Document:

[ **** ]
indicates confidential portions have been redacted and submitted separately
pursuant to confidentiality request with the Commission

 

DATED DECEMBER 16, 2005

 

LORANTIS LIMITED

 

and

 

CORIXA CORPORATION

 

 

AGREEMENT

 

 

 

THIS
AGREEMENT (this “Agreement”),
effective as of December 16, 2005 (the “Effective
Date”), is entered into as a DEED between:

 

(1)           LORANTIS LIMITED, an English corporation,
having a place of business at 410 Cambridge Science Park, Cambridge, CB4 OPE, (“Lorantis”); and

 

(2)           CORIXA CORPORATION, a Delaware corporation,
having a place of business at 1900 9th Avenue, Suite 1100, Seattle,
Washington 98101 (collectively “Corixa”).

 

RECITALS

 

(A)          Apovia
AG and Apovia Inc had expertise and intellectual property rights relating to a
Hepatitis B Virus antigen.

 

(B)           Corixa
has expertise and intellectual property rights relating to an adjuvant that may
be useful in connection with such Hepatitis B Virus antigen.

 

(C)           Corixa
entered into a collaboration agreement dated July 29, 2003 with Apovia AG
and Apovia Inc (“First Collaboration
Agreement”) for the research and development solely for uses
reasonably related to the development and submission of information under the
Federal Food, Drug and Cosmetic Act and/or the Public Health Service Act, and commercialization
of an immunotherapeutic vaccine designed to treat Hepatitis B in humans on the
terms and conditions set forth therein.

 

(D)          Lorantis
acquired the right, title and interest of Apovia AG and Apovia Inc in the
Hepatitis B Antigen and in the intellectual property owned by them under the
First Collaboration Agreement resulting from the collaboration and Apovia AG,
Apovia Inc, Corixa and Lorantis novated the First Collaboration Agreement so
that Lorantis takes the place of Apovia AG and Apovia Inc.

 

(E)           The
Parties terminated the First Collaboration Agreement and simultaneously entered
into a further collaboration agreement dated February 24, 2005 (“Second Collaboration Agreement”) for the
research and development of an immunotherapeutic vaccine designed to treat
Hepatitis B in humans on the terms and conditions set forth therein.

 

(F)           SMITHKLINE BEECHAM CORPORATION, a
corporation formed under the laws of the State of Pennsylvania, doing business
as GlaxoSmithKline, having its principal office at One Franklin Plaza,
Philadelphia, PA 19101 (“SKB”) has
acquired Corixa..

 

(G)           The
Parties now wish to terminate the Second Collaboration Agreement and enter into
the terms set out in this new agreement (the “Agreement”).

 

NOW
THEREFORE, in consideration of the foregoing premises and the
mutual covenants set forth below, the Parties agree as follows:

 

 

1.             DEFINITIONS

 

For purposes of
this Agreement, the terms set firth in this Clause 1 shall have the respective
meanings set forth below:

 

	
  “Affiliate”

  	
   

  	
  shall mean,
  with respect to any person or entity, any other person or entity which
  controls, is controlled by or is under common control with such person or
  entity. For purposes of this definition, a person or entity shall be in “control” of an entity if it owns or
  controls at least fifty percent (50%) of the equity securities of the subject
  entity entitled to vote in the election of directors (or, in the case of an
  entity that is not a corporation, for the election of the corresponding
  managing authority), or otherwise has the power to control the management and
  policies of such other entity;

  
	
   

  	
   

  	
   

  
	
  “Arising Patent Rights”

  	
   

  	
  shall have
  the meaning assigned to such term in Clause 6.2.

  
	
   

  	
   

  	
   

  
	
  “BLA”

  	
   

  	
  shall mean a
  biologics license application, product license application, new drug
  application, or similar application for marketing approval of a product
  submitted to the FDA, and/or its foreign equivalent;

  
	
   

  	
   

  	
   

  
	
  “cGMP”

  	
   

  	
  means
  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);

  
	
   

  	
   

  	
   

  
	
  “Collaboration Agreements”

  	
   

  	
  shall mean
  the First Collaboration Agreement and the Second Collaboration Agreement (or
  either of them as the case may be);

  

 

2

 

	
  “Confidential Information”

  	
   

  	
  shall mean,
  with respect to a Party, all information (and all tangible and intangible
  embodiments thereof), which is Controlled by such Party and which is not
  generally known. Notwithstanding the foregoing, Confidential Information of a
  Party shall not include information which, and only to the extent, the
  receiving Party can establish by written documentation (a) has been generally
  known prior to disclosure of such information by the disclosing Party to the
  receiving Party; (b) has become generally known, without the fault of
  the receiving Party, subsequent to disclosure of such information by the
  disclosing Party to the receiving Party; (c) has been received by the
  receiving Party at any time from a source, other than the disclosing Party,
  rightfully having possession of and the right to disclose such information
  free of confidentiality obligations; (d) has been otherwise known by the
  receiving Party free of confidentiality obligations prior to disclosure of
  such information by the disclosing Party to the receiving Party; or
  (e) has been independently developed by employees or others on behalf of
  the receiving Party without access to or use of such information disclosed by
  the disclosing Party to the receiving Party;

  
	
   

  	
   

  	
   

  
	
  “Commercialisation”

  	
   

  	
  shall
  include, without limitation, all activities relating to the import, export,
  application, advertising, promotion and other marketing, pricing and
  reimbursement, detailing, distribution, storage, handling, offering for sale
  and selling, customer service and support, post marketing authorisation
  clinical trials and all regulatory activities including adverse event
  reporting of a Product and all pricing and reimbursement activities (and the
  term “Commercialise” shall be
  construed accordingly);

  
	
   

  	
   

  	
   

  
	
  “Control”

  	
   

  	
  shall mean
  ownership, or, when used in reference to intellectual property rights that
  are subject to the grant of a license or sublicense, the right of the grantor
  to grant such licenses or sublicenses without breaching the existing terms of
  an agreement with a Third Party pursuant to which such license/sublicense
  rights are derived;

  
	
   

  	
   

  	
   

  
	
  “Corixa Know-How Rights”

  	
   

  	
  shall mean
  and he limited to all Know-How Controlled by Corixa as of the Effective Date
  or which was Controlled by Corixa or Controlled prior to the SKB acquisitions
  by those entities which were Affiliates of Corixa prior to this acquisition,
  in each case relating to the Corixa Licensed 

  

 

3

 

	
   

  	
   

  	
   

  
	
  “Corixa Licensed Technology”

  	
   

  	
  Technology,
  which in each case are necessary or useful to make or have made RC 529SE
  using RC 529 Adjuvant and for using RC 529SE in Products being Developed
  and/or Commercialised by Lorantis or its Permitted Sublicensees in the
  Lorantis Field; shall mean and be limited to all patentable inventions and
  Technology Controlled by Corixa as of the Effective Date or which was
  Controlled by Corixa or Controlled prior to the SKB acquisitions by those
  entities which were Affiliates of Corixa prior to this acquisition, which in
  each case are necessary or useful to make or have made RC 529SE using RC 529
  Adjuvant and for using RC 529SE in Products being Developed and/or
  Commercialised by Lorantis or its Permitted Sublicensees in the Lorantis
  Field. Subject to the exceptions set forth in the definition of Confidential
  Information, all Corixa Licensed Technology shall be Confidential Information
  of Corixa;

  
	
   

  	
   

  	
   

  
	
  “Corixa Patent Rights”

  	
   

  	
  shall mean
  and be limited to each of the following, taken collectively, that are
  Controlled by Corixa as of the Effective Date or which was Controlled by
  Corixa or Controlled prior to the SKB acquisitions by those entities which
  were Affiliates of Corixa prior to this acquisition: (a) all patent
  applications before or after the Effective Date filed in any country, in each
  case which restrict the use of, and only to the extent they restrict the use
  of, Corixa Licensed Technology; (b) all patents that have issued or in
  the future issue from any of the foregoing patent applications, including
  without limitation utility models, design patents and certificates of
  invention; and (c) all foreign equivalents, divisionals, continuations,
  continuations-in-part, reissues, renewals, Supplementary Protection
  Certificates, extensions or additions to any such patents and patent
  applications, which in each case are necessary or useful to make or have made
  RC 529SE using RC 529 Adjuvant for the purpose of using such RC 529SE in
  Products being Developed and/or Commercialised by Lorantis or its Permitted
  Sublicensees in the Lorantis Field:

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  The Corixa
  Patent Rights shall include, without limitation, the patents and patent
  applications set forth on Schedule 1 attached hereto to the extent in each
  case are necessary or useful to make or have made RC 529SE using RC 529
  Adjuvant for the purpose of using such RC 529SE in Products being Developed
  and/or Commercialised by 

  

 

4

 

	
  “CRO”

  	
   

  	
  Lorantis or
  its Permitted Sublicensees in the Lorantis Field; shall mean a Contract
  Research Organisation contracted to perform clinical trials as part of the
  Development Programme;

  
	
   

  	
   

  	
   

  
	
  “Development”

  	
   

  	
  shall
  include, without limitation, all research, improvement, application,
  preclinical testing, test method development and stability testing,
  toxicology, formulation, process development, manufacturing scale-up,
  qualification and validation, quality assurance/quality control, clinical
  trials, manufacturing clinical supplies, regulatory affairs, statistical
  analysis and report writing, and all other pre-marketing authorisation
  activities, together with all further research and/or development activities,
  (and the term “Develop” shall be
  construed accordingly);

  
	
   

  	
   

  	
   

  
	
  “Development Programme”

  	
   

  	
  shall mean
  the Development and Commercialisation program in relation to
  Product(s) (including potential Product(s)) undertaken (and to be
  undertaken) by Lorantis and/or or its Permitted Sublicensees;

  
	
   

  	
   

  	
   

  
	
  “Drug Master Manufacturing File” or “Drug Master File” or “DMF”

  	
   

  	
  shall means
  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 he filing of
  a drug master file or analogous documentation therewith;

  
	
   

  	
   

  	
   

  
	
  “Effective Date”

  	
   

  	
  shall have
  the meaning set forth in the first paragraph of this Agreement;

  
	
   

  	
   

  	
   

  
	
  “Existing Development Programme”

  	
   

  	
  shall mean
  the development programme(s) conducted under the terms of the
  Collaboration Agreements;

  
	
   

  	
   

  	
   

  
	
  “FDA”

  	
   

  	
  shall mean
  the Food and Drug Administration in the United States, or the successor
  thereto, or any foreign regulatory equivalent;

  
	
   

  	
   

  	
   

  
	
  “Hepatitis B Antigen”

  	
   

  	
  shall mean
  the antigen designated by Lorantis as [ **** ] the amino acid and nucleic
  acid sequences for which are set forth on Schedule 2 attached hereto, any
  fragment or fusion thereof and any virus-like particle that incorporates any
  fragment or fusion thereof, which is developed or used in 

  

 

5

 

	
  “IND”

  	
   

  	
  connection
  with the Development Programme (For clarity, the term “HepVax”, as used in
  the Development Programme, refers to the combination of RC 529 Adjuvant with
  a Hepatitis B Antigen. The Parties acknowledge that in the Second Development
  Agreement in the definition of Hepatitis B Antigen to “HepVax” should be more
  accurately construed as a reference to [ **** ]); shall mean an
  investigational new drug application filed with FDA, or any corresponding
  filing or submission with any foreign regulatory authority required to
  commence human clinical testing of any product;

  
	
   

  	
   

  	
   

  
	
  “Intellectual Property Rights”

  	
   

  	
  shall mean
  all intellectual property rights including Corixa Patent Rights, Corixa Know
  Flow Rights and Corixa Licensed Technology;

  
	
   

  	
   

  	
   

  
	
  “Know-How”

  	
   

  	
  shall mean
  technical information, know-how and materials, including without limitation
  materials, cell lines, cell banks, experimental protocols and procedures,
  biological, chemical, pharmacological, toxicological, preclinical, clinical,
  assay, control, manufacturing data and other information;

  
	
   

  	
   

  	
   

  
	
  “Lorantis Field”

  	
   

  	
  shall mean
  the treatment of Hepatitis B infection in humans;

  
	
   

  	
   

  	
   

  
	
  “Losses”

  	
   

  	
  shall mean
  any and all liabilities, damages, losses and expenses (including reasonable
  lawyers’ fees and disbursements). In calculating “Losses”, the duty to
  mitigate on the party of the party suffering the Losses shall be taken into
  account;

  
	
   

  	
   

  	
   

  
	
  “Parties” or “Party”

  	
   

  	
  shall mean
  Lorantis and Corixa or either of them and “Party” shall mean Lorantis or
  Corixa, as the case may be);

  
	
   

  	
   

  	
   

  
	
  “Patents”

  	
   

  	
  shall mean
  all patents and patent applications and utility models, including without
  limitation, any and all foreign equivalents, divisionals, continuations,
  continuations-in-part, reissues, renewals, Supplementary Protection
  Certificates, extensions or additions to any such patents and patent
  applications;

  
	
   

  	
   

  	
   

  
	
  “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;

  

 

6

 

	
  “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
  indication or indications in patients with the disease or indication under
  study or that would otherwise satisfy requirements of 21 CFR 3I2.21(c), or
  its foreign equivalent;

  
	
   

  	
   

  	
   

  
	
  “Product”

  	
   

  	
  shall mean a
  therapeutic vaccine product limited for use in the Lorantis Field and that
  contains RC 529SE and the Hepatitis B Antigen, but which contains no other
  formulation of RC 529 Adjuvant;

  
	
   

  	
   

  	
   

  
	
  “Quarter”

  	
   

  	
  shall mean
  in respect of each year each of the following 3 month periods: 1
  January to 31 March, 1 April to 30 June, 1 July to 30
  September and 1 October to 31 December;

  
	
   

  	
   

  	
   

  
	
  “RC 529 Adjuvant”

  	
   

  	
  shall mean
  and be limited to the TEA salt form of Corixa’s proprietary adjuvant
  designated “RC 529” having the structure indicated on Schedule 3 attached
  hereto;

  
	
   

  	
   

  	
   

  
	
  “RC 529SE”

  	
   

  	
  shall mean
  (a) Corixa’s proprietary adjuvant squalene emulsion designated “RC
  529SE” as such is formulated as of the Effective Date at Althea
  Technologies, Inc. for utilization in a two vial format for the delivery
  of the Hepatitis B Antigen, and (b) such reformulation of the foregoing
  that becomes necessary due to use in a single (rather than two) vial format for
  the delivery of the Hepatitis B Antigen;

  
	
   

  	
   

  	
   

  
	
  “RC 529 Manufacturing Technology”

  	
   

  	
  shall mean
  all technology, data including pre-clinical and clinical data, and know-how,
  materials, technology, processes, quality procedures, plans, formulations,
  techniques and specifications in each case whether or not patentable,
  required to manufacture RC529 Adjuvant according to cGMP;

  
	
   

  	
   

  	
   

  
	
  “Specifications”

  	
   

  	
  shall mean:

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (a)           manufacture and
  supply in accordance with cGMP and all other applicable laws and regulations
  concerning its manufacture and supply; and

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  (b)           compliance with such
  further specifications as the Parties may from time to time agree in writing;

  
	
   

  	
   

  	
   

  
	
  “Stocks”

  	
   

  	
  shall mean
  the stocks of RC 529SE listed in Schedule 6;

  

 

7

 

	
  “Sublicense”

  	
   

  	
  shall mean a
  sublicense of the rights granted to Lorantis hereunder to a Third Party. For
  the avoidance of doubt, whether an agreement is a “Sublicense” shall be
  determined by reference to this definition regardless of whether the
  agreement is titled with another label, such as “Co-Development Agreement”;

  
	
   

  	
   

  	
   

  
	
  “Successful Completion of a Phase II Trial”

  	
   

  	
  shall mean
  the final results of any Phase II Clinical Trial conducted as part of the
  Development Programme in respect of any Product, not revealing any adverse
  data that would prevent a Phase III Clinical Trial being undertaken in
  respect of such Product or data which suggests to a reasonably prudent person
  skilled in the field of clinical development that the undertaking of a Phase
  III Clinical Trial in respect of such Product would be unethical, imprudent,
  not commercially viable or otherwise undesirable. In any event the
  commencement of a Phase III Clinical Trial as part of the Development
  Programme in respect of any Product shall be deemed to constitute a
  “Successful Completion of a Phase II Trial” regardless of the results and
  data of any prior trial;

  
	
   

  	
   

  	
   

  
	
  “Technology”

  	
   

  	
  shall mean
  technology, data including pre-clinical and clinical data, and know-how,
  materials, the technology, processes, quality procedures, plans,
  formulations, techniques and specifications in each case whether or not
  patentable, including but not limited to the information specified in
  Schedule 4.1 (Technical Transfer of Information) and the technology, processes,
  quality procedures, formulations, techniques and specifications embodied
  therein, in each case whether or not patentable; and

  
	
   

  	
   

  	
   

  
	
  “Third Party”

  	
   

  	
  Shall mean
  any person or entity other than Lorantis and Corixa and their respective
  Affiliates.

