     Use of
Name or Endorsements.  By
entering into this CRADA, PHS does not directly or indirectly endorse any
product or service provided, or to be provided, whether directly or indirectly
related to either this CRADA or to any patent or other IP license or agreement
which implements this CRADA by its successors, assignees, or licensees.  The Collaborator shall not in any way state
or imply that this CRADA is an endorsement of any such product or service by
the U.S. Government or any of its organizational units or employees.  Collaborator issued press releases that
reference or rely upon the work of PHS under this CRADA shall be made available
to PHS at least 7 days prior to publication for review and comment.

 

13.11                     Exceptions
to this CRADA.  Any exceptions
or modifications to this CRADA that are agreed to by the Parties prior to their
execution of this CRADA are set forth in Appendix C.

 

13.12                     Reasonable
Consent.  Whenever a Party’s consent
or permission is required under this CRADA, such consent or permission shall
not be unreasonably withheld.

 

Article 14.                                     Duration
of Agreement

 

14.1                           Duration.  It is mutually recognized
that the duration of this project cannot be rigidly defined in advance, and
that the contemplated time periods for various phases of the RP are only good
faith guidelines subject to adjustment by mutual agreement to fit circumstances
as the RP proceeds.  In no case will the
term of this CRADA extend beyond the term indicated in the RP unless it is revised
in accordance with Article 13.6.

 

14.2                           Survivability.  The provisions of Articles
4.2, 5-8, 10.3-10.5, 11.1, 12.2-12.4, 13.1, 13.10 and 14.2 shall survive the
termination of this CRADA.

 

SIGNATURES BEGIN ON THE NEXT PAGE

 

 

	
  FOR PHS:

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  /s/ Alan S. Rabson

  	
   

  	
  12/22/07

  	
   

  
	
  Alan S. Rabson

  	
   

  	
  Date

  	
   

  
	
  Deputy Director, National Cancer Institute

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Mailing Address for Notices:

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Technology Transfer Branch

  	
   

  	
   

  	
   

  
	
  6120 Executive Blvd

  	
   

  	
   

  	
   

  
	
  Suite 450

  	
   

  	
   

  	
   

  
	
  Rockville, MD 20852-7181

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  FORTH COLLABORATOR:

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  /s/ Nicholas N. Vahanian

  	
   

  	
  1/5/04

  	
   

  
	
   

  	
   

  	
  Date

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Chief Medical and
  Operations Officer

  	
   

  	
   

  	
   

  
	
  Title

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  Mailing Address for Notices:

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
  NewLink Genetics

  	
   

  	
   

  	
   

  
	
  2901 South Loop Dr.

  	
   

  	
   

  	
   

  
	
  Suite 3900

  	
   

  	
   

  	
   

  
	
  Ames, IA 50010

  	
   

  	
   

  	
   

  

 

 

CRADA [*]

 

Appendix
A

 

Research Plan

 

[*]

 

 

CRADA # 1901

 

[*]

 

2

 

APPENDIX B

 

FINANCIAL AND STAFFING
CONTRIBUTIONS OF THE PARTIES

 

[*]

 

3

 

	
  NCI CRADA # 1901

  	
   

  	
  Confidential

  

 

INTRAMURAL CLINICAL TRIAL APPENDIX
C

 

EXCEPTIONS OR MODIFICATIONS TO
THIS CRADA

 

This
Appendix C contains standard modifications made to all NCI Intramural Clinical
CRADAs as well as certain modification made at the request of the Collaborator:

 

Amend Article 2.11 to read as follows:

 

2.11                           “Subject Data” means all recorded information first produced
in the performance of this CRADA by the Parties.  “Subject Data”
shall specifically exclude “Identifiable Private Information.”

 

Add the following new sections to the Article 2.  Definitions:

 

2.12                           “Adverse Drug Experience” means an adverse clinical
experience as defined under 21 C.F.R. § 310.305 or § 312.32 as applicable.

 

2.13                           “Annual Report” means the brief report of the progress of an
IND associated investigation which the IND sponsor is required to submit to the
FDA within 60 days of the anniversary date that the IND went into effect
(pursuant to 21 C.F.R. § 312.33).

 

2.14                           “FDA” means the U.S. Food and Drug Administration.

 

2.15                           “Identifiable Private Information” means patient-identifying
data from medical records or attached to patient specimens, to be obtained
prospectively or from stored medical records or specimens, that can be linked
to individual human subjects, either directly or indirectly through codes.

 

2.16                           “IND” means an Investigational New Drug Application submitted
to the FDA to receive approval to conduct experimental clinical trials.

 

2.17                           “Protocol” means the Protocol, including the Standard
Operating Procedure (SOP) numbered [*]

 

2.18                           “Steering Committee”: A CRADA Steering Committee will be
established with equal participation by PHS and the Collaborator.  The Steering Committee shall be composed of  at least the Principal Investigators on the CRADA, from
both PHS and the Collaborator. 
Additional PHS participants shall be chosen from the National Cancer
Institute.  The Steering Committee may be
augmented with staff from NCI and from the Collaborator as necessary with
expertise in such areas as toxicology, pharmacology, pharmaceutical
development, and biological testing areas. 
The Steering Committee will discuss and resolve issues related to:
compound supply, compounds quality and grade, and additional studies to develop
the most advantageous route and schedule for completing the Protocol.  

