Contract
Exhibit
10.7
This
Exclusive License and Consulting Agreement (the “Agreement”) is
entered into by and between CorMedix, a Delaware limited liability company (the
"Company"), and
Xxxx-Xxxxxxxx Polaschegg (the “Consultant”) as of
this 28 day of January, 2008 (the “Effective
Date”). Exhibit A includes
definitions of terms used but not otherwise defined within the body of this
Agreement, and Exhibit
A and such definitions shall be incorporated by reference to this
Agreement.
BACKGROUND
1. Consultant
is the owner of (i) the Gel Lock Invention, and (ii) the Treatments
Invention.
2. Consultant
had entered into that certain Exclusive License and Consulting Agreement (the
“Original Agreement”) with ND Partners, LLC (“NDP”), dated April 29, 2005 and
NDP assigned all rights, title and interest to the Original Agreement to Company
in connection with the License and Assignment Agreement entered into between NDP
and Company. Consultant and Company agree that this Agreement
replaces, in its entirety, the Original Agreement.
3. The
Company wishes to license the Assets from Consultant on an exclusive worldwide
basis, and Consultant wishes to grant an exclusive worldwide license in the
Assets to the Company.
4. The
Company wishes to receive consulting services from Consultant, and Consultant
wishes to provide consulting services to the Company.
AGREEMENT
In
consideration of the mutual covenants and promises contained herein and for
other good and valuable consideration, the receipt and sufficiency of which are
hereby acknowledged by the parties hereto, the parties agree as
follows:
I. LICENSE.
1. License Grant; Defense and
Ownership.
(a) Consultant
hereby grants to the Company a License to the Assets.
[*]
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.
(b) The
Company agrees to timely file and pursue, with respect to the Inventions, patent
applications, divisionals, and/or continuations-in-part in Japan and the United
States, to the extent patent protection is available in each of these
countries. The Company shall be responsible for seeking all necessary
approvals for the Assets and shall defend the Assets from third party
infringement. Any award collected from enforcing rights against any
third-party infringers shall be split between Company and Consultant after
deduction of costs for collecting the award at the ratio [*]. The
Company shall be responsible for taking all actions necessary to maintain,
preserve and protect its interests in the Assets, including, without limitation,
timely filing any registrations, documents or certificates with the appropriate
governmental authorities and paying all required fees in connection
therewith. The Company shall own any and all regulatory submissions,
including all applications and associated government licenses, approvals, and
certificates relating to the Assets. The Company shall, at its sole
expense, use Commercially Reasonable Efforts, itself or through the activities
of its Sublicensees and Affiliates, to perform the Development and secure the
Marketing Authorizations for Licensed Products. The Company’s
Development program shall include preclinical and clinical development of
Licensed Products, including research and development, manufacturing, and
laboratory and clinical testing throughout the Term of the
License. Specifically, Company intends to perform development work
including a pilot clinical trial for purposes of obtaining European Medical
Devise certification for the Gel lock invention in Europe within the first 2.5
years following the Effective Date. The Company shall, at its sole
expense, promptly following receipt of the necessary Marketing Authorizations,
use Commercially Reasonable Efforts to, itself or through the activities of its
Sublicensees and Affiliates, promote , market, sell and commercialize
thereafter, Licensed Product.
(c) Consultant
shall not at any time do or cause to be done any act or thing challenging,
contesting, impairing, invalidating, or tending to impair or invalidate any of
the Company’s rights in the Assets or any registrations derived from such
rights.
2.
Initial
Payment. In consideration of the License granted hereunder,
the Company shall pay to Consultant an aggregate of U.S. $5,000 within thirty
(30) days after the date of this Agreement.
3.
Royalty
Payments.
(a) The
Company shall pay Consultant royalty payments (the “Royalty Payments”)
with respect to products sold by the Company, any of its Affiliates or any of
their respective partners if the use, manufacture or sale of Assets contained
within such product is covered by or encompassed within the scope of one or more
claims contained in a then unexpired patent of an Invention as outlined in Table
1.
(A)
equal to
|
(C)
of Net Sales if cumulative Net
Sales
exceed
|
(D)
and are not more than
|
||
[*]
|
[*]
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.
