Document:

EX-10.20

 Exhibit 10.20 

RESOURCE GROUP MANAGEMENT SERVICES AGREEMENT 

This Resource Group Management Services Agreement (as amended, modified or supplemented from time to time, this
“Agreement”) is entered into as of September 8, 2011 by and between Valeritas, Inc., a Delaware corporation (the “Company”) and (iii) WCAS Management Corporation, a Delaware corporation
(“WCAS Management”). 
 RECITALS 

A. On the date hereof, the Company and Welsh, Carson, Anderson & Stowe XI, L.P., a Delaware limited partnership (“WCAS
XI”) and certain Affiliates of WCAS XI entered into a certain Series C Preferred Stock Agreement (the “Purchase Agreement”), whereby WCAS XI and certain of its Affiliates agreed to purchase a certain number of
shares of Series C Preferred Stock from the Company upon the terms and conditions contained therein, including the execution and delivery of this Agreement by the Company and WCAS Management. The transactions contemplated by the Purchase Agreement
are referred to herein as the “Contemplated Transactions”. 
 B. Indemnitees (as hereinafter defined) may have
certain rights to indemnification, advancement of expenses and/or insurance provided by WCAS Management or WCAS XI (or their respective Affiliates other than the Company), which the Company, WCAS Management and WCAS XI intend to be secondary to the
primary obligation of the Company to indemnify Indemnitees, as provided under the certificate of incorporation of the Company, and any other contract or organizational document or otherwise, between the Company, on the one hand, and the Indemnitees
party thereto, on the other hand, with the Company’s acknowledgement of and agreement to the foregoing being a material condition to Indemnitees’ willingness to provide services to the Company. 

C. The WCAS Resources Group consists of operating executives that have been recruited and retained by WCAS Management to provide consulting
services to the portfolio companies of the various investment partnerships that are from time to time managed by WCAS Management and the services provided by the WCAS Resources Group are of a nature otherwise available to such portfolio companies
from unaffiliated third parties (but not of a nature historically provided by the investment professionals of WCAS Management). 
 D. The
Company desires to retain WCAS Management to provide certain management, consulting, strategic, financial and other advisory services to the Company and its Affiliates and WCAS Management is willing to provide such services on the terms set forth
below. 
 AGREEMENT 

NOW, THEREFORE, in consideration of the mutual covenants contained herein, the parties hereto, intending to be legally bound, hereby agree as
follows: 
 1. Resources Group Services. WCAS Management hereby agrees that it will make available to the Company members of the WCAS
Resources Group selected by WCAS Management to provide strategic, managerial and operational advice to the senior management of the Company, including, without limitation, (i) advice with respect to the development and implementation of
strategies for improving operating performance, (ii) advice in connection with product and service offering development, marketing and distribution, (iii) advice in connection with the negotiation of agreements with suppliers, customers,
landlords, licensees, licensors, strategic partners and other persons with whom the Company conducts business, and (iv) advice in connection with strategic planning and analysis, human resources, executive recruitment and other operational
matters. 

 The WCAS Resources Group will devote such time and efforts to the performance of the services contemplated hereby
as WCAS Management deems reasonably necessary or appropriate. The Company acknowledges that the services of the WCAS Resources Group are not exclusive and that WCAS Management and its affiliates and the WCAS Resources Group will render similar
services to other persons and entities. WCAS Management and the Company understand that the Company may, at times, engage one or more consultants, investment bankers or financial or other advisers to provide services in addition to, but not in lieu
of, services provided under this Agreement. In providing services to the Company, WCAS Management will act as an independent contractor and it is expressly understood and agreed that this Agreement is not intended to create, and does not create, any
partnership, agency, joint venture or similar relationship and that neither WCAS Management, on the one hand, nor the Company, on the other, has the right or ability to contract for or on behalf of each other or to effect any transaction for each
other’s account. 
 2. Payment of Fees. 

(a) The Company shall be obligated to pay to WCAS Management (or an affiliate of WCAS Management designated by it) an annual
fee (the “Resource Group Fee”) equal to FIVE HUNDRED THOUSAND DOLLARS ($500,000), or such other amount as may be mutually agreed to from time to time by WCAS Management and the Company in order to reflect the scope of the services
being provided and the costs incurred by the WCAS Management (and its affiliates) in making available its WCAS Resources Group personnel for purposes of providing such services. The Resource Group Fee shall be payable in quarterly installments in
advance on or prior to the first day of each calendar quarter beginning on each January 1, April 1, July 1 and October 1; provided, that on the date hereof, the Company shall pay in advance the Resource Group Fee for the
period from the date hereof through December 31, 2011. Once paid, the Resource Group Fee shall be non-refundable. 
 (b) Each
payment made pursuant to this Section 2 will be paid by wire transfer of immediately available federal funds to an account specified by WCAS Management for such purposes, or by other means as WCAS Management and the Company may from time to
time agree. 
 3. Term. This Agreement will continue in full force and effect until December 31, 2021 (the “Initial
Termination Date”); provided that (a) this Agreement shall be automatically 

  
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extended for an additional one year period on the Initial Termination Date and on each December 31 thereafter (with the next succeeding December 31 becoming an “Extended Termination
Date”) unless the Company or WCAS Management provide written notice of their or its desire not to automatically extend the term of this Agreement to the other parties hereto at least 90 days prior to such Initial Termination Date or
Extended Termination Date, as applicable, (b) WCAS Management may terminate this Agreement upon not less than 10 days written notice to the Company, (c) the Company may, upon not less than 90 days prior written notice terminate this
Agreement in order to retain unaffiliated third parties to provide services in lieu of the services of the Resource Group to be provided under this Agreement and (d) this Agreement shall terminate automatically without further action by either
party hereto (i) upon a Liquidation Event (as defined in the Third Amended and Restated Certification of Incorporation of the Company, in effect as of the date hereof (the “Restated Charter”)), (ii) in the event WCAS XI
assigns, transfers or sells fifty percent (50%) or more of the shares of capital stock of the Company then held by WCAS XI (other than a transfer to an Affiliate of WCAS XI) and (iii) in the event of a Series C Step Down Event ( as defined
in the Restated Charter) (the period on and after the date hereof through the termination hereof being referred to herein as the “Term”); provided further, that each of (x) Sections 4, 5 and 8 of
this Agreement (whether in respect of or relating to services rendered during or after the Term) and (y) any and all accrued and unpaid obligations of the Company owed under Section 2 will all survive any termination of this Agreement.

 4. Expenses; Indemnification. 

(a) Expenses. The Company shall pay on demand all expenses incurred by WCAS Management, WCAS XI and their respective
Affiliates relating to operations of, or services provided by WCAS Management or any of its Affiliates to, the Company or any of its Affiliates from time to time and otherwise relating to any investment made by WCAS XI or any of its Affiliates in
the Company or any of its Affiliates or the ownership or sale of all or any part of such investments by WCAS XI or its Affiliates after the date hereof. Without limiting the generality of the foregoing, the Company agrees to pay on demand all
expenses incurred by WCAS Management, WCAS XI and their respective Affiliates in connection with, or relating to, (x) the preparation, negotiation and execution of this Agreement, the Purchase Agreement and the Ancillary Agreements (as defined
in the Purchase Agreement), any other agreement relating to any of the foregoing, and the consummation of the Contemplated Transactions and any other transactions entered into by the Company or any of its Affiliates during the Term (including any
future financing transactions with WCAS XI or any of its Affiliates, any public offering, any future acquisition by the Company or any of its Affiliates or any transaction that is a Liquidation Event (as defined in the Restated Charter) or
(y) any and all amendments, modifications, restructurings and waivers, and exercises and preservations of rights and remedies relating to any of the foregoing, and in each case will specifically include the fees and disbursements of counsel,
accountants, consultants or advisors retained by WCAS Management, WCAS XI or their respective Affiliates or their respective consultants or advisors, and any out-of-pocket expenses incurred by WCAS Management, WCAS XI or their respective Affiliates
in connection with the provision of services to the Company or any of its Affiliates from time to time or the attendance at any meeting of the managers, officers or board of directors (or equivalent thereof), including any committee thereof, of the
Company or any of its Affiliates. 

  
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 (b) Indemnity and Liability. The Company hereby indemnifies and agrees to
exonerate and hold each of WCAS Management, WCAS XI and each of their respective partners, shareholders, members, Affiliates, directors, officers, fiduciaries, managers, controlling persons, employees and agents and each of the partners,
shareholders, members, directors, officers, fiduciaries, managers, controlling persons, employees and agents of each of the foregoing (collectively, the “Indemnitees”), each of whom is an intended third party beneficiary of this
Agreement, free and harmless from and against any and all actions, causes of action, suits, claims, liabilities, losses, damages and all costs and expenses in connection therewith, including without limitation reasonable attorneys’ fees and
expenses (collectively, the “Indemnified Liabilities”), incurred by the Indemnitees or any of them as a result of, arising out of, or in any way relating to (i) this Agreement, the Purchase Agreement, any Ancillary Agreement
(as defined in the Purchase Agreement), the Restated Charter, the Contemplated Transactions and any other transaction to which the Company or any of its Affiliates are a party or any related transactions or (ii) operations of, or services
provided by WCAS Management or its Affiliates to, any of the Company or its Affiliates from time to time (including but not limited to any indemnification obligations assumed or incurred by any Indemnitee to or on behalf of any of the Company or any
of its accountants or other representatives, agents or Affiliates) except for any such Indemnified Liabilities arising from such Indemnitee’s gross negligence or willful misconduct, and if and to the extent that the foregoing undertaking may be
unavailable or unenforceable for any reason, the Company hereby agrees to make the maximum contribution to the payment and satisfaction of each of the Indemnified Liabilities that is permissible under applicable law. For purposes of this
Section 4(b), none of the circumstances described in the limitations contained in the immediately preceding sentence shall be deemed to apply absent a final non-appealable judgment of a court of competent jurisdiction to such effect, in
which case to the extent any such limitation is so determined to apply to any Indemnitee as to any previously advanced indemnity payments made by the Company, then such payments shall be promptly repaid by such Indemnitee to the Company. The rights
of any Indemnitee to indemnification hereunder will be in addition to any other rights any such person may have under any other agreement or instrument to which such Indemnitee is or becomes a party or is or otherwise becomes a beneficiary or under
law or regulation. The Company hereby agrees that it is the indemnitor of first resort (i.e., the obligations of the Company under the certificate of incorporation of the Company, or any other agreement that any of the Company may have with
the Indemnitees are primary and any obligation of WCAS Management or WCAS XI (or any of their respective Affiliates other than the Company) to provide advancement or indemnification for the same Indemnified Liabilities (including all interest,
assessment and other charges paid or payable in connection with or in respect of such Indemnified Liabilities) incurred by Indemnitee are secondary), and if WCAS Management or WCAS XI (or any Affiliate thereof other than the Company) pays or causes
to be paid, for any reason, any amounts otherwise indemnifiable hereunder or under any other indemnification obligation (whether pursuant to any other contract, any organizational document or otherwise) with any Indemnitee, then (i) WCAS
Management or WCAS XI (or such Affiliate, as the case may be) shall be fully 

  
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subrogated to all rights of Indemnitee with respect to such payment and (ii) the Company shall reimburse WCAS Management or WCAS XI (or such Affiliate) for the payments actually made. The
Company hereby unconditionally and irrevocably waives, relinquishes and releases (and covenants and agrees not to exercise, and to cause each Affiliate of the Company not to exercise), any claims or rights that the Company may now have or hereafter
acquire against any Indemnitee (in any capacity) that arise from or relate to the existence, payment, performance or enforcement of one of the Company’s obligations under this Agreement or under any indemnification obligation (whether pursuant
to any other contract, any organizational document or otherwise), including any right of subrogation, reimbursement, exoneration, contribution or indemnification and any right to participate in any claim or remedy of any Indemnitee against any other
Indemnitee, whether such claim, remedy or right arises in equity or under contract, statute, common law or otherwise, including any right to claim, take or receive from any Indemnitee, directly or indirectly, in cash or other property or by set-off
or in any other manner, any payment or security or other credit support on account of such claim, remedy or right. None of the Indemnitees will be liable to the Company or any of its Affiliates for any act or omission suffered or taken by such
Indemnitee that does not constitute willful misconduct. 
 5. Disclaimer and Limitation of Liability; Opportunities. 

