Exhibit 10.1
 
Portions of this exhibit marked [*] are requested to be treated confidentially
 
PRELIMINARY SERVICES AGREEMENT
 
This PRELIMINARY SERVICES AGREEMENT (this “Agreement”), dated as of April 8,
2015, is entered into by and among CorMedix Inc., a Delaware corporation with
offices located at 1430 U.S. Highway 206, Suite 200, Bedminster, New Jersey
07921 (the “Company”), and (RC)2 Pharma Connect, LLC, a New Jersey limited
liability company with offices located at 1200 MacArthur Boulevard, Suite 300,
Mahwah, NJ 07430 (the “Provider”).

RECITALS

A.           The Company and the Provider have exchanged proposals (as per the
attached Exhibit A) (the “Proposals”), pursuant to which the Provider has agreed
to perform certain manufacturing services relating to the active pharmaceutical
ingredient Taurolidine for the Company.

B.           The services to be performed by the Provider are set forth in a
Purchase Orders attached as Exhibit B to this agreement (the “Orders”). The
Orders includes a payment schedule and budget which sets forth the amounts to be
paid by the Company to the Provider in exchange for the Provider’s manufacturing
services.

c.           Capitalized terms not otherwise defined herein shall have the
meanings given to them in the Proposals and the Orders.

AGREEMENT

NOW, THEREFORE, in consideration of the premises and the mutual covenants
contained herein and for other good and valuable consideration, the receipt and
sufficiency of which are hereby acknowledged, the Company and the Provider
hereby agree as follows:

1.           SERVICES AND PAYMENT

(a)           Services.  The Provider shall perform the services and the Company
shall pay the Provider in connection with certain events as contemplated by the
Proposals and the Orders and as summarized below.

(i)  
Critical Parameters Evaluation.

Under the Orders, the Provider is to invoice the Company a total of $[*] plus
the cost of materials for the Critical Parameters Evaluation phase of the
manufacturing project. Of this total, $[*] (plus materials) has been invoiced
and paid by Cormedix. The Company and the Provider estimate that the balance of
all amounts due for the Critical Parameters Evaluation phase (inclusive of the
cost of materials) will be invoiced on or before April 15, 2015.
 
[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.
 
 
1

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

 
 
(ii)  
cGMP Analytical Work.

Under the Orders, the Provider will complete the analytical and development work
already in progress to support a cGMP 10kg “Demo” Batch at a cost to the Company
of $[*]. The Company and the Provider estimate that the total amount due for the
cGMP Analytical Work will be invoiced on or after April 15, 2015.

(iii)  
cGMP 10 kg “Demo” Batch.

Under the Orders, the Provider will produce a 10 kg batch of Taurolidine at a
cost to the Company of $[*]. The Company and the Provider estimate that the
total amount due for the cGMP 10 kg “Demo” Batch will be invoiced upon the
approval to produce the Engineering Batch on or after April 15, 2015.

(iv)  
cGMP Engineering Batch.

Under the Orders, the Provider will produce an Engineering Batch of Taurolidine
at a cost to the Company of approximately $[*]. The Company and the Provider
estimate that the total amount due for the cGMP Engineering Batch will be
invoiced on or after April 15, 2015.

(iii)  
cGMP Validation Batches.

Under the Orders, the Provider will produce three validation batches of
Taurolidine at a cost to the Company of $[*]. Of this total amount, the Company
will pay in accordance with the following schedule:

(1)           Approximately $[*] upon approval to purchase raw materials, which
the Company and the Provider estimate will occur on or after April 15, 2015.

(2)           Approximately $[*] upon the approval of the engineering and
validation process, which the Company and the Provider estimate will occur on or
after April 15, 2015.
 
(3)           Approximately $[*] to be paid in three equal installments of
approximately $[*] upon the successful completion of each of the three cGMP
Validation Batches, which the Company and the Provider estimate will occur
between June 1 and July 30, 2015.
 
(iv)  
Stability Program.

