Exhibit 10.45


 


CONFIDENTIAL TREATMENT HAS BEEN REQUESTED AS TO CERTAIN PORTIONS OF
THIS DOCUMENT. EACH SUCH PORTION, WHICH HAS BEEN OMITTED HEREIN AND REPLACED
WITH AN ASTERISK [*], HAS BEEN FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.


 


RESEARCH COLLABORATION AND COMMERCIALIZATION AGREEMENT


 


THIS
RESEARCH AND COMMERCIALIZATION AGREEMENT (the “Agreement”),
effective as of October 20, 2006 (the “Effective Date”), is entered by and
between CELLDEX THERAPEUTICS, INC., a New
Jersey corporation, with a principal place of business at 222 Cameron Drive, Suite 400,
Phillipsburg, New Jersey, NJ 08865, (“Celldex”) and the  LUDWIG INSTITUTE FOR CANCER RESEARCH,  a
Swiss not-for-profit corporation with a registered office at Stadelhoferstrasse
22, 8001 Zurich, Switzerland, and an office at 605 Third Avenue, 33rd Floor, New York, NY 10158 USA, (“Ludwig”).


 


BACKGROUND


 


A.            Ludwig and its affiliates are own or
Control certain intellectual property rights (as defined below) together with
all commercialization rights associated with such intellectual property;


 


B.            Celldex
wishes to secure a license to such intellectual property rights and to
establish an ongoing research collaboration with Ludwig; and


 


C.            Ludwig
proposes to grant certain rights to Celldex under the terms of this Agreement
and to enter into a research collaboration with Celldex.


 


NOW
THEREFORE, Celldex and Ludwig agree as follows:


 


1.                                      DEFINITIONS


 


1.1   “Affiliate”
shall mean any Person that, directly or indirectly, through one or more
intermediaries, controls, is controlled by, or is under common control with
another Person.  For purposes of this
definition only, “control” and, with correlative meanings, the terms “controlled
by” and “under common control with” shall mean (a) the possession, directly
or indirectly, of the power to direct the management or policies of a Person,
whether through the ownership of voting securities or by contract relating to
voting rights or corporate governance, or (b) the ownership, directly or
indirectly, of at least fifty percent (50%) of the voting securities or other
ownership interest of a Person; provided that, if local law restricts foreign
ownership, control will be established by direct or indirect ownership of the
maximum ownership percentage that may, under such local law, be owned by
foreign interests.  For purposes of this Section 1.1,
“Person” shall mean an individual, sole proprietorship, partnership, limited
partnership, limited liability partnership, corporation, limited liability
company, business trust, joint stock company, trust, unincorporated
association, joint venture or other similar entity or organization, including a
government or political subdivision, department or agency of a government.


 


1

















 


1.2   “Approval”
shall mean all approvals, licenses, registrations and authorizations of all
governmental agencies in a country necessary for the manufacture, use or sale
of a Licensed Product in the applicable country.


 


1.3   “Biological
License Application” or “BLA” shall
mean a Biological License Application as defined in the U.S. Food, Drug and
Cosmetics Act and the regulations promulgated thereunder, and any corresponding
or equivalent foreign application, registration or certification.


 


1.4   “Calendar Quarter”
shall mean each three-month period commencing January 1, April 1, July 1
or October 1 of each year during the term of this Agreement.


 


1.5   “Celldex
Clinical Reagent(s)” shall mean reagents utilizing Celldex Patent
Rights or Celldex Know-How and Ludwig Patent Rights or Ludwig Know-How and
produced by or for Celldex to a clinical grade of GMP quality for use within
the Research Program.


 


1.6   “Celldex APC
Targeting Technology” shall mean any molecules expressly designed to
selectively bind to antigen presenting cells through internalizing cell surface
receptors and to carry Ludwig Antigens into these cells for subsequent immune
processing which are covered or claimed, or for which the manufacture or use in
the Field is covered or claimed, by a Valid Claim of an issued patent or a
pending patent application within Celldex Patent Rights.


 


1.7   “Celldex
Patent Rights” shall mean all: (i) U.S. patent applications,
provisional applications, continuations, continuations-in-part, substitutions
and divisionals; (ii) issued U.S. patents, re-examinations, reissues,
renewals, extensions and term restorations; and (iii) non-U.S.
counterparts of the foregoing applications and patents in (i) and (ii);
that are in each case owned or Controlled by Celldex and that claim or cover
the composition of matter of, methods of making, or methods of using  molecules expressly designed to selectively
bind to antigen presenting cells through internalizing cell surface receptors
and to carry antigens into these cells for subsequent immune processing;  in each case whether such patents or
applications are filed before, on or after the date of this Agreement. Celldex
Patent Rights existing as of the Effective Date of this Agreement shall be identified
in Appendix B. Celldex may propose adding additional patents and applications
filed after the Effective Date of this Agreement to Appendix B and Ludwig shall
consider this request in good faith and provide its consent subject to Celldex’s
established right of use and Ludwig being able to extend the rights under this
Agreement having established that such consent does not conflict with license
rights granted by Ludwig to third parties prior to the Effective Date of this
Agreement.


 


1.8   “Celldex
Know-How” shall mean all data, information, inventions, discoveries,
processes, methods, compositions, formulae, procedures, protocols, techniques,
and results of experimentation and testing, including without limitation
clinical trial data, whether patentable or not, that are owned or Controlled by
Celldex and that relate to composition of matter of, methods of making, or
methods of using the Licensed Products.


 


1.9   “Celldex
Product” shall mean any product covered by Celldex Know-How or
within Celldex Patent Rights.


 


2

















 


1.10   “Collaboration
Steering Committee” shall have the meaning described in Article 2.2.


 


1.11   “Commercially
Reasonable Efforts” shall mean, with respect to a Licensed Product,
efforts and resources similar to those employed by companies in a similar stage
of development as Celldex to develop, manufacture or market a Licensed Product
of similar market potential at a similar stage in its Licensed Product life,
taking into account for example the establishment of the Licensed Product in
the marketplace, the competitiveness of alternative Licensed Products, the
likely proprietary position of the Licensed Product, the likelihood of
regulatory approval for the Licensed Product, the potential profitability of
the Licensed Product and Celldex’s resources available.  Commercially Reasonable Efforts shall be
determined on a market-by-market basis for each Licensed Product.


 


1.12   “Confidential
Information” shall mean, subject to the provisions of Article 9
hereof, any information, whether in oral, written, graphic, electronic or
tangible form, disclosed by one party to the other hereunder or under any
agreement governing the use and disclosure of confidential information entered
into by the parties prior to the Effective Date.


 


1.13   “Control”
or “Controlled” shall mean, with respect
to a particular item of information or intellectual property right, (i) that
the party owns or co-owns and has the ability to grant to the other party the
licenses to such item provided for herein, without violating the terms of any
agreement or other arrangement with any third party, and/or (ii) that the
party has a license to such item and has the ability to grant to the other
party the licenses to such item provided for herein, without violating the
terms of any agreement or other arrangement with any third party;  in each case whether such rights are acquired
before, on or after the date of this Agreement.


 


1.14   “Field”  shall mean any and all human and animal healthcare applications
including therapy, diagnosis and prognostic monitoring, and prophylaxis.


 


1.15   “FDA”
shall mean the U.S. Food and Drug Administration and any successor agency
thereto.