(a) Disclaimer; Standard of Care. WCAS Management makes no representations or warranties, express or implied, in respect
of the services to be provided by it hereunder. In no event will WCAS Management or any of the Indemnitees be liable to any of the Company or its Affiliates for any act, alleged act, omission or alleged omission that does not constitute gross
negligence or willful misconduct of WCAS Management or another Indemnitee as determined by a final, non-appealable determination of a court of competent jurisdiction. 

(b) Freedom to Pursue Opportunities. In recognition that WCAS Management, WCAS XI and their respective Affiliates
currently have, and will in the future have or will consider acquiring, investments in numerous companies with respect to which WCAS Management, WCAS XI or their respective Affiliates or the other Indemnitees may serve as an advisor, a director or
in some other capacity, and in recognition that WCAS Management, WCAS XI and their respective Affiliates and the other Indemnitees have myriad duties to various investors and partners, and in anticipation that the Company and WCAS Management or WCAS
XI (or one or more Affiliates, associated investment funds or portfolio companies, or clients of WCAS Management or WCAS XI) may engage in the same or similar activities or lines of business and have an interest in the same areas of corporate
opportunities, and in recognition of the benefits to be derived by the Company hereunder and in recognition of the difficulties that may confront any advisor who desires and endeavors fully to satisfy such advisor’s duties in determining the
full scope of such duties in any particular situation, the provisions of this Section 5(b) are set forth to regulate, define and guide the conduct of certain affairs of the Company as they may involve WCAS Management, WCAS XI or their
respective Affiliates or the other Indemnitees. Except as WCAS Management may otherwise agree in writing after the date hereof: 

(i) Each of WCAS Management, WCAS XI and their respective Affiliates and the other Indemnitees will have the right: (A) to
directly or indirectly engage in any business (including, without limitation, any business activities or lines of business that are the same as or similar to those pursued by, or competitive with, any of the Company or its Affiliates, (B) to
directly or indirectly do business with any client or customer of any of the Company or its Affiliates, (C) to take any other action that any of them believe in good faith is necessary to or appropriate to fulfill their obligations as described
in the first sentence of this Section 5(b), and (D) not to present potential transactions, matters or business opportunities to the Company or its Affiliates, and to pursue, directly or indirectly, any such opportunity for itself, and to
direct any such opportunity to another person. 

  
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 (ii) WCAS Management, WCAS XI and their respective Affiliates and the other
Indemnitees will have no duty (contractual or otherwise) to communicate or present any corporate opportunities to the Company or its Affiliates or to refrain from any action specified in Section 5(b)(i), and the Company on its own behalf
and on behalf of its Affiliates, hereby renounce and waive any right to require WCAS Management, WCAS XI or their respective Affiliates or the other Indemnitees to act in a manner inconsistent with the provisions of this Section 5(b).

 (iii) None of WCAS Management, WCAS XI or their respective Affiliates or the other Indemnitees will be liable to the
Company or its Affiliates for breach of any duty (contractual or otherwise) by reason of any activities or omissions of the types referred to in this Section 5(b) or of any such person’s participation therein. 

(c) Limitation of Liability. In no event will WCAS Management, WCAS XI or their respective Affiliates or the other
Indemnitees be liable to the Company or its Affiliates for any indirect, special, incidental or consequential damages, including, without limitation, lost profits or savings, whether or not such damages are foreseeable, or for any third party claims
(whether based in contract, tort or otherwise), relating to the services to be provided hereunder. 
 6. Assignment, etc. Except as
provided below, no party hereto has the right to assign this Agreement without the prior written consent of the other parties. Notwithstanding the foregoing, (a) WCAS Management may assign all or part of its rights and obligations hereunder to
any Affiliate of WCAS Management or WCAS XI that provides services similar to those called for by this Agreement, in which event WCAS Management will be released of all of its rights and obligations hereunder and (b) the provisions hereof for
the benefit of WCAS XI and the other Indemnitees other than WCAS Management shall also inure to the benefit of WCAS XI and such other Indemnitees and their successors and assigns, each of whom is an intended third party beneficiary of their
Agreement entitled to enforce its provisions as if a party hereto. 

  
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 7. Amendments and Waivers. No amendment or waiver of any term, provision or condition of
this Agreement will be effective, unless in writing and executed by each of WCAS Management and the Company. No waiver on any one occasion will extend to or effect or be construed as a waiver of any right or remedy on any future occasion. No course
of dealing of any person nor any delay or omission in exercising any right or remedy will constitute an amendment of this Agreement or a waiver of any right or remedy of any party hereto. 

8. Governing Law; Jurisdiction. 

(a) Choice of Law. This Agreement and all matters arising under or related to this Agreement will be governed by and
construed in accordance with the domestic substantive laws of the State of New York. 
 (b) Consent to Jurisdiction.
Each of the parties agrees that all actions, suits or proceedings arising out of, based upon or relating to this Agreement or the subject matter hereof will be brought and maintained exclusively in the federal and state courts of the State of New
York, County of New York. Each of the parties hereto by execution hereof (i) hereby irrevocably submits to the jurisdiction of the federal and state courts in the State of New York, County of New York for the purpose of any action, suit or
proceeding arising out of or based upon this Agreement or the subject matter hereof and (ii) hereby waives to the extent not prohibited by applicable law, and agrees not to assert, by way of motion, as a defense or otherwise, in any such
action, suit or proceeding, any claim that it is not subject personally to the jurisdiction of the above-named courts, that it is immune from extraterritorial injunctive relief or other injunctive relief, that its property is exempt or immune from
attachment or execution, that any such action, suit or proceeding may not be brought or maintained in one of the above-named courts, that any such action, suit or proceeding brought or maintained in one of the above-named courts should be dismissed
on grounds of forum non conveniens, should be transferred to any court other than one of the above-named courts, should be stayed by virtue of the pendency of any other action, suit or proceeding in any
court other than one of the above-named courts, or that this Agreement or the subject matter hereof may not be enforced in or by any of the above-named courts. Notwithstanding the foregoing, to the extent that any party hereto is or becomes a party
in any litigation in connection with which it may assert indemnification rights set forth in this Agreement, the court in which such litigation is being heard will be deemed to be included in clause (i). Each of the parties hereto hereby consents to
service of process in any such suit, action or proceeding in any manner permitted by the laws of the State of New York. The provisions of this Section 8 will not restrict the ability of any party to enforce in any court any judgment
obtained in a federal or state court of the State of New York. 
 (c) Waiver of Jury Trial. TO THE EXTENT NOT
PROHIBITED BY APPLICABLE LAW THAT CANNOT BE WAIVED, EACH OF THE PARTIES HERETO HEREBY WAIVES, AND COVENANTS THAT IT WILL NOT ASSERT (WHETHER AS PLAINTIFF, DEFENDANT, OR OTHERWISE), ANY RIGHT TO TRIAL BY JURY IN ANY FORUM IN RESPECT OF ANY ISSUE,
CLAIM, DEMAND, CAUSE OF ACTION, ACTION, SUIT OR PROCEEDING ARISING 

  
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OUT OF, BASED UPON OR RELATING TO THIS AGREEMENT OR THE SUBJECT MATTER HEREOF, IN EACH CASE WHETHER NOW EXISTING OR HEREAFTER ARISING AND WHETHER IN CONTRACT OR TORT OR OTHERWISE. EACH OF THE
PARTIES HERETO ACKNOWLEDGES THAT IT HAS BEEN INFORMED BY EACH OTHER PARTY THAT THE PROVISIONS OF THIS SECTION 8(C) CONSTITUTE A MATERIAL INDUCEMENT UPON WHICH SUCH PARTY IS RELYING AND WILL RELY IN ENTERING INTO THIS AGREEMENT AND THE
TRANSACTIONS CONTEMPLATED HEREBY. ANY OF THE PARTIES HERETO MAY FILE AN ORIGINAL COUNTERPART OR A COPY OF THIS AGREEMENT WITH ANY COURT AS WRITTEN EVIDENCE OF THE CONSENT OF EACH OF THE PARTIES HERETO TO THE WAIVER OF ITS RIGHT TO TRIAL BY JURY.

 9. Entire Agreement. This Agreement contains the entire understanding of the parties with respect to the subject matter hereof and
supersedes any prior communication or agreement with respect thereto. 
 10. Notice. All notices, demands, and communications
required or permitted under this Agreement will be in writing and will be effective if served upon such other party and such other party’s copied persons as specified below to the address set forth for it below (or to such other address as such
party will have specified by notice to each other party) if (i) delivered personally, (ii) sent and received by facsimile or (iii) sent by certified or registered mail or by Federal Express, UPS or any other comparably reputable
overnight courier service, postage prepaid, to the appropriate address as follows: 
 If to the Company, to it at: 

 

			
	750 Route 202 South, Suite 100
	Bridgewater, NJ 08807
	Attention:	  	
	Facsimile:	  	

 with a copy to: 
  

			
	Morgan, Lewis & Bockius LLP
	502 Carnegie Center
	Princeton NJ 08540-6241
	Attention:	  	
	Facsimile:	  	

  
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 If to WCAS Management or WCAS XI, to it at: 

 

			
	c/o Welsh, Carson, Anderson & Stowe
	320 Park Avenue, Suite 2500
	New York, New York 10022
	Attention:	  	
	Facsimile:	  	

 with a copy to: 
  

			
	Ropes & Gray LLP
	1211 Avenue of the Americas
	New York, New York 10036-8704
	Attention:	  	
		  	
	Facsimile:	  	

 Unless otherwise specified herein, such notices or other communications will be deemed effective, (a) on the date
received, if personally delivered or sent by facsimile during normal business hours, (b) on the business day after being received if sent by facsimile other than during normal business hours, (c) one business day after being sent by
Federal Express, UPS or other comparably reputable delivery service and (d) five business days after being sent by registered or certified mail. Each of the parties hereto shall be entitled to specify a different address by giving notice as
aforesaid to each of the other parties hereto. 
 11. Certain Definitions. As used herein, the following terms have the following
meanings: 
 “Affiliate” means, with respect to any specified Person at any time, each Person
directly or indirectly controlling, controlled by or under direct or indirect common control with such specified Person at such time. 

“Person” means any natural person, corporation, limited liability company, partnership, trust, joint
stock company, business trust, unincorporated association, joint venture, governmental authority or other legal entity of any nature whatsoever. 

