EXHIBIT 10.18
Portions of the following exhibit have been omitted under a request for
confidential treatment under Section 24b-2 of the Securities Act of 1934.
Locations of these omitted portions is denoted by the following legend. [ * * ]
LICENSE AGREEMENT
THIS LICENSE AGREEMENT ("Agreement") is made this 7th day of January, 2002, by
and between: Dr. Xxxx Xxxxx ("AG"), an individual residing at 00000 Xxxxxx
Xxxxxx, Xxx #000, Xxxxxxxx, XX 00000, Charak LLC ("CHARAK"), a corporation
organized under the laws of the State of Michigan located at 0000 Xxxxxxx Xxxxx
Xxxxx, Xxx Xxxxx, Xxxxxxxx and owned by AG, and Rockwell Medical Technologies,
Inc. ("RMTI"), a corporation organized under the laws of the State of Michigan
located in Wixom, Michigan.
WITNESSETH:
WHEREAS, CHARAK and AG represent and warrant that CHARAK is the owner of certain
proprietary information and technology, including medical and scientific
information, clinical and other information, submissions, and records relating
to FDA approval carried on heretofore, processes, methods, technical know-how
and information attributable to and known by AG personally including
confidential and trade secret information, and associated rights and tangible
property and U.S. and foreign patent applications pending all relating inter
alia to delivery of Iron Salt(s), especially ferric pyrophosphate, and
pharmaceutically acceptable salts thereof delivered through dialysate to
patients suffering from renal failure more specifically set forth in pending
U.S. Patent Application Nos. 08/775,595 (and related Provisional Application No.
60/055,315), and 09/367,629, and related International Patent Applications Nos.
PCT/US98/16383, (WO98US16383), (WO9907419A1) and (WO97US23719) (WO9829434A1)
(International Patent Applications and National State Patent Applications in
foreign countries based on such International Patent Applications (foreign
patent applications)), (all such patent applications and all patents issued
therefrom comprising the "Patent Rights," and all such technology hereinafter
collectively referred to as "CHARAK TECHNOLOGY"), subject only to the rights of
Xxxxx Xxxx Health Systems Inc., a Michigan Corporation ("HFHS") to use the
Patent Rights and know-how existing as of the date hereof for the sole purpose
of research at its principal research facility or patient use within the
existing HFHS facilities as the same may be expanded in the ordinary course of
business ("the HFHS Shop Right"); and
WHEREAS, RMTI desires to secure from CHARAK, and CHARAK is willing to
provide RMTI, upon certain terms and conditions, an exclusive, worldwide,
non-transferable license to use the CHARAK TECHNOLOGY (less the HFHS Shop Right)
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("the Licensed Technology,") which expression shall include Enhancements (as
herein defined) of CHARAK, AG, and/or CHARAK Affiliates (hereinafter defined)
including a license to manufacture, use, commercialize and sell liquid and/or
dry dialysate compositions which utilize and are protected by the Licensed
Technology ("the Licensed Products").
NOW THEREFORE, for and in consideration of the recitals and covenants
set forth herein, the parties agree as follows:
ARTICLE I
TERM
The term of this Agreement (the "Term") shall commence on the date first written
above and shall continue on a product by product and Enhancement by Enhancement
and country by country basis until the last patent included in the Patent Rights
covering a Licensed Product or Enhancement in any country in which RMTI remains
licensed hereunder expires, plus a period of ten years. The Term with respect to
any product or Enhancement in any country shall automatically be extended for
successive one (1) year periods unless, at least twelve months before the
expiration of the original or any renewal Term, either party gives written
notice to the other that it does not wish to extend the Agreement with respect
to such product or Enhancement in such country. For purposes of this Article, a
patent included in the Patent Rights covers a Licensed Product (or Enhancement)
if the manufacture, use and/or sale of the Licensed Product or Enhancement
would, absent a license granted hereunder, infringe such patent.
ARTICLE II
GRANT OF LICENSE
CHARAK hereby grants to RMTI, subject to the conditions herein including as
outlined in Article III and subject to the HFHS Shop Right, an exclusive,
worldwide, non-transferable license to manufacture, have manufactured,
commercialize, use, market, offer for sale, and sell the Licensed Products,
and/or otherwise exploit the Licensed Technology in the treatment of patients
with renal failure by hemodialysis, peritoneal dialysis or by any other therapy,
together with the right to grant sublicenses for any or all such Licensed
Product(s) and/or Licensed Technology, as set forth more fully hereinafter. The
Licensed
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Technology shall include all inventions, improvements, and modifications thereto
("Enhancements") made, conceived or acquired by CHARAK, AG and any CHARAK
Affiliate (as defined more particularly hereinafter) during the term of this
Agreement, and any patent based on and covering the same which CHARAK, AG or any
CHARAK Affiliate now or hereafter owns, controls or has the right to
commercially exploit.