 

 

The decisions made by the Steering Committee will be
mutual decisions, meaning both parties to the CRADA must agree, and will
include good discussion by all parties in presenting and evaluating the
data.  The ultimate goal in all the
decisions is to ensure that the full potential of the compound is realized with
the least cost in terms of resources.

 

2.19                           “Study” means the work performed by the Principal
Investigators in connection with the Protocol.

 

2.20                           “Study Drug” means [*].

 

Add a new Article 3.3
as follows:

 

3.3                                 Protocol
Modification.  The Study shall
be conducted in strict accordance 

with the Protocol and no changes in the finalized Protocol will be made unless
mutually agreed upon in writing by both Parties.  In the event that the appropriate
Institutional Review Board (IRB) requires changes in the Protocol or the
Informed Consent Form, both Parties agree to modify the Protocol and/or
Informed Consent Form as appropriate.

 

Add a new Article 3.4
as follows:

 

3.4                                 Investigational
New Drug Application.  The
Collaborator will submit an IND The Collaborator’s employees will be reasonably
available to respond to inquiries from the FDA regarding information or data
contained in the Collaborator’s IND, Drug Master File, New Drug Application, or
other information and data provided to PHS by the Collaborator pursuant to this
Article 3.3.  Nothing herein shall
require the Collaborator to undertake additional studies of any kind or to
prepare and submit any additional data to the FDA which are not already
included in the Collaborator’s IND, Drug Master File, or New Drug Applications.

 

The Collaborator may sponsor its own clinical trials
and hold its own IND for studies performed outside the scope of this CRADA from
which all data is proprietary to the Collaborator for purposes of this CRADA.

 

 

Add a new Article 3.5
as follows:

 

3.5                                 Drug
Information and Supply.  Collaborator
agrees to provide PHS [*] clinical-grade
Study Drug in sufficient quantity to complete the preclinical studies and
clinical trial Protocol(s) sponsored by PHS. Furthermore, Collaborator
agrees to provide [*] Study Drug, placebo or
unformulated analytical grade Study Drug, if available, to PHS for the
development of mutually agreed upon analytical assays or ancillary correlative
studies conducted in conjunction with the Research Plan and Protocol.  Collaborator will provide Certificates of
Analysis to PHS for each lot of finished product provided.  For inquiries related to Study Drug; the
contact person for PHS will be Dr. John C. Morris, Co-Director, Clinical
Trials, NCI Metabolism Branch (Telephone Number 301-432-2912) and the
Collaborator contact will be Nicholas Vahanian, M.D., Chief Medical Officer
(Telephone Number (515) 296-5555).

 

Add a new Article 3.6
as follows:

 

3.6                                 Drug
Delivery and Usage.  Collaborator
shall ship Study Drug to PHS in appropriately marked containers in accordance
with  21 C.F.R. § 312.6.  The Pls shall take reasonable steps to ensure
appropriate record keeping and appropriate usage of Study Drug is maintained in
accordance with the Protocol and any applicable laws and regulations relating
thereto.  Any unused quantity of Study
Drug shall be returned to Collaborator by PHS at the conclusion of the Study,
or earlier termination subject to Article 10.6 of this Appendix C

 

Add a new Article 3.7
as follows:

 

3.7                                 Protection
of Human Subjects and Appropriate Care of Laboratory Animals.  All human clinical trials performed under
this CRADA shall conform to the appropriate federal laws, including, but not
limited to all applicable FDA regulations and DHHS regulations relating to the
protection of human subjects (see 45 C.F.R. Part 46).  PHS will be responsible for obtaining a
properly executed written informed consent form from each patient prior to
participation in the Study.  PHS and
Collaborator also agree to comply with all applicable federal statutes and
Public Health Service policies relating to the use and care of laboratory
animals (see 7 U.S.C. 2131 et. 
seq.)  Additional information is
available from the NIH Office for Human Research Protection (OHRP), Telephone:
301-496-7163.

 

Add a new Article 3.8
as follows:

 

3.8                                 Monitoring.  New Link Genetics Corporation shall be
responsible for clinical site monitoring and the quality assurance of all
data.  Monitoring shall be done in
compliance with FDA Good Clinical Practices Guidelines.

 

Add the following to the end of Article 4.1
Interim Reports as follows:

 

Steering Committee reports or copies of Annual
Reports updating the progress of the CRADA research shall satisfy the reporting
requirements under this Article 

 

 

4.1.  In
addition, copies of the Annual Reports and other pertinent IND data (including,
but not limited to, clinical brochure data, and formulation and preclinical
data, including toxicology findings) shall be exchanged by the Parties as they
become available.

