Document:

Global Services Agreement

 EXHIBIT 10.3 
  
 Confidential Materials omitted and filed separately with the Securities and Exchange Commission. Asterisks denote such
omissions. 
  
 

 
 Solutia Pharmaceutical Services Division 
  
 GLOBAL SERVICES AGREEMENT 
  
 BETWEEN 
  
 AMCIS AG  
  
 AND 
  
 Fujisawa Deutschland GmbH 
  
 AND 
  
 Salmedix, Inc. 
  

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 TABLE OF CONTENTS 
  

					
			
	1	  	 DEFINITIONS
	  	4
			
	2	  	 PROJECTS
	  	6
			
	3	  	 ORGANIZATION, CO-OPERATION AND COMMUNICATION
	  	7
			
	4	  	 AMCIS OBLIGATIONS
	  	9
			
	5	  	 CUSTOMERS OBLIGATIONS
	  	10
			
	6	  	 NO SOLICITATION
	  	11
			
	7	  	 PAYMENT
	  	11
			
	8	  	 INTELLECTUAL PROPERTY
	  	12
			
	9	  	 CONFIDENTIALITY
	  	14
			
	10	  	 REPRESENTATIONS AND WARRANTIES
	  	16
			
	11	  	 LIABILITY AND INDEMNIFICATION
	  	17
			
	12	  	 INSURANCE
	  	19
			
	13	  	 TERM AND TERMINATION
	  	19
			
	14	  	 FORCE MAJEURE
	  	21
			
	15	  	 ASSIGNMENT
	  	22
			
	16	  	 INSPECTIONS AND AUDITS
	  	22
			
	17	  	 SEVERANCE
	  	24
			
	18	  	 WHOLE AGREEMENT
	  	24
			
	19	  	 NOTICES
	  	24
			
	20	  	 GOVERNING LAW
	  	25
			
	21	  	 RIGHTS CUMULATIVE
	  	25
			
	22	  	 WAIVER
	  	25

  

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 THIS AGREEMENT IS MADE BETWEEN: 
  

	(1)	AMCIS AG having an address at Hauptstrasse 159/173, CH-4416 Bubendorf, Switzerland (hereinafter referred to as “AMCIS”) and 

  

	(2)	a) Fujisawa Deutschland GmbH having an address at Berg-am-Laim-Strasse 129, 81673 München, Germany (hereinafter referred to as “Fujisawa”), and

  

	 	b)	Salmedix, Inc. having an address at 9380 Judicial Drive, San Diego, CA 92121, United States of America (hereinafter referred to as “Salmedix”).

  
 Fujisawa and Salmedix are hereinafter also referred to as
“Customer” or jointly as the “Customers”. 
  
 WHEREAS:

  

	A.	The Customers are pharmaceutical companies that are interested in making developments in the production process of Product (as hereinafter defined) as well as in the commercial
production thereof and AMCIS has a research and development division and a manufacturing facility with the capability to perform such work. 

  

	B.	Customers wish to have certain research and development work, as described in Work Order No.1 attached hereto and incorporated herein by reference as Annex 4, performed by
AMCIS (hereinafter referred to as “Initial Project”). Such work is to be performed in stages with both Customers jointly having the right and ability, subject to the terms of this Agreement, to terminate such work or change the programme
of work at any time. 

  

	C.	Beside the Initial Project, the Customers further wish to entrust AMCIS with the commercial production of the Product and AMCIS has the capacities for and is willing to perform such
commercial production under the terms and conditions as described in Work Orders No. 2 and No. 3 attached hereto and incorporated herein by reference as Annex 5 and Annex 6, respectively. 

  

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 NOW, THEREFORE, the Parties agree: 
  

	1	DEFINITIONS 

  

	1.1	In this Agreement, the following terms shall have the meanings now given to them: 

  

	 	(a)	“Agreement” shall include the terms of this Global Services Agreement together with the attached and subsequently agreed to Work Orders. 

  

	 	(b)	“Affiliate” means any company or organization which controls, is controlled by, or is under common control of, any of the Parties. The term “control” as used
herein means, in the case of a corporation, ownership, directly or indirectly, of at least *** of the stock entitled to vote for the election of Directors and, in the case of a non-stock company, the legal power to direct or cause the direction of
the general management and policies of such company. 

  

	 	(c)	“AMCIS Information” means Information that AMCIS owns or controls and has a right to disclose. 

  

	 	(d)	“AMCIS Intellectual Property” means Intellectual Property that AMCIS owns or controls and has a right to license or sublicense. 

  

	 	(e)	“API” means Active Pharmaceutical Ingredient. 

  

	 	(f)	“Customers Information” means Information that one or both Customers own or control and have a right to disclose. 

  

	 	(g)	“Customers Intellectual Property” means Intellectual Property that one or both Customers own or control and have a right to license or sublicense.

  

	 	(h)	“Effective Date” means Dec. 15th 2003.

  

	 	(i)	“Group” means AMCIS and its Affiliates or either of the Customers and its respective Affiliates, as the context requires. 

  

	 	(j)	“Information” means all technical, scientific, financial, business, commercial and other information, data and knowledge, in any form whatsoever and including Intellectual
Property, which one Party (“Recipient”) receives from the other (“Owner”) in connection with this Agreement other than technical, scientific, financial, business, commercial and other information, data and knowledge which:

  

	 	-	Recipient can demonstrate was in the public domain at the time of receipt by Recipient from Owner; or 

  

	 	-	after the time of receipt by Recipient from Owner, comes into the public domain other than by breach of this Agreement. (Such information, data and knowledge shall cease to be
Information at the date it comes into the public domain); or 

  

	***	Material has been omitted pursuant to a request for confidential treatment. 

  

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	 	-	at the time of receipt by Recipient from Owner, is already known to Recipient (or any member of its Group) other than through an association between any company within any
Recipient’s Group and any company within any Owner’s Group; or 

  

	 	-	after the time of receipt by Recipient from Owner, is disclosed to Recipient (or any member of its Group) by a Third Party which, in making such disclosure, is not acting in breach
or contravention of any express secrecy obligation owed to any company within Owner’s Group. (Such information, data and knowledge shall cease to be Information at the date of such disclosure by the Third Party); or 

  

	 	-	it can be demonstrated, by reference to reasonable, objective evidence, by Recipient to have been developed by Recipient (or any of the members of its Group) independently of
Information received from Owner pursuant to this Agreement. 

  
 For the purposes of this Agreement, Owner’s Information shall not be deemed to be in the public domain or known to Recipient solely because: 
  

	 	-	the general principle is in the public domain or known to Recipient (or any of its Affiliates) if the particular principle disclosed by Owner is not in the public domain or so
known; or 

  

	 	-	it constitutes a combination (not itself in the public domain or known to Recipient, or any of its Affiliates) of information that is in the public domain or so known.

  

	 	(k)	“Intellectual Property” means patents and applications for patents; trademarks and applications for trademarks; know-how, and, any and all other intellectual property, in
whatever form, whether registered or registrable; and whether otherwise protected or protectable. 

  

	 	(l)	“Parties” means (i) with regard to Joint Projects (as hereinafter defined) and as used elsewhere in this Agreement AMCIS on the one hand and Customers together on the
other hand and “Party” means either of them, as the context requires; and (ii) with regard to Sole Projects (as hereinafter defined) AMCIS on the one hand and the respective Customer requesting the Project on the other hand and
“Party” means either of them, as the context requires. 

  

	 	(m)	“Product” means API Bendamustine hydrochloride to be manufactured and packaged by AMCIS and ready for fill/finish pursuant to specifications and packaging specifications
mutually agreed upon in writing by AMCIS and the Customers attached hereto and incorporated herein by reference as Annex 1a and Annex 1b, respectively (collectively “Specifications”). 

  

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	 	(n)	A “Project” is a discrete package of work related to the Product which is to be performed by AMCIS, including without limitation the Initial Project. Each Project is
specifically described in the relevant Work Order. 

  

	 	(o)	“Project Result” means the output or results of any Project provided to Customers hereunder. 

  

	 	(p)	“Prohibited Use” means the *** 

  

	 	(q)	“Research Objective” is more specifically described in each Work Order, but, in general terms, means the primary scientific objective, underlying the Project.

  

	 	(r)	“Technical Information Package” means the information supplied by Customers for the purposes of the relevant Work Order, which details the proposed synthetic route,
reaction details, process yields, analytical methods, etc. 

  

	 	(s)	“Third Parties” means any entity or legal person other than members of any of the Parties’ Groups. 

  

	 	(t)	A “Work Order” means a sub-agreement, made between AMCIS and both or either of the Customers pursuant to this Agreement, within which a specific Project’s scope,
budget, set of deliverables, timeline and the AMCIS Affiliate appointed to assist AMCIS, as a joint Party, to perform the Project, are agreed. A Work Order may also describe the particulars concerning the exact nature of the structure to be
utilized— such as FTE, single Project, one-off process R&D or framework basis. Except to the extent specifically provided for, each Work Order shall be subject to, and considered a part of, this Agreement. However, notwithstanding the
foregoing such sub-agreement may contain special conditions, which shall take precedence over the terms of this Agreement for the purpose of the specific Project and the specific sub-agreement. 

  

	1.2	In this Agreement as the context requires: 

  

	 	-	a singular expression includes the plural and vice versa, 

  

	 	-	a gender-specific term shall include all other genders, and 

  

	 	-	a reference to this Agreement includes a reference to each Work Order. 

  

	1.3	In this Agreement, Article headings are for ease of reading and do not form part of this Agreement. 

  

	2	PROJECTS 

  

	2.1	Projects may be requested jointly by the Customers (a “Joint Project”) or separately by either of them (a “Sole Project”). In the case of a Sole Project, for
purposes of the relevant Sole Project this Agreement shall be read as if the Customer involved in the Sole Project is the sole contracting party of AMCIS. For the avoidance of doubt, such individual Customer shall be solely and exclusively
responsible for the rights and obligations of Customers hereunder as they relate to such Sole Project. 

  

	***	Material has been omitted pursuant to a request for confidential treatment. 

  

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 For the avoidance of doubt, any instructions regarding a Joint Project shall require the written approval
of both Customers. 
  

	2.2	The Initial Project, jointly requested by the Customers, is specifically described in Work Order No. 1 attached hereto and incorporated herein by reference as Annex 4.

  

	2.3	Beside the Initial Project, AMCIS agrees to manufacture such amount of the Product as separately ordered by each of Fujisawa and Salmedix under Work Order No. 2 and Work Order No.
3, respectively, attached hereto and incorporated herein by reference as Annex 5 and Annex 6, respectively. 

  

	2.4	When Customers, jointly or separately as the case may be, have any Project other than as stipulated under Articles 2.2 and 2.3 that they desire to have performed by AMCIS, Customers
will provide AMCIS, in writing, the details of such other Project. 

  
 After receiving such a request, AMCIS will respond to Customers within fifteen (15) business days, outlining whether or not AMCIS would be willing to undertake the proposed Project, and if so, under what conditions
and which AMCIS Affiliate shall assist in performing the work. Before starting any such other Project, the respective Parties shall agree upon a specific Work Order. 
  
 AMCIS is free to reject such other Projects in its sole discretion. 
  

	2.5	The allocation of pharmaceutical responsibilities for all Projects between AMCIS and Fujisawa shall be specified in the Quality Assurance (QA) Agreement attached hereto and
incorporated herein by reference as Annex 2. 

  
 The allocation of pharmaceutical responsibilities for all Projects between AMCIS and Salmedix shall be specified in the Quality Assurance (QA) Agreement attached hereto and incorporated herein by reference as Annex 3. 
  

	3	ORGANIZATION, CO-OPERATION AND COMMUNICATION 

  

	3.1	The strategic direction and overarching management of the Projects under this Agreement shall be managed by a committee (“Steering Committee”) consisting of two (2) or
three (3) representatives, as the case may be, one (1) each from and appointed by each of AMCIS, Fujisawa and Salmedix in case of Joint Projects and one (1) each from and appointed by each of AMCIS and the respective Customer in case of Sole
Projects. 

  

	3.2	Subject to this Agreement, the Steering Committee shall be self-governing and may concern itself with any and all aspects of Projects and the overall body of work. However, in
particular it will: 

  

	 	(a)	review and evaluate the progress of each Project. To this end, the Steering Committee may organize working groups to review technical progress and to make technical decisions. Such
working groups shall comply with instructions and directions issued from time-to-time by the Steering Committee. To the extent sensible in the circumstances, such instructions shall be given in writing. In addition, such instructions shall be given
in writing if the working group so requests; 

  

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	 	(b)	review and bring to the attention of each of the Parties’ quality unit for assessment and approval any quality issues as they arise in connection with any Project;

  

	 	(c)	manage the preparation of documents and all other matters arising in connection with the application for, and filing of, patents and other protections required in connection with
any Project or the overall body of work; 

  

	 	(d)	review and bring to the attention of each of the Parties’ regulatory unit for resolution any and all regulatory matters arising in connection with any Project;

  

	 	(e)	consider, and take decisions on, proposed changes to the scope or timing of Projects, and the introduction of new Projects. Each such action shall be recorded in writing or some
other permanent form; 

  

	 	(f)	review and make decisions on the staffing of Projects. Each such decision shall be recorded in writing or some other permanent form; 

  

	 	(g)	review (and from time-to-time amend as agreed) the budget associated with each individual Work Order; and 

  

	 	(h)	ensure that proper communications are made within AMCIS Group and Customer Group as required. 

  

	3.3	All decisions of the Steering Committee shall be unanimous. If there is no agreement between the Parties on a particular issue, the respective Customer or both Customers jointly, as
the case may be, shall have the final decision-making authority. 

  

	3.4	The Steering Committee shall not take any decision that, expressly or in effect, amounts to an amendment to this Agreement or any existing Work Order hereunder. In such case the
relevant Work Order shall be amended accordingly by duly authorized representatives of all Parties involved in the relevant Project. 

  

	3.5	Unless it determines otherwise, the Steering Committee shall meet in person at least once in each twelve (12) month period, the first period beginning on the Effective Date. In
addition, the members of the Steering Committee shall be generally available for routine discussions in connection with the Projects. 

  

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	3.6	Members of the Steering Committee shall be employees of the parties, and shall not be outside consultants, independent contractors or outside legal counsel. Each of AMCIS, Fujisawa
and Salmedix shall be solely responsible for appointing, removing and filling vacancies among its own representatives. Provided that such representatives are identified in advance of the relevant meeting; and provided that no member of the Steering
Committee has a reasonable objection, representatives of AMCIS Group and/or either Customer Group may attend Steering Committee meetings in addition to the then appointed members. At the invitation of the Steering Committee, such representatives may
address the Steering Committee and participate in its debates. However, unless the Steering Committee unanimously agrees to the contrary, such representatives may not participate in any decisions of the Steering Committee. 

 

	3.7	The Steering Committee shall ensure that proper written records of its meetings (in whatever form) are kept. After each such meeting, the written record of the meeting shall be
circulated to the members of the Steering Committee for comment and approval. Once approved, each such written record shall be signed by a representative of AMCIS and the Customers and, absent fraud, shall be regarded as a definitive record of the
meeting to which it refers. 

  

	3.8	As between Customer(s) and AMCIS, Customer(s) shall bear all costs related to Steering Committee’s carrying out its duties, including, without limitation, AMCIS’ travel
costs and lodging costs to attend Steering Committee meetings outside AMCIS’ headquarter located in Bubendorf; provided, however, that Customer(s) liability for AMCIS’s lost man hours shall not include time spent in Steering Committee
meetings. For Joint Projects, both Customers shall be jointly and severally liable for such Costs meetings. 

  

	4	AMCIS OBLIGATIONS 

  

	4.1	AMCIS shall provide such human and other resources as necessary to perform each Project, as specified in the relevant Work Order. 

  

	4.2	AMCIS shall work diligently and in good faith towards the completion of each Project within the agreed time targets (if any). However, unless and except to the extent expressly
stated otherwise in the relevant Work Order, AMCIS does not guarantee achievement of any specific or particular result or outcome nor guarantee completing a Project against a firm time limit. 

  

	4.3	The personnel that AMCIS causes to be applied in the performance of each Project shall be appropriately qualified and experienced for the tasks that they are to perform.

  

	4.4	Any machinery and equipment that AMCIS provides or causes to be applied in the performance of any Project shall be of an appropriate quality and, as required by normal practice,
shall be certified or approved by the relevant body or organization. 

  

	4.5	Any premises that AMCIS occupies or uses in the performance of any Project shall be of an appropriate quality and, as required by normal practice, shall be certified or approved by
such relevant body or organization as specified in the Work Order. 

  

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	4.6	AMCIS shall be responsible for complying with all US Federal-, European Union- and local Swiss laws, regulations, guidelines, ICH Q7A guidelines and local Swiss laws concerning
applicable worker health and environmental standards, and such current GLP, GCP and GMP guidelines as specified in the applicable Work Order and shall have and maintain, at its own cost, any and all licenses, permits and other authorizations, which
are required for its performance of this Agreement, including without limitation any Drug Master File necessary for the manufacture of Product. However, at their cost, Customers shall provide to AMCIS such cooperation and assistance as is reasonably
required by AMCIS to comply with this Section and as is expressly stipulated in the relevant Work Order. 

  

	4.7	AMCIS shall act on instructions properly given by the Steering Committee that are in accordance with this Agreement. 

  

	4.8	AMCIS shall perform this Agreement and each Project to the standards reasonably to be expected from a first-class provider of similar services in similar circumstances. No other or
additional qualitative or performance obligation shall be implied into this Agreement, unless expressly stipulated in the relevant Work Order. 

  

	4.9	AMCIS shall deliver in a timely manner all reports and items that, according to this Agreement or any Work Order, are to be so delivered. 

  

	4.10	AMCIS shall not *** 

  

	4.11	AMCIS shall not *** 

  

	5	CUSTOMERS OBLIGATIONS 

  

	5.1	Customers shall reasonably assist AMCIS towards the completion of each Project within the agreed time targets (if any) to the extent as is expressly stipulated in the relevant Work
Order. 

