Document:

Exhibit 10.1
	 

	 
		CONFIDENTIAL TREATMENT
	 

	 
		REQUESTED PURSUANT TO RULE
		24b-2
	 

	 
		 
	 

	 
		 
	 

	 
		CONFIDENTIAL
	 

	 
		Manufacturing and Service Contract
	 

	 
		For Commercial and Developmental
		Products
	 

	 
		Vion Pharmaceuticals, Inc.
	 

	 
		11/28/2006
	 

	 
		 
	 

	 
		 
	 

	 

	 
	 

	 
	 
		CONFIDENTIAL
	 

	 
		 
	 

	 
		TABLE OF CONTENTS
	 

	 
		 
	 

	 
			
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  Page
				

			 
	
				
				  ARTICLE 1 -
				

			 	
				
				   
				

			 	
				
				  DEFINITIONS
				

			 	
				
				  1
				

			 
	
				
				  ARTICLE 2 -
				

			 	
				
				   
				

			 	
				
				  DESCRIPTION OF WORK
				

			 	
				
				  7
				

			 
	
				
				  ARTICLE 3 -
				

			 	
				
				   
				

			 	
				
				  MANUFACTURE
				

			 	
				
				  8
				

			 
	
				
				  ARTICLE 4 -
				

			 	
				
				   
				

			 	
				
				  VOLUMES AND ALTERNATE SOURCE
				

			 	
				
				  12
				

			 
	
				
				  ARTICLE 5 -
				

			 	
				
				   
				

			 	
				
				  FORECASTS AND PURCHASE ORDERS
				

			 	
				
				  13
				

			 
	
				
				  ARTICLE 6 -
				

			 	
				
				   
				

			 	
				
				  PRICE AND PAYMENT
				

			 	
				
				  16
				

			 
	
				
				  ARTICLE 7 -
				

			 	
				
				   
				

			 	
				
				  QUALITY AGREEMENT
				

			 	
				
				  19
				

			 
	
				
				  ARTICLE 8 -
				

			 	
				
				   
				

			 	
				
				  INDEMNIFICATION
				

			 	
				
				  19
				

			 
	
				
				  ARTICLE 9 -
				

			 	
				
				   
				

			 	
				
				  CONFIDENTIALITY
				

			 	
				
				  21
				

			 
	
				
				  ARTICLE 10 -
				

			 	
				
				   
				

			 	
				
				  REPRESENTATIONS AND
				  WARRANTIES
				

			 	
				
				  22
				

			 
	
				
				  ARTICLE 11 -
				

			 	
				
				   
				

			 	
				
				  INTELLECTUAL PROPERTY
				

			 	
				
				  24
				

			 
	
				
				  ARTICLE 12 -
				

			 	
				
				   
				

			 	
				
				  TERM AND TERMINATION
				

			 	
				
				  25
				

			 
	
				
				  ARTICLE 13 -
				

			 	
				
				   
				

			 	
				
				  NOTICES
				

			 	
				
				  27
				

			 
	
				
				  ARTICLE 14 -
				

			 	
				
				   
				

			 	
				
				  WAIVER
				

			 	
				
				  28
				

			 
	
				
				  ARTICLE 15 -
				

			 	
				
				   
				

			 	
				
				  ASSIGNMENT OF AGREEMENT
				

			 	
				
				  28
				

			 
	
				
				  ARTICLE 16 -
				

			 	
				
				   
				

			 	
				
				  GOVERNING LAW
				

			 	
				
				  29
				

			 
	
				
				  ARTICLE 17 -
				

			 	
				
				   
				

			 	
				
				  FORCE MAJEURE
				

			 	
				
				  29
				

			 
	
				
				  ARTICLE 18 -
				

			 	
				
				   
				

			 	
				
				  TITLE OF GOODS
				

			 	
				
				  30
				

			 
	
				
				  ARTICLE 19 -
				

			 	
				
				   
				

			 	
				
				  ENTIRE AGREEMENT
				

			 	
				
				  30
				

			 
	
				
				  ARTICLE 20 -
				

			 	
				
				   
				

			 	
				
				  SEVERABILITY
				

			 	
				
				  30
				

			 
	
				
				  ARTICLE 21 -
				

			 	
				
				   
				

			 	
				
				  INDEPENDENT CONTRACTORS
				

			 	
				
				  30
				

			 
	
				
				  ARTICLE 22 -
				

			 	
				
				   
				

			 	
				
				  AMENDMENTS
				

			 	
				
				  31
				

			 
	
				
				  ARTICLE 23 -
				

			 	
				
				   
				

			 	
				
				  HEADINGS
				

			 	
				
				  31
				

			 
	
				
				  ARTICLE 24 -
				

			 	
				
				   
				

			 	
				
				  REVIEW BY LEGAL COUNSEL
				

			 	
				
				  31
				

			 
	
				
				  ARTICLE 25 -
				

			 	
				
				   
				

			 	
				
				  RECALL
				

			 	
				
				  31
				

			 
	
				
				  ARTICLE 26 -
				

			 	
				
				   
				

			 	
				
				  ENGLISH LANGUAGE
				

			 	
				
				  31
				

			 
	
				
				  ARTICLE 27 -
				

			 	
				
				   
				

			 	
				
				  EXPORT PROVISION
				

			 	
				
				  32
				

			 
	
				
				  ARTICLE 28 -
				

			 	
				
				   
				

			 	
				
				  ACKNOWLEDGEMENT OF COMPETITION FOR
				  COMPETITIVE PRODUCTS OR SERVICES
				

			 	
				
				  32
				

			 
	
				
				  ARTICLE 29 -
				

			 	
				
				   
				

			 	
				
				  EXECUTION
				

			 	
				
				  32
				

			 

 

	 
		 
	 

	 
		Manufacturing and Service Agreement (BVL and
		Vion Pharmaceuticals, Inc.)
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		ii
	 

	 
		 
	 

	 
	 

	 

	 
		CONFIDENTIAL
	 

	 
		ATTACHMENTS
	 

	 
		 
	 

	 
			
				
				  Attachment “A”
				  – Product Supplements (“A1” for the first
				  Product, “A2” for the second Product, etc.)
				

			 
	
				
				  A1.1
				

			 	
				
				   
				

			 	
				
				  Product Identification
				

			 
	
				
				  A1.2
				

			 	
				
				   
				

			 	
				
				  Product Testing Specification
				

			 
	
				
				  A1.3
				

			 	
				
				   
				

			 	
				
				  Materials Supplied By Customer And
				  BVL
				

			 
	
				
				  A1.4
				

			 	
				
				   
				

			 	
				
				  Forecasts
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  A1.4.1
				

			 	
				
				  Five-Year Forecasts
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  A1.4.2
				

			 	
				
				  Rolling 12 Month Forecast
				

			 
	
				
				  A1.5
				

			 	
				
				   
				

			 	
				
				  Pricing
				

			 
	
				
				  A1.6
				

			 	
				
				   
				

			 	
				
				  Territory (for Products identified in A1.1)
				

			 
	
				
				  Attachment “B”
				  – Purchase Order
				  Requirements
				

			 
	
				
				  Attachment “C”
				  – Monthly Storage Fees
				

			 
	
				
				  Attachment “D”
				  – Documents Supplied with Batch
				  Release
				

			 
	
				
				  Attachment “E”
				  – Quality Agreement
				

			 
	
				
				  Attachment “F” –
				  Customer Supplied Equipment
				

			 
	
				
				   
				

			 
	
				
				  Additional Attachments for Use
				  if “Territory” for any Product Includes the European
				  Union:
				

			 
	
				
				   
				

			 
	
				
				  Attachment “G”
				  – Representation regarding
				  Customer’s Qualified Person
				

			 
	
				
				  Attachment “H”
				  – cGMP Facility Compliance
				  Certificate
				

			 
	
				
				  Attachment “I”
				  – Statement relating to GMP Status
				  of the Manufacture & Supply of API
				

			 
	
				
				  Attachment “J”
				  – Certificate of Analysis for use
				  in the European Union Member States
				

			 

 

	 
		 
	 

	 
		Manufacturing and Service Agreement (BVL and
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		iii
	 

	 
		 
	 

	 
	 

	 

	 
		CONFIDENTIAL
	 

	 
		Manufacturing and Service
		Contract
	 

	 
		For Commercial and Developmental
		Products
	 

	 
		This Manufacturing and Service Contract for
		Commercial and Developmental Products (hereinafter this “Agreement”)
		is made effective as of November 28, 2006 (the “Effective Date”), by
		Ben Venue Laboratories, Inc., a corporation organized and existing under the
		laws of Delaware, with its principal office at 300 Northfield Road, Bedford,
		Ohio, 44146 (hereinafter “BVL”) and Vion Pharmaceuticals, Inc. a
		corporation organized and existing under the laws of Delaware, with its
		principal place of business at 4 Science Park, New Haven, CT 06511 (hereinafter
		“Customer”). BVL and Customer may be referred to in this Agreement
		jointly as the “Parties” or individually as a
		“Party.”
	 

	 
		WITNESSETH:
	 

	 
		WHEREAS, Customer is active in the
		pharmaceutical business and is the owner or licensee of all rights to certain
		proprietary technical information, patents and/or patent applications relating
		to Product (as defined below); and
	 

	 
		WHEREAS, BVL provides services to the
		pharmaceutical industry as a contract manufacturer which supplies its customers
		with sterile finished dosage forms which it has converted from materials
		supplied by those customers and/or supplied by BVL and provides Developmental
		services for sterile dosage forms; and
	 

	 
		WHEREAS, Customer and BVL desire to
		formalize their relationship through this Agreement for the Development and
		Manufacture of Product and intend for this Agreement to govern the
		Parties’ relationship; and
	 

	 
		WHEREAS, BVL possesses the requisite
		expertise, personnel and Facilities (as defined below) for the Development and
		Manufacture of finished sterile dosage forms of Product and is willing to
		provide Development services, allocate and commit resources and Manufacture (as
		defined below) such Product(s) on a contract basis, for Customer; and
	 

	 
		WHEREAS, Customer desires for BVL to reserve
		capacity and resources in order to provide Development and Manufacturing
		services for Customer. Customer also desires to have its Product exclusively
		Manufactured by BVL for its requirement of Product in the Territory, per the
		terms of this Agreement.
	 

	 
		NOW, THEREFORE, Customer and BVL agree as
		follows:
	 

	 
		ARTICLE 1 - DEFINITIONS
	 

	 
		In this Agreement, the following terms shall
		have the meanings set forth below:
	 

	 
			
				
				   
				

			 	
				
				  1.1.
				

			 	
				
				  “Act” means
				  the US Federal Food, Drug and Cosmetic Act of 1938, the Public Health Service
				  Act of 1944 and the regulations promulgated under that Act, as may be amended
				  from time to time. 
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.2.
				

			 	
				
				  “Active Pharmaceutical Ingredient” or “API” shall
				  mean bulk supplies of the pharmacologically active compound(s) comprising
				  Product and listed in each Attachment “A#.3,” (i.e., A1.3)
				  which Customer will provide to BVL in bulk form, 
				

			 

 

	 
		 
	 

	 
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		from time to time, for the sole purpose of
		Development and Manufacture of Product for Customer.
	 

	 
			
				
				   
				

			 	
				
				  1.3.
				

			 	
				
				  “Affiliate”
				  shall mean: (a) any corporation or business entity, fifty percent (50%) or more
				  of the voting stock or voting equity interests of which are owned directly or
				  indirectly by a Party; or (b) any corporation or business entity which directly
				  or indirectly owns fifty percent (50%) or more of the voting stock or voting
				  equity interests of a Party; or (c) any corporation or business entity directly
				  or indirectly controlling or under control of a corporation or business entity
				  as described in (a) or (b). 
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.4.
				

			 	
				
				  “Agency” and
				  “Agencies” shall mean the regulatory entities for each
				  respective country, states and/or territories as identified in and limited to
				  each Product’s definition of the Territory (i.e., for Product A1 see
				  Attachment A1.6); if Territory includes the United States, the FDA; if
				  Territory includes Canada and its Provinces, the Canadian Health Protection
				  Branch; if Territory includes any member state of the European Union, the
				  European Agency for Evaluation of Medicinal Products (hereinafter the
				  “EMEA”), if Territory includes Japan, the Japanese Ministry of
				  Health, Labor and Welfare; (b) any successor organization of any such entity;
				  and (c) any other government regulatory authority with regulatory oversight of
				  the Manufacturing or use of Product in or for the Territory, as such other
				  authorities are mutually agreed upon by the Parties in writing. 
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.5.
				

			 	
				
				  “Alternate Source” shall have the meaning ascribed thereto in
				  Section 4.2.
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.6.
				

			 	
				
				  “Applicable Law” shall mean all applicable ordinances, rules,
				  regulations, laws, guidelines, guidance, statutes, requirements and court
				  orders of any kind whatsoever, as amended from time to time, including the
				  bodies of law, regulations (including without limitation, cGMP or its
				  equivalent) for each country of the Territory. 
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.7.
				

			 	
				
				  “Batch”
				  shall mean a specific quantity of Product that is intended to be of uniform
				  character and quality and is produced during the same cycle of Manufacture as
				  defined by the applicable Batch Record. The Batch size for each Product is
				  specified in each Attachment “A#.1” (i.e., A1.1) to
				  this Agreement. “Lot” shall
				  have the same meaning as Batch.
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.8.
				

			 	
				
				  “Batch Records” shall have the meaning ascribed thereto in
				  Section 3.9.2.
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.9.
				

			 	
				
				  BVL Indemnitees” shall have the meaning ascribed thereto in
				  Section 8.1.
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.10.
				

			 	
				
				  “BVL Technology” shall mean the Technology of BVL that: (a) exists
				  prior to the Effective Date; or (b) is developed or obtained by or on behalf of
				  BVL independent of this Agreement and without reliance upon Confidential
				  Information of Customer; or (c) is developed by BVL after the Effective Date
				  without reference to Customer Confidential Information and which is not
				  Customer Product-specific.
				

			 

 

	 
		 
	 

	 
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				  1.11.
				

			 	
				
				  “cGMP” shall
				  mean the Current Good Manufacturing Practices in the Territory (Attachment
				  “A#.6”, i.e., A1.6) as may be amended or supplemented from time to
				  time; if in the United States, then cGMP shall including without limitation,
				  the Current Good Manufacturing Practices set forth in 21 C.F.R. 210 and 21
				  C.F.R. 211 and relevant FDA guidance documents; and if in the European Union,
				  then cGMP shall include, without limitation, the European Community Directive
				  91/356/EEC, Directive 2001/20/EC, Directive 2001/83/EC and all relevant
				  implementations of such directives and relevant guidelines including the EC
				  Guidelines, as may be amended or supplemented from time to time In the event of
				  any conflict among Applicable Laws pertaining to the Manufacture of Product,
				  current Good Manufacturing Practices as specified in the United States Code of
				  Federal Regulations will be applied unless the Parties agree otherwise in
				  writing.
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.12.
				

			 	
				
				  “Certificate of Analysis” shall mean a summary of the test results,
				  including the test methods, specification parameters, and the pass/fail
				  criteria, used in the determination of the quality and suitability of a
				  specific Batch of Product, including review and approval by the appropriate
				  quality assurance department at BVL
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.13.
				

			 	
				
				  “Certificate of Compliance” shall mean a document, signed by an authorized
				  representative of BVL, attesting that a particular Batch was manufactured in
				  accordance with cGMP and other Applicable Law.
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.14.
				

			 	
				
				  “Claims”
				  shall have the meaning ascribed thereto in Section 8.1.
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.15.
				

			 	
				
				  “Composition” shall mean any components and/or raw materials
				  that are used in the Manufacturing of Product and listed in each Attachment
				  “A#.3” (i.e., A1.3) hereto, which may be supplied by BVL or
				  Customer.
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.16.
				

			 	
				
				  “Confidential Information” shall have the meaning set forth in Section
				  9.1.
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.17.
				

			 	
				
				  “Contract Quarter” shall mean each three (3) month period commencing
				  on January 1, April 1, July 1, or October 1, during the term of this Agreement,
				  provided that the first Contract Quarter shall commence on the Effective Date
				  and end on the last day of the then-existing quarter and the last Contract
				  Quarter shall end on the expiration or termination of this Agreement. 
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.18.
				

			 	
				
				  “Contract Year” shall mean each twelve (12) month period
				  commencing on January 1, and each successive twelve month period thereafter
				  ending on December 31 of the same year; provided
				  that regardless of the Effective Date, the Contract Year of
				  the initial year of the Agreement shall commence on the Effective Date and end
				  on December 31 of the initial year; the Contract Year for the final year of the
				  Agreement shall end on December 31 or in the event of a termination of the
				  Agreement, upon the effective date of termination, whichever occurs
				  first.
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.19.
				

			 	
				
				  “Customer Indemnitees” shall have the meaning ascribed thereto in
				  Section 8.2.
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.20.
				

			 	
				
				  “Customer Technology” shall mean: (a) API; (b) Product and any
				  intermediates or derivatives thereof; (c) Specification; and (d) the Technology
				  of Customer owned, developed or obtained by or on behalf of Customer prior to
				  the Effective 
				

			 

 

	 
		 
	 

	 
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		Date, or developed or obtained by or on
		behalf of Customer independent of this Agreement and without reliance upon the
		Confidential Information, Improvements or Technology of BVL.
	 

	 
			
				
				   
				

			 	
				
				  1.21.
				

			 	
				
				  “Development,” “Develop,”
				  “Developmental” – shall mean all of the services provided in
				  support of the Manufacture of Product as defined by proposals submitted by BVL
				  to Customer.
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.22.
				

			 	
				
				  “Disclosing Party” means the party which is directly or indirectly
				  disclosing Confidential Information to the Receiving Party pursuant to this
				  Agreement. The Disclosing Party may also act as the Receiving Party of the
				  other party’s Confidential Information.
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.23.
				

			 	
				
				  “Drug Master File” or “DMF” means a drug master file
				  providing detailed information about the facility, the equipment and
				  manufacturing processes relating to the API and Product and such other
				  information as required by Applicable Laws, including 21 C.F.R. Section 314.420
				  and to the extent applicable any equivalent requirement in under Applicable
				  Laws including as required by the Committee for Proprietary Medicinal Products
				  Note for Guidance on the European Drug Master File Procedure for Active
				  Ingredients. 
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.24.
				

			 	
				
				  “Equipment”
				  shall mean the equipment described in the BVL master batch record which is: (a)
				  owned or leased by BVL or by the Customer; and (b) included in Attachment
				  “F” to this Agreement, and in each case will be used by BVL for the
				  Development and/or Manufacture of Product in accordance with the terms and
				  conditions of this Agreement. 
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.25.
				

			 	
				
				  “Facility”
				  and “Facilities” shall mean BVL’s Facility located at 300
				  Northfield Road, Bedford, Ohio, and 19200 Treat Road, Walton Hills, Ohio, all
				  other BVL facilities used in the Manufacturing of Product; provided that such
				  other facilities have been agreed upon by the Parties in writing in
				  advance.
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.26.
				

			 	
				
				  “FDA” shall
				  mean the U.S. Food and Drug Administration and any successor agency.
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.27.
				

			 	
				
				  “FDCA” shall
				  mean the United States Federal Food, Drug and Cosmetic Act, 21 U.S.C.
				  §§321 et seq., as amended from time to time.
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.28.
				

			 	
				
				  “Firm Order”
				  shall mean a binding commitment, as established by a Purchase Order issued by
				  Customer, to have a Batch of Product Manufactured by BVL hereunder. 
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.29.
				

			 	
				
				  “Five-Year Forecast” shall have the meaning ascribed thereto in
				  Section 5.1.
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.30.
				

			 	
				
				  “Force Majeure” shall have the meaning set forth in Article 17.
				  
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.31.
				

			 	
				
				  “Forecasts”
				  shall mean the collective reference to the Five-Year Forecast and the Rolling
				  Forecast.
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.32.
				

			 	
				
				  “Immediately” shall mean within twenty-four (24) hours.
				

			 

 

	 
		 
	 

	 
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				  1.33.
				

			 	
				
				  “Improvements” shall mean all Technology and discoveries,
				  inventions, developments, modifications, innovations, updates, enhancements,
				  improvements, writings or rights (whether or not protectable under patent,
				  trademark, copyright or similar laws) that are conceived, discovered, invented,
				  developed, created, made or reduced to practice in the Manufacture of Product
				  or performance of other services related to the Product under this
				  Agreement.
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.34.
				

			 	
				
				  “Investigation” shall mean a detailed and thorough review of any
				  atypical Manufacturing deviation (or any other matter requiring review pursuant
				  to the terms of this Agreement) that is documented in a written report and
				  approved at a senior management level. Each such written report shall include,
				  without limitation, a detailed description of the atypical event, deviation or
				  other matter, all steps taken to review such atypical event, deviation or other
				  matter, a root cause analysis, which other lots of Customer Product were
				  affected, if any, the proposed and/or taken corrective actions with applicable
				  timelines and a recommendation for permanent correction. 
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.35.
				

			 	
				
				  “Manufacture,” “Manufacturing,” and “Manufactured” shall mean all operations of BVL in the
				  scheduling, production, packaging, labeling, warehousing, quality control
				  testing (including in-process, release and stability testing when applicable),
				  release and shipping of Product to meet the Specification for Product.
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.36.
				

			 	
				
				  “Manufacturing Process” shall mean any and all processes (or any step in
				  any process) used or planned to be used by BVL to Manufacture Product, as
				  evidenced in the Batch Records.
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.37.
				

			 	
				
				  “Marketing Authorization” shall mean a New Drug Application filed with an
				  Agency outside the United States.
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.38.
				

			 	
				
				  “NDA” shall
				  mean a New Drug Application filed with the FDA.
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.39.
				

			 	
				
				  “Obsolete Materials” shall have the meaning set forth in Paragraph
				  6.4.2.
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.40.
				

			 	
				
				  “Order Deficit” shall have the meaning set forth in Paragraph
				  5.4.
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.41.
				

			 	
				
				  “Party” or
				  “Parties” shall have that meaning as set first in the first
				  unnumbered paragraph of this Agreement.
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.42.
				

			 	
				
				  “Product”
				  and “Products”
				  shall mean each of the final packaged dosage forms of the product(s) listed
				  separately in each Attachment “A#.1” (i.e., A1.1) to
				  this Agreement, as each such Attachment “A” may be amended from time
				  to time in writing by the Parties.
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.43.
				

			 	
				
				  “Promptly”
				  shall mean within thirty calendar (30) days.
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.44.
				

			 	
				
				  “Purchase Order” shall mean a written form submitted by Customer
				  to BVL authorizing the Manufacture of Product, Development or other services as
				  specified on the document which references this Agreement or a quotation number
				  provided by BVL or other document provided by BVL outlining the 
				

			 

 

	 
		 
	 

	 
		 
	 

	 
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		services to be performed, the price to be
		paid, and contains each of the requirements set forth on Attachment
		“B.” 
	 

	 
			
				
				   
				

			 	
				
				  1.45.
				

			 	
				
				  “Qualified Person” shall have the meaning set forth within the
				  European Union Directives, including without limitation, identified in Article
				  49 of Directive 2001/82/EC.
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.46.
				

			 	
				
				  “Quality Agreement” shall mean the separate quality agreement to be
				  executed at the same time as this Agreement by BVL and Customer and attached
				  hereto as Attachment “E.” The Quality Agreement constitutes an
				  integrated part of this Agreement and defines the quality assurance and
				  regulatory responsibilities of the Parties as they relate to this
				  Agreement.
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.47.
				

			 	
				
				  “Receiving Party” shall have the meaning ascribed thereto in
				  Section 9.1.
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.48.
				

			 	
				
				  “Records”
				  shall have the meaning ascribed thereto in Section 3.8.
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.49.
				

			 	
				
				  “Representative” shall have the meaning ascribed thereto in
				  Section 2.4.
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.50.
				

			 	
				
				  “Rolling Forecast” shall have the meaning ascribed thereto in
				  Section 5.1.2.
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.51.
				

			 	
				
				  “SOP’s”
				  of a Party shall mean such Party’s standard operating procedures as
				  defined in the controlled written documentation of such Party.
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.52.
				

			 	
				
				  “Specification” shall mean the quality standards, including
				  tests, analytical procedures and acceptance criteria that are established to
				  confirm the quality of Product which are mutually agreed to in writing and are
				  contained or referenced in the master batch record for Product or as otherwise
				  mutually agreed to in writing by the Parties.
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.53.
				

			 	
				
				  “Technology”
				  shall mean all methods, techniques, trade secrets, copyrights, know-how, data,
				  documentation, regulatory submissions, specifications and other intellectual
				  property of any kind (whether or not protectable under patent, trademark,
				  copyright or similar laws). 
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.54.
				

			 	
				
				  “Temporary Storage Period” shall have that meaning ascribed in Section
				  6.6.
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.55.
				

			 	
				
				  “Territory”
				  shall mean those countries and territories set forth in each Attachment
				  “A#.6” (i.e., A1.6) for the Product identified in each such
				  Attachment “A,” it being understood that different Products may have
				  different Territories for purposes of this Agreement.
				

			 

 

	 
			
				
				   
				

			 	
				
				  1.56.
				