 

Add a new Article 4.3
as follows:

 

4.3                                 Adverse
Drug Experience Reporting.  In accordance with FDA requirements, the
Party which holds the IND shall establish and maintain records and make reports
to the FDA as required by 21 C.F.R. 310.305 and 21 C.F.R. 312.32 as
applicable.  In the conduct of research
under this CRADA, the Parties also agree to adhere to specific NIH and NCI
guidelines and policies for reporting Adverse Drug Reporting, as specified in
Protocol [*]. 
The Party which holds the IND agrees to provide the other Party copies
of all Adverse Drug Experience reports concurrently with their submission to
the FDA, including copies of any warning letters or other information affecting
the safety and/or well-being of human subjects in research conducted under this
CRADA.

 

Add a new Article 4.4 as
follows:

 

4.4                                 Annual
Reports.  The IND
holder shall provide the other Party a copy of the Annual Report thirty (30)
days prior to submission of the Annual Report to the FDA: The reviewing Party
will then have fourteen (14) days to review the Annual Report and to provide
comments to the IND holder.

 

Amend Article 6.1 to read as follows:

 

6.1                                 Reporting.  The Parties shall promptly report to each
other in writing each Subject Invention and any patent applications filed
thereon resulting from the research conducted under this CRADA that is reported
to them by their respective employees. 
Each Party shall report all Subject Inventions to the other Party in
sufficient detail to determine inventorship. 
Such reports shall be treated as Proprietary/Confidential Information in
accordance with Article 8.4. 
Inventorship shall be determined in accordance with the rules of
inventorship under United States patent laws.

 

Amend Article 6.2 to read as follows:

 

6.2                                 Filing
of Patent Applications.  [*] shall be responsible for filing patent or other IP
applications for [*] Subject Inventions in a timely
manner and [*] and after consultation in good
faith with [*].  With respect to [*],
the invention shall be [[*].  [*] may, [*], file patent or other IP applications [*] for

 

[*] Subject
Inventions; provided that [*] shall have
the right to provide comments thereon and [*] shall
consider any such comments in good faith.  If [*] elects not
to file patent or other lP applications for [*]
Subject Inventions, [*] may do so [*].  If [*] decides not to [*] Subject
Invention, it shall [*].  If [*],[*] may [*] as it may
determine.

 

 

Add the following sentence to the end of Article 7.4 License in Collaborator Inventions.

 

In the exercise of such license, the Government
shall not publicly disclose trade secrets or commercial or financial
information that is privileged or confidential within the meaning of 5 U.S.C.
552(b)(4) or which would be considered as such if it had been obtained from
a non-Federal party.

 

Amend Article 8.3 to read as follows:

 

8.3                                 Dissemination
of Subject Data and Research Materials.  To the extent, permitted by law, the
Collaborator and PHS agree to use reasonable efforts to keep Subject Data and
Research Materials confidential until published (subject to the terms of Article 8.7)
or until corresponding patent applications are filed.  Any information that would identify human
subjects of research or patients will always be maintained confidentially.  To the extent permitted by law, the
Collaborator shall have  the exclusive
right to use  any and all CRADA Subject Data in
and for any regulatory filing by or on behalf of Collaborator; except that PHS
shall have the exclusive right to use Subject Data for that purpose, and
authorize others to do so, if the CRADA is terminated or if Collaborator
abandons its commercialization efforts related to the Study Drug.  Collaborator acknowledges the basic research
mission of the PHS, and agrees that after publication, PHS may make unpatented
Research Materials arising out of this CRADA available to third parties for
further research.

 

Amend Article 8.4 to read as follows:

 

8.4                                 Proprietary/Confidential
Information.  Each Party
agrees to limit its disclosure of Proprietary/Confidential Information to the
amount necessary to carry out the Research Plan of this CRADA, and shall place
a confidentiality notice on all such information.  Confidential oral communications shall be
reduced to writing within 30 days by the disclosing Party.  Each Party receiving Proprietary/Confidential
Information agrees that any information so designated shall be used by it only
for the purposes described in the attached Research Plan.  Any Party may object to the designation of
information as Proprietary/Confidential Information by another Party.  Subject Data and Research Materials developed
[*] may be designated as
Proprietary/Confidential Information when [*], and [*]. The exchange of other confidential information, e.g., Identifiable
Private Information, shall be subject to the terms of Article 8.8.  [*] Subject Data and
Research Material  derived from the Research Plan
may be disclosed by Collaborator to a third party under a confidentiality
agreement for the purpose of possible sublicensing pursuant to the Licensing
Agreement and subject to Article 8.7.

 

Amend Article 8.6 as follows:

 

8.6                                 Duration
of Confidentiality Obligation.  The obligation to maintain the
confidentiality of Proprietary/Confidential Information shall expire at the
earlier of the date when the information is no longer Proprietary Information
as defined in Article 2.7 or five (5) years after the expiration or
termination date of this CRADA. The Collaborator may request and the PHS shall
grant an extension to this term

 

 

when necessary to protect Proprietary/Confidential
Information relating to products not yet commercialized.