12. Severability. If in any judicial or arbitral proceedings a court or arbitrator refuses to enforce any provision of this Agreement,
then such unenforceable provision will be deemed eliminated from this Agreement for the purpose of such proceedings to the extent necessary to permit the remaining provisions to be enforced. To the full extent, however, that the provisions of any
applicable law may be waived, they are hereby waived to the end that this Agreement be deemed to be valid and binding agreement enforceable in accordance with its terms, and in the event that any provision hereof is found to be invalid or
unenforceable, such provision will be construed by limiting it so as to be valid and enforceable to the maximum extent consistent with and possible under applicable law. 

  
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 13. Counterparts. This Agreement may be executed in any number of counterparts and by each
of the parties hereto in separate counterparts, each of which when so executed will be deemed to be an original and all of which together will constitute one and the same agreement. 

[The remainder of this page is intentionally left blank. Signatures follow.] 

  
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 IN WITNESS WHEREOF, each of the parties has caused this Agreement to be executed on its behalf as
of the date first above written by a duly authorized representative thereof. 
  

							
	WCAS MANAGEMENT:	 		 	WCAS MANAGEMENT CORPORATION
				
		 		 	By:	 	/s/ JONATHAN RATHER
		 		 		 	  

		 		 	Name:	 	JONATHAN RATHER
		 		 	Title:	 	Treasurer
			
	THE COMPANY:	 		 	VALERITAS, INC.
				
		 		 	By:	 	  

		 		 	Name:	 	
		 		 	Title:	 	

 IN WITNESS WHEREOF, each of the parties has caused this Agreement to be executed on its behalf as
of the date first above written by a duly authorized representative thereof. 
  

							
	WCAS MANAGEMENT:	 		 	WCAS MANAGEMENT CORPORATION
				
		 		 	By:	 	  

		 		 	Name:	 	
		 		 	Title:	 	
			
	THE COMPANY:	 		 	VALERITAS, INC.
				
		 		 	By:	 	/s/ Kristine Peterson
		 		 		 	  

		 		 	Name:	 	Kristine Peterson
		 		 	Title:	 	CEOEX-10.21

 Exhibit 10.21 

FORMATION AGREEMENT 

FORMATION AGREEMENT, dated as of August 22, 2006 (the “Effective Date”), by and among Valeritas LLC, a Delaware limited
liability company (the “Company”), BTI Tech, Inc., a Delaware corporation (“BTI”) and BioValve Technologies, Inc., a Delaware corporation (“BioValve”) (this “Agreement”). 

RECITALS 
 WHEREAS, the Company,
BioValve and BTI are contemporaneously with the execution of this Agreement entering into a Limited Liability Company Agreement governing the Company (the “LLC Agreement”); 

WHEREAS, the Company, BioValve and BTI are entering into this Agreement to effect the transfer and contribution by BioValve and BTI to the
Company of the Contributed Assets and the Assumed Liabilities described herein; and 
 WHEREAS, in exchange for the Contributed Assets, the
Company is concurrently issuing to BioValve and BTI Membership Interests in the Company as set forth on Exhibit A hereto. 
 WHEREAS,
following the execution of this Agreement, (i) BioValve intends to enter into the Securities Purchase Agreement (the “Securities Purchase Agreement”), among BioValve, the Company and the other parties thereto, (ii) the
Company intends to enter into the Senior Secured Convertible Exchangeable Notes (the “Notes”) in favor of the Holders (as defined in the Notes), (iii) BioValve intends to enter into the Guaranty (the
“Guaranty”) in favor of the Payee (as defined in the Guaranty), (iv) the Company intends to enter into the Warrant Agreement (the “Warrant”) among the Company and the Holders (as defined in the Warrant) and
(v) the Company intends to enter into the Security Agreement (the “Security Agreement” and together with the Securities Purchase Agreement, the Note, the Guaranty and the Warrant, the “Bridge Loan Agreements”)
among the Company and the Investor (as defined in the Security Agreement). 
 NOW, THEREFORE, in consideration of the mutual covenants and
agreements set forth in this Agreement, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows: 

ARTICLE 1 

DEFINITIONS 

Section 1.1 Capitalized terms used in this Agreement shall have the following meanings (terms defined in the singular or the plural
include the plural or the singular, as the case may be): 
 “Agreement” has the meaning ascribed to it in the caption. 

  
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 “Affiliate” means, with respect to any Person, a Person who is an
“affiliate” of such first Person within the meaning of Rule 405 under the Securities Act. 
 “Apportioned
Obligations” means all real property taxes, personal property taxes and similar ad valorem obligations levied with respect to the Contributed Assets for a taxable period that includes (but does not end on) the Effective Date. 

“Assumed Accounts Payable” has the meaning ascribed to it in Section 2.4. 

“Assumed Liabilities” has the meaning ascribed to it in Section 2.4. 

“Benefit Plan” means any plan, program, or arrangement maintained by BioValve or any of its Affiliates or under which either
Bio Valve or any of its Affiliates has or may have any obligation to contribute, with respect to any of BioValve’s employees, whether such plan, program or arrangement is formal or informal, written or unwritten, and whether or not such plan,
program, or arrangement is an “employee benefit plan” subject to the Employee Retirement Income Security Act of 1974, as amended (“ERISA”). 

“BioValve” has the meaning ascribed to it in the caption. 

“BioValve Insurance Policies” means the policies insuring the Contributed Assets. 

“BTI” has the meaning ascribed to it in the caption. 

“Bridge Loan Agreements” has the meaning ascribed to it in the recitals. 

“Business Day” means any day other than a Saturday or Sunday or a day on which banking institutions located in New York City
are permitted or required by law, executive order or decree of a Governmental Entity to remain closed. 
 “Company” has the
meaning ascribed to it in the caption. 
 “Contingent Obligation” means, as applied to any Person, any direct or indirect
liability of that Person with respect to any Indebtedness, lease, dividend, guaranty, letter of credit or other obligation, contractual or otherwise (the “primary obligation”) of another Person (the “primary obligor”), whether or
not contingent, (a) to purchase, repurchase or otherwise acquire such primary obligations or any property constituting direct or indirect security therefor, (b) to advance or provide funds (i) for the payment or discharge of any such
primary obligation, or (ii) to maintain working capital or equity capital of the primary obligor or otherwise to maintain the net worth or solvency or any balance sheet item, level of income or financial condition of the primary obligor,
(c) to purchase property, securities or services primarily for the purpose of assuring the owner of any such primary obligation of the ability of the primary obligor to make payment of such primary obligation, or (d) otherwise to assure or
hold harmless the owner of any such primary obligation against loss or failure or inability to perform in respect thereof. The amount of any Contingent Obligation shall be deemed to be an amount equal to the stated or determinable amount of the
primary obligation in respect of which such Contingent Obligation is made or, if not stated or determinable, the reasonably anticipated liability in respect thereof. 
  

  
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 “Contract” means any loan or credit agreement, bond, debenture, note, mortgage,
indenture, guarantee, lease or other contract, commitment, agreement, instrument, obligation, undertaking, license, permit, concession, franchise or legally binding arrangement or understanding, whether written or oral. 

“Contributed Assets” has the meaning ascribed to it in Section 2.2. 

“Contributed Inventory” has the meaning ascribed to it in Section 2.2(b). 

“Control” or “Controlled” means, when used with respect to any intellectual property right or other
intangible property, and only in such case, the possession or right of use (whether by license or ownership, or by control over a subsidiary having possession or right of use by license or ownership) by a Person of the ability to grant to the other
Person access, right of use or a license or sublicense as provided herein without violating the terms of any written contract with any third party. 

“Device Assets” means all of BioValve’s assets relating to BioValve’s drug delivery/medical device initiative;
provided that following the contribution contemplated in Section 2.1, Device Assets shall include the assets and liabilities transferred to BTI pursuant to such contribution. 

“Disclosure Schedule” means the disclosure schedule prepared by BioValve and BTI and delivered on the date hereof. 

“Effective Date” has the meaning ascribed to it in the caption. 

“Excluded Liabilities” has the meaning ascribed to it in Section 2.5. 

“Governmental Entity” means any nation, state, province, county, city or political subdivision and any official, agency,
arbitrator, authority, court, department, commission, board, bureau, instrumentality or other governmental entity of any thereof, whether domestic or foreign. 

“Indebtedness” of any Person means, without duplication, (i) all indebtedness of such Person for borrowed money, with
respect to deposits or advances of any kind or for the deferred purchase price of property or services (other than current trade liabilities incurred in the ordinary course of business and payable in accordance with customary practices and not more
than 90 days past due), (ii) all obligations of such Person evidenced by bonds, debentures, notes or similar instruments, (iii) all obligations of such Person upon which interest charges are customarily paid, (iv) all obligations of
such Person under conditional sale or other title retention agreements relating to property or assets purchased by such Person, (v) all Indebtedness of others secured by (or for which the holder of such Indebtedness has an existing right,
contingent or otherwise, to be secured by) any Lien on property owned or acquired by such Person, whether or not the obligations secured thereby have been assumed, (vi) all guarantees by such Person of Indebtedness of others, (vii) all
capital lease obligations of such Person, (viii) all obligations of such Person in respect of interest rate protection agreements, foreign currency exchange agreements, caps or collar agreements or other interest or exchange rate hedging
arrangements either generally or under specific contingencies, (ix) all obligations of such Person as an account party in respect of letters of credit and banker’s acceptances, (x) all obligations of such Person consisting of
overdrafts (e.g., cash float reflected as a negative on the cash line), (xi) all obligations of such Person pursuant to any deferred compensation agreements and (xii) any Contingent Obligation of such Person. 

  
 – 3 – 

 “Insured Loss” has the meaning ascribed to it in Section 4.3. 

“Intellectual Property Rights” means (i) all intellectual property rights as listed in Section 1.1 of the
Disclosure Schedule, together with (ii) any other type of rights in Intellectual Property that are owned or Controlled by BioValve or BTI to the extent related to the Device Assets. 

“Intellectual Property” means any or all of the following and all rights in, arising out of, or associated therewith (in each
case in any domestic or foreign jurisdiction): (i) patents and applications therefor and all reissues, divisions, renewals, extensions, provisionals, continuations and continuations-in-part thereof; (ii) all inventions, discoveries and
ideas (whether patentable or not); (iii) trade secrets, proprietary information, know how, confidential information, technology and technical data, and all documentation relating to any of the foregoing and rights to limit the use of disclosure
thereof by any person; (iv) all copyrights, copyright registrations and applications therefor and all other rights corresponding thereto; (v) writings and other works, whether copyrightable or not; (vi) all trade names, trademarks,
service marks, brand names, certification marks, trade dress and other indications of origin, the goodwill associated with the foregoing and registrations of, and applications in any such jurisdiction to register, the foregoing, including any
extension, modification or renewal of any such registration or application; (vii) all databases and data collections and all rights therein; (viii) all computer software including all source code, object code, firmware, development tools,
files, records and data, and all media on which any of the foregoing is recorded; and (ix) all Web addresses, sites and domain names. 

“Legal Proceeding” has the meaning ascribed to it in Section 2.5(d). 

“Lien” means any lien, pledge, claim, charge, mortgage, encumbrance or other security interest of any kind, whether arising
by Contract or by operation of law. 
 “LLC Agreement” has the meaning ascribed to it in the recital. 