  

 

2.             REPRESENTATIONS
AND WARRANTIES

 

2.1           Each Party represents and warrants to the other Party as
follows:

 

(a)          Organization

 

Such Party is duly organized, validly existing and in good standing
under the laws of the jurisdiction in which it is organized,

 

8

 

(b)           Authorization and
Enforcement of Obligations

 

Such Party (a) has the requisite power and authority and the legal
right to enter into this Agreement and to perform its obligations hereunder;
and (b) 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.

 

(c)          Consents

 

All necessary consents, approvals and authorizations of all
governmental authorities and other persons or entities required to be obtained
by such Party in connection with this Agreement have been obtained.

 

(d)           No Conflict

 

The execution and delivery of this Agreement and the performance of
such Party’s obligations hereunder (a) do not conflict with or violate any
requirement of applicable laws, regulations or orders of governmental bodies;
and (b) do not conflict with, or constitute a default under, any
contractual obligation of such Party.

 

2.2           Corixa and SKB hereby represent and warrant to Lorantis as
of the Effective Date that: (a) Corixa Corporation, a Delaware corporation,
having a place of business at 1900 9th Avenue, Suite 1100, Seattle,
Washington 98101, continues as of the Effective Date to hold title to the
Intellectual Property Rights it Controlled immediately prior to SKB’s
acquisition of Corixa Corporation, including without limitation, the
Intellectual Property Rights which are the subject of the license rights
granted by Corixa to Lorantis under this Agreement, and (b) Corixa has not
transferred nor assigned any rights to the foregoing to the Affiliates of Corixa
and none of the foregoing Affiliates have rights in or to such intellectual
property which conflict with the license rights granted by Corixa to Lorantis
under this Agreement.

 

2.3           Corixa and SKB hereby acknowledge and agree that any
corporate reorganization of Corixa Corporation or other transfer or assignment
of the Intellectual Property Rights Controlled by Corixa Corporation as of the
Effective Date, whether within SKB or Affiliates of SKB, shall be subject to
and shall not adversely affect the license rights granted by Corixa to Lorantis
under this Agreement.

 

2.4          Disclaimer EXCEPT AS EXPRESSLY SET FORTH HEREIN, CORIXA MAKES NO
REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, REGARDING THE CORIXA KNOW-HOW
RIGHTS, THE CORIXA PATENT RIGHTS, THE CORIXA LICENSED TECHNOLOGY, AND THE
INCLUDING WITHOUT LIMITATION, ANY REPRESENTATION OR WARRANTY REGARDING
PATENTABILITY, VALIDITY, ENFORCEABILITY, MERCHANTABILITY, FITNESS FOR A
PARTICULAR PURPOSE OR NONINFRINGEMENT.  ALL
TECHNOLOGY AND INTELLECTUAL PROPERTY RIGHTS PROVIDED HEREUNDER IS PROVIDED “AS
IS”.

 

9

 

3.            TERMINATION

 

3.1           Second Collaboration Agreement shall terminate (in full and
notwithstanding any provision of the Second Collaboration Agreement to the contrary,
including without limitation the provisions which were to survive a termination
of the Second Collaboration Agreement and which are replaced with the
corresponding provisions of this Agreement) and cease to be of further effect.

 

3.2           Each Party hereby releases and discharges the other from all
their obligations and liabilities under the Second Collaboration Agreement or
otherwise as at the Effective Date.

 

3.3           Subject to the further terms of this Agreement, each Party
waives any and all claims of any nature whatsoever and howsoever arising
(whether now or in the future and whether presently known or unknown) which it
may have against the other under the Second Collaboration Agreement or
otherwise on or prior to the Effective Date.

 

3.4           The termination of the Second Collaboration Agreement
pursuant to Clause 3.1 shall be without prejudice to the rights of ownership
pursuant to Clause 7.1 of the-Second Collaboration Agreement arising prior to
the Effective Date (subject to the further terms of this Agreement).

 

3.5           In consideration of the agreement of Lorantis to the terms
of this Agreement (and in particular this Clause 3) Corixa shall pay [ **** ] (“Termination Payment”) to Lorantis.  The Termination Payment shall be made within
thirty (30) days of the Effective Date in immediately available funds to such
bank account as Lorantis shall notify to Corixa for such purpose in writing.
For the avoidance of doubt, the Parties acknowledge and agree that any and all
amounts due or payable under the Second Collaboration Agreement at any time,
including any outstanding invoiced amounts, have either been paid in full or
have been agreed by the Parties to be deemed to have been paid in full, and in
all cases are no longer due or payable. 
Each party shall be solely responsible for any tax, duty or other levy
owed by such party under applicable tax laws and regulations.  Any tax, duty or other levy paid or required
by notification of a tax authority to be withheld, if any, by Corixa on account
of the payments made by Corixa to Lorantis under this Agreement and which are
due to tax, duty or other levy which are owed by Lorantis shall be deducted
from the amount of the payment otherwise due hereunder and evidence of such
payment or withholding shall be provided to Lorantis by Corixa.

 

3.6           Term; Termination for Cause.  Unless terminated as provided for under this
Clause 3, the other Clauses of this Agreement shall continue in accordance with
their terms.  Either Party may terminate
the other Clauses of this Agreement immediately upon giving notice in writing
to the other Party if such other Party commits a material breach of this
Agreement and shall have failed to cure such material breach within sixty (60)
days after receiving written notice from the other Party with respect to do so.

 

10

 

4.            TECHNICAL TRANSFER

 

4.1           Promptly after the Effective Date Corixa shall deliver to
Lorantis the information expressly provided for on Schedule 4.1 hereto
(Technical Transfer of Information) which shall be used by Lorantis solely to
the extent Lorantis has been granted a license under Clause 5.1.

 

4.2           Following the execution of this Agreement, Corixa shall use
commercially reasonable efforts to provide the services to Lorantis specified
in Schedule 4.2 hereto (Technical Transfer Services).  Except as expressly provided for under
Schedules 4.1 or 4.2 hereof, Corixa shall not be under any obligation to
deliver to Lorantis any information or otherwise undertake any technical
transfer of any materials or technologies.

 

5.            CORIXA LICENSED IP

 

5.1           Subject to the terms and conditions of this Agreement,
Corixa hereby grants to Lorantis a worldwide, fully paid up, royalty-free,
perpetual, non-exclusive license under the Corixa Patent Rights, Corixa Know-How
Rights and Corixa Licensed Technology: (a) to use RC 529SE in Products
being Developed and/or Commercialised by Lorantis or its Permitted Sublicensees
in the Lorantis Field; (b) to make or have made RC 529SE using RC 529
Adjuvant for the limited use permitted by the license granted in the foregoing
subclause (a); and (c) to reformulate Corixa’s proprietary adjuvant
squalene emulsion designated “RC 529SE” which as of the Effective Date is
formulated at Althea Technologies, Inc. for utilization in a two vial
format for the delivery of the Hepatitis B Antigen, which reformulation becomes
necessary due to use in a single (rather than two) vial format for the delivery
of the Hepatitis B Antigen.  For the
avoidance of doubt, such license excludes and does not permit (W) the
manufacture or production of RC 529 Adjuvant, (X) or the manufacture or
production RC 529SE other than as set forth in Clause 6.1, (Y) or
reformulation of RC 529SE other than as expressly provided for above in this
Clause 5.1 as necessary for the purpose of moving to a single vial format, or (Z) the
transfer by Lorantis to a Third Party (who shall be granted appropriate
sublicense rights hereunder as necessary) of RC 529 Adjuvant or RC 529SE, in
each case other than in connection with use in Products being Developed and/or
Commercialised by Lorantis or its Permitted Sublicensees in the Lorantis Field
pursuant to the terms of this Agreement.

 

5.2           Lorantis may grant sublicences of the rights licensed to it
pursuant to Clause 5.1 to its Affiliates and Third Parties solely to the extent
that such Affiliates and Third Parties participate (a) in the making of RC
529SE from the RC 529 Adjuvant and/or (b) the Development and/or
Commercialisation of a Product using RC 529SE, provided in each case that
Lorantis provides Corixa with a fully-executed copy of any such sublicense
agreement within twenty (20) days following its execution, which sublicense
agreement shall reflect the terms, conditions and restrictions of this
Agreement applicable to activities undertaken by such Affiliates and Third
Parties, (collectively, the “Permitted Sublicensees”).  No Permitted
Sublicensee shall have any right to grant further sublicenses to the rights
sublicensed to it by Lorantis hereunder; provided however in the event that Lorantis grants to a single Permitted
Sublicensee all of the marketing rights to a Product together with an exclusive
grant under all of the license rights Lorantis is in 

 

11

 

receipt of from Corixa under this Agreement
pertaining to the marketing of the Product, then such Permitted Sublicensee
shall have the right to grant further sublicenses in a single tier; for the
avoidance of doubt, such sublicensees of such Permitted Sublicensee shall not
themselves have any right to grant further sublicenses.

 

5.3           Except as expressly set forth herein, the license rights
granted to Lorantis in Clause 5.1 do not include and Lorantis shall not acquire
the grant of any right or license in or to any Patents, Know-How, trade
secrets, materials, Confidential Information, trademarks, copyrights or other
intellectual property interests, whether by implication or otherwise, and no
Patents, Know-How, trade secrets, materials or intellectual property interests
shall be transferred hereunder, whether by implication or otherwise.  For the avoidance of doubt, the license
rights granted to Lorantis under this Agreement do not include and Lorantis
shall not acquire the grant of any right or license in or to any Patents,
Know-How, trade secrets, materials, Confidential Information, trademarks,
copyrights or other intellectual property interests Controlled by SKB or
Affiliates of SKB (except those Controlled by Corixa), whether by implication
or otherwise, and no such Patents, Know-How, trade secrets, materials or
intellectual property interests shall be transferred hereunder, whether by
implication or otherwise.

 

6.            RC 529SE; GRANT BACK

 

6.1          RC 529SE

 

Lorantis shall use the RC 529 Adjuvant supplied by Corixa hereunder
only for the purposes permitted under Clause 5.1.  Lorantis may formulate or have formulated by
Third Parties (who shall be granted appropriate sublicense rights hereunder as
necessary) the RC 529 Adjuvant supplied by Corixa hereunder into RC 529SE
pursuant to Clause 5.1.  Lorantis shall
use the RC 529 Adjuvant and RC 529SE in compliance with this Agreement and with
all applicable federal, state and local laws and regulations.  Other than making RC 529SE in accordance with
the appropriate processes and procedures therefor or as strictly necessary in
the course of reformulating RC 529SE pursuant to Clause 5.1, Lorantis shall not
make any derivatives (whether synthetic or otherwise), analogs, modifications,
or other products to or from RC 529 Adjuvant or RC 529SE.  Lorantis shall promptly report to Corixa any
violations or any attempt violate any of the foregoing restrictions.

 

6.2          Grant Back.

 

(a)           All right, title and interest in and to any
and all Patents first conceived after the Effective Date under or in connection
with the Development or Commercialisation of a Product or the exercise of any
license rights hereunder, whether by Lorantis, its Affiliates or Permitted
Sublicensees, in each case which relates to RC 529 Adjuvant or RC 529SE or any
improvement, derivative, modification or analogue to any of the foregoing, or
the use thereof, except to the extent involving the Hepatitis B Antigen or the
use thereof (“Arising Patent Rights”),
shall be owned solely by Corixa, and shall, upon transfer of ownership, become
included within the following license grant.

 

12

 

(b)           Subject
to the terms and conditions of this Agreement, Corixa hereby grants to Lorantis
a worldwide, fully paid up, royalty-free, perpetual, sub-licensable exclusive
license under the Arising Patent Rights to use RC 529SE in Products being
Developed and/or Commercialised by Lorantis or its Permitted Sublicensees in
the Lorantis Field.

 

(c)           Lorantis
agrees to reasonably assist Corixa in securing any intellectual property
protection for the Arising Patent Rights and to perform all acts and execute
appropriate documents that may be reasonably required to vest in Corixa rights
to the Arising Patent Rights.  Without
limiting the generality of the foregoing or being limited thereby, Lorantis
agrees to promptly disclose to Corixa any and all Arising Patent Rights as and
when they each first arise and provide Corixa with the information and access
to relevant personnel of Lorantis or its Affiliates or Sublicensees which are necessary
or useful to Corixa in its efforts to be assigned the Arising Patent Rights and
secure intellectual property protection for such rights.

 

7.            MAINTENANCE
PROSECUTION AND DEFENCE

 

7.1          Corixa Patent Prosecution and Maintenance.

 

Corixa shall at its own cost and expense have the sole right, and shall
in its sole discretion determine how, where and to what extent (if at all), to
procure, the timely filing, prosecution and maintenance of Corixa Patent Rights
and Arising Patent Rights through out the world; provided however in the event that Corixa decides to abandon
the filing, prosecution and/or maintenance of any Arising Patent Rights, then
it shall inform Lorantis of such decisions and allow Lorantis a reasonably
opportunity to assume at its own expense such filing, prosecution and/or
maintenance of such Arising Patent Rights.

 

7.2          Infringement

 

In the case
where at any time during the term of this Agreement Lorantis believes that an
infringement by a Third Party of the Corixa Patent Rights or Arising Patent
Rights may be occurring, which infringement entails the Development or
Commercialisation of a Product, Lorantis shall disclose full details of the
potential infringement to Corixa.  Corixa
shall at its own cost and expense have the sole right, and shall in its sole
discretion determine how, whether, where and to what extent (if at all), to
take action against such acts of infringement of the Corixa Patent Rights or
Arising Patent Rights, as the case may be; provided
however in the event that Corixa decides to take action against such
acts of infringement of such Arising Patent Rights, then it shall inform
Lorantis of such decisions and allow Lorantis a reasonably opportunity to
assume at its own expense the taking of action against such acts of infringement
of such Arising Patent Rights.

 

7.3          Third Party
Patents

 

If during the period of this Agreement either Party receives any
notice, claim or proceedings from any Third Party alleging infringement of that
Third Party’s intellectual 

 

13

 

property by reason of the Development or Commercialisation of a Product
by Lorantis or its Permitted Sublicensees hereunder:

 

7.3.1       The notified Party shall forthwith inform the other Party of
the notice, claim or proceeding;

 

7.3.2       Lorantis shall, at its own cost and expense, defend such
claim or other proceeding in accordance with the following:

 

(i)            Lorantis 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 Corixa shall not take any action (including without
limitation, the settlement of any claim) which prejudices any right or interest
of Lorantis other than with the prior written consent of Lorantis.  Each Patty shall provide all reasonable
necessary assistance to the other Party in relation to such proceedings and
Lorantis shall promptly indemnify Corixa and its Affiliates against the costs
of such activity, except to the extent Corixa and its Affiliates elects to be
separately represented at hearings and other proceedings (which shall be at
Corixa’s and such Affiliates’s discretion), in which case to the extent of such
separate representation, Corixa and such Affiliates shall bear its own cost and
expense; and

 

(ii)           if Lorantis 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.

 

8.            SUPPLY

 

8.1           Corixa shall supply (or in its sole discretion procure supply
from one or more Third Parties) to Lorantis and/or to its Permitted
Sublicensees (as directed by Lorantis):

 

(a)          at nil cost to Lorantis
and any such Permitted Sublicensees hereunder, (1) the Stocks and (2) up
to a cumulative total of 5 grams of RC 529 Adjuvant, which in each case shall
be used for Phase I Trials or Phase II Trials and ordered prior to the
Successful Completion of a Phase II Trial; and

 

(b)         such further amounts of
RC 529 Adjuvant which (1) are reasonably requested by Lorantis in good
faith for use in clinical development prior to the Successful Completion of a
Phase II Trial, and (2) following such request are agreed to be supplied
by Corixa in its good faith, reasonable discretion, and (3) if so agreed
by Corixa shall be separately paid for by Lorantis at an initial supply price
of [ **** ] per gram (the “Initial Supply
Price”).

 

14

8.2                                 After the Successful Completion
of a Phase II Trial, Corixa shall supply Lorantis and its Permitted
Sublicensees hereunder with RC 529 Adjuvant for a period up to the life of the
Products at commercially reasonable supply pricing (“Commercial Supply Pricing”) that is to be agreed upon by
the Parties but in any case allows Corixa with a commercially reasonable profit
margin above its cost of manufacture and/or supply.  The Parties agree and acknowledge that such
agreement on Commercial Supply Pricing will not include any upfront, milestone
or royalty payments.  The Parties will
use good faith efforts to agree upon such Commercial Supply Pricing in
sufficient time prior to the Successful Completion of a Phase II Trial to allow
for the uninterrupted Development and Commercialisation of the Products.  As necessary and appropriate, in such
agreement on Commercial Supply Pricing, the Parties shall agree to vary the
other supply terms set forth in this agreement including (but not necessarily
limited to) by providing for longer term good faith forecasting of supply
demand on a rolling basis, a portion of which forms the basis for firm orders,
which order and forecasting mechanism shall be acceptable to Corixa in its
reasonable judgment.