 

Add a new Article 8.8
as follows:

 

8.8.                              Access, Review
and Receipt of Identifiable Private Information.  Collaborator access to and review of Identifiable
Private Information shall be only for on-site quality auditing.  Collaborator will receive Identifiable
Private Information only if necessary for purposes of satisfying FDA or other
health authorities’ reporting requirements, and for internal research purposes
directly related to obtaining regulatory approval of the Study Drug.  Collaborator is prohibited from access,
review, receipt, or use of such information for other purposes.  All IRB approved protocols and informed
consent documents related to this research project will clearly describe this
practice.  If the Collaborator will have
access to Identifiable Private Information, the Protocol and the informed
consent must clearly state (i) the existence of the Collaborator; (ii) the
Collaborator’s access to Identifiable Private Information, if any; and (iii) the
extent to which confidentiality will be maintained.  For clinical protocol(s) involving a
third party, the other party’s access, review, receipt, or use of Identifiable
Private Information shall be subject to the same limitations as described in
this Article 8.8.

 

Add a new Article 10.6
as follows:

 

10.6                           Research
License and Alternative Sources of Supply In the Event Collaborator Terminates
Development of Study Drug

 

a.                                       In the event
Collaborator elects to terminate its development of Study Drug during the term
of this CRADA without the transfer of its

 

 

development efforts and obligations under this
agreement to another patty within  ninety (90)
days  of discontinuation, and PHS wants to
continue its development of Study Drug, then Collaborator will, upon written
notice from PHS:

 

(i)                                     provide PHS
with Study Drug and/or matching placebo from Collaborator inventory sufficient
to complete the Study in the manner described in the Protocol.  Or,

 

(ii)                                  arrange, at
Collaborator’s expense, for an independent contractor to manufacture and
provide PHS Study Drug and/or matching placebo sufficient to complete the Study
in the manner described in the Protocol,

 

b.                                      In the event
that Collaborator is unable to meet the obligations imposed by (i) or (ii) above,
at the discretion of PHS, Collaborator shall provide PHS all information
necessary to allow PHS to contract and manufacture said Study Drug and/ or
matching placebo independent of Collaborator for use in preclinical studies and
clinical trials.  Such obligation shall
last until either a date on which an alternate source of equivalent materials,
acceptable to PHS, can be obtained by PHS, or one year after the date of notification
by Collaborator to PHS that Collaborator elects to terminate its development of
Study Drug, whichever comes first.

 

c.                                       Collaborator
hereby grants to PHS a nonexclusive, nontransferable, irrevocable, paid-up
license to practice or have practiced for or on behalf of the United States any
invention which Collaborator may have or obtain on Study Drug, its manufacture,
or on the process for use of Study Drug, throughout the world; solely for
medical research purposes and not for commercialization, but this license shall
become effective only if and when Collaborator terminates its development of
Study Drug during the term of this CRADA without the transfer of its
development efforts to another party within ninety (90) days of termination,
and PHS elects to continue the development of Study Drug.

 

Amend Article 13.1 to read as follows:

 

13.1                           Governing
Law.  The construction, validity,
performance and effect of this CRADA shall be governed by Federal law, as
applied by the Federal Courts in the District of Columbia.  Federal law and regulations will preempt any
conflicting or inconsistent provisions in this CRADA. NCI and Collaborator, if
Collaborator is sponsoring trials at the NIH under this CRADA, shall comply
with all Department of Health and Human Services regulations relating to Human Subject
use, and all Public Health Service policies relating to the use and care of
laboratory animals.

 

 

Amend Article 13.2 as follows:

 

13.2                           Entire
Agreement.  This CRADA
(including the Appendices attached hereto) constitute the entire agreement
between the Parties concerning the subject matter of this CRADA and supersedes
any prior understanding or written or oral agreement.  In particular, the Confidential Disclosure
Agreement (CDA) [[*] between NCI and
Collaborator, executed on [*], will be
superseded by this CRADA.

 

Add a new Article 13.13
as follows:

 

13.13                     FDA
Meetings.  All meetings
with FDA concerning clinical studies for the development of Agent within the
scope of the CRADA Research Plan will be discussed by Collaborator and NIH in
advance and will be held on mutually agreed upon dates.  Collaborator reserves the right to set
jointly with NIH the agenda for any such meeting.

 

Add a new Article 13.14 as follows:

 

13.14                     Conflicts.  In the event of a conflict between Protocol [*] and the Model CRADA as modified by this Appendix C, the
terms of the Model CRADA and this Appendix C shall prevail.

 

Add a new Article 13.15
as follows:

 

13.15                     Statutory
Compliance.  PHS and
Collaborator agree to conduct the Study in accordance with the applicable
portions of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et. seq.,
and its implementing regulations and other applicable federal regulations.