2
Table
1
The
Royalty Payments shall be paid at the rate set forth in column (A) of Table 1
for Product or Products sold anywhere in the world. The calculation
of Net Sales is performed using the factors in Table 2 specified for various
territories.
Case
I
|
Case
II
|
Case
III
|
||
[*]
|
Table
2
Case I: [*]
Case II: [*]
Case
III: [*]
(b) Royalties
may also be additionally reduced if, Company determines, after consultation with
counsel, that it is reasonably necessary to obtain a third party license to
patent rights to avoid infringement thereof by a product embodying the Gel Lock
Invention (such third party patent rights “Blocking Rights”).
The
reduction in the royalties paid to Polaschegg may be reduced by an additional
[*]% of the aggregate amount paid by Company to third parties for Blocking
Rights. The
Treatments Invention shall not have a reduction of royalties based on additional
patented features.
|
(c)
|
The
Royalty Payment shall be paid in United States dollars by the Company
within [*] following the end of each calendar quarter (the first such
quarter to be that in which royalties first accrue) in an amount equal to
the Royalty Payment accruing during that calendar quarter measured in
currency of the country in which sales shall have been made by the
Company, its Affiliates or their respective partners and converted into
United States dollars at such country’s official banker’s rate in effect
on the last day of such calendar quarter. The Royalty Payment
shall be accompanied by reports which shall indicate the sales by the
Company, its Affiliates and their respective partners for the previous
calendar quarter and shall show the amount of the Royalty Payment due with
sufficient information to enable confirmation by
Consultant.
|
Examples
of Royalty Payment Calculations are outlined in Exhibit B.
[*]
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.
3
If a
dispute arises regarding the royalty payment and the calculation of the royalty
payment, the company shall continue to pay royalties without using reductions
pending resolution. The dispute shall be settled according to Section
7 - Arbitration. Any resulting payments made at the wrong rate shall
be corrected by future royalty payments. Failure to pay within sixty
days at the end of each calendar quarter constitutes a breach of the contract by
the Company.
4. Minimum Royalty
Payments.
Minimum Royalty Payments will be paid
on the inventions within rates already defined. If new IP is
developed and applied to the inventions then the Minimum Royalty Payment will be
adjusted according to the table below. The Minimum Royalty Payments
will not be additive, the highest Minimum Royalty Payment for a particular year
shall be paid and the Minimum Royalty Payment will continue until the last
patent expires. Minimum Royalty Payments shall cease to be paid upon
the first commercial sale of Invention, only if royalties from commercial sales
exceed Minimum Royalty Payments.
New
Minimum Royalty Payments
Royalty
for
Calendar
year
|
Gel Lock
Patent
|
Taurolidine
Treatment
Patent
|
Example:
First New
development
to inventions
Assume it
filed in 2009
|
Example:
Second New
development
to inventions
Assume it filed
in 2010
|
||||||||||||
2003
|
0 | [* | ] | [* | ] | |||||||||||
2004
|
0 | 0 | ||||||||||||||
05
|
0 | 0 | ||||||||||||||
06
|
0 | 0 | ||||||||||||||
07
|
0 | 0 | ||||||||||||||
08
|
$ | 25,000 | 0 | |||||||||||||
09
|
30,000 | $ | 25,000 | |||||||||||||
10
|
40,000 | 30,000 | ||||||||||||||
11
|
45,000 | 40,000 | ||||||||||||||
12
|
45,000 | 45,000 | ||||||||||||||
13
|
40,000 | 45,000 | ||||||||||||||
14
|
30,000 | 40,000 | ||||||||||||||
15
|
22,000 | 30,000 | ||||||||||||||
16
|
15,000 | 22,000 | ||||||||||||||
17
|
15,000 | 15,000 | ||||||||||||||
18
|
15,000 | 15,000 | ||||||||||||||
19
|
15,000 | 15,000 | ||||||||||||||
2020
|
10,000 | 15,000 | ||||||||||||||
21
|
10,000 | 10,000 | ||||||||||||||
22
|
0 | 10,000 | ||||||||||||||
23
|
0 | 0 | ||||||||||||||
24
|
0 | |||||||||||||||
25
|
||||||||||||||||
26
|
||||||||||||||||
27
|
||||||||||||||||
28
|
[*]
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.
