Exhibit
10.1


 


[****] Represents material which has been redacted pursuant to a
request for confidential treatment pursuant to Rule 24B-2 under the Securities
Exchange Act of 1934, as amended.


 


LICENSE
AGREEMENT


 


THIS LICENSE AGREEMENT (the “Agreement”) dated
the 16th day of December 2003 (The Effective Date), is made by and between
Kyosei Pharmaceutical Co. Ltd. (“KYOSEI”), a subsidiary of the Sakai Group
organized under the laws of Japan, having its principal place of business at
1-25-18 Okusawa, Otaru, Hokkaido, 047-0013, Japan and IMCOR, a division of Photogen Technologies, Inc. (“IMCOR”), a
Nevada corporation having its principal place of business at 6175 Lusk
Boulevard, San Diego, California 92121.


 


R E C I T A L S


 


WHEREAS, IMCOR owns Imagent® (perflexane lipid
microspheres) and related imaging assets and intellectual property;


 


WHEREAS, KYOSEI desires to secure the
exclusive right and license to use, develop, distribute, market and sell Imagent
in the Territory and the right to negotiate to obtain manufacturing rights of Imagent in the future;


 


NOW, THEREFORE, in consideration of the
promises and covenants contained herein and intending to be legally bound
hereby, the parties agree as follows:


 


1.                                       Definitions.


 


“Affiliate” of an entity means a person or
other entity that controls, is controlled by or is under common control with
such entity, whether by stock ownership or otherwise.


 


“Bankruptcy Event” means voluntary or
involuntary proceedings by or against an Entity are instituted in bankruptcy or
under any insolvency law, or a receiver or custodian is appointed for such
Entity, or proceedings are instituted by or against such Entity for corporate
reorganization or the dissolution of such Entity, which proceedings, if
involuntary, shall not have been dismissed within 60 days after the date
of filing, or such Entity makes an assignment for the benefit or creditors, or
substantially all of the assets of such Entity are seized or attached and not
released within 60 days thereafter.


 


“Calendar Quarter” means each three-month
period, or any portion thereof, beginning on January 1, April 1,
July 1 and October 1.


 


“Calendar Year” means a period of
12 months beginning on January 1 and ending on December 31.


 


“Completion of Trial” means the completion of
the clinical trial endpoint analysis final report.


 


1

















 


“Confidential Information” means and includes
all Technical Information, inventions, trade secrets, developments,
discoveries, software, know-how, methods, techniques, formulae, data, processes
and other proprietary ideas, whether or not patentable or copyrightable, that a
party identifies as confidential or proprietary at the time it is delivered or
communicated to the other party or that is not generally known to the public or
in the industry.


 


“Entity” means a corporation, an association,
a joint venture, a partnership, a trust, a business, an individual, a
government or political subdivision thereof, including an agency, or any other
organization which can exercise independent legal standing.


 


“Field of Use” means echocardiology and
ultrasound radiology


 


“FDA” means the United States Food and Drug
Administration.


 


“cGMP” means current Good Manufacturing
Practices under applicable ICH guidelines.


 


“ICH” means International Conference for
Harmonization.


 


“IMCOR” shall mean a division of Photogen
Technologies Inc. and its Affiliates.


 


“Imagent” means perflexane lipid
microspheres used as a contrast agent in conjunction with ultrasound, and
detailed in NDA #21-191.


 


“Initiation of Clinical Study” shall mean the
acceptance of the study plan by MHLW.


 


“Licensed Product(s)” means Imagent and any products, components or
kits with which it may be packaged and sold.


 


“MHLW” means the Japanese Ministry of Health,
Labor and Welfare.


 


“Net Sales” means the transfer of ownership
of units of Licensed Product(s) at the Yakka price in a bona fide non-affiliate
third party transaction for the sale, use, lease, transfer or other disposition
of Licensed Product(s)


 


“NDA” shall mean a New Drug Application and
all supplements filed pursuant to the requirements of the MHLW, including all
documents, data and other information concerning Licensed Product(s) which are
necessary for MHLW approval to market Licensed Product(s).


 


“Patent Rights” means those United States
patent applications listed in Exhibit “A,” hereto,  as may be amended from time to time, and foreign counterparts
including continuation, divisional and re-issue applications thereof and
continuation-in-part applications thereof “SAE” means a serious adverse event.


 


“SAKAI group” shall include but not be
limited to SAKAI Chemical Industry Co. Ltd., Kyosei Pharmaceutical Co. Ltd.,
and Kaigen Co. Ltd.


 


2

















 


“Technical Information” means research and
development information, unpatented inventions, know-how, trade secrets,
manufacturing and technical data in the possession of IMCOR on the Effective
Date of this Agreement or developed thereafter to produce the Licensed
Product(s).


 


“Territory” shall mean the country of Japan.


 


“Yakka Pricing” means the realized price
received for the sale of Licensed Product(s) as set by the Japan National
Health Insurance.


 


2.                                       License
Grant.  IMCOR grants to KYOSEI for the
term of this Agreement an exclusive, right and license, in the Field of Use
with the right to grant sublicenses, to clinically develop, package,
distribute, promote, market and sell Licensed Product(s) in the Territory.


 


A.                                   Notwithstanding
the granting of a sublicense to a third party or an Affiliate,  KYOSEI shall remain responsible to IMCOR for
all obligations contained in this Agreement and the sublicensee must be bound
in writing, for the benefit of IMCOR, to all the limitations and restriction
under this Agreement and no such sublicense shall be further
sublicensable.  Further, the written
Agreement of the sublicensee must be filed with IMCOR before the sublicense is
effective.


 


B.                                     Nothing
herein shall preclude KYOSEI from using a distributor to promote and distribute
the Licensed Product(s) in the Territory; provided, however, no Licensed
Product(s) will be directly or indirectly marketed, promoted or distributed to
any Entity outside the Territory.