			 	
				
				  “Third Party” shall mean any person or entity other than a
				  Party to this Agreement or such Party’s Affiliate.
				

			 

 

	 
		 
	 

	 
		 
	 

	 
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		ARTICLE 2 - DESCRIPTION OF
		WORK
	 

	 
			
				
				   
				

			 	
				
				  2.1.
				

			 	
				
				  API and Composition.
				

			 

 

	 
			
				
				   
				

			 	
				
				  2.1.1.
				

			 	
				
				  Customer shall, at its own expense,
				  supply BVL with sufficient quantities of API and Customer-supplied Composition,
				  including API, needed for the Development or Manufacture of Product, as
				  specified in the Forecasts and suppor[*]ting Purchase Orders, in order to meet
				  Customer’s requirements for commercial and/or Developmental quantities of
				  Product in finished dosage form. Customer will provide API and any other
				  mutually agreed, Customer-supplied composition at least [*] calendar days
				  in advance of scheduled Manufacturing date in accordance with BVL’s
				  SOP’s. Customer’s provision of API to BVL shall not exceed that
				  amount required for the existing, open Purchase Orders and, in any event, not
				  to exceed [*] months supply of API except as otherwise mutually
				  agreed-to by the Parties in writing.
				

			 

 

	 
		BVL agrees: (i) to account for all API and
		Customer-supplied Composition and to provide Customer with standard inventory
		reports upon request; (ii) to notify Customer when the amount of
		Customer-supplied Composition available at BVL reaches the minimum quantity of
		material as agreed by both Parties; (iii) not to provide API or
		Customer-supplied Composition to any Third Party without the express prior
		written consent of Customer; (iv) not to use API or Customer-supplied
		Composition for any purpose other than the Manufacture of Product or conducting
		other services under this Agreement, including, without limitation, not to
		analyze, characterize, modify or reverse engineer any API, or take any action
		to determine the structure or composition of any API, unless the foregoing is
		required under this Agreement; and (v) to destroy or return to Customer or its
		designee all unused quantities of API and Customer-supplied Composition
		according to Customer’s written directions. If no written directions are
		provided to BVL within thirty (30) days following termination of this
		Agreement, BVL may dispose of such Composition per cGMP(s) without liability to
		Customer.
	 

	 
			
				
				   
				

			 	
				
				  2.1.2.
				

			 	
				
				  Customer must give written
				  permission to BVL to do ID-only, by-label verification of any API or active
				  drug substance if no identification test is requested by Customer to be
				  performed by BVL.
				

			 

 

	 
			
				
				   
				

			 	
				
				  2.1.3.
				

			 	
				
				  BVL will release all materials
				  provided by BVL. In the event the Territory (Attachment “G”) includes
				  the European Union, then Customer’s Qualified Person shall be responsible
				  to certify compliance of the Customer-supplied API and for the release of
				  Product within the European Union. 
				

			 

 

	 
			
				
				   
				

			 	
				
				  2.1.4.
				

			 	
				
				  Customer will provide, or cause BVL
				  to Develop at mutually agreed upon fees, written quality control testing
				  requirements, methods, specifications and reference standards for the API and
				  Product. Customer will approve in writing initial testing documents, the Master
				  Production Record and any revisions of the documents thereafter. Revisions of
				  approved documents
				

			 

 

	 
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				  requested within [*] weeks prior to
				  scheduled manufacturing or other services may cause a delay or postponement of
				  manufacturing and/or other services requested by the Customer. BVL shall not be
				  responsible for any losses or other expenses resulting from any such delay.
				  Further, BVL shall be entitled to reimbursement for any and all additional
				  costs and expenses incurred by BVL in connection with any such revision or
				  delay.
				

			 

			
				
				   
				

			 	
				
				  2.1.5.
				

			 	
				
				  Customer is responsible for
				  notifying BVL with instruction for disposition of tailings and rejects, which
				  will be incorporated into the Master Batch Record and include a shipment
				  address for tailing and rejects if Customer requests return of tailings and
				  rejects.
				

			 

 

	 
			
				
				   
				

			 	
				
				  2.2.
				

			 	
				
				  Product
				  Manufacture. Pursuant to the provisions
				  of this Agreement, BVL shall Manufacture Customer’s requirements for
				  commercial and developmental quantities of Product in finished packaged dosage
				  form as defined in each Attachment “A#.4.1” (i.e., A1.4.1)
				  Such Product shall meet the Specification, the requirements of cGMP and all
				  Applicable Law.
				

			 

 

	 
			
				
				   
				

			 	
				
				  2.3.
				

			 	
				
				  Development
				  Services. Upon Customer’s request
				  and at Customer’s expense, BVL will perform Development work on Product in
				  accordance with proposals and quotations that are: (a) submitted to Customer at
				  Customer’s request by BVL based on information provided to BVL by
				  Customer; and (b) agreed upon by both Parties in writing via a Purchase Order
				  for the service that references such applicable proposal or quotation. 
				

			 

 

	 
			
				
				   
				

			 	
				
				  2.4.
				

			 	
				
				  Representatives. Each Party shall appoint a representative having
				  primary responsibility for day-to-day interactions with the other Party for the
				  services under this Agreement (each, a “Representative”). Both
				  Parties shall use reasonable efforts to provide the other with at least
				  forty-five (45) days prior written notice of any change in its Representative.
				  Except for notices or communications required or permitted under this
				  Agreement, which shall be subject to Article 13, or unless otherwise mutually
				  agreed by the Parties in writing, all communications between BVL and Customer
				  regarding the conduct of the services under this Agreement shall be addressed
				  to or routed directly through the respective Representatives of each Party, as
				  appropriate. 
				

			 

 

	 
			
				
				   
				

			 	
				
				  ARTICLE 3 -
				  MANUFACTURE
				

			 

 

	 
			
				
				   
				

			 	
				
				  3.1.
				

			 	
				
				  BVL Compliance. BVL has obtained, and will maintain at its sole cost
				  and expense throughout the term of this Agreement, all non-Product-specific
				  licenses, permits, certifications and approvals required under Applicable Law
				  for its Manufacturing Facilities; BVL’s Facilities conform, and will
				  throughout the term of this Agreement conform to cGMP and other Applicable Law.
				  
				

			 

 

	 
			
				
				   
				

			 	
				
				  3.2.
				

			 	
				
				  Facility. BVL shall perform all services under this Agreement at
				  the Facility, and shall hold at such Facility all Equipment, API, Composition
				  and other items used in such services. BVL shall not change the location of
				  such Facility or use any additional facility for the performance of services
				  under this Agreement without at 
				

			 

 

	 
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		least one hundred and fifty (150) days’
		prior written notice to, and prior written consent from, Customer, which
		consent shall not be unreasonably withheld or delayed (it being understood and
		agreed that Customer may withhold consent pending satisfactory completion of a
		quality assurance audit and/or regulatory impact assessment of the new location
		or additional facility, as the case may be). BVL shall maintain, at its own
		expense, the Facility and all Equipment required for the Manufacture of Product
		in a state of repair and operating efficiency consistent with the requirements
		of the cGMP and all other Applicable Law. 
	 

	 
			
				
				   
				

			 	
				
				  3.3.
				

			 	
				
				  Change Control. Any changes to the Specification, Manufacturing
				  Process, Equipment, testing procedures, validation, suppliers of raw materials
				  and components, or documentation systems that are specific to Product and
				  utilized or implemented by BVL and any changes effected by BVL that do or could
				  affect any government submission or approval required for Product, either
				  foreign or domestic as applicable for the Territory, shall be made only with
				  the prior written consent of the Parties and in accordance with change control
				  provisions of the Quality Agreement. In the event such changes are required by
				  an Agency, BVL will Promptly notify Customer. Customer may, from time to time,
				  change Specification upon mutual written consent of the Parties, and BVL will
				  not unreasonably withhold its consent to such change and will use reasonable
				  efforts to implement such change. 
				

			 

 

	 
			
				
				   
				

			 	
				
				  3.4.
				

			 	
				
				  Facilities and Product
				  Compliance. Product delivered to
				  Customer pursuant to this Agreement shall conform to the Specification and be
				  in compliance with all Applicable Law, including but not limited to the
				  requirements of cGMP. In the event of conflicting Applicable Law, Product will
				  comply with United States cGMP requirements unless otherwise agreed to by the
				  Parties.
				

			 

 

	 
			
				
				   
				

			 	
				
				  3.5.
				

			 	
				
				  Regulatory Communications and
				  Inspections. All information, documents
				  and updates with regard to the Manufacture of Product which are required by any
				  Agency shall be provided by BVL in a timely manner, and BVL shall submit to all
				  inquiries and inspections by any such Agency. All Product-specific documents
				  provided by BVL to any Agency shall be provided to Customer in advance of
				  submission to such Agency if feasible, and in no case shall such documents be
				  provided to Customer later than five (5) business days after such documents are
				  provided to any Agency. BVL shall notify Customer Immediately (or, if during a
				  weekend, upon the next business day) of all scheduled Product-specific Agency
				  inspections, and Customer shall have the right to be present for such
				  inspection. Any and all Product-specific written communications or notices of
				  inspection received from any Agency shall be provided by Customer and BVL to
				  the other Party no later than five (5) business days after such communications
				  are received by such Party; provided, however, that if such document is from
				  BVL, it may redact the confidential information of Third Parties from such
				  communications prior to providing same to Customer. 
				

			 

 

	 
			
				
				   
				

			 	
				
				  3.5.1.
				

			 	
				
				  BVL shall also notify Customer
				  Immediately of any notices, observations or other written communications from
				  such Agency regarding any deficiencies that have or may have a material adverse
				  effect on the Product or BVL’s ability to perform its obligations under
				  this Agreement.
				

			 

 

	 
		 
	 

	 
		 
	 

	 
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				  3.5.2.
				

			 	
				
				  Customer shall provide BVL with
				  copies of all Agency approval letters for Product for both clinical studies and
				  commercial use. In addition, Customer shall provide BVL on an annual basis with
				  its anticipated schedule of material Agency regulatory filings for the next two
				  calendar years. BVL acknowledges that such schedule may change at any
				  time.
				

			 

 

	 
			
				
				   
				

			 	
				
				  3.5.3.
				

			 	
				
				  BVL will provide, at CUSTOMER’s
				  request, a copy of the BVL Drug Master File (DMF) and authorization for FDA to
				  access the DMF. This may be used by the CUSTOMER only to prepare any required
				  Regulatory filing.
				

			 

 

	 
			
				
				   
				

			 	
				
				  3.6.
				

			 	
				
				  Health, Safety and Environmental
				  Compliance. Unless otherwise agreed by
				  the Parties, BVL will conduct all Manufacturing and Development operations
				  required for the Manufacture of Product under this Agreement. Dispensing and
				  other Manufacturing operations are to be performed using appropriate safety
				  measures and containment techniques as dictated by Applicable Law and industry
				  standards. BVL shall be solely responsible for implementing and maintaining
				  health and safety procedures for the Manufacture of Product and performance of
				  services under this Agreement and for the handling of any materials or
				  hazardous waste used in or generated by such activities. BVL, in consultation
				  with Customer, shall develop safety and handling procedures for API and
				  Product; provided, however, that Customer shall have no responsibility for
				  BVL’s health and safety program. The generation, collection, storage,
				  handling, transportation, movement and release of hazardous materials and waste
				  generated in connection with the Manufacture of Product and other services
				  under this Agreement shall be the responsibility of BVL at BVL’s cost and
				  expense, unless otherwise agreed to in writing by the Parties for special
				  situations or conditions. Without limiting other legally applicable
				  requirements, BVL shall prepare, execute and maintain, as the generator of
				  waste, all licenses, registrations, approvals, authorizations, notices,
				  shipping documents and waste manifests required under Applicable Law.
				

			 

 

	 
			
				
				   
				

			 	
				
				  3.7.
				

			 	
				
				  Subcontractors. Neither Party may subcontract with any Third Party to
				  perform any of its obligations hereunder without the prior written consent of
				  the other Party. In the event that a Party does subcontract with a permitted
				  Third Party pursuant to this Section 3.7, it shall be solely responsible for
				  the performance of any permitted subcontractor, and for costs, expenses,
				  damages, or losses of any nature arising out of such performance as if such
				  performance had been provided by itself under this Agreement. Each Party shall
				  cause any such permitted subcontractor to be bound by, and to comply with, all
				  confidentiality, quality assurance, regulatory and other obligations and
				  requirements as set forth in this Agreement. Notwithstanding the above,
				  Customer does use a subcontractor to produce API.
				

			 

			
				
				   
				

			 	
				
				  3.8.
				

			 	
				
				  Records. BVL shall keep complete and accurate Product-specific
				  records of (including, without limitation, reports, accounts, notes, data, and
				  records of all information and results obtained from) all work done by it under
				  this Agreement (collectively, the “Records”). BVL shall not transfer,
				  deliver or otherwise provide any such Records to any Third Party, except to an
				  Agency when requested by an Agency, without the prior written approval of
				  Customer. While in the possession or control of BVL, Records shall be available
				  during annual audits or as 
				

			 

 

	 
		 
	 

	 
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		otherwise mutually agreed to times for
		inspection, examination and review by or on behalf of Customer. All original
		Records of the Development services and Manufacture of Product hereunder shall
		be retained and archived by BVL in accordance with cGMP and Applicable Law, but
		in no case for less than a period of seven (7) years following completion of
		the applicable work or project. Upon Customer’s request, BVL shall
		promptly provide Customer with additional copies of such Records at
		Customer’s cost. Seven (7) years after completion of the applicable work
		or project, all of the aforementioned records shall be destroyed unless
		Customer instructs BVL in writing as to a contrary disposition for such
		files.
	 

	 
			
				
				   
				

			 	
				
				  3.9.
				

			 	
				
				  Product and Process Failure.
				  
				

			 

 

	 
			
				
				   
				

			 	
				
				  3.9.1.
				

			 	
				
				  Product shall be Manufactured in
				  accordance with cGMP and the Manufacturing Process approved mutually by
				  Customer and BVL. Each Batch of Product will be sampled and tested by BVL
				  against the Specification. The quality assurance department of BVL will review
				  the Records relating to the Manufacture of the Batch and will assess if the
				  Manufacture has taken place in compliance with cGMP and the Manufacturing
				  Process.
				

			 

 

	 
			
				
				   
				

			 	
				
				  3.9.2.
				

			 	
				
				  If, based upon such tests, a Batch
				  of Product conforms to the Specification and was Manufactured according to cGMP
				  and the Manufacturing Process, then a Certificate of Compliance will be
				  generated and approved by the quality assurance department of BVL. This
				  Certificate of Compliance, a Certificate of Analysis, and a complete and
				  accurate copy of the executed Batch records (collectively, the “Batch
				  Records”) for each Batch of Product (including all the Batch documentation
				  described in Attachment “D” to this Agreement) will be delivered to
				  Customer by a reputable overnight courier or by registered or certified mail,
				  postage prepaid, return receipt requested to verify delivery date. Unless the
				  Batch is shipped under Quarantine (as defined in Section 6.3 below), in the
				  event that Customer has not received all such Batch Records at the time of
				  receipt of BVL’s invoice for such Batch, Customer will notify BVL in
				  writing and BVL shall provide Customer a copy at no additional cost. In the
				  event that Customer requires additional copies of the Batch Records, these will
				  be provided by BVL to Customer at mutually agreed upon fees.
				

			 

 

	 
			
				
				   
				

			 	
				
				  3.9.3.
				

			 	
				
				  Customer will review the Batch
				  Records for each Batch of Product and may test samples of the Batch of Product
				  against the Specification. Customer will notify BVL in writing of its
				  acceptance or rejection of such Batch within 30 calendar days of receipt of BVL
				  batch release documents (Attachment D) relating to such Batch. If no acceptance
				  or rejection in writing is received by BVL within [*]days, the Batch will be
				  conclusively deemed accepted. During this review period, the Parties agree to
				  respond punctually, but in any event within [*] calendar
				  days, to any reasonable inquiry by the other Party with respect to such Batch
				  Records. Customer has no obligation to accept a Batch if such Batch does not
				  
				

			 

 

	 
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		comply with the Specification and/or was not
		Manufactured in compliance with cGMP and the Manufacturing Process.
	 

	 
			
				
				   
				

			 	
				
				  3.9.4.
				

			 	
				
				  In case of any disagreement between
				  the Parties as to whether Product conforms to the applicable Specification, a
				  representative sample of such Product shall be submitted to an independent
				  testing laboratory mutually agreed upon by the Parties for tests and final
				  determination of whether such Product conforms to such Specification. The
				  laboratory must meet cGMP requirements, be of recognized standing in the
				  industry, and consent to the appointment of such laboratory shall not be
				  unreasonably withheld or delayed by either Party. Such laboratory shall use the
				  validated test methods contained in the applicable Specification. The
				  determination of conformance by such laboratory with respect to all or part of
				  such Product shall be final and binding on the Parties. The fees and expenses
				  of the laboratory incurred in making such determination shall be paid by the
				  Party against whom the determination is made.
				

			 

 

	 
			
				
				   
				

			 	
				
				  3.9.5.
				

			 	
				
				  Subject to Section 6.4 and 8.5, if
				  the Batch of Product does not conform to the Specification, or was not
				  Manufactured in compliance with cGMP and the Manufacturing Process, then BVL
				  shall, after consultation with and written agreement from Customer:
				

			 

 

	 
			
				
				   
				

			 	
				
				  3.9.5.1.
				

			 	
				
				  refund any fees and expenses paid by
				  Customer on a pro rata basis over the usable portion for such Batch; or
				

			 

 

	 
			
				
				   
				

			 	
				
				  3.9.5.2.
				

			 	
				
				  at BVL’s cost and expense
				  produce a new Batch of Product as soon as reasonably possible. 
				

			 

 

	 
			
				
				   
				

			 	
				
				  3.9.6.
				

			 	
				
				  BVL or Customer may postpone all
				  scheduled Manufacture of the Product until such time as final disposition of
				  rejected Batch(s) has been determined and complete investigations have been
				  finalized with root cause analysis and corrective actions determined to prevent
				  further Batch rejections which will be agreed to in writing by the Parties. BVL
				  will perform such investigations, root cause analysis and corrective actions
				  diligently and expeditiously. Customer may request Manufacture in writing with
				  Customer’s assumption of financial responsibility in the event of further
				  batch rejection for similar reasons. 
				

			 

 

	 
			
				
				   
				

			 	
				
				  3.9.7.
				

			 	
				
				  Moreover, the Parties shall meet to
				  discuss, evaluate and analyze the reasons for and implications of the failure
				  to meet the Specification or comply with the cGMP and/or the Manufacturing
				  Process.
				

			 

 

	 
			
				
				   
				

			 	
				
				  ARTICLE 4 - VOLUMES AND ALTERNATE
				  SOURCE
				

			 

 

	 
			
				
				   
				

			 	
				
				  4.1.
				

			 	
				
				  Product Purchase and Supply
				  Obligations. BVL shall supply Customer
				  with all of Customer’s requirements of Product in accordance with the
				  terms of this Agreement for the Territory. Subject to the provisions of Section
				  4.2, Customer will purchase exclusively from BVL, and BVL will exclusively
				  supply to Customer, one-hundred percent (100%) of Customer’s forecasted
				  amounts of Product for commercial sale and Developmental use for the Territory
				  during the term of this Agreement. In the event that BVL, at any time during
				  the term of this Agreement, 
				

			 

 

	 
		 
	 

	 
		 
	 

	 
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		has reason to believe that it will be unable
		to perform or complete the Manufacturing and other services under this
		Agreement, BVL shall timely notify Customer thereof. 
	 

	 
			
				
				   
				

			 	
				
				  4.1.1.
				

			 	
				
				  In the event that Customer, at any
				  time during the term of this Agreement, has reason to believe that it will be
				  unable to meet its ordering obligations under this Agreement, Customer shall
				  promptly notify BVL thereof. Compliance by Customer with this Section 4.1 shall
				  not relieve Customer of any other obligation or liability under this Agreement.
				  
				

			 

 

	 
			
				
				   
				

			 	
				
				  4.2.
				

			 	
				
				  Alternate Source. Notwithstanding the provisions of Section 4.1,
				  Customer may qualify, at its discretion and cost, one or more Third Parties as
				  contract manufacturers of Product (an “Alternate Source”) as it deems
				  necessary to ensure uninterrupted supply of Product in the Territory, and may
				  obtain a quantity as mutually agreed in writing between the Parties of Product
				  from such Alternate Source in order to qualify and maintain such Alternate
				  Source as a Product manufacturer. Customer will notify BVL within thirty (30)
				  days of any decision to retain and or qualify an Alternate Source. Quantities
				  of Product to be obtained from an Alternate Source for such purposes will not
				  be included in the Forecasts. Furthermore, Customer’s exclusive purchase
				  obligations under Section 4.l shall not apply if: (a) BVL has failed to fulfill
				  Customer’s Purchase Orders of Product for a period of more than three (3)
				  consecutive months and such Purchase Orders have been placed according to the
				  terms of this Agreement; (b) BVL does not accept a Purchase Order placed by
				  Customer in accordance with the terms of this Agreement; (c) BVL is not in
				  compliance with Applicable Law with respect to the Facilities or the
				  Manufacture of Product and is unable to cure such non-compliance within thirty
				  (30) days following receipt of written notice from Customer; (d) an event of
				  Force Majeure has occurred which affects or which Customer reasonably believes
				  will affect BVL’s ability to supply Product for a period of at least three
				  (3) months; or (e) BVL remains in material breach of this Agreement after
				  written notice by Customer and an opportunity to cure such defect pursuant to
				  Section 12.3. In the case of a Force Majeure or other failure to supply
				  compliant Product to Customer, Customer may use an Alternate Source to supply
				  Customer’s requirements of Product until BVL is objectively able to
				  recommence production. 
				

			 

 

	 
			
				
				   
				

			 	
				
				  4.3.
				

			 	
				
				  Technical
				  Transfer. BVL shall assist Customer in
				  transferring the Manufacturing Process to an Alternate Source by providing such
				  technical assistance and documentation as necessary at reasonable fees mutually
				  agreed upon by the Parties. BVL shall provide such assistance at no charge in
				  the event that Customer is qualifying such Alternate Source due to a breach of
				  this Agreement by BVL, including without limitation, a failure by BVL to
				  fulfill its supply obligations hereunder for any reason other than a Customer
				  breach or Force Majeure. No Confidential Information of BVL shall be disclosed
				  to such Alternate Source, it being understood that any Product-specific
				  information contained in the master batch record for Product is not
				  Confidential Information of BVL and may be disclosed to the Alternate Source.
				  
				

			 

 

	 
		 
	 

	 
		 
	 

	 
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				  ARTICLE 5 - FORECASTS AND
				  PURCHASE ORDERS
				

			 

 

	 
			
				
				   
				

			 	
				
				  5.1.
				

			 	
				
				  Five-Year Forecast and Binding
				  Minimum Commitment. Attached hereto as
				  part of each Attachment “A#.4.1” (i.e., A1.4.1) is
				  Customer’s forecast of its requirements of Product for the first five (5)
				  Contract Years of the term of this Agreement (“Five-Year Forecast”).
				  [*].
				

			 

 

	 
			
				
				   
				

			 	
				
				  5.1.1.
				

			 	
				
				  Updates to Five-Year
				  Forecast. As the Five-Year Forecast
				  represents Customer’s minimum commitment of Product for the period
				  five-years from the Effective Date, only increases to the
				  Five-Year Forecasts shall be permissible, and then only upon written acceptance
				  by BVL. [*].
				

			 

 

	 
			
				
				   
				

			 	
				
				  5.1.2.
				

			 	
				
				  Extension of Agreement by
				  Amending the Five-Year Forecast. [*].
				

			 

 

	 
			
				
				   
				

			 	5.2.	
				
				  Five Year Product Forecast and
				  Scheduling. Customer and BVL shall
				  cooperate in estimating and scheduling the Manufacturing of Product. If
				  commercially 
				

			 

 

	 
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		reasonable for Customer to do so, the annual
		order of Product for commercial use will be divided into individual Batch
		Purchase Orders evenly distributed over the course of any twelve (12) month
		period; provided that the total quantities ordered by these Purchase Orders
		meets the requirements of this Article 5. Customer and BVL will make alternate
		arrangements in writing regarding the distribution of annual requirements due
		to market conditions, Development requirements or other needs.
	 

	 
			
				
				   
				

			 	
				
				  5.3.
				

			 	
				
				  Rolling Twelve (12) Month
				  Distribution Forecasts. One hundred
				  twenty (120) days in advance of the first day of each Contract Quarter during
				  the term of this Agreement, Customer will provide BVL with a twelve (12) month
				  rolling distribution forecast for all presentations of Product (“Rolling
				  Forecast”). The initial Rolling Forecast will be included in each
				  Attachment “A#.4.2” (i.e., A1.4.2) to
				  this Agreement. The first Contract Quarter of such Rolling Forecast will be
				  considered a Firm Order for which Customer will provide non-cancelable Purchase
				  Order for each Batch of Product in such period of the Rolling Forecast. 
				

			 

 

	 
			
				
				   
				

			 	
				
				  5.4.
				

