Document:

License Agreement between Amersham Health AS and KS Biomedix Limited

 Exhibit 4.20 
  

	*	CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. REDACTED PORTIONS OF THIS EXHIBIT ARE MARKED BY AN *.

  
 LICENSE AGREEMENT 
  
 BETWEEN 
  
 AMERSHAM HEALTH AS 
  
 - and - 
  
 K S BIOMEDIX LIMITED 
  

 This License Agreement (“Agreement”) is made the 11 December 2003 (“Effective Date”) by
and between 
  

	(1)	AMERSHAM HEALTH AS a company organized under the laws of Norway with offices at Nycoveien 2, PO Box 4220, Torshov, B0401, Oslo, Norway, (“AMERSHAM”); and

  

	(2)	K S BIOMEDIX LIMITED a company incorporated in England (Registered number 02468053) whose principal place of business is at 957 Buckingham Avenue, Slough, Berkshire, SL1 4NL,
England (“KSB”) 

  
 WHEREAS; 
  

	(A)	By a sublicense agreement (“Sublicense Agreement”) entered into as of 19th May 2000 (“Sublicense Date”) by and between Nycomed Imaging A.S.
(“NI”), a company organized under the laws of Norway with offices at Nycoveien 2, Post Office Box 4220, Torshov, N-0401, Oslo, Norway and Intelligene Expressions, Inc., a corporation organized under the laws of Canada, with offices
at Edmonton Research Park, 1938-94 Street, Edmonton, Alberta, Canada T6N J3 (“IEI”), NI granted rights to IEI in respect of certain patents licensed to NI by the National Institutes of Health (“NIH”) or the Centers
for Disease Control (“CDC”), (hereafter singly or collectively referred to as “PHS”), agencies of the United States Public Health Service within the Department of Health and Human Services and in certain materials
and processes of NI. 

  

	(B)	AMERSHAM is the successor in all respect of all rights of NI in and under the Sublicense Agreement and in connection with all intellectual property and know how the subject thereof
and KSB is the successor of JET in all respects. 

  

	(C)	The PHS patent tights licensed to NI by PHS were licensed to AMERSHAM by three patent license agreements, which have by an agreement of even date herewith between NIH, AMERSHAM and
KSB been assigned to KSB, such that AMERSHAM has no further or continuing rights therein (“Assignment Agreement”). 

  

	(D)	This Agreement replaces the Sublicense Agreement with effect from the Effective Date in all respects and acknowledges the termination of the rights sublicensed to KSB in respect of
the PHS patent rights (now assigned to KSB by the Assignment Agreement) and grants to KSB a license in respect of the AMERSHAM materials and processes, previously licensed under the Sublicense Agreement. 

  

 NOW, THEREFORE, for good and valuable consideration, the sufficiency of which is hereby acknowledged, the parties
agree as follows: 
  

	1.	DEFINITIONS. 

  

	 	1.1	Except as otherwise defined in this Agreement, capitalized terms shall have the meaning set forth in this Clause 1. 

  

			
	 “Affiliate”
	  	means in relation to either party any person who directly or indirectly controls, is controlled by or is under common control with that party. A person shall be regarded as in control of
another person if it owns directly or indirectly 50% (fifty per cent) or more of the voting stock or other ownership or income interest of the other person.
		
	 “Amersham Patent Rights”
	  	means the Patents listed in Schedule 2.
		
	 “Confidential Information”
	  	means: (a) all data information and materials included in or relating to the Licensed Rights; (b) any business or technical information of KSB or AMERSHAM, including but not limited to any
information relating to KSB’s or AMERSHAM’s product plans, designs, costs, finances, marketing plans, business opportunities, personnel, research, pending patent applications, development or know-how; and (c) the terms and conditions of
this Agreement and the Sublicense Agreement.
		
	 “FDA”
	  	means United States Food and Drug Administration of the Department of Health and Human Services, and any successor entity.
		
	 “KSB Know How”
	  	means all inventions, discoveries, trade secrets, information, experience, data, formulas, procedures and results, and improvements thereon whether or not patentable or patented, which were
created or obtained by KSB during the term of the Sublicense Agreement or during the term of this Agreement in connection with its activities related to the Licensed Rights, and reasonably required in connection with the manufacture, use or sale of
any Licensed Products.
		
	 “Licensed Rights”
	  	means all rights of AMERSHAM in:
		
	 	  	 (i)     the Materials;

		
	 	  	 (ii)     that certain fermentation manufacturing process developed under a research and development master
agreement between IEI and Hafslund Nycomed Pharma AG dated 1 December 1995 and assigned to NI on 11 June 1996; and

  

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	 	  	 (iii)  the Amersham Patent Rights;

		
	 “Licensed Fields of Use”
	  	means use for therapeutic treatment of all cancers of the central nervous system and/or the head and neck;
		
	 “Licensed Product(s)”
	  	means any product which, in the course of manufacture, use, or sale would, in the absence of this Agreement or the NIH Patent License, infringe one or more claims of the NIH Patent Rights,
that have not been held invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction, or which in any manner relies upon or involves use of the Licensed Rights;
		
	 “Licensed Territory”
	  	means all countries of the world.
		
	 “Materials”
	  	means those certain documents, materials and works of authorship created by AMERSHAM with respect to its development efforts prior to the Sublicense Date, as licensed to IEI under the terms
of the Sublicense Agreement, as listed in schedule 1; and
		
	 “Net Sales”
	  	means the total gross receipts for sales of Licensed Products by or on behalf of KSB, its Affiliates or its sublicensees, and from leasing, renting or otherwise making Licensed Products
available to others without sale or other dispositions, whether invoiced or not, less returns and allowances actually granted, packing costs, insurance costs, freight out, taxes or excise duties imposed on the transaction (if separately invoiced),
and wholesaler and cash discounts in amounts customary in the trade. No deductions shall be made for sales or other commissions paid to individuals, whether they be with independent sales agencies, or regularly employed by KSB or sub licensees, or
for the cost of collections.
		
	 “NIH Patent License”
	  	means the following license agreements as assigned to KSB by AMERSHAM under the Assignment Agreement:
		
	 	  	 (i)     Patent License Agreement, L-00696/0, dated February 7, 1996, and

  

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	 	  	 (ii)    Patent License Agreement, L-007-96, dated June 2002, and

		
	 	  	 (iii)  Patent License Agreement, L-287-00) dated June 2002

		
	 	  	and any agreement between NIH and KSB replacing or amending any such licenses, which continues to grant KSB rights in respect of the NIH Patent Rights.
		
	 “NIH Patent Rights”
	  	means the rights granted to AMERSHAM under the agreement referenced in paragraphs (i), (ii) and (iii) of the definition of NIH Patent License.
		
	 “Patents”
	  	means all patents or letters patent, claims in any patent and applications for the same and the right to apply for the same in any part of the world including, without limitation, all
reissues, extensions, substitutions, confirmations, registrations, revalidations, additions, continuations in part and divisions thereof and any Supplementary Protection Certificates.
		
	 “Royalty”
	  	shall have the meaning set forth in Clause 5.1 of this Agreement.

  

	 	1.2	In this Agreement unless the context otherwise requires:- 

  

	 	1.2.1 	references to “this Agreement” shall mean this Agreement and any and all Schedules to it as may be varied from time to time in accordance with its provisions;

  

	 	1.2.2 	unless the context otherwise requires, all references to a particular Clause or Sub-Clause, shall be a reference to that Clause or SubClause in this Agreement;

  

	 	1.2.3 	words importing the singular shall include the plural and vice versa; 

  

	 	1.2.4 	headings are for convenience only and shall be ignored in interpreting this Agreement; 

  

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	 	1.2.5 	the words “include” or “including” are to be construed without limitation to the generality of the preceding words. 

  

	2.	GRANT OF RIGHTS. 

  

	 	2.1	Subject to the terms and conditions of this Agreement, AMERSHAM hereby grants and KSB accepts an exclusive license under the Licensed Rights throughout the Territory to make and
have made, to use and have used, and to sell and have sold any licensed Products in the Licensed Fields of Use. 

  

	 	2.2	For the avoidance of doubt AMERSHAM grants to KSB an exclusive license under the Amersham Patent Rights to make, have made, to use and have used and to sell and have sold any
Licensed Products in the Licensed Fields of Use. 

  

	 	2.3	This Agreement confers no license or rights by implication, estoppel, or otherwise under any Patents of AMERSHAM other than Amersham Patent Rights. 

  

	 	2.4	KSB may enter into sublicensing agreements under the Licensed Rights Provided that KSB agrees to promptly forward to AMERSHAM a copy of each fully executed sublicense agreement, not
later than thirty (30) days after the execution of such agreement. 