 


3.                                       License
Fees, Milestones and Royalties.


 


A.                                   In
partial consideration of the exclusive license and services granted herein,
KYOSEI shall pay to IMCOR an amount equal to Ten Million Dollars ($10,000,000),
which amounts shall not be subject to offset [****] (License Fee) is due upon [****].


 


B.                                     In
further consideration of the exclusive license granted herein, KYOSEI shall pay
IMCOR Milestone payments as follows:


 


(i)                                    On [****] a payment of [****] is due to coincide
with [****].


 


(ii)                                 At the earlier occurrence of the following
events: [****]:  [****] milestone, in
consideration for services and assistance provided by IMCOR to reach the
milestone.


 


3

















 


(iii)                              At the earlier occurrence of the following
events: [****]:  [****] milestone, in
consideration for services and assistance provided by IMCOR to reach the
milestone.


 


(iv)                             At the earlier occurrence of the following
events: [****]:  [****] milestone, in
consideration for services and assistance provided by IMCOR to reach the
milestone.


 


(v)                                At the [****]:  [****]
milestone, in consideration for services
and assistance provided by IMCOR to reach the milestone.


 


C.                                     Payments to IMCOR shall
be made without deduction other than such an amount (if any) KYOSEI is required
by law to deduct and withhold. KYOSEI shall obtain a receipt from the relevant
taxing authorities for all withholding taxes paid and forward such receipts to
IMCOR to enable IMCOR to claim any and all tax credits for which it may be
eligible. KYOSEI shall use reasonable commercial efforts to enable or assist
IMCOR to claim exemption from such deductions or withholdings under any double
taxation or similar agreement or treaty between Japan and the United States,
which may be in force.


 


D.                                    In
further consideration
of the exclusive license granted herein, KYOSEI shall pay IMCOR a royalty of
[****] of the Net Sales, based on Yakka Pricing of Licensed Product(s) sold in
the Territory; provided, however, that, in the event that IMCOR’s patent
applications pending in Japan, as set forth in Exhibit A are denied so that
IMCOR cannot provide patent coverage for the Imagent®
technology, then the [****] royalty shall be reduced to [****]. Royalties are
payable beginning the first quarter after the first commercial sale of Licensed
Product(s) and quarterly thereafter.


 


4.                                       Research
And Development.


 


A.                                   KYOSEI will be responsible for developing a clinical and regulatory development work plan
to be presented to IMCOR, outlining timelines and budgets for the development
of Licensed Product(s).  KYOSEI will enter into a development
agreement with Sakai Chemical to support product development to include but not
be limited to toxicology, pre-clinical studies, clinical studies and regulatory
submissions.  IMCOR and
KYOSEI shall review the Development plan on a yearly basis. All final plans,
strategies and decisions regarding Licensed Product(s), preclinical, clinical
and regulatory development shall be made by KYOSEI, however, KYOSEI will take
into consideration recommendations from IMCOR. KYOSEI shall be responsible for expenses associated with regulatory and
clinical research intended for approvals, label expansion and/or new
indications.  KYOSEI shall be
responsible for all expenses clinical research intended for marketing and
promotion.


 


4

















 


B.                                     IMCOR
will be responsible for providing
pre-clinical, clinical and regulatory documentation needed by KYOSEI to submit
or supplement the submission of protocols, regulatory documentation to support
the clinical development and regulatory approval in the Territory. KYOSEI will
be responsible for translation of the documentation into Japanese.


 


C.                                     IMCOR
will be responsible for providing to
KYOSEI, Imagent
for pre-clinical and clinical development of Imagent [****] until
Licensed Product(s) is approved in the Territory. Imagent will be shipped, FOB
origin, to KYOSEI’s single designated shipping point within 30 days of the
receipt by IMCOR of a purchase order from KYOSEI. Imagent shipments for
pre-clinical and clinical use will be provided in the U.S. labeled and finished
kit product.  Product will be
manufactured and supplied under cGMP guidelines.


 


D.                                    IMCOR
shall make its personnel available at reasonable times for orientation and
training with respect to the use of Imagent in preclinical and clinical
testing. Each party shall bear it’s own respective expenses for training.


 


E.                                      KYOSEI
will provide to IMCOR the 6-month
pre-clinical and clinical demand for Licensed Product(s) two (2) months in
advance.  The first two months of which
will be considered by IMCOR as a firm order. KYOSEI may upon written request
adjust the second three months within 60 days of the first shipment.


 


F.                                      KYOSEI will use its reasonable best efforts to
clinically develop Imagent in the Territory, to include the
development of indications in the Field of Use of medicine.


 


G.                                     Each party will use its reasonable best efforts
to provide adverse events reporting for Imagent as outlined in Exhibit B.


 


H.                                    KYOSEI
will maintain and cause its
sublicensees to maintain, complete and accurate books and records, as required by
Japanese authorities which enable the approval and sale of Licensed
Product(s).  The records shall be
maintained for ten years after the submission of each report under
Section [4] hereof.  Upon
reasonable prior notice to KYOSEI, IMCOR and its clinical and regulatory
consultants shall have access to all books and records relating to the clinical
and regulatory development of Imagent by KYOSEI and its sublicensees to
conduct a review or audit thereof.  Such
access shall be available not more than once each year, during normal business
hours, and for five years after the expiration or termination of this
Agreement.