 

8.3                                 To the extent provided for under
Clause 8.1 or Clause 8.2 (if Commercial Supply Pricing has been agreed to),
Lorantis may by written notice to Corixa order RC 529 Adjuvant (an “Order”).  Such Order shall specify the quantity of RC
529 Adjuvant ordered, which quantities shall not cumulatively exceed the amount
set forth in Clause 8.1(a) above prior to the Successful Completion of a
Phase II Trial if Commercial Supply Pricing has not been agreed to yet, the
address to which such shipment shall be delivered and the required delivery
date therefor. Save with the written consent of Lorantis, the delivery date
shall be no later than 90 days after the date such Order is made.  In the event of a conflict between the terms
of any Order and this Agreement, the terms of this Agreement shall prevail.

 

8.4                                 To the extent provided for under
Clause 8.1 or Clause 8.2 (if Commercial Supply Pricing has been agreed to),
Corixa shall supply to Lorantis (at the applicable supply cost to Lorantis) the
quantity of RC 529 Adjuvant specified in each Order permitted hereunder on the
delivery date specified in such Order (or, provided that Corixa has given not
less than fifteen (15) days written notice to Lorantis, such other date as may
be specified by Corixa.  All orders shall
be in vial configurations, minimum batch sizes and meeting other reasonable
order characteristics as established by Corixa from time to time.

 

8.5                                 All RC 529 Adjuvant supplied
under Clause 8.1 or Clause 8.2 of this Agreement shall be F.C.A. (INCOTERMS
2000) to the address for delivery specified in the Order and shall be
accompanied by a written “Certificate of Analysis” confirming that such
quantity of RC 529 Adjuvant meets the Specification.

 

8.6                                 Title and risk of loss and
damage to RC 529 Adjuvant supplied by Corixa under Clause 8.1 or Clause 8.2 of
this Agreement shall pass to Lorantis upon delivery to the mode of carriage at
the facility where supply is originating from Corixa and/or a Supplier, as
applicable.

 

8.7                                 Corixa represents, warrants and
undertakes that all RC 529 Adjuvant supplied to Lorantis, its Affiliates and
Sublicensees under Clause 8.1 or Clause 8.2 of this Agreement 

 

15

 

shall be manufactured in accordance with cGMP
and satisfy the Specifications and shall be provided with a valid Certificate
of Analysis.  The Parties shall use good
faith efforts to negotiate a reasonable quality agreement pertaining to the
manufacture and supply of RC 529 Adjuvant supplied to Lorantis, its Affiliates
and Sublicensees under Clause 8.1 or Clause 8.2 of this Agreement, with the
goal of finalizing and entering into such quality agreement no later than four (4) months
following the Effective Date.

 

8.8                                 Corixa and its Affiliates shall,
and shall procure that its manufactures and suppliers of RC 529 Adjuvant (all
the foregoing person together, the “Suppliers”),
maintain all records required to comply with applicable laws, rules,
regulations, industry code of practice (including, without limitation, cGMP)
relating to the manufacture and supply of RC 529 Adjuvant which is provided to
Lorantis under Clause 8.1 or Clause 8.2 of this Agreement.  In particular, but without limitation, the
Suppliers shall maintain all records reasonably necessary to support compliance
with cGMP for such RC 529 Adjuvant, including batch records and stability
reports relating to such RC 529 Adjuvant, and the results of internal and
regulatory audits and inspections of the portions of the Supplier’s facilities
used in the manufacture and/or supply of such RC 529 Adjuvant. No more
frequently than once each calendar year, Lorantis, its Affiliates and
Sublicensees (together with their agents and representatives) may inspect (but
not take copies of) such records and inspect the portions of the Suppliers’
facilities used in the manufacture and/or supply of such RC 529 Adjuvant, upon
reasonable advance notice during normal business hours.  All such records shall be maintained for a
period of not less than three (3) years from their date or creation or
such longer period as may be required by applicable laws, rules, regulations or
industry codes of practice and in particular, but without limitation, all
records required to be maintained by applicable regulatory authorities relating
to the manufacture, stability and quality control of such RC 529 Adjuvant shall
be retained for a period of not less than three (3) years from the date of
quality control release of each batch of such RC 529 Adjuvant to which the said
records pertain.

 

8.9                                 In the event at any Corixa does
not supply (or does not procure the supply of) RC 529 Adjuvant to Lorantis or
its Permitted Sublicensees to permit uninterrupted Development and
Commercialisation of the Products in accordance with this Agreement, at any
time (whether before or after the Successful Completion of a Phase II Trial)
including, without limitation, in the event that the Parties are unable to
agree the terms of Commercial Supply Pricing pursuant to this Clause 8, then,
and only then, Corixa shall permit Lorantis to directly source RC 529 Adjuvant
from the Suppliers for the limited purposes and uses to which Lorantis and its
Permitted Sublicensees may use RC 529 Adjuvant as provided for under this
Agreement; provided however as and when orders under such supply are placed
with such Suppliers, Lorantis shall (in addition to paying such Suppliers) pay
Corixa the difference between any supply price Lorantis secures with such
Suppliers which is lower than the lesser of (a) the Initial Supply Price
and (b) the last written offer made by Corixa in negotiations regarding
Commercial Supply Pricing. Except in the event of an uncured material breach of
this Agreement by Lorantis or a Permitted Sublicensee or a uncured material
breach of an agreement between Corixa and a Supplier, Corixa agrees to maintain
in full force and effect any agreement under which any such Supplier has the
right to provide a supply of RC 529 Adjuvant. 
Lorantis shall provide Corixa with quarterly statements setting out any
supply taken under this Clause 

 

16

 

8.9, the amounts paid to such Suppliers
therefor and full accounting of any other consideration received by Lorantis
from such Suppliers for such amounts paid. Any amounts paid by Lorantis to such
Suppliers and supply of RC 529 Adjuvant received by Lorantis received in
connection therewith may not be combined expressly or implicitly with any other
transaction or supply of any other product or service.

 

9.            CONFIDENTIALITY

 

9.1                              Confidentiality

 

Each Party shall maintain in confidence the Confidential Information of
the other Party, shall not use or grant the use of the Confidential Information
of the other Party except as expressly permitted hereby, and shall not disclose
the Confidential Information of the other Party except on a need-to-know basis
to such Party’s Affiliates, Permitted Sublicensees hereunder and the directors,
officers, employees and legal and financial advisors of each of the foregoing
persons, and each of the foregoing person’s consultants or subcontractors, in
each case to the extent that such disclosure is necessary in connection with
such Party’s activities as expressly authorised by this Agreement (including,
without limitation, the conduct of the Development Programme).  To the extent that disclosure to any person
is authorized by this Agreement, prior to disclosure, a Party shall obtain, or
shall have obtained prior to the Effective Date, the written agreement of such
person to hold in confidence and not disclose, use or grant the use of the
Confidential Information of the other Party except as expressly authorised
under this Agreement.  Each Party shall
notify the other Party promptly upon discovery of any unauthorised use or
disclosure of the other Party’s Confidential Information.  Notwithstanding anything else to the contrary
(but with no further Patent license to Corixa in addition to that provided in
clause 6.2) if Lorantis intentionally or accidentally discloses any Know-How to
Corixa under or in connection with the Development or Commercialisation of a
Product or the exercise of any license rights hereunder, whether by Lorantis,
its Affiliates or Permitted Sublicensees, in each case which relates to RC 529
Adjuvant or RC 529SE or any improvement, derivative, modification or analogue
to any of the foregoing, or the use thereof, such Know How may be used
commercially by Corixa except to the extent involving the Hepatitis B Antigen
or the use thereof and in any case only outside the Lorantis Field.  However, Lorantis shall have no obligation to
disclose any Know-How to Corixa.

 

9.2                              Terms of Agreement

 

Neither Party shall disclose any terms or conditions of this Agreement
or the Collaboration Agreements to any Third Party without the prior written
consent of the other Party; provided, however, that a Party may disclose the
terms or conditions of this Agreement, (a) on a need-to-know basis to such
Party’s Affiliates, Sublicensees (or prospective Permitted Sublicensees) and
the directors, officers, employees and legal and financial advisors of each of
the foregoing persons, and each of the foregoing person’s consultants or
subcontractors to the extent such disclosure is reasonably necessary in
connection with such Party’s activities as expressly authorised by this
Agreement, and (b) to a Third Party in connection with (1) an equity
investment in or by such Party, (ii) a 

 

17

 

merger, consolidation or similar transaction involving such Party, (iii) the
sale of all or substantially all of the assets of such Party, or (iv) a public
offering of shares or securities on a securities exchange.  The Parties further agree that there shall be
no restriction on Corixa’s entitlement to use and disclose Confidential
Information relating to the performance, properties or other attributes of the
Corixa Licensed Technology to Third Parties in any way.  Notwithstanding the foregoing, the Parties
shall, consistent with the corporate communication policies of each
organization, enter into good faith discussions to reach agreement upon the
text of pro-forma press releases that each Party may wish to publicly release
which shall describe the terms and conditions of this transaction within four (4) months
following the Effective Date and once agreed upon such press releases shall be
attached hereto as Schedule 9.2, and each Party may disclose such information,
as modi fled by mutual written agreement between the Parties, without the
consent of the other Party.  Except as
expressly agreed pursuant to the foregoing clause, neither Party shall issue any
press release or make any other public announcement or statement concerning
this Agreement or the transactions covered by it or without the prior written
approval of the other Party (such approval not to be unreasonably withheld or
delayed), except as permitted under Clause 9.2, which for the avoidance of
doubt shall include making such announcements and disclosures, if any, as may
be legally required or required to meet the requirements of a national
securities exchange or another similar regulatory body, or in connection with a
public offering of securities or any filing with the U.S. Securities and
Exchange Commission or a foreign equivalent.

 

9.3                              Permitted Disclosures

 

The confidentiality obligations under this Clause 9 shall not apply to
the extent that such disclosure is required by applicable law, regulation or
order of a governmental agency or a court of competent jurisdiction or
securities exchange; provided, however, that such Party shall provide written
notice thereof to the other Party, consult with the other Party with respect to
such disclosure and provide the other Party sufficient opportunity to object to
any such disclosure or to request confidential treatment thereof (if
practicable).

 

10.          INDEMNIFICATION

 

10.1                           In addition to any other remedy
available to Lorantis, its Affiliates and Sublicensees, subject to Clauses 10.3
and 10.4, Corixa shall indemnify, defend and hold harmless Lorantis, its
Affiliates and Sublicensees (and each of their respective directors, officers
and employees) (the “Lorantis Indemnified Persons”) in full and on demand, from and against any and all
Losses incurred by them to the extent resulting from or arising out or in
connection with any claims made or suits brought by a third party
(collectively, “Lorantis Third Party Claims”) against any Lorantis Indemnified Person (or for which any
Lorantis Indemnified Person is liable) where the claimant has established in a
court of law that they suffered personal injury or death as a result of the
breach of the representation and warranty made by Corixa in Clause 8.7, except
for any Losses for which Lorantis has an obligation to indemnify Corixa
Indemnified Persons pursuant to Clause 10.2. 
For clarity, Corixa shall not be obligated to indemnify any Lorantis
Indemnified Person against any Lorantis Third Party Claims arising due to any 

 

18

 

negligence of any Lorantis Indemnified Person
or any breach of the terms of this Agreement by any such person (including, in
particular, any breach of Clause 8.7).

 

10.2                           In addition to any other remedy
available to Corixa and its Affiliates, subject to Clauses 10.3 and 10.4,
Lorantis shall indemnify, defend and hold harmless Corixa and its Affiliates
(and each of their respective directors, officers and employees) (the “Corixa Indemnified Persons”) in full and on demand, from
and against any and all Losses incurred by them to the extent resulting from or
arising out or in connection with any claims made or suits brought by a third
party (collectively, “Corixa Third Party Claims”) against any Corixa Indemnified Person (or for which any
Corixa Indemnified Person is liable) that allege that the claimant has suffered
personal injury or death: (i) as a result of any activity undertaken or
omission by Lorantis or its Permitted Sublicensees under this Agreement or
otherwise in connection with the Development or Commercialisation of any
Product(s); or (ii) relates the use of RC 529 Adjuvant or RC 529SE in any
Product, in each case except for any Losses for which Corixa has an obligation
to indemnify Lorantis Indemnified Persons pursuant to Clause 10.1.  For clarity, Lorantis shall not be obligated
to indemnify any Corixa Indemnified Person against any Corixa Third Party
Claims arising due to any negligence of any Corixa Indemnified Person or any
breach of the terms of this Agreement by any such person.

 

10.3                           An indemnified person under
Clause 10.1 or 10.2 (“Indemnified Party”)
shall give the indemnifying party under Clause 10.1 or 10.2 (“Indemnifying Party”) prompt written notice of any
Loss or discovery of fact upon which such Indemnified Party intends to base a
request for indemnification under Clause 10.1 or 10.2 (an “Indemnification Claim Notice”).  Where appropriate the Indemnifying Party
shall promptly send a copy of the Indemnification Claim Notice to its relevant
insurers and shall permit them to exercise their rights of subrogation and
hereafter in this Clause 10 “Indemnifying Party” shall be deemed to include any
such insurers in relation to such claim. 
In no event shall the Indemnifying Party be liable for any Loss that
results from any delay in providing the Indemnification Claim Notice. Each
Indemnification Claim Notice shall contain a description of the claim and the
nature and amount of the Loss claimed (to the extent that the nature and amount
of such Loss is known at such time).  The
Indemnified Party shall furnish promptly to the Indemnifying Party copies of
all correspondence, communications and official documents (including court
documents) received in respect of any such Loss.  For the avoidance of doubt, all
indemnification claims in respect of a Party, its Affiliates and its
Sublicensees (and each of their respective directors, officers and employees) (each,
an “Indemnitee”) shall be made solely by a
Party to this Agreement or its insurers.

 

10.4                           The obligations of an
Indemnifying Party under this Clause 10 shall be governed by and contingent
upon the following:

 

10.4.1                  At its option, the Indemnifying
Party may assume the defense of any Third Party Claim (being a Lorantis Third
Party Claim where the Indemnifying Party is Corixa and being a Corixa Third
Party Claim where the Indemnifying Party is Lorantis) (which, for the avoidance
of doubt, shall include the conduct of all dealings with such third party) by
giving written notice to the indemnified Party 

 

19

 

within fourteen (14) days after the
Indemnifying Party’s receipt of an Indemnification Claim Notice.  The assumption of the defense of a Third
Party Claim by the Indemnifying Party shall not be construed as an
acknowledgement that the Indemnifying Party is liable to indemnify any
Indemnitee in respect of the Third Party Claim, nor shall it constitute a
waiver by the Indemnifying Party of any defenses it may assert against any
Indemnified Party’s claim for indemnification.

 

10.4.2                  Upon the assumption of the
defence of a Third Party Claim by the Indemnifying Party:

 

(a)                                  subject to the
provisions of Clause 10.4.3, it shall have the right to and shall assume sole
control and responsibility for dealing with the Third Party and the Third Party
Claim, including the right to settle the claim on any terms the Indemnifying
Party chooses, but at all times in accordance with the provisions of Clause
10.4.4;

 

(b)                                 if it chooses, the
indemnifying Party may appoint as counsel in the defence of the Third Party
Claim any law firm or counsel selected by the Indemnifying Party; and

 

(c)                                  except as expressly
provided in Clause 10.4.3, the Indemnifying Party shall not be liable to the
indemnified Party for any legal expenses subsequently incurred by such
Indemnified Party or any Indemnitee in connection with the analysis, defence or
settlement of the Third Party Claim. In the event that it is ultimately
determined that the Indemnifying Party is not obligated to indemnify, defend or
hold harmless an Indemnitee from and against the Third Party Claim, the
Indemnified Party shall reimburse the Indemnifying Party for any and all costs
and expenses (including lawyers’ fees and costs of suit) and any Losses
incurred by the Indemnifying Party solely due to its defence of the Third Party
Claim with respect to such indemnified Party or Indemnitee (but not any Losses
for which it is otherwise liable or experiences).

 

10.4.3                  Without limiting Clause 10.4.4,
any Indemnitee shall be entitled to participate in, but not control, the
defence of a Third Party Claim by having its views regularly solicited by the
Indemnifying Party and, where proceedings are commenced, to retain counsel of its
choice for such purpose; provided, however, that such retention shall be at the
Indemnitee’s own expense unless, (a) the Indemnifying Party has failed to
assume the defence and retain counsel in accordance with Clause 10.4.1 (in
which case the indemnified Party shall control the defence), or (b) the
interests of the Indemnitee and the Indemnifying Party with respect to such
Third Party Claim are sufficiently adverse to prohibit the representation by
the same counsel of both Parties under applicable law, rule or requirement
of any professional body.

 

20

 

10.4.4                  With respect to any Losses
relating solely to the payment of money to the Third Party to settle the Third
Party Claim and that will not result in the Indemnified Party or the Indemnitee
becoming subject to injunctive relief or subject to any admission of liability,
fault or wrongdoing, and as to which the Indemnifying Party shall have
acknowledged in writing the obligation to indemnify the Indemnitee under Clause
10.4.1, the Indemnifying Party shall have the sole right to enter into any such
settlement including any consent judgment, on such terms as the Indemnifying
Party, in its sole discretion, shall deem appropriate.  With respect to all other Losses or where the
Indemnified Party or the Indemnitee will be subject to injunctive relief or any
admission of liability, fault or wrongdoing, where the Indemnifying Party has
assumed the defence of a Third Party Claim in accordance with Clause 10.4.1,
the Indemnifying Party shall have authority to consent to the entry of’ any
judgment, enter into any settlement or otherwise dispose of such Losses,
provided that it obtains the prior written consent of the Indemnified Party
(which consent shall be given, if at all, in the sole discretion of the
Indemnified Party).