			 	
				
				  Obligation of Supply and
				  Purchase. BVL shall be obligated to
				  Manufacture Product only in accordance with quantities forecasted and accepted
				  by BVL in the Five-Year Forecast in accordance with this Article 5 and each
				  Attachment “A#.4.1” (i.e.,
				  A1.4.1) of this Agreement. [*].
				

			 

 

	 
			
				
				   
				

			 	
				
				  5.5.
				

			 	
				
				  Additional and Development
				  Services. 
				

			 

 

	 
			
				
				   
				

			 	
				
				  5.5.1.
				

			 	
				
				  Development services required in
				  advance of Manufacture or in support of Manufacture will be mutually agreed to
				  by BVL and Customer. BVL will provide Customer with estimated quotations and
				  timelines for such Development activities. Customer will issue a non-cancelable
				  Purchase Orders referencing the quotation provided prior to BVL initiating the
				  Development services. In the event that Customer changes the scope of the
				  Development work such that the cost exceeds the quoted amount, BVL will issue a
				  revised quotation for which Customer will provide a new or revised Purchase
				  Order reflecting the revised amounts for services required. 
				

			 

 

	 
			
				
				   
				

			 	
				
				  5.5.2.
				

			 	
				
				  In the event that Customer requests
				  or an Agency requires additional services directly impacting the Product, BVL
				  will provide Customer with a quotation for such services. BVL will provide such
				  services only upon 
				

			 

 

	 
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		receipt from Customer of a binding Purchase
		Order referencing the quotation provided for the required service.
	 

	 
			
				
				   
				

			 	
				
				  5.6.
				

			 	
				
				  Supply of
				  Composition. It is BVL’s
				  responsibility to maintain a sufficient inventory of BVL-supplied Composition
				  from mutually approved vendors, in order to meet the Forecasts; provided,
				  however, that with respect to non-stock items BVL will not maintain an
				  inventory of BVL-supplied Composition in excess of the inventory required to
				  Manufacture the quantity of Product specified in the first Contract Quarter of
				  the current Rolling Forecast without Customer’s prior written consent,
				  which consent shall not be unreasonably withheld. It is Customer’s
				  responsibility to supply API and Customer-supplied Composition as indicated in
				  Attachment “A#.3” (i.e., A1.3)
				  Customer-supplied Composition shall be delivered to BVL at least four (4) weeks
				  in advance of the scheduled Manufacturing date and in accordance with BVL
				  SOP’s. Customer will provide adequate supply of reference standards upon
				  request by BVL. Customer will coordinate with BVL Materials Management
				  Department according to BVL SOP’s on the specifics related to each
				  shipment of material. BVL will be responsible to receive, sample, store and
				  maintain the inventory at BVL in accordance with BVL SOP’s and mutually
				  agreed to Specifications. At the beginning of each month BVL will provide a
				  standard monthly inventory report of Customer-supplied Composition. 
				

			 

 

	 
			
				
				   
				

			 	
				
				  5.7.
				

			 	
				
				  Notwithstanding anything to the
				  contrary set forth herein, this Section 5 shall survive any termination or
				  expiration of the Agreement for not less than the duration remaining on the
				  Five-Year Forecast.
				

			 

 

	 
			
				
				   
				

			 	
				
				  5.8
				

			 	
				
				  Notwithstanding the above
				  obligations and commitments of this Article 5, such obligations and commitments
				  shall not be enforced if conditions to evoke Section 3.9.5 are in effect and if
				  BVL has postponed scheduled Manufacture of the Product under Section 3.9.6. In
				  such case the parties agree to meet and determine the manufacturing and
				  purchase obligations of each party after corrective action has occurred.
				

			 

 

	 
			
				
				   
				

			 	
				
				  ARTICLE 6 - PRICE AND
				  PAYMENT
				

			 

 

	 
			
				
				   
				

			 	
				
				  6.1.
				

			 	
				
				  Price and Shipment. 
				

			 

 

	 
			
				
				   
				

			 	
				
				  6.1.1.
				

			 	
				
				  The prices to be paid by Customer
				  for the services and/or quantities of Product purchased pursuant to Article 5
				  of this Agreement are specified in each Attachment “A#.5”
				  (i.e., A1.5) or in applicable quotations provided to Customer
				  and confirmed by Customer’s Purchase Orders. 
				

			 

 

	 
			
				
				   
				

			 	
				
				  6.1.2.
				

			 	
				
				  Delivery terms for Products shall be
				  FCA Facility (at BVL’s dock) (Incoterms 2000). Customer shall assume title
				  and risk of loss of the finished Product upon delivery to carrier at BVL
				  Facility (BVL’s dock). BVL shall ensure that each Batch shall be delivered
				  to Customer, or Customer’s designee: (i) on or about the delivery date and
				  to the destination designated by Customer on the Purchase Order; and (ii) in
				  accordance with the instructions for shipping included on the Purchase Order
				  and packaging specified in the Master Batch Record or as otherwise agreed to by
				  the Parties in writing. A bill of lading shall be furnished to Customer with
				  respect to each shipment. Customer is 
				

			 

 

	 
		 
	 

	 
		 
	 

	 
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		responsible for all shipment costs and
		shipping charges will be paid directly by Customer. 
	 

	 
			
				
				   
				

			 	
				
				  6.2.
				

			 	
				
				  Price Adjustments.
				

			 

 

	 
			
				
				   
				

			 	
				
				  6.2.1.
				

			 	
				
				  Annual Price
				  Adjustments. For Products subject to
				  pricing as set forth on Attachment A#.5(a) (i.e., this
				  section does not apply to pricing arrangements entered into pursuant to A#.5(b)
				  which are not subject to annual price adjustments), BVL shall notify Customer
				  of any price adjustments for each presentation of Product included in
				  Attachment “A#.1” (i.e., A1.1) by
				  October 31 of each year during the term of this Agreement for the following
				  year beginning January 1. Prices for Product will be adjusted on an annual
				  basis by BVL for the next succeeding year based upon one of two methodologies
				  set forth below. At the outset of the Agreement, Customer shall choose
				  one of the following two methodologies for the duration of
				  the Agreement:
				

			 

 

	 
			
				
				   
				

			 	
				
				  6.2.1.1.
				

			 	
				
				  Annual Price adjustments [*]
				

			 

 

	 
		[*]
	 

	 
			
				
				   
				

			 	
				
				  6.2.1.3.
				

			 	
				
				  For the annual price adjustment
				  methodology, Customer elects: [*]
				

			 

 

	 
			
				
				   
				

			 	
				
				  6.2.2.
				

			 	
				
				  Price Adjustment on Product or
				  Process Specification Changes. BVL
				  reserves the right to adjust prices based on changes to the Specification or
				  Manufacturing Process for Product regardless of the event or action causing the
				  Specification or Manufacturing Process change (other than a change required as
				  a result of BVL’s negligence action, willful misconduct or breach of this
				  Agreement), including but not limited to changes in inspection, packaging and
				  labeling.
				

			 

 

	 
			
				
				   
				

			 	
				
				  6.2.3.
				

			 	
				
				  Prices for Development Services
				  and Development Manufacture. Pricing
				  for Product and Manufacturing Process Development services will be provided to
				  Customer in written proposals provided to Customer by BVL based on the services
				  requested by Customer. Customer will confirm its acceptance of a proposal by
				  issuing a Purchase Order referencing the quotation number provided on the
				  proposal.
				

			 

 

	 
			
				
				   
				

			 	
				
				  6.3.
				

			 	
				
				  Payment. 
				

			 

 

	 
			
				
				   
				

			 	
				
				  6.3.1.
				

			 	
				
				  The purchase price for Product or
				  services in an undisputed invoice shall be paid to BVL no later than thirty
				  (30) days after the date of BVL’s invoice to Customer. BVL will issue an
				  invoice for: (i) Product Manufacture at such time that BVL’s Quality
				  Control Department has completed its testing, found Product suitable to be
				  shipped and has shipped the documents identified in Attachment “D”
				  pursuant to release of Product; and (ii) or for other services, upon completion
				  of such other services as described in the applicable proposal. Customer may
				  request 
				

			 

 

	 
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		that a Batch be shipped before Customer
		release (i.e., shipment in “Quarantine”). In the event a Quarantine
		shipment is made, BVL will invoice on the shipment day. Customer will notify
		BVL in writing that a lot can be shipped in Quarantine and BVL will make all
		reasonable efforts to honor this request. Within thirty (30) days from the date
		of any disputed invoice, Customer must provide a written notice that conforms
		to the requirements of this Agreement of the disputed invoices and the reason
		such invoice is disputed. The Parties will negotiate in good faith to resolve
		such dispute within thirty (30) days following notice of such dispute. If the
		Parties are unable to reach an agreement, either party may pursue any remedies
		available to it under this Agreement at law or in equity.
	 

	 
			
				
				   
				

			 	
				
				  6.3.2.
				

			 	
				
				  In the event of nonpayment of
				  balances without written notice and reasonable cause within sixty (60) days of
				  the invoice date, Customer agrees to pay BVL a monthly late payment charge
				  equal to one and one-half percent (1.5%) of the unpaid balance. Should unpaid
				  balances on undisputed invoices extend beyond ninety (90) days after an invoice
				  has been issued, BVL reserves the right to require Customer to pay one hundred
				  (100%) of the full price for each Batch at the time of Purchase Order issuance
				  or may cancel all scheduled Manufacture until such time as all unpaid overdue
				  invoices, together with any and all late fees, have been paid. 
				

			 

 

	 
			
				
				   
				

			 	
				
				  6.4.
				

			 	
				
				  Payment for Non-Validated
				  Services or Production and Obsolete Materials. 
				

			 

 

	 
			
				
				   
				

			 	
				
				  6.4.1.
				

			 	
				
				  Customer will be required to pay BVL
				  for all Product Manufactured during any period when any Manufacturing Process
				  and material testing procedures have not been fully developed and validated,
				  regardless of whether Product is accepted or rejected by the Customer, unless
				  such rejection is due to BVL’s negligence, willful misconduct or breach of
				  this Agreement by BVL.
				

			 

 

	 
			
				
				   
				

			 	
				
				  6.4.2.
				

			 	
				
				  Customer will be required to pay BVL
				  for all packaging components and raw materials which were purchased by BVL for
				  use specifically in the Manufacture of Product covered by this Agreement,
				  should any of the BVL-supplied Composition become obsolete for any reason other
				  than BVL’s negligence, willful misconduct or breach of this Agreement (the
				  “Obsolete Materials”). Customer must agree to disposition of any
				  Obsolete Materials within 90 days from notification by BVL. If BVL does not
				  receive notification of where to ship unused or obsolete materials, BVL has the
				  right to dispose of such materials per governing cGMP(s) without liability to
				  Customer.
				

			 

 

	 
			
				
				   
				

			 	
				
				  6.5.
				

			 	
				
				  Cancellation Fees. In addition to any remedy set forth in Paragraph 5.4,
				  Customer will pay a cancellation fee equal to five percent (5%) of the price of
				  any Batch that is the subject of a Firm Order if such Batch is cancelled or
				  postponed by Customer 30 or more days in advance of the scheduled Manufacturing
				  date, unless such cancellation is under Section 3.9.6. If cancellation or
				  postponement is made less than 30 days in advance of the scheduled
				  Manufacturing date, unless such cancellation is under Section 3.9.6, Customer
				  is responsible for payment of one hundred (100%) of the price of the postponed
				  or cancelled 
				

			 

 

	 
		 
	 

	 
		 
	 

	 
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		Batch(es). BVL will use commercially
		reasonable efforts to mitigate and will attempt to use the capacity created by
		such postponement or cancellation and if it does so, Customer will only be
		responsible for payment of fifty percent (50%) of the full price of the
		postponed or cancelled Batch. 
	 

	 
			
				
				   
				

			 	
				
				  6.6.
				

			 	
				
				  Storage Fees. Customer is responsible for storage charges as
				  specified in Attachment “C” for Product stored for more than thirty
				  (30) beyond BVL’s release of such Product. Short-term storage of Product
				  in BVL’s warehousing Facilities beyond 30 calendar days must receive prior
				  written approval from BVL. Such approval will be granted only on a
				  space-available basis. If Customer and BVL agree to a storage arrangement and
				  duration for such temporary storage (the “Temporary Storage Period”),
				  then not less than thirty (30) days prior to the conclusion of the Temporary
				  Storage Period, BVL will provide written notice to Customer regarding the
				  expiration of the Temporary Storage Period. In response to such notice,
				  Customer shall provide BVL with shipment instructions for the Product in
				  temporary storage. Should Customer fail to provide written instructions, at the
				  expiration of the Temporary Storage Period, BVL shall ship the Product to
				  Customer at Customer’s cost at the Customer’s shipping address listed
				  on the Purchase Order.
				

			 

 

	 
			
				
				   
				

			 	
				
				  6.7.
				

			 	
				
				  Stability Program. During the term of this Agreement and upon
				  Customer’s request and BVL’s written agreement, BVL will conduct and
				  support, at Customer’s expense, all stability studies in progress or
				  planned (e.g., NDA annual stability studies) as of the Effective Date until
				  such studies are concluded. Customer shall be responsible for all costs of
				  conducting any stability studies. Stability program costs will be covered in a
				  separate quotation provided by BVL to Customer based on the agreed upon
				  protocol. Customer may also make arrangements for stability work to be
				  performed at a facility other than BVL at Customer’s expense.
				

			 

 

	 
			
				
				   
				

			 	
				
				  6.8.
				

			 	
				
				  Inspection, Packaging and
				  Labeling. Customer shall be responsible
				  for and bear all costs associated with the design, Development, quality release
				  and regulatory approval of all labeling and packaging materials for Product.
				  Customer shall perform its design, development, quality release and regulatory
				  approval obligations hereunder in a timely manner sufficient for BVL to satisfy
				  its Manufacturing obligations hereunder for Product. Labeling and packaging
				  developed by Customer will conform to labeling and packaging Specification
				  mutually agreed to in writing by the Parties and will conform to all Applicable
				  Law.
				

			 

 

	 
		ARTICLE 7 - QUALITY AGREEMENT
	 

	 
			
				
				   
				

			 	
				
				  7.1.
				

			 	
				
				  Quality Agreement. Certain quality matters relating to Product are
				  included in the Quality Agreement which is attached and incorporated herein by
				  reference as Attachment “E.” If any provision of the Quality
				  Agreement is inconsistent with the terms of this Agreement, the terms of this
				  Agreement shall prevail.
				

			 

 

	 
		ARTICLE 8 - INDEMNIFICATION
	 

	 
			
				
				   
				

			 	
				
				  8.1.
				

			 	
				
				  Customer
				  Indemnity. Customer hereby holds
				  harmless and indemnifies BVL, its Affiliates and its and their directors,
				  officers, employees and agents (the “BVL 
				

			 

 

	 
		 
	 

	 
		 
	 

	 
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		Indemnitees”) against any and all
		claims, losses, liabilities, lawsuits, proceedings, costs and expenses of any
		Third Party, including, without limitation, reasonable attorneys’ fees,
		and the cost of recalls (collectively, “Claims”) incurred by any BVL
		Indemnitee, based on, resulting from, arising out of or in connection with: (a)
		injuries and/or death resulting from, arising out of or in connection with any
		use of Product Manufactured by BVL, including, without limitation, Claims based
		on negligence, warranty, strict liability or any other theory of liability or
		violation of any Applicable Law; (b) any breach by Customer of its
		representations, warranties or covenants hereunder; or (c) any negligent act or
		the willful misconduct of any Customer Indemnitees in performing
		Customer’s obligations under this Agreement. However, such indemnity shall
		not apply to the extent that such injury to persons or property or death arises
		out of BVL’s breach of this Agreement or any of the warranties contained
		in this Agreement or its gross negligent or willful misconduct. 
	 

	 
			
				
				   
				

			 	
				
				  8.2.
				

			 	
				
				  BVL Indemnity. BVL hereby holds harmless and indemnifies Customer,
				  its Affiliates and its and their directors, officers, employees and agents (the
				  “Customer Indemnitees”) against any and all Claims based on,
				  resulting from, arising out of or in connection with any: (a) breach by BVL of
				  its representations, warranties or covenants hereunder; or (b) negligent act or
				  the willful misconduct of any BVL Indemnitees in performing BVL’s
				  obligations under this Agreement. However, such indemnity shall not apply to
				  the extent that such injury to persons or property or death arises out of
				  Customer’s labeling, marketing, handling, or storage of the Product;
				  Customer’s API or Customer-supplied materials; or as a result of
				  Customer’s breach of this Agreement or any of the warranties contained in
				  this Agreement or its gross negligent or willful misconduct. 
				

			 

 

	 
			
				
				   
				

			 	
				
				  8.3.
				

			 	
				
				  Indemnification
				  Procedures. Each Party agrees to notify
				  the other Party within ten (10) business days of receipt of any Claims, demands
				  or threats of suit for which the other Party may be liable under Section 8.1 or
				  8.2 as the case may be. The indemnifying Party shall have the right, but not
				  the obligation, to defend, to employ counsel of its choosing (such counsel to
				  be reasonably acceptable to the indemnified Party), to control, to negotiate,
				  and to settle such claims; provided, however, that the indemnified Party shall
				  be entitled to participate in the defense of such matter and to employ counsel
				  at its expense to assist therein. The Party seeking indemnification shall
				  provide the indemnifying Party with such information and assistance as the
				  indemnifying Party may reasonably request, at the expense of the indemnifying
				  Party. The Parties understand that no insurance deductible shall be credited
				  against losses for which a Party is responsible under this Article 8. 
				

			 

 

	 
			
				
				   
				

			 	
				
				  8.4.
				

			 	
				
				  Insurance. Customer and BVL will each, at its own cost and
				  expense, obtain and maintain in full force and effect, during the term of this
				  Agreement, Commercial General Liability insurance, written on the standard
				  approved Policy Form, and Blanket Contractual Liability, with limits of
				  liability of not less than $3,000,000 Combined Single Limit Bodily Injury and
				  Property Damage covering its duties and obligations under the Agreement.
				  Furthermore, during the term of this Agreement, BVL shall obtain and maintain
				  “All Risk” property insurance valued at replacement cost, covering
				  loss or damage to the Facility and Customer’s property and materials in
				  the care, custody, and control of BVL. Said policy or policies of insurance
				  shall include the other Party as an Additional Insured. The 
				

			 

 

	 
		 
	 

	 
		 
	 

	 
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		coverage limits may be provided through a
		combination of Primary, Excess/Umbrella or Self-Insured Retention. The coverage
		limit for Customer property shall be limited to $1,250,000 in aggregate per
		Contract Year. 
	 

	 
			
				
				   
				

			 	
				
				  8.5.
				

			 	
				
				  Reimbursement for Loss of API and
				  Customer-Supplied Composition. After
				  such time as all Production and testing procedures have been fully developed
				  and validated and a complete and successful technical transfer to BVL’s
				  production department has occurred, BVL agrees to reimburse Customer up to a
				  maximum of $[*] per Batch pro-rated over the usable portion of the Batch, if
				  applicable, for any loss of API or Customer-supplied Composition for each Batch
				  that does not meet Specification or was not Manufactured in accordance with the
				  Manufacturing Process or cGMP and therefore can not be released; provided that
				  the loss of such materials can be shown after Investigation to be caused solely
				  and directly by: (a) the failure of BVL to follow its SOP’s; or (b)
				  BVL’s negligence, willful misconduct or breach of this Agreement. In
				  addition to this payment, BVL will be responsible for all Manufacturing fees
				  incurred during the Manufacture of the failed Batch, pro-rated over the usable
				  portion of the Batch, if applicable. The monetary values of all
				  Customer-supplied raw ingredients, materials and/or components must be
				  disclosed by Customer to BVL in writing prior to production in the
				  questionnaire provided by BVL to Customer. The Customer is responsible for
				  notifying BVL in writing of any changes in the value of the ingredients, raw
				  materials and/or components supplied to BVL, and BVL shall not be liable for
				  any increase in the cost of the foregoing if Customer fails to provide the
				  abovementioned notice or timely updates thereto. Notwithstanding the foregoing
				  or any declared value of API costs in excess of $[*], in no event
				  shall BVL’s liability to Customer for API be in excess of the
				  $[*] set forth in this Section 8.5.
				

			 

 

	 
			
				
				   
				

			 	
				
				  8.6.
				

			 	
				
				  LIABILITY
				  LIMITATION. SECTION 8.5 IS
				  CUSTOMER’S SOLE AND EXCLUSIVE REMEDY FOR ANY PRODUCT THAT DOES NOT COMPLY
				  WITH THE SPECIFICATIONS CONTAINED IN THE MASTER BATCH RECORD. IN NO EVENT SHALL
				  BVL BE LIABLE FOR ANY LOSS, INJURY OR DAMAGE, HOWSOEVER ARISING, EXCEPT AS SET
				  FORTH IN PARAGRAPHS 8.2 AND 8.5. IN NO EVENT SHALL EITHER PARTY BE LIABLE FOR
				  ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL OR INDIRECT DAMAGES ARISING OUT OF THIS
				  AGREEMENT, HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY. THIS LIMITATION SHALL
				  APPLY EVEN IF THE OTHER PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH
				  DAMAGE; PROVIDED, HOWEVER, THAT THIS LIMITATION SHALL NOT APPLY TO DAMAGES
				  RESULTING FROM BREACHES BY A PARTY OF A DUTY IMPOSED UNDER ARTICLE 9
				  (CONFIDENTIALITY) OR TO ANY THIRD-PARTY LOSS, INJURY OR DAMAGE FOR WHICH BVL
				  SHALL BECOME LIABLE. UNDER NO CIRCUMSTANCES SHALL EITHER PARTY BE LIABLE TO THE
				  OTHER PARTY FOR LOST PROFITS, LOST MARKET SHARE OR ANY DAMAGES STEMMING FROM AN
				  INTERRUPTION OF SUPPLY. THESE LIMITATIONS SHALL APPLY NOTWITHSTANDING ANY
				  FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY. EXCEPT AS EXPLICITLY SET
				  FORTH TO THE CONTRARY HEREIN, IN NO EVENT SHALL BVL’S MAXIMUM TOTAL
				  AGGREGATE LIABILITY HEREUNDER EXCEED THE TOTAL FEES 
				

			 

 

	 
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		ACTUALLY PAID BY CUSTOMER FOR THE SERVICES
		PROVIDED PURSUANT TO THIS AGREEMENT. SUCH LIMITED WARRANTIES, LIMITATION OF
		LIABILITY AND SPECIAL PROVISIONS ARE INTEGRAL PARTS OF THIS AGREEMENT.
	 

	 
		ARTICLE 9 - CONFIDENTIALITY
	 

	 
			
				
				   
				

			 	
				
				  9.1.
				

			 	
				
				  Confidential
				  Information. As used in this Agreement,
				  “Confidential Information” means any scientific, technical, trade or
				  business information related to the subject of the Agreement, irrespective of
				  whether in human or machine-readable form, tangible or intangible, which is:
				  (a) given by the Disclosing Party to the Receiving Party or otherwise acquired
				  or perceived by the Receiving Party from the Disclosing Party; or (b) which is
				  developed by one Party for the other under the terms of this Agreement.
				  Confidential Information does not include information that: (a) is in
				  possession of the Receiving Party at the time of disclosure, as demonstrated by
				  written records and without obligation of confidentiality; (b) is or later
				  becomes part of the public domain through no fault of the Receiving Party; (c)
				  is received by the Receiving Party from a Third Party without breach of an
				  obligation of confidentiality; or (d) is developed independently by the
				  Receiving Party without any use of, access to, reference to, or reliance upon
				  the Disclosing Party’s Confidential Information, in whole or in part.
				  Disclosing Party is not obligated to mark information as
				  “CONFIDENTIAL” to be deemed Confidential Information under this
				  Agreement. Confidential Information of BVL includes, but is not limited to, BVL
				  Technology, BVL Improvements and BVL Manufacturing processes, techniques,
				  know-how and pricing information. Confidential Information of Customer
				  includes, but is not limited to, Customer Technology and Customer Improvements.
				  This Agreement shall not be construed as a grant of any right or license to the
				  Receiving Party with respect to Confidential Information of the Disclosing
				  Party or as a requirement of either Party to enter into any further arrangement
				  with respect to Confidential Information of the Disclosing Party. 
				

			 

 

	 
			
				
				   
				

			 	
				
				  9.2.
				