Table
3
Note:
Starting year of each patent is the year patent filed in any country (Priority
date)
4
(c) Notwithstanding
anything to the contrary in this Agreement, the Company shall no longer be
obligated to make any Royalty Payment or other payment with respect to any
Assets as to which the applicable patents have expired.
5.
Representations and
Warranties. Consultant hereby represents and warrants to the
Company that:
(a) Except
for the rights previously transferred to the Company, Consultant is the
exclusive owner of, and has good, valid and marketable title to the Assets, free
and clear of all mortgages, pledges, charges, liens, security interests, or
other encumbrances or agreements, has the right to use without payment to a
third party all of the Assets and has the right to license the Assets to the
Company pursuant to the terms of this Agreement. No claim is pending
or, to Consultant’s knowledge, threatened against Consultant to the effect that
(i) Consultant’s right, title and interest in and to the Assets is reduced,
invalid or unenforceable by Consultant or that any of the Assets infringes,
misappropriates, dilutes or otherwise violates the rights of a third party, or
(ii) challenging Consultant’s ownership or use of, or the validity,
enforceability or registerability of the Assets and, to the knowledge of
Consultant, there is no reasonable basis for a claim regarding any of the
foregoing.
(b) There
exists no prior act or current conduct or use by Consultant or any third party
that would void or invalidate any of the Assets, and Consultant has not brought
or threatened a claim against any person (i) alleging infringement,
misappropriation, dilution or any other violation of the Assets, or
(ii) challenging any person’s ownership or use of, or the validity,
enforceability or registerability of, any Assets and, to the knowledge of
Consultant, there is no reasonable basis for a claim regarding any of the
foregoing.
[*]
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.
5
(c) None
of the Assets infringes or is alleged to infringe any patent, trademark, service
xxxx, trade name, copyright or other proprietary right of any third party or is
a derivative work based on the work of any other person.
6. Company
may terminate the licensing agreement of an Asset by giving 60 days
notice. If the Company terminates the licensing agreement of an Asset
then the rights associated with such asset shall revert back to
Consultant. In this case the Consultant has the right to terminate
the Consulting Services. Consultant may terminate the licensing
agreement of an Asset if no product has been made available to the market eight
years after the Effective Date or the priority date of any new patent, whatever
is later. Consultant may terminate the licensing agreement and/or the Consulting
Services upon the material breach of this Agreement by Company, provided that
such breach has not been cured by Company within sixty days of receipt of notice
from Consultant that Company is in breach. In the event Consultant
terminates this Agreement, all rights of the Assets will revert to
Consultant.
II. CONSULTING
SERVICES.
1. Services. From
time to time, the Company may request Consultant to perform Services on its
behalf. If the Company requests Services from Consultant not related
to the Antimicrobial and Vascular Access Space, Consultant shall not be
obligated to perform such services but may, in his discretion, perform such
services on such terms and conditions as mutually agreed to between the Company
and Consultant. In the event the Company requests Consultant to
perform Services on its behalf and such requested Services may conflict with
other obligations of Consultant, then Consultant shall immediately notify the
Company of such conflict, and the parties shall then work together in good faith
to resolve such conflict in a mutually beneficially manner to permit Consultant,
without violating any obligations to any other party, to perform such
Services. The parties shall work together in good faith to set
reasonable deadlines and to communicate regularly to measure progress and to
adjust priorities, as may be necessary or appropriate from time to
time.
2. Time
Commitment. Consultant agrees to make himself available to the
Company to perform the Services for at least thirty (30) days each calendar year
during the Consulting Period. Company agrees to pay the equivalent of
at least thirty (30) days each calendar year to Consultant.
[*]
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.
6
3. Compensation of
Consultant. The Company shall pay Consultant 200 Euros per
hour for Services consisting of scientific work, 250 Euros per hour for Services
consisting of legal work (which shall include, without limitation, Services
provided with respect to infringement cases and serving as an expert witness) or
such other compensation mutually agreed to between the Company and
Consultant. Consultant shall be reimbursed by the Company for all
reasonable and bona fide business expenses which are pre-approved by the
Company. Any request for reimbursement shall be accompanied by proper
receipts for the reimbursable amounts.