ARTICLE III
CONSIDERATION FOR GRANT
3.1 Patent/Other Obligations and Costs. If RMTI deems it necessary for
CHARAK to obtain additional patent protection on any portion of the Licensed
Technology, whether now existing or developed in the future, not covered by
patents issued from the Patent Rights, to assure protection of their exclusive
license rights herein, CHARAK, at RMTI's expense, will prepare and file the
requested patent applications.
RMTI shall use its best reasonable efforts, on a country by country basis, to
obtain, and thereafter maintain, Foreign Registrations or Approvals to market
the Licensed Products in order to enable their full commercial exploitation,
commensurate with RMTI's size, capabilities, and reasonable business judgment as
to feasibility and return on investment, and will use best efforts to do so
within one year following the date of patent issuance in countries where patent
protection is obtained, but delay by regulatory authorities shall not be deemed
lack of best reasonable effort by RMTI.
After obtaining regulatory approval to market the Licensed Products, RMTI shall
use its best reasonable efforts on a country by country product by product basis
to market the Licensed Products.
All future costs for filing, prosecuting, and/or issuing patent applications
and/or maintaining patents (both existing patent applications and additional
patent applications requested by RMTI) covering either in full or part the
Licensed Technology, including maintenance fees once patent(s) issue, will be
borne by RMTI as long as this Agreement is in force, on a country by country
basis, except as provided below. In addition, RMTI agrees to reimburse AG for
all bona fide, reasonable and documented expenses related to prosecution, filing
and maintenance fees of patent applications within the Patent Rights incurred
prior to the date hereof, but only to the extent such expenses do not duplicate
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expenses reimbursed by Xxxxx, and only to the maximum allowable extent of Twenty
Five Thousand Dollars U.S. ($U.S. 25,000).
CHARAK warrants that it will keep RMTI and its designated counsel promptly and
fully advised, at RMTI cost, as to the status and course of prosecution of all
such pending patent applications, including supplying copies of all official
papers received, copies of all papers filed by the attorneys involved and copies
of all correspondence to and from such attorneys regarding such applications.
RMTI shall have the right to make final decisions as to what is done in each
step in the course of prosecution in all such cases so long as it is obligated
to pay the related expenses. In any instance where RMTI decides not to proceed
with or otherwise discontinue prosecution or maintenance of any patent or
application, it shall to the extent reasonably possible notify CHARAK in
sufficient time to permit CHARAK to act and CHARAK may elect to continue on its
own and at its own expense.
3.2 Conditionally Non-Refundable License Fee. RMTI agrees to pay CHARAK
a license fee, which shall be non-refundable except for CHARAK's breach of
warranty or fraud, payable in 6 segments as follows: Fifty Thousand US Dollars
(US $50,000) at the time of execution of this Agreement, to be paid in the
common stock of RMTI valued at a price per share corresponding to that existing
at the close of trading on the NASDAQ exchange on the previous day; Seventy Five
Thousand U.S. Dollars (U.S. $75,000) upon issuance of a U.S. Patent based on
U.S. Patent Application No. 08/775,595 with claims generally corresponding to
those present in the application prior to the date of execution hereof; Fifty
Thousand US Dollars (US $50,000) upon successful completion of Phase III
clinical trials and filing with the FDA for 510(k) approval; One Hundred
Thousand US Dollars (US $100,000) upon approval of the therapy by the US FDA;
One Hundred Seventy Five Thousand US Dollars (US $175,000) upon successful
assignment of a billing/reimbursement code for the Licensed Products by the
United States Health Care Financing Administration (HCFA); and One Hundred Fifty
Thousand U.S. Dollars (U.S. $150,000) upon the grant of Orphan Drug Status by
the FDA.
3.2.1 In the event of CHARAK or AG's breach of warranty or fraud during the
active term of this Agreement, the license fees received by CHARAK shall be
refundable as follows:
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- Full amount received by CHARAK, if such event occurs during the first
five years from the date of this Agreement, and
- Only one-half the amount received by CHARAK, if such event occurs
later.