			 	
				
				  Disclosure and
				  Use. The Receiving Party shall: (a)
				  maintain the confidentiality of the Disclosing Party’s Confidential
				  Information; (b) not disclose the Disclosing Party’s Confidential
				  Information to any Third Party without the prior written consent of the
				  Disclosing Party; and (c) use the Disclosing Party’s Confidential
				  Information only as necessary to fulfill its obligations or in the reasonable
				  exercise of rights granted to it hereunder. Notwithstanding the foregoing, a
				  Receiving Party may disclose: (i) Confidential Information of the Disclosing
				  Party to its Affiliates, and to its and their directors, employees,
				  consultants, and agents provided that in each case such individuals and
				  entities have a specific need to know such Confidential Information and are
				  previously bound by written obligation of confidentiality and restriction at
				  least as rigorous as those set forth herein; (ii) Improvements to the extent
				  required to exploit the grant of its rights under Article 11 of this Agreement;
				  and (iii) Confidential Information of the Disclosing Party to the extent such
				  disclosure is required to comply with Applicable Law or to defend or prosecute
				  litigation; provided, however, that prior to any such use or disclosure, the
				  Receiving Party shall provide written notice of such potential disclosure to
				  the Disclosing Party, and cooperate with Disclosing Party’s lawful
				  decision to avoid or minimize the degree of such disclosure. Receiving Party
				  shall permit the Disclosing Party the opportunity, if desired, to 
				

			 

 

	 
		 
	 

	 
		 
	 

	 
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		seek an appropriate protective order or
		other remedy with respect to narrowing the scope of such use or disclosure.
		Upon request, the Receiving Party shall return all copies of the Disclosing
		Party’s Confidential Information to the Disclosing Party, except for a
		single copy for the purpose of determining compliance with its obligations of
		this Agreement.
	 

	 
			
				
				   
				

			 	
				
				  9.3.
				

			 	
				
				  Publicity. Neither Party will issue any press release or other
				  public announcement concerning this Agreement or the transactions contemplated
				  by this Agreement without the prior written consent of the other Party, except
				  where such announcements are required by Applicable Law or the rules of any
				  stock exchange or NASDAQ. The Parties will use all reasonable efforts to
				  consult with each other and to cooperate with respect to the wording of any
				  such announcement. Product labeling (primary, secondary, and any insert) and
				  government filings may indicate that Product has been Manufactured for Customer
				  by BVL. 
				

			 

 

	 
		ARTICLE 10 - REPRESENTATIONS AND WARRANTIES
	 

	 
			
				
				   
				

			 	
				
				  10.1.
				

			 	
				
				  Representations of
				  BVL. BVL represents and warrants to
				  Customer that: (a) it has the full power and right to enter into this Agreement
				  and that there are no outstanding agreements, assignments, licenses,
				  encumbrances or rights of any kind held by other Parties, private or public,
				  materially inconsistent with the provisions of this Agreement; (b) the services
				  provided by BVL shall be performed with requisite care, skill and diligence, in
				  accordance with Applicable Laws and industry standards, and by individuals who
				  are appropriately trained and qualified; (c) to the best of its knowledge, the
				  services provided by BVL will not infringe the intellectual property rights of
				  any Third Party and it will promptly notify Customer in writing should it
				  become aware of any claims asserting such infringement; (d) at the time of
				  delivery to Customer, Product Manufactured under this Agreement: (i) will have
				  been Manufactured in accordance with cGMP and all other Applicable Laws, the
				  Manufacturing Process, the requirements of the Quality Agreement, and
				  Specification, and (ii) will not be adulterated or misbranded under the FDCA or
				  other Applicable Law; and (iii) upon receipt of payment by BVL, the product
				  correlating to such payment should be free and clear of all liens and
				  encumbrances; and (e) it has not been debarred, nor is it subject to a pending
				  debarment, and that it shall not use in any capacity in connection with the
				  services provided under this Agreement any person who has been debarred
				  pursuant to section 306 of the FDCA, 21 U.S.C. § 335a, or who is the
				  subject of a conviction described in such section. BVL agrees to inform
				  Customer in writing Immediately if BVL or any person who is performing services
				  on its behalf under this Agreement is debarred or is the subject of a
				  conviction described in section 306, or if any action, suit, claim,
				  investigation, or proceeding is pending relating to the debarment or conviction
				  of BVL or any person performing such services.
				

			 

 

	 
			
				
				   
				

			 	
				
				  10.2.
				

			 	
				
				  Representations of
				  Customer. Customer represents and
				  warrants to BVL that: (a) it has the full power and right to enter into this
				  Agreement and that there are no outstanding agreements, assignments, licenses,
				  encumbrances or rights held by other Parties or Third Parties, private or
				  public, inconsistent with the provisions of this Agreement; (b) to the best of
				  its knowledge the use of Customer Technology, Customer Improvements, and
				  Customer Confidential Information in the 
				

			 

 

	 
		 
	 

	 
		 
	 

	 
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		performance of services under this Agreement
		will not infringe the intellectual property rights of any Third Party and that
		it will promptly notify BVL in writing should it become aware of any claims or
		threats asserting such infringement; (c) that the API provided by Customer will
		be provided to BVL free and clear of any liens and encumbrances; (d)
		Customer’s further distribution of the Product will not cause the Product
		to be adulterated or misbranded under the FDCA or other Applicable Law; and (e)
		Customer has not been debarred, nor is it subject to a pending debarment
		pursuant to section 306 of the FDCA, 21 U.S.C. § 335a, nor is it the
		subject of a conviction described in such section. Customer agrees to inform
		BVL in writing Immediately if Customer is debarred or is the subject of a
		conviction described in section 306, or if any action, suit, claim,
		investigation, or proceeding is pending relating to the debarment or conviction
		of Customer.
	 

	 
			
				
				   
				

			 	
				
				  10.3.
				

			 	
				
				  Additional Representations of
				  Customer in the event that Product(s) will be Offered for Sale, Sold, Marketed
				  or Distributed for Developmental or Clinical Applications within the Member
				  States of the European Union. In the event that the Territory includes the
				  European Union or any member states thereof, then in addition to all other
				  warranties and representations set forth herein, Customer also represents and
				  warrants: (a) that Customer has properly appointed one or more Qualified
				  Person(s) in compliance with EU standards, including without limitation,
				  Article 49 of Directive 2001/82/EC, with respect to the Product(s) subject to
				  this Agreement; and (b) that Customer’s Qualified Person(s) shall fully
				  comply with all EU standards, directives and rules, including without
				  limitation, as set forth in Article 51 of 2001/83/EC. It is Customer’s
				  obligation to notify BVL as to whether the Territory includes an EU member
				  nation, or if a country within the Territory subsequently becomes a member of,
				  or subject to, the European Union.
				

			 

 

	 
			
				
				   
				

			 	
				
				  10.4.
				

			 	
				
				  DISCLAIMER. EXCEPT AS EXPRESSLY SET FORTH IN THIS AGREEMENT,
				  NEITHER PARTY MAKES ANY REPRESENTATIONS OR EXTENDS ANY WARRANTIES OF ANY KIND,
				  EITHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF
				  MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT. THIS IS
				  FOR ANY MATTER ARISING OUT OF OR RELATING TO THIS AGREEMENT, WHETHER SUCH
				  LIABILITY IS ASSERTED ON THE BASIS OF CONTRACT, TORT OR OTHERWISE, EVEN IF SUCH
				  PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. 
				

			 

 

	 
		ARTICLE 11 - INTELLECTUAL
		PROPERTY
	 

	 
			
				
				   
				

			 	
				
				  11.1.
				

			 	
				
				  Customer
				  Technology. Customer represents and
				  warrants that the Product(s) to be Manufactured by BVL do not infringe any U.S.
				  Patent or other intellectual patent rights in the Territory. All rights to and
				  interests in Customer Technology that qualifies as Confidential Information
				  under Article 9.1 of this Agreement shall remain solely in Customer and no
				  right or interest therein is transferred or granted to BVL. BVL acknowledges
				  and agrees that it does not acquire a license or any other right to Customer
				  Technology except for the limited purpose of carrying out its duties and
				  obligations under this Agreement and that such limited, non-exclusive, license
				  shall expire upon the completion of such duties and obligations or the
				  termination or expiration of this Agreement, whichever is the first to
				  occur.
				

			 

 

	 
		 
	 

	 
		 
	 

	 
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				  11.2.
				

			 	
				
				  BVL Technology. All rights to and interests in BVL Technology that
				  qualifies as Confidential Information under Article 9.1 of this Agreement shall
				  remain solely in BVL and no right or interest therein is transferred or granted
				  to Customer. Customer acknowledges and agrees that it shall not acquire a
				  license or any other right to BVL Technology except as otherwise set forth in
				  this Agreement.
				

			 

 

	 
			
				
				   
				

			 	
				
				  11.3.
				

			 	
				
				  Customer
				  Improvements. The Parties agree that
				  all Improvements that relate exclusively to the Confidential Information of
				  Customer or are Product-specific, shall be the sole and exclusive property of
				  Customer (“Customer Improvements”) and are hereby assigned to
				  Customer (or its designee) without additional compensation to BVL. BVL shall
				  take such steps as Customer may reasonably request (at Customer’s expense)
				  to vest in Customer (or its designee) ownership of the Customer
				  Improvements.
				

			 

 

	 
			
				
				   
				

			 	
				
				  11.4.
				

			 	
				
				  BVL Improvements. The Parties agree that all Improvements that are not
				  Customer Improvements shall be the sole and exclusive property of BVL
				  (“BVL Improvements”) and Customer hereby assigns the same to BVL (or
				  its designee) without additional compensation to Customer. Customer shall take
				  such steps as BVL may reasonably request (at BVL’s expense) to vest in BVL
				  (or its designee) ownership of the BVL Improvements. To the extent that BVL
				  incorporates a BVL Improvement into the Manufacturing Process of
				  Customer’s Product(s), BVL agrees to grant to Customer a non-exclusive,
				  sub-licensable, royalty-free license to use such Customer-approved, BVL
				  Improvement to manufacture, have manufactured, use, sell, have sold and/or
				  import the Products specifically covered by this Agreement in and for the
				  Territory. This grant shall be perpetual, but subject to termination in the
				  event that BVL is notified that such BVL Improvement infringes a Third
				  Party’s intellectual property rights, in which case the grant set forth in
				  this paragraph 11.4 is terminable with a 10-day written notice to Customer. The
				  foregoing license shall only be transferable as provided in Article 15.
				

			 

 

	 
		ARTICLE 12 - TERM AND
		TERMINATION 
	 

	 
			
				
				   
				

			 	
				
				  12.1.
				

			 	
				
				  Term. This Agreement shall become effective on the Effective
				  Date and, except as otherwise provided herein, shall be in effect for an
				  initial term of five (5) Contract Years. This Agreement may be extended
				  exclusively by amendment provided for in Section 5.1.1 – 5.1.2, unless
				  otherwise agreed to by the Parties in writing.
				

			 

 

	 
			
				
				   
				

			 	
				
				  12.2.
				

			 	
				
				  Termination by Either Party
				  Without Cause. Either Party may
				  terminate this Agreement without cause by providing twenty-four (24) months
				  written notice to the other Party. Notwithstanding such no-fault termination,
				  Customer shall be liable for the reserved capacity as set forth in Article 5,
				  and for any outstanding Development services or Purchase Orders.
				

			 

 

	 
			
				
				   
				

			 	
				
				  12.3.
				

			 	
				
				  Termination for
				  Breach. Either Party may terminate this
				  Agreement for a material breach by the other Party by giving the breaching
				  Party written notice, specifying the breach, and giving the breaching Party
				  three (3) months to cure such breach. If the default has not been cured at the
				  end of the three (3) month period, then, upon written notice thereof to the
				  breaching Party by the other Party this Agreement shall terminate. Termination
				  for breach will have no effect on 
				

			 

 

	 
		 
	 

	 
		 
	 

	 
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		performance obligations or amounts to be
		paid which have accrued up to the effective date of such termination.
		Notwithstanding the foregoing, if Customer’s unpaid, undisputed balance
		extends in any event beyond ninety (90) days, BVL shall have the right to
		require pre-payment for all future Manufacturing until such time as Customer
		has established a satisfactory payment history in BVL’s sole discretion.
		Notwithstanding anything to the contrary, in the event that Customer’s
		unpaid, undisputed balance extends in any event beyond one-hundred twenty (120)
		days, then BVL shall be entitled to: (a) terminate this Agreement without
		liability to Customer unless such payment default is cured in its entirety by
		Customer within thirty (30) days of written notice from BVL of its intent to
		terminate; or (b) cease production and/or service performance without liability
		until such default is cured.
	 

	 
			
				
				   
				

			 	
				
				  12.4.
				

			 	
				
				  Termination for
				  Bankruptcy. In the event of any
				  proceedings, voluntary or involuntary, in bankruptcy or insolvency, by or
				  against Customer or BVL, or the appointment with or without the Parties’
				  consent of a receiver for either Party, the other Party shall be entitled to
				  immediately terminate this Agreement upon written notice to the other Party
				  without any liability whatsoever. Such termination shall not affect any claim
				  for damages available to the terminating Party or for costs or fees accrued to
				  date.
				

			 

 

	 
			
				
				   
				

			 	
				
				  12.5.
				

			 	
				
				  Termination for Force
				  Majeure. In the case of a Force Majeure
				  event that will, or continues to, prevent performance (in whole or substantial
				  part) of this Agreement by a Party for a period of at least six (6) months, the
				  other Party shall be entitled to terminate this Agreement upon prior written
				  notice to the other Party without any liability whatsoever. 
				

			 

 

	 
			
				
				   
				

			 	
				
				  12.6.
				

			 	
				
				  Consequences of
				  Termination. 
				

			 

 

	 
			
				
				   
				

			 	
				
				  12.6.1.
				

			 	
				
				  In the event of termination of this
				  Agreement, the Parties will endeavor to transition the Manufacturing services
				  and technology transfer in such a manner as to not cause unreasonable
				  inconvenience to either Party. Termination by BVL shall not be effective until
				  Customer has located and arranged for continuation of Manufacture of Product
				  with another supplier, but in no event shall such supply obligation continue
				  for more than two (2) years after the date of termination notice of this
				  Agreement. The Parties will cooperate during such period to continue any such
				  ongoing services and BVL shall perform such functions reasonably necessary or
				  required in connection with the orderly wind-down of any active project as
				  required by the terms of this Agreement and Applicable Law. 
				

			 

 

	 
			
				
				   
				

			 	
				
				  12.6.2.
				

			 	
				
				  Promptly upon a termination of this
				  Agreement or at the request of the Disclosing Party, the Receiving Party shall
				  return to the Disclosing Party all Confidential Information of the Disclosing
				  Party in its possession, except for one copy that may be retained for archive
				  purposes. Furthermore, BVL shall promptly return all Customer-supplied
				  Composition, Customer-supplied Equipment, API, retained samples, reference
				  standards, data, reports and other property, information and/or know-how in
				  recorded form that was provided by Customer, or Developed in the performance of
				  the services under this Agreement, that are owned 
				

			 

 

	 
		 
	 

	 
		 
	 

	 
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		by or licensed to Customer, excepting that
		required to be retained by Applicable Law.
	 

	 
			
				
				   
				

			 	
				
				  12.6.3.
				

			 	
				
				  In the event of termination by BVL
				  pursuant to Section 12.2, Customer shall pay BVL for Manufacturing, Development
				  and other services completed up to the effective date of such termination
				  within thirty (30) days of Customer’s receipt of all results, reports,
				  data, samples, and other deliverables to be provided pursuant to this
				  Agreement. In the event the funds received by BVL prior to such termination
				  exceed costs incurred to the date of termination, BVL shall refund the
				  difference to Customer within thirty (30) days after the effective date of
				  termination. In the event of a no-fault termination by BVL pursuant to Section
				  12.2, Customer shall not be liable under Section 5.4 for that portion of the
				  Five-Year Forecast following the effective date of the termination.
				

			 

 

	 
			
				
				   
				

			 	
				
				  12.6.4.
				

			 	
				
				  Upon any termination (i) other than
				  BVL’s breach of this Agreement; or (ii) for BVL’s breach of this
				  Agreement and subject to the mutual agreement of the parties, Customer: (a)
				  shall purchase from BVL any existing inventories of Product conforming to the
				  Specification and Manufactured in accordance with cGMP and the Manufacturing
				  Process, at the then-current price for such Product; and (b) may either: (i)
				  purchase any Product in process held by BVL as of the date of the termination,
				  at a price to be mutually agreed (it being understood that such price shall
				  reflect, on a pro rata basis, work performed and non-cancelable, out-of-pocket
				  expenses actually incurred by BVL with respect to the Manufacture of such
				  in-process Product) or (ii) reimburse BVL for all work performed and
				  non-cancelable costs, and out-of-pocket expenses incurred by BVL and direct BVL
				  to dispose of such material at Customer’s cost. 
				

			 

 

	 
			
				
				   
				

			 	
				
				  12.6.5.
				

			 	
				
				  If Customer terminates this
				  Agreement for any reason, Customer shall reimburse BVL for the costs of any
				  BVL-supplied Composition that cannot be canceled, unless these materials can be
				  utilized by BVL on other projects. This reimbursement shall be made within
				  thirty (30) days after receipt by Customer of an invoice itemizing the material
				  costs. BVL agrees to transfer to Customer any materials for which Customer has
				  paid under this provision. Termination shall have no effect on payment
				  obligations that have accrued up to the effective date of termination.
				  Furthermore, unless Customer has terminated this Agreement pursuant to Sections
				  12.3, 12.4, or 12.5, Customer shall pay BVL as provided in Section 5.4. 
				

			 

 

	 
			
				
				   
				

			 	
				
				  12.6.6.
				

			 	
				
				  Upon the effective date of
				  termination or expiration of this Agreement, and subject to 12.6.1, Customer
				  shall have no further obligations to BVL with respect to the Forecasts and BVL
				  will have no further obligations to Manufacture Product. 
				

			 

 

	 
			
				
				   
				

			 	
				
				  12.7.
				

			 	
				
				  Injunctive Relief for Breach or
				  Threatened Breach. The Parties agree
				  that should this Agreement be breached, money damages may be inadequate to
				  remedy such a breach. As a result, the non-breaching Party shall be entitled to
				  seek, and a court of competent jurisdiction may grant, specific performance and
				  
				

			 

 

	 
		 
	 

	 
		 
	 

	 
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		injunctive or other equitable relief as a
		remedy for any such breach or threatened breach of this Agreement. Such remedy
		shall be in addition to all other remedies, including money damages, available
		to a non-breaching Party at law or in equity.
	 

	 
			
				
				   
				

			 	
				
				  12.8.
				

			 	
				
				  Survival. Expiration or termination of this Agreement for any
				  reason shall not relieve either Party of any obligation accruing prior to such
				  expiration or termination or of any rights and obligations of the Parties that
				  by their terms survive termination or expiration of this Agreement, including,
				  without limitation, the representations and warranties (Article 10), duties of
				  confidentiality (Article 9), indemnification (Article 8), intellectual property
				  (Article 11), governing law and jurisdiction (Article 16) and Quality Agreement
				  (Attachment “E”) of this Agreement. Notwithstanding anything to the
				  contrary set forth herein, the obligations identified in this Paragraph 12.8
				  shall survive for a period of not less than ten (10) years from any termination
				  or expiration of this Agreement.
				

			 

 

	 
		ARTICLE 13 -
		NOTICES
	 

	 
			
				
				   
				

			 	
				
				  13.1.
				

			 	
				
				  All notices concerning this
				  Agreement shall be given in writing, as follows: (i) by actual delivery of the
				  notice into the hands of the Party entitled to receive it, in which case such
				  notice shall be deemed given on the date of delivery; or (ii) by Federal
				  Express, UPS, DHL or any other overnight carrier, in which case the notice
				  shall be deemed given two (2) days from the date of transmission. All notices
				  which concern this Agreement shall be addressed as follows:
				

			 

 

	 
		If to BVL:
	 

	 
		Ben Venue Laboratories, Inc.
	 

	 
		300 Northfield Road 
	 

	 
		Bedford, Ohio 44146
	 

	 
		Attn: Vice President, Contract Manufacturing
		Services 
	 

	 
		With copy to:
	 

	 
		Ben Venue Laboratories, Inc.
	 

	 
		300 Northfield Road 
	 

	 
		Bedford, Ohio 44146
	 

	 
		Attn: Legal Department, Division
		Counsel
	 

	 
		If to Customer:
	 

	 
		Vion Pharmaceuticals, Inc.
	 

	 
		4 Science Park
	 

	 
		New Haven, CT 06511
	 

	 
		Attn: Howard B. Johnson, President &
		CFO
	 

	 
		With a copy to:
	 

	 
		Vion Pharmaceuticals, Inc.
	 

	 
		4 Science Park
	 

	 
		New Haven, CT 06511
	 

	 
		Attn: Karen Schmedlin, Vice-President,
		Finance & Chief Accounting Officer
	 

	 
		 
	 

	 
		 
	 

	 
		 
	 

	 
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		ARTICLE 14 -
		WAIVER
	 

	 
			
				
				   
				

			 	
				
				  14.1.
				

			 	
				
				  No failure on the part of either
				  Party to exercise, and no delay in exercising, and no course of dealing with
				  respect to, any right, power or privilege under this Agreement shall operate as
				  a waiver thereof, nor shall any single or partial exercise of any right, power
				  or privilege under this Agreement preclude any other or further exercise
				  thereof or the exercise of any other right, power or privilege.
				

			 

 

	 
		ARTICLE 15 - ASSIGNMENT OF AGREEMENT
	 

	 
			
				
				   
				

			 	
				
				  15.1.
				

			 	
				
				  Neither this Agreement, nor any
				  rights or obligations hereunder, may be assigned by either Party hereto without
				  the prior written consent of the other Party, which consent shall not be
				  unreasonably withheld; provided, however, that either Party may, without such
				  consent, but with notice to the other Party, assign this Agreement, in whole or
				  in part: (a) in connection with the transfer or sale of all or substantially
				  all of the assets of such Party or the line of business or Product to which
				  this Agreement relates; (b) to the successor entity or acquirer in the event of
				  the merger, consolidation or change of control of a Party hereto; or (c) to any
				  Affiliate of the assigning Party. Any subsequent assignee, purchaser, or
				  transferee shall be bound by the terms of this Agreement.
				

			 

 

	 
		ARTICLE 16 - GOVERNING LAW
	 

	 
			
				
				   
				

			 	
				
				  16.1.
				

			 	
				
				  This Agreement and the rights and
				  obligations of the Parties hereunder shall be governed by Delaware law and, to
				  the extent the laws of the State of Delaware are preempted or otherwise made
				  inapplicable by federal law, the laws of the United States of America. Each of
				  the Parties irrevocably and unconditionally:
				

			 

 

	 
			
				
				   
				

			 	
				
				  16.1.1.
				

			 	
				
				  agrees that any suit, action or
				  legal proceeding arising out of or relating to this Agreement shall be
				  instituted in the United States District Court for Delaware, or if such court
				  does not possess subject matter jurisdiction, of any type, or will not accept
				  jurisdiction, in any court of general jurisdiction in Wilmington,
				  Delaware;
				

			 

 

	 
			
				
				   
				

			 	
				
				  16.1.2.
				

			 	
				
				  consents and submits to the
				  exclusive jurisdiction of such foregoing courts in any such suit, action or
				  proceeding;
				

			 

 

	 
			
				
				   
				

			 	
				
				  16.1.3.
				

			 	
				
				  consents to personal jurisdiction in
				  such courts;
				

			 

 

	 
			
				
				   
				

			 	
				
				  16.1.4.
				

			 	
				
				  waives any objection which it may
				  have to laying of venue of any such suit, action or proceeding in said courts;
				  and
				

			 

 

	 
			
				
				   
				

			 	
				
				  16.1.5.
				

			 	
				
				  waives any claim or defense of
				  inconvenient forum.
				

			 

 

	 
		ARTICLE 17 - FORCE MAJEURE
	 

	 
			
				
				   
				

			 	
				
				  17.1.
				

			 	
				
				  No Party shall be liable for a
				  failure or delay in performing any of its obligations under this Agreement if,
				  and only to the extent that, such failure or delay (directly or indirectly) is
				  due to causes beyond the reasonable control of the affected 
				

			 

 

	 
		 
	 

	 
		 
	 

	 
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		Party, including: (i) acts of God; (ii)
		fire, explosion, or unusually severe weather; (iii) war, whether declared or
		undeclared, invasion, riot or other material civil unrest; (iv) enactment or
		change of laws and regulations by any Agency or Government, conflict of laws or
		regulations by any Agency or government, orders, restrictions, actions,
		embargoes or blockages; (v) national or regional emergency; (vi) injunctions,
		strikes, lockouts, labor trouble or other industrial disturbances (regardless
		of the reasonableness of the demands of labor); and (vii) acts of terrorism
		(“Force Majeure”). 
	 

	 
			
				
				   
				

			 	
				
				  17.2.
				

			 	
				
				  The Party whose performance of this
				  Agreement is affected or potentially affected by an event of Force Majeure
				  shall promptly notify the other Party of the Force Majeure condition,
				  explaining the nature, details and expected duration thereof, and shall exert
				  reasonable efforts to eliminate, cure or overcome any such condition and to
				  resume performance of its obligations under this Agreement as soon as possible.
				  Upon termination of the event of Force Majeure, the performance of any
				  suspended obligation or duty shall promptly recommence. 
				

			 

 

	 
		ARTICLE 18 - TITLE OF GOODS
	 

	 
			
				
				   
				

			 	
				
				  18.1.
				

			 	
				
				  Title to API and Customer-supplied
				  Composition shall remain with Customer at all stages of the Manufacturing
				  Process. BVL shall provide within the Facility an area or areas where the API,
				  Customer-supplied Composition, Product, any intermediates (and components
				  thereof), and any work in process are segregated and stored in accordance with
				  the Specification and cGMP, and in such a way as to be able at all times to
				  clearly distinguish the same from products and materials belonging to BVL, or
				  held by it for a Third Party’s account. 
				