 


5

















 


I.                                         Any
modification or improvement to Technical Information used to produce Licensed
Product(s) made by IMCOR before the termination of this Agreement shall be
included in the License granted without additional charge to KYOSEI.  In addition, KYOSEI will promptly disclose
and hereby grants back to IMCOR a worldwide (except for Japan), royalty-free,
exclusive, sublicensable license to fully exploit any modifications or
improvements made by or for KYOSEI during the same period.  The foregoing shall be deemed to include,
without limitation, (A) any patent covering an invention the manufacture, use or
sale of which would be covered by or within the scope of a claim of a patent
licensed to KYOSEI hereunder and (B) any patent that (alone or together with
others) tends to define, describe or surround any part of IMCOR’s Technical
Information or any invention claimed in a patent licensed to KYOSEI hereunder)
and KYOSEI shall not, except in Japan, license to third parties the
modifications or improvements derived from or based on any of IMCOR’s Technical
Information. The parties agree to promptly disclose such modifications and
improvements to each other.


 


5.                                       Manufacturing
And Packaging.


 


A.                                   IMCOR
will enter into a supply agreement for Imagent with KYOSEI. 
Product will be manufactured and supplied under cGMP guidelines.  Labeling and packaging responsibilities will
be negotiated in the Supply Agreement. 
The definitive Supply Agreement will be negotiated between the parties a
time to be determined in the discretion of
Kyosei, but no later than the initiation of Phase 3 clinical trials subject to
the following terms:


 


B.                                     The right to transfer manufacturing to KYOSEI will be negotiated in
the future. KYOSEI will give IMCOR written notification 6 months in advance of
its desire to manufacture in the Territory. Transfer fees, costs of technical
transfer, and cost of goods after transfer will be negotiated in good faith by
both parties during the 6-month period.


 


C.                                     Upon
reasonable prior notice to IMCOR, KYOSEI and its consultants shall have access
to all books and records relating to the manufacture and supply of Imagent
by IMCOR and its sublicensees to conduct a review or audit thereof.  Such access shall be available not more than
once each year, during normal business hours, and for five years after the
expiration or termination of this Agreement.


 


D.                                    Upon
approval by MHLW in the Territory, KYOSEI will pay IMCOR an amount equal to
[****] of the Yakka Price of Licensed
Product(s) for commercial shipments. IMCOR and KYOSEI agree to negotiate the
transfer cost, if the cost of Imagent exceeds an acceptable transfer price
in the future to include any changes in currency exchange rates.


 


E.                                      KYOSEI
will supply IMCOR a written purchase order
for a 6-month demand forecast for Imagent. The first 3 months of the Demand
forecast will be considered by IMCOR as a firm order. KYOSEI may adjust the
second 3 months of the demand forecast with 60 days written notice.


 


F.                                      IMCOR
will notify KYOSEI of any change to manufacturing site, raw materials,
packaging materials, or processes to the Product.


 


6

















 


G.                                     The
Supply Agreement will provide for the ability of IMCOR to continue to provide
Product to KYOSEI following the termination of this agreement.


 


6.                                       Marketing
and Sales.


 


A.                                   A
separate and definitive marketing and sales agreement will be negotiated
between the parties, at the discretion of Kyosei but not later than the
submission of the NDA, subject to the following terms.


 


B.                                     KYOSEI
shall use its reasonable best efforts to develop for commercial use and to
market and sell Licensed Product(s) in the Territory as soon as practical,
consistent with sound and reasonable business practices.


 


C.                                     KYOSEI
will present to IMCOR the marketing and sales plan and budget. IMCOR and KYOSEI
shall review the marketing plan on a yearly basis in order to optimize customer
acceptance and effective promotion of Licensed Product(s). All final plans,
strategies and decisions regarding Licensed Product(s) marketing, sales
distribution and pricing shall be made by KYOSEI, however, KYOSEI will take
into consideration recommendations from IMCOR.


 


D.                                    KYOSEI
will be responsible for the sales and marketing expenses for Licensed
Product(s) in the Territory.


 


E.                                      KYOSEI
shall market and distribute Licensed Product(s) on their own merit and not in a
manner intended to promote other products or services.


 


7.                                       Reports
And Records.


 


A.                                   IMCOR
and KYOSEI will nominate a Project Team consisting of 2 members of senior
management from each party to oversee the progress of the development and
marketing plans. The team will meet at least twice a year to review progress
and report to each of their respective Management Boards.


 


B.                                     KYOSEI
shall deliver to IMCOR within 30 days after the end of each Calendar Quarter a
report, certified by the chief financial officer of KYOSEI setting forth in
reasonable detail the calculation of the royalties due to IMCOR for such
Calendar Quarter.


 


C.                                     Royalties
payable under Sections [3.B(iv)] hereof shall be paid within 30 days
following the last day of the Calendar Quarter in which the royalties accrue.


 


D.                                    KYOSEI
shall maintain and cause its sublicensees to maintain, complete and accurate
books and records, which enable the royalties payable hereunder to be
verified.  The records for each calendar
quarter shall be maintained for three years after the submission of each report
under Section [3] hereof.  Upon
reasonable prior notice to KYOSEI, IMCOR and its accountants shall have access
to all books and records relating to the sales of Licensed Product(s) by KYOSEI
and its sublicensees to conduct a review or audit thereof.  Such access shall be available not more than
once each calendar year, during normal business hours, and for each of three
years after the expiration or termination of this Agreement.


 


7

















 


8.                                       Currency,
Place Of Payment.  All dollar amounts
referred to in this Agreement are expressed in United States dollars.  All payments to IMCOR under this Agreement
shall be made in United States dollars by wire transfer to a financial
institution and account designated by IMCOR. 
All computations for purposes of determining Net Sales shall be
converted into United States dollars at the conversion rate for the foreign
currency as published in the eastern edition of The Wall Street Journal as
of the last business day of the applicable Calendar Quarter.  Payments are due IMCOR in full within 30
days, except for the initial license fee payment, which is due upon signing of
this Agreement.


