Exhibit 10.18


 


RESEARCH, DEVELOPMENT AND LICENSE AGREEMENT


 


THIS AGREEMENT, is
effective as of the 24th day of October, 2005 (the “Effective Date”), by and
between Aksys, Ltd., a Delaware corporation with its principal offices at Two
Marriott Drive, Lincolnshire, Illinois 60069 (hereinafter “Client”), and DEKA PRODUCTS LIMITED PARTNERSHIP, a New
Hampshire limited partnership with its principal offices at 340 Commercial
Street, Manchester, New Hampshire 03101, and its general partner, DEKA RESEARCH AND DEVELOPMENT CORP., a New
Hampshire corporation of the same address (hereinafter “DEKA”).


 


W I T N E S S E T H:


 


WHEREAS, DEKA
has expertise in the design, development, and testing of sophisticated medical
devices and currently owns or, as a result of the Development Program defined
herein, may come to develop and own, certain patent rights, trade secrets,
and/or confidential know-how; and


 


WHEREAS, Client
wishes to fund and desires that DEKA undertake a Development Project involving
such patent rights, trade secrets, and/or confidential know-how to attempt to
develop a Licensed Product, as defined herein; and


 


WHEREAS, DEKA
desires that such Licensed Product, if successfully developed, be made
available to the relevant medical markets for use within the field specified
herein; and


 


WHEREAS, Client
wishes to have developed and bring to the relevant medical markets such
Licensed Product and to obtain a license to such patent rights, trade secrets,
and/or confidential know-how for such Licensed Product on the terms stated
herein;


 


NOW, THEREFORE, in
consideration of the premises and mutual covenants herein contained, the
parties hereto agree as follows:


 


SECTION 1 -
DEFINITIONS


 


Where capitalized and used in this
Agreement, the following terms shall have the ascribed meanings:


 


1.1           The
term “Affiliate” shall mean any company or other legal entity, other than
Client, in whatever country organized, controlling, controlled by, or under
common control with Client.  The term “control”
means the possession, direct or indirect, of the power


 


Omitted portions are
indicated by [***].  


 


Confidential
information redacted and filed separately with the Commission.


 


1





















 


(whether or not exercised) to direct or
cause the direction of the management and policies of an entity, whether
through the ownership of voting securities, by contract, or otherwise, and the
term “entity” includes an individual, corporation or other entity.


 


1.2           The
term “Confidential Information” shall mean all data, samples, materials, and
other information, and all copies thereof, made or disclosed for or in
contemplation of the Development Program by a party, its employees, or its
contractors (the “Disclosing Party”) to the other party, its employees or
contractors (the “Receiving Party”) and that: a) if disclosed in written form,
is marked “Confidential” and/or “Proprietary” or b) if disclosed in another
form, is orally declared to be confidential and/or is the type of information
that a reasonable person would assume to be confidential.


 


1.3           The
term “Development Program” has the meaning set forth in Section 2.1
herein.


 


1.4           The
term “Hemodialysis Field” has the meaning set forth in Attachment A.


 


1.5           The
term “ Hemodialysis Licensed Patents” shall mean:  1) the patent and patent applications set
forth on the list attached to and incorporated into this Agreement as
Attachment B; 2) all patents and patent applications owned or licensable by
DEKA relating to the Hemodialysis Field filed after November 22, 2004; and
3) all divisionals, continuations, continuations-in-part, reexaminations,
reissues, and foreign counter-parts of any of the forgoing.


 


1.6           The
term “License” shall mean the license granted by DEKA to Client under Section 8
herein.


 


1.7           The
term “Licensed Patents” shall mean the Hemodialysis Licensed Patents and the
Solution Preparation Licensed Patents.


 


1.8           The
term “Licensed Product” shall mean any product, process, or other subject
matter for which the manufacture, use, sale, lease, or import of such product,
process, service, or other subject matter would, but for the license granted
herein, infringe directly or indirectly, any Valid Claim.


 


1.9           The
term “Licensed Subject Matter” shall mean the Licensed Patents and Technical
Information.


 


1.10         The
term “National Introduction” shall mean the date that a Licensed Product is
first made generally available for use by or sale to customers in commercially
reasonable quantities in the United States.


 


1.11         The
term “Net Sales” shall mean the gross revenue received by Client or an
Affiliate or a Sublicensee from the sale, lease, performance or use of any
Licensed Product


 


Omitted portions are
indicated by [***].  


 


Confidential
information redacted and filed separately with the Commission.


 


2





















 


by, to, or for any entity (other than an
Affiliate) less the following amounts to the extent separately stated on an
invoice and actually paid or allowed in the ordinary course of business:


 


i.              discounts,
including cash (trade or quantity) discounts or rebates, actually allowed or
granted from the billed amount; and


 


ii.                                       freight,
postage, and duty charges paid for delivery; and


 


iii.                                    credits
due to returned or rejected goods;


 


iv.                                   amounts
written off as bad debt.


 


1.12         The
term “Solution Preparation Field” has the meaning set forth in Attachment C.


 


1.13         The term “Securities” shall mean the Warrant and any shares of common
stock issuable upon the exercise of the Warrant.