3.3 Royalty. RMTI shall pay Charak a Royalty ("Royalty") based on RMTI's
average actual selling price of Licensed Products, as particularly specified
herein, where the selling price of Licensed Products exceeds [*
*], at rates set forth below, and, if the
selling price of Licensed Products is below [*
*], RMTI shall pay Charak a Royalty ("Royalty") based on
RMTI's Revenue Advantage, which will be based on RMTI's increase in per unit
revenue, received by RMTI, for liquid and dry dialysate products which embody
Licensed Technology ("Licensed Products") with respect to the per unit revenue
received by RMTI in that country for liquid and dry dialysate products that do
not embody Licensed Technology ("Conventional Products").
The Royalty Rate to be used in calculating Royalty payable to CHARAK for each
country or territory in which Licensed Products are sold by RMTI at per-drum
sales prices of [* *], for sales of
Licensed Products at per-drum prices between [*
*] and for per drum sales prices of Licensed Products less than
[* *] of the prevailing RMTI Revenue
Advantage, in countries where the Licensed Products are covered by patents which
have not expired or been invalidated or held unenforceable by a court of
competent jurisdiction, and in countries where the Licensed Products are subject
to a grant of regulatory exclusivity. In all other countries or territories, and
after any or all patents included in Licensed Technology have expired or
regulatory exclusivity has expired, the corresponding Royalty Rates shall be
reduced to [*
*].
The Revenue Advantage Royalty will be calculated by using the increase in the
"average actual selling price" of Licensed Products over the "base average
actual selling price" of Conventional Products, on a 55-gallon drum equivalent
basis ("a unit") in each country or territory where Licensed Products are sold.
The "average actual selling price" of the Licensed Products in a given country
is the weighted average actual gross invoice price received by RMTI per unit
sold to independent and unrelated third parties in or for that
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country in the normal course of business, less any and all chargebacks, rebates,
discounts, buying group discounts, taxes, duties, handling or other charges,
credits, fees allowances, and returns, on a 55-gallon drum equivalent basis
(i.e., per unit) sold by RMTI during the 12 month period preceding the month in
which RMTI sells Licensed Products during each quarterly period for which a
Royalty is payable. The "base average actual selling price" in a given country
is the weighted average actual selling price of liquid and dry dialysate
products without the Licensed Technology (Conventional Products), on a per unit
basis, sold in that country. If RMTI sells Licensed Products in any new
territory for which it does not already have a "base average actual selling
price" of its Conventional Products, it will initially use the same "base
average actual selling price" as that prevailing in the United States, which
will then be applied to the weighted average actual selling price of Licensed
Products in the territory involved to calculate the "Revenue Advantage".
Royalty to CHARAK for Licensed Product drum prices less than [* *] =
Royalty Rate x Unit Volume x Revenue Advantage [i.e., Average Actual Selling
Price with Licensed Technology minus Average Actual Selling Price without
Licensed Technology].
If the Licensed Technology is sold separately from RMTI's Conventional Product,
the Licensed Technology will earn a specified royalty. The royalty will be
[* *] of revenue of the Licensed Technology in all countries,
provided it has exclusivity via a patent or Orphan Drug Designation. If after
any or all patents included in Licensed Technology have expired or regulatory
exclusivity has expired, or there is no exclusivity, the corresponding Royalty
Rate shall be [* *] in all countries.
The Royalty shall be payable to CHARAK within one month of the quarter most
recently ended and RMTI shall provide duly verified details and computation
basis for computation to CHARAK for CHARAK's verification/audit.
3.4 Sublicense Rights. CHARAK grants RMTI the right to issue
sublicenses for the Licensed Technology, to the full extent of but not exceeding
the rights of RMTI under this Agreement, or less than that, on particular terms
and conditions deemed best by RMTI in each instance, with appropriate disclosure
of CHARAK's rights. RMTI shall promptly advise CHARAK as to the issuance of each
and every such sublicense, identifying the sub-licensee by name and address,
shall promptly account to CHARAK for all sales of Licensed Products by such
sub-licensees, and shall pay royalties to CHARAK
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for such sub-licensee sales within thirty (30) days following the end of each
quarter, on the same overall basis as RMTI is itself obligated to CHARAK for
RMTI's sales under this Agreement, but based on the pricing used by each
Sublicensee in each country or territory.
3.5 Commercialization and Technical Support. RMTI undertakes and agrees
with CHARAK to faithfully and diligently exploit, on the basis set forth in
paragraph 3.1 hereinabove, the commercial potential of the Licensed Technology.
