Unassociated Document


    Exhibit
10.13

     

     

    
      	
              MANUFACTURER:

            	
              ■  NAVINTA,
      LLC

            
	
              MANUFACTURER
      CONTACT:

            	
              ■  CHRISTOPHER
      NEWTON,Ph.D.

            
	
              CUSTOMER
      CONTACT:

            	
              ■  JOHN
      C. HOUGHTON

            
	
              EFFECTIVE
      DATE:

            	
              ■  DECEMBER
      7, 2009

            


    

     

    TAUROLIDINE
SUPPLY AGREEMENT

    


    THIS  SUPPLY
AGREEMENT is made and entered into as of December 7th,
2009  (the “Effective Date”) by
and between CORMEDIX INC. 86 Summit Ave., Summit, NJ 07901,  (together
with its Affiliates, “Customer”) and NAVINTA, LLC, a  corporation
having an address at 1499 Lower Ferry Road, Ewing, NJ 08618 (“Manufacturer”).

    


    RECITALS:

    


    WHEREAS,
Customer desires to engage Manufacturer to perform certain Development or
Manufacturing Services (as those terms are defined below), on the terms and
conditions set forth below, and Manufacturer desires to perform such Services
for Customer.

    


    AGREEMENT:

    


    NOW,
THEREFORE, in consideration of the foregoing premises and the mutual covenants
of the parties set forth in this Agreement, the parties hereto agree as
follows:

    


    1.           Definitions.  Unless
this Agreement expressly provides to the contrary, the following terms, whether
used in the singular or plural, have the respective meanings set forth
below:

    


    1.1         “Affiliate” means,
with respect to a party, any person or entity which controls, is controlled by
or is under common control with such party.  As used in this
Agreement, “control” means (a) in
the case of corporate entities, direct or indirect ownership of at least fifty
percent (50%) of the stock or shares having the right to vote for the election
of directors, and (b) in the case of non-corporate entities, the direct or
indirect power to manage, direct or cause the direction of the management and
policies of the non-corporate entity or the power to elect at least fifty
percent (50%) of the members of the governing body of such non-corporate
entity.

    


    1.2         “Agreement” means
this  Supply Agreement, together with all Appendices attached hereto,
as amended from time to time by the parties in accordance with Section 15.6, and
all fully signed Work Orders entered into by the parties.

    


    1.3         “API/Drug Substance”
means the active pharmaceutical ingredient identified on the applicable Work
Order or any intermediate thereof.

    


    1.4         “Applicable Law” means
all applicable ordinances, rules, regulations, laws, guidelines, guidances,
requirements and court orders of any kind whatsoever of any Authority, as
amended from time to time, including without limitation, cGMP (if
applicable).

    


    [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission.  Confidential treatment has
been requested with respect to the omitted portions.

     

    
      
         


      

      
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    1.5         “Authority” means any
government regulatory authority responsible for granting approvals for the
performance of Services under this Agreement or for issuing regulations
pertaining to the Manufacture and/or use of Product in the intended country of
use, including, without limitation, the FDA.

    


    1.6         “Batch” means a
specific quantity of Product that is intended to be of uniform character and
quality, within specified limits, and is produced during the same cycle of
Manufacture as defined by the applicable Batch Record.

    


    1.7         “Batch Documentation”
has the meaning set forth in Section 6.2.

    


    1.8         “Certificate of
Analysis” means a document, signed by an authorized representative of
Manufacturer, describing Specifications for, and testing methods applied to,
Product, and the results thereof.

    


    1.9         “Certificate of
Compliance” means a document, signed by an authorized representative of
Manufacturer, certifying that a particular Batch was manufactured in accordance
with cGMP (if applicable), all other Applicable Law, and the
Specifications.

    


    1.10       “cGMP” means current
good manufacturing practices applicable to the Manufacture of Product
promulgated by any Authority.

    


    1.11       “Change Order” has the
meaning set forth in Section 5.3.

    


    1.12       “Confidential
Information” has the meaning set forth in Section 10.

    


    1.13       “Develop” or “Development” means
the studies and other activities conducted by Manufacturer under this Agreement
to develop all or any part of a Manufacturing Process including, without
limitation, analytical tests and methods, formulations and dosage
forms.

    


    1.14       “Equipment” means any
equipment or machinery, including Customer Equipment, used by Manufacturer in
the Development and/or Manufacturing of Product, or the holding, processing,
testing, or release of Product.

    


    1.15       “Facility” means the
facilities of Manufacturer identified in the applicable Work Order.

    


    1.16       “FDA” means the United
States Food and Drug Administration, and any successor agency having
substantially the same functions.

    


    1.17       “FDCA” means the
United States Federal Food, Drug and Cosmetic Act, 21 U.S.C. §321 et seq., as
amended from time to time.

    


    1.18       “Forecast” means firm work orders for the first six months and
rolling forecast for the twelve months for each year for the product covered
under this agreement. Manufacturer will provide appropriate lead time
requirements to the Customer for firm work orders for the six month cycle for a
given year.

    


    [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission.  Confidential treatment has
been requested with respect to the omitted portions.

     

    
      
         


      

      
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    1.19       “Customer Indemnitee”
has the meaning set forth in Section 12.1.

    


    1.20       “Customer Equipment”
means the Equipment, if any, identified on the applicable Work Order as being
provided by Customer or purchased or otherwise acquired by Manufacturer at
Customer’s expense.

    


    1.21       “Customer Materials”
means the materials, and any intermediates or derivatives thereof, identified in
the applicable Work Order as being provided by Customer including labels (if
any) for Product.

    


    1.22       “Customer Technology”
means (a) Customer Materials, (b) Product and any intermediates or derivatives
thereof, (c) Specifications, and (d) the Technology of Customer owned, developed
or obtained by or on behalf of Customer prior to the Effective Date, or
developed or obtained by or on behalf of Customer independent of this Agreement
and without reliance upon the Confidential Information of
Manufacturer.

    


    1.23       “force
majeure” has the meaning set forth in Section 15.3.

    


    1.24       “Improvements” means
all Technology and discoveries, inventions, developments, modifications,
innovations, updates, enhancements, improvements, writings or rights (whether or
not protectable under patent, trademark, copyright or similar laws) associated
with Product that are conceived, discovered, invented, developed, created, made
or reduced to practice in the performance of Services under this
Agreement.

    


    1.25       “IND” means an
Investigational New Drug application filed with the FDA in accordance with
Applicable Law.

    


    1.26       “Manufacture” and
“Manufacturing”
means any steps, processes and activities necessary to produce Product,
including without limitation, the manufacturing, processing, packaging,
labeling, quality control testing, release, storage or supply of
Product.

    


    1.27       “Manufacturer
Indemnitee” has the meaning set forth in Section 12.2.

    


    1.28       “Manufacturer
Technology” means the Technology of Manufacturer (a) existing prior to
the Effective Date, or (b) developed or obtained by or on behalf of Manufacturer
independent of this Agreement and without reliance upon Confidential Information
of Customer.

    


    1.29       “Manufacturing
Process” means any and all processes (or any step in any process) used or
planned to be used by Manufacturer to Manufacture Product, as evidenced in the
Batch Documentation or master Batch Documentation.