 
Under the Orders, the Provider will invoice the Company a total of $[*] in
connection with the stability program.

(iii)  
Estimated Commercial Cost.

 
[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 
2

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

 

The Company and the Provider agree that the commercial cost of the Taurolidine
is not expected to exceed $[*] per kilogram.

(vi)           Manufacturing Services Agreement.

The Company and the Provider agree to use their best efforts to negotiate a
manufacturing services agreement within sixty (60) days of the date of this
Agreement, which agreement would cover the business terms that are the subject
of and contemplated in the Proposals and Orders.

(b)           Payment Procedures

(i)           Invoicing

The Provider shall invoice the Company for all amounts due under the Orders. The
Company shall pay such invoices in cash in accordance with the Provider’s
standard terms and conditions with respect to invoicing as described in the
Proposals and Orders.

 (ii)           Provider’s Failure to Perform

As set forth in Section 3.2 of the Proposals, the Services to be performed by
the Provider under the Proposals and the Orders shall 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. In the event the Services performed do not meet the requirements of
the Proposals in any material respect, the Provider shall, at the Company’s
written request (which may be via e-mail), either promptly re-perform such
Services at no additional cost to the Company or provide the Company with a full
refund of amounts paid by the Company for such Services.

2.
PROVIDER’S REPRESENTATIONS AND WARRANTIES.

The Provider represents and warrants to the Company that as of the date hereof:

(a)           The Provider is an entity duly organized, validly existing and in
good standing under the laws of the jurisdiction of its organization.  The
Provider has the requisite power and authority to enter into and to consummate
the transactions contemplated by this Agreement and otherwise to carry out its
obligations hereunder.

(b)           This Agreement has been duly and validly authorized, executed and
delivered on behalf of the Provider and constitutes the legal, valid and binding
obligation of the Provider enforceable against the Provider in accordance with
its terms, except as such enforceability may be limited by general principles of
equity or applicable bankruptcy, insolvency, reorganization, moratorium,
liquidation and other similar laws relating to, or affecting generally, the
enforcement of applicable creditors’ rights and remedies.

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.
 
 
3

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

 
 
(c)           The execution, delivery and performance by the Provider of this
Agreement and the consummation by the Provider of the transactions contemplated
hereby will not (i) result in a violation of the organizational documents of the
Provider, (ii) conflict with, or constitute a default (or an event which with
notice or lapse of time or both would become a default) under, or give to others
any rights of termination, amendment, acceleration or cancellation of, any
agreement, indenture or instrument to which the Provider is a party, or (iii)
result in a violation of any law, rule, regulation, order, judgment  or decree
applicable to the Provider, except in the case of clauses (ii) and (iii) above,
for such conflicts, defaults, rights or violations which would not, individually
or in the aggregate, reasonably be expected to have a material adverse effect on
the ability of the Provider to perform its obligations hereunder.

3.
REPRESENTATIONS AND WARRANTIES OF THE COMPANY.

The Company represents and warrants to the Provider that, as of the date hereof:

(a)   The Company is duly organized and validly existing and in good standing
under the laws of the jurisdiction of its organization. The Company has the
requisite power and authority to enter into and to consummate the transactions
contemplated by this Agreement and otherwise to carry out its obligations
hereunder.

(b)           This Agreement has been duly and validly authorized, executed and
delivered on behalf of the Company and constitutes the legal, valid and binding
obligation of the Provider enforceable against the Company in accordance with
its terms, except as such enforceability may be limited by general principles of
equity or applicable bankruptcy, insolvency, reorganization, moratorium,
liquidation and other similar laws relating to, or affecting generally, the
enforcement of applicable creditors’ rights and remedies