 

Amend Article 14.2 as follows:

 

14.2                           Survivability.  The provisions of Articles 3.5, 4.2, 4.3,
5-8, 8.8, 10.2, 10.3 10.5, 10.4, 10.6, 11.1,
12.2-12.4, 13.1, 13.10 and 14.2 shall survive the termination of this CRADA

 

 

Reviewer’s Copy

 

INTRAMURAL CLINICAL TRIAL
APPENDIX C

 

EXCEPTIONS OR MODIFICATIONS TO
THIS CRADA

 

This
Appendix C contains standard modifications made to all NCI Intramural Clinical
CRADAs as well as certain modification made at the request of the Collaborator:

 

Where NCI standard modifications for Clinical CRADAs
are contemplated within the text of a CRADA boilerplate Article, additions are
shown by underline while deletions are shown by strikethrough.  Other standard additions are shown following
the phrase “Add.....”

 

Where the Collaborator has requested modifications
within the text of a CRADA boilerplate Article or within the text of a
newly added Article, additions are shown by highlighted underline while
deletions are shown by highlighted strikethrough.

 

Amend
Article 2.11 to read as follows:

 

2.11                           “Subject Data”
means all recorded information first produced in the performance of this CRADA
by the Parties.  “Subject Data” shall
specifically exclude “Identifiable Private Information.”

 

Add
the following new sections to the Article 2.  Definitions:

 

2.12                           “Adverse Drug
Experience” means an adverse clinical experience as defined under 21 C.F.R. §
310.305 or § 312.32 as applicable.

 

2.13                           “Annual Report”
means the brief report of the progress of an IND associated investigation which
the IND sponsor is required to submit to the FDA within 60 days of the
anniversary date that the IND went into effect (pursuant to 21 C.F.R.
§ 312.33).

 

2.14                           “FDA” means the
U.S. Food and Drug Administration.

 

2.15                           “Identifiable
Private Information” means patient-identifying data from medical records or
attached to patient specimens, to be obtained prospectively or from stored medical
records or specimens, that can be linked to individual human subjects, either
directly or indirectly through codes.

 

2.16                           “IND” means an
Investigational New Drug Application submitted to the FDA to receive approval
to conduct experimental clinical trials.

 

1

 

2.17                           “Protocol”
means the Protocol, including [*]                    
                    
, which is attached hereto as Appendix D and is made a part of this Agreement.

 

2.18                           “Sterring
Committee” means the joint PHS/Collaborator research and
           
            development
team whose composition and responsibilities with regard to the clinical
experiments performed under this CRADA are detailed in the Protocol attached
hereto as Appendix D.

 

2.18                           “Steerinq
Committee”:  A CRADA Steering Committee
will be established with equal participation by PHS and the Collaborator.  The Steering Committee shall be composed of
at least the Principal Investigators on the CRADA, from both PHS and the
Collaborator.  Additional PHS
participants shall be chosen from the National Cancer Institute.  The Steering Committee may be augmented with
staff from NCI and from the Collaborator as necessary with expertise in such
areas as toxicology, pharmacology, pharmaceutical development, and biological
testing areas.  The Steering Committee
will discuss and resolve issues related to: 
compound supply, compounds quality and grade, and additional studies to
develop the most advantageous route and schedule for completing the
Protocol.  The decisions made by the
Steering Committee will be mutual decisions, meaning both parties to the CRADA
must agree, and will include good discussion by all parties in presenting and
evaluating the data.  The ultimate goal
in all the decisions is to ensure that the full potential of the compound is
realized with the least cost in terms of resources.

 

2.19                           “Study” means
the work performed by the Principal Investigators in connection with the
Protocol.

 

2.20                           “Study Drug”
means            [*]

 

Add
a new Article 3.3 as follows:

 

3.3                                 Protocol
Modification.  The Study shall be done
conducted in strict accordance with the Protocol and no changes in the
finalized Protocol will be made unless mutually agreed upon in writing by both
Parties.  In the event that the
appropriate Institutional Review Board (IRB) requires changes in the Protocol
or the Informed Consent Form, both Parties agree to modify the Protocol and/or
Informed Consent Form as appropriate.

 

Add
a new Article 3.4 as follows:

 

3.4                                 Investigational
New Drug Application.  The Parties
expect that either PHS or Collaborator will submit an IND which may
cross reference an IND, Drug Master File, or New Drug Application held by the
PHS ether.  In the event PHS
elects to file its own IND, the Collaborator agrees to provide PHS background
data and information and agrees to execute such documents as may be reasonably
required to effect such cross reference. 
The Collaborator’s employees will be reasonably available to respond to
inquiries from the FDA regarding information or data contained in the
Collaborator’s IND, Drug Master File, New Drug Application, or other
information and data provided to PHS by the Collaborator pursuant to this Article 3.3.  Nothing herein shall require the Collaborator
to undertake additional studies of any kind or to prepare and submit any
additional data to the FDA which are not already included in the Collaborator’s
IND, Drug Master File, or New Drug 

 

2

 

Applications. 
In the event the Collaborator supplies Proprietary/Confidential
Information CONFIDENTIAL information directly to PHS in support of a PHS
IND, such information will be protected in accordance with the corresponding
Confidentiality provisions of Article 8 of this CRADAAgreement.

 

The Collaborator may sponsor its own clinical trials
and hold its own IND for studies performed outside the scope of this CRADA from
which all data is proprietary to the Collaborator for purposes of this CRADA.

