Document:

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

 

10

 

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:
[*]

 

	
  Celldex
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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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  Date

  	
   

  	
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Content:
[*]

 

	
  Celldex
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  Territory

  	
   

  	
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Content:
[*]

 

	
  Celldex
  Ref and 

  Territory

  	
   

  	
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*Confidential

 

6

 

	
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** [*].

 

Content: [*]

 

	
  Celldex
  Ref and

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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:
[*]

 

	
  Reference
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  and/or Publication No.

  	
   

  	
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*Confidential

 

9

 

	
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Content:
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*Confidential

 

10

 

	
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Content:[*]

 

	
  Reference
  and Territory

  	
   

  	
  Serial No. and/or

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  Date

  	
   

  	
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*Confidential

 

1

 

PART III
- ROCKEFELLER PATENTS/APPLICATIONS LICENSED TO CELLDEX:

 

[*]:

 

Content:
[*]

 

	
  Celldex
  Ref and

  Territory

  	
   

  	
  Serial No. and/or

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PART IV-
CASES IN PREPARATION

 

Content:  [*]

 

	
  Celldex
  Ref and

  Territory

  	
   

  	
  Serial No. and/or 

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*Confidential

 

2Exhibit 10.46

 

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.

 

Vaccine Adjuvant License and Collaboration Agreement

 

This Agreement is made on the
30th day of May, 2008 (“Effective Date”) by and among 3M COMPANY (“3M”) and 3M
INNOVATIVE PROPERTIES COMPANY (“3M IPC”), a wholly-owned subsidiary of 3M, both
with a principal address as 3M Center, St. Paul, MN 55144 (collectively “3M”);
and Celldex Therapeutics, with a principal address at 222 Cameron Drive Suite 400,
Phillipsburg, NJ  08865 (“CELLDEX”).

 

RECITALS

 

CELLDEX has
expertise and technology relating to vaccine products, including for example
proprietary Antigen Presenting Cell (“APC”) technology platform for the
development of vaccines for prophylactic and/or therapeutic immunization
against infectious disease and oncology (cancer).

 

3M, through
its Drug Delivery Systems Division, has expertise and technology (with know-how
and patents owned by 3M IPC) relating to toll-like receptor (TLR) 7 and/or 8
immune response modifier (“IRM”) compounds, formulations, conjugation,
delivery, and manufacturing including proprietary IRM compounds such as
resiquimod and others, that are useful as vaccine adjuvants.

 

CELLDEX
wishes to use certain 3M IRM compounds as vaccine adjuvants, and 3M wishes to
license such compounds to CELLDEX for use with CELLDEX’s APC technology for the
development of vaccines.  Further,
CELLDEX may wish to have 3M collaborate in connection with the production,
selection, formulation, conjugation, use or delivery of the 3M IRM compounds
under a mutually agreed work plan to conduct such work.

 

1

 

If results of
vaccine development efforts are successful, CELLDEX may wish to market
commercial vaccine products in combination with the 3M IRM compound(s) as
vaccine adjuvants.

 

IT IS
THEREFORE AGREED as follows:

 

ARTICLE 1.   DEFINITIONS

 

For the purposes of this Agreement, the terms defined in this Article shall
have the meaning specified and shall be applicable both to the singular and
plural forms.

 

“3M Background Patent Rights” shall mean the Patents
owned or controlled by 3M IPC or 3M IPC Affiliates or to which 3M IPC or 3M IPC
Affiliates otherwise has the right to license, including a licensable interest
in any jointly owned Patents, and which are listed on Exhibit A, part
1.  The data regarding a patent or
application, and additional applications in a patent family, listed on Exhibit A,
part 1, shall be updated by 3M IPC from time-to-time or upon request by
CELLDEX.  For the avoidance of doubt, any
such additional 3M Background Patent Rights added to Exhibit A, part 1
during the term of this Agreement will be covered by the grant of rights under Section 2.1.  For further avoidance of doubt, no patent
families are included in 3M Background Patent Rights other than those listed on
Exhibit A, part 1, provided, however, that (i) 3M IPC is not aware of
any other Patent Rights existing as of the Effective Date owned or controlled
by 3M IPC or its Affiliates that would cover the Licensed Compounds per se, the
existing resiquimod gel formulation provided by 3M, or their use as Vaccine
Adjuvants (as opposed to other specific formulations or other specific methods
of delivery thereof), and (ii) in the event additional Licensed Compounds
are added to this Agreement, 3M IPC will add applicable Patent Rights to Exhibit A,
part 1.

 

“3M Know-How” shall mean any substantial
proprietary Confidential Information and data which is not in the public domain
provided by 3M to develop, use, manufacture, commercialize or obtain Regulatory
Approval of a Product, including any access or right of reference to data in a
Drug Master File or similar safety data package for resiquimod or other
Licensed Compound or Product.

 

2

 

“3M Patent Rights”
shall mean 3M Background Patent Rights and 3M Program Patent Rights.

 

“3M Program Patent Rights” shall mean Patents owned or
controlled by 3M IPC or 3M IPC Affiliates or to which 3M IPC or 3M IPC
Affiliates otherwise has the right to license, including any interest in any
jointly owned Patents, on inventions conceived during and arising out of work
conducted under this Agreement.  Exhibit A,
part 2, shall be updated by 3M IPC to include 3M Program Patent Rights promptly
upon first filing an application on a program invention and at any other time
upon request by CELLDEX to include applicable 3M Program Patent Rights of 3M
covering a Licensed Compound, Vaccine Adjuvant and/or Product conceived during
and arising out of work conducted under this Agreement.  For the avoidance of doubt, any such
additional 3M Program Patent Rights added to Exhibit A, part 2 during the
term of this Agreement will be covered by the grant of rights under Section 2.1.

 

“3M Workplan” shall mean activities, if any,
to be undertaken by 3M to assist CELLDEX with development of Product(s) in
the Field, which may be incorporated into this Agreement upon written agreement
of 3M and CELLDEX.

