Exhibit 10.3


 


[ **** ]
indicates confidential portions have been redacted and submitted separately
pursuant to


confidentiality
request with the Commission


 


Execution Copy


 


LICENSE
AGREEMENT


 


THIS LICENSE AGREEMENT
(the “Agreement”) is made as
of  September 1, 2006 (the “Effective Date”) between Duke University,
a North Carolina corporation with offices at 2020 West Main Street, Suite 101,
Durham, North Carolina 27705, and its Affiliates (“Duke”), and Celldex Therapeutics, Inc., a Delaware
corporation with a business address at 222 Cameron Drive, Suite 400,
Phillipsburg, New Jersey 08865 (“Celldex”).  Celldex and Duke each may be referred to
herein individually as a “Party”
or collectively as the “Parties.”


 


RECITALS


 


A.                                   Duke is the holder
of that certain Investigator Sponsored IND FDA No. 9944 (the “Duke IND”) and certain related assets, all as more fully set
forth on Schedule A (the “Licensed Assets”).


 


B.                                     Celldex wishes to
obtain a license to access and reference the Licensed Assets on an exclusive
basis for, among other things, use in its pursuit of its own filings with the
FDA relating to potential Celldex Products (as these terms are defined herein),
and Duke is willing to grant such a license, in accordance with the terms and
conditions of this Agreement.


 


NOW, THEREFORE, in
consideration of the foregoing premises and for other good and valuable
consideration, the receipt and sufficiency of which are acknowledged, the
Parties, intending to be legally bound, do hereby agree as follows:


 


1.                                      Definitions.


 


As used in this Agreement, the following
terms have the meanings set forth below.


 


1.1                                 “Affiliate”
means any corporation, company, partnership, joint venture, firm or other
entity that controls, is controlled by, or is under common control with a
Party.  For purposes of this definition, “control”
means (a) in the case of corporate entities, direct or indirect ownership
of at least fifty percent (50%) of the stock or shares entitled to vote for the
election of directors; and (b) in the case of non-corporate entities,
direct or indirect ownership of at least fifty percent (50%) of the equity
interest with the power to direct the management and policies of such
noncorporate entities.


 


1.2                                 “BLA”
means a biologic license application.


 


1.3                                 “Celldex
Product” or “Celldex Products”
means (a) any product or products Exploited by Celldex or its Affiliates
or their respective Sublicensees/Licensees that is the subject of or that
utilizes or is derived from any Licensed Asset; or (b) any service
provided by or on behalf of Celldex or its Affiliates or their respective
Sublicensees/Licensees, which service is the subject of, or that utilizes or is
derived from any Licensed Asset.


 


1.4                                 “Change of
Control” means, with respect to a Party, the merger, consolidation
or similar transaction, or the sale of all or substantially all of a Party’s
assets, or a line of business


 





















 


of a Party, that pertains to the exercise of such Party’s
rights or the performance of such Party’s obligations under this Agreement.


 


1.5                                 “Claim” has the meaning
set forth in Section 3.3.2(a).


 


1.6                                 “Control” means, with
respect to any Licensed Asset, possession of the right, whether directly or
indirectly, and whether by ownership, license or otherwise, to grant a
sublicense under such Licensed Asset as provided for herein without violating
the terms of any agreement or other arrangement with any Third Party.


 


1.7                                 “EMEA” means European
Medicines Agency.


 


1.8                                 “Exploit” or “Exploitation” means to research, develop,
commercialize, make, have made, import, use, sell or offer for sale, alone or
in collaboration with a Third Party.


 


1.9                                 “FDA” means the
United States Food & Drug Administration or any successor entity.


 


1.10                           “Field” means
therapeutic vaccines and antibodies for the treatment of glioblastoma
multiforme and other cancers of the brain.


 


1.11                           “IND” means an
investigational new drug application.


 


1.12                           “Indemnified Party” has the
meaning set forth in Section 3.3.2(a).


 


1.13                           “Indemnitee” has the
meaning set forth in Section 3.3.2(a).


 


1.14                           “Losses” has the meaning
set forth in Section 3.3.1.


 


“Net Sales”
means [ **** ].


 


1.15                           “Person” means any
individual, partnership, joint venture, corporation, limited liability company,
trust, unincorporated organization, government or department or agency of a
government or other entity.


 


1.16                           “Shares” has the
meaning set forth in Section 4.1.


 


1.17                           “IND Sponsor” shall mean Dr. John
Sampson, Associate Professor-Surgery, (Neurosurgery) Duke University Medical
Center.


 


1.18                           “Sublicensee/Licensee” and “Sublicensees/Licensees” means permitted
Third Party (including Affiliates) licensees and sublicensees and future
downstream sub-sublicensees of the Licensed Assets pursuant to the terms of and
subject to the restrictions provided for in this Agreement.


 


1.19                           “Sublicense/License” and “Sublicenses/Licenses” means the license or
sub-license or future downstream sub-sublicense agreements under any Licensed
Asset entered into by Sublicensees/Licensees.


 


2





















 


1.20                           “Third Party” means any Person
other than Celldex, Duke or their Affiliates.