    


    [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission.  Confidential treatment has
been requested with respect to the omitted portions.


    
      
         


      

      
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    1.30       “Net
Sales” shall mean the U.S. net sales for a Product as reported by Customer in
its U.S. financial statements under U.S. General Accepted Accounting Procedure
(GAAP) principles, and incorporates, to the extent related to the sale thereof,
discounts, charge backs, credits, returns, rebates and allowances actually
granted, which were imposed on the sales transactions under the ordinary course
of business (whether or not separately invoiced).

    


    1.31       “Product” means
Taurolidine API/Drug Substance, in each case as specified in the applicable Work
Order, including, if applicable, bulk packaging and/or labeling as provided in
such Work Order.

    


    1.32       “Quality Agreement”
has the meaning set forth in Section 2.2.

    


    1.33       “Records” has the
meaning set forth in Section 5.4(a).

    


    1.34       “Representative” has
the meaning set forth in Section 3.1.

    


    1.35       “Reprocess” and “Reprocessing” means
introducing a Product back into the process and repeating appropriate
manipulation steps that are part of the established Manufacturing
Process.  Continuation of a process step after an in-process control
test show the process to be incomplete is not considered
reprocessing.

    


    1.36       “Rework” and “Reworking” means
subjecting a Product to one or more processing steps that are different from the
established Manufacturing Process.

    


    1.37       “Services” means the
Development, Manufacturing and/or other services described in a Work Order
entered into by the parties.

    


    1.38       “Specifications” means
the list of tests, references to any analytical procedures and appropriate
acceptance criteria which are numerical limits, ranges or other criteria for
tests described in order to establish a set of criteria to which Product at any
stage of Manufacture should conform to be considered acceptable for its intended
use that are provided by or approved by Customer, as such specifications are
amended or supplemented from time to time by Customer in writing.

    


    1.39       “Technology” means all
methods, techniques, trade secrets, copyrights, know-how, data, documentation,
regulatory submissions, specifications and other intellectual property of any
kind (whether or not protectable under patent, trademark, copyright or similar
laws).

    


    1.40       “Work Order” means a
written binding work order, substantially in the form attached hereto as Appendix A, for the
performance of Services by Manufacturer under this Agreement.

    


    [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission.  Confidential treatment has
been requested with respect to the omitted portions.

     

    
      
         


      

      
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      2.           Engagement of
Manufacturer.

    

     

    2.1         Services and Work
Orders.   From time to time, Customer may wish to engage
Manufacturer to perform Services for Customer. Such Services will be set forth
in a Work Order. Each Work Order will be appended to this Agreement and will set
forth the material terms for the project, and may include the scope of work,
specified Services, Specifications, deliverables, timelines, milestones (if
any), quantity, budget, payment schedule and such other details and special
arrangements as are agreed to by the parties with respect to the activities to
be performed under such Work Order.  No Work Order will be effective
unless and until it has been agreed to and signed by authorized representatives
of both parties.  Documents relating to the relevant project,
including without limitation Specifications, proposals, quotations and any other
relevant documentation, will be attachments to the applicable Work Order and
incorporated in the Work Order by reference.  Each fully signed Work
Order will be subject to the terms of this Agreement and will be incorporated
herein and form part of this Agreement.  Manufacturer will perform the
Services specified in each fully signed Work Order, as amended by any applicable
Change Order(s), and in accordance with the terms and conditions of such Work
Order and this Agreement.  Notwithstanding the foregoing, nothing in
this Agreement will obligate either party to enter into any Work Order under
this Agreement.

    


    2.2         Quality Agreement. If
appropriate or if required by Applicable Law, the parties will also agree upon a
Quality Agreement containing quality assurance provisions for the Manufacture of
Product (“Quality
Agreement”), which agreement will also be attached to the applicable Work
Order and incorporated by reference in the Work Order.

    


    2.3         Conflict Between
Documents. If there is any conflict, discrepancy, or inconsistency
between the terms of this Agreement and any Work Order, Quality Agreement,
purchase order, or other form used by the parties, the terms of this Agreement
will control.

    


    2.4         Exclusivity.  Manufacturer
shall supply to Customer Product, described under
1.31, as per the terms of an executed Work Order, on an exclusive
worldwide basis in the field of the prevention and treatment of human infection
and/or dialysis (the “Exclusive
Field”).  For the avoidance of doubt, Manfuracturer shall not, during
the term of this Agreement, supply to any
third party the Product and/or taurolidine for use in the Exclusive
Field.  The exclusivity described in this section shall remain in effect so long as Customer purchases
certain Minimum Product Supply as described in the following
paragraph.

    


    2.5         Minimum Purchase
Requirement.  In order to maintain exclusivity in the Exclusive
Field (as defined in the preceding section), Customer shall be required to
purchase a minimum amount of Product and/or taurolidine: (i) by June 30th 2010;
and (ii) annually following the first commercial sale of a Product by Customer
(the “First Commercial Sale”).  The Minimum Purchase Requirement and
pricing for the Product and/or taurolidine is outlined as follows:

    


    (a)  Customer shall purchase
[*] of Product and/or taurolidine by December 30th 2010 at
a total cost of Three Hundred and Fifty Thousand Dollars ($350,000), [*] percent
([*]%) of which (or [*] Dollars, $[*]) shall be due and owing to Manufacturer
within [*] of the execution of this Agreement and an applicable Work
Order.  The remaining [*] percent ([*]%) of the purchase price for
such [*] quantity shall be due and owing to Manufacturer no later than [*]
following delivery of such Product to Customer, subject to the provisions of
this Agreement regarding conformance, acceptance and rejection;

    


    [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission.  Confidential treatment has
been requested with respect to the omitted portions.

     

    
      
         


      

      
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    (b)  [*]

    


    (c)  [*]

    


    2.6         Sales Milestone
Payments. Customer shall pay to Manufacturer the following
non-refundable, non-creditable one-time milestone payments within [*] following
the first achievement of the applicable milestone event with a Product as long
as the Customer or its assignee markets Product:

    


    (a)  [*];

    


    (b)  [*];

    


    (c)  [*];

    


    (d)  [*];
and

    


    (e)  [*].

    


    3.           Project
Performance.

    


    3.1         Representatives. Each
party will appoint a representative having primary responsibility for day-to-day
interactions with the other party for the Services (each, a “Representative”), who
will be identified in the applicable Work Order.  Each party may
change its Representative by providing written notice to the other party in
accordance with Section 15.3; provided that Manufacturer will use reasonable
efforts to provide Customer with at least forty-five (45) days prior written
notice of any change in its Representative for the Services.  Except
for notices or communications required or permitted under this Agreement, which
will be subject to Section 15.3, or unless otherwise mutually agreed by the
parties in writing, all communications between Manufacturer and Customer
regarding the conduct of the Services pursuant to such Work Order will be
addressed to or routed directly through the parties’ respective
Representatives.

    


    3.2         Communications.  The
parties will hold project team meetings via teleconference or in person, on a
periodic basis as agreed upon by the Representatives.  Manufacturer
will make written reports to Customer as specified in the applicable Work
Order.

