Document:

Exhibit 10.12

 

DATED 9 JUNE 2004

Execution Version

 

 

ELAN PHARMA
INTERNATIONAL LTD.

 

AND

 

IMCOR PHARMACEUTICAL
CO.

 

 

LICENCE AGREEMENT

 

 

Matheson Ormsby Prentice

30 Herbert Street

Dublin 2

Ireland

 

TEL  +
353 1 619 9000

FAX  +
353 1 619 9010

\MOP_DUBLIN\1013796.3

 

 

CONTENTS

 

	
  1

  	
  Preliminary

  	
   

  
	
  2

  	
  The Licences

  	
   

  
	
  3

  	
  Intellectual Property

  	
   

  
	
  4

  	
  Financial Provisions

  	
   

  
	
  5

  	
  Development/Manufacturing/ Exploitation

  	
   

  
	
  6

  	
  Regulatory Approvals

  	
   

  
	
  7

  	
  Insurance

  	
   

  
	
  8

  	
  Customer Complaints and Product Recall

  	
   

  
	
  9

  	
  Warranty and Indemnity

  	
   

  
	
  10

  	
  Duration and Termination

  	
   

  
	
  11

  	
  Consequences of Termination/Survival

  	
   

  
	
  12

  	
  Confidentiality

  	
   

  
	
  13

  	
  Payments, Reports and Audits

  	
   

  
	
  14

  	
  Miscellaneous Provisions

  	
   

  
	
  Schedule 1

  	
   

  
	
   

  	
  Elan Patents

  	
   

  

 

 

THIS AGREEMENT is dated 9 June 2004.

 

BETWEEN:

 

(1)           ELAN PHARMA INTERNATIONAL LTD., a company incorporated under the laws of Ireland, and having its
registered office at WIL House, Shannon Business Park, Shannon, County Clare,
Ireland; and

 

(2)           IMCOR PHARMACEUTICAL CO.,
a company incorporated under the laws of Nevada, having its principal place of
business at 6175 Lusk Boulevard, San Diego, CA 92121.

 

RECITALS:

 

A.            Elan
is beneficially entitled to the use of various patents which have been granted
or are pending under the International Convention in relation to the
development and production of drug specific dosage forms for pharmaceutical
products and processes.

 

B.            IMCOR
wishes to enter into this Agreement to obtain the right to utilize the Elan
Intellectual Property to import, use, offer for sale and sell the Product in
the Field in the Territory.

 

NOW
IT IS HEREBY AGREED AS FOLLOWS:

 

1              Preliminary

 

1.1           Definitions:

 

“Affiliate” shall mean any corporation or entity controlling, controlled or
under the common control of any other corporation or entity, excluding, in the
case of Elan, an Elan JV.  For the
purpose of this definition, “control” shall mean direct or indirect ownership
of fifty percent (50%) or more of the stock or shares entitled to vote for the
election of directors. IMCOR is not an Affiliate of Elan.

 

“Agreement” shall mean this licence agreement (which expression shall be deemed
to include the Recitals and Schedules hereto).

 

“Commercialization
Agreement” shall mean:

 

(a)           any
license agreement, research and development agreement, or alternative form of
collaboration or commercialization agreement, such as, but not limited to, a
co-promotion or co-marketing arrangement to research, develop, import, make,
use, offer for sale, and/or sell the Product(s) in the Territory;

 

(b)           any
Disposal Agreement; or

 

(c)           an
agreement comprising an option to do any of the foregoing.

 

“Confidential
Information” shall have the meaning
set forth in Clause 12.

 

“Compound” shall mean the diagnostic imaging agent compound NC-67722 (formerly
known as WIN 67722).

 

“Disposal Agreement” shall
mean any agreement for the assignment or outright sale or disposition, in whole
or in part, of the intellectual property rights in the Product(s).

 

1

 

“Effective
Date” shall mean the date of this
Agreement.

 

“Elan” shall mean EPIL and its Affiliates.

 

“Elan
Improvements” shall mean any and all
improvements, made to the Elan Patents and/or the Elan Know-How that are
conceived, created, developed and/or otherwise invented by IMCOR at any time
after the Effective Date.

 

“Elan
Intellectual Property” shall mean the
Elan Patents, Elan Know How and, subject to the provisions of Clause
3.2.2,  Elan Improvements.

 

“Elan
JV” shall mean an entity that Elan
and a third party (i) establish or have established; (ii) take shareholdings in
or have a right to take shareholdings in; and (iii) grant certain licenses in
and to certain intellectual property rights for the purpose of implementing a
strategic alliance.

 

“Elan
Know-How” shall mean the rights owned
by Elan on the Effective Date to the specific scientific, pharmaceutical or
technical information, data, discovery, invention (whether patentable or not),
know-how, substances, techniques, processes, systems, formulations, designs and
expertise relating to nanoparticulate medical diagnostic imaging agents
including, without limitation, (i) methods for making medical diagnostic
imaging agents in nanoparticulate form and related compositions; and (ii)
medical diagnostic imaging agents, methods of treatment using medical
diagnostic imaging agents and related compositions, which is not generally
known to the public.

 

The primary
examples of the Elan Know-How existing as of the Effective Date are set forth
in Schedule 1, which listing is not necessarily exhaustive.

 

“Elan
Licence” shall have the meaning set
forth in Clause 2.1.

 

“Elan
Patents” shall mean any and all
Patent Rights owned or controlled by Elan, now existing, currently pending or
hereafter filed by Elan relating to nanoparticulate medical diagnostic imaging
agents including, without limitation, (i) methods for making medical diagnostic
imaging agents in nanoparticulate form and related compositions; and (ii)
medical diagnostic imaging agents, methods of treatment using medical
diagnostic imaging agents and related compositions.  Representative Elan Patents existing as of the Effective Date are
set forth in Schedule 1.

 

“EPIL” or “Elan Pharma International
Limited” shall mean Elan Pharma International Limited, a private
limited company incorporated under the laws of Ireland.

 

“FDA” shall mean the United States Food and Drug Administration or any
other successor agency whose approval is necessary to market the Product(s) in
the USA.