 


1.16   “First
Commercial Sale” shall mean, with respect to each Licensed Product
in each country, the first bona fide commercial sale by Celldex, its Affiliates
or Sub-licensees of such Licensed Product following Marketing Approval in such
country; provided, however, that where such first commercial sale has occurred
in a country for which government pricing or government reimbursement approval
is needed for widespread commercial sale (for clarification, the parties
acknowledge that no such approval is currently required in the United States),
then such sales shall not be deemed a First Commercial Sale until such pricing
or reimbursement approval has been obtained.


 


1.16.1 “Full Length Antigens”
shall mean the full length protein forms of the Ludwig Antigens [*].


 






* Confidential


 


3

















 


1.17     “IND”
shall mean an Investigational New Drug application, as defined in the U.S.
Food, Drug and Cosmetics Act and the regulations promulgated thereunder, or any
corresponding or equivalent foreign application, registration or certification.


 


1.18     “Licensed Product” will mean any Targeted Antigen Reagent
that is covered or claimed, or for which the manufacture or use in the Field is
covered or claimed, by a Valid Claim of an issued patent or a pending patent
application within Ludwig’s Patent Rights and which would be in breach of
Ludwig’s Patent Rights without a license to such Ludwig Patent Rights under
this Agreement.


 


1.19     “Ludwig Antigens” shall mean any antigen in
nucleotide, polynucleotide or peptide, polypeptide or full length gene or full
length protein form which is covered or claimed, or for which the manufacture
or use in the Field is covered or claimed, by a Valid Claim of an issued patent
or a pending patent application within Ludwig Patent Rights


 


1.19.1  “Ludwig
Know-How” shall mean all data,
information, inventions, discoveries, processes, methods, compositions,
formulae, procedures, protocols, techniques, and results of experimentation and
testing, including without limitation clinical trial data, whether patentable
or not, that are owned or Controlled by Ludwig and that relate to composition
of matter of, methods of making, or methods of using the Ludwig Antigens


 


1.20     “Ludwig Patent Rights” shall mean all: (i) U.S.
patent applications, provisional applications, continuations,
continuations-in-part, substitutions and divisionals; (ii) issued U.S.
patents, re-examinations, reissues, renewals, extensions and term restorations;
and (iii) non-U.S. counterparts of the foregoing applications and patents
in (i) and (ii); that are in each case owned or Controlled by Ludwig and
that claim or cover the composition of matter of, methods of making, or methods
of using Full Length Antigens and Part-Length Antigens listed in Appendix A.


 


1.21     “Marketing
Approval” shall mean, with respect to each country of the Territory
for a particular Licensed Product, approval of the applicable MAA filed in such
country by the health regulatory authority in such country that is the
counterpart of the FDA.  It is understood
that Marketing Approval does not necessarily include pricing or reimbursement
approval.


 


1.22     “Marketing
Approval Application” or “MAA” shall
mean, on a Licensed Product-by-Licensed Product basis, a New Drug Application
or Biologics License Application as required under the U.S. Food, Drug and
Cosmetics Act and the regulations promulgated thereunder, or a comparable
filing in a foreign country.


 


1.23     “Net Sales”
shall mean, for any period, the gross amount invoiced by the Celldex and its
Affiliates and Sublicensees for the sale of Licensed Product(s) to third
parties, less deductions for:


 


(a) normal and
customary trade, quantity and cash discounts and sales returns and allowances
(other than allowances for doubtful accounts), including (i) those granted
on account of price adjustments, billing errors, rejected goods, damaged goods,
returns and rebates, (ii) administrative and other fees and reimbursements
and similar payments directly related to the sale or delivery of Licensed
Product(s) paid to wholesalers and other distributors, buying groups,
pharmacy benefit management organizations, health care insurance carriers and
other 


 


4

















 


institutions, (iii) allowances,
rebates and fees directly related to the sale or delivery of Licensed Product(s) paid
to distributors and (iv) chargebacks;


 


(b) freight,
postage, shipping and insurance costs to the extent that such items are
included in the gross amount invoiced;


 


(c) customs and
excise duties and other duties related to the sales to the extent that such
items are included in the gross amount invoiced;


 


(d) rebates and
similar payments made with respect to sales paid for or reimbursed by any
governmental or regulatory authority such as, by way of illustration and not in
limitation of the parties’ rights hereunder, Federal or state Medicaid,
Medicare or similar state program or equivalent foreign governmental program;


 


(e) sales and other
taxes and duties directly related to the sale or delivery of Licensed Product(s) (but
not including taxes assessed against the income derived from such sale) to the
extent that such items are included in the gross amount invoiced;


 


(f) distribution
costs and expenses to the extent that such items are included in the gross
amount invoiced; and


 


(g) any such
invoiced amounts that are not collected by the parties or their Affiliates or
Sublicensees;


 


provided, however, that
with respect to the deductions specified in subsections (a) through (g) above,
an amount shall be deducted only once regardless of how many categories may
apply to it.


 


Any of the deductions
listed above that involves a payment by Celldex or its Affiliates or
Sub-licensees shall be taken as a deduction in the Calendar Quarter in which
the payment is accrued by such entity. 
Deductions pursuant to subsection (g) above shall be taken in the
Calendar Quarter in which such sales are no longer recorded as a
receivable.  For purposes of determining
Net Sales, the Licensed Product(s) shall be deemed to be sold when
invoiced and a “sale” shall not include transfers or dispositions for
charitable, promotional, pre-clinical, clinical, regulatory or governmental
purposes.


 


For purposes of
calculating Net Sales of Licensed Products, sales between or among Celldex or
its Affiliates or Sublicensees shall be excluded from the computation of Net
Sales, but sales by Celldex or its Affiliates or its Sub-licensees to third
parties shall be included in the computation of Net Sales.


 


In the event that a
Licensed Product is sold in any country in the form of a combination Licensed
Product containing one or more therapeutically active ingredients with respect
thereto, the parties shall negotiate in good faith to determine what portion of
the net sales of such combination Licensed Product in such country shall be
treated as “Net Sales” under this Agreement, which determination shall be based
on the value added by such other therapeutically active ingredients, to the
invoice price of such combination Licensed Product.


 


1.24   “Non-Exclusive
Commercial License” shall have the meaning set forth in Section 4


 


5

















 


1.25   “Part Length
Antigen(s)” shall mean Polypeptide Sequence forms of the Ludwig
Antigens [*].


 


1.26   “Phase I
Clinical Trial” shall mean a human clinical trial, the principal
purpose of which is a preliminary determination of safety in healthy
individuals or patients as required in 21 C.F.R. §312, or a similar clinical
study prescribed by the regulatory authorities in a country other than the
United States.  A Phase I Clinical Trial
shall be deemed to have commenced when the first subject in the study has been
enrolled.


 


1.27   “Polypeptide
Sequence” shall mean a protein sequence of less than 20 amino acids.


 


1.28   “Research
Program Period” shall mean the period commencing on the Effective
Date and ending on the earlier of (i) the termination of the Research
Program pursuant to Section 2.7, the expiration of any extension(s), or (ii) the
termination of the Agreement.


 


1.29   “Research
Program” shall mean the program of research as defined under Article 2
herein.


 


1.30   “Sub-licensee”
shall mean a third party to whom Celldex has granted a license or sublicense,
as the case may be, pursuant to Section 4.3, to develop, make, have made,
import, use, sell, offer for sale or otherwise exploit Licensed Products


 


1.31   “Targeted
Antigen Reagent” shall mean any protein construct which contains
Full Length Antigen(s) and/or Part Length Antigen(s) in whole or
in part combined either through chemical conjugation or genetic fusion with
Celldex APC Targeting Technology and any fragments or derivatives of any such
construct.