    


    3.3         Subcontracting.  Manufacturer
may  subcontract with any third party to perform any of its
obligations under this Agreement with  prior
written  notification  to Customer.  Manufacturer
will be solely responsible for the performance of any permitted subcontractor,
and for costs, expenses, damages, or losses of any nature arising out of such
performance as if such performance had been provided by Manufacturer itself
under this Agreement.  Manufacturer will cause any such permitted
subcontractor to be bound by, and to comply with, the terms of this Agreement,
as applicable, including without limitation, all confidentiality, quality
assurance, regulatory and other obligations and requirements of Manufacturer set
forth in this Agreement.

    


    [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission.  Confidential treatment has
been requested with respect to the omitted portions.

     

    
      
         


      

      
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    3.4         Duty to
Notify.  If Manufacturer, at any time during the term of this
Agreement, has reason to believe that it will be unable to perform or complete
the Services, Manufacturer will promptly notify Customer
thereof.  Compliance by Manufacturer with this Section 3.4 will not
relieve Manufacturer of any other obligation or liability under this
Agreement.

    


    4.           Materials and
Equipment.

    


    4.1         Supply of
Materials.  Unless the parties otherwise agree in a Work Order,
Manufacturer will supply, in accordance with  the relevant approved
raw material specifications, all materials to be used by Manufacturer in the
performance of Services under a Work Order other than the Customer Materials
specified in such Work Order.  Customer or its designees will provide
Manufacturer with the Customer Materials.  Manufacturer agrees (a) to
account for all Customer Materials,. (b) not to provide Customer Materials to any
third party without the express prior written consent of Customer, (c) not to
use Customer Materials for any purpose other than conducting the Services,
including, without limitation, not to analyze, characterize, modify or reverse
engineer any Customer Materials or take any action to determine the structure or
composition of any Customer Materials unless required pursuant to a signed Work
Order, and (d) to destroy or return to Customer all unused quantities of
Customer Materials according to Customer’s written directions.

    


    4.2         Ownership of
Materials.  Customer will at all times retain title to and
ownership of the Product, any intermediates (and components thereof), and any
work in process at each and every stage of the Manufacturing
Process.  Manufacturer will provide within the Facility an area or
areas where the Product, any intermediates (and components thereof), and any
work in process are segregated and stored in accordance with the Specifications
and cGMP (if applicable), and in such a way as to be able at all times to
clearly distinguish such materials from products and materials belonging to
Manufacturer, or held by it for a third party's account Manufacturer will ensure
that,  Product, any intermediates (and components thereof), and any
work in process are free and clear of any liens or encumbrances.

     

    5.           Development and Manufacture
of Product.

    


    5.1         Resources; Applicable
Law.  Manufacturer will comply with all Applicable Law in
performing Services.

    


    5.2         Facility.

    


    (a)  Performance of
Services.  Manufacturer will perform all Services at the
Facility; provide all staff necessary to perform the Services in accordance with
the terms of the applicable Work Order and this
Agreement.  Manufacturer will not change the location of such Facility
or use any additional facility for the performance of Services under this
Agreement without at least one hundred and fifty (150) days prior written notice
to, and prior written consent from, Customer, which consent will not be
unreasonably withheld or delayed (it being understood and agreed that Customer
may withhold consent pending satisfactory completion of a quality assurance
audit and/or regulatory impact assessment of the new location or additional
facility, as the case may be).

    


    [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission.  Confidential treatment has
been requested with respect to the omitted portions.

     

    
      
         


      

      
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    (b)  Validation.  Manufacturer
will be responsible for performing all validation of the Facility, Equipment and
cleaning and maintenance processes employed in the Manufacturing Process in
accordance with cGMP, Manufacturer’s SOPs, the applicable Quality Agreement,
Applicable Law, and in accordance with any other validation procedures
established by  Manufacturer or their designated third
party.  Manufacturer will also be responsible for ensuring that all
such validated processes are carried out in accordance with their
terms.

    


    (c)   Licenses and
Permits.  Manufacturer will be responsible for obtaining, at
its expense, any Facility or other licenses or permits, and any regulatory and
government approvals necessary for the performance of Services by Manufacturer
under this Agreement.  At Customer’s request, Manufacturer will
provide Customer with copies of all such approvals and submissions to
Authorities, and Customer will have the right to use any and all information
contained in such approvals or submissions in connection with regulatory
approval and/or commercial development of Customer’s Product.

    


    (d)   Access to
Facility.  Manufacturer will permit Customer or its duly
authorized representatives to observe and consult with Manufacturer during the
performance of Services under this Agreement, including without limitation the
Manufacturing of any Batch of Product.  Manufacturer also agrees that
Customer and its duly authorized agents will have continuous access, during
operational hours and during active Manufacturing, to inspect the Facility and
Manufacturing Process to ascertain compliance by Manufacturer with the terms of
this Agreement, including, without limitation, inspection of (i) the Equipment
and materials used in the performance of Services, (ii) the holding facilities
for such materials and Equipment, and (iii) all Records relating to such
Services and the Facility.  Customer will also have the right, at its
expense, to conduct “mock” pre-approval audits upon reasonable notice to
Manufacturer, and Manufacturer agrees to cooperate with Customer in such “mock
audits.”

    


    5.3         Changes to Work Orders,
Manufacturing Process and Specifications.

    


    (a)    Changes to Work
Orders.  If the scope of work of a Work Order changes, then the
applicable Work Order may be amended as provided in this Section 5.3(a). If a
required modification to a Work Order is identified by Customer, or by
Manufacturer, the identifying party will notify the other party in writing as
soon as reasonably possible.  Manufacturer will provide Customer with
a change order containing a description of the required modifications and their
effect on the scope, fees and timelines specified in the Work Order (“Change Order”) and
will use reasonable efforts to do so within ten (10) business days of receiving
or providing such notice, as the case may be. No Change Order will be effective
unless and until it has been signed by authorized representatives of both
parties.  If Customer does not approve such Change Order, and has not
terminated the Work Order, but requests the Work Order to be amended to take
into account the modification, then the parties will use reasonable efforts to
agree on a Change Order that is mutually acceptable.  If practicable,
Manufacturer will continue to work on the existing Work Order during any such
negotiations, provided such efforts would facilitate the completion of the work
envisioned in the proposed Change Order, but will not commence work in
accordance with the Change Order until it is authorized in writing by
Customer.

    


    [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission.  Confidential treatment has
been requested with respect to the omitted portions.

     

    
      
         


      

      
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    (b)    Process/Specifications
Changes.  Any change or modification to the Manufacturing
Process or Specifications for any Product must be in accordance with applicable
regulatory procedures and with prior notification to the  Customer and
their written consensus.  Any changes will be made in accordance with
the change control provisions of the applicable Quality Agreement.

    


    5.4         
Record and Sample
Retention.

    


    (a)     Records.  Manufacturer
will keep complete and accurate records (including without limitation reports,
accounts, notes, data, and records of all information and results obtained from
performance of Services) of all work done by it under this Agreement, in form
and substance as specified in the applicable Work Order, the applicable Quality
Agreement, and this Agreement (collectively, the “Records”).  Records
will be available at reasonable times for inspection, examination and copying by
or on behalf of Customer.  All original Records of the Development and
Manufacture of Product under this Agreement will be retained and archived by
Manufacturer in accordance with cGMP (if applicable) and Applicable Law, but in
no case for less than a period of five (5) years following completion of the
applicable Work Order.  Upon Customer’s request, Manufacturer will
promptly provide Customer with copies of such Records  Five (5) years after completion of a
Work Order, all of the aforementioned records will be sent to Customer or
Customer’s designee; provided, however, that
Customer may elect to have such records retained in Manufacturer’s archives for
an additional period of time at a reasonable charge to Customer.

