Document:

Exhibit 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

 

32Exhibit 10.47

 

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.

 

Execution Copy

 

Exclusive Patent And Know-How License Agreement

 

THIS AGREEMENT dated as of November 5, 2008 (the “Effective Date”) is
between:

 

(1)           UNIVERSITY
OF SOUTHAMPTON (“Southampton”), an institution
incorporated by Royal Charter with registration number RC000668 and whose
administrative offices are at Highfield, Southampton, United Kingdom, SO17 1BJ;
and

 

(2)           CELLDEX RESEARCH CORPORATION,  a company incorporated in
the State of Delaware with offices located at 222 Cameron Drive, Phillipsburg,
NJ 08865, U.S.A., and its parent corporation, CELLDEX
THERAPEUTICS, INC.,  a company
incorporated in the State of Delaware with offices located at 119 Fourth
Avenue, Needham, MA 02494-2725, U.S.A. (collectively, “Celldex”).

 

RECITALS:

 

(A)          Professor Martin Glennie and colleagues
within Cancer Sciences at Southampton have determined that [*] as vaccines for the treatment of disorders that may
benefit from immune stimulation;

 

(B)           Southampton
filed a UK National patent application entitled [*],
included in the Patents, to protect this invention. Southampton also has
generated an [*], included in the Materials;

 

*Confidential

 

1

 

(C)           The research programme conducted by Professor Martin
Glennie and colleagues which generated the Intellectual Property (as defined
below) was funded by Tenovus, a cancer charity registered in England and Wales
under number 1054015. Under the terms and conditions of Tenovus grant funding,
Tenovus have co-ownership rights in the Intellectual Property.  Pursuant to an Assignment Agreement dated 29 February 2008,
Tenovus’ rights in the Licensed IP have vested in Cancer Research Technology
Ltd, Sardinia House, Sardinia Street, London WC2A 3NL, England (“CRT”).
Southampton and CRT are therefore co-owners of the Licensed IP.  Under the terms of the CRT Agreement dated October 13,
2008 attached hereto as Schedule 2, CRT has granted Southampton the
rights to grant exclusive licenses to the Patents, Materials and Know How;

 

(D)          Southampton wishes to continue to carry out further research
and development on the application of its [*] for
treating disorders that may benefit from immune stimulation. Southampton wishes
to retain the right to license the combination of its Materials and [*] to Third Parties;

 

(E)           Celldex wishes to seek to generate its own [*] and to develop an adjuvant/vaccine based on [*];

 

(F)           Celldex seeks rights to the Intellectual
Property to undertake the proposed development and to manufacture, have
manufactured, import, sell and use adjuvants/vaccines incorporating [*] antibodies and/or to secure sublicenses with Third
Parties; and

 

(G)           Southampton
is willing to provide Celldex rights to the Intellectual Property subject to
the provisions of this Agreement.

 

IT IS AGREED as follows:

 

*Confidential

 

2

 

1.             Definitions

 

In this
Agreement, the following words shall have the following meanings:

 

	
  Academic
  Partner

  	
   

  	
  means a
  charitable body or academic institution or any non-for-profit entity (or similar
  entity).

  
	
   

  	
   

  	
   

  
	
  Academic
  Research

  	
   

  	
  means
  academic, non-commercial research and teaching conducted alone or in
  collaboration with other Academic Partners. For the avoidance of doubt,
  Academic Research excludes any Sponsored Research.

  
	
   

  	
   

  	
   

  
	
  Affiliate

  	
   

  	
  Means any
  company, partnership or other entity which directly or indirectly Controls,
  is Controlled by or is under common Control with any other entity.

  
	
   

  	
   

  	
   

  
	
  Claims

  	
   

  	
  Means all
  demands, claims and liability (whether criminal or civil, in contract, tort
  or otherwise) for losses, damages, legal costs and other expenses of any
  nature whatsoever and all costs and expenses (including legal costs) incurred
  in connection therewith.

  
	
   

  	
   

  	
   

  
	
  Combination
  Product

  	
   

  	
  Means a
  product that contains a Licensed Product and at least one other essential
  functional component.

  
	
   

  	
   

  	
   

  
	
  Commercial
  Partner

  	
   

  	
  Means any
  entity which is not an Academic Partner.

  
	
   

  	
   

  	
   

  
	
  Confidential
  Information

  	
   

  	
  Means
  proprietary information and trade secrets or confidential information
  relating to the business affairs or finances of the other Party supplied or
  otherwise made available to them or coming into their possession in relation
  to the performance of this Agreement, irrespective of form.

  
	
   

  	
   

  	
   

  
	
  Control

  	
   

  	
  Means direct
  or indirect beneficial ownership of 50% (or, outside a Party’s home
  territory, such lesser percentage as is the maximum, permitted level of
  foreign investment) or more of the share capital, stock or other
  participating interest carrying the right to vote or to

  

 

3

 

	
   

  	
   

  	
  distribution
  of profits of that Party, as the case may be.

  
	
   

  	
   

  	
   

  
	
  Cover(ed)

  	
   

  	
  Means, with
  respect to any Patent and the subject matter at issue, that, but for a
  license granted under a Valid Claim of such Patent, the manufacture, use,
  sale, offer for sale, or importation of the subject matter at issue would
  infringe such Valid Claim on a country-by-country basis, or, in the case of a
  Patent that is a patent application, would infringe a Valid Claim on a
  country-by-country basis in such patent application if it were to issue as a
  patent.

  
	
   

  	
   

  	
   

  
	
  Diligent
  and Reasonable Efforts

  	
   

  	
  Means, with
  respect to the efforts to be expended by a Party with respect to the
  objective that is the subject of such efforts, such reasonable, good faith
  efforts and resources to accomplish such objective that such Party would
  normally use to accomplish a similar objective under similar circumstances,
  it being understood and agreed that with respect to the development or
  commercialization of a Licensed Product, such efforts shall be similar to
  those efforts and resources commonly used by that Party to develop or
  commercialize a product owned by it or to which it otherwise has rights that
  is at a similar stage of development or product life and is of similar market
  potential as the relevant Licensed Product, taking into account product
  labelling or anticipated labelling, present and future market potential, past
  performance of Licensed Products and such Party’s own pharmaceutical products
  that are of similar market potential, financial return, medical and clinical
  considerations, present and future regulatory environment and competitive
  market conditions, all as measured by the facts and circumstances at the time
  such efforts are due. Diligent and Reasonable
  Efforts shall be secured through the reporting obligations of
  Section 5.2 and Southampton’s right of termination of Section 5.4. 

   

  Diligent and
  Reasonable Efforts shall be determined on a market-by-market and
  indication-by-indication basis for a particular Licensed Product, and it is
  anticipated that the level of effort will be

  

 

4

 

	
   

  	
   

  	
  different
  for different markets, and will change over time, reflecting changes in the
  status of the Licensed Product and the market(s) involved.

  
	
   

  	
   

  	
   

  
	
  Effective
  Date

  	
   

  	
  Means the
  effective date of this Agreement as set forth above.

  
	
   

  	
   

  	
   

  
	
  Field

  	
   

  	
  Means all
  therapeutic or prophylactic uses, including uses as adjuvants or vaccines, in
  the Territory of [*], alone
  or in combination with any other pharmaceutical agent, other than the
  Southampton Field.

  
	
   

  	
   

  	
   

  
	
  Intellectual Property

  	
   

  	
  Means the Patents, Materials, Know-how, and
  Confidential Information.

  
	
   

  	
   

  	
   

  
	
  Know-how

  	
   

  	
  Means
  Confidential Information in the form of technical information in the Field
  relating to the Patents, Materials and/or Licensed Products and developed by
  or under the supervision of Professor Martin Glennie prior to the Effective
  Date and specifically set forth on Schedule 1 Part B hereof and
  transferred to Celldex prior to the end of the Extended Transfer Period
  pursuant to Section 3.1 hereof, including any utility models and registered designs, together with
  applications for any of the foregoing and the right to apply for any of the
  foregoing, copyrights, database rights and design rights and in which
  Southampton has the necessary rights to enable it to grant the license set
  out in Clause 2.1.2.

  
	
   

  	
   

  	
   

  
	
  Licensed
  Products

  	
   

  	
  Means any
  and all products in the Field that are developed, manufactured, sold or
  otherwise supplied by Celldex or its sub-licensee (including any Affiliate of
  Celldex) and (a) which is Covered by the Patents in the country of
  manufacture and/or sale, and/or (b) incorporate or was developed making
  use of any of the Know-how and/or Materials.