4. Non-Competition. During
the term of this Agreement and the Non-Compete Period, Consultant shall not
engage in any business that competes, directly or indirectly, with the business
of the Company with respect to the Assets or with any other idea, invention or
activity within the Antimicrobial and Vascular Access
Space. Consultant may, however, pursue ideas, inventions or
activities with respect to New Ideas to which the Company has waived or not
exercised in Right of First Refusal (as defined herein) in accordance with this
Agreement. Consultant agrees and acknowledges that the restrictions
set forth in this paragraph are reasonable and necessary to protect legitimate
business interests of the Company and that payments to be made to Consultant
hereunder are in consideration of such restrictions and other rights transferred
to the Company hereunder.
5. Non-Solicitation.
Consultant agrees that until the end of the Non-Compete Period, Consultant
(whether as a partner, shareholder, member, owner, officer, director, employee,
principal, agent, creditor, trustee or consultant of any entity or otherwise)
will not, without the prior written consent of the Company, directly or
indirectly, (a) induce or attempt to influence any employee, consultant or
contractor of the Company or any of its subsidiaries to leave their employ, (b)
hire or contract with any person who is an employee, consultant or contractor of
Company or any of its subsidiaries, (c) aid or agree to aid any competitor,
customer or supplier of Company or any of its subsidiaries in any attempt to
hire any person who shall have been employed with Company or any of its
subsidiaries within the eighteen month period preceding such requested aid, or
(d) induce or attempt to influence any person or business entity who was a
customer, supplier or partner of Company or any of its subsidiaries during any
portion of the Non-Compete Period to transact business with a competitor of the
Company or any of its subsidiaries.
[*]
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.
7
6. Non-Disclosure. Consultant
acknowledges that his relationship with the Company is one of high trust and
confidence in that in the course of his service to the Company, he will have
access to and contribute to confidential and proprietary information of the
Company. Consultant agrees to hold in confidence and not to directly
or indirectly reveal, publish, disclose, or transfer any of the Confidential
Information to any person or entity without the prior written consent (which
shall include approval given via email) of the Company. Consultant
agrees not to utilize Confidential Information for any purposes, except in the
course of Consultant’s rendering of services to the Company. Any and
all materials furnished to Consultant by the Company or relating to the business
of the Company shall be returned to the Company upon the Company’s
request. Consultant understands that the Company is now, and may
hereafter be subject to, non-disclosure or confidentiality agreements with third
parties that require the Company to protect and/or refrain from the use of
confidential or proprietary information of such third parties in accordance with
the terms set forth therein. As directed by the Company, Consultant
hereby agrees to be bound by, and hereby becomes bound to, the terms of such
agreements in the event that Consultant has access to the confidential and
proprietary information of such third parties.
7. Assignment and Disclosure of
Developments. If at times during the Consulting Period,
Consultant shall (either alone or with others), while performing Services for
the Company, make, conceive, create, discover, invent or reduce to practice any
invention, idea, composition, method, modification, discovery, design,
development, improvement, process, software program, work of authorship,
documentation, formula, data, technique, know-how, trade secret or intellectual
property right whatsoever or any interest therein, whether or not patentable or
registrable under patent, copyright, trademark or similar statutes or subject to
analogous protection (herein called “Developments”), and
if said “Developments” are directly related to the Assets then:
(i) such
Developments and the benefits thereof are and shall immediately become the sole,
exclusive and absolute property of the Company and its successors and assigns,
as “works made for hire” or otherwise to the fullest extent permissible by
law;
(ii) Consultant
shall promptly disclose to the Company (or any persons designated by it) each
such Development;
(iii) as
may be necessary to ensure the Company’s ownership of such Developments,
Consultant hereby assigns any rights (including, but not limited to, any
patents, copyrights and trademarks) he may have or acquire in the Developments
and benefits and/or rights resulting therefrom to the Company and its successors
and assigns without further consideration or compensation (other than royalties
and other amounts to be paid pursuant to this Agreement);
(iv) Consultant
shall communicate, without delay, and without disclosing to others the same, all
available information relating thereto (with all necessary documentation, code,
specifications, plans and models) to the Company; 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.