    


    (b)    Sample
Retention.  Manufacturer will take and retain, for such period
and in such quantities as may be required by cGMP (if applicable) and the
applicable Quality Agreement, samples of Product from the Manufacturing Process
produced under this Agreement.  Further, Manufacturer will submit such
samples to Customer, upon Customer’s written request.

    


    5.5          Regulatory
Matters.

    


    (a)     Regulatory
Approvals.  Customer will be responsible for obtaining, at its
expense, all regulatory and governmental approvals and permits necessary for
Customer’s use of the Product under this
Agreement, including, without limitation, IND submissions and any analogous
submissions filed with the appropriate Authority of a country other than the
United States.  Manufacturer will be responsible for providing
Customer with all supporting data and information relating to the Product for obtaining such approvals,
including, without limitation, all Records, raw data, reports, authorizations,
certificates, methodologies, Batch Documentation, raw material specifications,
SOPs, standard test methods, Certificates of Analysis, Certificates of
Compliance and other documentation in the possession or under the control of
Manufacturer.  Manufacturer shall be responsible for production and
filing of the Drug Master File for the Product with the FDA on a timely,
competent and professional basis.

    


    [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission.  Confidential treatment has
been requested with respect to the omitted portions.

     

    
      
         


      

      
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    (b)    Regulatory
Inspections.  Manufacturer will permit Customer or its agents
to be present and participate in any visit or inspection by any Authority of the
Facility (to the extent it relates the
Product) or the Manufacturing Process.  Manufacturer will give
as much advance notice as possible to Customer of any such visit or
inspection.  Manufacturer will provide to Customer a copy of any
report or other written communication received from such Authority in connection
with such visit or inspection, and any written communication received from any
Authority relating to any Product, the Facility (if it relates to or affects the
Development and/or Manufacture of Product) or the Manufacturing Process, within
three (3) business days  or sooner after receipt thereof, and will
consult with Customer before responding to each such
communication.  Manufacturer will provide Customer with a copy of its
final responses within five (5) business days after submission
thereof.

    


    5.6          Waste
Disposal.  The generation, collection, storage, handling,
transportation, movement and release of hazardous materials and waste generated
in connection with the Services will be the responsibility of Manufacturer at
Manufacturer’s sole cost and expense.  Without limiting other
applicable requirements, Manufacturer will prepare, execute and maintain, as the
generator of waste, all licenses, registrations, approvals, authorizations,
notices, shipping documents and waste manifests required under Applicable
Law.

    


    5.7          Safety
Procedures.  Manufacturer will be solely responsible for
implementing and maintaining health and safety procedures for the performance of
Services and for the handling of any materials or hazardous waste used in or
generated by the Services.  Manufacturer, in consultation with
Customer, will develop safety and handling procedures for API/Drug Substance and
Product; provided, however, that
Customer will have no responsibility for Manufacturer’s health and safety
program.

     

    5.8          Technology
Transfer.  Within ninety
(90) days of a Supply Failure by Manufacturer (as defined hereinafter),
or in any event if such Supply Failure is not fully cured within ninety (90) days of the occurrence of the Supply
Failure, then Customers’s minimum purchase obligations (as outlined in Section
2.5) and sales milestone payment obligations (as outlined in Section 2.6) will
terminate altogether and Manufacturer shall provide to Customer, or its
designee, all Manufacturing information, including, without limitation,
documentation, technical assistance, materials and cooperation by appropriate
employees of Manufacturer as Customer or its designee may reasonably require in
order to Manufacture Product.  A “Supply Failure” shall include any
inability on the part of Manufacturer to meet Customers supply demands with
respect to quantity or quality based on a firm six
(6) month and twelve (12) months rolling forecasts and ordering
provisions.  In the event Customer requests technology transfer
pursuant to this Section 5.8 (based on an uncured Supply Failure), Customer
shall be obligated to pay to Manufacturer royalties on the Net Sales of Product
manufactured using the Manufacturer Technology or the Manufacturer
Process.  Specifically, Customer shall be required to pay to
Manufacturer as long as Customer or its assignee markets Product:

    


    (a)   [*];

    


    (b)   [*];
and

    


    [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission.  Confidential treatment has
been requested with respect to the omitted portions.

     

    
      
         


      

      
        Page 10
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    (c)    [*].

    


    
      	
              6.

            	
              Testing and Acceptance
      Process.

            


    

    


    6.1          Testing by
Manufacturer.  The Product to be supplied under this Agreement will be
Manufactured in accordance with cGMP, unless otherwise stated in the Work Order,
and the Manufacturing Process approved by the Customer.  Each Batch of
Product will be sampled and tested by Manufacturer against the Specifications,
and the quality assurance department of Manufacturer will review the records
relating to the Manufacture of the Batch and will assess if the Manufacture has
taken place in compliance with cGMP (if applicable) and the Manufacturing
Process.

    


    6.2          Provision of
Records.  If, based upon such tests, a Batch of Product
conforms to the Specifications and was Manufactured according to cGMP (if
applicable) and the Manufacturing Process, and then a Certificate of Compliance
will be completed and approved by the quality assurance department of
Manufacturer. This Certificate of Compliance, a Certificate of Analysis, the
Specifications, and a complete and accurate copy of the Batch records
(collectively, the “Batch Documentation”)
for each Batch of Product will be delivered to Customer by a reputable overnight
courier or by registered or certified mail, postage prepaid, return receipt
required to verify delivery date. Upon request, Manufacturer will also deliver
to Customer all raw data, reports, authorizations, certificates, methodologies,
raw material specifications, SOPs, standard test methods, and other
documentation in the possession or under the control of Manufacturer relating to
the Manufacture of each Batch of Product.  If Customer has not
received all such Batch Documentation at the time of receipt of the Batch,
Customer will notify Manufacturer in writing.  If Customer requires
additional copies of such Batch Documentation, these will be provided by
Manufacturer to Customer at cost.

    


    6.3          Review of Batch
Documentation; Acceptance. Customer will review the Batch Documentation
for each Batch of Product and may test samples of the Batch of Product against
the Specifications.  Customer will notify Manufacturer in writing of
its acceptance or rejection of such Batch within thirty (30) business days of
receipt of the complete Batch Documentation relating to such Batch. During this
review period, the parties agree to respond promptly, but in any event within
ten (10) days, to any reasonable inquiry by the other party with respect to such
Batch Documentation.  Customer has no obligation to accept a Batch if
such Batch does not comply with the Specifications and/or was not Manufactured
in compliance with cGMP (if applicable) and the Manufacturing
Process.

    


    [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission.  Confidential treatment has
been requested with respect to the omitted portions.

