genzyme

       PHARMACEUTICALS
	
      GENZYME
      CORPORATION

      CNE KENDALL
      SQUARE

      CAMBRIDGE, MA
      02139-1562, USA

      617-252-7500

      FAX
      617-252-7772

      www.genzyme.com




 

 

AMENDED
AND RESTATED SUPPLY AGREEMENT

 

THIS
AMENDED AND RESTATED SUPPLY AGREEMENT (“Agreement”)
dated as of October
8, 2003, is
by and between Genzyme Corporation, with principal offices located at One
Kendall Square, Cambridge, Massachusetts 02139 ("Vendor") and Photogen
Technologies, Inc., through its IMCOR Pharmaceutical Division, a Nevada
corporation with its principal offices located at 6175 Lusk Boulevard, San
Diego, California 92121 ("IMCOR").

WHEREAS,
Vendor entered into a Supply Agreement with Alliance Pharmaceutical Corp. dated
as of May 16, 2000 (the "Original Supply Agreement");

WHEREAS,
Photogen Technologies, Inc. has acquired the business of Alliance Pharmaceutical
Corp. to which the Original Supply Agreement relates;

WHEREAS,
IMCOR and Vendor now desire to modify the terms of their relationship and amend
and restate the Original Supply Agreement as provided herein;

WHEREAS,
Vendor has by virtue of its proprietary technologies and know-how developed and
manufactures or by virtue of its distribution relationship with the manufacturer
has adequate access to the material described on Exhibit "A" attached hereto
(the "Material"); and

WHEREAS,
IMCOR
desires to secure a long-term supply of commercial quantities of the
Material for its product described on Exhibit "A" (the "Product") if and when
such Product is
approved by the FDA and Vendor is willing to supply such quantities of its
Material to IMCOR as IMCOR's exclusive supplier of the product.

NOW,
THEREFORE,
in
consideration of the mutual promises and covenants set forth herein, the parties
agree as follows.

1.  Supply. During
the term of this Agreement, IMCOR shall purchase all of its requirements of
Material for commercial manufacturing from Vendor and Vendor shall sell to IMCOR
such quantities of the Material as ordered from time to time by IMCOR. Nothing
herein shall limit Vendor's ability to supply Material to other
customers.

2.  Duration. This
Agreement shall have effect upon execution and shall remain in effect for the
initial term indicated on Exhibit "A" (the "Term") Thereafter, this Agreement
shall be renewed automatically for successive two-year periods unless terminated
by either party by written notice not later than eighteen months prior to
expiration of the initial term or any renewal period.

3.  Specification
and Quality Control Standards; GMP Compliance.

3.1  The
quantities of the Material to be supplied hereunder shall be manufactured by
Vendor in accordance with all applicable laws, rules and regulations, and in
conformity
with the specification and quality control standards set forth in Exhibit "B"
attached hereto
(collectively, the "Specifications"). If IMCOR wishes to change the
Specifications, Vendor shall use its reasonable endeavors to carry out such
change subject to agreement on a reasonable change (increase or decrease) in
price, if appropriate, to reflect any costs or savings consequent thereon.
Vendor shall consult with and must obtain written consent from IMCOR reasonably
in advance of making any changes in the Specifications, or other aspect of the
production, storage, and transport of Material which would or
might:

 

 




















 

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

 




	(a)  	
      Cause
      a potential change in the Material purity
profile;





	(b)  	
      Require
      IMCOR to revalidate its own process or
methods;





	(c)  	
      Require
      IMCOR to re-audit Vendor,





	(d)  	
      Require
      IMCOR or Vendor to submit or resubmit any documentation to the
      FDA.




 

Subject
to the foregoing, Vendor may otherwise alter the Specifications upon sixty days
prior written notice to IMCOR.