  

	3.	SUBLICENSE AGREEMENT 

  

	 	3.1	It is acknowledged and agreed that with effect from the Effective Date the Sublicense Agreement shall be terminated in all respects and shall be of no further effect.

  

	 	3.2	Each of KSB and AMERSHAM confirms and acknowledges that it has no claim against the other arising under or in connection with the Sublicense Agreement in any manner and that neither
party has any liability to the other arising under or in connection with the Sublicense Agreement. 

  

	 	3.3	Each of KSB and AMERSHAM acknowledges and confirms that by the Assignment Agreement all rights and obligations of AMERSHAM in respect of the NIH Patent License have with effect from
the Effective Date been transferred to KSB. 

  

	4.	PATENT FILING, PROSECUTION, MAINTENANCE AND ENFORCEMENT. 

  

	 	4.1	 AMERSHAM has responsibility for the preparation, filing, prosecution, and maintenance of any and all Patents included in the Licensed Rights. AMERSHAM shall have
the sole right to conduct the preparation, filing, prosecution and maintenance of any and all Patents included in the Amersham Patent Rights. KSB shall promptly inform AMERSHAM as to all matters that 

  

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come to its attention that may affect the preparation, filing, prosecution, or maintenance of the Amersham Patent Rights; KSB may provide comments and
suggestions to AMERSHAM with respect to such preparation, filing and maintenance. 

  

	 	4.2	KSB agrees to notify AMERSHAM promptly of each infringement or possible infringement of the Amersham Patent Rights, as well as any facts which may affect the validity, scope, or
enforceability of the Amersham Patent Rights, including any declaratory judgment actions, of which KSB becomes aware. Except as set forth herein, AMERSHAM shall have the sole right to litigate the Amersham Patent Rights against third parties
provided that AMERSHAM neither represents nor warrants that it will commence legal actions against third parties infringing the Amersham Patent Rights. 

  

	 	4.3	In the event that AMERSHAM decides not to bring suit, KSB may: 

  

	 	4.3.1 	bring suit in its own name, at its own expense, and on its own behalf for infringement of presumably valid claims in the Amersham Patent Rights, including defending against any
counterclaims of invalidity or non-infringement of the Amersham Patent Rights; and 

  

	 	4.3.2 	in any such suit, engage infringement and collect for its use, damages, profits, and awards of whatever nature recoverable for such infringement; and 

  

	 	4.3.3 	settle any claim or suit for infringement of the Amersham Patent Rights. KSB agrees to keep AMERSHAM reasonably appraised of the status and progress of any litigation. Before KSB
commences an infringement action, KSB shall notify AMERSHAM. 

  

	 	4.4	AMERSHAM shall cooperate fully with KSB in connection with an infringement action initiated under Clause 4.3. AMERSHAM agrees promptly to provide access to all necessary documents
and to render reasonable assistance in response to a request by KSB at KSB’s expense. 

  

	 	4.5	In any infringement action commenced under Clause 4.3, the expenses including costs, fees, attorney fees, and disbursements, shall be paid by KSB. 

  

	5.	PAYMENT; ROYALTIES. 

  

	 	5.1	KSB shall pay to AMERSHAM a royalty on all sales of Licensed Products throughout the Licensed Territory at the rate of * of aggregate Net Sales. 

  

	 	5.2	The Royalty shall continue to be payable in respect of all sales of Licensed Products until the expiry of the last to expire of any NIH Patent Rights. 

  

	 	5.3	No minimum royalties shall be payable and there shall be no “antistacking” royalty adjustments. 

  

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	6.	PAYMENT; MILESTONES 

  

	 	6.1	KSB agrees to pay AMERSHAM the following non-refundable milestone payments as set out in this clause 6. KSB expressly acknowledges and agrees that none of the Milestone Payments set
out in this section shall be credited against any Royalties due under clause 5. AMERSHAM expressly acknowledges and agrees that the milestone payments set forth in this clause 6 are one time payments only. 

  

	 	6.1.1 	a one time payment of the higher of US$* or * of any signing fee paid to KSB by the first sub-licensee or partner signed by KSB in respect of the grant of sales and marketing rights
for the Licensed Product in North America, payable within thirty (30) days of date of signature of such sublicense; and 

  

	 	6.1.2 	a one time payment of US$* payable within thirty (30) days of first approval by the FDA for commercial distribution of any Licensed Product in the United States; and

  

	 	6.1.3 	a one time payment of US$* payable within thirty (30) days of first approval by the EMEA for commercial distribution of any Licensed Product in any of the United Kingdom, Germany,
France, Italy or Spain. 

  

	7.	PAYMENT; GENERAL 

  

	 	7.1	All payments under this Agreement shall be made in U.S. dollars to the bank account designated by AMERSHAM for such purpose. For conversion of foreign currency to U.S. dollars, the
conversion rate shall be the rate quoted in The Wall Street journal on the day that the payment is due. KSB shall be solely responsible for the costs incurred in effecting the exchange into US Dollars and in effecting payment by electronic transfer.

  

	 	7.2	Payments shall be made upon delivery of the Royalty report under clause 8.2 and a copy of each such report shall be mailed to AMERSHAM at its address for Notices.

  

	 	7.3	All Royalties and milestone payments due under this Agreement shall be paid in full without any set off, deduction or withholding except any such withholding tax which KSB is
required by law to deduct or withhold. If KSB is required by law to make any such tax deduction or withholding KSB shall do all in its power which may be necessary to enable or assist AMERSHAM to claim exemption from or (if that is not possible) a
credit for the deduction or withholding under any applicable double taxation or similar, agreements from time to time in force and shall from time to time give AMERSHAM proper evidence as to the deduction or withholding made from any payment due
under this Agreement. 

  

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	 	7.4	All amounts which remain unpaid after its due date shall be subject to interest charges at the rate of one percent (1%) per month, or the highest rate permitted by law, whichever is
lower. 

  

	8.	RECORDS AND AUDIT 

  

	 	8.1	KSB agrees to keep accurate and correct records of Licensed Products made, used, or sold appropriate to determine the amount of Royalties due to AMERSHAM hereunder. Such records
shall be retained for at least five (5) years following a given reporting period. They shall be available during normal business hours at KSB’s premises for inspection at the expense of AMERSHAM by an accountant or other designated auditor
selected by AMERSHAM for the sole purpose of verifying reports and payments hereunder. The accountant or auditor shall only disclose to AMERSHAM information relating to the accuracy of reports and payments made under this Agreement. If an inspection
shows an under reporting or underpayment in excess of five (5%) percent for any twelve (12) month period, KSB shall pay the unreported Royalties, including any late charges as required by Clause 7.4. All payments required under this Clause 8.1 shall
be due within thirty (30) days of the date AMERSHAM provides KSB notice of the payment due. 

  

	 	8.2	KSB shall submit to AMERSHAM within thirty (30) days after each calendar half-year ending June 30 and December 31 a royalty report setting forth for the preceding half year period
the amount of the Licensed Products sold by or on behalf of KSB in each country within the Licensed Territory, the Net Sales, and the amount of Royalties accordingly due. With each such royalty report, KSB shall submit payment of the earned
Royalties due. If no earned royalties or payments are due to AMERSHAM for any reporting period, the written report shall so state. The Royalty report shall be certified as correct by an authorized officer of KSB. 

  

	9.	PERFORMANCE BY KSB 

  

	 	9.1	KSB shall use commercially reasonable efforts to introduce the Licensed Products into the commercial market as soon as practicable. The efforts of a sub licensee or partner shall be
considered the efforts of KSB. 

  

	10.	WARRANTY AND DISCLAIMERS. 

  

	 	10.1	Except as specifically stated herein, AMERSHAM makes no representations or warranties as to any aspect of the licensed Products or Licensed Rights. AMERSHAM does not make any
representation or warranty as to the business prospects of the Licensed Products. KSB acknowledges and agrees that: 

  

	 	10.1.1 	KSB has conducted its own review and analysis, as it deemed necessary and appropriate, of the business prospects of the Licensed Products and is not relying on any representations
or warranties from AMERSHAM as to the business prospects; and 

  

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	 	10.1.2 	in making the decision to license the Licensed Rights KSB has relied solely on independent investigations made by KSB or KSB’s financial and legal advisors, has had the
opportunity to review information and have questions answered by management and employees of AMERSHAM, and deems such information received and reviewed adequate to evaluate the merits and risks of the business prospects of the Licensed Products.

  

	 	10.2 	Each party represents and warrants to the other as at the Effective Date that: 

  

	 	10.2.1 	It is duly organized and validly existing under the laws of its state or country of incorporation, and has full corporate power and authority to enter into this Agreement and to
carry out the provisions thereof. 

