PFC/NYCOMED

EXECUTION COPY  










DEVELOPMENT, ASSIGNMENT 



AND 



SUPPLY AGREEMENT 



BETWEEN 



PFC THERAPEUTICS, LLC 



AND 



NYCOMED DANMARK APS 























	1.	DEFINITIONS	3 
	
2.	GRANT OF RIGHTS	9 
	
3.	ASSIGNEE'S MAIN OBLIGATIONS	10 
	
4.	ASSIGNOR'S MAIN OBLIGATIONS	11 
	
5.	DEVELOPMENT	12 
	
6.	MARKETING AUTHORIZATIONS	14 
	
7.	COMPENSATION	15 
	
8.	REPORTS; PAYMENT METHOD; CURRENCY	16 
	
9.	MANUFACTURE AND SUPPLY	19 
	
10.	INTELLECTUAL PROPERTY	22 
	
11.	REPRESENTATIONS AND WARRANTIES	24 
	
12.	INDEMNIFICATION	27 
	
13.	TERM AND TERMINATION	28 
	
14.	CONSEQUENCES OF TERMINATION	29 
	
15.	CONFIDENTIALITY, PUBLICATIONS, PUBLICITY	31 
	
16.	PERFORMANCE BY AFFILIATES	33 
	
17.	DISPUTE RESOLUTION	33 
	
18.	MISCELLANEOUS	34 









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        THIS
DEVELOPMENT, ASSIGNMENT AND SUPPLY AGREEMENT (the “Agreement”) is made and
entered into as of April 1, 2004 (the “Effective Date”), by and between
PFC, THERAPEUTICS, LLC, a Delaware limited liability company
(“Assignor”), with a business address of 6175 Lusk Boulevard, San Diego,
California 92121, and NYCOMED DANMARK ApS, a Danish corporation
(“Assignee”), located at Langebjerg 1, DK-4000 Roskilde, Denmark.
Assignor and Assignee are referred to in this Agreement individually as a
“Party” and collectively as “Parties.” 



RECITALS 



        A.     Whereas
Assignor is a pharmaceutical development company currently specializing           in the
development of blood substitution products and owns certain rights to the
          Product (as defined below);  



        B.     Whereas
Assignee is a pharmaceutical company possessing expertise in the           development
and commercialization of pharmaceutical products;  



        C.     Whereas
Assignor and Assignee intend to complete the clinical development of the
          Product with the purpose of achieving registration and commercialization of the
          Product within the Territory (as defined below);  



        D.     Whereas
Assignee  for that same purpose intends to assume control and maintain Assigned Technology (as           defined
below) in the Territory and Assignor intends to assign such Assigned           Technology
to Assignee.  



        In
consideration of the mutual covenants contained in this Agreement and other good and
valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the
Parties agree as follows: 



1.    DEFINITIONS 



        The
capitalized terms used in this Agreement will have the meanings given to them in this
Section 1 and throughout this Agreement. 



        1.1.    “Affiliate” means
a corporation or other business entity which,           directly or indirectly, through
one or more intermediaries, controls, is           controlled by or is under common
control with a Party. For purposes of this           definition only, “control” and,
with corresponding meanings, the terms           “controlled by” and “under
common control with” means (a)           the possession, directly or indirectly, of
the power to direct the management or           policies of a legal entity, whether
through the ownership of voting securities           or by contract relating to voting
rights or corporate governance, or (b) the           ownership, directly or indirectly,
of more than 50% of the voting securities or           other ownership interest of a
legal entity; provided, however, that if local law           restricts foreign ownership,
control will be established by direct or indirect           ownership of the maximum
ownership percentage that may, under such local law, be           owned by foreign
interests.  



        1.2.    “Assignment
Agreement” means the agreement attached as Exhibit           1.2.  







3 














        1.3.    “Assigned
Technology” means the Assigned Patents, Assigned           Know-How and any
Improvements (exclusive of Assignee’s part of any Joint           Inventions in any
such Improvements).  



        1.4.    “Assignee
Trademarks” means any trademarks or trade names used           or registered by
Assignee as of the Effective Date or during the Term.  



        1.5.    “Assigned
Know-How” means (a) any non-public or           confidential sections of
the Assignor’s MAA, and (b) all right, title           and interest in the
Territory to any other non-public or confidential Know-How           owned or under the
control of Assignor during the Term that is useful or           necessary for the
performance of pre-clinical or clinical development of the           Product in the
Territory, for the filing and maintenance of Marketing           Authorizations in the
Territory, or the commercialization, marketing or           manufacture of the Product in
the Territory.  



        1.6.    “Assigned
Patents” means the Patents listed in Exhibit 1.6,any           other Patents
owned or under the control of Assignor during the Term that would           be infringed,
in the absence of an assignment, by the manufacture, use, sale,           offer for sale
or importation of a Product and Patents on Improvements, in the           Territory.  



        1.7.    “Assignor
Trademarks” means any trademarks or trade names used           or registered by
Assignor as of the Effective Date or during the Term .  



        1.8.    “Business
Day”means a day other than a Saturday, Sunday, Bank           Holiday or other
public holiday in Denmark or the State of New York.  



        1.9.    “Call
Option Letter”means a letter as attached as Exhibit 1.9.  



        1.10.   “Clinical
Trials” means planned experiments which involve           subjects or patients
and are designed to elucidate the most appropriate           treatment of future patients
with a given medical condition. A clinical trial           uses results based on a
limited sample of patients to make inferences about how           treatment should be
conducted in the general population of patients who require           treatment in the
future.  



        1.11.  “CMC
Data” means those data required by Part 2 of the Annex to           Directive
2001/83/EC (including, without limitation, any updates and/or           amendments
thereto) including the qualitative and quantitative particulars of           the
constituents, the description of the manufacturing method and the controls           and
tests carried out at all relevant stages of the manufacturing process.  



        1.12.  “Competing
Product” means any fluorochemical emulsion with           approved indications
comparable to a Product that, during the term of this           Agreement, in spite of
Assignee’s reasonable efforts to legally prevent the           sale of such product,
is sold in a country of the Territory and has a 10% market           share as determined
by IMS audit data or any equivalent source of data in such           country during the
most recently completed calendar quarter.  



        1.13.  “Confidential
Information” means and includes all Know-How,           patent applications
formulas, designs, drawings, specifications, catalogs, data           sheets, sales and
technical bulletins, service manuals, mechanical diagrams, and           all other
information, whether or not reduced to writing, relating to the           formula,
design, manufacture, use, and service of the Product, as well as to any           other
information relating to the Assignor’s business or the           Assignee’s
Business, as the case may be, that may be divulged to the           Assignor or the
Assignee, as the case may be, in the course of its performance           of this
Agreement.  




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        1.14.  “Development
Costs” means all costs incurred by Assignee in the           development of the
Product by Assignee itself, or through Third Parties acting           on behalf of
Assignee, and any costs or fees for preparation, filing,           prosecution,
maintenance, defence or enforcement of Patents or Product           Trademarks in the
Territory.  



        1.15.  “Development
Plan” means a plan or plans prepared by Assignee           describing all
activities in the development program for Product, including the           protocols and
timelines of the Clinical Trials relevant for the preparation of           the Dossier.  



        1.16.  “DMF” means
a drug master file to be maintained with the           applicable regulatory authorities
in each country of the Territory.  



        1.17.  “Dossier” means
the master regulatory dossier relating to           Product for obtaining Marketing
Authorization for such Product in the Territory           with the relevant authorities,
including relevant Product and Scientific Data,           pre-clinical data, CMC Data.  



        1.18.  “EU” means
the countries listed in Exhibit 1.18 under           “EU”.  



        1.19.   “First
Commercial Sale” means, the first sale to a Third Party           of a Product
in a country in the Territory after all necessary regulatory           approval and
Marketing Authorization has been achieved for distribution and sale           of such
Product.  



        1.20.  “Improvement” means
any invention, discovery or Know-How,           whether or not patentable, relating to
Products that is developed solely or           jointly by Assignor, Assignee, their
Affiliates or their Third Party contractors           after the Effective Date in the
course of performing the Development Plan or           commercializing a Product in the
Territory or through independent development           activities by Assignor.  



        1.21.  “Inspection
on Receipt” means the procedures relating to the           inspection of Product
on receipt to ensure compliance with Specifications to be           carried out by or on
behalf of Assignee upon delivery, in accordance with the           Quality Agreement.  



        1.22.  “Intellectual
Property” means all Patents, trademarks and trade           names, service
marks, registered designs, applications for any of the foregoing           and the right
to apply for any of the foregoing in any part of the world,           copyright, design
right, inventions, confidential information (including           Know-How) and any other
similar right situated in any country in the world.  



        1.23.  “Interim
Analysis Date” means the date of delivery of a final           report stating
the results of the interim analysis as defined in the Development           Plan. The
Interim Analysis Date shall in no event be later than September 30,           2005.  




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        1.24.  “Joint
Inventions” means any invention or discovery made or           conceived jointly
by an employee(s), consultant(s) or agent(s) of Assignor and           employee(s),
consultant(s) or agent(s) of Assignee, as determined in accordance           with United
States patent laws or equivalent legislation in the Territory. Joint           Inventions
expressly exclude jointly invented Improvements.  



        1.25.  “Know-How” means
information, results and data of any type           whatsoever, in any tangible or
intangible form whatsoever, including databases,           practices, methods,
techniques, specifications, formulations, formulae,           knowledge, know-how, skill,
experience, test data including pharmacological,           medicinal chemistry,
biological, chemical, biochemical, toxicological and           clinical test data,
analytical and quality control data, stability data, studies           and procedures,
and manufacturing process and development information, results           and data.  



        1.26.  “MAA” means
a Marketing Authorization Application submitted to           the appropriate regulatory
body in the Territory for the purposes of obtaining           approval for the marketing
of a Product in such country.  



        1.27.  “Marketing
Authorization” means any approvals (including Price           & Reimbursement
Approvals) and any master files, DMFs, establishment           licenses, registrations or
authorizations of any national, supranational or           local regulatory agency,
department, bureau or other governmental entity,           necessary for the manufacture,
use, storage, importation, export, transport,           distribution or sale of a Product
(including the approval of an MAA) in the           Territory.  



        1.28.  “Net
Sales” Net Sales means the total amount actually received           by Assignor
or its Affiliate in connection with sales of Products to any person           or entity
that is not an Affiliate of Assignor, after deduction of all the           following to
the extent applicable to such sales:  



		        1.28.1   all
trade, case and quantity credits, discounts, refunds or rebates, including without
limitation rebates accrued, incurred or paid to assistance program and any other price
reductions required by a governmental agency;  







		        1.28.2   allowances
or credits for returns, including without limitation amounts received for sales which
become the subject of a subsequent temporary or partial recall by a regulatory agency for
safety or efficacy reasons outside the control of Nycomed, and retroactive price
reductions (including managed care and similar types of rebates);  







		        1.28.3   cost
of freight, postage, and freight insurance;  







		        1.28.4   sales
taxes, value added taxes, excise taxes, and customs duties; and  







		        1.28.5   cost
of export licenses and any taxes (excluding income taxes or similar taxes), fees or other
charges associated with the exportation or importation of Products.  







		        1.28.6   A
sale or transfer by Assignee to an Affiliate or licensee of Assignee for resale by such
Affiliate shall not be considered a sale for the purpose of this provision but the resale
by such Affiliate shall be a sale for such purposes. Transfers for preclinical trials and
Clinical Trials, testing or market research or promotional purposes shall not be a sale
for the purpose of calculating Net Sales.  







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		        1.28.7   If
a Product is sold in conjunction with a product or service (e.g. as a bundled or
combination therapy) that is not a Product, the Net Sales of such combination product for
purposes of determining royalties payable on sales thereof shall be calculated by first
determining the Net Sales of such combination product as above, and then multiplying such
number by the applicable fraction from the following three options:  







		        1.28.8   If
the Product(s) and other component(s) in such combination product all are sold
separately, then such fraction shall be A/(A+B),  







		           i)       where,
for the combination product:  







		           ii)      “A” is
the listed sale price(s) of the Product(s) in such combination           product when
sold separately; and  







		           iii)     “B” is
the listed sale price(s) of the product component(s) in such           combination
product when sold separately.  







		    1.28.9          If
the product component(s) in the combination product is not sold separately, then such
fraction shall be A/C, where “A” is as above, and C is the average listed sale
price of the combination product.  







		    1.28.10   If
neither the Product(s) nor the product component(s) in the combination product are sold
separately, then such fraction shall be a fraction reasonably reflecting the relative
value contributed by the Product(s) to the total value of the combination product, with
such fraction to be established by mutual agreement of the Parties based on good faith,
reasonable negotiation. If the Parties cannot reach such agreement within sixty (60) days
of Nycomed’s submitting the matter for agreement, the Parties shall resolve such
issue by having the fraction determined by binding arbitration under Section 17.  







        1.29.  “Patent” means
patents, letters patent, applications           (provisional and non-provisional) for
patents, and any patents issuing therefrom           and from any patent application
claiming, or entitled to claim; priority from           any such application for patent;
any divisions, continuations, continued           prosecution applications,
continuations-in-part, SPCs, utility models and any           equivalents, substitutions,
confirmations, registrations, revalidations,           additions, reexamination
certificates of any of the foregoing and any patents           issuing on any of the
foregoing; and any reissue patents, patent extensions and           patent term
restorations of any of the foregoing.  



        1.30.  “Price
& Reimbursement Approvals” means approval or listing           on official
price lists, reimbursement schedules or hospital recommendation           lists as
appropriate for the individual markets in the Territory.  



        1.31.  “Product” means
all injectable fluorochemical emulsions capable           of transporting oxygen in
therapeutic effective amounts in the bloodstream for           all medical uses,
including without limitation, a product existing as of the           Effective Date
having a composition agreed upon by the Parties and set out in           the
Specifications (“Existing Product”), that (a) the making, using,
          offering for sale, or selling of which without a license or assignment would
          infringe a Valid Claim of a patent within the Assigned Patents, (b) is
developed           using the Assigned Technology, and/or (c) is a modification or change
in the           formula of the Existing Product.  




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        1.32.  “Product
and Scientific Data” means the data listed in Exhibit           1.32 and any
other data related to the Product and all other documentation or           correspondence
obtained in the use of or in connection with the Product in           development of the
Product, in pre-clinical trials or in Clinical Trials, (such           as
pharmacokinetics, metabolism, pharma-codynamics, dose response, safety,
          efficacy and other pharmacological data) as well as data related to the
          manufacture of the Product.  



        1.33.  “Product
Trademarks” means any trademarks, trade dress, logos,           slogans, and
designs, whether or not registered in the Territory, used to           identify or
promote a Product in the Territory, but excluding any Assignee           Trademarks or
Assignor Trademarks.  



        1.34.  “Quality
Agreement” means the technical manufacturing agreement           in the form of
Exhibit 1.34 as required in connection with the Marketing           Authorization;  



        1.35.  “SPC” means
in relation to any Product a Supplementary           Protection Certificate for medicinal
products and their equivalents provided           under Council Regulation (EEC) No.
1768/92 of 18th June 1992, as may be amended,           or analogous extensions of Patent
protection in any jurisdiction.  



        1.36.  “Specifications” means
the specification for Product as           specified from time to time in the Assignee
Marketing Authorization(s), and           attached as schedule to the Quality Agreement.  



        1.37.  “Transfer
Price” means the price payable from Assignee to           Assignor for Product
upon delivery.  



        1.38.  “Term” has
the meaning set forth in Section 13.1 of this           Agreement.  



        1.39.  “Territory” means
the countries listed in Exhibit 1.18.  



        1.40.  “Third
Party” means any individual or entity other than           Assignor, Assignee
and their respective Affiliates.  



        1.41.  “Unit” means,
with respect to each Product, one unlabeled vial           of Product.  



        1.42.  “Valid
Claim” means any claim of an issued patent which has not           (a) been held
permanently unenforceable, unpatentable or invalid by a decision           of a court or
governmental agency of competent jurisdiction, which decision is           not appealable
or is not appealed within the time allowed for an appeal, (b)           been admitted to
be invalid or unenforceable generally through reissue,           disclaimer or otherwise,
(c) expired or been cancelled and/or (d) been           intentionally abandoned.  





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2.    GRANT OF RIGHTS 



        2.1.     Grants
to Assignee.  



		        2.1.1    Assignment
to Assignee. As of the Effective Date, the Parties have signed and executed the
Assignment Agreement transferring all right, title and interest to the Assigned
Technology in the Territory to Assignee.  







		        2.1.2    Call
Option. Assignee shall have the option, until sixty (60) Business Days after the
Interim Analysis Date, to include the Republic of China in the Territory by having the
Call Option Letter signed and executed by Assignor.  







		        2.1.3    Rights
of Assignee. Assignor acknowledges that during the Term, Assignee shall have the
exclusive right under the Assigned Technology and the Product Trademarks to market, sell,
offer to sell, use, import and export, distribute and license Products in the Territory,
and submit for approval for or amendment of Marketing Authorization for the Product in
the Territory.  







		        2.1.4    Assignee’s
Manufacturing Right. Beginning at the earlier of i) three (3) years from the date of
the First Commercial Sale in the Territory or ii) Assignor’s breach of its
obligations of supply of Product under Sections 5 and 9 in a period exceeding 2 months,
Assignee shall have the exclusive right to manufacture, or have manufactured, Product for
use in the Territory; provided, however, that in the event Assignee exercises its right
under this Section 2.1.4, Assignee shall use commercially reasonable efforts to
manufacture, or have manufactured, the Product for use in the Territory.  







		        2.1.5    Dossier. The
Dossier(s) shall be the sole property of Assignee, and Assignor hereby assigns by way of
future assignment any rights in or to any amendments or modifications to, or translations
of, the Dossiers which it may affect or which may be affected on its behalf, in
connection with its use of the Dossiers under the terms of this Agreement; provided,
however, that Assignor shall have reasonable access to and use of the Dossiers for
Assignor’s use in seeking Marketing Authorizations outside the Territory.  







		        2.1.6    Reference
to Assignor Marketing Authorizations. Subject to the terms and conditions set forth
in this Agreement, Assignor hereby grants to Assignee a fully paid, non-exclusive right
and license to reference any Marketing Authorizations under the control of Assignor for
Products outside the Territory for the purpose of obtaining Marketing Authorization of
Products in one or more countries in the Territory.  







		        2.1.7    Ownership.Subject
to the rights of reference and use granted to Assignor in Section 2.2 below, Assignee
shall own all rights in Dossiers, Marketing Authorizations in the Territory, Product and
Scientific Data, and the information and data contained therein.  







        2.2.     Grants
to Assignor.  



		        2.2.1     Except
as to Assignee as set out in subsection 2.3, Assignee hereby grants to Assignor the
exclusive right (a) to use, outside the Territory, any clinical and non-clinical data
generated by or on behalf of Assignee in the course of developing Products, and (b) to
reference any Marketing Authorizations obtained for Products in the Territory, for the
purpose of developing and pursuing Marketing Authorizations for Products outside the
Territory.  








9 









		        2.2.2     All
Product and Scientific Data shall belong to Assignee and except as to Assignee as set out
in subsection 2.3 Assignee issues an exclusive, irrevocable, free license to Assignor to
use the Product and Scientific Data outside the Territory. Assignee shall throughout the
Term provide copies of all Product and Scientific Data to Assignor, or as it may direct,
as soon as practicable after such Product and Scientific Data is generated or comes into
the possession and control of Assignee.  