 

“Field” shall mean x-ray, CT, and/or MRI diagnostic imaging agents using
radio-opaque molecules containing Iodine that passively target to lymphnodes
involved in a disease state following parenteral administration to a mammal to
locate, diagnose and/or treat cancer and/or other diseases.

 

For the
avoidance of doubt, the Field does not include:

 

(i)            active
targeting agents, including but not limited to monoclonal antibodies,
short-chain antibodies or any other active targeting agents including protein,
peptide or peptidomimetic targeting agents; or

 

2

 

(ii)           ultrasound
diagnostic imaging agents.

 

“Force
Majeure” shall mean causes beyond a
Party’s reasonable control, including, without limitation, acts of God, fires,
strikes, acts of war, or intervention of a Governmental Authority or RHA.

 

“Governmental
Authority” shall mean all
governmental and regulatory bodies, agencies, departments or entities which
regulate, direct or control commercial and other related activities in or with
the Territory.

 

“IMCOR” shall mean IMCOR Pharmaceutical Co. and its Affiliates.

 

“In Market” shall mean the
sale of the Product(s) by IMCOR, and/or an Affiliate of IMCOR, to an
unaffiliated third party, such as a wholesaler, managed care organization,
hospital or pharmacy, and shall exclude the transfer pricing of the Product(s)
by one IMCOR Affiliate to another IMCOR Affiliate.

 

“Infringement
Claim” shall have the meaning set out
in Clause 3.4.

 

“Net
Revenues” shall mean:

 

(a)           all
license fees, license option payments (whether in relation to the grant or
exercise of any license option), sublicense fees, milestone payments, and
royalties on sales of the Product(s), and any other kinds of revenue or
consideration whatsoever received by IMCOR, and/or an Affiliate of IMCOR, in
respect of the commercialization of the Product(s);

 

(b)           any
net manufacturing profits realized by IMCOR, and/or an Affiliate of IMCOR, on
any supply of Product(s);

 

(c)           any
consideration received by IMCOR, and/or an Affiliate of IMCOR, under any
Disposal Agreement;

 

(d)           research
and development payments received by IMCOR, and/or an Affiliate of IMCOR, in
relation to research and development of the Product(s), where such payments are
made other than for reimbursement of direct expenses incurred by IMCOR, and/or
an Affiliate of IMCOR, and other than on an FTE rate based on then current
standard industry rates; where such payments are made other than on an FTE rate
based on then current standard industry rates, the surplus over the current
industry standard FTE rates shall be included in the calculation of Net
Revenues; and

 

(e)           in the
context of any Commercialization Agreement, any premium paid by a subscriber
for stock of IMCOR, and/or an Affiliate of IMCOR;

 

(i)            where
IMCOR, and/or an Affiliate of IMCOR, is not publicly listed on a recognized
stock exchange, the premium paid over the fair market value of such stock as
reasonably determined by the board of directors of IMCOR, and/or an Affiliate
of IMCOR, in good faith and certified in a board resolution, taking into
account (i) the most recently or concurrently completed arm’s length transaction
in which the primary consideration for the stock is cash between IMCOR, and/or
an Affiliate of IMCOR, and an unaffiliated third party that is not part of a
strategic investment and the closing of which occurs 

 

3

 

within the six months preceding or on the
date of such calculation, if any) and shall be reasonably agreed to by the Elan
(provided that in the event Elan reasonably does not agree with IMCOR’s, and/or
an Affiliate of IMCOR’s, fair market value determination, Elan and IMCOR,
and/or an Affiliate of IMCOR, shall jointly appoint an independent
nationally-recognized third party to determine the fair market value), (ii) the
general market conditions for private biotech securities, and (iii) the general
state of progress in clinical and commercial activities in IMCOR, and/or an
Affiliate of IMCOR,; or

 

(ii)           where
IMCOR, and/or an Affiliate of IMCOR, is publicly listed on a recognized stock
exchange, the premium paid over the average closing price of such stock of
IMCOR, and/or an Affiliate of IMCOR, for the 30 trading day period immediately
prior to any such subscription;

 

having taken
account of deductions in respect of any customs and excise duties or other
sales taxes that are actually paid by IMCOR, and/or an Affiliate of IMCOR,
(but, for the avoidance of doubt, not income or corporation tax), directly
related to the receipt of revenue by IMCOR, and/or an Affiliate of IMCOR, as
set forth above.

 

“Net Sales” shall mean that sum determined,
in accordance with generally accepted accounting principles, by deducting the
following deductions from the aggregate gross In Market sales proceeds billed
for the Product(s) by IMCOR, and/or an Affiliate of IMCOR:

 

(i)            customs
and excise duties or other sales taxes (but, for the avoidance of doubt) not
income or corporation tax), directly related to the sale of the Product(s)
which are actually paid by IMCOR, and/or an Affiliate of IMCOR;

 

(ii)           a discount from the gross sales proceeds to cover such normal costs as
are incurred by IMCOR, and/or an Affiliate of IMCOR, in respect of industry
standard transport, shipping and insurance costs; and industry standard or
mandatory discounts or rebates directly related to the sale of the Product(s);
and

 

(iii)          amounts
repaid or credited by IMCOR, and/or an Affiliate of IMCOR, consistent with its
normal business practices for similar products, by reason of the rejection or
return of goods.

 

“Party” shall mean Elan or IMCOR; and “Parties” shall mean Elan and IMCOR.

 

“Patent
Rights” shall mean any and all
patents and patent applications, including all divisionals, continuations,
continuations-in-part, extensions, patents-of-additions, re-examinations,
re-issues, supplementary protection certificates and foreign counterparts of such
patents and patent applications and any patents issuing thereon and extensions
thereon.

 

“Product(s)” shall mean a formulation
containing x-ray, CT, and/or MRI Compound in nanoparticulate form in the Field.

 

“Regulatory
Application” shall mean any regulatory
application or any other application for Regulatory Approval for the
Product(s), which IMCOR will file in the Territory, including any supplements
or amendments thereto which IMCOR may file.

 

4

 

“Regulatory
Approval” shall mean the final
approval to market the Product(s) in any country of the Territory, including
pricing and reimbursement approval and any other approval which is required to
launch the Product(s) in the normal course of business.