3.2  Vendor
shall make available to IMCOR such data and information in relation to Material
as is reasonably necessary to ascertain compliance with this Agreement and to
qualify the use of Material in the Product with appropriate regulatory
authorities. However, nothing
here shall be construed as placing Vendor under an obligation to disclose to
IMCOR any data
relating to the actual production or purification of the Material except as
Vendor deems appropriate for IMCOR to satisfy itself regarding the security or
quality of supply of the Material or unless IMCOR is required to supply any such
data to any appropriate regulatory authorities,
in which case Vendor shall provide such information to IMCOR or arrange for
direct
disclosure to such regulatory authorities at IMCOR's expense. IMCOR may visit
and inspect Vendor's facilities used in the Manufacture and testing of the
Material once per year with reasonable prior notice.

3.3  Vendor
shall carry out the production and purification of the Material to be supplied
hereunder in accordance with the U.S. Food and Drug Administration ("FDA") and
Good Manufacturing Practice ("GMP") regulations and shall allow inspection of
Vendor facilities by U.S. or foreign regulatory authority representatives to
enable the said representatives to verify Vendor's compliance with GMP and all
other relevant regulations. Vendor may altar the production and purification
processes for the Material upon prior written notice to IMCOR but only if Vendor
follows all appropriate regulatory procedures and obtains any relevant
regulatory approvals and there is no change to the specification and quality
control standards for the Material.

4.  Estimates
and Orders. As soon
as practical after the effective date of this Agreement, and within the last
[****] days of
each calendar quarter thereafter, IMCOR shall deliver to vendor
a [****] month
rolling Forecast (the "Forecast") of the quantity of material to be purchased
by IMCOR. The [****] of such
Forecast will be considered a firm
commitment for production quantities and the remainder of the Forecast shall be
advisory only.
Accordingly, the [****] quantity
in each subsequent Forecast shall be identical to the [****] quantity
in the previous "Forecast" unless the parties otherwise agree in
writing. Within
[****] days of
delivery of each Forecast, IMCOR shall submit to Vendor a written delivery
"Order" for the Material which shall represent the [****] firm
commitment as illustrated by the Forecast.

5.  Delivery. The
Material shall be supplied D.D.U. San Diego, California with any and all freight
and packaging expenses being prepaid by Vendor and added to Vendor's invoice to
IMCOR for payment by IMCOR. Title to and risk of loss of the Material shall pass
to IMCOR at the time of delivery to a carrier designated by IMCOR or, if not
delivered but stored by Vendor at IMCOR's request, at the time such Material is
actually segregated and stored in facilities reasonably designed and maintained
for storage of the materials. All shipments shall meet the specifications set
forth in Exhibit "B" and be accompanied by a Certificate of Analysis. Material
Orders shall be delivered to IMCOR in accordance with a delivery schedule
provided by IMCOR in the Order, provided that no delivery be required to be made
within one hundred and twenty (120) days of such Order.

 

 




















 


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


 

6.  Prices
and Payment.

6.1  IMCOR
shall pay the prices specified in Exhibit "C" for the Material delivered by
Vendor.

6.2  The price
does not include sales, use, excise or any other similar taxes imposed by
Federal, state or local governments, and accordingly such taxes shall be paid by
IMCOR.

6.3  Invoices
for Material shall be sent to IMCOR on or after the date of shipment of
Material. Payment shall be made by IMCOR as follows: (i) [****] of the
payment for the Material in the Order (the "Order Payment") shall be paid upon
submission of the Order pursuant to Section 4 hereof, (ii) [****] of the
Order Payment shall be due upon delivery of the Material and (iii) [****] of the
Order Payment shall be due within [****] days
from the date of invoice, net of any and all invoice fees or other fees or
charges, other than those specified in this Agreement.

6.4  IMCOR
shall pay Vendor a fee of [****] United
States dollars [****] per
calendar quarter (the "Regulatory Fee") for costs incurred by Vendor that
are
associated with the filing and maintenance of the Drug Master File (DMF) and all
supporting documentation. The first quarterly Regulatory Fee shall be due upon
execution and delivery of this
Agreement and the remaining quarterly Regulatory Fees shall be due on the first
day of each calendar
quarter thereafter; provided
however, that if
IMCOR's total Orders in any calendar year exceed
[****] United
States dollars [****], IMCOR's
obligation to pay the Regulatory Fee as set forth in this Section 6.4 shall
terminate.