        2.3.    No
limitation of use. Notwithstanding any other provision of this           Agreement,
in addition to its other rights under this Agreement, Assignee shall           have the
right to exploit and use, outside the Territory, any data generated           under this
Agreement for products, other than Product, developed by or on behalf           of the
Assignee. In addition, (a) the grant of rights under subsections 2.2.1           and
2.2.2 shall not limit Assignee’s exclusive right to the use of such           data
in the Territory, (b) Assignee’s global right to use such data for           other
products than the Product and (c) The assignment to Assignee under this
          agreement shall not limit Assignor’s right and ownership to the Assignor
          Technology outside the Territory.  



        2.4.     Joint
Inventions.  



		        2.4.1     Each
Party shall have the exclusive right under the Joint Invention(s) for research,
development and commercialization of Products in its respective Territory.  







		        2.4.2     In
relation to use of Joint Inventions with other products, the Parties shall negotiate in
good faith the scope of each other’s uses of any such Joint Inventions, and the
distribution of proceeds from sales, licensing, assignment or other transfer of rights
under Joint Inventions to each other and/or Third Parties. Neither of the Parties shall
grant any rights under Joint Inventions to Third Parties before agreement concerning
distribution of proceeds has been reached.  







3.    ASSIGNEE’S MAIN
OBLIGATIONS 



        3.1.    Under
the terms of this Agreement, Assignee shall:  



		        3.1.1     be
responsible for the development of the Product in the Territory, including the
preparation and execution of the Development Plan and communication with the authorities
and investigators in the Territory as set out in Section 5;  







		        3.1.2     prepare
and submit the Dossier with the relevant regulatory authorities for obtainment of
Marketing Authorization as set out in Section 6;  







		        3.1.3     register,
maintain, defend and enforce the Assigned Technology in the Territory as set out in
Section 10;  







10 










		        3.1.4     import,
label, package, import analyze and release the Products ready for sale to end users in
the Territory as set out in the Quality Agreement;  







		        3.1.5     launch
and commercialize the Product throughout the Territory;  







		        3.1.6     obtain
any and all import licenses and governmental approvals that may be necessary in the
Territory to permit the sale and purchase of the Product;  







		        3.1.7     comply
with any and all governmental laws, regulations, and orders that may be applicable to
Assignee by reason of its execution of this Agreement;  







		        3.1.8     cover
all costs related to the development and manufacturing scale-up of the Existing Product
performed by a Third Party contract manufacturer up to an amount of US $ *, as
set out in Section 5; and  







		        3.1.9     assist
Assignor on negotiating a manufacturing agreement for the commercial supply of Product
from a Third Party manufacturer and for supply of raw material as set out in Section 5.  







        3.2.    Except
as otherwise indicated herein, Assignee shall bear all costs related to           the
activities listed in subsection 3.1.  



     4.    
          ASSIGNOR’S MAIN OBLIGATIONS 



        4.1.    Under
the terms of this Agreement, Assignor shall:  



		        4.1.1     simultaneously
with the execution of this Agreement, assign the Assigned Technology in the Territory to
Assignee as set out in the Assignment Agreement.  







		        4.1.2     deliver
all information related to the Product and the development hereof available to Assignor
as set out in Sections 5, 6 and 10;  







		        4.1.3     transfer
the Assigned Technology including assistance by Key Personnel of transfer of Assigned
Know How as set out Sections 2, 5 and 10;  







		        4.1.4     maintain
the Patents claiming any parts of the Product outside the Territory as set out in Section
10.4.3;  







		        4.1.5     pay
costs exceeding US $ * for development and manufacturing scale-up of Product as set out
in Section 5.  







		        4.1.6     manufacture
and supply or have manufactured and supplied Product to Assignee for clinical development
as set out in Section 5; and  











        *
Certain information on this page has been omitted and filed separately with the
Commission.  Confidential treatment has been requested with respect to the omitted
portions. 




11 









		        4.1.7     manufacture
and supply or have manufactured and supplied Product for commercialization as set out in
Section 9.  







        4.2.    Except
as otherwise indicated herein, Assignor shall bear all costs related to           the
activities listed in subsection 4.1.  



     5.    
          DEVELOPMENT 



        5.1.    Joint
Development Committee. 



		        5.1.1     The
Parties shall establish a joint development committee (“Development Committee”)
consisting of two (2) representatives of each of the Parties. The initial members of the
Development Committee shall be the persons listed under “Development Committee
Members” in Exhibit 5.1.  







		        5.1.2     The
Development Committee will perform the following functions (a) monitor the progress of,
and provide input to, Assignee’s efforts in seeking approval of the Product in the
Territory and any further development of the Product, and Assignor’s corresponding
efforts outside the Territory; (b) oversee and monitor the development and scale-up of
the manufacturing process for Product pursuant to any Development Program; (c) confirm
agreed upon specifications for the Existing Product, (d) notify the Parties of
Improvements, and (e) address and attempt to resolve conflicts or disputes between the
Parties that may arise during the course of performing this Agreement.  







		        5.1.3     The
respective Development Committee members of each of the Parties shall appoint the persons
necessary for the performance of the activities listed in this Section 5. The key persons
listed in Exhibit 5.1 (“the Key Persons or Key Personnel”) shall be among the
appointed persons. The appointed persons shall be made available to the extent reasonably
necessary for the performance of the tasks to which they are appointed and shall perform
those activities at the cost of the Party by whom they were appointed or as specified in
Exhibit 5.1.  







		        5.1.4     Assignor
shall, if reasonably necessary, allow Assignee to contract with any Assignor Key
Personnel on a consultancy basis.  







		        5.1.5     Each
Party will select one of the representatives to the Development Committee as such Party’s
primary contact person for communication between the Parties relating to any development,
technical and patent aspects of this Agreement. An alternate member designated by a Party
may serve on the Development Committee temporarily in the absence of a permanent member,
and may replace such permanent member on a permanent basis, if necessary. Each Party will
bear its own costs of participation in the Development Committee.  







		        5.1.6     The
Development Committee will have only such powers as are specifically delegated to it in
this Agreement, and will have no power to amend this Agreement or waive a Party’s
rights or obligations under this Agreement. Delegation of powers to the Development
Committee will not relieve either Party from its obligations under this Agreement.  








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		        5.1.7     The
Development Committee will hold meetings at such times and places as will be determined
by the contact persons appointed under subsection 5.1.3 above, but in no event will such
meetings be held in person or by teleconference or video conference less frequently than:
(a) once every three (3) months during the period commencing on the Effective Date and
ending upon the first anniversary of receipt of Marketing Authorization in EU, and (b)
after such period, once every year. The first meeting of the Development Committee will
take place within sixty (60) days after the Effective Date. The contact persons will
establish an agenda for each such meeting and will designate representatives of the
Parties who will have management responsibility for the issues on the agenda for such
meeting  







		        5.1.8     Assignee
shall have the ultimate authority in relation to activities in the Development Plan
performed on behalf of Assignee. Assignor shall have the ultimate authority in relation
to activities in the Development Plan performed on behalf of Assignor.  







        5.2.     Initiation
of Clinical Trials.  



		        5.2.1     Assignee
shall as soon as reasonably practicable following the Effective Date, but in any event no
later than thirty (30) days from the Effective Date, present to the Development Committee
a draft Development Plan containing headlines for planned activities. A Development Plan
shall include a time schedule for interaction with the relevant authorities, a Clinical
Trial program together with a timetable for all required actions for the completion of
the Dossier in respect of the initial indication of Product. The Development Plan shall
be amended taking into consideration the advice taken from such authorities. The
Development Committee shall discuss and amend the Development Plan within fifteen (15)
days.  







		        5.2.2     Assignor
shall notify the Development Committee of development activities outside the Territory.  







		        5.2.3     Assignee
shall have the ultimate authority in relation to activities related to the Clinical
Trials performed on behalf of Assignee. Assignor shall have the ultimate authority in
relation to activities related to Clinical Trials performed on behalf of Assignor.  







		        5.2.4     Assignor
shall as soon as reasonably possible, but in no event more than five (5) days after
Effective Date, collect and deliver to Assignee all Product and Scientific Data available
to Assignor for Assignee’s preparation of a draft Development Plan.  







		        5.2.5     Assignor
shall notify Assignee from time to time of all requirements applicable outside the
Territory in connection with the conduct of Clinical Trials in so far as Assignor may
request Assignee to comply with such requirements in the conduct of the Clinical Trials
and Assignee shall only be liable under this Agreement in the event it has been duly
informed of and has accepted such requirements by Assignor. Assignee shall reasonably
take into consideration that Assignor will use the data obtained outside the Territory.  







        5.3.    Supply
of Clinical Trial Material and Preparation of Commercial Supply. 




13 









		        5.3.1     Assignor
shall enter into a development and manufacture agreement with a Third Party manufacturer.
Assignor shall ensure that the contract manufacturer conducts scale-up of the Existing
Product to ensure Clinical Trial supply.  







		        5.3.2     Assignor
shall make available and transfer all Know-How relating to manufacture of Product, to the
manufacturer and Assignee in order to ensure the scale-up of the Existing Product or
other agreed upon Product necessary for the Clinical Trial supply of such Product and the
further development of such Product. Assignor shall at its cost ensure sufficient raw
material supply to manufacturer necessary for scale-up of such Product.  







		        5.3.3     Assignee
shall make available personnel to negotiate with Assignor the agreement mentioned in
subsection 5.3.1. with the Third Party contract manufacturer and shall approve of such
agreement before entered into.  







		        5.3.4     The
Parties shall mutually set out a project plan describing each step of transfer of
technology related to the manufacture and the cost thereof.  







		        5.3.5     In
relation to payment of that Third Party contract manufacturer for the preparation of the
manufacture of the Clinical Trial supply Assignee shall cover the initial US $ * of
the incurred cost. Assignor shall pay any incurred costs exceeding US $ *.  







		        5.3.6     Assignor
shall supply the total requirement of Product for performance of Clinical Trials in the
Territory to Assignee. The Product for Clinical Trials shall be supplied at a rate of the
actual cost for such Product when acquired from the Third Party contract manufacturer
plus handling fees (e.g. shipping, insurance), but in no event more than US $ * per Unit.
Any commercial supply of Product shall be delivered under the terms set out in Section 9.  







		        5.3.7     Assignor
warrants that all Products delivered for Clinical Trial supply upon delivery have been
manufactured in accordance with cGMPs, conforms with the Specifications, and has a
remaining shelf life of at least twelve (12) months.  







		        5.3.8     Assignor
is responsible for the supply of raw material to the Third Party contract manufacturer.
Upon Assignor’s request Assignee shall to the extent possible and reasonable make
available personnel for negotiation of an agreement with a supplier of raw material.  







6.    MARKETING
AUTHORIZATIONS 



        6.1.    Assignee
shall as soon as reasonably practicable after completion and evaluation           of the
results of the Clinical Trials compile and submit the Dossier in respect           of the
Product with the relevant authorities and shall use all reasonable           endeavors to
conduct the approval process in order to obtain a Marketing           Authorization for
Product in the EU.  







        *
Certain information on this page has been omitted and filed separately with the
Commission.  Confidential treatment has been requested with respect to the omitted
portions. 



14 










		        6.1.1     To
the extent either Party receives any written or oral communications relating to a Product
from any regulatory authority in the Territory, such Party will promptly inform the other
Party thereof (including by providing a copy of any written communication or a written
account of any oral communication), but in no event later than ten (10) Business Days
after receipt of such communication.  







		        6.1.2     Each
Party will promptly notify the other Party, and provide such other Party with a copy, of
any correspondence or other reports or complaints submitted to or received by the first
Party from any regulatory authority in the Territory or from any other Third Party
claiming that any product promotional materials (including advertising and other
promotional materials used in connection with the marketing, promotion and sale of the
Product) are inconsistent with a Product’s labeling or are otherwise in violation of
applicable law or regulation.  







		        6.1.3     Each
Party will provide the other Party upon request with a copy of any documents or reports
filed with any regulatory authority during the Term with respect to a Product.  







        6.2.    Countries
outside EU. In respect of all parts of the Territory outside           the EU,
Assignee’s obligations are as follows: If Assignee reasonably           considers
that the commercial value of Product in such part of the Territory           does not
justify the approval costs and/or the marketing costs, Assignee may           elect not
to develop further any such Product in respect of that part of the           Territory.  



        6.3.    Each
of Assignee and Assignor shall use all reasonable endeavors to procure and
          maintain the maximum period of data exclusivity according to European Council
          Directive 2001/83, as may be amended from time to time, or equivalent local
          legislation in each part of the Territory in respect of Dossiers filed by
          Assignee in connection with any application for or the maintenance of any
          Marketing Authorizations for any Products in the Territory.  



        6.4.    Price
& Reimbursement Approvals. To the extent applicable, Assignee           shall
apply for Price & Reimbursement Approvals with the relevant           authorities at
the appropriate time relative to grant of Marketing           Authorization.  



        6.5.    Ownership
and Maintenance of Marketing Authorizations. Assignee shall be           the
Marketing Authorization holder in respect of all Products in each part of           the
Territory and shall assume all responsibilities towards the regulatory
          authorities. Assignee shall maintain the Marketing Authorizations at its costs
          in the Territory for the Term. Assignor will, throughout the Term, at its own
          costs, provide reasonable technical and scientific support to enable Assignee
to           maintain Marketing Authorizations in the Territory.  



     7.    
          COMPENSATION 



        7.1.    Assignee
shall finance all Development Costs and the application for Marketing
          Authorization as set out in Sections 5 and 6. The Parties acknowledge that
those           Development Costs shall be in lieu of any fee or development milestone.  



15 










        7.2.    Sales
milestones. Assignee will make the following one-time only payments in the
          amounts set forth below within fifteen (15) Business Days of the occurrence of
          the following events (meaning presentation of Assignee’s report of Net
          Sales as set out in Section 8 presenting the below mentioned amounts):  



	MILESTONE EVENT
	MILESTONE PAYMENT

	(1) First time the annual Net Sales of the Product	US $ *
	exceeds US $ 100 million
	

	(2) First time the annual Net Sales of the Product	US $ *
	exceeds US $ 200 million
	







        7.3.    Sales
Price. Assignee shall at its sole discretion decide the price at           which the
Product is to be sold to Third Party customers.  



        7.4.    Cost
of Goods. During the period that Assignor supplies Product to           Assignee for
sale in the Territory, Assignee shall pay to Assignor a cost of           goods equal to
*% of Net Sales for Products delivered by or on behalf of           Assignor.  



        7.5.    Royalties. 



		        7.5.1    Royalty
Amount. Subject to Section 8.5 below, Assignee will pay to Assignor a royalty equal to
* % of Net Sales for annual Net Sales up to US $ * and *  % of Net Sales for any
part of the annual Net Sales exceeding US $ *.  







		        7.5.2    Royalty
Term. Royalties due under the preceding subsection 7.5.1 will to the extent permitted
by law be payable on a country-by-country and Product-by-Product basis until the later
of: (i) the expiration of the last-to-expire issued Patent within the Assigned Technology
containing a Valid Claim covering such Product in such country, or (ii) 15 years from the
First Commercial Sale of such Product in such country.  







		        7.5.3    Royalty
Adjustment. Notwithstanding the provisions of subsection 7.5.1, if a Product is
not covered in a particular country in the Territory by a Patent in the Assigned
Technology, then the royalty amounts described in subsection 7.5.1 of this Agreement will
remain unchanged with respect to such Product in such country; provided that the royalty
payable on such Product in such country will be reduced to zero (0) in the event of a
Competing Product.  







     8.    
          REPORTS; PAYMENT METHOD; CURRENCY. 



        8.1.    Transfer
Price. Upon delivery Assignee shall pay to Assignor the Transfer           Price
which shall be agreed between the Parties no later than three months prior           to
expected First Commercial Sale. The Transfer Price shall be stated in EURO           per
Unit.  







        *
Certain information on this page has been omitted and filed separately with the
Commission.  Confidential treatment has been requested with respect to the omitted
portions. 




16 









        8.2.    The
Transfer Price is payable 30 Business Days from delivery.  



        8.3.    Reconciliation
between Transfer Price and cost of goods. Within thirty           (30) Business Days
of the end of each calendar quarter, Assignee shall effect a           reconciliation
between the Transfer Price paid by Assignee and the cost of goods           actually due
according to Section 7.4 to Assignor calculated at the applicable           percentage of
Net Sales. Such reconciliation will be calculated in EURO at the           exchange rate
defined according to Section 8.4. below. The balance shall be           exchanged between
the Parties through invoice or credit note issued no later           than sixty (60)
Business Days from the end of that calendar quarter.  



        8.4.    Assignee
will provide Assignor within thirty (30) Business Days after the end of           each
calendar quarter with a report stating the volume of Products sold or           otherwise
disposed of in each country of the Territory and providing the           calculations for
the Net Sales and royalties due. Within sixty (60) Business           Days after the end
of each calendar quarter, Assignee will transfer, by wire,           the amount of
royalties and cost of goods due to such bank account as Assignor           may indicate
from time to time. All such amounts shall first be calculated in           the domestic
currency of the sale and then converted into, and paid in EURO. For           the purpose
of the above calculation, the Net Sales shall be converted into EURO           using the
average rate of exchange for such calendar quarter published by the           European
Central Bank (as listed on the internet address www.ecb.de) or the           statutory
exchange rate.  



        8.5.    Payment
to Baxter. 



		        8.5.1     Assignor
has certain obligations, among others, of payment of royalties to Baxter pursuant to that
certain Percentage Fee Agreement dated June 13, 2003. As required by such Percentage Fee
Agreement, Assignee has assumed certain payment obligations only as it relates to
specified Products in the Territory. Assignor acknowledges and agrees that Assignee shall
make such payments directly to Baxter. Any such monies paid to Baxter by Assignee shall
be deducted from the royalty payable from Assignee to Assignor under this agreement.  







		        8.5.2     The
Parties acknowledge that the Percentage Fee Agreement establishes a cap on payments due
to Baxter. To ensure that payments to Baxter do not exceed the cap, the parties shall
agree upon a mechanism to coordinate their separate payments to Baxter and each Party
shall provide the other with a copy of all reports submitted to Baxter indicating the
amount paid for the relevant reporting period as well as the total amount paid to date.  







        8.6.     Taxes.  



		        8.6.1     Any
and all amounts payable by Assignee to the Assignor hereunder are exclusive of and shall
be made free and clear of and without the withholding of or deduction for or on account
of any present of future taxes, duties, levies or other governmental charges, however
designated, other than tax imposed on the overall net income or net worth of the Assignor
(all such non-excluded items, whether or not collected by withholding or deduction, being
hereafter referred to as “Taxes”), except Taxes required by law or the
administration thereof to be withheld or deducted. If Assignee is required by law or a
governmental body charged with the administration thereof to withhold or deduct any Taxes
from or in respect of any amount payable by Assignee to the Assignor hereunder then (i)
the amount payable shall be increased to such amount which, after making all required
withholdings or deductions of Taxes therefrom, will equal the amount payable hereunder
had no such withholdings or deductions been required; (ii) Assignee shall make such
withholdings or deductions; (iii) Assignee shall pay the full amount withheld or deducted
to the relevant taxation or other authority in accordance with applicable laws; and (iv) Assignee
shall promptly deliver to the Assignor a receipt or similar documentation of the relevant
authority evidencing the payment of such Taxes.  








17 









		        8.6.2     Assignor
will credit to Assignee any withholding tax Assignor recovers through a foreign tax
credit that Assignor actually uses to reduce its US tax liabilities, up to the additional
amount as described above, that Assignee has paid to Assignor with respect to that
recovered tax. The Parties will mutually assist each other in claiming exemption from or
reducing such deductions or withholdings under any applicable income tax treaty by
providing or filing such documentation (including certificates of residence provided by
the Parties) as may be required to claim such exemption or reduction.  