 


1.32   “Territory”
shall mean all countries of the world.


 


1.33   “Valid Claim”
shall mean a claim of an unexpired patent or pending patent application which
shall not have been withdrawn, canceled, or disclaimed, nor held invalid or
unenforceable by a court of competent jurisdiction or a regulatory agency with
relevant authority in any unappealed or unappealable decision in the relevant
country


 


2.                                      RESEARCH
PROGRAM


 


2.1   Research
Program.  Celldex and Ludwig
agree to enter into a research collaboration in which Celldex will provide
certain research reagents to Ludwig for Ludwig to incorporate into its
preclinical and clinical research programs in cancer immunotherapy.


 


2.2   Management
of Research Program.  Celldex
and Ludwig will appoint a Collaboration Steering Committee (“CSC”) comprising
two representatives of Celldex and two representatives of Ludwig to meet no
less than twice yearly and to perform the following tasks: (a) agree the
specific goals and objectives of the Research Program, and (b) review and
report on Research Program progress. 
Decisions of the CSC will require majority agreement for 


 






* Confidential


 


6

















 


implementation.  In the event that the CSC fails to reach
agreement on the goals and objectives of the Research Program, Celldex and
Ludwig executives will meet to resolve such matters.


 


2.3   Reagents for
the Research Program.  Celldex
agrees to make available to Ludwig for use within the Research Program reagents
incorporating Ludwig Patent Rights and Ludwig Know-How which Celldex generates
or has generated using the Ludwig Patent Rights and Ludwig Know-How licensed
under the terms of this agreement.


 


2.4   Reagents for
Clinical Use in the Research Program.  Celldex agrees to make available to Ludwig
without charge for use within the Research Program Celldex Clinical Reagents
once they are produced by Celldex and under a Celldex IND provided that Celldex
is not required to provide funding to Ludwig to support the use of such Celldex
Clinical Reagents by Ludwig.  Such
provision of Celldex Clinical Reagents to Ludwig is not intended to release
Celldex from its obligations of diligence under Article 8 herein.  Ludwig shall not be obligated to undertake
clinical trials of such Celldex Clinical Reagents if Ludwig’s resources or
funding available to Ludwig for such clinical trials is deemed by Ludwig to be
insufficient for such purpose.


 


2.5   Data arising
from the Research Program.  Celldex
and Ludwig agree to share data and findings arising from the Research Program
through reports prepared for and reviewed by the CSC.  Celldex hereby agrees that Ludwig shall have
the right to reference the Celldex IND pursuant to the Research Program.


 


2.6   Term of the
Research Program.  Celldex and
Ludwig agree that the Research Program will run for a [*] from
the Effective Date and subject to the agreement of the Parties will extended
annually thereafter by agreement of the CSC.


 


2.7   Termination
of the Research Program.  Either
Party may terminate the Research Program after [*].


 


3.                                      RESEARCH
LICENSES


 


3.1   Research
Licenses to Ludwig for Each Targeted Antigen Reagent.  Celldex hereby grants to Ludwig a
non-exclusive, non-sublicenseable, non-transferable license under the Celldex
Patent Rights and Celldex Know-How during the Research Program Period to
conduct pre-clinical research pursuant to the Research Program using Targeted
Antigen Reagent(s).


 


3.2   Research
Licenses to Ludwig for Each Celldex Clinical Reagent.  Celldex hereby grants to Ludwig a
non-exclusive, non-sublicenseable, non-transferable license under the Celldex
Patent Rights and Celldex Know-How during the Research Term to conduct clinical
research pursuant to the Research Program using Celldex Clinical Reagent(s).


 






* Confidential


 


7

















 


3.3   Research License Period.


 


Initial
Research License Period. 
The Initial Research License
Period for a particular Targeted Antigen Reagent or Celldex Clinical Reagent
shall commence on the date that CSC agrees to initiate research on either a
Targeted Antigen Reagent or Celldex Clinical Reagent within the Research
Program and shall expire [*].


 


Extension
of Research License Period.  The
Research License Period can be extended on a case-by-case basis with the
agreement of the CSC only and a maximum of up to [*].


 


3.4   Termination
of Specific Research License.  Celldex may terminate the Research License for
any Targeted Antigen Reagent or Celldex Clinical Reagent at any time by giving
written notice to Ludwig provided that any clinical trials already underway by
Ludwig which have been initiated as part of the Research Program are allowed to
reach final patient recruitment and treatment.


 


4.                                      OPTIONS;
COMMERCIAL LICENSES


 


4.1   Non-Exclusive Commercial
License to Celldex. Ludwig hereby agrees to grant to Celldex a
Non-exclusive, worldwide license, with rights to grant sub-licenses, under
Ludwig Patent Rights and Ludwig Know-How to research, develop, make, have made,
use, import, offer for sale, sell and have sold Licensed Products in the Field.
For the avoidance of doubt no right or license is granted by Ludwig to Celldex
under Ludwig Patent Rights and Ludwig Know-How to research, develop, make, have
made, use, import, offer for sale, sell and have sold Full Length Antigen or Part Length
Antigen except as part of a Targeted Antigen Reagent incorporated in a Licensed
Product.


 


4.2   Termination
of Non-Exclusive Commercial License. 
If Celldex elects not to pursue the development of a given Ludwig
Antigen as part of a Licensed Product, it may identify such Ludwig Antigen to
Ludwig and thereafter payment as defined under Article 5 hereunder shall
cease for such Ludwig Antigen.  All
Celldex rights to such Ludwig Antigen will cease thereafter.


 


4.3   Sublicenses.
Celldex may grant sublicenses under the Ludwig Patent Rights and
Ludwig Know-How to the extent necessary to develop, make, have made, import,
use, offer for sale and sell Licensed Products. 
Each sublicense granted by Celldex shall be consistent with all the
terms and conditions of this Agreement, and subordinate thereto, and Celldex
shall remain responsible to Ludwig for the compliance of each such Sub-licensee
with the financial and other obligations due under this Agreement. Following
execution of any such sublicense Celldex shall inform Ludwig of the name of the
sublicensee and terms of the granted sublicense. Celldex shall not grant any
sublicense under this clause 4 to any third party associated with the
manufacture and sale of tobacco related products.


 






* Confidential


 


8

















 


Research Rights. Ludwig
on behalf of itself and the Cornell Research Foundation (“CRFI”), Cornell
University, the Memorial Sloan Kettering Cancer Center (“MSKCC”), the
University of Oxford (“UO”), and the Academisch Ziekenhuis Leiden (“AZL”)
retain an irrevocable, nonexclusive, and nontransferable right to practice for
their own educational and research purposes, the inventions claimed under
Ludwig Patent Rights and Ludwig Know-how.


 


5.                                      CONSIDERATION


 


5.1   Non-Exclusive Commercial
License Fees.  Within thirty (30) days following the
Effective Date of this Agreement Celldex hereby agrees to pay Ludwig an annual
license fee of US Dollars $7,500 for each Full Length Antigen and an annual
license fee of US Dollars $2,500 for each Part Length Antigen until said
Full Length Antigen or Part Length Antigen enters the earlier of a Celldex
sponsored randomized Phase II or Phase III clinical trial as part of a Targeted
Antigen Reagent at which point such annual license fee for said Full Length
Antigen or Part Length Antigen shall terminate.