  
	
   

  	
   

  	
   

  
	
  Materials

  	
   

  	
  Means [*] thereof generated by Celldex, its Affiliates or
  sub-licensees.

  

 

*Confidential

 

5

 

	
  Net
  Receipts

  	
   

  	
  Means the
  amount of any payment (excluding Value Added Tax) and the value of any non
  monetary receipt (subject to the provisions below) obtained by, or due to,
  Celldex or its Affiliate, in relation to the sub-licensing (including the
  grant of any option over a sub-license) of any of the Intellectual Property
  and including any of the following:

   

  (a)        up-front, milestone (whether at the stage of development,
  marketing or otherwise), success, bonus, maintenance and periodic (including
  annual) payments due under any sub-license agreement;

   

  (b)        payments in respect of the funding of research or development
  activities related to any Licensed Product, to the extent that such payments
  exceed a reasonable level of payment for such activities;

   

  (c)        where any sub-license is to be granted under cross licensing
  arrangements, the value of any cross license obtained under such
  arrangements, solely to the extent that the value of such cross license has
  been independently valued in and is easily ascertainable from a separate
  non-exclusive arms-length agreement between the cross licensor and an
  independent Third Party;

   

  (d)        any premium paid over the fair market value of shares, options or
  other securities in respect of any of the share capital of Celldex or its
  Affiliate;

   

  (e)        any loan, guarantee or other financial benefit made or given other
  than on normal market terms; and

   

  (f)         payments in the form of any shares, options or other securities
  that are not freely transferable and that are obtained from a Third Party,
  valued at the time such shares, options, or other securities are monetized.
  Net receipts in the form of freely transferable shares, options, or other
  securities 

  

 

6

 

	
   

  	
   

  	
  shall be
  subject to Section 4.6.1;

   

  but
  excluding (i) any payments in respect of the funding of research or
  development activities related to any Licensed Product not included in (b) above,
  (ii) any payment at the fair market value for shares, options or other
  securities in respect of any of the share capital of Celldex or its
  Affiliate, (iii) any sum of money falling within the definition of Net
  Sales Value, or (iv) any non-monetary value received with the exception
  of Third Party shares, options or other securities as set forth above.

  
	
   

  	
   

  	
   

  
	
  Net
  Sales Value

  	
   

  	
  Means the
  invoiced price of Licensed Products sold by Celldex, its Affiliates or its
  sub-licensees under any of the Intellectual Property to independent Third
  Parties in arm’s length transactions exclusively for money or, where the sale
  is not at arm’s length and exclusively for money the price that would have
  been so invoiced if it had been at arm’s length and exclusively for money
  after deduction of all documented:

   

  (a)        normal trade discounts actually granted and any credits actually
  given for rejected or returned Licensed Products including, those granted on
  account of price adjustments, billing errors, rejected goods, damaged or defective
  goods, recalls, returns, rebates, chargeback rebates, reimbursements or
  similar payments granted or given to wholesalers or other distributors,
  buying groups, health care insurance carriers or other institutions;

   

  (b)        costs of packaging, insurance, carriage and freight, provided in
  each case that the amounts are separately charged on the relevant invoice;

   

  (c)        value added tax or other sales tax; and

   

  (d)        import duties or similar applicable government levies;

   

  (e)        bad debts related to such Licensed Product to the extent actually
  written-off;

  

 

7

 

	
   

  	
   

  	
  provided
  that such deductions do not exceed reasonable and customary amounts in the
  markets in which such sales occurred.

   

  In the case
  of Combination Products, Net Sales Value means the gross amount billed or
  invoiced on sales of the Combination Product less the deductions set forth
  above, multiplied by a proration factor that is determined as follows:

   

  (i)    If all essential functional components of
  the Combination Product were sold separately during the same or immediately
  preceding Sales Year, the proration factor shall be determined by the formula
  [A/(A+B)], where A is the aggregate gross sales price of each of the
  essential functional components including the Licensed Product during such
  period when sold separately from the other essential functional components,
  and B is the aggregate gross sales price of each of the essential functional
  components excluding the Licensed Product during such period when sold separately
  from the Licensed Product components, the periods not being more than 12
  months from date of proration; or

   

  (ii)   If all essential functional components of
  the Combination Product were not sold separately during the same or
  immediately preceding Sales Year (i.e., if at least one of the essential
  functional components was not sold separately), the proration factor shall be
  determined by the formula [C/C+D], where C is the fair market value of the
  Licensed Product essential functional components during the prior Sales Year
  and D is the fair market value of the other essential functional components
  during the prior Sales Year with such fair market values being determined in
  good faith by agreement of the Parties.

   

  Sales
  between Celldex, its Affiliates and sub-licensees shall not be considered for
  the purposes of this definition unless there is no subsequent sale to a
  person who is not Celldex, its Affiliate or sub-licensee in an arm’s length
  transaction exclusively for money.

  

 

8

 

	
  Parties

  	
   

  	
  Means
  Southampton, and Celldex, and “Party” shall mean any of them.

  
	
   

  	
   

  	
   

  
	
  Patents

  	
   

  	
  Means any
  and all of the patents, patent applications, author certificates, inventor
  certificates, utility models (i) owned or otherwise controlled by
  Southampton as of the Effective Date that relate to the Field, including the
  patents and patent applications referred to in Schedule 1 Part A, and
  (ii), owned or otherwise controlled by Southampton during the Term that
  relate to the Field, including in each case any continuations, continuations
  in part, extensions, reissues, re-examination, divisions, renewals,
  substitutions, confirmations, registrations, revalidations and additions of
  or to them, and any patents, patent applications, supplementary protection
  certificates and similar rights that are based on or derive priority from the
  foregoing and related international or foreign patents and applications
  anywhere in the world.

  
	
   

  	
   

  	
   

  
	
  Phase I Trial

  	
   

  	
  Means a clinical trial generally
  consistent with U.S. 21 C.F.R. §312.21(a) or any foreign counterpart
  thereof initiated by or on behalf of Celldex with respect to a Licensed
  Product anywhere in the Territory.

  
	
   

  	
   

  	
   

  
	
  Phase II Trial

  	
   

  	
  Means a clinical trial generally consistent with U.S. 21 C.F.R.
  §312.21(b) or any foreign counterpart thereof, including without
  limitation a Phase IIa study, initiated by or on behalf of Celldex with
  respect to a Licensed Product anywhere in the Territory.

  
	
   

  	
   

  	
   

  
	
  Phase III Trial

  	
   

  	
  Means a clinical trial generally consistent with U.S. 21 C.F.R.
  §312.21(c) or any foreign counterpart thereof, including without
  limitation a Phase II/III study, initiated by or on behalf of Celldex with

  

 

9

 

	
   

  	
   

  	
  respect to a Licensed Product anywhere in the Territory

  
	
   

  	
   

  	
   

  
	
  Sales
  Year

  	
   

  	
  Means each
  period of a year commencing on the first day of July that follows the
  date of first commercial sale by Celldex or any sub-licensee for the first
  Licensed Product, or on any anniversary of that date.

  
	
   

  	
   

  	
   

  
	
  Sponsored
  Research

  	
   

  	
  means
  research undertaken at the request of, or in collaboration with, any entity
  which is a Commercial Partner where any resulting Intellectual Property is
  encumbered in favour of such entity.

  
	
   

  	
   

  	
   

  
	
  Southampton
  Field

  	
   

  	
  Means all
  therapeutic or prophylactic uses, including uses as adjuvants or vaccines, in
  the Territory of [*] in
  combination with the Southampton-proprietary [*] thereof
  where such use includes the in vivo administration
  of such [*] and such [*] to
  a mammal or the in vitro use of such [*]and such [*], wherein
  the [*].

  
	
   

  	
   

  	
   

  
	
  Term

  	
   

  	
  Means the
  term of this Agreement as set forth in Clause 8.1.

  
	
   

  	
   

  	
   

  
	
  Territory

  	
   

  	
  Means the
  world

  
	
   

  	
   

  	
   

  
	
  Third
  Party

  	
   

  	
  Means an
  entity or person other than Southampton or Celldex or their respective
  Affiliates and sub-licensees under this Agreement.