     

    
      
         


      

      
        Page 11
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    6.4          Disputes.  In
case of any disagreement between the parties as to whether Product conforms to
the applicable Specifications or cGMP (if applicable), the quality assurance
representatives of the parties will attempt in good faith to resolve any such
disagreement and Customer and Manufacturer will follow their respective SOPs to
determine the conformity of the Product to the Specifications and cGMP (if
applicable).  If the foregoing discussions do not resolve the
disagreement in a reasonable time (which will not exceed thirty (30) days), a
representative sample of such Product will be submitted to an independent
testing laboratory mutually agreed upon by the parties for tests and final
determination of whether such Product conforms with such
Specifications.  The laboratory must meet cGMP (if applicable), be of
recognized standing in the industry, and consent to the appointment of such
laboratory will not be unreasonably withheld or delayed by either
party.  Such laboratory will use the test methods contained in the
applicable Specifications.  The determination of conformance by such
laboratory with respect to all or part of such Product will be final and binding
on the parties.  The fees and expenses of the laboratory incurred in
making such determination will be paid by the party against whom the
determination is made.

    


    6.5          Product Non-Compliance and
Remedies. If a Batch of Product fails to conform to the Specifications or
was not Manufactured in compliance with cGMP (if applicable) and the
Manufacturing Process, then Manufacturer will, at Customer’s sole
option:

    


    (a)   refund
in full the fees and expenses paid by Customer for such Batch; or

    


    (b)   at
Manufacturer’s cost and expense, produce a new Batch of Product as soon as
reasonably possible; or

    


    (c)    Rework
or Reprocess the Product, at Manufacturer’s cost and expense, so that the Batch
can be deemed to have been Manufactured in compliance with cGMP (if applicable)
and the Manufacturing Process, and to conform to Specifications.

    


    Moreover,
the parties will meet to discuss, evaluate and analyze the reasons for and
implications of the failure to comply with cGMP (if applicable) and/or the
Manufacturing Process and will decide whether to proceed with or to amend the
applicable Work Order, or to terminate such Work Order.

    


    6.6          Disposition of
Non-Conforming Product.  The ultimate disposition of
non-conforming Product will be the responsibility of
Manufacturer’s  quality assurance department and
Manufacturer’s  expense, in due consultation with the
Customer.

    


    7.           Shipping and
Delivery.

    


    7.1          Shipping;
Delivery.  Manufacturer agrees not to ship Product to Customer
or its designee until it has received a written approval to release and ship
from Customer.  Manufacturer will ensure that each Batch will be
delivered to Customer’s designee, (a) on the delivery date and to the
destination designated by Customer in writing, and (b) in accordance with the
instructions for shipping and packaging specified by Customer in the applicable
Work Order or as otherwise agreed to by the parties in writing. Delivery terms
will be FCA the Facility (Incoterms 2000).  A bill of lading will be
furnished to Customer with respect to each shipment.

    


    8.           Price and
Payments.

    


    8.1          Price.  The
price of Product and/or the fees for the performance of Services will be set
forth in the applicable Work Order.

     

    
      [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission.  Confidential treatment has
been requested with respect to the omitted portions.


    

    
      
         


      

      
        Page 12
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    8.2          Invoice.  Manufacturer
will invoice Customer according to the payment schedule in the applicable Work
Order.  Payment of undisputed invoices will be due [*] after receipt
of the invoice by Customer.

    


    8.3          Payments.  Customer
will make all payments pursuant to this Agreement by check or wire transfer to a
bank account designated in writing by Manufacturer.  All payments
under this Agreement will be made in United States Dollars.

    


    8.4          Financial
Records.  Manufacturer will keep accurate records of all
Services performed and invoice calculations, and, upon the request of Customer,
will permit Customer or its duly authorized agents to examine such records
during normal business hours for the purpose of verifying the correctness of all
such calculations. Such audit shall not be more than once in a calander
year.

    


    8.5          Taxes.  Duty,
sales, use or excise taxes imposed by any governmental entity that apply to the
provision of Services will be borne by Customer (other than taxes based upon the
income of Manufacturer).

    


    9.           Intellectual Property
Rights.

    


    9.1          Customer
Technology.  All rights to and interests in Customer Technology
will remain solely in Customer and no right or interest therein is transferred
or granted to Manufacturer.  Manufacturer acknowledges and agrees that
it does not acquire a license or any other right to Customer Technology except
for the limited purpose of carrying out its duties and obligations under this
Agreement and that such limited, non-exclusive, license will expire upon the
completion of such duties and obligations or the termination or expiration of
this Agreement, whichever is the first to occur.

    


    9.2          Manufacturer
Technology.  All rights to and interests in Manufacturer
Technology will remain solely in Manufacturer as it relates to Product and no
right or interest therein is transferred or granted to
Customer.  Customer acknowledges and agrees that it will not acquire a
license or any other right to Manufacturer Technology except as otherwise set
forth in this Agreement.

    


    9.3          Improvements.  The
parties agree that it will be owned on the
basis of inventorship (i.e., whoever invents, owns) To the extent any such
Improvements are useful or necessary in the Manufacturing of the Product, then
Manufacturer shall make available such Improvements for use in connection with
the Manufacturing of the Product for no additional fees or royalties other than
those outlined herein.

     

    [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission.  Confidential treatment has
been requested with respect to the omitted portions.

     

    
      
         


      

      
        Page 13
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                  10.

                	
                  Confidentiality.

                


        

      

       

    

    10.1          Definition.  As
used in this Agreement, “Confidential
Information” means any scientific, technical, trade or business
information which is given by one party to the other and which is treated by the
disclosing party as confidential or proprietary or is developed by one party for
the other under the terms of this Agreement.  The disclosing party
will, to the extent practical, use reasonable efforts to label or identify as
confidential, at the time of disclosure all such Confidential Information that
is disclosed in writing or other tangible form.  Confidential
Information of Manufacturer includes, but is not limited to, Manufacturer
Technology, whether or
not labeled confidential. Confidential Information of Customer includes, but is
not limited to, Customer Technology whether or not labeled
confidential.

    


    10.2          Obligations.  Each
party agrees (a) to keep confidential the Confidential Information of the other
party, (b) not to disclose the other party’s Confidential Information to any
third party without the prior written consent of such other party, and (c) to
use such Confidential Information only as necessary to fulfill its obligations
or in the reasonable exercise of rights granted to it under this Agreement;
provided, however, that the foregoing obligations shall not apply to
Confidential Information that is (i) in possession of the receiving party at the
time of disclosure, as reasonably demonstrated by written records and without
obligation of confidentiality, (ii) later becomes part of the public domain
through no fault of the receiving party, (iii) received by the receiving party
from a third party without obligation of confidentiality, or (iv) developed
independently by the receiving party without use of, reference to, or reliance
upon the disclosing party’s Confidential Information by individuals who did not
have access to Confidential Information. Notwithstanding the foregoing, a party
may disclose (y) Confidential Information of the other party to its Affiliates,
and to its and their directors, employees, consultants, and agents in each case
who have a specific need to know such Confidential Information and who are bound
by a like obligation of confidentiality and restriction on use, and (z)
Confidential Information of the other party to the extent such disclosure is
required to comply with Applicable Law or the rules of any stock exchange or
listing entity, or to defend or prosecute litigation; provided, however, that
the receiving party provides prior written notice of such disclosure to the
disclosing party and takes reasonable and lawful actions to avoid or minimize
the degree of such disclosure.  Moreover, Customer may disclose
Confidential Information of Manufacturer relating to the Development and/or
Manufacture of Product to entities with whom Customer has (or may have) a
marketing and/or development collaboration and who have a specific need to know
such Confidential Information and who are bound by a like obligation of
confidentiality and restrictions on use.