8
(v) Consultant
shall assist the Company in all respects in obtaining, maintaining and securing
any patent, copyright and/or other statutory or non-statutory protection which
may be obtained for the foregoing as the Company may request and hereby assigns
to the Company all rights and interests in and to any such patents, copyrights
and other protection.
(vi) Company
will compensate Consultant for these efforts according to the agreed consulting
rate and royalty payments due under this Agreement.
8.
Cooperation in Perfecting
Rights to Developments. Consultant will, during and after the
Consulting Period, at the request and sole cost of the Company, promptly sign,
execute, make and do all such deeds, documents, acts and things as the Company
and its duly authorized agents may reasonably require:
(a) to
apply for, obtain, register and vest in the name of the Company alone (unless
the Company otherwise directs) letters patent, copyrights, trademarks or other
analogous protection in any country throughout the world and when so obtained or
vested to renew and restore the same; and
(b) to
defend any judicial, opposition or other proceedings in respect of such
applications and any judicial, opposition or other proceedings or petitions or
applications for revocation of such letters patent, copyright, trademark or
other analogous protection.
In the event the Company is unable,
after reasonable effort, to secure Consultant’s signature on any application for
letters patent, copyright or trademark registration or other documents regarding
any legal protection relating to a Development, whether because of Consultant’s
physical or mental incapacity or for any other reason whatsoever, Consultant
hereby irrevocably designates and appoints the Company and its duly authorized
officers and agents as Consultant’s agent and attorney-in-fact, to act for and
in Consultant’s behalf and stead to execute and file any such application or
applications or other documents and to do all other lawfully permitted acts to
further the prosecution and issuance of letters patent, copyright or trademark
registrations or any other legal protection thereon with the same legal force
and effect as if executed by Consultant.
[*]
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.
9
9. No Violation of Rights of
Third Parties. Consultant hereby represents that Consultant is
not a party to, or bound by the terms of, any agreement with any third party
which conflicts with this Agreement, including requiring Consultant to refrain
from using or disclosing any trade secret or confidential or proprietary
information in the course of Consultant’s consulting engagement with the Company
or to refrain from competing, directly or indirectly, with the business of such
third party. Consultant further represents that the performance of
all the terms of this Agreement and Consultant’s performance as a consultant of
the Company does not and will not breach any agreement to keep in confidence
proprietary information, knowledge or data acquired by Consultant in confidence
or in trust prior to Consultant’s engagement as a consultant by the Company, and
Consultant will not disclose to the Company or induce the Company to use any
confidential or proprietary information or material belonging to any third
party. Consultant has not entered into, and Consultant agrees not to
enter into, any agreement, either written or oral, in conflict with the terms of
this Agreement.
10. Right of First
Refusal. If Consultant conceives of a New Idea expanding or
competing with the ideas laid out in the Assets during the Consulting Period and
the Company is interested in obtaining a license to such New Idea, Consultant
shall first offer to license the New Idea to the Company and the parties shall
work together in good faith towards the successful negotiation of such a
license.
11. Indemnification. In
cases where any loss or damage results from or arises out of any
misrepresentation, any non-fulfillment of any representation, responsibility,
covenant or agreement on the part of either party hereto, or such party’s
negligence or misconduct (including but not limited to cases where a third party
initiates a claim, suit, judgment, or cause of action against the other party)
(collectively, the “Indemnifying Party”), the Indemnifying Party shall be solely
liable for, and shall indemnify, defend, and hold harmless the other party and
his or its Affiliates, strategic partners, managers, members, successors and
assigns from any such claims, suits, judgments, causes of action, losses, or
damages, and shall pay reasonable attorneys' fees, costs and expenses incident
thereto; provided, however, in no event shall either party to this Agreement be
liable for any amounts in excess of payments actually made to Consultant
pursuant to this Agreement. For purposes of clarity, this paragraph
II.11 shall not apply in cases where the Indemnifying Party’s liability arose
from or relates to actions taken or not taken at the instruction of the other
party hereto and such indemnifying party takes or omits to take such action
while using his or its best efforts in furtherance thereof.
