Unassociated Document




LICENSE
AGREEMENT








by
and between










The
Beth Israel Deaconess Medical Center




and




DNAPrint
Genomics, Inc.













dated
as of 




April
4, 2005 




 




















 



	
      1.
      DEFINITIONS
	
      2




 



		
      1.1.
	
      Agreement
	
      2

	 	
      1.2.
	
      Affiliate
	
      2

	 	
      1.3.
	
      Applicable
      Percentage
	
      2

	 	
      1.4
	
      Commercial
      Sales
	
      2

	 	
      1.5.
	
      Confidential
      Information
	
      2

	 	
      1.6.
	
      Effective
      Date
	
      3

	 	
      1.7.
	
      Federal
      Patent Policy
	
      3

	 	
      1.8.
	
      FDA
	
      3

	 	
      1.9.
	
      Licensed
      Field
	
      3
      

	 	
      1.10.
	
      Licensed
      Patent
	
      3

	 	
      1.11.
	
      Licensed
      Technology
	
      3

	 	
      1.12.
	
      Licensed
      Territory
	
      3

	 	
      1.13.
	
      Licensed
      Product
	
      3

	 	
      1.14.
	
      Net
      Sale
	
      4

	 	
      1.15.
	
      Party
	
      4

	 	
      1.16.
	
      Person
	
      4

	 	
      1.17.
	
      Sublicensee
	
      4




 



	
      2.
      LICENSE
	
      4




 



	 	
      2.1.
	
      Grant
      of License
	
      5

	 	
      2.2
	
      Licensor's
      Warranty of Title
	
      5

	 	
      2.3
	
      Federal
      Patent Policy
	
      5

	 	
      2.4
	
      Pre-existing
      Third Party Rights
	
      5

	 	
      2.5
	
      Licensor's
      Retained Rights Publication
	
      5

	 	
      2.6.
	
      Sublicensing
	
      5

	 	
      2.7
	
      Restriction
      on other Rights
	
      6

	 	 	 	 



 



	
      3.
      CONSIDERATION, RECORD-KEEPING AND PAYMENTS
	
      6




 


	 	
      3.1.
	
      Payments
      and Other Consideration
	
      6

	 	
      3.2.
	
      Reports
	
      7

	 	
      3.3.
	
      Form
      of Payment; Taxes
	
      7

	 	
      3.4.
	
      Interest
	
      7




 



	
      4.
      PROTECTION OF INTELLECTUAL PROPERTY RIGHTS
	
      8




 


	 	
      4.1.
	
      Patent
      Prosecution/Patent Costs
	
      8

	 	
      4.2.
	
      Confidential
      Information
	
      8

	 	
      4.3.
	
      Enforcement
      of Intellectual Property Rights
	
      8

	 	
      4.4
	
      Infringement
      of Third Party Rights
	
      9

	 	 	 	
       




 



	
      5.
      OPERATIONS UNDER THE LICENSE
	
      10




 


	 	
      5.1.
	
      Due
      Diligence
	
      10

	 	
      5.2
	
      Reports
	
      10

	
       
	
      
      5.3.

	
      
      Compliance
      with Law

	
      
      10


	 	
      5.4.
	
      Marking
	
      10

	 	
      5.5.
	
      Publicity
	
      10




 







II












 


	
      6.
      INDEMNIFICATION; INSURANCE; WARRANTY DISCLAIMER
	
      11




 



	 	
      6.1.
	
      Indemnification
	
      11

	 	
      6.2.
	
      Insurance
	
      12

	 	
      6.3.
	
      Warranty
      Disclaimer
	
      12




 



	
      7.
      TERM AND TERMINATION
	
      13




 


	 	
      7.1.
	
      Term
	
      13

	 	
      7.2.
	
      Termination
      by Licensor
	
      13

	 	
      7.3.
	
      Termination
      by Licensee
	
      13

	 	
      7.4.
	
      Effect
      of Termination
	
      13




 



	
      8.
      DISPUTE RESOLUTION
	
      15




 



	 	
      8.1.
	
      Arbitration
	
      15




 



	
      9.
      GENERAL
	
      15




 


	 	
      9.1.
	
      Assignment
	
      15

	 	
      9.2.
	
      Entire
      Agreement/Amendments
	
      15

	 	
      9.3.
	
      Notices
	
      15

	 	
      9.4.
	
      Governing
      Law
	
      16

	 	
      9.5.
	
      Headings
	
      16

	 	
      9.6.
	
      Independent
      Contractors
	
      16

	 	
      9.7.
	
      Severability
	
      16

	 	
      9.8.
	
      No
      Waiver
	
      17

	 	
      9.9.
	
      Limitation
      of Liability
	
      17

	 	
      9.10.
	
      Counterparts
	
      17

















 


	
      Schedule
      1.8
	
      LICENSED
      FIELD
	
      19

	
      Schedule
      1.10
	
      LICENSED
      PATENTS
	
      20

	
      Schedule
      1.12
	
      LICENSED
      TERRITORY
	
      21

	
      Schedule
      3.1(i)
	
      LICENSING
      FEES
	
      22

	
      Schedule
      3.1(ii)
	
      RUNNING
      ROYALTIES
	
      23

	
      Schedule
      3.1(iii)
	
      MINIMUM
      ROYALTIES
	
      24

	 	 	
       

	
      Schedule
      3.1(v)
	
      MILESTONE
      PAYMENTS
	
      25

	
      Schedule
      3.1(vi)
	
      SUBLICENSING
      AND OTHER FEES
	
      26

	
      Schedule
      4.1
	
      PATENT
      PROSECUTION
	
      27

	
      Schedule
      5.1
	
      SPECIFIC
      DUE DILIGENCE OBLIGATIONS
	
      
      28





 







III












LICENSE
AGREEMENT


 

THIS
AGREEMENT is made as of April 4, 2005(the "Effective Date") by and between The
Beth Israel Deaconess Medical Center, a Massachusetts nonprofit corporation,
having its principal place of business at 330 Brookline Avenue, Boston, MA 02215
("Licensor"), and DNAPrint Genomics, Inc. a for-profit corporation having its
principal place of business at 900 Cocoanut Avenue, Sarasota, Florida 34236
("Licensee").




Licensor
owns the rights to the Licensed Technology, as defined below. 




Licensee
wishes to obtain a license, under the Licensed Technology, to make, have made,
use and sell Licensed Products, as defined below.




Licensor
wishes to grant such a license to Licensee on the terms and conditions of this
Agreement.