(c)           The execution, delivery and performance by the Company of this
Agreement and the consummation by the Company of the transactions contemplated
hereby will not (i) result in a violation of the organizational documents of the
Company, (ii) conflict with, or constitute a default (or an event which with
notice or lapse of time or both would become a default) under, or give to others
any rights of termination, amendment, acceleration or cancellation of, any
agreement, indenture or instrument to which the Company is a party, or (iii)
result in a violation of any law, rule, regulation, order, judgment  or decree
applicable to the Company, except in the case of clauses (ii) and (iii) above,
for such conflicts, defaults, rights or violations which would not, individually
or in the aggregate, reasonably be expected to have a material adverse effect on
the ability of the Company to perform its obligations hereunder
 
4.           CONFIDENTIAL INFORMATION.

(a) All technical, business, regulatory, and marketing informa­tion provided to
Provider by on behalf of the Company, including but not limited to that
concerning Taurolidine, and all information generated in the course of
Provider’s performance under the Proposals and Orders, is considered by the
Company to be proprietary and confidential (all of the foregoing, collectively,
the “Company Confidential Information”).  Provider agrees to treat it as such,
according the CorMedix Confidential Information the same protections as its own
proprietary and confidential information of a similar nature, which shall be no
less than reasonable level of such protection.  Provider agrees that it shall
not disclose Company Confidential Information to any third party or use any
Company Confidential Information for any purpose other than for the purposes of
fulfilling its obligations under the Proposals and Orders.
 
 
4

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

 
 
(b) Nothing in this Section 4 shall be construed to prevent Provider from:

(i) disclosing Company Confidential Information to a court or regulatory
authority as necessary in con­nection with its obligations under this Agreement,
the Proposals or the Orders; or

(ii) disclosing such information as is required by law or judicial order to be
disclosed,

provided that in either case Provider (i) provides advance written notice of
such disclosure as soon as reasonably practicable, (ii) assists the Company, as
reasonably requested by the Company, in seeking or obtaining confidential or
protective treatment of such information, and (iii) minimizes the extent of such
disclosure to the extent legally permissible.

(c) The confidentiality obligations of this Section 4 shall not extend to
information which:
 
(i) is or becomes known to the public through no fault or action by Provider; or

(ii) is disclosed to Provider without restriction on disclosure by a third party
not un­der an obligation of secrecy to the Company.

5.           INTELLECTUAL PROPERTY.

All materials, documents, and deliverables of any kind supplied to the Company
from Provider or generated by Provider as a result of the services performed the
Proposals or Orders or access to or knowledge of Company Confidential
Information shall be the sole and exclusive property of the Company.  Provider
hereby assigns all such materials, documents, and deliverables to the Company,
including all associated intellectual property rights. Any invention, discovery,
know-how or improvement that is conceived or made solely by one or more
employees, consultants, agents, contractors, or representatives of Provider or
jointly by employees, consultants, agents, contractors, or representatives of
Provider or the Company in the course of the performance by Provider under the
Proposals or Orders or as a result of Provider’s access to Company Confidential
Information (collectively, “Inventions”) shall be owned by the
Company.  Provider covenants and warrants that all employees, consultants,
agents, contractors, or representatives of it are contractually or legally
obligated to assign all of their rights in Inventions to Provider.  Provider
hereby assigns to the Company all right, title, and interest in any Company
Inventions and all associated patents rights and other intellectual property
rights, free and clear of all liens, claims, or encumbrances.  Provider shall
take all reasonable actions and execute all documents reasonably requested by
the Company to effect the purposes of the foregoing.  Provider agrees to assist
the Company, at the Company’s reasonable expense, in preparing and prosecuting
patent applications and patent extensions or in obtaining other forms of
intellectual property right protections on any Company Inventions assigned to
the Company under this Section 5 which the Company elects to protect.
 