  
 In case it is agreed in the Work Order
that Customers shall provide AMCIS with personnel, such personnel shall be appropriately qualified for the tasks which they are to perform. 
  
 In case it is agreed in the Work Order that any materials and equipment shall be provided to AMCIS by Customers, such materials and equipment shall be of
an appropriate quality and quantity as described in the relevant Work Order and, as required by normal practice, shall be certified or approved by such relevant body or organization as specified in the Work Order. 
  

	5.2	Any approval, consent or authorization which is required to be given by Customers to AMCIS in connection with this Agreement shall be given by one or both Customers, as applicable,
and shall be given promptly, provided this is reasonable and such approval, consent or authorization does not in effect amount to an amendment of this Agreement. 

  

	***	Material has been omitted pursuant to a request for confidential treatment. 

  

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	5.3	Customers shall be responsible for the effects of any and all delays, which are caused or contributed to by the directions, acts and omissions of Customers or the Steering Committee
in connection with this Agreement or any Project; provided, however, that AMCIS shall make reasonable efforts to inform and discuss with Customers about the possible effects and/or delays of such directions, acts, or omissions.

  

	6	NO SOLICITATION 

  

	6.1	In respect of any employee of any Party (or former employee) who has been, within the immediately preceding twelve (12) months working on a Project pursuant to this Agreement
(“Person”), any other Party shall not actively seek to encourage a Person to take up employment (full or part-time, or as an independent contractor or on any other basis) with such other Party. However, this restriction shall not work to
prevent such other Party from offering employment to a person who, without encouragement from such other Party, has responded to a public advertisement of an employment opportunity. 

  

	7	PAYMENT 

  

	7.1	Each Project budget and the payment provisions (i.e., method of compensating AMCIS for its services) applicable in respect of each Project are exclusively to be set out in the
relevant Work Order. Any Project budget, and any of the applicable payment provisions, may be amended from time-to-time and at any time by agreement between the Parties as set forth in an amendment to the relevant Work Order.

  

	7.2	Project related expenditures and materials or Third Party services purchased shall only be billed separately to Customers, by AMCIS if expressly stipulated in the relevant Work
Order. 

  

	7.3	Unless otherwise expressly stipulated in the relevant Work Order, payments due under this Agreement shall be made not later than the *** after the date of each invoice. From the day
following the due date of payment until the day of payment, late payments shall accrue interest at the rate of *** 

  
 All payments due under this Agreement shall be made without any set-off, withholding or deduction whatsoever. If a deduction or withholding is required by
law, then the payment due under this Agreement shall be increased (“grossed up”) by such an amount so as to deliver to AMCIS the total amount due under this Agreement. 
  

	7.4	In addition to payments expressly provided for in each Work Order, Customers shall reimburse AMCIS for any and all expenses or increases in labour which it incurs as a result of
complying with directions given by the Steering Committee or by the Customers during the course of this Agreement, provided that such 

  

	***	Material has been omitted pursuant to a request for confidential treatment. 

  

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	    	directions substantially differ from AMCIS obligations under the relevant Work Order and provided that the direction is given in writing and expressly provides for the
reimbursement. AMCIS shall invoice Customers for such amounts and shall support each such invoice with appropriate proof of payment of the sums concerned. 

  

	7.5	Unless otherwise expressly stipulated in the relevant Work Order, all payments to be made under this Agreement shall be paid in US Dollars. 

  

	7.6	In respect of any payment due under this Agreement, if on the date of payment the exchange rate between the Euro and the currency specified in the Work Order (as reported in Wall
Street Journal) has changed, in either direction by more than *** from the rate as existed upon the Effective Date (as reported in the Wall Street Journal), then such payments will be capped at *** (as the case may be) of the original converted
amount. 

  

	7.7	Customers shall be jointly and severally liable for any Joint Projects undertaken hereunder. 

  

	8	INTELLECTUAL PROPERTY 

  

	8.1	All Information and all rights or access to Intellectual Property which Customers provide to AMCIS in connection with this Agreement and all Information relating to Customers, their
respective businesses or their respective products or developmental products shall be and remain the property of, or under the control of, Customers and AMCIS shall keep such Information confidential pursuant to the terms of Article 9 herein. AMCIS
shall have a non-exclusive, non-transferable, non-assignable royalty-free license to use any and all Customer Information and Customers Intellectual Property that Customers have provided to AMCIS hereunder, solely for the purpose of performing its
obligations under this Agreement. 

  

	 8.2      
	 (a)       In the event that any inventions, including, without limitation, all copyrightable
material, all notes, data, results, records, inventions, improvements, developments, discoveries and trade secrets, are conceived or reduced to practice in the performance of this Agreement (“Inventions”), all right, title and interest in
and to any Inventions(s) that relate to Customer Information, Customers Intellectual Property or the Product, the use, formulation or manufacture thereof (including without limitation the process and manufacture associated with intermediates
involved in such use, formulation or manufacture), or any other product or process belonging to Customers or their respective licensors, or to any improvement(s), modification(s), enhancement(s) or refinement(s) of any of same, whether conceived or
reduced to practice solely by a Party or jointly with other Parties, shall belong jointly to Customers (“Customers Inventions”). 

  
 AMCIS shall hereby - and shall cause each of its employees, contractors 
  

	***	Material has been omitted pursuant to a request for confidential treatment. 

  

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 and agents performing services on Customers’ behalf hereunder to - assign all right, title and
interest in and to all Customers Inventions to Customers, jointly, and shall, upon Customers’ request and at Customers’ expense, execute such documents and take such other actions as Customers deem necessary for Customers to document their
ownership interest in any Customers Inventions and/or to obtain, enforce and defend Intellectual Property rights relating thereto. All Customers Inventions and any information with respect thereto shall be subject to the confidentiality provisions
of Article 9 herein as if Customers were the owner thereof and shall be handed over to Customers at their sole and exclusive discretion at any time. 
  

	 	(b)	Subject to Section 8.2 (a) above, all right, title and interest in and to Inventions that are conceived or reduced to practice solely by AMCIS or its employees, contractors and/or
agents in performance of any Project hereunder other than Customers Inventions (“AMCIS Inventions) shall belong to AMCIS. AMCIS shall consult with Customers regarding any actions that may be necessary or helpful in protecting intellectual
property rights in any AMCIS Invention, and shall coordinate with Customers to determine what action, if any, to take with respect to filing and prosecuting patent applications for same in a timely manner in order to obtain patent protection that
is, to the extent possible, beneficial to the contractual parties. 

  

	 	(c)	Subject to Section 8.2 (a) above, all right, title and interest in and to Inventions that are conceived or reduced to practice jointly by an employee(s), contractor(s) or agent(s)
of AMCIS and Customers in performance of any Project hereunder other than Customers Inventions shall jointly belong to AMCIS and Customers (“Joint Inventions”). 

  

	 	(d)	AMCIS shall (i) promptly disclose in writing to Customers all AMCIS Inventions and Joint Inventions and (ii) provided Customers are not in breach of Section 7 herein, grant, and
hereby does grant, Customers, jointly, a non-exclusive, worldwide, perpetual, irrevocable, fully paid royalty-free license to use each such AMCIS Invention and AMCIS part of the Joint Invention for the development and manufacture of their respective
compounds, with the right to sublicense same to a Third Party solely for the development and manufacture of compounds on Customers’ behalf. 

  

	 	(e)	Customers shall grant, and hereby does grant, AMCIS a non-exclusive, worldwide, perpetual, irrevocable, fully paid royalty-free license to use each such Customers Invention for any
use throughout the world other than a Prohibited Use. 

  

	8.3	In performing work pursuant to this Agreement, AMCIS will not knowingly utilize 

  

 Page 13 of 27 

	    	technology or incorporate into any Project any technology which could infringe any valid and enforceable Intellectual Property right of a Third Party. AMCIS will use reasonable
diligence to ensure that processes or technology they propose to use do not infringe the rights of Third Parties. However, AMCIS makes no warranty or representation that the use of the Project Result or the Project Result will not infringe the
rights of Third Parties and it is understood AMCIS does not carry on any patent infringement or freedom to operate searches related thereto as a part of its services hereunder. 

  

	8.4	While performing under this Agreement, AMCIS and its employees may add to its and their general skills and knowledge of how to perform such work and work of a similar or like
nature. Subject to the terms of Article 9, such knowledge shall be available, without restriction and without charge, to AMCIS for the performance of other projects for members of its Group and for Third Parties; provided AMCIS shall not be
permitted to use such knowledge for a Prohibited Use. Notwithstanding the foregoing, AMCIS shall not use or reference Customers’ Information for any purpose whatsoever, including without limitation, for the performance of other projects for
members of its Group or for Third Parties, unless expressly permitted hereunder or without Customers’ express prior written consent. 

  

	8.5	Each Party agrees that it may be in their best interests to present Information at conferences or to publish in journals such Information, subject to any Owner’s prior written
consent for publication. If a Party wishes to present or publish any Information of which they are not the Owner and that has not been previously disclosed to the public, such Party shall submit a manuscript of the conference abstract or the
research paper for the Owner’s review prior to submission to the conference or the publisher. The non-publishing Party shall have thirty (30) days after the receipt from the publishing Party of such manuscript to review the manuscript and to
request reasonable modifications thereof. If the non-publishing Party does not provide any request for any modifications during such review period or, if the non-publishing Party provides a request for modification, then after such request is
complied with by the publishing Party to the reasonable satisfaction of the non-publishing Party, the publishing Party may submit the manuscript for publication. Unless approved by the non-publishing Party in writing, such publication shall not
contain Information of the non-publishing Party. If such publication contains patentable technology, the non-publishing Party may request the publishing party to delay the publication for a period reasonably necessary for the non-publishing Party to
obtain patent protection therefor.  

  

	9	CONFIDENTIALITY 

  

	9.1	In consideration of the Owner allowing the Recipient access to and use of Information, Recipient shall so receive and use Information subject to, and strictly in accordance with,
this Agreement. 

  

	9.2	The mere disclosure of Information pursuant to this Agreement shall not operate to transfer to Recipient any of Owner’s rights, of whatever nature, in such Information. On
receipt of Information, Recipient shall have only such rights in respect thereof as are expressly granted in this Agreement. 

  

 Page 14 of 27 

	9.3	Recipient shall use and may disclose to members of its Group Information received from Owner only to the extent necessary for the purposes of performing its obligations under this
Agreement. 

  

	9.4	Recipient shall disclose Owner’s Information only to those of Recipient’s personnel, and the personnel of Recipient’s Group, who need to have access thereto for the
purposes of this Agreement. Recipient shall ensure that each of such personnel is bound by restrictions at least as onerous as those placed on Recipient by this Agreement. 

  

	9.5	Neither Recipient nor any of its Group personnel shall disclose Owner’s Information to any Third Party except that Recipient may make, or may permit, such disclosure if Owner
has given its prior, written consent to the specific disclosure or it is otherwise permitted pursuant to written agreements between Owner and Recipient. 

  

	9.6	If, at the request of a relevant authority or on the advice of counsel, a member of the Recipient’s Group is required, or reasonably believes it is under an enforceable legal
obligation, to disclose Owner’s Information to a Third Party then, to the extent possible without being in breach of any legally enforceable obligation, Recipient shall give notice thereof to Owner. Owner shall then be free to challenge such
disclosure provided that it shall hold harmless and indemnify Recipient against any and all costs, charges, expenses (including legal expenses), fines, claims, damages and other losses, which Recipient suffers or incurs in connection, directly or
indirectly, with such challenge. 

  

	9.7	Subject to GMP and local legal requirements relating to the keeping of copies, at the request, deliverable at any time, of Owner, Recipient shall return any or all of Owner’s
Information to Owner, or, at Recipient’s option: certify to Owner that Owner’s Information has been destroyed; or, certify to Owner that, in accordance with this Agreement or Owner’s prior instructions, Owner’s Information has
been delivered to a Third Party of Owner’s choice. Notwithstanding this obligation, Recipient may retain one copy of Owner’s Information for its records solely for determining its confidentiality obligations hereunder. Such records shall
be subject to this Agreement. 

  

	9.8	Notwithstanding the termination of this Agreement for any reason whatsoever, the confidentiality provisions contained in this Agreement shall remain in full force and effect.

  

	9.9	The fact of, and the terms and scope of, this Agreement shall be and remain confidential and shall not be disclosed by either Party without the prior, written consent of the other
Party. Notwithstanding the foregoing, (a) Salmedix may issue a press release or public announcement concerning any aspect of Salmedix’s development or commercialization of the Product and (b) Salmedix may disclose the existence of this
Agreement and the terms and conditions hereof, without the 

  

 Page 15 of 27 

	    	prior written consent of the other Parties, as reasonably necessary in connection with the due diligence process associated with any future capital investment in Salmedix or the
negotiation or exploration of a possible strategic transaction. 

  

	9.10	For the avoidance of doubt, 

  

	 	a)	Information disclosed by AMCIS to one of the Customers under a Joint Project may be freely disclosed by that Customer to the other Customer; 

  

	 	b)	Information disclosed by one of the Customers to AMCIS under a Joint Project may be freely disclosed by AMCIS to the other Customer; 

  

	 	c)	Information disclosed by either of AMCIS, Fujisawa or Salmedix under a Sole Project shall not be disclosed to the respective Customer not involved in the relevant Project.

  

	9.11	For the avoidance of doubt, the confidentiality obligations between the Customers shall be governed by the License Agreement between Fujisawa and Salmedix, dated May 1, 2003, as the
same may be amended from time to time (hereinafter “Customer License Agreement”). 

  
 Notwithstanding the foregoing, Customer Information relating to Joint Projects may be freely disclosed by either Customer to the extent such disclosure
may be required for transferring the production process of Product from AMCIS to any other contract manufacturer. 
  

	10	REPRESENTATIONS AND WARRANTIES  

  

	10.1	Each of AMCIS, Fujisawa and Salmedix warrant that, as of the Effective Date: 

  

	10.1.1	It is a corporation duly organized, validly existing and is in good standing under the laws of the state or country of its incorporation, is qualified to do business and is in good
standing as a foreign corporation in each jurisdiction in which the conduct of its business or the ownership of its properties requires such qualification, except where the failure to be so qualified could not, either individually or in the
aggregate, reasonably be expected to have a material adverse effect on it or its performance hereunder (a “Material Adverse Effect”) and has all requisite power and authority, corporate or otherwise, to conduct its business as now being
conducted, to own, lease and operate its properties and to execute, deliver and perform this Agreement. 

  

	10.1.2	The execution, delivery and performance by it of this Agreement have been duly authorized by all necessary corporate action and do not and will not (a) require any consent or
approval of its stockholders, (b) violate any provision of any law, rule, regulations, order, writ, judgment, injunctions, decree, determination award presently in effect having applicability to it, except where such violation could not reasonably
be expected to have a Material Adverse Effect, or any provision of its certificate of incorporation or by-laws or (c) result in a breach of or constitute a default under any material agreement, mortgage, lease, license, permit or other instrument or
obligation to which it is a contracting party or by which it or its properties may be bound or affected, except any such breach or default which could not reasonably be expected to have a Material Adverse Effect. 

  

 Page 16 of 27 

	10.1.3	This Agreement is a legal, valid and binding obligation of it enforceable against it in accordance with its terms and conditions, except as such enforceability may be limited by
applicable bankruptcy, insolvency, moratorium, reorganisation or similar laws, from time to time in effect, affecting creditor’s rights generally. 

  

	11	LIABILITY AND INDEMNIFICATION 

  

	11.1	Except in the case of AMCIS’ intentional misconduct, fraud or gross negligence and except as otherwise provided in the Work Order, a Party’s total liability, howsoever
arising in connection, directly and indirectly, under this Agreement shall not exceed an amount equal to the total revenue derived by AMCIS from Customers under the individual Work Order directly connected to the liability. 

 

	11.2	Notwithstanding and without prejudice to any other provision of this Agreement and except in case of intentional misconduct, fraud or gross negligence, the Parties shall have no
liability whatsoever or howsoever arising for any: pure economic loss; loss of profit; loss of business; loss of contracts; and, indirect or consequential losses suffered or incurred by any member of either Customer Group or AMCIS as the case may be
and arising in connection, directly or indirectly, with this Agreement. 

  

	11.3	FUJISAWA SHALL INDEMNIFY AND HOLD HARMLESS AMCIS GROUP AND/OR SALMEDIX GROUP AGAINST ANY AND ALL THIRD PARTY CLAIMS FOR PERSONAL DEATH OR INJURY UNDER STATUTORY PROVISIONS OF CIVIL
LAW DUE TO ANY BREACH OF ITS OBLIGATIONS HEREUNDER, PROVIDED, HOWEVER, THAT FUJISAWA SHALL HAVE NO DUTY TO INDEMNIFY OR HOLD HARMLESS AMCIS GROUP AND/OR SALMEDIX GROUP FOR ANY THIRD PARTY CLAIM TO THE PROPORTIONAL EXTENT ARISING OUT OF OR RELATED TO
THE INTENTIONAL MISCONDUCT, FRAUD OR GROSS NEGLIGENCE OF AMCIS GROUP OR ANY AMCIS EMPLOYEE, CONTRACTOR OR AGENT IN THE COURSE OF AMCIS’S PERFORMANCE UNDER THIS AGREEMENT AND/OR OF SALMEDIX GROUP OR ANY SALMEDIX EMPLOYEE, CONTRACTOR OR AGENT IN
THE COURSE OF SALMEDIX’S PERFORMANCE UNDER THIS AGREEMENT, RESPECTIVELY. 