Licensor
and Licensee have therefore agreed as follows.




I.
DEFINITIONS




The
following terms shall have the meanings indicated in this
Agreement:




1.1 Agreement
shall
mean this Agreement, including all schedules and attachments
hereto.




1.2 Affiliate
shall
mean any company, corporation, business or entity controlled by, controlling, or
under common control with either Licensee or Licensor. For this purpose,
"control" means direct or indirect beneficial ownership of at least fifty
percent (50%) interest in the voting stock (or the equivalent) of such
corporation or other business or having the right to direct, appoint or remove a
majority or more of the members of its board of directors (or their equivalent),
or having the power to control the general management of such company,
corporation, business or entity, by contract, law or otherwise.




1.3 Applicable
Percentage -- see
Schedule 3.1(ii) attached hereto.




1.4 Commercial
Sale shall
mean any sale where any Licensed Product is sold or commercially disposed of for
value in an arm's length sale to an independent third party in the Licensed
Territory after Licensee has received full regulatory approval for such sale
from the appropriate jurisdiction. Commercial Sale shall not include sales for
purposes of testing, or research, including clinical studies, or sales in
limited numbers for the purpose of introducing a Licensed Product as part of a
promotion. 




1.5 Confidential
Information shall
mean any and all information of or about a Party including all information
relating to any technology, product, process or intellectual property of such
Party (including, but not limited to, owned or licensed intellectual property
rights, data, knowhow, samples, technical and non-technical materials and
specifications) as well as any business plan, financial information or other
confidential commercial information of or about such Party. Notwithstanding the
foregoing, information of or about a Party shall not be considered Confidential
Information with respect to such Party to the extent that the Person possessing
such information can demonstrate by written record or other suitable physical
evidence that:










2












(a) such
information was lawfully in such Person's possession or control prior to the
time such information was disclosed to such Person by the Party to whom the
information relates;




(b) such
information was developed by such Person independently of and without reference
to Confidential Information, provided, however that without limiting the
generality of the foregoing, the Confidential Information of Licensor shall not
become the Confidential Information of Licensee by virtue of this
Agreement;




(c) such
information was lawfully obtained by such Person from a third party under no
obligation of confidentiality to the Party to whom such information relates;
or




(d) such
information was at the time it was disclosed or obtained by such Person, or
thereafter became, publicly known otherwise than through a breach by such Person
of such Person's obligations to the Party to whom such information
relates.




1.6 Effective
Date -- See
Preamble.




1.7 Federal
Patent Policy shall
mean 35 U.S.C. § 200 et seq. and all regulations promulgated thereunder, as
amended, and any successor statutes or regulations.




1.8 FDA
shall
mean the United States Food and Drug Administration.




1.9 Licensed
Field shall
mean the field described in Schedule 1.8.




1.10
 Licensed
Patent shall
mean any of those patents and patent applications described on Schedule 1.10 and
any divisional, continuation, continuation-in-part (only to the extent that the
continuation in part covers the original information in the initial patent
application which is the subject of this License), reissue, renewal or extension
thereof or substitute therefor, or any patent issuing therefrom. 




1.11
Licensed
Technology shall
mean the Licensed Patents.




1.12
 Licensed
Territory shall
mean the territory described in Schedule 1.12. 




1.13 Licensed
Product shall
mean:










3












(a) any
product the manufacture, use or sale of which would, absent the license granted
by Licensor to Licensee herein, infringe any valid claim included in any
Licensed Patent or any portion thereof; or




(b) any
product developed in whole or in part through use of a process which is covered
by a valid claim included in any Licensed Patent or any portion
thereof.




1.14 Net
Sale shall
mean:




(a) in
any case where any Licensed Product is sold or commercially disposed of for
value in an arm's length sale to an independent third party, the gross invoice
price for such Licensed Product, less the following permitted deductions to the
extent that such items are reflected in the price charged and do not exceed
reasonable and customary amounts in the country in which the transaction occurs:
(a) trade and quantity discounts or rebates actually taken or allowed, (b)
credits or allowances given or made for rejections or return of any previously
sold Licensed Product actually taken or allowed, (c) any tax or government
charge (including any tax such as a value added or similar tax or government
charge, but not including any tax levied with respect to income) levied on the
sale, transportation or delivery of the Licensed Product and born by the seller
thereof, (d) any charges for freight or insurance billed to the final customer
and (e) any sale previously taken into account as a Net Sale to the extent that
it is subsequently deemed a bad debt by Licensee in accordance with
GAAP.




(b) in
any case where any Licensed Product is sold, leased or otherwise commercially
disposed of (including, without limitation, disposition in connection with the
delivery of other products or services) in a transaction that is not an arm's
length sale to an independent third party, the greatest of: (a) the Net Sale
amount for such transaction determined as provided in (i) above or (b) if there
has been any arm's length sale of a similar Licensed Product to an independent
third party, the Net Sale amount, determined as provided in (i) above, for the
most contemporaneous such sale or (c), if there has been no such arm's length
sale, the gross sales asking price for the Licensed Product.




1.15 Party
shall
mean each party to this Agreement and their respective successors and permitted
assigns.




1.16 Person shall
mean any natural person or legal entity.




1.17 Sublicensee shall
mean any Person to whom Licensee grants a sublicense of some or all of the
rights granted to Licensee under this Agreement.










4












II.
LICENSE




2.1 Grant
of License.
Licensor hereby grants to Licensee an exclusive, royalty-bearing license,
including the right to grant sublicenses, under the Licensed Technology, to
make, have made, use, offer to sell and sell Licensed Products in the Licensed
Territory in the Licensed Field. 




2.2 Licensor’s
Representation of Title. Licensor
represents to Licensee that Licensor is the assignee of the rights granted by
this License.




2.3 Federal
Patent Policy. To the
extent that any invention included within the Licensed Technology has been
partially funded by the United States Government, the United States Government
retains certain rights in such research as set forth in the Federal Patent
Policy. As a condition of the license granted hereby, Licensee shall comply with
all aspects of the Federal Patent Policy applicable to the Licensed Technology
in the Licensed Territory in the Licensed Field. Nothing contained in this
Agreement obligates or shall obligate Licensor to take any action which would
conflict in any respect with its past, current or future obligations to the U.S.
Government under the Federal Patent Policy with respect to the Licensed
Technology in regard to work already performed or to be performed by Licensor.
Licensor shall, however, use its reasonable best efforts to take all necessary
action to reserve for Licensee exclusive rights to the Licensed Technology in
the Licensed Territory in the Licensed Field to the extent permitted under the
Federal Patent Policy.