  
	
   

  	
   

  	
   

  
	
  Tobacco Party

  	
   

  	
  means any corporation, company, partnership or
  other organisation or person with a material interest in the tobacco
  industry;

  

 

*Confidential

 

10

 

	
  Valid
  Claim

  	
   

  	
  means a
  claim of an issued (granted) and unexpired patent, or a claim of a pending
  patent application, where such pending application has been pending for less
  than ten (10) years from its earliest priority date, or a claim of an
  issued (granted) and unexpired patent issued from such a pending patent
  application during or after such ten (10) year period, which in any of
  the foregoing cases has not been withdrawn, cancelled, abandoned, disclaimed,
  or held permanently revoked, unenforceable or invalid by a decision of an administrative
  agency or court or other governmental agency of competent jurisdiction,
  unappealable or unappealed within the time allowed for appeal, and which has
  not been admitted to be invalid or unenforceable through reissue or
  disclaimer or otherwise;

  

 

2              Grant of rights

 

2.1           Subject to Clause 2.4, Southampton hereby grants to Celldex, subject
to the provisions of this Agreement:

 

2.1.1        an
exclusive non-transferable (except as expressly permitted under this Agreement)
license in the Field under the Patents, with the right to sublicense, subject
to clause 2.3 below, to research, develop, manufacture, have manufactured, use,
import, offer for sale and sell Licensed Products in the Territory;

 

2.1.2        an
exclusive license in the Field to use the Know-How, with the right to
sub-license, subject to clause 2.3 below, to research, develop, manufacture,
have manufactured, use, import, offer for sale and sell Licensed Products in
the Territory;

 

2.1.3        an
exclusive license in the Field to use the Materials subject to clause 2.3

 

11

 

below, solely
for research and development purposes. 
For the avoidance of doubt Celldex shall not humanise any of the
Materials nor administer the Materials, or any substances contacted with the Materials,
to human subjects.

 

2.2           The Parties shall execute such formal licenses as may be necessary
or appropriate for registration with Patent Offices and other relevant
authorities in particular territories. 
In the event of any conflict in meaning between any such license and the
provisions of this Agreement, the provisions of this Agreement shall
prevail.  The Parties shall use
reasonable endeavours to ensure that, to the extent permitted by relevant
authorities, this Agreement shall not form part of any public record.

 

2.3           Celldex shall be entitled to grant sub-licenses of its rights under
this Agreement to any person and any sub-license granted shall contain the
right to grant further sub-licenses, provided that:

 

2.3.1        a
sub-license shall include obligations on the sub-licensee which are equivalent
to relevant obligations on Celldex under this Agreement;

 

2.3.2        within
sixty (60) days of the grant of any sub-license Celldex shall provide to
Southampton a true copy of it, in English, and Celldex shall disclose the terms
of any such sub-license agreement only to the extent that such terms impact
payments due from Celldex to Southampton, and to the extent that a sub-licensee
permits Celldex to disclose the terms of such a sub-license agreement; and

 

2.3.3        Celldex
shall not be relieved of any of its obligations under this agreement as a
result of such sub-license, including but not limited to its obligation to make
payments under Section 4, and its obligation to commercialize the Licensed
Technology under Section 5; and

 

2.3.4        [*].

 

*Confidential

 

12

 

2.4           Reserved
Rights

 

2.4.1        The
Parties acknowledge that under the terms of the CRT Agreement, CRT has reserved
its rights to a worldwide, perpetual, irrevocable, fully paid-up, royalty-free,
non-exclusive right in and to the Intellectual Property for CRT to conduct
Academic Research (such right may be licensed by CRT solely to Academic
Partners, including, for the avoidance of doubt, any researchers funded or employed
by Tenovus and/or Cancer Research UK) the (“CRT Reserved Rights”).

 

2.4.2        Southampton
reserves a worldwide, perpetual, irrevocable, fully paid-up, royalty-free,
non-exclusive right in and to the Intellectual Property for Southampton and its
Affiliates, to conduct Academic Research. 
For the avoidance of doubt, such rights shall include the right to
provide Materials to Academic Partners under limited material transfer
agreement with substantially similar terms to those set out in Schedule 3.

 

2.4.3        In no event, however, shall Southampton or CRT have the right to
conduct Sponsored Research relating to the Patents, Know-How or Materials in
the Field and/or the Licensed Products.

 

2.4.4        Except for the licenses expressly granted by this Clause 2,
Southampton reserves all its rights. For the avoidance of doubt, such
reservation of rights includes the exclusive right for Southampton and its
Affiliates to use, license and sublicense Patents, Know-how and Materials for
the research and development, manufacture, having manufactured, use, import,
offer for sale and sale, of pharmaceutical product solely in the Southampton
Field.

 

2.5           Celldex shall ensure that all of the Licensed Products marketed by
it and its sub-licensees are of satisfactory quality and comply with all
applicable laws and regulations in each part of the Territory.

 

3              Know-how
and Confidential Information

 

3.1           Southampton shall transfer the Know-how to Celldex within eight (8) months
after the 

 

13

 

Effective
Date (“Transfer Period”).  Celldex and
Southampton shall cooperate in arranging meetings as reasonably necessary for
the effective transfer of the Know-how. 
On conclusion of the Transfer Period Celldex shall confirm in writing to
Southampton that transfer of the Know-how is complete, or provide details to
Southampton of any outstanding Know-how which Celldex considers to have not
been transferred. Southampton shall thereafter have thirty (30) days to
transfer such outstanding Know-how to Celldex, or confirm to Celldex that no
such Know-how exists (together with the Transfer Period, the “Extended Transfer
Period”).

 

3.2           Celldex acknowledges that the Know-how is at an early stage of
development.  Accordingly, specific
results cannot be guaranteed and any results, materials, information or other
items (together “Delivered Items”) provided under this Agreement are provided “as
is” and without any express or implied warranties, representations or
undertakings. As examples, but without limiting the foregoing, Southampton
gives no warranty that Delivered Items are of merchantable or satisfactory
quality, are fit for any particular purpose, comply with any sample or
description, or are viable, uncontaminated, safe or non-toxic, provided that
Southampton will notify Celldex prior to transferring such Delivered Items to
Celldex of any dangerous or harmful properties of such Delivered Items actually
known by Southampton at the time of such transfer.

 

3.3           Celldex undertakes that for
a period of 10 years from the Effective Date or for so long as any substantial
part of the Know-how remains subject to the obligations of confidence of Clause
3.4, whichever is the shorter, it shall protect the Know-how as Confidential
Information and shall not use the Know-how for any purpose except as expressly
licensed hereby and in accordance with the provisions of this Agreement.

 

3.4           Each Party (“Receiving Party”) undertakes:

 

3.4.1        to maintain as secret and confidential all Confidential Information
obtained directly or indirectly from the other Party (“Disclosing Party”) in
the course of or in anticipation of this Agreement and to respect the
Disclosing Party’s rights therein;

 

14

 

3.4.2        to use the same exclusively for the purposes of this Agreement;

 

3.4.3        to disclose the same only to those of its employees, directors,
Affiliates, advisors, contractors and sub-licensees pursuant to this Agreement
(if any) to whom and to the extent that such disclosure is reasonably necessary
for the purposes of this Agreement; and

 

3.4.4        to procure that each of its employees, directors, Affiliates,
advisors, contractors and sub-licensees are bound by appropriate
confidentiality and non-use obligations in respect of Confidential Information
belonging to the other Party.

 

3.5           The provisions of Clause 3.4 shall not apply to Confidential
Information which the Receiving Party can demonstrate by reasonable, written
evidence:

 

3.5.1        was, prior to its receipt by the Receiving Party from the Disclosing
Party, in the possession of the Receiving Party and at its free disposal; or

 

3.5.2        is subsequently disclosed to the Receiving Party without any
obligations of confidence by a Third Party without any obligation of confidence
to the Disclosing Party and who has not derived it directly or indirectly from
the Disclosing Party; or

 

3.5.3        is or becomes generally available to the public through no act or
default of the Receiving Party or its agents, employees, Affiliates or
sub-licensees; or

 

3.5.4        the Receiving Party is required to disclose to the courts of any
competent jurisdiction, or to any government regulatory agency or financial
authority, provided that the Receiving Party shall (i) inform the
Disclosing Party as soon as is reasonably practicable, and (ii) at the Disclosing
Party’s request seek to persuade the court, agency or authority to have the
information treated in a confidential manner, where this is possible under the
court, agency or authority’s procedures.