 

Add
a new Article 3.5 as follows:

 

3.5                                 Drug
Information and Supply.  Collaborator
agrees to provide PHS [*]
clinical-grade Study Drug in sufficient quantity to complete the preclinical
studies and clinical trial Protocol(s) sponsored by PHS. Furthermore,
Collaborator agrees to provide [*] Study Drug,
placebo or unformulated analytical grade Study Drug or metabolites, if
available, to PHS for the development of mutually agreed upon analytical assays
or ancillary correlative studies conducted in conjunction with the Research
Plan and Protocol PHS sponsored protocols.  Collaborator will provide Certificates of
Analysis to PHS for each lot of finished product provided.  For inquiries related to Study Drug, the
contact person for PHS will be Dr. John C. Morris, Co-Director, Clinical
Trials, NCI Metabolism Branch (Telephone Number 301-432-2912) and the
Collaborator contact will be Nicholas Vahanian, M.D., Chief Medical Officer
(Telephone Number (515) 296-5555).

 

Add
a new Article 3.6 as follows:

 

3.6                                 Drug Delivery
and Usage.  Collaborator shall ship Study
Drug to PHS in appropriately marked containers in accordance with 21 C.F.R. §
312.6.  The Pls shall take reasonable
steps to ensure appropriate record keeping and appropriate usage of Study Drug
is maintained in accordance with the Protocol and any applicable laws and
regulations relating thereto.  Any unused
quantity of Study Drug shall be returned to Collaborator by PHS at the
conclusion of the Study, or earlier termination subject to Article 10.6 of
this Appendix C.

 

Add
a new Article 3.7 as follows:

 

3.7                                 Protection of
Human Subjects and Appropriate Care of Laboratory Animals.  All human clinical trials performed under
this CRADA shall conform to the appropriate federal laws, including, but not
limited to all applicable FDA regulations and DHHS regulations relating to the
protection of human subjects (see 45 C.F.R. Part 46).  PHS will be responsible for obtaining a
properly executed written informed consent form from each patient prior to
participation in the Study.  PHS and
Collaborator also agree to comply with all applicable federal statutes and
Public Health Service policies relating to the use and care of laboratory
animals (see 7 U.S.C. 2131 et, seq.) Additional information is available from
the NIH Office for Human Research Protection (OHRP), Telephone: 301-496-7163.

 

Add
a new Article 3.8 as follows:

 

3.8                                 Monitoring.  New Link Genetics Corporation shall be
responsible for clinical site monitoring and the quality assurance of all
data.  Monitoring shall be done in
compliance with FDA Good Clinical Practices Guidelines.

 

3

 

Add
the following to the end of Article 4.1 Interim Reports as follows:

 

Steering Committee reports or copies of Annual
Reports updating the progress of the CRADA research shall satisfy the reporting
requirements under this Article 4.1. 
In addition, copies of the Annual Reports and other pertinent IND data
(including, but not limited to, clinical brochure data, and formulation and
preclinical data, including toxicology findings) shall be exchanged by the
Parties as they become available.

 

Add
a new Article 4.3 as follows:

 

4.3                                 Adverse Drug
Experience Reporting.  In accordance with
FDA requirements, the Party which holds the IND shall establish and maintain
records and make reports to the FDA as required by 21 C.F.R. 310.305 and 21
C.F.R. 312.32 as applicable.  In the
conduct of research under this CRADA, the Parties also agree to adhere to
specific NIH and NCI guidelines and policies for reporting Adverse Drug
Reporting, as specified in Protocol [*].  The Party which holds the IND agrees to
provide the other Party copies of all Adverse Drug Experience reports
concurrently with their submission to the FDA, including copies of any warning
letters or other information affecting the safety and/or well-being of human
subjects in research conducted under this CRADA.

 

Add
a new Article 4.4 as follows:

 

4.4                                 Annual
Reports.  The IND holder shall provide
the other Party a copy of the Annual Report thirty (30) days prior to
submission of the Annual Report to the FDA. The reviewing Party will then have
fourteen (14) days to review the Annual Report and to provide comments to the
IND holder.

 

Amend
Article 6.1 to read as follows:

 

6.1                                 Reporting.  The Parties shall promptly report to each
other in writing each Subject Invention and any patent applications filed
thereon resulting from the research conducted under this CRADA that is reported
to them by their respective employees. 
Each Party shall report all Subject Inventions to the other Party in
sufficient detail to determine inventorship. 
Such reports shall be treated as Proprietary/Confidential Information in
accordance with Article 8.4.  Inventorship
shall be determined in accordance with the rules of inventorship under
United States patent laws.