    


    10.3          Public Statements.
Except to the extent required by Applicable Law or the rules of any stock
exchange or listing entity, neither party will make any public statements or
releases concerning this Agreement or the transactions contemplated by this
Agreement, or use the other party’s name in any form of advertising, promotion
or publicity, without obtaining the prior written consent of the other party,
which consent will not be unreasonably withheld or delayed.

    


    11.           Representations and
Warranties.

    


    11.1          Manufacturer’s
Representations and Warranties.  Manufacturer represents and
warrants to Customer that:

    


    [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission.  Confidential treatment has
been requested with respect to the omitted portions.

     

    
      
         


      

      
        Page 14
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    (a)  it
has the full power and right to enter into this Agreement and that there are no
outstanding agreements, assignments, licenses, encumbrances or rights of any
kind held by other parties, private or public, inconsistent with the provisions
of this Agreement;

    


    (b)  the
Services will be performed with requisite care, skill and diligence, in
accordance with Applicable Law and industry standards, and by individuals who
are appropriately trained and qualified;

    


    (c)   to
the best of its knowledge, the Services will not infringe the intellectual
property rights of any third party and it will promptly notify Customer in
writing should it become aware of any claims asserting such
infringement;

    


    (d)   at
the time of delivery to Customer, the Product Manufactured under this Agreement
(i) will have been Manufactured in accordance with cGMP (if applicable) and all
other Applicable Law, the Manufacturing Process, the applicable Quality
Agreement, and Specifications, and (ii) will not be adulterated or misbranded
under the FDCA or other Applicable Law; and

    


    (e)    it
has not been debarred, nor is it subject to a pending debarment, and that it
will not use in any capacity in connection with the Services any person who has
been debarred pursuant to section 306 of the FDCA, 21 U.S.C. § 335a, or who is
the subject of a conviction described in such section.  Manufacturer
agrees to notify Customer in writing immediately if Manufacturer or any person
who is performing Services is debarred or is the subject of a conviction
described in section 306, or if any action, suit, claim, investigation, or
proceeding is pending, or to the best of Manufacturer’s knowledge, is
threatened, relating to the debarment or conviction of Manufacturer or any
person performing Services.

    


    11.2          Customer Representations and
Warranties.  Customer represents and warrants to Manufacturer
that:

    


    (a)   it
has the full power and right to enter into this Agreement and that there are no
outstanding agreements, assignments, licenses, encumbrances or rights held by
other parties, private or public, inconsistent with the provisions of this
Agreement, and

    


    (b)   to
the best of its knowledge, the use of Customer Technology as described in any
work order will not infringe the intellectual property rights of any third party
and that it will promptly notify Manufacturer in writing should it become aware
of any claims asserting such infringement.

    


    11.3          Disclaimer of Other
Representations and Warranties.  EXCEPT AS EXPRESSLY SET FORTH
IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATIONS OR EXTENDS ANY
WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED
TO, WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR
NON-INFRINGEMENT.

    


    [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission.  Confidential treatment has
been requested with respect to the omitted portions.

     

    
      
         


      

      
        Page 15
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    12.           Indemnification.

    


    12.1         Indemnification by
Manufacturer.  Manufacturer will indemnify, defend and hold
harmless Customer, its Affiliates and their respective officers, directors,
employees and agents (each a “Customer Indemnitee”)
from and against any and all losses, damages, liabilities or expenses (including
reasonable attorneys fees and other costs of defense) (collectively, “Losses”) in
connection with any and all actions, suits, claims or demands that may be
brought or instituted against any Customer Indemnitee by any third party based
on, arising out of, or resulting directly from (a) any breach by Manufacturer of
its representations, warranties or covenants under this Agreement, or (b) any
negligent act or omission or the willful misconduct of any Manufacturer
Indemnitees in performing obligations under this Agreement that results in a
claim for damages.

    


    12.2         Indemnification by
Customer.  Customer will indemnify, defend and hold harmless
Manufacturer, its Affiliates and their respective officers, directors, employees
and agents (each a “ Manufacturer
Indemnitee”) from and against any and all Losses in connection with any
and all actions, suits, claims or demands that may be brought or instituted
against any Manufacturer Indemnitee by any third party based on, or arising out
of, or resulting directly from (a) the use of the Product, except to the extent
that such Losses are within the scope of the indemnification obligation of
Manufacturer under Section 12.1, (b) any breach by Customer of its
representations, warranties or covenants under this Agreement, or (c) any
negligent act or omission or the willful misconduct of any Customer Indemnitees
in performing obligations under this Agreement that results in a claim for
damages.

    


    12.3         Procedures.  Each
party agrees to notify the other party within thirty (30) days of receipt of any
claims made for which the other party might be liable under Section 12.1 or
12.2, as the case may be. Subject to Section 12.4, the indemnifying party will
have the right to defend, negotiate, and settle such claims.  The
party seeking indemnification will provide the indemnifying party with such
information and assistance as the indemnifying party may reasonably request, at
the expense of the indemnifying party.  The parties understand that no
insurance deductible will be credited against losses for which a party is
responsible under this Section 12.

    


    12.4         Settlement.  Neither
party will be responsible or bound by any settlement of any claim or suit made
without its prior written consent; provided, however, that the indemnified party
will not unreasonably withhold or delay such consent.  If a settlement
contains an absolute waiver of liability for the indemnified party, and each
party has acted in compliance with the requirements of Section 12.3, then the
indemnified party’s consent will be deemed given. Notwithstanding the foregoing,
Manufacturer will not agree to settle any claim on such terms or conditions as
would impair Customer’s ability or right to Manufacture, market, sell or
otherwise use Product, or as would impair Manufacturer’s ability, right or
obligation to perform its obligations under this Agreement.

    


    [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission.  Confidential treatment has
been requested with respect to the omitted portions.

     

    
      
         


      

      
        Page 16
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    12.5         Limitation of
Liability.  NOTWITHSTANDING ANYTHING IN THIS AGREEMENT TO THE
CONTRARY, IN NO EVENT WILL EITHER PARTY BE LIABLE FOR ANY SPECIAL, INCIDENTAL,
CONSEQUENTIAL OR INDIRECT DAMAGES ARISING OUT OF THIS AGREEMENT, HOWEVER CAUSED
AND ON ANY THEORY OF LIABILITY. THIS LIMITATION WILL APPLY EVEN IF THE OTHER
PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGE; PROVIDED, HOWEVER, THAT THIS
LIMITATION WILL NOT APPLY TO DAMAGES RESULTING FROM BREACHES BY A PARTY OF ITS
DUTY OF CONFIDENTIALITY AND NON-USE IMPOSED UNDER SECTION 10 OR ITS
INDEMNIFICATION OBLIGATIONS UNDER THIS SECTION 12.