 


1.14         The term “Solution Preparation Licensed
Patents” shall mean all patents and patent applications relating to the
Solution Preparation Field that result from the performance of the Development
Program, along with all divisionals, continuations, continuations-in-part,
reexaminations, reissues, and foreign counter-parts of any of the
foregoing.  The Solution Preparation
Licensed Patents do not include any patents or patent applications filed on or
before November 22, 2004.


 


1.15         The
term “Sublicensee” shall mean any non-Affiliate third party to whom Client
grants a sublicense of Client’s rights hereunder.


 


1.16         The term
“Technical Information” shall mean any information and materials owned by DEKA
that relate to or are useful in connection with subject matter within the
Hemodialysis Field or the Solution Preparation Field other than the Licensed
Patents and are useful for the development of the Licensed Products.


 


1.17         The
term “Valid Claim” shall mean a claim of any issued and unexpired patent
included with the Licensed Patents that has not been held invalid in a final
decision of a court of competent jurisdiction from which no appeal may be taken
and that has not been disclaimed or admitted to be invalid or unenforceable
through reissue or otherwise.


 


SECTION 2 -
RESEARCH AND DEVELOPMENT


 


2.1           Subject
to the terms of this Agreement and for so long as Client reimburses DEKA’s
development costs in the manner set forth in Section 3 herein, DEKA shall
use its


 


Omitted portions are
indicated by [***].  


 


Confidential
information redacted and filed separately with the Commission.


 


3





















 


commercially reasonable efforts to
attempt to develop a manufacture-ready prototype of  Licensed Product pursuant to the “Pluto”
Hemodialysis System Project Plan (DEKA Document L DKPL-01-100), as may be
revised from time to time.  For purposes
of this Agreement, the term “Development Program” shall mean all such efforts
relating to the development of Licensed Products, including DEKA’s development
efforts on the Client’s behalf prior to the Effective Date of this
Agreement.  This Agreement is not a
performance contract.  DEKA makes no
warranties or representations regarding DEKA’s ability to:  develop a marketable Licensed Product; obtain
any additional patent or governmental approval; or achieve any particular
objective or result.


 


2.2           Client
shall be responsible for and shall use its commercially reasonable efforts to
obtain, in a timely manner, all regulatory approvals necessary for the
marketing of Licensed Products in the Hemodialysis and/or Solution Preparation
Fields.  This includes preparation of all
applications to the United States Food and Drug Administration (“FDA”), whether
by application for pre-market approval or 510K notification or otherwise.  DEKA shall assist Client in obtaining such approval
and Client shall reimburse DEKA for such assistance in accordance with the
formula set forth in Section 3 herein.


 


SECTION 3 -
FUNDING OF RESEARCH AND DEVELOPMENT


 


3.1           Client
shall reimburse DEKA on a cost plus system for the Development Program pursusant
to the terms set forth in Attachment D.


 


SECTION 4 –
GRANT OF WARRANTS


 


4.1           Client
agrees to issue to DEKA a common stock purchase warrant pursuant to the terms
set forth in Attachment E.


 


4.2           DEKA is purchasing the Securities for
its own account and not with a view to the distribution thereof.   DEKA is an “accredited investor” within the
meaning of Rule 501 of Regulation D. 
DEKA understands that the Securities are being offered and sold to it in
reliance upon specific exemptions from the registration requirements of United
States federal and state securities laws and that Client is relying upon the
truth and accuracy of, and DEKA’s compliance with, the representations,
warranties, agreements, acknowledgments and understandings of DEKA set forth
herein in order to determine the availability of such exemptions and the
eligibility of DEKA to acquire the Securities. 
DEKA and its advisors, if any, have been furnished with all materials
relating to the business, finances and operations of Client, that have been
requested by DEKA or its advisors, if any. 
DEKA and its advisors, if any, have been afforded the opportunity to ask
questions of Client.  DEKA acknowledges
and understands that its investment in the Securities involves a significant
degree of risk, including the risks reflected in documents filed by Client with
the United States Securities and Exchange Commission.


 


Omitted portions are
indicated by [***].  


 


Confidential
information redacted and filed separately with the Commission.


 


4





















 


SECTION 5 -
COMMERCIALIZATION


 


5.1           Client
shall use commercially reasonable efforts to achieve National Introduction of a
Licensed Product as soon as practicable, and in any event by not later than
twelve (12) months after both:  (i) DEKA
has delivered to Client an initial manufacture-ready prototype of a Licensed
Product, and (ii) Client has obtained all regulatory approvals necessary
to market and sell such Licensed Product in the United States.  Without limiting the full scope of Client’s
obligation to use commercially reasonable efforts, it shall be considered a
material breach of Client’s obligation to use commercially reasonable efforts,
pursuant to this Section 5.1, if Client discontinues, suspends, or
substantially reduces efforts toward commercialization of Licensed Products for
any three (3) consecutive months prior to National Introduction.


 


5.2           After
National Introduction, Client shall use commercially reasonable efforts to
continue to commercialize Licensed Products in the United States and in
commercially reasonable markets outside of the United States.