 


9.                                       Trademarks.  IMCOR grants an exclusive royalty-free
license for the use of IMCOR’s registered trademark, Imagent throughout the
Territory.  Imagent or Licensed Product(s) cannot be altered except as
provided to translate in Japanese.  If
requested in writing by IMCOR, all promotional materials, Licensed Product(s),
and product packaging will include (in easily readable, non-obscured type that
is of reasonable size in light of the other names and notices) the mark “Imagent,” a legend that IMCOR owns such mark and any
reasonable patent, patent application or other proprietary markings and notices
of IMCOR.  Use of such mark and related
goodwill will inure to IMCOR’s benefit. 
IMCOR will have the right of prior approval with respect to any
promotional materials, packaging or statements regarding Licensed Product(s) or
the mark “Imagent” and the
right to make quality inspections of KYOSEI’s plants and products.  Except as expressly provide herein, (i)
KYOSEI will not use or register the mark “Imagent” or the name or any similar mark or name
anywhere in the world, and (ii) KYOSEI has no right or license with respect to
any mark, name or designation of or used by IMCOR.


 


10.                                 Confidentiality.


 


A.                                   The
parties agree to maintain in confidence, not to disclose to any third party and
not to use for any purpose other than to fulfill obligations under this
Agreement, any Confidential Information of the other party received pursuant to
this Agreement.  Each party agrees to
ensure that its employees and consultants have access to Confidential
Information only on a need-to-know basis and are obligated in writing to abide
by the obligations hereunder.  The
foregoing obligation shall not apply to:


 


(i)                                    Information
that is known to or independently developed by the receiving party prior to the
time of disclosure, in each case, to the extent evidenced by written records
promptly disclosed to the disclosing party upon receipt of the confidential
information;


 


(ii)                                 Information
disclosed to the receiving party by a third party that has a right to make such
disclosure;


 


(iii)                              Information
that becomes patented, published or otherwise part of the public domain as a
result of acts by the disclosing party or a third person obtaining such
information as a matter of right; or


 


8

















 


(iv)                             Information
that is required to be disclosed by order of a governmental authority or a
court of competent jurisdiction; provided that the disclosing party shall use
its best efforts to obtain confidential treatment of such information by the
agency or court.


 


B.                                     The
placement of a copyright notice on any confidential information shall not be
construed to mean that such information has been published and will not release
either party from its obligation of confidence hereunder.


 


11.                                 Term
And Termination.


 


A.                                   This
Agreement, unless sooner terminated as provided herein, shall terminate upon
the expiration of the last to expire Patent Rights, or 10 years from the launch
of the Licensed Product, whichever is longer. Upon the natural expiration of
the term of this Agreement, KYOSEI shall have a fully paid-up, irrevocable
exclusive license to use, market, sell, and distribute Licensed Product(s) in
the Territory.


 


B.                                     IMCOR
may, at its option, terminate this Agreement upon thirty (30) days written
notice in the event of any of the following:


 


(i)                                    By
ceasing to make, or have made, Imagent;


 


(ii)                                 KYOSEI
becomes more than 60 days in arrears in payment of royalties or expenses
due pursuant to this Agreement and KYOSEI does not provide full payment within
20 business days after written notice thereof;


 


(iii)                              KYOSEI
becomes subject to a Bankruptcy Event; or


 


(iv)                             KYOSEI
breaches this Agreement and does not cure such breach within thirty (30) days
written notice thereof.


 


C.                                     KYOSEI
may terminate this Agreement if any of the following occur:


 


(i)                                    IMCOR
becomes subject to a Bankruptcy Event; or


 


(ii)                                 IMCOR
breaches this Agreement and does not cure such breach or have in progress a
good faith effort to cure within sixty (60) days after written notice
thereof.


 


(iii)                              Clinical
results fail to allow KYOSEI to file for registration of the Licensed Product.


 


(iv)                             A
SAE, as defined in ICH guidelines, occurs in the clinical development of the
Licensed Product resulting in the inability to continue clinical development.


 


9

















 


D.                                    In
addition to paragraph B, IMCOR may, at this option, temporarily suspend
shipments of Licensed Product(s) if it reasonably believes that human health or
safety would be harmed.


 


E.                                      Upon
termination of this Agreement, the parties shall, upon request, return to the
other party all Confidential Information of such requesting party fixed in any
tangible medium of expression as well as any data generated during the term of
this Agreement which will facilitate the development of the technology licensed
hereunder.


 


F.                                      KYOSEI’s
obligation to pay license fees royalties or milestone payments accrued under
Section [3] hereof shall survive termination of this Agreement.  In addition, the provisions of
Sections [10], [11], [12], [13.D], [18], [19.C], [19.E] shall survive such
termination.


 


12.                                 Patent
Maintenance And Reimbursement.  IMCOR
shall control and pay costs of and diligently prosecute and maintain Patent
Rights licensed hereunder.  IMCOR may by
written notice elect to stop paying for the preparation and maintenance of
Patent Rights pertaining to Licensed Product(s) in the Territory in which
event, KYOSEI may assume the obligation of maintaining for its own benefit any
such patent or patent application.  When
KYOSEI assumes the obligation of maintaining a patent or patent application
under this section, KYOSEI’s license hereunder in such country shall terminate,
except where IMCOR’s decision to stop paying is based on a good faith
determination as indicated by patent counsel of unpatentability in such country,
with timely notice of such determination to IMCOR.


 


13.                                 Infringement
And Litigation.


 


A.                                   IMCOR
and KYOSEI are responsible for notifying each other promptly of any
infringement of Patent Rights which may come to their attention, including
notice to the other of any certification filed under the United States “Drug
Price Competition and Patent Term Restoration Act of 1984.”  IMCOR and KYOSEI shall consult one another
in a timely manner concerning any appropriate response thereto.


 


B.                                     IMCOR
shall have the first right, but not the obligation to prosecute such
infringement at its own expense.  IMCOR
shall not settle or compromise any such suit in a manner that imposes any
obligations or restrictions on KYOSEI or grants any rights to the Technical
Information or the Patent Rights, in the territory without KYOSEI’s written
permission which consent will not be unreasonably withheld after due
consideration of IMCOR’s policies pertaining to intellectual property.  Financial recoveries from any such
litigation will be entirely retained by IMCOR.