 


2.                                      License.


 


2.1                                 License
Grant. 
Subject to the terms and conditions of this Agreement, Duke hereby
grants to Celldex an exclusive, perpetual (subject to the termination
provisions of Section 2.3), royalty and fee-bearing, worldwide license,
with the right to sublicense to Sublicensees/Licensees solely as provided in
this Article 2, under the Licensed Assets, to Exploit Celldex
Products.  For avoidance of doubt, the
license granted by Duke to Celldex under this Section 2.1 shall include,
without limitation, the right to access all data used and/or referenced by Duke
in connection with the filing of the Duke IND with the FDA and other regulatory
agencies worldwide and the Licensed Assets and the right to cross reference the
Duke IND and the Licensed Assets in Celldex’s own filings with the FDA and
other regulatory agencies worldwide relating to Celldex Products.  In this connection, Duke hereby agrees to
provide Celldex with a cross reference letter in form and substance
satisfactory to Celldex, the FDA and other regulatory agencies worldwide to the
extent the data is applicable to such filings. 
Such cross-reference letter shall be sufficient to allow Celldex to
cross reference the Duke IND and the Licensed Assets, as appropriate, in
Celldex’s own filings with the FDA and other regulatory agencies worldwide in
connection with Celldex Products.


 


2.2                                 License
Fees in Connection with a Sublicense/License.  Except as provided in Article 4 of this
Agreement, if Celldex or any of its Affiliates enters into a
Sublicense/License, it shall have no obligation to Duke or its Affiliates with
respect to any license fees, milestone payments, royalties, or any other
financial consideration received by Celldex pursuant to such Sublicense/License.


 


2.3                                 Term
and Termination of License.


 


2.3.1                             Term.  The license provided for in Section 2.1
shall run until terminated in accordance with this Section 2.3.


 


2.3.2                             Termination
by Duke.  Duke shall have the right
to terminate this license if and only if Celldex fails to pay amounts due under
Article 4 or otherwise materially breaches this Agreement and fails to
cure such payment default or breach within thirty (30) days after written
notice from Duke specifying the nature of such default or breach.


 


2.3.3                             Termination
by Celldex.  Celldex shall have the
right at any time to terminate this license in whole or as to any portion of
the Licensed Assets by giving ninety (90) days’ advance notice in writing to
Duke; provided  however, that Celldex’s obligations under Article 4
shall survive any such partial termination for any portion of the Licensed
Assets that have not been terminated.


 


2.3.4                             Sublicenses/Licenses.  In the event of termination pursuant to Section 2.3.2,
any Sublicense/License provided for under this Agreement entered into by
Celldex may be terminated at the sole discretion of Duke.


 


2.3.5                             Survival.  Termination or expiration of this Agreement
for any reason shall be without prejudice to any rights that shall have accrued
to the benefit of a Party prior to 


 


3





















 


such termination or expiration.  Such termination or expiration shall not
relieve a Party from obligations that are expressly indicated to survive the
termination or expiration of this Agreement.


 


2.4                                 Notice
of Licenses and Sublicenses.  Celldex shall provide Duke with written
notice within thirty (30) days after the granting of any Sublicense/License of
rights under any Licensed Assets by Celldex or its respective Sublicensees/Licensees,
which notice shall contain the name of the grantee of such Sublicense/License
and the date of the grant of such Sublicense/License.


 


3.                                      Warranties,
Covenants and Indemnities.


 


3.1                                 Representations
and Covenants of Duke.  Duke represents and covenants that as of the
Effective Date:  (a) Duke and its
Affiliates have the unencumbered and unrestricted right to grant Celldex rights
in the Licensed Assets in accordance with this Agreement without any payment or
other (to the extent material to Celldex’s rights hereunder) obligations to
Third Parties other than those set forth in this Agreement; (b) Duke and
its Affiliates do not have any existing agreements or arrangements with Third
Parties relating to the Licensed Assets that would conflict with Duke’s or its
Affiliates’ obligations to Celldex and its Affiliates or Duke’s or its
Affiliates’ performance under this Agreement, and Duke and its Affiliates will
not enter into any agreements or arrangements with Third Parties relating to
the Licensed Assets that would conflict with Duke’s or its Affiliates’
obligations to Celldex and its Affiliates or Duke’s or its Affiliates’
performance under this Agreement; (c) no Third Party has notified Duke in
writing that the Licensed Assets are invalid or unenforceable; (d) Duke
has full right, power and authority to grant the licenses granted by it under
this Agreement and to enter into and perform its obligations under this
Agreement; (e) neither Duke nor its Affiliates has any agreement or
arrangement with a Third Party with respect to such Licensed Assets that
affects its Control of the Licensed Assets or would otherwise adversely affect
Celldex’s license with respect to such Licensed Assets under this Agreement; (f) Duke
has provided Celldex with true and complete copies of all written materials
included within the Licensed Assets; and (g) Duke, as the sponsor of the
Duke IND (so noted as the Licensed Asset(s) on Schedule A to this
Agreement), has the full power, right and authority to provide Celldex with
access to and has permission to cross reference all appropriate and relevant
historical data contained therein, ever cognizant of any HIPPA regulations
and/or limitations and to include all data generated by any collaborating
investigator involved in conducting research and clinical development under the
requisite provisions of the Duke IND.


 


3.2                                 Disclaimers.


 


3.2.1                             No
Implied Warranties.  EXCEPT AS
OTHERWISE EXPRESSLY SET FORTH HEREIN, NEITHER PARTY MAKES ANY REPRESENTATIONS
OR EXTENDS ANY WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED.