 


5.2   Milestone Payments.


 


5.2.1   Milestones.  Within thirty (30) days following the
approval of the first BLA, or equivalent, on a Licensed Product and on a
Targeted Antigen Reagent by Targeted Antigen Reagent basis, with respect to
each Targeted Antigen Reagent subject to a Non-Exclusive Commercial License,
Celldex shall pay to Ludwig [*].


 


5.2.2   Subsequent
Licensed Products.  Once a
milestone payment has been made as defined under Section 5.5.1 on a first
Targeted Antigen Reagent no further Milestone Payment shall be due on a
subsequent Licensed Product containing such Targeted Antigen Reagent. For the
avoidance of doubt, this would include combination Licensed Products wherein a
previously paid milestone on a Targeted Antigen Reagent would not incur
additional milestone payment; however, incorporation of Targeted Antigen
Reagent(s) for which a milestone had not been previously been paid would
be subject to this first milestone payment under Section 5.2.1.  This will ensure that each Ludwig Antigen
will be eligible for a single milestone payment under Section 5.2.1.


 


5.2.3   Reports.  Except as set forth in Section 8.4,
within fifteen (15) days of the occurrence of any event which would trigger a
milestone payment according to this Section 5.2, Celldex shall provide
notice to Ludwig of such occurrence.


 


5.3   Sublicense Payments


 


Celldex
agrees to pay Ludwig [*] of all fees
received as part of a sub-license of Celldex’s rights under Article 4
excepting fees received in the form of equity investments in Celldex, or fees
received in return for research and development costs incurred or services
provided by Celldex to such sub-licensee.


 






* Confidential


 


9

















 


5.4   Royalties.


 


5.4.1   Royalty on
Net Sales.  In partial
consideration for any Non-Exclusive Commercial License granted by Ludwig,
Celldex shall pay to Ludwig a [*] royalty on
annual worldwide Net Sales of Licensed Product on a country-by-country basis.


 


5.4.2   Royalty
Term.  The royalties due
pursuant to this Section 5.4 shall be payable on a country-by-country
basis until the date which is the expiration of the last to expire of the
patents within the Ludwig Patent Rights covering the Licensed Product in such
country (such expiration to occur only after expiration of extensions of any
nature to such patents which may be obtained under applicable statutes or
regulations in the respective countries of the Territory, such as the Drug
Price Competition and Patent Term Restoration Act of 1984 in the U.S.A. and
similar patent extension laws in other countries),.


 


5.4.3   Third Party
Royalties. In the event Celldex needs to acquire a license to any
third party’s intellectual property relating directly to Ludwig Antigens
without which Celldex would be unable to develop or commercialize the Full
length Antigens or Part Length Antigens as part of a Licensed Product,
then Celldex would be able to offset the royalties and fees it pays to such
third party against the royalty owed to Ludwig, up to a maximum offset of [*] of the amount otherwise owed to Ludwig.


 


5.4.4   Royalties to
Celldex on Reversion of Rights. 
In the event that rights to a Licensed Product revert to Ludwig for any
reason whatever, the Parties agree to negotiate in good faith the terms of
royalty and milestone payments to Celldex in recognition of the investment made
by Celldex and Ludwig in such Licensed Product.


 


6.                                      PAYMENTS


 


6.1   Timing of
Royalty Payments.  All
royalties due to Ludwig shall be paid within thirty (30) days after the last
day of the Calendar Quarter in which they accrue.


 


6.2   Payment
Method.  All cash amounts due
Ludwig hereunder shall be paid in U.S. dollars by wire transfer in immediately
available funds to an account designated by Ludwig.


 


6.3   Currency;
Foreign Payments.  If any
currency conversion shall be required in connection with the payment of any
royalties hereunder, such conversion shall be made by using the exchange rate
for the purchase of U.S. dollars reported by the Chase Manhattan Bank on the
last business day of the Calendar Quarter to which such royalty payments
relate.  If at any time legal
restrictions prevent the prompt remittance of any royalties owed on Net Sales
in any jurisdiction, Celldex may notify Ludwig and make such payments by
depositing the amount thereof in local currency in a bank account or other
depository in such country in the name of Ludwig, and Celldex shall have no
further obligations under this Agreement with respect thereto.


 






* Confidential


 


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6.4   Taxes.  All royalty amounts required to be paid to
Ludwig pursuant to this Agreement may be paid with deduction for withholding
for or on account of any taxes (other than taxes imposed on or measured by net
income) or similar governmental charge imposed by a jurisdiction other than the
United States (“Withholding Taxes”).  At
Ludwig’s request, Celldex shall provide Ludwig a certificate evidencing payment
of any Withholding Taxes hereunder and shall reasonably assist Ludwig to obtain
the benefit of any applicable tax treaty.


 


7.                                      REPORTS
AND RECORDS


 


7.1   Royalty
Reports.  Celldex shall
deliver to Ludwig within thirty (30) days after the last day of each Calendar
Quarter in which Licensed Products are sold a report setting forth in
reasonable detail the calculation of the royalties payable to Ludwig for such
Calendar Quarter identifying, by country and Licensed Product, the Licensed
Products sold by Celldex and its Affiliates and Sub-licensees, and the
calculation of Net Sales and royalties due to Ludwig.


 


7.2   Inspection
of Books and Records.  Celldex
and its Affiliates and Sub-licensees shall maintain accurate books and records,
which enable the calculation of milestone payments and royalties payable
hereunder to be verified.  Celldex and
its Affiliates and Sub-licensees shall retain the books and records for each
quarterly period for five (5) years the submission of the corresponding
report under Section 7.1 hereof. 
Upon thirty (30) days prior notice to Celldex, independent accountants
selected by Ludwig and reasonably acceptable to Celldex, may have access to the
books and records of Celldex and its Affiliates and Sub-licensees during normal
business hours to conduct a review or audit, solely, however, to the extent
necessary for the purpose of verifying the accuracy of Celldex’s payments and
compliance with this Agreement.  Celldex
shall promptly pay to Ludwig any underpayment with interest from the date such
amount(s) were due, at the prime rate reported by the Chase Manhattan
Bank, New York, New York, plus two percent (2%).  Any such inspection or audit shall be at
Ludwig’s expense; provided, however, in the event an inspection reveals
underpayment of five percent (5%) or more in any audit period, in addition to
any underpayment Celldex also shall pay the costs of the inspection.


 


8.                                      DILIGENCE


 


8.1   Reasonable
Efforts.  Celldex shall use Commercially Reasonable
Efforts to (i) achieve regulatory approvals for the sale of Licensed
Products throughout the Territory by submitting registration packages requesting
approval for commercial sale of the Licensed Product as soon as reasonably
practicable and (ii) actively pursue commercial sales of each Licensed
Product in each country in which all necessary regulatory approvals are
obtained.  Commencing as of the Effective
Date, Celldex shall use Commercially Reasonable Efforts to develop, clinically
test, manufacture and commercialize Licensed Products.  All costs of development, clinical testing,
manufacturing and commercialization shall be borne by Celldex, its Affiliates
or Sublicensees save for those costs incurred by Ludwig pursuant to Section 3.2.