 


SECTION 6 -
PROPRIETARY INFORMATION


 


6.1           All
Confidential Information of a Disclosing Party disclosed to a Receiving Party
shall be treated by the Receiving Party as confidential throughout the term of
this Agreement and for so long thereafter as the information remains
confidential as defined below.  The
Receiving Party shall: treat and safeguard such Confidential Information in the
same manner as its own proprietary information of a similar type; limit access
to only those employees and contractors who need to know for purposes of this
Agreement; require all such employees and contractors to agree, in writing,
with the receiving party to keep such information confidential; and not use
such Confidential Information except as necessary to develop, manufacture,
market, service, sell, and lease Licensed Products.  The above-mentioned obligation of
confidentiality shall not apply to information that:


 


i.              at
the time of the disclosure was known to the Receiving Party and was not
previously subject to any obligation of confidentiality; or


 


ii.             was generally available to the public or was otherwise
part of the public domain at the time of its disclosure; or


 


iii.            becomes generally available to the public or otherwise
part of the public domain after its disclosure other than through an act of
omission or commission of the Receiving Party in breach of this Agreement; or


 


iv.            becomes known to the receiving party by disclosure of a
third party under no obligation of confidentiality to the Disclosing Party, or


 


Omitted portions are
indicated by [***].  


 


Confidential
information redacted and filed separately with the Commission.


 


5





















 


v.             is
hereafter independently developed by personnel of the Receiving Party that are
not and have not been exposed to the Confidential Information of the Disclosing
Party, provided that the burden of proving such independent development shall
be on the Receiving Party.


 


6.2           The
Receiving Party shall not be liable to the Disclosing Party for disclosure of
any Confidential Information received hereunder if such disclosure is made
pursuant to a governmental or judicial mandate, provided that the Receiving party
shall have given the Disclosing Party prompt notice of such mandate prior to
the submission of such Confidential Information, and further provided that the
Receiving Party shall have taken no efforts to prevent or interfere with any
lawful efforts the Disclosing Party might take to intervene in such proceedings
or otherwise prevent such disclosure.


 


6.3           DEKA
shall have the right to utilize and disclose Licensed Subject Matter to
develop, use, and sell (by licensing others and otherwise) products, unless
such product would violate any exclusive right granted pursuant to Section 8
herein; provided, however, that DEKA protects, through appropriate
confidentiality agreements with third parties, all Technical Information so as
to preserve the confidentiality thereof.


 


6.4           DEKA
may disclose to other licensees the scope of the License granted to Client
hereunder.


 


SECTION 7-
OWNERSHIP OF LICENSED SUBJECT MATTER


 


7.1           Subject
to the License, DEKA shall own title to any and all intellectual property
rights created as a result of, or in conjunction with, the Development Program,
except that Client shall own title to any and all intellectual property created
and developed solely by the Client independent of any assistance from DEKA as a
result of the Client’s own development efforts.


 


7.2           DEKA
represents and warrants that it and its employees have entered into agreements
wherein its employees agreed to assign their rights in and to all inventions,
as well as all patents and patent applications directed to such inventions,
resulting from their employment with DEKA to DEKA.  DEKA will use its best efforts to enforce the
same to ensure that DEKA has perfected its title to the Licensed Subject
Matter.  Furthermore, DEKA represents and
warrants that it has caused or will cause all additional DEKA employees, or
personnel performing work pursuant to the Development Program, to execute
similar agreements with respect to the rights in and to all inventions, as well
as all patents and patent applications directed to such inventions, resulting
from their association with DEKA and will use commercially reasonable efforts
to enforce such agreements to ensure that DEKA has perfected its title to the
Licensed Subject Matter.


 


Omitted portions are
indicated by [***].  


 


Confidential information
redacted and filed separately with the Commission.


 


6





















 


7.3           Client
represents and warrants that it and its employees have entered into agreements
wherein its employees agreed to assign their rights in and to all inventions,
as well as all patents and patent applications directed to such inventions,
resulting from their employment with Client to Client.  Client will use its best efforts to enforce
the same to ensure that DEKA has perfected its title to the Licensed Subject
Matter.  Furthermore, Client represents
and warrants that it has caused or will cause all additional employees of
Client, or personnel performing work pursuant to the Development Program on
Client’s behalf, to execute similar agreements with respect to the rights in
and to all inventions, as well as all patents and patent applications directed
to such inventions, resulting from their association with Client and will use
commercially reasonable efforts to enforce such agreements to ensure that DEKA
has perfected its title to the Licensed Subject Matter.


 


7.4           During
the term of this Agreement, DEKA shall, in a commercially reasonable time
period, disclose to Client any Hemodialysis Patents and/or Technical
Information owned by DEKA that it believes to be reasonably related to the
Hemodialysis Field and that is created, developed, invented, acquired, or made
by or for DEKA, or rights to which are acquired by DEKA, during the term of
this Agreement.


 


SECTION 8 -
LICENSE


 


8.1           DEKA
hereby grants to Client the worldwide, exclusive right to practice the
Hemodialysis Licensed Patents to make, have made, use, offer for sale, sell,
and import Licensed Products within the Hemodialysis Field and to sublicense
others to do so.  DEKA further hereby
grants to Client the right to utilize Technical Information for Licensed
Products within the Hemodialysis Field and to sublicense others to do so.  All rights granted to Client herein may be
exercised by Affiliates.


 


8.2           DEKA
hereby grants to Client the worldwide right to practice the Solution
Preparation Licensed Patents to make, have made, use, offer for sale, sell and
import Licensed Products within the Solution Preparation Field and to
sublicense others to so.  DEKA further
hereby grants to Client the right to utilize Technical Information for Licensed
Products within the Solution Preparation Field and to sublicense others to do
so.  All rights granted to Client herein
may be exercised by Affiliates.