    


    13.           Insurance.

    


    13.1         Insurance.  Manufacturer
and Customer shall maintain during the term of this Agreement and for at least
five (5) years thereafter (for claims made coverage) policies of insurance in
the amounts and of the types reasonably appropriate for the conduct of their
respective business.  Manufacturer and Customer shall maintain the
following minimum insurance coverage with financially-sound and
nationally-reputable insurers:  Comprehensive Liability with
contractual and product liability insurance.

    


    13.2         Evidence of Manufacturer’s
Insurance.  Manufacturer will furnish to Customer a certificate
from an insurance carrier (having a minimum AM Best rating of A) demonstrating
the insurance requirements set forth above. The insurance certificate will
confirm each of the following:

    


    (a)           excluding
Manufacturer’s Worker’s Compensation policy, Customer is named as an additional
insured with respect to matters arising from this Agreement;

    


    (b)           such
insurance is primary and non-contributing to any liability insurance carried by
Customer; and

    


    (c)           thirty
(30) days prior written notice will be given to Customer of cancellation or any
material change in the policies.

    


    13.3         Evidence of
Customer’s
Insurance.  Customer will furnish to Manufacturer a certificate
from an insurance carrier (having a minimum AM Best rating of A) demonstrating
the insurance requirements set forth above. The insurance certificate will
confirm each of the following:

    (a)           excluding
Customer’s Worker’s Compensation policy, Manufacturer is named as an additional
insured with respect to matters arising from this Agreement;

    


    (b)           such
insurance is primary and non-contributing to any liability insurance carried by
Customer; and

    


    (c)           thirty
(30) days prior written notice will be given to Manufacturer of cancellation or
any material change in the policies.

    


    13.4         Insurance
Information.  Manufacturer will comply, at Customer’s expense,
with reasonable requests for information made by Customer’s insurance provider
representative(s), including permitting such representative(s) to inspect the
Facility during operational hours and upon reasonable notice to Manufacturer. In
regard to such inspections, the representative(s) will adhere to such guidelines
and policies pertaining to safety and non-disclosure as Manufacturer may
reasonably require.

    


    [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission.  Confidential treatment has
been requested with respect to the omitted portions.

     

    
      
         


      

      
        Page 17
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    14.           Term and
Termination.

    


    14.1          Term.  This
Agreement will take effect as of the Effective Date and, unless earlier
terminated pursuant to this Section 14, will expire on the later of (a) five (5)
years from the Effective Date, or (b) the completion of Services under the last
Work Order executed by the parties prior to the 5th
anniversary of the Effective Date.  The term of this Agreement may be
extended by Customer continuously for additional two (2) year periods upon
written notice to Manufacturer at least thirty (30) days prior to the expiration
of the then current term under existing terms and conditions.

    


    14.2          Termination by
Customer.  Customer will have the right, in its sole
discretion, to terminate this Agreement and/or any Work Order (a) upon thirty
(30) days prior written notice to Manufacturer, or (b) immediately upon written
notice if (i) in Customer’s reasonable judgment, Manufacturer is or will be
unable to perform the Services in accordance with the agreed upon timeframe and
budget set forth in the applicable Work Order, or (ii) Manufacturer fails to
obtain or maintain any material governmental licenses or approvals required in
connection with the Services.

    


    14.3          Termination by
Manufacturer.  Manufacturer will have the right, in its sole
discretion, to terminate this Agreement and/or any Work Order (upon written
thirty (30) days prior notice if (i) in Manufacturer’s reasonable judgment,
Customer is or will be unable to purchase the Product as expected and per
schedule in accordance with the agreed upon timeframe and budget set forth in
the applicable Work Order, or (ii) Customer fails to obtain or maintain any
material governmental licenses or approvals required in connection with the
Product.

    


    14.4          Termination by Either
Party.  Either party will have the right to terminate this
Agreement or any signed Work Orders that are pending by written notice to the
other party, upon the occurrence of any of the following:

    


    (a)   the
other party files a petition in bankruptcy, or enters into an agreement with its
creditors, or applies for or consents to the appointment of a receiver or
trustee, or makes an assignment for the benefit of creditors, or becomes subject
to involuntary proceedings under any bankruptcy or insolvency law (which
proceedings remain undismissed for sixty (60) days);

    


    (b)   the
other party fails to start and diligently pursue the cure of a material breach
of this Agreement within thirty (30) days after receiving written notice from
the other party of such breach; or

    


    (c)    a  force majeure event that
will, or continues to, prevent performance (in whole or substantial part) of
this Agreement or any pending Work Order for a period of at least ninety (90)
days.  In the case of a force majeure event relating
to a pending Work Order, the right to terminate will be limited to such Work
Order.

    


    [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission.  Confidential treatment has
been requested with respect to the omitted portions.

     

    
      
         


      

      
        Page 18
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    14.5          Effect of
Termination.  Manufacturer will, upon receipt of a termination
notice from Customer, promptly cease performance of the applicable Services and
will take all reasonable steps to mitigate the out-of-pocket expenses incurred
in connection therewith.  In particular, Manufacturer will use its
best efforts to:

    


    (a)   immediately
cancel, to the greatest extent possible, any third party
obligations;

    


    (b)   promptly
inform Customer of any irrevocable commitments made in connection with any
pending Work Order(s) prior to termination;

    


    (c)    promptly
return to the vendor for a refund all unused, unopened materials in
Manufacturer’s possession that are related to any pending Work Order; provided
that Customer will have the option, but not the obligation, to take possession
of any such materials;

    


    (d)    promptly
inform Customer of the cost of any remaining unused, unreturnable materials
ordered pursuant to any pending Work Order(s), and either deliver such materials
to Customer (or its designee) or properly dispose of them, as instructed by
Customer; and

    


    (e)     perform
only those services and activities mutually agreed upon by Customer and
Manufacturer as being necessary or advisable in connection with the close-out of
any pending Work Order(s).

    


    14.6          Return of
Materials/Confidential Information.  Upon the expiration or
termination of this Agreement, each party will promptly return all Confidential
Information of the other party that it has received pursuant to this
Agreement.

    


    14.7          Inventories.  Upon
expiration or termination of this Agreement or a pending Work Order, Customer
(a) will purchase from Manufacturer any existing inventories of Product
conforming to the Specifications and Manufactured in accordance with cGMP (if
applicable) and the Manufacturing Process, at the price for such Product set
forth in the applicable Work Order, and (b) may either (i) purchase any Product
in process held by Manufacturer as of the date of the termination, at a price to
be mutually agreed (it being understood that such price will reflect, on a pro
rata basis, work performed and non-cancelable out-of-pocket expenses actually
incurred by Manufacturer with respect to the Manufacture of such in-process
Product), or (ii) direct Manufacturer to dispose of such material at Customer’s
cost.

    


    14.8          Payment
Reconciliation.  Within thirty (30) days after the close-out of
a Work Order, Manufacturer will provide to Customer a written itemized statement
of all work performed by it in connection with the terminated Work Order, an
itemized breakdown of the costs associated with that work, and a final invoice
for that Work Order.  If Customer has pre-paid to Manufacturer more
than the amount in a final invoice then Manufacturer agrees to promptly refund
that money to Customer, or to credit the excess payment toward another existing
or future Work Order, at the election of Customer.