RMTI, at its sole cost and expense, shall be responsible for all regulatory
affairs associated with the Licensed Products during the active term of this
Agreement in all countries or territories for which this agreement remains in
effect, including clinical trials and commercialization submissions to the U. S.
Food and Drug Administration, but CHARAK and AG shall assign to RMTI all rights
and status obtained prior to the date of this Agreement and shall cooperate and
assist RMTI in all ways and at all times reasonably requested by RMTI. RMTI
shall prepare and submit in its name a completed new drug and/or device
application (NDA) (or the equivalent in other countries) for the Licensed
Product and shall use its best reasonable efforts to obtain FDA approval of the
NDA. RMTI shall be responsible for obtaining applicable State
regulatory/formulary approvals for the marketing, sale and distribution of
Licensed Products in both the U.S. and foreign countries.
Throughout the term of this Agreement, CHARAK and AG agree to provide, and RMTI
agrees to pay CHARAK and/or AG for, such reasonable technical and clinical
consultation and support at mutually convenient times during normal business
hours as RMTI may request, including the services of AG, which shall be
exclusive to RMTI with respect to all aspects of the Licensed Technology. AG's
services shall be billed, for the first year of this Agreement, at the rate of
US $1,500.00 per day, or US $187.50 per hour, and all other personnel will be
billed at mutually agreed-upon market rates. All costs and expenses will be
reimbursed promptly upon invoicing by CHARAK and/or AG.
3.6 Audits. RMTI shall make its and its Affiliate(s) records pertaining
to the performance of this Agreement available to independent auditors
designated by and at the expense of CHARAK, at RMTI's facilities and at
reasonable and mutually convenient times during normal business hours, for audit
purposes and shall take any reasonable
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actions required to facilitate such audit. All information obtained during any
such audit shall be deemed confidential, and such auditors shall report only the
conclusion reached by their audit relative to accuracy and adequacy of payments
including Royalty payments made to CHARAK hereunder. No such audit shall be
conducted more frequently than once per year, or carry back more than two years.
It is however agreed that if as a result of any such audit it is found that RMTI
has knowingly not duly met its payment obligations to CHARAK then the cost of
such audit shall be borne by RMTI. RMTI shall include this same obligation in
any sublicenses it issues, except that the facilities involved shall be those of
each sublicensee, as determined most appropriate by them.
ARTICLE IV
REPRESENTATIONS BY AND OTHER
UNDERTAKINGS BY CHARAK, AG. AND RMTI
4.1 CHARAK for itself and all CHARAK Affiliates, and AG warrant to RMTI
that CHARAK is the sole and exclusive owner of the Licensed Technology as of the
date of execution hereof, subject only to the HFHS Shop Right, and that CHARAK
has the right to grant the license granted hereunder; that no agreement or other
document effective as of the date of execution hereof is in force which is in
conflict herewith and neither CHARAK or AG will execute any such agreement
during the active term hereof; that CHARAK officers have the full right,
authority and authorization to execute this Agreement and to grant the rights
granted to RMTI hereunder; and that no consent or authorization of any third
party is required as a condition precedent to its execution or performance of
this Agreement.
4.2 RMTI hereby represents to CHARAK that no agreement or other
document in force as of the date hereof is in conflict herewith; that its
officers have the full right, authority and authorization to execute this
Agreement; and that no consent or authorization of any third party is required
as a condition precedent to its execution or performance of this Agreement.
4.3 RMTI shall be responsible for and use its best efforts to make sure
that no Licensed Products will knowingly be sold or otherwise distributed by it
or its sublicenses/Affiliates that are not in full compliance with all legal and
regulatory requirements. RMTI assures CHARAK that the Licensed Products shall be
developed,
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manufactured, transported, stored, handled, packaged, marketed, promoted,
distributed, offered for sale and sold in accordance with all regulatory
authorities, including without limitation, the FDA, in any country of the
licensed territory, including, without limitation, cGCP, cGLP, cGMP regulations.
The Licensed Products shall not be adulterated or misbranded as defined by the
Federal Food, Drug and Cosmetic Act when delivered and shall not be a product
which would violate any section of such Act if introduced in interstate
commerce.
4.4 AG and CHARAK shall promptly and diligently pursue a grant of
regulatory exclusivity ("Orphan Drug Status) from the US FDA for the Licensed
Products at their own expense in the name of RMTI.