 


8.3           DEKA
reserves the right to utilize (by licensing others and otherwise) the Licensed
Patents, except as specifically granted in Section 8.1 and 8.2 above, and
the right to utilize (by licensing others and otherwise) Technical Information.


 


8.4           Any
sublicense granted by Client must be consistent herewith and expressly subject
to the terms hereof and Client shall remain responsible for performance of
Client’s obligations hereunder.


 


Omitted portions are
indicated by [***].  


 


Confidential
information redacted and filed separately with the Commission.


 


7





















 


SECTION 9 –
LICENSE PAYMENTS


 


9.1           In
consideration for the rights and licenses granted by DEKA to Client, Client
shall pay DEKA a quarterly royalty pursusant to the terms set forth in
Attachment F and in this Section 9.


 


9.2           Client
shall keep accurate books and records of sales of Licensed Products and of all
payments due DEKA hereunder.  Client
shall, on or before each February 15, May 15, August 15, and November 15
of each year during the term of Client’s obligation to pay royalties per Section 9.1,
above, deliver to DEKA written reports of Net Sales during the preceding
calendar quarter (ending December 31, March 31, June 30, and September 30).
Such reports shall include the Net Sales made during the calendar quarter, the
number of patients utilizing Licensed Products upon which Net Sales are due as
of the last day of the quarter, and a calculation of the of royalties due; and
shall be accompanied by payment of the monies due.


 


9.3           DEKA
shall have the right, one per year and at DEKA’s expense (except as provided
below), to nominate an independent accountant reasonably acceptable to Client
who shall sign a confidentiality agreement with Client and who shall have
access to Client and its Affiliates’ and Sublicensees’ records upon reasonable
notice and during reasonable business hours for the purpose of verifying the
royalties payable under this Agreement for the three (3) preceding years,
and the accountant shall disclose to DEKA only information relating to the
accuracy of the royalty reports and the royalty payments made in accordance
with this Agreement.  If the independent
accountant concludes that additional royalties are owed for any period, then:
Client shall pay to DEKA the additional royalties and interest thereon from the
date payment should have been made at the rate of “Prime Rate” reported in The
Wall Street Journal on the date of the accountant’s report plus two percent
(2%) per annum, payment to be made within thirty (30) days of DEKA’s delivery
of the accountant’s report to Client; and, if the unpaid royalties are five
percent (5%) or more of the total amount actually due for the relevant period,
Client shall reimburse DEKA for the accountant’s reasonable charges for
services rendered in connection with such inspection.  Any overpayments made by Client to DEKA
revealed by DEKA’s audit shall be credited against future royalty payments.


 


9.4           All
royalty payments under this Agreement shall be made in United States
Dollars.  Net Sales received by Client,
its Affiliates, or Sublicensees in other than United States Dollars shall first
be converted to United States Dollars and posted to Client’s general ledge as
per its normal business practices and in accordance with GAAP.  Royalty payments to DEKA shall be based upon
the amounts so posted.


 


9.5           Any
sum required under United States tax laws to be withheld by Client, its
Affiliates, or Sublicensees from payments shall be promptly paid by Client to
the appropriate tax authorities and Client shall provide DEKA with official tax
certificates documenting remittance of the taxes to the relevant authorities.


 


Omitted portions are
indicated by [***].  


 


Confidential
information redacted and filed separately with the Commission.


 


8





















 


SECTION 10 -
PATENT FILINGS


 


10.1         DEKA
shall promptly disclose to Client all inventions that are or are reasonably
likely to be the subject of Licensed Patents. 
DEKA may elect to file and prosecute patent applications directed to any
such inventions.  Such applications shall
be filed and prosecuted utilizing patent counsel selected by DEKA, except as
set forth in Section 10.2 below. 
DEKA shall pay for patent counsel and other expenses, including
maintenance fees, incurred in connection with its filing for, prosecuting,
and/or maintaining patent protection in the United States, except as provided
below.


 


10.2 
Should DEKA elect not to file and/or prosecute such patent application
or applications, DEKA shall promptly advise Client and Client may elect to file
and/or prosecute such patent application or applications in DEKA’s name at
Client’s expense utilizing patent counsel selected by DEKA.


 


10.3         Client
shall notify DEKA when Client desires DEKA to file for patent protection in any
country other than the United States. 
Client shall pay for patent counsel and other expenses, including
maintenance fees, incurred in connection with filing for, prosecuting, and/or
maintaining patent protection outside the United States using patent counsel
selected by Client, except that DEKA shall have the right to approve patent
counsel selected by Client, which approval shall be timely and not be
unreasonably withheld.


 


10.4         Client
shall promptly disclose to DEKA any intellectual property rights related to the
subject matter of the Development Program to which Client claims title pursuant
to Section 7.1 above.  Client may
elect to file and prosecute patent applications directed to any intellectual
property to which Client has title pursuant to Section 7.1 above.


 


10.5         With
respect to all patent applications referred to above, and to the extent the
parties are able to do so, the parties shall provide each other with reasonable
opportunity to advise the other and shall cooperate with each other in the
prosecution of all patent applications.