			 

 

	 
			
				
				   
				

			 	
				
				  18.2.
				

			 	
				
				  BVL shall at all times take such
				  measures as are required to protect the API, Customer-supplied Composition,
				  Product, and any work in process from risk of loss or damage at all stages of
				  the Manufacturing Process. BVL shall ensure that the API, Customer-supplied
				  Composition, Product, and any work in process are free and clear of any liens
				  or encumbrances resulting from any act or omission of BVL. BVL shall
				  Immediately notify Customer if at any time it believes any API,
				  Customer-supplied Composition or Product have been damaged, lost or
				  stolen.
				

			 

 

	 
		ARTICLE 19 -  ENTIRE AGREEMENT
	 

	 
			
				
				   
				

			 	
				
				  19.1.
				

			 	
				
				  This Agreement, together with the
				  Attachments identified herein that shall form part of this Agreement,
				  constitutes the entire understanding between the Parties and is intended as a
				  final expression of their agreement and as a complete statement of terms and
				  conditions thereof, and shall not be amended except in writing signed by an
				  authorized representative of each Party and specifically referring to this
				  Agreement. If there is any inconsistency between this Agreement and any other
				  writings, which are referred to or are incorporated herein, or any Purchase
				  Orders, invoices, or other documents relating to Product, the terms and
				  conditions of this Agreement shall take precedence in any contract
				  construction. This Agreement supersedes any previous agreements or arrangements
				  between the Parties and any customary practice of the Parties at variance with
				  the terms hereof. Neither Party may rely upon oral representations that are
				  inconsistent with the terms of this Agreement.
				

			 

 

	 
		 
	 

	 
		 
	 

	 
		 
	 

	 
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		ARTICLE 20 -
		SEVERABILITY
	 

	 
			
				
				   
				

			 	
				
				  20.1.
				

			 	
				
				  In the event any provision of this
				  Agreement is held to be invalid or unenforceable, the valid or enforceable
				  portion thereof and the remaining provisions of this Agreement will remain in
				  full force and effect.
				

			 

 

	 
		ARTICLE 21 - INDEPENDENT CONTRACTORS
	 

	 
			
				
				   
				

			 	
				
				  21.1.
				

			 	
				
				  Neither Party shall have the right
				  to control the activities of the other in the performance of this Agreement and
				  each shall perform as an independent contractor, and nothing herein shall be
				  construed to be inconsistent with that relationship or status. Under no
				  circumstances shall the employees or agents of one Party be considered
				  employees or agents of the other. This Agreement shall not constitute, create,
				  or in any way be interpreted as a joint venture, partnership, or formal
				  business organization of any kind.
				

			 

 

	 
		ARTICLE 22 - AMENDMENTS
	 

	 
			
				
				   
				

			 	
				
				  22.1.
				

			 	
				
				  No provision of this Agreement or
				  the Attachments attached hereto may be modified or supplemented, except by an
				  instrument in writing signed by both BVL and Customer.
				

			 

 

	 
		ARTICLE 23 - HEADINGS
	 

	 
			
				
				   
				

			 	
				
				  23.1.
				

			 	
				
				  The Article headings appearing
				  herein are included only for the convenience of reference and are not intended
				  to affect the interpretation of any provision of this Agreement.
				

			 

 

	 
		ARTICLE 24 - REVIEW BY LEGAL COUNSEL
	 

	 
			
				
				   
				

			 	
				
				  24.1.
				

			 	
				
				  Each Party has carefully reviewed
				  this Agreement, and understands its terms. Each Party has been given sufficient
				  opportunity to seek legal advice prior to signing this Agreement, and has
				  either sought legal advice with counsel experienced in issues of
				  confidentiality in regards to this Agreement, or has relied wholly upon that
				  Party’s own judgment and knowledge in executing this Agreement. Each Party
				  fully understands and voluntarily accepts each and every provision contained in
				  this Agreement. Failure to seek legal advice prior to signing this Agreement
				  does not excuse either Party from failure to understand the terms and
				  conditions set forth in this Agreement. This Agreement has been prepared on the
				  basis of the mutual understanding of the Parties and in the event of an
				  ambiguity, such ambiguity shall not be strictly construed against either Party
				  as a drafter of this Agreement.
				

			 

 

	 
		ARTICLE 25 - RECALL
	 

	 
			
				
				   
				

			 	
				
				  25.1.
				

			 	
				
				  In the event: (a) any Agency or
				  governmental authority issues a request, directive, or order that Product be
				  recalled; or (b) a court of competent jurisdiction orders such a recall; or (c)
				  the Parties reasonably determine after consultation with each other that
				  Product should be recalled, the Parties shall take all appropriate corrective
				  action. Customer shall also retain the right to conduct a Product recall for
				  any safety reasons Customer deems significant. In the event 
				

			 

 

	 
		 
	 

	 
		 
	 

	 
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		that Product is recalled or that Customer is
		required to disseminate information regarding Product covered by this
		Agreement, Customer shall so notify BVL and, not later than may be required to
		permit Customer to meet such obligations, BVL shall provide Customer with such
		assistance in connection with such recall as may reasonably be requested by
		Customer. BVL will only be financially responsible for the costs of any recall
		for which its negligence or willful misconduct is solely responsible for such
		recall, subject to the limitations defined in Section 8.5.
		
	 

	 
		ARTICLE 26 - ENGLISH
		LANGUAGE
	 

	 
			
				
				   
				

			 	
				
				  26.1.
				

			 	
				
				  This Agreement, all schedules,
				  attachments, and exhibits hereto, and all reports, documents and notices
				  required hereunder, referred to herein or requested by the Parties, in
				  connection with this Agreement shall be written in the English language. Except
				  as otherwise required by Applicable Law, the binding version of all of the
				  foregoing shall be the English version.
				

			 

 

	 
		ARTICLE 27 - EXPORT
		PROVISION
	 

	 
			
				
				   
				

			 	
				
				  27.1.
				

			 	
				
				  Customer agrees and understands that
				  the information and any materials provided by BVL under this Agreement are
				  subject to United States laws and regulations, which may restrict exports,
				  re-exports or other transfers to other countries and Parties. Customer agrees
				  that no materials or information provided to it under this Agreement will be
				  exported re-exported, transferred or disclosed contrary to the applicable laws
				  and regulations of the United States, or to any country, entity or other Party
				  which is ineligible to receive such items under U.S. laws and regulations,
				  including the regulations of the U.S. Department of Commerce and the U.S.
				  Department of Treasury.
				

			 

 

	 
		ARTICLE 28 - ACKNOWLEDGEMENT
		OF COMPETITION FOR COMPETITIVE PRODUCTS OR SERVICES
	 

	 
			
				
				   
				

			 	
				
				  28.1.
				

			 	
				
				  Each Party understands and
				  acknowledges that the other Party individually or in collaboration with others
				  may now or hereafter develop or market products which compete with its own
				  products or services. Subject to the confidentiality obligations set forth in
				  Article 9, nothing in this Agreement shall impair the right of either Party to
				  develop, make, use, procure, or market other products or services now or in the
				  future which may be competitive to those products or services offered by the
				  other Party to this Agreement, including without limitation the Products or
				  services Manufactured pursuant to this Agreement. Neither Party is under a duty
				  to disclose any planning or other information relating to competition with the
				  other’s products or services.
				

			 

 

	 
		ARTICLE 29 - EXECUTION
	 

	 
		IN WITNESS WHEREOF, the Parties hereto have
		executed this Agreement by their duly authorized representatives as of the
		dates set forth below:
	 

	 
		 
	 

	 
		 
	 

	 
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		FOR: BEN VENUE LABORATORIES,
		INC.:
	 

	 
		Signature:____[*]____________________________
		Date:_12/7/2006__________
	 

	 
			
				
				  [*]
				

			 
	
				
				  Vice President, Contract
				  Manufacturing Services
				

			 

 

	 
		 
	 

	 
			
				
				  For:
				

			 	
				
				  Vion Pharmaceuticals,
				  Inc.
				

			 

 

	 
		 
	 

	 
		Signature:_/s/ /Howard B.
		Johnson_______________ Date:_12/1/2006__________
	 

	 
			
				
				   
				

			 	
				
				  Howard B. Johnson, President &
				  CFO
				

			 

 

	 
		 
	 

	 
		______________
	 

	 
		[*]
		Confidential Treatment Requested
	 

	 
		 
	 

	 
		 
	 

	 
		 
	 

	 
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		Attachment “A1”
	 

	 
		Product Supplements
	 

	 
		A1.1(b) PRODUCT
		IDENTIFICATION
	 

	 
		As per proposal sent to Customer by BVL
		dated December 5, 2006. Quotation Number: 101180 and 101361.
	 

	 
		 
	 

	 
		 
	 

	 
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		Vion Pharmaceuticals, Inc.)
	 

	 
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		Attachment “A1”
	 

	 
		Product Supplements
	 

	 
		A1.2(b) PRODUCT TESTING
		SPECIFICATION
	 

	 
		As per proposal sent to Customer by BVL
		dated December 5, 2006. Quotation Number: 101180 and 101361.
	 

	 
		 
	 

	 
		 
	 

	 
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		Vion Pharmaceuticals, Inc.)
	 

	 
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		CONFIDENTIAL
	 

	 
		 
	 

	 
		 
	 

	 
		Attachment “A1”
	 

	 
		Product Supplements
	 

	 
		A1.3(b) MATERIALS SUPPLIED BY CUSTOMER
		AND BVL
	 

	 
		As per proposal sent to Customer by BVL
		dated December 5, 2006. Quotation Number: 101180 and 101361.
	 

	 
		* Customer shall provide updates to the
		prices of Customer-supplied composition prices whenever Customer orders and/or
		purchases Customer-supplied composition. BVL shall have the right, upon demand,
		to audit any documentation (without limitation, including purchase orders,
		invoices, manifests, payments, etc.) to substantiate Customer’s price
		claims.
	 

	 
		 
	 

	 
		 
	 

	 
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		Attachment “A1”
	 

	 
		Product Supplements
	 

	 
		A1.4.1 FORECASTS 
	 

	 
		Five-Year Forecast – to be submitted by Customer to BVL on an annual
		basis by [*] each year. BVL will supply Customer with an electronic copy of the
		Five-Year Forecast form. Subject to the terms of the Agreement, the following
		represents the understanding of the Parties with respect to the volumes to be
		associated with this Agreement for the five (5) Contract Years of this
		Agreement.
	 

	 
		NOTE: PURSUANT TO SECTION 5.1.1 –
		5.1.2, UPDATES OF THE FIVE-YEAR FORECAST [*]
	 

	 
		CUSTOMER MAY ENTER A “ZERO”
		FIGURE FOR ANY YEAR IN WHICH IT DOES NOT WISH TO HAVE BVL ALLOCATE CAPACITY;
		HOWEVER, IN THE ABSENCE OF A WRITTEN CONFIRMATION ACCEPTING CUSTOMER’S
		OFFER TO AMEND THE FIVE-YEAR FORECAST, BVL MAKES NO REPRESENTATION THAT IT WILL
		HAVE CAPACITY AND/OR MANUFACTURE CUSTOMER’S PRODUCT FOR SUCH PERIODS,
		WHICH SHALL REMAIN EXCLUSIVELY IN BVL’S DISCRETION.
	 

	 
		PURSUANT TO SECTION 5.1, NOTWITHSTANDING
		THE FOREGOING, ADDITIONAL VOLUMES OF PRODUCT MAY BE REQUESTED FROM TIME TO TIME
		BY THE CUSTOMER AND SUCH ADDITIONAL VOLUME MAY BE MUTUALLY AGREED TO IN WRITING
		AT THE DISCRETION OF THE PARTIES.
	 

	 
		 
	 

	 
			
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  Contract Year 1 

				  Initial (Partial) 

				  Year in which 

				  the Agreement 

				  is Executed 
 2007
				

			 	
				
				   
				

			 	
				
				   Contract 
 Year 2 
 2008
				

			 	
				
				   
				

			 	
				
				  Contract 
 Year 3 
 2009
				

			 	
				
				   
				

			 	
				
				  Contract 
 Year 4 
 2010
				

			 	
				
				   
				

			 	
				
				  Contract 
 Year 5 
 2011
				

			 	
				
				   
				

			 
	
				
				  Product Description
				

			 	
				
				   
				

			 	
				
				  BVL End Item Number
				

			 	
				
				   
				

			 	
				
				  Batch Size/Order Quantity 
				

			 	
				
				   
				

			 	
				
				   Batches
				

			 	
				
				   
				

			 	
				
				   Batches
				

			 	
				
				   
				

			 	
				
				   Batches
				

			 	
				
				   
				

			 	
				
				   Batches
				

			 	
				
				   
				

			 	
				
				   Batches
				

			 	
				
				   
				

			 
	
				
				  [*] 10mg/ml
				  liquid, 10ml in a 10ml vial labeled vials bulk packaged
				

			 	
				
				   
				

			 	
				
				  TBD
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 
	
				
				  [*] 10mg/ml
				  liquid, 10ml in a 10ml vial labeled vials bulk packaged
				

			 	
				
				   
				

			 	
				
				  TBD
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 

 

	 
		 
	 

	 
		______________
	 

	 
		[*]
		Confidential Treatment Requested
	 

	 
		 
	 

	 
		 
	 

	 
		 
	 

	 
		 
	 

	 
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		Vion Pharmaceuticals, Inc.)
	 

	 
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		Attachment “A1”
	 

	 
		Product Supplements
	 

	 
		A1.4.2 ROLLING 12 MONTH
		FORECAST
	 

	 
		Pursuant to Section 5.3, Customer shall
		provide a Rolling Forecast quarterly to BVL. BVL will provide Customer with an
		electronic copy utilizing Microsoft Word of the following form for submission,
		which will include twelve (12) monthly periods for forecasting. Customer shall
		provide the Rolling Forecast one hundred twenty (120) days in advance of the
		first day of each Contract Quarter.
	 

	 
		(The format is for
		representation only, do not enter information below)
	 

	 
		 
	 

	 
			
				
				  Product Description
				

			 	
				
				   
				

			 	
				
				  BVL End Item Number
				

			 	
				
				   
				

			 	
				
				  Batch Size/Order Quantity 
				

			 	
				
				   
				

			 	
				
				  Month 1 
				

			 	
				
				   
				

			 	
				
				  Month 2
				

			 	
				
				   
				

			 	
				
				  Month 3
				

			 	
				
				   
				

			 	
				
				  . . .
				

			 	
				
				   
				

			 	
				
				  Month 12
				

			 	
				
				   
				

			 
	
				
				  Enter Product Description including
				  packaging for each end item 
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 

 

	 
		 
	 

	 
		 
	 

	 
		 
	 

	 
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		Attachment “A1”
	 

	 
		Product Supplements
	 

	 
		A1.5(b) PRICING
	 

	 
		As per proposal sent to Customer by BVL
		dated October 12, 2006. Quotation Number: 101180 and 101361.
	 

	 
		 
	 

	 
		 
	 

	 
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		Vion Pharmaceuticals, Inc.)
	 

	 
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		Attachment “A1”
	 

	 
		Territory
	 

	 
		A1.6 TERRITORY
	 

	 
		As used herein, “Territory” shall
		have the following meaning for the Product identified in this Attachment
		“A1.1”:
	 

	 
		 
	 

	 
			
				
				  Country
				

			 	
				
				   
				

			 	
				
				  Filing Type
				

			 	
				
				   
				

			 	
				
				  Date Filed or 

				  Approximate Date of 

				  Planned Filing
				

			 	
				
				   
				

			 	
				
				  Registration 

				  Number if Filed
				

			 
	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				   
				

			 

 

	 
		______________
	 

	 
		[*]
		Confidential Treatment Requested
	 

	 
		 
	 

	 
		 
	 

	 
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		Vion Pharmaceuticals, Inc.)
	 

	 
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		Attachment “B”
	 

	 
		Purchase Order Requirements
	 

	 
		The following Information shall be provided
		on each Purchase Order:
	 

	 
			
				
				  1.
				

			 	
				
				  BVL end item number 
				

			 

 

	 
			
				
				  2.
				

			 	
				
				  BVL Product description
				

			 

 

	 
			
				
				  3.
				

			 	
				
				  Batch Size in vials from Quotation
				  or as described in Attachment “A”
				

			 

 

	 
			
				
				  4.
				

			 	
				
				  Number of Batches
				

			 

 

	 
			
				
				  5.
				

			 	
				
				  Delivery Date (Date for BVL to
				  release the lot and deliver product & Batch Records)
				

			 

 

	 
			
				
				  6.
				

			 	
				
				  BVL Quotation Number if
				  Product/Service not included in Attachment “A”, or Reference this
				  Agreement Date
				

			 

 

	 
			
				
				  7.
				

			 	
				
				  Delivery Address
				

			 

 

	 
			
				
				  8.
				

			 	
				
				  Shipping requirements &
				  Instructions (temperature, dedicated trucks, preferred carrier, overnight etc.)
				  Contact name for Preferred Carrier, Temperature Monitors, Ship on BVL Release
				  or Hold for Customer Authorization to Ship.
				

			 

 

	 
			
				
				  9. 
				

			 	
				
				  Billing Address
				

			 

 

	 
			
				
				  10.
				

			 	
				
				  Special Instructions for Specific
				  Batch
				

			 

 

	 
		(Examples)
	 

	 
		“Annual Stability Batch”
	 

	 
		“Process Validation Batch”
	 

	 
		“Special Sampling Instructions mutually
		agreed to and included in Batch Record” 
	 

	 
			
				
				  11.
				

			 	
				
				  Customer Lot# and Expiration Date if
				  Applicable
				

			 

 

	 
		 
	 

	 
		 
	 

	 
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		CONFIDENTIAL
	 

	 
		Attachment “C”
	 

	 
		MONTHLY STORAGE FEES
	 

	 
		Effective through December 31, 2007
	 

	 
		BVL has limited storage capacity. Therefore,
		Customers are expected to have Product shipped to them no later than thirty
		(30) days after BVL Quality Operations has released their Product and has
		shipped the documents identified Attachment D to Customer. Should unforeseen
		events lead to a request by a Customer for storage beyond this thirty (30) day
		grace period, the Customer must request such storage by BVL in writing at least
		fifteen (15) days before the initial thirty (30) day grace period has expired.
		The request will be granted only if BVL has sufficient storage capacity to
		accommodate the request. Then, the following terms will apply.
	 

	 
		Monthly storage fees are assessed on a per
		lot basis, and begin to accrue thirty (30) days following the BVL release date
		of the Batch by BVL’s Quality Operations Dept. BVL will request that a
		separate Purchase Order be issued for the storage charges. These charges listed
		below will be reviewed and updated annually. 
	 

	 
		Monthly Storage Charge - per square foot per
		month
	 

	 
		 
	 

	 
			
				
				  Room Temperature Storage
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				  Refrigerated Storage
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				  Freezer Storage
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 

 

	 
		Minimum Storage Charge - per lot per
		month
	 

	 
		 
	 

	 
			
				
				  Room Temperature Storage
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				  Refrigerated Storage
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				  Freezer Storage
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 

 

	 
		______________
	 

	 
		[*]
		Confidential Treatment Requested
	 

	 
		 
	 

	 
		 
	 

	 
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		Vion Pharmaceuticals, Inc.)
	 

	 
		Page 42
	 

	 
		 
	 

	 
	 

	 

	 
		CONFIDENTIAL
	 

	 
		Attachment “D”
	 

	 
		Documents to be supplied by BVL to
		Customer as part of Batch release
	 

	 
			
				
				  1.)
				

			 	
				
				  BVL Certificate of Analysis
				

			 

 

	 
			
				
				  2.)
				

			 	
				
				  BVL Certificate of Compliance
				

			 

 

	 
			
				
				  3.)
				

			 	
				
				  Copies of the executed Batch Record
				  
				

			 

 

	 
			
				
				  4.)
				

			 	
				
				  Raw Material Certificates of
				  Analysis generated by BVL used in the lot (Part of Batch Record)
				

			 

 

	 
			
				
				  5.)
				

			 	
				
				  Reports documenting deviations and
				  Investigations (Part of Batch Record)
				

			 

 

	 
			
				
				  6.)
				

			 	
				
				  Out Of Specification Results and
				  Investigations (Part of Batch Record)
				

			 

 

	 
			
				
				  7.)
				

			 	
				
				  Testing Documentation (Part of Batch
				  Record)
				

			 

 

	 
		NOTE: Raw analytical data, Environmental
		data (Airborne particulates, Pressure differential between Manufacturing rooms
		and the other data BVL is monitoring) is not copied or otherwise provided to a
		Customer except that these data can be inspected as part of scheduled or for
		cause audits by the Customer. 
	 

	 
		 
	 

	 
		 
	 

	 
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		Page 43
	 

	 
		 
	 

	 
	 

	 

	 
		CONFIDENTIAL
	 

	 
		Attachment “E”
	 

	 
		Quality Agreement
	 

	 
		This Quality Agreement
		(“Quality Agreement”) is a required and integral part of the
		Manufacturing and Service Contract (“Agreement”)
		with an Effective Date of November 28, 2006 to which it is attached and
		integrated. This Quality Agreement defines the roles and responsibilities for
		BVL quality operations when providing services for Customer and further defines
		how BVL and Customer will interact with each other. 
	 

	 
		E.1 Purpose and Term of the Quality Agreement
	 

	 
		Capitalized terms used in this Quality
		Agreement and not otherwise defined shall have the meanings ascribed thereto in
		the Agreement unless otherwise specified. This Quality Agreement outlines the
		responsibilities of Customer and BVL with respect to the quality assurance and
		cGMP compliance of the Product and is the Quality Agreement referenced in the
		Agreement. In the event of any conflict between the terms of this Quality
		Agreement and the Agreement, the terms of the Agreement will control. 
	 

	 
		A matrix of responsibilities included at the
		end of this document delineates the primary responsible Party for the various
		aspects of this Quality Agreement. 
	 

	 
		This Quality Agreement commences with the
		Effective Date of the Agreement and remains in effect through the term of that
		Agreement. In the event that the Agreement is terminated for any reason
		provided for therein, the Quality Agreement will terminate on the later of: (i)
		the expiration date of the last Batch of Product produced by BVL for commercial
		distribution; (ii) completion of any ongoing stability studies; or (iii) two
		years of the termination of the Agreement. 
	 

	 
		All changes in this Quality Agreement must
		be documented in writing as an Addendum to the original Quality Agreement and
		reviewed and approved in writing by representatives from Customer and
		BVL.
	 

	 
		This Quality Agreement is between Customer
		and BVL. 
	 

	 
		E.1.1 Customer Quality
		Representatives:
	 

	 
		 
	 

	 
			
				
				  Name:
				

			 	
				
				   
				

			 	
				
				  Leyla Toksoy
				

			 
	
				
				  Title:
				

			 	
				
				   
				

			 	
				
				  Director, Quality Assurance &
				  Regulatory Affairs
				

			 
	
				
				  Company:
				

			 	
				
				   
				

			 	
				
				  Vion Pharmaceuticals, Inc.
				

			 
	
				
				  Street Address:
				

			 	
				
				   
				

			 	
				
				  4 Science Park
				

			 
	
				
				  City, State Zip:
				

			 	
				
				   
				

			 	
				
				  New Haven, CT 06511
				

			 
	
				
				  Phone:
				

			 	
				
				   
				

			 	
				
				  203-672-4516
				

			 
	
				
				  Fax:
				

			 	
				
				   
				

			 	
				
				  203-498-4220
				

			 
	
				
				  E-mail:
				

			 	
				
				   
				

			 	
				
				  ltoksoy@vionpharm.com
				

			 

 

	 
		 
	 

	 
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		Vion Pharmaceuticals, Inc.)
	 

	 
		Page 44
	 

	 
		 
	 

	 
	 

	 

	 
		CONFIDENTIAL
	 

	 
		This Quality Agreement has been reviewed and
		approved by:
	 

	 
		FOR CUSTOMER: 
	 

	 
			
				
				  SIGNATURE:__/s/ /Leyla
				  Toksoy___________________
				

			 	 	
				
				  DATE:__12/1/2006____
				

			 

 

	 
		E.1.2 BVL Quality
		Representatives:
	 

	 
		 
	 

	 
			
				
				  Name:
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				  Title:
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				  Company:
				

			 	
				
				   
				

			 	
				
				  Ben Venue Laboratories, Inc.
				

			 
	
				
				  Street Address:
				

			 	
				
				   
				

			 	
				
				  300 Northfield Road
				

			 
	
				
				  City, State Zip: 
				

			 	
				
				   
				

			 	
				
				  Bedford, OH 44146-0568
				

			 
	
				
				  Phone:
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				  Fax:
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				  E-mail:
				

			 	 	
				
				  [*]
				

			 

 

	 
		FOR BVL: 
	 

	 
			
				
				   
				

			 	
				
				  SIGNATURE:__________[*]_____________
				

			 	
				
				  DATE:
				  12/11/2006    
				

			 

 

	 
		E.1.3 BVL Business
		Representative:
	 

	 
		 
	 

	 
			
				
				  Name:
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				  Title:
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				  Company:
				

			 	
				
				   
				

			 	
				
				  Ben Venue Laboratories, Inc.
				