 

15

 

3.6           Southampton
may disclose the existence and terms of this Agreement without prior approval
to Tenovus, registered charity number 1054015 and Cancer Research Technology
the technology transfer company wholly owned by Cancer Research UK, registered
charity number 4325234 and any other third Party(ies) who have funded some or
all of the development of the Intellectual Property, and whose consents are
required for Southampton to enter into this Agreement, provided that Tenovus
and such other Third Party(ies) are bound by appropriate confidentiality and
non-use obligations in respect of Confidential Information under this
Agreement.

 

4      Payments

 

4.1           In consideration for the rights granted hereunder, during the Term
and subject to Clause 4.4, Celldex shall pay to Southampton:

 

4.1.1        Within thirty (30) days after the Effective Date an upfront license
fee in the amount of [*];

 

4.1.2        The sum of [*] within
thirty (30) days after the initial human dosing study of the first Licensed
Product to achieve such milestone in the Field;

 

4.1.3        The sum of [*] within
thirty (30) days after the first human dosing in the first phase II study of
the first Licensed Product to achieve such milestone in the Field;

 

4.1.4        The sum of [*] within thirty (30) days after the first human dosing in
the first phase III study of the first Licensed Product to achieve such
milestone in the Field;

 

4.1.5        The sum of [*] within
thirty (30) days after the first submission for regulatory approval in the
Territory with respect to the first Licensed Product to achieve such milestone
in the Field .

 

*Confidential

 

16

 

4.1.6        The sum of [*] within
thirty (30) days after the first commercial sale of the first Licensed Product
to achieve such milestone in the Field.

 

For the
avoidance of doubt each of the sums due under Sections 4.1.2-4.1.6 shall be
payable only once, on the first Licensed Product in the Field to achieve each
given milestone of Sections 4.1.2-4.1.6

 

4.2           During the Term, Celldex shall pay to Southampton on a
country-by-country and Licensed Product-by-Licensed Product basis (i) a
royalty of [*] of Net Sales Value of all
Licensed Products Covered by at least one Valid Claim of the Patents, or (ii) a
royalty of [*] of Net Sales Value of all Licensed
Products that are not Covered by at least one Valid Claim of the Patents and,
incorporates or makes use of any Know-how which remains subject to the
provisions of Clause 3.4 hereof or incorporates or makes use of any Materials,
sold or otherwise supplied by Celldex, its Affiliates and/or its sub-licensees.
For avoidance of doubt, the royalties payable under these Sections 4.2(i) and
4.2(ii) are mutually exclusive, and only one or the other, but not both,
may be payable on the sale of a given Licensed Product.

 

4.3           During the Term, and subject to Clause 4.4, Celldex shall pay to
Southampton on a country-by-country and Licensed Product-by-Licensed Product
basis (i) a royalty of [*] of Net
Receipts received with respect to all Licensed Products sublicensed hereunder
and Covered by at least one Valid Claim of the Patents, or (ii) a royalty
of [*] of Net Receipts received with
respect to all Licensed Products sublicensed hereunder and not Covered by at
least one Valid Claim of the Patents and which incorporates or makes use of any
Know-how which remains subject to the provisions of Clause 3.4 hereof or
incorporates or makes use of any Materials. 
For avoidance of doubt, the royalties payable under these Sections 4.3(i) and
4.3(ii) are mutually exclusive, and only one or the other, but not both,
may be payable with respect to such Licensed Products sublicensed hereunder.

 

*Confidential

 

17

 

4.4           In the event any of the milestone events set forth in Clauses
4.1.2-4.1.6 above are first achieved by a sub-licensee of Celldex or its
Affiliates, the amount payable to Southampton by Celldex will be the greater of
(i) the milestone amount set forth in the applicable Section 4.1.2-4.1.6,
or (ii) the amount payable to Southampton under Clause 4.3 on the Net
Receipts received by Celldex from such sub-licensee as a result of such
sub-licensee first achieving such milestone.

 

4.5           No lump sum payments shall be refundable or creditable against any
other sum or lump sum payable by Celldex for any reason

 

4.6           Non-monetary consideration:

 

4.6.1        Where Net Receipts are in the form of freely-transferable shares in
the share capital of a sub-licensee, Celldex shall pay the royalty due under
this Agreement on such Net Receipts by causing the appropriate percentage
number of such freely-transferable shares to be transferred to, and registered
in the name of Southampton.

 

4.7           Royalties to Third Parties.

 

In the event
that Celldex is obligated to pay a royalty to a Third Party in order to avoid
infringement arising from the manufacture, having manufactured, sale, offer for
sale, use or importation of Licensed Products, then Celldex shall be entitled
to offset [*] of such royalties paid to such
Third Parties against the royalty payable to Southampton under this Clause 4
provided that in no event shall the royalties payable to Southampton under
Clause 4 be reduced by more than [*] of the
royalty that would have been payable in the absence of this clause on Net Sales
Value in the aggregate. The deductions referred to in this Clause shall only be
made where the infringement of the Third Party patent arises from the use of
the inventions claimed in the Patents, and not from the use of any other
intellectual property that Celldex chooses to use in the manufacture and sale
of any Licensed Product.

 

*Confidential

 

18

 

4.8           Floor on reductions.

 

In no event
shall the reductions of royalty provided for under this Agreement result in the
royalty payable to Southampton in respect of any individual royalty-bearing
Licensed Product being reduced below (i) [*] of
Net Sales Value for a royalty payable under Section 4.2(i), or [*] of Net Sales Value for a royalty payable under Section 4.2(ii).

 

4.9           Payment
frequency.

 

Royalties due
under this Agreement shall be paid within 60 days of the end of each year
ending on 30 June, in respect of sales of Licensed Products made and Net
Receipts generated during such Sales Year and shall continue to pay royalties
at such intervals until no further royalties are due following termination as
set out in Clause 8. For the avoidance of doubt if sales commence during a
Sales Year then royalties shall be due and payable on the first 30 June following
the commencement of sales for that part of the Sales Year to which sales
relate.

 

4.10         Celldex
shall make the payments due to Southampton in pounds sterling.  Where Celldex receives payment in a currency
other than pounds sterling, Celldex shall convert the relevant sum due to
Southampton into pounds sterling. 
Celldex shall use the conversion rate of such other currency as quoted
by National Westminster Bank plc in London as at the close of business on the
last business day of the Sales Year with respect to which the payment is
made.  If by law, regulation, or fiscal
policy of a particular country, conversion into pound sterling or transfer of
funds of a convertible currency to the United Kingdom is restricted or forbidden,
Celldex shall give Southampton prompt notice in writing and shall pay the
royalty and other amounts due through such means or methods as are lawful in
such country as Southampton

 

*Confidential

 

19

 

may reasonably
designate.  Failing the designation by
Southampton of such lawful means or methods within thirty (30) days after such
notice is given by Celldex, Celldex shall deposit such royalty payment or other
amount in local currency to the credit of Southampton in a recognized banking
institution selected by Celldex and identified in a written notice to
Southampton, and such deposit shall fulfil all obligations of Celldex to
Southampton with respect to such royalties payment or other amount.

 

4.11                           All sums due under this Agreement:

 

4.11.1      shall be inclusive of any income tax or other charges or taxes,
excluding Value Added Tax, and shall not be increased beyond the sums described
in Clauses 4.1-4.3 to offset any income tax or other charges or taxes, that are
to be paid by Southampton, provided, however, that Celldex may deduct from such
sums due under this Agreement any withholding or other taxes or charges as
Celldex is required to deduct to comply with applicable laws.   The Parties shall cooperate and take all
steps reasonably and lawfully available to them to avoid deducting such taxes
or other charges and to obtain double taxation relief.  If Celldex is required to make any such
deduction it shall provide Southampton with such certificates or other
documents as it can reasonably obtain to enable Southampton to obtain
appropriate relief from double taxation of the payment in question;

 

4.11.2      shall be made by the due date, failing which Southampton may charge
interest on any outstanding amount on a daily basis at a rate equivalent to 3%
per annum above the National Westminster Bank plc base lending rate then in
force in London.