7.  Confidentiality. Each
party hereto (a "Recipient") recognizes that the other party hereto and its
subsidiaries and affiliated corporations (a "Discloser") own or have licensed
certain confidential information, including but not limited to secret or
confidential data, proprietary information, trade secrets, technology, formulae,
processes, procedures, scientific studies, regulatory submissions, business
plans, information and the like, whether all of the same be in writing or not,
and that Discloser has disclosed or may disclose to Recipient portions of
such
confidential information (all of which
is referred to as "Confidential
Information"). Use of the
Confidential Information shall be
solely for the purposes of complying
with this
Agreement. Recipient agrees to maintain the confidential status of such
Confidential Information and not to disclose the same to persons not authorized
herein or otherwise authorized in writing by Discloser to receive such
Confidential Information. Confidential Information shall not include information
that was (i) in the
public domain prior to the time of its disclosure under this Agreement;
(ii) entered
the public domain after the time of its disclosure under this Agreement through
means other than an unauthorized disclosure resulting from an act or omission by
the receiving party; (iii) was
independently developed or discovered by the receiving party prior to the time
of its disclosure under this Agreement; (iv) is or
was disclosed to the receiving party at any time, whether prior to or after the
time of its disclosure under this Agreement, by a third party having no
fiduciary relationship with the disclosing party and having no obligation of
confidentiality
with respect to
such Confidential
Information; or (v) is
required to be
disclosed to comply
with applicable laws or regulations, or with a court or administrative order,
provided that the disclosing party receives prior written notice of such
disclosure and that the receiving party takes all reasonable and lawful actions
to obtain confidential treatment for such disclosure and, if possible, to
minimize the extent of such disclosure

 

 




















 

8.  Termination
/ Breach.
Notwithstanding any other provisions of this Agreement, either party, at its
option, may terminate this Agreement;

8.1  Should
the other commit an act of bankruptcy, be declared bankrupt, voluntarily file or
have voluntarily filed against it, a petition for bankruptcy or reorganization
unless such petition is dismissed within 60 days of filing, enter into an
arrangement for benefit or creditors, enter into a procedure of winding up or
dissolution or should a Trustee or Receiver be appointed for its business,
assets or operations; or

8.2  Unless
excused pursuant to Section 14 of this Agreement, upon 120 days written
notice, should the other fail to comply with or to perform any of its
obligations under this Agreement
unless such failure or non-performance is corrected within the 120 day period
following notification, or such extended period as shall be agreed between
parties.

8.3  If the
FDA and all applicable foreign agencies fail to approve the Product or
subsequently rescind the approval of the Product, by giving written notice
thereof to the other party.

8.4  Notwithstanding
the foregoing, if Vendor fails to provide the material in accordance with this
Agreement and the Order more that two times, IMCOR may by providing sixty (60)
days written notice, change this Agreement into a nonexclusive purchase
agreement. If Vendor is able to provide Material within the 60-day notice period
set forth herein, this Agreement shall retain its exclusivity
provision.

9.  Limited
Warranty. Vendor
warrants that the Material shall be manufactured in accordance with all
applicable laws, rules and regulations, according to cGMPs, and in conformity
with Specifications. This warranty is in lieu of, and VENDOR SPECIFICALLY
DISCLAIMS AND EXCLUDES, ALL OTHER WARRANTIES, EXPRESS, IMPLIED OR STATORY,
INCLUDING THE WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR
PURPOSE.

10.  Limitation
of Liability. Vendor
will not under any circumstances be liable to IMCOR for incidental, special or
consequential damages (including, but not limited to, loss of profits, revenue
or business) resulting from or in any way related to a breach of any
representation or warranty hereunder. This limitation does not apply to claims
for personal injury by a third party.