 

“Affiliate”
shall mean (1) any individual or Entity who, whether now existing or
created in the future, that in whatever country organized or resident, directly
or indirectly through one or more intermediaries, is controlled by, or is under
common control with, or controls, a Party; or (2) any Entity, whether now
existing or created in the future, in which any Party or any individual or
Entity recited in the preceding paragraph (1) directly or indirectly
through one or more intermediaries has at least a forty percent (40%) ownership
or voting rights interest (whether through stock ownership, stock power, voting
proxy, or otherwise) or has the maximum ownership interest it is permitted to
have in the country where such Entity exists.

 

“Approval
Application” shall mean an application for Regulatory
Approval required before commercial sale or use of a Product as a drug in a
regulatory jurisdiction, including but not limited to an Investigational New
Drug (“IND”) application as defined in the United States Food, Drug and
Cosmetic Act and regulations promulgated thereunder, or any corresponding
foreign equivalent thereof or comparable regulatory or scientific filing to initiate
human clinical exposure.

 

3

 

“CELLDEX
Know-How” shall mean any substantial proprietary Confidential
Information and data which is not in the public domain provided by CELLDEX
useful to develop, use, manufacture, commercialize or obtain regulatory
approval of a Product.

 

“CELLDEX Program Patent Rights” shall
mean Patents owned or controlled by CELLDEX or its Affiliates or to which
CELLDEX or its Affiliates otherwise has the right to license, including a
licensable interest in any jointly owned Patents, on inventions conceived
during and arising out of work conducted under this Agreement.  Exhibit B shall be updated by
CELLDEX  to include CELLDEX Program
Patent Rights promptly upon first filing an application on a program invention
and at any other time upon request by 3M IPC to include applicable Patents of
CELLDEX covering a Product conceived during and arising out of work conducted
under this Agreement.

 

“CELLDEX APC Targeting Technology”
shall mean: Any molecule or DNA vaccine that encodes for the molecule composed
of an antibody or antibody fragment attached covalently or via a high-affinity
bond to a vaccine antigen expressly designed to selectively bind to antigen
presenting cells, including conventional dendritic cells, through cell surface
receptors and to carry the vaccine antigen into these cells for subsequent
immune processing.

 

“CELLDEX Workplan” shall mean the description(s) set
forth in Exhibit C of activities to be undertaken by CELLDEX for the
development of Product(s) in the Field, as entered in Exhibit C or
which may be amended at CELLDEX’s sole discretion.

 

“cGMP”                shall mean manufacture in
accordance with:

 

(a)           Directive
91/412/EEC and Directive 2003/94/EC or any other applicable European Community
legislation or regulation as amended and applicable from time to time;

 

(b)           the
current principles and guidelines of good manufacturing practice for medicinal
products for human use and “substantial conformity with good manufacturing
requirements” (as such phrase is used in Section 802(f)(1) of the
Federal Food, Drug and Cosmetic Act, as such Act may be amended from time to
time); and

 

(c)           US
Code of Federal Regulations, Title 21, Part 210 (Current Food
Manufacturing Practice in Manufacturing, Processing, Packaging or Holding of
Drugs), Part 211 (Current Food Manufacturing Practice for Finished
Pharmaceuticals);

 

4

 

“Drug Master File”
or “DMF” shall mean all filings and
submissions of information to the FDA pursuant to US in 21 CFR 314.420 and
otherwise in connection with the filing of a drug master file with the FDA in
the United States, and, in any jurisdiction outside the United States, all
analogous filings and submissions of information to any other regulatory body
in such other jurisdiction in relation to the filing of a drug master file or
analogous documentation therewith.

 

“Entity” shall
mean any corporation, firm, partnership, proprietorship, or other form of
business organization.

 

“Earned Royalty” shall mean the royalties paid or payable
under this Agreement based on Net Sales of Product covered by a Granted Claim
of 3M Patent Rights or using 3M Know-How. 
For purposes of this Agreement, the term “covering” or “covered” in the
context of a Granted Claim means that but for the licenses granted herein the
Product in question or the manufacture, use, sale, offer for sale, or
importation of such a Product would infringe a Granted Claim according to the
law of the applicable jurisdiction.

 

“Field” shall mean human prophylactic or
therapeutic vaccination against any and all cancer disease states and selected
infectious diseases, as listed in the attached Exhibit D.

 

“Improvement(s)”
shall mean findings, improvements, enhancements, discoveries, technologies,
information, inventions, additions, modifications, adaptations, advances,
developments, uses, formulations, variations, enhancements, improvements or
changes (whether or not patented or patentable) with respect to the Licensed
Compounds (or other 3M IRM compounds) conceived, developed and/or reduced to
practice during the term of this Agreement.

 

“Licensed
Compound”  shall
mean resiquimod (or resiquimod gel), the compounds listed in Exhibit E
(which may be amended upon mutual agreement to add new compounds), including
any salt, solvate, ester, enantiomer, conjugate or prodrug thereof.  As used herein, “conjugate” or “conjugated”
refers to attachment of a Licensed Compound directly or indirectly to a vaccine
antigen via a covalent or high-affinity non-covalent bond such that the
Licensed Compound and vaccine antigen remain linked together (as a Product) for
co-presentation to immune system cells.

 

“Net Sales”
shall mean the amount invoiced by CELLDEX, its Affiliate, or its Sublicensee
for sale of Product in an arms length transaction to a Third Party, less sales,
excise 

 

5

 

or use taxes or transportation charges shown on the face of the
invoice, less credits for defective or returned Products, and less all regular
trade and discount allowances.  Product
sold in transactions involving consideration other than or in addition to cash
shall be deemed to have been sold at the highest price charged by CELLDEX, its
Affiliate or Sublicensee to the applicable class of trade in the relevant
annual period (or, if all transactions in the applicable class of trade involve
consideration other than or in addition to cash, the highest price charged by
CELLDEX, its Affiliate or Sublicensee in the relevant annual period irrespective
of class of trade).  Leasing, lending,
consigning, or any other activity by means of which a Third Party acquires the
right to possession or use of a Product shall be considered to be a sale for
the purpose of determining Net Sales. 
Net Sales shall be deemed to be at least fair market value.  For clarity, the value of donations of
Product cannot be deducted in calculating Net Sales.

 

“Party” or “Parties” shall mean CELLDEX, 3M, and/or 3M
IPC, as applicable.