ARTICLE V
INFORMATION AND OWNERSHIP REGARDING THE LICENSED TECHNOLOGY
5.1 The Licensed Technology, (except for FDA-related rights, etc.) and
all inventions, improvements, enhancements and modifications thereto made,
conceived or developed by CHARAK or AG, or by any other person or entity
controlled or owned by either (all jointly and severally constituting the
"CHARAK Affiliates") after the date of this Agreement, and any patent covering
such inventions, improvements, enhancements, modifications in whole or part
which said CHARAK Affiliates now or hereafter own, control, or have the right to
commercially exploit, ("CHARAK Enhancements") shall remain the sole and
exclusive property of one or more of the CHARAK Affiliates but shall be deemed
included as elsewhere specified herein as within the license hereby granted.
CHARAK Affiliates shall, upon demand, execute and deliver to RMTI, or cause to
be executed and delivered to RMTI, such conventional documents as are deemed
reasonably necessary or advisable by counsel for RMTI for filing in the
appropriate public offices to evidence the grant of the exclusive license for
the Licensed Technology hereby granted to RMTI.
5.2 CHARAK, AG and all CHARAK Affiliates expressly assure RMTI that
they believe that there is nothing that would invalidate/restrict their rights
in the Licensed Technology, except the HFHS Shop Right.
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5.3 All inventions, improvements, enhancements and modifications to the
Licensed Technology made, conceived or developed solely by RMTI or its agents
and representatives without involvement of CHARAK, AG or any CHARAK Affiliates
after the date of this Agreement which absent a license would infringe Licensed
Patents, and any patent covering the same ("RMTI Enhancements"), shall be the
sole property of RMTI but may be used non-commercially by CHARAK during the
active term of this Agreement.
5.4 All inventions which have at least one inventor which is either AG
or a CHARAK Affiliate and at least one inventor which is neither AG
nor a CHARAK Affiliate shall (as between RMTI and CHARAK) be
assigned to CHARAK and RMTI jointly and shall be part of the
Licensed Technology under this Agreement.
ARTICLE VI
INFRINGEMENT, INDEMNIFICATION AND INSURANCE
6.1 (i) RMTI and CHARAK shall each promptly inform the other in writing
of any alleged infringement or unauthorized use by a third party of Licensed
Technology of which it becomes aware and provide such other with any available
evidence of such unauthorized activity.
6.2 RMTI shall have the right, but not the obligation to defend any and
all charges of infringement of intellectual property rights concerning the
manufacture, use, sale, offer for sale, or importation of the Licensed Products
whether such charge is made against RMTI, an RMTI Affiliate or sub-licensee or
CHARAK, or an Affiliate of CHARAK, or any combination thereof. RMTI shall also
have the right, but not the obligation to bring charges of infringement against
any other party on behalf of itself, its Affiliates or sub-licensee, and/or
CHARAK for infringement of the Patent Rights. In all such cases, RMTI shall have
the right, but not the obligation, to control such litigation or threatened
litigation, including the right to choose counsel, the right to direct the
conduct of the litigation, the right to settle or compromise the case or
position, and to take any other action as RMTI may, in its own discretion deem
appropriate. Upon request of RMTI, CHARAK agrees to permit RMTI to bring suit in
CHARAK's name and to join in such suit.