 

“RHA” shall mean all relevant government health authorities (or successor
agency thereof) in each country of the Territory whose approval is necessary to
market the Product(s) in the relevant country of the Territory.

 

“Termination
Agreement” shall mean the Termination
Agreement dated as of the Effective Date between Elan Corporation plc, Elan,
Elan International Services Ltd., IMCOR and Sentigen Ltd.

 

“Term” shall mean the term of this Agreement, as set out in
Clause 10.

 

“Territory” shall mean all of the countries of the world.

 

“WIN
License Agreement” shall mean the
License Agreement between Elan and IMCOR referred to in Clause 4.2.1(a) of
the Termination Agreement.

 

“$” shall mean United States Dollars.

 

“US” or “USA” shall mean
the United States of America.

 

1.2           Interpretation

 

In this
Agreement:

 

1.2.1        the
singular includes the plural and vice versa, the masculine includes the
feminine and vice versa and references to natural persons include corporate
bodies, partnerships and vice versa.

 

1.2.2        any
reference to a Clause or Schedule, unless otherwise specifically provided,
shall be respectively to a Clause or Schedule of this Agreement.

 

1.2.3        the
headings of this Agreement are for ease of reference only and shall not affect
its construction or interpretation.

 

2              The Licences

 

2.1           Elan Licence to IMCOR

 

Subject to the
terms of this Agreement, Elan hereby grants to IMCOR for the Term a
non-exclusive licence to the Elan Intellectual Property to make and have made,
import, use, offer for sale and sell the Product(s) in the Field in the
Territory (the “Elan Licence”).

 

2.2           Sub-licensing by IMCOR

 

IMCOR
shall not be entitled, without the prior written consent of Elan which shall
not be unreasonably withheld, to grant sub-licences in respect of the Elan
Intellectual Property.

 

3              Intellectual
Property

 

3.1           Ownership of Intellectual Property

 

Elan shall
remain the owner of the Elan Intellectual Property.

 

5

 

3.2           Patent prosecution and maintenance

 

3.2.1        Elan, at
its sole discretion and expense, may:

 

(i)            secure
the grant of any patent applications within the Elan Improvements, the Elan
Patents and/or the Elan Know-How;

 

(ii)           file
and prosecute patent applications on patentable inventions and discoveries
relating to the same;

 

(iii)          defend
all such applications against third party oppositions; and

 

(iv)          maintain
in force any issued letters patent relating to the same.

 

3.2.2        IMCOR
shall promptly notify Elan of any Elan Improvements.  IMCOR shall fully cooperate with Elan in perfecting Elan’s
ownership and other proprietary rights in respect of any of the Elan
Improvements and shall execute and deliver to Elan any documents that Elan may
reasonably require with respect thereto. Thereafter, provided that IMCOR has
fully complied with the obligations of this Clause 3.2.2, such Elan
Improvements shall be deemed included in the Elan Licence granted to IMCOR
hereunder.

 

3.2.3        IMCOR
shall provide Elan with reasonable support in the filing, prosecution,
maintenance and defence of any patents and/or patent applications in the
Territory in respect of any Elan Improvements and shall provide all information
and/or data in IMCOR’s possession or control that is necessary to support the
filing, prosecution, maintenance and defence of any such patents and/or patent
application in the Territory.

 

3.3           Enforcement

 

3.3.1        IMCOR
shall promptly inform Elan in writing of any actual or alleged unauthorized use
of the Elan Intellectual Property by a third party in the Territory in the
Field of which it becomes aware and shall provide Elan with any available
evidence of such unauthorized use; provided that no loss of privilege would
occur.

 

3.3.2        Elan
shall have the right, but not the obligation, to enforce the Elan Intellectual
Property for Elan’s own benefit.  IMCOR
shall reasonably cooperate with Elan to enforce such rights, provided that
IMCOR shall be reimbursed for reasonable out-of-pocket expenses incurred in
providing such cooperation. Elan shall advise IMCOR of any such suit or
proceedings that Elan commences.

 

3.4           Notification of Infringement Claims

 

3.4.1        IMCOR and
Elan shall promptly notify each other in writing of any claim made against
IMCOR or Elan alleging infringement or other unauthorised use of the
proprietary rights of a third party arising from the exploitation of the Elan
Intellectual Property, including the manufacture, importation, use, offer for
sale, sale or other commercialisation of the Product(s) (“Infringement Claim”).

 

3.4.2        Elan
shall have the right, but not the obligation, to take over the conduct and
control of any Infringement Claim; provided, however, that IMCOR’s indemnity
obligations under Clause 9.3.3 shall continue in such circumstances.

 

6

 

[****] 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.

 

3.4.3        Elan
shall have no liability to IMCOR whatsoever or howsoever arising for any
losses, costs and/or expenses incurred by IMCOR as a result of having to cease
selling the Product or having to defer the launch of selling the Product,
whether as a result of a court order or otherwise.

 

4              Financial
Provisions

 

4.1           In
consideration of the Elan Licence, IMCOR shall pay to Elan the following
non-refundable amounts:-

 

4.1.1        if IMCOR,
and/or an Affiliate of IMCOR, sells the Product(s) then [****] of Net Sales in
the Territory during the Term; and

 

4.1.2        if IMCOR,
and/or an Affiliate of IMCOR, enters into a Commercialization Agreement with
any third party then [****] of Net Revenues in the Territory during the Term.

 

5              Development/Manufacturing/ Exploitation

 

5.1           IMCOR
will be solely responsible for the development, manufacture, storage, handling,
packaging, promotion, distribution, marketing and sale of the Product(s) in
each country of the Territory and for ensuring that all such activities are in
strict compliance with all the legal and regulatory requirements of each
country in the Territory (including, for the avoidance of doubt, all legal and
regulatory requirements relating to patent marking).

 

5.2           All
advertising, promotional materials and marketing costs in respect of the
Product(s) shall be borne solely by IMCOR.

 

5.3           IMCOR
shall research, develop, make, have made, import, export, use, offer for sale
and sell the Product(s) in accordance with all statutes, regulations and
requirements of the FDA and other RHAs, including without limitations, cGMP,
cGLP, cGMP regulations.