 


SECTION 11 –
INFRINGEMENT


 


11.1         Each
party shall promptly notify the other in writing if the party becomes aware of
any actually or reasonably suspected infringement or misappropriation by a
third party of any Licensed Subject Matter within the Hemodialysis and/or
Solution Preparation Fields, including with such written notice any evidence
available to it of such infringement or misappropriation by such third
party.  As between the parties to this
Agreement, DEKA has the initial right to control an action to enforce the
Licensed Subject Matter against a third party infringer or to defend against a
declaratory judgment action with respect thereto


 


Omitted portions are
indicated by [***].  


 


Confidential
information redacted and filed separately with the Commission.


 


9





















 


(for purposes of this Section 11,
the term “Enforcement Action” shall mean each of such actions).   DEKA shall bear the expense of any
Enforcement Action brought by it and shall retain all damages or other monies
awarded or received in settlement of such Enforcement Action.  DEKA shall not settle any such Enforcement
Action without Client’s consent, which shall be timely and not be unreasonably
withheld, if such Enforcement Action may reasonably impact Client’s
business.  Client will cooperate with
DEKA in any such Enforcement Action and shall have the right to consult with
DEKA and be represented by its own counsel at its own expense.


 


11.2         If,
after the expiration of sixty (60) days from the date of notice by Client
pursuant to Section 11.1, DEKA has not overcome the prima facia case of
infringement or misappropriation, obtained a discontinuance of the infringement
or misappropriation, or initiated an Enforcement Action, then Client shall have
the right, but not the obligation, to bring an Enforcement Action against such
third party and join DEKA as a party plaintiff, provided that Client shall bear
all expenses of such Enforcement Action. 
DEKA shall reasonably cooperate with Client in such Enforcement Action,
including, without limitation, by providing Client with reasonable access to
materials and witnesses.  DEKA shall have
the right to consult with Client and to participate in and be represented by
independent counsel in such Enforcement Action, at DEKA’s own expense except as
provided below.  Client shall not settle
any such litigation unless DEKA gives prior, written consent, which consent
shall be timely and not be unreasonably withheld.  Any damages or other monies awarded or received
in settlement of an Enforcement Action brought by Client shall be first applied
to reimburse Client’s reasonable unreimbursed expenses, then applied to DEKA’s
reasonable unreimbursed expenses.  Any
remainder relating to infringement or misappropriation within the “Hemodialysis
and/or Solution Preparation Fields” shall then be paid to Client, except, to
the extent a portion of the amount recovered is intended to compensate Client
for the lost sales of Licensed Products, then Client shall pay to DEKA an
amount equivalent to the amount of royalties that Client would have paid to
DEKA had Client made such sales.  Any
remainder relating to infringement or misappropriation outside of the “Hemodialysis
and/or Solution Preparation Fields” shall be paid to DEKA.


 


11.3         In
the event Client is charged with infringement, based on the sale of Licensed
Products, by a third party, Client shall immediately notify DEKA in writing and
DEKA shall have the first right (but not the duty) to defend such claim with
counsel acceptable to Client.  If DEKA
does not notify Client that DEKA will defend such claim within thirty (30)
days, then Client shall have the right to defend against such charge of
infringement.


 


SECTION 12 -
TERMINATION


 


12.1         Upon
any material breach of, or default under, this Agreement by a party, the other
party may terminate this Agreement: upon ninety (90) days’ written notice to
the defaulting party in the event of a breach or default other than
non-payment; or upon ten


 


Omitted portions are
indicated by [***].  


 


Confidential
information redacted and filed separately with the Commission.


 


10





















 


(10) days’ written notice to the
defaulting party in the event of failure to make any payment when due.  Said notice shall become automatically
effective at the end of such period unless, during such period, the defaulting
party shall cure such breach or default.


 


12.2         Client
shall have the right to terminate this Agreement on ninety (90) days advance
notice.  During such ninety (90) day
period, Client shall continue to reimburse DEKA per Section 3 and
Attachment E, but monthly reimbursement to DEKA shall not exceed the average
reimbursement rate of the prior three (3) months.  Upon such termination, the License shall terminate.


 


12.3         The
provisions hereof relating to indemnification, ownership of Licensed Subject
Matter, and protection of Confidential Information shall survive termination.


 


12.4         If
Client defaults or breaches and fails to cure per Section 12.1:  the License shall terminate; and DEKA may
pursue all available remedies, at law or in equity.


 


12.5         If
Client terminates for any reason other than DEKA’s default or breach and
failure to cure per Section 12.1, the License shall terminate.


 


SECTION 13 -
NOTICE


 


13.1         Any
notices given under this Agreement shall be in writing and shall be deemed
delivered when sent by first class mail, postage prepaid, addressed to a party
at the address set forth above.  Each
party may change its notice address by written notice to the other.


 


SECTION 14 -
GENERAL


 


14.1         Use of Name.  No party to this Agreement shall employ or
use the name of the other party in any promotional materials or advertising
without the prior written permission of such other party.