2.4 Pre-existing
Third Party Rights. There
are no pre-existing third party rights in the License granted by Licensor to
Licensee under this Agreement.




2.5 Licensor's
Retained Rights/Publication. All
rights granted by Licensor to Licensee hereunder are subject to Licensor's
retained rights which are as follows:




(i)
Notwithstanding the exclusive rights granted to Licensee hereunder, Licensor
retains, for itself and its Affiliates, a royalty-free right to make and use
Licensed Products or use Licensed Technology solely for research, teaching or
other scientific or academic purposes.




(ii)
Licensor also retains for itself, its employees and its Affiliates and their
employees the right to present at symposia, national, regional or professional
meetings (a "Presentation") and to publish in scientific journals or otherwise
(a "Publication") scientific findings from research related to the Licensed
Technology provided that the Presentation or Publication does not violate any
confidentiality provision found in this Agreement, is not proprietary to the
Licensee, Confidential Information or otherwise encumbered.










5












2.6
Sublicensing.
Licensee shall have the right to grant sublicenses consistent with the terms and
conditions of this Agreement provided that Licensee shall be responsible for the
operations of any Sublicensee relevant to this Agreement as if such operations
were carried out by Licensee itself, including (without limitation) the payment
of any royalties or other payments provided for hereunder, regardless of whether
the terms of any Sublicense provides for such amount to be paid by the
Sublicensee directly to Licensor. Except as Licensor may in its discretion
otherwise agree in writing, any sublicense granted by Licensee under this
Agreement shall provide for termination upon termination of this Agreement. The
standard form of any sublicense agreement shall be consistent with the foregoing
terms and other applicable provisions of this Agreement and shall be subject to
prior approval by Licensor, which approval shall not be unreasonably withheld.
Once Licensee obtains Licensor’s pre-approval of a standard form sublicense
agreement, Licensor’s prior approval of sublicensing agreements is not required;
provided, however, Licensee shall obtain Licensor's prior written approval of
each sublicensee’s identity, which approval shall not be unreasonably withheld.
Licensee shall provide to Licensor a copy of all sublicense agreements within
thirty days of executing the same.




2.7
Restriction
on other Rights. No
license is granted to any right not specifically listed or referenced in this
Agreement.




III.
CONSIDERATION,
RECORD-KEEPING AND PAYMENTS




3.1
Payments and Other Consideration.




3.1.a Licensing
Fees.
Licensee shall pay to Licensor those licensing fees specified in Schedule
3.1(i), at the time and in the manner specified therein.




3.1.b Running
Royalties.
Licensee shall pay or cause to be paid to Licensor a running royalty equal to
the Applicable Percentage of all Net Sales of any Licensed Product sold by
Licensee or any Sublicensee as specified in Schedule 3.1(ii), at the times and
in the manner specified therein.




3.1.c. Minimum
Royalties.
Licensee shall pay to Licensor the minimum royalty payments specified on
Schedule 3.1(iii), at the times and in the manner specified
therein.




3.1.d. Milestone
Payments.
Licensee shall pay or cause to be paid to Licensor those milestone payments
specified in Schedule 3.1(v), on the terms and conditions specified
therein.




3.1.e. Sublicensing
and Partnering.
Licensee shall pay or shall cause to be paid to Licensor those sublicensing and
partnering fees specified in Schedule 3.1(vi), on the terms and conditions
specified therein.




3.1.f. Records. During
the term of this Agreement and for three (3) years thereafter, Licensee shall
keep complete and accurate records of Licensee's and any Sublicensee's sales of
Licensed Products and such other matters as may affect the determination of any
amount payable to Licensor hereunder in sufficient detail to enable Licensor or
Licensor's representatives independent authority to determine any amounts
payable to Licensor under this Agreement. Licensee shall permit Licensor or its
representatives, at Licensor's expense (except as provided below), to examine
periodically its books, ledgers, and records during regular business hours for
the purpose of and to the extent necessary to verify any report required under
this Agreement or the accuracy of any amount payable hereunder. Licensee shall
also permit Licensor or its representatives to examine periodically any
documents relating to its sublicensing of the Licensed Technology during regular
business hours. Should any examination conducted by Licensee or its
representatives pursuant to the provisions of this paragraph result in an
increase of more than 10% in any payment due Licensor hereunder, Licensee shall
be obligated to pay any out of pocket expenses incurred by Licensor with respect
to such examination. In the event any examination conducted by Licensee or its
representatives reveals any overpayment made to Licensor by Licensee, the
overpayment will be returned to Licensee and Licensee is not obligated to pay
any out-of-pocket expenses incurred by Licensor with respect to such
examination.










6












3.2. Reports. Within
60 days after March 31, June 30, September 30 and December 31 of each year,
Licensee shall deliver to Licensor a true and accurate report, giving such
particulars of the business conducted by Licensee and any Sublicensees during
the preceding three (3) calendar months under this Agreement as are pertinent to
an accounting for any royalty or other payments hereunder. If no payments are
due, it shall be so reported.




3.3
Form
of Payment; Taxes. All
amounts payable to Licensor hereunder shall be payable in United States funds
without deductions for taxes, assessments, fees, or charges of any kind.
Licensee shall be responsible for the payment of all withholding taxes imposed
by any country on any royalty or other payment payable to Licensor hereunder and
the percentage or other amounts payable to Licensor hereunder shall not be
reduced to reflect the payment of any such withholding tax. All amounts payable
to Licensor hereunder shall be payable in United States dollars in Boston,
Massachusetts, or at such other place as Licensor may reasonably designate,
provided,
however, that if
the law of any foreign country prevents any payment payable to Licensor
hereunder to be made in Boston, Massachusetts, or as otherwise designated by
Licensor or prevents any such payment to be made in United States dollars,
Licensor agrees to accept such royalty in form and place as permitted, including
deposits by Licensee in the applicable foreign currency in a local bank or banks
in such country designated by Licensee. If any currency conversion is required
in connection with any payment to Licensor hereunder, such conversion shall be
made at the buying rate for the transfer of such other currency as quoted by
The
Wall Street Journal 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.