 

10.4.5                  If the Indemnifying Party does
not to diligently defend or prosecute any Third Party Claim, the Indemnified
Party shall retain control of the defense thereof and admit any liability with
respect to, and settle, compromise and discharge, any such Third Party Claim
without first obtaining prior written consent of the Indemnifying Party.  The Indemnifying Party shall be liable for
any settlement or other disposition of Losses by an Indemnified Party or an
Indemnitee under such a Third Party Claim.

 

10.4.6                  If the Indemnifying Party
chooses to defend any Third Party Claim, the Indemnified Party shall, and shall
cause each other Indemnitee to, reasonably cooperate in the defense thereof and
shall furnish such records, information and testimony, provide such witnesses
and attend such conferences, discovery proceedings, hearings, trials and
appeals as may be reasonably requested in connection therewith.  Such cooperation shall include access during
normal business hours by the Indemnifying Party to, and reasonable retention by
the Indemnified Party of, records and information that are reasonably relevant
to such Third Party Claim, and making the Indemnified Party, the Indemnitees
and its and their employees and agents available on a mutually convenient basis
to provide additional information and explanation of any records or information
provided, and the Indemnifying Party shall reimburse the Indemnified Party for
all of its related reasonable out-of-pocket expenses.

 

10.4.7                  Except as expressly provided
above, the reasonable costs and expenses, including fees and disbursements of
counsel, incurred by the Indemnified Party where it participates in the defence
under Clause 10.4.3 or Clause 10.4.5 shall be reimbursed on a Quarterly basis
by the Indemnifying Party, without prejudice to the Indemnifying Party’s right
to contest the Indemnified Party’s right to indemnification and subject to
refund in the event the Indemnifying Party is ultimately held not to be obligated
to indemnify the Indemnified Party.

 

21

 

10.5                           Except with respect to Third
Party Claims under Clause 10.1 or 10.2 or a breach of Clause 9, neither Party
shall be liable to the other in contract, tort, negligence, breach of statutory
duty or otherwise for any loss, damage, costs or expenses of any nature
whatsoever incurred or suffered by the other or its Affiliates, or the case of
Lorantis, its Permitted Sublicensees, (or any of their respective directors,
officers and employees): for an indirect or consequential or punitive nature,
including any indirect or consequential economic loss or other indirect or
consequential loss of’ turnover, profits, loss of enterprise value, business or
goodwill or otherwise.

 

11.          GUARANTEE

 

SKB hereby unconditionally and irrevocably guarantees to Lorantis the
performance of all the contractual obligations of Corixa under this Agreement
pursuant and subject to the terms set forth herein.

 

12.          MISCELLANEOUS

 

12.1                        Governing Law

 

This Agreement
shall be governed by, interpreted and construed in accordance with the laws of
the State of New York, without giving effect to conflicts of laws principles.

 

12.2                        Waiver

 

No waiver by a
Party hereto of any breach or default of any of the covenants or agreements
herein set forth shall be effective unless set forth in a writing signed by the
waiving Party or shall be deemed a waiver as to any subsequent and/or similar
breach or default.

 

12.3                        US Bankruptcy Code

 

All rights and
licenses granted under or pursuant to this Agreement by Corixa are, and shall
otherwise be deemed to be, for purposes of Clause 365 (n) of the U.S.
Bankruptcy Code, licenses of rights to “intellectual property” as defined under
Clause 101 of the U.S. Bankruptcy Code. 
The Parties agree that the Parties as licensees of such rights under
this Agreement, shall retain and may fully exercise all of their rights and
elections under the U.S. Bankruptcy Code. 
The Parties further agree that, in the event of the commencement of a bankruptcy
proceeding by or against either Party under the U.S. Bankruptcy Code, the other
Party shall be entitled to a complete duplicate of (or complete access to, as
appropriate) any such intellectual property and all embodiments of such
intellectual property, and same, if not already in the their possession, shall
be promptly delivered to them upon any such commencement of a bankruptcy
proceeding upon its written request therefor.

 

 

22

 

12.4                           Surviving Provisions

 

Save as may be
expressly specified otherwise in this Agreement the provisions of Clauses 9, 10
and 12 of this Agreement shall survive any expiration or termination of this
Agreement.

 

12.5                        Assignment

 

Neither this
Agreement nor any right or obligation hereunder may be assigned or delegated,
in whole or part, by either Party without the prior express written consent of
the other; provided, however, that either party may, without the written
consent of the other, assign this Agreement and its rights and delegate its
obligations hereunder in connection with the transfer or sale of all or
substantially all of its business or the assets to which this Agreement
relates, or in the event of its merger, consolidation, change in control or
similar transaction.  Any permitted
assignee shall assume all obligations of its assignor under this
Agreement.  Any purported assignment in
violation of this Clause 12.5 shall be void.

 

12.6                        Independent Contractors

 

The
relationship of the Parties hereto is that of independent contractors.  Neither Party hereto shall be deemed to be
the agent, partner or joint venturer of the other for any purpose as a result
of this Agreement or the transactions contemplated thereby.

 

12.7                        Further Actions

 

Each Party
agrees to execute, acknowledge and deliver such further documents and
instruments and to perform all such other acts as may be necessary or
appropriate in order to carry out the purposes and intent of this Agreement.

 

12.8                        Notices

 

All requests
and notices required or permitted to be given to the Parties hereto shall be
given in writing, shall expressly reference the clause(s) of this
Agreement to which they pertain, and shall be delivered to the other Party,
effective on receipt, at the appropriate address as set forth below or to such
other addresses as may be designated in writing by the Parties from time to
time during the Term of this Agreement.

 

If to Lorantis:

 

Lorantis
Limited

410 Cambridge
Science Park Cambridge CB4 OPE

Attn: Chief
Executive Officer

 

Copy to: VP
Business Development 25

 

23

 

If to Corixa or SKB:

 

Corixa Corporation

1900 9th Avenue, Suite 1100

Seattle, Washington 98101

Attn: President

 

With a copy
to:

 

GlaxoSmithKline Biologicals S.A.

rue de l’lnstitut 89

1330 Rixensart, Belgium

Attention: President, General Manager

Facsimile No.: +32-2-656 8000

 

and: Attention: Senior Counsel

Facsimile No.: +32-2-656 8144

 

12.9                        Force Majeure

 

Non-performance
of a Party (other than for the payment of money) shall be excused to the extent
that performance is rendered impossible by strike, fire, earthquake, flood,
governmental acts or orders or restrictions, failure of suppliers, or any other
reason where failure to perform is beyond the reasonable control and not caused
by the negligence, intentional conduct or misconduct of the nonperforming
Party; provided, however, that the nonperforming Party shall use commercially
reasonable efforts to resume performance as soon as reasonably practicable.

 

12.10                  Complete Agreement

 

This Agreement
constitutes the entire agreement between the Parties regarding the subject
matter hereof, and all prior representations, understandings and agreements
regarding the subject matter hereof, either written or oral, expressed or
implied, are superseded and shall be and of no effect.

 

12.11                  Counterparts

 

This Agreement
may be executed in counterparts, each of which shall be deemed to be an
original and together shall be deemed to be one and the same agreement.

 

12.12                  Headings

 

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

 

24

 

IN
WITNESS WHEREOF, the Parties have caused this
Agreement by way of DEED to be
executed and delivered by their respective duly authorized officers as of the
day and year first above written.

 

 

	
  EXECUTED and DELIVERED by

  	
  )

  	
  /s/ Donald
  F. Parman

  
	
  CORIXA CORPORATION

  	
  )

  	
   

  
	
   

  	
  )

  	
  Donald F.
  Parman, Director and

  
	
  acting by
  its duly authorised officer

  	
  )

  	
  Vice
  President

  
	
   

  	
   

  	
   

  
	
   

  	
  )

  	
   

  

 

	
  EXECUTED and DELIVERED by

  	
  )

  	
   

  
	
  LORANTIS LIMITED

  	
  )

  	
  Director

  
	
   

  	
  )

  	
   

  
	
  acting by
  its duly authorised officers

  	
  )

  	
   

  
	
   

  	
   

  	
  Director/Secretary

  
	
   

  	
   

  	
   

  

 

SMITHKLINE
BEECHAM CORPORATION, a corporation formed under the
laws of the State of Pennsylvania, doing business as GlaxoSmithKline, having
its principal office at One Franklin Plaza, Philadelphia, PA 19101 (“SKB”), hereby acknowledges and agrees that
it has specific rights and obligations pursuant to Clauses 2.2, 2.3 and 11 of
this Agreement and hereby agrees to perform such obligations.

 

 

Acknowledged and agreed:

 

SMITHKLINE BEECHAM CORPORATION

 

 

	
   

  	
  By:

  	
  /s/ Donald F. Parman

  	
   

  
	
   

  	
   

  	
  Donald F. Parman, Vice President

  

 

25

 

SCHEDULE 1

CORIXA PATENT RIGHTS

 

	
  135

  	
   

  	
  US

  	
   

  	
  08/853.826

  	
   

  	
  08-May-1997

  	
   

  	
  6,113,918

  	
   

  	
  05-Sep-2000

  	
   

  	
  Granted

  
	
  135 C1

  	
   

  	
  US

  	
   

  	
  09/074,720

  	
   

  	
  07-May-1998

  	
   

  	
  6,355,257

  	
   

  	
  12-Mar-2002

  	
   

  	
  Granted

  
	
  135 C2

  	
   

  	
  US

  	
   

  	
  09/439,839

  	
   

  	
  12-Nov-1999

  	
   

  	
  6,303,347

  	
   

  	
  16.Oct-2001

  	
   

  	
  Granted

  
	
  135 C3

  	
   

  	
  US

  	
   

  	
  09/905,160

  	
   

  	
  12-Jul-2001

  	
   

  	
  6,764,840

  	
   

  	
  20-Jul-2004

  	
   

  	
  Granted

  
	
  135 C4

  	
   

  	
  US

  	
   

  	
  10/043,086

  	
   

  	
  08-Jan-2002

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Published

  
	
  135 C5

  	
   

  	
  US

  	
   

  	
  10/137,730

  	
   

  	
  30-Apr-2002

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Pending

  
	
  135

  	
   

  	
  WO

  	
   

  	
  US98/09385

  	
   

  	
  07-May-1998

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Converted

  
	
  135

  	
   

  	
  AP

  	
   

  	
  AP/P/99101693

  	
   

  	
  07-May-1998

  	
   

  	
  AP1181

  	
   

  	
  30-Jun-2003

  	
   

  	
  Granted

  
	
  135

  	
   

  	
  AT

  	
   

  	
  98922 1313.7

  	
   

  	
  07-May-1998

  	
   

  	
  0983286

  	
   

  	
  28-Jul-2004

  	
   

  	
  Granted

  
	
  135

  	
   

  	
  AU

  	
   

  	
  74747/98

  	
   

  	
  07-May-1998

  	
   

  	
  740663

  	
   

  	
  21-Feb-2002

  	
   

  	
  Granted

  
	
  135

  	
   

  	
  BE

  	
   

  	
  98922138.7

  	
   

  	
  07-May-1998

  	
   

  	
  0983286

  	
   

  	
  28-Jul-2004

  	
   

  	
  Granted

  
	
  135

  	
   

  	
  BR

  	
   

  	
  PI9809791-1

  	
   

  	
  07-May-1998

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Pending

  
	
  135

  	
   

  	
  CA

  	
   

  	
  2,288,601

  	
   

  	
  07-May 1998

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Pending,

  
	
  135

  	
   

  	
  CH

  	
   

  	
  98922138.7

  	
   

  	
  07-May-1998

  	
   

  	
  0983286

  	
   

  	
  28-Jul-2004

  	
   

  	
  Granted

  
	
  135

  	
   

  	
  CN

  	
   

  	
  98806169.4

  	
   

  	
  07-May-1998

  	
   

  	
  98806169.4

  	
   

  	
  22-Dec-2004

  	
   

  	
  Granted

  
	
  135

  	
   

  	
  DE

  	
   

  	
  98922138.7

  	
   

  	
  07-May-1998

  	
   

  	
  0983286

  	
   

  	
  28-301-2004

  	
   

  	
  Granted

  
	
  135

  	
   

  	
  DK

  	
   

  	
  98922138.7

  	
   

  	
  07-May-1998

  	
   

  	
  0983286

  	
   

  	
  28-Jul-2004

  	
   

  	
  Granted

  
	
  135

  	
   

  	
  EP

  	
   

  	
  98922138.7

  	
   

  	
  07-May-1998

  	
   

  	
  0983286

  	
   

  	
  28-Jul-2004

  	
   

  	
  Granted

  
	
  135

  	
   

  	
  ES

  	
   

  	
  98922138.7

  	
   

  	
  07-May-1998

  	
   

  	
  0983286

  	
   

  	
  28-Jut-2004

  	
   

  	
  Granted

  
	
  135

  	
   

  	
  Fl

  	
   

  	
  98922138.7

  	
   

  	
  07-May-1998

  	
   

  	
  0983286

  	
   

  	
  28-Jul-2004

  	
   

  	
  Granted

  
	
  135

  	
   

  	
  FR

  	
   

  	
  98922138,7

  	
   

  	
  07-May- 998

  	
   

  	
  0983286

  	
   

  	
  28-Jul-2004

  	
   

  	
  Granted

  
	
  135

  	
   

  	
  GB

  	
   

  	
  98922138.7

  	
   

  	
  07-May-1998

  	
   

  	
  0983286

  	
   

  	
  28-Ju1-2004

  	
   

  	
  Granted

  
	
  135

  	
   

  	
  HK

  	
   

  	
  00105686.8

  	
   

  	
  07-May-1998

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Pending

  
	
  135

  	
   

  	
  HU

  	
   

  	
  P0004147

  	
   

  	
  07-May-1998

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Published

  
	
  135

  	
   

  	
  ID

  	
   

  	
  W-991539

  	
   

  	
  07-May-1998

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Published

  
	
  135

  	
   

  	
  IE

  	
   

  	
  98922138.7

  	
   

  	
  07-May-1998

  	
   

  	
  0983286

  	
   

  	
  28-Jul-2004

  	
   

  	
  Granted

  
	
  135

  	
   

  	
  IL

  	
   

  	
  132739

  	
   

  	
  07-May-1998

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Pending

  
	
  135

  	
   

  	
  IT

  	
   

  	
  98922138.7

  	
   

  	
  07-May-1998

  	
   

  	
  0983286

  	
   

  	
  28-Jul-2004

  	
   

  	
  Granted

  
	
  135

  	
   

  	
  JP

  	
   

  	
  10-548512

  	
   

  	
  07-May-1998

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Published

  
	
  135

  	
   

  	
  KP

  	
   

  	
  99-1020

  	
   

  	
  07-My-1998

  	
   

  	
  35917

  	
   

  	
  16-Nov-2001

  	
   

  	
  Granted

  
	
  135

  	
   

  	
  KR

  	
   

  	
  99-7010285

  	
   

  	
  07-May-1998

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Pending

  
	
  135

  	
   

  	
  MX

  	
   

  	
  9910262

  	
   

  	
  07-May-1998

  	
   

  	
  228177

  	
   

  	
  31-May2005

  	
   

  	
  Granted

  
	
  135

  	
   

  	
  NL

  	
   

  	
  98922138.7

  	
   

  	
  07-May-1998

  	
   

  	
  0983286

  	
   

  	
  28-Jul-2004

  	
   

  	
  Granted

  
	
  135

  	
   

  	
  NZ

  	
   

  	
  500938

  	
   

  	
  07-May-1998

  	
   

  	
  500938

  	
   

  	
  09-Sep-2002

  	
   

  	
  Granted

  
	
  135

  	
   

  	
  OA

  	
   

  	
  9900244

  	
   

  	
  07-May-1998

  	
   

  	
  11214

  	
   

  	
  12-Jun-2000

  	
   

  	
  Granted

  
	
  135

  	
   

  	
  PL

  	
   

  	
  P343205

  	
   

  	
  07-May-1998

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Pending

  
	
  135

  	
   

  	
  PT

  	
   

  	
  98922138.7

  	
   

  	
  07-May-1998

  	
   

  	
  0983286

  	
   

  	
  28-Jul-2004

  	
   

  	
  Granted

  
	
  135

  	
   

  	
  SE

  	
   

  	
  98922138.7

  	
   

  	
  07-May-1998

  	
   

  	
  0983286

  	
   

  	
  28-Jul-2004

  	
   

  	
  Granted

  
	
  135 2

  	
   

  	
  WO

  	
   

  	
  US00/31340

  	
   

  	
  13-Nov-2000

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Converted

  
	
  135 2

  	
   

  	
  AR

  	
   

  	
  P000105962

  	
   

  	
  10-Nov-2000

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Pending

  

 

26

 

	
  135 2

  	
   

  	
  AU

  	
   

  	
  19189/01

  	
   

  	
  13-Nov-2000

  	
   

  	
  773921

  	
   

  	
  23-Sep-2004

  	
   