11.  Inspection. IMCOR
shall stole Material under appropriate conditions and not later
than 45 days after receipt of each consignment of the Material sold hereunder,
IMCOR shall examine
such consignments of the Material for compliance with the Specifications and
shall notify Vendor of any non-compliance without delay within such 45 day
period. In the event of any dispute as to the compliance of the Material with
the Specifications, representative samples of the Material will be provided to
an independent testing service (the "Testing Service) that shall be
identified by mutual agreement within ninety (90) days of the date hereof, and
the results provided
by the Testing Service shall be finally determinative. The incorrect party shall
be responsible for all costs incurred by the Testing Service. In no event shall
acceptance relieve Vendor from any obligations under warranties, unless
non-conformity should reasonably have been detected by IMCOR using reasonable
diligence. Vendor shall replace any delivery of the Material that the Testing
Service deems to be non-conforming as soon as possible, but in any event, within
120 days of the date of receipt of notice thereof.

12.  Indemnity.

12.1  IMCOR
shall indemnify, defend and hold harmless Vendor and its affiliates and each of
their respective directors, officers, employees and agents against all claims,
losses, damages and expenses, including attorneys' fees (collectively "Losses")
relating to (i) any
death or personal injury arising from use of the Product containing Material
purchased hereunder, except those arising as a result of Vendor's negligence or
a breach of Vendor's agreements, and warranties hereunder and (ii) a breach
of the terms of this Agreement by IMCOR. Vendor shall notify IMCOR of any such
claim received by Vendor and IMCOR shall have the right to control the conduct
of the defense or settlement of the claim. IMCOR shall at its own expense keep
in force during the term of this Agreement as well as for a period of ten years
thereafter adequately funded self-insurance or policies of insurance. Such
insurance should provide coverage to the extent required by local laws and
pharmaceutical industry practice. IMCOR shall upon the request of Vendor provide
Vendor with a certificate of insurance or other documentation as proof of the
insurance requirement herein.

 

 




















 

12.2   Vendor
hereby agrees to indemnify, defend and hold harmless IMCOR and its affiliates,
and each of their respective directors, officers and employees and agents, from
and against any and all Losses incurred by IMCOR, based on or arising out of
Vendor's breach of the limited warranty as set forth in Section 10 herein or
Vendor's negligence. Vendor agrees to
maintain in effect for the term of this Agreement and ten years thereafter
adequately funded self-insurance or policies of insurance providing coverage to
the extent required by local law and pharmaceutical industry
practice.

13.  Generic
Drug Enforcement Act of 1992. Vendor
represents that it and its employees have never been (i) debarred
or (ii)
convicted of a crime for which a person can be debarred, under Section 306(a) or
306(b) of the Generic Drug Enforcement Action of 1992. Vendor represents that it
has never been and, to the best of its knowledge after due inquiry, none of its
employees, affiliates or agents has ever been (a) threatened to be debarred or
(b) indicted for a crime or otherwise engaged in conduct for which a person can
be debarred, under Section 306(a) or (b). Vendor agrees that it will promptly
notify IMCOR in the event of any such debarment, conviction, threat or
indictment.

14.  Force
Majeure. If the
performance by any party of any obligation under this Agreement
other than the payment of money, is prevented or impaired by Force Majeure for
any cause
beyond the reasonable control of the defaulting party, such party shall be
excused from performing so long as such situation continues to prevent or impair
performance; provided the party
claiming such excuse shall have promptly notified the other party of the
existence, nature, duration
and other details of such cause and shall at all times use its reasonable effort
to resume a complete
performance. If any party anticipates that a Force Majeure may occur that party
shall notify
the other immediately and explain the nature, details and expected duration
thereof. The affected party will advise the other from time to time as to the
progress in remedying the situation and as to the time when the affected party
expects to resume its obligations and shall notify the others as to the
expiration of any Force Majeure as soon as the affected party knows the date
thereof. "Force Majeure" shall mean an event beyond the reasonable control of a
party including,
but not limited to, fire, flood, sabotage, shipwreck, embargo, explosion,
accident, riot, act of
governmental authority (including, without limitation, acts relating to raw
material or product allocation), acts of God and acts of war.