  

	 	10.2.2 	It is duly authorized to execute and deliver this Agreement and to perform its obligations hereunder, and the person or persons executing this Agreement on its behalf has been duly
authorized to do so by all requisite corporate action. 

  

	 	10.2.3 	This Agreement is legally binding upon it and enforceable in accordance with its terms. The execution, delivery and performance of this Agreement by it to the best of its knowledge
does not conflict with any agreement instrument or understanding, oral or written, to which it is a party or by which it may be bound, nor violate any material law or regulation of any court, governmental body or administrative or other agency
having jurisdiction over it. 

  

	 	10.3	AMERSHAM does not represent or warrant the validity of the Amersham Patent Rights and makes no representations or warranties whatsoever with regard to the scope of the Amersham
Patent Rights, or that the Amersham Patent Rights may be exploited without infringing other patents or other intellectual property rights of third parties, or that the Licensed Products are acceptable for filing with the FDA, or whether any
authorization or approval will be obtained from the FDA. 

  

	 	10.4	THE LICENSED RIGHTS ARE LICENSED TO KSB ON AN “AS IS” BASIS, AND AMERSHAM MAKES NO WARRANTIES, EXPRESS OR IMPLIED, OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE
OF ANY SUBJECT MATTER DEFINED BY THE CLAIMS OF THE AMERSHAM PATENT RIGHTS OR THE LICENSED RIGHTS OR OTHERWISE. 

  

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	11.	INDEMNIFICATION. 

  

	 	11.1 	KSB shall indemnify and hold AMERSHAM its Affiliates, officers, directors, and employees, harmless from and against all liability, demands, damages, expenses, and losses, including
but not limited to death, personal injury, illness, or property damage in connection with or arising out of: 

  

	 	11.1.1 	the use by or on behalf of KSB, its Affiliates, sub licensees, directors, employees, or third parties of any Licensed Rights; or 

  

	 	11.1.2 	the design, manufacture, distribution, or use of any Licensed Products. 

  

	 	11.2 	Under no circumstances shall AMERSHAM be liable to KSB for any liability, loss or damage arising from the development, use or exploitation of any Licensed Product by KSB, its sub
licensees or partners. 

  

	12.	LIMITATION OF LIABILITY 

  

	 	12.1 	IN NO EVENT WILL EITHER PARTY BE LIABLE TO THE OTHER FOR ANY LOST REVENUES OR PROFITS, COST OF PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES, OR ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL
OR PUNITIVE DAMAGES, WHETHER BASED ON BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE), PRODUCT LIABILITY, OR OTHERWISE, AND WHETHER OR NOT SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGE. 

  

	13.	TERM AND TERMINATION 

  

	 	13.1	This Agreement shall come into force and effect on the Effective Date, and, unless sooner terminated by the parties as otherwise provided, shall continue in effect until the last to
expire of the NIH Patent Rights and the Amersham Patent Rights (“Term”). 

  

	 	13.2	This Agreement shall terminate forthwith in the event that the NIH Patent license shall be terminated by either party thereto, save only where such termination arises by reason of a
restatement or substitution of the NIH Patent License agreed between the parties thereto and notwithstanding such termination an agreement granting rights to KSB substantially in the form of the rights granted under the NIH Patent License shall
continue. KSB undertakes to notify Amersham promptly in the event of any termination or purported termination of the NIH Patent License. 

  

	 	13.3	Upon any termination of this Agreement for any reason: 

  

	 	13.3.1 	Not later than thirty (30) days following such termination, each party shall return to the other any and all Confidential Information of the other party in its possession or
control, which shall include, without limitation, all information relating to the Licensed Rights; and 

  

	 	13.3.2 	KSB shall: 

  

	 	(a)	 promptly deliver to AMERSHAM all KSB Know-How, and KSB 

  

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hereby grants to AMERSHAM a perpetual, nonexclusive license (with the right to sublicense) to use KSB Know How as needed for AMERSHAM and its sub licensees
to fully exercise the Licensed Rights; and 

  

	 	(b)	if required by AMERSHAM, assign to AMERSHAM all its rights under and to the NIH Patent License. 

  

	 	13.3.3	Notwithstanding such terminations Clauses 8.1, 11, 12, 14, 15, 16 and 17 shall continue in accordance with their terms. 

  

	14.	CONFIDENTIALITY. 

  

	 	14.1	Confidential Information shall not include information that: 

  

	 	14.1.1 	is in or enters the public domain without breach of this Agreement (or previous breach of the terms of the Sublicense Agreement) through no fault of the receiving party;

  

	 	14.1.2 	the receiving party was demonstrably in possession of prior to first receiving it from the disclosing party; 

  

	 	14.1.3 	the receiving party can demonstrate was developed by the receiving party independently and without use of or reference to the disclosing party’s Confidential Information; or

  

	 	14.1.4 	the receiving party receives from a third party without restriction on disclosure and without breach of a nondisclosure obligation. 

  

	 	14.2	Each party will maintain the Confidential Information of the other party in strict confidence and will exercise due care with respect to the handling and protection of such
Confidential Information, consistent with its own policies concerning protection of its own Confidential Information of like importance. Each party will use the Confidential Information of the other party only as expressly permitted herein, and will
disclose such Confidential Information only to its employees and consultants as is reasonably required in connection with the exercise of its rights and obligations under this Agreement (and only subject to binding use and disclosure restrictions at
least as protective as those set forth herein executed in writing by such employees and consultants). 

  

	 	14.3	Each party may disclose Confidential Information of the other party pursuant to the order or requirement of a court, administrative agency, or other governmental body, provided that
the receiving party gives reasonable notice to the other party to contest such order or requirement. Any such disclosure by the receiving party of the Confidential Information of the disclosing party, will in no way, be deemed to change, affect or
diminish the confidential and proprietary status of such Confidential Information. 

  

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	 	14.4	Each party acknowledges that improper use or disclosure of the Confidential Information of the other party may cause substantial harm to the other party that may not be remedied by
the payment of damages alone. Accordingly, each party will be entitled to preliminary and permanent injunctive relief and other equitable relief for any breach of this Clause 14. 

  

	15.	GENERAL PROVISIONS. 

  

	 	15.1	Neither party may waive or release any of its rights or interests in this Agreement except in writing. The failure of either party to assert a right hereunder or to insist upon
compliance with any term or condition of this Agreement shall not constitute a waiver of that right by either party or excuse a similar subsequent failure to perform any such term or condition by this other party. 

  

	 	15.2	This Agreement constitutes the entire agreement between the Parties relating to the subject matter hereof and relating to the Sublicense Agreement and the Licensed Rights and all
prior negotiations, representations, agreements, and understandings are merged into, extinguished by, and completely expressed by this Agreement. 

  

	 	15.3	The provisions of this Agreement are severable, and in the event that any provision of this Agreement shall be determined to be invalid or unenforceable under any controlling body
of law, such determination shall not in any way affect the validity or enforceability of the remaining provisions of this Agreement. 

  

	 	15.4	If either party desires a modification to this Agreement, the Parties shall, upon reasonable notice of the proposed modification by the party desiring the change, confer in good
faith to determine the desirability of such modification. No modification will be effective until a written amendment is signed by the signatories to this Agreement. 

  

	 	15.5	This Agreement may be executed in multiple counterparts, each of which when so executed, shall be deemed to be an original copy hereof, and all such counterparts together shall
constitute one single agreement. 

  

	 	15.6	This Agreement shall not be assigned by KSB except 

  

	 	15.6.1 	with the prior written consent of AMERSHAM, such consent to be reasonably given; or 

  

	 	15.6.2 	as part of a sale or transfer of substantially the entire business of KSB relating to operations which concern this Agreement and KSB shall notify AMERSHAM within 10 days of any
assignment of this Agreement by KSB under this clause 15.6.2. 

  

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	16.	LAW AND JURISDICTION 

  

	 	16.1	The construction, validity, performance, and effect of this Agreement shall be governed by the laws of New Jersey and of the United States, excepting those portions thereof relating
to conflicts of law. All disputes arising under this Agreement shall be resolved solely in the federal or state courts situated in New Jersey and both parties hereby submit to the personal jurisdiction thereof. 

  

	17.	NOTICES 

  

	 	17.1	All notices required or permitted by this Agreement shall be given by prepaid, registered or certified mail properly addressed to the other party at the addresses designated below

  
 KSB 
 KS Biomedix Limited 
 957, Buckingham Avenue,

 Slough 
 Berkshire 

SL1 3NL 
 England 
  
 Marked for the attention of: the Finance Director 
  
 AMERSHAM 
  
 Amersham Health AS 
 Nycoveien 2 
 PO Box 4220 
 Torshov 
 N.0401 
 Oslo 
 Norway 
  
 Marked for the attention of: the Finance Director 
  
 With a copy to 
  
 Amersham Health Inc. 
 101 Carnegie Center 
 Princeton 
 New Jersey 
 08450-6231 
 USA 
  

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 Marked for the attention of: General Counsel 
  
 And any modification to such address must itself be notified in writing to
the other party in accordance with the terms of this Clause 17.1. 
  