			 
	
				
				  Street Address:
				

			 	
				
				   
				

			 	
				
				  300 Northfield Road
				

			 
	
				
				  City, State Zip: 
				

			 	
				
				   
				

			 	
				
				  Bedford, OH 44146-0568
				

			 
	
				
				  Phone:
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				  Fax:
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 

 

	 
		______________
	 

	 
		[*]
		Confidential Treatment Requested
	 

	 
		 
	 

	 
		Manufacturing and Service Agreement (BVL and
		Vion Pharmaceuticals, Inc.)
	 

	 
		Page 45
	 

	 
		 
	 

	 
	 

	 

	 
		CONFIDENTIAL
	 

	 
		 
	 

	 
			
				
				  E-mail:
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 

 

	 
		FOR BVL: 
	 

	 
			
				
				   
				

			 	
				
				  SIGNATURE:__________[*]_____________
				

			 	
				
				  DATE:_12/7/2006___________
				

			 

 

	 
			
				
				   
				

			 	
				
				  E.1.4
				

			 	
				
				  On-Call Customer
				  Representative:
				

			 

 

	 
		In addition to the foregoing contact
		information, Customer will provide the name and phone numbers of a contact
		person(s) who may be called at any hour during the times when BVL is
		Manufacturing the Product, as follows:
	 

	 
		 
	 

	 
			
				
				  Name:
				

			 	
				
				   
				

			 	
				
				  Leyla Toksoy
				

			 
	
				
				  Title:
				

			 	
				
				   
				

			 	
				
				  Director, Quality Assurance &
				  Regulatory Affairs
				

			 
	
				
				  Company:
				

			 	
				
				   
				

			 	
				
				  Vion Pharmaceuticals, Inc.
				

			 
	
				
				  Street Address:
				

			 	
				
				   
				

			 	
				
				  4 Science Park 
				

			 
	
				
				  City, State Zip:
				

			 	
				
				   
				

			 	
				
				  New Haven, CT 06511
				

			 
	
				
				  Phone:
				

			 	
				
				   
				

			 	
				
				  203-672-4516 / cell
				  203-314-5527
				

			 
	
				
				  Fax:
				

			 	
				
				   
				

			 	
				
				  203-498-4220
				

			 
	
				
				  E-mail:
				

			 	
				
				   
				

			 	
				
				  ltoksoy@vionpharm.com 
				

			 

 

	 
		E.2 Quality Responsibilities
	 

	 
		The activities for and associated with the
		manufacturing of the Product must meet the current cGMPs as set forth in the
		“Code of Federal Regulations of the U.S. Food and Drug
		Administration”, 21 CFR Parts 210 & 211, as well as “The Rules
		Governing Medicinal Products in the European Community”, volume IV,
		“Guide to good manufacturing practice for medicinal products”, as
		well as the requirements of any applicable national guidelines to which the
		Product has been registered. In the event of a conflict in cGMPs, the U.S. Code
		of Federal Regulations shall apply.
	 

	 
		BVL is responsible for review and approval
		of all manufacturing, testing, and support documentation executed in the
		Production of each Batch of the Product as included or referenced in the Master
		Batch Record and for providing formal release to Customer. Customer is
		responsible for further release of each Batch of the Product for commercial and
		any other use. 
	 

	 
		Any dispute between Customer and BVL with
		regard to acceptance of the Product shall be subject to the procedures as set
		out in the Agreement between Customer and BVL. Customer’s disposition will
		be independent of BVL’s review and release.
	 

	 
		______________
	 

	 
		[*]
		Confidential Treatment Requested
	 

	 
		 
	 

	 
		 
	 

	 
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		Vion Pharmaceuticals, Inc.)
	 

	 
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		BVL is responsible for maintaining training
		records for all personnel that perform cGMP functions relating to the Customer
		operations performed at the site, including personnel in QA/QC, manufacturing,
		etc. 
	 

	 
		 
	 

	 
		 
	 

	 
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				  E.3
				

			 	
				
				  Regulatory Compliance and
				  Product Licensure
				

			 

 

	 
			
				
				   
				

			 	
				
				  E.3.1
				

			 	
				
				  Customer is the owner of the Product
				  and is responsible for product licensure, annual reports, and any other
				  regulatory filings that are required for the marketing of Product, and is
				  responsible to ensure that all of such filings with regulatory authorities are
				  consistent with the Specification and the Master Production Record. This
				  includes the supplement of product registration to update commitments, methods,
				  records, or specifications based upon regulatory requirements defined in 21 CFR
				  Part 314.
				

			 

 

	 
			
				
				   
				

			 	
				
				  E.3.2
				

			 	
				
				  In the event that the Territory as
				  defined herein includes the European Union or any member states thereof, then
				  in addition to all other responsibilities, Customer shall also: 
				

			 

 

	 
			
				
				   
				

			 	
				
				  E.3.2.1
				

			 	
				
				  certify in writing to BVL that it
				  has properly appointed one or more Qualified Person(s) in compliance with EU
				  Directives, standards and rules, including without limitation, Article 49 of
				  Directive 2001/82/EC, with respect to the Product(s) subject to this Agreement;
				  and further that Customer’s Qualified Person(s) shall fully comply with
				  all EU standards, directives and rules, including without limitation, as set
				  forth in Article 51 of 2001/83/EC, in a form substantially similar to that set
				  forth as Attachment “G”;
				

			 

 

	 
			
				
				   
				

			 	
				
				  E.3.2.2
				

			 	
				
				  as appropriate, cause its Qualified
				  Person to certify that the Facility supplying the API complies with EU GMP in a
				  form substantially similar to that set forth as Attachment
				  “H”;
				

			 

 

	 
			
				
				   
				

			 	
				
				  E.3.2.3
				

			 	
				
				  cause its Qualified Person to
				  certify the GMP status of the manufacturing and supply of an Active
				  Pharmaceutical Ingredient in a form substantially similar to that set forth as
				  Attachment “I”; and
				

			 

 

	 
			
				
				   
				

			 	
				
				  E.3.2.4
				

			 	
				
				  for each batch of Product
				  Manufactured by BVL, as appropriate, provide a Certificate of Analysis in a
				  form substantially similar to that set forth as Attachment
				  “J.”
				

			 

 

	 
			
				
				  E.4
				

			 	
				
				  Change Control 
				

			 

 

	 
		BVL will utilize a documented system of
		procedures for the control of changes to raw materials, packaging materials,
		utilities, facilities, equipment, manufacturing methods, and Product
		specifications and requirements, sampling, test methods, and release
		requirements. BVL will be responsible for contacting Customer to discuss
		changes which impact the Manufacturing license for any Territory.
		Product-specific changes will not be made without mutual approval. Customer
		will be responsible for applying for any necessary variation to the
		Manufacturing license(s) to allow production of the Product(s).
	 

	 
			
				
				   
				

			 	
				
				  E.4.1
				

			 	
				
				  Master Production
				  Records
				

			 

 

	 
		Master Production Records (MPRs) are
		documents that specify or reference the manufacturing instructions, related
		bills of material, in process testing, and production specifications used in
		the production process. These documents are developed and approved by BVL and
		Customer. Customer’s approval of the initial MPR must be received at least
		eight (8) weeks prior to the start of manufacture. Subsequent revisions 
	 

	 
		 
	 

	 
		 
	 

	 
			
				
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		and edits to the MPR shall be submitted at
		least eight (8) weeks and approved at least two (2) weeks prior to
		manufacture.
	 

	 
			
				
				   
				

			 	
				
				  E.4.2
				

			 	
				
				  Specification
				

			 

 

	 
		Specification initiation or revision that
		affects the scientific or technical content requires approval in writing by BVL
		and Customer before proposed changes are implemented. This applies to
		manufacturing, testing, storage, and labeling of the Product, as well as any
		changes to the specifications for raw materials and Product. Editorial or
		format changes to applicable specifications not affecting the
		scientific/technical content or intent of the specification will not require
		approval by Customer. Those documents requiring Customer approval are as
		follows:
	 

	 
		Product Specification to include Analytical
		Methods
	 

	 
		Master Production Records to include In
		Process Limits and Manufacturing Site Changes
	 

	 
		Raw Material Specifications
	 

	 
		When Customer initiates a change request on
		all applicable specifications, the appropriate BVL department shall be provided
		the proposed specification and appropriate documentation that summarizes and
		justifies each change.
	 

	 
			
				
				   
				

			 	
				
				  E.4.3
				

			 	
				
				  Packaging and Labeling
				  Specifications
				

			 

 

	 
		The packaging and labeling specifications
		are documents that describe the labeling artwork, container/closure, Product
		packaging for shipment, shipper specifications and drawings used in the
		packaging of the Product. These packaging and labeling specifications are
		Developed and approved by BVL and Customer. This information will be
		incorporated into the MPR, associated Product Specific SOPs, and raw material
		specifications, as appropriate. 
	 

	 
			
				
				   
				

			 	
				
				  E.4.4
				

			 	
				
				  Product Changeover
				

			 

 

	 
		BVL will follow its validated cleaning
		protocols based on product classifications per BVL SOP’s.
	 

	 
			
				
				   
				

			 	
				
				  E.4.5
				

			 	
				
				  Changes to the Plant
				

			 

 

	 
		BVL will notify Customer in advance of any
		changes of utilities, in the layout or structure of the equipment or in the
		operation and structure of the plant, which could have an adverse impact on the
		manufacturing of the Product or the quality of the Product. BVL shall not be
		obligated to obtain prior approval for changes required as a result of an
		Agency’s order, provided BVL promptly notifies Customer of any such
		proposed change and consults with Customer before implementation of such
		changes and its potential impact on Customer Product.
	 

	 
			
				
				  E.5
				

			 	
				
				  Documentation
				  Retention
				

			 

 

	 
		Batch specific documentation
		(e.g., executed batch records, investigation reports,
		Certificates of Analysis) will be retained by BVL for one (1) year beyond the
		expiration date of the Agreement, or in the event the Agreement is ongoing,
		then for not more than seven (7) years from the Manufacturing date BVL will
		notify Customer prior to destruction of the records and customer 
	 

	 
		 
	 

	 
		 
	 

	 
			
				
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		must provide a response to BVL as to the
		disposition of the documents within thirty (30) calendar days or the record
		will be destroyed. Customer may request that such records be transferred to
		Customer at Customer’s expense.
	 

	 
		For the basic product specific documentation
		(e.g., master production records, SOPs, validation
		documentation) the retention should be for the life of the product,
		i.e., until the registration for the product has been
		withdrawn and the responsibility of Customer with support from BVL. Such
		documents will be returned to the Customer in the event of termination of the
		Agreement, withdrawal of all registrations for the Product, or upon cessation
		of the business relationship between Customer and BVL and completion of
		BVL’s compliance with Applicable Laws. 
	 

	 
			
				
				  E.6
				

			 	
				
				  Materials 
				

			 

 

	 
		E.6.1 BVL is responsible for performing raw
		material and supplies procurement, QC testing, and material handling and
		submission of samples to outside testing laboratories (as applicable). BVL will
		obtain approval from Customer if BVL needs to subcontract the analytical
		release testing of raw materials provided by Customer. 
	 

	 
		E.6.2 BVL shall maintain an approved
		suppliers list in accordance with BVL’s procedures. BVL will provide the
		material name and supplier name upon request. Changes to non-compendial raw
		materials, such as a new supplier or process changes, shall be approved by
		Customer. Copies of vendor audit reports will be available for review during
		annual audits to confirm approval status of the vendors. BVL has the right to
		redact such audit reports.
	 

	 
		E.6.3 All materials purchased for use in the
		manufacture, storage and shipping of product will be purchased, received,
		inspected as appropriate, sampled (see E6.1) tested as appropriate, stored, and
		handled in accordance with BVL’s SOP’s. BVL agrees to sample and
		retain sufficient amounts of all raw materials, except water, compressed gases
		and any highly volatile compounds. The amount of retained samples is specified
		in BVL’s raw material specifications. All materials shall be in accordance
		with the approved specifications.
	 

	 
		E.6.4 BVL will qualify primary vendors of
		all raw materials and components. Vendor qualification will be in accordance
		with BVL SOP’s.
	 

	 
		E.6.5 BVL will provide, at Customer’s
		request, a copy of the BVL Drug Master File (DMF) and authorization for FDA to
		access the DMF. This may be used by the Customer to prepare a regulatory
		filing. BVL shall, upon Customer’s request, assist Customer with all other
		applicable filings for the non-US market in accordance with proposals submitted
		to Customer and confirmed by Purchase Order.
	 

	 
			
				
				  E.7
				

			 	
				
				  Product
				  Specification
				

			 

 

	 
		The Product must be manufactured, packaged,
		labeled, and handled according to the Specifications and procedures mutually
		agreed to in writing between Customer and BVL. Customer and BVL shall develop
		all in-process and Product release specifications, including acceptance limits
		for each required test. Establishment of appropriate test methods and
		supporting test method validation will be performed by BVL and approved by
		Customer. Each lot of Product manufactured by BVL for Customer will be sampled
		and tested in accordance with the Specification.
	 

	 
		 
	 

	 
		 
	 

	 
			
				
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				  E.8
				

			 	
				
				  Manufacturing and Packaging of
				  the Product
				

			 

 

	 
		E.8.1 The manufacturing of the Product will
		be done under cGMP and in accordance with specific procedures and instructions
		mutually agreed upon between Customer and BVL, and documented in the MPR. The
		Date of Manufacture will be as specified in the Product
		Specification. 
	 

	 
		E.8.2 Any regulations regarding storage of
		different types of products shall be adhered to. 
	 

	 
		E.8.3 The manufacturing of Customer’s
		Product by BVL must be in adherence to the Specification as mutually agreed
		upon, and in compliance with all cGMPs and any other applicable regulatory
		requirements. BVL will provide documentation for each Batch as agreed upon
		between Customer and BVL and specified in Attachment “D.” 
	 

	 
			
				
				  E.9
				

			 	
				
				  Testing of the
				  Product
				

			 

 

	 
		E.9.1 The testing of the Product is carried
		out by BVL according to the Specification. For those procedures which appear in
		the current USP/NF or other recognized standard references, qualification of
		the method for the Product and a statement indicating the reference shall
		suffice. For all Product-specific test methods utilized by BVL, documentation
		supporting the validation of the test method shall be available for review
		during annual audits by Customer. 
	 

	 
		E.9.2 If any Third Party is utilized to
		perform testing of raw materials or release/stability testing the vendor(s)
		must be qualified by BVL as required by BVL SOPs and approved for use by
		Customer. The Third Party vendor must utilize validated or qualified test
		methods and provide complete documentation and copies of associated raw data
		upon request.
	 

	 
		E.9.3 Customer will provide BVL a reference
		standard in accordance with BVL procedures for use in Product testing, as
		needed, and BVL will maintain the reference standard under appropriate storage
		conditions with appropriate controls. Customer is responsible for performing
		qualification of the reference standard in accordance with approved validated
		protocols.
	 

	 
		E.9.4 BVL will provide to Customer a
		Certificate of Analysis and any other associated testing documentation for each
		Batch of Product manufactured as specified in Attachment “D.”
		Customer reserves the right to inspect and/or test all Batches of the Product
		produced by BVL prior to Customer’s acceptance and distribution.
	 

	 
			
				
				  E.10
				

			 	
				
				  Notification and Approval of
				  Deviations
				

			 

 

	 
		BVL must notify Customer within three (3)
		business days from the initiation of the investigation, whenever there is a
		significant deviation from stated procedures or specifications. A significant
		deviation is defined as any Out Of Specification (OOS) result and/or any
		manufacturing, packaging, labeling, or testing deviation that may affect the
		quality, safety or efficacy of the Product. BVL will only release/reject a
		Product Batch as an outcome of a BVL and Customer approved investigation
		report. In the event of conflict, BVL may release or reject any Product Batch
		at its sole discretion. Customer is responsible for the final product
		disposition of a product released by BVL.
	 

	 
		 
	 

	 
		 
	 

	 
			
				
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		All deviations will be investigated and
		fully documented by BVL in accordance to BVL procedures. This documentation
		will be retained as part of the batch documentation for the Batch affected.
		When deemed necessary, Customer reserves the right to request the need for a
		more in-depth investigation of the deviation by BVL. BVL and Customer will work
		together in determining the need for additional investigational work. Customer
		approval shall be obtained in writing (fax or PDF electronic document
		confirmation is acceptable) for any significant deviation. The approval must be
		received within three (3) business days of the completion of the investigation.
		Customer and BVL will jointly provide the documented product impact assessment
		for all deviations that impact the Product. The documented assessment must be
		received within 5 (five) business days of the completion of the investigation.
		In cases where Customer requests a deviation, the request must be submitted in
		writing. Customer is responsible for notifying the FDA regarding any required
		Field Alert Report according to 21 CFR 314.81. BVL shall be notified by the
		Customer of any Field Alerts filed for Product. 
	 

	 
		The Investigation Report for significant
		deviations will be approved by both BVL and Customer as stated below. The
		approved document will become part of the batch record of that specific lot of
		material. Any resulting corrective and preventative actions shall be followed
		through timely closure in accordance to BVL procedure. Approval by the
		appropriate Quality Assurance functions is solicited and may be obtained via
		fax or electronic copy.
	 

	 
		 
	 

	 
			
				
				  Failure 
				

			 	
				
				   
				

			 	
				
				  Approval Requirements
				

			 
	
				
				  Product 
				

			 	
				
				   
				

			 	
				
				  Customer and BVL
				

			 
	
				
				  Raw Materials sourced and used by
				  BVL
				

			 	
				
				   
				

			 	
				
				  BVL
				

			 

 

	 
		In the event of a dispute regarding the
		failure of Product, an independent, mutually acceptable qualified Third Party
		may be engaged to determine failure. The Third Party’s decision will
		determine acceptance of the Product and shall be subject to the procedures as
		set out in the Agreement.
	 

	 
		Reprocessing would always be considered a
		significant deviation, and would only be performed if validated by BVL and
		approved by BVL and Customer. 
	 

	 
			
				
				  E.11
				

			 	
				
				  Release and Shipment of the
				  Product
				

			 

 

	 
		E.11.1 A Certificate of Compliance (COC), a
		Certificate of Analysis (COA), copies of executed batch records, deviations and
		investigation reports, and any applicable documentation shall be provided to
		Customer by BVL within one (1) week after the Batch is released by BVL QA as
		specified in Attachment D. 
	 

	 
		E.11.2 Customer is responsible for
		acceptance and disposition of the Product after review of BVL’s documents
		to be supplied by BVL to Customer as part of Batch release as specified in
		Attachment D. Customer shall reserve the right to revoke any acceptance of a
		Product if a latent defect is discovered and: (i) such defect is solely
		attributable to BVL; and (ii) Customer notifies BVL of a latent defect within
		five (5) days of discovery of such latent defect; in which case Customer shall
		have thirty (30) days from such notice to investigate such defect and reject
		the Product.
	 

	 
		 
	 

	 
		 
	 

	 
			
				
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		E.11.3 The disposition of the Product, which
		is defined as the release for clinical or commercial distribution, is the
		responsibility of Customer. BVL has the responsibility to release the Product
		to Customer. BVL will not ship any of Customer’s Product to any
		destination until the final disposition by Customer, unless prior approval has
		been received in writing from Customer to perform such shipments. Such receipt
		of written shipping approval will not exceed thirty (30) days beyond BVL’s
		release to Customer unless Customer provides written notice disputing the
		release of the Batch. 
	 

	 
		E.11.4 BVL will control and coordinate all
		shipping activity unless specified by Customer. Shipping instructions will be
		provided in the associated Batch Purchase Order (PO). Shipping validation will
		be Customer’s responsibility, but will be performed in collaboration with
		BVL and appropriate qualified contractors.
	 

	 
		 
	 

	 
		 
	 

	 
			
				
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				  E.12
				

			 	
				
				  Retained Samples of the
				  Product
				

			 

 

	 
		BVL agrees to store retained samples for all
		BVL composition used in the Product(s) in accordance with BVL SOP’s.
		
	 

	 
		Final Product retains shall be the
		responsibility of Customer.
	 

	 
			
				
				  E.13
				

			 	
				
				  Storage of
				  Product
				

			 

 

	 
		BVL will store Product prior to final
		Customer disposition and shipment in accordance with the Specification and BVL
		SOPs.
	 

	 
			
				
				  E.14
				

			 	
				
				  Stability
				  Activities
				

			 

 

	 
		The responsibility for stability testing and
		reporting shall belong to BVL so long as Customer contracts such activities
		with BVL. Stability protocols will be prepared by BVL and jointly reviewed and
		approved by BVL and Customer. BVL will provide stability reports to Customer in
		accordance with specifications contained in stability proposals. Data
		interpretation and the updating of stability information to regulatory
		documents for the Product is the responsibility of Customer. All stability
		related activities under the responsibility of BVL shall be completed in
		accordance with BVL SOPs.
	 

	 
			
				
				  E.15
				

			 	
				
				  Process Validation
				  
				

			 

 

	 
		E.15.1 The Manufacturing Process and control
		procedures (including, but not limited to cleaning procedures; aseptic
		procedures, process hold times, in-process stability, and development and
		justification of all processing parameters) shall be validated and qualified by
		BVL according to the Manufacturing Process Validation (MPV) plan for Product in
		the facility and using the equipment BVL intends to employ to make
		Customer’s Product, as further defined in Section 15.2.
	 

	 
		E.15.2 The MPV will be created with input
		from both BVL and Customer for Customer’s process. The MPV will be jointly
		generated and approved by BVL and Customer. The MPV will contain all of the
		required activities and the acceptance criteria and is approved and documented.
		The MPV is executed on at least three (3) consecutive Batches of Product
		produced by BVL for Customer as mutually agreed to between Customer and BVL. If
		there are any problems during the execution of the MPV, then, upon discovery
		shall be communicated to Customer. If the problems cannot be resolved, the MPV
		must be repeated on additional Batches until at least three (3) consecutive
		Batches of Customer’s Product meet all specification requirements. Any
		problems encountered during the execution of the MPV must be documented by BVL.
		
	 

	 
		E.15.3 All related validation/qualification
		documents will be assembled in a process validation summary report and reviewed
		and approved by BVL and Customer. Customer will retain copies of the approved
		protocols and final reports.
	 

	 
			
				
				  E.16
				

			 	
				
				  Product
				  Complaints
				

			 

 

	 
		E.16.1 Customer, or their agent, will
		receive complaints and communicate with their Customers and close all
		complaints related to the Product. Customer will inform BVL within 5 business
		days of registration of a complaint, or sooner as required, of complaints
		involving potential Product issues that may be related to Manufacturing. Upon
		written request by Customer, BVL will investigate the complaints as required
		and 
	 

	 
		 
	 

	 
		 
	 

	 
			
				
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		provide a written report on the results of
		the investigation to Customer in no more than thirty (30) working days, or
		sooner if agreed to by the Parties. Customer will communicate with the
		Customers and/or regulatory authorities the results of the complaint
		investigation, if necessary.
	 

	 
		E.16.2 In the event of a notification by
		Customer to BVL of a serious adverse event (SAE) potentially related to
		Manufacturing of the Product, BVL will provide all necessary support and
		assistance in the relevant phase of the investigation and provide a written
		response within an agreed upon time frame that allows Customer to respond to
		the applicable regulatory agency within 15 days of their notification.
	 

	 
		E.16.3 Customer shall provide complaint
		files to BVL onsite, or via fax or other electronic means, within one (1)
		business day if they are required during a FDA inspection.
	 

	 
			
				
				  E.17
				

			 	
				
				  Returned Goods
				

			 

 

	 
		Customer will be responsible for returned
		goods. The specific handling of returned goods will be specified and documented
		by Customer, as required. BVL will not have responsibility for returned goods
		unless if a latent defect is discovered and: (i) such defect is solely
		attributable to BVL; and (ii) Customer notifies BVL of a latent defect within
		five (5) days of discovery of such latent defect; in which case Customer shall
		have thirty (30) days from such notice to investigate such defect and reject
		the Product. 
	 

	 
			
				
				  E.18
				

			 	
				
				  Recall of the Marketed
				  Product
				

			 

 

	 
		In the event of recall, withdrawal, or field
		correction of Product, i.e., if the
		Product violates applicable laws, regulations, agreed upon specifications, or
		is deemed unacceptable for some other reason, whether or not such action is
		requested by any governmental agency, Customer shall immediately notify BVL
		Quality Assurance in writing. During a Product recall, withdrawal, or field
		correction, BVL shall fully cooperate with Customer in conducting the necessary
		investigational activities when appropriate.
	 