 

4.12                           Celldex shall:

 

4.12.1      keep at its normal place of business detailed and up to date records
and accounts showing the quantity, description and value of Licensed Products
sold by it, and the amount of sublicensing revenues received by it in respect 

 

20

 

of
Licensed Products, on a country by country basis, and being sufficient to
ascertain the payments due under this Agreement.  Such records and accounts shall be kept for
six (6) years following the end of the year to which they relate.

 

4.12.2      make such records and accounts available, on reasonable notice, for
inspection no more than once per calendar year during business hours by an
independent certified public accountant appointed by Southampton and reasonably
acceptable to Celldex for the purpose of verifying the accuracy of any
statement or report given by Celldex to Southampton under this clause 4.  The accountant shall be required to keep
confidential all information learnt during any such inspection, and disclose to
Southampton only such details as may be necessary to report on the accuracy of
Celldex’ statement or report. 
Southampton shall be responsible for the accountant’s charges unless the
accountant certifies that there is an underpayment of five percent or more in
any royalty statement, in which case Celldex shall pay his charges in respect
of that inspection.

 

4.12.3      Ensure that Southampton has the same rights as those set out in this
Clause 4.12 in respect of any sub-licensees of Celldex which is sub-licensed
under the Patents or Know-how pursuant to this Agreement.

 

4.13         All payments made to Southampton under this Agreement shall be made
to the following bank account, details of which may change from time to time on
written notice from Southampton to Celldex:

 

Fortis Bank SA/NV UK Branch

Account:
35962001

Sort Code
40-52-62

IBAN
GB54GEBA40526235962001

Swift GEBAGB22

 

And include the following reference: 3332

 

21

 

5          Commercialisation

 

5.1           Celldex shall use Diligent and Reasonable Efforts to develop and
commercially exploit at least one Licensed Product in the Field and Territory.

 

5.2           Without
prejudice to the generality of Celldex’s obligations under Clause 5.1, Celldex
shall provide every six months to Southampton an updated, written development
plan, showing all past, current and projected activities taken or to be taken
by Celldex to bring Licensed Products to market and maximise the sale of
Licensed Products in the Territory.  The
first plan shall be due on the 30th of June following the Effective Date
and then 31st December and the 30th of June each year
thereafter until this Agreement is terminated. 
Receipt of any such plan by Southampton shall not be taken to waive or
qualify Celldex’s obligations under Clause 5.1.

 

5.3           Celldex
shall be exclusively responsible for the technical and commercial development
and manufacture of Licensed Products and for incorporating any modifications or
developments thereto that may be necessary or desirable and for all Licensed
Products sold or supplied, and accordingly Celldex shall indemnify the
Southampton Indemnitees in the terms of Clause 7.3.1.  It may, however, subcontract or sub-license
such activities in accordance with accepted industrial practices.

 

5.4           In the
event that Celldex fails to materially comply with the obligations set forth in
Section 5.1, such failure will be deemed to be a material breach of this
Agreement subject to the termination provisions of Sections 8.2.1 and 8.2.1.1,
provided however that Celldex shall have ninety (90) days to remedy such breach
or to otherwise negotiate with Southampton a mutually acceptable schedule to
fulfil the diligence obligations of Section 5.1, and Southampton agrees
that its acceptance of such a schedule shall not be unreasonably withheld or
delayed.

 

6      Intellectual Property

 

6.1       From the Effective Date Southampton shall be responsible for the
prosecution and maintenance of the Patents and Celldex shall reimburse
Southampton for future and ongoing costs and expenses incurred in such
prosecution and maintenance of the 

 

22

 

Patents
within fourteen days of notification in writing from Southampton setting out
such costs and expenses. Celldex agrees to reimburse such reasonable costs and
expenses up to a total of [*] per year.
Reimbursement of any such costs and expenses in excess of a total of [*] in any given calendar year will be subject to the prior
written agreement of Celldex, which will not unreasonably be refused.

 

6.2       Southampton shall:

 

6.2.1     endeavour to obtain granted patents in the name of Southampton
pursuant to each of the Patents;

 

6.2.2     subject to clause 6.2.4, consult with Celldex regarding which
national territories to pursue and comply with reasonable requests of Celldex
on which such territories to pursue and choice of patent counsel, and
Southampton shall not discontinue prosecution of any of the Patents in any
territory without Celldex’s consent provided that Celldex provide Southampton
with requests not to file or to discontinue prosecution of any of the Patents
in any territory within 14 days of Southampton consulting Celldex.

 

6.2.3     subject to clause 6.2.4, consult with Celldex in relation to all
changes to patent claims or specifications that would have the effect of
reducing or limiting the extent of the patent coverage and comply with
reasonable requests of Celldex in connection with any such changes;

 

6.2.4     Southampton shall keep Celldex fully-informed of the status of the
Patents and will promptly provide Celldex with copies of all substantive
documentation submitted to, or received from, the patent offices or other
authority in connection therewith.  With
respect to any substantive submissions or elections that Southampton is
required to or otherwise intends to submit to a patent office or other
authority, Southampton shall provide a draft of such submission to Celldex

 

*Confidential

 

23

 

at least
thirty (30) days prior to the deadline for or the intended filing date of such
submission, whichever is earlier (or as soon as possible if Southampton has
less than thirty (30) days’ notice of a deadline for submission).  Celldex shall have the right to review and
comment upon any such submission by Southampton to a patent office, and will
provide such comments, if any, no later than ten (10) days prior to the
applicable deadline or intended filing date. 
Southampton shall consider in good faith all comments provided by
Celldex.  If Southampton disagrees with
any comment provided by Celldex, Southampton shall provide Celldex with an
explanation for such disagreement.  If Celldex
does not accept Southampton’s explanation, then Celldex shall have final
decision-making authority with respect to any Patent containing any claims that
relate solely to the Field or to a Licensed Product, provided, however, that if
Celldex decides to abandon prosecution of any potentially patentable claims in
an application, Southampton may file such claims in any available further
application at its own cost and expense.;

 

6.2.5              pay all official fees in respect of the Patents as and when due;

 

6.2.6              In the event that Celldex elects not to reimburse Southampton for
any of its reasonable costs and expenses in filing, prosecuting or maintaining
any of the Patents (an “Unsupported Patent”) in any of the United States,
France, Germany, Italy, Spain, United Kingdom, China, India, Canada or Japan
(each, a “Major Market Country”), and provided that such Unsupported Patent is
unrelated to any Patents which Celldex continues to support in such Major
Market Country, then the license granted to Celldex under 2.1.1 shall terminate
forthwith solely with respect to such Unsupported Patent in such unsupported
Major Market Country only.  For the
avoidance of doubt, Southampton shall be free to undertake such filing,
prosecution or maintenance at its own expense, and dispose of such rights, in
such Unsupported Patent in such unsupported Major Market Country only at its
sole discretion.  In the event that
Celldex elects not to reimburse Southampton for an Unsupported Patent in any country
other than a Major Market Country (each, a “non-Major Market Country”), and
provided that such Unsupported Patent is unrelated to any Patents which Celldex
continues to support in such 

 

24

 

non-Major Market Country, then the license granted to Celldex under
2.1.1 shall become non-exclusive forthwith solely with respect to such
Unsupported Patent in such unsupported non-Major Market Country only.  For the avoidance of doubt, Southampton shall
be free to undertake such filing, prosecution or maintenance at its own expense
in such Unsupported Patent in such unsupported non-Major Market Country only at
its sole discretion.

 

6.2.7              The Parties shall cooperate with each other in obtaining patent term
extension, such as extension under 35 U.S.C. § 156, patent term restoration or
supplemental protection certificates or their equivalents in any country in the
Territory where applicable to Patents exclusively licensed to Celldex under
this Agreement.

 

6.3        Infringement of the Patents

 

6.3.1              Each Party shall inform the other Party promptly if it becomes aware
of any infringement or potential infringement of any of the Patents to which
Celldex has a current license under the terms of this Agreement, and the
Parties shall consult with each other to decide the best way to respond to such
infringement

 

6.3.2              If the Parties fail to agree on a joint programme of action,
including how the costs of any such action are to be borne and how any damages
or other sums received from such action are to be distributed, then Celldex
shall be entitled to take action against the Third Party at its sole expense,
subject to the following provisions of this Clause 6.

 

6.3.3              Before starting any legal action under Clause 6, Celldex shall
consult with Southampton as to the advisability of the action or settlement,
its effect on the good name of Southampton, the public interest, and how the
action should be conducted.