  	
  Granted

  
	
  135 2

  	
   

  	
  BR

  	
   

  	
  P10015501-2

  	
   

  	
  13-Nov-2000

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Pending

  
	
  135 2

  	
   

  	
  CA

  	
   

  	
  2,391,299

  	
   

  	
  13-Nov-2000

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Pending

  
	
  135 2

  	
   

  	
  CN

  	
   

  	
  00816859.8

  	
   

  	
  13-Nov-2000

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Published

  
	
  135 2

  	
   

  	
  CO

  	
   

  	
  00082801

  	
   

  	
  10-Nov-2000

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Pending

  
	
  135 2

  	
   

  	
  EP

  	
   

  	
  00982119.0

  	
   

  	
  13-Nov-2000

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Published

  
	
  135 2

  	
   

  	
  GC

  	
   

  	
  P/2000/1083

  	
   

  	
  05-Dec-2000

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Abandoned

  
	
  135 2

  	
   

  	
  IlK

  	
   

  	
  03103454.0

  	
   

  	
  l3-Nov-2000

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Pending

  
	
  135 2

  	
   

  	
  JP

  	
   

  	
  2001-537329

  	
   

  	
  l3-Nov-2200

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Published

  
	
  135 2

  	
   

  	
  MX

  	
   

  	
  2002-02477

  	
   

  	
  12-Nov-2000

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Pending

  
	
  135 2

  	
   

  	
  MY

  	
   

  	
  P120005304

  	
   

  	
  10-Nov-2000

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Allowed

  
	
  135 2

  	
   

  	
  NO

  	
   

  	
  2002-2207

  	
   

  	
  13-Nov-2000

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Pending

  
	
  135 2

  	
   

  	
  NZ

  	
   

  	
  518860

  	
   

  	
  13-Nov-2000

  	
   

  	
  518860

  	
   

  	
  10-Mar-2005

  	
   

  	
  Granted

  
	
  135 2

  	
   

  	
  PH

  	
   

  	
  1-2000-03118

  	
   

  	
  10-Nov-2000

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Abandoned

  
	
  135 2

  	
   

  	
  PK

  	
   

  	
  1032/2000

  	
   

  	
  1I-Nov-2000

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Pending

  
	
  135 2

  	
   

  	
  TW

  	
   

  	
  89123832

  	
   

  	
  07-Feb-2001

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Abandoned

  
	
  135 2

  	
   

  	
  VE

  	
   

  	
  2527-2000

  	
   

  	
  13-Nov-2000

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  Abandoned

  

 

27

 

SCHEDULE 2

 

HEPATITIS B ANTIGEN AMINO ACID AND NUCLEOTIDE
SEQUENCES

 

[ **** ]

 

28

 

SCHEDULE 3

RC 529 STRUCTURE

 

Graph omitted

 

29

 

SCHEDULE 4.1

 

TECHNICAL TRANSFER OF INFORMATION

 

The information to he provided
by Corixa to Lorantis pursuant to Clause 4 hereof shall include:

 

1.                                       Within
three (3) business days following the Effective Date, Corixa shall (a) provide
to Lorantis the name, address and telephone of a point of contact at Althea
Technologies, Inc., Corixa’s contract manufacturer for the formulation of
RC 529 Adjuvant into RC 529SE as of the Effective Date, and (b) instruct
Althea Technologies, Inc. to cooperate with Lorantis in its exercise of
its rights under this Agreement.

 

2.                                       Within
one (1) month following the Effective Date, Corixa shall provide Lorantis
with complete copies of the following internal Corixa documentation:

 

(a)           Manufacturing instructions for RC-529-SE,
200 ug/mL 4% Squalene, Unidose (Part Number 60545).

 

(b)           The following SOPS which comprise the
analysis of RC-529-SE:

 

SOP # QC-411 (Sterility)

SOP # QC-156 (RC-529 Quantitation)

SOP # QC-660 (Pyrogenicity)

SOP # QC-780 (Appearance)

SOP # QC-836 (Squalene quantitation)

SOP # QC-839 (Residual solvents)

SOP # QC-517 (Osmolarity)

SOP # QC-525 (pH)

 

(c)           Specifications for Finished Products
for RC-529-SE (Part Number 60545).

 

(d)           Summary report of stability data for
RC-529-SE (Part Number 60545).

 

3.                                       Within
one (1) month following the Effective Date, Corixa shall deliver to
Lorantis complete copies of the following internal Corixa documentation:

 

(a)           Final SOP for the Mouse
immunogenicity potency assay for [ **** ].

 

(b)           Final development report for the
development and qualification of the mouse immunogenicity assay for [ **** ].

 

4.                                       Within
three (3) business days following the Effective Date, Corixa shall deliver
to Lorantis complete copies of the following documents, files and
correspondence:

 

30

 

(a)           Pre-IND request letter sent to the
FDA by Corixa, and pre-IND documentation compiled in preparation for this
meeting.

 

(b)           Copies of all correspondence between
the FDA and Corixa, including telephone logs and facsimiles.

 

32 ,

 

(c)           Copies of all minutes of the meetings
between Corixa and Lorantis of the joint HepVax development team,

 

(d)           Copies of all minutes of the meetings
between Corixa and Lorantis of the Joint Management Committee.

 

5.                                       Within
three (3) business days following the Effective Date, Corixa shall deliver
to Lorantis complete copies of the following documents, files and
correspondence relating to the HBV Expert Panel, clinical study design,
including:

 

(a)           HepVax Advisory Meeting briefing
document dated: June 13, 2005.

 

(b)           List of expert advisors and their
contact information present at the June 13, 2005 HepVax Advisory Meeting.

 

(c)           Final minutes of the June 13,
2005 HepVax Advisory Meeting.

 

(d)           Draft clinical protocol entitled: A
PHASE I RANDOMIZED, DOUBLE-BLIND, CONTROLLED, DOSE-ESCALATION SAFETY AND
IMMUNOGENICITY TRIAL OF HEPVAX IN HEALTHY ADULTS, Corixa Corporation Protocol
CCHV001-01, June 29, 2005.

 

In this Schedule 4:

 

“copies” shall
include electronic copies (for example, on CD-Rom) in machine readable format
(for example, accessible using Microsoft Windows applications); where copies
are to be provide on “request”
such copies shall be provided as soon as reasonably practicable (and in any
event within thirty (30) days).

 

“access” means
access on a dates and times reasonably convenient to both Parties during the
hours 9am - 5:30pm, on any day other than a Saturday, Sunday or public bank
holiday in the place where the information in question is located, provided
that notice requesting such access has been provided to Corixa not less than
ten (10) days prior to the date access is desired by Lorantis. Corixa
shall procure that reasonable facilities are provided in connection with any
person exercising such right of access, including without limitation, access to
copying facilities. Access shall be limited to only those employees of Lorantis
minimally necessary to view and copy (where appropriate) the documents and
information in question (all such employees being subject to the obligations of
confidentiality set out in Clause 9 in respect of Confidential Information of
Corixa).

 

31

 

SCHEDULE 4.2

TECHNICAL TRANSFER SERVICES

 

The assistance to be provided
by Corixa to Lorantis pursuant to Clause 4 hereof shall include:

 

1)                                      During
the period beginning on the Effective Date and ending four (4) months
after the Effective Date, Corixa shall make a project manager for the RC 529
Adjuvant project leader reasonably available for up to ten (10) hours per
month up to a maximum of thirty (30) total hours during this period for the
limited purpose of undertaking and delivering to Lorantis the technical
transfer of information and materials contemplated by Schedule 4.1.

 

i)                                         This
person will be responsible for coordinating the efforts of Corixa staff to
complete all of the items in Schedules 4.1 and 4.2.

 

ii)                                      This
person will be responsible for ensuring that the delivery of all of the items
in Schedules 4.1 and 4.2 to Lorantis occurs in accordance with this Agreement.

 

iii)                                   This
person will be the primary contact person for Lorantis regarding the items in
Schedules 4.1 and 4.2.

 

2)                                      Upon
Lorantis’s request, and subject to Corixa’s prior review (under terms of
confidentiality) and approval of applicable sections of the submission that
references Corixa’s Drug Master Fite #BB-MF 10937 (the “DMF”), which approval
shall not be unreasonably withheld, Corixa shall notify FDA in writing of its
permission to allow Lorantis to cross-reference the DMF in its regulatory
filings relating to the Product. Corixa’s review and response to Lorantis’s
submissions shall be completed within forty-five (45) days. Corixa shall
provide Lorantis with a copy of this letter of cross-reference within ten (10) business
days following the completion of its review of such submission. if Lorantis is
making a filing in a jurisdiction where Corixa does not have a DMF, then Corixa
shall provide Lorantis with the information Lorantis reasonably needs in order
to make such filing. Notwithstanding the foregoing in this item 2 or the
provision of item 3 set forth below or anything else in this Agreement to the
contrary, Lorantis shall have no right to receive copies of or to use
confidential information of Corixa contained within or which supports the DMF which
relate to the manufacturing of the RC 529 Adjuvant, its testing and release or
any RC 529 Manufacturing Technology.

 

3)                                      Corixa
shall use reasonable commercial efforts to complete and deliver to Lorantis the
final report of the HepVax in vivo potency assay qualification, including
quality control, which assay qualification has been undertaken by Corixa prior
to the Effective Date and is close to completion as of the Effective Date.
Included within the foregoing is the quality control analysis for the release
of the current cGMP batch of [ **** ], and analysis of [ **** ] stability
samples up to the three month time point, including production of appropriate
reports. For the avoidance of doubt Lorantis shall be responsible for any and
all other work on such assay and its qualification, including all 

 

32

 

quality and
development work associated therewith. Corixa shall use reasonable commercial
efforts to make the appropriate Corixa staff available for an average of one
meeting a month at a location convenient to Corixa, to train Lorantis staff, or
those at a CRO nominated by Lorantis, for up to 4 (four) months after the
Effective Date, as indicated:

 

i)                                         Finalize
the development report for the Development and Qualification of the Murine
Potency assay for [ **** ].

 

ii)                                      Finalize
the SOP for the potency assay.

 

iii)                                   Perform
quality control analyses on the cGMP batch of [ **** ] and report.

 

iv)                                  Perform
stability analyses on [ **** ] up to and including the 3 month timepoint
(expected February 2006).

 

v)                                     Train
Lorantis-nominated staff in the assay to ensure successful transfer to
Lorantis-nominated laboratory.

 

4)                                      Corixa
shall provide 1 FTE for 2 weeks to train employees of Lorantis, or those at a
Lorantis-nominated CRO, on the quantitative assays for the analysis and release
of RC-529-SE, and provide 0.25 FTE to assist in the qualification of the assays
in their laboratories for up to 4 (four) months after the Effective Date.

 

i)                                         Corixa
staff will train Lorantis-nominated staff on the proper performance of the
following quantitative assays: RC-529 Quantitation (SOP # QC- 156), Squalene
quantitation (SOP # QC-836), Residual solvents (SOP # QC-839), Osmolarity (SOP
# QC-517), and pH (SOP # QC-525). Training will consist of bench level, “hands
on” running of each assay until the person being trained is considered capable
of performing each assay in accordance with the specific SOP.

 

ii)                                      Corixa
will assist Lorantis in the qualification of the assays by providing assistance
in the selection of instrumentation and reagents, assistance in the writing of
qualification protocols, assistance in the evaluation of qualification data
and, if needed, assistance in solving problems that may arise during assay
qualification.

 

iii)                                   Corixa
will continue to perform such analyses for up to 4 (four) months after the
Effective Date so as to continue in that time period the RC-529-SE stability
study until such time as the RC-529-SE analytical assays have been
appropriately re-established by Lorantis, and arrangements made for the
stability samples to be transferred to the Lorantis-nominated facility.

 

33

 

Corixa shall
consider in good faith making available a project manager to provide such assistance,
out-of-pocket expenses being at Lorantis’s expense, as may reasonably be
requested by Lorantis from time-to-time during preparation of the Hepvax IND.
Corixa shall provide appropriate information requested by Lorantis pertaining
to RC-529-SE in order to facilitate Lorantis answering questions from the FDA
or other regulatory authorities. All such assistance shall be provided for such
time as the IND is accepted by the regulatory authority.

 

Upon
reasonable request of Lorantis made during the first year after the Effective
Date, Corixa shall use commercially reasonable efforts to promptly disclose and
deliver to Lorantis such Corixa Know-How and Corixa Licensed Technology as is
licensed to Lorantis hereunder and is the subject of the request but not included
on either Schedule 4.1 or 4.2.

 

34

 

SCHEDULE 6

STOCKS

 

The complete cGMP’ batch (less
quality control, release, retention and three month stability samples) of
RC-529SE manufactured and filled at Althea Technologies on, or around, 26-27 September 2005.
The transferred stock will have been subjected to quality control testing, be
demonstrated to be within the specifications defined for this material, and be
reviewed and released, as defined by standard Corixa procedures. The material
will be accompanied by a written “Certificate of Analysis”.

 

35

 

SCHEDULE 9.2

PRESS RELEASE

 

<to be added within 4 months
following the Effective Date in accordance with clause 9.2>

 

36Exhibit 10.7

 

[ **** ]
indicates confidential portions have been redacted and submitted separately
pursuant to confidentiality request with the Commission

 

CLINICAL
TRIAL RESEARCH AGREEMENT

 

This Agreement is
entered into as of the last date on the signature page hereof (“Effective
Date”), by and between DUKE UNIVERSITY,
a nonprofit educational and health care institution located at Office of Grants
and Contracts, DUMC Box 3001, 107 Seeley G. Mudd Building, Durham, NC 27710,
hereinafter called “Institution,” and MEDAREX, INC.,
a New Jersey corporation with its principal place of business located at 707
State Road, Suite 206, Princeton, New Jersey 08540-1437, hereinafter
called “Medarex”.

 

RECITALS

 

WHEREAS,
Medarex desires Institution to study the safety and/or efficacy of [ **** ]
(the “Study Drug”); and

 

WHEREAS,
Institution is willing to perform certain clinical trial research with the
Study Drug pursuant to the terms of this Agreement (the “Study”);

 

WHEREAS,
the Study contemplated by this Agreement is of mutual interest and benefit to
Institution and Medarex, and will further the instructional and research
objectives of Institution in a manner consistent with its status as a nonprofit
educational and health care institution,

 

NOW
THEREFORE, based upon the promises and mutual covenants set
forth herein, the parties hereto agree as follows:

 

AGREEMENT

 

1.                                      SCOPE OF
WORK

 

Institution and
Principal Investigator (defined in Article 2 below) agree to perform the
Study under this Agreement strictly in accordance with the terms of the final
protocol, including as it may be amended in accordance with the terms of
this Agreement, for the Study entitled “A Phase I Open-Label, Dose-Escalation,
Multi-Dose Study of [ **** ]” which is attached as Exhibit A (the “Protocol”)
and which is incorporated into this Agreement by reference. Institution
represents and warrants that, to its best knowledge, its facilities and
population are adequate to perform the Study contemplated by this
Agreement and the Protocol. Institution and Principal Investigator agree that
all aspects of the Study shall be conducted in conformity with all applicable
supranational, national, state and other local laws and regulations, including
any applicable requirements of the Health Insurance Portability and
Accountability Act of 1996 and the United States Food and Drug Administration (“FDA”)
(collectively, “Applicable Law”).

 

 

2.                                      PRINCIPAL
INVESTIGATOR

 

A.                                    Appointment and Substitution of
Principal Investigator.

 

(i)                                    Institution’s principal
investigator is Michael Morse, M.D., (who with any sub-investigators shall be
collectively referred to as “Principal Investigator”). Principal Investigator
shall direct and supervise the performance of the Study in accordance with
applicable Institution policies, the Protocol and this Agreement.

 

(ii)                                In the event that the Principal
Investigator who signs either the Protocol and/or this Agreement leaves or is
removed from the Institution or otherwise becomes unavailable to direct and
supervise the performance of the Study, then Institution shall, within ten (10) days
of such event, provide written notice thereof to Medarex and propose a
replacement for the Principal Investigator with appropriate qualifications. Any
successor to Principal Investigator must be approved, in writing, by Medarex
and such successor shall be required to agree to all the terms and conditions
of the Protocol and this Agreement and to sign each such document as evidence
of such agreement (although failure to so sign shall not relieve such successor
from abiding with all the terms and conditions of the Protocol and this
Agreement). If Institution does not identify a qualified successor to Principal
Investigator as provided above, or if the Medarex does not approve the
successor proposed by the Institution, Medarex shall have the right to
terminate this Agreement as provided in Section 6. A.

 

B.                                    No Debarment.

 

(i)                                    Institution and Principal
Investigator represent that they shall not use in any capacity, in connection
with any services to be performed under this Agreement, any individual who has
been debarred pursuant to § 306(a) or § 306(b) of the
Federal Food, Drug and Cosmetic Act, or excluded from a federal healthcare
program (“Debarred”).

 

(ii)                                Institution and Principal
Investigator agree to immediately inform Medarex in writing if any person
who is performing services hereunder is Debarred or if any action, suit, claim,
investigation or legal or administrative proceeding is pending, or, to the best
of Institution’s knowledge, is threatened, that could result in Institution or
any person performing services hereunder becoming Debarred.