 


3.3                                 Indemnities.


 


3.3.1                             Indemnities.  Celldex and Duke shall indemnify, defend and
hold the other Party (and such other Party’s Affiliates and
Sublicensees/Licensees and their respective 


 


4





















 


officers, directors, representatives and
agents) harmless for any and all losses, liabilities, damages, settlements,
costs, legal fees and other expenses incurred in connection with any and all
suits, investigations, claims, demands by a Third Party, including personal
injury, property damage or death (collectively, “Losses”)
against either Party based on a breach by the indemnifying Party, the
indemnifying Party’s Affiliates or, with respect to Celldex,
Sublicensees/Licensees or their respective representatives, agents, employees,
or officers, of any representation, warranty, covenant or other obligation
under this Agreement; provided, however, that the foregoing shall not apply to
the extent the Loss is found to be based upon the gross negligence, recklessness
or willful misconduct of the Party seeking indemnification.


 


3.3.2                             Indemnification
Process.


 


(a)          All
indemnification claims in respect of a Party, its Affiliates, their respective
Sublicensees/Licensees or their respective directors, officers, employees and
agents (each, an “Indemnitee”)
shall be made solely by such Party to this Agreement (the “Indemnified  Party”).  The
Indemnified Party shall give the indemnifying Party prompt written notice of
any Loss or discovery of fact upon which such indemnified Party intends to base
a request for indemnification under this Section 3.3 (a “Claim”), but in no event shall the
indemnifying Party be liable for any Losses that result from any delay in
providing such notice.


 


(b)         At its option,
the indemnifying Party may assume the defense of any Claim.  Upon assuming the defense of a Claim, the
indemnifying Party may appoint as lead counsel in the defense of the Claim any
legal counsel selected by the indemnifying Party that is reasonably acceptable
to the Indemnified Party.  Should the
indemnifying Party assume the defense of a Claim, the indemnifying Party shall
not be liable to the Indemnified Party for any legal expenses subsequently
incurred by such Indemnified Party or an Indemnitee in connection with the analysis,
defense or settlement of the Third Party Claim; provided that the Indemnified Party shall be entitled to
participate in, but not control, the defense of such Claim and to employ
counsel of its choice for such purpose, which shall be at the Indemnified Party’s
own expense unless (A) the employment thereof has been specifically
authorized by the indemnifying Party in writing, (B) the indemnifying
Party has failed to assume the defense and employ counsel in accordance with
this Section 3.3.2(b) (in which case the Indemnified Party shall
control the defense) or (C) the interests of the Indemnified Party or the
Indemnitee, on the one hand, and the indemnifying Party, on the other, with
respect to such Claim are sufficiently adverse to prohibit the representation
by the same counsel of both parties under applicable law, ethical rules or
equitable principles (in which case the Indemnified Party shall control the
defense with respect to it and the Indemnitee).


 


(c)          With respect to
any Losses relating solely to the payment of money damages in connection with a
Claim and that will not result in the Indemnified Party’s or any other
Indemnitee becoming subject to injunctive or other relief or otherwise
adversely affecting the business of the Indemnified Party or such Indemnitee in
any manner, and as to which the indemnifying Party shall have acknowledged in
writing the obligation to indemnify the Indemnified Party and such Indemnitee
hereunder, the indemnifying Party shall have the sole right to consent to the entry
of any judgment, enter into any settlement or otherwise dispose of such Loss,
on such terms as the indemnifying Party, in its sole discretion, shall deem
appropriate.  With respect to all other
Losses in connection with Claims, where the indemnifying Party has 


 


5





















 


assumed the defense
of the Claim in accordance with Section 3.3.2(b), the indemnifying Party
shall have authority to consent to the entry of any judgment, enter into any
settlement or otherwise dispose of such Loss provided it obtains the prior
written consent of the Indemnified Party (which consent shall not be
unreasonably withheld, conditioned or delayed). 
The indemnifying Party shall not be liable for any settlement or other
disposition of a Loss by an Indemnified Party or an Indemnitee that is reached
without the written consent of the indemnifying Party, not to be unreasonably
withheld, conditioned or delayed. 
Regardless of whether the indemnifying Party chooses to defend or
prosecute any Claim, no Indemnified Party or Indemnitee shall admit any
liability with respect to, or settle, compromise or discharge, any Claim
without the prior written consent of the indemnifying Party, not to be
unreasonably withheld, conditioned or delayed.


 


(d)         Regardless of
whether the indemnifying Party chooses to defend or prosecute any Claim, the
Indemnified Party shall, and shall cause each Indemnitee to, cooperate in the
defense or prosecution thereof and shall furnish such records, information and
testimony, provide such witnesses and attend such conferences, discovery
proceedings, hearings, trials and appeals as may be reasonably requested in
connection therewith.


 


4.                                      Consideration
to Duke


 


4.1                                 Upfront
Payments.  In
partial consideration of the Licensed Assets licensed to Celldex and Duke’s
other covenants hereunder, Celldex shall [ **** ].