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6.2.1 RMTI shall bear the expense for protecting the Patent Rights
during any infringement proceeding and shall receive the full benefit of any
recovery or settlement in connection with any such proceeding; provided,
however, that in the event CHARAK elects to participate in the expense of such
proceeding, any recovery and any expense relating to the protection of such
Patent Rights shall be shared by CHARAK and RMTI as follows:
(a) First, all expenses to be incurred by the parties in
protection of any Patent Rights and (including, without
limitation, attorney fees) shall be borne 85% by RMTI and 15%
by CHARAK and any recovery or award obtained shall first be
applied to reimburse RMTI and CHARAK in proportion to their
participation in such expenses;
(b) Any cash recovery other than a royalty remaining after the
reimbursement of RMTI and CHARAK of all such expenses shall be
distributed 85% to RMTI and 15% to CHARAK;
(c) If RMTI settles the litigation under terms requiring the
payment of a royalty to the infringer, RMTI shall bear 85% of
such payment and CHARAK shall bear 15% of such payment. The
amounts payable by CHARAK shall first be applied against the
royalties he is otherwise entitled to receive hereunder;
(d) In the event RMTI elects not to take any action against an
infringer of Patent Rights within ninety (90) days after
actual notice of infringement, CHARAK shall have the right,
but not the obligation, to do so and in which event CHARAK
shall be responsible for the costs of such litigation. In all
such cases CHARAK shall have the right to control such
litigation, including the right to choose counsel, the right
to direct the conduct of the litigation, the right to settle
or compromise the case and take any other action as CHARAK
may, in his discretion deem appropriate; provided, however,
that CHARAK may not grant a license or sublicense under the
Patent Rights to any third party for as long as the Patent
Rights are licensed exclusively to RMTI hereunder nor may
CHARAK enter into an agreement of any kind which would
interfere with, reduce or conflict with
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the rights granted to RMTI hereunder. RMTI shall not be
entitled to any recovery procured by CHARAK from such
protection of Patent Rights by way of settlement, judgment or
otherwise; provided, however, if RMTI elects to participate in
any such action before the suit is filed in court, the costs
shall be borne by and allocated between and recoveries shall
be distributed to CHARAK and RMTI mutatis mutandis in the same
manner as provided above except that 85% of the costs and
recoveries shall be borne by and distributed to CHARAK and 15%
of the costs and recoveries shall be borne by and distributed
to RMTI.
Notwithstanding the foregoing any infringement settlement that includes a
license for future sales of Licensed Products shall be regarded a sublicense and
shall be subject to the terms of this Agreement like any other sublicense.
6.3.2 CHARAK Affiliates shall indemnify and hold harmless RMTI and its
Affiliates and their officers, directors and employees from and against any and
all Losses arising directly out of or resulting directly from any breach by
CHARAK or any of its Affiliates of any of its warranties, representations,
obligations or covenants contained herein.
6.3.3 Neither party shall be liable, one to the other, for any
indirect, special, punitive, consequential or exemplary damages arising
out of or in connection with this Agreement.
6.4 Insurance. RMTI agrees to purchase, at its sole cost, comprehensive
general liability insurance (occurrence or claims-made form) for bodily injury
and property damage, including contractual and product liability, in an amount
of not less than $3,000,000 combined single limits and provide CHARAK with a
certificate of insurance naming CHARAK as an additional insured. Such contract
of insurance shall be primary with respect of any other insurance available to
CHARAK and shall contain a waiver of subrogation by RMTI's insurance carrier
against CHARAK and its insurance carrier with respect to all obligations assumed
by RMTI pursuant to this Agreement. Such insurance shall contain provisions to
the effect that policy limits may not be reduced, terms changed, or the policy
cancelled without prior written consent from RMTI, and RMTI shall not give such
consent without first obtaining CHARAK's consent, which shall not be
unreasonably withheld.
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6.5 Infringement. RMTI shall promptly confer and provide to one another
all available information pertaining to any and all charges and claims of
infringement that are made or brought against RMTI and/or CHARAK related to the
exercise of the license granted to RMTI pursuant to this Agreement, and RMTI
shall have the right but not the obligation to defend against such charges at
its own expense. CHARAK shall cooperate fully with such efforts. In any case or
instance where RMTI chooses not to defend any such infringement, RMTI shall duly
inform CHARAK in advance in writing, and shall provide relevant information then
known to RMTI in sufficient detail for CHARAK and/or its attorneys to understand
the merits and posture of the case. Upon such intimation CHARAK shall have the
right to defend such case and if CHARAK so chooses RMTI shall cooperate fully
with such efforts. The costs for the same shall be borne by the party carrying
on such defense and, in the event that CHARAK elects to defend the infringement,
any damage assessment in excess of what RMTI could have settled the case for, if
any, shall also be paid by CHARAK.
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6.6 Indemnification.
6.6.1 RMTI shall indemnify and hold harmless CHARAK, AG and
their Affiliates and their officers, directors and employees
from and against any and all claims, losses, damages,
judgments, costs, awards, expenses (including reasonable
attorney's fees) and liabilities of every kind (collectively,
"Losses") arising directly out of or resulting directly from
any breach by RMTI of any of its warranties, guarantees,
representations, obligations or covenants contained herein.
"Affiliate" shall mean any corporation or partnership or other
entity, which directly or indirectly controls, is controlled
by, or is under common control with CHARAK and/or Xx. Xxxxx.
"Control" shall mean the legal power to direct or cause the
direction of the general management or partners of such entity
whether through the ownership of voting securities, by
contract or otherwise.