 

(iii)                            Principal Investigator
represents that s/he is not Debarred and that no action, suit, claim
investigation or legal or administrative proceeding is pending or threatened
that could result in Principal Investigator becoming Debarred, and Principal
Investigator agrees to immediately inform Medarex in writing if any such
action, suit, claim, investigation or legal or administrative proceeding is
threatened or commenced.

 

C.                                    Disclosure of Financial Interest.

 

(i)                                    Institution shall ensure that
the Principal Investigator and other researchers engaged in a Study
individually complete the form for the disclosure of financial interests
and arrangements as attached at Appendix B as updated from time to time by
Medarex to conform with applicable laws and regulations (the “Disclosure”)
and return it to Medarex. If circumstances change during the Study, and the
Disclosure submitted by Principal Investigator is 

 

2

 

no longer truthful
and accurate, then Principal Investigator will promptly submit to Medarex an
updated Disclosure reflecting the new circumstances.

 

(ii)                                Medarex will hold any
Disclosures in confidence and will only use such Disclosure in meeting FDA
regulatory requirements under 21 C.F.R. Part 54. By completing the
Disclosure, Principal Investigator certifies that the Disclosure supplied is
truthful and accurate. Failure to return a completed Disclosure to Medarex
shall be a material breach of this Agreement that may result in Medarex
terminating this Agreement.

 

3.                                      PROJECT
MONITOR AND INSPECTION RIGHTS

 

A.                                    Medarex may designate from
time to time certain of its employees, consultants or contractors as project
monitors (“Project Monitor(s)”). During the Study and for a reasonable time
after completion or early termination of the Study, the Project Monitor(s) may,
with reasonable advance notice and during regular business hours:

 

(i)                                    examine and inspect Institution
facilities used in the performance of the Study; and

 

(ii)                                inspect, audit, and copy or have
copied, all data and work product generated in the performance of the Study
conducted under this Agreement, and all other data necessary for Medarex to
confirm that the Study is being conducted in conformance with the Protocol and
in compliance with all Applicable Law.

 

B.                                    Institution agrees to cooperate
with and assist Medarex, to the extent deemed reasonable by Medarex, in order
to facilitate the Project Monitor’s examination, inspection, auditing and
copying of materials relating to the Study and in order to enforce the rights
granted to Medarex in this Article 3.

 

C.                                    Principal Investigator and
Institution agree to take any action necessary, as reasonably requested by
Medarex, to properly correct or address any deficiencies noted by the Project
Monitors during any audit and agree to cooperate with Medarex with respect to
any action taken to address any such deficiencies.

 

4.                                      CLINICAL
TRIAL APPROVALS

 

A.                                    Institution shall be responsible
for obtaining the following:

 

(i)                                    approval of the Protocol, any
informed consent relating to the Study and advertisement, if any, pertaining to
the enrollment of subjects in the Study by the appropriate Institutional Review
Board (“IRB”) prior to beginning any Study on human subjects; and

 

(ii)                                an informed consent which
complies with all Applicable Law signed by or on behalf of each human subject
prior to the subject’s participating in the Study.

 

B.                                    In the event the IRB requires
changes in the Protocol or form of informed consent, Institution shall
advise Medarex in advance of such changes and all modifications to the
Protocol, and Medarex must approve all such changes in advance. Institution and
Principal 

 

3

 

Investigator shall not modify the Protocol or
the informed consent as approved by the IRB without the prior written approval
of Medarex.

 

5.                                      TERM OF
AGREEMENT

 

A.                                    The term of this Agreement shall
commence on the Effective Date and shall expire upon the completion of the
Study and the receipt and acceptance by Medarex of the final Study
documentation required to be provided under the Protocol.

 

B.                                    It is anticipated that the Study
shall begin on March 2004, and shall be completed on March 2005. If
at any time Institution or Principal Investigator have reason to believe that
the Study shall not be initiated or completed as per the above schedule, they
shall advise Medarex in writing of the reason(s) and length of additional
time required to commence or complete work, and if such delay is due to the
negligence or willful misconduct of Institution or Principal Investigator, then
Medarex may terminate this Agreement as provided in Article 6.

 

6.                                      TERMINATION
AND ENROLLMENT CAP

 

A.                                    Medarex may terminate this
Agreement by giving thirty (30) days written notice to Institution. In the
event thirty (30) days is determined by Institution to be insufficient notice
based upon evaluation of risks to enrolled research subject(s) then
receiving the Study Drug, the parties shall cooperate to safely withdraw
subjects from drug treatment as soon as reasonably possible. Notwithstanding
the foregoing, in the event Medarex believes that immediate termination is
necessary due to its evaluation of risks to enrolled research subject(s),
Medarex may terminate this Agreement immediately.

 

B.                                    Notwithstanding any other
provision hereof, Medarex shall be entitled to terminate this Agreement for any
Material Breach which shall be defined as Institution’s failure to comply with (a) its
obligations and responsibilities hereunder and the terms and conditions of this
Agreement (b) the Protocol; or (c) Applicable Law relevant to the
Study.

 

C.                                    In the event of any termination:

 

(i)                                    Institution and Principal
Investigator shall return to Medarex all unused materials, including but not
limited to, Study Drug and clinical supplies (unless written authorization to
retain or destroy them is given by Medarex, in which case Institution and
Principal Investigator shall comply with the applicable provisions of Article 12
hereof);

 

(ii)                                except in the event of
termination because of a Material Breach by Institution or Principal
Investigator, and unless otherwise specified in writing between the parties,
the total sums payable by Medarex pursuant to this Agreement shall be pro-rated
for actual work performed and non-cancelable expenses incurred in accordance
with the Protocol to date of termination with any unexpended portion of funds
previously paid by Medarex to Institution being refunded to Medarex;

 

(iii)                            in the event of termination as a
result of a Material Breach, the parties agree to make a good faith effort to
reach agreement to compensate Institution for actual work performed and
non-cancelable expenses incurred in accordance with the Protocol to date of 

 

4

 

termination to the extent that such work can
be used in the further development of the Study Drug, but in no event more than
the pro-rated amounts as provided in subsection (ii) above; and

 

(iv)                               Institution and Principal
Investigator shall return to Medarex all Confidential Information provided by
Medarex (as defined in Article 9 hereof) in the possession of Institution
and Principal Investigator.

 

D.                                    The termination of this
Agreement shall not relieve either party of its obligation to the other in
respect of:

 

(i)                                    retaining in confidence all
Confidential Information (as defined in Article 9 hereof);

 

(ii)                                complying with record keeping
and reporting obligations (as set forth in Article 7 hereof);

 

(iii)                            providing prior review for any
publications (as set forth in Article II hereof) and obtaining written
approval and consents for publicity and promotional purposes (as set forth in Article 18
hereof);

 

(iv)                               compensation by Medarex for
services performed by Institution to date of termination, except as set forth
in Article 6.C(iii) hereof;

 

(v)                                   complying with obligations
relating to clinical supplies (as set forth in Article 12 hereof);

 

(vi)                               indemnification and insurance
(as set forth in Article 13 hereof);

 

(vii)                           inspection rights (as set forth
in Article 3 hereof); and

 

(viii)                       obligation to assist in
obtaining patent protection (as set forth in Article 14 hereof), if
applicable

 

all of which
obligations are binding on the appropriate party and shall survive any
termination and remain in full force and effect as set forth in this Agreement.

 

E.                                      Institution and Principal
Investigator agree that during the term of this Agreement and for a period of
six (6) months thereafter, they shall neither directly nor indirectly
solicit for employment, or otherwise retain employees of Medarex, whom
Institution and Principal Investigator have encountered as a result of
performance of the Study(ies) for Medarex.

 

F.                                      Institution shall neither
disclose to Medarex nor induce Medarex to use any secret or confidential
information or material belonging to third parties, including other sponsors of
other clinical trials.

 

G.                                    Medarex reserves the right to
limit enrollment in the Study by giving written notice, or by giving notice by
telephone followed by written notice, to Institution and Principal Investigator
to cease further enrollment in the Study beyond the number of patients set
forth in 

 

5

 

such notice (the “Enrollment Cap”). Upon
receipt of such notice, Institution and Principal Investigator agree to enroll
no further patients in the Study. Unless otherwise specified in writing between
the parties, in the event of such a notice to cease further enrollment, the
total sums payable by Medarex pursuant to this Agreement shall be pro-rated for
the number of patients enrolled to the date of such notice, with any funds for
patients beyond the Enrollment Cap previously paid by Medarex to Institution
being refunded to Medarex.

 

7.                                      RECORDS AND
REPORTS

 

A.                                    Principal Investigator and
Institution shall have the following record keeping and reporting obligations:

 

(i)                                    preparation and maintenance of
complete, accurate written records, accounts, notes, reports and data relating
to the Study under this Agreement; and

 

(ii)                                preparation of and submission to
Medarex (in a periodic and timely manner during the term of this Agreement) all
raw data and other material as required in the Protocol in the form of
properly completed patient case report forms (“Case Report Forms”) or into an
electronic database (i.e., remote data entry) made available by Medarex for
each patient as provided in the Protocol. Case Report Forms and the electronic
database shall be the exclusive property of Medarex.

 

B.                                    Principal Investigator and
Institution agree to notify Medarex within twenty-four (24) hours after
learning of any serious and/or unexpected adverse drug reaction affecting any
patient in the Study. Principal Investigator and Institution further agree to
follow up such notification of adverse drug reaction with appropriate reports
to Medarex and, as appropriate, regulatory authorities in compliance with the
Protocol and Applicable Law.

 

C.                                    Principal Investigator and
Institution further agree to maintain records and data during and after the
term or early termination of this Agreement in compliance with Applicable Law.

 

D.                                    Principal Investigator and
Institution agree to notify Medarex within twenty-four (24) hours in the event
that the FDA or any other regulatory authority notifies the Study site of a
pending inspection/audit. In addition, Principal Investigator and Institution
shall forward to Medarex any written communication received as a result of the
inspection/audit within twenty-four (24) hours of receipt of such communication
and Institution agrees to allow Medarex to assist in responding to any such
communication that requires a response. Such responses by Institution shall be
made within two (2) weeks of issuance of any such communication or within
any earlier deadline set by the issuing regulatory authority or Applicable Law.
Principal Investigator and Institution shall also provide to Medarex copies of
any documents related to the Study provided to any inspector or auditor. If the
FDA or other regulatory authority requests or requires any action to be taken
to address any such communication, Principal Investigator and Institution
agree, after consultation with Medarex, to take such action as necessary to
address such communication, and agree to cooperate with Medarex with respect to
any such communication and/or action taken with respect thereto.

 

6

 

8.                                      COST
AND PAYMENT

 

Medarex shall pay
Institution for the performance of the Study as provided in the budget for the
Study that is attached as Exhibit C (the “Budget”) and which is
incorporated into this Agreement by reference. The parties acknowledge that the
payment(s) set forth in the Budget are adequate consideration for the work
undertaken hereunder. Unless otherwise agreed in writing by a duly authorized
officer of Medarex, Medarex shall have no obligation to make any payments to
Institution or Principal Investigator in addition to those contained in the
Budget.

 

9.                                      CONFIDENTIAL
INFORMATION

 

A.                                    “Confidential Information” shall
mean any and all confidential or proprietary information obtained from Medarex,
or generated, created or learned by Institution or Principal Investigator as a
result of performing the Study under this Agreement, including without limitation
commercial, scientific, medical and technical information and data relating to
Medarex, the Study Drug or any Study, any information derived therefrom, the
Protocol, the investigator’s brochure, interim results and any other
information or material disclosed under secrecy agreements previously entered
into between the parties. During and for a period of five (5) years after
the term or early termination of this Agreement, Institution and Principal
Investigator shall retain in confidence all Confidential Information. Confidential
Information shall not include information:

 

(i)                                    which is or becomes public
knowledge through no fault of Institution or Principal Investigator; or

 

(ii)                                which is lawfully made available
to Institution or Principal Investigator by an independent third party owing no
obligation of confidentiality to Medarex with regard thereto (and such lawful
right can be properly demonstrated by Institution or Principal Investigator);
or

 

(iii)                            which is already in Institution’s
or Principal Investigator’s possession at the time of receipt from Medarex (and
such prior possession can be properly demonstrated by contemporaneous written
records belonging to Institution or Principal Investigator); or

 

(iv)                               which is independently developed
by Institution personnel without access to or reliance upon Confidential
Information provided by Medarex hereunder (and such independent development can
be properly demonstrated by contemporaneous written records belonging to
Institution or Principal Investigator).

 

B.                                    Subject to applicable federal,
state or local legal and regulatory requirements, Institution and Principal
Investigator agree to promptly return to Medarex, upon its request, all
Confidential Information obtained from Medarex pursuant to this Agreement; provided,
however, that Institution’s legal counsel may retain one copy of such
Confidential Information in a secure location for purposes of identifying
Institution’s obligations under these confidentiality provisions, and provided
further, that Principal Investigator may retain a copy of the Study
results for use in accordance with the terms of this Agreement.

 

C.                                    Institution and Principal
Investigator shall not use Confidential Information for any purpose other than
performance in accordance with this Agreement. Institution and Principal
Investigator shall limit disclosure of Confidential Information received
hereunder to only those of their representatives, agents, officers and
employees (collectively, “Agents”) who are directly 

 

7

 

involved with the Study and only if such
Agents are subject to binding obligations of confidentiality at least as
protective as those agreed upon in this Agreement. Institution and Principal
Investigator shall protect the confidentiality of Confidential Information
using at least the same level of effort as it uses to protect their own
confidential or proprietary information, but in no event shall Institution and
Principal Investigator use less than commercially reasonable efforts.

 

D.                                    Institution and Principal
Investigator acknowledge and expressly agree that any disclosure of
Confidential Information in violation of this Agreement may be detrimental
to Medarex’s business and may cause it irreparable harm and damage. In
accordance with Applicable Law and in addition to any other rights and remedies
provided herein, Medarex shall be entitled to seek equitable relief by way of
injunction or otherwise.

 

10.                               PERMITTED
DISCLOSURES

 

Notwithstanding
anything to the contrary in this Agreement, Institution may disclose
Confidential Information to the extent, and to the persons and/or entities,
required by governmental law, rule, regulation or order; provided, however,
that if possible, Institution both (i) gives prompt notice to Medarex of
the disclosure requirement in order to allow to Medarex to obtain any available
limitation on or exemptions from such disclosure requirement, and (ii) reasonably
cooperates in such efforts by Medarex.

 

11.                               DATA,
PUBLICATIONS AND OTHER RIGHTS

 

In recognition of
the importance of disseminating information relating to any novel or important
observations or results arising from the Study and understanding that such need
must be balanced with Medarex’s obligations to maintain control over
Confidential Information as well as to comply with appropriate rules and
regulations of the FDA, the parties hereby agree to the following:

 

A.                                    All research data and results
generated during the course of the Study shall be the property of Medarex, and
Medarex shall have the right to use such data and results for any purpose in
accordance with applicable law; provided, however that Medarex agrees to
collect, use and disclose data from the Study with respect to any Study subject
only in accordance with the authorization contained in the informed consent(s) obtained
from such Study subject as part of the Study, unless otherwise required by
law. Institution shall be free to use the results of the Study for its own
internal, non-commercial research, educational, clinical and publication purposes
without the payment of royalties or other fees. Principal Investigator and
Institution further agree to execute any documents or under take any further
actions if requested by Medarex to assign and transfer title to such data.

 

B.                                    Subject to the terms and
conditions of this Agreement, Institution and. Principal Investigator have the
right to publish or publicly present the results of the Study. Principal
Investigator and Institution agree not to publish or publicly present any
interim results of the Study without the prior written consent of Medarex, as
provided below. Principal Investigator and Institution further agree to provide
thirty (30) days written notice to Medarex prior to submission for publication
or presentation to permit Medarex to review drafts of abstracts and 

 

8

 

manuscripts for publication (including,
without limitation, slides and texts of oral or other public presentations and
texts of any transmission through any electronic media, e.g., any computer
access system such as the Internet, World Wide Web, etc., collectively or
individually a “Public Presentation”) which contain any results arising out of
the Study. Medarex shall have the right to review and comment, with respect to
a Public Presentation, including but not limited to, the data analysis and
presentation.

 

If the parties
disagree concerning the accuracy and appropriateness of the data analysis and
presentation, and/or presence of Medarex’s Confidential Information, Institution
agrees to meet with Medarex’s representatives at the Study site or as otherwise
agreed, prior to submission or performance of a Public Presentation, for the
purpose of making good faith efforts to discuss and resolve any such
disagreement.

 

C.                                    If the Study is part of a
multi-center study, Institution and Principal Investigator agree that an
initial Public Presentation of the Study results shall occur only as a
multi-center publication of the results obtained by all the sites participating
in that study, unless specific written permission is obtained in advance from
Medarex for separate Public Presentation of that site’s results. The Public
Presentation review procedures set forth in Article 11.B and E shall apply
to the Public Presentation of the Study results as part of such
multi-center publication.