3.4
Interest. In the
event that any payment due hereunder is not made when due, the payment shall
accrue interest beginning on the first day following the calendar quarter to
which such payment relates calculated at the annual rate of the sum of (a) two
percent (2%) plus (b) the prime interest rate quoted by The
Wall Street Journal on the
date said payment is due, or on the date the payment is made, whichever is
higher, the interest being compounded on the last day of each calendar quarter,
provided that in no event shall said annual rate exceed the maximum interest
rate permitted by law in regard to such payments. Such royalty payment when made
shall be accompanied by all interest so accrued. Said interest and the payment
and acceptance thereof shall not negate or waive the right of Licensor to any
other remedy, legal or equitable, to which it may be entitled because of the
delinquency of the payment.










7













IV.
PROTECTION OF INTELLECTUAL PROPERTY RIGHTS

 


4.1 Patent
Prosecution/Patent Costs.
Licensor and Licensee shall prosecute and maintain the Licensed Patents as
provided in Schedule 4.1.




4.2 Confidential
Information. Each
Party shall maintain the Confidential Information of the other Party in
confidence to the same extent that such Party maintains and protects its own
Confidential Information, and shall not disclose, divulge or otherwise
communicate such Confidential Information to others, or use it for any purpose,
except pursuant to, and in order to carry out, the terms and objectives of this
Agreement or with the express written consent of the Party who provided such
Confidential Information. Each Party also hereby agrees to take reasonable and
customary steps to prevent and restrain the unauthorized disclosure of such
Confidential Information by any of its directors, officers, employees,
consultants, sub-contractors, sub-licensees or agents. The provisions of this
paragraph shall not apply to any Confidential Information of a Party which is
required to be disclosed by another Party to comply with any lawfully issued
subpoena or court order, or applicable laws or regulations, but only to the
extent required by such subpoena, court order, law or regulation and further
provided that the Party making any disclosure pursuant to the provisions of this
sentence shall provide prior written notice of such disclosure to the other
Party sufficiently in advance of such disclosure to allow such other Party to
respond and to take reasonable and lawful action to avoid and/or minimize the
degree of such disclosure.




4.3 Enforcement
of Intellectual Property Rights. In the
case of any infringement of any Licensed Patent or any violation of any other
intellectual property right contained in the Licensed Technology by any third
party (an "Infringer") in the Licensed Field in the Licensed Territory during
the term of this Agreement, Licensee shall have the right and the obligation, at
Licensee's expense, to cause such third party to cease such infringement and to
otherwise enforce such Licensed Patent or such other intellectual property
right. Licensor shall assist Licensee as reasonably requested, at Licensee's
expense, in taking any such action against any such Infringer. Any amount
recovered as a result of any action taken by Licensee hereunder shall be first
applied to reimbursing Licensee for its out-of-pocket expenses incurred in
connection therewith and the remainder, if any, shall be divided appropriately
between Licensee and Licensor with reference to the relative monetary injury
suffered by each of them by reason of the infringement for which said amounts
are recovered. If, following reasonable notice from the Licensor, Licensee shall
fail to take any action against any Infringer which Licensor may reasonably deem
necessary or desirable to prevent such infringement or violation, or to recover
damages therefor, in addition to any other remedy available to it, Licensor may,
upon notice to Licensee, take any steps Licensor may deem appropriate against
such Infringer at Licensor's own expense. Licensee shall assist Licensor, at
Licensor's expense, as reasonably requested in taking any such action against
any such Infringer. Any amount recovered as a result of any such action taken by
Licensor shall be first applied to reimbursing Licensor for its out-of-pocket
expenses incurred in connection therewith and the remainder, if any, shall be
divided appropriately between Licensor and Licensee with reference to the
relative monetary injury suffered by each of them by reason of the infringement
for which said amounts are recovered. This paragraph shall survive the
termination or expiration of this Agreement.










8












4.4  Infringement
of Third Party Rights.
Licensee shall promptly advise Licensor in writing of any notice or claim of any
infringement and of the commencement against it of any suit or action for
infringement of a third party patent made or brought against Licensee and based
upon or arising under the license granted under this Agreement. In such event,
Licensee shall have at all times the right to immediately suspend
commercialization and the right either to:

 


	 	a.
      	request
      that Licensor enter into negotiation with such third party to obtain
      rights for Licensee under the third party patent; or
	 	 	 
	 	b.
      	request
      that Licensor defend such claim, suit or action at Licensor's expense;
      or
	 	 	 
	 	c.	terminate
      this Agreement.




 


Licensor
shall not be obligated to enter into negotiations with such third party to
obtain rights for Licensee under the third party patent nor obligated to defend
such claim, suit or action. If Licensor, in its sole discretion, elects to enter
into negotiations with such third party to obtain rights for Licensee under the
third party patent or if Licensor, in its sole discretion, elects to undertake
at its own expense the defense of any such claim, suit or action, Licensee shall
render Licensor all reasonable assistance that may be required by Licensor in
the negotiations or in the defense of such claim, suit or action. Licensor has
the primary right to control the defense of any such claim, suit or action by
counsel of its own choice. The Parties agree to cooperate reasonably in any such
defense.




Notwithstanding
the foregoing, if Licensor has not within ninety (90) days (or such lesser
period of time as is necessary to avoid entry of a default judgment against
Licensor or Licensee) from the date of receipt of a request from Licensee,
either entered into negotiations with such third party to obtain rights for
Licensee under the third party patent or initiated legal action to defend such
claim, suit or action, it shall, upon written request of Licensee, grant to
Licensee the right to enter into such negotiations or defend such claim, suit or
action. Licensee shall be entitled to deduct from royalties due Licensor, all
reasonable costs and expenses (including, but not limited to, legal fees, expert
witness fees, and trial consultants’ fees) incurred in entering into such
negotiations or defending such claim, suit or action. Licensee shall not settle
or compromise any such suit or action without the Licensor’s written consent,
which consent shall not be unreasonably withheld or delayed. 










9













V.  OPERATIONS
UNDER THE LICENSE



5.1 Due Diligence.






5.1.1.
General
Obligation.
Licensee shall use commercially reasonable efforts, which efforts shall not be
less than efforts expended by biopharmaceutical companies of similar size,
scale, and capacity in connection with similar development projects, to
diligently commercialize the Licensed Technology. In the event that Licensor
believes Licensee has failed to comply with its general due diligence
obligations under this paragraph, Licensor shall provide written notice to
Licensee stating, in detail, the basis for Licensor’s belief. Within 60 days of
Licensee's receipt of a detailed written notice from Licensor, Licensee shall
provide to Licensor either (i) a response detailing the basis for the Licensee’s
position that the Licensor’s belief is in error, or (ii) a commercially
reasonable plan to remedy such failure within a time period not to exceed 210
days from the date of Licensee's receipt of such notice. In the case of (ii),
the Licensee shall cure such failure in accordance with such plan within the
time provided for under such plan. 