“Membership Interest” has the meaning ascribed to it in the LLC Agreement. 

“Nonassignable Contract” has the meaning ascribed to it in Section 5.8. 

“Person” means an individual, corporation, partnership, limited liability company, joint venture, association, trust,
unincorporated organization or other entity or any Governmental Entity. 
 “Scheduled Contracts” has the meaning ascribed
to it in Section 2.2(c). 
 “Securities Act” means the Securities Act of 1933, as amended. 

“Tax” means: (i) any United States federal, state, local and foreign income, profits, franchise, license, capital, transfer,
ad valorem, wage, severance, occupation, import, custom, gross receipts, payroll, sales, employment, use, stamp, alternative or add-on minimum, environmental, withholding and any other tax, duty, assessment or governmental tax charge of

  
 – 4 – 

 
any kind whatsoever, imposed or required to be withheld by any taxing authority; (ii) any interest, additions to tax, or penalties applicable or related thereto; and (iii) any amount
described in clause (i) or (ii) for which a Person is liable as a successor or transferee, or by Contract, indemnity or otherwise. 

“Transfer Taxes” means all transfer, value-added, sales, use, stamp, registration and other such Taxes and fees (including
any penalties and interest). 
 ARTICLE 2 

ASSET TRANSFER; MEMBERSHIP INTERESTS 

Section 2.1 Contribution to BTI. Immediately prior to the contribution contemplated in Section 2.2, BioValve, hereby assigns,
transfers, conveys and delivers to BTI, free and clear of all Liens, and BTI hereby acquires from BioValve, all of the right, title and interest of BioValve in and to one (1) percent of the assets, properties, rights and business of BioValve as
of the Effective Date to the extent relating to the Device Assets of every kind, nature, type and description, real, personal and mixed, tangible and intangible, wherever located, whether known or unknown, fixed or unfixed, or otherwise, whether or
not specifically referred to in this Agreement and whether or not reflected on the books and records of BioValve. 
 Section 2.2
Contribution of Assets. Except as provided in Section 2.3, as of the Effective Date, and after giving effect to the conveyance set forth in Section 2.1, BioValve and BTI hereby assign, transfer, convey and deliver to the Company
free and clear of all Liens (other than Liens resulting from Assumed Liabilities), and the Company acquires from BioValve and BTI, all of the right, title and interest of BioValve and BTI in and to all of the assets, properties, rights and business
of BioValve and BTI as of the Effective Date (other than any Excluded Asset) to the extent relating to the Device Assets of every kind, nature, type and description, real, personal and mixed, tangible and intangible, wherever located, whether known
or unknown, fixed or unfixed, or otherwise, whether or not specifically referred to in this Agreement and whether or not reflected on the books and records of BioValve or BTI (collectively, the “Contributed Assets”) including the
following: 
 (a) all supplies and inventories, including goods in transit, finished goods, works-in-process, components, raw materials and
any other inventory (the “Contributed Inventory”); 
 (b) all assets, furniture and fixtures (of every kind and nature and
description, whether tangible or intangible, real, personal or mixed, in each case to the extent related to the Device Assets) that are physically located on the Effective Date at the premises referenced in Section 4.2 hereof; 

(c) the Contracts set forth on Section 2.2(c) of the Disclosure Schedule (the “Scheduled Contracts”) specifying in each
case the name of, date of and parties to such Contract and all amendments, modifications and supplements thereto; 
 (d) all lists,
documents, records, written information, product data, manuals, studies, reports, computer files and other computer readable media and any confidential information that has been reduced to writing or electronic form, in each case, to the extent
related to the Device Assets; 

  
 – 5 – 

 (e) all rights under express or implied warranties from suppliers and vendors to the extent such
rights relate to the Device Assets; 
 (f) all Intellectual Property Rights and related goodwill; 

(g) all rights under any non-disclosure agreements, non-solicitation agreements and non-competition agreements entered into with any parties
to the extent related to the Device Assets as set forth in Section 2.2(g) of the Disclosure Schedule; 
 (h) all prepaid expenses and
other deposits to the extent related to the Device Assets; 
 (i) other than with respect to Taxes, all rights and claims, including
refunds, relating to or arising out of the Device Assets; and 
 (j) all other assets or movable property to the extent related to the
Device Assets. 
 Section 2.3 Excluded Assets. Notwithstanding anything herein to the contrary and for the avoidance of doubt,
the parties hereto acknowledge and agree that the following assets, properties, contracts and rights of BioValve or BTI (collectively, the “Excluded Assets”) are not included among the Contributed Assets and are excluded from the
contribution contemplated by Section 2.2: 
 (a) all cash held by BioValve or BTI; 

(b) all accounts receivable or notes receivable of BioValve or BTI; 

(c) all insurance contracts maintained by or on behalf of BioValve or its Affiliates and all rights thereunder; 

(d) all rights of BioValve or BTI under this Agreement; 

(e) BioValve’s and BTI’s corporate seals, minute books and other corporate records; 

(f) all refunds, rebates, abatements, or credits for Taxes; 

(g) all Benefit Plans and the assets thereof; 

(h) all claims, rights, benefits and interests arising under or resulting from any Excluded Asset or Excluded Liability; 

(i) all shares or other ownership interests held by BioValve or its Affiliates in any Person; 

  
 – 6 – 

 (j) all of the Contracts listed in Section 2.3(j) of the Disclosure Schedule; and 

(k) all other assets, properties, contracts and rights of BioValve or BTI to the extent unrelated to the Device Assets, as well as any items
listed in Section 2.3(k) of the Disclosure Schedule. 
 Section 2.4 Assumption of Liabilities. Except as otherwise provided
in this Agreement, from and after the Effective Date, the Company shall assume and be liable for the following (and only the following) liabilities and obligations of BioValve or BTI, as applicable: (a) all unpaid ordinary course, trade
accounts payable related to the Device Assets (other than payables to Affiliates of BioValve or BTI), listed in Section 2.4(a) of the Disclosure Schedule (the “Assumed Accounts Payable”), (b) the Indebtedness of BioValve
or BTI listed in Section 2.4(b) of the Disclosure Schedule and (c) the liabilities and obligations of BioValve or BTI to the extent related to the ownership, use or possession of the Contributed Assets (other than accounts payable that are
not Assumed Accounts Payable or Indebtedness not assumed pursuant to the foregoing Section 2.4(b) or liabilities that are Excluded Liabilities) (the liabilities and obligations described in clauses (a) through (c) are referred to
collectively as the “Assumed Liabilities”). 
 Section 2.5 Liabilities Not Assumed by the Company.
Notwithstanding anything to the contrary in this Agreement, the Company shall not assume, or in any way be liable or responsible for, any obligations or liabilities of BioValve or BTI, direct or indirect, known or unknown, fixed or unfixed, choate
or inchoate, liquidated or unliquidated, secured or unsecured, accrued, absolute, contingent or otherwise, except for the Assumed Liabilities (the “Excluded Liabilities”), and BioValve and BTI shall hold the Company harmless with
respect to the Excluded Liabilities. For the avoidance of doubt, the term Assumed Liabilities does not include Excluded Liabilities. Without limiting the generality of the foregoing, Excluded Liabilities shall include the following obligations and
liabilities: 
 (a) any liability or obligation of BioValve or BTI arising (i) from its failure to perform, or its negligent
performance of, its obligations under, or (ii) out of or relating to any breach or claim of breach of a representation, warranty, covenant or agreement of BioValve contained in, any of the Scheduled Contracts that arose prior to the Effective
Date; 
 (b) any liability, obligation or expense of any kind or nature relating to Taxes owed by BioValve or any of its Affiliates
(excluding the Company and any subsidiary of the Company but including any contractual liability with respect to Taxes of another Person and any liabilities, obligations and expenses pursuant to any tax sharing agreement, tax indemnification or
similar arrangement); 
 (c) other than as set forth in Section 2.5(c) of the Disclosure Schedule any liability or obligation of
BioValve, BTI or otherwise relating to the Device Assets to BioValve or BTI or any of their respective directors, officers, Affiliates or stockholders; 

(d) any liability, obligation, cost or expense of BioValve or any of its Affiliates arising out of or relating to any investigation, claim,
action, suit, complaint, dispute, audit, demand, litigation or judicial, administrative or arbitration proceeding (collectively, “Legal 

  
 – 7 – 

 
Proceeding”) to which the Company, BioValve or BTI is or was a party and that (A) was commenced before the Effective Date and that relates to or arises out of the Device Assets
(including, without limitation, the Legal Proceedings listed in Section 2.5(d) of the Disclosure Schedule) or (B) does not relate to or arise out of the Device Assets (regardless of whether such Legal Proceeding is commenced before or
after the date hereof) and, in each case, any contingency reserve related thereto; 
 (e) except to the extent expressly set forth in
Section 2.4, any liability or obligation of BioValve or BTI with respect to any Indebtedness, including any accrued interest, fees and any penalties thereon; 

(f) except as set forth in Section 2.5(c) of the Disclosure Schedule or Section 4.1 hereof, any liability or obligation of BioValve or
BTI to or with respect to directors, officers, employees, former employees, consultants and former consultants and Benefit Plans and other employee and employment-related liabilities, including, without limitation, any liability for severance,
incentive, bonus or other compensation, health, welfare and other benefit plans of BioValve; 
 (g) any accounts payable other than the
Assumed Accounts Payable; and 
 (h) all liabilities and obligations of BioValve or BTI under this Agreement. 

Section 2.6 Membership Interests. In consideration of the transfer of the Contributed Assets, (i) BioValve shall receive 99%
of all Membership Interests and (ii) BTI shall receive 1% of all Membership Interests. 
 ARTICLE 3 

REPRESENTATIONS AND WARRANTIES 

Except as otherwise contemplated by this Agreement, the LLC Agreement or the Bridge Loan Agreements, BioValve and BTI each represent and
warrant to the Company as follows, as of the Effective Date: 
 Section 3.1 Contracts. BioValve’s right, title and interest
in and to each of the Scheduled Contracts may be assigned to the Company without the consent or approval of any other Person. 