	 
			
				
				  E.19
				

			 	
				
				  Audits and Inspections of
				  Facilities and Product
				

			 

 

	 
		E.19.1 Upon scheduling in advance, Customer
		shall have the right to [*] annual audit [*] per Contract Year and at such
		other times as mutually agreed upon by the Parties for cause to: (i) observe,
		inspect, and audit the manner in which BVL conducts Manufacture of Customer
		Product(s); (ii) inspect BVL’S Facilities and records relating to
		BVL’S quality and other controls related to its Manufacture of the
		Product(s); or (iii) observe and audit the books and records of BVL relating to
		the existence, safeguard, use and maintenance by BVL of the Customer
		Composition. Customer annual audits will be limited to [*] auditors for 2 days.
		If resources are requested by the Customer to accommodate additional auditors
		or audit days outside the defined limit, then subject to the mutual agreement
		of the parties, BVL will provide Customer with a quotation of such services.
		BVL shall make such books and records available to Customer for review.
		Customer and any third-Party consultant appointed by Customer shall have
		reasonable access to observe and inspect BVL’S Facilities and SOPs with
		respect to the Product, including all analytical and Manufacturing
		documentation related to the Product upon reasonable prior notice to and
		scheduling in advance by BVL. Any such Customer appointed third-Party
		consultant must be pre-approved by BVL, although such approval shall not be
		
	 

	 
		______________
	 

	 
		[*]
		Confidential Treatment Requested
	 

	 
		 
	 

	 
		 
	 

	 
		 
	 

	 
			
				
				  Manufacturing and Service Agreement
				  (BVL and Vion Pharmaceuticals, Inc.)
				

			 

 

	 
		Page 55
	 

	 
		 
	 

	 
	 

	 

	 
		CONFIDENTIAL
	 

	 
		 
	 

	 
		 
	 

	 
		unreasonably or untimely withheld.
		Information provided during audits will be limited to technical information
		related to the Manufacture of Product. No financial information is provided for
		auditing. 
	 

	 
		E.19.2 Customer employees and
		Customer’s consultants who inspect BVL’S Facilities shall at all
		times comply with BVL’s rules, regulations and SOPs relating to their
		inspection, and Customer assumes responsibility for the presence and actions of
		its employees and consultants on BVL’s premises.
	 

	 
		E.19.3 BVL will notify Customer of any
		inspections or actions by regulatory agencies or other enforcement bodies which
		impact Product. BVL will provide Customer with the applicable or redacted
		written observations of all such Product Specific regulatory audits in no more
		than 5 business days. If the inspection is specific to Product, Customer will
		have up to 2 representatives on site during the inspection to address product
		specific questions, and these representatives will be permitted to participate
		in the inspection when required. Customer shall provide to BVL any requested
		documents if they are required for a regulatory inspection. Customer must
		notify BVL immediately of any activities or communications that may result in
		an inspection of BVL. BVL will respond to regulatory authority PAI observations
		within 15 days if possible and all other Product-specific inspection
		observations within 30 days or the time specified by that agency, which ever is
		less and will consult with Customer as appropriate.
	 

	 
		E.19.4 Customer reserves the right to be
		on-site at BVL during the manufacture of Product, and/or during the inspection
		of Product by any regulatory agencies. Customer shall provide at least one (1)
		week advance notice to be on site at BVL during manufacture.
	 

	 
			
				
				  E.20
				

			 	
				
				  Reprocessing
				

			 

 

	 
		Reprocessing can only be performed per
		written agreement between both BVL and Customer. Reprocessing directions must
		be established to define the process. If the Product is registered,
		reprocessing parameters must be validated, submitted, and approved prior to
		implementation and batch release. Reprocessing of material or product must be
		documented to state rationale and justification. 
	 

	 
			
				
				  E.21
				

			 	
				
				  Annual Product Review
				  (APR)
				

			 

 

	 
		Customer will be responsible for the Annual
		Product Review (APR).
	 

	 
			
				
				  E.22
				

			 	
				
				  Annual Quality Agreement
				  Review
				

			 

 

	 
		Not less than once per Contract Year during
		the term of the Agreement, the Parties shall meet and confer in good faith to
		review the Quality Agreement and make such changes as may be mutually agreed
		upon in writing by the Parties.
	 

	 
		(Quality Matrix begins on following
		page)
	 

	 
		 
	 

	 
		 
	 

	 
			
				
				  Manufacturing and Service Agreement
				  (BVL and Vion Pharmaceuticals, Inc.)
				

			 

 

	 
		Page 56
	 

	 
		 
	 

	 
	 

	 

	 
		CONFIDENTIAL
	 

	 
		Quality Agreement
		Distribution of Responsibility Matrix:
	 

	 
		 
	 

	 
			
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  Responsible
				  Party
				

			 
	
				
				  Item
				

			 	
				
				   
				

			 	
				
				  Activity
				

			 	
				
				   
				

			 	
				
				  Customer
				

			 	
				
				   
				

			 	
				
				  BVL
				

			 
	
				
				  1. Purpose and Term
				  of the Quality Agreement
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				  2. Quality
				  Responsibility
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

				
				   
				

				
				   
				

				
				   
				

				
				   
				

				
				   
				

				
				   
				

				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				  3. Regulatory
				  Compliance and Product Licensure
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

				
				   
				

				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				  4. Change
				  Control
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 

 

	 
		______________
	 

	 
		[*] Confidential Treatment Requested
	 

	 
		 
	 

	 
		Manufacturing and Service
		Agreement (BVL and Vion Pharmaceuticals, Inc.)
	 

	 
		Page 57
	 

	 
		 
	 

	 
		 
	 

	 
	 

	 

	 
		CONFIDENTIAL
	 

	 
		 
	 

	 
			
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  Responsible
				  Party
				

			 
	
				
				  Item
				

			 	
				
				   
				

			 	
				
				  Activity
				

			 	
				
				   
				

			 	
				
				  Customer
				

			 	
				
				   
				

			 	
				
				  BVL
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

				
				   
				

				
				   
				

				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				  4.1 Master
				  Production Record
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				  4.2
				  Specifications
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				  4.3 Packaging and
				  Labeling Specifications
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				  4.4 Product
				  Changeover
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

				
				   
				

				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				  4.5 Changes to the
				  Plant
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				  5.
				  Documentation
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

				
				   
				

				
				   
				

				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 

 

	 
		______________
	 

	 
		[*] Confidential Treatment Requested
	 

	 
		 
	 

	 
		Manufacturing and Service
		Agreement (BVL and Vion Pharmaceuticals, Inc.)
	 

	 
		Page 58
	 

	 
		 
	 

	 
		 
	 

	 
	 

	 

	 
		CONFIDENTIAL
	 

	 
		 
	 

	 
			
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  Responsible
				  Party
				

			 
	
				
				  Item
				

			 	
				
				   
				

			 	
				
				  Activity
				

			 	
				
				   
				

			 	
				
				  Customer
				

			 	
				
				   
				

			 	
				
				  BVL
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				  6.
				  Materials
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

				
				   
				

				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

				
				   
				

				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

				
				   
				

				
				   
				

				
				   
				

				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

				
				   
				

				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

				
				   
				

				
				   
				

				
				   
				

				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

				
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				   
				

			 

 

	 
		______________
	 

	 
		[*] Confidential Treatment Requested
	 

	 
		 
	 

	 
		Manufacturing and Service
		Agreement (BVL and Vion Pharmaceuticals, Inc.)
	 

	 
		Page 59
	 

	 
		 
	 

	 
		 
	 

	 
	 

	 

	 
		CONFIDENTIAL
	 

	 
		 
	 

	 
			
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  Responsible
				  Party
				

			 
	
				
				  Item
				

			 	
				
				   
				

			 	
				
				  Activity
				

			 	
				
				   
				

			 	
				
				  Customer
				

			 	
				
				   
				

			 	
				
				  BVL
				

			 
	
				
				  7. Product
				  Specification
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	  	
				
				  [*]
				

			 	  	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				  8. Manufacturing and
				  Packaging of the Product
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

				
				   
				

				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				  9. Testing of
				  Product
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				  10. Notification and
				  Approval of Deviations
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

				
				   
				

				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

				
				   
				

				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 

 

	 
		______________
	 

	 
		[*] Confidential Treatment Requested
	 

	 
		 
	 

	 
		Manufacturing and Service
		Agreement (BVL and Vion Pharmaceuticals, Inc.)
	 

	 
		Page 60
	 

	 
		 
	 

	 
		 
	 

	 
	 

	 

	 
		CONFIDENTIAL
	 

	 
		 
	 

	 
			
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  Responsible
				  Party
				

			 
	
				
				  Item
				

			 	
				
				   
				

			 	
				
				  Activity
				

			 	
				
				   
				

			 	
				
				  Customer
				

			 	
				
				   
				

			 	

				
				  BVL
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

				
				   
				

				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				  11. Release and
				  Shipment of Product
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

				
				  
				

				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

				
				   
				

				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 

 

	 
		______________
	 

	 
		
		  [*]
		  Confidential Treatment Requested
		

	 

	 
		 
	 

	 
		Manufacturing and
		Service Agreement (BVL and Vion Pharmaceuticals, Inc.)
	 

	 
		Page 61
	 

	 
		 
	 

	 

	 
	 

	 

	 
		CONFIDENTIAL
	 

	 
		 
	 

	 
			
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  Responsible
				  Party
				

			 
	
				
				  Item
				

			 	
				
				   
				

			 	
				
				  Activity
				

			 	
				
				   
				

			 	
				
				  Customer
				

			 	
				
				   
				

			 	

				
				  BVL
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				  12. Retained Samples
				  of the Product
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				  13. Storage of
				  Product
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				  14. Stability
				  Activities
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				  15. Process
				  Validation 
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
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				  16. Product
				  Complaints
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 

 

	 
		______________
	 

	 
		[*]
		Confidential Treatment Requested
	 

	 
		 
	 

	 
		Manufacturing and Service
		Agreement (BVL and Vion Pharmaceuticals, Inc.)
	 

	 
		Page 62
	 

	 
		 
	 

	 

	 
	 

	 

	 
		CONFIDENTIAL
	 

	 
		 
	 

	 
			
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  Responsible
				  Party
				

			 
	
				
				  Item
				

			 	
				
				   
				

			 	
				
				  Activity
				

			 	
				
				   
				

			 	
				
				  Customer
				

			 	
				
				   
				

			 	
				
				  BVL
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
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				  17. Returned
				  Goods
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

				
				   
				

			 	
				
				   
				

			 	
				
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				  18. Recall of
				  Marketed Product
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

				
				   
				

			 	
				
				   
				

			 	
				
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				  [*]
				

			 
	
				
				  19. Audits and
				  Inspections of Facilities and Product
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

			 	
				
				   
				

			 	
				
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				  [*]
				

			 	
				
				   
				

			 	
				
				   
				

			 

 

	 
		______________
	 

	 
		
		  [*]
		  Confidential Treatment Requested
		

	 

	 
		 
	 

	 
		Manufacturing and Service
		Agreement (BVL and Vion Pharmaceuticals, Inc.)
	 

	 
		Page 63
	 

	 
		 
	 

	 

	 
	 

	 

	 
		CONFIDENTIAL
	 

	 
		 
	 

	 
		 
	 

	 
			
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  Responsible
				  Party
				

			 
	
				
				  Item
				

			 	
				
				   
				

			 	
				
				  Activity
				

			 	
				
				   
				

			 	
				
				  Customer
				

			 	
				
				   
				

			 	
				
				  BVL
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

				
				   
				

				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
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				  20.
				  Reprocessing
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
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				  21. Annual Product
				  Review
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				  22.
				  Certifications
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				  [*]
				

			 	
				
				   
				

			 	
				
				   
				

			 

 

	 
		______________
	 

	 
		
		  [*]
		  Confidential Treatment Requested
		

	 

	 
		 
	 

	 
		Manufacturing and Service
		Agreement (BVL and Vion Pharmaceuticals, Inc.)
	 

	 
		Page 64
	 

	 
		 
	 

	 

	 
	 

	 

	 
		CONFIDENTIAL
	 

	 
		 
	 

	 
			
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  Responsible
				  Party
				

			 
	
				
				  Item
				

			 	
				
				   
				

			 	
				
				  Activity
				

			 	
				
				   
				

			 	
				
				  Customer
				

			 	
				
				   
				

			 	

				
				  BVL
				

			 
	
				
				   
				

			 	
				
				   
				

			 	
				
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				  [*]
				

			 	
				
				   
				

			 	
				
				   
				

			 

 

	 
		______________
	 

	 
		
		  [*]
		  Confidential Treatment Requested
		

	 

	 
		 
	 

	 
		Manufacturing and Service
		Agreement (BVL and Vion Pharmaceuticals, Inc.)
	 

	 
		Page 65
	 

	 
		 
	 

	 

	 
	 

	 
	 
		CONFIDENTIAL
	 

	 
		 
	 

	 
		Attachment “F”
	 

	 
		Customer Supplied Equipment
	 

	 
		[PAGE INTENTIONALLY LEFT BLANK]
	 

	 
		 
	 

	 
		 
	 

	 
		Manufacturing and Service Agreement (BVL and
		Vion Pharmaceuticals, Inc.)
	 

	 
		Page 66
	 

	 
		 
	 

	 
	 

	 

	 
		CONFIDENTIAL
	 

	 
		 
	 

	 
		Attachment “G”
	 

	 
		Representation regarding Customer’s
		Qualified Person
	 

	 
		CUSTOMER LETTERHEAD
	 

	 
		Customer Address
	 

	 
		BEN VENUE LABORATORIES, INC.
	 

	 
		ATTN: COMPLIANCE MANAGER
	 

	 
		A Boehringer Ingelheim Company
	 

	 
		300 Northfield Road
	 

	 
		Bedford, Ohio 44146
	 

	 
		Dear BVL COMPLIANCE MANAGER,
	 

	 
		Please take notice that Vion
		Pharmaceuticals, Inc., hereby certifies in writing to BVL that it has properly
		appointed one or more Qualified Person(s) in compliance with EU Directives,
		standards and rules, including without limitation, Article 49 of Directive
		2001/82/EC, with respect to the Product(s) subject the agreement between Ben
		Venue Laboratories, Inc. and [Company]. Said Qualified Person shall fully
		comply with all EU standards, directives and rules, including without
		limitation, as set forth in Article 51 of 2001/83/EC, and shall be responsible
		for release of Product(s) into EU member states.
	 

	 
		 
	 

	 
			
				
				   
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  Sincerely,
				

			 
	
				
				

			 	
				
				   
				

			 	
				
				   
				

			 	
				
				  
 Name

				  Title
				

			 

 

	 
		 
	 

	 
		 
	 

	 
		Manufacturing and Service Agreement (BVL and
		Vion Pharmaceuticals, Inc.)
	 

	 
		Page 67
	 

	 
		 
	 

	 
	 

	 

	 
		CONFIDENTIAL
	 

	 
		 
	 

	 
		Attachment “H”
	 

	 
		GMP Facility Compliance Certificate FOR
		API SUPPLIER
	 

	 
		 
	 

	 
			 	
				
				  Manufacturing
				  Facility:
				

			 	
				
				   
				

			 	
				
				  NAME OF API
				  SUPPLIER
 ADDRESS

				  Phone: 
 Fax:
				

			 

 

	 
		I INSERT NAME have reviewed the audit report
		for the above listed facility and I am satisfied that:
	 

	 
			
				
				   
				

			 	
				
				  •
				

			 	
				
				  The named site has an acceptable
				  level of compliance with GMP.
				

			 

 

	 
			
				
				   
				

			 	
				
				  •
				

			 	
				
				  The auditors were adequately
				  qualified to conduct such audits on an impartial basis.
				

			 

 

	 
		
		  Signature:________________________________
		            Date: ____________
		  
		

	 

	 
		Printed Name:
		____________________________
	 

	  

	 
		Title: Qualified
		Person                                           
	 

	 
		CUSTOMER NAME
	 

	 
		CUSTOMER ADDRESS
	 

	 
		CITY, STATE ZIP COUNTRY 
	 

	 
		TELEPHONE
	 

	 
		FAX
	 

	 
		 
	 

	 
			
				
				  THE CONTENTS OF THIS DOCUMENT ARE CONFIDENTIAL
				  TO CUSTOMER
				

			 

 

	 
		 
	 

	 
		 
	 

	 
		Manufacturing and Service Agreement (BVL and
		Vion Pharmaceuticals, Inc.)
	 

	 
		Page 68
	 

	 
		 
	 

	 
	 

	 

	 
		CONFIDENTIAL
	 

	 
		 
	 

	 
		Attachment “I”
	 

	 
		Statement relating to GMP Status of the
		Manufacture & Supply of EACH BATCH OF API
	 

	 
		QUALIFIED PERSON’S STATEMENT
		CONCERNING THE GMP STATUS OF THE MANUFACTURE AND SUPPLY OF A SPECIFIC ACTIVE
		PHARMACEUTICAL INGREDIENT BATCH
	 

	 
		I
		_________________________________________________ being a Qualified Person
		Responsible for the certification of the manufacture of:
	 

	 
		[Name of pharmaceutical finished or
		intermediate products]
	 

	 
		Manufacturer’s Authorization No:
		______________________________ EEA member state:
		________________________
	 

	 
		Confirms the following:
	 

	 
		The Active Pharmaceutical Ingredient:
	 

	 
		________________________________________________________________________________________________
	 

	 
		Grade (Insert manufacturer’s grade or
		identifying code): ________________________________________________
	 

	 
		Manufactured by the company: (company
		name)
	 

	 
		at the following site address: (company
		address)
	 

	 
		Supplied by: (Company acting as agent/vendor
		as applicable)
	 

	 
		At
		(address)____________________________________________________________________________________
	 

	 
		has been assessed by me and that the stated
		products are certified as complying with the requirements of the European Union
		and are compliant with standards of GMP equivalent to those laid down in
		Directive 2003/94/EC and/or Directive 91/412/EEC and Annex 18 of the EU GMP
		Guide to Good Manufacturing Practice.
	 

	 
			
				
				   
				

			 	
				
				   Signature:_______________________________________
				  
				

			 	
				
				  Date: _______________
				

			 

 

	 
		QP CUSTOMER NAME
	 

	 
		QP CUSTOMER ADDRESS
	 

	 
		CITY, STATE ZIP COUNTRY 
	 

	 
		TELEPHONE
	 

	 
		FAX
	 

	 
		 
	 

	 
		 
	 

	 
		Manufacturing and Service Agreement (BVL and
		Vion Pharmaceuticals, Inc.)
	 

	 
		Page 69
	 

	 
		 
	 

	 
	 

	 

	 
		CONFIDENTIAL
	 

	 
		 
	 

	 
		Attachment “J”
	 

	 
		Certificate of Analysis for use in the
		European Union Member States
	 

	 
		Ben Venue Laboratories, Inc.
	 

	 
		A Boehringer Ingelheim Company
	 

	 
		300 Northfield Road
	 

	 
		Bedford, Ohio 44146
	 

	 
		Phone: (440) 232-3320
	 

	 
		Fax: (440) 439-6398
	 

	 
		Site of Manufacture: Ben Venue Laboratories, Inc.
	 

	 
		 
	 

	 
			
				
				   
				

			 	 	
				
				   
				

			 	
				
				  Certificate of
				  Analysis
				

			 
	  	
				
				  CUSTOMER NAME

				  CUSTOMER ADDRESS

				  CITY, STATE ZIP COUNTRY

				  PHONE
 FAX
				

			 	
				
				   
				

			 	
				
				  Certificate
				  Date:___________________________
 Delivery References:______________________

				  Purchase
				  References:______________________
 Order
				  References:__________________________
 Customer References:_____________________
				

			 

 

	 
		Description of API:
	 

	 
		Regulatory Statements:
	 

	 
		This material has been manufactured, packed
		and tested in accordance with current GMP. The documentation for this batch has
		been reviewed and it is confirmed that this batch complies with GMP and
		licensed details.
	 

	 
		Batch Number:
	 

	 
		Date of manufacture:
	 

	 
		Expiry date:
	 

	 
		 
	 

	 
			

				
				  Test Description
				

			 	

				
				  Specification
				

			 	

				
				  Result
				

			 

 

	 
		 
	 

	 
		 
	 

	 
		 
	 

	 
		Authorized
		Signature:____________________________ Name:___________________
	 

	 
		Date:_________________________________________
	 

	 
		Position:
		______________________________________
	 

	 
		 
	 

	 
			
				
				  THE CONTENTS OF THIS DOCUMENT ARE CONFIDENTIAL
				  TO CUSTOMER
				

			 

 

	 
		 
	 

	 
		 
	 

	 
		Manufacturing and Service Agreement (BVL and
		Vion Pharmaceuticals, Inc.)
	 

	 
		Page 70Exhibit 10.66

                              EMPLOYMENT AGREEMENT

          THIS EMPLOYMENT AGREEMENT, made as of December 5, 2006 (this
"Agreement"), by and between Castle Brands Inc., a Delaware corporation (the
"Company"), and Herbert Roberts (the "Executive"), an individual residing at 51
Manor Pond Lane, Irvington, New York, 10533.

          In consideration of the mutual covenants set forth in this Agreement,
the parties hereto agree as follows:

                                   AGREEMENT:

          1. Employment. Subject to the terms of this Agreement, the Company
agrees to employ Executive, and Executive agrees to accept such employment, as
Senior Vice President, Chief Financial Officer and Treasurer of the Company. As
such, Executive will have responsibility for such job-related duties as will be
assigned to Executive from time to time by the Chief Executive Officer and/or
President of the Company.

          2. Performance of Services. Executive agrees that throughout the term
of his employment hereunder he will devote his full business time, attention,
knowledge and skills, faithfully, diligently and to the best of his ability, in
furtherance of the business of the Company and its direct or indirect
subsidiaries and will perform the duties assigned to him from time to time
pursuant to Section 1 hereof, subject, at all times, to the direction and
control of the Chief Executive Officer and/or President of the Company, and to
the policies of the Company generally applicable to its executives. During the
term of his employment hereunder, Executive will not accept other employment or
permit his personal business interests to materially interfere with his duties
hereunder.

          3. Term. Executive will be employed for a term commencing on December
5, 2006 (the "Effective Date") and ending on December 4, 2010 (the "Term"),
unless his employment is terminated prior to the expiration of the Term pursuant
to Section 6 hereof. At the end of the term, if the Company does not offer to
renew Executive's employment hereunder for an additional three years, on
substantially the same terms, the Company shall continue to pay to Executive his
Base Salary, benefits for a period of six (6) months after expiration of the
Term.

          4. Compensation. During the Term of this Agreement the Company agrees
to pay to Executive:

               (a) Salary. A salary (the "Base Salary") at the rate of
US$250,000 per year, payable in accordance with the Company's standard payroll
practices for executives as in effect from time to time. Such Base Salary may be
increased (but not decreased), in the sole discretion of the Compensation
Committee of the Board of Directors of the Company, on the basis of periodic
reviews, which shall occur no less frequently than on an annual basis.

               (b) Stock Option Grants. Executive shall be entitled to options
to purchase Common Stock of the Company to the extent granted by the
Compensation Committee of the Board of Directors of the Company.

               (c) Incentive Bonus. In each fiscal year, the Executive shall be
eligible to receive an annual performance bonus equal to up to 60% of the Base
Salary in effect

on March 31 of such fiscal year, subject to successful achievement of goals and
objectives to be agreed upon by the Executive and the Compensation Committee of
the Board of Directors of the Company, payable in accordance with the Company's
standard practices for executives as in effect from time to time.

               (d) Vacation. Executive shall be entitled to twenty (20) paid
vacation days in each calendar year, plus paid Company holidays.

               (e) Other Benefits. Executive will be entitled to participate, to
the extent he is eligible under the terms and conditions thereof, in all
profit-sharing, hospitalization, insurance, medical, disability, or other fringe
benefit or executive perquisite plans generally available to other senior
executives of the Company.

          5. Expenses. The Company will reimburse Executive for all expenses
reasonably incurred by him in connection with the performance of his duties
hereunder and the business of the Company upon the submission to the Company of
appropriate invoices therefor, all in accordance with the Company's policies and
procedures as in effect from time to time for senior executives of the Company.

          6. Termination.

               (a) Termination by the Company Without Cause. The Company may
terminate the employment of Executive hereunder at any time without Cause (as
hereinafter defined). Notice of any such termination must be in writing and will
be effective upon receipt by Executive. In the event that the employment of
Executive is terminated pursuant to this Section 6(a) and if Executive fully
complies with Sections 7, 9, 10 and 22 of this Agreement, the Company will
continue to pay to Executive the Base Salary per annum as in effect on the date
of such termination, in accordance with the standard payroll practices of the
Company as in effect from time to time, for a term of twelve (12) months
immediately following the date of such termination. In addition, in the event
that the employment of Executive is terminated pursuant to this clause (a), the
annual incentive bonus described in Section 4(c) will be paid, if any, to
Executive with respect to the year in which termination occurs (pro rated for
the portion of the year in which Executive was so employed). If Executive fully
complies with Sections 7, 9, 10 and 22 of this Agreement, the Company shall
during the twelve (12) month period immediately following termination of
Executive pursuant to this clause (a), to the extent permissible under any
relevant benefit plans of the Company, continue to provide participation to
Executive in all other benefits provided for under Section 4(e) hereof, at the
Company's expense. If Executive fully complies with Sections 7, 9, 10 and 22 of
this Agreement, on the date of termination pursuant to this Section 6(a), the
vesting of any options held by Executive shall accelerate with respect to the
number of shares of the Company's common stock that equals (x) the number of
shares that would have vested during the 12 months following termination of
Executive pursuant to this Section 6(a) multiplied by (y) a fraction, the
numerator of which is the number of full calendar months that have elapsed since
the last vesting date or the original issue date (if a vesting date has not
occurred) and the denominator of which is the number of full calendar months
from the last vesting date or the original issue date (if a vesting date has not
occurred) to the vesting date occurring during the 12 months following
termination. Further, if Executive fully complies with Sections 7, 9, 10 and 22
of this Agreement, any stock option held by Executive that is vested at the time
of Executive's termination pursuant to this Section 6(a) (including any portion
of such option for which vesting was accelerated pursuant to the

                                      -2-

preceding sentence) will be exercisable until the earlier to occur of (i) the
expiration date of such option pursuant to its terms and (ii) twelve (12) months
following the date of termination pursuant to this Section 6(a).