ARTICLE VII
TERMINATION
7.1 This Agreement may be terminated as follows:
7.1.1 At the sole option of CHARAK and upon written notice by
CHARAK, in the event RMTI fails to meet any of its financial
obligations under this Agreement, but RMTI will have
forty-five (45) days following receipt of notice to cure the
violation.
7.1.2 At the option of either party and upon sixty (60) days
written notice, in the event of the other party's failure to
perform any of its non-financial duties or obligations under
this Agreement, but the defaulting party may cure and nullify
the violation during the notified period following receipt of
notice.
7.1.3 At the option of RMTI, at any time during the term
hereof with respect to any country, upon six (6) months
written notice.
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7.1.4 a. At the option of CHARAK, in the event RMTI shall
at any time be insolvent or shall have had a petition in
bankruptcy filed by or against it, provided, however, that
such petition is not dismissed within 120 days of the filing
thereof. For purposes of this agreement, "insolvent" shall
mean a party is unable to pay its debts as such debts mature.
b. In any particular country in which exclusivity due
to Patent Rights or regulatory action exists, in the event
RMTI fails to apply for Marketing Authorization within twelve
(12) months after successful completion of Phase III or
equivalent Clinical Studies needed for regulatory approval
(the "Target Date") unless such failure or delay is due to
events or circumstances beyond the reasonable control of RMTI.
7.2 Remedies hereunder are not exclusive. The non-breaching party shall
have all remedies available at law or in equity. The provisions of
Article VIII and the obligations for payment of Royalties under Section
3.3, so long as there is a Revenue Advantage as per Section 3.3, and
RMTI obligations to CHARAK for any due and accrued License fees and/or
other payments to CHARAK shall survive any termination of this
Agreement.
7.3 Upon termination of this Agreement, any sublicenses granted
pursuant to this Agreement by RMTI shall also stand terminated
simultaneously, but subject to same survival of obligations after
termination as contained in Section 7.2 above being applicable to such
sub-licensee(s), unless CHARAK agrees in writing to the continuance of
any sub-license(s) on such terms and conditions as CHARAK may decide
for such continuation.
ARTICLE VIII
CONFIDENTIALITY
8.1 Definition of Confidential Information. As used in this Agreement,
"Confidential Information" shall mean all information which is transmitted in
written, graphic or photographic form and marked as "Confidential" or
transmitted in oral form and reasonably known to be confidential or claimed to
be so by the discloser at the time of transmittal or before any non-confidential
disclosure of it by the recipient, but Confidential
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Information does not include that which (a) can be shown by the receiving party
to have been in its possession prior to disclosure to it by the transmitting
party; (b) at the time of disclosure hereunder is, or thereafter becomes,
through no fault of the receiving party, part of the public domain by
publication or otherwise; or (c) is furnished to the receiving party by a third
party after the time of disclosure hereunder as a matter of right, who owes no
obligation of confidentiality to the transmitting party with respect to the
Confidential Information.
8.2 Exchange of Information. All Confidential Information exchanged
between CHARAK and RMTI pursuant to this Agreement or previously exchanged
between CHARAK and RMTI relating to the subject matter hereof, shall be kept
confidential by each party with the same degree of care normally accorded by
such party to its own confidential information except for purposes authorized by
this Agreement. Neither party shall disclose such Confidential Information to
any person or entity during the term of this Agreement and for a period of five
(5) years after the termination of this Agreement, unless previously authorized
in writing by the other party; provided, however, that each party may disclose
said Confidential Information to responsible officers (including authorized
representatives) and employees of any party who requires said information for
the purposes contemplated by this Agreement, provided that said officers and
employees shall have assumed like obligations of confidentiality.
ARTICLE IX
ASSIGNABILITY
9.1 Notwithstanding the references in this Agreement to
non-transferability of the license contained herein, (i) CHARAK shall
be permitted to assign its rights and obligations under this Agreement
to a third party purchaser of all or substantially all of CHARAK 's
business pertaining directly to the Licensed Technology, and (ii) RMTI
shall be permitted to assign its rights and obligations under this
Agreement to a third party purchaser of all or substantially all of
RMTI's business pertaining directly to sale or use of the Licensed
Products, but only by an express undertaking by the purchasers to
faithfully uphold and perform all of RMTI's duties and obligations
hereunder, which shall not be divided or fractionalized by any such
assignment. This Agreement shall be binding upon and
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shall inure to the benefit of CHARAK and RMTI and their permitted
assigns and successors in interest.