 


14.2         Indemnity and Insurance.


 


14.2.1 Client shall indemnify, defend and
hold harmless DEKA, and each of DEKA’s partners, shareholders, directors,
officers, and employees, from and against any and all demands, claims, actions,
suits, proceedings, liabilities, obligations, damages, losses, costs and
expenses (including reasonable attorneys’ fees and disbursements) arising out
of the following: (i) any claim of a third party including, without
limitation, a patient upon whom the Licensed Product is used, a purchaser or
other user of a Licensed Product, and any other person alleging damages caused
by the Licensed Product or any component thereof alleging product liability,
negligence, or any other cause of action of any nature seeking to impose
liability for product design or manufacture; or (ii) any violation of any 


 


Omitted portions are
indicated by [***].  


 


Confidential
information redacted and filed separately with the Commission.


 


11





















 


governmental regulation by the sale or
use of a Licensed Product.


 


14.2.2 In the event of any claim under Section 14.2.1,
DEKA shall promptly notify Client of such claim, provided that failure to
provide such notice shall not release Client from any of its indemnification
obligations hereunder unless Client is materially prejudiced by the delay in
notification.  Client will undertake the
defense of any such claim by counsel of Client’s choosing and shall have
control of the defense of, and have the right to compromise, any such
claim.  DEKA will provide Client with all
information reasonably requested by Client, and will cooperate with Client in
defending such claim.  DEKA’s actual
costs in connection therewith will be reimbursed by Client.  DEKA, at its sole option and expense, may
participate in such defense through separate counsel of its own choosing.


 


14.2.3 In the event Client, within a
reasonable time after notice of any such claim, fails to undertake the defense
of such claim, DEKA (upon further notice to Client) shall have the right to
undertake the defense, compromise or settlement of such claim, subject to
Client’s right (and continuing obligation) to assume the defense of such claim,
and subject to DEKA’s right to obtain full reimbursement from Client.


 


14.2.4 
During the term of this Agreement, Client shall, and shall cause any
Affiliates or Sublicensees utilizing any rights granted under this License
Agreement to, procure and maintain insurance at its own cost and expense for
any claim of personal injury, property damage, or other cause of action arising
from any Licensed Product, or component of any product, or the use thereof,
with limits of not less than $5 million per occurrence of loss or damage.  Such policies of insurance shall name DEKA
and/or its designees as an additional insured and shall provide that such
policies shall not be cancelled on not less than twenty (20) days prior written
notice to DEKA.


 


14.2.5 The provisions of Section 14.3
hereof regarding arbitration shall not apply to disputes with third parties
arising out of this Section 14.2, but shall apply in determining the
respective obligations of Client and DEKA to each other under this Section 14.2.


 


14.3         Arbitration.


 


14.3.1 Any controversy or claim arising
out of or relating to this Agreement, or the breach thereof, except as
specifically provided in Section 14.3.3, shall be settled by a final and
binding arbitration with a single arbitrator in accordance with Commercial
Arbitration Rules of the American Arbitration Association.  The judgment upon the award rendered by the
arbitrator may be entered in any court having jurisdiction thereof without
right of appeal and both parties hereby consent to the entry of such
judgment.  Unless otherwise agreed,
arbitration shall be conducted in Boston, Massachusetts.  Damages, compensation, costs and expenses
(including reasonable attorneys’ fees) shall be allocated as part of the award
of the arbitrator.  The award of the
arbitrator shall not be judicially appealable. 
Any fixed sum damage amount found by the arbitrator shall be a liability
of the party against which 


 


Omitted portions are
indicated by [***].  


 


Confidential
information redacted and filed separately with the Commission.


 


12





















 


the finding is made, and shall be paid in
full within thirty (30) days of the date of the award.  The responsible party shall pay interest at
the variable rate of Prime Rate as reported in The Wall Street Journal
on the date of the award plus two percent (2%) per annum, plus all costs of
collection, including reasonable attorneys’ fees, in the event of non-payment
within such period.


 


14.3.2 Except as provided in Section 14.3.3,
neither party shall institute any legal or equitable action against the other
in any case with respect to a controversy or claim arising out of or relating
to this Agreement, or the breach thereof, except to compel arbitration pursuant
hereto or to confirm the arbitrator’s award.


 


14.3.3 The parties may commence an
equitable action upon the material breach or threatened material breach of any
obligation of confidentiality under Section 7 hereof.


 


14.4         Except
as provided in Section 14.2, in no event shall either DEKA or Client be
liable for special, indirect, incidental or consequential damages, whether
based on contract, tort or any other legal theory.


 


14.5         DEKA,
for all purposes related to this Agreement, shall be deemed an independent
contractor of Client, and nothing in this Agreement shall be deemed to create a
relationship of employment or agency, or to constitute DEKA and Client as
partners or joint venturers.


 


14.6         Each
party hereto acknowledges and agrees:


 


i.              that
no representation or promise not expressly contained in this Agreement has been
made by the other party hereto or by any of its agents, employees,
representatives or attorneys concerning the subject matter of this Agreement;


 


ii.             that this Agreement is not being entered into on the
basis of or in reliance on any promise or representation, express or implied,
covering the subject matter hereof other than those which are set forth
expressly in this Agreement; and


 


iii.            that each party has had the opportunity to be represented
by counsel of its own choice in this matter, including during the negotiations
which preceded the execution of this Agreement.


 


14.7                           DEKA
represents and warrants that:


 


14.7.1      DEKA Products Limited Partnership is a
limited partnership duly organized, validly existing, and in good standing
under the laws of New Hampshire;


 


Omitted portions are
indicated by [***].  