 


4.2                                 Royalties.


 


4.2.1                        Royalty
Obligation.  Subject to Section 4.2.5
below, in partial consideration of the Licensed Assets licensed to Celldex
hereunder, and Duke’s other covenants and agreements hereunder, Celldex shall
pay Duke an earned royalty in the amount of [ **** ].  For avoidance of doubt, in no event shall
Duke be entitled to any royalties on Net Sales of any Celldex Product which is
outside the Field.


 


4.2.2                        Credit.  All amounts paid to Duke by Celldex pursuant
to Section 4.3 below shall be credited against future earned royalty
payments otherwise due under this Section 4.2 [ **** ].


 


4.2.3                        Royalty
Payments.  Running royalties shall be
payable on a quarterly basis, within sixty (60) days after the end of each
calendar quarter, based upon the Net Sales during such calendar quarter,
commencing with the calendar quarter in which the first commercial sale of a
Celldex Product is made.  Royalties shall
be calculated in accordance with U.S. GAAP and with the terms of this Article 4.


 


4.2.4                        Royalty
Statements.  Celldex shall deliver to
Duke within forty-five (45) days after the end of each calendar quarter in
which Celldex Products for which Celldex owes a royalty hereunder are sold, a
detailed statement showing Net Sales of each such Celldex Product on a country
by country basis during the applicable calendar quarter; and the amount and
calculation of royalties due on such Net Sales.


 


6





















 


4.2.5                        Third
Party Royalty Offsets.  For each
Celldex Product sold by Celldex, its Affiliates and Sublicensees/Licensees that
is subject to the royalty payment obligation set forth in Section 4.2.1,
Celldex, its Affiliates and its Sublicensees/Licensees shall receive a credit
against amounts otherwise owed to Duke under Section 4.2.1 equal to the
royalties that Celldex, its Affiliates and its Sublicensees/Licensees are
required to pay to Third Parties on Net Sales of such Celldex Product, [ **** ]
of the Net Sales of that Celldex Product for which such Third-Party royalties
are being paid.  If Celldex or any of its
Affiliates or Sublicensees/Licensees is required to pay royalties to a Third
Party on the Celldex Products, Celldex shall use commercially reasonable
efforts to have any royalties owed to such Third Party reduced by the same
proportion as the royalties are reduced pursuant to this Section 4.2.5.  For avoidance of doubt, “commercially
reasonable efforts,” shall be deemed not to require any payment of money or
other financial consideration by Celldex, its Affiliates or
Sublicensees/Licensees to any Third Party. 
Notwithstanding the above offsets, in no event shall Celldex’s
obligation to make payments to Duke under this Agreement fall below [ **** ] per
year in any one-year reporting period in which earned royalties on Net Sales of
Celldex Products in the Field are due and owing to Duke under Section 4.2
hereof.


 


4.3                                 Milestone
Payments, License Maintenance Fees and Other Charges.  In partial consideration of the Licensed
Assets licensed to Celldex hereunder, and Duke’s other covenants and agreements
hereunder, Celldex shall pay to Duke the following additional payments as
follows:


 


(a)          [ **** ] after
the first BLA (or EMEA equivalent) filing for first claim indication for a
Celldex Product in the Field;


 


(b)         [ **** ] after
first approval of first claim indication for a Celldex Product in the Field in
the United States, European Union or Japan; and


 


(c)          [ **** ] after
EACH first approval of subsequent claim(s) indication for a Celldex
Product in the Field in the United States, European Union or Japan.


 


(d)         [ **** ].  Any and all payments made by Celldex to Duke
pursuant to Sections 4.2, 4.3(a), (b) and(c) or 4.5 shall be credited
against Celldex’s payment obligations under this subsection 4.3(d).


 


4.4                                 Payment
Method. 
All amounts due by Celldex under Section 4.3 hereof shall be paid
in U.S. dollars by wire transfer in immediately available funds to an account
designated by Duke or, at Celldex’s discretion, if the Common Stock is listed
or quoted on the Nasdaq National Market or other nationally recognized
exchanges in the United States, the European Union, Canada or Japan, in shares
of Common Stock, but in no case shall such payment in Common Stock represent
more than 50% of the total payment due under Section 4.3.  For purposes of this Section 4.4, the
dollar value per share to be attributed to the Common Stock issued to Duke
hereunder shall be the average of the closing prices of the Common Stock on its
primary exchange for the ten (10) trading days preceding the date such
payment is to be determined.


 


7





















 


4.5                                 Sublicensing
Payments. 
Celldex shall pay to Duke [ **** ] of all payments received by Celldex
or its Affiliates from any Sublicensee/Licensee with respect to product
development and/or territorial sales rights for Celldex Products.  For avoidance of doubt, Celldex shall have no
payment obligations under this Section 4.5 for any payment received by
Celldex in consideration for [ **** ] or with respect to collaborative research
and development activities performed by Celldex or its collaborative partners.


 


4.6                                 Records
Retention; Audit.


 


4.6.1                             Record
Retention.  Celldex shall maintain (and shall
ensure that its Affiliates and their respective Sublicensees/Licensees shall
maintain) complete and accurate books, records and accounts that fairly reflect
their respective  Net Sales and the
components thereof with respect to  Celldex
Products in sufficient detail to confirm the accuracy of any payments required
hereunder and in accordance with GAAP, which books, records and accounts shall
be retained by Celldex until one (1) year after the end of the period to
which such books, records and accounts pertain.