15.  Records. All
records relating to the manufacture of Material shall be retained for a period
of not less than five years from the date of manufacture of Material or six
months from the expiration of the final released Material, whichever is later.
Prior to the destruction of any record, written notice shall be provided to
IMCOR and IMCOR shall have the right to request and retain said
records.

 

 




















 

16.  Notices. Any
notice required or permitted to be given or made under this Agreement
shall
be in
writing and sent by telefax or registered letter or by recognized overnight
courier (i.e. Federal Express) to the other party at its address indicated on
the first page of this Agreement, or to such other address as the addressee
shall have furnished in writing. Notice shall be deemed received three days
after deposit in the mail or, if sent by courier or facsimile, upon
receipt.

17.  Entire
Agreement. The
terms and provisions contained in this Agreement, constitute the entire
Agreement between the parties with respect to the transactions contemplated
hereby and shall supersede all previous communications. Representations,
agreements or understandings, either oral or written, between the parties hereto
with respect to the subject matter hereof, and no agreement or understanding
varying or extending this Agreement will be binding upon either party hereto,
unless in writing and signed by both parties.

18.  Non-Waiver. Failure
to terminate this Agreement following breach or failure to comply with this
Agreement, shall not constitute a waiver of a party's defenses, rights or causes
of action arising from such or any further breach or non-compliance. Any waiver
must be expressly in writing. The waiver by any of the parties to this Agreement
of any breach of any provision hereof by the other party or parties shall not be
construed to be a waiver of a succeeding breach of such provisions or a waiver
of the provision itself.

19.  Severability
and Survival. If and
to the extent that any court, arbitrator or tribunal of
competent jurisdiction holds any of the terms, provisions or conditions or parts
thereof of this Agreement
or the application hereof to any circumstances, to be invalid or to be
unenforceable in a final
non-appealable order, the remainder of this Agreement and the
application of such terms, provisions
or conditions or parts thereof to circumstances other than those as to which it
is held invalid
or unenforceable shall not be affected thereby, and each of the other terms,
provisions and conditions of this Agreement shall be valid and enforceable to
the fullest extent of the law. Sections 7, 10 and 12 shall survive and
termination of this Agreement.

20.  Assignment. Neither
party shall at any time, without the prior written consent of the other party
assign or otherwise transfer its rights or obligations under this Agreement in
whole or in part to any other party whatsoever, provided that either party may
assign or transfer its rights and obligations hereunder to a third party as part
of a divestment or licensing of all or substantially all of the business to
which this Agreement pertains and has the resources to comply with the terms of
this agreement.

21.  Controlling
Provisions. In
ordering and delivering supplies of the Material the parties may employ their
standard forms; however, nothing contained on such forms shall be construed
to modify, amend, add to or delete the terms of this Agreement and in the event
of any conflict
between them, the terms of this Agreement shall prevail.

22.  Arbitration
and Governing Law.

22.1  In the
event that any dispute arises out of this Agreement, the parties shall endeavor
to settle such dispute amicably between themselves. In the event that the
parties fail to achieve
an amicable settlement of any such dispute, that dispute shall be submitted to
arbitration under the
commercial arbitration rules of the American Arbitration Association and the
award or decision
made in such arbitration shall be final and binding upon the
parties.

22.2  This
Agreement shall be governed by and construed and interpreted in accordance with
the laws of the State of New York, with disregard to its conflicts of law
rules.

 




















 

23.  Relationship
of Parties. The
relationship of parties under this Agreement is that of independent contractors.
No party shall be deemed to be the partner or agent of the other, and no party
is authorized to take any action binding upon the other.

 

IN
WITNESS WHEREOF, Vendor and IMCOR have caused this Agreement to be executed by
their duly authorized officers as of the day and year first written
above.