 
5

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

 

 
6.
MISCELLANEOUS.

(a) Governing Law; Jurisdiction; Jury Trial.  All questions concerning the
construction, validity, enforcement and interpretation of this Agreement shall
be governed by the internal laws of the State of Delaware, without giving effect
to any choice of law or conflict of law provision or rule (whether of the State
of Delaware or any other jurisdictions) that would cause the application of the
laws of any jurisdictions other than the State of Delaware. Each party hereby
irrevocably submits to the exclusive jurisdiction of the state and federal
courts sitting in The City of Wilmington, State of Delaware, for the
adjudication of any dispute hereunder or in connection herewith or with any
transaction contemplated hereby or discussed herein, and hereby irrevocably
waives, and agrees not to assert in any suit, action or proceeding, any claim
that it is not personally subject to the jurisdiction of any such court, that
such suit, action or proceeding is brought in an inconvenient forum or that the
venue of such suit, action or proceeding is improper. Each party hereby
irrevocably waives personal service of process and consents to process being
served in any such suit, action or proceeding by mailing a copy thereof to such
party at the address for such notices to it under this Agreement and agrees that
such service shall constitute good and sufficient service of process and notice
thereof. Nothing contained herein shall be deemed to limit in any way any right
to serve process in any manner permitted by law.  EACH PARTY HEREBY IRREVOCABLY
WAIVES ANY RIGHT IT MAY HAVE TO, AND AGREES NOT TO REQUEST, A JURY TRIAL FOR THE
ADJUDICATION OF ANY DISPUTE HEREUNDER OR IN CONNECTION WITH OR ARISING OUT OF
THIS AGREEMENT OR ANY TRANSACTION CONTEMPLATED HEREBY.

(b) Counterparts.  This Agreement may be executed in two or more identical
counterparts, all of which shall be considered one and the same agreement and
shall become effective when counterparts have been signed by each party and
delivered to the other party. In the event that any signature is delivered by
facsimile transmission or by an e-mail which contains a portable document format
(.pdf) file of an executed signature page, such signature page shall create a
valid and binding obligation of the party executing (or on whose behalf such
signature is executed) with the same force and effect as if such signature page
were an original thereof.

(c) Headings; Gender.  The headings of this Agreement are for convenience of
reference and shall not form part of, or affect the interpretation of, this
Agreement. Unless the context clearly indicates otherwise, each pronoun herein
shall be deemed to include the masculine, feminine, neuter, singular and plural
forms thereof. The terms “including,” “includes,” “include” and words of like
import shall be construed broadly as if followed by the words “without
limitation.”  The terms “herein,” “hereunder,” “hereof” and words of like import
refer to this entire Agreement instead of just the provision in which they are
found.
 
 
6

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

 
 
(d) Severability.  If any provision of this Agreement is prohibited by law or
otherwise determined to be invalid or unenforceable by a court of competent
jurisdiction, the provision that would otherwise be prohibited, invalid or
unenforceable shall be deemed amended to apply to the broadest extent that it
would be valid and enforceable, and the invalidity or unenforceability of such
provision shall not affect the validity of the remaining provisions of this
Agreement so long as this Agreement as so modified continues to express, without
material change, the original intentions of the parties as to the subject matter
hereof and the prohibited nature, invalidity or unenforceability of the
provision(s) in question does not substantially impair the respective
expectations or reciprocal obligations of the parties or the practical
realization of the benefits that would otherwise be conferred upon the parties.
The parties will endeavor in good faith negotiations to replace the prohibited,
invalid or unenforceable provision(s) with a valid provision(s), the effect of
which comes as close as possible to that of the prohibited, invalid or
unenforceable provision(s).

(e) Entire Agreement; Amendments. This Agreement and the instruments referenced
herein supersede all other prior oral or written agreements between the
Provider, the Company, its Subsidiaries, their affiliates and Persons acting on
their behalf solely with respect to the matters contained herein and therein
(other than the Proposals and the Orders), and this Agreement, the Proposals,
the Orders and the instruments referenced herein and therein contain the entire
understanding of the parties solely with respect to the matters covered herein
and therein. In the event of a conflict between the terms of this Agreement and
the Proposals and/or Orders, the terms of this Agreement will control. For
clarification purposes, the Recitals are part of this Agreement. No provision of
this Agreement may be amended other than by an instrument in writing signed by
the Company and the Provider.  No waiver shall be effective unless it is in
writing and signed by an authorized representative of the waiving party.