 


C.                                     If
IMCOR fails to prosecute such infringement, KYOSEI shall have the right, but
not the obligation, to prosecute such infringement at its own expense.  In such an event IMCOR shall retain the
rights to represented by at its own counsel at it’s own expense.  In such event, financial recoveries will be
entirely retained by KYOSEI.


 


10

















 


D.                                    In
any action to enforce any of the Patent Rights, either party, at the request
and expense of the other party shall cooperate to the fullest extent reasonably
possible.  This provision shall not be
construed to require either party to undertake any activities, including legal
discovery, at the request of any third party except as may be required by
lawful process of a court of competent jurisdiction.


 


14.                                 Representations
and Disclaimer Of Warranty.


 


A.                                   IMCOR
represents and warrants to KYOSEI that it has the right to enter into this
Agreement and grant the licenses described herein.  IMCOR represents that to its knowledge the Patent Rights will not
infringe on any rights of any other party with respect to its use, manufacture
or sale of Imagent
as of the date of this Agreement.


 


B.                                     Except
as set forth above, all technology licensed under this Agreement is provided on
an “as is” basis and IMCOR makes no representations or warranties, express or
implied, with respect thereto.  All
Licensed Product(s) are covered by IMCOR’s standard published warranty (copies
of which are available from IMCOR). 
KYOSEI shall make no representations or warranties with respect to the
Licensed Product(s) other than those specifically set forth in said warranty.


 


THIS WARRANTY IS IN
LIEU OF ALL OTHER WARRANTIES, EXPRESS, IMPLIED OR STATUTORY, INCLUDING WITHOUT
LIMITATION THE IMPLIED WARRANTIES OF NON-INFRINGEMENT, MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE AND ANY IMPLIED WARRANTIES ARISING OUT OF A
COURSE OF DEALING, CUSTOM OR TRADE USAGE, AND SETS FORTH KYOSEI’S AND KYOSEI’S
CUSTOMERS’ SOLE REMEDIES IN CONNECTION WITH SUCH WARRANTY.  IN NO EVENT SHALL IMCOR BE LIABLE TO KYOSEI,
KYOSEI’S CUSTOMERS OR ANYONE IN ANY MANNER OR TO ANY EXTENT WITH RESPECT TO THE
LICENSED PRODUCT(S) EXCEPT AS EXPRESSLY STATED HEREIN.


 


C.                                     KYOSEI
shall notify IMCOR of any proceeding or claim relating to the Licensed
Product(s) in the Territory and shall promptly furnish IMCOR with copies of all
documents filed in connection with such proceeding or claim.


 


11

















 


D.                                    In
no event shall IMCOR be liable to KYOSEI, or to any person or entity claiming
through, on behalf or against KYOSEI, for consequential, incidental or indirect
damages (including without limitation, lost profits, revenues, anticipated
sales, business opportunities, goodwill or interruption of business), or
punitive or exemplary damages, whether in tort or contract or pursuant to
statute, regulation or otherwise. 
KYOSEI agrees that any amounts it may spend in the performance of this
Agreement, including without limitation the establishment and maintenance of
additional or existing sales, management, warehouse, delivery, administrative
or other personnel, or other equipment or facilities, adverting and promotion
costs, or for any other purpose, shall be spent and incurred voluntarily by KYOSEI
with the knowledge that this Agreement may be terminated as provided in this
Agreement, and thus KYOSEI shall make no claim against IMCOR, and IMCOR shall
not be liable, with respect to any investment or expenditures incurred by
KYOSEI in anticipation of the continuance of this Agreement.


 


15.                                 Indemnification.


 


A.                                   Each
Party (an “Indemnifying Party”) agrees to defend, indemnify and hold harmless
the other party and its respective trustees, officers, agents and employees
(individually, an “Indemnified Party” and collectively, the “Indemnified
Parties”), from and against any and all claims for liability, loss, damage,
action or expense suffered or incurred by the Indemnified Parties (including
reasonable attorney’s fees and expenses) (individually, a “Liability,” and
collectively, the “Liabilities”) which results from or arises out of:  (i) claims resulting from the development,
use, manufacture, promotion, sale or other disposition of Licensed Product(s),
Technical Information, and all technology licensed under this Agreement by an
Indemnified Party, its assignees, sublicensees, vendors or other third parties;
and (ii) claims for the enforcement by an Indemnified Party of its rights under
this section.  Without limiting the
foregoing, an Indemnifying Party will defend, indemnify and hold harmless the
Indemnified Parties from and against any Liabilities resulting from:


 


(a)                                  Claims
for product liability, a SAE due to adulterated product or other claim of any
kind related to the use by a third party of a Licensed Product(s) that was
manufactured, sold or otherwise disposed by an Indemnifying Party, its
assignees, sublicensees, vendors or other third parties;


 


(b)                                 claims
by a third party that the Patent Rights, Technical Information or any
technology licensed under this Agreement or the design, composition,
manufacture, use, sale or other disposition of Licensed Product(s) in the
Territory infringes or violates any patent, copyright, trademark or other
intellectual property rights of such third party excluding matters represented by IMCOR in Section [14.A] above; and


 


(c)                                  claims
resulting from clinical trials or studies conducted by or on behalf of an
Indemnifying Party, relating to Licensed Product(s), Technical Information, or
any technology licensed under this Agreement, including, without limitation,
any claim by or on behalf of a human subject of any such clinical trial or
study, any claim arising from the procedures specified in any protocol used in
any such clinical trial or study, any claim or deviation, authorized or
unauthorized,


 


12

















 


from the protocols of any such clinical trial
or study, and any claim resulting from or arising out of the manufacture or
quality control by a third party of any substance administered in any clinical
trial or study, but only to the extent such claims result from the gross
negligence or willful misconduct of the Indemnifying Party or its employees or
agents and only to the extent such claims do not result from the negligence of
the Indemnifying Party.