 

D.                                    A Public Presentation shall not
contain any Confidential Information provided by Medarex other than Study
results and information necessary for the accurate presentation, interpretation
and validation of the Study results. At Medarex’s request, Medarex shall be
acknowledged as one of several or as the sole financial sponsor, as the case may be,
of the Study reported in the Public Presentation.

 

E.                                      If Medarex believes there is
patentable subject matter contained in any Public Presentation submitted for
review, Medarex shall promptly identify such subject matter to Institution, and
Institution shall delay any Public Presentation for up to an additional sixty
(60) days to allow Medarex to obtain patent protection or take other measures,
as Medarex deems necessary. At Medarex’s request and expense, Institution shall
use its best efforts to assist Medarex to file a patent application covering
such subject matter with the United States Patent and Trademark Office or
through the Patent Cooperation Treaty prior to any Public Presentation.

 

F.                                      Medarex grants Institution the
right, subject to the provisions of this Agreement, to use the results of the
Study, including but not limited to, the results of tests and any raw data and
statistical data generated therefrom, in accordance with the provisions of Article 11A
above.

 

12.                               CLINICAL
SUPPLIES

 

A.                                    Institution and Principal
Investigator shall use the Study Drug and clinical supplies solely for the
purpose of conducting the Study according to the Protocol and not for purposes
that are contrary to the provisions of the Protocol or outside the scope of the
Protocol. Medarex shall make available to Institution and Principal
Investigator sufficient quantities of Study Drug to carry out the Study.

 

B.                                    Institution and Principal
Investigator shall take responsibility for and reasonable steps to maintain
appropriate records and assure appropriate supply, handling, storage,

 

9

 

distribution and usage of these materials in
accordance with the Protocol and Applicable Law.

 

C.                                    All unused Study Drug will be
returned to Medarex at Medarex’s expense by Institution at the conclusion of
the Study, or upon earlier termination of this Agreement, unless Medarex gives
Institution or Principal Investigator written authorization to destroy or
retain Study Drug. If Medarex authorizes Institution or Principal Investigator
to destroy unused Study Drug, then Institution or Principal Investigator shall
provide Medarex with certification of the Study Drug’s destruction according to
Applicable Law.

 

13.                               INDEMNIFICATION
AND INSURANCE

 

A.                                    Medarex shall indemnify, defend
and hold harmless Institution, its trustees, officers, agents, employees and
Principal Investigator, (and any named co-investigator) (collectively, “Institution
Indemnitees”) from and against any and all losses, settlements, damages,
judgments, expenses and costs (including reasonable attorneys’ fees and court
costs) (“Losses”) resulting from any third-party claim, action or suit (“Third-Party
Claim”) arising from an Institution Indemnitee’s performance of the Study in
strict accordance with this Agreement.

 

B.                                    Notwithstanding the foregoing,
Medarex shall have no indemnification obligation or liability, and Institution
shall indemnify, defend and hold harmless Medarex, its parent corporation,
subsidiaries, affiliates, officers, directors, agents, and employees for Losses
resulting from any Third-Party Claim that arose from:

 

(i)                                    failure of an Institution
Indemnitee to adhere to the terms and provisions of the Protocol or agreed
amendments thereto or Medarex’s written recommendations and instructions
relative to the administration and use of any drug substances involved in the
Study, including, but not limited to, the Study Drug, any comparative drug and
any placebo;

 

(ii)                                failure of an Institution
Indemnitee to comply with any Applicable Law relevant to the performance of an
Institution Indemnitee’s obligations under this Agreement;

 

(iii)                            failure of an Institution
Indemnitee to render services in a professional manner or to conduct the Study
in a normal, prudent manner; or

 

(iv)                               negligence, recklessness or
willful misconduct or omission by an Institution Indemnitee related to the
performance of services under this Agreement.

 

C.                                    A condition of Medarex’s
indemnity obligation is that, whenever Principal Investigator and/or
Institution has information from which it may reasonably conclude a
Third-Party Claim has occurred, Institution shall immediately give notice to
Medarex of all pertinent data surrounding such Third-Party Claim. In addition,
Principal Investigator and Institution shall comply with all of their
obligations with regard to adverse event reporting procedures as set forth in
this Agreement and the Protocol and any appendix or attachment thereto. In the
event a Third-Party Claim is made or suit is brought, Institution and Principal
Investigator shall assist Medarex and cooperate in the gathering of information
with respect to the time, place, and circumstances and in obtaining the names
and addresses of the injured parties and available witnesses. Principal
Investigator and Institution agree to cooperate with and to authorize Medarex
to carry out sole management and defense of such claim or action. Neither
Principal Investigator nor 

 

10

 

Institution, its trustees, officers, a gents
or employees shall compromise or settle any claim or action without the prior
written approval of Medarex.

 

D.                                    Medarex will reimburse
Institution and/or the Study subject for the reasonable costs and expenses
incurred in diagnosing and treating unanticipated adverse effects, injuries,
illnesses, or reactions that result from the use or application of Medarex`s
investigational drug or device in the course of this Study.

 

E.                                      Institution shall secure and
maintain in full force and effect through the performance of the Study (and
following termination or early termination of the Study to cover any claims
arising from the Study) insurance coverage for:

 

(i)                                    medical professional and/or
medical malpractice liability (including coverage of Principal Investigator);

 

(ii)                                general liability (including
coverage for the Study site); and

 

(iii)                            worker’s compensation, each such
insurance coverage in amounts required by Applicable Law and appropriate to the
conduct of Institution’s business activities and the services contemplated by
the Study.

 

Upon request of
Medarex, copies of certificates evidencing such insurance coverage will be made
available to Medarex, and Institution shall provide thirty (30) days’ prior
written notice to Medarex in the event of cancellation or any material change
in such insurance.

 

F.                                      Medarex represents that it
carries insurance coverage to protect against liability under this provision in
amounts equal to at least three million dollars ($3,000,000) per occurrence
combined single limit and ten million dollars ($10,000,000) annual aggregate,
and Medarex agrees to furnish to Institution a certificate of insurance acceptable
to Institution indicating the required coverage.

 

14.                               INVENTIONS
AND PATENTS

 

A.                                    Neither anything contained in
this Agreement nor the delivery of any Confidential Information to or by
Institution or Principal Investigator shall be deemed to grant Institution or
Principal Investigator any right or licenses under any ideas, know-how, trade
secrets, technologies, discoveries, inventions, improvements, modifications or
works of authorship, whether patentable, copyrightable or not, and all patent,
copyright, trade secret or other intellectual property rights arising therefrom
in any country of the world (“Inventions”) of Medarex (“Medarex Inventions”).

 

B.                                    Inventorship or authorship of
Inventions that are made, conceived, reduced to practice, authored or otherwise
developed or generated either solely by personnel of one Party or jointly by
personnel of both Parties, in whole or in part, in the course of activities in
connection with this Agreement (“Study Inventions”) shall be determined in
accordance with United States patent or copyright laws, respectively, or by
mutual agreement if the Study Invention is not patentable. Institution and
Principal Investigator will disclose to Medarex in writing any and all Study
Inventions within forty-five (45) working days of the earliest of such Study
Invention’s 

 

11

 

conception, reduction to practice, invention,
fixation in a tangible medium of expression or development. All such Study
Inventions and any information with respect thereto, shall be deemed to be
confidential, and shall be held in confidence by both parties subject to the
provisions in Article 9.

 

C.                                    Medarex shall exclusively own
all right, title and interest in and to all Medarex Inventions and all intellectual
property rights appurtenant thereto. Title to Study Inventions shall reside
with Medarex if Medarex personnel are the sole inventors, with Institution if
Institution personnel are the sole inventors, and will be held jointly if both
Institution and Medarex personnel are inventors. To the extent that Institution
owns the rights of sole or joint inventorship of a Study Invention, Medarex is
hereby granted, without option fee other than the consideration of the research
sponsored herein and the reimbursement of Institution for a 11 patent expenses
incurred prior to and during the option period related to the Study Invention,
an option to acquire an exclusive, worldwide, fee and royalty-bearing license
of Institution’s rights to any Study Invention, which option shall extend for
ninety (90) days after Medarex’s receipt of a Study Invention disclosure. If
Medarex notifies Institution in writing of its exercise of the option within
the option period, then the parties will proceed in good faith to negotiate a license
agreement within sixty (60) days after notification of exercise; and if Medarex
does not exercise this option, or notifies Institution that it will not
exercise this option, or the parties fail to sign a license agreement within
said sixty (60) day negotiation period, then Medarex shall no longer own any
rights in the subject Study Invention.

 

15.                               NOTICE

 

Whenever any
notice is to be given hereunder, it shall be in writing and mailed postage
prepaid by certified or registered mail, return receipt requested, or
personally delivered to the appropriate party at the address indicated below,
or at such other place or places as either party may designate in a
written notice to the other:

 

	
  To
  Institution:

  	
  Office of
  Grants and Contracts

  
	
   

  	
  Duke
  University Medical Center. Box 3001

  
	
   

  	
  107 Seeley
  G. Mudd Building

  
	
   

  	
  Durham, NC
  27710

  
	
   

  	
  Attn.: Holly
  Snair, Interim Director

  
	
   

  	
   

  
	
  With a copy
  to:

  	
  Duke
  University

  
	
   

  	
  Office of
  University Counsel

  
	
   

  	
  2400 Pratt
  Street, Suite 4000

  
	
   

  	
  Durham, NC
  27705

  
	
   

  	
   

  
	
  To Medarex:

  	
  Medarex, Inc.

  
	
   

  	
  519 Route
  173 W

  
	
   

  	
  Bloomsbury,
  NJ 08801

  
	
   

  	
  Attn.:
  Richard Romasz

  
	
   

  	
   

  
	
  With a copy
  to:

  	
  Medarex, Inc.

  
	
   

  	
  707 State
  Road

  

 

12

 

	
   

  	
  Suite 206

  
	
   

  	
  Princeton,
  NJ 08540

  
	
   

  	
  Attn.:
  General Counsel

  

 

Notice shall be
deemed to have been received at the earlier of receipt or five (5) days
from the date of mailing (in the case of a letter).

 

16.                               ASSIGNMENT

 

This Agreement is
not assignable or delegable by Institution and any attempted assignment or
delegation in violation hereof shall be null and void. Medarex may assign
this Agreement, without the prior consent of Institution, to an affiliated
company or to a successor of substantially all of Medarex’s business interests
by a merger, acquisition or transfer of assets. Notwithstanding such
assignment, Medarex shall remain liable for all of its obligations under this
Agreement.

 

17.                               APPLICABLE
LAW

 

This Agreement
shall be governed by the laws of the State of North Carolina as applied to
agreements executed and performed entirely within the State of North Carolina
by North Carolina residents. If either party engages attorneys to enforce any
rights arising out of or relating to this Agreement, the prevailing party shall
be entitled to recover its fees expended in engaging such attorneys.

 

18.                               PUBLICITY

 

Neither party
shall use the name of the other party nor the name of any division or
affiliated companies of Medarex for promotional purposes without the prior
written consent of the party whose name is proposed to be used. Subject to the
publication rights of Institution, no news release, publicity or other public
announcement, either written or oral, regarding this Agreement or performance
hereunder or results arising from the Study, shall be made by Institution
without the prior written approval of Medarex.

 

19.                               INDEPENDENT
CONTRACTOR

 

Institution and
Principal Investigator are acting in the capacity of independent contractors
hereunder and not as employees, agents or joint venturers of or with Medarex. Neither
Institution nor Principal Investigator shall have any authority to represent,
bind or act on behalf of Medarex.

 

20.                               AGREEMENT
MODIFICATIONS

 

Neither this
Agreement nor the Protocol may be altered, amended or modified except by
written document signed by duly authorized representatives of both parties.

 

21.                               SEVERABILITY

 

If any term or
condition of this Agreement, the deletion of which would not adversely 

 

13

 

affect the receipt
of any material benefit by either party hereunder, shall be held illegal,
invalid or unenforceable, the remaining terms and conditions of this Agreement
shall not be affected thereby and such terms and conditions shall be valid and
enforceable to the fullest extent permitted by law.

 

22.                               NO WAIVER

 

Failure on the part of
Medarex to exercise or enforce any right conferred upon it hereunder shall not
be deemed to be a waiver of any such right nor operate to bar the exercise or
enforcement thereof at any time or times thereafter.

 

23.                               FORCE
MAJEURE

 

Noncompliance by
either party with the obligations of this Agreement due to force majeure, (laws
or regulations of any government, war, civil commotion, destruction of
production facilities and materials, fire, flood, earthquake or storm, labor
disturbances, shortage of materials, failure of public utilities or common
carriers), or any other causes beyond the reasonable control of the applicable
party, shall not constitute breach of this Agreement and such party shall be
excused from performance hereunder to the extent and for the duration of such
prevention, provided it first notifies the other party in writing of such
prevention and that it uses its best efforts to cause the event of the force
majeure to terminate, be cured or otherwise ended.

 

24.                               ENTIRE
UNDERSTANDING

 

This Agreement,
including any exhibits and schedules hereto, constitutes the entire agreement
between the parties with respect to the subject matter hereof. This Agreement
supersedes and cancels all previous agreements among the parties, written and
oral in respect of the subject matter hereof. In the event of any inconsistency
between this Agreement and the attached Protocol, the terms of this Agreement
shall govern except with regard to adverse event reporting procedures which
shall be governed by the Protocol and any appendix or attachment thereto.

 

IN
WITNESS WHEREOF, the parties have caused this Agreement to be
executed, by duly authorized representatives, as of the last date written
below.

 

	
  DUKE UNIVERSITY

  	
  MEDAREX, INC.

  
	
   

  	
   

  
	
  BY

  	
  /s/ R.
  Sanders Williams, M.D.

  	
   

  	
  BY

  	
  /s/ Geoff
  Nichol

  	
   

  
	
   

  	
   

  
	
  NAME 

  	
  R. Sanders
  Williams, M.D.

  	
   

  	
  NAME 

  	
  Geoff Nichol

  	
   

  
	
   

  	
   

  
	
  TITLE 

  	
  Dean of
  School of Medicine

  	
   

  	
  TITLE

  	
  Senior VP of
  Product Development

  	
   

  
	
   

  	
   

  
	
  DATE

  	
  3/29/04

  	
   

  	
  DATE 

  	
  4/5/04

  	
   

  
	
   

  	
   

  
	
  AGREED AND
  ACCEPTED:

  	
   

  
	
   

  	
   

  
	
  /s/ Michael
  Morse

  	
   

  	
   

  
											

 

14

 

	
  Michael Morse, MD

  	
   

  
	
  Principal
  Investigator

  	
   

  
	
  DATE

  	
     3/11/04

  	
   

  	
   

  
				

 

15

 

EXHIBIT A

 

PROTOCOL

 

16

 

EXHIBIT B

 

DISCLOSURE OF FINANCIAL INTERESTS AND ARRANGEMENTS

OF INVESTIGATOR OR OTHER RESEARCHER

 

As a condition of
participating as a clinical investigator (“Investigator”) in the protocol
entitled, “                                                                                ”
(the “Study”) which is sponsored by Medarex, Inc., a New Jersey
corporation (“Sponsor”), please provide the appropriate information and
responses to the following statements.

 

	
  Investigator’s
  Name:

  	
   

  	
   

  
	
   

  
	
  Title:

  	
   

  	
   

  
	
   

  
	
  Organization/Institution:

  	
   

  	
  Date:

  	
   

  	
   

  
								

 

Please mark the
applicable checkboxes.

 

	
  ·

  	
   

  	
  I have financial
  arrangement(s) with Sponsor in which the value of the compensation for
  conducting the Study could be influenced by the outcome of the Study.

  
	
   

  	
   

  	
   

  
	
  ·

  	
   

  	
  I have received
  or will receive from Sponsor, since February 2, 1999 and during the time
  of the Study and for one year after its completion, payment(s) of other
  sorts (e.g., grants to fund other ongoing research, compensation in the form
  of equipment not for the Study, retainer for ongoing consultation, or
  honoraria) that have a monetary value of more than $25,000. Such payments)
  exclude the costs of conducting the Study or other clinical studies.

  
	
   

  	
   

  	
   

  
	
  ·

  	
   

  	
  I have any
  proprietary interest(s) in the product tested in the Study.

  
	
   

  	
   

  	
   

  
	
  ·

  	
   

  	
  During the time
  of the Study and for one year after its completion, I will hold significant
  equity interest in Sponsor. “Significant equity interest” means any
  (l) ownership interest, stock options or other financial interest whose
  value cannot be readily determined through reference to public prices; or
  (2) equity interest in a publicly traded corporation that exceeds
  $50,000.

  

 

For those
statements I have checked, details of the individuals financial arrangements
and interests are attached, along with a description of steps taken to minimize
the potential bias of Study results by any of the disclosed arrangements or
interests.

 

Sponsor agrees to
treat as confidential all financial arrangements and interests attached to this
Exhibit and to use such disclosure to meet the requirements placed on
Sponsor under 21 C.F.R. Part 54. 
Investigator acknowledges and agrees that Sponsor may use such
disclosure for this purpose.  During the
time of the Study and for one year after its completion, Investigator shall notify
Sponsor in writing of any change to the information provided in this Exhibit.