 

5.4           For
the avoidance of doubt, Elan shall have no responsibility of any nature
whatsoever to carry out any work or activity of the kind described in this
Clause 5 or any other work or activity whatsoever, otherwise than as
expressly agreed in this Agreement.

 

6              Regulatory
Approvals

 

6.1           For the
avoidance of doubt, IMCOR shall have full responsibility for its dealings with
the FDA and other RHAs relating to the Product(s) and Elan shall have no
responsibility of any nature relating thereto; provided, however, that IMCOR
shall promptly advise Elan of any notices or other communications relating to
the safety of any Product.

 

6.2           Any
and all Regulatory Applications filed by IMCOR for the Product(s) shall be the
property of IMCOR; provided, however, that IMCOR shall permit Elan to utilize
all information contained in any Regulatory Application or Regulatory Approvals
relating to the Elan Intellectual Property in relation to Elan’s regulatory
filings of any kind.

 

6.3           For
the avoidance of doubt, the costs and expenses of any filings and proceedings
made by IMCOR to a Governmental Authority and the FDA and other RHAs, including
post approval studies required by such authorities in respect of the
Product(s), and the maintenance of any approval relating thereto including
Regulatory Approvals, shall be paid by IMCOR.

 

7

 

7              Insurance

 

7.1           During
the term of this Agreement and for a period of five years thereafter, IMCOR
shall maintain adequate comprehensive general liability insurance, including
product liability insurance and insurance in respect of any clinical trials, on
the Product(s).

 

8              Customer Complaints and Product Recall

 

8.1           IMCOR
shall establish a procedure for formal adverse event handling and reporting.

 

8.2           IMCOR
shall be responsible for furnishing post-marketing reports to the applicable
RHA’s and other relevant governmental agencies and, at Elan’s request, shall
copy Elan on all such communications with the RHA’s and other relevant
regulatory agencies.

 

8.3           In the
event of any recall of the Product for any reason whatsoever, including as
suggested or requested by any Governmental Authority and/or RHA, IMCOR shall
perform the recall of the Product(s) in the Territory and in all events the
recall costs shall be borne by IMCOR. IMCOR shall immediately notify Elan in
writing of any such event.

 

9              Warranty
and Indemnity

 

9.1           Elan
represents and warrants to IMCOR as of the Effective Date, as follows:

 

9.1.1        Elan has
the right to enter into this Agreement and to grant the Elan Licence;

 

9.1.2        there are
no agreements between Elan and any third party that conflict with the Elan
Licence.

 

9.2           IMCOR
represents and warrants to Elan as of the Effective Date, as follows:

 

9.2.1        IMCOR has
the right to enter into this Agreement;

 

9.2.2        there are
no agreements between IMCOR and any third party that conflict with this
Agreement.

 

9.3           IMCOR
shall indemnify, defend and hold harmless Elan against any and all claims and
proceedings (whether successful or otherwise), liabilities, expenses, including
reasonable attorney’s fees, responsibilities and damages by reason of any
claim, including without limitation, proceedings, action, liability or injury
arising out of:

 

9.3.1        the
research, development, testing, manufacture, transport, packaging, use,
storage, handling, distribution, marketing, advertising, promotion and/or sale
of the Product(s) by IMCOR, or any of its Affiliates or any third party on
behalf of IMCOR;

 

9.3.2        any
claims or proceedings made or brought against Elan or IMCOR on behalf of any
persons seeking damages for personal injury (including death) and/or for costs
of medical treatment, which claims relate in any way to the Product(s); and

 

9.3.3        any
Infringement Claim.

 

9.4           In
fulfilling its indemnification obligations hereunder, IMCOR shall:

 

9.4.1        reasonably
and regularly consult with Elan in relation to the progress and status of any
action, claim or proceedings; and

 

8

 

9.4.2        not make
any statements, enter into any settlement, agreement or consent to any judgment
in respect of any actions, claims and/or proceedings, without Elan’s prior
written consent.

 

9.5           SUBJECT TO CLAUSE 9.1, ELAN IS
GRANTING THE ELAN LICENCE HEREUNDER ON AN “AS IS” BASIS WITHOUT REPRESENTATION
OR WARRANTY WHETHER EXPRESS OR IMPLIED (FROM ELAN OR ANY OF ITS AFFILIATES),
INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OR
INFRINGEMENT OF THIRD PARTY RIGHTS, AND ALL SUCH WARRANTIES ARE EXPRESSLY
DISCLAIMED.

 

9.6           NOTWITHSTANDING ANYTHING TO THE CONTRARY IN
THIS AGREEMENT, ELAN (AND ITS AFFILIATES) AND IMCOR SHALL NOT BE LIABLE TO THE
OTHER BY REASON OF ANY REPRESENTATION OR WARRANTY, CONDITION OR OTHER TERM OR
ANY DUTY OF COMMON LAW, OR UNDER THE EXPRESS TERMS OF THIS AGREEMENT, FOR ANY
CONSEQUENTIAL, SPECIAL OR INCIDENTAL OR PUNITIVE LOSS OR DAMAGE (WHETHER FOR
LOSS OF CURRENT OR FUTURE PROFITS, LOSS OF ENTERPRISE VALUE OR OTHERWISE) AND
WHETHER OCCASIONED BY THE NEGLIGENCE OF THE RESPECTIVE PARTIES, THEIR EMPLOYEES
OR AGENTS OR OTHERWISE.

 

10            Duration
and Termination

 

10.1         This
Agreement shall expire on the execution of the WIN License Agreement.

 

10.2         In the
event that the WIN License Agreement is not executed then, this Agreement shall
be deemed to have come into force on the Effective Date and, subject to the
rights of termination outlined in this Clause 10 and the provisions of
applicable laws, will expire on a country by country basis:-

 

10.2.1      on the 15th
anniversary of the date of the launch of the Product(s) in the country
concerned; or

 

10.2.2      in any
country upon the expiration of the life of the last to expire patent included
in the Elan Patents in that country;

 

whichever date
is later to occur (the “Term”).