	 	17.2	It shall be permitted for Notices to be served hereunder by facsimile transmission and for this purpose the following fax numbers shall apply: 

  
 KSB (44) (0) 01753 706607 
  
 AMERSHAM: 
  
 With copy to: 
  
 Provided that such notice shall be confirmed by written notice sent by post. 
  

	 	17.3	In the absence of proof to the contrary, notice shall be deemed served: 

  

	 	17.3.1 	in the event of notice served by post, if properly sent and addressed, four working days after the day of dispatch; and 

  

	 	17.3.2 	in the event of notice sent by facsimile transmission, if properly sent and addressed and where evidence of transmission is available, two working hours after the time of
transmission on. 

  

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 IN WITNESS WHEREOF, the parties have caused this Agreement to be signed by their duly authorized representatives.

  

									
	 K S BIOMEDIX LIMITED
	 	 	 	 AMERSHAM HEALTH A.S.

					
	By:	 	 /s/ D. A. Oxlade
	 	 	 	By:	 	 /s/ Kevin Quinn

	 Name:
	 	 D. A. Oxlade
	 	 	 	 Name:
	 	 Kevin Quinn

	 Title:
	 	 Director
	 	 	 	 Title:
	 	 Director

  

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 SCHEDULE 1 
 MATERIALS 
  

	1.	A Locked Clinical Database containing clinical information in AMERSHAM’s possession prior to the Sublicense Date. 

  

	2.	A final Phase II clinical report delivered to KSB under the Sublicense Agreement. 

  

	3.	Technical Data relating to licensed Products delivered by Amersham under the Sublicense Agreement such technical data including, as applicable, (a) biological materials in
AMERSHAM’s possession or control related to the NIH Patent Rights, (b) available data in AMERSHAM’s possession or control generated from AMERSHAM’s clinical trials relating to Licensed Products, (c) available data in AMERSHAM’s
possession or control submitted to regulatory authorities relating to Licensed Products, and (d) available data in AMERSHAM’s possession, or control relating to patent prosecution concerning Licensed Products. 

  

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 SCHEDULE 2 
 AMERSHAM PATENT RIGHTS 
  
 EP 00906484.1

 US 09/914162 
 US 10/690855 
  

 17Drug Delivery Patent Sublicense Agreement

 Exhibit 4.21 
  

	*	CONFIDENTIAL INFORMATION HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION. REDACTED PORTIONS OF THIS EXHIBIT ARE MARKED BY AN *.

  
 DRUG DELIVERY
PATENT SUBLICENSE AGREEMENT 
  
 This Drug Delivery Patent Sublicense Agreement (Agreement) is entered into as of May      2002 (Effective Date) by and between Amersham Health A.S.
(formerly Nycomed Imaging A.S.), a company organized under the laws of Norway with offices at Nycoveien 2, Post Office Box 4220, Torshov, N-0401, Oslo, Norway (AH), and KS Avicenna, Inc. (formerly INTELLIgene Expressions Inc.) a
corporation organized under the laws of Canada, with offices at Edmonton Research Park, 1938-94 Street, Edmonton, Alberta, Canada T6N 1J3 (KSA). 
  

WHEREAS, pursuant to a Patent License Agreement, L-007-96/0, dated July 17, 2000, AH is the licensee of certain patent rights from the National
Institutes of Health (NIH) or the Centers for Disease Control (CDC), or the Food and Drug Administration (FDA) hereafter singly or collectively referred to as PHS, agencies of the
United States Public Health Service within the Department of Health and Human Services (the Existing Drug Delivery Agreement). 
  
 WHEREAS, AH wishes to sublicense the certain patent rights (defined below) licensed under the Existing Drug Delivery Agreement to, and KSA wishes
to obtain such rights, all as set forth under the terms of this Agreement. 
  
 NOW, THEREFORE, for good and valuable consideration, the sufficiency of which is hereby acknowledged, the parties agree as follows: 
  

	1.	DEFINITIONS. Except as otherwise defined in this Agreement, capitalized terms shall have the meaning set forth in this Section 1.

  
 FDA means the United States Food
and Drug Administration of the Department of Health and Human Services, and any successor entity. 
  
 Government means the government of the United States of America. 
  
 Licensed Fields of Use means the use of the Licensed Patent Rights in the intratumoral delivery of Licensed
Products as defined in the Primary Sublicense Agreement (defined below), for the in vivo therapeutic treatment of human cancers of the central nervous system and/or the head and neck. 
  
 Licensed Patent Rights means: 
  
 (a) U.S. patent applications and patents listed in Appendix A, all divisions and continuations of these
applications, all patents issuing from such applications, divisions, and continuations, and any reissues, reexaminations, and extensions of all such patents; 
  

 (b) to the extent that the following contain one or more claims directed to the invention
or inventions claimed in (a) above: (i) continuations-in-part of (a) above; (ii) all divisions and continuations of these continuations-in-part; (iii) all patents issuing from such continuations-in-part, divisions, and continuations; and (iv) any
reissues, reexaminations, and extensions of all such patents; 
  
 (c) to the extent that the following contain one or more claims directed to the invention or inventions claimed in (a) above: all counterpart foreign applications and patents to (a) and (b) above, including those
listed in Appendix A. 
  
 Licensed Patent Rights shall
not include (b) or (c) above to the extent that they contain one or more claims directed to new matter which is not the subject matter of a claim in (a) above. 
  
 Licensed Product(s) means tangible materials which, in the course of manufacture, use, or sale
would, in the absence of this Agreement, infringe one or more claims of the Licensed Patent Rights that have not been held invalid or unenforceable by an unappealed or unappealable judgment of a court of competent jurisdiction. 
  
 Licensed Process(es) means processes
which, in the course of being practiced would, in the absence of this Agreement, infringe one or more claims of the Licensed Patent Rights that have not been held invalid or unenforceable by an unappealed or unappealable judgment of a court of
competent jurisdiction. 
  
 Licensed Territory means
the Licensed Territory as defined in the Primary Sublicense Agreement (defined below). 
  
 Net Sales means the total gross receipts for sales of Licensed Products or practice of Licensed Processes by or on behalf of KSA or its sublicensees, and from leasing, renting or otherwise making
Licensed Products available to others without sale or other dispositions, whether invoiced or not, less returns and allowances actually granted, packing costs, insurance costs, freight out, taxes or excise duties imposed on the transaction (if
separately invoiced), and wholesaler and cash discounts in amounts customary in the trade. No deductions shall be made for sales or other commissions paid to individuals, whether they be with independent sales agencies or regularly employed by KSA,
or sublicensees, or for the cost of collections. 
  
 PHS
Payment means the payment obligations from AH to PHS under the Existing Drug Delivery Agreement, which shall include ongoing royalties and any milestone payments described thereunder. 
  
 PHS Flowthrough Terms means those provisions setting forth
certain rights of PHS and obligations of KSA to PHS, as set forth in Appendix B to this Agreement. 
  
 Primary Sublicense Agreement means a sublicense agreement between AH and KSA dated May 19, 2000. 
  
 Royalty and Royalties shall have the meaning set forth in Section 4.1 of this Agreement.

  

 2 

	2.	GRANT OF RIGHTS. 

  
 2.1 To Licensed Patent Rights. Subject to the terms and conditions of this Agreement, AH hereby grants and KSA accepts a non-exclusive license
under the Licensed Patent Rights in the Licensed Territory to make and have made, to use and have used, and to sell and have sold any Licensed Products in the Licensed Fields of Use and to practice and have practiced any Licensed Processes in the
Licensed Fields of Use. 
  
 2.2 Limitations. This Agreement
confers no license or rights by implication, estoppel, or otherwise under any patent applications or patents of AH or PHS other than Licensed Patent Rights regardless of whether such patents are dominant or subordinate to Licensed Patent Rights.

  
 2.3 Sublicensing Rights. 
  
 2.3.1 Ability to Sublicense. Upon written approval by
PHS, which approval will not be unreasonably withheld, nor will a decision on approval be unduly delayed, KSA may enter into sublicensing agreements under the Licensed Patent Rights subject to the Royalty obligations set forth in Section 4.1 herein,
provided that such Licensed Patent Rights may be sublicensed only to a party to whom KSA has granted a sublicense under the Sublicense Agreement, effective May 19, 2000 between KSA and AH (the Primary Sublicense Agreement). 
  