 

Amend
Article 6.2 to read as follows:

 

6.2                                 Filing of
Patent Applications.  [*] shall be responsible for filing patent or other IP
applications for its own solely Invented Subject Inventions in a timely
manner and [*] and after consultation in
good faith with [*].  The parties will consult and mutually
determine a filing strategy for [*] subject
inventions.  With respect to [*], the invention shall be [*].[*]may,
[*], file patent or other IP
applications [*] for such [*];
provided that PHS shall have the right to provide comments thereon and
Collaborator shall consider any such comments in good faith.  If Collaborator elects not to file patent or
other IP applications for such [*], PHS may do
so at its 

 

4

 

own expense in the name of both Parties.  If either Party decides [*],
it shall offer to [*] to [*].  If the other
Party [*], the offering Party may [*] as it may determine.

 

Add
the following sentence to the end of Article 7.4 License in Collaborator Inventions.

 

In the exercise of such license, the Government
shall not publicly disclose trade secrets or commercial or financial
information that is privileged or confidential within the meaning of 5 U.S.C.
552(b)(4) or which would be considered as such if it had been obtained
from a non-Federal party.

 

Amend
Article 8.3 to read as follows:

 

8.3                                 Dissemination
of Subject Data and Research Materials. 
To the extent permitted by law, the Collaborator and PHS agree to use
reasonable efforts to keep Subject Data and Research Materials confidential
until published (subject to the terms of Article 87) or until
corresponding patent applications are filed. 
Any information that would identify human subjects of research or
patients will always be maintained confidentially.  To the extent permitted by law, the
Collaborator shall have the exclusive right to use any and all CRADA Subject
Data in and for any regulatory filing by or on behalf of Collaborator, except
that PHS shall have the exclusive right to use Subject Data for that purpose,
and authorize others to do so, if the CRADA is terminated or if Collaborator
abandons its commercialization efforts related to the Study Drug.  Collaborator acknowledges the basic research
mission of the PHS, and agrees that after publication, PHS may make unpatented
Research Materials arising out of this CRADA available to third parties for
further research.

 

Amend
Article 8.4 to read as follows:

 

8.4                                 Proprietary/Confidential
Information.  Each Party agrees to limit
its disclosure of Proprietary/Confidential Information to the amount necessary
to carry out the Research Plan of this CRADA, and shall place a confidentiality
notice on all such information. 
Confidential oral communications shall be reduced to writing within 30
days by the disclosing Party.  Each Party
receiving Proprietary/Confidential Information agrees that any information so
designated shall be used by it only for the purposes described in the attached
Research Plan.  Any Party may object to
the designation of information as Proprietary/Confidential Information by
another Party.  Subject Data and Research
Materials developed [*] may be
designated as Proprietary/Confidential Information when they are [*], and [*]. The
exchange of other confidential information, e.g., patient identifying data
Identifiable Private Information,  should be similarly limited and
treated  shall be subject to the terms of Article 8.98.  [*] Subject
Data and Research Material derived from the Research Plan may be disclosed by
Collaborator to a third party under a confidentiality agreement for the purpose
of possible sublicensing pursuant to the Licensing Agreement and subject to Article 8.7.

 

Amend
Article 8.6 as follows:

 

8.6                                 Duration of
Confidentiality Obligation.  The
obligation to maintain the confidentiality of Proprietary/Confidential
Information shall expire at the earlier of the date when the information is no
longer Proprietary Information as defined in Article 2.7 or five 

 

5

 

(5)three(3) years after the
expiration or termination date of this CRADA. 
The Collaborator may request and the PHS shall grant an extension to

 

this term when necessary to protect.  Proprietary/Confidential Information relating
to products not yet commercialized.

 

Add
a new Article 8.8 as follows:

 

8.8                                 Multi-Party
Data and Intellectual Property Rights. 
For clinical protocol(s) 

          where Agent is used in
combination with another compound(s), which is (are) proprietary to an
entity(ies) not a Party to this CRADA [hereinafter referred to as Second
Party], the access and use of data derived from such combination studies,
[hereinafter referred to as Multi-Party Data], by the Collaborator and Second
Party shall be co-exclusive as follows:

 

a.                                       In situations
where Agent is to be used in combination with another proprietary compound, PHS
will provide all Parties with notice regarding the existence and nature of any
agreements governing their use of Agent including, the design of the proposed
combination protocol(s) and the existence of any obligations that might
restrict PHS’s participation in the proposed combination protocols.

 

b.                                      Collaborator
agrees to permit use of the Multi-Party Data from these trials by the Second
Party to the extent necessary to allow said Second Party to develop, obtain
regulatory approval or commercialize its own proprietary compound.  However, this provision will not apply unless
said Second Party also agrees to Collaborator’s reciprocal use of Multi-Party
Data.

 

c.                                       Collaborator
and Second Party must agree in writing prior to the commencement of the
combination trials that each will use the Multi-Party Data solely for
development, regulatory approval, and commercialization of its own proprietary
compound(s).