 

“Patents” shall mean  patents
and patent applications, utility certificates, improvement patents and models
and certificates of addition and all foreign counterparts of them in all
countries, including any divisional applications and patents, refilings,
renewals, re-examinations, continuations, continuations-in-part, patents of
addition, extensions, (including patent term extensions), reissues,
substitutions, confirmations, registrations, revalidations, pipeline and
administrative protections and additions, and any equivalents of the foregoing in
any and all countries of or to any of them, as well as any supplementary
protection certificates and equivalent protection rights in respect of any of
them.

 

“Phase I Clinical Trial” shall mean a human
clinical trial that is intended to initially evaluate the safety and/or
pharmacological effect of a product in subjects or that would otherwise satisfy
requirements of 21 CFR 312.21(a), or its foreign equivalent.

 

“Phase II Clinical Trial” shall mean a human clinical trial in any
country that is intended to initially evaluate the effectiveness of a product
for a particular indication or indications in patients with the disease or
indication under study or that would otherwise satisfy requirements of 21 CFR
312.21(b), or its foreign equivalent.

 

“Phase III Clinical Trial” shall means a human clinical trial in any
country that is intended to prove statistically sound evidence of the effect
and safety of a product for a particular 

 

6

 

indication or indications in patients
with the disease or indication under study or that would otherwise satisfy
requirements of 21 CFR 312.21(c), or its foreign equivalent.

 

“Product” shall mean any combination of (i) a
CELLDEX APC Targeting Technology vaccine with (ii) a Licensed Compound to
be utilized as a Vaccine Adjuvant.  For
the avoidance of doubt, a single Product may serve to provide immunization for
multiple diseases in the Field.

 

“Regulatory
Approval” shall mean any and all approvals,
authorizations, licenses or registrations of any federal, state or local
regulatory agency, department, bureau or other governmental entity (including
but not limited to the U.S. Food and Drug Administration (“FDA”), necessary for
the manufacture, use, storage, import, transport and/or sale of products in a
regulatory jurisdiction.

 

“Regulatory
Authority” shall mean (i) with respect to the
United States, the FDA, or such other agency or instrumentality of the United
States to which the responsibilities and authority of the FDA are given or
delegated from time to time, (ii) with respect to the European Union, the
European Medicines Evaluation Agency (“EMEA”), and (iii) with respect to
each other jurisdiction, the agencies or instrumentalities of such jurisdiction
having substantially the same responsibilities and authority of the FDA or
EMEA.

 

“Sublicensee” shall mean a non-Affiliate
person or entity to whom CELLDEX or a direct sublicensee of CELLDEX has granted
a sublicense pursuant to and in accordance with Article 2 of this Agreement.

 

“Territory” shall mean worldwide.

 

“Third Party” shall mean an entity other than CELLDEX,
3M, 3M IPC, or Affiliates thereof.

 

“Vaccine Adjuvant” shall mean a Licensed
Compound which is used to induce, augment, fine-tune, enhance, or desensitize
an antigen-specific immune response to an antigen contained in a vaccine or
generated by a DNA vaccine for the therapeutic treatment of an existing disease
or prophylactic use as protection against future disease (including
desensitization to allergens).  [*]

 

* Confidential

 

7

 

“Granted Claim”  shall mean a claim of an issued
(granted) and unexpired patent within the 3M Patent Rights that has not been
held invalid by an administrative agency or court of competent jurisdiction in
any unappealed or unappealable decision.

 

ARTICLE
2.                  LICENSE

 

2.1                              3M
IPC (and Affiliates if applicable) hereby grants to CELLDEX a worldwide,
royalty-bearing, exclusive license to 3M Patent Rights and 3M Know-How to
`make, have made, use, import, offer to sell, and sell Product using Licensed
Compound supplied
by 3M (or supplied by a third party under Section 7.2 if
applicable) for use in the Field.  For
the avoidance of doubt, the license grant under this Section 2.1 provides
for CELLDEX to utilize Licensed Compound related to the research and
development of a Product for use in the Field.

 

2.2                              CELLDEX,
and any direct Sublicensee of CELLDEX granted in accordance with this Article 2,
shall have the right to grant one or more sublicenses hereunder in connection
with Licensed
Compound (as related to the research and development of a Product for use in
the Field) and any Product developed by CELLDEX without the prior
written consent of 3M provided that:

 

(a)           CELLDEX shall notify
3M in writing of the grant of any sublicense, identify the sublicense and
assure itself of the integrity and financial responsibility of the Party to
whom a sublicense is granted (“Sublicensee”); and,

 

(b)           each Sublicensee
shall agree to be bound by all of the obligations, terms and conditions that
obligate, bind or affect CELLDEX under this Agreement to the extent that such
obligations, terms and conditions are relevant given the nature of the rights
granted by CELLDEX to any given sublicense.

 

2.3                              CELLDEX
hereby grants to 3M a non-exclusive,
royalty-free, fully paid up license, with rights to sublicense, to any CELLDEX
Improvements, provided that such license shall exclude use of Licensed
Compounds with CELLDEX APC Technology until after the Term.

 

8

 

2.4                              Neither
3M, 3M IPC nor CELLDEX grant any right or license under any patent rights,
know-how, or other intellectual property rights other than as expressly
provided above.

 

ARTICLE
3.                  TECHNICAL
COLLABORATION AND REGULATORY SUPPORT

 

3.1                              3M will provide to CELLDEX certain information regarding the Licensed
Compounds including 3M Know-How and other information to support Approval
Applications in the Territory.  At CELLDEX’s
request and expense, and with reasonable advance notice, 3M may at 3M’s option,
attend and participate in meetings with a Regulatory Authority in seeking
Regulatory Approval of a Product.  3M
shall have no obligation to generate any additional data regarding a Licensed
Compound except as provided under a 3M Workplan.