Section 3.2 Purchase for Investment. The Membership Interests issued or issuable to each of BioValve and BTI under this Agreement
are being acquired for its own account for the purpose of investment. BioValve and BTI will refrain from transferring or otherwise disposing of any of the Membership Interests, or any interest therein, in such manner as to cause the Company to be in
violation of the registration requirements of the Securities Act, or applicable state securities or blue sky laws. 
 Section 3.3
Investment Experience. Each of BioValve and BTI understands that the transactions contemplated by this Agreement involve substantial risk. BioValve and BTI are each an “accredited investor”, as such term is defined in Rule 501(a) of
Regulation D under 

  
 – 8 – 

 
the Securities Act. Without limiting the generality of the foregoing, each of BioValve and BTI has experience as an investor and acknowledges that it is able to fend for itself, can bear the
economic risk of its investment in the Membership Interests for an indefinite period of time, and has such knowledge and experience in financial and business matters that it is capable of evaluating the merits and risks of its investment in the
Membership Interests and protecting its own interests in connection with such investment. 
 Section 3.4 Restricted Securities.
Each of BioValve and BTI understands that the Membership Interests are characterized as “restricted securities” under the Securities Act inasmuch as they are being acquired by it in a transaction not involving a public offering, and that
the Membership Interests may be resold without registration under the Securities Act only in certain limited circumstances. Each of BioValve and BTI is familiar with and understands the resale limitations imposed by the Securities Act. Each of
BioValve and BTI further understands that the Membership Interests (together with any securities that may be issued to BioValve and BTI, respectively, from time to time in respect thereof) are subject to the restrictions on transfer set forth in
this Article 3 and the LLC Agreement. 
 ARTICLE 4 

COVENANTS 

Section 4.1 Access to Employees. BioValve shall provide the Company access, at cost, the services of its current employees and
BioValve shall cause such employees to provide their services to the Company until such time as the Company is able to hire its own personnel to replace the services provided by such employees. BioValve shall deliver to the Company weekly invoices
reflecting the cost of such services, which the Company shall promptly pay. The Company shall have the right to, in its reasonable discretion, audit such invoices. Following the completion of such audit, BioValve shall promptly refund to the Company
any amounts that were improperly charged to, and paid by, the Company. 
 Section 4.2 Lease. BioValve shall provide the Company
and its personnel, at cost, access to and the use of the premises leased by BioValve and located at 155 Flanders Road, Westborough, MA. BioValve shall deliver to the Company weekly invoices reflecting the cost of such services, which the Company
shall promptly pay. The Company shall have the right to, in its reasonable discretion, audit such invoices. Following the completion of such audit, BioValve shall promptly refund to the Company any amounts that were improperly charged to, and paid
by, the Company. 
 Section 4.3 Insurance. BioValve shall use its commercially reasonable efforts to cause to be transferred to
the Company, to the extent permitted under the relevant BioValve Insurance Policies and applicable law, any claim, chose in action or other right that BioValve may have to insurance coverage or insurance proceeds under any BioValve Insurance Policy
with respect to any loss, liability, claim, damage or expense of or with respect to the Contributed Assets arising out of occurrences prior to the Effective Date (an “Insured Loss”). To the extent such transfer does not occur, upon
the request of the Company, BioValve will use its commercially reasonable efforts to promptly assist the Company in tendering claims for any Insured Losses to the applicable insurers under the BioValve Insurance Policies and provide the Company with
the proceeds of claims made by or with respect to such Insured Losses subject to the self-insured limits and deductibles under the applicable policy. 

  
 – 9 – 

 Section 4.4 Reimbursement for Certain Legal Expenses. The Company will reimburse
BioValve for the reasonable and documented legal fees and expenses that are incurred by BioValve following the date of this Agreement (but excluding any amounts paid in settlement by BioValve, or awarded against BioValve by a court of competent
jurisdiction) with respect to the Legal Proceedings listed in Section 2.5(d) of the Disclosure Schedule; provided that such reimbursement shall not exceed $10,000. 

ARTICLE 5 

MISCELLANEOUS 

Section 5.1 Survival. All representations and warranties shall terminate on the date that is eighteen (18) months following
the Effective Date. Each covenant or agreement contained in this Agreement shall survive indefinitely. 
 Section 5.2
Assignment. Neither this Agreement nor any of the rights, interests or obligations hereunder shall be assigned, in whole or in part, by operation of law or otherwise by any of the parties hereto without the prior written consent of the other
parties hereto. Any purported assignment without such consent shall be void. Subject to the preceding sentence, this Agreement shall be binding upon, inure to the benefit of and be enforceable by, the parties hereto and their respective successors
and assigns. 
 Section 5.3 Specific Enforcement. The parties hereto agree that irreparable damage would occur in the event that
any of the provisions of this Agreement were not performed in accordance with their specific terms or were otherwise breached. It is accordingly agreed that the parties hereto shall be entitled to an injunction or injunctions to prevent breaches of
this Agreement and to enforce specifically the terms and provisions of this Agreement, this being in addition to any other remedy to which they are entitled at law, in equity or otherwise. 

Section 5.4 Entire Agreement. This Agreement and the LLC Agreement contain the entire agreement and understanding between the
parties hereto with respect to the subject matter hereof and thereof and supersede all prior agreements and understandings, both written and oral, with respect to the transactions contemplated thereby. 

Section 5.5 No Third-Party Beneficiaries. This Agreement is for the sole benefit of the parties hereto and their permitted
successors and assigns and nothing herein express or implied shall give or be construed to give to any Person, other than the parties hereto and such successors and assigns, any legal or equitable rights or remedies. 

Section 5.6 Counterparts. This Agreement may be executed in one or more counterparts, all of which shall be considered one and the same
agreement and shall become effective when one or more counterparts have been signed by each of the parties hereto and delivered to the other parties hereto. 

  
 – 10 – 

 Section 5.7 Governing Law; Jurisdiction; Venue; Service Of Process; Waiver of Jury
Trial. This Agreement shall be governed by, and construed in accordance with, the laws of the State of New York, regardless of the laws that might otherwise govern under applicable principles of conflicts of laws thereof. Each party hereto
irrevocably submits to the exclusive jurisdiction of (a) the Supreme Court of the State of New York, New York County and (b) the United States District Court for the Southern District of New York for the purposes of any suit, action or
other proceeding arising out of this Agreement, any of the other Transaction Agreements or any transaction contemplated hereby and thereby. Each party agrees to commence any action, suit or proceeding relating hereto in the United States District
Court for the Southern District of New York or if such suit, action or other proceeding may not be brought in such court for jurisdictional reasons, in the Supreme Court of the State of New York, New York County. Each party irrevocably and
unconditionally waives any objection to the laying of venue of any action, suit or proceeding arising out of this Agreement, the other Transaction Agreements and the transactions contemplated hereby or thereby in (i) the Supreme Court of the
State of New York, New York County or (ii) the United States District Court for the Southern District of New York, and hereby further irrevocably and unconditionally waives, and shall not assert by way of motion, defense, or otherwise, in any
such Legal Proceeding, any claim that it is not subject personally to the jurisdiction of the above-named courts, that its property is exempt or immune from attachment or execution, that the Legal Proceeding is brought in an inconvenient forum, that
the venue of the Legal Proceeding is improper, or that this Agreement or any other Transaction Agreement may not be enforced in or by any of the above-named courts. Each party irrevocably and unconditionally waives any right to trial by jury with
respect to any Legal Proceeding relating to or arising out of this Agreement or any other Transaction Agreement or any of the transactions contemplated hereby or thereby. 

Section 5.8 Nonassignable Contracts. 

(a) In the event that the transactions contemplated by this Agreement involve the assignment of rights under any contract, agreement, license,
claim, or of other rights, assets, or property, which are nonassignable without the consent, authorization or approval of the other party or parties thereto or any other third party (a “Nonassignable Contract”), and such consent,
authorization or approval shall not have been obtained by BioValve, prior to the Effective Date, then, notwithstanding anything in this Agreement to the contrary (and without relieving BioValve of any liability or obligation it may have under this
Agreement), any such Nonassignable Contract shall not be assigned (except any rights to receive payments thereunder) until all such necessary consents, authorizations and approvals with respect to such Nonassignable Contract shall have been
obtained, whereupon BioValve shall, without further consideration, promptly assign or cause the assignment of same to the Company. 
 (b)
Until such time, if any, as all the necessary consents, authorizations and approvals shall have been obtained for the assignment of a Nonassignable Contract, BioValve shall (i) use commercially reasonable efforts, and the Company shall reasonably
cooperate therewith, to obtain any such consents and waivers and (ii) shall pay over any amounts received by BioValve after the Effective Date in respect of any Nonassignable Contract, and the Company shall pay over to BioValve any amounts paid, or
expenses incurred, by BioValve in performing any Nonassignable Contract after the Effective Date. 

  
 – 11 – 

 Section 5.9 Further Assurances. Each of the parties shall use reasonable commercial
efforts to take, or cause to be taken, all actions and to do, or cause to be done, all things necessary, proper or advisable to consummate and make effective as promptly as practicable the transactions contemplated by this Agreement. 

[Signature page to follow] 

  
 – 12 – 

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

					
	BioValve Technologies, Inc.
		
	By:	 	 /s/ Robert R. Gonnelli

		 	Name:	 	Robert R. Gonnelli
		 	Title:	 	President & CEO
	
	BTI Tech, Inc.
		
	By:	 	 /s/ Robert R. Gonnelli

		 	Name:	 	Robert R. Gonnelli
		 	Title:	 	President & CEO
	
	Valeritas LLC
		
	By:	 	 /s/ Robert R. Gonnelli

		 	Name:	 	Robert R. Gonnelli
		 	Title:	 	President & CEO

 Exhibit A 
  

					
	 Name
	  	Membership Interest	 
		
	 BioValve Technologies, Inc.
	  	 	99	% 
	 BTI Tech, Inc.
	  	 	1	% 

 

 
 DISCLOSURE SCHEDULE 

Reference is made to the Formation Agreement dated as of August 22, 2006, by and among BioValve Technologies, Inc., BTI Tech, Inc. and
Valeritas LLC (the “Formation Agreement”). Capitalized terms used herein and not otherwise defined herein shall have the respective meanings ascribed to such terms in the
Formation Agreement. 
 This Disclosure Schedule is qualified in its entirety by reference to specific provisions of the Formation
Agreement, and is not intended to constitute, and shall not be construed as constituting, representations or warranties of BioValve or BTI except as and to the extent provided in the Formation Agreement. Inclusion of information herein shall not be
construed as an admission that such information is material to the business, assets, financial condition or results of operations of the businesses taken as a whole. 

Matters reflected in this Disclosure Schedule are not necessarily limited to matters required by the Formation Agreement to be reflected in
the Disclosure Schedule. Such additional matters are set forth for information purposes and do not necessarily include other matters of a similar nature. 

Headings have been inserted on the sections of the Disclosure Schedule for convenience of reference only and shall to no extent have the
effect of amending or changing the express description of the sections as set forth in the Formation Agreement. Any fact or item disclosed in any section or subsection of the Disclosure Schedule shall be deemed to be disclosed with regard to any
other section or subsection of the Disclosure Schedule, so long as it is reasonably apparent from the face of such disclosure that such disclosure is applicable as an exception to the representation and warranty in such other section or subsection
(by cross-reference or otherwise). 