               (b) Termination by the Company for Cause. The Company may
terminate the employment of Executive hereunder for Cause (as hereinafter
defined). Executive shall be entitled to thirty (30) days prior written notice
of the Company's intent to terminate Executive hereunder and the right to
address and/or cure such Cause during such thirty (30) day notice period. Any
notice of intent to terminate for Cause must specify the particular grounds
therefor in reasonable detail. In the event that the employment of Executive is
terminated pursuant to this clause (b), the Company will pay to Executive the
amount of all accrued but unpaid Base Salary to the date of such termination,
but no annual incentive bonus will be paid with respect to (x) the year in which
termination occurs, or (y) the immediately prior year if Executive is terminated
under this clause (b) prior to payment of the bonus applicable to such prior
year. As used herein, "Cause" means Executive's (i) personal dishonesty, (ii)
willful misconduct, (iii) breach of fiduciary duty, (iv) failure to
substantially perform assigned duties relating to Executive's performance
hereunder (other than any such failure owing to Executive becoming Disabled (as
hereinafter defined)) as reasonably determined by a majority of the entire
Compensation Committee of the Board of Directors of the Company, after
consultation with the Chief Executive Officer of the Company, (v) conviction of,
or the entry by the Executive of any plea of guilty or nolo contendre to, any
felony or other lesser crime that would require removal from his position at the
Company (e.g. any alcohol or drug related misdemeanor) or (vi) material breach
of any provision of this Agreement as reasonably determined by the Compensation
Committee of the Board of Directors of the Company, after consultation with the
Chief Executive Officer; provided, however, that in any of the foregoing
circumstances, Executive has failed to cure such Cause within the fifteen (15)
day period referenced in the second sentence of this Section 6(b). In the event
Executive is terminated for Cause solely pursuant to (iv) or (vi) above, any
stock option held by Executive that is vested at the time of such termination
may be exercised until the earlier to occur of (i) the expiration date of such
option pursuant to its terms and (ii) one year after such termination. In the
event Executive is terminated for Cause other than solely pursuant to (iv) or
(vi) above, any stock option held by Executive shall immediately expire and no
longer be exercisable upon such termination.

               (c) Termination by Executive. Executive may terminate his
employment hereunder (x) at any time without cause or (y) for Good Reason (as
hereinafter defined). Notice of any such termination must be in writing and will
be effective sixty (60) days after receipt by the Company or such earlier date
as may be specified by the Company after receipt of such notice. In the event
that Executive terminates employment pursuant to subclause (x) of this clause
(c), the Company will pay to Executive the amount of all accrued but unpaid Base
Salary to the date of such termination, but no annual incentive bonus will be
paid with respect to the year in which termination occurs. In the event that
Executive terminates employment hereunder pursuant to subclause (y) of this
clause (c) and Executive fully complies with Sections 7, 9, 10 and 22 of this
Agreement, Executive will be entitled to the same salary, benefits and bonus
payments as would be provided were he to be terminated by the Company without
Cause pursuant to Section 6(a) above. Further, in the event Executive terminates
his employment hereunder for Good Reason or without cause and Executive fully
complies with Sections 7, 9, 10 and 22 of the Agreement, any stock option held
by Executive that is vested at the time of Executive's termination will be
exercisable until the earlier to occur of (A) the

                                      -3-

expiration date of such option pursuant to its terms and (B) one year following
the termination of Executive's employment. As used herein, "Good Reason" means a
termination by Executive of Executive's employment hereunder within thirty (30)
days after (i) any material diminution in the nature, title or status of
Executive's job responsibilities from those in effect on the Effective Date or
the most recent anniversary thereof, (ii) dissolution or divestiture of all or a
significant portion of the Company or other material change in the Company,
which in each case would materially adversely diminish the nature, title or
status of Executive's job responsibilities, (iii) relocation by the Company of
the Executive's office to any location not within fifty (50) miles from
Executive's principal place of employment as of the Effective Date or (iv) the
Company's material breach of any provision of this Agreement which is not cured
within fifteen (15) business days after written notice thereof from Executive to
the Company.

               (d) Termination Upon Death. This Agreement will terminate
automatically on the death of Executive. In the event that the employment of
Executive is terminated pursuant to this clause (d), the Company will promptly
pay to the representative of Executive the amount of all accrued but unpaid Base
Salary to the date of such termination, the annual incentive bonus, if any,
described in Section 4(c) with respect to the year in which termination occurs
(pro rated for the portion of the year in which Executive was so employed), and
an amount equal to six (6) months Base Salary. Further, any stock option held by
Executive that is vested at the time of death will be exercisable by Executive's
personal representative or estate for a period of two (2) years from date of
death and all unvested stock options held by Executive shall fully vest and be
exercisable by Executive's personal representative or estate for a period of two
years from date of death.

               (e) Termination by the Company by Reason of Disability. The
Company may terminate the employment of Executive hereunder after Executive
becomes Disabled. Notice of any such termination must be in writing and will be
effective thirty (30) days after receipt by Executive. In the event that the
employment of Executive is terminated pursuant to this clause (e), the Company
will pay to Executive or his representative the amount of all accrued but unpaid
Base Salary to the date of such termination less the amount, if any, received by
Executive from any disability insurance maintained by the Company, the annual
incentive bonus described in Section 4(c), if any, with respect to the year in
which termination occurs (pro rated for the portion of the year in which
Executive was so employed) and an amount equal to one year's Base Salary to be
paid as a lump sum on termination. Further, any stock option held by Executive
that is vested at the time of termination for disability will be exercisable for
a period of two (2) years from date of such termination for disability and all
unvested stock options held by Executive shall fully vest and be exercisable for
a period of two (2) years from date of termination for disability. As used
herein, the term "Disabled" means Executive becoming physically or mentally
disabled or incapacitated to the extent that he has been or will be unable to
perform his duties hereunder on account of such disabilities or incapacitation
for a continuous period of six (6) months as determined by a qualified
independent physician or group of physicians selected by the Company and
approved by Executive or his representative, such approval not to be
unreasonably withheld.

               (f) Change of Control. A "Change of Control" shall have occurred
if: (i) any person (as such term is used in Section 13(d) of the Securities
Exchange Act of 1934, as amended (the "Exchange Act")) becomes the "beneficial
owner" (as determined pursuant to Rule 13d-3 of the Exchange Act), directly or
indirectly, of securities of the Company representing

                                      -4-

more than thirty-five percent (35%) of the aggregate voting power of the
Company's then outstanding securities, other than by acquisition directly from
the Company; (ii) there has been a merger or equivalent combination involving
the Company after which forty-nine percent (49%) or more of the voting stock of
the surviving corporation is held by persons other than former shareholders of
the Company; (iii) during any period of two consecutive years, individuals who
at the beginning of such period were members of the Board of Directors of the
Company cease for any reason to constitute at least a majority thereof (unless
the appointment, election, or the nomination for election by the Company's
stockholders, of each director elected during such consecutive two-year period
was approved by a vote of at least two-thirds of the directors then still in
office who were directors at the beginning of such period); or (iv) the Company
sells or disposes of all or substantially all of its assets. In the event that
the employment of Executive is terminated following or in connection with a
Change in Control either by the Executive for Good Reason or by the Company or
its successor without Cause, the Company or its successor, as applicable, will
continue to pay to Executive the Base Salary per annum as in effect on the date
of such termination, in accordance with the standard payroll practices of the
Company as in effect from time to time, for a term of twenty-four (24) months
following the date of such termination. During such twenty-four (24) month
period, the Company shall continue to provide participation to the Executive in
all other benefits provided for under Section 4(e) hereof. In addition, in the
event that the employment of Executive is terminated pursuant to this clause
(f), the annual incentive bonus described in Section 4(c) will be paid to
Executive with respect to the year in which termination occurs (pro rated for
the portion of the year in which Executive was so employed). Further, all
unvested stock options will vest without further action on the date of
termination and all stock options shall be exercisable during the remainder of
their original terms.

               (g) Release and No Further Obligations. As a condition to the
payments and other consideration provided to Executive under each clause of this
Section 6, the Executive shall have executed and delivered to the Company the
form of general release attached hereto as Exhibit A. Except as otherwise
expressly provided in this Agreement and that certain Stock Option Agreement,
dated as of even date hereof, by and between the Company and Executive, from and
after the effective date of any termination of Executive's employment hereunder
pursuant to this Section 6, the Company will have no further obligations (for
the payment of money or otherwise) to Executive or his representative, as
applicable.

          7. Confidentiality.

               (a) Executive will not, at any time following the Effective Date,
regardless of whether Executive continues to be employed by the Company and, if
Executive's employment has been terminated, regardless of the manner, reason,
time or cause thereof, directly or indirectly reveal, report, publish, disclose,
transfer or furnish to any person not entitled to receive the same for the
immediate benefit of the Company any Proprietary Information (as hereinafter
defined). The term "Proprietary Information" means all information of any nature
whatsoever, and in any form, which at the time or times concerns or relates to
any aspect of any business that the Company, or its direct or indirect
subsidiaries are involved in or actively contemplating (the "Business") and
which is confidential or proprietary to the Company. Proprietary Information
includes, but is not limited to, items, materials and information concerning the
following: marketing plans or strategies; budgets; designs; promotional
strategies; client preferences and policies; creative activities for clients;
concepts; intellectual property and

                                      -5-

trade secrets; product plans; financial information and all documentation,
reports and data (recorded in any form) relating to the foregoing.
Notwithstanding the foregoing, "Proprietary Information" does not include any
information to the extent it becomes publicly known through no fault of
Executive or any information which Executive is required to disclose as a result
of a subpoena or other legal process.

               (b) Executive agrees that all memoranda, notes, records, papers
or other documents, computer disks, computer software programs and the like and
all copies thereof, relating to the Business (the "Business Records") are and
will be the sole and exclusive property of the Company or its direct or indirect
subsidiaries, as the case may be. Except for use for the benefit of the Company
or its direct or indirect subsidiaries, as the case may be. Executive will not
copy or duplicate any of the Business Records, nor remove them from the
facilities of the Company or its direct or indirect subsidiaries, as the case
may be. Executive must comply with any and all procedures which the Company or
its direct or indirect subsidiaries may adopt from time to time to preserve the
confidentiality of Proprietary Information and the confidentiality of property
of the types described immediately above, whether or not such property contains
a legend indicating its confidential nature.

               (c) Upon termination of Executive's employment with the Company
for any reason whatsoever and at any other time upon the Company's request,
Executive (or his personal representative) must deliver to the Company all
property described in this Section 7 which is in his possession or control.

          8. Representation and Warranty. Executive represents and warrants to
the Company that he is not a party to any employment agreement or other
agreement which restricts, interferes with or impairs, or which might be claimed
to restrict, interfere with or impair, in any way, Executive's use of any
information or Executive's execution or performance of this Agreement.

          9. Discoveries and Improvements. Executive acknowledges and agrees
that all inventions, discoveries, and improvements, whether patentable or
unpatentable, made, devised, or discovered by Executive, whether by himself, or
jointly with others, from the date hereof until the expiration of the Term
hereof, reasonably deemed to be directly related to or pertaining in any way to
the Business, will be promptly disclosed in writing to the Chief Executive
Officer (or such other officer as the Chief Executive Officer may designate) of
the Company and will be the sole and exclusive property of the Company.
Executive agrees to execute any assignments to the Company or its nominee of his
entire right, title, and interest in and to any such inventions, discoveries,
and improvements and to execute and deliver at the cost of the Company any other
instruments and documents that may be requested by the Company that are
requisite or desirable in applying for and obtaining patents, copyrights or
trademarks, with respect thereto in the United States and in all foreign
countries. Executive further agrees, whether or not in the employ of the
Company, to cooperate, to the extent and in the manner requested by the Company,
in the prosecution or defense of any patent, trademark or copyright claims or
any litigation or other proceeding involving any inventions, trade secrets,
processes, discoveries, or improvements covered by this Agreement, provided that
all expenses thereof shall be paid by the Company.

                                      -6-

          10. Restrictive Covenants.

               (a) Executive acknowledges and agrees that his position with the
Company places him in a position of confidence and trust with respect to
Proprietary Information. Executive consequently agrees that it is reasonable and
necessary for the protection of the goodwill of the Business that Executive make
the covenants contained herein. Accordingly, Executive agrees that, during the
Term of this Agreement and for a period of twelve (12) months after the date of
expiration or termination of Executive's employment hereunder for any reason
whatsoever, Executive will not, without the prior written consent of the Company
and provided that the Company has not failed to make any payments to the
Executive when due in accordance with the provisions of Section 6 hereof and
otherwise comply with the terms and conditions of this Agreement, (i) employ,
solicit or encourage to leave the employ of the Company, or to become employed
by any person other than the Company, any employee of the Company, or any
individual who was an employee of the Company during the one year prior to the
termination or expiration of Executive's employment, (ii) persuade or attempt to
persuade any customer of the Company as of the date of the termination or
expiration of Executive's employment or during the one year prior to the
termination or expiration of Executive's employment to cease doing business
with, or to reduce the amount of business it does with, the Company, or solicit
the business of any of the Company's customers as of the date of the termination
or expiration during the one year prior to the termination or expiration of
Executive's employment hereunder with respect to any product or service which
competes with the products and services of the Company as of the date of
termination of Executive's employment or (iii) compete with the Company as a
consultant to, employee of, or equity participant in, any venture which competes
with the Business within the United States of America. No provision of this
Section 10 shall prohibit Executive from merely owning (i.e., having no
participation or involvement in the management) no more than three percent (3%)
of the outstanding equity securities of any actively traded public entity.

               (b) Executive has carefully considered the nature and extent of
the restrictions upon him and the rights and remedies conferred upon the Company
under Sections 10 and 11 of this Agreement and hereby acknowledges and agrees
that the same are reasonable in time and territory, are designed to avoid
competition which otherwise would be unfair to the Company, do not stifle the
inherent skill and experience of Executive, would not operate as a bar to
Executive's sole means of support, are required to protect the legitimate
interests of the Company and do not confer a benefit upon the Company
disproportionate to the benefit otherwise afforded Executive by this Agreement.

          11. Certain Remedies. The parties hereto acknowledge that in the event
of a breach or a threatened breach by Executive of any of his obligations under
Sections 7, 9 or 10 of this Agreement the Company will not have an adequate
remedy at law. Accordingly, in the event of any such breach or threatened breach
by Executive, the Company will be entitled to such equitable and injunctive
relief as may be available to restrain Executive and any business, firm,
partnership, individual, corporation or entity participating in such breach or
threatened breach from the violation of the provisions hereof, and nothing
herein will be construed as prohibiting the Company from pursuing any other
remedies available at law or in equity for such breach or threatened breach,
including the recovery of damages.

          12. Notices. All notices hereunder must be in writing and addressed to
the Secretary of the Company at 570 Lexington Avenue, 29th Floor, New York, NY,
10022 and to

                                      -7-

Executive at the address listed above. Each such address for notice may be
changed by notice of such change given to the other party hereto. All such
notices will be effective upon receipt.

          13. Entire Agreement. This Agreement constitutes the entire agreement
of the parties hereto with respect to the subject matter hereof and supersedes
all prior or contemporaneous agreements, whether written or oral, of the parties
or affiliates hereto relating to the subject matter hereof. No amendment, waiver
or modification hereof will be valid or binding unless made in writing and
signed by the parties hereto (in the case of an amendment or modification) or by
the party against whom enforcement is sought (in the case of a waiver).

          14. Governing Law/Arbitration. This Agreement will be governed,
interpreted and construed according to the internal laws of the State of New
York without regard to conflict of laws principles. Any controversy or claim
arising out of, or relating to, this Agreement or the breach thereof, must be
promptly settled by arbitration by a panel of three (3) arbitrators in New York,
New York, in accordance with the Commercial Rules of the American Arbitration
Association then in effect, and judgment upon the award rendered may be entered
in any court having jurisdiction thereof. It is expressly understood that the
arbitrators will have the authority to grant legal and equitable relief,
including both temporary restraints and preliminary injunctive relief to the
same extent as could a court of competent jurisdiction, and that the arbitrators
are empowered to order either side to fully cooperate in promptly resolving any
controversies or claims under this Agreement. Notwithstanding the foregoing, in
the event of a breach or threatened breach by Executive of any provision of
Section 7, 9 or 10 of this Agreement, the Company will be entitled to seek an
injunction from any court of competent jurisdiction in the State of New York and
Executive hereby submits to the personal jurisdiction of any such court.

          15. Severability. Should any part of this Agreement be held or
declared to be void or illegal for any reason by an arbitrator or court of
competent jurisdiction, such provision will be ineffective, but all other parts
of this Agreement which can be effected without such illegal part will
nevertheless remain in full force and effect. In such a case, the parties shall,
and the court of competent jurisdiction may, replace the invalid provision with
a legally permissible arrangement, which comes nearest to the intended purpose
of the invalid provision.

          16. Headings. The Section headings contained in this Agreement are for
reference purposes only and will not affect the meaning or interpretation of
this Agreement.

          17. Withholding. Anything to the contrary notwithstanding, all
payments required to be made by the Company hereunder to Executive will be
subject to withholding of such amounts relating to taxes (whether or not related
to payments required to be made by the Company hereunder) as the Company may
reasonably determine it should withhold pursuant to any applicable law or
regulation.

          18. Counterparts. This Agreement may be executed in one or more
counterparts, each of which will be deemed to be an original, but all of which
will collectively constitute a single original.

          19. No Reliance; Opportunity to Consult with Counsel. The parties
hereto each represent to the other that in executing this Agreement each does
not rely upon, and has not relied upon, any representation or statement not set
forth herein with regard to the subject matter,

                                      -8-

basis or effect of this Agreement or otherwise. Executive acknowledges that he
has had an opportunity to consult with an attorney of his choice prior to
executing this Agreement.

          20. No Assignment. Neither this Agreement nor the right to receive any
payments hereunder may be assigned by Executive except as provided for herein.
This Agreement will be binding upon Executive, his heirs, executors and
administrators and upon the Company, its successors and assigns.

          21. No Duty to Mitigate. Executive shall not be required to mitigate
the amount of any damages that Executive may incur or other payments to be made
to Executive hereunder as a result of any termination or expiration of this
Agreement, nor shall any payments to Executive be reduced by any other payments
Executive may receive.

          22. Non-Disparagement. Executive agrees not to publicly criticize,
denigrate or disparage the Company, its past and present direct and indirect
subsidiaries, affiliates, successors, assigns and all of their past and present
employees, officers and directors. The Company agrees not to, and to use
commercially reasonable efforts to cause its past and present direct and
indirect subsidiaries, affiliates, successors, assigns and all of their past and
present employees, officers and directors not to, publicly criticize, denigrate
or disparage Executive.

          23. Survival. The provisions of Sections 6, 7, 9, 10, 11, 14, 15, 17,
20, 21, 22 and this Section 23 will survive the termination or expiration of
this Agreement.

          24. Failure to Utilize. The Company will have no obligation to use
Executive's services or the rights granted hereunder in connection therewith or
otherwise, and the Company will be deemed to have fully satisfied its
obligations hereunder by paying to Executive the compensation due Executive in
accordance with the terms of this Agreement.

          IN WITNESS WHEREOF, the parties hereto have caused this Agreement to
be duly executed as of the day and year first above written.

Castle Brands Inc.                          Executive

By: /s/ Mark Andrews                        By: /s/ Herb Roberts
    -------------------------------------       --------------------------------
    Name: Mark E. Andrews III                   Name: Herbert Roberts
    Title: Chairman and Chief
           Executive Officer

                                      -9-

                                    EXHIBIT A

                             FORM OF GENERAL RELEASE

                                 GENERAL RELEASE

     1. (a) As a condition to and in consideration of the payments and benefits
described in Section 6 of the Employment Agreement, dated as of December 5,
2006, between Castle Brands Inc. and me relating to my employment with Castle
Brands Inc., and for other good and valuable consideration, I, with the
intention of binding myself and my heirs, beneficiaries, trustees,
administrators, executives, assigns and legal representatives (collectively, the
"Releasors"), hereby irrevocably and unconditionally release, remise, and
forever discharge Castle Brands Inc. and its subsidiaries and affiliates, and
the Releasees (as hereinafter defined) with respect to any and all agreements,
promises, rights, liabilities, claims, and demands of any kind whatsoever (upon
any legal or equitable theory, whether contractual, common law, or statutory,
under federal, state or local law or otherwise), whether known or unknown,
asserted or unasserted, fixed or contingent, apparent or concealed, that the
Releasors ever had, now have or hereafter can, shall or may have for, upon, or
by reason of any matter, cause or thing whatsoever existing, accruing, arising
or occurring at any time on or prior to the date I execute this General Release,
including, without limitation, (i) any and all rights and claims arising out of
or in connection with my employment by Castle Brands Inc., the terms and
conditions of such employment, or the termination of my employment; (ii) any and
all contract claims, claims for bonuses, claims for severance allowances or
entitlements; (iii) fraud claims, defamation, disparagement and other personal
injury and tort claims; and (iv) claims under any federal, state, or municipal
employee benefit, wage payment, discrimination, or fair employment practices law
(e.g., on the basis of sex, religion, age, race, or disability), statute, or
regulation, and claims for costs and expenses (including but not limited to
experts' fees and attorneys' fees) with respect thereto. This General Release
includes, without limitation, any and all rights and claims under the Title VII
of the Civil Rights Act of 1964, as amended, the Employee Retirement Income
Security Act of 1974, the Americans with Disabilities Act of 1990, the U.S.
Pregnancy Discrimination Act, the U.S. Family and Medical Leave Act, the U.S.
Fair Labor Standards Act, the U.S. Equal Pay Act, The Workers Adjustment and
Notification Act, the Equal Pay Act of 1963, the Age Discrimination in
Employment Act of 1967, the Older Workers Benefit Protection Act of 1990, the
Civil Rights Act of 1866, the Family and Medical Leave Act of 1993, the Civil
Rights Act of 1991, the New York Conscientious Employee Protection Act, the New
York Equal Pay Act, the New York Smokers' Rights Law, the New York Family Leave
Act, the New York Genetic Privacy Act, and the New York Constitution, in each
case as such laws have been or may be amended. Nothing in this General Release
shall deprive me of any compensation that was earned but not paid prior to my
termination; accrued benefits to which I have acquired a vested right under any
employee benefit plan or policy, stock plan or deferred compensation
arrangement; any other benefits or any health care continuation coverage to the
extent required by applicable law; or any right that I may have under the
Employment Agreement dated February 17, 2006.

          (b) For purposes of this General Release, the term "Castle Brands Inc.
and the Releasees" includes Castle Brands Inc., its past and present direct and
indirect subsidiaries, affiliates, successors, assigns, and all of its and their
past, preset, and future employees, officers,

directors, attorneys, agents, and legal representatives, whether acting as
agents or in individual capacities, and this General Release shall inure to the
benefit of and shall be binding and enforceable by all such entities and
individuals.

     2. Notwithstanding anything to the contrary in this General Release, in the
event that any of the parties released under this General Release initiates a
lawsuit or other claim (each, an "Original Lawsuit or Claim") against any of the
Releasors, the Releasors may counterclaim or bring any lawsuit or other claim
against such released party and/or Castle Brands Inc. and/or its subsidiaries so
long as such counterclaim, lawsuit or other claim is related to the Original
Lawsuit or Claim. Except as specifically stated in this Section 2, this Section
2 shall not effect the other provisions of this General Release

     3. (a) Opportunity to Review. I acknowledge that before signing this
General Release, I was given a period of at least twenty-one (21) days in which
to review and consider it. I acknowledge that I was encouraged by Castle Brands
Inc. to review this General Release, and that to the extent I wish to do so I
have done so. I further acknowledge that I have read this General Release in its
entirety, and that I fully understand the terms and legal effect of this General
Release. I am entering into this General Release voluntarily and of my own free
will. If I executed this General Release before the end of the twenty-one (21)
day period, such early execution was completely voluntary, and I had reasonable
and ample time in which to review this General Release.

          (b) Revocability. I agree that, for a period of seven days after I
sign this General Release (the "Revocation Period"), I have the right to revoke
it by providing notice, in writing (delivered by hand or by overnight mail), to
Castle Brands Inc., Attention: Chief Executive Officer. Notwithstanding anything
contained herein to the contrary, this General Release will not become effective
and enforceable until after the expiration of the Revocation Period.

Date signed:

-----------------------------------------
Name:

                                       2

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