 

3.2                              Each
Party shall appoint a person (a “Program Manager”) to coordinate this Article 3
of this Agreement.  The Program Managers
shall be the primary contacts between the Parties, and each Party shall notify
the other within thirty (30) days after the date of this Agreement of the
appointment of its Program Manager and shall notify the other Party as soon as
practicable upon changing this appointment. 
As between the Parties, CELLDEX shall be solely responsible, at its own cost,
expense and discretion, for designing, creating and finalizing a commercially
reasonable plan for the development of a Product sufficient to obtain
Regulatory Approval of such Product within the Territory, and then implementing
and carrying out all activities contemplated under such development plan such
as all research, development, scientific, medical, regulatory and other
activities.  Notwithstanding the
foregoing, CELLDEX shall use commercially reasonable efforts to develop and
commercialize a Product throughout the Territory.  CELLDEX shall provide 3M a reasonable summary
of such CELLDEX Workplans to allow 3M to monitor progress and estimated
milestone timing.  CELLDEX shall provide
bi-annual updates of progress and/or material changes 

 

9

 

under CELLDEX Workplans to 3M via contact
with 3M’s designated Program Manager.  If
CELLDEX terminates work on a Product for cancer or fails to use reasonable
diligence after three years from the Effective Date to progress any program for
a disease target listed in the Field other than cancer, 3M shall have the right
to remove such disease target from the Field definition.  CELLDEX shall promptly inform 3M of any
discontinued programs and 3M shall have the right to update Field definition to
remove such disease target.

 

3.3                              3M
will supply or have supplied, [*] for CELLDEX’s
use under a CELLDEX Workplan from initiation of pre-clinical studies through
completion of a Phase I Clinical Trial, or 3M’s use under a 3M Workplan
within [*] weeks of receiving such request.  3M shall invoice CELLDEX at a rate of $[*] for the time required to produce and release any
Licensed Compounds supplied by 3M to CELLDEX for Phase II and Phase III
Clinical Trial studies, or other U.S. dollar amount as agreed.    3M shall invoice CELLDEX upon shipment of
such supplies.   CELLDEX shall pay 3M
within 30 days of 3M’s invoice date.

 

3.4                              CELLDEX
may request 3M to conduct work such as to identify IRM molecules for
pre-clinical development and/or to synthesize conjugatable and non-conjugatable
IRM molecules for preclinical and clinical development and to manufacture and
perform stability studies for toxicology and clinical supplies.  If 3M determines that it has the capacity and
capability to conduct the work, CELLDEX and 3M shall agree on a 3M Workplan to
define the scope, deliverables and timing for such work.  3M will use reasonable commercial efforts to
carry out such work in a timely manner under the Workplan.  CELLDEX will fund any such work by 3M at 3M’s
then-prevailing hourly rate  [*].  3M shall invoice CELLDEX for such work on a
monthly basis.  CELLDEX shall pay 3M
within 30 days of 3M’s invoice date.

 

3.5                              As
between CELLDEX and 3M, CELLDEX shall own all Approval Applications and
Regulatory Approvals related to the development and commercialization of a
Product in the Territory.

 

* Confidential

 

10

 

3.6                              CELLDEX
(or one of its Affiliates or Sublicensees) shall be responsible for and act as
the sole point of contact for communications with Regulatory Authorities in
connection with the development, commercialization, and manufacturing of a
Product in the Territory.  To the extent
3M receives any written or oral communication from any Regulatory Authority
relating to a Product, 3M shall (i) refer such Regulatory Authority to
CELLDEX, and (ii) as soon as reasonably practicable, notify CELLDEX of
such communication.

 

3.7                              Each
Party shall maintain records, in sufficient detail and in good scientific
manner appropriate for patent purposes, which shall be complete and accurate
and shall fully and properly reflect all work done and results achieved in the
performance of obligations under this Agreement.

 

3.8                              CELLDEX
shall, following the Effective Date, bear all costs relating to obtaining,
supporting and maintaining Regulatory Approvals in the Territory.

 

ARTICLE 4.                                                          PROGRAM IP OWNERSHIP

 

4.1                              Inventions
conceived during and out of the work under this Agreement, and patents and
applications filed thereon, shall be owned according to U.S. law as follows:
those conceived solely by employees or agents of one Party shall be owned by
that Party; those conceived jointly by an employee or agent of 3M and an
employee or agent of CELLDEX shall be owned jointly by 3M IPC and CELLDEX each
joint owner having the right, subject to this Agreement, to practice, license,
and transfer its rights in joint inventions without permission of or accounting
to the other(s).

 

4.2                              Each
Party may prepare, file, prosecute, maintain, abandon, terminate, enforce, and
otherwise handle solely owned patent rights at its sole discretion and
expense.  Joint patent applications and
patents may be prepared, filed, prosecuted, and maintained primarily by CELLDEX
at its expense if claiming an invention that is based primarily on use or
formulation of the CELLDEX vaccine(s) and by 3M at 

 

11

 

its expense if based primarily on use or
formulation of resiquimod or other Licensed Compound, and if the invention
being claimed is not clearly either of the foregoing, the Parties will agree in
good faith how best to handle the cost, preparation, filing, prosecution, maintenance,
abandonment, or termination of such joint applications and patents.

 

4.3                               Infringement

In the case where at any time during the term of this Agreement either
Party believes that an infringement within the scope of the exclusive license
granted under Section 3.1 by a Third Party of the 3M Patent Rights is
occurring, which infringement entails the development or commercialization of a
product the same as any Product or that directly competes with any Product,
such Party shall disclose the basis for such belief to the other Party.

 

4.4                              Third
Party Patents

If during the term of this Agreement either Party receives any notice,
claim or proceedings from any Third Party alleging infringement of that Third
Party’s intellectual property by reason of either Party’s activities under this
Agreement, then:

 

(a)  the notified Party shall forthwith inform the other Party of
the notice, claim or proceeding;

 

(b)  if the alleged infringement is due in particular to Licensed
Compound (i.e., but for Licensed Compound, as opposed to a different adjuvant
compound, there would be no infringement), then 3M shall have the right , but
shall not be obliged to, at its own cost and expense, defend such claim or
other proceeding in accordance with the following:

 

(i)  3M shall have sole conduct of the
claim and any proceedings including any counterclaim for invalidity or
unenforceability or any declaratory judgment action and including the right to
settle provided always that 3M shall not settle any claim which prejudices any
right or interest of CELLDEX other than with the prior written consent of
CELLDEX.  If 3M elects to unilaterally
control the 

 

12

 

conduct of such claim or proceeding, 3M shall
pay its counsel and other litigation fees and pay the full cost of damages
awarded in favor of the patentee for past infringement but shall have no other
duty or liability to CELLDEX.  CELLDEX
shall provide reasonable assistance to 3M in relation to such proceedings
provided 3M shall reimburse CELLDEX for its reasonable out-of-pocket expenses
in providing any such requested assistance, but not any other expenses if, for
example, CELLDEX elects to be separately represented (which shall be at CELLDEX’s
discretion), in which case such separate representation shall be at CELLDEX’s
cost and expense;

 

(ii)  if 3M succeeds in any such
proceedings whether at trial or by way of settlement, it shall be entitled to
retain any part of an award of costs and damages made in such proceedings or
settlement sum paid that is necessary to recover its costs and the balance
shall then be shared between the Parties in proportion to the loss suffered by
each Party in consequence of such proceedings.