 

10.3         In
addition to the rights of termination provided for elsewhere in this Agreement,
either Party will be entitled forthwith to terminate this Agreement by written
notice to the other Party if:

 

10.3.1      the other
Party commits a material breach of any of the provisions of this Agreement, and
fails to cure the same within 60 days after receipt of a written notice from
the other Party hereto giving full particulars of the breach and requiring it
to be remedied; provided, that if the breaching Party has proposed a course of
action to cure the breach and is acting in good faith to cure same but has not
cured the breach by the 60th day, such period shall be extended by such period
as is reasonably necessary to permit the breach to be cured, provided that such
period shall not be extended by more than 90 days, unless otherwise agreed in
writing by the Parties;

 

10.3.2      the other
Party goes into liquidation under the laws of any applicable jurisdiction
(except for the purposes of amalgamation or reconstruction and in such manner
that 

 

9

 

the company resulting therefrom effectively
agrees to be bound by or assume the obligations imposed on that other Party
under this Agreement);

 

10.3.3      a receiver,
administrator, examiner, trustee or similar officer is appointed over all or
substantially all of assets of the other Party under the laws of any applicable
jurisdiction; and/or

 

10.3.4      any
proceedings are filed or commenced by that other Party under bankruptcy,
insolvency or debtor relief laws, or anything analogous to any of the foregoing
under the laws of any applicable jurisdiction occurs in relation to the other
Party.

 

10.4         In
addition to rights of termination provided elsewhere in this Agreement, Elan
will be entitled forthwith to terminate this Agreement by written notice to
IMCOR if IMCOR directly or indirectly, contests or otherwise disputes the
ownership, scope, or validity of any of the Elan Intellectual Property, or
supports any such claim by a third party.

 

11            Consequences of Termination/Survival

 

11.1         Upon
exercise of those rights of termination specified in Clause 11 or
elsewhere in this Agreement, this Agreement shall, subject to the provisions of
the Agreement which survive the termination of the Agreement and
Clause 11.2 automatically terminate forthwith and be of no further legal
force or effect.

 

11.2         Upon
expiration or termination of this Agreement by either Party, the following
shall be the consequences relating to the Territory or the particular country,
as applicable:-

 

11.2.1      any sums
that were due from IMCOR to Elan under the provisions of Clause 4 or
otherwise howsoever prior to the termination or expiry hereof shall be paid in
full within 30 days of such termination or expiration and Elan shall not be
liable to repay to IMCOR any amount of money paid or payable by IMCOR to Elan
up to the date of the termination or expiry;

 

11.2.2      all
confidentiality provisions set out herein shall remain in full force and
effect;

 

11.2.3      all
representations and warranties shall insofar as are appropriate remain in full
force and effect;

 

11.2.4      the rights
of inspection and audit shall continue in force for the period referred to in
the relevant provisions of this Agreement;

 

11.2.5      all rights
and licences granted in and pursuant to this Agreement shall cease for the
Territory or for such particular country or countries in the Territory, as the
case may be, and shall immediately revert to Elan.  Following such expiration or termination, IMCOR may not
thereafter use the Elan Intellectual Property in the Territory or in such
particular country or countries in the Territory, as the case may be.

 

11.3         If this
Agreement is terminated pursuant to Clause 10.1 then no provisions shall
survive and all terms and provisions of this Agreement shall cease to have
effect and be null and void upon the termination of this Agreement.

 

11.4         If this
Agreement is terminated for any reason other than pursuant to clause 10.1,
then the provisions of Clauses 1, 3, 4, 6, 7, 8, 9, 10, 11, 12 and 13
shall survive the termination of this Agreement under this Clause 11; all
other terms and provisions of this Agreement shall cease to have effect and be
null and void upon the termination of this Agreement.

 

10

 

12            Confidentiality

 

12.1         Confidentiality

 

12.1.1      The Parties
agree that it will be necessary, from time to time, to disclose to each other
confidential and proprietary information, including without limitation,
inventions, trade secrets, specifications, designs, data, know-how and other
proprietary information relating to the Field, the Product(s), processes,
services and business of the disclosing party.

 

The foregoing
shall be referred to collectively as “Confidential
Information”.

 

12.1.2      Any
Confidential Information disclosed by the disclosing Party shall be used by the
receiving Party exclusively for the purposes of fulfilling the receiving
Party’s obligations under this Agreement and for no other purpose.

 

12.1.3      Save as
otherwise specifically provided herein, and subject to Clause 12.2 and 12.3,
each Party shall disclose Confidential Information of the other Party only to
those employees, representatives and agents requiring knowledge thereof in
connection with fulfilling the Party’s obligations under this Agreement, and
not to any other third party.

 

Each Party
further agrees to inform all such employees, representatives and agents of the
terms and provisions of this Agreement relating to Confidential Information and
their duties hereunder and to obtain their agreement hereto as a condition of
receiving Confidential Information.

 

Each Party
shall exercise the same standard of care as it would itself exercise in
relation to its own confidential information (but in no event less than a
reasonable standard of care) to protect and preserve the proprietary and
confidential nature of the Confidential Information disclosed to it by the
other Party.

 

Upon
termination or expiration of this Agreement, each Party shall promptly, upon
request of the other Party, return all documents and any copies thereof
containing Confidential Information belonging to, or disclosed by, such other
Party, save that it may retain one copy of the same solely for the purposes of
ensuring compliance with this Clause 12.

 

12.1.4      Any breach
of this Clause 12 by any person informed by one of the Parties is considered a
breach by the Party itself.

 

12.1.5      Confidential
Information shall be deemed not to include:

 

(i)            information
which is in the public domain;

 

(ii)           information
which is made public through no breach of this Agreement;

 

(iii)          information
which is independently developed by a Party, as evidenced by such Party’s
records;

 

(iv)          information
that becomes available to a receiving Party on a non-confidential basis,
whether directly or indirectly, from a source other than the other Party
hereto, which source did not acquire this information on a confidential basis.

 

11

 

12.1.6      The
provisions relating to confidentiality in this Clause 12 shall remain in effect
during the term of this Agreement, and for a period of 10 years following the
expiration or earlier termination of this Agreement.

 

12.1.7      The Parties
agree that the obligations of this Clause 12 are necessary and reasonable in
order to protect the Parties’ respective businesses, and each Party agrees that
monetary damages may be inadequate to compensate a Party for any breach by the
other Party of its covenants and agreements set forth herein.