12. Taxes and Legal
Authority. The parties acknowledge and agree that under this
Agreement, Consultant is and remains an independent contractor and in no way is
or shall become an employee or agent of the Company or its Affiliates either
under the laws of the United States of America, Austria or any other state,
country or territory. Consultant is not the legal representative of
the Company for any purpose whatsoever (unless the Company, in writing,
specifically authorizes Consultant to so act), and Consultant shall not have the
power to bind or obligate the Company for any purpose
whatsoever. Consultant agrees that he has and shall retain sole
responsibility for all employment taxes and insurance and all income taxes and
related taxes due under either the laws of the United States or any of its
political subdivisions or the laws of Austria or any of its political
subdivisions or taxes due or payable in any other state, country, or
territory. The Company shall have the right to withhold taxes from
payments to Consultant if required to do so by either United States law or
Austrian law or by any international treaty.
[*]
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.
10
13. Consultant
Rights. Notwithstanding anything to the contrary contained
herein, Consultant shall have the right to write and publish papers regarding
the Assets and speak publicly about the Assets, provided, however, during the
consulting period Consultant shall deliver to the Company at least 30 days prior
to publication a copy of any proposed publication or writing relating to the
Assets and the Company shall have the right to review and approve the contents
of such publication or writing with respect to the Assets to ensure that the
speculations and/or conclusions in such publication or writing (a) are in line
with the Company’s interests and, (ii) do not violate any provision of this
Agreement. This limitation does not apply to information
available in the public domain or data already generated prior to the Effective
Date.
14. Freedom to Conduct Business
Unimpaired. Consultant acknowledges and agrees that the
Company, its Affiliates and their respective partners shall be free to pursue
their respective business goals and that Net Sales may be affected
thereby. This Agreement shall not be deemed to impose any express or
implied obligation on the Company, its Affiliates or their respective partners
to maximize Net Sales for all or any portion of any period with respect to which
amounts may be payable hereunder or to impair the freedom of the Company, its
Affiliates or their respective partners to conduct their respective businesses
as they deem appropriate.
III. MISCELLANEOUS.
1. Injunctive
Relief. Each of the parties hereto acknowledges that any
remedy at law for breach of the other party’s covenants under this Agreement
will be inadequate and, accordingly, in the event of any breach or threatened
breach of this Agreement, the non-breaching party shall be entitled, in addition
to all other remedies, to injunctive relief restraining any such breach, without
any bond or other security being required.
2. Non-Waiver. No
delay or omission by either party hereto in exercising any right under this
Agreement shall operate as a waiver of that or any other right. A
waiver or consent given by either party on any one occasion shall be effective
only in that instance and shall not be construed as a bar or waiver of any right
on any other occasion.
3. Amendment. This
Agreement may be amended or modified only by a written instrument executed by
both the Company and Consultant.
[*]
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.
11
4. Assignment. This Agreement and the rights
and duties appertaining hereto may not be assigned by either party without first
obtaining the written consent of the other party, which consent shall not be
unreasonably withheld. Any such purported assignment without the written consent
of the other party shall be deemed null and void. Notwithstanding the
foregoing, either party may assign this Agreement without the consent of the
other party (i) to a purchaser, merging, or consolidating corporation, or
acquirer of all or substantially all of the other party’s assets or business (or
that portion thereof to which this Agreement relates) and/or pursuant to any
reorganization of the party or (ii) to an Affiliate of the party.
5. Entire
Agreement. This Agreement contains the entire understanding
between the parties regarding the subject matter hereof and supersedes, replaces
and takes precedence over any prior understanding or oral or written agreement
between the parties respecting the subject matter of this
Agreement. There are no representations, agreements, arrangements,
nor understandings, oral or written, between the parties hereto relating to the
subject matter of this Agreement which are not fully expressed
herein.
6. Severability. In
the event any provision of this Agreement shall be held invalid, the same shall
not invalidate or otherwise affect in any respect any other term or terms of
this Agreement, which term or terms shall remain in full force and
effect.