 

(c)  If 3M elects not to unilaterally
control the conduct of such claim or proceeding, or if the alleged infringement
is not due to Licensed Compound, then CELLDEX shall be fully responsible for
defending conducting such claim or proceeding at its sole cost and expenses and
shall indemnify and hold harmless 3M for any damages or liability resulting
from such litigation.  3M shall provide
reasonable assistance to CELLDEX in relation to such proceedings provided
CELLDEX shall reimburse 3M for its reasonable out-of-pocket expenses in
providing any such requested assistance, but not any other expenses if, for
example, 3M elects to be separately represented (which shall be at 3M’s
discretion), in which case such separate representation shall be at 3M’s cost
and expense

 

13

 

ARTICLE 5.                                                          FEES AND MILESTONE PAYMENTS

 

5.1                              CELLDEX
shall pay 3M IPC [*] within 10 days of the
Effective Date.

 

5.2                              On
the first and second anniversary of the Effective Date, CELLDEX shall pay 3M
IPC [*]. 
This fee will enable CELLDEX to continue to develop different
pre-clinical Products directed toward filing of an Approval Application with a
Regulatory Authority (“Clinical Candidate”), as designated in writing to 3M IPC
by CELLDEX.  Beginning on the third
anniversary of the Effective Date, CELLDEX shall pay 3M [*].

 

5.3                              CELLDEX
shall notify 3M IPC upon achieving the following clinical development milestone
payments for each Product containing a different vaccine antigen and/or
different Licensed Compound and shall pay 3M IPC within 30 days of the
following clinical development events:

 

	
  Development Milestones Payments

  	
   

  	
   

  	
   

  
	
  [*]

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  [*]

  	
   

  
	
  [*]

  	
   

  	
  [*]

  	
   

  

 

*Major Market is defined as [*].

 

* Confidential

 

14

 

ARTICLE 6.                                                     ROYALTIES

 

6.1                              CELLDEX
shall pay 3M IPC an Earned Royalty of [*] of Net
Sales of Product covered by a Granted Claim of 3M Patent Rights or using 3M
Know-How, [*].

 

6.2                              CELLDEX
shall pay the Earned Royalties due under this Agreement not later than 30 days
following each calendar quarter in which the Earned Royalties accrue.  If necessary, royalty amounts may be
estimated and subsequently reconciled in the next royalty payment.  CELLDEX shall account for all sales of
Products by their Affiliates and Sublicensees and shall submit a single payment
for all sales of Products. Each payment shall be accompanied by a royalty
report identifying the unit volume, Net Sales, and royalty due for each
licensed Product on a country-by-country basis. 
Payments for royalties, as well as hourly charges for work under 3M
Workplans, annual fees, and milestones with Reference Fields indicating the
reason for payment shall be made by wire transfer to:

 

Wells Fargo Bank NA

420 Montgomery St

San Francisco, CA 94104-1298

 

ABA Number:  121000248

Beneficiary:  3M Company

Account Number:  0000030103

 

Agreement Control
Number

Reference
Field:    Vaccine Adjuvant Annual Fees,
Milestones, or Royalty

 

or to such other
address as 3M IPC may from time to time designate.

Payments for
hourly work by 3M shall be made net 30 days and as addressed in 3M’s invoices
for such work.

 

* Confidential

 

15

 

6.3                              3M
may inspect and audit the records of CELLDEX and its Sublicensees pertaining to
the sale of Products through third party accountants of its own selection and
reasonably acceptable to CELLDEX. 
CELLDEX shall provide such accountants with access to the records during
reasonable business hours, to check, at 3M’s expense, the royalty due
hereunder.  Any such audit shall not
unreasonably interfere with the ability of CELLDEX to conduct its normal
business.  Such access need not be given
to any such set of records more often than once each year nor more than 3 years
after the date of any report to be audited, and the accountants shall report to
3M only the amount of royalty due and any other corrections to previous royalty
reports.  Such 3M accountant may be
required by CELLDEX to enter into a reasonably acceptable confidentiality
agreement, and in no event shall such accountants disclose to 3M any
information other than such as relates to the accuracy of reports and payments
made or due hereunder.  3M shall give
CELLDEX written notice of its election to inspect and audit the records related
to the royalty due hereunder not less than 30 business days prior to the
proposed date of review by 3M’s third party accountants. CELLDEX shall maintain
sufficient records to permit the inspection and auditing permitted hereunder
for three years after the date of each respective reporting period.  CELLDEX shall prepare its records and reports
according to generally accepted accounting principles.

 

6.4                              Any
late payments under this Agreement shall accrue interest at a rate of 1.0% per
month.  In the event that an audit reveals
an underpayment by CELLDEX, it shall pay the past due royalty and interest
within 30 days.  In the event that an
audit reveals an underpayment of more than 5% of the amount due, CELLDEX shall,
in addition to interest due on the late amount, pay for 3M’s reasonable costs
in conducting the audit.

 

16

 

ARTICLE 7.                             COMMERCIAL SUPPLY OF LICENSED COMPOUNDS

 

7.1                                 [*]

 

7.2                                 [*]

 

ARTICLE 8.                                                          CONFIDENTIALITY, STUDY RESULTS, AND PUBLICATION

 

8.1                              During
the course of this Agreement, 3M, 3M IPC and CELLDEX may each disclose
confidential and/or proprietary information, including but not limited to each
Party’s materials, other proprietary materials and technologies, economic
information, business or research strategies, trade secrets and material
embodiments thereof (each Party’s “Confidential Information”), to the other
solely for the purpose of carrying out a CELLDEX Workplan or 3M Workplan, or
both.