 

	
  Investigator’s
  signature:

  	
   

  	
  Date:

  	
   

  	
   

  

 

17

 

EXHIBIT C

 

BUDGET

 

18

 

DUKE
UNIVERSITY BUDGET DEVELOPMENT WORKSHEET

	
  Sponsor:

  	
  Medarex, Inc.

  
	
  Study:

  	
  MDX-1307

  
	
  PI:

  	
  Michael
  Morse. M.D.

  

 

Budget
for One (1) Patient

 

	
  Screening

  	
   

  	
  No. of Units

  (if applicable)

  	
   

  	
  Price

  	
   

  	
  Overhead

  (25%)

  	
   

  	
  Total Price

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  [ **** ]

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  

 

19

 

DUKE
UNIVERSITY PAYMENT SCHEDULE

	
  Sponsor:

  	
  Medarex

  
	
  Study:

  	
  MDX1307-01

  
	
  PI:

  	
  Michael
  Morse, M.D.

  

 

PAYMENT SCHEDULE

 

EXHIBIT A

 

Payments
shall be made to Duke University (Institution) by the Medarex (Sponsor) according
to the following schedule:

 

[
**** ]

 

20

 

CONTRACT COVER SHEET

 

Date:  4/04

 

Contract
Title:  Duke University

 

Primary
Medarex Business or Scientific Contact:

 

(Printed)
Name:     CRA: Andrea Kelly

 

       Contact:  Carol Craig

 

Department:    Clinical Operations

 

Responsible
Medarex Attorney:

 

(Printed)
Name:     Brian Stalter

 

Notes:  Clinical Trial Research Agreement

 

21

 

FIRST ADDENDUM

TO

CLINICAL TRIAL RESEARCH AGREEMENT

 

This First Addendum to Clinical
Trial Research Agreement (the “Addendum”) is entered into as of the last date
on the signature page hereof (the “Effective Date”), by and between DUKE UNIVERSITY, a non-profit educational and healthcare
institution located at Office of Research Administration, 2424 Erwin Road, Suite 1103,
Durham, NC 27705, hereinafter called the “Institution” and CELLDEX
THERAPEUTICS, INC., a Delaware corporation with its principal place
of business located at 222 Cameron Drive, Suite 400, Phillipsburg, NJ
08865, hereinafter called “Celldex.”

 

WHEREAS,
the Institution had previously entered into that certain Clinical Trial
Research Agreement (the “Agreement”) dated as of April 5, 2004 with
Medarex, Inc. (“Medarex”); and

 

WHEREAS,
on April 6, 2004 Medarex and Celldex entered into that certain Assignment
and License Agreement (the “Assignment”), pursuant to which Medarex assigned
the Agreement to Celldex in accordance with the terms of Section 16 of the
Agreement; and

 

WHEREAS,
as of the date of the Assignment, Celldex was a wholly-owned subsidiary and an
affiliate of Medarex; and

 

WHEREAS,
as of the Effective Date of this Addendum, Celldex is a majority-owned
subsidiary and an affiliate of Medarex; and

 

WHEREAS,
the Institution and Celldex desire to make certain modifications to the terms
of the Agreement;

 

NOW,
THEREFORE, based upon the promises and mutual
covenants set forth herein, the parties agree as follows:

 

1.             NAME REFERENCES.  The parties agree that all references in the
Agreement to Medarex, Inc. shall be amended to read Celldex Therapeutics, Inc.
and all references to Medarex shall be amended to read Celldex.  In addition, except as set forth in the
immediately succeeding sentence, all references in the Agreement to [ **** ]
shall be amended to read [ **** ]. 
Similarly, all references in the Study title to [ **** ] shall be
amended to read [ **** ].

 

2.             TERM OF AGREEMENT.  The first sentence of Section 5B shall
be amended to read as follows:

 

“It is anticipated that the
Study shall begin in March 2004 and shall be completed on or before June 30,
2009.”

 

22

 

3.             INDEMNIFICATION AND INSURANCE.  Section 13D shall be amended to read in
its entirety as follows:

 

“D.     Celldex agrees to pay any
reasonable medical expenses for treatment of research related injuries which
are a direct result of the investigational drug or device properly administered
in accordance with the Study Protocol to the extent the expenses for such
treatment are not covered by the injured Study subject’s commercial medical
insurance.  However, it is understood and
agreed that neither Institution nor Study subject will be required to seek
reimbursement from Medicare, Medicaid or Tricare.”

 

4.             BUDGET.   Patients enrolled in the fourth cohort of
Protocol [ **** ], as provided for in the 6th Amendment to the Clinical Study
Protocol, will be reimbursed according to Exhibit A (the “Budget”), dated September 25th,
2006, attached hereto, the terms of which Exhibit A are incorporated in
full into this Addendum by reference.

 

5.             NOTICE.  Section 15 shall be amended to read the
Institution’s address and the address for the copy as follows:

 

	
  “To Institution:

  	
   

  	
  Office of Research Administration

  
	
   

  	
   

  	
  2424 Erwin Road, Suite 1103

  
	
   

  	
   

  	
  Durham, NC 27705

  
	
  With a copy to:

  	
   

  	
  Michael Morse, M.D.

  
	
   

  	
   

  	
  Box 3233 Med Ctr

  
	
   

  	
   

  	
  Durham, NC 27710”

  

 

5.             COST AND PAYMENT.  Section 8 shall be amended to read the
Institution’s new mailing address for payments as follows:

 

	
  Payee:

  	
   

  	
  Duke University

  
	
  Mailing address:

  	
   

  	
  Clinical Research Office Support

  
	
   

  	
   

  	
  2424 Erwin Road, Suite 504

  
	
   

  	
   

  	
  Durham, NC 27705

  
	
   

  	
   

  	
  ATTN: Post-Award Division

  

 

IN WITNESS
WHEREOF, the parties have caused this Addendum to be
executed, by duly authorized representatives, as of the last date written
below.

 

	
  DUKE UNIVERSITY

  	
   

  	
  CELLDEX THERAPEUTICS, INC.

  	
   

  
	
   

  	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  By:

  	
      /s/ R. Sanders
  Williams

  	
   

  	
  By:

  	
      /s/ Thomas Davis

  	
   

  	
   

  
	
  Name:

  	
  R. Sanders Williams, M.D.

  	
  Name: 

  	
  Thomas Davis, MD

  
	
  Title:

  	
  Dean, Schoo1 of Medicine

  	
  Title:

  	
  CMO

  
	
  Date:

  	
  11/14/06

  	
  Date:

  	
  11/20/06

  
									

 

23

 

EXHIBIT A

 

Budget for One (1) Patient (Cohort 4; Patients treated at 2.5 mg [
**** ] with GM-CSF)

 

	
  Screening

  	
   

  	
  No. of Units

  (if applicable)

  	
   

  	
  Price

  	
   

  	
  Overhead

  (25%)

  	
   

  	
  Total Price

  	
   

  
	
  Study
  Coordinator

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Protocol
  Review/Initiation visit with sponsor

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Obtain
  informed consent

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Inclusion/Exclusion
  Criteria-review patient chart

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Collect demographic
  data

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Patient
  setup (study calendar, supplies, scheduling visits, blood work, patient
  assistance)

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  ECOG
  Performance Status

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Tumor
  Archived

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Medical
  History

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Chest X-ray
  and EKG

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Vital signs,
  body weight and height

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Record
  Concomintant Medication

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  AE/Toxicity
  Assessment

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Pull scans,
  film, retrieve tissue, blood sample

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Schedule lab
  tests, cardiology and radiology procedures

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Kit
  preparation, form completion and shipping

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Query case
  report forms (per visit)

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Record in
  case report forms (per visit)

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Phlebotomist:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Sample
  collection

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Principal
  Investigator:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Protocol
  Review

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  PI Fee

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Data
  Manager:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Case Report
  Review/Training

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Case Report
  Form database setup-patient entry

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Clinical
  Procedures and Tests:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  CT Scans
  (Abd., chest, pelvis)

  	
   

  	
  soc

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
  Total
  Screening Fee:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  

 

24

 

	
  Treatment (Visit 2, 7 and 8)

  	
   

  	
  No. of Units

  (if applicable)

  	
   

  	
  Price

  	
   

  	
  Overhead

  (25%)

  	
   

  	
  Total Price

  	
   

  
	
  Study
  Coordinator:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Vital Signs

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  ECOG
  Performance Status

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Record
  Concomintant Medication

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  CDX 1307
  Vaccination

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  AE/Toxicity
  Assessment

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Kit
  preparation, form completion and shipping

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  GM-CSF

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  500 mcg vial

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Dispensing
  Fee

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Phlebotomist:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Sample
  Collection

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Principal
  Investigator:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PI Fee

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  NA

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Data
  Manager:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Case Report
  Form Entry

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Clinical
  Procedures and Tests:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Leukapheresis

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Other
  Facility Fee Charges (Room Use at Duke Clinic)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  NA

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Pharmacy:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Dispense

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Total
  Visit 2, 7 and 8 Fees:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  

 

	
  Treatment (Visit 3, 4 and 6)

  	
   

  	
  No. of Units

  (if applicable)

  	
   

  	
  Price

  	
   

  	
  Overhead

  (25%)

  	
   

  	
  Total Price

  	
   

  
	
  Study
  Coordinator:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Vital Signs

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Record
  Concomintant Medication

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  AE/Toxicity
  Assessment

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Kit
  Preparation, form completion and shipping

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Phlebotomist:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Sample
  Collection

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Principal
  Investigator:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PI Fee

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Data
  Manager:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Case Report
  Form Entry

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Clinical
  Procedures and Tests:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Physical
  Exam (visit 3 & 4)

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Leukapheresis

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Other
  Facility Fee Charges (Room Use at Duke Clinic)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  NA

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Pharmacy:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Dispense

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
  Total
  Visit 3, 4 and 6 Fees:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  

 

25

 

	
  Treatment (Visit 5)

  	
   

  	
  No. of Units

  (if applicable)

  	
   

  	
  Price

  	
   

  	
  Overhead

  (25%)

  	
   

  	
  Total Price

  	
   

  
	
  Study
  Coordinator:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Vital Signs

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Record
  Concomintant Medication

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  CDX-1307
  Vaccination

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  AE/Toxicity
  Assessment

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Kit
  Preparation, form completion and shipping

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  GM-CSF

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  500 mcg vial

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Dispensing
  Fee

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Phlebotomist:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Sample
  Collection

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Principal
  Investigator:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PI Fee

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Data
  Manager:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Case Report
  Form Entry

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Clinical
  Procedures and Tests:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  NA

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Other
  Facility Fee Charges (Room Use at Duke Clinic)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Nurse
  Room (nurse visit only)

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Pharmacy:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Dispense

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Total
  Visit 5 Fee:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  

 

	
  Treatment (Treatment Visit 9)

  	
   

  	
  No. of
  Units

  (if applicable)

  	
   

  	
  Price

  	
   

  	
  Overhead

  (25%)

  	
   

  	
  Total
  Price

  	
   

  
	
  Study
  Coordinator:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Vital Signs

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Record
  Concomintant Medication

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  AE/Toxicity
  Assessment

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Kit
  preparation, form completion and shipping

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Principal
  Investigator:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PI Fee

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Phlebotomist:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Sample
  Collection

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Data
  Manager:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Case Report
  Form Entry

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Clinical
  Procedures and Tests:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Leukapheresis

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Pharmacy:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Dispense

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
  Total
  Visit 9 Fee:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  

 

26

 

	
  Treatment (Visit 10, 11 and 12)

  	
   

  	
  No. of
  Units

  (if applicable)

  	
   

  	
  Price

  	
   

  	
  Overhead

  (25%)

  	
   

  	
  Total
  Price

  	
   

  
	
  Study
  Coordinator:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Vital Signs

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  ECOG
  Performance Status

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Chest X-ray
  and EKG

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Record
  Concomintant Medication

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  AE/Toxicity
  Assessment

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Kit
  preparation, form completion and shipping

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Phlebotomist:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Sample
  Collection

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Principal
  Investigator:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PI Fee

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  NA

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Data
  Manager:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Case Report
  Form Entry

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Clinical
  Procedures and Tests:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  NA

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Other
  Facility Fee Charges (Room Use at Duke Clinic)

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  NA

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Pharmacy:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  NA

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  	
  $

  	
  0.00

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Total
  Visit 10, 11 and 12 Fees:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  

 

27

 

	
  Treatment (Treatment Visit 9)

  	
   

  	
  No. of
  Units

  (if applicable)

  	
   

  	
  Price

  	
   

  	
  Overhead

  (25%)

  	
   

  	
  Total
  Price

  	
   

  
	
  Study
  Coordinator:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Vital Signs

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  ECOG
  Performance Status

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Record
  Concomintant Medication

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  AE/Toxicity
  Assessment

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Kit
  preparation, form completion and shipping

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Phlebotomist:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Sample
  Collection

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Principal
  Investigator:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  PI Fee

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  NA

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Data
  Manager:

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Case Report
  Form Entry

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Subtotal:

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  
	
  Total
  Fee For Each Follow-up Visit Per Patient

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
   

  	
  [ **** ]

  	
   

  

 

	
  OTHER COSTS-For items to be
  invoiced

  	
   

  	
  Price

  	
   

  	
  Overhead

  (25%)

  	
   

  	
  Total
  Price

  	
   

  
	
  CT chest
  w/wo enhancement ([ **** ]); CT abdomen w/wo enhancement ([ **** ]); CT
  pelvis w/wo enhancement ([ **** ]) [ **** ]per scan

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  IRB Protocol
  Amendment review (each new amendment reviewed by full board)

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  IRB Protocol
  Renewal (yearly)

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Hotel Stays
  (per night) if requested for patients living beyond 35 miles from Duke

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Meals-if
  requested for patients living beyond 35 miles from Duke-per day

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Parking-per
  day (only for patients staying overnight to receive treatment living 35 miles
  beyond Duke)(per day)

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Tumor hCG-B
  Immunohistochemistry

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Screen
  Failure Visits (1 enrolled for every 3 screened) (Note, Sponsor will be
  billed for every required test by protocol completed for screening
  separately; [ **** ]will be used to offset nursing time.)

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  

 

Note: For Items and services that are
provided solely to satisfy data collection and analysis needs and are not used
in the direct clinical management of the patient.

 

28

 

Payment Schedule

Exhibit A

 

Payments shall be made to Duke University (Institution)
by Celldex (Sponsor) according to the following schedule:

 

I.  Payment Schedule:  Sponsor agrees to make payment to institution
on a quarterly basis.  Payments will be
based on the number of patients enrolled, each visit completed, and CRF’s and
study materials receiving during the quarter.

 

The Institution will be paid according to the following milestones
visits below to institution:

 

	
  Screening/BL

  	
   

  	
  [ **** ]

  	
   

  
	
  Visit 2

  	
   

  	
  [ **** ]

  	
   

  
	
  Visit 3

  	
   

  	
  [ **** ]

  	
   

  
	
  Visit 4

  	
   

  	
  [ **** ]

  	
   

  
	
  Visit 5

  	
   

  	
  [ **** ]

  	
   

  
	
  Visit 6

  	
   

  	
  [ **** ]

  	
   

  
	
  Visit 7

  	
   

  	
  [ **** ]

  	
   

  
	
  Visit 8

  	
   

  	
  [ **** ]

  	
   

  
	
  Visit 9

  	
   

  	
  [ **** ]

  	
   

  
	
  Visit 10

  	
   

  	
  [ **** ]

  	
   

  
	
  Visit 11

  	
   

  	
  [ **** ]

  	
   

  
	
  Visit 12

  	
   

  	
  [ **** ]

  	
   

  
	
  Total

  	
   

  	
  [ **** ]

  	
   

  

 

Follow-up (see note below)

Each patient follow-up visit (every 3 months or until progression of
disease up to 3 years at $637.50 per patient/per visit to be invoiced
separately.)

 

	
  II. OTHER COSTS-For items to be invoiced

  	
   

  	
  Price

  	
   

  	
  Overhead

  (25%)

  	
   

  	
  Total Price

  	
   

  
	
  CT chest
  w/wo enhancement [ **** ]); CT abdomen w/wo enhancement ([ **** ]); CT pelvis
  w/wo enhancement [ **** ])

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  IRB Protocol
  Amendment review (each new amendment reviewed by full board)

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  IRB Protocol
  Renewal (yearly)

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Hotel Stays
  (per night) if requested for patients living beyond 35 miles from Duke

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Meals-if
  requested for patients living beyond 35 miles from Duke-per day

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Parking-per
  day (only for patients staying overnight to receive treatment living 35 miles
  beyond Duke)(per day)

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Tumor hCG-B
  Immunohistochemistry

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  
	
  Screen
  Failure Visits (1 enrolled for every 3 screened) (Note, Sponsor will be
  billed for every required test by protocol completed for screening
  separately; [ **** ] will be used to offset nursing time.)

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  	
  [ **** ]

  	
   

  

 

Note: For Items and services that are
provided solely to satisfy data collection and analysis needs and are not used
in the direct clinical management of the patient.

 

III.  Materials

Sponsor agrees to supply any materials associated with the performance
on this study.  Materials include but are
not limited to:

Test tubes and storage devices for specimens to be shipped

Packing materials for shipment of research specimens

Mail Express Account Numbers for lab shipments

 

29

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