 

5.1.2. Specific Due Diligence
Obligations.
Licensee shall also comply with each of the more specific due diligence
requirements specified in Schedule 5.1. 

 

5.2 Reports.
Licensee shall provide to Licensor at least once per year a report of its
activities and efforts toward commercialization of the Licensed Technology in
sufficient detail to allow Licensor to monitor Licensee's compliance with the
due diligence provisions of this Agreement and shall provide to Licensor those
additional reports, if any, specified in Schedule 5.1.




5.3
Compliance
with Law.
Licensee shall comply with and shall insure that any Sublicensee complies with
all government statutes and regulations that relate to Licensed Products,
including, but not limited to, FDA statutes and regulations and the Export
Administration Act of 1979 (50 App. U.S.C. §2401 et.seq.), as amended, and the
regulations promulgated thereunder, and any applicable similar laws and
regulations of any other country. Without limiting the generality of the
foregoing, Licensee agrees that all Licensed Products used or sold in the United
States shall be manufactured substantially in the United States to the extent
required by and in compliance with the Federal Patent Policy.




5.4  Marking.
Licensee shall cause all Licensed Products sold in the United States to be
marked with all applicable U.S. Patent Numbers, to the full extent required by
United States law. Licensee shall similarly cause all Licensed Products shipped
to or sold in any other country to be marked in such a manner as to conform with
the patent laws and practice of such country.




5.5  Publicity. Except
as required by law, Licensee shall not use the name of the Licensor nor
Licensor's Affiliates, nor that of any staff member, employee, or student of
Licensor or its Affiliates, or any adaptation thereof, in any advertising,
promotional or sales literature, offering materials, business plan or any other
form of publicity without Licensor’s prior written consent, and the consent of
the individual staff member, employee or student if such individual's name is so
used.










10












A.
Licensor
Policies.
Licensee acknowledges that Licensor's employees and the employees of Licensor's
Affiliates are subject to the applicable policies of Licensor and such
Affiliates, including, without limitation, policies regarding conflicts of
interest, intellectual property and other matters. Licensee shall provide
Licensor with any agreement it proposes to enter into with any employee of
Licensor or any of Licensor's Affiliates (including, without limitation, any
member of the medical or research staff of Licensor or any Affiliate of
Licensor) for Licensor's prior review and shall not enter into any oral or
written agreement with any such employee which conflicts with any such policy.
Licensor shall provide Licensee, at Licensee's request, with copies of any such
policies applicable to any such employee. 




B.
Research
Agreement.
Licensee and Licensor shall enter into a Research Agreement, as more
specifically described in Schedule 5.6. 




C.
Clinical
Trials.
Licensee hereby grants to Licensor, on behalf of Licensor and its Affiliates,
those rights in regard to clinical trials of Licensed Products described on
Schedule 5.7.




VI.
INDEMNIFICATION;
INSURANCE; WARRANTY DISCLAIMER




6.1.
Indemnification





a.
Licensee shall indemnify, defend and hold harmless Licensor and its trustees,
officers, medical and professional staff, employees, and agents and their
respective successors, heirs and assigns (the "Licensee Indemnitees"), against
any liability, damage, loss or expense (including reasonable attorney's fees and
expenses of litigation) incurred by or imposed upon the Licensee Indemnitees or
any one of them in connection with any claims, suits, actions, demands or
judgments arising out of any theory of product liability (including, but not
limited to, actions in the form of tort, warranty, or strict liability)
concerning any product, process or service made, used or sold pursuant to any
right or license granted under this Agreement.




b.
Licensees indemnification under (i) above shall not apply to any liability,
damage, loss or expense to the extent that it is directly attributable to the
negligent activities, reckless misconduct or intentional misconduct of the
Licensee Indemnitees.




c.
Licensee agrees, at its own expense to defend against any actions brought or
filed against any party indemnified hereunder with respect to the subject of
indemnity contained herein, whether or not such actions are rightfully
brought.










11












This
entire Section 6.1 shall survive expiration or termination of this
Agreement.




6.2.
Insurance




a.
Beginning at the time as any such product, process or service is being
commercially distributed or sold (other than for the purpose of obtaining
regulatory approvals) by Licensee or by a Sublicensee, Affiliate or agent of
Licensee, Licensee shall, at its sole cost and expense, procure and maintain
commercial general liability insurance in amounts not less than $2,000,000 per
incident and $2,000,000 annual aggregate and naming the Indemnitees as
additional insureds. Such commercial general liability insurance shall provide
(a) product liability coverage and (b) contractual liability coverage for
Licensee's indemnification under Section 6.1 of this Agreement. If Licensee
elects to self-insure all or part of the limits described above (including
deductibles or retentions which are in excess of $250,000 annual aggregate) such
self-insurance program must be acceptable to the Licensor and the Risk
Management Foundation of the Harvard Medical Institutions, Inc. The minimum
amount of insurance coverage required under this Section 6.2 shall not be
construed to create a limit of Licensee's liability with respect to its
indemnification under Section 6.1 of this Agreement.




b.
Licensee shall provide Licensor with written evidence of such insurance upon
request of Licensor. Licensee shall provide Licensor with written notice at
least fifteen (15) days prior to the cancellation, non-renewal or material
change in such insurance; if Licensee does not obtain replacement insurance
providing comparable coverage within such fifteen (15) day period, Licensor
shall have the right to terminate this Agreement effective at the end of such
fifteen (15) day period without notice of any additional waiting
periods.




c.
Licensee shall maintain such commercial general liability insurance during (a)
the period that any such product, process or service is being commercially
distributed or sold (other than for the purpose of obtaining regulatory
approvals) by Licensee or by a Sublicensee, affiliate or agent of Licensee and
(b) a reasonable period after the period referred to in (iii) (a) above which in
no event shall be less than fifteen (15) years.




    d. This
Section 6.2 shall survive expiration or termination of this Agreement. Any
Sublicensee shall maintain insurance in favor of Licensor under the same terms
as set forth above.




6.3
Warranty
Disclaimer




LICENSOR
MAKES NO EXPRESS OR IMPLIED WARRANTY INCLUDING, WITHOUT LIMITATION, ANY IMPLIED
WARRANTY OF MERCHANTABILITY OR ANY IMPLIED WARRANTY OF FITNESS FOR A PARTICULAR
PURPOSE WITH RESPECT TO ANY OF THE LICENSED TECHNOLOGY OR ANY LICENSED PRODUCTS
AND HEREBY DISCLAIMS THE SAME.