 


4.6.2                             Audit.  Duke shall have the right for a period of one
(1) year after receiving any Celldex report to have an independent
certified public accounting firm of nationally recognized standing, reasonably
acceptable to Celldex, to have access during normal business hours, and upon
reasonable prior written notice, to such of the records of Celldex (and its
Affiliates and their respective Sublicensees/Licensees) as may be reasonably
necessary to verify the accuracy of such Net Sales and related expenses for
that calendar quarter. Duke shall not have the right to conduct more than one
such audit in any twelve (12)-month period. 
The accounting firm shall disclose to each Party whether such Net Sales
and related expenses, as applicable,  are
correct or incorrect and the specific details concerning any
discrepancies.  No other information
shall be provided to Duke.  Duke shall
bear the cost of such audit unless the audit reveals a variance of more than
five percent (5%) from the reported results, in which case Celldex shall bear
the cost of the audit.  The results of
such accounting firm shall be final, absent manifest error. Duke agrees to hold
in strict confidence all information concerning royalty payments and reports, and
all information learned in the course of any audit or inspection, except to the
extent necessary for Duke to reveal such information in order to enforce its
rights under this Agreement or if disclosure is required by law.  The failure of Duke to request verification
of any report or statement during said one-year period shall be considered
acceptance of the accuracy of such report. 
Duke shall cause its accounting firm to enter into a reasonably
acceptable confidentiality agreement with Celldex obligating such firm to
maintain all such financial information in confidence pursuant to such
confidentiality agreement.


 


4.6.3                             Payment
of Additional Royalties.  If, based
on the results of such audit, additional payments are owed by Celldex under
this Agreement, Celldex shall make such additional payments within forty-five
(45) days after the date on which such accounting firm’s written report is
delivered to Celldex.


 


5.                                      Additional
Agreements, Covenants, Representations of Duke and Celldex.


 


5.1                                 Material
Transfer. 
Upon Celldex’s request, Duke shall provide Celldex with all PEP-3
product required by Celldex, its Affiliates or Sublicensees/Licensees for use
in clinical 


 


8





















 


trials, other reagents/data, monoclonal antibody cell lines,
tumor models, or other tangible materials, documents or data possessed by Duke
or its employees or Affiliates and requested by Celldex for the purpose of
advancing Celldex’s research and development programs, including, without
limitation, access and reference to all existing and future data relevant to
the PEP 3 (Celldex CDX 110 GBM) vaccine program as contained in the Licensed
Assets and/or otherwise generated under any sponsored research agreement
executed and conducted between the parties.


 


5.2                                 Agreements
Regarding Shares.  Duke
agrees that it shall be subject to and shall enter into all stockholder
agreements, holdback agreements and related documents as shall be required of
the other holders of Celldex’s Common Stock from time to time.  Duke hereby further agrees that, to the
extent requested by Celldex or any managing underwriter of Celldex, Duke will
not sell, make short sale of, loan, grant any options for the purchase of, or
otherwise dispose of (other than to donees who agree to be similarly bound):  (i) any Shares during a period of up to
three hundred sixty (360) days following the completion of the initial public
offering of Celldex’s Common Stock or (ii) any of the Shares during a
period of up to ninety (90) days following the completion of any subsequent
public offering (or such shorter period as Celldex or any managing underwriter
may authorize); provided, however, that the preceding restrictions shall apply
to Duke only to the same extent, if any, that such restrictions apply to all
directors, officers and holders of at least 5% of Celldex’s Common Stock at the
time.  Duke shall enter into customary
lock-up agreements as is reasonably requested by Celldex or any underwriter
with respect to the Shares; provided, however, that such lock-up agreements shall
apply to Duke only to the same extent, if any, that the subject lock-up
agreements apply to all directors, officers and holders of at least 5% of
Celldex’s Common Stock at the time.


 


5.3                                 Investment
Representations. 
Duke acknowledges that the Shares are being issued under the exemption
from registration provided by Section 4(2) of the Securities Act of
1933, as amended (the “Securities Act”)
and that the Shares have not been registered under the Securities Act or the
securities laws of any jurisdiction. 
Duke represents, warrants and acknowledges as follows:  it is an “accredited investor,” as defined in
Regulation D under the Securities Act; it has had a meaningful opportunity to
ask questions concerning Celldex and the Shares of the executive officers of
Celldex; it has had full access to all relevant information concerning Celldex
and its investment in the Shares; there are substantial restrictions on the
transferability of the Shares and there is no public market for the Shares, and
therefore it may not be possible to liquidate the Shares in the case of
emergency; Duke is acquiring the Shares for its own investment purposes and not
with a view to, or in connection with a sale or distribution thereof; Duke has
no contract, understanding, undertaking, agreement or arrangement, formal or
informal, to sell, transfer or pledge to any person the Shares or any part
thereof and it consents to the placement of restrictive legends on the stock
certificates representing the Shares, which will be in substantially the
following form:


 


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


 


9

















 


5.4                                 Celldex
Clinical Studies. 
Upon commercially reasonable terms and conditions to be mutually agreed
upon by the Parties, Celldex shall use its best efforts to include Duke as a
clinical trial site for the development of a PEP 3 vaccine program for the
development of Glioblastoma Multiforme (GBM) and other related brain cancers to
be initiated by Celldex or its Affiliates. 
Celldex will use commercially reasonable efforts to provide clinical
grade material, to the extent available to Celldex, for use in future
Duke-initiated clinical trials that have been approved by Celldex; provided
that Duke shall agree to provide Celldex with access to any and all data and
results arising out of any such clinical trials at no additional cost beyond
the sponsored studies to Celldex.  The
terms and conditions governing Duke’s agreement to provide access to such data
shall be set forth in a separately negotiated and budgeted Sponsored Research
Agreement between the parties.


