Exhibit 10.1
 
Portions of this exhibit marked [*] are requested to be treated confidentially
 
MANUFACTURER:
n       NAVINTA, LLC
MANUFACTURER CONTACT:
n       CHRISTOPHER NEWTON, Ph.D.
CUSTOMER CONTACT:
n       JOHN C. HOUGHTON
EFFECTIVE DATE:
n       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).
 
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

--------------------------------------------------------------------------------

 
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.
 
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.
 
 
2

--------------------------------------------------------------------------------

 
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.
 
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.
 
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.
 
 
3

--------------------------------------------------------------------------------

 
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;
 
(b) Following the First Commercial Sale, Customer shall purchase a minimum
amount of 150 kg of Product and/or taurolidine on an annual basis. Customer
shall be required to purchase such minimum amount for a period of five (5) years
following the First Commercial Sale. Notwithstanding anything to the contrary
herein, after expiration of such five-year period following the First Commercial
Sale, Customer and Manufacturer shall negotiate in good faith a new minimum
purchase requirement, which shall be less than the minimum purchase requirement
for the initial five-year period. Further, Customer and Manufacturer shall
discuss in good faith a reduction in the minimum purchase requirement promptly
upon entry of a generic product (based on an API equivalent to the Product
and/or taurolidine) into the market place. Customer currently anticipates
consummating the First Commercial Sale of Product and/or taurolidine by the
fourth quarter of 2012 (the “Anticipated Date of First Commercial Sale”). The
Anticipated Date of First Commercial sale shall be adjusted to take into account
delays in the Customer's development timeline that are outside of the Customer's
reasonable control (such as those required by the Applicable Authorities).
 
(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) (a) [*] Dollars ($[*]) on the date that Net Sales of a Product by Customer
and its Affiliates first equal, in the aggregate, [*] Dollars ($[*]) for the
Product;
 
(b) [*] Dollars ($[*]) on the date that Net Sales of a Product by Customer and
its Affiliates first equal, in the aggregate, [*] Dollars ($[*]) for the
Product;
 
(c) [*] Dollars ($[*]) on the date that Net Sales of a Product by Customer and
its Affiliates first equal, in the aggregate, [*] Dollars ($[*]) for the
Product;
 
(d) [*] Dollars ($[*]) on the date that Net Sales of a Product by Customer and
its Affiliates first equal, in the aggregate, [*] Dollars ($[*]) for the
Product; and
 
(e) [*] Dollars ($[*]) on the date that Net Sales of a Product by Customer and
its Affiliates first equal, in the aggregate, [*] Dollars ($[*]).
 
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.
 
 
4

--------------------------------------------------------------------------------

 
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.
 
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).
 
(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.
 
 
5

--------------------------------------------------------------------------------

 
(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.
 
(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.
 
(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.
 
 
6

--------------------------------------------------------------------------------

 
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) [*] percent ([*]%) of Net Sales of such Product for annual sales of such
Product of less than [*] Dollars ($[*]);
 
(b) [*] percent ([*]%) of Net Sales of such Product for annual sales of such
Product of between [*] Dollars ($[*]) and [*] Dollars ($[*]); and
 
(c) [*] Percent ([*]%) of Net Sales of such Product for annual sales of such
Product of greater than [*] Dollars ($[*]).
 
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.
 
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:
 
 
7

--------------------------------------------------------------------------------

 
(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.
 
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.
 
10.           Confidentiality.
 
 
8

--------------------------------------------------------------------------------

 
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:
 
(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.
 
 
9

--------------------------------------------------------------------------------

 
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.
 
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.
 
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.
 
 
10

--------------------------------------------------------------------------------

 
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.
 
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.
 
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;
 
 
11

--------------------------------------------------------------------------------

 
(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.
 
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.
 
 
12

--------------------------------------------------------------------------------

 
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.
 
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.
 
 
13

--------------------------------------------------------------------------------

 
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  

 
 
 
14

--------------------------------------------------------------------------------