7. Arbitration. The
parties agree that any claim or dispute arising out of or relating to this
Agreement, its performance, or alleged breach which is not disposed of by
agreement of the parties shall be finally settled by binding arbitration in
Brussels in accordance with the Rules of Arbitration of the ICC as presently in
force by a single, impartial arbitrator, chosen mutually by the parties hereto.
The arbitrator shall have no jurisdiction to award punitive damages. Any award
in such arbitration shall be in writing in English specifying the factual and
legal basis therefor and shall be final and binding upon the parties, and
judgment upon the award rendered by the arbitrator may be entered in any court
having jurisdiction thereof. The costs of an arbitrator (including
any required travel and lodging expenses of the arbitrator) shall be borne
one-half (1/2) by each party to the arbitration. All other expenses
and costs incurred in connection with an arbitration hearing or proceeding shall
be paid by the party incurring such expenses or costs. The procedures
described in this Section III.7 shall be the exclusive manner for any party
hereto to seek enforcement or interpretation of the terms of, or to resolve any
dispute under, this Agreement. Notwithstanding anything to the
contrary in this Section III.7, the Company shall be permitted to enforce its
rights under Section III.1 in any court having jurisdiction. The
parties hereto consent to the jurisdiction of any court located in London,
England for purposes of Section III.1 hereof and for purposes of enforcing an
arbitration award entered into accordance herewith. This Agreement
shall be governed and construed by the laws of London, England and
any arbitrator shall render any decision in accordance with such
laws.
[*]
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.
12
8. Interpretation. If
any restriction set forth in this Agreement is found by any court of competent
jurisdiction or arbitrator to be unenforceable because it extends for too long a
period of time or over too great a range of activities or in too broad a
geographic area, it shall be interpreted to extend only over the maximum period
of time, range of activities or geographic area as to which it may be
enforceable.
9. The
Product will carry information in the package insert and User manual stating the
patent numbers which cover the product.
*
* * * *
[*]
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.
13
IN
WITNESS WHEREOF, the undersigned have executed this Agreement as of the date
first set forth above.
COMPANY:
|
|
/s/
Xxxxx Xxxxxx
|
|
Name:
|
Xxxxx
Xxxxxx
|
Its:
|
CEO
|
CONSULTANT:
|
|
/s/
Xxxx-Xxxxxxxx Polaschegg
|
|
Xxxx-Xxxxxxxx
Polaschegg
|
[*]
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.
14
EXHIBIT
A
DEFINITIONS
Breach
and the like shall mean:
(a) the
Company fails to make a Royalty Payment or any other royalty payment required to
be made by the Company to Consultant hereunder;
(b) the
Company fails to make any filing or payment required to keep an Asset current
within the extended period allowed; or
(c) the
Company does not file and pursue patent applications, divisionals, and/or
continuations-in-part for each Invention in each of the United States, Japan,
and the European Five, to the extent patent protection is available in each of
these countries (including all possible extensions of time).
“Affiliate” shall mean
any partnership, corporation, other legal entity or person that directly or
indirectly through one or more intermediaries, controls, is controlled by, or is
under common control with, the Company.
“Antimicrobial and Vascular
Access Space” shall mean: (a) composition, methods, and designs that
provide or enhance antimicrobial protection for medical devices and/or fluid
conduits for vascular access, (b) treatments, formulations, and methods of use
comprising Taurolidine, and not including (x) any improved and/or novel vascular
access devices and methods, work or method used for hydraulical or mechanical
characterization of access devices, e.g., hydraulic resistance, residence time,
flow, flow distribution, mechanical dimensions and strength, or (y) any work or
method for characterizing fistulas, grafts, blood vessels, detecting stenosis in
or blood loss from blood vessels or extracorporeal circuits).
“Assets” shall mean
the Inventions, together with (A) all developments, know-how, and other
intellectual property rights, including but not limited to all trademarks,
copyrights and patents relating thereto, that relate to or derive from the
Inventions for any application, such as catheter lock gels, microbiology test
data and so forth, and (B) the Developments.
[*]
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.