 

8.2                              The
recipient of Confidential Information shall (i) not disclose it to any
Third Party except employees, consultants, and agents to whom such disclosure
is necessary to the purpose of this Agreement and who are bound by
confidentiality obligations at least as stringent as herein, (ii) protect
it with the same degree of care used to protect its own confidential
information of a like nature, but no less than a reasonable degree of care, (iii) not
use it for any purpose other than as set forth under this Agreement, and (iv) return
it upon request of the disclosing Party.

 

* Confidential

 

17

 

8.3                              The
obligations set forth in paragraph 8.2 shall apply only to Confidential
Information that is (a) disclosed in writing and is marked to indicate it
is confidential at the time of disclosure, or that is (b) disclosed in any
other manner and is indicated to be confidential at the time of disclosure and
thereafter is also summarized and marked to indicate it is confidential in a
written memorandum delivered to the receiving Party within thirty days of the
disclosure, or that is (c) disclosed in the form of tangible products or
materials transmitted with an accompanying written memorandum indicating that
the disclosure is confidential.  Further,
it is understood that 3M shall not receive on a confidential basis any
information regarding Licensed Compounds or uses, formulations or delivery
thereof, and CELLDEX shall not receive on a confidential basis any information
regarding CELLDEX’s vaccine’s or uses, formulations or delivery thereof.

 

8.4                              Information
shall no longer be deemed Confidential Information 5 years following the
termination or expiration of this Agreement, or if the information (i) was
in recipient’s possession before receipt from discloser and was not acquired,
directly or indirectly, from discloser on a confidential basis, (ii) is
received in good faith from a Third Party not subject to an obligation of
confidentiality owed to discloser or a Third Party, (iii) is independently
developed by recipient without reference to or use of Confidential Information
received hereunder, or (iv) is already or becomes available to the public
through no fault of the recipient (v) is required by judicial or
administrative process to be disclosed, provided that recipient shall promptly
notify discloser with enough time to oppose such process.  A recipient Party may include information of
the other in a patent application only to the extent required (e.g., to comply
with best mode) and provided that it is raised in advance and there is no
reasonable objection by the other Party.

 

8.5                              With
specific regard to pre-clinical and clinical study results from work under this
Agreement  generated by CELLDEX or Third
Parties, each Party shall treat such data as confidential but shall have the
right to use the data for its own internal research purposes and shall have a
limited right to disclose the data to individual 

 

18

 

Third Parties provided that such disclosure
shall not without written permission of the other Party include information
that would (i) in the case of disclosures by CELLDEX, identify 3M or
suggest (e.g., via mechanism of action) that Licensed Compounds were used, or (ii) in
the case of disclosures by 3M, identify CELLDEX or suggest that a CELLDEX
vaccine was used.  For avoidance of
doubt, (i) CELLDEX may disclose that a novel vaccine adjuvant was used in
the work, and 3M may disclose the results obtained using a particular vaccine;
and, (ii) pursuant to Section 3.5, CELLDEX shall own all Approval
Applications and Regulatory Approvals related to the development and
commercialization of a Product in the Territory.  For the avoidance of doubt, 3M shall not have
access to CELLDEX Regulatory Applications, but shall have the right to use data
generated in support of such Regulatory Applications as it relates to the
Licensed Compound.

 

8.6                              Any
peer-reviewed journal publication or public presentation at scientific
meetings, or the like, of the data shall be only with the mutual consent of the
Parties, shall include employees of both Parties as authors if academically
appropriate, and shall identify both 3M and CELLDEX unless one Party requests
not to be identified or to exclude identification of 3M IRM compounds or the
CELLDEX APC vaccine candidate.  Any proposed
journal publication or presentation at a public meeting of the data shall be
submitted by the publishing or presenting Party to the other Party for review,
comment and removal of said Party’s Confidential Information at least thirty
(30) days in advance of submission to the proposed publisher or conference.

 

8.7                              The
terms of this Agreement shall be deemed confidential, but existence and general
nature of this Agreement or that the Parties have a relationship regarding the
subject matter hereof shall not be deemed confidential.

 

19

 

ARTICLE 9.                             WARRANTIES
AND INDEMNIFICATION

 

9.1                              Each
Party warrants that (i) it has the right to enter into this Agreement; (ii) it
has no obligations to any other person or entity which are in conflict with its
obligations under this Agreement; (iii) it has taken all requisite action
on its part to authorize the execution and delivery of this Agreement and the
performance of its obligations hereunder. This Agreement has been duly executed
and delivered on behalf of such Party, and constitutes a legal, valid, binding
obligation, enforceable against such Party in accordance with its terms.

 

9.1.1.                  Except as
disclosed to or otherwise known by CELLDEX, 3M IPC (or an Affiliate) owns and/or
has the right to license the 3M Background Patent Rights as set forth in this
Agreement.

 

9.1.2.                  Except as
disclosed to or otherwise known by CELLDEX, 3M IPC does not have actual
knowledge, through its in-house patent counsel, that any Third Party patent
would be infringed by Licensed Compound or its manufacture by 3M.

 

9.2                              3M
warrants that any Licensed Compound, or formulation thereof, it supplies to
CELLDEX for clinical testing or commercial supply will meet agreed upon
specifications and be manufactured in accordance with cGMP.

 

9.4                              EXCEPT
AS SET FORTH IN THIS PARAGRAPH 9.1 and 9.2, NO PARTY GIVES ANY EXPRESS OR
IMPLIED WARRANTY PURSUANT TO THIS AGREEMENT, THE PERFORMANCE OR NONPERFORMANCE
OF THIS AGREEMENT OR ANY OTHER MATTER OR SUBJECT ARISING OUT OF THIS AGREEMENT,
INCLUDING BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND
FITNESS FOR A PARTICULAR PURPOSE, NONINFRINGEMENT OF THIRD PARTY PATENT RIGHTS,
OR THE SCOPE, VALIDITY, OR ENFORCEABILITY OF ANY LICENSED PATENT RIGHTS.