 


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information redacted and filed separately with the Commission.


 


13





















 


14.7.2      DEKA Research And Development Corp. is a
corporation duly organized, validly existing, and in good standing under the
laws of New Hampshire;


 


14.7.3      DEKA, to the best of its knowledge, has
the full right and power to enter into, and perform its obligations under, this
Agreement, and that there are no outstanding agreements, assignments or
encumbrances in existence inconsistent with the provisions of this Agreement.


 


14.7.4      DEKA, to the best of its knowledge, is the
legal owner of the Licensed Subject Matter.


 


14.8                           Client
represents and warrants that:


 


14.8.1      Client is a corporation duly organized,
validly existing, and in good standing under the laws of Delaware;


 


14.8.2      Client, to the best of its knowledge, has
the full right and power to enter into, and perform its obligations under, this
Agreement, and that there are no outstanding agreements, assignments or
encumbrances in existence inconsistent with the provisions of this Agreement.


 


14.9         No
party shall be liable for any failure to perform as required by this Agreement
to the extent such failure to perform is caused by any reason beyond the party’s
control, or by reason of any of the following: labor disturbances or disputes,
accidents, failure of any required governmental approval, civil disorders, acts
of aggression, acts of God, failure of utilities, mechanical breakdowns,
material shortages, disease, or similar occurrences.  This section shall not apply to any
obligation to make any payment to the other party.


 


14.10  
Neither this Agreement nor any rights hereunder may be assigned or
otherwise transferred by DEKA, in whole or in part, whether voluntary or by
operation of law, including by way of sale of assets, merger or consolidation,
without the prior written consent of Client, which consent shall not be
unreasonably withheld. Client shall not assign this Agreement without the prior
written consent of DEKA, except that Client may assign this Agreement and its
rights hereunder to an Affiliate or to a purchaser of all or substantially all
of the assets of the business unit or units to which this Agreement relates
regardless of the form of the transaction. Subject to the foregoing, this
Agreement will be binding upon and inure to the benefit of the parties and
their respective successors and assigns.


 


14.11  
If any part of this Agreement is held (by final judicial decree) void,
invalid or unenforceable, such ruling shall not affect the validity or enforceability
of the remainder of this Agreement, but such part shall be deemed modified to
the extent necessary, in the


 


Omitted portions are
indicated by [***].  


 


Confidential
information redacted and filed separately with the Commission.


 


14





















 


opinion of the judicial authority, to
render such term or condition enforceable, and the rights and obligations of
the parties shall be construed and enforced accordingly, preserving to the
fullest permissible extent the intent and agreements of the parties as set
forth in this Agreement.


 


14.12  
This Agreement contains the entire Agreement between the parties.  No amendments or modifications to this
Agreement shall be effective unless made in writing and signed by an authorized
representative of each party.  Further,
the parties agree that the Recitals and the Attachments attached hereto are
specifically incorporated into the Agreement by reference herein.


 


14.13  
This Agreement shall be governed by and construed in accordance with the
laws of the State of New York, without giving effect to any choice of law
provision or rule that would cause the application of the laws of any
other jurisdiction.


 


14.14  
No party, except as required by law, shall originate any publicity, news
release or public announcement, written or oral, whether to the public or
press, stockholders or otherwise, relating to this Agreement, including its
existence, the subject matter to which it relates, or any of its terms, to any
amendment hereto or performance hereunder, without the express written
permission of the other party, which permission will not be unreasonably
withheld.   The parties expressly agree that Client may
disclose the existence of this Agreement, the subject matter to which it relates,
its terms, amendments or either party’s performance hereunder, in each case to
the extent such disclosure is required by the Securities Exchange Act of 1934
or any other law (“Required Disclosure”), which may include, without
limitation, Client’s filing of this Agreement, or some portion thereof, with
the Securities and Exchange Commission pursuant to a Current Report on Form 8-K
or other Exchange Act report.  Client
shall meet and confer with DEKA in good faith prior to making any Required
Disclosure to ensure that, to the extent reasonably possible, Confidential
Information, including any confidential business information, is not disclosed.


 


14.15       The
License shall be deemed a license of “intellectual property” for purposes of
the United States Code, Title 11, Section 365(n). In the event of a party’s
bankruptcy and a subsequent rejection or disclaimer of this Agreement by a
bankruptcy trustee or by that party as a debtor-in-possession, whether under
the law of the United States or elsewhere, or in the event of a similar action
under applicable law, the other party may elect to retain its license rights,
subject to and in accordance with the provisions of the United States Code,
Title 11, Section 365(n) or other applicable law.


 


14.16  
This Agreement is subject to any law, regulation, order or other
restriction on the export or re-export of technology licensed under this
Agreement as may be imposed from time to time by the governments of the United
States, or any other country, or any agency thereof.  Neither party shall knowingly export 


 


Omitted portions are
indicated by [***].  


 


Confidential
information redacted and filed separately with the Commission.


 


15





















 


or
re-export or cause to be exported or re-exported, directly or indirectly, any
technology licensed under this Agreement from the other party to any country
for which the United States or any other government, or any agency thereof,
requires an export license or other government approval at the time of such
export without first obtaining any required license or approval.