        8.7.     Audit
Rights; Adjustments.  



		        8.7.1     Assignee
will permit an independent certified public accountant designated by Assignor and
reasonably acceptable to Assignee (the “Auditor”), to have access to
Assignee’s records and books during regular business hours for the sole purpose of
determining the accuracy of the amounts reported and actually paid or otherwise payable
to Assignor under the terms of this Agreement (the “Audit”). Any Audit
will cover a period not to exceed 3 years immediately preceding such audit. Assignor will
bear all costs and expenses in connection with the Audit; provided, however, that
if any Audit reveals an understatement of Net Sales greater than 5% of the stated amount,
then Assignee will bear all costs and expenses in connection with such Audit. Any such
Audit will be performed upon at least thirty (30) Business Days prior written notice
during regular business hours, and not more than once in each calendar year during the
term of this Agreement and during each calendar year in the 3-year period following
expiration or termination of this Agreement.  







		        8.7.2     The
Auditor will execute a written confidentiality agreement with Assignee and will disclose
to Assignor only the amount and accuracy of payments reported and actually paid or
otherwise payable under this Agreement. The Auditor will send a copy of the report to
Assignee at the same time it is sent to Assignor. The report sent to Assignee will also
include the methodology and calculations used to determine the results.  







		        8.7.3     If
the Audit results in a determination that Net Sales have been overstated, then Assignor
will repay the amount of any resulting overpayment within thirty (30) Business Days after
receipt of the Auditor’s report.  







        8.7.4     If
the Audit results in a determination that Net Sales have been understated, then any
resulting underpayment will be paid to Assignor within thirty (30) Business Days after
receipt of the Auditor’s report including an annual interest rate of 4% of the
outstanding amount calculated from the period when the amount was originally due until
the actual payment of the amount.  



18 










9.    MANUFACTURE AND SUPPLY 



        9.1.     Tech
Transfer to Assignee.  



		        9.1.1     In
the event Assignee requests Assignor, and Assignee has such right according to Section
2.1.3, Assignor shall initiate the following activities:  







		        (a)    provide
reasonable assistance to Assignee to obtain Marketing Authorization or
          amendments to Marketing Authorizations that are reasonably necessary;  







		        (b)    provide
Assignee with reasonable access to any relevant Know-How and other           information
relating to the manufacture of Product owned or controlled by           Assignor at such
time; and  







		        (c)    use
reasonable efforts to facilitate the transfer of manufacturing technology           from
any of Assignor’s suppliers.  







        9.2.    Supply
of Product. 



		        9.2.1     Assignor
undertakes to manufacture and supply Product to Assignee and Assignee undertakes to
purchase Product from Assignor for the Territory, in accordance with the terms and
conditions of this Agreement.  







		        9.2.2     Assignor
shall deliver Products to Assignee in accordance with delivery dates specified in Binding
Orders as defined in Section 9.3. The Products shall be delivered as unlabelled vials
released for dispatch to Assignee.  







		        9.2.3     The
Product will be delivered EXW (as defined in INCOTERMS, 2000) Assignor’s
manufacturing or supply location. Title and risk of loss shall pass to Assignee upon
delivery of the Product, by or on behalf of the Assignor, to a shipping carrier for
transportation to Assignee. Under no circumstances shall the Assignor be deemed the
importer of record.  







		        9.2.4     Assignor
acknowledges that, when delivered, all Products supplied under this Agreement shall have
a remaining shelf life of at least twenty (20) months.  







		        9.2.5     The
Parties shall enter into the Quality Agreement substantially equal to the template
attached as Exhibit 1.34 concerning the commercial supply of Products. Upon Assignee’s
request the Parties shall enter into a Quality Agreement concerning Product supplied for
Clinical Trials. Assignor shall use reasonable efforts to procure for the signing of the
Quality Agreement between Assignee and Assignor’s suppliers if so reasonably
requested by Assignee.  







		        9.2.6    Audits: In
order to ensure that the requirements set out in this Agreement are complied with,
Assignee shall be entitled to carry out audits as specified in the Quality Agreement at
the Assignor or its designated supplier at any time with prior notification.  








19 









        9.3.     Forecasts,
Delivery and Orders.  



		        9.3.1    Assignee
shall submit to Assignor each calendar quarter a rolling forecast by each Product for the
following twelve (12) months showing its best estimate of quantities of the Products
needed for such 12-month-period and required delivery dates for such quantities in each
month (“Rolling Forecast”). Assignee undertakes to place orders to Assignor for
the quantities specified for the first three months of such Rolling Forecast (“Binding
Orders”). Assignor shall acknowledge and accept each Binding Order in writing (“Acceptance”)
to Assignee and undertakes to issue within ten (10) Business Days an Acceptance in
respect of each Binding Order placed by Assignee in accordance with the first three
months of such Rolling Forecast and to fulfill all such Binding Orders in accordance with
the required delivery dates specified therein.  







		        9.3.2     Assignor
shall notify Assignee within ten (10) Business Days after receiving from Assignee a
forecast if Assignor anticipates that it will not have the capacity required to produce
the amounts set out in such Rolling Forecast. In such situation the Parties shall discuss
in good faith to find possibilities to accommodate Assignee’s anticipated
requirements. For the avoidance of doubt the above provision by no means relieves
Assignor from its obligation according subsection 9.3.1.  







        9.4.     Quality
–Defective Product.  



		        9.4.1     As
soon as reasonably practicable upon the receipt of Product from Assignor, Assignee (or
its designated nominee) shall test such batch in accordance with the Inspection on
Receipt and otherwise in accordance with the Quality Agreement, provided always that the
performance of the Inspection on Receipt shall not relieve Assignor of any obligation or
liability arising by reason of any breach by it of its obligations or liability under
Sections 5, 6, 11 and 12.  







		        9.4.2     Assignee
shall notify Assignor in writing in the event that it becomes aware by reason of the
Inspection on Receipt or otherwise that all or any part of any batch of Product delivered
to it fails to comply with the warranty given under Section 11 (a) Within ninety (90)
Business Days from the date of receipt of such batch of Product by Assignee (or its
designee) where such failure to comply is apparent from the Inspection on Receipt; or (b)
Where such failure is not so apparent, within twenty five (25) Business Days after
Assignee becomes aware of such failure.  







		        9.4.3     In
the event of notification under Section 9.4.2 Assignee (or its designee) shall give full
details in such notification of such claim and shall give Assignor reasonable access to
such batch to investigate the matter before the remainder of the Product in the same
consignment is used or returned to Assignor.  







		        9.4.4     Assignor
shall promptly replace all such defective Product within thirty (30) Business Days of
receipt of notice under Section 9.4.2 and shall make arrangements for the return or
disposal, at Assignor option, of all such non-complying Product. Assignor shall pay all
shipping and related charges in connection with the shipment of replacement Product. If
Assignee at its discretion informs Assignor that Assignee does not want replacement of
the defective Products, Assignor shall promptly issue a credit note for any invoice
issued in respect of any returned batch.  








20 









		        9.4.5     In
the event of a conflict between the test results of Assignee and Assignor with respect to
any shipment of Product hereunder, a sample of such Product shall be submitted to an
independent laboratory for testing using the criteria set out in the Quality Agreement.
Such independent laboratory shall be as agreed between the parties or in the absence of
agreement (at the request of either party) each Party shall select an independent
laboratory, and such independent laboratories shall select a third independent laboratory
to conduct the testing. Such laboratory shall act as an expert, not as an arbitrator. The
test results obtained by such laboratory shall be reported to Assignee and Assignor and
shall in the absence of manifest error be final and binding on the parties. The fees and
expenses of such laboratory testing shall be borne entirely by the party against whom
such laboratory’s findings are made.  







        9.5.     Samples.  



        Assignor
will deliver up to 10 Units of Product per hospital to be used as free samples of Product
at the direct cost of manufacturing, and without payment of Royalties. Assignor warrants
that the samples of Product shall comply in all respects with the Specifications 



        9.6.    Adverse
Drug Events Reporting.  




















21 












		        9.6.1     The
Parties shall establish and maintain a system for exchanging safety information on the
preparations of the Product. This system shall enable both parties to meet the safety
regulatory requirements imposed by authorities both locally and internationally and to
follow current international guidelines and standards in pharmacovigilance.  







		        9.6.2     With
Assignee being the holder of the Marketing Authorization in the Territory, Assignee will
provide a full system for pharmacovigilance fulfilling the EU legislation on
Pharmacovigilance for Centrally Authorized Products (London 15 April 1997 CPMP/183/97)
including the Qualified Person for Pharmacovigilance as required by the EU legislation
(Directive 75/319/EC, chapter Va 20 May 1997 as amended). Assignee will also prepare
Periodic Safety Updates (ICH format) and maintain a Company Core Safety Information Sheet
(CCSI) for EU.  







		        9.6.3     During
the Development Program Assignee will hold the database for reporting of Suspected
Serious Unexpected Adverse Reactions and prepare Annual Safety Reports according to the
EU Council of Directive 2001/20/EC.  







		        9.6.4     Any
clinical and pre-clinical safety data (Investigator Brochures and clinical and
pre-clinical reports on the preparations of Product held by Assignor should be provided
to Assignee as reference documents to evaluate the safety data to be collected in the
pre-marketing development program.  







		        9.6.5     A
copy of all expedited Individual Case Safety Reports (ICSRs) and SUSARs, annual safety
reports and PSURs will be forwarded to the Assignor. A detailed pharmacovigilance
agreement between Assignee and Assignor substantially in accordance with the template set
out in Exhibit 9.6 should be established at least 3 month prior to Assignor or any
Partner of Assignor requires information on pre- or post marketing safety data for
regulatory reasons.  







     10.  
          INTELLECTUAL PROPERTY 



        10.1.  Assignor’s
Obligation to Inform. As of the Effective           Date, Assignor has disclosed
to Assignee the complete text of all           pending patent applications included
in the Assigned Patents as of the Effective           Date, as well as copies of all
correspondence concerning the prosecution thereof           made or received by or on
behalf of Assignor to or from patent offices and any           information or
correspondence received by or on behalf of Assignor from patent           offices
concerning the institution of any interference, opposition,           re-examination,
reissue, revocation, nullification or any official proceeding           involving any
Assigned Patents, in each case to the extent in existence as of           the Effective
Date.  In addition, during the Term, Assignor will disclose           to Assignee
the complete text of all patent applications included in the           Assigned Patents
that are filed after the Effective Date, as well as copies of           all
correspondence concerning the prosecution thereof made or received by or on
          behalf of Assignor to or from patent offices and any information or
          correspondence received by or on behalf of Assignor from patent offices
          concerning the institution of any interference, opposition, re-examination,
          reissue, revocation, nullification or any official proceeding involving any
          Assigned Patents after the Effective Date, and if possible transmit such
          information electronically to Assignee or, at the expense of Assignee, ship
such           materials to a place of destination to be named by Assignee. Assignor
shall           promptly inform Assignee of the issuance of any Assigned Patents.
Assignor shall           provide prompt written notice to Assignee of each Improvement
made by or on           behalf of Assignor.  




22 









        10.2.  Unpatented
knowledge. As soon as reasonably possible after Effective           Date, Assignor
shall make available the Key Personnel as requested by Assignee           to discuss and
document Assigned Know-How, including without limitation any           Improvements not
yet documented and disclosed to Assignee or patented. Such Key           Personnel shall
be instructed by Assignor to disclose to Assignee all relevant           information
relating to any such Improvements and further development of the           Product. Any
such information disclosed shall be covered by subsection 10.3           below. Assignee
shall pay reasonable travel and accommodation costs for the Key           Personnel made
available.  



        10.3.  Patent
Filing, Prosecution and Maintenance. Subject to the terms and           conditions
set forth in this Section 10.3, Assignee has the exclusive right to           file,
prosecute and maintain all Assigned Patents in the Territory.  



		        10.3.1  With
respect to Assigned Patents, as of and after the Effective Date, Assignee shall at its
discretion prosecute and, for issued Patents, maintain such Assigned Patents in the
Territory.  







		        10.3.2  Assignor
shall consent to and execute the necessary documents in order to have Assignee registered
as owner of the Assigned Patents in the Territory.  







		        10.3.3   With
respect to Improvements, Assignee may apply for patent protection in all countries of the
Territory for any Improvement that in Assignee’s reasonable opinion is patentable.
If Assignee elects not to file a patent application claiming or covering an Improvement
in a particular country, then Assignee will give prompt written notice to Assignor of
such decision, but in any event within sixty (60) Business Days before the time limit, if
any, set forth in the appropriate laws and regulations for the filing of such
application. In such case, Assignor may elect at its sole discretion to undertake the
preparation, filing, prosecution or maintenance of a patent application claiming or
covering such Improvement in such country at its sole expense. In that event Assignor
will own any such patent application and patents issuing therefrom and will be solely
responsible for all associated costs; provided, however, that, during the Term Assignor
shall not use its ownership of any such patent application and patents issuing therefrom
to limit or restrict Assignee’s sales of a Product in the Territory. This obligation
of non enforcement against Assignee shall extend to all third parties to whom any rights
are transferred. Assignee will execute such documents and perform such acts as may be
reasonably necessary for Assignor to commence such prosecution.  







        10.4.   Enforcement
Rights.  



		        10.4.1  Notification
of Infringement. If either Party learns of any misappropriation of any proprietary
Product information such as trade secrets, copyrights or Assignee Trademarks, Assignor
Trademarks or Product Trademarks (the “Product Rights”) or any infringement or
threatened infringement by a Third Party of the Assigned Technology, in each case, in the
Territory, such Party will promptly notify the other Party and will provide such other
Party with all available evidence of such misappropriation or infringement.  








23 









		        10.4.2     Enforcement
of Patents and Product Rights in the Territory: 







		           (a)    Assignee
will have the right, but not the obligation at its cost to institute,           prosecute
and control any action or proceeding with respect to infringement in           the
Territory of the Assigned Technology or any misappropriation of rights in           the
Territory, by counsel of its own choice, and will consult with Assignor on           any
actions that Assignee proposes to take in such action or proceeding.           Assignor
will have the right, at its own expense, to be represented in any such           action
by counsel of its own choice.  







		           (b)    If
Assignee fails to bring an action or proceeding or otherwise take appropriate
          action in Assignee’s discretion to abate such infringement or
          misappropriation in the Territory within a period of ninety (90) Business Days
          of written notice by Assignor to Assignee requesting such action, Assignor will
          have the right, but not the obligation, to bring and control, by counsel of its
          own choice, any such infringement or misappropriation action or proceeding.
          Assignee will cooperate with Assignor in any such action or proceeding brought
          by Assignor against a Third Party, and will have the right to consult with
          Assignor and to participate in and be represented by independent counsel in
such           litigation at its own expense.  







		           (c)    If
a Party brings any action or proceeding under this subsection 10.4.2, the           other
Party agrees, at the request of the first Party, to be joined as a party
          plaintiff if necessary to prosecute the action or proceeding and to give the
          first Party reasonable assistance and authority to file and prosecute the suit,
          including without limitation providing commercial, clinical or manufacturing
          data available to the Parties, executing necessary documents, and providing
          expert support.  







		        10.4.3  Maintenance
of Patents outside Territory. Assignor shall at its cost maintain Patents of the same
patent families as, or corresponding to, the Assigned Patents outside the Territory. If
Assignor no longer maintains such Patents, Assignor shall duly inform Assignee in order
to give Assignee reasonable notice to take over maintenance of those Patents. In that
event the Patents maintained by Assignee shall be assigned to Assignee on terms
substantially equal to the terms set out in the Assignment agreement.  







		        10.4.4  Settlement
with a Third Party. The Party that controls the prosecution of a given action under
subsection 10.4.2. will also have the right to control settlement of such action;
provided, however, that no settlement will be entered into which would limit the scope or
enforceability of any Assigned Patents without the written consent of Assignor, such
consent not to be unreasonably withheld.  







		        10.4.5  Enforcement
Costs and Awards. Any costs and attorneys’ fees incurred in connection with an
action or proceeding brought by a Party pursuant to subsections 10.4.2 (a) and 10.4.2(b)
of this Agreement shall be borne by the Party bringing the action. Any damage award
resulting from any such action, will be retained by the Party covering the costs
according to Section 10.4.  








24 









        10.5.  Defense
and Settlement of Third Party Claims. Subject to Section 10.6           below,if
a Third Party asserts that a Patent, trade secret, or other           intangible right
owned or exclusively licensed by it is infringed or           misappropriated by the
manufacture, use, sale, or offer for sale of a Product in           the Territory, the
Assignee shall duly consult with Assignor and shall at           Assignee’s
discretion defend such right. Assignor shall duly assist           Assignee at Assignee’s
costs.  



        10.6.  Withdrawal
due to alleged infringement. In the event Assignee receives           notice from a
Third Party alleging that the manufacture, use or sale of the           Product in the
Territory infringes such Third Party’s Intellectual Property           rights,
Assignee shall provide Assignor with prompt written notice thereof and           the
Parties shall consult with each other in good faith regarding such           allegation.
Assignee shall consider Assignor’s suggestions and comments           regarding such
alleged infringement; provided, however, that Assignee shall have           the right
— after such consultation with Assignor — at its own           discretion to
withdraw the Product from the market and keep it off the market           until the issue
is resolved through acknowledgment of non-infringement by the           Third Party or
through court ruling in the relevant part of the Territory. Such           withdrawal
shall not constitute a breach of any of Assignee’s obligations           set out in
this Agreement.  



     11.  
          REPRESENTATIONS AND WARRANTIES 



        11.1.  Mutual
Representations and Warranties. Each of the Parties hereby           represents and
warrants to the other Party that:  



		        11.1.1  such
Party is an entity duly organized, validly existing and in good standing under the laws
of the state or country in which it was formed;  







		        11.1.2  this
Agreement is a legal and valid obligation binding upon such Party and enforceable against
such Party in accordance with its terms;  







		        11.1.3  the
execution, delivery and performance of this Agreement by such Party does not conflict
with any agreement, instrument or understanding, oral or written, to which it is a Party
or by which it is bound;  







		        11.1.4  to
the best of such Party’s knowledge, the execution, delivery and performance of this
Agreement by such Party does not violate any law or regulation of any court, governmental
body or administrative or other agency having jurisdiction over such Party;  







		        11.1.5  such
Party has the full power and authority to enter into this Agreement and to carry out the
obligations contemplated hereby;  







		        11.1.6  such
Party has not, and during the Term will not, grant any right to any Third Party relating
to its respective Patents and Know-How which would conflict with the rights granted to
the other Party hereunder;  







		        11.1.7  such
Party has taken all necessary corporate action on its part to authorize the execution and
delivery of this Agreement.  







        11.2.  Assignor’s
Additional Representations and Warranties. Assignor           hereby represents and
warrants to Assignee that:  




25 









		        11.2.1     To
the best of Assignor’s knowledge (including the knowledge of Assignor’s
external patent advisor), as of the Effective Date, neither the Products nor the
manufacture, use or sale of the Products nor the practice in the Territory of the
Products do not infringe the Intellectual Property rights of any Third Party in the
Territory or constitute a misappropriation of the trade secrets in the Territory or other
Intellectual Property rights of any person or entity within the Territory.  







		        11.2.2     Assignor
has not, and during the term of the Agreement will not, grant any right to any Third
Party relating to the Products in the Territory which would conflict with the rights
granted to Assignee hereunder.  







		        11.2.3     To
the best of Assignor’s knowledge, no Third Party in the Territory is infringing any
of the Assigned Patents claiming any part of the Products or using any of the Assigned
Know-How.  







		        11.2.4     Assignor
has obtained the assignment of all interests and all rights of any and all Third Parties
(including, but not limited to employees) with respect to any Assigned Patents.  







		        11.2.5     As
of the Effective Date, Assignor has not been served with any interference action or
litigation with respect to any Assigned Patents claiming any part of the Product or
related to the Product or the manufacture hereof, and Assignor has not received any
written communication which expressly threatens interference actions or other litigation
before any patent and trademark office, court, or any other governmental entity in any
jurisdiction in regard to any such Patents.  