  
 SALMEDIX SHALL INDEMNIFY AND HOLD HARMLESS AMCIS GROUP AND/OR FUJISAWA GROUP AGAINST ANY AND ALL THIRD PARTY CLAIMS FOR PERSONAL DEATH OR INJURY UNDER STATUTORY PROVISIONS OF CIVIL LAW DUE TO ANY BREACH OF ITS
OBLIGATIONS HEREUNDER, PROVIDED, HOWEVER, THAT SALMEDIX SHALL HAVE NO DUTY TO INDEMNIFY OR HOLD HARMLESS AMCIS GROUP AND/OR FUJISAWA GROUP FOR ANY THIRD PARTY CLAIM TO THE PROPORTIONAL EXTENT ARISING OUT OF OR RELATED TO THE INTENTIONAL MISCONDUCT,
FRAUD OR GROSS NEGLIGENCE OF 
  

 Page 17 of 27 

 AMCIS GROUP OR ANY AMCIS EMPLOYEE, CONTRACTOR OR AGENT IN THE COURSE OF AMCIS’S PERFORMANCE UNDER
THIS AGREEMENT AND/OR OF FUJISAWA GROUP OR ANY FUJISAWA EMPLOYEE, CONTRACTOR OR AGENT IN THE COURSE OF FUJISAWA’S PERFORMANCE UNDER THIS AGREEMENT, RESPECTIVELY. 
  
 AMCIS SHALL INDEMNIFY AND HOLD HARMLESS EACH CUSTOMER GROUP AGAINST ANY AND ALL THIRD PARTY CLAIMS FOR PERSONAL DEATH OR
INJURY UNDER STATUTORY PROVISIONS OF CIVIL LAW DUE TO ANY BREACH OF AMCIS’ OBLIGATIONS HEREUNDER, PROVIDED, HOWEVER, THAT IN CASE OF JOINT PROJECTS AMCIS SHALL HAVE NO DUTY TO INDEMNIFY OR HOLD HARMLESS EITHER CUSTOMER GROUP FOR ANY THIRD PARTY
CLAIM TO THE PROPORTIONAL EXTENT ARISING OUT OF OR RELATED TO THE INTENTIONAL MISCONDUCT, FRAUD OR GROSS NEGLIGENCE OF ANY CUSTOMER GROUP OR ANY EMPLOYEE, CONTRACTOR OR AGENT OF SUCH CUSTOMER GROUP IN THE COURSE OF ANY CUSTOMER’S PERFORMANCE
UNDER THIS AGREEMENT AND PROVIDED THAT IN CASE OF SOLE PROJECTS AMCIS SHALL HAVE NO DUTY TO INDEMNIFY OR HOLD HARMLESS THE RESPECTIVE CUSTOMER GROUP INVOLVED IN THE SOLE PROJECT FOR ANY THIRD PARTY CLAIM TO THE PROPORTIONAL EXTENT ARISING OUT OF OR
RELATED TO THE INTENTIONAL MISCONDUCT, FRAUD OR GROSS NEGLIGENCE OF SUCH CUSTOMER GROUP OR ANY EMPLOYEE, CONTRACTOR OR AGENT OF SUCH CUSTOMER GROUP IN THE COURSE OF SUCH CUSTOMER’S PERFORMANCE UNDER THIS AGREEMENT. 
  

	11.4	For purposes of indemnification hereunder, the Indemnitee (as hereinafter defined) shall include its employees, officers and directors and also include Third Parties that supply
services to AMCIS to support a Project, provided that such Third Party support is expressly allowed for in the relevant Work Order. 

  

	11.5	Any product, material or substance which is either (i) provided to AMCIS by or for Customers in connection with this Agreement; or, (ii) produced by AMCIS for Customers in
connection with this Agreement (hereinafter collectively referred to as “Customer Property”) shall be stored by AMCIS in an appropriate manner for the purpose of the Project and in accordance with the local laws and regulations. If any
Customer Property is lost, damaged or destroyed whilst in the custody, or under the control, of AMCIS then, unless such loss, damage or destruction is a direct and proximate result of AMCIS’ breach of this Agreement, negligence, wilful
misconduct or fraud, AMCIS shall have no liability whatsoever and howsoever arising. Should Customer Property be stored by AMCIS due to breach of contract by Customers or due to instructions given by Customers beyond the purpose of the Project
specified in the Work Order, Customer Property will be insured at the expense of Customers, or, at Customers option, disposed of at Customers’ cost. 

  

 Page 18 of 27 

	11.6	A Party that intends to claim indemnification under this Article 11 (the “Indemnitee”) shall promptly notify the indemnifying Party (the “Indemnitor”) of any
claim, demand, action or other proceeding in respect of which the Indemnitee and/or any member of its respective Group intend to claim such indemnification, and the Indemnitor shall have the right to participate in, and, to the extent the Indemnitor
so desires, to assume the defense thereof with counsel selected by the Indemnitor and reasonably satisfactory to the Indemnitee; provided, however, that the Indemnitee shall have the right to retain its own counsel, with the fees and expenses to be
paid by the Indemnitee. 

  
 The indemnity
provisions in this Article 11 shall not apply to amounts paid in settlement of any claim, demand, action or other proceeding if such settlement is effected without the consent of the Indemnitor, which consent shall not be withheld or delayed
unreasonably. The failure to deliver notice to the Indemnitor within a reasonable time after the commencement of any such action, if prejudicial to the Indemnitor’s ability to defend such action, shall relieve such Indemnitor of any liability
to the Indemnitee under this Article 11, but the omission to so deliver notice to the Indemnitor will not relieve it of any liability that it may have to any Indemnitee otherwise than under this Article 11. 
  

	11.7	The Indemnitor may not settle the action or otherwise consent to an adverse judgment in action or other proceeding that materially diminishes the rights or interests of the
Indemnitee without the express written consent of the Indemnitee, unless it involves full release of the Indemnitee. The Indemnitee under this Article 11 and its employees and agents, shall cooperate fully with the Indemnitor and its legal
representatives in the investigation of any action, claim or liability covered by this indemnification. 

  

	12	INSURANCE 

  

	12.1	Each of AMCIS, Fujisawa and Salmedix shall have and maintain the insurance coverage that is customary in its industry or otherwise as required by applicable law. Except to the
extent insurance coverage is required pursuant to the Work Order, and also subject to the foregoing, each of AMCIS, Fujisawa and Salmedix may self-insure its liabilities under this Agreement or shall otherwise purchase and maintain such insurance.

  

	13	TERM AND TERMINATION 

  

	13.1	This Agreement shall commence upon the Effective Date and thereafter shall continue in full force and effect for an initial period of ***. Thereafter it shall continue in full force
and effect until terminated by any of AMCIS, Fujisawa or Salmedix upon *** prior written notice. Notwithstanding the foregoing, either Customer may terminate this Agreement by written notice at any time in the event there are no outstanding Work
Orders in effect for such Customer (whether related to Sole Projects or Joint Projects). Termination of Projects that have been started and not yet completed on date of termination shall be governed by Article 13.2. 

  

	***	Material has been omitted pursuant to a request for confidential treatment. 

  

Page 19 of 27 

	13.2	Unless the Work Order provides otherwise, Joint Projects may be terminated at any time by joint termination notice of both Customers and Sole Projects may be terminated at any time
by the relevant Customer involved, provided that AMCIS is given written notice at least sixty (60) days prior to such termination. 

  
 If work on any Project is terminated pursuant to this Article 13.2, AMCIS shall immediately use commercially reasonable efforts to reduce and/or mitigate
further cost to Customer(s) and mitigate all non-cancellable obligations. Subject to the immediately preceding sentence, Customer(s) will make payment for any work performed during such sixty (60)-day period and AMCIS will deliver Customer(s) the
Project Results as achieved as of the effective date of the termination working towards the Project Goals as specified in the applicable Work Order or under each applicable Project; provided, however, that such termination shall not terminate any
other Project not so terminated nor the rights and duties of Customer(s) and AMCIS pursuant to this Agreement until each of the then-current Projects is completed or terminated; and Customer(s) shall make a termination fee as specified in the
applicable Work Order. Notwithstanding the foregoing, any breach by a Customer of a payment obligation shall be subject to a fifteen (15) day cure period, instead of the sixty (60) day cure period contained above. 
  

	13.3	Upon any material breach or default by either Party in the performance of any obligation to be performed by such a Party under this Agreement, the non-breaching Party or Party not
in default, shall give notice in writing to the breaching Party or Party in default, specifying the breach or matter in default. Unless such breach or default is cured within sixty (60) days following the giving of such notice, (or if such cure
cannot be completed within such sixty (60) day period, if the cure has not been undertaken promptly upon receipt of such notice, and diligently pursued thereafter) the Party giving such notice may thereafter terminate this Agreement with immediate
effect; provided that if one of the Customers is in material breach or default hereunder and the other Customer is capable of curing and willing to cure, and such other Customer provides written notice to AMCIS of such desire and thereafter begins
performing on behalf of the Customer in breach, AMCIS shall have no right to terminate pursuant to this Article 13.3. 

  

	13.4	This Agreement may be terminated with immediate effect by one Party if: the other Party becomes bankrupt, insolvent, or is otherwise incapable of paying its bills as they fall due;
or, if the other Party has a receiver, administrator in bankruptcy or any analogous person appointed to run such Party’s business affairs; provided that if one of the Customers is the bankrupt Party and the other Customer provides written
notice to AMCIS of its desire to perform on behalf of the bankrupt Party and thereafter begins performing on behalf of the Customer in breach, AMCIS shall have no right to terminate pursuant to this Article 13.4. Any decision to terminate this
Agreement under this Article 13.4 shall be communicated to the other Party within the ninety (90) days after the Party making the decision has become aware of the event which gives rise to the right to terminate. 

  

 Page 20 of 27 

	13.5	This Agreement and any then-current Work Order or Project, may be terminated in certain cases of Force Majeure as provided in Article 14. 

  

	13.6	If this Agreement is terminated under Article 13.3 or 13.4 then, at the option of the Party effecting the termination, each then-current Work Order may also be terminated.

  

	13.7	Unless otherwise expressly provided in this Agreement or agreed in writing between the Parties, the provisions of Articles 1, 7 (in respect of payments outstanding at date of
termination), 8, 9, 11, 13, 16 and 17 shall continue to bind the Parties and have full force and effect even after the termination of this Agreement. 

  

	13.8	In the event that either of Fujisawa or Salmedix terminates this Agreement for any reason whatsoever, the Agreement shall continue in full force and effect between the remaining
parties and shall be read thereafter as if the remaining parties are the sole Parties to this Agreement, subject, however, to the joint and several liability of Fujisawa and Salmedix for any then remaining payment obligation of the Customers. For
sake of clarity, in such case neither of the remaining parties shall take on any rights or obligations of the terminating Party unless otherwise agreed upon in the relevant Work Order, subject, however, to the joint and several liability of Fujisawa
and Salmedix for any then remaining payment obligation of the Customers. 

  

	14	FORCE MAJEURE 

  

	14.1	One Party shall have no liability to the other Party for any failure to perform all or any part of this Agreement if and to the extent that such failure is the result of a Force
Majeure Event. For the purposes of this Agreement, “Force Majeure Events” shall mean: acts of God; fire, flood, tempest, exceptional weather conditions, earthquakes; breakage or failure of apparatus or machinery; strikes, lockouts and
other industrial action; war (declared or not), civil insurrection, act of Government, or any other event or occurrence, which reasonably is beyond the control of the Party which has failed to perform under this Agreement; provided, however, that
there shall be no economic force majeure. Performances hereunder, other than for payment of monies owed, shall be suspended during the pendency of the Force Majeure Event. This Section shall not apply to excuse any Customer payment obligation.

  

	14.2	If performance, in whole or material part, of this Agreement is suspended for more than 120 consecutive days or 180 days in any one 12 month period as a result of Force Majeure
Events, either Party shall have the right to terminate this Agreement or the relevant Work Order or Project, by giving written notice to that effect to the other Party. If the cause of the force majeure has not disappeared within the sixty (60) days
after the delivery of such a notice, this Agreement, Work Order or Project (as the case may be) shall terminate. 

  

 Page 21 of 27 

	15	ASSIGNMENT  

  

	15.1	Except as provided below, the rights and obligations under this Agreement may be assigned in whole, but not in part, by AMCIS, Fujisawa or Salmedix only with the prior, written
consent of each of the other Parties. Such consent shall not be withheld or delayed unreasonably. Notwithstanding the foregoing, AMCIS, Fujisawa or Salmedix may assign this Agreement to a duly capable Affiliate or to a successor owner of
substantially all of the assets or business of such Party involved in performance hereunder by giving written notice to the other Parties. Unless specifically agreed otherwise, assignment of this Agreement shall assign each then-current Work Order,
provided that in case of an assignment by AMCIS each then-current Work Order shall only be assigned with the prior, written consent of the Customer(s) involved in the respective Work Order. Such consent shall not be withheld, conditioned or delayed
unreasonably. 

  

	15.2	*** 

  

	16	INSPECTIONS AND AUDITS 

  

	16.1	Throughout the term of this Agreement and for such periods of time as may be required by law thereafter, AMCIS shall keep accurate records pertaining to each Project. AMCIS shall
record all information relating to Projects in written or electronic form. Such records shall be kept separately from written records that document other research and development or manufacturing that may be conducted by AMCIS. All such written
records shall be maintained in a form sufficient to satisfy regulatory authorities, specifically, electronic form records must be Part 11 of the US Code of Federal Regulations (CFR) compliant in the event written duplicates of said records do not
exist. Moreover, from time-to-time, upon Customers’ request, AMCIS will promptly provide copies of any of the records that it maintains for Customers. 

  

	16.2	Customers are and shall be the sole and exclusive owner of all laboratory notebooks (and all information therein) relating to or resulting from Projects. For each Project, AMCIS
shall maintain laboratory notebooks and related data notebooks in accordance with industry standard practices. Moreover, from time-to-time, upon Customers’ request, AMCIS will promptly provide copies of any of laboratory notebooks and related
data notebooks that it maintains for Customers. 

  

	***	Material has been omitted pursuant to a request for confidential treatment. 

  

Page 22 of 27 

	16.3	Upon ten (10) business days’ written notice from Customers, AMCIS shall permit Customers’ independent auditors to have access during normal business hours to the books and
records of AMCIS and its approved subcontractors as may be reasonably necessary to verify the accuracy of any financial reports, financial updates, billings or payments made under this Agreement. The audit shall be limited to books and records for
any calendar year ending not more than *** prior to the date of such notice. All financial reports, invoices and payments not disputed as to correctness by Customers within *** after receipt thereof shall thereafter conclusively be deemed correct
for all purposes. Such audit shall be at Customers’ expense. Within thirty (30) days after both Parties have received an audit report, Customers or AMCIS, as appropriate, will compensate the other Party for any errors or omissions revealed by
an audit. This audit right shall survive for a period of *** from the date this Agreement terminates or expires and, with regard to any specific Project, *** from the completion or termination of such Project. Notwithstanding the foregoing,
Customers shall not have the right to audit any lump-sum payments under this Agreement. 

  

	16.4	Upon ten (10) business days’ written notice from Customers, AMCIS shall permit Customers or Customers’ representative to have access during normal business hours to audit
the books and records of AMCIS and its approved subcontractors as may be reasonably necessary to confirm that Project Services have been performed accurately and in compliance with (i) prevailing professional standards of quality, including without
limitation cGMP, cGLP and ICH guidelines, (ii) applicable Customers protocols and/or Specifications of which AMCIS was reasonably advised, and (iii) applicable laws. Such an audit shall be at Customers’ expense. This audit right shall survive
for a period of one (1) year from the date this Agreement terminates or expires and, with regard to any specific Project, *** from the completion or termination of such Project. 

  

	16.5	AMCIS shall notify Customers representative as stated in the relevant Work Order within forty-eight (48) hours after it receives notice of any regulatory authority inspection and/or
communication directly relating to any Project. AMCIS shall consult with Customers prior to responding to any such regulatory authority if the communication relates directly to any Project and undertakes best efforts to immediately notify and
consult with Customers prior to taking any action. In addition, AMCIS shall provide to Customers copies of any resulting document of action within five (5) working days after the receipt from the applicable regulatory authority.

  

	16.6	Before commencing any audit work described in Sections 16.3 or 16.4 above, the Third Party auditors or representatives shall execute confidentiality agreements with, and reasonably
satisfactory to, AMCIS. 

  

	16.7	In addition to the access and audit rights of the parties set forth in Sections 16.3 and 16.4 above, upon reasonable prior notice from the Customers, AMCIS shall afford

  

	***	Material has been omitted pursuant to a request for confidential treatment. 

  

Page 23 of 27 

	    	to the Customers reasonable access during normal business hours (and at such other times as the Parties may mutually agree) to the relevant books, records and other information of
AMCIS in order to monitor AMCIS’s compliance with its obligations under this Agreement, including without limitation, regulatory compliance. Such access shall be available during normal business hours. Any inspection conducted by either party
pursuant to this Section 16.7 shall be at the sole cost and expense of the Customers, unless it is occasioned by a regulatory communication to AMCIS related to the Product or any Project. 

  

	17	SEVERANCE 

  
 If any provision of this Agreement is declared by any judicial or other competent authority to be void, voidable, illegal or otherwise unenforceable the Parties shall amend that provision in such reasonable manner as
achieves the intention of the Parties without illegality or, at the discretion of the Party negatively affected, it may be severed from this Agreement. In each such case, the remaining provisions of this Agreement shall remain in full force and
effect unless the effect of such declaration is, based on objective and reasonable standards, to defeat the original intention of the Parties in which event the Parties shall agree a course of action or, if they cannot, this Agreement shall
terminate forthwith. 
  

	18	WHOLE AGREEMENT 

  
 This Agreement, which expression shall include each Work Order, contains the whole agreement between the Parties in respect of the subject matter hereof and shall prevail on any other terms, in particular the general
terms and conditions used by either Party under execution of this Agreement. Neither Party has relied upon any oral or written representation made to it by the other or its employees or agents, except to the extent expressly included in this
Agreement. Each Party has made its own independent investigations into all matters relevant to it. 
  