 2.3.2 Applicability of PHS Flowthrough Terms. KSA
agrees that any sublicenses granted by it shall provide that the rights of and obligations to PHS as set forth in the PHS Flowthrough Terms of this Agreement shall be binding upon the sublicensee(s) as if it were a party to this Agreement. KSA
further agrees to attach copies of the PHS Flowthrough Terms to all such sublicense agreements. 
  
 2.3.3 Sublicensee s Rights upon Termination. Any sublicenses granted by KSA shall provide for the termination of the sublicense, or
the conversion to a license directly between such sublicensees and PHS, at the option of the sublicensee, upon termination of this Agreement or upon termination of the L-006-96/0 Patent License Agreement, effective February 7, 1996, between Nycomed
Imaging A.S. (as the successor in interest to Nycomed Pharma A.S.) and PHS (the Existing Agreement), including any sublicense thereof. Such conversion is subject to PHS approval and contingent upon acceptance by the sublicensee
of the remaining provisions of this Agreement. 
  
 2.3.4 Copies to AH. KSA agrees to promptly forward to PHS and AH a copy of each fully executed sublicense agreement, in all events not later than thirty (30) days after the execution of such agreement. 
  
 2.4 Reserved Government Rights; PHS Flowthrough Provisions.

  
 2.4.1 Government Reserved Rights.
Prior to the initial transfer by or on behalf of KSA or its sublicensees of Licensed Products or the initial practice of a Licensed Process by or on behalf of KSA or its sublicensees in exchange for cash or some equivalent to which value can be
assigned for the purpose of determining Net Sales, KSA agrees to provide PHS reasonable quantities of Licensed Products or materials made through the Licensed Processes for PHS research use. 
  

 3 

 2.4.2 Manufacturing in US for US Distribution. KSA agrees that products used or
sold in the United States embodying Licensed Products or produced through use of Licensed Processes shall be manufactured substantially in the United States, unless a written waiver is obtained in advance from PHS. 
  
 2.4.3 PHS Flowthrough Provisions. KSA understands and
agrees that the Licensed Patent Rights are licensed to AH from PHS under the Existing Drug Delivery Agreement, and that PHS requires that the PHS Flowthrough Provisions apply to any licensee of the Licensed Patent Rights. The PHS Flowthrough
Provisions are incorporated herein by reference, and KSA understands and agrees that PHS shall have the rights to bring suit directly against KSA to enforce its rights under this Agreement. 
  

	3.	DOMESTIC AND FOREIGN PATENT FILING, PROSECUTION AND
MAINTENANCE; PATENT ENFORCEMENT. 

  
 3.1 Filing, Prosecution and Maintenance. PHS has responsibility for the preparation, filing, prosecution, and maintenance of any and all patent
applications included in the Licensed Patent Rights and shall furnish copies of relevant patent-related documents as PHS deems necessary to AH who agrees to furnish such copies to KSA. As between the parties, PHS shall have the sole right to conduct
the preparation, filing, prosecution and maintenance of any and all patent applications or patents included in the Licensed Patent Rights. KSA shall promptly inform PHS and AH as to all matters that come to its attention that may affect the
preparation, filing, prosecution, or maintenance of the Licensed Patent Rights; KSA may provide comments and suggestions to AH and PHS with respect to such preparation, filing and maintenance. 
  
 3.2 Patent Enforcement. KSA agrees to notify AH and PHS promptly of
each infringement or possible infringement, as well as any facts which may affect the validity, scope, or enforceability of the Licensed Patent Rights of which KSA becomes aware. Except as set forth herein, as between the parties, AH and PHS shall
have the sole right to pursue claims of infringement of the Licensed Patent Rights against third parties; provided, however, that AH neither represents nor warrants that it will commence legal actions against third parties infringing the Licensed
Patent Rights. 
  
 3.3 Potential Enforcement by KSA.
Pursuant to this Agreement and the provisions of Chapter 29 of Title 35, United States Code, KSA may: a) bring suit in its own name, at its own expense, and on its own behalf for infringement of presumably valid claims in the Licensed Patent Rights;
b) in any such suit, engage infringement and collect for its use, damages, profits, and awards of whatever nature recoverable for such infringement; and c) settle any claim or suit for infringement of the Licensed Patent Rights provided, however,
that PHS and appropriate Government authorities shall have the first right to take such actions and shall have a continuing right to intervene in such suit. KSA shall take no action to compel the Government either to initiate or to join in any such
suit for patent infringement. KSA may request the Government to initiate or join any such suit if necessary to avoid dismissal of the suit. Should the Government be made a party to any such suit, KSA shall reimburse the Government for any costs,
expenses, or fees which the Government incurs as a result of such motion or other action, including any 

  

 4 

 
and all costs incurred by the Government in opposing any such motion or other action. Upon KSA s payment of all costs incurred by the Government, as a result
of KSA s joinder motion or other action, these actions by KSA will not be considered a default in the performance of any material obligation under this Agreement. In all cases, KSA agrees to keep PHS and AH reasonably apprised of the status and
progress of any litigation. Before KSA commences an infringement action, KSA shall notify PHS and give careful consideration to the views of PHS and to any potential effects of the litigation on the public health in deciding whether to bring suit.

  
 3.4 AH Cooperation in KSA Enforcement Actions. AH shall
cooperate fully with KSA in connection with an infringement action initiated under Section 3.3. AH agrees promptly to provide access to all necessary documents and to render reasonable assistance in response to a request by KSA at KSA s expense.

  
 3.5 Declaratorv Judgment Actions. In the event that a
declaratory judgment action alleging invalidity or non-infringement of any of the Licensed Patent Rights shall be brought against KSA or raised by way of counter claim or affirmative defense in an infringement suit brought by KSA under Section 3.3,
pursuant to this Agreement and the provisions of Chapter 29 of Title 35, United States Code or other statutes, KSA may: a) defend the suit in its own name, at its own expense, and on its own behalf for presumably valid claims in the Licensed Patent
Rights; b) in any such suit, ultimately to enjoin infringement and to collect for its use, damages, profits, and awards of whatever nature recoverable for such infringement; and c) settle any claim or suit for declaratory judgment involving the
Licensed Patent Rights provided, however, that PHS and appropriate Government authorities shall have the first right to take such actions and shall have a continuing right to intervene in such suit. KSA shall take no action to compel the Government
either to initiate or to join in any such declaratory judgment action. KSA may request the Government to initiate or join in any such suit if necessary to avoid dismissal of the suit. Should the Government be made a party to any such suit by motion
or any other action of KSA, KSA shall reimburse the Government for any costs, expenses, or fees which the Government incurs as a result of such motion or other action. Upon KSA s payment of all costs incurred by the Government as a result of KSA s
joinder motion or other action, these actions by KSA will not be considered a default in the performance of any material obligation under this Agreement. If KSA elects not to defend against such declaratory judgment action, PHS, at its option, may
do so at its own expense. In all cases, KSA agrees to keep AH reasonably apprised of the status and progress of any litigation. Before KSA commences an infringement action, KSA shall notify PHS and AH and give careful consideration to the views of
PHS and to any potential effects of the litigation on the public health in deciding whether to bring suit. 
  

	4.	PAYMENTS. 

  
 4.1 Royalty. The parties agree and acknowledge that pursuant to Section 2.6.1 of the Primary Sublicense Agreement, the license granted pursuant to
Article 2 of this Agreement is granted for no additional payments beyond those set forth in the Primary Sublicense Agreement, except only as set forth in Section 4.2. Accordingly, KSA shall not owe any additional royalties under this Agreement for
the sale of Licensed Products or practice of Licensed Processes, provided that KSA shall remain responsible for the payment of royalties in accordance with the Primary Sublicense Agreement such that any Net Sales, as defined herein, have been
accounted for under the Primary Sublicense Agreement and applicable royalties have been paid to AH with 

  

 5 

 
respect to such Net Sales. In the event that such royalties are not paid under the Primary Sublicense Agreement, KSA shall pay AH a royalty based on Net
Sales, as defined herein, at the same rates and amounts and on the same terms and conditions as specified in Section 4 of the Primary Sublicense Agreement (hereinafter referred to as the Royalty or Royalties).
Additionally and for example, while the Primary Sublicense Agreement and this Agreement are in effect, KSA shall pay AH the royalty rate set forth in the Primary Sublicense Agreement on Net Sales of Licensed Products or practice of Licensed
Processes as those terms are defined under the Primary Sublicense Agreement and this Agreement, specifically, the applicable royalty rate under the Primary Sublicense Agreement and zero percent (0.0%) under this Agreement. AH agrees that the Royalty
shall not be applied to any component of the Licensed Products or Licensed Processes, as defined herein, required to deliver the Licensed Products as defined in the Primary Sublicense Agreement and not claimed in the Licensed Patents as defined
herein. 
  