		        11.2.6     Assignor
owns all Intellectual Property necessary for fulfilling the aims and intentions set out
in this Agreement, including, without limitation, the assignment of rights in the
Assigned Technology to Assignee.  







		        11.2.7     Assignor
owns all rights related to the Products and may grant to Assignee the rights set forth in
this Agreement without breaching any agreement with any Third Party.  







		        11.2.8     Assignor
warrants and represents that it is not aware of any basis for finding that the Assigned
Patents are invalid and unenforceable.  







		        11.2.9     Assignor
warrants and represents that after release of the encumbrance described in subsection
13.3 below and except for certain security rights under the Percentage Fee agreement
mentioned in subsection 8.5.1 there are no outstanding agreements, assignments or
encumbrances in existence, concerning, involving, under or for the Assigned Technology.
Assignor further warrants and represents that it has no outstanding duty or obligation to
convey or grant any rights to any Third Party with respect to the Assigned Technology.  







		        11.2.10   Assignor
warrants and represents that it has perfected its ownership interest in the Intellectual
Property, and has recorded its ownership interest with the Patent and Trademark Office.  








26 









		        11.2.11   Assignor
warrants and represents that the Assigned Patents are in full force and effect and that
any and all maintenance and other fees have been paid.  







		        11.2.12   The
Assignor warrants and represents that prior to the Effective Date, it has used its best
efforts to maintain the Assigned Technology in confidence and has not disclosed,
distributed, or disseminated such information to anyone who is not in turn under an
obligation to the Assignor to maintain this information in confidence.  







		        11.2.13   Assignor
has provided Assignee’s internal patent counsel, during a due diligence meetings
conducted on November 24 and November 25, 2003, with access to complete copies of the
most current versions of all pending patent applications included in the Assigned Patents
and all correspondence between Assignor and any patent office with respect to the pending
patent applications included in the Assigned Patents as of the Effective Date, all
relevant information on patent applications and such copies accurately reflect the scope
of such patent applications as of the Effective Date.  







		        11.2.14    As
of the Effective Date, there are no inquiries, actions or other proceedings pending
before or, to the best of Assignor’s knowledge, threatened by any regulatory
authority or other government agency with respect to the Existing Product or any facility
where the Existing Product is manufactured, and Assignor has not received written notice
threatening any such inquiry, action or other proceeding. As of the Effective Date, there
are no investigations pending before or, to the best of Assignor’s knowledge,
threatened by any regulatory authority or other government agency with respect to the
Existing Product or any facility where the Existing Product is manufactured, and Assignor
has not received written notice threatening any such investigation. Assignor shall
promptly notify Assignee in writing upon learning of any such actual or threatened
investigation, inquiry or proceeding.  







		        11.2.15    As
of the Effective Date, the development and manufacture of the Existing Product has been
conducted by Assignor and its Affiliates and, to the best of Assignor’s knowledge,
its subcontractors are in compliance in all material respects with all applicable laws,
rules and regulations, and as of the Effective Date, neither Assignor nor its Affiliates,
and to the best of Assignor’s knowledge, its subcontractors, have received any
notice in writing, or otherwise has knowledge of any facts, which have, or reasonably
should have, led Assignor to believe that any of the INDs or other regulatory submissions
relating to the Existing Product are not currently in good standing with, the FDA.  







		        11.2.16    Assignor
has, up to and including the Effective Date, endeavored in good faith to furnish Assignee
with all material information requested by Assignee concerning the quality, toxicity,
safety and/or efficacy concerns that may materially impair the utility and/or safety of
Products.  







        11.3.   Product
Warranty.  



		        11.3.1   Assignor
hereby warrants and undertakes that upon delivery of each batch of Product all Product in
such batch shall comply in all respects with the Specifications, including without
limitation, having been manufactured in accordance with cGMPs or other relevant standard.  








27 









		        11.3.2    The
foregoing warranty is exclusive and in lieu of all other express and implied warranties,
including but not limited to implied warranties of merchantability and fitness for
particular purpose, related to this Agreement, and the warranties in the 1980 U.N.
Convention on Agreements for the International Sales of Goods, the Uniform Commercial
Code and other relevant laws shall not apply. With the exclusion of gross negligence and
willful misconduct neither of the Parties shall be subject to any consequential or
indirect damages with respect to claims made hereunder or by any purchaser or user of the
Product.  







     12.    
          INDEMNIFICATION 



        12.1.  Indemnification
by Assignee. Assignee will indemnify, defend and hold           Assignor and its
directors, officers, employees, agents and Affiliates harmless           from and against
any liabilities, damages, costs or expenses, including           reasonable attorneys
fees (collectively, “Losses”), which arise out           of, relate to or
result from the breach by Assignee of any of its           representations, warranties or
obligations contained within this Agreement or           any claim or action arising
from, relating to or in connection with the           manufacture of the Product
delivered from or on behalf of the Assignee.           Notwithstanding the foregoing,
Assignee will not indemnify Assignor for any           Losses to the extent that Assignee
is entitled to seek indemnification from           Assignor for such Losses under Section
12.2 of this Agreement.  



        12.2.  Indemnification
by Assignor. Assignor will indemnify, defend and hold           Assignee and its
directors, officers, employees, agents and Affiliates harmless           from and against
any Losses which arise from any claim, lawsuit or other action           to the extent
such Losses arise out of, relate to or result from the breach by           Assignor of
any of its representations, warranties or obligations contained           within this
Agreement or any claim or action arising from or relating in           connection with
the manufacture of the Product delivered from or on behalf of           Assignor.
Notwithstanding the foregoing, Assignor will not indemnify Assignee           for any
Losses to the extent that Assignor is entitled to seek indemnification           from
Assignee for such Losses under Section 12.1 of this Agreement.  



        12.3.  Indemnification
Procedures. A Party which intends to claim           indemnification under Section
12.1 or 12.2 of this Agreement (the           “Indemnitee”) will promptly
notify the other Party (the           “Indemnitor”) in writing of any claim,
lawsuit or other action in           respect of which the Indemnitee or any of its
directors, officers, employees,           and Affiliates intend to claim such
indemnification within a reasonable period           of time after the assertion of such
claim; provided, however, that the failure           to provide written notice of such
claim within a reasonable period of time will           not relieve the Indemnitor of any
of its obligations hereunder, except to the           extent that the Indemnitor is
prejudiced by such failure to provide prompt           notice. The Indemnitor will have
the right to assume the complete control of the           defense, compromise or
settlement of any such claim with the prior written           consent of such Indemnitee,
which such consent will not be unreasonably           withheld; provided, however, that
Indemnitee will have the right to withhold           such consent in its sole discretion
if such defense, compromise or settlement           includes any admission of wrongdoing
on the part of an Indemnitee, or limits the           scope of any claims in or
enforceability of any Patents owned by or licensed to           the Indemnitee. The
Indemnitor may at its own expense, employ legal counsel to           defend the claim at
issue. At any time after Indemnitor has assumed defense of a           claim, the
Indemnitor may exercise, on behalf of the Indemnitee, any rights           which may
mitigate the extent or amount of such claim; provided, however, the           Indemnitee:
(a) may, in its sole discretion and at its own expense, employ legal           counsel to
represent it (in addition to the legal counsel employed by the           Indemnitor) in
any such matter, and in such event legal counsel selected by the           Indemnitee
will be required to confer and cooperate with such counsel of the           Indemnitor in
such defense, compromise or settlement for the purpose of           informing and sharing
information with the Indemnitor; (b) will, at its own           expense, make available
to Indemnitor those employees, officers and directors of           Indemnitee whose
assistance, testimony or presence is necessary, useful or           appropriate to assist
the Indemnitor in evaluating and in defending any such           claim; provided,
however, that any such access will be conducted in such a           manner as not to
interfere unreasonably with the operations of the businesses of           Indemnitee; and
(c) will otherwise fully cooperate with the Indemnitor and its           legal counsel in
the investigation and defence of such claim. The rights and           remedies provided
pursuant to this Section 12 are the sole and exclusive           remedies of the Parties
hereto with respect to Losses.  




28 









        12.4.  Insurance. Each
Party will maintain commercially reasonable insurance           coverage commensurate
with its obligations under this Agreement. Such           commercially reasonable
insurance coverage will include comprehensive general           liability insurance
coverage, including product liability, with a minimum limit           of not less than
US$ *, which shall be in effect at initiation of the           Clinical Trials
in the Territory.  



     13.  
          TERM AND TERMINATION 



        13.1.  Term
of the Agreement. The term of this Agreement (the “Term”) will
commence on the Effective Date and, unless           terminated earlier pursuant to this
Section 13, will expire on a           country-by-country basis upon the later of (a) the
date of expiration of all           royalty obligations in a given country in the
Territory pursuant to subsection           7.5.2. of this Agreement, and (b) the date 15
years after the date of First           Commercial Sale of a Product in such country
under this Agreement.  



        13.2.  Assignee’s
right to Terminate. Assignee may terminate the Agreement           without cause (a)
before the First Commercial Sale of the Product in any country           within the
Territory with service of thirty (30) Business Days written notice           and (b)
after the First Commercial Sale of the Product in any country within the
          Territory with service of 3 months written notice.  



        13.3.  Termination
due to Third Party rights. Assignor has granted a lien on the           Assigned
Technology to a Third Party company, which is planned to be released           and
subsumed through a refinancing of Assignor. The intended release of the lien           is
described in an agreement with that certain Third Party, which is attached as
          Exhibit 13.3. Assignor has informed Assignee that the lien will be released as
          set out in Exhibit 13.3. In the event the lien has not been released within two
          hundred (200) days from Effective Date as established by competent written
          evidence, Assignee shall have the right to terminate the Agreement without
          notice.  



        13.4.  Termination
due to Third Party enforcement of rights. In the event a           Third Party takes
ownership of any or all parts of the Assigned Technology,           Nycomed shall have
the right to terminate the Agreement without notice, unless           such ownership is
caused through a breach by Assignee of its obligations towards           Assignor or any
Third Parties.  







        *
Certain information on this page has been omitted and filed separately with the
Commission.  Confidential treatment has been requested with respect to the omitted
portions. 



29 










        13.5.  Termination
for Material Breach. In the event of a material breach of           this Agreement by
either Party, which is not cured within sixty (60) Business           Days following
receipt of written notice of the such breach from the           non-breaching Party, the
non-breaching Party will have the right to terminate           this Agreement by written
notification to the other Party, effective immediately           upon receipt.  



        13.6.  Termination
for Bankruptcy. Either Party may immediately terminate this           Agreement upon
the occurrence of either of the following: (a) the entry of a           decree or order
for relief by a court having jurisdiction in the premises in           respect of the
other Party in an involuntary case under any applicable national,           federal, or
state insolvency or other similar law, and the continuance of any           such decree
or order unstayed and in effect for a period of sixty (60)           consecutive days; or
(b) the filing by the other Party of a petition for relief           under any applicable
national, federal, or state insolvency or other similar           law. All licenses
granted under or pursuant to this Agreement, including           amendments hereto, by
each Party to the other Party are, for all purposes of 11           U.S.C. Section
365(n), intended to be licenses of rights to Intellectual           Property as defined
in 11 U.S.C.  



     14.  
          CONSEQUENCES OF TERMINATION 



        14.1.  General. No
termination of this Agreement will relieve any Party hereto           from any liability
which, at the time of such termination, has already accrued           to the other Party
or which is attributable to a period prior to such           termination, nor preclude
either Party from pursuing any rights and remedies it           may have under this
Agreement or at law or in equity which accrued or are based           upon any event
occurring prior to such termination.  



        14.2.  Termination
under 13.2. In the event of termination by Assignee of this           Agreement under
Section 13.2, Assignee shall forthwith after the effective date           of termination:  



		        14.2.1    upon
written request of Assignor, provide to Assignor the Dossier, all Product and Scientific
Data and any other documents, materials, data or information within Assignee’s
possession or control containing or evidencing any Intellectual Property of Assignor and
all Assignor Confidential Information:  







		        14.2.2    cease
all exploitation and marketing of Products provided always that Assignee shall be
entitled to continue to sell Products for a period of six calendar months thereafter in
order to fulfill existing orders only (subject always to payment of Royalties) and
provided that Assignee shall not sell such inventory in a manner detrimental to the
market for Products in the Territory;  







		        14.2.3    give
or procure for Assignor access to all data filed in connection with the Marketing
Authorizations for the Products in the Territory;  







		        14.2.4      allow
Assignor to cross-reference the file relating to the Products held by each relevant
Regulatory Authority for the purpose of transferring the Marketing Authorization for the
Products in the Territory to Assignor or as it may nominate;  








30 









		        14.2.5      subject
to Assignee’s right to sell its inventory of Products pursuant to Section 14.2.2,
transfer the adverse event database for the Products relating to the Territory to
Assignor; and  







		        14.2.6      in
the event of termination during the development use all reasonable endeavors to effect an
orderly transfer to Assignor (or as it may direct) of the management and conduct of the
Clinical Trials performed by or on behalf of Assignee and to fulfill Third Party
obligations related to the Clinical Trials, including requirements of authorities,
ethical committees etc.  







        14.3.  Termination
under 13.3. In the event of termination under subsection 13.3           Assignee
shall perform the acts set out in subsection 14.2 above. Assignor shall
          reimburse Assignee all documented cost incurred through entering into and
          performing under the Agreement. Such amount shall be payable promptly upon
          Assignee’s production of due documentation for those costs.  



        14.4.  Assignee’s
termination under 13.4. In the event of Assignee’s           termination under
subsection 13.4 of this Agreement, Assignee’s rights           shall continue in
full force and effect but all of its obligations to Assignor           shall terminate as
of the date of such breach; if Assignor is responsible for           manufacture and
supply of Product to Assignee, Assignee shall have the right to           obtain its
supply of Product from Assignor’s Third Party contract           manufacturer with
no obligation to Assignor. Assignor shall immediately transfer           to Assignee any
and all manufacturing technology and Know-How, and provide to           Assignee, at
Assignor’s expense, reasonable technical assistance with           respect to such
technology and Know-How.  



        14.5.  Assignor’s
termination under 13.5. In the event of Assignor’s           termination under
subsection 13.5 of this Agreement, Assignee shall perform the           acts set out in
subsection 14.2 above.  



        14.6.  Licenses
Upon Expiration. Upon expiration of this Agreement pursuant to           Section 13.1
of this Agreement with respect to a country in the Territory,           Assignee’s
rights in the Assigned Technology shall become irrevocable and           Assignee shall
have no obligation to Assignor with respect to such Assigned           Technology.  



        14.7.  Royalty
to Assignee in the event of new partner.          In the event Assignee terminates
the Agreement prior to First Commercial Sale           and Assignor subsequently
generates revenues through the exploitation of the           Assigned Technology in the
Territory (either by itself or through a Third           Party), Assignor shall pay
Assignee a royalty of * % of Net Sales of the           Product in the Territory
until such time as up to an aggregate total of $* of Assignee’s
Development Costs are reimbursed. The           above provision in this subsection 14.6
shall only apply if Assignee’s           termination is due to safety or efficacy
issues, or due to changes in the market           situation relevant for the Product.  



        14.8.  Survival. In
the event of expiration or termination of this Agreement           pursuant to Section 13
of this Agreement, except as may otherwise be expressly           set forth herein, the
following sections will survive, together with the           definitions of any defined
terms used therein: Sections 11, 12, 15, 17 and 18.           All other provisions,
including all rights and obligations thereunder, will           terminate and be of no
further force and effect.  



31 





	*  	Certain
information on this page has been omitted and filed separately with the Commission.
 Confidential treatment has been requested with respect to the omitted portions.












     15.  
          CONFIDENTIALITY, PUBLICATIONS, PUBLICITY 



        15.1.  Confidential
Information. Each Party acknowledges that the other           Party’s
Confidential Information comprises valuable trade secrets and is           proprietary.
Each Party will hold in strict confidence the other Party’s           Confidential
Information and will not disclose the same to any other person,           firm or
corporation, except as allowed hereunder. Notwithstanding the foregoing,           the
obligation of confidentiality contained in this Agreement will not apply to           the
extent that the receiving Party can demonstrate, by competent written proof,
          that such Confidential Information:  



		        15.1.1   Was,
at the time of disclosure, published, publicly known or otherwise in the public domain,
other than through any act or omission by the receiving Party;  







		        15.1.2   Was
already known to the receiving Party, other than under an obligation of confidentiality
or non-use, prior to the time of disclosure;  







		        15.1.3   was
disclosed to the receiving Party in good faith, without an obligation of confidentiality,
by a Third Party not under any obligation of confidence with respect to such information;
or  







		        15.1.4   was
independently developed by the receiving Party without use of or reference to the
disclosing Party’s Confidential Information.  







        15.2.  Treatment
of Confidential Information. The Parties agree that during the           term of this
Agreement and for ten (10) years after its expiration or           termination for any
reason whatsoever, a Party receiving Confidential           Information of the other
Party will: (a) treat any such Confidential Information           disclosed to it by the
other Party as strictly confidential; (b) except as           necessary in the
performance of this Agreement, not disclose such Confidential           Information to
Third Parties without the prior written consent of the other           Party, other than
to its Affiliates, sublicensees, collaborators or any           consultants, provided
that such disclosure be under confidentiality agreements           with provisions
comparable to those contained in this Agreement; (c) not use           such Confidential
Information for purposes other than those authorized expressly           herein; and (d)
use reasonable efforts to prevent inadvertent disclosure of such           Confidential
Information, provided however, that the obligations under this           Section 15.2
shall continue in force and effect with respect to each item of           Confidential
Information that is identified as a trade secret by the disclosing           party at the
time of or within thirty (30 ) days after its initial disclosure           hereunder,
until such time as such item of Confidential Information is no longer
          susceptible of being kept a trade secret.  



        15.3.  Access. Access
to Confidential Information will be limited to those           employees or consultants
of the Party receiving such information or of such           Party’s Affiliates who
reasonably require such information in order to           carry out activities authorized
pursuant to this Agreement. Such employees or           consultants will be advised of
the confidential nature of the Confidential           Information and the related
confidentiality undertaking  



32 










        15.4.  Permitted
Disclosures. Notwithstanding any other provision in this           Agreement, a
receiving Party may disclose Confidential Information of the           disclosing Party
to the extent such disclosure is required by law or court           order, provided that
the receiving Party gives the disclosing Party prompt           written notice of the
requirement to disclose and reasonably cooperates with the           disclosing Party to
seek a protective order or other restrictions on the           disclosure of such
Confidential Information of the disclosing Party. Any such           required disclosure
will be limited only to that Confidential Information that           is required to be
disclosed and such disclosed Confidential Information will           remain Confidential
Information hereunder despite the required disclosure. A           receiving Party may
also disclose Confidential Information of the disclosing           Party in connection
with filing, prosecuting, defending and/or enforcing           Patents, seeking or
maintaining Marketing Authorizations and developing           Products.  



        15.5.  Return
of Confidential Information. Upon termination or expiration of           this
Agreement, each Party hereto and its Affiliates will return all           Confidential
Information of the other Party in their possession to the other           Party;
provided, however, that each Party may retain: (a) a single archival copy           of
the Confidential Information of the other Party solely for the purpose of
          determining the extent of disclosure of Confidential Information hereunder and
          assuring compliance with the surviving provisions of this Agreement; (b) any
          portion of the Confidential Information of the other Party which is contained
in           laboratory notebooks; and (c) any portion of the Confidential Information of
the           other Party which a Party is required by mandatory applicable law to
retain.  