  
 1 

 1.1 – Intellectual Property Rights 

 

											
	 R&G

Case #
	 	 Patent

Number
	 	 Allowance

Date
	 	 Inventor
	 	 Title
	 	 Ctry

						
	BVTP-P01-002	 	US 6,406,455 B1	 	18-Jun-02	 	Willis et al.	 	Injection Devices	 	US
						
	BVTP-P02-002	 	US 6,960,184	 	1-Nov-05	 	Willis et al.	 	Injection Devices	 	US
						
	BVTP-PEP-002	 	1144031	 	26-Oct-05	 	Willis et al.	 	Injection Devices	 	note #1
						
	BVTP-P01-003	 	US 6,314,317 B1	 	6-Nov-01	 	Willis	 	Electroactive Pore	 	US
						
	BVTP-P02-003	 	US 6,490,483 B1	 	3-Dec-02	 	Willis	 	Electroactive Pore	 	US
						
	BVTP-PAU-003	 	767510	 	26-Feb-04	 	Willis	 	Electroactive Pore	 	Australia
						
	BVTP-PO1-004	 	US 6,616,627 B2	 	9-Sep-03	 	Willis et al.	 	Needleless Injection Syringe	 	US
						
	BVTP-PAUI-004	 	783680	 	9-Mar-06	 	Willis et al.	 	Needleless Injection Syringe	 	Australia
						
	BVTP-P03-007	 	pending	 	pending	 	Gonnelli et al.	 	Dermal Drug Injection Systems	 	US
						
	BVTP-P01-011	 	US 6,939,324	 	6-Sep-05	 	Gonnelli et al.	 	 Fluid Delivery and Measurement Systems and Methods

Floating Needle Fluid Delivery Systems
	 	US
						
	BVTP-PO1-029	 	US 7,027,478	 	11-Apr-06	 	Ackley	 	Microneedle Array Systems to align and form optical components	 	US
						
	BVTP-P01-506	 	US 6,503,231 B1	 	7-Jan-03	 	Prausnitz et al.	 	Microneedle Device for Transport of Molecules Across Tissue	 	US
						
	BVTP-PO2-506	 	US 6,334,856 B1	 	1-Jan-02	 	Prausnitz et al.	 	Microneedle Devices and Methods of Manufacture and use Thereof	 	US
						
	BVTP-PCA-506	 	2330207	 	30-Aug-05	 	Prausnitz et al.	 	Microneedle Devices and Methods of Manufacture and use Thereof	 	Canada
						
	BVTP-PAU-506	 	767122	 	18-Sep-03	 	Prausnitz et al.	 	Microneedle Devices and Methods of Manufacture and use Thereof	 	Australia
						
	BVTP-PO1-538	 	US 6,611,707 B1	 	26-Aug-03	 	Prausnitz et al.	 	Microneedle Drug Delivery Device	 	US
						
	BVTP-PO1-592	 	US 6,743,211 B1	 	1-Jun-04	 	Prausnitz et al.	 	Devices and Methods for Enhanced Microneedle Penetration of Biological Barriers	 	US
						
	BVTP-PEP-003	 	In process	 	7-Apr-06	 	Willis	 	Electroactive Pore	 	EU

 Note 1 - Austria, Belgium, France, Germany, Luxembourg, UK 

  
 2 

											
	 R&G

Case #
	 	 Patent

Application
	 	 Filed
	 	 Inventor
	 	 Title
	 	 Ctry

						
	BVTP-PO3-002	 	11/063,500	 	22-Feb-05	 	Willis et al.	 	Injection Devices	 	US
						
	BVTP-PWO-002	 	US99/30172	 	17-Dec-99	 	Willis et al.	 	Injection Devices	 	PCT
						
	BVTP-PO3-003	 	10/306,767	 	26-Nov-02	 	Willis	 	Electroactive Pore	 	US
						
	BVTP-PWO-003	 	US00/04273	 	18-Feb-00	 	Willis	 	Electroactive Pore	 	PCT
						
	BVTP-PJP-003	 	2000-599456	 	18-Feb-00	 	Willis	 	Electroactive Pore	 	Japan
						
	BVTP-PIL-003	 	144948	 	18-Feb-00	 	Willis	 	Electroactive Pore	 	Israel
						
	BVTP-PHK-003	 	2102212.6	 	18-Feb-00	 	Willis	 	Electroactive Pore	 	Hong Kong
						
	BVTP-PCA-003	 	2362814	 	18-Feb-00	 	Willis	 	Electroactive Pore	 	Canada
						
	BVTP-P02-004	 	10/658,116	 	8-Sep-03	 	Willis et al.	 	Needleless Injection Syringe	 	US
						
	BVTP-PW0-004	 	US01/00346	 	4-Jan-01	 	Willis et al.	 	Needleless Injection Syringe	 	PCT
						
	BVTP-PEP-004	 	1908589.3	 	4-Jan-01	 	Willis et al.	 	Needleless Injection Syringe	 	EU
						
	BVTP-PCA-004	 	2396569	 	4-Jan-01	 	Willis et al.	 	Needleless Injection Syringe	 	Canada
						
	BVTP-PA1-004	 	2006200790	 	28-Feb-06	 	Willis et al.	 	Needleless Injection Syringe	 	Australia
						
	BVTP-PO1-007	 	10/001,002	 	14-Nov-01	 	Gonnelli et al.	 	Dermal Drug Injection Systems	 	US
						
	BVTP-PO2-007	 	09/999,549	 	30-Nov-01	 	Gonnelli et al.	 	Dermal Drug Injection Systems	 	US
						
	BVTP-PWO-007	 	US01/46029	 	30-Nov-01	 	Gonnelli et al.	 	Dermal Drug Injection Systems	 	PCT
						
	BVTP-PKR-007	 	2003-7007279	 	30-Nov-01	 	Gonnelli et al.	 	Dermal Drug Injection Systems	 	Korea
						
	BVTP-PJP-007	 	2002-552611	 	30-Nov-01	 	Gonnelli et al.	 	Dermal Drug Injection Systems	 	Japan
						
	BVTP-PEP-007	 	01994145.9	 	30-Nov-01	 	Gonnelli et al.	 	Dermal Drug Injection Systems	 	EU
						
	BVTP-PCA-007	 	2430499	 	30-Nov-01	 	Gonnelli et al.	 	Dermal Drug Injection Systems	 	Canada

  
 3 

											
	 R&G

Case #
	 	 Patent

Application
	 	 Filed
	 	 Inventor
	 	 Title
	 	 Ctry

						
	BVTP-PAU-007	 	2002246572	 	30-Nov-01	 	Gonnelli et al.	 	Dermal Drug Injection Systems	 	Australia
						
	BVTP-PO2-011	 	11/219944	 	6-Sep-05	 	Gonnelli et al.	 	 Fluid Delivery and Measurement Systems and Methods

Floating Needle Fluid Delivery Systems
	 	US
						
	BVTP-PWO-011	 	US01/46028	 	30-Nov-01	 	Gonnelli et al.	 	 Fluid Delivery and Measurement Systems and Methods

Floating Needle Fluid Delivery Systems
	 	PCT
						
	BVTP-PEP-011	 	01988242.2	 	30-Nov-01	 	Gonnelli et al.	 	 Fluid Delivery and Measurement Systems and Methods

Floating Needle Fluid Delivery Systems
	 	EU
						
	BVTP-PCA-011	 	2430590	 	30-Nov-01	 	Gonnelli et al.	 	 Fluid Delivery and Measurement Systems and Methods

Floating Needle Fluid Delivery Systems
	 	Canada
						
	BVTP-PO1-023	 	10/251,480	 	19-Sep-02	 	Gonnelli	 	Microneedle, Microneedle arrays, and systems and methods relating to same	 	US
						
	BVTP-PO1-025	 	10/252,739	 	23-Sep-02	 	Gonnelli	 	Gas Pressure Actuated Microneedle Arrays, and Systems and methods relating to same	 	US
						
	BVTP-PWO-025	 	US02/30117	 	23-Sep-02	 	Gonnelli	 	Gas Pressure Actuated Microneedle Arrays, and Systems and methods relating to same	 	PCT
						
	BVTP-PEP-025	 	2766341.8	 	23-Sep-02	 	Gonnelli	 	Gas Pressure Actuated Microneedle Arrays, and Systems and methods relating to same	 	EU
						
	BVTP-PCA-025	 	2499838	 	23-Sep-02	 	Gonnelli	 	Gas Pressure Actuated Microneedle Arrays, and Systems and methods relating to same	 	Canada
						
	BVTP-PO1-027	 	09/747,768	 	22-Dec-00	 	Ackley	 	Stacked Microneedle Systems	 	US
						
	BVTP-PWO-027	 	US00/35144	 	22-Dec-00	 	Ackley	 	Stacked Microneedle Systems	 	PCT
						
	BVTP-PEP-027	 	00990324.6	 	22-Dec-00	 	Ackley	 	Stacked Microneedle Systems	 	EU
						
	BVTP-PCA-027	 	2396767	 	22-Dec-00	 	Ackley	 	Stacked Microneedle Systems	 	Canada
						
	BVTP-PA1-027	 	2005222551	 	22-Dec-00	 	Ackley	 	Stacked Microneedle Systems	 	Australia
						
	BVTP-P02-028	 	10/412,384	 	11-Apr-03	 	Ackley	 	Microneedle Adapter	 	US
						
	BVTP-PW0-028	 	US01/46845	 	8-Nov-01	 	Ackley	 	Microneedle Adapter	 	PCT

  
 4 

											
	 R&G

Case #
	 	 Patent

Application
	 	 Filed
	 	 Inventor
	 	 Title
	 	 Ctry

						
	BVTP-PWO-029	 	US01/49797	 	20-Dec-01	 	Ackley	 	Microneedle Array Systems to align and form optical components	 	PCT
						
	BVTP-P01-030	 	10/260,711	 	30-Sep-02	 	Gonnelli	 	Switchable Microneedle Arrays and Systems and Methods relating to same	 	US
						
	BVTP-PWO-030	 	US02/30993	 	30-Sep-02	 	Gonnelli	 	Switchable Microneedle Arrays and Systems and Methods relating to same	 	PCT
						
	BVTP-PEP-030	 	02780401.2	 	30-Sep-02	 	Gonnelli	 	Switchable Microneedle Arrays and Systems and Methods relating to same	 	EU
						
	BVTP-PCA-030	 	2500452	 	30-Sep-02	 	Gonnelli	 	Switchable Microneedle Arrays and Systems and Methods relating to same	 	Canada
						
	BVTP-P02-032	 	10/993,927	 	19-Nov-04	 	Gonnelli	 	Microneedle with Membrane	 	US
						
	BVTP-PWO-032	 	US02/31153	 	30-Sep-02	 	Gonnelli	 	Microneedle with Membrane	 	PCT
						
	BVTP-PEP-032	 	02773681.8	 	30-Sep-02	 	Gonnelli	 	Microneedle with Membrane	 	EU
						
	BVTP-PCA-032	 	2500453	 	30-Sep-02	 	Gonnelli	 	Microneedle with Membrane	 	Canada
						
	BVTP-P01-034	 	10/681,777	 	7-Oct-03	 	Gonnelli et al.	 	Microneedle Array Patch	 	US
						
	BVTP-PEP-034	 	03808167.5	 	7-Oct-03	 	Gonnelli et al.	 	Microneedle Array Patch	 	EU
						
	BVTP-PWO-034	 	US03/31847	 	7-Oct-03	 	Gonnelli et al.	 	Microneedle Array Patch	 	PCT
						
	BVTP- P01-035	 	10/831,354	 	23-Apr-04	 	Gonnelli et al.	 	Hydraulically Actuated Pump for Long Duration Medicament Administration	 	US
						
	BVTP-PWO-035	 	US04/12797	 	23-Apr-04	 	Gonnelli et al.	 	Hydraulically Actuated Pump for Long Duration Medicament Administration	 	PCT
						
	BVTP-PEP-035	 	04760179.4	 	23-Apr-04	 	Gonnelli et al.	 	Hydraulically Actuated Pump for Long Duration Medicament Administration	 	EU
						
	BVTP-PJP-035	 	2006-513327	 	23-Apr-04	 	Gonnelli et al.	 	Hydraulically Actuated Pump for Long Duration Medicament Administration	 	Japan

  
 5 

											
	 R&G

Case #
	 	 Patent

Application
	 	 Filed
	 	 Inventor
	 	 Title
	 	 Ctry

						
	BVTP-PCA-035	 	2523267	 	23-Apr-04	 	Gonnelli et al.	 	Hydraulically Actuated Pump for Long Duration Medicament Administration	 	Canada
						