ARTICLE X
GOVERNING LAW
10.1 This Agreement shall be governed by and construed in accordance
with the laws of the State of Michigan and the Federal laws relating to patents,
with jurisdiction in the State of Michigan.
ARTICLE XI
NOTICES
11.1 For purposes of notices given pursuant to this Agreement, the
addresses as set forth in Section 11.2 shall be used unless changed by written
notice given by one party to the other:
11.2 For the purposes of notices under Section 11.1 above, the
following addresses shall be used:
For AG: Xxxx Xxxxx, MD
For CHARAK: Charak LLC
0000 Xxxxxxx Xxxxxx Xxxxx
Xxx Xxxxx, XX 00000
Attn.: Xxxx Xxxxx, President and CEO
Facsimile Number: 000 000 0000
For RMTI: Rockwell Medical Technologies, Inc.
00000 Xxxxx Xxxx
Xxxxx, XX 00000
Attn.: Xxx Xxxxxxx, Chairman, President, and CEO
Facsimile Number: (000) 000-0000
11.3 All notices hereunder shall be in writing and shall be deemed
given when (a) personally delivered; or (b) when received, if mailed by
certified mail, return receipt requested, postage prepaid; or (c) when received
when sent by courier service, UPS, or
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equivalent carrier; or (d) on the first business day after receipt of facsimile
copy when transmitted by confirmed facsimile, with hard copy mailed by United
States mail.
ARTICLE XII
MISCELLANEOUS
12.1. Headings. The headings used in this Agreement are for purposes of
convenience and ready referral and shall not be deemed to limit or expand the
construction of any paragraph to which they appertain.
12.2 Severability. The invalidity or unenforceability of any provision
of this Agreement shall not affect or limit the validity or enforceability of
any other provision hereof.
12.3 No Waiver. No waiver by either party or any breach of the terms of
this Agreement shall be deemed a waiver of any subsequent breach thereof.
12.4 Entire Understanding. This Agreement embodies the entire
understanding and agreement between the parties and supersedes all previous
negotiations, representations and writings, written or oral, with respect to the
subject matter hereof. This Agreement may be amended or modified only by an
instrument in writing, duly signed by the parties hereto.
12.5 This agreement may be executed in more than one counterpart, each
of which shall be deemed an original document, and all of which taken together
shall be one and the same Agreement.
12.6 Dr. Xxxx Xxxxx assures RMTI and warrants that CHARAK is and will
remain fully capable of performing all of its obligations under this Agreement,
that all statements and verifications of CHARAK and AG herein are believed in
good faith to be true, and that AG will faithfully and satisfactorily provide
all services and information required of him by this Agreement. RMTI assures
CHARAK and AG that RMTI has full corporate power and authority to enter into
this Agreement, consummate the transactions contemplated herein and perform its
obligations hereunder and RMTI shall faithfully and satisfactorily perform its
obligations as required of it by this Agreement.
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12.7 Force Majeure - If either CHARAK /AG or RMTI shall be prevented by
fire, war, civil disturbances, acts of God, intervention of a Government
Authority, or other similar events beyond the reasonable control of CHARAK/AG or
RMTI from performing their respective obligations hereunder, neither CHARAK/AG
nor RMTI shall be liable to the other for damages ("Force Majeure"). The party
being able to perform may, at its sole option, extend the duration for the
performance of the obligations by the other under this Agreement by a term equal
in length to the period during which the other party was unable to perform its
obligations hereunder on account of Force Majeure, or waive such obligations.
12.8 Independent Contractor --CHARAK/AG's relationship with
RMTI under this Agreement shall be that of independent contractor. Nothing in
this Agreement shall be deemed or construed by the parties hereto or by any
third parties creating the relationship of principal and agent, employer and
employee or of partnership or of joint venture between the parties hereto.
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IN WITNESS WHEREOF, the parties hereto have executed this Agreement as
of the day and year first above written.
ATTEST: CHARAK LLC
By: /s/ Dr. Xxxx Xxxxx
---------------------------- ---------------------------
Dr. Xxxx Xxxxx
President and CEO
ATTEST: ROCKWELL MEDICAL TECHNOLOGIES, INC.
By: /s/ Xxxxxx Xxxxxxx
---------------------------- ---------------------------
Xxxxxx Xxxxxxx
Chairman, President, CEO
ATTEST: DR. XXXX XXXXX
By: /s/ Dr. Xxxx Xxxxx
---------------------------- ---------------------------
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