12












LICENSOR
MAKES NO EXPRESS OR IMPLIED WARRANTY THAT THE MANUFACTURE, USE OR SALE OF ANY
LICENSED PRODUCT WILL NOT INFRINGE ANY PATENT OR OTHER RIGHT OF ANY PARTY AND
HEREBY DISCLAIMS THE SAME.   







VII.
TERM
AND TERMINATION




7.1
Term. Unless
terminated earlier under the provisions of this Agreement, this Agreement will
expire when Licensee has no further obligation to make or cause to be made any
royalty or other payment under Section 3 of this Agreement.




7.2
Termination
by Licensor.
Licensor shall have the right to terminate this Agreement and the license
granted hereunder upon the happening of any of the following
events:




a.
Licensee fails to pay or cause to be paid any royalty or other material payment
which has become due to Licensor under Section 3 of this Agreement, within
thirty (30) days after receiving a written request from Licensor to make such
payment or to cause such payment to be made;




b.
Licensee fails to comply with any due diligence requirement provided for in
Section 5.1; or




c. Licensee
is in breach of or default under any other material provision of this Agreement
and has not cured such breach or default within sixty (60) days after written
notice from Licensor to Licensee specifying the nature of such breach or
default





7.3. Termination
by Licensee.
Licensee shall have the right to terminate this Agreement in the event that
Licensor is in breach of or has defaulted under any provision of this Agreement
and has not cured such breach or default within thirty (30) days after written
notice from Licensee to Licensor specifying the nature of such breach or
default. 

 



7.4. Effect of Termination.


 


a. Upon
termination of this Agreement for any reason, nothing herein shall be construed
to release either Party from any obligation that matured prior to the effective
date of such termination. 




b. Upon
any termination of this Agreement by Licensor, Licensee shall permit Licensor to
purchase and otherwise have the benefit of all regulatory approvals of, or
clinical trials or other studies conducted on, and all filings made with
regulatory agencies in connection with, the Licensed Technology (“R&D
Materials”) in order to assist Licensor or its licensees in developing the
Licensed Technology and obtaining any approvals required to make, have made,
use, offer to sell or sell Licensed Products. In the event Licensor desires to
purchase the R&D Materials, it shall provide written notice of same to
Licensee within a reasonable time following termination of the Agreement. Upon
Licensee’s receipt of the written notice, Licensee and Licensor shall mutually
select a valuation expert knowledgeable in the valuation of the R&D
Materials. The expert shall provide an appraisal of the R&D Materials within
sixty (60) days of his or her selection, which appraisal shall be binding on all
parties. In the event the Licensor and the Licensee cannot mutually agree on the
selection of an appraiser within thirty (30) days following Licensee’s written
notice to Licensor, Licensee and Licensor shall each select a valuation expert
knowledgeable in the valuation of the R&D Materials. The two experts
selected by the Licensor and the Licensee shall evaluate and provide an
appraisal of the R&D Materials within sixty (60) days of their selection,
which appraisal shall be binding on all parties. In the event the valuation
experts selected by the parties cannot agree on an appraisal, they shall select
a third valuation expert, who shall review all relevant information and shall
issue a final appraisal within thirty (30) days of his selection, which shall be
binding on Licensor and Licensee. Each party shall bear its own costs in
connection with the valuation process, including the fees associated with its
own valuation expert. In the event a third valuation expert is required, the
Licensor and the Licensee shall each pay one-half of all associated expenses.


 







13












c. The
provisions of Sections 4.2 (Confidential Information), 4.3 (Enforcement of
Intellectual Property Rights), 6.1 (Indemnification), 6.2 (Insurance), 6.3
(Warranty Disclaimer), and 8 (Dispute Resolution) shall survive termination of
this Agreement for any reason.

 




	
      i.    
	Licensee and any Sublicensee may,
      after Termination, sell all Licensed Products which are in inventory at
      the time of termination, and complete and sell Licensed Products which
      Licensee can clearly demonstrate were in the process of manufacture at the
      time of such termination, provided that Licensee shall pay to Licensor any
      royalties due on the sale of such Licensed Products and shall submit
      reports, in accordance with this Agreement.



 







14












VIII.
DISPUTE
RESOLUTION




8.1
Arbitration. Any
controversy, claim or other dispute arising out of this Agreement or relating to
the subject matter hereof shall be decided by binding arbitration. Each party
shall select an arbitrator from a list of qualified arbitrators practicing in
the Boston metropolitan area, and these two arbitrators shall select a third
arbitrator. The arbitrators together shall agree on customary rules and
procedures, and may, but are not obligated to, adopt the rules employed by the
American Arbitration Association. Nothing contained herein shall subject the
parties to the jurisdiction of the American Arbitration Association or its fee
structure. This agreement to arbitrate shall be specifically enforceable under
the prevailing arbitration law. The award rendered by the arbitrator shall be
final and binding on all parties, and judgment may be entered thereon in any
court having jurisdiction thereof. The arbitration shall be held in the Boston,
Massachusetts metropolitan area. All costs and fees associated with the
arbitrators and the arbitration shall be shared equally by the parties. In
addition, each party shall pay its own attorney’s fees.




IX.
GENERAL




9.1
Assignment. This
Agreement shall be binding upon and shall inure to the benefit of each Party and
each Party's respective transferees, successors and assigns, provided,
however, that
neither Party shall have the right to assign this Agreement or its rights and
obligations hereunder to any other Person without the prior written consent of
the other Party, except as expressly provided in this paragraph. Each Party may
assign or otherwise transfer this Agreement and the License granted hereby and
the rights acquired by it hereunder in connection with a sale or other transfer
of such Party's entire business or that part of such Party's business to which
the License granted hereby relates, provided, in all such cases, that any such
assignee or transferee has agreed in writing to be bound by the terms and
provisions of this Agreement or is so bound by operation of law. Any purported
assignment in violation of the provisions of this paragraph shall be null and
void.




9.2
Entire Agreement/Amendments This
Agreement constitutes the entire and only agreement between the Parties relating
to Licensed Invention, and all prior negotiations, representations, agreements
and understandings are superseded hereby. No agreements amending, altering or
supplementing the terms hereof may be made except by means of a written document
signed by a duly authorized representative of each Party.