 


5.5                                 Submission
of IND Data to the FDA.  As soon as reasonably practicable, Duke shall
provide the FDA with the appropriate IND data tables related to the Duke
IND.  The parties hereto acknowledge and
agree that the Duke IND will represent supportive information for the filing of
a Celldex IND.  Duke acknowledges that
the FDA will need complete data in order to evaluate the previous human
experience.  Duke hereby agrees to submit
to the FDA, as soon as reasonably practicable, as an IND serial submission, a
complete listing of data currently available from patients on the Activate
trial. Such submission shall include all adverse event and SAE information
(with severity of event, duration and attribution) and Time to Progression and
survival information on all patients. 
Additional data will be provided by Duke at the FDA’s request, provided
that such data is available as part of the Licensed Assets and as required by
the FDA as part of the Duke IND filing. 
If additional data is requested which is not readily available, the
Parties agree to confer as to how to address such request, the potential costs
associated therewith and how to resolve the issue.


 


5.6                                 Duke
Protocols. 
Upon Celldex’s request, Duke shall provide Celldex with the detailed
protocol used for immunohistochemistry (IHC) in the clinical trials as well as
all relevant information related to the manufacturing and safety of the PEP 3vaccine
used in connection with the Duke IND.


 


5.7                                 Research
Grant. 
Celldex, at its sole discretion and in a time frame it shall elect,
should it so choose, will provide an Unrestricted Research Grant in the
aggregate amount of [ **** ] (the “Grant”) to the laboratory of Dr. John
Sampson, Associate Professor – Surgery (Neurosurgery), Duke University School
of Medicine.  The Grant shall be used to
provide funding for related research in the Field.  The Grant shall be made in the installments
as set forth below:


 


	
  Amount

  	
   

  	
  Payment Date

  
	
   

  	
   

  	
   

  
	
  [ **** ]

  	
   

  	
  Upon
  execution of an Unrestricted Research Grant Agreement Letter.

  
	
   

  	
   

  	
   

  
	
  [ **** ]

  	
   

  	
  Within
  thirty (30) days of the date of the Unrestricted Grant Agreement Letter.

  
	
   

  	
   

  	
   

  
	
  [ **** ]

  	
   

  	
  Within
  ninety (90) days of the date of the 

  



 


10

















 


	
   

  	
   

  	
  Unrestricted
  Research Grant Agreement Letter; provided that such final payment shall only
  be due and payable upon the submission by Duke to Celldex of a Statement of
  Research Intent describing a Research Program agreeable to both Parties.
  Further, periodic reports, not less than quarterly after the commencement of
  the research conducted under such research plan shall be provided to CELLDEX;
  and in the event that data or other information generated under such research
  plan is deemed to be within the definition and scope of Licensed Assets under
  the terms of this Agreement, then all such data and/or information shall be
  made available and accessible to CELLDEX for its evaluation and use.

  



 


6.                                      Confidentiality.


 


6.1                                 Treatment
of Confidential Information.  Each Party shall maintain all information of
the other Party and its Affiliates in confidence, including the existence and
terms and conditions of this Agreement, and shall not disclose, divulge or
otherwise communicate such 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, and hereby agrees to exercise every reasonable precaution to prevent
and restrain the unauthorized disclosure or use of such information by any of
its Affiliates, directors, officers, employees, consultants, subcontractors,
sublicensees or agents.


 


6.2                                 Release
from Restrictions. The provisions of Section 6.1 shall
not apply to any information disclosed hereunder that: (a) was known or
used by the receiving Party or its Affiliates prior to its date of disclosure
to the receiving Party, as evidenced by the prior written records of the
receiving Party or its Affiliates; or (b) either before or after the date
of the disclosure to the receiving Party is lawfully disclosed without
restriction to the receiving Party or its Affiliates by an independent,
unaffiliated Third Party rightfully in possession of the confidential
information (but only to the extent of the rights received from such Third
Party); or (c) either before or after the date of the disclosure to the
receiving Party becomes published or generally known to the public through no
fault or omission on the part of the receiving Party or its Affiliates; or (d) is
generally made available by the disclosing Party to Third Parties without
restriction; Further, the receiving Party shall have the right to disclose
information disclosed by the other Party (x) to the extent necessary to
comply with applicable laws, to defend or prosecute litigation or to comply
with governmental regulations, or the rules of a stock exchange or NASDAQ,
provided that the receiving Party
provides prior written notice of such disclosure to the other Party and takes
reasonable and lawful actions to avoid or minimize the degree of such
disclosure including assisting the Party whose information is being disclosed
to seek confidential treatment or a protective order, or (y) to existing
or potential acquirers or merger candidates, existing or potential
Sublicensees/Licensees, investment bankers, existing or potential investors,
venture capital firms or other financial institutions or investors for purposes
of obtaining 


 


11





















 


financing, each of whom prior to disclosure must be bound by
obligations of confidentiality and non-use at least equivalent in scope to
those set forth in this Article 6.