 


8.2   Lack of
Diligence.  Ludwig may
terminate the Non-Exclusive Commercial License granted herein to Celldex with
respect to a particular Licensed Product, on a Licensed Product-by-Licensed
Product and country-by-country basis, effective upon written notice to Celldex,
if Celldex:


 


11

















 


8.2.1   abandons development and/or
commercialization of the applicable Licensed Product in that particular country
and (i) decides not to engage in efforts to sublicense such Licensed
Product or (ii) discontinues reasonable sublicensing efforts for more than
one (1) year, or


 


8.2.2   suspends the development and/or
commercialization of the applicable Licensed Product in a particular country
for more than one (1) year, except for suspensions (i) that have been
requested by official regulatory and safety bodies, or (ii) that Ludwig
agrees are necessary for investigating and clarifying untoward pharmacological,
pharmacokinetic, toxicological, or human-clinical observations of the
applicable Licensed Product.


 


8.3   Diligence Obligations.  The parties agree that the following
diligence obligations shall apply to Celldex’s development and
commercialization efforts with regard to a Licensed Product:


 


8.3.1   Celldex agrees that [*].


 


8.3.2   If upon the second anniversary
of the date that [*].


 


8.3.3   If upon the [*].


 


8.4   Reports to Ludwig. 
During the term of this Agreement, Celldex shall keep Ludwig informed of
its development and commercialization activities subject to this Agreement, and
on February 28th of each year shall provide Ludwig with a
reasonably detailed written summary of such events and activities in the
preceding year.  When the registration
package requesting Approval for commercial sale of any Licensed Product
receives Approval in the United States of America, any country in Europe, or
Japan, Celldex will notify Ludwig in writing within ten (10) business days
thereof.


 


8.5   Regulatory Filings.  Celldex (or its designee) shall file and hold
title to all regulatory applications, Approvals and supplements thereto
relating to Licensed Products; provided, in the event that the Non-Exclusive
Commercial License rights of Celldex terminate with regard to any Licensed
Product and/or country due to Celldex’s decision to terminate its license
pursuant to Section 4.1.2 or pursuant to Sections 8.2, 8.3, 8.6 or 13,
Ludwig (or its designee) shall have access to and the right to reference,
without charge, all such regulatory applications, Approvals and supplements
with regard to the applicable Licensed Product and/or country, and Celldex
shall cooperate with Ludwig to enable Ludwig (or its designee) to practice the
foregoing rights.  Ludwig shall reimburse
Celldex for any reasonable fees actually incurred by Celldex and that are
charged by a governmental authority that are necessary to effect Ludwig’s right
to reference all such regulatory applications, Approvals and supplements with
regard to the applicable Licensed Product and/or country pursuant to this Section 8.5.  Such rights to Ludwig described in this Section 8.5
shall be subject to the provisions of Article 9.


 






* Confidential


 


12

















 


8.6   Abandoned Licensed Products. 
Celldex shall promptly notify Ludwig should it elect to abandon its
rights to pursue commercialization of any Licensed Product in any country.  In such event, the terms of Section 4.2
shall apply with respect to such Licensed Product in such country and the
Non-Exclusive Commercial License therefor.


 


9.                                      CONFIDENTIALITY


 


9.1   Confidential
Information.  Except as
expressly provided herein, the parties agree that for the term of the Agreement
and for five (5) years thereafter, the receiving party shall keep
completely confidential and shall not publish or otherwise disclose and shall
not use for any purpose except for the purposes contemplated by this Agreement
any Confidential Information of the other party, except to the extent that it
can be established by the receiving party by competent proof that such
Confidential Information:


 


was already known to the receiving party, other than
under an obligation of confidentiality, at the time of disclosure;


 


was generally available to the public or otherwise
part of the public domain at the time of its disclosure to the receiving party;


 


became generally available to the public or otherwise
part of the public domain after its disclosure and other than through any act
or omission of the receiving party in breach of this Agreement;


 


was independently developed by the receiving party as
demonstrated by documented evidence prepared contemporaneously with such
independent development; or


 


was subsequently lawfully disclosed to the receiving
party by a person other than a party hereto.


 


9.2   Permitted
Use and Disclosures.  Each
party hereto may use or disclose information disclosed to it by the other party
to the extent such use or disclosure is reasonably necessary in complying with
applicable governmental regulations or otherwise submitting information to tax
or other governmental authorities, conducting clinical trials, or making a
permitted sublicense or otherwise exercising its rights hereunder, provided
that if a party is required to make any such disclosure of another party’s
confidential information, other than pursuant to a confidentiality agreement,
it shall (i) give reasonable advance notice to the latter party of such
disclosure, (ii) if such advance notice is not possible, provide notice of
such disclosure immediately thereafter, (iii) to the extent possible,
minimize the extend of such disclosure, and (iv) save to the extent
inappropriate in the case of patent applications, use its best efforts to
secure confidential treatment of such information prior to its disclosure
(whether through protective orders or otherwise), it being understood that any
information so disclosed shall otherwise remain subject to the limitations on
use and disclosure hereunder.


 


9.3   Public
Disclosure.  Except as
otherwise required by law, rule or regulation, neither party shall issue a
press release or make any other public disclosure of the terms of this
Agreement without the prior approval of the other party of such press release
or public disclosure 


 


13

















 


and the content thereof;
provided, however, the parties agree that disclosures of information for which
consent has been previously obtained and of information of a similar nature to
that which has been previously disclosed publicly with respect to this
Agreement, each shall not require advance approval. Each party shall submit any
such press release or public disclosure requiring the other party’s approval to
the other party, and the receiving party shall have three (3) business
days to review and approve any such press release or public disclosure, which
approval shall not be unreasonably withheld. 
If the receiving party does not respond in writing within such three (3) business
day period, the press release or public disclosure shall be deemed
approved.  In addition, if a public
disclosure is required by law, rule or regulation, including without
limitation in a filing with the Securities and Exchange Commission other than a
filing on a Form 10Q, the disclosing party shall provide copies of the
disclosure reasonably in advance of such filing or other disclosure for the
non-disclosing party’s prior review and comment.


 


9.4   Confidential
Terms.  Except as expressly
provided herein, each party agrees not to disclose any terms of this Agreement
to any third party without the consent of the other party; except that such
consent shall not be required for disclosure to actual or prospective investors
or to a party’s accountants, attorneys and other professional advisors.  In addition, the terms of this Agreement may
be disclosed pursuant to confidentiality obligations at least as strict as is
set forth herein, to sublicensees and actual or potential acquirors or
acquirees.


 


9.5   Program
Information.  Ludwig agrees to
maintain in confidence and not to use for any purpose, without the prior
written consent of Celldex, other than provided for in this Agreement, any
data, results, plans or information generated by Ludwig in the course of the
Research Program that relates to Targeted Antigen Reagent or Celldex Clinical
Reagent (“Celldex Program Information”). 
Celldex Program Information shall be deemed to be the Confidential
Information of Celldex as governed by the terms of this Article 9.


 


10.                               REPRESENTATIONS
AND WARRANTIES


 


10.1   Ludwig.  Ludwig represents and warrants that the
execution, delivery and performance of this Agreement have been duly authorized
by all necessary corporate action on the part of Ludwig; and it has not entered
into and will not enter into an agreement that is inconsistent with the rights
and licenses granted to Celldex in this Agreement.