        15.6.  Confidentiality
of the Agreement Terms. Neither Party will disclose the           terms of this
Agreement to any Third Party without the prior written consent of           the other
Party; provided, however, that either Party may disclose the terms of           this
Agreement to actual or prospective investors and corporate partners           (including
SubAssignees), to a Party’s accountants, attorneys and other           professional
advisors, and as required by applicable laws and regulations of the           U.S.
Securities and Exchange Commission and any stock exchange on which a           Party’s
(or any Affiliate of any Party) stock is traded.  



        15.7.  Publications. Any
proposed written publication of research results           arising from this Agreement
will be submitted to the other Party at least twenty           five (25) Business Days
days prior to submission for publication, and at least           ten (10) Business Days
prior to oral, or other non-written format, disclosure or           the submission of an
abstract. During this twenty five (25) Business Day period           for publication
submissions and ten (10) Business Day period for abstracts or           oral, or other
non-written format, disclosures, the reviewing Party shall           identify information
that in the reasonable judgment of such Party (a) will           interfere with such Party’s
rights hereunder (including any effect on           patentability of disclosed
information) and/or (b) constitutes such Party’s           Confidential Information.
Should the reviewing Party require additional time to           conduct its review the
submitting Party agrees to postpone the oral disclosure           and submission of the
manuscript or the abstract for up to an additional sixty           (60) days. Each Party
agrees to delete from any proposed manuscript, abstract or           oral disclosure,
information identified by the other Party as its Confidential           Information.  




33 









        15.8.  Publicity. Neither
Party will make any public announcement concerning the           existence, or the terms,
of this Agreement, without the prior written approval           of the other Party with
regard to the form, content and precise timing of such           announcement, except
such as may be required to be made by either Party in order           to comply with
applicable law, regulations, court order, or tax or securities           filings. A Party
disclosing under the above provision according to law shall           provide the other
Party with a copy of the disclosed information. Such consent           will not be
unreasonably withheld or delayed by such other Party. Prior to any           such public
announcement, the Party wishing to make the announcement will submit           a draft of
the proposed announcement to the other Party as soon as possible and           in no
event less than ten (10) Business Days in advance to enable the other           Party to
consider and comment thereon. Notwithstanding anything to the contrary           in this
Agreement, nothing in this Section 15.8 is intended to prohibit either           Party
from republishing or restating information relating to this Agreement that           has
already been approved by the other Party for use in a prior press release or
          public announcement.  



     16.  
          PERFORMANCE BY AFFILIATES 



            The
Parties recognize that each Party may perform some or all of its obligations under this
Agreement through Affiliates, provided, however, that each Party will remain responsible
for the performance by its Affiliates and will cause its Affiliates to comply with the
provisions of this Agreement in connection with such performance and any act or omission
committed by an Affiliate shall be deemed to have been conducted by the Party itself. 



     17.  
          DISPUTE RESOLUTION 



        17.1.  The
Parties will try to settle their differences amicably between themselves. In
          the event of any controversy or claim arising out of or relating to any
          provision of this Agreement or the performance or alleged non-performance of a
          Party of its obligations under this Agreement (“Dispute”), a
          Party may notify the other Party in writing of such Dispute. If the Parties are
          unable to resolve the Dispute within twenty (20) Business Days of receipt of
the           written notice by the other Party, such dispute will be referred to the
Chief           Executive Officers of each of the Parties (or their respective designees)
who           will use their good faith efforts to resolve the Dispute within fifteen
(15)           Business Days after it was referred to the Chief Executive Officers.  



        17.2.  Subject
to subsection 17.1 and subsection 17.3 of this Agreement, any Dispute           that is
not resolved as provided in the preceding Section 17.1, whether before           or after
termination of this Agreement, that in any way relates to the Agreement           will be
““arbitrated under the international arbitration rules (the “Rules”)
of the American Arbitration Association by three (3)           independent and impartial
arbitrators in accordance with said Rules. The           arbitration will be conducted in
English and will be held in New York, New York.           The award in the arbitration
will be final and enforceable in any court of           competent jurisdiction.  



        17.3.  Patents
and Trademarks. Any dispute, controversy or claim between the           Parties
relating to the scope, validity, enforceability or infringement of any           Patent
licensed under this Agreement or of any trademark rights related to a           Product
will be submitted to a court of competent jurisdiction in the territory           in
which such Patent or trademark rights were granted or arose.  




34 









     18.  
          MISCELLANEOUS 



        18.1.  Further
Assurances. At any time during the term of this Agreement,           Assignee and
Assignor each will, at the request of the other Party, use           reasonable efforts
to (a) deliver to the other Party such records, data or other           documents
consistent with the provisions of this Agreement, (b) execute, and           deliver or
cause to be delivered, all such assignments, consents, documents or           further
instruments of transfer or license, and (c) take or cause to be taken           all such
other actions, as a Party may reasonably deem necessary or desirable in           order
for such Party to obtain the full benefits of this Agreement and the
          transactions contemplated hereby.  



        18.2.  Assignment. Except
as set out in Sections 2.1.3 and 16.1, Neither Party           will assign its rights or
obligations under this Agreement to any Third Party           without the prior written
consent of the other Party (which consent shall not be           unreasonably withheld),
except that either Party may assign such rights and           obligations, without
consent, to the surviving entity pursuant to a merger,           acquisition or
consolidation, or to a Third Party acquiring all or substantially           all assets of
a Party. All permitted assignments by either Party of any of its           rights under
this Agreement will be subject to all of the terms and conditions           of this
Agreement. All successors, permitted assignees of either Party will be           subject
to, and will be bound in writing by, all the terms and conditions of           this
Agreement. Any purported assignment not permitted under the terms of this
          Agreement will be null, void, and of no effect.  



        18.3.  Independent
Contractors. The Parties hereto are independent contractors.           Nothing
contained herein will constitute either Party the agent of the other           Party for
any purpose whatsoever, or constitute the Parties as partners or joint
          ventures. Employees of each Party remain employees of said Party and will be
          considered at no time agents of or owing a fiduciary duty to the other Party.
          Neither Party hereto will have any implied right or authority to assume or
          create any obligations on behalf of or in the name of the other Party or to
bind           the other Party to any other contract, agreement or undertaking with any
Third           Party.  



        18.4.  Waiver. The
failure of either Party to enforce any provision of this           Agreement at any time
will not be construed as a present or future waiver of           such or any other
provision of this Agreement. The express waiver by either           Party of any
provision or requirement hereunder will not operate as a future           waiver of such
or any other provision or requirement and will be effective only           if set forth
in a written instrument signed by a duly authorized representative           of the Party
waiving such provision or requirement.  



        18.5.  Amendment. The
Parties hereto may amend, modify or alter any of the           provisions of this
Agreement, but such amendment, modification or alteration           will be valid and
binding on either Party only if made by a written instrument           that explicitly
refers to this Agreement and that is signed by a duly authorized           representative
of each Party.  



        18.6.  Severability. In
the event that any provision in this Agreement is held           to be unlawful or
invalid in any jurisdiction, the meaning of such provision           will be construed to
the greatest extent possible so as to render it           enforceable. If no such
construction can render such provision enforceable, it           will be severed. The
remainder of this Agreement will remain in full force and           effect, and the
Parties will negotiate in good faith a reasonable substitute           provision that is
valid and enforceable in such jurisdiction. If the Parties are           unable to agree
on a substitute provision, and if the unlawful or invalid           provision was an
essential element of this Agreement without which one of the           Parties would not
have entered into this Agreement, as evidenced by this           Agreement as a whole,
then such Party may terminate this Agreement by written           notice to the other
Party effective upon receipt.  




35 









        18.7.  Notice. All
notices hereunder must be given in writing and will be deemed           given if
delivered personally or by facsimile transmission (receipt confirmed),           mailed
by registered or certified mail (return receipt requested) with postage
          prepaid, or sent by express courier service (FedEx or other reputable,
          internationally recognized courier service), to the Parties at the following
          addresses (or at such other address for a Party as will be specified by like
          notice; provided that notices of a change of address will be effective only
upon           receipt thereof).  




		
	If to Assignor:
	PFC Therapeutics, LLC

6175 Lusk Boulevard

San Diego, California 92121

Attention: Duane J. Roth, Manager

Facsimile: (858) 410-5306 

	With copies to:
	Foley & Lardner LLP

402 W. Broadway, 23rd Floor

San Diego, California 92101

Attention: Kenneth D. Polin

Facsimile: (619) 234-3510 

	If to Assignee:
	Nycomed Danmark ApS

Langebjerg 1

DK-4000 Roskilde

Denmark

Attention: Managing Director

Facsimile: +4546756968 

	With copies to:
	With copy to Nycomed Danmark ApS

Langebjerg 1

DK-4000 Roskilde

Denmark

Attention: General Counsel

Facsimile: +4766763513 







        18.8.  Force
Majeure. Neither Party will be deemed to be in breach of this           Agreement as
a result of default, delay or failure to perform by such Party           which is due to
any cause beyond the reasonable control of such Party, including           without
limitation, fire, earthquake, acts of God, severe weather, acts of war,
          strikes, lockouts or other labor disputes, riots, civil disturbances, actions
or           inactions of governmental authorities (except actions in response to a
breach of           applicable laws by such Party), or epidemics. In the event of any
such force           majeure, the Party affected will promptly notify the other Party,
will use           commercially reasonable efforts to overcome such force majeure, and
will keep           the other Party informed with respect thereto. If such force majeure
continues           for a period of more than one hundred and eighty (180) Business Days,
the Party           not subject to such force majeure may terminate this Agreement by
written notice           to the other Party.  



        18.9.  Counterparts. This
Agreement may be executed by the Parties in one or           more identical counterparts,
all of which together will constitute this           Agreement. If this Agreement is
executed in counterparts, no signatory hereto           will be bound until both Parties
have duly executed a counterpart of this           Agreement.  




36 









        18.10.  Governing
Law. This Agreement will be governed by, and construed an           interpreted in
accordance with, the laws of the State of New York without giving           effect to any
choice of law rule that would cause the application of the laws of           any
jurisdiction other than the internal laws of the State of New York to the           right
and duties of the Parties.  



        18.11.  Construction. Unless
used in combination with the word           “either,” the word “or” is
used throughout this Agreement in           the inclusive sense (and/or). The captions of
this Agreement are for convenience           of reference only and in no way define,
describe, extend or limit the scope or           intent of this Agreement or the intent
of any provision contained in this           Agreement. The term “including” as
used herein will mean including,           without limiting the generality of any
description preceding such term. No rule           of strict construction will be applied
against either Party hereto.  



        18.12.  English
Language. This Agreement has been written and executed in the           English
language. Any translation into any other language will not be an           official
version of this Agreement, and in the event of any conflict in           interpretation
between the English version and such translation, the English           version will
control.  



        18.13.  Entire
Agreement. This Agreement, including any Exhibits attached hereto,
          constitutes the entire agreement of the Parties with respect to the subject
          matter hereof, and supersedes all prior and contemporaneous agreements,
          understandings and negotiations, whether oral or written, with respect to such
          subject matter, including, without limitation, the Confidential Disclosure
          Agreement; provided, however, that no agreement between the Parties
          executed contemporaneously with this Agreement will be so superseded by this
          Agreement.  




[Remainder of page
intentionally left blank. Signature page follows.] 













37 












            The
Parties have caused this Agreement to be executed as of the Effective Date by signature of
their duly authorized representatives. 





PFC THERAPEUTICS LLC 




By:  /s/  Duane J. Roth



Title:  Manager





NYCOMED DANMARK APS 




By:  /s/  Bent
Kjærsgård 



Title:  Managing Director 




By:  /s/  Maj-Britt Kaltoft 



Title:  VP Inlicensing 













38 












LIST OF EXHIBITS

 





	EXHIBIT	NUMBER
	
ASSIGNMENT AGREEMENT	 	 	 	1	.2
	
ASSIGNED PATENTS	 	 	 	1	.6
	
CALL OPTION LETTER	 	 	 	1	.9
	
TERRITORY	 	 	 	1	.18
	
PRODUCT AND SCIENTIFIC DATA	 	 	 	1	.32
	
QUALITY AGREEMENT	 	 	 	1	.34
	
DEVELOPMENT COMMITTEE AND KEY PERSONS	 	 	 	5	.1
	
LETTER OF ASSUMPTION	 	 	 	8	.5
	
PHARMACOVIGILANCE	 	 	 	9	.6
	
RELEASE OF THIRD PARTY ENCUMBRANCE	 	 	 	13	.3


























EXHIBIT 1.2 



ASSIGNMENT AGREEMENT 



            This
Assignment Agreement is made as of the 1st day of April 2004 (“Effective
Date”), by and between Nycomed Danmark ApS, a corporation organized and existing
under the laws of the State of Denmark and having a place of business at Langebjerg
1, 4000 Roskilde, Denmark (“ASSIGNEE”), 



and 



        PFC
Therapeutics LLC a corporation organized and existing under the laws of Delaware and
having a place of business at 6175 Lusk Blvd., San Diego, CA 92121 (“ASSIGNOR”).  




        WHEREAS,
ASSIGNOR and ASSIGNEE are parties to that certain Development, Assignment and Supply
Agreement dated as of the date hereof (the “Development Agreement”), to which
this Agreement is an Exhibit, which conveys to ASSIGNEE exclusive rights in the IP (as
defined below) for, among other products and methods, a perflubron based emulsion
identified as Oxygent (“Oxygent”) in the Territory as defined below.  




        WHEREAS
ASSIGNEE has agreed with Assignor to to fund the development of Oxygent in on the terms
and conditions set out in the Development Agreement.  




        WHEREAS
ASSIGNOR has granted the rights to exploit Oxygent in the Territory;  




        NOW
THEREFORE, in consideration of the foregoing recitals and the mutual promises herein
after set forth, the parties hereto agree as follows:  




        As
used in this Assignment, the following terms shall have the following respective
meanings:  




     1.    
          Definitions 



        A.    Intellectual
Property. Intellectual Property (“IP”) means and           includes Patent
Rights, Technology, and Trademarks.  




        B.    Patent
Rights. Patent Rights means (i) the inventions and subject matter           described
and claimed in the patents and patent applications (provisional and
          non-provisional) listed on Exhibit A, (ii) any patents issuing therefrom
          anywhere in the world covering such inventions and subject matter, (iii) any
          patent application claiming or entitled to claim priority on any of the
          foregoing and any patent issuing thereon, (iv) any continuations,
          continuations-in-part, divisionals, renewals, substitutions and re-examinations
          of any of the foregoing, (v) any patents issuing from any of the foregoing, and
          (vi) any reissues and extensions of any such patents, (collectively, Patent
          Rights).  







2  










        C.    Technology.
Technology means and includes information, know-how, designs,           plans,
specifications, methods, clinical data, compositions, techniques,           software, and
other technical information whether or not patentable relating to,           necessary or
useful for the practice of the Patent Rights.  




        D.    Territory.
means the Countries listed in Exhibit 1.19  




        E.    Trademarks.
Trademarks means and includes any trademarks, service marks,           trade names and
the like, whether or not registered, for Oxygent and any and all           goodwill
associated therewith.  




     2.    
          Assignment of the IP. The ASSIGNOR hereby assigns to ASSIGNEE the entire
          right, title, and interest in, to, and under the Patent Rights and the use of
          the Technology in the Territory. Additionally, in connection with this overall
          assignment of the IP, on the Effective Date hereof, the ASSIGNOR, for
          recordation purposes, shall sell, assign, transfer and set over, unto ASSIGNEE
          or its designee, the entire right, title and interest in and to the IP, by
          executing assignments in the forms set forth in Exhibit B hereto. 



     3.    
          Non-disclosure and Non-use by the ASSIGNOR. 



        The
ASSIGNOR shall use its best efforts to maintain the IP in confidence and shall not
disclose, distribute, or disseminate such information to anyone without the express prior
written consent of ASSIGNEE.  




        The
ASSIGNOR shall not use the Patent Rights in any manner or for any purpose and shall not
use the Technology in any manner or for any purpose in the Territory.  




     4.    
          Cooperation by ASSIGNOR. ASSIGNOR shall fully cooperate with ASSIGNEE in
          the preparation and prosecution of all patent applications and the maintenance,
          defense and enforcement of any patents included in the IP, and in connection
          with the Technology and the Trademarks which cooperation shall include, but not
          be limited to, execution by ASSIGNOR of any and all papers and instruments as
          are necessary or helpful to ASSIGNEE in preparing, filing, prosecuting,
          maintaining, and transferring ownership, if appropriate, of all such patent
          applications, patents, Technology and Trademarks. If, for any reason, ASSIGNEE
          is unable to obtain ASSIGNOR’s signature on any document or consent
          necessary for any of the foregoing activities after reasonable efforts, ASSIGNOR
          hereby appoints _______________ [blank] and _______________ [blank] or their designees, of
          ASSIGNEE to transact all business in connection with the IP, to the extent
          permitted by law. ASSIGNOR understands and agrees that such power of attorney is
          irrevocable. 



     5.    
          Consideration. The consideration shall be as set out in the Development
          Agreement. 



     6.    
          Rights and Obligations of the Parties. 



        A.              ASSIGNEE
shall have the sole and exclusive right, but not the obligation, to           file,
prosecute, maintain, enforce and defend any and all patent applications           and
patents within the Patent Rights in and outside the Territory and the
          Technology in the Territory, and to use, enforce and defend any Trademarks
          within the IP in the Territory, at its own expense.  




3 









        B.              Within
five (5) days after the Effective Date, ASSIGNOR shall transfer to           ASSIGNEE all
if its files and any other documentation on the IP.  




     7.    
          Representations and Warranties. 



        ASSIGNOR
warrants and represents that it has the full right and power to enter into and perform
its obligations under this Agreement.  




        ASSIGNOR
warrants and represents that it owns the entire right, title and interest in and to the
IP without any liens or encumbrances (except for a security interest created in favor of
Baxter Healthcare Corporation (“Baxter”) under that certain Percentage Fee
Agreement dated June 19, 2003 by and between ASSIGNOR, ASSIGNEE and Baxter (the “Baxter
Lien”)) of any kind, and that it has the sole right to transfer such right, title
and interest to ASSIGNEE.  




        ASSIGNOR
warrants and represents that it is not aware of any basis for finding that any issued
patents within the IP are invalid and/or unenforceable, or that any of the claims of any
patent application if issued is invalid and/or unenforceable.  




        ASSIGNOR
warrants and represents that, to the best of its knowledge, the practice of the IP will
not infringe any third party intellectual property rights.  




        ASSIGNOR
warrants and represents that, as of the Effective Date, Assignor has not been served with
any interference action or litigation with respect to any or all of the IP, and Assignor
has not received any written communication which expressly threatens interference actions
or other litigation before any patent and trademark office, court, or any other
governmental entity in any jurisdiction in regard to any such IP.  




        ASSIGNOR
warrants and represents that there are no outstanding agreements, assignments or
encumbrances in existence, concerning, involving, under or for the IP (except for the
Baxter Lien). ASSIGNOR further warrants and represents that it has no outstanding duty or
obligation to convey or grant any rights to any third party with respect to the IP
(except for the Baxter Lien).  




        ASSIGNOR
warrants and represents that it has perfected its ownership interest in the IP, and has
recorded its ownership interest with the United States Patent and Trademark Office, a
copy of such recordal is attached hereto as Exhibit B.  




        ASSIGNOR
warrants and represents that the patents and patent applications within the IP are in
full force and effect and that any and all fees due have been paid.  




        The
ASSIGNOR warrants and represents that prior to the Effective Date, it has used its best
efforts to maintain the IP in confidence and has not disclosed, distributed, or
disseminated such information to anyone who is not in turn under an obligation to the
ASSIGNOR to maintain this information in confidence.  




        ASSIGNOR
warrants and represents that to its knowledge, no third party is infringing any patents
within the IP.  