 


7.                                      Miscellaneous.


 


7.1                                 Construction.  Except where the context requires otherwise,
whenever used the singular includes the plural, the plural includes the
singular, the use of any gender is applicable to all genders and the word “or”
has the inclusive meaning represented by the phrase “and/or”.  Whenever this Agreement refers to a number of
days, unless otherwise specified, such number refers to calendar days.  The headings of this Agreement are for
convenience of reference only and do not define, describe, extend or limit the
scope or intent of this Agreement or the scope or intent of any provision
contained in this Agreement.  The term “including”
or “includes” as used in this Agreement means including, without limiting the
generality of any description preceding such term.  The wording of this Agreement shall be deemed
to be the wording mutually chosen by the Parties and no rule of strict
construction shall be applied against any Party.


 


7.2                                 Publicity.  Except as otherwise required by law, rule or
regulation, neither Party shall issue a press release regarding this Agreement
or originate any publicity, news release or other public announcement, written
or oral, relating to this Agreement without the prior written approval of the
other Party; provided, however, that the Parties agree that
disclosures of information for which consent has been previously obtained shall
not require additional approval.  If a
public disclosure is required by law, rule or regulation, the disclosing
Party shall provide copies of the disclosure reasonably in advance of such
filing or other disclosure for the nondisclosing Party’s prior review and
comment; provided, however, that no such review and comment shall
be required for any filing with the Securities and Exchange Commission,
including on Form 10K or Form 10Q or Form 8K or other similar
filing under the Securities Exchange Act of 1934, as amended, or a Registration
Statement under the Securities Act of 1933, as amended


 


7.3                                 No
Implied Licenses. 
Only the licenses granted pursuant to the express terms of this
Agreement shall be of any legal force and effect.  No license rights shall be created by
implication or estoppel.


 


7.4                                 No
Agency. 
Nothing herein shall be deemed to constitute any Party as the agent or
representative of the other Party, or the Parties as joint venturers or
partners for any purpose.


 


7.5                                 Notice.   Any
notice, request, demand, waiver, consent, approval or other communication
permitted or required under this Agreement shall be in writing, shall refer
specifically to this Agreement and shall be deemed given only if delivered by
hand or by nationally recognized overnight delivery service that maintains
records of delivery, addressed to the Parties at their respective addresses set
forth below or to such other address as the Party to whom notice is to be given
may have provided to the other Party in accordance with this Section 7.5.  Such notice shall be deemed to have been
given as of the date delivered by hand 
or on the third business day (at the place of delivery) after deposit
with a nationally recognized overnight delivery service.


 


12





















 


	
  If to Duke:

  	
   

  	
  For delivery
  via the U.S. Postal Service

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Office of Corporate and Venture Development

  
	
   

  	
   

  	
  Duke University

  
	
   

  	
   

  	
  Attention: License Administrator

  
	
   

  	
   

  	
  31 Tower Blvd., Suite 1300

  
	
   

  	
   

  	
  Box 90083

  
	
   

  	
   

  	
  Durham, NC 27708 USA

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  For
  delivery via nationally/internationally recognized courier

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Office of Corporate and Venture Development

  
	
   

  	
   

  	
  Duke University

  
	
   

  	
   

  	
  Attention: License Administrator

  
	
   

  	
   

  	
  31 Tower Blvd., Suite 1300

  
	
   

  	
   

  	
  Box 90083

  
	
   

  	
   

  	
  Durham, NC 27705 USA

  
	
   

  	
   

  	
   

  
	
  With a copy
  to (if of a legal nature):

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  Office of University Counsel

  
	
   

  	
   

  	
  Duke University

  
	
   

  	
   

  	
  2400 Pratt Street, Suite 4000

  
	
   

  	
   

  	
  Durham, NC 27710

  
	
   

  	
   

  	
   

  
	
  If to
  Celldex:

  	
   

  	
  Celldex
  Therapeutics, Inc.

  
	
   

  	
   

  	
  222 Cameron
  Drive, Suite 400

  
	
   

  	
   

  	
  Phillipsburg,
  NJ 08865

  
	
   

  	
   

  	
  Attention:
  President

  
	
   

  	
   

  	
   

  
	
  With copies
  to:

  	
   

  	
  Satterlee
  Stephens Burke & Burke LLP

  
	
   

  	
   

  	
  230 Park
  Avenue

  
	
   

  	
   

  	
  New York, NY
  10169

  
	
   

  	
   

  	
  Attn:
  Dwight A. Kinsey, Esq

  
				



.


 


7.6                                 Assignment.  This Agreement, and the rights and
obligations hereunder, may not be assigned or transferred, in whole or in part,
by any Party without the prior written consent of the other Party, except (a) to
Affiliates of such Party, or (b) in connection with a Change of Control,
provided that any assignee or the successor entity agrees to be bound by the
terms and conditions of this Agreement and provided furthermore that the
assigning Party, if it survives, continues to remain primarily liable for
performance of any Affiliate to which it assigns the Agreement or any of its
rights or obligations hereunder, and (c) if Celldex transfers a Celldex
Product to a Third Party provided such entity agrees to be bound by the terms
and conditions of this Agreement and provided furthermore that Celldex
continues to remain primarily liable for performance by the Third Party to
which it assigns the Agreement or any of its rights or obligations
hereunder.  Without limiting the
preceding sentence, all validly assigned rights of a Party shall inure to the
benefit of and be enforceable by, and all validly delegated obligations of such
Party shall be binding on and be enforceable against, the permitted successors
and assigns 


 


13





















 


of such Party.  Any
attempted assignment or delegation in violation of this Section 7.6 shall
be void.  The license granted in this
Agreement shall be binding on any successor of Duke in Control of the Licensed
Assets.