 

The Parties
agree that any such violation or threatened violation may cause irreparable
injury to a Party and that, in addition to any other remedies that may be
available, in law and equity or otherwise, each Party shall be entitled to seek
injunctive relief against the threatened breach of the provisions of this
Clause 12, or a continuation of any such breach by the other Party, specific performance
and other equitable relief to redress such breach together with damages and
reasonable counsel fees and expenses to enforce its rights hereunder.

 

12.2         Announcements

 

Subject to
Clause 12.3, no announcement or public statement concerning the existence,
subject matter or any term of this Agreement shall be made by or on behalf of
any Party hereto without the prior written approval of the other Party.

 

The terms of
any such announcement shall be agreed in good faith by the Parties.

 

12.3         Required Disclosures

 

12.3.1      A Party
(the “Disclosing Party”) will be entitled to make an announcement or public
statement concerning the existence, subject matter or any term of this
Agreement, or to disclose Confidential Information that the Disclosing Party is
required to make or disclose pursuant to:

 

(i)            a
valid order of a court , Governmental Authority, or RHA; or

 

(ii)           any
other requirement of law or any securities or stock exchange;

 

provided that
if the Disclosing Party becomes legally required to make such announcement,
public statement or disclosure hereunder, the Disclosing Party shall give the
other Party or Parties hereto prompt notice of such fact to enable the other
Party or Parties hereto to seek a protective order or other appropriate remedy
concerning any such announcement, public statement or disclosure.

 

The Disclosing
Party shall fully co-operate with the other Party or Parties hereto in
connection with that other Party’s or Parties’ efforts to obtain any such order
or other remedy.

 

If any such order
or other remedy does not fully preclude announcement, public statement or
disclosure, the Disclosing Party shall make such announcement, public statement
or disclosure only to the extent that the same is legally required.

 

12.3.2      Each of the
Parties shall be entitled to provide a copy of this Agreement (and any
subsequent amendments hereto) to a potential third party purchaser in
connection with Clause 14.1; and Elan (and/or any Affiliate) shall also be so
entitled in connection with Clause 14.1.2 provided that the relevant third
party purchaser or 

 

12

 

assignee has entered into a confidentiality
agreement on terms no less protective than the terms of this Clause 12.

 

13            Payments,
Reports and Audits

 

13.1         With reference to Clause 4, IMCOR and/or an
Affiliate of IMCOR shall keep true and accurate records of Net Sales and/or Net
Revenues.  Where IMCOR and/or an
Affiliate of IMCOR has Net Sales and/or Net Revenues, IMCOR and/or an Affiliate
of IMCOR (as the case may be) shall deliver to Elan a written statement (the “Statement”)
thereof within 45 days following the end of each calendar  quarter (or any part
thereof).  The financial officers of
Elan and IMCOR shall agree upon the precise format of the Statement.

 

13.2         Payments
due on Net Sales and/or Net Revenues on sales amounts in a currency other than US
Dollars shall first be calculated in the foreign currency and then converted to
US Dollars on the basis of the exchange rate in effect for the purchase of US
Dollars with such foreign currency quoted in the Wall Street Journal (or
comparable publication if not quoted in the Wall Street Journal).

 

13.3         Any income or other taxes which IMCOR and/or an
Affiliate of IMCOR is required by law to pay or withhold on behalf of Elan with
respect to such Net Sales and/or Net Revenues payments under this Agreement
shall be deducted from the amount of such Net Sales and/or Net Revenues
payments.  IMCOR and/or an Affiliate of
IMCOR, as the case may be, shall furnish Elan with proof of such payments.  IMCOR and/or an Affiliate of IMCOR, as the
case may be, shall promptly provide Elan with a certificate or other
documentary evidence to enable Elan to support a claim for a refund or a foreign
tax credit with respect to any such tax so withheld or deducted by IMCOR and/or
an Affiliate of IMCOR.  The Parties will
reasonably cooperate in completing and filing documents required under the
provisions of any applicable tax treaty or under any other applicable law, in
order to enable IMCOR and/or an Affiliate of IMCOR, as the case may be, to make
such payments to Elan without any deduction or withholding.

 

13.4         Payment
of monies hereunder shall be made by IMCOR and/or an Affiliate of IMCOR, as the case may be, to Elan within 45
days of the Statement.

 

13.5         All
payments due hereunder shall be made in U.S. Dollars.

 

13.6         All payments due hereunder shall be made to the
designated bank account of Elan in accordance with such timely written
instructions as Elan shall from time to time provide.

 

13.7         Without prejudice to Elan’s other remedies
hereunder, IMCOR and/or an Affiliate of IMCOR, as the case may be, shall pay
interest to Elan on sums not paid to Elan on the date on which payment should
have been made pursuant to the applicable provisions of this Agreement (“Due Date”)
over the period from the Due Date until the date of actual payment (both before
and after judgment) at the Prime Rate
publicly announced by Morgan Guaranty Trust Company of New York at its
principal office on the Due Date (or next to occur business day, if such date
is not a business day) plus 5%,
such interest to be payable on demand from time to time and compounded monthly.

 

13.8         For the
180 day period following the close of each calendar year of the Agreement,
IMCOR and/or an Affiliate of
IMCOR, as the case may be, will, in the event that Elan
reasonably requests such access, provide Elan’s independent certified
accountants (reasonably acceptable to IMCOR and/or an Affiliate of IMCOR) with access,
during regular business hours and subject to the confidentiality provisions as
contained in this Agreement, to IMCOR and/or an Affiliate of IMCOR, as the case may be, books and records solely for the purpose of verifying 

 

13

 

the accuracy and reasonable composition of
the calculations hereunder for the calendar year then ended.

 

13.9         In the
event that IMCOR and/or an
Affiliate of IMCOR shall sell the Product(s) to any
third party, or enter into any agreement with respect thereto with any third
party, together with other products of IMCOR or an Affiliate of IMCOR, by the
method commonly known in the pharmaceutical industry as “bundling” and the
price attributable to the Product(s) is less than the average price which would
have been attributable thereto on an “arms length” basis, the Net Revenues and/or Net Sales attributable
thereto hereunder shall be adjusted by the Parties to reflect an average price
on an “arms length” basis.