4 










        ASSIGNOR
warrants and represents that the patents and patent applications within IP are not, and
have not been, the subject of any inventorship challenges and are not involved in any
pending or threatened interference actions.  




     8.    
          Binding Agreement. All the terms, conditions and provisions of this
          Agreement shall be binding upon and inure to the benefit of the parties hereto,
          and upon and to their successors and permitted assigns. 



     9.    
          Entire Agreement. This Agreement and the Exhibits hereto, together with
          the Development Agreement and the exhibits hereto constitute the entire
          understanding and agreement between the parties hereto with respect to the
          subject matter hereof. No modifications, supplementation, extension or waiver of
          any provisions of this Agreement or any release of any right hereunder shall be
          valid, unless the same is in writing and is consented to by the parties hereto. 



     10.    
          Severability. In the event that any part or provision of this Agreement
          is deemed by a court of competent jurisdiction to be invalid, illegal, or
          unenforceable in any respect, such invalidity, illegality, or unenforceability
          shall not affect any other part or provision of this Agreement, but this
          Agreement shall be construed as if such invalid, illegal, or unenforceable part
          or provision had never been contained therein. 



     11.    
          Assignment. Neither this Agreement, nor any right or obligation hereunder
          may be assigned by ASSIGNOR without prior written consent of ASSIGNEE. 



     12.    
          Governing Law. This Agreement shall be governed by and interpreted in
          accordance with the laws of the State of New York. 



     13.    
          Arbitration. Any controversy or claim arising out of or relating to this
          Agreement, or the breach thereof, shall be settled by binding arbitration in New
          York. Said arbitration shall be conducted in accordance with the rules then
          prevailing of the American Arbitration Association (“AAA”) with three
          (3) arbitrators, one arbitrator to be selected by ASSIGNOR, one arbitrator to be
          selected by ASSIGNEE and the third arbitrator to be selected by the other two
          arbitrators. The arbitration shall be conducted in the English language. The
          costs and fees for the arbitrators shall be borne equally by the parties;
          otherwise, each party shall bear its own costs of the arbitration. Judgment upon
          the award rendered by the arbitrator shall be final and non-appealable and may
          be entered in any court having jurisdiction thereof. 



     14.    
          Counterparts. This Agreement may be executed simultaneously in two (2)
          counterparts, each of which shall be deemed to be original, but all of which
          together shall constitute one and the same agreement. 



     15.    
          Headings. The headings in this Agreement are intended solely for
          convenience of reference and shall be given no effect in the construction or
          interpretation of this Agreement. 






5 











IN WITNESS WHEREOF, the parties
hereto have caused this Agreement to be executed as specified below. 





	PFC THERAPEUTICS, LLC


		NYCOMED DANMARK ApS.



	By:	  /s/  Duane J. Roth
		By:	  /s/  Bent Kjærsgård

	Title:	  Manager
		Title:	  Managing Director

	Date:	  April 15, 2004
		Date:	  April 1, 2004




























6 










EXHIBIT A 



	
	
	

	Country      
Application No.      
Patent No.       
	Title / INVENTOR(S)       
	Date Filed      
Date Issued      
Expiration Date       

	Europe	Brominated Perfluorocarbon Emulsions	13 January 1987 
	0 231 070	for Internal Animal Use for Contrast	10 June 1998
	(Registered in Germany, Spain, 	Enhancement and Oxygen Transport /	Exp: 13 Jan 2007
	France, UK, Italy)	LONG
	
	
	

	Europe	Biocompatible, Stable, and	5 August 1988 
	0 307 087	Concentrated Fluorocarbon Emulsions	8 June 1994
	(Registered in Austria, Belgium,	for Contrast Enhancement and Oxygen	Exp: 5 August 2008
	Germany, Spain, France, UK, Italy,	Transport in Internal Animal Use / LONG
	Luxembourg, Netherlands, Sweden)
	
	
	

	Ireland	Fluorocarbon Emulsions for In Vivo 	5 August 1988 
	2416/88	Use / LONG	6 July 1995
	64245		Exp: 5 August 2008
	
	
	

	Norway	Fluorocarbon Emulsions for In Vivo 	4 August 1988 
	19883456	Use / LONG	21 August 1996
	179162		Exp: 4 August 2008
	
	
	

	Europe	Fluorocarbon Emulsions Having	5 July 1989 
	0 480 925	Saturated PhospholAssigned	24 September 1997
	(Registered in Austria, Belgium, France,	Technologyid Emulsifiers / LONG	Exp: 5 July 2009
	Germany, Italy, Luxembourg, 
	Netherlands, Sweden, Switzerland, UK)
	
	
	

	Europe	AmphAssigned Technologyhilic Fluorine	8 August 1991 
	0 548 096	Derivatives with Telomeric Structures;	8 November 1995
	(Registered in Austria, Belgium,	Preparation Procedure and Biomedical	Exp: 08 Aug 2011
	Switzerland/Liechtenstein, Germany,	Applications / PAVIA, PUCCI, RIESS,
	Denmark, Spain, France, UK, Greece,	ZARIF
	Italy, Luxembourg, Netherlands, Sweden)
	
	
	

	Europe	Stabilization of Fluorocarbon	27 October 1993 
	0 666 736	Emulsions / WEERS, KLEIN, JOHNSON	18 December 1996
	(Registered in Germany, Denmark, 		Exp: 27 Oct 2013
	France, UK, Italy)
	
	
	

	Europe	Fluorocarbon Emulsions with Reduced	1 March 1994 
	94910799.9	Gas-Trapping Properties / WEERS,	14 July 1999
	0 689 422	SCHUTT, PELURA, KEAssigned	Exp: 1 March 2014
	(Registered in Belgium, Germany,	TechnologyERT
	Denmark, Spain, France, UK, Italy,
	Sweden)
	
	
	




















EXHIBIT B 



Recorded Assignment(s)
to Assignor 






































EXHIBIT 1.6 



ASSIGNOR PATENTS 



	
	
	

	Country      
Application No.      
Patent No.       
	Title / INVENTOR(S)       
	Date Filed      
Date Issued      
Expiration Date       

	Europe	Brominated Perfluorocarbon Emulsions	13 January 1987
	0 231 070	for Internal Animal Use for Contrast	10 June 1998
	(Registered in Germany, Spain,	Enhancement and Oxygen Transport /	Exp: 13 Jan 2007
	France, UK, Italy)	LONG
	
	
	

	Europe	Biocompatible, Stable, and	5 August 1988
	0 307 087	Concentrated Fluorocarbon Emulsions	8 June 1994
	(Registered in Austria, Belgium,	for Contrast Enhancement and Oxygen	Exp: 5 August 2008
	Germany, Spain, France, UK, Italy,	Transport in Internal Animal Use /
	Luxembourg, Netherlands, Sweden)	LONG
	
	
	

	Ireland	Fluorocarbon Emulsions for In Vivo	5 August 1988
	2416/88	Use / LONG	6 July 1995
	64245		Exp: 5 August 2008
	
	
	

	Norway	Fluorocarbon Emulsions for In Vivo	4 August 1988
	19883456	Use / LONG	21 August 1996
	179162		Exp: 4 August 2008
	
	
	

	Europe	Fluorocarbon Emulsions Having	5 July 1989
	0 480 925	Saturated PhospholAssigned	24 September 1997
	(Registered in Austria, Belgium,	Technologyid Emulsifiers / LONG	Exp: 5 July 2009
	France, Germany, Italy, Luxembourg,
	Netherlands, Sweden, Switzerland, UK)
	
	
	

	Europe	AmphAssigned Technologyhilic Fluorine	8 August 1991
	0 548 096	Derivatives with Telomeric Structures;	8 November 1995
	(Registered in Austria, Belgium,	Preparation Procedure and Biomedical	Exp: 08 Aug 2011
	Switzerland/Liechtenstein, Germany,	Applications / PAVIA, PUCCI, RIESS,
	Denmark, Spain, France, UK, Greece,	ZARIF
	Italy, Luxembourg, Netherlands, Sweden)
	
	
	

	Europe	Stabilization of Fluorocarbon	27 October 1993
	0 666 736	Emulsions / WEERS, KLEIN, JOHNSON	18 December 1996
	(Registered in Germany, Denmark,		Exp: 27 Oct 2013
	France, UK, Italy)
	
	
	

	Europe	Fluorocarbon Emulsions with Reduced	1 March 1994
	94910799.9	Gas-Trapping Properties / WEERS,	14 July 1999
	0 689 422	SCHUTT, PELURA, KEAssigned	Exp: 1 March 2014
	(Registered in Belgium, Germany,	TechnologyERT
	Denmark, Spain, France, UK,
	Italy, Sweden)
	
	
	





















Exhibit 1.9 



CALL OPTION LETTER 



This Call Option Letter is entered
into as of _________________. 



Whereas PFC, THERAPEUTICS, LLC,
a Delaware limited liability company (“PFC”), with a business address of
6175 Lusk Boulevard, San Diego, California 92121, and NYCOMED DANMARK APS, a
Danish corporation (“Nycomed”), located at Langebjerg 1, DK-4000
Roskilde, Denmark on the _____________ have entered into a Development, Assignment and
Supply (the “Assignment Agreement”) whereby certain Patents and technology was
assigned to Nycomed;  



WHEREAS those above mentioned rights
were assigned in relation to a certain Territory, including mainly Europe and CIS;  



WHEREAS the parties do now wish to
extend that Territory to include the Republic of China;  



NOW THEREFORE the parties mutually
agree as follows:  



All terms in capital letters shall
have the meaning as defined in the Assignment Agreement.  



Upon execution of this document The
Republic of China shall be included in the Territory and all rights and obligations in
the Assignment Agreement related to the Territory shall include China as well.  



30 Business Days from execution of
this letter Nycomed shall pay to PFC the sum of $ *.  



30 Business Days from grant of first
regulatory approval in the Republic of China, Nycomed shall pay to PFC the sum of $ *.  



            The
Parties have caused this Letter to be executed as of the date first written above by
signature of their duly authorized representatives. 





	PFC THERAPEUTICS LLC


	
	By:   	 
	
	Title:	 
	






	NYCOMED DANMARK APS


	
	By:   	 
	
	Title:	 
	












* Certain information on this page
has been omitted and filed separately with the Commission.  Confidential treatment has
been requested with respect to the omitted portions. 










EXHIBIT 1.18 



TERRITORY 



	The EU
(the below          
 And any other          

countries joining the          

EU during the term          

of the agreement)          
	The CIS                                   
	Europe                    

outside the EU                    
	The Middle East          

	Austria	Armenia	Albania	Bahrain
	

	Belgium	Azerbadjan	Andorra	Egypt
	

	Denmark	Belarus	Bosnia-Herzegovina	Iran
	

	Finland	Georgia	Bulgaria	Iraq
	

	France	Kazakstan	Croatia	Israel
	

	Germany	Kyrgyzstan	Croatia	Jordan
	

	Greece	Moldova	Cyprus	Kuwait
	

	Ireland, Rep. of	Russia	Czech Republic	Lebanon
	

	Italy	Tadsjikistan	Estonia	Oman
	

	Luxembourg	Turkmenistan	FYR Macedonia	Qatar
	

	Netherlands	Ukraine	Hungary	Saudi Arabia
	

	Portugal	Uzbekistan	Iceland	Syria
	

	Spain		Latvia	United Arab Emirates
	

	Sweden		Liechtenstein	Yemen
	

	United Kingdom		Lithuania
	

			Malta
	

			Monaco
	

			Norway
	

			Poland
	

			Romania
	

			San Marino
	

			Serbia-Montenegro
	

			Slovakia
	

			Slovenia
	

			Switzerland
	

			The Vatican State
	

			Turkey
	

			Yugoslavia
	























Exhibit 1.32 



PRODUCT AND SCIENTIFIC
DATA 



[Exhibit begins on
following page.] 








































		
	Alliance Pharmaceutical	Oxygent Overview of Clinical and Preclinical Data  
	San Diego, California, USA






TABLE OF CONTENTS 



			
	I 	
EXECUTIVE SUMMARY 	2  
	      A 	      Background Information 	2  
	      B 	      Information included in this Document	3  
	II 	
REVISED CLINICAL DEVELOPMENT PLAN FOR OXYGENT 	4  
	      A 	      Product Data and Background Information 	4  
	            1	            Product Data	4 
	            2	            Background Information	4 
	      B 	      New Phase 3 Protocol for Transfusion Indication 	5  
	            1	            Rationale	5 
	            2	            Proposed Phase 3 Study Design	6 
	            3	            Study Design Considerations	8 
	            4	            Blinding and Bias Considerations	9 
	            5	            Design Features to Clarify the Safety Profile of Oxygent	10 
	            6	            Rationale for 2.7-g PFC/kg Dose	12 
	            7	            Protocol Schematic for Proposed Phase 3 Study	14 
	            8	            Schedule of Visits, Tests, and Assessments for Proposed Phase 3 Study	16 
	      C 	      Additional Clinical Studies and Planned in Support of indication 	20  
	            1	            Phase 2 High-Dose Study	20 
	            2	            Phase I Pharmacokinetic Study	20 
	III 	
PREVIOUS HUMAN EXPERIENCE 	21  
	      A 	      Overview of Completed Studies 	21  
	      B 	      Summary of Phase 3 Study in General Surgery Subjects (OXHT-014-INT) 	29  
	            1	            Study Design	29 
	            2	            Evaluation of Efficacy	30 
	            3	            Evaluation of Safety	32 
	            4	            Conclusions	34 
	      C 	      Summary of Phase 3 Study in Cardiopulmonary Bypass Subjects (OXHT-017-INT) 	35  
	            1	            Study Design	35 
	            2	            Evaluation of Efficacy	36 
	            3	            Evaluation of Safety	36 
	            4	            Conclusions	40 
	      D 	      Human Pharmacokinetic Data 	41  
	            1	            Pharmacokinetics in Healthy Volunteers	41 
	            2	            Pharmacokinetics of Oxygent in Subjects Undergoing Noncardiac Surgical Procedures	42 
	            3	            Pharmacokinetics of Oxygent in Subjects Undergoing Cardiac Surgical Procedures	43 
	IV 	
NONCLINICAL PROGRAM 	45  
	      A 	      Nonclinical Pharmacology 	45  
	            1	            Efficacy Studies	45 
	            2	            Safety Studies	45 
	      B 	      Nonclinical Toxicology 	45  
	      C 	      Nonclinical Pharmacokinetics, Distributions, and Drug Metabolism 	45  
	V 	
REFERENCES 	47  
	
APPENDICES 
	
APPENDIX A: NONCLINICAL SUMMARY 
	APPENDIX B: BLOOD HARVESTING TECHNIQUES AND RISKS OF ALLOGENEIC BLOOD TRANSFUSTIONS 






			
	April 2003 	1 	CONFIDENTIAL 















Exhibit 1.34 



QUALITY AGREEMENT 



[Exhibit begins on following
page.] 



































Template/Draft2 





			
	Date:		 

	Number of pages:		 

	Copies:		 

	Name and number

of Appendices:		
 

			 

			 

			 













QUALITY (GMP)
AGREEMENT
FOR
THIRD PARTY CONTRACT
MANUFACTURE  



Between  



NYCOMED DANMARK APS,
&

PFC THERAPEUTICS LLC
&
THIRD PARTY
MANUFACTURER  






















A G R E E M E N T 



        THIS
AGREEMENT (the “QA Agreement”), is made on March xx 2004 between Nycomed
Danmark ApS, whose registered office is at Langebjerg 1, 4000 Roskilde Denmark,
hereinafter referred to as “NYCOMED”, and PFC Therapeutics, whose registered
office is at 6175 Lusk Boulevard, San Diego, C.A. 92121 USA, hereinafter referred to as
the “PFC” and PFC’s assigned Third Party Contract Partner referred to as
“PFC’s TPCP.  




        WITNESSETH  




WHEREAS NYCOMED and PFC have entered
into an agreement dated March xx, 2004 concerning Development, Assignment and Supply
agreement (hereinafter “the Development Agreement”) relating to transfer of
rights to and relating to the supply of the product OXYGENT/ AF 014 (hereinafter “the
Product”). 



WHEREAS PFC will have the Product
supplied to Nycomed manufactured by PFC’s TPCP 



NOW THEREFORE, the parties hereto have
adopted and are bound by the following conditions of this Agreement: 



        The
contract manufacture of the Product shall be performed as stipulated in the Nycomed
Marketing Authorization and the documentation material exchanged between NYCOMED, PFC and
PFC’s TPCP.  




This documentation material is part
of the basis of the approval by the relevant Health Authorities as well as NYCOMED’s
quality control procedures. 



	1.  	Drug
Law Regulations  






	1.1  	PFC’s
TPCP will under PFC’s responsibility perform obligations under this QA Agreement, as
PFC has previously informed NYCOMED that PFC’s TPCP will perform that obligation.
Accordingly, PFC’S TPCP will be mentioned as a responsible party under this QA
Agreement. However, notwithstanding anything to the contrary, PFC shall not delegate the
manufacture and final release of the (bulk) product to any other third party without
Nycomed’s prior written consent. 






	1.2  	PFC
and PFC’S TPCP are jointly and severally liable towards Nycomed for acts and
omissions under the performance of the obligations in the QA Agreement, notwithstanding
whether the obligation is contributed to PFC or PFC’S TPCP. 






	1.3  	PFC’S
TPCP affirms that it holds the required Manufacturing Authorization (as defined in the
Development Agreement) pursuant to the local Drug Law for the manufacture of the product
listed in Appendix 1 (herein referred to as the PRODUCT.) 






	1.4  	The
parties shall be obliged to immediately advise each other’s Contact Department and
Individuals (art. 10) of any changes in the Manufacturing Authorization with regard to
the PRODUCT. 






	1.5  	PFC'S
TPCP shall be obliged to forward to NYCOMED a copy of PFC'S TPCP's Manufacturing
Authorization          (art. 1.1) in case of changes or updates.















	1.6  	The
manufacture will take place at:






XXXXX  



	1.7  	PFC’S
TPCP and PFC warrant that the PRODUCT is manufactured according to and upon delivery in
any respect corresponds to the documents and specifications agreed upon and inserted in
the Nycomed Marketing Authorization as specified in Appendix 2. 






	1.8  	PFC’S
TPCP and PFC warrant that the PRODUCT will be manufactured, analysed and stored according
to the at all time governing US and EU-Guide to Good Manufacturing Practice for Medicinal
Products, as well as the agreed directives of NYCOMED. (art.1.1) 






	1.9  	PFC’S
TPCP and PFC carries any and all responsibility of faults or damage caused during the
manufacture of the PRODUCT in deviation of this Quality agreement. 






	1.10  	NYCOMED’s
manufacturing and quality control/assurance personnel as well as the responsible
supervisory authorities have the right at any given time during normal working hours, to
enter into and inspect PFC’S TPCP’s production facilities and quality
systems/documents for the PRODUCT, upon reasonable prior notice to both PFC and PFC’S
TPCP. 






	2.  	Starting
Materials and Packaging Materials  






	2.1  	The
starting materials and packaging materials for manufacture of the Bulk Drug PRODUCT shall
be provided by PFC and PFC’S TPCP, checked for accordance with the specifications
contained in the Nycomed Marketing Authorizations as listed in Appendix 3, and
approved for manufacturing by PFC’S TPCP. 






	2.2  	PFC
and PFC’S TPCP are responsible for auditing and qualifying vendors of the Active
Pharmaceutical Ingredients (API’s) and starting materials for the PRODUCT. 






	2.3  	The
secondary printed packaging materials for the Finished Drug PRODUCT specified in the
Nycomed Marketing Authorization’s shall be provided by NYCOMED, checked for
accordance with the specifications, and approved for manufacturing by NYCOMED. 