 


7.7                                 No
Modification. 
This Agreement may be amended only by a writing signed by authorized
representatives of the Parties.


 


7.8                                 Waiver.  The waiver by any Party of a breach or a
default of any provision of this Agreement by the other Party shall not be
construed as a waiver of any succeeding breach of the same or any other
provision, nor shall any delay or omission on the part of any Party to exercise
or avail itself of any right, power or privilege that it has or may have
hereunder operate as a waiver of any right, power, or privilege by such Party.


 


7.9                                 Severability.  To the fullest extent permitted by applicable
law, the Parties waive any provision of law that would render any provision in
this Agreement invalid, illegal or unenforceable in any respect.  If any provision of this Agreement is held to
be invalid, illegal or unenforceable, in any respect, then such provision will
be given no effect by the Parties and shall not form part of this
Agreement.  To the fullest extent
permitted by applicable law and if the rights or obligations of any Party will
not be materially and adversely affected, all other provisions of this
Agreement shall remain in full force and effect and the Parties will use their
best efforts to negotiate a provision in replacement of the provision held
invalid, illegal or unenforceable that is consistent with applicable law and
achieves, as nearly as possible, the original intention of the Parties.


 


7.10                           Counterparts.  This Agreement may be executed in any number
of counterparts, each of which shall be deemed an original but all of which
together shall constitute one and the same instrument.


 


7.11                           Governing
Law; Jurisdiction and Venue.  This Agreement shall in all events and for
all purposes be governed by, and construed in accordance with, the laws of the
State of Delaware without regard to any choice of law principle that would
dictate the application of the law of another jurisdiction.  The
Parties hereby irrevocably and unconditionally consent to the exclusive
jurisdiction of the courts of the State of Delaware and the United States
District Court for the District of Delaware for any action, suit or proceeding (other
than appeals therefrom) arising out of or relating to this Agreement, and agree
not to commence any action, suit or proceeding (other than appeals therefrom)
related thereto except in such courts. 
The Parties further hereby irrevocably and unconditionally waive any
objection to the laying of venue of any action, suit or proceeding (other than
appeals therefrom) arising out of or relating to this Agreement in the courts
of the State of Delaware or the United States District Court for the District of
Delaware, and hereby further irrevocably and unconditionally waive and agree
not to plead or claim in any such court that any such action, suit or
proceeding brought in any such court has been brought in an inconvenient forum.  Each Party hereto further agrees that service
of any process, summons, notice or document by U.S. registered mail to its
address set forth below shall be effective service of process for any action,
suit or proceeding brought against it under this Agreement in any such court.


 


14





















 


7.12                           No
Consents. 
Neither Party requires any consents, permissions, waivers or licenses
from third parties in order to provide each other with the license rights
provided for herein or to otherwise satisfy the terms of this Agreement.


 


7.13                           Entire
Agreement. 
This Agreement constitutes the entire agreement of the Parties with
regard to its subject matter, and supersedes all previous written or oral
representations, agreements and understandings between the Parties.


 


15





















 


IN WITNESS WHEREOF, duly-authorized
representatives of the Parties have signed this License Agreement as a document
under seal as of the Effective Date.


 


	
  DUKE UNIVERSITY

  	
  CELLDEX THERAPEUTICS, INC.

  
	
   

  	
   

  
	
   

  
	
  By:

  	
   

  	
   

  	
  By:

  	
      /s/ Anthony Marucci

  
	
  Name:

  	
  Name:

  	
  Anthony S. Marucci

  
	
  Title:

  	
  Title: Vice President and Chief Financial

  
	
   

  	
   

  	
  Officer

  
						



 


16

















 


Schedule A


Licensed Assets


 


The Licensed Assets shall
include, without limitation, that certain Investigator IND FDA No. 9944
and all information relevant to FDA review of IND FDA No. 9944.  Access to and the right to cross reference
other INDs cited in IND FDA No. 9944, to wit, INDs FDA Nos. 8319, 4250,
8434, 7462 and 4966 and so referenced therein will be extended to Celldex, but
only to the extent of Duke’s power and ability to do so.  The Licensed Assets shall also include (i) any
and all associated Phase I and Phase II clinical trial data for the EGFRvIII
peptide vaccine held by Dr. John Sampson, Associate Professor,
Neurosurgery, Duke University Medical Center, which such data shall include all
data associated with patients treated with the PEP-3 vaccine under said IND FDA
No. 9944; (ii) any and all data and other information developed as a
consequence of the activities funded by the Unrestricted Research Grant, in so
far as it may relate to said IND; and (iii) all relevant historical data,
inclusive of all data produced by any collaborating investigators conducting
work under the Investigator IND FDA No. 9944. Any such data and
information shall also be accessible to and referenceable by Celldex.


 


17