 


B.                                     An
Indemnified Party entitled to indemnification shall give written notice to the
Indemnifying Party of any claims that may be subject to indemnification,
promptly after learning of such claim, and the Indemnifying Party shall assume
the defense of such claims with counsel reasonably satisfactory to the
Indemnified Party.  If such defense is
assumed by the Indemnifying Party with counsel so selected, the Indemnifying
Party will not be subject to any liability for any settlement of such claims
made by the Indemnified Party without its consent (but such consent will not be
unreasonably withheld or delayed), and will not be obligated to pay the fees
and expense of any separate counsel renamed by the Indemnified Party with
respect to such claims.


 


16.                                 Insurance.


 


A.                                   KYOSEI
shall procure and maintain a policy or policies of comprehensive general
liability insurance, including broad form and contractual liability, in a
minimum amount of $1,000,000 combined single limit per occurrence and in the
aggregate as respects personal injury, bodily injury and property damage
arising out of KYOSEI’s performance under this Agreement.


 


B.                                     As
long as it is consistent with sound and reasonable business practices, KYOSEI
shall, upon commencement of clinical trials involving Imagent, procure and
maintain a policy or policies of product liability insurance in a minimum
amount of $3,000,000 combined single limit per occurrence and in the aggregate
as respects bodily injury and property damage arising out of KYOSEI’s
performance under this Agreement.


 


C.                                     The
policy or policies of insurance specified herein shall be issued by an
insurance carrier with an A.M. Best rating of “A” or better and shall name
IMCOR as an additional insured with respect to IMCOR’s performance under this
Agreement.  KYOSEI shall provide IMCOR
with certificates evidencing the insurance coverage required herein and all
subsequent renewals thereof.  Such certificates
shall provide that KYOSEI’s insurance carrier(s) notify IMCOR in writing at
least 30 days prior to cancellation or material change in coverage.


 


D.                                    IMCOR
and KYOSEI shall periodically review the adequacy of the minimum limits of
liability specified herein.  If IMCOR
and KYOSEI agree, and if additional insurance is reasonably available,
additional insurance will be obtained. 
The specified minimum insurance amounts shall not constitute a
limitation on KYOSEI’s obligation to indemnify IMCOR under this Agreement.


 


13

















 


17.                                 Independent
Contractor.  Nothing herein shall be
deemed to establish a relationship of principal and agent between IMCOR and
KYOSEI, nor any of their agents or employees for any purpose whatsoever.  This Agreement shall not be construed as
constituting IMCOR and KYOSEI as partners, or as creating any other form of
legal association or arrangement which would impose liability upon one party
for the act or failure to act of the other party.


 


18.                                 Arbitration.  Upon failure to resolve any dispute
controversy or claim arising out of, relating to or in connection with any
provision of this Agreement, such controversy or claim shall be finally settled
by Arbitration.  Arbitration shall be
held in San Diego, California in the English language and conducted in
accordance with the Commercial Arbitration Rules of the American Arbitration
Association.  The decision of such
Arbitration shall be conclusive and binding upon both parties.  If a party commences any arbitration or
proceeding against the other party to enforce this Agreement or any rights
related thereto, the prevailing party in such action shall be entitled to
recovery from the other party the reasonable attorneys’ fees and other
reasonable costs and expenses incurred by that prevailing party in connection
with such action and in connection with enforcing any judgment, award or order
thereby obtained.  Judgment on the award
may be entered by any court of competent jurisdiction and enforced by such
court.  KYOSEI, at it’s expense, will
hire it’s own translator.


 


19.                                 Additional
Provisions.


 


A.                                   Notices,
payments, statements, reports and other communications under this Agreement
shall be in writing and shall be deemed to have been received as of the date
dispatched if sent by public overnight courier (e.g. Federal Express) and
addressed as follows:


 


	
  If for KYOSEI:

  
	
   

  
	
   

  	
  1-25-18, Okusawa, Otaru

  
	
   

  	
  Hokkaido, 047—0013, Japan

  
	
   

  	
  Attention: 
  President

  
	
   

  
	
  If for IMCOR:

  
	
   

  
	
   

  	
  IMCOR, A Division of Photogen Technologies,
  Inc.

  
	
   

  	
  6175 Lusk Boulevard

  
	
   

  	
   

  
	
   

  	
  San Diego, California 92121

  
	
   

  	
  Attention: 
  President

  



 


Either party may change its official address upon written notice to the
other party.


 


B.                                     This
Agreement shall be construed and governed in accordance with the laws of the
States of Nevada and California and of the United States, as applicable,
without giving effect to conflict of law provisions.


 


14

















 


C.                                     Any
modification of this Agreement shall be in writing and signed by an authorized
representative of each party.


 


D.                                    In
the event that a party to this Agreement perceives the existence of a dispute
with the other party concerning any right or duty provided for herein, the
parties shall, as soon as practicable, confer in an attempt to resolve the
dispute.  If such dispute is not
resolved in 30 days, either party may call for Arbitration pursuant to
Section 18.


 


E.                                      A
waiver by either party of a breach or violation of any provision of this
Agreement shall be in writing and will not constitute or be construed as a
waiver of any subsequent breach or violation of that provision or as a waiver
of any breach or violation of any other provision of this Agreement.


 


F.                                      Any
of the provisions of this Agreement which are determined to be invalid or
unenforceable in any jurisdiction shall be ineffective to the extent of such
invalidity or unenforceability in such jurisdiction, without rendering invalid
or unenforceable the remaining provisions hereof or affecting the validity or
unenforceability of any of the terms of this Agreement in any other
jurisdiction.  In such event, the
parties will negotiate to modify the provision to one that is valid and
enforceable and most closely achieves their intent.