 Nothing in this Agreement shall be deemed to supersede or amend the Customer License Agreement. 
  

	19	NOTICES 

  
 Any notice to be served on one Party by the other shall be sent by prepaid recorded delivery or registered post to the address of the relevant Party shown at the head of this Agreement or by facsimile transmission or
by electronic mail or by telex and shall be deemed to have been received by the addressee within 72 hours of posting or 24 hours if sent by facsimile transmission or by electronic mail or by telex to the correct facsimile number or electronic mail
number of the addressee (with correct answerback). 
  
 For the avoidance of doubt,
any such notice to Customers shall be provided to all Customers. 
  

 Page 24 of 27 

	20	GOVERNING LAW 

  
 This Agreement shall be interpreted, enforced and governed, in all respects, by the laws of Germany. 
  

	21	RIGHTS CUMULATIVE 

  
 All rights granted to either of the Parties shall be cumulative and no exercise by either of the Parties of any right under this Agreement shall restrict or prejudice the exercise of any other right granted by this
Agreement or otherwise available to it. 
  

	22	WAIVER 

  
 The failure by either Party to enforce at any time or for any period any one or more of the terms or conditions of this Agreement shall not be waiver of them or of the right at any time subsequently to enforce all
terms and conditions of this Agreement 
  

 Page 25 of 27 

 IN WITNESS OF THE FOREGOING, the Parties have caused their authorized representatives to sign: 
  
 Fujisawa Deutschland GmbH 
  

					
	 /s/ W.Tinhof

	 	 /s/ Wolfgang Schoch

	 	 March 19th, 2004

	 Dr. W. Tinhof
	 	 Wolfgang Schoch
	 	 (Date)

	 - President -
	 	 - Executive Vice President -
	 	 

  

			
	 Salmedix, Inc.
	 	 
	  
 /s/ F. Andrew
Dorr

	 	 April 23, 2004

	 F. Andrew Dorr
 C.O.O.
	 	 (Date)

  
 AMCIS AG 
  

					
	 /s/ P. M. Muller

	 	     /s/ A. Ackermann

	 	 April 02, 2004

	 Dr. P. M. Muller
	 	 A. Ackermann
	 	 (Date)

	 C.O.O.
	 	 Head of Finance
	 	 

  

 Page 26 of 27 

 List of Annexes: 
  

			
	 Annex 1:
	  	Specifications of Product
		
	 	  	- Annex 1a: Product Specifications
		
	 	  	- Annex 1b: Packaging and Shipment Criteria
		
	 Annex 3:
	  	Quality Assurance (QA) Agreement between AMICS and Salmedix
		
	 Annex 4:
	  	Work Order No. 1
		
	 Annex 6:
	  	Work Order No. 3

  

 Page 27 of 27 

 Annex 1a 
  
 to the Global Service Agreement 
 between AMCIS AG and Fujisawa
Deutschland GmbH and Salmedix, Inc. 
  
 Product
Specifications 
  
 Specification Bendamustine 
  
 *** 
  
  
 *** 
  

	***	Material has been omitted pursuant to a request for confidential treatment. 

  

Page 1 of 10 

  
 *** 
  

	***	Material has been omitted pursuant to a request for confidential treatment. 

  

Page 2 of 10 

 *** 
  

	***	Material has been omitted pursuant to a request for confidential treatment. 

  

Page 3 of 10 

 Annex 1b 
 to the Global Service Agreement 
 between AMCIS AG and Fujisawa Deutschland GmbH and Salmedix, Inc. 
  
 Packaging and Shipment Criteria 
  
 *** 
  

	***	Material has been omitted pursuant to a request for confidential treatment. 

  

Page 4 of 10 

  
 *** 
  

	***	Material has been omitted pursuant to a request for confidential treatment. 

  

Page 5 of 10 

 *** 
  

	***	Material has been omitted pursuant to a request for confidential treatment. 

  

Page 6 of 10 

  
 *** 
  

	***	Material has been omitted pursuant to a request for confidential treatment. 

  

Page 7 of 10 

 *** 
  

	***	Material has been omitted pursuant to a request for confidential treatment. 

  

Page 8 of 10 

 *** 
  

	***	Material has been omitted pursuant to a request for confidential treatment. 

  

Page 9 of 10 

 *** 
  
 In WITNESS OF THE FOREGOING, the Parties have caused their authorized representatives to sign Annex 1a and Annex 1b: 
  
 Salmedix Inc.: 
  

			
	  
 /s/    F.
Andrew Dorr

	  	  
 April 23, 2004

	 F. Andrew Dorr
 C.O.O.
	  	 (Date)

  
 Fujisawa Deutschland GmbH: 

					
			
	   /s/ B. Huber

	  	   /s/ C. Wagner

	 	 March 19th, 2004

	 Dr. B. Huber
	  	 Cornelia Wagner
	 	 (Date)

	 -        Director
	  	 - Head Contract
	 	 
	          Manufacturing -
	  	   Manufacturing -
	 	 

  
 AMCIS
AG: 

					
			
	   /s/ P. M. Muller

	  	 /s/ H. Loos

	 	 Apr. 04, 2004

	 Dr. P. M. Muller
	  	 H. Loos
	 	 (Date)

	 C.O.O.
	  	 Head Quality
	 	 
	 	  	 Management
	 	 

  

	***	Material has been omitted pursuant to a request for confidential treatment. 

  

Page 10 of 10 

 Annex 3 
  
 SOLUTIA 
  
 Solutia Pharmaceutical Services Division 
  
 AMCIS 
  
 Solutia Pharmaceutical Services Division

 TABLE OF CONTENTS 
  

					
	 	  	 	  	Page

	 1.
	  	DEFINITIONS	  	1
			
	 2.
	  	OBJECTIVE	  	2
			
	 3.
	  	MANUFACTURE	  	2
			
	 4.
	  	PRE-SHIPMENT TESTING AND RELEASE FOR SHIPMENT CRITERIA	  	3
			
	 5.
	  	FAILURE INVESTIGATION	  	3
			
	 6.
	  	CHANGE CONTROL	  	3
			
	 7.
	  	PERSONNEL QUALIFICATIONS AND RESPONSIBILITIES	  	4
			
	 8.
	  	EQUIPMENT	  	4
			
	 9.
	  	MATERIAL CONTROLS OF CHEMICALS	  	4
			
	 10.
	  	RECORDS AND REPORTS	  	4
			
	 11.
	  	21 CFR PART 11: ELECTRONIC RECORDS; ELECTRONIC SIGNATURES	  	5
			
	 12.
	  	INSPECTIONS / AUDITS / VENDOR QUALIFICATION	  	5
			
	 13.
	  	RETAINS	  	5
			
	 14.
	  	SIGNATURES	  	6
			
	 	  	APPENDICES	  	 
	 	  	RESPONSIBILITIES MATRIX A	  	1
	 GMP MATRIX B
	  	1
	 CONTACT PERSONS AND FUNCTION
	  	3

  

 -i- 

 This Supplement is attached to and made part of the Global Services Agreement (the “Services
Agreement”), and is made this 28th day of February, 2004 between: 
  

	(1)	Amcis AG having an address at Hauptstrasse 159/173, CH-4416 Bubendorf, in Switzerland (hereinafter referred to as “Amcis”), and 

  

	(2)	Salmedix, Inc. having an address at 9380 Judicial Drive, San Diego, CA 92121 ([858-622-5063] and such Affiliates being, referred to as “Customer”).

  
 WHEREAS: 
  

	A.	As specified in the Services Agreement, Customer has retained Amcis to perform certain research and development and cGMP work which will entail in part making certain compounds
available to Customer; and 

  

	B.	Whereas, the parties to set forth and clarify certain agreed practices and procedures with regard to quality and testing. 

  
 NOW, THEREFORE, the Parties agree: 
  

	1.	DEFINITIONS 

  

	1.1	In this Supplement, the following terms shall have the meanings now given to them: 

  

	(a)	“Finished Goods” means any intermediate or active pharmaceutical ingredient (API) produced by Amcis to be shipped to the Customer or any Third Party as specified by the
Customer. 

  

	(b)	“Third Parties” means any entity or legal person other than members of the Amcis or Customer Group. 

  

	(c)	“Release Testing” means analytical testing of the quality attributes of the Finished Goods prior to shipment. 

  

	(d)	“Release Decision” means the decision taken to release Finished Goods for shipment to the Customer. Such a decision can only be taken once the Finished Goods have been
checked for compliance with Amcis internal SOPs and guidelines, and with the requirements agreed upon with the Customer and laid down in the project info sheet, or any equivalent document, e.g. project master plan. 

  

	(e)	“GMP” means Good Manufacturing Practices for the manufacture of intermediates and APIs. Amcis applies appropriate levels of control, depending on the use of the Finished
Goods as specified by the Customer. Amcis uses the following terms: “pre-clinical GMP”, “clinical GMP”, and “commercial GMP”, respectively (ref. Exhibit B). 

  

	(f)	“Pre-clinical GMP” means the manufacture and control of Finished Goods prepared for non-human use, e.g. in pre-clinical toxicology studies. Fast Track projects follow the
same guidelines. Details are given in the matrix in Exhibit B. 

  

	(g)	“Fast Track” means the manufacture and control of Finished Goods prepared for non-human use, e.g. in research studies. Details are given in the matrix in Exhibit B.

	(h)	“Clinical GMP” means the manufacture and control of Finished Goods prepared for human or veterinary use, e.g. as part of controlled clinical trials. Details are given in
the matrix in Exhibit B. 

  

	(i)	“Commercial GMP” means the manufacture and control of Finished Goods prepared for commercial human or veterinary use, or for use in late-phase clinical trials. Details are
given in the matrix in Exhibit B. 

  

	1.2	In this Supplement, Article headings are for ease of reading and do not form a substantive part of hereof. 

  

	2.	OBJECTIVE 

  

	2.1	The objective of this Supplement is to clearly define the practical and technical obligations and responsibilities of the Customer and of Amcis with regard to the quality management
and compliance of any project, which is undertaken (ref. Matrix in Exhibit A). 

  

	2.2	The basic rules governing the appropriate level of control are given in ICH guideline Q7A “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients”,
adopted in the EU in November 2000, adopted in the U.S.A. in September 2001, and adopted in Japan in November 2001. 

  

	2.3	This is to reflect general principles, with specifics defined in individual project info sheets, or project master plan covering each Project. Should there be a conflict between the
terms of this Supplement and the rest of the terms of the Services Agreement of which this Supplement is a part, then the terms of the rest of the Services Agreement shall control. 

  

	3.	MANUFACTURE 

  

	3.1	Customer will specify in advance to Amcis whether manufacture is for potential clinical or commercial use. 

  

	3.2	When clinical or commercial use is specified, all such manufacture conducted by Amcis on behalf of Customer will be conducted in accord with appropriate level of GMP.

  

	3.3	Manufacturing batch records will be approved by Salmedix Quality Unit and Product Development group prior to initiation of manufacturing. Significant changes in these manufacturing
practices will be communicated to Customer’s Quality Unit in writing for assessment of impact and approval before implementation. 

  

	3.4	All executed batch records for manufactured materials will be reviewed by Amcis Quality Unit. After review by Amcis Quality Unit, the executed batch record will be forwarded to
Salmedix for review. Salmedix and Amcis Quality Unit shall ensure that the lot was manufactured under cGMP conditions and may require additional comments, further investigations or clarification within the batch record prior to Salmedix’s
approval. Only after approval of the executed batch records by both Amcis’ and Salmedix’s Quality Units, the lot will be released. 

  

	3.5	Customer must be notified prior in the case that Amcis outsources manufacturing or processing. Outsourcing may only be performed by vendors qualified by Amcis and Salmedix Quality
Units. 

  

	3.6	Outsourcing of manufacturing, processing, or analytical work by Customer is not subject to activities covered by Amcis. Amcis takes no responsibility for the work or output of such
Third Party. 

  

 2 

	3.7	Amcis shall have a procedure for reprocessing material and if reprocessing becomes routine how the process will be incorporated into manufacturing process. 

 

	4.	PRE-SHIPMENT TESTING AND RELEASE FOR SHIPMENT CRITERIA 

  

	4.1	Customer may specify minimum quality attributes on a project basis (project info sheet, or project master plan). Internal Amcis release is in accord with Amcis written procedures
and is based on review of both testing and manufacturing records. 

  

	4.2	Amcis will test Customer products using qualified equipment and calibrated systems. Failures will be documented and Customer notification will be in accord with project info sheet,
or project master plan. 

  

	4.3	Finished Goods analytical methods developed by Amcis shall be approved by the appropriate Customer contact. Amcis developed finished goods methods will be used only when Customer
method is not available. 

  

	4.4	Customer shall notify Amcis of any update to Customer test procedures being used at Amcis. 

  

	4.5	Shipment criteria are defined in the project info sheet, or project master plan. 

  

	5.	FAILURE INVESTIGATION 

  

	5.1	In the event that any analysis results in a failure against the Specifications, Amcis will initiate laboratory investigation based on Amcis SOPs. In case that the failure is not due
to analytical error notification to Customer’s Quality Unit will be within two business days after discovery of the failure. Copies of completed laboratory investigations should be sent to Salmedix Quality Unit 

  

	5.2	Customer Quality Unit will be directly notified by Amcis QA for those failure investigations which might impact on lot releasability. This formal notification will occur at the
start of the investigation. 

  

	6.	CHANGE CONTROL 

  

	6.1	Amcis has a Change Control SOP. 

  

	6.2	Amcis will be notified in writing of a change made by Customer. 

  

	6.3	Customer is notified in writing of a change and or deviation made by Amcis during manufacturing or testing. Amcis and Salmedix Quality Units will make a determination of whether
change is major or minor according to the impact on product quality. In the event of a planned change or deviation Salmedix Quality Unit will be notified of minor changes and/or deviations and approve major changes and/or deviations.

  

	6.4	Transfer of process manufacturing and analytical test methodology between Third Parties and AMCIS must be communicated in writing to Customer Quality Unit in advance of the
transfer. 

  

	6.5	Analytical methods or process transfers will require approved protocols that include defined acceptance criteria. The protocols shall be approved by the transferring parties’
quality assurance units and other designated units. The technology transfer is considered transferred after the protocol has been executed and the data has been reviewed and approved by respective quality assurance units and other designated units.

  

 3 

	7.	PERSONNEL QUALIFICATIONS AND RESPONSIBILITIES 

  

	7.1	Each person at Amcis should be educated, trained and qualified to perform their job function under cGMP conditions. 

  

	7.2	There shall be an adequate number for qualified people to perform work during any part of development or manufacturing of materials and to work under cGMP at all times.

  

	7.3	Each person involved in the development or manufacturing of materials is responsible to work under cGMP conditions. 

  

	8.	EQUIPMENT 

  

	8.1	The equipment used during any manufacturing process should have a suitable design, size and location in the facility for its use in operations and maintenance.

  

	8.2	Each piece of equipment shall be made in that it will not react, absorb or add any substance to the material being made in the manufacturing process. 

  

	8.3	Each piece of equipment and its components shall be cleaned at appropriate levels that would not affect any material being manufactured. There will be written procedures for
validated methods on how the equipment is to be cleaned and maintained. 

  

	8.4	All equipment that is used in manufacturing shall have routine calibration and maintenance, written procedures and shall be qualified regarding installation and qualification.

  

	9.	MATERIAL CONTROLS OF CHEMICALS 

  

	9.1	There should be written procedures describing the receiving, storage, identification, handling, sampling, testing of materials. 

  

	9.2	There should be procedures describing the handling, storage and shelflife of materials in all phases of manufacturing, i.e. quarantine, Work In Progress or released.

  

	9.3	Distribution procedures shall be written describing the distribution of materials, including First In First Out (FIFO). 

  

	10.	RECORDS AND REPORTS 

  

	10.1	All records and reports used in the manufacturing of materials will be retained at Amics for a minimum of 10 years after the expiration date or a change in time in writing by
Salmedix. These documents are to include but not be limited to components testing or specifications, batch records, validation reports, etc. 

  

	10.2	All records and reports shall be available for authorized inspection at any time. 

  

	10.3	Batch production and control records shall be issued and reconciled by the Quality Unit. The documents are to be completed at the time of manufacturing. Accurate accounts of the
documents are to be fully investigated and kept with the executed batch record. 

  

	10.4	All laboratory records shall include sample, equipment, test procedure, data collection/storage, calculations, materials used and evaluation of results versus specifications.

  

 4 

	11.	21 CFR PART 11: ELECTRONIC RECORDS; ELECTRONIC SIGNATURES 

  

	11.1	Amcis currently uses a hybrid system wherein hardcopies of electronic data are defined as “originals”. Amcis is monitoring and assessing industry approach to compliance
and developing their program according to industry standards. Amcis further understands that Customer (or Customer designee) may conduct a site audit of their 21 CFR Part 11 program. 

  

	12.	INSPECTIONS / AUDITS / VENDOR QUALIFICATION 

  

	12.1	Customer can have access to the latest certificate related to regulatory agency inspections related to processes or equipment associated with Customer Project on request.

  

	12.2	Subcontracting to any Third Party by Amcis (ref. 3.4) is subject to Amcis vendor qualification procedures and approval by Salmedix Quality Assurance Unit. 

 

	12.3	Subcontracting to any Third Party by Customer (ref. 3.5) is subject to Customer’s vendor qualification procedures. 

  

	12.4	Salmedix will perform audits on a biannual basis, if needed. In the event of major changes in the manufacturing facility and or business practices Salmedix may audit more
frequently. 

  

	13.	RETAINS 

  

	13.1	Procedures should be in place for the handling, quantity and storage of retain samples for raw materials, intermediates and drug substance. 