15
“Commercially Reasonable
Efforts” - means, with respect to Development and Commercialization, the
carrying out of obligations or tasks using efforts and resources, including
reasonably necessary personnel, equivalent to the efforts that a similarly
situated biotechnology or pharmaceutical company (as the case may be) would
typically devote to a product of similar market potential, profit potential and
strategic value and at a comparable stage in development or product life
resulting from its own research efforts with a view toward optimizing the
economic potential of the Licensed Product, based on conditions then prevailing
and taking into account issues of safety and efficacy, product profile,
difficulty in developing the Licensed Product, market size and
conditions, competition, the patent or other proprietary position of the
Licensed Product, the regulatory structure involved and the potential
profitability of the Licensed Product marketed or to be marketed.
“Confidential
Information” means information or material proprietary to the Company or
designated as confidential by the Company, which Consultant develops or of which
he may obtain knowledge or access to as a result of his relationship with the
Company. This includes information originated, discovered, or
developed in whole or in part by Consultant under this Agreement and includes,
but is not limited to the following types of information and other information
of a similar nature (whether or not reduced to writing): business plans, methods
and practices of doing business, financial information and terms and conditions
of current contractual relations with customers and/or suppliers, pricing
information, and customer and supplier lists. Confidential
Information also includes any information which the Company treats as
proprietary or designates as confidential, whether or not owned or developed by
the Company.
“Consulting Period”
shall mean the period commencing on the date of this Agreement and terminating
on the third anniversary hereof.
“Gel Lock Invention”
shall mean the U.S. patent application #20040156908 titled “Prevention of
Indwelling Device Related Infection: Composition and Methods”, together will all
divisionals, continuations-in-part and all other associated U.S. and foreign
applications filed or to be filed in connection therewith.
“Inventions” shall
mean the Gel Lock Invention and the Treatments Invention, collectively, and each
of the Inventions shall be an “Invention”.
“License” shall mean
an exclusive, worldwide, perpetual, non-terminable, fully paid-up (subject to
royalties and terms described in this Agreement) license to the
Assets to practice, make, use, offer to sell, sell, design, reproduce, market,
display, operate, transfer or dispose of the Assets.
[*]
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.
16
“Net Sales” shall mean
the invoiced price of a Product sold commercially by the Company, its Affiliates
or any of their strategic partners minus all discounts, allowances, returns,
rebates, transportation costs, shipping costs, insurance charges, duties,
value-added taxes and sales taxes. The invoiced price of Products
sold by the Company, its Affiliates or any of their respective strategic
partners to any of its or their respective Affiliates for the purpose of resale
by such party shall not be included in Net Sales, but the resale of such
Products by such parties shall be included in Net Sales.
“New Idea” shall mean
any idea, composition, method, modification, discovery, design, development,
improvement, process, technique, know-how or intellectual property in the field
of or related to the Antimicrobial and Vascular Access Space developed,
conceived of or created outside of the consulting relationship between
Consultant and the Company, and to which no third party (other than Consultant)
has any rights.
“Non-Compete Period”
shall mean a period commencing on the date hereof and continuing for six (6)
months after the later of (a) the termination of this Agreement, or (b) the
latest date on which the Company is obligated to make a Royalty Payment or any
other royalty payment hereunder.
“Services” shall
include, without limitation, providing research and development assistance on
catheter lock gels, sepsis treatments, and other potential products that may be
derived from the Assets, producing embodiments of such potential products,
providing advice and assistance with respect to maintenance of the Assets, using
reasonable best efforts to obtain, protect and enforce all legal protections for
inventions relating to the Assets and assisting the Company with its
development, marketing and sales of products and services in the Antimicrobial
and Vascular Access Space.
“Treatments Invention”
shall mean the provisional U.S. patent application filed on April 28, 2004
titled “Taurolidine Formulations and Delivery: Therapeutic Treatments and
Antimicrobial Protection against Bacterial Biofilm Formation”, together with
patent applications, divisionals, continuations-in-part, and all other
associated U.S. and foreign applications filed or to be filed.
[*]
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.
17
EXHIBIT
B
Royalty
Payment Calculations and Sample Example
[*]
[*]
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.
18