 


G.                                     Nothing
in this Agreement, express or implied, is intended to confer on any person
other than the parties hereto or their permitted assigns, any benefits, rights
or remedies.


 


H.                                    This
Agreement has been prepared in the English language and shall be construed in
the English language.


 


I.                                         Immediately
following the execution of this Agreement KYOSEI shall submit this Agreement
and any other necessary documents to all authorities of the Japanese government
whose approval may be necessary to tender this Agreement effective and
enforceable in accordance with its terms. 
IMCOR will cooperate with KYOSEI in all respects to accomplish the
foregoing.


 


J.                                        The
rights and obligations of the parties under this Agreement may not be assigned
or transferred (and any attempt to do so will be void) except (i) rights to
receive money may be assigned, and (ii) this Agreement and IMCOR’S rights and
obligations hereunder may be assigned by IMCOR to an acquiror directly or
indirectly of all or substantially all the Imagent assets or related rights.


 


K.                                    Headings
and captions are for convenience only and are not to be used in the
interpretation of this Agreement.


 


L.                                      This
Agreement contains the entire agreement of the parties concerning the subject
matter hereof and supersedes all proposals, oral or written, all negotiations,
conversations, or discussions between or among the parties relating to the
subject matter of this Agreement and all past dealing or industry custom.


 


15

















 


M.                                 Neither
party hereto shall be responsible for any failure to perform its obligations
under this Agreement (other than obligations to pay money or obligations under
Section 12) if such failure is caused by acts of God, war, strikes,
revolutions, lack or failure of transportation facilities, laws or governmental
regulations or other causes that are beyond the reasonable control of such
party. Obligations hereunder, however, shall in no event be excused but shall
be suspended only until the cessation of any cause of such failure. In the
event that such force Majeure should obstruct performance of this Agreement for
more than six (6) months, the parties hereto shall consult with each other to
determine whether this Agreement should be modified. The party facing an event
of force Majeure shall use its best reasonable endeavors in order to remedy
that situation as well as to minimize its effects. A case of force Majeure
shall be notified to the other party by telefax within five (5) days after its
occurrence and shall be confirmed by a letter.


 


N.                                    Each
party shall comply with all applicable export laws, restrictions, and
regulations of the United States and Japan or any authority thereunder and will
not export or re-export, any product, technology or information it obtains or
learns pursuant to this Agreement (or any direct product thereof) in violation
of any such laws, restrictions or regulations.


 


O.                                    Each
party recognizes that IMCOR grants no license, by implication or otherwise,
except for the licenses expressly set forth and granted in this Agreement.


 


P.                                      IMCOR
shall not enter into any merger or any transaction involving the sale] of all
or substantially all of its assets (including Imagent)
unless the surviving entity to such merger, or the acquirer of IMCOR’s assets,
agrees in writing to assume all of the obligations of IMCOR to KYOSEI in this
Agreement.


 


 


[Signature page follows]


 


16

















 


IN WITNESS WHEREOF the parties, intending to
be legally bound, have caused this Agreement to be executed by their duly
authorized representatives.


 


	
  IMCOR,

  	
  KYOSEI PHARMACEUTICAL
  Co., LTD.

  
	
  A DIVISION OF PHOTOGEN TECHNOLOGIES, INC.

  	
   

  
	
   

  	
   

  
	
   

  	
   

  
	
  By:

  	
  /s/ Taffy Williams

  	
   

  	
  By:

  	
  /s/ 
  Shigeharu Higuchi

  	
   

  
	
  Name: Taffy Williams

  	
  Name: Shigeharu Higuchi

  
	
  Title: President & Chief Executive
  Officer

  	
  Title: President

  
						



 


17

















 


Exhibit
A


 


•                                         Stabilized
Microbubble Compositions


 


U.S. Patent No. 5,639,443


 


•                                         Osmotically Stabilized Microbubble
Preparations


 


U.S. Patent No. 6,258,339


U.S. Patent Application Pending


 


•                                         Stabilized Microbubble Compositions
for Ultrasound


 


U.S. Patent No.  5,605,673


Australia Patent No. 694135


Australia Patent No. 731099


Patent Applications pending in Australia,
Canada, Europe, Japan, and Hong Kong


 


•                                         Systems for the Formation of
Microbubbles


 


U.S. Patent No. 5,720,938


 


•                                         Ultrasound Imaging Method Using
Microbubbles


 


U.S. Patent No. 5,626,833


 


•                                         Methods of Imaging Using Osmotically
Stabilized Microbubble Preparations


 


U.S. Patent No. 6,287,539


 


•                                         Stable Microbubble Precursors


 


U.S. Patent No. 5,695,741


 


•                                         Ultrasonic Imaging System Utilizing
a Long-Persistence Contrast Agent


 


U.S. Patent No.  6,280,704


U.S. Patent Application Pending


 


•                                         Stabilized Gas Emulsion Containing
Phospholipid for Ultrasound Contrast Enhancement


 


U.S. Patent No. 5,798,091


Hungary Patent No. P9802095


Patent Applications pending in the U.S., Europe,
Australia, Canada, China, Finland, Hong Kong, Japan, Mexico, Norway, Poland,
and South Korea


 


•                                         Kits and Systems for Ultrasonic
Imaging


 


U.S. Patent No.  6,280,705


 


18

















 


•                                         Microbubbles
Containing Fluorinated Gas or Vapor


 


U.S. Patent Application Pending


 


•                                         Mixed Gas Microbubble Compositions


 


U.S. Patent Application Pending


 


•                                         Harmonic Ultrasound Imaging with
Microbubbles


 


U.S. Patent No. 5,540,909


Australia Patent No. 693608


German Utility Patent No. 295 22 119.4


Patent Applications pending in the U.S.,
Europe, Canada, Australia, Hong Kong, and Japan


 