 

6.3.4              Celldex shall reimburse Southampton for any reasonable expenses
incurred in assisting it in such action. Celldex shall pay Southampton
royalties, in 

 

25

 

accordance
with Clause 4, on any compensatory damages received from such action as if such
damages were Net Sales Value on the sale of Licensed Products or Net Receipts,
depending on the nature of the payment. 
Celldex shall retain any enhanced damages or attorneys fees received
from such action.

 

6.3.5              Celldex shall have the right to join Southampton to any suit, at
Celldex’s own expense, to enforce such rights if necessary to establish
standing to bring such suit, subject to being indemnified and secured in a
reasonable manner as to any costs, damages, expenses or other liability, and
Southampton shall have the right to be separately represented by its own
counsel at its own expense.  In addition,
Southampton reserves the right to join in any suit, at Southampton’s own
expense, to enforce such rights.

 

6.4        Infringement of Third Party
rights

 

6.4.1              If any warning letter or other notice of infringement is received by
a Party, or legal suit or other action is brought against a Party, alleging
infringement of Third Party rights in the manufacture, use or sale of any
Licensed Product or use of any Patents, that Party shall promptly provide full
details to the other Parties, and the Parties shall discuss the best way to
respond.

 

6.4.2              Celldex
shall have the right but not the obligation to defend such suit and shall have
the right to settle with such Third Party, provided that if any action or
proposed settlement involves the making of any statement, express or implied,
concerning the validity of any Patent, the consent of Southampton must be
obtained before taking such action or making such settlement, such consent not
to be unreasonably withheld or delayed.

 

7      Warranties

 

7.1       Southampton warrants and undertakes as follows:

 

7.1.1     Under the terms of the employment contracts between Southampton and
its 

 

26

 

employees, Southampton owns, or in the case of Know-how at the time of
transfer to Celldex of such Know-how shall own, such employees’ entire right,
title and interest in the rights under the Patents, Know How and Materials,
that it has entered into the CRT Agreement, a true copy of which is attached
hereto as Schedule 2, that the CRT Agreement is in full force and
effect, that neither party to the CRT Agreement is in breach of that agreement,
and to Southampton’s knowledge there are no current facts or circumstances that
would give rise to a claim of breach of the CRT Agreement by either party to
that agreement, and that so far as it is aware having undertaken reasonable
diligence, it has the right and authority to license the Patents, Know How and
Materials and enter into this Agreement;

 

7.1.2     It has not done, and shall not do nor agree to do during the
continuation of this Agreement any of the following things if to do so would be
inconsistent with the exercise by Celldex of the rights granted to it under
this Agreement, namely:

 

7.1.2.1              other than as stated herein, grant or agree to grant any rights in
the Patents in the Field in the Territory with the exception of the provisions
of Clause 6.2.6 above.

 

7.1.2.2              assign, mortgage, charge or otherwise transfer any of the Patents in
the Territory or  any of its rights or obligations
under this Agreement, with the exception of the provisions of Clause 6.2.6
above.

 

7.1.3     As of the Effective Date,
Southampton and CRT are the sole registered proprietors and sole owners of the
Patents and such Patents are free from any claims or encumbrances except as
expressly stated herein; under the CRT Agreement, Southampton is solely and
beneficially entitled to the Patents free from any claims or encumbrances
whatsoever (subject to 7.2);  Southampton
has full right, power and authority to grant the licenses granted by it under
this Agreement and to enter into and perform its obligations under this
Agreement, and except for the CRT Agreement, neither Southampton nor CRT has
any agreement or arrangement (including any licenses of right and/or compulsory

 

27

 

license or any other permissions), nor
subject to Clause 2.4, will enter into any such agreement or arrangement with a
Third Party with respect to use of or interest in such Patents in the Field
during the continuation of this Agreement. 
Southampton hereby undertakes that it shall not, during the term of this
Agreement, modify, amend, terminate or allow termination of the CRT Agreement.

 

7.1.4     As of the Effective Date, Southampton and CRT are the sole
registered proprietors and sole owners and are beneficially entitled to any
relevant Know-How in existence as of the Effective Date and Materials,
Southampton has full right, power and authority to grant the licenses granted
by it under this Agreement and to enter into and perform its obligations under
this Agreement, and, except as set forth in Clause 7.1.6,  Southampton does not have, and subject to
Clause 2.4, will not enter into during the continuation of the Agreement, any
agreement or arrangement (including any licenses of right and/or compulsory
license or any other permissions) with a Third Party with respect to use of or
interest in such Know How and Materials in the Field.  With respect to Know-how arising after the
Effective Date and during the Extended Transfer Period, Southampton shall seek
to obtain all rights necessary to enable the grant of the license set out in
Clause 2.1.2.  Southampton shall ensure
that such rights are obtained by Southampton prior to any transfer of such
Know-how to Celldex.

 

7.1.5     As of the Effective Date it is not aware of any prior art, other
than that already disclosed to Celldex in writing in the form of the Due
Diligence Report, prepared by Hunton and Williams and dated July 31 2006,
and UK Patent Office Search Report, which could have a material effect on the
allowability or validity of the Patents. As of the Effective Date no Third
Party has notified Southampton in writing that any of the Patents are invalid
or unenforceable.

 

7.1.6     As of the Effective Date, it has granted three Material Transfer
Agreements for the Know-How and Material to academic institutions for research
purposes only.  True copies of which are
attached hereto as Schedule 3.

 

28

 

7.1.7     As of the Effective Date and having made no specific enquiry, it is
not aware and has not been notified that practice of the Patents or
commercialisation of Licensed Products infringes or would infringe the rights
of any Third Party

 

7.1.8     As of the Effective Date and so far as it is aware, having made no
specific enquiry of any Third Party, there is no subsisting infringement by any
Third Party of any of the Patents or other Intellectual Property assigned or
licensed under this Agreement.

 

7.2                       No other warranties

 

7.2.1           Southampton and Celldex acknowledge that, in entering into this
Agreement, it does not do so in reliance on any representation, warranty or
other provision except as expressly provided in this Agreement, and any
conditions, warranties or other terms implied by statute or common law are
excluded from this Agreement to the fullest extent permitted by law.

 

7.2.2           Without limiting the scope of clause 7.2.1 above and except as set
forth in clause 7.2.1 above, Southampton does not make any representation nor
give any warranty or undertaking except to the extent set forth above:

 

7.2.2.1     as to the efficacy or usefulness of the Intellectual Property; or

 

7.2.2.2     that any of the Patents is or will be valid or subsisting or (in the
case of an application) will proceed to grant; or

 

7.2.2.3     that the use of any of the Intellectual Property, the manufacture,
sale or use of the Licensed Products or the exercise of any of the rights
granted under this Agreement will not infringe any other intellectual property
or other rights of any other person; or

 

7.2.2.4     that the Intellectual Property or any other information communicated
by Southampton to Celldex under or in connection with this Agreement will
produce Licensed Products of satisfactory quality or 

 

29

 

fit for the purpose for which Celldex intended; or

 

7.2.2.5     as imposing any obligation on
Southampton to bring or prosecute actions or proceedings against Third Parties
for infringement or to defend any action or proceedings for revocation of any
of the Patents; or

 

7.2.2.6     as imposing any liability on Southampton in the event that any Third
Party supplies Licensed Products to customers located in the Territory.

 

7.3                                 Indemnity

 

7.3.1        Celldex
shall indemnify and hold harmless Southampton, CRT and Tenovus and their
Affiliates, and respective officers, directors, Council members, employees,
researchers and representatives (together, the “Southampton Indemnitees”)
against any and all Third Party Claims that may be asserted against or suffered
by any of the Southampton Indemnitees and which relate to the use by Celldex or
any of its sub-licensees of the Intellectual Property or otherwise in
connection with the development, manufacture, use or sale of or any other
dealing in any of the Licensed Products by Celldex or any of its sub-licensees,
or subsequently by any customer or any other person, including Claims based on
product liability laws, provided, however, that such indemnification shall not
apply to any Claim to the extent directly attributable to (i) a breach by
Southampton of any of the warranties or representations set forth in Clause
7.1; (ii) negligent activities or intentional misconduct of the
Southampton Indemnitees, or (iii) the settlement of a claim, suit, action,
or demand by Southampton Indemnitees without the prior approval of
Celldex.  In addition, Celldex shall put
in place (prior to first commercial sale of a Licensed Product) product
indemnity insurance in an amount not less than [*]

 

*Confidential

 

30

 

for injuries
to any one person arising out of a single occurrence or for injuries to all
persons arising out of a single occurrence which shall last for the term of
this agreement and extend for at least 6 years after expiry or termination of
this Agreement and shall send a copy of such insurance documentation to
Southampton.