    


    [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission.  Confidential treatment has
been requested with respect to the omitted portions.

     

    
      
         


      

      
        Page 19
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    14.9          Survival.  Expiration
or termination of this Agreement for any reason will not relieve either party of
any obligation accruing prior to such expiration or termination or of any rights
and obligations of the parties that by their terms survive termination or
expiration of this Agreement or of any Work Order, including, without
limitation, Sections 1, 4, 5.2(c), 5.2(d), 5.4, 5.5, 5.8, 9 through 13, 14.4,
14.5, 14.6, 14.7, 14.8 and 15, and the provisions of the applicable Quality
Agreement.

    


    15.           Miscellaneous.

    


    15.1         Independent
Contractor.  All Services will be rendered by Manufacturer as
an independent contractor and this Agreement does not create an
employer-employee relationship between   Customer and
Manufacturer. Manufacturer will not in any way represent itself to be a partner
or joint venturer of or with Customer.

    


    15.2         Force
Majeure.  Except as
otherwise expressly set forth in this Agreement, neither party will have
breached this Agreement for failure or delay in fulfilling or performing any
term of this Agreement when such failure or delay is caused by or results from
causes beyond the reasonable control of the affected party, including, without
limitation, fire, floods, embargoes, shortages, epidemics, quarantines, war,
acts of war (whether war be declared or not), insurrections, riots, civil
commotion, strikes, acts of God or acts, omissions, or delays in acting, by any
governmental authority (“force
majeure”).  The party affected by any event of force majeure will promptly
notify the other party, explaining the nature, details and expected duration
thereof.  Such party will also notify the other party from time to
time as to when the affected party reasonably expects to resume performance in
whole or in part of its obligations under this Agreement, and to notify the
other party of the cessation of any such event.  A party affected by
an event of force
majeure will use its reasonable efforts to remedy, remove, or mitigate
such event and the effects thereof with all reasonable dispatch.  If a
party anticipates that an event of force majeure may occur, such
party will notify the other party of the nature, details and expected duration
thereof. Upon termination of the event of force majeure, the
performance of any suspended obligation or duty will promptly
recommence.

    


    15.3         Notices.  All
notices must be written and sent to the address or facsimile number identified
below or in a subsequent notice.  All notices must be given (a) by
personal delivery, with receipt acknowledged, (b) by facsimile followed by hard
copy delivered by the methods under (c) or (d), (c) by prepaid certified or
registered mail, return receipt requested, or (d) by prepaid recognized next
business day delivery service.  Notices will be effective upon receipt
or at a later date stated in the notice.

    


    [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission.  Confidential treatment has
been requested with respect to the omitted portions.

     

    
      
         


      

      
        Page 20
of 22

        
          

        

      

      
         


      

    

     

    If to
Manufacturer, to:

     

    Navinta,
LLC

     

    ATTN.  Christopher
Newton, Ph.D.

     

    1499
Lower Ferry Road

     

    Ewing, NJ
08619

     

     

     

    If to
Customer, to:

    


    CorMedix
Inc.

    ATTN.
John C. Houghton

    86 Summit
Ave.

    Summit,
NJ 07901

    


    15.4        Assignment.  This
Agreement may not be assigned or otherwise transferred by either party without
the prior written consent of the other party; provided, however, that
Customer may, without such consent, but with notice to the Manufacturer, assign
this Agreement, in whole or in part, (a) in connection with the transfer or sale
of all or substantially all of its assets or the line of business or Product to
which this Agreement relates, (b) to a successor entity or acquirer in the event
of a merger, consolidation or change of control, or (c) to any Affiliate. Any
purported assignment in violation of the preceding sentence will be
void.  Any permitted assignee will assume the rights and obligations
of its assignor under this Agreement.

    


    15.5        Entire
Agreement.  This Agreement, including the attached Appendices
and any fully-signed Work Orders, each of which are incorporated herein,
constitute the entire agreement between the parties with respect to the specific
subject matter hereof and all prior agreements including but not limited to the
Confidentality Agreement entered into by the Parties, effective October 2nd
2006 with respect
thereto are superseded.  Each party hereto confirms that it is not
relying on any representations or warranties of the other party except as
specifically set forth herein.

    


    15.6        No Modification. This
Agreement and and/or any Work Order or Quality Agreement may be changed only by
a writing signed by authorized representatives of both parties.

    


    15.7        Severability;
Reformation.  Each provision in this Agreement is independent
and severable from the others, and no restriction will be rendered unenforceable
because any other provision may be invalid or unenforceable in whole or in
part.  If the scope of any restrictive provision in this Agreement is
too broad to permit enforcement to its full extent, then such restriction will
be reformed to the maximum extent permitted by law.

    


    [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission.  Confidential treatment has
been requested with respect to the omitted portions.

     

    
      
         


      

      
        Page 21
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    15.8          Governing
Law.  This Agreement will be construed and interpreted and its
performance governed by the laws of the state of New Jersey, U.S.A, without regard to any choice
of law principle that would dictate the application of the law of another
jurisdiction. The application of the 1980 United Nations Convention on Contracts
for the International Sale of Goods is hereby specifically
excluded.

    


    15.9          Waiver.  No
waiver of any term, provision or condition of this Agreement in any one or more
instances will be deemed to be or construed as a further or continuing waiver of
any other term, provision or condition of this Agreement.  Any such
waiver, extension or amendment will be evidenced by an instrument in writing
executed by an officer authorized to execute waivers, extensions or
amendments.

    


    15.10        Counterparts.  This
Agreement may be executed in any number of counterparts, each of which will be
deemed an original and all of which together will constitute one and the same
instrument.

    


    15.11        Headings.  This
Agreement contains headings only for convenience and the headings do not
constitute or form a part of this Agreement, and should not be used in the
construction of this Agreement.

    


    15.12        No Benefit to Third
Parties.  The representations, warranties, covenants and
agreements set forth in this Agreement are for the sole benefit of the parties
hereto and their successors and permitted assigns, and they will not be
construed as conferring any rights on any other persons.

    


    IN
WITNESS WHEREOF, the parties hereto have caused this Agreement to be executed by
their duly authorized representatives as of the Effective Date.

    


    
      
        
          
            
              	
                      CORMEDIX
      INC.

                    	 
      	
                      NAVINTA,
      LLC

                    
	 
      	 
      	 
      	 
      	 
      
	
                      By

                    	
                      /s/ John C. Houghton

                    	 
      	
                      By

                    	
                      /s/ Pankaj Dave

                    
	 
      	 
      	 
      	 
      	 
      
	
                      Print
      Name

                    	
                      John C. Houghton

                    	 
      	
                      Print
      Name

                    	
                      Pankaj Dave

                    
	 
      	 
      	 
      	 
      	 
      
	
                      Title

                    	
                      President and CEO

                    	 
      	
                      Title

                    	
                      Vice President

                    
	 
      	 
      	 
      	 
      	 
      
	
                      Date

                    	
                      12/7/09

                    	 
      	
                      Date

                    	
                      12/4/09

                    


            

          

        

      

    

    


    [*]
Certain information in this document has been omitted and filed separately with
the Securities and Exchange Commission.  Confidential treatment has
been requested with respect to the omitted portions.

     

    
      
         


      

      
        Page 22
of 22