 


10.2   Celldex.  Celldex represents and warrants that: (i) it
is a company duly organized, validly existing and in good standing under the
laws of New Jersey; (ii) the execution, delivery and performance of this
Agreement have been duly authorized by all necessary corporate action on the
part of Celldex; and (iii) it has not entered into and will not enter into
an agreement that is inconsistent with the performance of its obligations
hereunder.


 


10.3   Disclaimer
of Warranties.  TARGETED
ANTIGEN REAGENTS AND CELLDEX CLINICAL REAGENTS ARE PROVIDED TO LUDWIG “AS IS”,
AND EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, CELLDEX MAKES NO
REPRESENTATIONS AND EXTENDS NO WARRANTIES OR CONDITIONS OF ANY KIND, EITHER
EXPRESS OR IMPLIED, WITH RESPECT TO THE TARGETED ANTIGEN REAGENTS OR CELLDEX
TECHNOLOGY, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY,
FITNESS FOR A PARTICULAR PURPOSE, VALIDITY OF THE PATENT RIGHTS LICENSED
HEREUNDER, OR NON-INFRINGEMENT OF THE INTELLECTUAL PROPERTY RIGHTS OF THIRD
PARTIES.


 


14

















 


10.4   Disclaimer.
EXCEPT AS OTHERWISE PROVIDED HEREIN, NOTHING IN THIS AGREEMENT IS OR SHALL BE
CONSTRUED AS:


 


10.4.1   A WARRANTY OR REPRESENTATION
BY LUDWIG AS TO THE VALIDITY OR SCOPE OF ANY CLAIM OR PATENT WITHIN THE LUDWIG
PATENT RIGHTS;


 


10.4.2   A WARRANTY OR REPRESENTATION
THAT ANYTHING MADE, USED, SOLD OR OTHERWISE DISPOSED OF UNDER ANY LICENSE
GRANTED IN THIS AGREEMENT IS OR WILL BE FREE FROM INFRINGEMENT OF ANY PATENT
RIGHTS OR OTHER INTELLECTUAL PROPERTY RIGHT OF ANY THIRD PARTY;


 


10.4.3   AN OBLIGATION TO BRING OR
PROSECUTE ACTIONS OR SUITS AGAINST THIRD PARTIES FOR INFRINGEMENT OF ANY OF THE
LUDWIG PATENT RIGHTS; OR


 


10.4.4   GRANTING BY IMPLICATION,
ESTOPPEL, OR OTHERWISE ANY LICENSES OR RIGHTS UNDER PATENTS OR OTHER RIGHTS OF
LUDWIG OR THIRD PARTIES, REGARDLESS OF WHETHER SUCH PATENTS OR OTHER RIGHTS ARE
DOMINANT OR SUBORDINATE TO ANY PATENT WITHIN THE LUDWIG PATENT RIGHTS.


 


10.5   Limitation of Liability. 
LUDWIG’S LIABILITY ARISING OUT OF THIS AGREEMENT SHALL BE LIMITED TO THE
AGGREGATE VALUE OF THE CONSIDERATION RECEIVED BY LUDWIG FROM CELLDEX UNDER THIS
AGREEMENT.  IN NO EVENT SHALL EITHER
PARTY BE LIABLE TO THE OTHER PARTY OR ANY OTHER PERSON FOR ANY SPECIAL,
CONSEQUENTIAL OR INCIDENTAL DAMAGES, HOWEVER CAUSED AND ON ANY THEORY OF
LIABILITY ARISING OUT OF THIS AGREEMENT, AND WHETHER OR NOT SUCH PARTY HAS BEEN
ADVISED OF THE POSSIBILITY OF SUCH DAMAGE. 
THESE LIMITATIONS SHALL APPLY NOT WITHSTANDING ANY FAILURE OF ESSENTIAL
PURPOSE OF ANY LIMITED REMEDY PROVIDED HEREIN.


 


11.                               INTELLECTUAL
PROPERTY; OWNERSHIP OF MATERIALS


 


11.1   Inventorship.  Subject
to the terms of this Article 11, inventorship of any inventions arising
out of the Research Program shall be determined according to U.S. law.  Ludwig agrees to license to Celldex its
interest in any invention or other intellectual property made by Ludwig or its
respective employees, consultants or agents in the course of activities in
connection with the Research Program that relates to the Targeted Antigen
Reagents or Celldex Clinical Reagents provided by Celldex.  In consideration of the provision of this
license referenced in this Section 11.1 above, such inventions and patent
applications or patents corresponding to such inventions shall be considered as
Ludwig Patent Rights pursuant to Section 5.


 


11.2   Patent
Filings.  Ludwig hereby
covenants that neither Ludwig nor its Affiliates nor their respective
employees, consultants or agents shall file any patent applications disclosing
or claiming inventions made using Targeted Antigen Reagents or Celldex Clinical
Reagents, or the making or using thereof, without Celldex’s prior written consent
and without agreement 


 


15

















 


between the parties as to
how commercialization rights related to any such inventions shall be
apportioned between the parties.  In the
event Ludwig breaches this covenant, in addition to any other remedies Celldex
may have, Ludwig shall (i) license to Celldex its interest to all patent
applications and patents issuing thereon, and (ii) execute those
documents, as requested by Celldex, necessary to document and/or perfect the
licensing of such patent applications and patents issuing thereon.


 


11.3   Patent
Prosecution.


 


11.3.1   Celldex
Patent Rights.  Celldex shall
be solely responsible, at its expense and in its sole discretion, for the
preparation, filing, prosecution and maintenance of the patent applications and
patents owned by or on behalf of Celldex relating to Targeted Antigen Reagents
or Celldex Clinical Reagents in countries selected by Celldex, and for
conducting any interferences, reexaminations, reissues, oppositions, or request
for patent term extension relating thereto.


 


11.3.2   Ludwig
Patent Rights.  Ludwig shall
be responsible, at its expense and in its sole discretion, for the preparation,
filing, prosecution and maintenance of the Ludwig Patent Rights and for
conducting any interferences, reexaminations, reissues, oppositions, or request
for patent term extensions relating thereto.


 


11.4   Infringement
Claims.  If the manufacture,
importation, sale or use of a Licensed Product pursuant to this Agreement results
in any claim, suit or proceeding alleging patent infringement against Ludwig or
Celldex, such party shall promptly notify the other party hereto.  The defendant shall keep each other party
hereto reasonably informed of all material developments in connection with any
such claim, suit or proceeding.


 


12.                               INDEMNIFICATION


 


12.1   Ludwig.  Ludwig shall indemnify, defend and hold
harmless Celldex and its directors, officers and employees (each an “Celldex
Indemnitee”) from and against any and all liabilities, damages, losses, costs
or expenses (including attorneys’ and professional fees and other expenses of
litigation and/or arbitration) (“Liabilities”) resulting from a claim, suit or
proceeding made or brought by a third party against an Celldex Indemnitee arising
from or occurring as a result of any breach of the representations and
warranties set forth in Section 10.1, except to the extent caused by the
negligence or willful misconduct of Celldex.