 

9.5                              3M
shall indemnify, defend and hold CELLDEX harmless against any and all Third
Party loss or liability for any and all judgments, claims, causes of action, 

 

20

 

suits, proceedings, losses, damages, demands,
fees, expenses, fines, penalties or costs (including without limitation
reasonable attorney’s fees, costs and disbursements) arising from any claim by
such Third Party made against CELLDEX to the extent such claim results from 3M’s
breach of the warranty provided above, however, 3M shall be liable only to the
extent such breach resulted in the harm or injury for which CELLDEX seeks
indemnification.  CELLDEX’s sole remedy
for supply of defective Licensed Compounds, or formulation thereof, shall be
replacement of such material or refund of the supply cost paid to 3M for such
material.

 

9.6                              CELLDEX
shall indemnify, defend  and hold 3M and
3M IPC harmless from any and all Third Party loss or liability for any and all
judgments, claims, causes of action, suits, proceedings, damages, demands,
fees, expenses, fines, penalties and costs (including without limitation
reasonable attorney’s fees, costs and disbursements) arising from any claim by
such Third Party made against 3M/3M IPC that results from CELLDEX’s or its agent’s
use, sale, testing, or clinical studies of Licensed Compounds, or formulation
thereof, or Product except to the extent that such loss or liability is due to
3M’s breach of the warranty set forth above.

 

9.7                              Notwithstanding anything in this
Agreement to the contrary neither Party shall be liable to the other for any
indirect, incidental, special, punitive or consequential damages related to
Licensed Compounds, formulation thereof, or Product, or performance or
non-performance of this Agreement regardless of the legal theory asserted
including, but not limited to, contract, fault, negligence or strict liability.

 

ARTICLE
10.                      TERM AND
TERMINATION

 

10.1                        This
Agreement shall, unless earlier terminated, expire at the end of CELLDEX’s
obligation to pay royalties under Article 6 expires.

 

21

 

10.2         CELLDEX
shall have the right to terminate without cause at any time on 60 days written
notice to 3M.

 

10.3         3M
shall have the right to terminate this Agreement on 60 days written notice in
the event CELLDEX takes action directly or indirectly to challenge the
validity, scope or enforceability of any of the 3M Patent Rights.

 

10.4         Either
Party may terminate this Agreement upon 60 days written notice of material
breach by the other Party and failure to cure such breach within such 60 days
time.

 

10.5         In
the event CELLDEX terminates this Agreement under Section 10.2 or 10.4 or
3M terminates under Sections 10.3 or 10.4, all licenses to CELLDEX under this
Agreement shall immediately terminate and CELLDEX shall destroy any unused
amounts of Licensed Compound at 3M’s written request, provided that CELLDEX,
its Affiliates and any sublicensee thereof may, however, after the effective
date of such termination, sell all Products, and complete manufacture and/or
formulation at the time of such termination and sell, have sold, or offer for
sale the same, provided that CELLDEX shall make the payments and submit reports
to 3M as required in Article 6 of this Agreement.

 

ARTICLE 11.       MISCELLANEOUS

 

11.1         This
Agreement contains the complete and entire agreement between the Parties
hereto, and supersedes any previous communications, representations, or
agreements whether verbal or written relating to the subject matter hereof.

 

11.2         No
change, addition, waiver, amendment, or modification of any of the terms or
conditions hereof shall be valid or binding on either Party unless in writing
and signed by authorized representatives of all Parties.

 

11.3         Notices
under this Agreement shall be given in writing and delivered by mail or
facsimile to the Parties as follows:

 

22

 

To 3M:

 

3M Drug Delivery Systems Division

3M Center Bldg. 275-3E-10

St. Paul, Minnesota 55144

 

Attention: 
General Manager

 

With a copy to:

 

Chief Intellectual Property
Counsel

Office of Intellectual Property Counsel

3M Innovative Properties
Company

Building 220-10W-01

3M Center

St. Paul, Minnesota 55144

 

To CELLDEX:

 

Celldex Therapeutics

222 Cameron Drive, Suite 400

Phillipsburg, New Jersey 08865

Attention: VP Business Development

Facsimile: (908) 454-1911;

 

with copies to:

Fox Rothschild LLP

2700 Kelly Road, Suite 300

Warrington, PA  18976-3624

Attention:  Jeffrey H. Nicholas, Esq.

Facsimile:  (215) 345-7507;

 

11.4         This
Agreement may not be assigned by a Party without the prior written consent of
the other Party, and any purported assignment without such consent shall be
void, provided however, (i) CELLDEX may assign this Agreement without such
consent in connection with the sale or transfer of substantially all of its
business to which this Agreement relates, or (ii) 3M and 3M IPC may assign
this Agreement without such consent in connection with the sale or transfer of
substantially all of 3M’s business to which this Agreement relates.

 

23

 

11.5         Any
questions, claims, disputes or litigation arising from or related to the
making, performance or alleged breach of this Agreement, or to any available
remedies (a “dispute”), shall be governed by the laws of Minnesota, without
regard to conflicts of law principles, and shall be resolved as follows: (i) upon
written notice of dispute (the “notice”), by in-person negotiation between
business representatives of the Parties who have authority to fully resolve the
dispute; (ii) if within 60 days of the notice the dispute has not been
fully resolved, the Parties shall conduct a confidential mediation using a
location, mediator, and rules acceptable to both Parties (with the costs
of mediation shared equally); (iii) if the dispute is not then resolved,
and as a last resort only, either Party may commence litigation; provided
that any lawsuit must be filed and maintained exclusively in the state or
federal courts of Minnesota.  THE PARTIES
HEREBY WAIVE ANY CONSTITUTIONAL, STATUTORY OR COMMON LAW RIGHT TO A TRIAL BY
JURY.  Nothing herein shall preclude
either Party from taking whatever actions it deems necessary to prevent
immediate, irreparable harm to its interests.

 

11.6         If
one or more provisions of this Agreement is for any reason found to be invalid
or unenforceable or ruled by a court or other government body of competent
jurisdiction to be invalid or unenforceable, that provision or provisions shall
be deemed severed from the rest of the Agreement and all other provisions
within the Agreement nevertheless will remain enforceable.  The Parties shall replace any such
invalidated or unenforceable provision(s) with a valid and enforceable
provision(s), by mutual consent, which will achieve the economic effect
sufficiently similar to the invalid or unenforceable provision(s) so that
it can be reasonably assumed that the Parties would have entered into this
Agreement with such a replacement provision or provisions in place.