 

7.3.2        Southampton
shall indemnify Celldex and its Affiliates and sub-licensees and their
respective officers, directors, employees, researchers and representatives
(together, the “Celldex Indemnitees”) against all Third Party Claims that may
be asserted against or suffered by any of the Celldex Indemnitees arising
solely out of breach by Southampton or its Affiliates of the representations
and warranties of Clause 7.1, provided, however, that such indemnification
shall not apply to any Claim to the extent directly attributable to (i) negligent
activities or intentional misconduct of the Celldex Indemnitees, or (ii) the
settlement of a claim, suit, action, or demand by Celldex Indemnitees without
the prior approval of Southampton.

 

7.3.3.       As a condition precedent to a Party’s (the “Indemnifying Party”)
obligations to indemnify, defend and hold harmless any Southampton Indemnitee
or Celldex Indemnitee (collectively, an “Indemnified Party”) pursuant to Clause
7.3.1 or 7.3.2 above, the Indemnified Party shall immediately notify in
writing, and provide a copy to, the Indemnifying Party of any complaint,
summons or other written or verbal notice that the Indemnified Party receives
of any claim that may be subject to such obligations.  An Indemnified Party’s failure to deliver
written notice, to the extent prejudicial to the Indemnifying Party’s ability
to defend such claim, shall relieve the Indemnifying Party of liability to the
Indemnified Party under Clause 7.3.1 or 7.3.2 hereof, as applicable.  The Indemnified Party shall allow the
Indemnifying Party the control of the defence and settlement thereof, and
assist in such defence and settlement as the Indemnifying Party may reasonably
request in connection with the defence and settlement of the claim (at the
Indemnifying Party’s sole cost and expense), and the Indemnifying Party shall
assume the defence thereof with counsel mutually satisfactory to the Parties;
provided, that the 

 

31

 

Indemnified
Party shall have the right to participate in any such proceeding with counsel
of its choosing at its own expense.  No
Indemnified Party may settle a claim or action covered by this Clause 7 without
the prior written consent of the Indemnifying Party (which consent shall not be
unreasonably withheld, delayed or conditioned). 
Any payment made by an Indemnified Party in violation of this Clause 7.3.3
to settle any such claim or action shall be at its own cost and expense.

 

7.3.4.       Limitation of liability. Except for the
obligations set forth in this clause 7, and unless otherwise expressly stated
in this agreement, in no event will either party be liable to the other for
lost revenue, lost profits, or lost savings or any consequential, incidental,
special exemplary, punitive or indirect damages to the other party, however
caused, in connection with this agreement, even if the party has notice of the
possibility of such damages.

 

8                                         Duration and Termination

 

8.1                                 This
Agreement shall come into effect on the Effective Date and, unless terminated
earlier in accordance with this Clause 8, shall continue in force on a
country-by-country basis and expire on the later of (the “Term”):

(i) the
date of expiration or termination of the last to expire or last to terminate
Valid Claim that Covers the Licensed Products on sale in such country on such
date of expiration or termination of such Valid Claim; or

(ii) the
date that is ten (10) years after the date of the first commercial sale of
the first Licensed Product in such country.

 

8.2                                 Early
termination

 

8.2.1        Without prejudice to any other right or remedy, any Party may
terminate this Agreement at any time by notice in writing to the other Party (“Other
Party”), such notice to take effect as specified in the notice:

 

8.2.1.1.    if the Other Party is in material breach of this Agreement and, in
the 

 

32

 

case of
a breach capable of remedy within 90 days, the breach is not remedied within 90
days of the Other Party receiving notice specifying the breach and requiring
its remedy; or

 

8.2.1.2     if: (A) the Other Party becomes insolvent or unable to pay its
debts as and when they become due, (B) an order is made or a resolution is
passed for the winding up of the Other Party (other than voluntarily for the
purpose of solvent amalgamation or reconstruction), (C) a liquidator,
administrator, administrative receiver, receiver or trustee is appointed in
respect of the whole or any part of the Other Party’s assets or business, (D) the
Other Party makes any composition with its creditors, (E) the Other Party
ceases to continue its business, or (F) as a result of debt and/or
maladministration the other Party takes or suffers any similar or analogous
action.

 

8.2.2        Southampton may terminate this
Agreement by giving written notice to Celldex in accordance with the provisions
of Clause 5.4

 

8.2.3        Celldex may terminate this Agreement at any time by providing 6
months notice in writing to Southampton. 
A Party’s right of termination under this Agreement, and the exercise of
any such right, shall be without prejudice to any other right or remedy
(including any right to claim damages) that such Party may have in the event of
a breach of contract or other default by the other Party.

 

8.3                        Consequences
of termination

 

8.3.1        Upon termination of this Agreement by expiry under Clause 8.1, or by
Celldex pursuant to Clause 8.2.1, the licenses granted to Celldex under Clause
2 shall become non-exclusive, perpetual, irrevocable, fully-paid up and royalty
free.

 

8.3.2       Upon termination of this Agreement by Southampton pursuant to Clause
8.2.1 or 8.2.2, or by Celldex pursuant to Clause 8.2.3, then:

 

33

 

8.3.2.1     Celldex and its sub-licensees shall be entitled to sell, use or
otherwise dispose of (subject to payment of royalties under Clause 4) any
unsold or unused stocks of the Licensed Products for a period of 6 months
following the date of termination;

 

8.3.2.2     subject to 8.3.2.1 above, Celldex shall no longer be licensed to use
or otherwise exploit in any way, either directly or indirectly, the Patents, in
so far and for as long as any of the Patents remains in force, or the Know-how;

 

8.3.2.3     subject to 8.3.2.1 above, Celldex shall consent to the cancellation
of any formal license granted to it, or of any registration of it in any
register, in relation to any of the Patents;

 

8.3.2.4     subject as provided in this Clause
8.3, and except in respect of any accrued rights, neither Party shall be under
any further obligation to the other; and

 

8.3.2.5     Notwithstanding anything to the contrary contained herein, in the
event the Agreement or any license right thereunder terminates for any reason
other than an uncured breach by Celldex that is caused directly or indirectly
by its sub-licensee, and the sub-license to such sub-licensee is in force and
effect as of the date of such termination, such sub-licensee shall automatically
become a direct licensee of Southampton under the terms and conditions of this
Agreement,  such direct license to be of
the same scope licensed by Celldex to such sub-licensee under such sub-license,
provided that nothing herein shall be construed to require (i) Southampton
to assume obligations to such sub-licensee that are beyond those obligated to
Celldex hereunder, or (ii) such sub-licensee to make any payments to
Southampton that are in excess of those amounts that would have been due from
Celldex to Southampton under this Agreement had this Agreement not been
terminated. Southampton agrees that any 

 

34

 

sub-licensee
under this Agreement shall be deemed to be a Third Party beneficiary of the
provisions of this Section 8.3.2.5 as such provisions apply to such
sub-licensee. Southampton as a charitable body it retains the right to decline
taking on a sub licensee as a direct licensee if that sub licensee is a Tobacco
Party or involved in the weapons industry or is known to be involved in
unethical business practices such as exploitation of child labour .

 

8.3.3        Upon termination of this
Agreement by Southampton pursuant to Clause 8.2.1 or 8.2.2, then at Southampton’s
written request, received by Celldex within fourteen (14) days after the
effective termination date, the Parties shall negotiate in good faith the terms
of an agreement between them on reasonable commercial terms taking full account
in such circumstances of the stage of development and Celldex’s financial
investment in the Licensed Products to that stage, as well as other factors,
under which Celldex would:

 

8.3.3.1     transfer to Southampton exclusively all clinical and other data
relating to the development of Licensed Products;

 

8.3.3.2     to the extent possible, seek to have any product licenses, pricing
approvals and other permits and applications transferred into the name of
Southampton or its nominee;

 

8.3.3.3     grant Southampton an exclusive, worldwide license, with the rights
to grant sub-licenses, under any non-severable improvements and other
intellectual property owned or controlled by Celldex relating to the Licensed
Products; and

 

8.3.3.4     grant Southampton and/or its nominee the right to continue to use
any product name that had been applied to the Licensed Products prior to
termination of this Agreement.