 4.2 Continuing Royalty. Notwithstanding the
terms of Section 4.1, after expiration of the last to expire of the Licensed Patent Rights, as defined in the Primary Sublicense Agreement, and until expiration of the last to expire of the Licensed Patent Rights, as-defined herein, KSA shall pay AH a royalty of * of Net Sales as defined in this Agreement and, without duplication, Net Sales as
defined in the Primary Sublicense Agreement (without regard to the term of any patent) in combination with Net Sales as defined in this Agreement. KSA further agrees that the total earned royalties due to AH can rise to a maximum total of * should
the provisions of the related non-exclusive patent licenses, the Manufacturing Patent License Agreement and Chloroquine Patent Sublicense Agreement between the parties and dated on even date herewith, be in effect. In such a case, * under this
Agreement, * under such Manufacturing Patent License Agreement and * under such Chloroquine Patent Sublicense Agreement. 
  
 4.3 Payment Terms. All payments, if any, under this Agreement shall be made in U.S. dollars. For conversion of foreign currency to U.S. dollars,
the conversion rate shall be the rate quoted in The Wall Street Journal on the day that the payment is due. All checks and bank drafts shall be drawn on United States banks and shall be payable to Amersham Health, A.S. Any loss of exchange,
value, taxes, or other expenses incurred in the transfer or conversion to U.S. dollars shall be paid entirely by KSA. All Royalty payments due under this Agreement shall be mailed to the following address: Nycoveien 2, Post Office Box 4220, Torshov,
N-0401, Oslo, Norway, Attention: Jim Martin. The Royalty report required by Section 5.2 of this Agreement shall accompany each such payment and a copy of such report shall also be mailed to AH at its address for notices. All amounts payable under
this Agreement are exclusive of all sales, use, value-added, withholding, and other taxes and duties. KSA will pay all taxes and duties assessed in connection with this Agreement and its performance by any authority within or outside of the U.S.,
except for taxes payable on AH s net income. AH will be promptly reimbursed by KSA for any and all taxes and duties that AH may be required to pay in connection with this Agreement or its performance. AH shall cooperate and assist KSA with any steps
that may be required to minimize the payment of taxes and duties under this Section or recover part or all of any taxes or duties paid under this Section. All amounts which remain unpaid after its due date shall be subject to interest charges at the
rate of one percent (I%) per month, or the highest rate permitted by law, whichever is lower. 
  

 6 

	5.	RECORDS AND AUDITS; REPORTS. 

  
 5.1 Record keeping and Audits. KSA agrees to keep accurate and
correct records of Licensed Products made, used, or sold and Licensed Processes practiced under this Agreement appropriate to determine the amount of Royalties, if any, due AH. Such records shall be retained for at least five (5) years following a
given reporting period. They shall be available during normal business hours at KSA s premises for inspection at the expense of AH by an accountant or other designated auditor selected by AH for the sole purpose of verifying reports and payments
hereunder. The accountant or auditor shall only disclose to AH information relating to the accuracy of reports and payments made under this Agreement. If an inspection shows an under reporting or underpayment in excess of five (5%) percent for any
twelve (12) month period, then KSA shall pay the unreported Royalties, including any late charges as required by Section 4.3 of this Agreement. All payments required under this Section shall be due within thirty (30) days of the date AH provides KSA
notice of the payment due. 
  
 5.2 Royalty Report. KSA
shall submit royalty reports in accordance with the provisions of the Primary Sublicense Agreement, until expiry thereof. Thereafter, upon royalties becoming due under section 4.2 of this Agreement, KSA shall submit to AH within thirty (30) days
after each calendar half-year ending June 30 and December 31 a royalty report setting forth for the preceding half-year period the amount of the Licensed Products sold or Licensed Processes practiced by or on behalf of KSA in each country within the
Licensed Territory, the Net Sales, and the amount of Royalties accordingly due. With each such royalty report, KSA shall submit payment of the earned Royalties due. If no earned royalties or payments are due to AH for any reporting period, the
written report shall so state. The Royalty report shall be certified as correct by an authorized officer of KSA. 
  
 5.3 Additional Reports. AH and KSA acknowledge that KSA is obligated to submit certain written reports to PHS and AH under the Primary Sublicense
Agreement. In the event that PHS requires that any additional reports be submitted under the Existing Drug Delivery Agreement, KSA shall provide such reports in a timely fashion upon request from either PHS or AH. 
  

	6.	PERFORMANCE BY KSA. 

  
 6.1 Efforts to Commercialize. KSA shall use its reasonable best efforts to introduce the Licensed Products into the commercial market or apply the
Licensed Processes to commercial use as soon as practicable. Reasonable best efforts for the purpose of this provision shall include, but not be limited to, adherence to the Commercial Development Plan and performance of the Benchmarks as per
Section 5.2.1 of the Primary Sublicense Agreement. The efforts of a sublicensee shall be considered the efforts of KSA. 
  
 6.2 Efforts to Make Available to Public. Upon first commercial sale, until the expiration of this Agreement, KSA shall use reasonable best efforts
to keep Licensed Products and Licensed Processes reasonably accessible to the public in the Licensed Territory. 
  
 6.3 Indigent Patient Access Program. Following regulatory marketing approval for Licensed Products and/or Licensed Processes in the United States,
KSA agrees to set up an 

  

 7 

 
indigent patient access program for Licensed Products or to include Licensed Products in an existing indigent patient access program such that Licensed
Products and/or Licensed Processes may be provided to qualified indigent citizens of the United States who are not covered under any public or private health plan. 
  

	7.	WARRANTY AND DISCLAIMERS; INDEMNIFICATION BY KSA; LIMITATION OF
LIABILITY. 

  
 7.1 Due Diligence by KSA. Except as specifically stated herein, AH makes no representations or warranties as to any aspect of the Licensed Products or Licensed Processes. AH does not make any representation or
warranty as to the business prospects of the Licensed Products or Licensed Processes. KSA acknowledges and agrees that (a) KSA has conducted its own review and analysis, as it deemed necessary and appropriate, of the business prospects of the
Licensed Products or Licensed Processes and is not relying on any representations or warranties from AH as to the business prospects; and (b) in making the decision to license the Licensed Patent Rights, KSA has relied solely on independent
investigations made by KSA or KSA s financial and legal advisors, has had the opportunity to review information and have questions answered by management and employees of AH, and deems such information received and reviewed adequate to evaluate the
merits and risks of the business prospects of the Licensed Products and Licensed Processes. 
  
 7.2 Mutual Authority. Each party represents and warrants to the other that: 
  
 7.2.1 Corporate Power. It is duly organized and validly existing under the laws of its state or country of incorporation, and has
full corporate power and authority to enter into this Agreement and to carry out the provisions hereof. 
  
 7.2.2 Due Authorization. It is duly authorized to execute and deliver this Agreement and to perform its obligations hereunder, and
the person or persons executing this Agreement on its behalf has been duly authorized to do so by all requisite corporate action. 
  
 7.2.3 Binding Agreement. This Agreement is legally binding upon it and enforceable in accordance with its terms. The execution,
delivery and performance of this Agreement by it to the best of its knowledge does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound, nor violate any material law or
regulation of any court, governmental body or administrative or other agency having jurisdiction over it. 
  
 7.3 Disclaimers. 
  
 7.3.1 No Warranty of Scope, Infringement, or Approvals. AH does not represent or warrant the validity of the Licensed Patent Rights
and makes no representations or warranties whatsoever with regard to the scope of the Licensed Patent Rights, or that the Licensed Patent Rights may be exploited without infringing other patents or other intellectual property rights of third
parties, or that the Licensed Products or Licensed Processes are acceptable for filing with the FDA or whether any authorization or approval will be obtained from the FDA. 
  

 8 

 7.3.2 General Disclaimer. THE LICENSED PATENT RIGHTS ARE LICENSED TO KSA ON AN AS
IS BASIS, AND AH MAKES NO WARRANTIES, EXPRESS OR IMPLIED, OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE OF ANY SUBJECT MATTER DEFINED BY THE CLAIMS OF THE LICENSED PATENT RIGHTS OR OTHERWISE. 
  