 

11.7         This
Agreement may be executed in one or more counterparts, each of which shall be
deemed to be an original document, but all such separate counterparts shall
constitute only one and the same instrument. 
One or more counterparts may be 

 

24

 

delivered by facsimile transmission and such transmission shall be
valid and binding to the same extent as if it were an original.

 

11.8         Neither
Party shall be held liable or responsible to the other Party nor be deemed to
have defaulted under or breached this Agreement for failure or delay in
fulfilling or performing any term of this Agreement when such failure or delay
is caused by or results from causes beyond the reasonable control of the
affected Party, including but not limited to fire, floods, embargoes, war, acts
of war (whether war is declared or not), insurrections, riots, civil
commotions, strikes, lockouts or other labor disturbances, acts of God or acts,
omissions or delays in acting by any governmental authority of the other Party;
provided, however, that the Party so affected shall use reasonable commercial
efforts to avoid or remove such causes of nonperformance, and shall continue
performance hereunder with reasonable dispatch whenever such causes are
removed.  Either Party shall provide the
other Party with prompt written notice of any delay or failure to perform that
occurs by reason of force majeure.  The
parties shall mutually seek a resolution of the delay or the failure to perform
as noted above.

 

11.9         Each Party agrees to execute, acknowledge and
deliver such further instruments, and do all further similar acts, as may be
necessary or appropriate to carry out the purposes and intent of this
Agreement. At the request and
expense of CELLDEX, 3M agrees to execute any such further documents or other
instruments presented by CELLDEX as may be necessary to register or record the
exclusive licenses herein at any and all Patent Offices as may be deemed
appropriate by CELLDEX in its discretion, and 3M shall reasonably cooperate
with CELLDEX as necessary to effect such registration or recordal.

 

11.10       The
Parties acknowledge that this Agreement, including the details of the Exhibits
hereto, includes a good faith effort by the Parties under the circumstances to
identify, as of the Effective Date, all Patents to be licensed to CELLDEX by 3M
hereunder with respect to the Licensed Products (as reasonably understood by 3M
as of the Effective Date based on information provided by CELLDEX), but that 

 

25

 

such effort may be incomplete or may be under-inclusive with respect to
such Patents.  In the event that, at any time and from time to time during
the term of this Agreement CELLDEX in good faith identifies additional Patents
existing as of the Effective Date owned or controlled by 3M IPC or its
Affiliates that would cover the Licensed Compounds per se,
the existing resiquimod gel formulation provided by 3M, or their use as Vaccine
Adjuvants (as opposed to other specific formulations or other specific methods
of delivery thereof) and which should have been included in Exhibit A, Part 1
pursuant to this Agreement but which were not so included, CELLDEX shall notify
3M in writing with respect to such relevant Patents, and 3M will at 3M’s
election either add applicable Patents that would cover the Licensed Compounds
per se or their use as Vaccine Adjuvants to Exhibit A, Part 1, or
give CELLDEX a worldwide, royalty-free, nonexclusive, fully paid-up, perpetual
(except in the case of termination by CELLDEX under Section 10.2 or 10.4
or by 3M under Sections 10.3 or 10.4), sublicensable, assignable license as to
such Patents to make, have made, use, import, offer to sell, and sell Product
using Licensed Compound subject to any preexisting written obligations 3M may
have made to Third Parties in good faith (without knowing that such Patent covers
a CELLDEX Product) prior to receiving such notice from CELLDEX.

 

11.11       Headings used herein are
for the convenience only and shall not in any way affect the construction of,
or be taken into consideration in interpreting this Agreement.

 

EXECUTED and AGREED to by the Parties:

 

 

For and on behalf of 3M COMPANY

 

 

	
  Signed:

  	
  /s/ Jim A. Vaughan

  	
   

  	
  Dated:

  	
    May 30, 2008

  
	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Printed:

  	
  Jim A. Vaughan

  	
   

  	
  Title:

  	
  Div V.P.

  
						

 

26

 

	
  3M INNOVATIVE PROPERTIES COMPANY

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Signed:

  	
  /s/ Robert W. Sprague

  	
   

  	
  Dated:

  	
    June 2, 2008

  
	
   

  	
   

  	
   

  
	
  Printed:

  	
    Robert W. Sprague

  	
   

  	
  Title:

  	
    Secretary

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  CELLDEX THERAPEUTICS

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Signed:

  	
    /s/ Anthony S. Marucci

  	
   

  	
  Dated:

  	
    June 2, 2008

  
	
   

  	
   

  	
   

  
	
  Printed:

  	
  Anthony S. Marucci

  	
   

  	
  Title:

  	
  Chief Executive Officer

  
						

 

27

 

Exhibit A

Part 1 — 3M Background Patent Rights

 

 

Part 2 — 3M Program Patent Rights

 

28

 

Exhibit B

CELLDEX Program Patent Rights

 

29

 

Exhibit C

Workplan(s)

 

Celldex’s overall strategy is to develop a potent regimen for promoting
a broad immune response to selected disease—specific antigens. Celldex has
developed APC-targeted vaccines that efficiently deliver antigens to the immune
system using human monoclonal antibodies that bind dendritic cells and other
APCs (antigen presenting cells). Celldex’s vaccines are currently using two
platforms — One based on targeting to mannose receptors, the other targets
DEC-205 receptors. In each case, the vaccines require combination with “adjuvants”
to maximize the immune response. Preclinical studies have demonstrated that [*], which may be further enhanced with additional immune
modulators. Celldex plans to transition these studies to human clinical trials
by initiating one or more Pilot and Phase II studies in cancer patients with
APC-targeted vaccines [*]. The
timing of initiation and completion of these studies is subject to a number of
factors that include: regulatory acceptance of proposed studies, requirement of
toxicology studies, clinical supplies, and Celldex resources.

 

A brief outline is presented below:

 

1. [*]

 

2.  [*]

 

3. [*]

 

Based upon these studies, Celldex will explore additional opportunities
for combination programs in both Cancer and Infectious disease indications.

 

* Confidential

 

30

 

Exhibit D

Diseases

 

Diseases:

·                  Cancer

·                  Infectious
Diseases:

·                  [*]

·                  [*]

·                  [*]

 

* Confidential

 

31

 

Exhibit E

Compounds

 

[*]

 (list to be
expanded/amended as appropriate)

 

* Confidential

 

32

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