  

 5 

	14.	SIGNATURES 

  
 IN WITNESS OF THE FOREGOING, the Parties have caused their authorised representatives to sign: 
  
 CUSTOMER 
  

			
	 /s/    [signature illegible]

	 	 25 March 2004

	Management	 	Date
		
	 /s/    [signature illegible]

	 	 25 Mar 04

	 Quality Unit
	 	 Date

  

	Amcis	

  

			
	 /s/    H. LOOS

	 	 02-Mar-2004

	Hartmut Loos (Quality Management)	 	Date
		
	 /s/    W. ALTHERR

	 	 02-Mar-2004

	Werner Altherr (Customer Project Management)	 	Date

 Responsibilities Matrix A 
  
 The Responsibilities Matrix details the various responsibilities assigned to either the Customer or Amcis. 
  
 *** 
  

	***	Material has been omitted pursuant to a request for confidential treatment. 

  

Page 1 of 2 

 *** 
  

	***	Material has been omitted pursuant to a request for confidential treatment. 

  

Page 2 of 2 

 GMP MATRIX B 
  
 ICH guideline Q7a, Section 19.10 (describing controls applied to APIs for use in clinical trials) states, “not all
controls in the previous sections of the guide are appropriate for the manufacture of a new API for investigational use during its development. Section 19 provides specific guidance unique to these circumstances”. 
  
 ICH guideline Q7a, Section 19.11 states, “The controls used in the
manufacture of APIs for use in clinical trials should be consistent with the stage of development of the drug product incorporating the API. Process and test procedures should be flexible to provide for changes as knowledge of the process increases
and clinical testing of a drug product progresses from pre-clinical stages through clinical stages. Once drug development reaches the stage where the API is produced for use in drug products intended for clinical trials, manufacturers should ensure
that APIs are manufactured in suitable facilities using appropriate production and control procedures to ensure the quality of the API”. 
  
 Accordingly, a GMP Matrix has been developed to describe those activities that are to be undertaken for different types of projects as follows:

  
 *** 
  

	***	Material has been omitted pursuant to a request for confidential treatment. 

  

Page 1 of 3 

 *** 
  

	***	Material has been omitted pursuant to a request for confidential treatment. 

  

Page 2 of 3 

 Contact Persons and Function 
  
 *** 
  

	***	Material has been omitted pursuant to a request for confidential treatment. 

  

Page 3 of 3 

 Annex 4  
  
 to the Global Service Agreement 
 between AMCIS AG and Fujisawa
Deutschland GmbH and Salmedix, Inc. 
  
 Work order No. 1
 
  
 for the Process Transfer, Validation and Production
of Bendamustine API 
  
 between 
  

	(3)	AMCIS AG having its address at Hauptstrasse 159/173, CH-4416 Bubendorf, Switzerland (hereinafter referred to as “AMCIS”), and 

  

	(4)	a) Fujisawa Deutschland GmbH having its address at Berg-am-Laim-Strasse 129, 81673 München, Germany (hereinafter referred to as “Fujisawa”), and

  
 b) Salmedix, Inc. having its address at
9380 Judicial Drive, San Diego, CA 92121, United States of America (hereinafter referred to as “Salmedix”). 
  
 WHEREAS: 
  

	A.	This Work Order has been made pursuant to the Global Service Agreement between AMCIS, Fujisawa and Salmedix with its Effective Date Dec. 15th 2003 (hereinafter referred to as “Global Service Agreement”), the terms and conditions thereof shall govern this Work Order.

  

	B.	The division of pharmaceutical responsibilities between AMCIS and Fujisawa and AMCIS and Salmedix is specified in the respective Quality Assurance (QA) Agreements attached to the
Global Service Agreement as Annex 2 and Annex 3, respectively incorporated herein by reference (hereinafter “QA Agreement”), the terms and conditions thereof shall additionally govern this Work Order.

  

	C.	This Work Order covers the process transfer, process optimization, demonstration and validation of the process for producing Product (as defined in the Global Service Agreement)
according to ICH-cGMP guidelines. Validation will be performed during the production of 3 x 8 kg serial batches of Product. 

  

	D.	This Work Order is based on the synthesis scheme (as attached hereto and incorporated herein by reference as Appendix 1) provided in the Technical Information Package as
supplied to AMCIS by Fujisawa and Salmedix under the Confidentiality Agreement between AMCIS and Fujisawa dated April 4th 2003 and the Confidentiality Agreement between AMCIS and Salmedix dated February 25th 2003,
respectively. The technical information is supplemented by information obtained in discussions with Fujisawa and Degussa (current manufacturer of Product for Fujisawa). 

  

 Page 1 of 10 

	E.	The goals of this Project are: 

  

	 	•	Transfer of the current Bendamustine production process from *** to AMCIS. 

  

	 	•	***, improvement of yields, process safety and environmental considerations are desired and will be considered for implementation. 

  

	 	•	Establishment of the commercial production process for Product in the plant of AMCIS in Bubendorf 

  

	1.	SCOPE OF WORK TO BE PERFORMED BY AMCIS 

  

	1.1.	AMCIS undertakes best efforts to 

  

	 	•	Use existing analytical methods to establish the impurity profiles. GMP conformity regarding the transfer and qualification of analytical methods is included as part of this Work
Order. 

  

	 	•	Monitor the impact of the process changes on the impurity profile of Product and ensure that the impurity profile is equal or better than in the given process.

  

	 	•	Demonstrate the process with ***; 

  

	 	•	In collaboration with the Customers, determine the appropriate API starting material for initiation of the GMP process and define any process and analytical method validation
requirements. 

  

	 	•	Manufacture *** in accordance with ICH-cGMP and Specifications. See Section 1.4 below and MSA. 

  

	 	•	Provide documentation in the form of a Development Report, Tech Transfer Protocol to demonstrate comparability and a Final Project Report. See QA Agreement for approval process.

  

	 	•	Preparation of all necessary regulatory documentation and files required for submission, including: 

  

	 	•	US Drug Master File for Salmedix 

  

	 	•	European Drug Master File for Fujisawa 

  

	 	•	Technology Transfer 

  

	1.2.	Key considerations for Process Development 

  

	 	•	The process will be run as described in the Technical Information Package provided by Salmedix and Fujisawa. Process safety and optimization will be addressed in the Stepwise
Considerations listed in Section 1.3 below. AMCIS reserves the right to ensure safe operations of the process in accordance with the Policies and Procedures Guideline in the Pharmaceutical Services Division. AMCIS will endeavor to follow the process
outlined by Salmedix 

	***	Material has been omitted pursuant to a request for confidential treatment. 

  

 Page 2 of 10 

 and Fujisawa however; process modifications to eliminate *** and hazardous processing conditions are
desired. In case the proposed improvements under review by AMCIS will not meet the desired results AMCIS confirms to stay with the process as defined by Salmedix and Fujisawa in the Technical Information Package. All process changes and potential
differences in the impurity profile of Product will be reviewed with Salmedix and Fujisawa before implementation into the GMP manufacturing process. 
  

	1.3.	Stepwise considerations for Process Development 

  
 *** 

	***	Material has been omitted pursuant to a request for confidential treatment. 

  

 

 Page 3 of 10 

 *** 
  

	1.4.	AMCIS shall make best efforts to produce the following lots of Product according to the process received from Salmedix and Fujisawa and in conjunction with the requested development
defined in this Work Order: 

  

			
	 •      ***
	  	***
	 •      ***
	  	***

  
 Estimated delivery to
Salmedix and/or Fujisawa is per the dates listed above for each item. The material will be produced under ICH-cGMP conditions and release for shipment of the Product will be made by AMCIS according to the Specifications (as stipulated in Annex
1a and Annex 1b attached to the Global Service Agreement and incorporated herein by reference). The final specifications will be defined in mutual discussions, between AMCIS and Salmedix and Fujisawa. 
  
 No validation of analytical methods is included in this Work Order, however,
transfers of previously validated analytical methods will be corroborated by Criteria agreed upon by AMCIS, Salmedix and Fujisawa. Fujisawa and Salmedix may independently establish transfer processes in line with their respective methods,
specifications and regulatory requirements. See QA Agreement for approval process. 
  
 The documentation stated under section 1.1., the Batch History as well as a copy of the complete batch documentation will be provided as part of this Work Order. 
  
 If at any stage during the manufacture of Product AMCIS believes that it
will not be able to meet the target as specified above, AMCIS will promptly inform Salmedix and Fujisawa and the Parties will enter good faith negotiations with a view to reassessing the target quantity and/or specification. 

	***	Material has been omitted pursuant to a request for confidential treatment. 

  

 Page 4 of 10 

	1.5	*** 

  
 In case the validation fails due to the fact that one or more testing parameters do not meet the acceptance criteria, any additional necessary actions will be identified between the parties and the resulting costs
will be covered by ***. In the event that validation fails due to a major deviation to the approved batch record, AMCIS will repeat the process at no cost to the Customers. 
  

	2.	PAYMENT 

  

	2.1	In consideration of the work to be performed by AMCIS pursuant to Section 1 Salmedix and Fujisawa shall remunerate AMCIS on the basis of the payment schedule attached hereto and
incorporated herein by reference as Appendix 2 and in accordance with the Baseline Plan attached hereto and incorporated herein by reference as Appendix 3. 

  
 AMCIS agrees to issue separate invoices to Fujisawa and Salmedix. 
  

	2.2	The budget of the payment schedule has been prepared based on details set forth in the Technical Information Package received from Salmedix and Fujisawa. It has been assumed that
the process in the Technical Information Package will perform as described. 

  
 However, deviations from this may necessitate an amendment to the proposed budget. Should this arise, the Parties shall meet in good faith to discuss the changed requirements and the impact on the budget. In
particular, should additional purification steps or analytical methods be required to meet the resulting specifications and/or should the optimization of the process result in significant cost savings, the costs will be revised. Cost to conduct the
manufacturing as originally proposed by Salmedix and Fujisawa was used in the determination of manufacturing costs which have been presented to the companies by AMCIS. Consequently, failure to modify the process by any or all of the methods
described above under Section 1.3, will not result in an increased cost of manufacturing. 
  

	2.3	The budget is based on the following assumptions: 

  

	 	•	The estimate assumes that the synthetic procedure described in the given technical information can be performed accordingly and gives material in a quality according to
specification attached to the Global Service Agreement. 

  

	 	•	Raw material costs are included in the project price. 

	***	Material has been omitted pursuant to a request for confidential treatment. 

  

 Page 5 of 10 

	 	•	Third Party tests *** are not included in the cost estimate and will be invoiced at cost in a 50/50 ratio to the customers. A copy of the invoice of the third party will be provided
to each of Salmedix and Fujisawa. 

  

	 	•	Analytical method transfer is included as required by Salmedix and Fujisawa. Transfers of previously validated analytical methods will be corroborated by criteria mutually agreed to
by Salmedix, Fujisawa and AMCIS. Fujisawa and Salmedix may independently establish transfer processes in line with their respective methods, specifications and regulatory requirements. See QA Agreement for approval process. 

 

	 	•	In case of a qualified supplier the release of the starting materials and raw materials are by aspect, identity and certificate of analysis of the supplier. In case of a
non-qualified supplier the release of the materials are in accordance with the DMF provided by Fujisawa or to be mutually agreed. 

  

	 	•	All intermediates will be fully tested according to the specifications in the DMF provided by Fujisawa. AMCIS may develop alternative in process (intermediate) testing methods which
improve the GMP compliance of the process and anticipated successfulness of ultimate validation of said methods. Any cost increase has to be prior approved by the Customers. 

  

	 	•	Reference standards for testing of the product will be provided by Fujisawa until the completion of this Work Order. 

  

	 	•	The material will be produced according to ICH-cGMP guidelines for Active Pharmaceutical Ingredients (API). 

  

	 	•	All quantities of the target material prepared during the campaign in excess of the target quantity will be supplied to Salmedix or Fujisawa free of charge.

  

	2.4.	All payments are to be made to AMCIS bank account as separately informed of. 

  

	2.5	Communications regarding invoicing and payment related to this should be between: 

  

			
	 AMCIS AG
 Dr. Werner Altherr
 Haupstrasse 159/173
 Bubendorf CH-4416
 Switzerland
 Tel +41 61 935 5310
	 	 Fujisawa Deutschland GmbH
 Accounting Department
 Berg-am-Laim-Str. 129,
 81673 München, Germany

	***	Material has been omitted pursuant to a request for confidential treatment. 

  
  

 Page 6 of 10 

			
	 	 	 Salmedix, Inc.
 Julie Crawford
 9380 Judicial Drive, San Diego,
 CA 92121, United States of America

  

	3.	TERMINATION 

  
 Salmedix and Fujisawa have jointly the right to cancel this Work Order at any time in accordance with Article 13.2 of the Global Service Agreement. 
  
 In such event AMCIS is entitled to charge Customer with: 
  

	(a)	The total costs incurred up to the date of actual termination of AMCIS’s activities, including an amount covering irrevocable commitments of AMCIS to Third Parties which AMCIS
is able to demonstrate were either reasonable or approved by Customer, already made before AMCIS’s receipt of the written notice of cancellation and relating to that part of the manufacturing of the Product which will not be carried out due to
the aforesaid cancellation and, 

  

	(b)	An amount equal to 20 percent (20%) of the total amount which AMCIS would have received from Customers for the full and proper performance of this Work Order now being cancelled by
Customers under this Clause. 

  
 The foregoing clause does not apply
if Customer cancels the manufacturing because AMCIS is in breach of the terms of the Agreement. 
  
 In WITNESS OF THE FOREGOING, the Parties have caused their authorised representatives to sign: 
  

			
	Salmedix Inc.:	 	 
		
	 /S/    F. ANDREW
DORR        

	 	 April 23, 2004

	 F. Andrew Dorr
 C.O.O.
	 	(Date)

  
 Fujisawa Deutschland GmbH: 

 

					
	   /s/ B. Huber

	 	   /s/ C. Wagner

	 	March 19th, 2004
	 Dr. B. Huber
	 	 Cornelia Wagner
	 	(Date)
	 -   Director
	 	 -   Head Contract
	 	 
	 Manufacturing -
	 	 Manufacturing -
	 	 

  
 AMCIS AG: 
  

					
	 /s/ P. M. Muller

	 	 /s/ W. Althern

	 	April 1st, 2004
	 Dr. P.M. Muller
	 	Cornelia Wagner	 	(Date)
	 -   C.O.O.
	 	 -   Customer Project
	 	 
	 	 	 Manager
	 	 
	 	 	 	 	 

 Manufacturing -Manufacturing - 
  
  

 Page 7 of 10 

 Appendix 1 
 to the Work Order No. 1 
 between AMCIS AG and Fujisawa Deutschland GmbH and Salmedix, Inc. 
  
 Bendamustine Synthesis Scheme 
  
 [***] 
  

	***	Material has been omitted pursuant to a request for confidential treatment. 

  

Page 8 of 10 

 Appendix 2 
 to the Work Order No. 1 
 between AMCIS AG and Fujisawa Deutschland GmbH and Salmedix, Inc. 
  
 Payment Schedule 
  
 (based on the quotation AM180303.6 of Amcis, dated August 20, 2003)

  

							
	 Payment according to the
 following
milestones:

	  	Cost to be charged
to Salmedix:

	  	Cost to be charged
to Fujisawa:

	  	 Timelines
under the
Baseline Plan*
 (Schedule 3)

	 - Execution of LOI (Letter of intent)
	  	***	  	***	  	***
	 - Execution of MSA (Manufacturing Service Agreement)
	  	***	  	***	  	***
	 - Raw material (will be invoiced acc. to the real consumption and not exceed the mentioned amount)
	  	***	  	***	  	***
	 - Delivery of ***
	  	***	  	***	  	***
	 - Upfront payment on initiation of the production of ***
	  	***	  	***	  	***
	 - Upfront payment prior to the analytics of the three batches
	  	***	  	***	  	***
	 - Upfront payment prior to the preparation of the registration documents
	  	***	  	***	  	***
	 - Shipment of first batch to Salmedix:
	  	***	  	***	  	***
	 - Shipment of 2 batches to Fujisawa:
	  	***	  	***	  	***
	 - Analytics
	  	***	  	***	  	***
	 - Delivery of the US-DMF
	  	***	  	***	  	***
	 - Delivery of the EU-DMF
	  	***	  	***	  	***

	*	date of payment has to be adapted to the achievement of the milestones in the timelines 

	***	Material has been omitted pursuant to a request for confidential treatment. 

  
 The cost for shipment and insurance will be covered by the respective Customers. 
  

 Page 9 of 10 

 Appendix 3 
 to the Work Order No. 1 
 between AMCIS AG and Fujisawa Deutschland GmbH and Salmedix, Inc. 
  
 Baseline Plan 
  
 [***] 

	***	Material has been omitted pursuant to a request for confidential treatment. 

  

 Page 10 of 10 

 Annex 6 
 to
the Global Service Agreement 
 between AMCIS AG and Fujisawa Deutschland GmbH and Salmedix, Inc. 
  
 Work order No. 3 
 for the commercial production of Bendamustine API 
  
 between 
  

	(1)	AMCIS AG having its address at Hauptstrasse 159/173, CH-4416 Bubendorf, Switzerland (hereinafter referred to as “AMCIS”), and 

  

	(2)	Salmedix, Inc, having an address at 9380 Judicial Drive, San Diego, CA 92121 (hereinafter referred to as “.Salmedix”) 

  
 Whereas: 
  

	A.	This Work Order has been made pursuant to the Global Service Agreement between AMCIS AG, Fujisawa Deutschland GmbH and Salmedix, Inc. dated December 15, 2003 (hereinafter referred
to as “Global Service Agreement”), the terms and conditions thereof shall govern this Work Order. 

  

	B.	This Work Order covers the commercial production of Product (as defined in the Global Service Agreement). 

  

	C.	The division of pharmaceutical responsibilities between the parties hereto is specified in the Quality Assurance (QA) Agreement attached to the Global Service Agreement as Annex
3 and incorporated herein by reference (hereinafter “QA Agreement”), the terms and conditions thereof shall additionally govern this Work Order. 