	3.  	Manufacture  






	3.1  	The
PRODUCT shall be manufactured in batches, ensuring adherence to the NYCOMED Marketing
Authorization as well as ensuring the quality in accordance with the US and EU Guidelines
for Good Manufacturing Practices. 






	3.2  	PFC
and PFC’S TPCP agree neither to make changes to the manufacturing process nor to
assign manufacture to third parties without having obtained the prior written consent of
NYCOMED. 






	3.3  	If,
due to a change or variation, validation is considered appropriate by PFC’S TPCP,
the validation protocol and the validation report shall be agreed upon and approved by
NYCOMED. 






2 










	4.  	Quality Controls during
and after manufacture  







	4.1  	PFC'S
TPCP shall conduct final quality controls according to the NYCOMED Marketing
Authorization.






	4.2  	PFC'S
TPCP is responsible for monitoring the stability of the finished Bulk PRODUCT according
to the EU          GMP.






	4.3  	Nycomed
is responsible for the conduct of import analysis as a full finished product analysis at
the first entry to EU for products to be marketed by Nycomed in the EU. 






	4.4  	PFC'S
TPCP is responsible for conduct of annual Product Quality Review according to the EU GMP.






	5.  	Retention
of Reference Samples  






	5.1  	PFC’S
TPCP shall retain reference samples of all starting materials and packaging materials
provided by PFC and PFC’S TPCP as well as reference samples of the manufactured bulk
PRODUCT for 6 years, or at least 1 year past the expiry date, whichever is the later. 






	5.2  	NYCOMED
shall retain reference samples of the released finished drug PRODUCT for 6 years or at
least 1 year past the expiry date, whichever is the later. 






	6.  	Documentation  






	6.1  	PFC’S
TPCP shall keep records on all manufacturing and control steps on the basis of
EU-GMP-guidelines and keep same for a minimum of 10 years. 






	6.2  	PFC’S
TPCP shall allow NYCOMED and/or the responsible supervisory authority to inspect all
testing and manufacturing documentation related to the product. 






	7.  	Release  






	7.1  	NYCOMED
shall receive copies of the Complete Batch Documentation with the first 3 batches of the
Bulk PRODUCT.






	7.2  	Release
of Bulk PRODUCT is the responsibility of PFC’S TPCP. Release will be conducted
according to PFC’S TPCP’s internal procedures agreed with NYCOMED and PFC,
based upon the requirements stipulated in the NYCOMED Marketing Authorizations. 






	7.3  	PFC’S
TPCP shall issue a detailed certificate of analysis thereon including date of manufacture
and expiry date, signed by PFC’S TPCP’s Authorised Person, and containing the
following statement: “This is to certify that this Product batch was manufactured
and released in accordance with the Quality (GMP) Agreement of 27.08.03 between PFC, PFC’S
TPCP and NYCOMED, and Current US and EU Good Manufacturing Practices”. 






	7.4  	For
further batches NYCOMED shall receive an Abridged Batch Documentation, which shall
contain as a minimum: 






3 










	 	7.4.1 	Certificate
of Compliance in the form of a short manufacturing report:






	 	7.4.2 	Results
of in-process control; and






	 	7.4.3 	A
detailed Certificate of Analysis. 






	8.  	Storage,
Packaging  






	8.1  	PFC’S
TPCP shall be responsible for storage of all starting materials and Bulk PRODUCT, as well
as for packaging the Bulk PRODUCT for transportation in suitable and well-closed
containers. 






	8.2  	The
shipping containers for the Bulk PRODUCT shall be provided by PFC’S TPCP displaying
the following data: 






	 	8.2.1 	Name
and address of Nycomed Danmark ApS, Langebjerg 1, 4000 Roskilde Denmark. 






	 	8.2.2 	Product
name including strength and dosage form as well as NYCOMED’s Item number (Material
number), stated on the Purchase Order from NYCOMED. 






	 	8.2.3 	Quantity
(gross and net weight), number of units.






	 	8.2.4 	Batch
number. 






	 	8.2.5 	Expiry
date. 






	9.  	PRODUCT
DEFECTS  






	9.1  	PFC'S
TPCP shall:






	 	9.1.1 	respond
to queries concerning PRODUCT defects as fast and comprehensively as possible.






	 	9.1.2 	make
available to NYCOMED the relevant batch documentation in the event of PRODUCT defects.
This shall also apply if an authority requests it. 






	9.2  	If
quality control conducted at NYCOMED proves that the PRODUCT or its documentation is not
in accordance with this Agreement and the jointly established documentation, NYCOMED is
entitled to reject that batch. In the event of disagreement as to the quality of the
PRODUCTS the procedures set out in the Development Agreement subsection 9.4 shall apply. 






	10.  	CONTACT
DEPARTMENTS AND INDIVIDUALS  






	10.1  	PFC'S
TPCP agree to provide answers as soon as possible, to all enquiries and complaints from
NYCOMED.






	10.2  	Any
communication between NYCOMED, PFC and PFC’S TPCP regarding the Quality Agreement
shall be addressed to the following Position/Individuals unless an other
Position/Individual is appointed and notification of such replacement has been sent to
the other party: 







4 












		
	NYCOMED Danmark

Contact Individual

Contact Position  

Telephone number  

Fax number        

24 hour contact   


	
Mr.  Ernst Bachmann

 Responsible Pharmacist

+45 46 77 13 33

+45 46 75 66 40

+45 46 77 11 11

	PFC:

Contact Individual          

Contact Position

Telephone number

Fax number

24 hour contact phone number


	
XXXX

	PFC's TPCP

Contact Individual

Contact Position:

Telephone Number:           

Fax number:                 

24 hour Contact phone number
	


+

+







 


Authorised Person: 



NYCOMED:


 






Name: Mr Ernst Bachmann 



Title: Responsible Pharmacist 



Date:


 



PFC.


 







Name: 



Title: 



Date: 








5 















PFC’S TPCP:


  






Name:  



Title:  



Date:  

























6 














APPENDIX 1 



TO THE
QUALITY (GMP) AGREEMENT
FOR
THIRD PARTY CONTRACT
MANUFACTURE 



between 



NYCOMED 



and 



PFC 



& 



PFC’S TPCP 



     



PRODUCT 



OXYGENT/AF 0144 

























APPENDIX 1 



TO THE
QUALITY (GMP) AGREEMENT
FOR


THIRD PARTY CONTRACT MANUFACTURE 



Between 



NYCOMED 



and 



PFC 



& 



PFC’S TPCP 



     




		NYCOMED
	PFC
	PFC'S

TPCP

				
	Responsible for:	 	 	 
	 
	ACTIVE PHARMACEUTICAL INGREDIENT ("Any substance which is intended to furnish
	pharmacological activity or other direct effect")
	 
	•    Quality specifications for active ingredient (including update	•	•	•
	following changes in legal requirements and recommendations):
	 
	•    Supply of active ingredient:		•	•
	 
	•    Auditing and Qualification of Vendors		•	•
	 
	•    Inspection, testing and release of active ingredient:			•
	 
	•    ID test of active ingredient before release for manufacture			•
	 
	•    Retention of batch control records for active ingredient:			•
	 
	•    Retention of batch control records for ID test on active ingredient:			•
	 
	•    Retention of reference samples of active ingredient:			•
	 












		NYCOMED
	PFC
	PFC'S

TPCP

				
	STARTING MATERIALS (In this Enclosure meaning: "Any substance
	used in the production of a medicinal product, but excluding
	active ingredients and packaging materials")
	 
	•    Quality specifications for starting materials (including update	•	•	•
	following changes in legal requirements and recommendations):
	 
	•    Supply of starting materials:			•
	 
	•    Inspection, testing and release of starting materials:			•
	 
	•    ID test of starting materials before release for manufacture			•
	 
	•    Retention of batch control records for starting materials:			•
	 
	•    Retention of batch control records for ID test on starting materials:			•
	 
	•    Retention of reference samples of starting materials:			•
	 
	BULK PRODUCT ("Any product which has completed all
	processing stages up to, but not including, final packaging")
	 
	•    Master Manufacturing formula and method:			•
	 
	•    Manufacturing of bulk product including in-process controls:			•
	 
	•    Quality control specification for bulk product (including update	•		•
	following changes in legal requirements and recommendations):
	 
	•    Inspection, testing and release of bulk product:			•
	 
	•    Retention of batch manufacturing records for bulk product:			•
	 
	•    Retention of control records for bulk product:			•
	 
	•    Retention of reference sample of bulk product:			•
	 
	•    Packaging of bulk product for distribution to NYCOMED:			•
	 
	•    Annual product quality review of the manufacturing process in			•
	the light of experience:
	 
	PACKAGING MATERIALS ("Any material employed in the
	packaging of a medicinal product, excluding any outer
	packagings used for transportation or shipment. Packaging
	materials are referred to as primary or secondary according
	to whether or not they are intended to be in direct contact
	with the product")
	 
	•    Quality specifications for packaging materials (including update	•		•
	following changes in legal requirements and recommendations):
	 
	•    Supply of packaging materials:			•
	 
	•    Approval of master for printed packaging materials:			•
	 
	•    Inspection, testing and release of packaging materials:			•
	 
	•    Retention of batch control records for packaging materials:			•
	 
	•    Retention of reference samples of packaging materials:			•
	 












		NYCOMED
	PFC
	PFC'S

TPCP

				
	PACKAGING ("All operations, including filling and labelling,
	which a bulk product has to undergo in order to become a
	finished product. Note: Sterile filling would not normally be
	regarded as part of packaging, the bulk product being the filled,
	but not finally packaged, primary containers")
	 
	•    Master packaging instruction:			•
	 
	•    Allocation of batch number:			•
	 
	•    Filling in primary packaging material including in-process controls:			•
	 
	•    (Ink-Jet)Labelling of primary packaging material including in-process			•
	controls:
	 
	•    Packaging in secondary packaging material including in-process controls:	•		
	 
	•    Labelling of secondary packaging material including in-process controls:	•		
	 
	•    Retention of batch packaging records:	•		
	 
	PRODUCT (cf. Appendix 1)
	 
	•    Specifications (including update following changes in legal	•		•
	requirements and recommendations):
	 
	•    Inspection, testing and release of Bulk Product for distribution to			•
	 
	NYCOMED:
	 
	•    Inspection and release of Product or Finished Product for sale by	•		
	 
	Qualified Person (cf. 2001/83/EC):
	 
	•    Holder of Marketing Authorization:	•		
	 
	•    Retention of reference sample for finished Product:	•		
	 
	•    Retention of import control records for finished Product:	•		
	 
	STABILITY MONITORING, (post marketing)
	 
	•    Bulk product Stability programme and evaluation of result:			•
	 
	PRODUCT QUALITY REVIEW
	 
	•    Annual product quality review with regard to manufacture and control (as
	a result of technical and scientific development)
	 












		NYCOMED
	PFC
	PFC'S

TPCP

				
	COMPLAINTS & RECALLS
	 
	•    Collection of complaints:	•		
	 
	•    Investigation of complaints:	•		•
	 
	•    Corrective action:			•
	 
	•    Answer to complainant:
	 
	•    Filing:	•		•
	 
	•    Recall:	•		



































APPENDIX 3 



TO THE
QUALITY (GMP) AGREEMENT
FOR

THIRD PARTY CONTRACT MANUFACTURE 



Between 



NYCOMED 



and 



PFC 



& 



PFC’S TPCP

 



     



PRODUCT SPECIFICATIONS as approved in
the relevant Nycomed Marketing Authorizations. 



MA number in EU 



MA number in other territories 





























	3.  	PHYSICAL,
CHEMICAL, AND PHARMACEUTICAL PROPERTIES AND FORMULATION  






	3.1  	AF0144  






The drug product, AF0144, is an
emulsion of * and * in * saline that is terminally heat sterilized,
pyrogen-free, and milky white to off-white in appearance, AF0144 is a *% w/v * emulsion (*
in * of emulsion) containing *% w/v *, *% w/v/ *, and *% w/v *. AF0144 has an osmolality
of * to *, a pH of *, and a viscosity of approximately *. 



	3.2  	CHEMISTRY
OF ACTIVES PHARMACEUTICAL INGREDIENTS  






AF0144 contains * active
pharmaceutical ingredients: *. 



The chemical formula of * is *. Its
structure is *. The Chemical Abstract Service (CAS) number is *. Other physical parameters
include: 




	 	Boiling point
Vapor pressure 	
                            *
* 








The chemical formula of * is *. Its
structure is *. The CAS number is *. Other physical parameters include: 




	 	Boiling point
Vapor pressure 	
                            *
* 









	3.3  	SUPPLY
AND STORAGE  






AF0144 is supplied in * single-use
bottles labeled with the formulation number. The bottle is sealed with a spikable rubber
stopper and an aluminum overseal. AF0144 must be stored refrigerated between *. Storage
below * may result in freezing. If AF0144 is frozen, it should not be used. 















* Certain information on this page
has been omitted and filed separately with the Commission.  Confidential treatment has
been requested with respect to the omitted portions. 












EXHIBIT 5.1 










KEY PERSONNEL AND
COMMITTEE MEMBERS 



KEY PERSONNEL


 



	PFC  	NYCOMED  






	 	
Peter
Keipert
Simon Faithful
Ernst G. Schutt
Leo
Trevino (currently employed by IMCOR )
John
Wurst 










JOINT DEVELOPMENT
COMMITTEE MEMBERS


  



	PFC  	NYCOMED 

































EXHIBIT 8.5 



LETTER OF ASSIGNMENT
AND ASSUMPTION 



[EXHIBT BEGINNING ON
FOLLOWING PAGE] 




































        THIS
ROYALTY PAYMENT AND RELEASE AGREEMENT, dated as of March 25, 2004 (this “Agreement”),
is entered into by and between Nycomed Danmark APS, a Danish corporation (“Nycomed”),
and Baxter Healthcare Corporation, a Delaware corporation (“Baxter”).  




W I T N E S S E T H 



        WHEREAS,
Baxter, Alliance Pharmaceutical Corp., a New York corporation (“Alliance”) and
PFC Therapeutics, LLC a Delaware limited liability company (“PFC”) are party to that
certain Percentage Fee Agreement, effective as of June 19, 2003
(the “Percentage Fee Agreement”) pursuant to which Baxter obtained a
security interest in certain intellectual property rights owned by Alliance, including,
among others, the European patents (defined below) in the European Territory (defined
below) (the “European Oxygent Patents”);  





        WHEREAS,
PFC is the owner of all right, title and interest in the European Oxygent Patents by
assignment from Alliance;  





        WHEREAS,
simultaneously herewith PFC is assigning all right, title and interest in the European
Oxygent Patents to Nycomed;  





        WHEREAS,
the parties hereto desire that Baxter release its security interests in the right, title
and interest of Alliance and PFC in the European Oxygent Patents; and  





        WHEREAS, in
exchange for the releases described in the immediately preceding paragraph
          Nycomed is willing to undertake the royalty payment obligations set forth
          herein.  





        NOW,
THEREFORE, in consideration of the premises and for other valuable consideration, the
receipt and sufficiency of which the parties hereto hereby acknowledge and agree as
follows:  





	1.  	Definitions  






        As
used herein, the following terms shall have the following meanings:  




        “European
Gross Sales” means the gross revenue, receipts or value of credits received from
the sale; if any, of all European Products in the European Territory (as defined below),
including the fair market value of goods or services received in barter transactions, net
only of returns and allowances in the ordinary course of business.  




        “European
Patents” means the patents listed in Schedule A hereto.  




        “European
Products”means all injectable perflurochemical emulsions capable of transporting
oxygen in therapeutic amounts in the bloodstream for all medical uses, including
therapeutic and diagnostic, covered by the European Oxygent Patents, which will be
evaluated, developed, and/or acquired during the term of this Agreement to the extent
owned by, licensed to or controlled by Nycomed or its licensees and affiliates,
including, but not limited to, those products specifically listed on Schedule [A] hereto.  




        “European
Territory” shall have the meaning set forth on Schedule B hereto.  













        “Maximum
Percentage Fee” means $* (US $ *). 




        “Royalty”means
*% of European Gross Sales, if any, of the European Products.  




        “Products”means
all injectable perflurochemical emulsions capable of transporting oxygen in therapeutic
amounts in the bloodstream for all medical uses, including therapeutic and diagnostic,
which have been evaluated, developed and/or acquired prior to this Agreement or will be
evaluated, developed, and/or acquired during the term of this Agreement to the extent
owned by, licensed to or controlled by Alliance, PFC or their licensees and affiliates.  




	2. 	Payments






	(a)  	In
the event of any European Gross Sales of the European Products, Nycomed
               agrees to pay Baxter the Royalty up to, but not in excess of, the Maximum
               Percentage Fee; provided that once Baxter has received an aggregate
               amount equal to the Maximum Percentage Fee in respect of the Products,
whether                pursuant to this Agreement, the Percentage Fee Agreement or any
other agreement,                the payment obligations under this Section 2(a) shall
immediately terminate. 






	(b)  	The
Royalty owed by Nycomed to Baxter shall be calculated on a semi-annual
               calendar basis (the “Royalty Period”) and shall be
               payable no later than sixty (60) days after the termination of the
preceding                semi-annual period. Each such Royalty Period shall commence on
the first (1st)                day of each January and each July and shall continue for
six (6) months; provided that the first Royalty Period shall begin on the date
hereof and                the last Royalty Period shall end on the date of the
termination hereof. 






	(c)  	For
each Royalty Period, Nycomed shall provide Baxter with a written Royalty
               payment statement in a form reasonably acceptable to Baxter. Such Royalty
               payment statement shall set forth the European Gross Sales of the European
               Products and any Royalty payable hereunder for the applicable Royalty
Period.                Such statements shall be furnished to Baxter hereunder regardless
of whether any                European Products were sold during the applicable Royalty
Period or whether any                actual Royalty was owed during such period. 






	(d)  	All
payments due to Baxter from Nycomed hereunder shall be converted into U.S.
              Dollars at the average rate of exchange for the Royalty Period for
which                payments are being remitted according to Nycomed’s normal
procedures for                calculating the same and shall be made by check or wire
transfer to a designated                Baxter account. If the transfer or conversion
into U.S. Dollars in any such                instance is not lawful or possible, the
payment of each party of the                payments due, as is necessary, shall be
made by the deposit thereof, in whatever                currency is allowable, to the
credit and account of Baxter’s choice located                in that country. Prompt
notice of said deposit shall be given by Nycomed to                Baxter. 






	(e)  	Any
income or other taxes that Nycomed is required to pay or withhold on behalf
               of Baxter with respect to amounts payable to Baxter under this Agreement
shall be                deducted from such amounts payable. Nycomed shall furnish Baxter
with proof of                such payments. Any such tax required to be paid or withheld
shall be an expense                of and borne solely by Baxter. Any amounts withheld by.
or paid to a third party                by, Nycomed pursuant to this paragraph shall be
considered as having been paid                to Baxter pursuant to paragraph (a) above
for purposes of determining whether                the Maximum Percentage Fee has been
paid. 










        *
Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted
portions. 



2 









	(f)  	The
receipt or acceptance by Baxter of any Royalty payment statement or payment
               shall not prevent Baxter from subsequently challenging the validity or
accuracy                of such statement or payment. 






	(g)  	Late
payments shall incur interest at the lesser of the rate of *               (*%)
per month or the maximum rate allowed by law from the date such payments
               were originally due. 






	3. 	Audit






	(a)  	Baxter
shall have the right upon reasonable notice to appoint an independent
               certified public accountant, to which Nycomed has no reasonable objection,
to                inspect Nycomed books and records and all other documents and material
in                Nycomed’s possession or control relating to the determination of
the                Royalty payable to Baxter hereunder, during normal business hours for
the                purpose of verifying the amounts payable as provided in this Agreement
for the                three (3) preceding years; provided, however, that
this right may                not be exercised more than once in any calendar year, and
said accountant, under                an obligation of confidentiality to Nycomed, shall
disclose to Baxter only                information relating to the accuracy of the
Royalty statements and the payments                made according to this Agreement. 