	BVTP-PAU-035	 	2004232858	 	23-Apr-04	 	Gonnelli et al.	 	Hydraulically Actuated Pump for Long Duration Medicament Administration	 	Australia
						
	BVTP-P01-037	 	11/198024	 	5-Aug-05	 	McAllister	 	Methods and Devices for Delivering Agents Across Biological Barriers	 	US
						
	BVTP-P01-038	 	11/175990	 	5-Jul-05	 	Gonnelli	 	Methods and Devices for Delivering GLP-1 and Uses Thereof	 	US
						
	BVTP-PWO-038	 	US05/023818	 	5-Jul-05	 	Gonnelli	 	Methods and Devices for Delivering GLP-1 and Uses Thereof	 	PCT
						
	BVTP-P03-506	 	09/372,197	 	11-Aug-99	 	Prausnitz et al.	 	Microneedle Device for Transport of Molecules Across Tissue	 	US
						
	BVTP-P04-506	 	10/010,723	 	6-Dec-01	 	Prausnitz et al.	 	Microneedle Devices and Methods of Manufacture and use Thereof	 	US
						
	BVTP-PWO-506	 	US99/13226	 	10-Jun-99	 	Prausnitz et al.	 	Microneedle Devices and Methods of Manufacture and use Thereof	 	PCT
						
	BVTP-PJP-506	 	2000-553570	 	10-Jun-99	 	Prausnitz et al.	 	Microneedle Devices and Methods of Manufacture and use Thereof	 	Japan
						
	BVTP-PEP-506	 	99928580.2	 	10-Jun-99	 	Prausnitz et al.	 	Microneedle Devices and Methods of Manufacture and use Thereof	 	EU
						
	BVTP-PC1-506	 	2510389	 	10-Jun-99	 	Prausnitz et al.	 	Microneedle Devices and Methods of Manufacture and use Thereof	 	Canada
						
	BVTP-PA1-506	 	2004200303	 	10-Jun-99	 	Prausnitz et al.	 	Microneedle Devices and Methods of Manufacture and use Thereof	 	Australia
						
	BVTP-Po2-538	 	10/454,973	 	4-Jun-03	 	Prausnitz et al.	 	Microneedle Drug Delivery Device	 	US

  
 6 

											
	 R&G

Case #
	 	 Patent

Application
	 	 Filed
	 	 Inventor
	 	 Title
	 	 Ctry

						
	BVTP-P01-539	 	09/453,109	 	2-Dec-99	 	Prausnitz et al.	 	Microneedle device for Extraction and Sensing of Bodily Fluids	 	US
						
	BVTP-P01-590	 	10/023,259	 	14-Dec-01	 	Park et al.	 	Microneedle Devices and Production Thereof	 	US
						
	BVTP-PWO-590	 	US01/49018	 	14-Dec-01	 	Park et al.	 	Microneedle Devices and Production Thereof	 	PCT
						
	BVTP-PEP-590	 	01270134.8	 	14-Dec-01	 	Park et al.	 	Microneedle Devices and Production Thereof	 	EU
						
	BVTP-PAU-590	 	2002253812	 	14-Dec-01	 	Park et al.	 	Microneedle Devices and Production Thereof	 	Australia
						
	BVTP-P02-592	 	10/856,691	 	28-May-04	 	Prausnitz et al.	 	Devices and Methods for Enhanced Microneedle Penetration of Biological Barriers	 	US
						
	BVTP-PWO-592	 	US00/15312	 	2-Jun-00	 	Prausnitz et al.	 	Devices and Methods for Enhanced Microneedle Penetration of Biological Barriers	 	PCT
						
	BVTP-PEP-592	 	00939538.5	 	2-Jun-00	 	Prausnitz et al.	 	Devices and Methods for Enhanced Microneedle Penetration of Biological Barriers	 	EU
						
	BVTP-PCA-592	 	2376128	 	2-Jun-00	 	Prausnitz et al.	 	Devices and Methods for Enhanced Microneedle Penetration of Biological Barriers	 	Canada
						
	BVTP-PA1-592	 	2005200910	 	2-Jun-00	 	Prausnitz et al.	 	Devices and Methods for Enhanced Microneedle Penetration of Biological Barriers	 	Australia
						
	BVTP-P01-593	 	10/861,244	 	4-Jun-04	 	Wang et al.	 	Drilling Microneedle Device	 	US
						
	BVTP-PWO-593	 	US04/017850	 	4-Jun-04	 	Wang et al.	 	Drilling Microneedle Device	 	PCT
						
	BVTP-PEP-593	 	04754457.2	 	4-Jun-04	 	Wang et al.	 	Drilling Microneedle Device	 	EU
						
	BVTP-PAU-593	 	2004251699	 	4-Jun-04	 	Wang et al.	 	Drilling Microneedle Device	 	Australia
						
	BVTP-P60-1000	 	pending	 	30-Mar-06	 	Gonnelli et al.	 	Dual-Cartridge Fluid Delivery System	 	US

  
 7 

 2.2(c) – Scheduled Contracts. 

 

					
	 Partner
	  	 Date
	  	 Description

	Centocor, Inc.	  	December 31, 2003	  	Centocor to evaluate the use of BioValve’s needle free injection devices in certain biologic pharmaceutical products.
			
	Georgia Tech Research Corp. and Redeon, Inc.	  	March 23,1999	  	Georgia Tech Research grants to Redeon an exclusive nontransferable license with a right to sub-license technology pertaining to “Microneedle Device for Transport of Molecules Across Tissue.” Redeon was subsequently
purchased by BioValve Technologies Inc.
			
	Taming of the Shrewsbury LLC	  	June 2, 2006	  	Letter of Intent regarding possible lease of property located at 800 Boston Turnpike, Shrewsbury, MA for a period of ten (10) years and three (3) months effective November 1, 2006.

 Purchase Orders 
  

													
	 Vendor Name
	  	PO #	 	  	PO Total	 	  	Outstanding
Balance	 
	 Polymer Conversions
	  	 	112666	  	  	$	5,065.00	  	  	$	150.00	  
	 DA/PRO Rubber
	  	 	112674	  	  	$	5,235.00	  	  	$	4,400.00	  
	 CiDRA Precision Services
	  	 	112691	  	  	$	7,740.00	  	  	$	1,962.09	  
	 McMaster-Carr
	  	 	112526	  	  	$	527.24	  	  	$	527.24	  
	 Steris
	  	 	112706	  	  	$	715.00	  	  	$	715.00	  
	 Omega Engineering
	  	 	112756	  	  	$	375.00	  	  	$	375.00	  
	 Boston Analytical
	  	 	112790	  	  	$	18,000.00	  	  	$	18,000.00	  
	 Kimble Glass
	  	 	112791	  	  	$	5,000.00	  	  	$	5,000.00	  
	 Endevco Corp
	  	 	112802	  	  	$	220.00	  	  	$	220.00	  
	 Integra Companies
	  	 	112808	  	  	$	63.95	  	  	$	63.95	  
	 Acro Associates
	  	 	112811	  	  	$	339.00	  	  	$	339.00	  
	 MSC Industrial
	  	 	112821	  	  	$	154.71	  	  	$	154.71	  
	 Electron Technologies Corp
	  	 	112822	  	  	$	375.00	  	  	$	375.00	  
		  				  	$	43,809.90	  	  	$	32,281.99	  

  
 8 

 510(k) Filings 

BioValve has three regulatory filings. One for Mini-Ject, one for the h-Patch and one for Mini-Ject IFU. All are 510(k) submissions and are cleared by the FDA.
Clinical studies are not required for 510(k) approvals but these submissions contained reports of clinical studies. 
 BioValve Mini-Ject Needlefree
Injection System 510(k) filing #K032976 
 This submission contains the summary from one clinical study titled “Study to Compare Comfort of a Novel
Needle-free Injection System with Conventional Needle and Syringe”. 
 Study Protocol BTI/ Miniject 2K3-01 was conducted under Western IRB #
P957954389. The 510 (k) approval was granted April 16 2004. 
 BioValve Insulin Delivery System (BIDS) 510(k) filing #K050971 

This submission contains the clinical report titled “A Pilot Study Investigating the Pharmacodynamic Profile of Insulin Aspart, Administered
Subcutaneously Via a Basal/Bolus Insulin Delivery System During a 3-day In-Patient and 4-Day Outpatient Period in Patients with Type 2 Diabetes Mellitus on Lantus With or Without Oral Antidiabetic Therapy”. 

Study Protocol BTI BIDS 2004-01 was conducted at Profil Institute in Germany. 

No changes have been made to the Instructions for Use since the approval August 16, 2005. 

BioValve Mini-Ject Needlefree Injection System 510K filing # K051985 

This filing was a Special 510(k) which covers a modification to the “Instructions For Use for the Mini-Ject” for clarification and updating. The
change was made to the label contraindication section that was approved by the FDA August 17, 2005. 

  
 9 

 2.2(g) – Rights under any non-disclosure agreements, non-solicitation agreements and
non-competition agreements 
 See items listed in Section 2.2(c) of the Disclosure Schedule. 

  
 10 

 2.3(j) Excluded Contracts 

 

	 	•	 	National Institute of Mental Health (“NIMH”) SBIR Grant 9R44MH73359-03 granted March 3rd 2005. 

 

	 	•	 	License Agreement with the University of North Carolina and Purdue Research Foundation assigning rights to certain technologies relating to Dopamine Receptor Ligands. 

 

	 	•	 	NIMH together with Yale University and Columbia University to undertake research in DAR 100A for treatment of schizophrenia. Agreement being negotiated. 

 

	 	•	 	NIMH together with Treatment Units for Research on Neurocognition and Schizophrenia (TURNS) (Harvard University and Washington University, undertake research for treatment of schizophrenia. Agreement being negotiated.

  
 11 

 2.3(k) Excluded Assets 

Any rights related to: 
  

	 	•	 	Any Intellectual Property relating to the DarPharma Compounds Portfolio. 

  

	 	•	 	Any drug compound Dar 100, Dar 100 A. 

  

	 	•	 	Any synthesized analogs and active molecules from the DarPharma Compounds. 

  

	 	•	 	The draft agreement between BioValve and Dr. Seymour Fein relating to the low level use of Desmopressin to aid in the control of Nocturia and other urinary conditions. 

Excluded Assets 
 Ramsey Office 

 

			
	 Number
	  	 Description

	1	  	Acer 15” Plasma Screen
	1	  	Dell Docking Station
	1	  	Dell Latitude D600 Laptop Computer
	1	  	Mac G5 Desktop Computer
	1	  	Mac 21” Plasma Screen
	1	  	i-Mac 20” Computer
	1	  	HP 240 All-in-One Printer
	1	  	HP 3550 Printer and wireless network
	1	  	Canon D860 Copier
	1	  	Brother Intellifax 2820
	1	  	Executive Machine Shredder
	5	  	ATT Phones
	1	  	Motorola SB V1250 Cable Modem
	1	  	Mac Airport Extreme Router A1034
	1	  	GE Water Cooler
	1	  	Sharp Carousel Microwave
	1	  	Cusinart Coffee Maker
	5	  	Global Horizontal Filing Cabinets
	5	  	Steelcase Desks
	4	  	Steelcase Credenzas
	6	  	Office Star Swivel Desk Chairs
	8	  	Office Star Guest Chairs
	1	  	Boardroom Table
	10	  	Boardroom Chairs
	1	  	Boardroom Credenza
	1	  	Framed Whiteboard
	2	  	Boardroom Partition Screens
	2	  	8 ft. cubicles with built in desks and cupboards.
	1	  	Small Conference Table
	4	  	Chairs
	1	  	Vacuum
	1	  	5-Drawer Yawnee Erbe File Cabinet
	2	  	5-Drawer Steelcase Horizontal File Cabinets
	3	  	Bookshelves
	12	  	Potted Plants

  
 12 

 Westborough 
  

							
	 Number
	 	 Description
	 	 Model No.
	 	 Serial No.

