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


 


32