•                                         Improved Methods for Harmonic
Imaging with Ultrasound


 


U.S. Patent No. 5,733,527


 


•                                         Systems for Harmonic Ultrasound
Imaging


 


U.S. Patent No. 6,019,960


 


•                                         Methods of Harmonic Imaging Using
Phospholipid Stabilized Microbubbles


 


U.S. Patent No. 6,056,943


 


•                                         Methods of Harmonic Imaging Using
Multiple Frequencies


 


U.S. Patent No. 6,036,644


 


•                                         Gas Emulsions Stabilized with
Fluorinated Ethers Having Low Ostwald Coefficients


 


U.S. Patent No.  5,804,162


U.S. Patent No. 6,193,952


Australia Patent No. 712946


Patent Applications pending in the U.S.,
Europe, Australia, Canada, Japan, Poland, Hungary, Israel, Norway,
Czechoslovakia, China and South Korea


 


•                                         Methods and Apparatus for Monitoring
and Quantifying the Movement of Fluid


 


U.S. Patent Application Pending


 


•                                         Diagnostic Imaging of Lymph
Structures


 


U.S. Patent Application Pending


 


19

















 


Exhibit
“B”


 


(a)                                  Clinical
safety data management in the preclinical stage in Japan.


 


(i)                                    IMCOR shall provide any and all case reports
of ADR related to Licensed Product(s) from any and all sources, which are
obtained during each Calendar Quarter, by written summarized in CIOMS II
format. This report shall be provided for KYOSEI within 30 days following the
end of each Calendar Quarter.


 


(ii)                                 KYOSEI
may call for CIOMS I in regard to the cases, which is reported in said CIOMS
II, to be considered as important. IMCOR shall promptly provide respective
CIOMS I for KYOSEI.


 


(iii)                              IMCOR
shall inform KYOSEI of the following research reports on Licensed Product(s) as
soon as possible.


 


(1)         Reports which show that a
serious disease (such as cancer, hearing impairment, or loss of eyesight) has
occurred or might occur as a result of ADR.


 


(2)         Pronounced
change in onset trends including number of cases, incidence, or onset
conditions of ADR.


 


(3)      Reports that Licensed
Product(s) is not indicated for the disease targeted in the study.


 


(iv)                             In
the case any and all measures are taken to discontinue manufacture, import, or
sales of Licensed Product(s), or to recall or discard the Licensed Product(s),
or other measures taken to prevent risk to public health and hygiene, IMCOR
shall notify KYOSEI of the information as below as soon as possible but no
later than 7 calendar days after first knowledge by IMCOR:


 


(1)         Modifications or limitations on indications or dosage and
administration due to problems with efficacy or safety.


 


(2)         Discontinuation of manufacture, import, or sale, and/or modifications
in manufacturing method, duet to insufficient efficacy or problems with safety.


 


(3)         Product recall or disposal due to problems with efficacy or safety etc.


 


(4)         Among amendments to the Precautions, major modifications etc.
accompanying the distribution of a Dear Doctor Letter.


 


(5)         Discontinuation or suspension of an entire clinical trial because of
problems with efficacy, safety, or quality.


 


(6)         Intensification etc. of safety measures resulting from the distribution
of a Dear Doctor Letter during a clinical trial.


 


(v)                                 Whenever
IMCOR makes reports that is required in ICH E2C that FDA shall be notified of,
IMCOR shall provide KYOSEI with the said report no later than 30 calendar days
after the day of creation.


 


20

















 


(b)                                 Clinical
safety data management in and after the clinical development phase in Japan.


 


(i)                                    IMCOR
and KYOSEI shall provide each other any and all case reports of ADR related to
Licensed Product(s) from any and all sources, which are obtained during each
Calendar Quarter, by written summarized in CIOMS II format. This report shall
be provided for each other within 30 days following the end of each Calendar
Quarter.


 


(ii)                                 IMCOR and KYOSEI shall notify each other of
any and all serious ADR of Licensed Product(s), in CIOMS I format as soon as
possible but no later than 7 calendar days after first knowledge by IMCOR or
KYOSEI. Follow-up information should be actively sought and submitted as it
becomes available.


 


(iii)                             IMCOR and KYOSEI shall inform each other of
the following research reports on Licensed Product(s) as soon as possible.


 


(1)         Reports which show that a serious disease (such as cancer, hearing
impairment, or loss of eyesight) has occurred or might occur as a result of
ADR.


 


(2)         Pronounced change in onset trends including number of cases, incidence,
or onset conditions of ADR.


 


(3)         Reports that Licensed Product(s). is not indicated for the disease
targeted in the study.


 


(iv)                               In
the case any and all measures are taken to discontinue manufacture, import, or
sales of Licensed Product(s), or to recall or discard the Licensed Product(s),
or other measures taken to prevent risk to public health and hygiene, IMCOR and
KYOSEI shall notify each other of the information as below as soon as possible
but no later than 7 calendar days after first knowledge by IMCOR or KYOSEI:


 


(1)         Modifications or limitations on indications or dosage and
administration due to problems with efficacy or safety.


 


(2)         Discontinuation of manufacture, import, or sale, and/or modifications
in manufacturing method, duet to insufficient efficacy or problems with safety.


 


(3)         Product recall or disposal due to problems with efficacy or safety etc.


 


(4)         Among amendments to the Precautions, major modifications etc.
accompanying the distribution of a Dear Doctor Letter.


 


(5)         Discontinuation or suspension of an entire clinical trial because of
problems with efficacy, safety, or quality.


 


(6)         Intensification etc. of safety measures resulting from the distribution
of a Dear Doctor Letter during a clinical trial.


 


(v)                                  Whenever
IMCOR makes reports that is required in ICH E2C that FDA shall be notified of,
IMCOR shall provide KYOSEI with the said report no later than 30 calendar days
after the day of creation.


 


21