 


12.2   Celldex.    Celldex shall indemnify, defend and hold harmless each of Ludwig,
Cornell Research Foundation Inc (“CRFI”), Memorial Sloan Kettering Cancer
Center (“MSKCC”), University of Oxford (“UO”) Academish Ziekenhuis Leiden (“AZL”),
and their trustees, officers, agents and employees and those of Cornell University
(each an “Indemnitee”) from and against any and all liabilities, damages,
losses costs or expenses including reasonable attorney’s and professional fees
and other reasonable expenses of litigation and/or arbitration (collectively a “liability”)
resulting from a successful claim, suit or proceeding made or brought by a
Third Party against an Indemnitee which is finally decided by a court of
competent jurisdiction in a final non-appealable decision, arising or occurring
as a result of (i) any breach of the warranties by Celldex set forth in
this Agreement; (ii) any development, testing, manufacture, importation,
use, offer for sale, sale or other distribution of any Licensed Product by
Celldex or its Affiliates, agents or sublicensee (including without limitation,
product liability claims); or (iii) 


 


16

















 


the
practice by Celldex of any right granted herein, except, (I) with respect
to Ludwig, CRFI, MSKCC, UO or AZL, to the extent that the claim in respect of
which indemnity is sought results from the negligence or willful misconduct of
Ludwig, CRFI, MSKCC, UO or AZL and except, (II) with respect to Ludwig, to
the extent that the claim in respect of which indemnity is sought results from (a) any
breach by Ludwig of its warranties in Section 9; or (b) any breach by
Ludwig of any other term or condition of this Agreement, and provided that, in
all cases, (A) Ludwig notifies Celldex in writing promptly after it
becomes aware of such claim; (B) Ludwig makes no admissions or prejudicial
statements in respect of such claim and incurs no costs without Celldex prior
written authorization and procures that no indemnitee Indemnitee makes any such
admission or prejudicial statement nor incurs any such costs; (C) Ludwig
allows Celldex, at its expense, to take over conduct of the claim; and (D) Ludwig
provides to Celldex all reasonable assistance and information relating to the
claim and complies with all reasonable instructions relating to the claim given
by Celldex.


 


13.                               TERM
AND TERMINATION


 


13.1   Term.  The term of this Agreement shall commence on
the Effective Date.  Unless earlier
terminated as provided in Article 8 and this Article 13, this
Agreement shall continue in full force and effect on a country-by-country and
Licensed Product-by-Licensed Product basis until there are no remaining royalty
payment obligations in a country, at which time the Agreement shall expire in
its entirety in such country.  Upon such
expiration and following the completion of the payment of all royalties due
with respect to a particular Licensed Product in such country, Celldex shall
have a fully paid, royalty-free, perpetual license under the Ludwig Patent
Rights and Ludwig Know How to commercialize such Licensed Product in such country.


 


13.2   Termination
for Cause.  In the event one
party has materially breached in the performance of any of its obligations
hereunder, and such breach has continued for sixty (60) days after written
notice thereof was provided to the breaching by the non-breaching, the other
party may terminate this Agreement.  Any
termination shall become effective at the end of such sixty (60) day period
unless the breaching party has cured any such breach prior to the expiration of
the sixty (60) day period.  Notwithstanding
the above, in the case of a failure to timely pay any amounts due hereunder,
the period for cure of any subsequent breach following notice thereof shall be
thirty (30) days and, unless payment is made within such period the termination
shall become effective at the end of such period.  Further, if such uncured material breach
involves only a specific Licensed Product, then the Agreement shall terminate
only as to the rights relating to such Licensed Product.


 


13.3   Termination
for Insolvency.  If voluntary
or involuntary proceedings by or against a party are instituted in bankruptcy
under any insolvency law, or a receiver or custodian is appointed for such
party, or proceedings are instituted by or against such party for corporate
reorganization or the dissolution of such party, which proceedings, if
involuntary, shall not have been dismissed within sixty (60) days after the
date of filing, or if such party makes an assignment for the benefit of
creditors, or substantially all of the assets of such party are seized or
attached and not released within sixty (60) days thereafter, the other party
may immediately terminate this Agreement effective upon notice of such
termination.


 


17

















 


13.4   Effect of
Termination or Expiration.


 


13.4.1   Accrued
Rights and Obligations. 
Termination or expiration of this Agreement for any reason shall not
release either party hereto from any liability which, at the time of such
termination or expiration, has already accrued to the other party or which is
attributable to a period prior to such termination or expiration or preclude
either party from pursuing any rights and remedies it may have hereunder or at
law or in equity with respect to any breach of, or default under, this Agreement.  It is understood and agreed that monetary
damages may not be a sufficient remedy for any breach of this Agreement and
that the non-breaching party may be entitled to injunctive relief as a partial
remedy for any such breach.


 


13.4.2   Return of Confidential
Information.  Upon any
termination or expiration of this Agreement, Celldex and Ludwig shall promptly
return to the other party all Confidential Information of the other; provided,
however, that counsel of each party may retain one (1) copy of such
Confidential Information for archival purposes and for ensuring compliance with
Article 9.


 


13.4.3   Inventory on
Hand.  In the event this
Agreement is terminated for any reason, Celldex and its Sublicensees shall have
the right to sell or otherwise dispose of the inventory of any Licensed Product
subject to this Agreement then on hand until the first anniversary of the
effective date of such termination, any such sale or distribution to be subject
to the relevant terms of this Agreement, including without limitation Articles
5, 6 and 7


 


13.4.4   Licenses.  Except for expiration under Section 13.1,
the license(s) granted Celldex in this Agreement shall terminate upon any
termination of this Agreement and in such event Celldex shall cease, and cause
its Affiliates and Sublicensees to cease, all development and commercialization
of Licensed Products.  Any assignment to
Ludwig pursuant to Sections 2.4, and 11.1 shall remain in effect following any
termination of this Agreement.


 


13.5   Survival.  Sections 2.6, 7.2, 10.3, 10.4, 11.1, 11.2,
11.3, 11.4, 13.4 and 13.5,  and
Articles 9 and 12  of this
Agreement shall survive expiration or termination of this Agreement for any
reason, except that Article 12 shall survive only with respect to
liabilities that arise from acts or circumstances that occurred prior to
termination or expiration.  Section 13.1
of this Agreement shall survive expiration of this Agreement.


 


14.                               MISCELLANEOUS


 


14.1   Governing
Law.  This Agreement and any
dispute arising from the performance or breach hereof shall be governed by and
construed and enforced in accordance with the laws of the state of New Jersey,
without reference to conflicts of laws principles.  Any claim or controversy arising out of or related
to this Agreement or any breach hereof shall be submitted to a court of
applicable jurisdiction in the State of New Jersey, and each party hereby
consents to the jurisdiction and venue of such court.


 


14.2   Independent
Contractors.  The relationship
of the parties hereto is that of independent contractors.  The parties hereto are not deemed to be
agents, partners or joint venturers of the others for any purpose as a result
of this Agreement or the transactions contemplated thereby.


 


14.3   Assignment.  Neither party may assign this Agreement to
any third party without the written consent of the other party, which consent
shall not be unreasonably withheld; 


 


18

















 


provided, however, that
either party may assign this Agreement, without the other party’s consent (a) to
its Affiliates, and (b) to an entity that acquires all or substantially
all of the business or assets of the assigning party to which this Agreement
pertains, whether by merger, reorganization, acquisition, sale or otherwise.


 


14.4   Binding
Effect.  This Agreement shall
be binding upon and inure to the benefit of the parties and their successors
and permitted assigns.


 


14.5   Notices.  All notices, requests and other
communications hereunder shall be in writing and shall be personally delivered
or sent by facsimile transmission or by registered or certified mail, return
receipt requested, postage prepaid, in each case to the respective address
specified below, or such other address as may be specified in writing to the
other parties hereto.  Any such notice
shall be deemed to have been given as of the day of personal delivery, one (1) day
after the date sent by facsimile transmission or five (5) days following
the date deposited with the United States Postal Service as registered or certified
mail, return receipt requested.