(f) Notices. Any notices, consents, waivers or other communications required or
permitted to be given under the terms of this Agreement must be in writing and
will be deemed to have been delivered: (i) upon receipt, when delivered
personally; (ii) upon receipt, when sent by facsimile (provided confirmation of
transmission is mechanically or electronically generated and kept on file by the
sending party); or (iii) one (1) Business Day after deposit with an overnight
courier service with next day delivery specified, in each case, properly
addressed to the party to receive the same. The addresses and facsimile numbers
for such communications shall be as follows.
 
If to the Company:
 
CorMedix Inc.
1430 U.S. Highway 206, Suite 200
Bedminster, NJ 07921
Telephone:  (908) 517-9500
Facsimile:  (908) 429-4307
Attention:  Chief Executive Officer
 
 
7

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

 
 
If to the Provider:
 
(RC)2 Pharma Connect, LLC
1200 MacArthur Boulevard, Suite 300
Mahwah, NJ 07430 Telephone:  908-275-8320
Facsimile:   201-962-7881
Attention:    William T. Cain, Ph.D.

Written confirmation of receipt (A) given by the recipient of such notice,
consent, waiver or other communication, (B) mechanically or electronically
generated by the sender’s facsimile machine containing the time, date, recipient
facsimile number and an image of the first page of such transmission or (C)
provided by an overnight courier service shall be rebuttable evidence of
personal service, receipt by facsimile or receipt from an overnight courier
service in accordance with clause (i), (ii) or (iii) above, respectively.

(g) Successors and Assigns.  This Agreement shall be binding upon and inure to
the benefit of the parties and their respective successors and permitted
assigns.

(h) No Third Party Beneficiaries.  This Agreement is intended for the benefit of
the parties hereto and their respective permitted successors and assigns, and is
not for the benefit of, nor may any provision hereof be enforced by, any other
Person.

(i) Survival.  The representations, warranties, agreements and covenants shall
survive each Closing.

(j) Further Assurances.  Each party shall do and perform, or cause to be done
and performed, all such further acts and things, and shall execute and deliver
all such other agreements, certificates, instruments and documents, as any other
party may reasonably request in order to carry out the intent and accomplish the
purposes of this Agreement and the consummation of the transactions contemplated
hereby.

(k) Construction. The language used in this Agreement will be deemed to be the
language chosen by the parties to express their mutual intent, and no rules of
strict construction will be applied against any party.  No specific
representation or warranty shall limit the generality or applicability of a more
general representation or warranty.

 
[Signature pages follow]
 
 
8

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

 
 
IN WITNESS WHEREOF, the Provider and the Company have caused their respective
signature page to this Agreement to be duly executed as of the date first
written above.
 

  COMPANY:           CORMEDIX INC.          
 
By:
/s/ Randy Milby       Name: Randy Milby       Title: Chief Executive Officer    
     

 
[Signature page to Preliminary Services Agreement]

 
9

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

 

IN WITNESS WHEREOF, the Provider and the Company have caused their respective
signature page to this Agreement to be duly executed as of the date first
written above.
 
 

  PROVIDER:           (RC)2 PHARMA CONNECT, LLC          
 
By:
/s/ William T. Cain       Name: William T. Cain       Title: Executive Vice
President          

 
 
 
[Signature page to Preliminary Services Agreement]
 
 
10

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

 

 
Exhibit A

Proposals

Proposal
 
Date
 
Work
[*]
 
[*]
 
[*]
[*]
 
[*]
 
[*]
[*]
 
[*]
 
[*]
[*]
 
[*]
 
[*]

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

 
11

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

 
 
Exhibit B

Orders

Purchase Order
 
Date
 
Work
[*]
 
[*]
 
[*]
[*]
 
[*]
 
[*]

 

[*] Confidential treatment requested; certain information omitted and filed
separately with the SEC.

12

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