 


IN WITNESS WHEREOF, the
parties hereto have executed this Agreement by their duly authorized officers
or representatives.


 


	
   

  	
   

  	
  DEKA PRODUCTS LIMITED
  PARTNERSHIP

  
	
   

  	
   

  	
  By DEKA Research & Development

  
	
   

  	
   

  	
  Corporation, its sole general partner

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Date: 

  	
   

  	
   

  	
   

  	
  By:

  	
   

  	
   

  
	
   

  	
   

  	
  Dean Kamen, President

  	
   

  
							



 


Omitted portions are
indicated by [***].  


 


Confidential
information redacted and filed separately with the Commission.


 





















 


	
   

  	
   

  	
  DEKA
  RESEARCH & DEVELOPMENT CORP.

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Date: 

  	
   

  	
   

  	
   

  	
  By:

  	
   

  	
   

  
	
   

  	
   

  	
  Dean Kamen, President

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
   

  	
   

  	
  AKSYS, LTD.

  
	
   

  	
   

  	
   

  
	
  Date: 

  	
   

  	
   

  	
   

  	
  By:

  	
   

  	
   

  
	
   

  	
   

  	
  William C.
  Dow

  	
   

  
	
   

  	
   

  	
  President and Chief Executive Officer

  



 


Attachments:


 


Attachment A – Definition of Hemodialysis Field


Attachment B – Hemodialysis Licensed Patents (as of September 21,
2005)


Attachment C – Definition of Solution Preparation Field


Attachment D – Funding of Research and Development


Attachment E – Warrant Schedule and Terms


Attachment F – License Payments


 


Omitted portions are
indicated by [***].  


 


Confidential
information redacted and filed separately with the Commission.


 





















 


RESEARCH, DEVELOPMENT AND LICENSE AGREEMENT


 


ATTACHMENT A


 


[***]


 


Omitted portions are
indicated by [***].  


 


Confidential information redacted and filed separately with the
Commission.


 





















 


RESEARCH, DEVELOPMENT AND LICENSE AGREEMENT


 


ATTACHMENT B


 


[***]


 


Omitted portions are
indicated by [***].  


 


Confidential
information redacted and filed separately with the Commission.


 
















 


RESEARCH, DEVELOPMENT AND LICENSE AGREEMENT


 


ATTACHMENT C


 


[***]


 


Omitted portions are
indicated by [***].  


 


Confidential
information redacted and filed separately with the Commission.


 
















 


RESEARCH, DEVELOPMENT AND LICENSE AGREEMENT


 


ATTACHMENT D


 


[***]


 


Omitted portions are
indicated by [***].  


 


Confidential
information redacted and filed separately with the Commission.


 
















 


RESEARCH, DEVELOPMENT AND LICENSE AGREEMENT


 


ATTACHMENT E


 


E.1                                Client agrees to issue to DEKA a common
stock purchase warrant (the “Warrant”) for the purchase of 350,000 shares of
common stock of Client. The exercise price of the Warrant shall be the average
of the high and the low price of trading of Client common stock on the NASDAQ
National Market System (or such other exchange ortrading platform as may then
be the principal medium for trading in shares common stock of Client) on the
date of execution of this Agreement. Provided that this Agreement has not been
terminated, the warrant shall have a term often years and a vesting schedule
that provides as follows:


 


a.                                       Vesting related to
concept freeze:  100,000 warrant shares shall vest upon
achieving concept freeze, pursuant to DEKA’s Standard Operating Procedures, for
a Licensed Product under the Development Program described in Section 2.1 (the
“Pluto Product”), except that:


 


•                  If the concept freeze is not achieved by
[***] of the 100,000 shares shall not vest;


 


•                  If the concept freeze is still not
achieved by [***] of the 100,000 shares shall not vest.


 


b.                                      Vesting Related to completion of
Prototype:  100,000 shares shall
vest upon completion of a representative form-factor working prototype of the
Pluto Product, except that:


 


•                  If the prototype is not delivered by
[***] of the 100,000 shares shall not vest;


 


•                  If the prototype is still not delivered
by [***] of the 100,000 shares shall not vest.


 


c.                                       Vesting Related to Turnover to
Manufacturing:  100,000 warrant
shares shall vest upon transfer of responsibility for manufacture of
the Pluto Product to a manufacturing facility (potentially including DEKA’s
internal manufacturing assets), except that:


 


•                  If the turnover to manufacturing does not
occur by [***] of the 100,000 shares shall not vest;


 


•                  If the turnover to manufacturing does not
occur by [***]  of the 100,000 shares
shall not vest.


 


d.                                      Vesting Related to Commercial Shipment:  50,000 warrant shares shall vest upon the
first commercial shipment of the Pluto Product, except that:


 


•                  If the first commercial shipment has not
occurred by [***] of the 50,000 shares shall not vest;


 


•                  If the first commercial shipment still
has not occurred by [***] of the 50,000 shares shall not vest.


 


Omitted portions are
indicated by [***].  


 


Confidential
information redacted and filed separately with the Commission


 
















 


RESEARCH, DEVELOPMENT AND LICENSE AGREEMENT


 


ATTACHMENT F


 


[***]


 


Omitted portions are
indicated by [***].


 


Confidential
information redacted and filed separately with the Commission.