 


	
   

  	
  If to Ludwig:

  	
   

  	
  Ludwig Institute for
  Cancer Research

  
	
   

  	
   

  	
   

  	
  650 Third Avenue (33rd Fl)

  
	
   

  	
   

  	
   

  	
  New York, NY 10158

  
	
   

  	
   

  	
   

  	
  U.S.A.

  
	
   

  	
   

  	
   

  	
  Attn: President

  
	
   

  	
   

  	
   

  	
  Fax No.: (212) 450-1555

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  With a copy to:

  	
   

  	
  Ludwig Institute for Cancer
  Research

  
	
   

  	
   

  	
   

  	
  650 Third Avenue (33rd Fl)

  
	
   

  	
   

  	
   

  	
  New York, NY 10158

  
	
   

  	
   

  	
   

  	
  U.S.A.

  
	
   

  	
   

  	
   

  	
  Attn:  Executive Director for Intellectual
  Property

  
	
   

  	
   

  	
   

  	
  Fax No.: (212) 450-1555

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  If to Celldex:

  	
   

  	
  Celldex Therapeutics
  Inc

  
	
   

  	
   

  	
   

  	
  222 Cameron Drive

  
	
   

  	
   

  	
   

  	
  Suite 400

  
	
   

  	
   

  	
   

  	
  Phillipsburg

  
	
   

  	
   

  	
   

  	
  New Jersey

  
	
   

  	
   

  	
   

  	
  NJ 08865

  
	
   

  	
   

  	
   

  	
  Attn:  Chief Executive Officer

  
	
   

  	
   

  	
   

  	
  Fax No.: (908) 454-1911

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
  With a copy to:

  	
   

  	
  Celldex Therapeutics
  Inc

  
	
   

  	
   

  	
   

  	
  222 Cameron Drive

  
	
   

  	
   

  	
   

  	
  Suite 400

  
	
   

  	
   

  	
   

  	
  Phillipsburg

  
	
   

  	
   

  	
   

  	
  New Jersey

  
	
   

  	
   

  	
   

  	
  NJ 08865

  
	
   

  	
   

  	
   

  	
  Attn: Chief Financial Officer

  
	
   

  	
   

  	
   

  	
  Fax No.: (908) 454-1911

  



 


19

















 


14.6   Force
Majeure.  Neither party shall
lose any rights hereunder or be liable to the other party for damages or losses
(except for payment obligations) on account of failure by the non-performing
party where the cause of such failure is (i) beyond the reasonable control
of such non-performing party, such causes including without limitation war,
strike, fire, acts of gods, earthquake, flood, lockout, embargo, governmental
acts or orders or restrictions, or failure of suppliers, (ii) not caused
by the negligence, intentional conduct or misconduct of such non-performing
party, and (ii) such non-performing party has exerted all reasonable
efforts to avoid or remedy such force majeure; provided, however, that in no
event shall a party be required to settle any labor dispute or disturbance.


 


14.7   Advice of
Counsel.  Ludwig and Celldex
have each consulted counsel of their choice regarding this Agreement, and each
acknowledges and agrees that this Agreement shall not be deemed to have been
drafted by one party or another and shall be construed accordingly.


 


14.8   Compliance
with Laws.  Subject to the
provisions of Article 9, each party shall use reasonable efforts to furnish
to the other party any information reasonably requested or required by that
party during the term of this Agreement or any extensions hereof to enable that
party to comply with the requirements of any U.S. or foreign federal, state
and/or government agency.


 


14.9   Further
Assurances.  At any time or
from time to time on and after the date of this Agreement, either party shall
at the request of the other party hereto (i) subject to the provisions of Article 9,
deliver to the requesting party any records, data or other documents consistent
with the provisions of this Agreement, and (ii) execute, and deliver or
cause to be delivered, all such consents, documents or further instruments of
transfer or license.


 


14.10 Retained Rights; No
Further Rights.  Only the
licenses granted pursuant to the express terms of this Agreement shall be of
any legal force or effect.  No other
license rights shall be granted or created by implication, estoppel or
otherwise.


 


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


 


14.12 Waiver.  It is agreed that no waiver by either party
hereto of any breach or default of any of the covenants or agreements herein
set forth shall be deemed a waiver as to any subsequent and/or similar breach
or default.


 


14.13 Complete Agreement.  This Agreement constitutes the entire
agreement, both written and oral, between the parties with respect to the
subject matter hereof, and all prior agreements respecting the subject matter
hereof, either written or oral, expressed or implied, including without
limitation the Material Transfer Agreement, are superseded hereby, merged and
canceled, and are null and void and of no effect.  No amendment or change hereof or 


 


20

















 


addition hereto shall be effective or binding on either of the parties
hereto unless reduced to writing and duly executed on behalf of both parties.


 


14.14   Use of Name.  Except as required by law, neither party
shall use the name or trademarks of the other party without the prior written
consent of such other party.


 


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


 


14.16   Counterparts.  This Agreement may be executed in two (2) counterparts,
each of which shall be deemed an original and which together shall constitute
one instrument.


 


IN WITNESS WHEREOF,
Ludwig and Celldex have executed this Agreement by their respective duly
authorized representatives.


 


	
  LUDWIG

  	
   

  	
  CELLDEX

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  By:

  	
  /s/ Edward A.
  McDermott, Jr.

  	
   

  	
  By:

  	
  /s/ Ronald C. Newbold

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Print Name: 

  	
  Edward A.
  McDermott, Jr.

  	
   

  	
  Print Name:

  	
  Ronald C. Newbold

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Title:

  	
  President

  	
   

  	
  Title:

  	
  Vice President,
  Business Development

  



 


21














 


Appendix A                           Ludwig Patent Schedule


 


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*Confidential


 


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*Confidential


 


2

















 


[*]


 


	
  LICR REF

  	
   

  	
  Content/patent no.

  	
   

  	
  Term

  	
   

  	
  Status

  	
   

  
	
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*Confidential


 


3














 


Appendix B                           Celldex
Patent Schedule


 


PART I
- PATENTS/APPLICATIONS ASSIGNED TO CELLDEX:


 


Content:
[*]


 


	
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Content:
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*Confidential


 


4

















 


Content:
[*]


 


	
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*Confidential


 


5

















 


Content: [*]


 


	
  Celldex
  Ref and

  Territory

  	
   

  	
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Content:
[*]


 


	
  Celldex
  Ref and

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Content:
[*]


 


	
  Celldex
  Ref and 

  Territory

  	
   

  	
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  Date

  	
   

  	
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*Confidential


 


6

















 


	
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** [*].


 


Content: [*]


 


	
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*Confidential


 


7

















 


	
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*Confidential


 


8

















 


PART II - MEDAREX
PATENTS/APPLICATIONS LICENSED TO CELLDEX:


 


[*]:


 


Content:
[*]


 


	
  Reference
  and Territory

  	
   

  	
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  Date

  	
   

  	
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Content:
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*Confidential


 


9

















 


	
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Content:
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Content:[*]


 


	
  Reference
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*Confidential


 


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PART III
- ROCKEFELLER PATENTS/APPLICATIONS LICENSED TO CELLDEX:


 


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  Celldex
  Ref and

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PART IV-
CASES IN PREPARATION


 


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*Confidential


 


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