 

8.8.                              Access, Review
and Receipt of Identifiable Private Information.  Collaborator access to and review of
Identifiable Private Information shall be only for on-site quality
auditing.  Collaborator will receive
Identifiable Private Information only if necessary for purposes of satisfying
FDA or other health authorities’ reporting requirements, and for internal
research purposes directly related to obtaining regulatory approval of the AgentStudy
Drug.  Collaborator is prohibited
from access, review, receipt, or use of such information for other purposes.  All IRB approved protocols and informed
consent documents related to this research project will clearly describe this
practice.  If the Collaborator will have
access to Identifiable Private Information, the protocolProtocol
and the informed consent must clearly state (i) the existence of the
Collaborator; (ii) the Collaborator’s access to Identifiable Private
Information, if any; and (iii) the extent to which confidentiality will be
maintained.  For clinical protocol(s) involving
a third party, the other party’s access, review, receipt, or use of
Identifiable Private Information shall be subject to the same limitations as
described in this Article 8.8.

 

6

 

Add the following sentence to the end of Article 10.2 Unilateral
Termination.

 

Any Research Materials within Collaborator’s
possession which are a product of the Study must be transferred immediately to
PHS before the desired termination date of the CRADA.

 

Add
a new Article 10.6 as follows:

 

10.6                           Research
License and Alternative Sources of Supply In the Event Collaborator Terminates
Development of Study DrugAgent

 

a.                                       In the event
Collaborator elects to terminate its development of Study Drug during the
term of this CRADA without the transfer of its development efforts and
obligations under this agreement to another party within ninety (90) days of
discontinuation, and PHS wants to continue its development of Study Drug, then
Collaborator will, upon written notice from PHS:

 

(i)                                     provide PHS
with Study Drug and/or matching placebo from Collaborator inventory sufficient
to complete the Study in the manner described in the Protocol.  Or,

 

(ii)                                  arrange, at
Collaborator’s expense, for an independent contractor to manufacture and
provide PHS Study Drug and/or matching placebo sufficient to complete the Study
in the manner described in the Protocol

 

b.                                      In the event
that Collaborator is unable to meet the obligations imposed by (i) or (ii) above,
at the discretion of PHS, Collaborator shall provide PHS all information
necessary to allow PHS to contract and manufacture said Study Drug and/ or
matching placebo independent of Collaborator for use in preclinical studies and
clinical trials.  Such obligation shall
last until either a date on which an alternate source of equivalent materials,
acceptable to PHS, can be obtained by PHS, or two  one year after
the date of notification by Collaborator to PHS that Collaborator elects to
terminate its development of Study Drug, whichever comes first.

 

c.                                       Collaborator
hereby grants to PHS a nonexclusive, nontransferable, irrevocable, paid-up
license to practice or have practiced for or on behalf of the United States any
invention which Collaborator may have or obtain on Study Drug, its manufacture,
or on the process for use of Study Drug, throughout the world, solely
for medical research purposes and not for commercialization, but this
license shall become effective only if and when Collaborator terminates its
development of Study Drug during the term of this CRADA without the
transfer of its development efforts to another party

 

7

 

within ninety (90) days of termination, and PHS
elects to continue the development of Study Drug.

 

Amend
Article 13.1 to read as follows:

 

13.1                           Governing Law.  The construction, validity, performance and
effect of this CRADA shall be governed by Federal law, as applied by the
Federal Courts in the District of Columbia. 
Federal law and regulations will preempt any conflicting or inconsistent
provisions in this CRADA.  NCI and
Collaborator, if Collaborator is sponsoring trials at the NIH under this CRADA,
shall comply with all Department of Health and Human Services regulations
relating to Human Subject use, and all Public Health Service policies relating
to the use and care of laboratory animals.

 

Amend
Article 13.2 as follows:

 

13.2                           Entire
Agreement.  This CRADA (including the
Appendices attached hereto) constitute the entire agreement between the
Parties concerning the subject matter of this CRADA and supersedes any prior
understanding or written or oral agreement. 
In particular, the Confidential Disclosure Agreement (CDA) [*] between NCI and Collaborator executed on [*] will be superseded by this CRADA.

 

Add
a new Article 13.13 as follows:

 

13.13                     FDA Meetings.  All meetings with FDA concerning clinical
studies for the development of Agent within the scope of the CRADA Research
Plan will be discussed by Collaborator and NIH in advance and will be held on
mutually agreed upon dates.  Collaborator
reserves the right to set jointly with NIH the agenda for any such meeting.

 

Add
a new Article 13.14 as follows:

 

13.14                     Conflicts.  In the event of a conflict between the
Protocol [*]  as attached as Appendix D
and the Model CRADA as modified by this Appendix C, the terms of the Model
CRADA and this Appendix C shall prevail.

 

8

 

Add
a new Article 13.15 as follows:

 

13.15                     Statutory Compliance.  PHS and Collaborator agree to conduct the
Study in accordance with the applicable portions of the Federal Food, Drug, and
Cosmetic Act, 21 U.S.C. § 301 et. seq., and its implementing regulations and
other applicable federal regulations.

 

Amend
Article 14.2 as follows:

 

14.2                           Survivability.  The provisions of Articles 3.5, 4.2, 4.3,
5-8, 8.8, 10.2, 10.3 10.5, 10.4, 10.6, 11.1,
12.2-12.4, 13.1, 13.10 and 14.2 shall survive the termination of this CRADA.

 

9

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