	1	 	Varian ProStar HPLC Column Valve Module	 	320	 	560
	1	 	Varian ProStar HPLC Solvent Delivery Module	 	210	 	1114
	1	 	Varian ProStar HPLC Solvent Delivery Module	 	210	 	1116
	1	 	Varian ProStar HPLC UV VIS Detector	 	500	 	134
	1	 	VWR Thermo -80° C Freezer	 	5416	 	802199
	1	 	Amana Refrigerator	 	DRB2101A	 	11306610AC
	1	 	Metler Balance	 	AG245	 	1117461638
	1	 	NuAire CO2 Incubator	 	NU5500	 	15358092500
	1	 	Forma Scientific Incubator	 	3158	 	30861-2272
	1	 	DuPont Sorvall Refrigerated High Speed Centrifuge	 	RC-5B	 	-
	1	 	Forma Scientific Class IIA/B3 Biological Safety Cabinet	 	1184	 	14486-269
	1	 	Packard Top Count NXT Microplate Scintillation and Luminescence Counter	 	C990600	 	428654
	1	 	Packard Top Count NXT Microplate Scintillation and Luminescence Counter Base	 	A7401279	 	-
	1	 	Jouan Centrifuge	 	CR4-22	 	49311011
	1	 	Packard Multiprobe Liex Robotic Liquid Handling System	 	AMP11E1	 	A28655
	1	 	Scotsman Ice Cooler	 	AFE400A-1A	 	564246-09D
	1	 	Perkin Elmer GeneAmp	 	PCR9600	 	N15115
	1	 	Metler Balance	 	AG 204	 	
	1	 	Metler Top Loading Balance	 	PG2002-5	 	
	1	 	Edwards Vacuum Pump	 	RV5	 	027254982
	1	 	VWR Vacuum Oven	 	1400E	 	1203501
	1	 	Turner BioSystems Fluorometer	 	Modulus	 	PP#1
	1	 	Motic Digital Microscope	 	DM 143	 	-
	1	 	Cavro Syringe Pump	 	XLP 6000	 	XLP 0508231604
	1	 	DryVac System	 	-	 	-
	1	 	4X4 Cimaric Stirrer	 	-	 	-
	1 set	 	Balance Standards 2100g to 0.01g	 	-	 	-
	1	 	RV2 Stage w/LN Cord	 	-	 	-
	1	 	7X7 Cimaric Stirrer	 	-	 	-
	1	 	Rotary Evaporator	 	-	 	-
	1	 	Recirculating Water Aspirator	 	-	 	-
	1	 	Marble Balance Slab	 	-	 	-
	1	 	Tank Dolly	 	-	 	-

  
 13 

							
	1	 	Hydrogenation Apparatus	 	-	 	-
	1	 	HPLC System	 	-	 	-
	1	 	ph Meter	 	-	 	-
	1	 	Chiracel System	 	-	 	-
	79 feet	 	VWR Lab Casework and Epoxy Table Tops	 	-	 	-
	1	 	VWR 6” Fume Hood with Fan	 	-	 	-
	1	 	VWR Oven	 	13506FM	 	1000799
	1	 	VWR Refrigerator	 	-	 	-
	1	 	Kenmore Freezer	 	-	 	-
	1	 	Thermolyne Furnace	 	FB1415M	 	1.049E+12
	1	 	Branson Ultrasonic Cleaner	 	1510R	 	RKB0503848100
	1	 	Metler Balance	 	AG 245	 	119130501
	1	 	YSI Glucose Analyzer	 	2300D	 	01G0908AA
	1	 	OHAUS Balance	 	E12140	 	F0541120072983
	1	 	Dell Computer and Monitor for Lab	 	-	 	-
	1	 	Medica Ion Analyzer	 	Easylyte	 	19863ANKC
	1	 	Barnstead Nanopure Diamond	 	D11901	 	1190010113360
	1	 	National Glassware Washer	 	MLW661E	 	80947
	1	 	National Oven	 	NL141D	 	80826
	1	 	Geltinge Castle Autoclave	 	133LS	 	99J60370
	Several	 	Microneedle Sheets	 	-	 	-
	Several	 	Microneedles on Reels	 	-	 	-
	Several	 	Microneedle Launcher Prototypes	 	-	 	-
	1	 	Canon Copier	 	NP6050	 	NDK19924
	1	 	Minolta Color Laser Printer	 	QMSMC 2200	 	90251968
	20	 	Desk and Side Chairs	 	-	 	-
	24 feet	 	VWR lab casework and epoxy table tops.	 	-	 	-
	3	 	Desktop computers and monitors	 	-	 	-
	8	 	Small bags of vials containing drug compound and or cell lines (stored in the freezer)	 		 	
	17g	 	Dar100	 	Lot#911.H.94.505	 	-
	200g	 	Dar 200A	 	 Lot#01DAR09-01
 (DR-05-522)-18
	 	-
	2	 	1 kg. batches of DAR 100A	 	-	 	-

  
 14 

 2.4(a) Assumed Accounts Payable 

See attached list of Accounts Payable. 

  
 15 

 BioValve Technologies Inc. 

A/P Aging Summary 
 As of
August 22, 2006 
  

					
	 101 Investment Corp.
	  	 	10,000.00	  
	 Acme Dry Ice Co.
	  	 	204.00	  
	 American Medical Instruments, Inc.
	  	 	-1,465.45	  
	 Apple Rubber Products Inc.
	  	 	-7.00	  
	 Applied Technical Services, Inc.
	  	 	236.75	  
	 Aquawave of New England, LLC
	  	 	84.00	  
	 AT Conference
	  	 	229.85	  
	 Auto-Form
	  	 	-1,500.00	  
	 AXIS, Inc.
	  	 	360.00	  
	 Barnes & Thornburg
	  	 	30,767.38	  
	 Boston Analytical Inc.
	  	 	13,651.00	  
	 C-Axis Inc.
	  	 	-109.42	  
	 Cablevision
	  	 	-159.90	  
	 Cintas Corporation
	  	 	396.67	  
	 Cintas Corporation - 15050
	  	 	255.78	  
	 CNF Pharma LLC
	  	 	4,962.00	  
	 Coffee Pause
	  	 	250.95	  
	 CT Corporation System
	  	 	72.00	  
	 Drummond Scientific Company
	  	 	978.88	  
	 EFD, Inc.
	  	 	-57.38	  
	 Electron Technologies Corp.
	  	 	388.44	  
	 Evan Fray-Witzer
	  	 	5,580.00	  
	 Flanders 155 LLC
	  	 	1,060.33	  
	 Guardian
	  	 	-8,581.98	  
	 Hayes Instrument Service
	  	 	561.00	  
	 lntrex.Net
	  	 	180.00	  
	 Jesse Segovia
	  	 	2,750.00	  
	 KNF&T, Inc.
	  	 	738.75	  
	 Lampin Corporation
	  	 	218.58	  
	 McMaster-Carr Supply Co.
	  	 	1,088.77	  
	 MSC
	  	 	253.10	  
	 MW Industries
	  	 	847.00	  
	 National Facility Services
	  	 	1,045.00	  
	 Omega Engineering, Inc.
	  	 	386.10	  
	 Palladium Networks, Inc.
	  	 	496.10	  
	 PharmaBooks Ltd.
	  	 	2,439.00	  
	 Poland Spring
	  	 	21.18	  
	 Precision Electronic Glass, Inc.
	  	 	1,599.12	  
	 Primus
	  	 	66.45	  
	 Primus - 201-818-1724
	  	 	46.17	  
	 Pro Source
	  	 	11,700.00	  
	 PSE&G
	  	 	21.67	  
	 Raines International
	  	 	35,805.00	  
	 RDS Machine, Inc.
	  	 	853.45	  
	 Rockland Electric Company
	  	 	319.93	  
	 Roger’s General Machining, Inc.
	  	 	-519.50	  
	 Ropes & Gray
	  	 	185,736.70	  
	 Sensor System Solutions, Inc.
	  	 	50.00	  
	 SG&W
	  	 	500.00	  
	 Staples Business Advantage
	  	 	571.85	  
	 Strategic Research Institute
	  	 	10,000.00	  
	 The Hartford
	  	 	632.00	  
	 TM Electronics, Inc.
	  	 	500.00	  
	 Verizon- 2300
	  	 	742.53	  
	 Verizon- 9500
	  			
	 Verizon - 201-825-8882
	  	 	561.62	  
	 Verizon Online
	  	 	101.17	  
	 Verizon Wireless
	  	 	792.33	  

  
 Page 1 of 2 

 BioValve Technologies Inc. 

A/P Aging Summary 
 As of
August 22, 2006 
  

					
	 Verizon Wireless - 108362196
	  	 	866.68	  
	 VWR Scientific Products
	  	 	70,000.00	  
	 W. B. Mason Company Inc.
	  	 	94.07	  
	 Wilman Perez
	  	 	715.50	  
	 Z-Tech Associates
	  	 	1,170.00	  
		  	  
	  
	 
		
	 TOTAL
	  	 	391,548.22	  
		  	  
	  
	 

 “Any accounts payable of BioValve which are the responsibility of the Company pursuant to Section 5.17(b) of the
Contribution Agreement, to be entered into, by and among BioValve, BTI, the Company and Paramount Acquisition Corp.” 

  
 Page 2 of 2 

 2.4(b) Assumed Indebtedness 

Promissory Note, dated as of July 15, 2006, in the principal amount of $300,000, by BioValve in favor of Robert Gonnelli. 

Promissory Note, dated as of August 15, 2006, in the principal amount of $300,000, by BioValve in favor of Elizabeth Gordon. 

Promissory Note, dated as of June 20, 2006, in the principal amount of $300,000, by BioValve in favor of Peter Raia. 

Promissory Note, dated as of August 17, 2006, in the principal amount of $100,000, by BioValve in favor of Robert Gonnelli. 

  
 16 

 2.5 (c) Liabilities 

See items list in Section 2.4(b) of the Disclosure Schedule. 

  
 17 

 2.5 (d) – Legal Proceedings 

Manta Product Development v. BioValve 
 Complaint: Manta Product
Development, Inc seeks to recover from BioValve for labor, services and materials rendered by Manta and provided to BioValve. Manta is claiming $36,318.23 plus 18% contract interest, attorney’s fees and costs. 

Hunter Partners Inc. v BioValve and Robert Gonnelli. 

Complaint: Hunter Partners were retained to search for a candidate for the position of Vice President R&D at BioValve. BioValve terminated the search but
Hunter Partners claims BioValve employed a candidate presented by them and is owed $22,500 from the retained search for a VP of R&D, $50,000 for the placement of Mark Lewis and $2,093.53 for out of pocket expenses (totaling $74,593.53). 

  
 18

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