 

14            Miscellaneous
Provisions

 

14.1         Assignments/Sub-contracting

 

14.1.1      Subject to
Clause 14.1.2, this Agreement shall not be assigned by any Party hereto without
the prior written consent of the other Party or Parties hereto, save that any
Party:

 

(i)            may
assign this Agreement in whole or in part and delegate its duties hereunder to
its Affiliate or Affiliates without such consent; and

 

(ii)           may
assign its rights and obligations to a successor (whether by merger,
consolidation, reorganisation or other similar event) or purchaser of all or
substantially all of its assets relating to such Party’s technology related to
this Agreement, provided that such successor or purchaser has agreed in writing
to assume all of such Party’s rights and obligations hereunder and a copy of
such assumption is provided to the other Parties.

 

14.1.2      Elan
(and/or any Affiliate) shall be entitled to assign the rights of Elan (or any
Affiliate) to the royalty payments under Clause 4 and Clause 13 without the
consent of any other Party hereto.  Elan
(and/or any Affiliate) shall notify the other Parties hereto of any such
assignment within a reasonable time following any such assignment.

 

14.2         Governing law and jurisdiction

 

14.2.1      This
Agreement shall be governed by and construed in accordance with the laws of the
State of New York without regard to conflicts of law principles under the laws
of the State of New York.

 

14.2.2      For the
purposes of this Agreement, the Parties submit to the nonexclusive jurisdiction
of the State and Federal Courts of New York.

 

14.3         Notices

 

14.3.1      Any notice
to be given under this Agreement shall be sent in writing in English by
registered airmail, internationally recognized courier or telefaxed to the
following addresses:

 

If to IMCOR at:

 

6175 Lusk Boulevard

San Diego, CA 92121

Attention:              President

 

14

 

Telephone:            (858)
410 5200

Fax:                         (858) 410 5602

 

with a copy to:

 

Grippo & Elden

Suite 3600

227 West Monroe

Chicago, Illinois 60606

USA

Attention: 
Theodore W Grippo

Telephone 
312 704 7720

Fax: 
312 558 1195

 

If to Elan at:

 

Elan Pharma International Limited

C/o Lincoln House

Lincoln Place

Dublin 2

Ireland

Attention:             Secretary

Telephone:            709 4000

Fax:                         662 4949

 

or to such
other address(es) and telefax numbers as may from time to time be notified by
any Party to the others hereunder.

 

14.3.2      Any notice
sent by mail shall be deemed to have been delivered within seven (7) working
days after dispatch or delivery to the relevant courier and notice sent by fax
shall be deemed to have been delivered upon confirmation receipt.  Notice of change of address shall be
effective upon receipt.

 

14.4         Waiver

 

No waiver of
any right under this Agreement shall be deemed effective unless contained in a
written document signed by the Party charged with such waiver, and no waiver of
any breach or failure to perform shall be deemed to be a waiver of any future
breach or failure to perform or of any other right arising under this
Agreement.

 

14.5         Severability

 

If any
provision in this Agreement is agreed by the Parties to be, or is deemed to be,
or becomes invalid, illegal, void or unenforceable under any law that is
applicable hereto:

 

14.5.1      such
provision will be deemed amended to conform to applicable laws so as to be
valid and enforceable; or

 

14.5.2      if it
cannot be so amended without materially altering the intention of the Parties,
it will be deleted, with effect from the date of this Agreement or such earlier
date as the Parties may agree, and the validity, legality and enforceability of
the remaining provisions of this Agreement shall not be impaired or affected in
any way.

 

15

 

14.6         Further Assurances

 

At the request
of any of the Parties, the other Party or Parties shall (and shall use
reasonable efforts to procure that any other necessary parties shall) execute
and perform all such documents, acts and things as may reasonably be required
subsequent to the signing of this Agreement for assuring to or vesting in the
requesting Party the full benefit of the terms hereof.

 

14.7         Successors

 

This Agreement
shall be binding upon and inure to the benefit of the Parties hereto and their
respective successors and permitted assigns.

 

14.8         Amendments

 

No amendment,
modification or addition hereto shall be effective or binding on any Party
unless set forth in writing and executed by a duly authorized representative of
each Party.

 

14.9         Counterparts

 

This Agreement
may be executed in any number of counterparts, each of which when so executed
shall be deemed to be an original and all of which when taken together shall
constitute this Agreement.

 

14.10       Costs

 

Each Party shall bear its own
costs and expenses in connection with the transactions contemplated by this
Agreement.

 

14.11       Force Majeure

 

Neither Party
to this Agreement shall be liable for failure or delay in the performance of
any of its obligations hereunder if such failure or delay results from Force
Majeure, but any such failure or delay shall be remedied by such Party as soon
as practicable.

 

14.12       Relationship of the Parties

 

The Parties
are independent contractors under this Agreement.  Nothing herein contained shall be deemed to create or establish
an employment, agency, joint venture, or partnership relationship between the
Parties or any of their agents or employees, or any other legal arrangement
that would impose liability upon one Party for the act or failure to act of the
other Party.

 

No Party shall
have any express or implied power to enter into any contracts, commitments or
negotiations or to incur any liabilities in the name of, or on behalf of, any
other Party, or to bind any other Party in any respect whatsoever.

 

14.13       Entire agreement

 

14.13.1    This
Agreement sets forth all of the agreements and understandings between the
Parties with respect to the subject matter hereof.  There are no agreements or understandings with respect to the
subject matter hereof, either oral or written, between the Parties other than
as set forth in this Agreement.

 

16

 

14.13.2    No provision
of this Agreement shall be construed so as to negate, modify or affect in any
way the provisions of any other agreement between the Parties unless
specifically provided herein and only to the extent so specified.

 

17

 

IN WITNESS WHEREOF, the parties hereto have executed this Agreement.

 

 

	
  SIGNED

  	
   

  
	
  for and on behalf of

  	
   

  
	
  Elan Pharma International Ltd.

  	
   

  
	
   

  	
   

  	
   

  
	
  By :

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Name:

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Title:

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  SIGNED

  	
   

  	
   

  
	
  For and on behalf of

  	
   

  
	
  IMCOR
  Pharmaceutical Co.