 


	IMCOR, A DIVISION OF
      PHOTOGEN
TECHNOLOGIES, INC. 	 	 	GENZYME
      CORPORATION
 
	 	 	 	 
	JACK DEFRANCO 	 	 	DANIEL O’NEIL HAYDEN 
	 	 	 	 
	By: /s/ Jack
      DeFranco	 	 	By: /s/ Daniel O’Neil
      Hayden
	
      

    	 	 	
      

    
	Title: Senior Vice
      President	 	 	Title: Senior Vice
      President & General Manager



 

 























 

[****]
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.

 

 

Exhibit
"A"
to Supply
Agreement
between
IMCOR, a Division of Photogen Technologies, Inc.
and
Genzyme
Corporation


 


	
      1.
	
      Vendor
      Material:
	
      1,2-Dimyristoyl-sn-glycero-3-phosphocholine,
      Genzyme product code # LP-04-058, DMPC

	 	 	 
	
      2.
	
      IMCOR
      Product:
	
      IMAGENT
      ® perflexane lipid microspheres

	 	 	 
	
      3.
	
      Contract
      Term:
	
      [****]
      years

	 	 	 
	
      4.
	
      Pricing:
	
      A.  
      See Exhibit "C"

	 	 	 
	 	 	
      B.  
      If government regulations or similar mandatory requirements cause
      the
      cost to Vendor or raw materials to vary substantially, the
      parties
      shall meet to agree to a corresponding variation in the price of the
      Material. 

	 	 	 
	
      5.
	
      Primary
      Contact:
	
      A.  
      IMCOR

      A
      Division of Photogen Technologies, Inc.Address: 6175

      Lusk
      Boulevard, San Diego, CA 92121

      Phone:
      (858) 410-5601

      Fax:
      (858) 410-5602

	 	 	 
	 	 	
      B.
      Vendor Genzyme Corporation

      Name:
      William DeVroom

      Address:
      One Kendall Square, Cambridge, MA 02139 

      Phone:
      (800) 868-8208

      Fax:
      (617) 252-7772 








 



























Exhibit
"B"
to Supply
Agreement

between
IMCOR, a Division of Photogen Technologies, Inc.
and

Genzyme
Corporation

 

SPECIFICATIONS
AND QUALITY CONTROL STANDARDS

See
attachment "Component Purchase Specifications"

 

 




















 


[****]
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.
 

Exhibit
"C"
to Supply
Agreement

between IMCOR, a Division of Photogen Technologies,
Inc.
and
Genzyme
Corporation


(SUBJECT
TO MODIFICATION]
PRICING

 

Increments
purchased shall be aggregated with all purchases in the same year, with the
total amount purchased reset to 0 on each January 1 during the term, and priced
according to the schedule
below. For example, if [****] kg was
purchased in a calendar year, the first [****] kg would
be priced
at [****] and the
additional [****] kg would
be priced at [****] per
kg.

 


	
      Product
	
      Amount
      Purchased (kg)
	
      Price
      per kg ($)

	
      1,2-Dimyristoyl-sn-

      glycero-3-phosphocholine,

      Genzyme
      product code #

      LP-04-058,
      DMPC
	
      [****]

       
	
      [****]

       

	
      1,2-Dimyristoyl-sn-

      glycero-3-phosphocholine,

      Genzyme
      product code #

      12-04-058,
      DMPC
	
      greater
      than [****] kg
      and less

      than
      or equal to [****]
      kg

       
	
      [****]

       

	
      1,2-Dimyristoyl-sn-

      glycero-3-phosphocholine,

      Genzyme
      product code #

      LP-04-058,
      DMPC
	
      greater
      than [****] kg
      and less

      than
      or equal to [****] kg

       
	
      [****]

       

	
      1,2-Dimyristoyl-sn-

      glycero-3-phosphocholine,

      Genzyme
      product code #

      LP-04-058,
      DMPC
	
      Greater
      than [****]
      kg

       
	
       

      [****]