9.3
Notices. Any
notice, communication or payment required or permitted to be given or made
hereunder shall be in writing and, except as otherwise expressly provided in
this agreement, shall be deemed given or made and effective (i) when delivered
personally; or (ii) when delivered by telex or telecopy (if not a payment); or
(iii) when received if sent by overnight express or mailed by certified,
registered or regular mail, postage prepaid, addressed to parties at their
address stated below, or to such other address as such party may designate by
written notice in accordance with the provisions of this Section
9.3.

 







15













	 	
      
	
      LICENSOR:






	 	
      
	
      Chief,
      Business Ventures





	 	 	Technology
      Ventures Office




	 	 	Beth
      Israel Deaconess Medical Center




	 	 	330
      Longwood Avenue




	 	 	Boston,
      MA 02215




	 	 	 




	With
      a copy to:	 	General
      Counsel




	 	 	Legal
      Department  




	 	 	CareGroup,
      Inc.




	 	 	109
      Brookline Ave.




	 	 	Boston,
      MA 02215




	 	 	
       





	LICENSEE:	 	Richard Gabriel




	 	 	DNAPrint Genomics, Inc.




	 	 	900 Cocoanut Avenue




	 	 	Sarasota, FL 34236




	 	 	 




	With a copy to:	 	Thomas P. McNamara, P.A.




	 	 	2909 Bay to Bay Blvd., Suite 309




	 	 	Tampa, FL 33629




 

9.4  Governing
Law. This
Agreement shall be construed and enforced in accordance with the domestic
substantive laws of Massachusetts without regard to any choice or conflict of
laws rule or principle that would result in the application of the domestic
substantive law of any other jurisdiction other than (i) United States federal
law, to the extent applicable and (ii) in regard to any question affecting the
construction or effect of any patent, the law of the jurisdiction under which
such patent is granted.


9.5  Headings.
Headings included herein are for convenience only, and shall not be used to
construe this Agreement.

 

9.6  Independent Contractors. For the
purposes of this Agreement and all services to be provided hereunder, each shall
be, and shall be deemed to be, an independent contractor and not an agent,
partner, joint venturer or employee of the other party. Neither party shall have
authority to make any statements, representations or commitments of any kind, or
to take any action which shall be binding on the other party, except as may be
explicitly provided for herein or authorized in writing


 

9.7  Severability. If any
provision of this Agreement shall be found by a court of competent jurisdiction
to be void, invalid or unenforceable, the same shall either be reformed to
comply with applicable law or stricken if not so conformable, so as not to
affect the validity or enforceability of this Agreement.

 







16












9.8  No Waiver. Failure
of either party to enforce a right under this Agreement shall not act as a
waiver of that right or the ability to later assert that right relative to the
particular situation involved or to terminate this Agreement arising out of any
subsequent default or breach.

 

9.9  Limitation of Liability. Neither
Party shall be liable to the other Party for indirect, incidental or
consequential damages arising out of any of the terms or conditions of this
Agreement or with respect to its performance or lack thereof.


 


9.10 
Counterparts. This
Agreement may be executed in any number of counterparts, each of which shall
constitute an original document, but all of which shall constitute the same
agreement.



 

[THE REST
OF THIS PAGE IS INTENTIONALLY LEFT BLANK]

 







17












 

IN
WITNESS WHEREOF, the parties have caused this Agreement to be executed by their
duly authorized representatives as of the date first set forth above.





 



	 	THE BETH ISRAEL DEACONESS
      MEDICAL CENTER 	 	 	[LICENSEE]
	 	 	 	 	 
	 	 	 	 	 
	 	 	 	 	 
	By:		 	By:	
	 	
      

      Paul F. Levy 	 	 	
      

      Richard Gabriel
	 	Title: President 	 	 	Title: President 










18












Schedule
1.8






LICENSED
FIELD


 

All
fields of use.

 







19












Schedule
1.10






LICENSED
PATENTS




The
following patents and patent applications:




APPENDIX
A:




Recombinant
Fusion Dimers:




US
Patents:




1. US
Patent Application Serial No. 08/890,929, issued 6/05/01, entitled “Production
and use of Recombinant Protein Multimers with Increased Biological
Activity”




2. US
Patent Application Serial No. 6,187,564
CIP, issued 2/03/98,
entitled “Production and use of Recombinant Protein Multimers with Increased
Biological Activity”

 

Foreign
Patents:

 

1.
PCT/US98/13944(EPO, CA, AU, JP), filed 7/10/98, entitled “Production and use of
Recombinant Protein Multimers with Increased Biological Activity”

 

Chemically
Cross-Linked Dimers:




US
Patents:

 


	1.  	
      U.S.
      Patent Application Serial No.5,747,445, issued 5/05/98, entitled “Modified
      Polypeptides with Increased Biological
Activity”








	2.  	
      U.S.
      Patent Application Serial No.5,919,758, issued 7/06/99, entitled “Modified
      Polypeptides with Altered Biological
Activity”








	3.  	
      U.S.
      Patent Application Serial No.6,107,272, issued 8/22/00, entitled “Modified
      Polypeptides with Increased Biological
Activity”







Foreign
Patents:

 


	1.  	
      PCT/US95/03242(EPO,
      AU, CA, JP), issued 3/15/95, entitled “Modified Polypeptides with
      Increased Biological Activity”








	2.  	
      PCT/US97/22503(EPO,
      AU, CA, JP), pending, entitled “Modified Polypeptides with Increased
      Biological Activity”




 







20












Schedule
1.12




LICENSED
TERRITORY




All
territories, worldwide

 







21














Schedule
3.1(i)




LICENSING
FEES







Upon
execution of this Agreement, Licensee shall pay to Licensor $25,000 as a license
signing fee.




Each of
the fees specified in this Schedule are non-refundable and shall not be credited
against any other payments due to Licensor under this Agreement, unless
otherwise stated in this Agreement or subsequent amendments of this
Agreement.










22












Schedule
3.1(ii)




RUNNING
ROYALTIES




Licensee
shall pay or cause be paid, to Licensor a running royalty equal to the
Applicable Percentage of Net Sales of Licensed Products, as
follows:




The
running royalty shall equal 4%
of Net
Sales. 

 

AND:




Licensee
shall pay any applicable withholding taxes. 