  

	1.	SCOPE OF WORK TO BE PERFORMED BY AMCIS 

  

	1.1	AMCIS undertakes best efforts to 

  

	 	•	manufacture and package such amount of Product as separately ordered by .Salmedix in writing from time to time in accordance with the Specifications (as stipulated in Annex
1a and Annex 1b attached to the Global Service Agreement and incorporated herein by reference) and in accordance with cGMP. At delivery Product shall have a remaining shelf life of *** 

  

	 	•	maintain adequate storage accommodation for Product in AMCIS’ warehouse until delivery to .Salmedix or its nominee; 

  

	***	Material has been omitted pursuant to a request for confidential treatment. 

	 	•	perform quality check test and inspection for Product to confirm its conformity with the Specifications, and to release them together with the Certificate of Analysis (which shall
include the results of such test and inspection) and the Quality Assurance Statement written in English on a lot basis; 

  

	 	•	to manufacture, package, label, deliver and handle the Product and otherwise perform its obligations hereunder (i) in a good and workmanlike fashion; (ii) in strict compliance with
(a) Good Manufacturing Practices as required by any relevant governmental authorities and (b) any and all applicable laws, regulations, rulings, guidelines, rules and procedures; and (iii) in accordance with the terms and conditions of this
Agreement; 

  

	 	•	to maintain any and all quality programs required by applicable laws, regulations and/or Fujisawa’s or Salmedix’s policies in effect from time to time and acceptable to
AMCIS; 

  

	1.2	Each time .Salmedix decides to order, it shall order the minimum quantity of *** of Product or a multiple thereof. 

  

	1.3	*** Salmedix shall provide AMCIS with a written estimate of its requirements of Product *** 

  

	1.4	All amounts of Product as ordered by *** shall be delivered to *** or its designated nominee at AMCIS’ risk and expense in accordance with *** instruction not less than ***
from *** firm order. 

  
 Any and all freight and
insurance costs shall be borne by .Salmedix. 
  

	2.	WARRANTY 

  

	2.1	AMCIS warrants and represents that all quantities of Product delivered hereunder shall comply with all applicable laws and regulations and shall meet the Specification and the terms
and conditions of this Work Order. 

  

	2.2	In case that .Salmedix has found that the delivery by AMCIS has quantitative shortcomings, that any quantity of Product delivered by AMCIS does not comply with applicable laws and
regulations and/or does not conform to the Specifications and/or the terms and conditions hereof (collectively referred to as “Defect”), Salmedix shall report the Defect to AMCIS within four (4) weeks after the Defect has come to
Salmedix’s knowledge. 

  

	2.3	In case of any Defect, Salmedix shall have the right – without prejudice to any other liability of AMCIS hereunder – to demand from AMCIS free of charge the immediate
replacement of the faulty shipment and/or rectification of any quantitative deficiency by Product in such quality as warranted pursuant to Section 2.1 hereof. 

  

	***	Material has been omitted pursuant to a request for confidential treatment. 

 The faulty shipment shall at AMCIS’ discretion and at AMCIS’ costs and risk either be returned
to AMCIS or its nominee or be destroyed in accordance with the applicable laws and regulations. 
  

	2.4	AMCIS undertakes to respond comprehensively and without delay to all enquiries and requests by Salmedix regarding a Defect in Product and shall make available to Salmedix. All
batch-related information if requested so by Salmedix or any regulatory body within five (5) working days. 

  

	2.5	In the event AMCIS does not confirm the Defect reported by Fujisawa, the parties to this Work Order shall endeavour to settle such dispute amicably and constructively between
themselves. In the event they fail to agree within four (4) weeks after receipt of the notice of defect, the *** with offices at *** shall be entrusted with the examination, the results of which shall be binding on both parties. All costs incurred
for such examination shall be borne by the losing party. 

  

	2.6	All claims by Salmedix regarding a Defect in Product are subject to a limitation period of two (2) years from date of release. Thereafter claims may not be asserted.

  

	3.	PAYMENT 

  

	3.1	In consideration of the work to be performed by AMCIS pursuant to Section 1 Salmedix shall pay AMCIS the supply price of USD *** / kg *** USD per kilogram) of Product. Salmedix and
AMCIS may from time to time negotiate multi-lot or quantity discounts. 

  

	3.2	Payments due under Section 3.1 shall be paid upon invoice *** days after shipment to AMCIS bank account: 

  
 Credit Suisse, CH-4410 Liestal 
  

	***	Material has been omitted pursuant to a request for confidential treatment. 

	3.4	Communications regarding invoicing and payment related to this should be between: 

  

			
	AMCIS AG	 	Salmedix, Inc.
		
	 Dr. Werner Altherr
 Haupstrasse 159/173
 Bubendorf CH-4416
 Switzerland
 Tel +41 61 935 5310
	 	 Julie Crawford
 Accounting Department
 9380 Judicial Drive
 San Diego, CA 92121, USA
 Tel +1 858 622 6679

  

	4.	TERM & TERMINATION 

  

	4.1	This Work Order shall commence upon the Effective Date (as defined in the Global Service Agreement) and thereafter shall continue in full force and effect for an initial period of 8
years. Thereafter it shall continue in full force and effect until terminated by any of the parties hereto upon eighteen (18) months prior written notice. 

  

	4.2	Notwithstanding Section 4.1 above, Salmedix has the right to cancel this Work Order at any time in accordance with Article 13.2 of the Global Service Agreement.

  
 In WITNESS OF THE FOREGOING, the Parties have caused their
authorised representatives to sign: 
  

							
	Salmedix, Inc.:	 	 	 	AMCIS AG:
				
	  
 /s/    F. ANDREW
DORR        

 F. Andrew Dorr,
C.O.O
	 	 	 	  
 /s/    P.M.
MULLER        

 Dr. P.M. Muller,
C.O.O.

	  	  
 /s/    W.
ALTHERN        

 Dr.
W. Althern
 Customer Project Manager

	 Date    April 23, 2004
	 	 	 	 Date    April 15, 2004Loan and Security Agreement

 EXHIBIT 10.4 
  
 This LOAN AND SECURITY AGREEMENT (this “Agreement”) dated the Effective Date between SILICON VALLEY BANK
(“Bank”) and SALMEDIX, INC. (“Borrower”), provides the terms on which Bank will lend to Borrower and Borrower will repay Bank. The parties agree as follows: 
  

	1.	ACCOUNTING AND OTHER TERMS 

  
 Accounting terms not defined in this Agreement will be construed following GAAP. Calculations and determinations must be made following GAAP. The term
“financial statements” includes the notes and schedules. The terms “including” and “includes” always mean “including (or includes) without limitation” in this or any Loan Document. Capitalized terms in this
Agreement shall have the meanings set forth in Section 13. 
  

	2.	LOAN AND TERMS OF PAYMENT 

  
 2.1 Credit Extensions. Borrower will pay Bank the unpaid principal amount of all Credit Extensions and interest on the unpaid principal amount of the Credit
Extensions in accordance with the terms and conditions hereof. 
  
 2.1.1 Equipment Advances. 
  
 (a) Subject
to the terms and conditions of this Agreement, Bank agrees to lend to Borrower, from time to time prior to the Commitment Termination Date, equipment advances (each an “Equipment Advance” and collectively the “Equipment
Advances”) in an aggregate amount not to exceed the Committed Equipment Line. When repaid, the Equipment Advances may not be re-borrowed. The proceeds of the Equipment Advances will be used solely to reimburse Borrower for the purchase of
Eligible Equipment purchased on and 90 days prior to the making of an Equipment Advance, provided, how ever, with respect to the first Equipment Advance hereunder only (and only if such Equipment Advance is made
substantially concurrently of the date of the execution hereof), the proceeds of such Equipment Advance may be used to reimburse Borrower for the purchase of equipment purchased on and after January 1, 2003. 
  
 (b) To obtain an Equipment Advance, Borrower will deliver to Bank a completed
supplement in substantially the form attached as Exhibit C (the “Loan Supplement”), copies of invoices for the Financed Equipment, together with a UCC Financing Statement covering the Equipment described on the Loan Supplement, and such
additional information as Bank may request, all at least five (5) Business Days before the proposed funding date (the “Funding Date”). On each Funding Date, Bank will specify in the Loan Supplement for each Equipment Advance, the Basic
Rate, the Loan Factor, and the Payment Dates. If Borrower satisfies the conditions of each Equipment Advance specified herein, Bank will disburse such Equipment Advance by internal transfer to Borrower’s deposit account with Bank. Each
Equipment Advance may not exceed 100% of the Original Stated Cost of the proposed Financed Equipment. 
  
 (c) Bank’s obligation to lend the undisbursed portion of the Committed Equipment Line will terminate if, in Bank’s sole discretion, there has
been a material adverse change in the general affairs, management, results of operation, condition (financial or otherwise) or the prospects of Borrower, whether or not arising from transactions in the ordinary course of business, or there has been
any material adverse deviation by Borrower from the most recent business plan of Borrower presented to and accepted by Bank prior to the execution of this Agreement. 
  

 2.2 Interest Rate; Payments. 
  
 (a) Principal and Interest Payments On Payment Dates. Borrower will repay each Equipment Advance on the terms
provided in the Loan Supplement relating thereto. Borrower will make payments monthly in advance of principal and accrued interest for each Equipment Advance (collectively, “Scheduled Payments”) on the first Business Day of the month
following the Funding Date (or commencing on the Funding Date if the Funding Date is the first Business Day of the month) with respect to such Equipment Advance and continuing thereafter during the Repayment Period on the first Business Day of each
calendar month (each a “Payment Date”), in an amount equal to the Loan Factor multiplied by the Loan Amount for such Equipment Advance. All unpaid principal and accrued and unpaid interest are due and payable in full on the last Payment
Date with respect to such Equipment Advance. Payments received after 12:00 noon Pacific time are considered received at the opening of business on the next Business Day. An Equipment Advance may only be prepaid in accordance with the terms hereof.

  
 (b) Interest Rate. Borrower will pay interest on the
Payment Dates (as described above) at the per annum rate of interest equal to the Basic Rate determined by Bank as of the Funding Date for each Equipment Advance in accordance with the definition of the Basic Rate. Any amounts outstanding during the
continuance of an Event of Default shall bear interest at a per annum rate equal to the Basic Rate plus five percentage points (5%). If any change in the law increases Bank’s expenses or decreases its return from the Equipment Advances,
Borrower will pay Bank upon request the amount of such increase or decrease. 
  
 (c) Interim Payment. In addition to the Scheduled Payments, on the Funding Date for each Equipment Advance (unless the Funding Date is the first Business Day of the month) Borrower shall pay to Bank, on behalf
of Bank, the projected interest to accrue from the Funding Date to the first Payment Date, pursuant to subsection (b) of this Section. 
  
 (d) Prepayment Upon an Event of Loss. If any Financed Equipment is subject to an Event of Loss and Borrower is required to or elects to prepay the
Equipment Advance with respect to such Financed Equipment pursuant to Section 6.7, then such Equipment Advance shall be prepaid to the extent and in the manner provided in such section. 
  
 (e) Mandatory Prepayment Upon an Acceleration. If the Equipment Advances are accelerated following the occurrence of
an Event of Default or otherwise (other than following an Event of Loss), then Borrower will immediately pay to Bank (i) all unpaid Scheduled Payments (including principal and interest) with respect to each Equipment Advance due prior to the date of
prepayment, (ii) all remaining Scheduled Payments (including principal and interest unpaid) due after such date, (iii) all accrued unpaid interest, including the default rate of interest, to the date of the prepayment, but without duplication of any
other payment item included herein; and (iv) all other sums, if any, that shall have become due and payable hereunder with respect to this Agreement. 
  
 (f) Permitted Prepayment of Loans. If the Bank consents in writing, Borrower shall have the option to prepay some or all of the Equipment Advances
(but in any event no repayment of a portion of any Equipment Advance shall be permitted) advanced by Bank under this Agreement, provided Borrower (i) provides written notice to Bank of its request to prepay the Equipment Advances at least
thirty (30) days prior to such prepayment, (ii) Bank consents thereto, and (iii) Borrower pays, on the date of the prepayment (1) all unpaid Scheduled Payments (including principal and interest) with respect to each Equipment Advance due prior to
the date of prepayment; (2) all remaining Scheduled Payments due after such date; (3) all other unpaid 

  

 -2- 

 
accrued interest to the date of the prepayment (but without duplication of any sum in item (1) hereof); and (4) all other sums, if any, that shall have
become due and payable hereunder with respect to the Equipment Advances so repaid as otherwise applicable under this Agreement. 
  
 2.3 Request to Debit. Bank may debit any of Borrower’s deposit accounts for principal and interest payments or any amounts Borrower owes Bank when due.
Bank will notify Borrower when it debits Borrower’s accounts. These debits are not a set-off. 
  
 2.4 Deposit; Bank Expenses. 
  
 (a) Good Faith Deposit. Borrower has made a good faith deposit with Bank of $5,000 which shall be applied to the Bank Expenses hereunder upon the closing hereof. 
  
 (b) Bank Expenses. Borrower will pay to Bank all Bank Expenses (including
reasonable attorneys’ fees and expenses) incurred through and after the Closing Date when due. 
  
 2.5 Additional Costs. If any law or regulation increases Bank’s costs or reduces its income for any loan, Borrower will pay the increase in cost or reduction in income or additional expense

  

	3.	CONDITIONS OF CREDIT EXTENSIONS 

  
 3.1 Conditions Precedent to Initial Credit Extension. Bank’s obligation to make the initial Credit Extension is subject to the condition precedent that
it receive the agreements, documents and fees it requires. 
  
 3.2
Conditions Precedent to all Credit Extensions. Bank’s obligations to make each Credit Extension, including the initial Credit Extension, is subject to the following: 
  
 (a) the satisfaction of the conditions set forth in section 2.1.1 hereof with respect to the making of an Equipment Advance;
and 
  
 (b) the representations and warranties in Section 5 hereof
must be materially true on the date of the submission of the Loan Supplement relating to the proposed Equipment Advances and on the effective date of each Credit Extension and no Event of Default may have occurred and be continuing, or result from
the Credit Extension. Each Credit Extension is Borrower’s representation and warranty on that date that the representations and warranties in Section 5 remain true in all material respects. 
  

	4.	CREATION OF SECURITY INTEREST 

  
 4.1 Grant of Security Interest. Borrower grants Bank a continuing security interest in all presently existing and later acquired Collateral to secure all
Obligations and performance of each of Borrower’s duties under the Loan Documents. Any security interest will be a first priority security interest in the Collateral. If the Agreement is terminated, Bank’s lien and security interest in the
Collateral will continue until Borrower fully satisfies its Obligations. 
  

 -3- 

	5.	REPRESENTATIONS AND WARRANTIES 

  
 Borrower represents and warrants as follows: 
  
 5.1 Due Organization and Authorization. Each of Borrower and its Subsidiaries is duly existing and in good standing in its state of formation and qualified
and licensed to do business in, and in good standing in, any state in which the conduct of its business or its ownership of property requires that it be qualified. The execution, delivery and performance of the Loan Documents have been duly
authorized, and do not conflict with Borrower’s formation documents, nor constitute an event of default under any material agreement by which Borrower is bound. Borrower is not in default under any agreement to which or by which it is bound in
which the default could cause a Material Adverse Change. 
  
 5.2
Collateral. Borrower has good title to the Collateral, free of Liens. 
  
 5.3 Litigation. Except as shown in the Schedule, there are no actions or proceedings pending or, to Borrower’s knowledge, threatened by or against Borrower or any Subsidiary of Borrower in which an adverse decision could
cause a Material Adverse Change. 
  
 5.4 No Material Adverse Change in
Financial Statements. All consolidated financial statements for Borrower and its Subsidiaries delivered to Bank fairly present in all material respects Borrower’s consolidated financial condition and Borrower’s consolidated results
of operations. There has not been any material deterioration in Borrower’s consolidated financial condition since the date of the most recent financial statements submitted to Bank. 
  
 5.5 Solvency. The fair salable value of Borrower’s assets (including goodwill minus disposition costs) exceeds the fair
value of its liabilities; the Borrower is not left with unreasonably small capital after the transactions in this Agreement; and Borrower is able to pay its debts (including trade debts) as they mature. 
  
 5.6 Regulatory Compliance. Borrower is not an “investment company” or
a company “controlled” by an “investment company” under the Investment Company Act. Borrower is not engaged as one of its important activities in extending credit for margin stock (under Regulations T and U of the Federal Reserve
Board of Governors). Borrower has complied with the Federal Fair Labor Standards Act. Borrower has not violated any laws, ordinances or rules, the violation of which could cause a Material Adverse Change. None of Borrower’s or any of its
Subsidiary’s properties or assets has been used by Borrower or such Subsidiary or, to the best of Borrower’s knowledge, by previous Persons, in disposing, producing, storing, treating, or transporting any hazardous substance other than by
legally doing so. Each of Borrower and its Subsidiaries has timely filed all required tax returns and paid, or made adequate provision to pay, all material taxes. Each of Borrower and its Subsidiaries has obtained all consents, approvals and
authorizations of, made all declarations or filings with, and given all notices to, all government authorities that are necessary to continue its business as currently conducted. 
  
 5.7 Subsidiaries. Borrower does not own any stock, partnership interest or other equity securities except for Permitted
Investments. 
  
 5.8 Full Disclosure. No representation, warranty or
other statement of Borrower in any certificate or written statement given to Bank contains any untrue statement of a material fact or omits to state a material fact necessary to make the statements contained in the certificates or statements not
misleading. 
  

 -4- 

	6.	AFFIRMATIVE COVENANTS 

  
 Borrower will do all of the following: 
  
 6.1 Government Compliance. Borrower will maintain its corporate existence and good standing in its jurisdiction of incorporation and maintain qualification
in each jurisdiction in which the failure to so qualify could have a material adverse effect on Borrower’s business or operations. Borrower will cause each of its Subsidiaries to maintain such Subsidiary’s corporate existence and good
standing in its jurisdiction of incorporation and maintain qualification in each jurisdiction in which the failure to so qualify could have a material adverse effect on Borrower’s business or operations. Borrower will comply, and will cause
each of its Subsidiaries to comply, with all laws, ordinances and regulations to which it is subject, the noncompliance with which could have a material adverse effect on Borrower’s business or operations or cause a Material Adverse Change.