 7.4 Indemnification by KSA. KSA shall indemnify and hold AH and PHS,
its affiliates, officers, directors, employees, students, fellows, agents, and consultants harmless from and against all liability, demands, damages, expenses, and losses, including but not limited to death, personal injury, illness, or property
damage in connection with or arising out of (a) the use by or on behalf of KSA, its sublicensees, directors, employees, or third parties of any Licensed Patent Rights, or (b) the design, manufacture, distribution, or use of any Licensed Products,
Licensed Processes, or other products or processes developed in connection with or arising out of the Licensed Patent Rights. KSA agrees to maintain a liability insurance program consistent with sound business practice, with a minimum coverage of
Ten Million Dollars (US$10,000,000), provided that the obligation to place liability insurance shall not become applicable until thirty (30) days prior to the first application for Institutional Review Board (IRB) Approval for Clinical Trials and
such insurance program shall be satisfied by and not in addition to the obligations of KSA under Section 7.4 of the Primary Sublicense Agreement. 
  
 7.5 Indemnification by AH. AH shall indemnify and hold KSA, its affiliates, officers, directors, employees, agents, and consultants harmless from
and against all liability, demands, damages, expenses, and losses, including but not limited to death, personal injury, illness, or property damage in connection with or arising out claims brought by or for individuals who were administered a
product embodying Licensed Products or using Licensed Process(es) that were created via AH’s development efforts prior to the Effective Date. 
  
 7.6 Exclusion of Damages and Limitation of Liability. IN NO EVENT WILL EITHER PARTY BE LIABLE TO THE OTHER FOR ANY LOST REVENUES OR PROFITS, COST
OF PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES, OR ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES, WHETHER BASED ON BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE), PRODUCT LIABILITY, OR OTHERWISE, AND WHETHER OR NOT SUCH PARTY HAS BEEN
ADVISED OF THE POSSIBILITY OF SUCH DAMAGE. EXCEPT FOR THE INDEMNIFICATION UNDER SECTION 7.5 ABOVE, UNDER NO CIRCUMSTANCES SHALL AH BE LIABLE TO KSA FOR ANY AMOUNT GREATER THAN THE AMOUNT PAID BY KSA TO AH UNDER THE TERMS OF THIS AGREEMENT.

  

	8.	TERM AND TERMINATION. 

  
 8.1 Term. This Agreement shall come into force and effect on the Effective Date, and, unless sooner terminated by the
parties as otherwise provided, shall continue in effect until the last to expire of the Licensed Patent Rights (Term). 
  

 9 

 8.2 Events of Termination. Either party (or the specific party named below, as applicable) will
have the right to terminate this Agreement if or upon: 
  
 8.2.1 Breach. The other party breaches any material term or condition of this Agreement and fails to cure such breach within sixty (60) days after written notice, which shall include without limitation any failure of KSA to meet the
Benchmarks as may be modified under Section 5.2.2 of the Primary Sublicense Agreement; 
  
 8.2.2 Termination of Other Agreements. The termination of the Existing Drug Delivery Agreement or, prior to the expiration thereof,
the termination of the Existing Agreement including any sublicense thereof or the termination of the Primary Sublicense Agreement; 
  
 8.2.3 Voluntary Bankruptcy. The other party becomes the subject of a voluntary petition in bankruptcy or any voluntary proceeding
relating to insolvency, receivership, liquidation, or composition for the benefit of creditors; 
  
 8.2.4 Involuntary Bankruptcy. The other party becomes the subject of an involuntary petition in bankruptcy or any involuntary
proceeding relating to insolvency, receivership, liquidation, or composition for the benefit of creditors, if such petition or proceeding is not dismissed within sixty (60) days of filing; 
  
 8.2.5 Government Restrictions. The Licensed Products
and Licensed Processes may no longer be used, sold or otherwise distributed in the Licensed Territory due to government laws or regulations prevailing in the Licensed Territory; 
  
 8.2.6 Termination by PHS. This Agreement, and/or AH’s license to the Licensed Patent Rights from
PHS under the Existing Drug Delivery Agreement, is terminated as a result of PHS reserved rights under either agreement; or 
  
 8.2.7 Nonuse by KSA. KSA determines that it does not wish to initiate or continue commercialization or other use of the Licensed
Patent Rights under this Agreement, and provides AH with at least ninety (90) days prior written notice of its intent to terminate this Agreement. 
  
 8.3 Rights upon Termination. Upon any termination of this Agreement for any reason: 
  
 8.3.1 Not later than thirty (30) days following such termination, each party shall return to the other any
and all Confidential Information of the other party in its possession or control. 
  
 8.3.2 In the event that AR terminates this Agreement, KSA shall promptly deliver to AH all KSA Know-How, and KSA hereby grants to AH a
perpetual, nonexclusive license (with the right to sublicense) to use KSA Know-How as needed for AH and its sublicensees to fully exercise the Licensed Patent Rights. For purposes of this Agreement, KSA Know-How means all inventions,
discoveries, trade secrets, information, experience, data, formulas, procedures and results, and improvements thereon, whether or not patentable or patented, which are created or obtained by KSA during the term of this Agreement in connection with
its activities related to the Licensed Patent Rights, and which may be necessary or useful in the manufacture, use or sale of any Licensed Products or Licensed Processes. 
  

 10 

 8.3.3 KSA shall have the right to convert its license to the Licensed Patent Rights under
this Agreement into a license directly from PHS, upon PHS approval of same and KSA’s consent to applicable provisions required by PHS. 
  

	9.	CONFIDENTIALITY. 

  
 9.1 Confidential Information. “Confidential Information” means: (a) any business
or technical information of KSA or AH, including but not limited to any information relating to KSA’s or AH’s product plans, designs, costs, finances, marketing plans, business opportunities, personnel, research, pending patent
applications, development or know-how; and (b) the terms and conditions of this Agreement. 
  
 9.2 Exceptions. Confidential Information shall not include information that: (a) is in or enters the public domain without breach of this Agreement through no fault of the receiving party; (b) the receiving
party was demonstrably in possession of prior to first receiving it from the disclosing party; (c) the receiving party can demonstrate was developed by the receiving party independently and without use of or reference to the disclosing party’s
Confidential Information; or (d) the receiving party receives from a third party without restriction on disclosure and without breach of a nondisclosure obligation. 
  
 9.3 Obligations. Each party will maintain the Confidential Information of the other party in strict confidence and
will exercise due care with respect to the handling and protection of such Confidential Information, consistent with its own policies concerning protection of its own Confidential Information of like importance. Each party will use the Confidential
Information of the other party only as expressly permitted herein, and will disclose such Confidential Information only to its employees and consultants as is reasonably required in connection with the exercise of its rights and obligations under
this Agreement (and only subject to binding use and disclosure restrictions at least as protective as those set forth herein executed in writing by such employees and consultants). KSA expressly understands and agrees that AH shall have the right to
disclose Confidential Information of KSA to PHS solely to the degree required by AH’s disclosure obligations under the Existing Drug Delivery Agreement. However, each party may disclose Confidential Information of the other party pursuant to
the order or requirement of a court, administrative agency, or other governmental body, provided that the receiving party gives reasonable notice to the other party to contest such order or requirement. Any such disclosure by the receiving party of
the Confidential Information of the disclosing party, will, in no way, be deemed to change, affect or diminish the confidential and proprietary status of such Confidential Information. 
  
 9.4 Injunctive Relief. Each party acknowledges that improper use or disclosure of the Confidential Information of the
other party would cause substantial harm to the other party that could not be remedied by the payment of damages alone. Accordingly, each party will be entitled to preliminary and permanent injunctive relief and other equitable relief for any breach
of this Section 9. 
  

	10.	PHS CONSENTS. PHS hereby agrees as follows: 

  
 10.1 Approval of Sublicense. PHS has, in accordance with Article 4 of the Existing Drug Delivery Agreement, approved
this Agreement. 
  

 11 

 10.2 Communications and Approvals. KSA shall have the right to report on AH’s behalf to, and
to seek approvals on AH’s behalf from, PHS as contemplated under Sections 2.3.1, 2.3.2, 2.3.3, 2.4.1, 2.4.2, 2.4.3, 3.1, 3.2, 3.3, 3.4, 3.5, 5.1, 5.2, and 5.3 of this Agreement. Any reports or communications contemplated under those Sections
shall be treated by PHS as reports or communications from AH. Any approvals given by PHS under the above referenced Sections shall be deemed an approval by AH under this Agreement. 
  

	11.	GENERAL PROVISIONS. 

  
 11.1 Waiver. Neither party may waive or release any of its rights or interests in this Agreement except in writing.
The failure of either party to assert a right hereunder or to insist upon compliance with any term or condition of this Agreement shall not constitute a waiver or that right by either party or excuse a similar subsequent failure to perform any such
term or condition by this other party. 
  