Licensee's
obligation to pay a running royalty with respect to the Net Sale of any Licensed
Product shall terminate on a country-by-country basis, upon the later of (i) the
last to expire of any Licensed Patent applicable to the manufacture, use or sale
of such Licensed Product and (ii) the date that is [15] years
from the First Commercial Sale in such country. First Commercial Sale shall
mean, with respect to any country, the first bona fide arm's-length sale of
Licensed Product in such country following receipt of all regulatory approvals
necessary to commence regular, commercial scale sales of Licensed Product in
such country. Any sale prior to receipt of all approvals necessary to commence
commercial sales, such as any so-called "named patient sale" or "compassionate
use" sale, shall not be a First Commercial Sale.

 

By way of
example, if seventeen years after the First Commercial Sale of a Licensed
Product in Country Z, a Licensed Product is manufactured in Country X, where
such manufacture would, but for the license granted hereby, infringe a valid
claim of an unexpired Licensed Patent, Licensee shall pay or cause to be paid to
Licensor a running royalty on the Net Sales of such product in Country Z as
compensation to Licensor for the license to manufacture such product in Country
X, even if the sale of such product in Country Z would not infringe any valid
claim of any Licensed Patent.




Within 60
days of the end of each calendar quarter in which any Net Sales occur, Licensee
shall calculate the running royalty amount owed to Licensor and shall remit to
Licensor the amount owed to Licensor. Such payment shall be accompanied by a
statement showing the calculation of the amount owed for each country, the total
Net Sales of Licensed Product by country for that quarter, the exchange rate
used to convert any royalty amounts into United States dollars and the total Net
Sales for that quarter in all countries. For purposes of determining when a sale
of a Licensed Product occurs, the sale shall be deemed to occur on the date the
Licensee invoices the purchaser in a Commercial Sale. Notwithstanding any
language contained herein, any Commercial Sale that is subsequently deemed a bad
debt by Licensee in accordance with GAAP shall no longer be considered a Net
Sale for purposes of calculating Licensee’s royalty obligations under this
License. Any royalty paid by Licensee in connection with a Net Sale subsequently
deemed a bad debt shall reduce, dollar for dollar, any future royalty payment
due Licensor. 












23












Schedule
3.1(iii)

 

MINIMUM
ROYALTIES







Upon
commencement of Commercial Sales anywhere, Licensee shall pay $100,000 per
year.




The
foregoing minimum royalties shall be non-refundable to Licensee and shall be
creditable against any royalties subsequently due during the next
year.

 







24












Schedule
3.1(v)




MILESTONE
PAYMENTS







Licensee
shall make the following payments to Licensor within 15 days of the initial
occurrence of each of the following events:









	
      Event
	 	
      Amount
	 
	 	 	 	 
	Initiation
      of the first Phase I trial of Licensed Product (either chemically linked
      or recombinant fusion EPO dimers)
	 	$
	
      150,000
	* 
	 	 	 	 	 
	Initiation
      of first Phase II trial of a Licensed Product (either chemically linked of
      recombinant fusion dimers)
	 	$
	
      250,000
	* 
	 	 	 	 	 
	Regulatory
      approval by Asian or [South American Country] for EPO
    dimers
	 	$
	
      150,000
	 
	 	 	 	 	 
	First
      commercial sale of Licensed Product of EPO dimers in [Asian or South
      American Country]
	 	$
	
      150,000
	 
	 	 	 	 	 
	Regulatory
      approval by US FDA of recombinant fusion or chemically linked EPO
      dimers
	 	$
	
      450,000
	 
	 	 	 	 	 
	Regulatory
      Approval by EMEAA of recombinant fusion or chemically linked EPO
      dimers
	 	$
	
      500,000
	 
	 	 	 	 	 
	First
      commercial sale of a Licensed Product in the United States or Europe of
      recombinant fusion or chemically linked EPO dimers
	 	$
	
      500,000
	 













The
foregoing milestone payments shall be non-refundable to Licensee and are not
creditable against any other payments payable to Licensor under this Agreement.








*
50% to be credited against future product royalties

 







25












Schedule
3.1(vi)






SUBLICENSING
AND OTHER FEES







In the
event Licensee shall receive, in connection with the grant to any third party or
parties of a sublicense or other right, license, privilege or immunity to make,
have made, use, offer to sell, sell or otherwise dispose of Licensed Products,
any of the following forms of consideration, Licensee shall pay to Licensor
within 30 days of Licensee's receipt of any such consideration the specified
amount: 




BIDMC to
receive 20% of fees, earned royalties (if earned royalties percentage is greater
than those end-sales net royalties as above), and lump sum or milestone payments
attributable to sublicenses of Recombinant Fusion Dimer Licensed Patent Rights;
And,


 

BIDMC to
receive 15% of fees, earned royalties (if earned royalties percentage is greater
than those end-sales net royalties as above), and lump sum or milestone payments
attributable to sublicenses of Chemically Cross-Linked Dimer Licensed Patent
Rights, including but not limited to technology access fees, license issue fees,
but excluding research support received by DNAP.












26












Schedule
4.1

 

PATENT
PROSECUTION







Licensor
shall be responsible for prosecuting and maintaining all Licensed Patents.
Without limiting the generality of the foregoing, Licensee shall reimburse
Licensor for all costs incurred as of and following the Effective Date, in
connection with the preparation, filing, prosecution and maintenance of any
patent applications and patents included in the Licensed Patents. Licensee shall
cooperate with Licensor in regard to such maintenance and prosecution. Licensor
shall provide Licensee with copies of all filings and relevant documentation and
an opportunity to comment thereon prior to their submission. Should Licensor
determine to abandon prosecution of, or to cease to maintain, any Licensed
Patent, in any jurisdiction, Licensor shall so notify Licensee and shall permit
Licensee, should Licensee choose to do so, at Licensee’s expense, to continue to
prosecute or maintain such Licensed Patent in such jurisdiction, and Licensor
shall cooperate with Licensee in regard thereto.










27












Schedule
5.1




SPECIFIC
DUE DILIGENCE OBLIGATIONS




Prior to
execution and delivery of this Agreement, Licensee shall produce a development
and commercialization plan acceptable to Licensor. Such plan shall indicate (to
the extent practicable and on a product-by-product basis, if appropriate)
Licensee's currently expected research and development budget; regulatory
approval, patent prosecution, marketing and manufacturing strategies; and
expected sources of funding. In addition, Licensee shall adhere to the following
diligence milestones:







	
      Event:
	
      Date:

	 	 
	
      Production
      of GMP grade EPO dimers
	
      03/2006

	 	 
	
      First
      commercial sale of a Licensed Product in Asia or S.
America
	
      12/2011

	 	 
	
      First
      commercial sale of Licensed Product in US/Western Europe
	
      12/2012








 






28