  
 6.2 Financial Statements, Reports, Certificates. 
  
 (a) Borrower will deliver to Bank: (i) as soon as available, but no later
than 15 days after the last day of each month, a company prepared cash summary position report in form acceptable to Bank; (ii) as soon as available, but no later than 45 days after the last day of each quarter, a company prepared
consolidated balance sheet and income statement covering Borrower’s consolidated operations during the then ended quarterly period, in a form acceptable to Bank and certified by a Responsible Officer; (iii) as soon as available, but no later
than 120 days after the end of Borrower’s fiscal year, audited consolidated financial statements prepared under GAAP, consistently applied, together with an unqualified opinion on the financial statements from an independent certified
public accounting firm acceptable to Bank; (iv) a prompt report of any legal actions pending or threatened against Borrower or any Subsidiary that could result in damages or costs to Borrower or any Subsidiary of $100,000 or more; and (v) budgets,
sales projections, operating plans or other financial information Bank requests. 
  
 (b) Within 45 days after the last day of each quarter, Borrower will deliver to Bank with the quarterly financial statements a Compliance Certificate signed by a Responsible Officer in the form of Exhibit D.

  
 6.3 [Reserved] 
  
 6.4 Taxes. Borrower will make, and cause each of its Subsidiaries to make,
timely payment of all material federal, state, and local taxes or assessments and will deliver to Bank, on demand, appropriate certificates attesting to the payment. 
  
 6.5 Insurance. Borrower will keep its business and the Collateral insured for risks and in amounts, as Bank requests.
Insurance policies will be in a form, with companies, and in amounts that are reasonably satisfactory to Bank. All property policies will have a lender’s loss payable endorsement showing Bank as an additional loss payee and all liability
policies will show the Bank as an additional insured and provide that the insurer must give Bank at least 20 days notice before canceling its policy. At Bank’s request, Borrower will deliver certified copies of policies and evidence of all
premium payments. Subject to Section 6.7 (a) below, so long as no Event of Default has occurred and is continuing, Borrower shall have the option of applying the proceeds of any casualty policy to the replacement or repair of destroyed or damaged
property; provided that, after the occurrence and during the continuance of an Event of Default, all proceeds payable under any such casualty policy shall, at the option of Bank, be payable to Bank on account of the Obligations. 
  

 -5- 

 6.6 Primary Accounts; Bank Deposits. Borrower will maintain its primary depository, investment and
operating accounts with Bank. Further, and without limitation of the foregoing, Borrower will use its best efforts to maintain at all times with Bank deposits in an aggregate amount equal to at least three months of cash expenditures of Borrower
based on the most recently ended three month period or other period acceptable to Bank, provided that it is understood and agreed that no Default or Event of Default shall arise from the Borrower’s failure to maintain such aggregate
amount of deposits with Bank. 
  
 6.7 Loss; Destruction; or Damage.

  
 Borrower will bear the risk of the Financed Equipment
being lost, stolen, destroyed, or damaged. If during the term of this Agreement any item of Financed Equipment is lost, stolen, destroyed, damaged beyond repair, rendered permanently unfit for use, or seized by a governmental authority for any
reason for a period equal to at least the remainder of the term of this Agreement (an “Event of Loss”), then in each case, Borrower: 
  
 (a) Prior to the occurrence of an Event of Default, at Borrower’s option, will (i) pay to Bank on account of the Obligations all accrued interest to
the date of the prepayment, plus all outstanding principal; or (ii) repair or replace any Financed Equipment subject to an Event of Loss provided the repaired or replaced Financed Equipment is of equal or like value to the Financed Equipment subject
to an Event of Loss and provided further that Bank has a first priority perfected security interest in such repaired or replaced Financed Equipment. 
  
 (b) During the continuance of an Event of Default, on or before the Payment Date after such Event of Loss for each such item of Financed Equipment subject
to such Event of Loss, Borrower will, at Bank’s option, pay to Bank an amount equal to the sum of: (i) all accrued and unpaid Scheduled Payments (with respect to such Equipment Advance related to the Event of Loss) due prior to the next such
Payment Date due prior to the date of such payment, (ii) all regularly Scheduled Payments (including principal and interest) due after to the date of such payment, plus (iii) all other sums, if any, that shall have become due and payable, including
interest at the Default Rate with respect to any past due amounts. 
  
 (c) On the date of receipt by Bank of the amount specified above with respect to each such item of Financed Equipment subject to an Event of Loss, this Agreement shall terminate as to such Financed Equipment. If any proceeds of insurance or
awards received from governmental authorities are in excess of the amount owed under this Section, Bank shall promptly remit to Borrower the amount in excess of the amount owed to Bank. 
  
 6.8 Expression of Interest Regarding Investment. The parties hereto acknowledge and agree that, to the extent availability for
investment exists in each Equity Round (as defined below), as Borrower shall reasonably determine, Borrower shall upon any such determination of investment availability, notify Bank and its Bank affiliates (including, without limitation, Silicon
Valley Bancshares and Silicon Valley BancVentures, Inc.) of the option to invest up to $750,000 on a joint basis in each succeeding Equity Round after the date hereof on the same terms, conditions and pricing offered to the investors in each such
Equity Round. Borrower shall provide Bank with at least 30 days prior written notice of the proposed closing date of each Equity Round (such notice being referred to as the “Equity Notice”) if the opportunity for investment by Bank exists;
otherwise, Borrower shall notify Bank that it has determined that no opportunity for investment by Bank in such Equity Round exists. The Equity Notice is to contain the terms, conditions, and pricing of such Equity Round is to be delivered to Bank
at its address of Silicon Valley Bank, General Counsel, 3003 Tasman Drive, HG 180, Santa Clara, California 

  

 -6- 

 
95054. Regardless of the foregoing, Bank and Bank affiliates shall have the right, in their sole discretion, to determine whether to participate in such an
available Equity Round without any obligation to do so. “Equity Round” as used herein shall mean each of the equity financing transactions of Borrower on and after the date hereof 
  
 6.9 Further Assurances. Borrower will execute any further instruments and take
further action as Bank requests to perfect or continue Bank’s security interest in the Collateral or to effect the purposes of this Agreement. 
  

	7.	NEGATIVE COVENANTS 

  
 Borrower will not do any of the following without the Bank’s written consent, which will not be unreasonably withheld: 
  
 7.1 Dispositions. Convey, sell, lease, transfer or otherwise dispose of
(collectively a “Transfer”), or permit any of its Subsidiaries to Transfer, all or any material part of its business or property, other than a Transfer (i) of Inventory in the ordinary course of business; (ii) of nonexclusive licenses and
similar arrangements for the use of the property of Borrower or its Subsidiaries in the ordinary course of business; (iii) of worn-out or obsolete Equipment, other than for Financed Equipment; (iv) Transfers comprising or resulting in Permitted
Liens or (v) other Transfers which in the aggregate do not exceed $100,000, but not including any Collateral. 
  
 7.2 Changes in Business or Business Locations. Engage in or permit any of its Subsidiaries to engage in any business other than the businesses currently engaged in by Borrower. Borrower will not, without
at least 30 days prior written notice to Bank, relocate its principal executive office or add any new offices or business locations. 
  
 7.3 Transactions. Enter into any transaction outside of the ordinary course of business of Borrower, consistent with past business practices. 
  
 7.4 Encumbrance. Other than for Permitted Liens, create, incur, or allow any
Lien on any of the Collateral, or create, incur, or allow any Lien on any other assets or property of Borrower, or assign or convey any right relating thereto, or permit any of Collateral that is subject to the Bank’s first priority security
interest in the Collateral to change. 
  
 7.5 Compliance. Become an
“investment company” or a Person controlled by an “investment company” under the Investment Company Act; undertake as one of its important activities extending credit to purchase or carry margin stock, or use the proceeds of any
Advance for that purpose; fail to meet the minimum funding requirements of ERISA, permit a Reportable Event or Prohibited Transaction, as defined in ERISA, to occur; fail to comply with the Federal Fair Labor Standards Act or violate any other law
or regulation, if the violation could have a material adverse effect on Borrower’s business or operations or cause a Material Adverse Change, or permit any of its Subsidiaries to do so. 
  

 -7- 

	8.	EVENTS OF DEFAULT 

  
 Any one of the following is an “Event of Default” hereunder: 
  
 8.1 Payment Default. Borrower fails to pay any of the Obligations within 3 days after their due date. During the additional
period the failure to cure the default is not an Event of Default (but no Credit Extensions will be made during the cure period); 
  
 8.2 Covenant Default. If Borrower does not perform any obligation in Section 6 or violates any covenant in Section 7; or 
  
 If Borrower does not perform or observe any other material term, condition or
covenant in this Agreement, any Loan Documents, or in any agreement between Borrower and Bank and as to any default under such other term, condition or covenant that can be cured, has not cured the default within 10 days after it occurs, or if the
default relating thereto cannot be cured within 10 days or cannot be cured after Borrower’s attempts within 10 day period, and the default may be cured within a reasonable time, then Borrower has an additional period (of not more than 30 days)
to attempt to cure the default. During the additional time, the failure to cure the default is not an Event of Default (but no Credit Extensions will be made during the cure period); 
  
 8.3 Material Adverse Change. (i) A material impairment in the perfection or priority of the Bank’s security interest in
the Collateral or in the value of such Collateral which is not covered by adequate insurance occurs; (ii) a material adverse change in the business, operations, or condition (financial or otherwise) of the Borrower occurs; or (iii) a material
impairment of the prospect of repayment of any portion of the Obligations occurs (any of the foregoing is referred to herein as the a “Material Adverse Change”); 
  
 8.4 Attachment. (i) Any material portion of Borrower’s assets is attached, seized, levied on, or comes into possession of
a trustee or receiver and the attachment, seizure or levy is not removed in 10 days; (ii) Borrower is enjoined, restrained, or prevented by court order from conducting a material part of its business; (iii) a judgment or other claim becomes a Lien
on a material portion of Borrower’s assets; or (iv) a notice of lien, levy, or assessment is filed against a material portion of Borrower’s assets by any government agency and not paid within 10 days after Borrower receives notice. These
are not Events of Default if stayed or if a bond is posted pending contest by Borrower (but no Credit Extensions will be made during the cure period); 
  
 8.5 Insolvency. (i) Borrower becomes insolvent; (ii) Borrower begins an Insolvency Proceeding; or (iii) an Insolvency Proceeding is begun against Borrower
and not dismissed or stayed within 30 days (but no Credit Extensions will be made before any Insolvency Proceeding is dismissed); 
  
 8.6 Other Agreements. If there is a default in any agreement between Borrower and a third party that gives the third party the right to accelerate any
Indebtedness exceeding $250,000 or that could cause a Material Adverse Change; 
  
 8.7 Judgments. If a money judgment or judgments in the aggregate of at least $100,000 is rendered against the Borrower and is unsatisfied and unstayed for 10 days (but no Credit Extensions will be made before the judgment is
stayed or satisfied); or 
  
 8.8 Misrepresentations. If Borrower or
any Person acting for Borrower makes any material misrepresentation or material misstatement now or later in any warranty or representation in this 

  

 -8- 

 
Agreement or in any communication delivered to Bank or to induce Bank to enter this Agreement or any Loan Document (with it being recognized that financial
projections and forecasts provided by Borrower in good faith and based upon reasonable assumptions are not viewed as facts and that actual results during the period or periods covered by such projections and forecasts may differ from the projected
or forecasted results). 
  

	9.	BANK’S RIGHTS AND REMEDIES 

  
 9.1 Rights and Remedies. When an Event of Default occurs and continues Bank may, without notice or demand, do any or all of the following: 
  
 (a) Declare all Obligations immediately due and payable (but if an Event of
Default described in Section 8.5 occurs all Obligations are immediately due and payable without any action by Bank); 
  
 (b) Stop advancing money or extending credit for Borrower’s benefit under this Agreement or under any other agreement between Borrower and Bank;

  
 (c) Make any payments and do any acts it considers necessary
or reasonable to protect its security interest in the Collateral. Borrower will assemble the Collateral if Bank requests and make it available as Bank designates. Bank may enter premises where the Collateral is located, take and maintain possession
of any part of the Collateral, and pay, purchase, contest, or compromise any Lien which appears to be prior or superior to its security interest and pay all expenses incurred. Borrower grants Bank a license to enter and occupy any of its premises,
without charge, to exercise any of Bank’s rights or remedies; 
  
 (d) Apply to the Obligations any (i) balances and deposits of Borrower it holds, or (ii) any amount held by Bank owing to or for the credit or the account of Borrower; 
  
 (e) Ship, reclaim, recover, store, finish, maintain, repair, prepare for sale, advertise for sale, and sell the Collateral.
Bank is granted a non-exclusive, royalty-free license or other right to use, without charge, Borrower’s labels, patents, copyrights, mask works, rights of use of any name, trade secrets, trade names, trademarks, service marks, and advertising
matter, or any similar property as it pertains to the Collateral, in completing production of, advertising for sale, and selling any Collateral and, in connection with Bank’s exercise of its rights under this Section, Borrower’s rights
under all licenses and all franchise agreements inure to Bank’s benefit; and 
  
 (f) Dispose of the Collateral according to the Code or otherwise pursuant to law. 
  
 9.2 Power of Attorney. When an Event of Default occurs and continues, Borrower irrevocably appoints Bank as its lawful attorney to: (1) make, settle, and
adjust all claims under Borrower’s insurance policies to the extent of Bank’s insurable interest; and (ii) transfer the Collateral into the name of Bank or a third party as the Code permits. Bank may exercise the power of attorney to sign
Borrower’s name on any documents necessary to perfect or continue the perfection of Bank’s security interest hereunder regardless of whether an Event of Default has occurred. Bank’s appointment as Borrower’s attorney in fact, and
all of Bank’s rights and powers, coupled with an interest, are irrevocable until all Obligations have been fully repaid and performed and Bank’s obligation to provide Credit Extensions terminates. 
  

 -9- 

 9.3 [Reserved] 
  
 9.4 Bank Expenses. If Borrower fails to pay any amount or furnish any required proof of payment to third persons Bank may make all or part of the payment or
obtain insurance policies required in Section 6.5, and take any action under the policies Bank deems prudent. Any amounts paid by Bank are Bank Expenses and immediately due and payable, bearing interest at the then applicable rate and secured by the
Collateral. No payments by Bank are deemed an agreement to make similar payments in the future or Bank’s waiver of any Event of Default. 
  
 9.5 Bank’s Liability for Collateral. If Bank complies with reasonable banking practices, it is not liable or responsible for: (a) the safekeeping of
the Collateral; (b) any loss or damage to the Collateral; (c) any diminution in the value of the Collateral; or (d) any act or default of any carrier, warehouseman, bailee, or other person. Borrower bears all risk of loss, damage or destruction of
the Collateral. 
  
 9.6 Remedies Cumulative. Bank’s rights and
remedies under this Agreement, the Loan Documents, and all other agreements are cumulative. Bank has all rights and remedies provided under the Code, by law, or in equity. Bank’s exercise of one right or remedy is not an election, and
Bank’s waiver of any Event of Default is not a continuing waiver. Bank’s delay is not a waiver, election, or acquiescence. No waiver is effective unless signed by Bank and then is only effective for the specific instance and purpose for
which it was given. 
  
 9.7 Demand Waiver. Borrower waives demand,
notice of default or dishonor, notice of payment and nonpayment, notice of any default, nonpayment at maturity, release, compromise, settlement, extension, or renewal of accounts, documents, instruments, chattel paper, and guaranties held by Bank on
which Borrower is liable. 
  

	10.	NOTICES 

  
 Unless otherwise provided in this Agreement, all notices or demands by any party relating to this Agreement or any other agreement entered into in
connection herewith shall be in writing and (except for financial statements and other informational documents which may be sent by first-class mail, postage prepaid) shall be personally delivered or sent by a recognized overnight delivery service,
by certified mail, postage prepaid, return receipt requested, or by telefacsimile to Borrower or to Bank, as the case may be, at its addresses set forth below: 
  

			
	 If to Borrower:
	  	 SALMEDIX, INC.
 9380 Judicial Drive
 San Diego, CA 92121
 FAX: 858-622-5060

		
	 If to Bank:
	  	 Silicon Valley Bank
 4445 Eastgate Mall, Suite
110
 San Diego, CA 92121
 Attn: Ms. Linda S. Le Beau

FAX: 858-622-1692

  

	11.	CHOICE OF LAW, VENUE AND JURY TRIAL WAIVER 

  
 California law governs the Loan Documents without regard to principles of conflicts of law. Borrower and Bank each submit to the exclusive jurisdiction of
the State and Federal courts in San Diego County, California. BORROWER AND BANK EACH WAIVE THEIR RIGHT TO A JURY TRIAL OF ANY CLAIM OR CAUSE OF ACTION ARISING OUT 

  

 -10- 

 
OF OR BASED UPON THIS AGREEMENT, THE LOAN DOCUMENTS OR ANY CONTEMPLATED TRANSACTION, INCLUDING CONTRACT, TORT, BREACH OF DUTY AND ALL OTHER CLAIMS. THIS
WAIVER IS A MATERIAL INDUCEMENT FOR BOTH PARTIES TO ENTER INTO THIS AGREEMENT. EACH PARTY HAS REVIEWED THIS WAIVER WITH ITS COUNSEL. 
  

	12.	GENERAL PROVISIONS 

  
 12.1 Successors and Assigns. This Agreement binds and is for the benefit of the successors and permitted assigns of each party. Borrower may not assign this
Agreement or any rights or Obligations under it without Bank’s prior written consent which may be granted or withheld in Bank’s discretion. Bank has the right, without the consent of or notice to Borrower, to sell, transfer, negotiate, or
grant participation in all or any part of, or any interest in, Bank’s obligations, rights and benefits under this Agreement, the Loan Documents or any related agreement. 
  