	(b)  	In
the event that such inspection reveals an underpayment by Nycomed of the
               actual Royalty owed Baxter, Nycomed shall pay the difference, plus
interest                calculated at the rate of * (*%) per month or the maximum rate
allowed by law                from the date such payments were originally due. If such
underpayment is in                excess of $* for any Royalty Period, Nycomed shall also
reimburse Baxter for the                cost of such inspection. 






	(c)  	All
books and records relative to Nycomed’s obligations hereunder shall be
               maintained in a location where such books and records are customarily kept
by                Nycomed and made accessible to Baxter for inspection at such location
for at                least two (2) years after termination of this Agreement. 






	4. 	Release






	(a)  	Baxter
hereby agrees that the liens and security interests of Baxter in the
               right, title and interest of Alliance and PFC in the European Patents, the
               European Products and any proceeds of the foregoing are hereby released
               automatically and without any additional action on the part of the Baxter
or any                other person. 






	(b)  	Baxter
hereby agrees and acknowledges that (i) the assignments by PFC and
               Alliance of the European Patents contemporaneously herewith are effective
and                (ii) Nycomed shall be under no obligations with respect to the
Percentage Fee                Agreement as a result of the assignment by Alliance and PFC
of the European                Patents or otherwise. 










        *
Certain information on this page has been omitted and filed separately with the
Commission. Confidential treatment has been requested with respect to the omitted
portions. 



3 











	(c)  	Baxter
agrees to execute and deliver to Nycomed promptly upon request such
               additional documents as Nycomed may reasonably request to evidence the
               transactions contemplated hereby. 






	(d)  	Baxter
hereby authorizes Nycomed to prepare and file such UCC-3 termination
               statements, patent assignment terminations or other documents as Nycomed
may                reasonably deem necessary or desirable in connection with the
termination of the                security interests granted to Baxter under the
Percentage Fee Agreement without                the signature of Baxter to the extent
permitted by law. 






	5. 	
Assignment and Assumption of European Patents.  Nycomed may assign,
               sell, license or transfer any European Patents (or rights therein), only
upon                the condition that the assignee or transferee expressly assumes the
obligations                to Baxter of Nycomed under this Agreement. In the event that
rights in any of                the European Patents are transferred by means of a
license: (i) if such license                contains a territorial or other restriction
limiting the licensee’s rights                in respect of the sale of European
Products, the condition to such transfer                contained in this Section 5 shall
be deemed satisfied by an express assumption of                the obligations of Nycomed
under this Agreement; provided, however, that the assumption of the
obligation to make Royalty payments                hereunder shall be limited to
Royalties payable in respect of European Gross                Sales by such licensee and
any, direct or indirect, sub-licensee, successor or                assign thereof; and
(ii) the parties shall cooperate with respect to accounting                for any
Royalty payments. 






	6. 	Termination






	(a)  	Unless
earlier terminated pursuant to Section 6(b), this Agreement shall
               terminate upon the earlier of (i) the receipt by Baxter of the Maximum
               Percentage Fee, or (ii) reassignment to PFC of the European Patents. 






	(b)  	Notwithstanding
the foregoing, Nycomed shall have the right to terminate this                Agreement at
any time on thirty (30) days written notice to Baxter such                termination to
become effective at the conclusion of such 30-day period.  If this                Agreement
is terminated pursuant to this subsection 6(b), then Nycomed shall pay                to
Baxter the Maximum Percentage Fee, less any Royalty payments made under this
               Agreement. 






	7. 	Miscellaneous






	(a)  	Further
Assurances. Each party agrees to cooperate fully with the other
               parties and to execute such further instruments, documents and agreements
and to                give such further written assurances as may be reasonably
requested by any                other party to better evidence and reflect the
transactions described herein and                contemplated hereby and to carry into
effect the intents and purposes of this                Agreement. 






	(b)  	Notices. Whenever
any party hereto desires or is required to give any                notice, demand, or
request with respect to this Agreement, each such                communication shall be in
writing and shall be effective only if it is delivered                by personal service
or mailed, United States registered or certified mail,                postage prepaid,
return receipt requested (and shall he deemed to have been                received three
(3) days after deposit into the United States mail), or sent by                prepaid
overnight courier or facsimile, receipt confirmed, addressed as follows: 







4 










		
	If to Baxter: 	With a copy in each case to: 
	Baxter Healthcare Corporation	Butler, Snow, O'Mara, Stevens & 
	One Baxter Parkway	Cannada, PLLC
	Deerfield. Illinois 60015	Post Office Box 22567
	Attn: General Counsel	Jackson, Mississippi. 39225-2567
	Fax No.: 847-948-2450	Attn:Selby A. Ireland
	 	Fax No.: 601-985-4500
	 
	If to Nycomed: 
	Nycomed Danmark ApS
	Langebjerg 1
	4000 Roskilde
	Attn.: General counsel
	Fax No +4766763513	









Unless otherwise stated above, such
communications shall be effective when they are received by the addressee thereof in
conformity with this Section. Any party may change its address for such communications
giving notice thereof to the other parties in conformity with this Section. 



	(c)  	Governing
Law. This Agreement has been entered into and shall be                construed and
enforced in accordance with the laws of the State of New York,                without
reference to the choice of law principles thereof except as provided in
               the UCC as to matters of perfection and priority of security interests. 






	(d)  	Successors
and Assigns. This Agreement may not be assigned by Nycomed,                except
pursuant to Section 5, without the prior written consent of Baxter, which
               will not be unreasonably withheld. This Agreement shall be binding upon
and                shall inure to the benefit of the parties hereto, their legal
representatives,                successors and assigns. 






	(e)  	Severability. If
any provision of this Agreement, or the application                thereof, shall for any
reason or to any extent be invalid or unenforceable, the                remainder of this
Agreement and application of such provision to other persons                or
circumstances shall continue in full force and effect and in no way be
               affected, impaired or invalidated. 






	(f)  	Entire
Agreement. This Agreement, the Schedules and the Exhibits and the
               other agreements and instruments referenced herein constitute the entire
               understanding and agreement of the parties with respect to the subject
matter                hereof and supersedes all prior agreements and understandings. 






	(g)  	Other
Remedies. Except as otherwise provided herein, any and all remedies
               herein expressly conferred upon a party shall be deemed cumulative with
and not                exclusive of any other remedy conferred hereby or by law, or in
equity on such                party, and the exercise of any one remedy shall not
preclude the exercise of any                other. 






	(h)  	Amendments
and Waivers. Any term or provision of this Agreement may                be
amended, and the observance of any term of this Agreement may be waived
               (either generally or in a particular instance and either retroactively or
               prospectively) only by a writing signed by each of the parties hereto
(excluding                Alliance and PFC). The waiver by a party of any breach hereof
or default in the                performance hereof shall not be deemed to constitute a
waiver of any other                default or any succeeding breach or default. This
Agreement may not be amended                or supplemented by any party hereto except
pursuant to a written amendment                executed by each of the parties. 







5 









	(i)  	No
Waiver. The failure of any party to enforce any of the provisions
               hereof shall not be construed to be a waiver of the right of such party
               thereafter to enforce such provisions. 






	(j)  	Counterparts. This
Agreement may be executed in any number of                counterparts, each of which
shall be an original as against any party whose                signature appears thereon
and all of which together shall constitute one and the                same instrument.
This Agreement shall become binding when one or more                counterparts hereof,
individually or taken together, shall bear the signatures                of all of the
parties reflected hereon as signatories. 






	(k)  	No
Third Party Beneficiary. Nothing expressed or implied in this
               Agreement is intended, or shall he construed, to confer upon or give any
person                other than the parties hereto and their respective legal
representatives,                successors and assigns, any rights or remedies under
or by reason of this                Agreement. 






	(l)  	WAIVER
OF JURY TRIAL. EACH PARTY HERETO HEREBY WAIVES, TO THE                FULLEST
EXTENT PERMITTED BY APPLICABLE LAW, ANY RIGHT IT MAY HAVE TO A
               TRIAL BY JURY IN RESPECT OF ANY LITIGATION DIRECTLY OR INDIRECTLY ARISING
OUT OF, UNDER OR IN CONNECTION WITH THIS AGREEMENT.






	(m)  	Confidentiality. The
parties to the Agreement shall disclose any                information provided in the
course of this Agreement, which is a trade secret,                confidential or
proprietary information (including financial information) not                publicly
known only to those of its agents and employees to whom it is necessary                in
order properly to carry out their duties as limited by the terms and
               conditions hereof. Both during and after the term of this Agreement all
               disclosures shall be held in strict confidence by such agents and
employees. 






        IN
WITNESS WHEREOF, the parties hereto have caused this Agreement to be duly executed and
delivered by their respective officers thereunto duly authorized as of the date first
written above.  



		BAXTER HEALTHCARE CORPORATION, a Delaware corporation



		By:   	/s/ Ronald F. Quadrel 

			Name:  Ronald F. Quadrel

Title:  President, Anesthesia & Critical Care








		NYCOMED DANMARK APS, a Danish corporation



		By:   	/s/  Bent
Kjærsgård 

			Name:  Bent
Kjærsgård

Title:  Managing Director









6 













SCHEDULE A 



PATENTS 



ASSIGNOR PATENTS 



	
	
	

	Country      
Application No.      
Patent No.      
	Title / INVENTOR(S)      
	Date Filed      
Date Issued      
Expiration Date      

	Europe	Brominated Perfluorocarbon Emulsions for	13 January 1987
	0 231 070	Internal Animal Use for Contrast	10 June 1998
	(Registered in Germany, Spain, France,	Enhancement and Oxygen Transport / LONG	Exp: 13 Jan 2007
	UK, Italy
	

	Europe	Biocompatible, Stable, and Concentrated	5 August 1988
	0 307 087	Fluorocarbon Emulsions for Contrast	8 June 1994
	(Registered in Austria, Belgium,	Enhancement and Oxygen Transport in	Exp: 5 August 2008
	Germany, Spain, France, UK, Italy,	Internal Animal Use / LONG
	Luxembourg, Netherlands, Sweden)
	

	Ireland	Fluorocarbon Emulsions for In Vivo	5 August 1988
	2416/88	Use / LONG	6 July 1995
	64245		Exp: 5 August 2008
	

	Norway	Fluorocarbon Emulsions for In Vivo	4 August 1988
	19883456	Use / LONG	21 August 1996
	179162		Exp: 4 August 2008
	

	Europe	Fluorocarbon Emulsions Having Saturated	5 July 1989
	0 480 925	PhospholAssigned Texchnologyid	24 September 1997
	(Registered in Austria, Belgium, France,	Emulsifiers / LONG	Exp: 5 July 2009
	Germany, Italy, Luxembourg, 
	Netherlands, Sweden, Switzerland, UK)
	

	Europe	AmphAssigned Technologyhilic Fluorine	8 August 1991
	0 548 096	Derivatives with Telomeric Structures;	8 November 1995
	(Registered in Austria, Belgium,	Preparation Procedure and Biomedical	Exp: 08 Aug 2011
	Switzerland/Liechtenstein, Germany,	Applications / PAVIA, PUCCI, RIESS,
	Denmark, Spain, France, UK, Greece,	ZARIF
	Italy, Luxembourg, Netherlands, 
Sweden)
	

	Europe	Stabilization of Fluorocarbon Emulsions /	27 October 1993
	0 666 736	WEERS, KLEIN, JOHNSON	18 December 1996
	(Registered in Germany, Denmark, 		Exp: 27 Oct 2013
	France, UK, Italy)
	

	Europe	Fluorocarbon Emulsions with Reduced	1 March 1994
	94910799.9	Gas-Trapping Properties / WEERS, SCHUTT,	14 July 1999
	0 689 422	PELURA, KEAssigned TechnologyERT	Exp: 1 March 2014
	(Registered in Belgium, Germany, 
	Denmark, Spain, France, UK, Italy, 
Sweden
	






7 













SCHEDULE B 



EUROPEAN TERRITORY 





					
	

	EU:	Sweden	Croatia	Kazakhstan	 
	

	Germany	 	Bosnia	Kyrgystan
	

	Netherlands	 	Yugosloavia	Moldova
	

	Belgium	EUROPE	Romania	Russia
	

	Luxembourg	OUTSIDE EU:	Bulgaria	Turkmenistan
	

	France	Norway	Macedonia	Tadsjikjstan
	

	Denmark	Estonia	Albania 	Ukraine	
	

	United Kingdom	Lithuania	Greece	Uzbekistan
	

	The Republic of	Latvia	Monaco	 
	

	Ireland	Poland	 	OTHER:
	

	Spain	Switzerland	 	Egypt
	

	Portugal	Slovenia	CIS:	Turkey
	

	Italy	Slovakia	Armenia	China
	

	Austria	Czech Republic	Azebadjan	 
	

	Finland	Hungary	Belarus	 
	



























EXHIBIT 9.6 



PHARMACOVIGILANCE 



[EXHIBT BEGINNING ON
FOLLOWING PAGE] 






































Pharmacovigilance
Agreement on (product name) 


 


between  



(Other Company Name)  



and  



Nycomed  





































Preamble 



The parties shall establish a
system for exchanging of safety information on (product name). The system shall enable
both parties to meet the safety regulatory requirements imposed by authorities both
locally and internationally and to follow current international guidelines. 



Specific
Pharmacovigilance Agreement 



1.   Agreement 



		
	

	Area/countries covered: 	 
	

	Type of agreement: 	�   Co-promotion
	 	�   Distribution agreement
	 	�   Granting MA holdership
	 	�   Other:
	

	Scope of agreement: 	Exchange of all relevant safety data as specified in
	 	Pharmacovigilance Guidelines CPMP/PhVWP/108/99 and
	 	national requirements. This includes:
	 	Reports from any source.
	








2.   Product 




		
	

	Product (generic name(-s): 	 
	

	Product (preferred brand name): 
	

	Type of product: 	�   Raw material
	 	�   Bulk tablets
	 	�   Finished product
	









3.   Territory 



		
	

	Area/countries covered: 	 
	


















4.   Licensing partners 



		
	

	Licensor: 	Nycomed
	

	Licensee: 	(Other Company Name)
	

	Market Authorisation Holder: 	Nycomed or Other Company Name
	









5.   Status of product 



		
	

	Regulatory status: 	�   EU centralised procedure
		�   Mutual recognition procedure
		�   National procedure
		�   Other, Specify:
	









6.   Pharmacovigilance 



		
	

	Format 	According to CPMP/PhVWP/108/99 ( Line-Listings for Non-SADR’s
	 	and PSUR’s).and CIOMS form (SADR’s) or E2B for electronic
	 	submission.
	

	Definitions 	AE, ADR, SAE, SADR, Minimum Information, PSUR’s,
	 	Line-Listings, CCSI, Unexpected, Listed, Unlisted and
	 	Timeframes according to CPMP/Ph/VWP/108/99.
	

	Data Elements 	The data to be transmitted between parties for individual
	 	case reports shall comply with Definitions above. The minimum
	 	requirement is the defined Minimum Information, but a full
	 	report is required whenever possible. - In case of use of
	 	electronic exchange E2B format information in all major
	 	fields (re ICH E2B guideline) must be complied with)
	

	Final Causality and medical assessment 	Is the responsibility of Licensor.
	 	Nycomed performs the final causality for the PSUR.
	

	Causality and medical assessment standards: 	Terms to be used by Licensor:
	 	Probable: good reasons and sufficient documentation to assume
	 	a causal relationship.
	 	Possible: A causal relationship is conceivable and cannot be
	 	dismissed.
	 	Unlikely: The event is most likely related to an etiology
	 	other than the drug.
	 	Not related: A reaction on which sufficient information
	 	exists to indicate that the etiology is unrelated to the
	 	product.
	 	Not assessable: Causality is not assessable, e.g. because of
	 	insufficient evidence, conflicting data or poor documentation.
	







2 








		
	

	Safety Actions: 	Any possible safety actions related to the product -as for
	 	example:
	 	changes to the SPC communications with regulatory authorities
	 	or the medical profession shall be send to Licensor in a
	 	timely manner for information. If specific safety measures
	 	are to be taken, the Licensee shall ensure the implementation
	 	of such in the territory.
	

	Safety Manager: 	Licensee shall designate a qualified person, Safety Manager,
	 	to be responsible for handling adverse events. Licensor shall
	 	be notified immediately of any changes to this.
	

	Regulatory Reporting: 	Reports received by Licensee from Licensor shall be reported
	 	to Local Drug Regulatory authority according to national
	 	regulation.
	

	Time frames for reporting:(definition of 	Serious Adverse Drug Reactions:  
	seriousness according to ICH)	All SADR’s and follow-up reports hereof shall be reported
	 	immediately and in English - within max.3 working days -
	 	after recognition by Licensee to Licensor by telephone,
	 	e-mail or fax. The report must fulfil at least the Minimum
	 	Information (see: Definitions).
	 	Licensor will report probably or possibly related SADR's from
	 	any market to Licensee within 10 calendar days after receipt
	 	of a valid report.
	 	Non-serious Adverse Drug Reactions:  
	 	Non-serious ADR’s shall be reported by Licensee to Licensor
	 	within 30 calendar days after recognition.
	 	Licensor will report all probably or possibly related adverse
	 	events occurring in other markets to the Licensee by
	 	6-monthly updates/listings.
	







3 








		
	

	Literature reviews, 	Licensor 
	Main responsible unit:
	Local responsibility:
	 	Licensee
	

	Periodic Safety Updates, 	Licensor 
	Responsibility to provide:
	For which countries and time intervals?	Licensee Fill in relevant information
	

	Company Core Safety Information 
	(CCSI) (or harmonized SPC) 	Licensor 
	Responsibility to prepare and update:
	

	Clinical trials 	If Licensee wishes to perform a local trial (third party
	General:  	clinical trial) , Licensor must receive the final protocol.
	 	Only SADR’s should be reported- as described under time
	Reporting:  	frames. Licensor will porcess these as spontaneous reports
	

	Responsibility of the International Safety	Licensor
	Database for the product:
	








7.   Various 



		
	

	Location of International Safety Database 	Nycomed, Roskilde, Denmark
	

	Eventualities 	In cases unforeseen by above procedures the Safety Managers
	 	of each Company will liase immediately with each other in
	 	order to resolve the situation.
	

	Term 	This agreement shall come into effect by the day of signature
	 	of both parties and continue in force until the termination
	 	of the Licensing Contract.
	

	Confidentiality 	The parties shall keep confidential any pharmacovigilance and
	 	regulatory information.
	








4 










8.   Contact Persons and
Addresses 



		
	

	Licensor 	Nycomed
	Contact person and Pharmacovigilance department	Central Pharmacovigilance
	 	Langebjerg 1
	 	4000 Roskilde
	 	DENMARK
	 	Director Central Pharmacovigilance, Jens Peter Balling, MD.
	 	Tel: 45 46771637
	 	Fax: 45 46775999
	 	e-mail: jep@nycomed.com
	 	day to day operations: cpv@nycomed.com
	

	Licensee	Licensee contact detals
	








9.   Signatures 


		
	

	Place and date 	Signature 
	 	Pharmacovigilance responsible person
	 	Licensor
	

	Place and date 	Signature 
	 	Pharmacovigilance responsible person
	 	Licensee
	














5 












EXHIBIT 13.3 



RELEASE OF THIRD PARTY
ENCUMBRANCE 



[EXHIBT BEGINNING ON
FOLLOWING PAGE] 




(This Exhibit 13.3 is
filed elsewhere with this Form 10-QSB as Exhibit 10.1)