 

8.3.4        Upon termination of this Agreement for any reason the provisions of
clauses 3, 4 (solely in respect of sales made prior to termination or under
clause 

 

35

 

8.3.2(1)),
7.3, 8.3 and 9 shall remain in force. 
Upon expiration or termination of this Agreement pursuant to clause 8.1,
or termination by Celldex pursuant to clause 8.2.1, clause 2 shall also remain
in force.

 

9                                         General

 

9.1                                 Force majeure

 

No Party shall
have any liability or be deemed to be in breach of this Agreement for any
delays or failures in performance of this Agreement which result from
circumstances beyond the reasonable control of that Party, including without
limitation labour disputes involving that Party.  The Party affected by such circumstances
shall promptly notify the other Parties in writing when such circumstances
cause a delay or failure in performance and when they cease to do so.

 

9.2                                 Severability

 

If any provision of this
Agreement is declared by any judicial or other competent authority to be void,
voidable, illegal or otherwise unenforceable then the remaining provisions of
this Agreement shall continue in full force and effect.  The judicial or other competent authority
making such determination shall have the power to limit, construe or reduce the
duration, scope, activity and/or area of such provision, and/or delete specific
words or phrases as necessary to render such provision enforceable.

 

9.3                                 Waiver

 

Failure or delay by any
party to exercise any right or remedy under this Agreement shall not be deemed
to be a waiver of that right or remedy, or prevent it from exercising that or
any other right or remedy on that occasion or on any other occasion.

 

9.4                                 Entire
Agreement and Amendments

 

9.4.1        This Agreement constitutes
the entire Agreement and understanding of the parties relating to the subject
matter of this Agreement and supersedes all 

 

36

 

prior oral or written
agreements, representations, understandings or arrangements between the parties

 

9.4.2        The parties acknowledge
that they are not relying on any agreement, understanding, arrangement,
warranty, representation or term which is not set out in this Agreement

 

9.4.3        Nothing in this Clause 9.4
shall operate to:

 

9.4.3.1     exclude any provision
implied into this Agreement by law and which may not be excluded by law; or

 

9.4.3.2     limit or exclude any
liability, right or remedy to a greater extent than is permissible under law.

 

9.4.4        No change may be made to
this Agreement except in writing signed by the duly authorised representatives
of each of the parties.

 

9.5                                 Relationship of
the Parties

 

9.5.1        Nothing in this Agreement
shall create, evidence or imply any agency, partnership or joint venture
between the parties.

 

9.5.2        No party shall act or
describe itself as an agent of any of the other parties nor shall a party
represent that it has any authority to make commitments or the behalf of the
other party.

 

9.6                                 Assignment and
Sub-contracting

 

This Agreement
is personal to the parties and neither party shall assign, transfer,
sub-license, sub-contract, charge or otherwise deal in its rights or
obligations under this Agreement except as expressly provided in the Agreement,
except that Celldex may assign or transfer its rights or obligations to any
purchaser of Celldex or of the relevant business or assets of Celldex to which
the rights or obligations under this Agreement relate.

 

37

 

9.7        Interpretation.

 

In this Agreement:

 

9.7.1        the headings are used for convenience only and shall not affect its
interpretation;

 

9.7.2        references to persons shall include incorporated and unincorporated
persons; references to the singular include the plural and vice versa; and
references to the masculine include the feminine;

 

9.7.3        references to Clauses and
Schedules mean clauses of, and schedules to, this Agreement;

 

9.7.4        references in this Agreement to termination shall include
termination by expiry; and

 

9.7.5        where the word “including” is used it shall be understood as meaning
“including without limitation”.

 

9.8        Notices

 

9.8.1        Any notice to be given under this Agreement shall be in writing and
shall be sent by first class mail or air mail, or by fax (confirmed by first
class mail or air mail) to the address of the relevant Party set out below:

 

Mylène Ployaert,

Assistant Director, Centre for Enterprise &
Innovation,

John Fairclough Centre, Building #27

University of Southampton

Highfield, Southampton

SO17 1BJ

 

Celldex Research Corporation

Senior Vice President, Business Development

222 Cameron Drive

Suite 400

Phillipsburg, NJ 08865

 

38

 

Celldex Therapeutics, Inc.

Chief Executive Officer

119 Fourth Avenue

Needham, MA 02494-2725

 

9.8.2        Notices sent as above shall be
deemed to have been received three working days after the day of posting (in
the case of inland first class mail), or seven working days after the date of
posting (in the case of air mail), or on the next working day after
transmission (in the case of fax messages, but only if a transmission report is
generated by the sender’s fax machine recording a message from the recipient’s
fax machine, confirming that the fax was sent to the number indicated above and
confirming that all pages were successfully transmitted).

 

9.9        Publicity

 

Either party has the right
to publish that they have entered into this agreement and information about
this agreement and the party wishing to publish such information shall send a
copy to the other party for reference at least twenty four hours prior to
publication.

 

9.10      Law and
Jurisdiction.

 

The validity, construction
and performance of this Agreement shall be governed by English law and the
parties accept the exclusive jurisdiction of the English courts in respect
thereto.

 

9.11      Further
action

 

Each Party
agrees to execute, acknowledge and deliver such further instruments, and 

 

39

 

do all further
similar acts, as may be necessary or appropriate to carry out the purposes and
intent of this Agreement.  At the request of Celldex, Southampton
agrees to execute any such further documents or other instruments 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
Southampton shall cooperate with Celldex as necessary to effect such
registration or recordal.

 

9.12      Third parties

 

Except for the rights of CRT as provided in Clause
2.4, the rights of the Southampton Indemnitees as provided in Clause 7.3 and
the rights of sub-licensees under Clause 8.3.2.5, which may be enforced by
those persons in their own right, this Agreement does not create any right
enforceable by any person who is not a party to it (“Third Party”) under the
Contracts (Rights of Third Parties) Act 1999, but this Clause does not affect
any right or remedy of a Third Party which exists or is available apart from
that Act.  The Parties may amend, renew,
terminate or otherwise vary all or any of the provisions of this Agreement,
including Clauses 7.3 and 8.3.2.5, without the consent of the Indemnitees.

 

[The
Remainder of this Page Intentionally Left Blank]

 

40

 

AGREED by the
Parties through their authorised signatories:-

 

	
  For and
  on behalf of

  	
   

  	
  For and
  on behalf of

  
	
   

  	
   

  	
   

  
	
  University
  of Southampton

  	
   

  	
  Celldex
  Therapeutics, Inc.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  /s/ Sue
  Sundstrom

  	
   

  	
  /s/ Anthony
  S. Marucci

  
	
  Signed

  	
   

  	
  Signed

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Sue Sundstrom

  	
   

  	
  Anthony S.
  Marucci

  
	
  Print Name

  	
   

  	
  Print Name

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Director,
  Life Science Enterprise

  	
   

  	
  President
  and CEO

  
	
  Title

  	
   

  	
  Title

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  24
  November 2008

  	
   

  	
  November 11,
  2008

  
	
  Date

  	
   

  	
  Date

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  For and
  on behalf of

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Celldex
  Research Corporation

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  /s/ Anthony
  S. Marucci

  	
   

  	
   

  
	
  Signed

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Anthony S.
  Marucci

  	
   

  	
   

  
	
  Print Name

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  President
  and CEO

  	
   

  	
   

  
	
  Title

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  November 11,
  2008

  	
   

  	
   

  
	
  Date

  	
   

  	
   

  

 

41

 

SCHEDULE 1

 

Part A — Patents

 

[*]

[*]

 

Part B — Materials
and Know-how

 

Materials to include: [*]

 

Know-How to include:

 

Know-how in
developing functional [*] that is:

 

1)                                      [*]

 

2)                                     [*]

 

3)                                     [*]

 

4)                                     [*]

 

5)                                     [*]

 

AND excluding
any generic methods or information which have applications outside the Field.

 

*Confidential

 

42

 

SCHEDULE 2

 

CRT AGREEMENT

 

43

 

SCHEDULE 3

 

MTA’s

 

44

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00155-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00155-of-00352.parquet"}]]