 12.2 Indemnification. Borrower will indemnify, defend and hold harmless Bank and its officers, employees and agents against:
(a) all obligations, demands, claims, and liabilities asserted by any other party in connection with the transactions contemplated by the Loan Documents; and (b) all losses or Bank Expenses incurred, or paid by Bank from, following, or consequential
to transactions between Bank and Borrower (including reasonable attorneys’ fees and expenses), except, in all cases, for losses caused by Bank’s gross negligence or willful misconduct. 
  
 12.3 Time of Essence. Time is of the essence for the performance of all
Obligations in this Agreement. 
  
 12.4 Severability of Provision.
Each provision of this Agreement is severable from every other provision in determining the enforceability of any provision. 
  
 12.5 Amendments in Writing, Integration. All amendments to this Agreement must be in writing signed by both Bank and Borrower. This Agreement and the Loan
Documents represent the entire agreement about this subject matter, and supersedes prior or contemporaneous negotiations or agreements. All prior or contemporaneous agreements, understandings, representations, warranties, and negotiations between
the parties about the subject matter of this Agreement and the Loan Documents merge into this Agreement and the Loan Documents. 
  
 12.6 Counterparts. This Agreement may be executed in any number of counterparts and by different parties on separate counterparts, each of which, when
executed and delivered, are an original, and all taken together, are one Agreement. 
  
 12.7 Survival. All covenants, representations and warranties made in this Agreement continue in full force while any Obligations remain outstanding. The obligations of Borrower in Section 12.2 to indemnify Bank will survive
until all statutes of limitations for actions that may be brought against Bank have run. 
  
 12.8 Attorneys’ Fees, Costs and Expenses. In any action or proceeding between Borrower and Bank arising out of the Loan Documents, the prevailing party will be entitled to recover its reasonable
attorneys’ fees and other costs and expenses incurred, in addition to any other relief to which it may be entitled, whether or not a lawsuit is filed. 
  

 -11- 

	13.	DEFINITIONS 

  
 “Advance” or “Advances” is also referred to herein as an Equipment Advances or the Equipment Advances, as applicable.

  
 “Affiliate” of a Person is a Person that owns
or controls directly or indirectly the Person, any Person that controls or is controlled by or is under common control with the Person, and each of that Person’s senior executive officers, directors, partners and, for any Person that is a
limited liability company, that Person’s managers and members. 
  
 “Bank Expenses” are all audit fees and expenses and reasonable costs or expenses (including reasonable attorneys’ fees and expenses) for preparing, negotiating, administering, defending and enforcing the Loan Documents
(including appeals or Insolvency Proceedings). 
  
 “Basic
Rate” is, as of the Funding Date, the per annum rate of interest (based on a year of 360 days) equal to the sum of (a) the U.S. Treasury note yield to maturity for a term equal to the Treasury Note Maturity as quoted in The Wall Street
Journal on the day the Loan Supplement is prepared, plus (b) the Loan Margin, provided that the Basic Rate shall under no circumstances be deemed less than a rate equal to 7.68% per annum. 
  
 “Borrower’s Books” are all Borrower’s books and
records including ledgers, records regarding Borrower’s assets or liabilities, the Collateral, business operations or financial condition and all computer programs or discs or any equipment containing the information. 
  
 “Business Day” is any day that is not a Saturday, Sunday or
a day on which the Bank is closed. 
  
 “Closing
Date” is the date of this Agreement. 
  
 “Code” is the California Uniform Commercial Code, as amended or otherwise modified from time to time. 
  
 “Collateral” is the property described on Exhibit A. 
  
 “Committed Equipment Line” is a line of credit of up to $500,000. 
  
 “Commitment Termination Date” is December 31, 2003.

  
 “Contingent Obligation” is, for any Person,
any direct or indirect liability, contingent or not, of that Person for (i) any indebtedness, lease, dividend, letter of credit or other obligation of another such as an obligation directly or indirectly guaranteed, endorsed, co-made, discounted or
sold with recourse by that Person, or for which that Person is directly or indirectly liable; (ii) any obligations for undrawn letters of credit for the account of that Person; and (iii) all obligations from any interest rate, currency or commodity
swap agreement, interest rate cap or collar agreement, or other agreement or arrangement designated to protect a Person against fluctuation in interest rates, currency exchange rates or commodity prices; but “Contingent Obligation” does
not include endorsements in the ordinary course of business. The amount of a Contingent Obligation is the stated or determined amount of the primary obligation for which the Contingent Obligation is made or, if not determinable, the maximum
reasonably anticipated liability for it determined by the Person in good faith; but the amount may not exceed the maximum of the obligations under the guarantee or other support arrangement. 
  

 -12- 

 “Credit Extension” is each Advance and each other extension of credit by Bank for
Borrower’s benefit. 
  
 “Default” means an
event which, with notice or passage of time or both, would constitute an Event of Default. 
  
 “Effective Date” is the date Bank executes this Agreement. 
  
 “Eligible Equipment” is computer, laboratory test and measurement equipment, office equipment and furnishings, and Other Equipment,
subject to (1) the limitations set forth below in the definition thereof and (2) provided that any such Other Equipment complies with all of Borrower’s representations, warranties and covenants in favor of the Bank and which is acceptable to
Bank in all respects. All Equipment financed with the proceeds of Equipment Advances shall be new when purchased, provided that Bank, in its sole discretion, may finance used equipment. 
  
 “Equipment” is all present and future machinery, equipment,
tenant improvements, furniture, fixtures, vehicles, tools, parts and attachments in which Borrower has any interest. 
  
 “Equipment Advance” and “Equipment Advances” are defined in Section 2.1.1. 
  
 “ERISA” is the Employment Retirement Income Security Act of
1974, and its regulations. 
  
 “Event of Loss”
shall have the meaning set forth in Section 6.7 hereof. 
  
 “Financed Equipment” is defined in the Loan Supplement. 
  
 “Funding Date” shall have the meaning ascribed to such term in section 2.1.1 hereof. 
  
 “GAAP” shall mean generally accepted accounting principles, consistently applied. 
  
 “Guarantor” is any present or future guarantor of the
Obligations. 
  
 “Indebtedness” is (a)
indebtedness for borrowed money or the deferred price of property or services, such as reimbursement and other obligations for surety bonds and letters of credit, (b) obligations evidenced by notes, bonds, debentures or similar instruments, (c)
capital lease obligations and (d) Contingent Obligations. 
  
 “Insolvency Proceeding” is any proceeding by or against any Person under the United States Bankruptcy Code, or any other bankruptcy or insolvency law, including assignments for the benefit of creditors, compositions,
extensions generally with its creditors, or proceedings seeking reorganization, arrangement, or other relief. 
  
 “Interim Payment” shall have the meaning set forth in section 2.2(c) hereof. 
  
 “Lien” is a mortgage, lien, deed of trust, charge, pledge,
security interest or other encumbrance. 
  
 “Loan
Amount” is the aggregate original amount of each Equipment Advance. 
  

 -13- 

 “Loan Documents” are, collectively, this Agreement, any note, or notes or guaranties
executed by Borrower, and any other present or future agreement between Borrower and/or for the benefit of Bank in connection with this Agreement, all as amended, extended or restated. 
  
 “Loan Factor” is the percentage which results from amortizing the Equipment Advance over the Repayment
Period, using the Basic Rate as the interest rate. 
  
 “Loan Margin” is 550 basis points. 
  
 “Loan Supplement” has the meaning ascribed to such term in section 2.1.1 hereof. 
  
 “Material Adverse Change” has the meaning set forth in Section 8.3 hereof. 
  
 “Maturity Date” is, with respect to each Equipment Advance, the last day of the Repayment Period for such
Equipment Advance, or, if earlier, the date of acceleration of such Equipment Advance by Bank following an Event of Default. 
  
 “Obligations” are debts, principal, interest, Bank Expenses and other amounts Borrower owes Bank now or later, including Equipment
Advances, and including interest accruing after Insolvency Proceedings begin and debts, liabilities, or obligations of Borrower assigned to Bank. 
  
 “Original Stated Cost” is (i) the original cost to the Borrower of the item of new Equipment net of any and all freight, installation,
tax or (ii) the fair market value assigned to such item of used Equipment by mutual agreement of Borrower and Bank at the time of making of the Equipment Advance. 
  
 “Other Equipment” custom equipment, software licenses, leasehold improvements, furnishings, freight, taxes
and other items that the Bank determines to be acceptable to it in its discretion. Unless otherwise agreed to by Bank in writing: not more than 25% of all Equipment Advances shall relate to and be based on Other Equipment, which shall be determined
as of the earlier of the following: (A) the Commitment Termination Date, (B) the date that no further availability exists hereunder for further Equipment Advances or (C) such other date as the Bank shall determine is appropriate if the making of any
further Equipment Advances would necessarily result in a breach of the foregoing percentage limitation. 
  
 “Payment Date” shall have the meaning ascribed to such term in section 2.2(a) hereof. 
  
 “Permitted Liens” are: 
  
 (a) Liens as in existence as shown on the Schedule attached hereto.

  
 (b) Liens for taxes, fees, assessments or other government
charges or levies, either not delinquent or being contested in good faith and for which Borrower maintains adequate reserves on its Books, if they have no priority over any of Bank’s security interests; 
  
 (c) Purchase money Liens (i) on Equipment acquired or held by Borrower or its
Subsidiaries incurred for financing the acquisition of the Equipment, or (ii) existing on equipment when acquired, if the Lien is confined to the property and improvements and the proceeds of the equipment, but in no event shall any of the
foregoing in this clause (b) pertain to the Collateral; 
  

 -14- 

 (d) Liens securing claims or demands of materialmen, mechanics, carriers, warehousemen, landlords and
other like persons or entities imposed without action of such parties; provided that payment thereof is not yet required; and 
  
 (e) Liens incurred or deposits made in the ordinary course of Borrower’s business in connection with worker’s compensation, unemployment
insurance, social security and other like laws. 
  
 “Person” is any individual, sole proprietorship, partnership, limited liability company, joint venture, company, trust, unincorporated organization, association, corporation, institution, public benefit corporation, firm,
joint stock company, estate, entity or government agency. 
  
 “Prime Rate” is Bank’s most recently announced “prime rate,” even if it is not Bank’s lowest rate. 
  
 “Repayment Period” is 36 months. 
  
 “Responsible Officer” is each of the Chief Executive Officer, the President, the Chief Financial Officer, and the Controller of Borrower.

  
 “Schedule” is any attached schedule of
exceptions. 
  
 “Scheduled Payments” shall have
the meaning ascribed to such term in section 2.2(a) hereof. 
  
 “Subordinated Debt” is debt incurred by Borrower subordinated to Borrower’s indebtedness owed to Bank and which is reflected in a written agreement in a manner and form acceptable to Bank and approved by Bank in
writing. 
  
 “Subsidiary” is for any Person,
joint venture, or any other business entity of which more than 50% of the voting stock or other equity interests is owned or controlled, directly or indirectly, by the Person or one or more Affiliates of the Person. 
  

 -15- 

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

									
	 BORROWER:
  
 SALMEDIX, INC.
	 	 	 	 Bank:
  
 SILICON VALLEY BANK

					
	By	 	/s/    ANITA I. BUSQUETS        	 	 	 	By	 	/s/    LINDA LEBEAU        
	 	 	
	 	 	 	 	 	

	 Title
	 	Chief Financial & Admin Officer	 	 	 	 Title
	 	SVP
				
	 	 	 	 	 	 	 Effective Date: June 25, 2003

  

 -16- 

 EXHIBIT A 
  

The Collateral consists of all of Borrower’s right, title and interest in and to the following Borrower’s personal property: 
  
 All Financed Equipment, including, without limitation, all goods, equipment and general
intangibles financed by the Bank; and all substitutions for, additions and accessions to and proceeds thereof; and all Borrower’s Books relating to the foregoing and any and all claims, rights and interests in any of the above and all
substitutions for, additions and accessions to and proceeds thereof. 
  

 EXHIBIT B 
  

[Reserved] 
  

 EXHIBIT C 
  

FORM OF LOAN AGREEMENT SUPPLEMENT 
  
 LOAN AGREEMENT SUPPLEMENT No. [    ] 
  
 LOAN AGREEMENT SUPPLEMENT No. [    ], dated
                , 200   (“Supplement”), to the Loan and Security Agreement dated as of June     , 2003 (the
“Loan Agreement) by and between the undersigned (“Borrower”), and Silicon Valley Bank (“Bank”). Capitalized terms used herein but not otherwise defined herein are used with the respective meanings given to such terms in the
Loan Agreement. 
  
 To secure the prompt payment by Borrower of all amounts
from time to time outstanding under the Loan Agreement, and the performance by Borrower of all the terms contained in the Loan Agreement, Borrower grants Bank, a first priority security interest in each item of equipment and other property described
in Annex A hereto, which equipment and other property shall be deemed to be additional Financed Equipment and Collateral. The Loan Agreement is hereby incorporated by reference herein and is hereby ratified, approved and confirmed. 
  
 Annex A (Equipment Schedule) and Annex B (Loan Terms Schedule) are attached hereto.

  
 The proceeds of the Loan should be transferred to Borrower’s account with
Bank set forth below: 
  
 Bank Name:  Silicon Valley Bank

 Account No.:
                             
  
 Borrower hereby certifies that (a) the foregoing information is true and correct and authorizes Bank to endorse in its respective books and
records, the Basic Rate applicable to the Funding Date of the Loan contemplated in this Loan Agreement Supplement and the principal amount set forth in the Loan Terms Schedule; (b) the representations and warranties made by Borrower in the Loan
Agreement are true and correct on the date hereof and will be true and correct on such Funding Date. No Event of Default has occurred and is continuing under the Loan Agreement. This Supplement may be executed by Borrower and Bank in separate
counterparts, each of which when so executed and delivered shall be an original, but all such counterparts shall together constitute but one and the same instrument. 
  
 This Supplement is delivered as of this day and year first above written. 
  

													
	 SILICON VALLEY BANK
	 	 	 	 SALMEDIX, INC.

							
	By:	 	 	 	 	 	 	 	By:	 	 	 	 
	 	 	 	 	
	 	 	 	 	 	 	 	

	 	 	 Name:
	 	 	 	 	 	 	 	 Name:
	 	 
	 	 	 	 	
	 	 	 	 	 	 	 	

	 	 	 Title:
	 	 	 	 	 	 	 	 Title:
	 	 
	 	 	 	 	
	 	 	 	 	 	 	 	

  
 Annex A - Description of Financed
Equipment 
 Annex B - Loan Terms Schedule 
  

 Annex A to Exhibit C 
  
 The Financed Equipment being financed with the Equipment Advance which this Loan Agreement Supplement is being executed is listed below.
Upon the funding of such Equipment Advance, this schedule automatically shall be deemed to be a part of the Collateral. 
  

									
	 Description of Equipment:

	 	 Make

	 	 Model

	  	Serial #

	  	Invoice #

  

 2 

 Annex B to Exhibit C 
  
 LOAN TERMS SCHEDULE #             
  
 Loan Funding Date:         ,
200   
  
 Original Loan Amount:
$             
  
 Basic Rate:             % 
  
 Loan Factor:             % 
  
 Scheduled Payment Dates and Amounts: 
  
 One (1) payment of $         due 
              payment of $         due
monthly in advance from          through             . 
 One (1) payment of $         due 
  
 Maturity Date:              
  

			
	 Payment No.

	  	Payment Date

	 1
	  	 
	 2
	  	 
	 3
	  	 
	 4
	  	 

  
 . . . 
 [36] 
 . . . 
  

 3 

 EXHIBIT D 
 COMPLIANCE CERTIFICATE 
  

			
	TO:	  	SILICON VALLEY BANK
		
	FROM:	  	SALMEDIX, INC.

  
 The undersigned
authorized officer of SALMEDIX, INC. certifies that under the terms and conditions of the Loan and Security Agreement between Borrower and Bank (the “Agreement”), (i) Borrower is in complete compliance for the period ending
                         with all required covenants except as noted below and (ii) all representations and warranties in
the Agreement are true and correct in all material respects on this date. Attached are the required documents supporting the certification. The Officer certifies that these are prepared in accordance with Generally Accepted Accounting Principles
(GAAP) consistently applied from one period to the next except as explained in an accompanying letter or footnotes. The Officer acknowledges that no borrowings may be requested at any time or date of determination that Borrower is not in compliance
with any of the terms of the Agreement, and that compliance is determined on an ongoing basis and not just at the date this certificate is delivered. 
  
 Please indicate compliance status by circling Yes/No under “Complies” column. 
  

					
	 Reporting Covenant

	  	 Required

	  	Complies

	 Cash Summary Report
	  	Monthly within 15 days	  	Yes    No
	 Quarterly Financial Statements and Compliance Certificate
	  	Quarterly within 45 days	  	Yes    No
	 Annual (CPA Audited)
	  	FYE within 120 days	  	Yes    No

  

									
	 	 	 	 	BANK USE ONLY
	 Comments Regarding Exceptions: See Attached.
	 	 	 	 
	 	 	 	 	 Received by:
	 	 
	 	 	 	 	 	 	 	

	 Sincerely,
	 	 	 	 	 	AUTHORIZED SIGNER
				
	 SALMEDIX, INC.
	 	 	 	 Date:
	 	 
	 	 	 	 	 	 	 	

					
	By	 	 	 	 	 	Verified:	 	 
	 	 	
	 	 	 	 	 	

	 	 	 Title:
	 	 	 	 	 	AUTHORIZED SIGNER
					
	 Date:
	 	 	 	 	 	 Date:
	 	 
	 	 	
	 	 	 	 	 	

					
	 	 	 	 	 	 	Compliance Status:	 	Yes         No

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