 11.2 Entire
Agreement. Save only as provided in the Primary Sublicense Agreement and the Existing Drug Delivery Agreement, this Agreement constitutes the entire agreement between the Parties relating to the subject matter of the Licensed Patent Rights and
all prior negotiations, representations, agreements, and understandings are merged into, extinguished by, and completely expressed by this Agreement. 
  
 11.3 Severability. The provisions of this Agreement are severable, and in the event that any provision of this Agreement shall be determined to be
invalid or unenforceable under any controlling body of law, such determination shall not in any way affect the validity or enforceability of the remaining provisions of this Agreement. 
  
 11.4 Modification. If either party desires a modification to this Agreement, the Parties shall, upon reasonable
notice of the proposed modification by the party desiring the change, confer in good faith to determine the desirability of such modification. No modification will be effective until a written amendment is signed by the signatories to this
Agreement. 
  
 11.5 Governing Law; Dispute Resolution. The
construction, validity, performance, and effect of this Agreement shall be governed by the laws of New Jersey and of the United States, excepting those portions thereof relating to conflicts of law. All disputes arising under this Agreement shall be
resolved solely in the federal or state courts situated in New Jersey and both parties hereby submit to the personal jurisdiction thereof. 
  
 11.6 Notices. All notices required or permitted by this Agreement shall be given by prepaid, first class, registered or certified mail properly
addressed to the other party at the address designated on the first page of this Agreement, or to such other address as may be designated in writing by such other party, and shall be effective as of the date of the postmark of such notice.

  
 11.7 Assignment. This Agreement shall not be assigned
by KSA except (a) with the prior written consent of AH, such consent to be reasonably given; or (b) as part of a sale or transfer of substantially the entire business of KSA relating to operations which concern this Agreement. KSA shall notify AH
within ten (10) days of any assignment of this Agreement by KSA. In the event that any such assignment by KSA shall cause a payment to be due from AH 

  

 12 

 
to PHS under Section 14.07 of the Existing Drug Delivery Agreement, KSA shall promptly make such payment to AH for delivery to PHS. 
  
 11.8 Use of Items from AH and its Licensors. KSA agrees in its use of
any AH supplied items to comply with all applicable statutes, regulations, and guidelines, including Public Health Service and National Institutes of Health Regulations and guidelines. KSA agrees not to use the materials for research involving human
subjects or clinical trials in the United States without complying with 21 CFR Part 50 and 45 CFR Part 46. KSA agrees not to use the items for research involving human subjects or clinical trials outside of the United States without notifying AH, in
writing, of such research or trials and complying with the applicable regulations of the appropriate national control authorities. Written notification to AH of research involving human subjects or clinical trials outside of the United States shall
be given no later than sixty (60) days prior to commencement of such research or trials. 
  
 11.9 Export Control. KSA acknowledges that it is subject to and agrees to abide by the United States laws and regulations (including the Export Administration Act of 1979 and Arms Export Control Act)
controlling the export of technical data, computer software, laboratory prototypes, biological material, and other commodities. The transfer of such items may require a license from the cognizant agency of the U.S. Government or written assurances
by KSA that it shall not export such items to certain foreign countries without prior approval of such agency. AH neither represents nor warrants that a license is or is not required or that, if required, it shall be issued. 
  
 11.10 Marking of Licensed Products. KSA agrees to mark the Licensed
Products or their packaging sold in the United States with all applicable U.S. patent numbers and similarly to indicate Patent Pending status. All Licensed Products manufactured in, shipped to, or sold in other countries shall be marked in such a
manner as to preserve AH’s or its licensor’s patent rights in such countries. 
  
 11.11 Survival. Sections 2.3.3, 2.4, 4, 7, 8, 9 and 11 of this Agreement shall survive termination of this Agreement. 
  
 11.12 Counterparts. This Agreement may be executed in multiple counterparts, each of which when so executed, shall be deemed to be an original copy
hereof, and all such counterparts together shall constitute one single agreement. 
  
 [Remainder of Page Left Blank] 
  

 13 

 [Signature Page to Sublicense Agreement] 
  
 IN WITNESS WHEREOF, the parties have caused this Agreement to be signed by
their duly authorized representatives. 
  

									
	 KS AVICENNA, INC.
	 	 	 	 AMERSHAM HEALTH A.S.

					
	By:	 	 /s/ Fahar Merchant
	 	 	 	By:	 	 /s/ Ase Aulie Michelet

					
	Name:	 	 Fahar Merchant
	 	 	 	Name:	 	 Ase Aulie Michelet

					
	Title:	 	 Chief Technology Officer
	 	 	 	Title:	 	 President Amersham Health A5

  

 APPENDIX A 
 PATENTS OR PATENT APPLICATIONS 
  
 U.S. Patent 5,720,729 (USSN 08/616,785), issued on February 24, 1998 and entitled; Convection-Enhanced Drug Delivery, Inventors: Drs. Douglas W. Laske (NINDS), Edward H.
Oldfield (NINDS), Richard H. Bobo (NINDS), Robert L. Dedrick (NCRR) and Paul F. Morrison (NCRR). 
  

 APPENDIX B 
  
 PHS FLOWTHROUGH TERMS 
  
 1. Manufacturing in US for US Distribution. KSA agrees that products used or sold in the United States embodying Licensed Products or produced
through use of Licensed Processes shall be manufactured substantially in the United States, unless a written waiver is obtained in advance from PHS. 
  
 2. Government Reserved Rights. Prior to the initial transfer by or on behalf of KSA or its sublicensees of Licensed Products or the initial
practice of a Licensed Process by or on behalf of KSA or its sublicensees in exchange for cash or some equivalent to which value can be assigned for the purpose of determining Net Sales, KSA agrees to provide PHS reasonable quantities of Licensed
Products or materials made through the Licensed Processes for PHS research use. 
  
 3. Recordkeeping and Audits. KSA agrees to keep accurate and correct records of Licensed Products made, used, or sold and Licensed Processes practiced under this Agreement appropriate to determine the amount of
royalties due AH. Such records shall be retained for at least five (5) years following a given reporting periods. They shall be available during normal business hours at KSA’s premises for inspection at the expense of PHS by an accountant or
other designated auditor selected by PHS for the sole purpose of verifying reports and payments hereunder. The accountant or auditor shall only disclose to PHS information relating to the accuracy of reports and payments made under this Agreement.
If an inspection shows an under reporting or underpayment in excess of five (5%) percent for any twelve (12) month period, then KSA shall pay the unreported Royalties, including any late charges as required by Section 4.5 of this Agreement. All
payments required under this Section shall be due within thirty (30) days of the date PHS provides KSA notice of the payment due. 
  
 7. Efforts to Commercialize. KSA shall use its reasonable best efforts to introduce the Licensed Products into the commercial market or apply the
Licensed Processes to commercial use as soon as practicable. Reasonable best efforts for the purpose of this provision shall include, but not be limited to, adherence to the Commercial Development Plan. The efforts of a sublicensee shall be
considered the efforts of KSA. 
  
 8. Efforts to Make Available
to Public. Upon first commercial sale, until the expiration of this Agreement, KSA shall use the reasonable best efforts to keep Licensed Products and Licensed Processes reasonably accessible to the public in the Licensed Territory. 

 
 9. Indemnification by KSA. KSA shall indemnify and hold AH and PHS,
its employees, students, fellows, agents, and consultants harmless from and against all liability, demands, damages, expenses, and losses, including but not limited to death, personal injury, illness, or property damage in connection with or arising
out of (a) the use by or on behalf of KSA, its sublicensees, directors, employees, or third parties of any Licensed Patent Rights, or (b) the design, manufacture, distribution, or use of any Licensed Products, Licensed Processes, or other products
or processes developed in connection with or arising out of the Licensed Patent Rights. KSA agrees to maintain a liability insurance program consistent with sound business practice. 
  

 10. PHS reserves the right according to 35 U.S.C. Section 209(f)(4) to terminate or modify this Agreement
if it is determined that such action is necessary to meet requirements for public use specified by Federal regulations issued after the date of the license and such requirements are not reasonably satisfied by KSA. 
  
 11. Within thirty (30) days of receipt of PHS unilateral decision to modify
or terminate this Agreement, KSA may, consistent with the provisions of 37 CFR Section 404.11, appeal the decision by written submission to the Director of NIH or designee. The decision of the NIH Director or designee shall be the final agency
decision. KSA may thereafter exercise any and all administrative or judicial remedies that may be available. 
  
 12. Within ninety (90) days after termination or expiration of this Agreement, a final report shall be submitted by KSA. Any royalty payments, including
those related to patent expense, due to AH or PHS shall become immediately due and payable upon termination or expiration. If terminated, sublicensees may elect to convert their sublicenses to direct licenses with PHS in accordance with the terms of
this Agreement.

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