  	
   

  
	
   

  	
   

  	
   

  
	
  By :

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Name:

  	
   

  	
   

  
	
   

  	
   

  	
   

  
	
  Title:

  	
   

  	
   

  

 

18

 

[****] 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.

 

SCHEDULE 1

 

Elan Patents

 

 

 

[****]

 

19Exhibit 10.13

 

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

 

EXECUTED
VERSION

June  9, 2004

 

 

Elan Drug Delivery, Inc.

3000 Horizon Drive

King of Prussia, PA 19406

USA

 

Elan Pharma International Ltd.

WIL House

Shannon Business Park

Shannon

County Clare

Ireland

 

 

The purpose of this Non-Binding
Term Sheet is to set forth certain non-legally binding terms based upon which
Elan Corporation plc (“Elan”),
Elan Pharma International Ltd. (“EPIL
Shannon”), Elan Drug Delivery, Inc. (“EDD”)
and Photogen Technologies Inc. (“Photogen”)
have agreed, pursuant to Clause 4.2 of a Termination Agreement between Elan,
EPIL Shannon, Elan International Services Limited, Photogen and Sentigen Ltd.,
to negotiate in good faith the full terms of certain agreements as outlined
below.

 

 

Terms for WIN
67722:

 

1.                 License Agreement

 

EPIL
Shannon shall license the patents listed in Schedule 1 and certain know-how
(the “Elan Licensed Patents and Know-How”)
and the Elan Improvements to Photogen to make and have made, import, use, offer
for sale and sell WIN 67722  for all in
vivo diagnostic and drug applications (the License”).  In consideration of the License, EPIL Shannon
shall receive royalties equal to the greater of:

 

1.1           [****]

 

1.2           [****]

 

The
Term of the License shall be set out in the substantive agreements.

 

The
“Elan Improvements” shall mean any
and all improvements to the Elan Licensed Patents and Know-How that are
conceived, created, 

 

 

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

 

developed and/or otherwise invented by Elan
and/or Photogen under the License or the Services and Manufacturing Agreement.

 

2.                 Services
and Manufacturing Agreement

 

EDD and
Photogen shall agree the terms of a Services and Manufacturing Agreement to
provide for:

 

2.1                                 [****]

 

2.2                                 [****]

 

2.3                                 [****]

 

3.                 Photogen can acquire certain 2, 10 and
60 Liter NanoMillsTM from NanoMill Vendors in collaboration with EDD, to be used
in accordance with the terms and conditions of a license agreement as agreed to
by Photogen, NanoMill Vendors and EDD.

 

4.                 Photogen shall grantback to EPIL
Shannon a non-exclusive, royalty free, sublicenseable license to all
improvements made to the Elan Licensed Patents and Know-How.

 

5.             Photogen
shall agree to defend and indemnify and hold Elan, EPIL Shannon and EDD and
their affiliates harmless against any and all claims, damages, losses, or other
liabilities and expenses made or brought against Elan, EPIL Shannon, EDD or any
of their affiliates arising out of or in connection with Photogen’s or its
licensees’ activities in relation to WIN 67722.

 

6.             Photogen
can acquire small-scale NanoMillsTM (10 ml, 100ml and MagMill) from EDD at the
price listed in EDD’s current pricing schedule.

 

7.     Confidentiality: 

 

7.1                                 Subject
to the provisions of Clause 7.2, each party together with its servants and
agents shall keep secret, carefully guard and maintain as strictly confidential
all confidential information disclosed to it by the other party hereunder and
shall not directly or indirectly disclose or release any confidential
information to any person or entity other than professional advisers advising
on the proposed transaction without with the prior consent in writing of the
other party.

 

For the
avoidance of doubt certain trade secrets and enabling know-how classified by
Elan as “Highly Confidential Information” will be 

 

 

shared only under terms to be defined in
the Services and Manufacturing Agreement.

 

Confidential
information for the purposes of this Clause 7 shall not include information
which:

 

(1)                                  is in the public domain or becomes part of the public domain
otherwise than by breach by the recipient party of its confidentiality
obligations hereunder; or

 

(2)                                  is in the possession of the recipient party prior to its
being provided to it by the other party; or

 

(3)                                  becomes
available to the recipient party on a non-confidential basis from a third party
who is not bound by confidentiality obligations to the other party with respect
to such information; or

 

(4)                                  is independently discovered by the recipient party without
the aid, application or use of confidential information.

 

7.2                                 The
provisions of this Non-Binding Term Sheet shall not prohibit or restrict the
disclosure by either party of information required by law to be filed with, or
otherwise provided to any regulatory body, court of law, government agency or
authority in any jurisdiction.

 

7.3                                 No
party shall disclose the existence of this Non-Binding Term Sheet, the subject
matter hereof, or the fact that discussions are taking place, nor originate any
publicity, news release or other public announcement, written or oral in
relation hereto, without the prior consent in writing of the other party.

 

8.     Non-Legally
Binding Status;

 

8.1                                 It is agreed by EPIL
Shannon, EDD and Photogen that this Non-Binding Term Sheet shall not be legally
binding between the parties, except clauses 7, 8 and 9 which clauses will
become legally binding upon execution by the parties of this Term Sheet.

 

8.2                                 Save
as otherwise provided in this clause 8, no legally binding relations relating
to the proposed transaction exist or will exist between any of the parties
hereto until such time as formal agreements providing for the proposed
transaction have been negotiated, executed by the parties and delivered.

 

 

9.               This
Non-Binding Term Sheet shall be governed by and construed in accordance with
the laws of the State of New York.

 

 

	
  SIGNED on
  behalf of Elan Drug Delivery, Inc.:

  
	
   

  
	
   

  	
   

  
	
   

  
	
  Date:

  
	
   

  
	
  SIGNED on
  behalf of Elan Pharma International Limited:

  
	
   

  
	
   

  	
   

  
	
   

  
	
  Date:

  
	
   

  
	
  SIGNED on
  behalf of Photogen Technologies, Inc:

  
	
   

  
	
   

  	
   

  
	
   

  
	
  Date:

  

 

 

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

 

SCHEDULE 1

 

ELAN PATENTS 

 

 

[****]

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