FIRST AMENDMENT TO FORMATION AGREEMENT

Exhibit 10.22

FIRST AMENDMENT TO

This First Amendment to the Formation Agreement (“Amendment”), effective as of August 26, 2008 (“Amendment Effective Date”), is between Valeritas, Inc., a Delaware corporation (“Company”) and BioValve Technologies, Inc., a Delaware corporation (“BioValve”) and amends that certain Formation Agreement among the parties and BTI Tech, Inc., a Delaware corporation (“BTI”) dated August 22, 2006 (“Agreement”).

WHEREAS, the parties desire to clarify certain understandings under the Agreement and amend other aspects of the Agreement and the Disclosure Schedule thereto (“Disclosure Schedule”), each as specified herein.

WHEREAS, on August 6, 2008, BTI was merged into and with BioValve.

NOW THEREFORE, in consideration of the premises and the parties’ mutual covenants, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties agree as follows.

AGREEMENT

1. Definitions. Except as otherwise set forth herein, all capitalized terms used in this First Amendment shall have the same meanings as set forth in Agreement.

2. Device Assets. The definition for “Device Assets” in Section 1.1 shall be deleted in its entirety and replaced with the following:

“‘Device Assets’ means all of BioValve’s assets relating to BioValve’s drug delivery/medical device initiative, including without limitation the Patch Technology, Microneedle Technology, Needle-free Technology, Rapid Infusion Technology (as those terms are defined in Schedule 1.1 of the Disclosure Schedule to the Agreement (‘Disclosure Schedule’ ), all precursors, portions and work in progress with respect thereto, and all other assets listed on Schedule 1.1 or otherwise necessary to the use and exploitation thereof, 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.”

3. Contribution of Assets. The first paragraph of Section 2.2 shall be deleted in its entirety and replaced by the following:

“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 Company, irrevocably and exclusively throughout the world, free and clear of all Liens, all right, title, and interest (including all Intellectual Property) in and to the Device Assets and all other 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, whether known or unknown, fixed or unfixed, tangible or intangible, whether or not specifically referred to in this Agreement, as amended, and whether or not reflected on the books and records of BioValve or BTI (collectively, the “Contributed Assets”). For the avoidance of doubt, Company has no obligation to license back to BioValve any right or interest in the Contributed Assets for any purpose. The Contributed Assets shall include, without limitation, 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”), including any licenses contained therein, and any sums due to BioValve or BTI under any of the Scheduled Contracts;

(d) all lists, documents, records, written information, notebooks, production drawings, production specifications, supplier lists, prototypes, 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;

(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, the Intellectual Property Rights thereto and all 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;

(j) all rights, title and interests in and to trademarks set forth on Schedule 1.1, together with the goodwill symbolized thereby and associated therewith;

(k) all other assets or movable property to the extent related to the Device Assets or necessary to exploit or commercialize the Device Assets; and

(1) all licenses, permits, authorizations and approvals of, all pricing agreements and price reimbursement agreements with, and all registrations, filings and other notifications to, any governmental agency or department necessary for the manufacturing, packaging, marketing, distribution, sale and/or use of the Device Assets within any country or regulatory jurisdiction anywhere in the world, including, without limitation, any 510(k) clearances received from the U.S. Food and Drug Administration.

4. Assumption of Liabilities. Section 2.4 shall be deleted in its entirety and replaced by the following:

“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: (a) all unpaid ordinary course, trade accounts payable related to the Device Assets (other than payables to Affiliates of BioValve) listed in Section 2.4(b) of the Disclosure Schedule (the “Assumed Accounts Payable”), (b) the Indebtedness of BioValve listed in Section 2.4(b) of the Disclosure Schedule, (c) the liabilities and obligations of BioValve 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) and (d) up to $75,000 in the aggregate of any liabilities incurred by BioValve relating to the Legal Proceedings set forth in Section 2.5(d) of the Disclosure Schedule.”

5. Excluded Liabilities. The following language shall be added at the beginning of Section 2.5(d):

“(d) Except as specifically assumed by the Company pursuant to clause (d) of Section 2.4,”

6. Further Assurances. The following language shall be added to the end of Section 2 as a new Section 2.7:

“Section 2.7 Further Assurances. BioValve and BTI agree to assist Company, at the Company’s expense, in every proper way to evidence, record and perfect the assignment in Section 2.2 herein, to apply for and obtain recordation of and from time to time enforce, maintain and defend the assigned rights, and to transfer and assign any regulatory approvals, including but not limited to FDA 510(k) clearances, relating to the Device Assets to the Company. BioValve and BTI further agree to assist Company in every proper way, at the Company’s expense, to obtain any consents required under Section 2.2(c) and to execute any agreements as reasonably requested by Company to effect the provisions of this Agreement.”

7. Contract Representations and Warranties. The following language shall be added to the end of Section 3.1:

“No Scheduled Contract or Assumed Liability includes BioValve’s or BTI’s agreement to indemnify, hold harmless or defend any third party with respect to any assertion of infringement or other violation of Intellectual Property Rights or warranting the lack thereof. All of the Scheduled Contracts are currently in effect, in good standing and without any breach or default by either party. No event or circumstance has occurred, exists or is contemplated (including, without limitation, as a result of the authorization, execution and delivery of this Agreement or the performance of any obligations under this Agreement or the consummation of any of the transactions contemplated thereby), that with or without notice or the lapse of time, could result in the (i) breach of any Scheduled Contract or Assumed Liability, (ii) loss or expiration of any right or option by BioValve or BTI (or the gain thereof by any third party) under any Scheduled Contract or (iii) release, disclosure or delivery to any third party of any part of the Intellectual Property Rights.”

8. Intellectual Property Representations and Warranties. The following language shall be added to the end of Section 3 as new Sections 3.5 through 3.10:

“Except as otherwise set forth in the amended Disclosure Schedule delivered in connection with this Amendment:

Section 3.5 Authority and No Conflict. BioValve and BTI have the full power, right and authority to enter into and make the contributions and assignments and perform its other obligations under this Agreement without the consent, approval or authorization of any other person or entity, and this Agreement constitutes BioValve and BTI’s valid and binding obligation enforceable in accordance with its terms. The execution and delivery of this Agreement by BioValve and BTI, and their compliance with the terms thereof, do not and will not conflict with or result in a breach of any terms of, or constitute a default under, any agreement, obligation or instrument to which BioValve or BTI is a party or by which it is bound.

Section 3.6 Ownership. BioValve and BTI are the sole and exclusive owners of the Contributed Assets and there are no shared ownership interests of any kind in or to any of the Contributed Assets. All of the Intellectual Property Rights in the Contributed Assets are valid, enforceable and subsisting. No governmental registration of any of the Intellectual Property Rights has lapsed, expired or been canceled, abandoned, opposed or the subject of a reexamination request.

Section 3.7 No Outstanding Rights. BioValve and BTI have not previously assigned, transferred, licensed, pledged or otherwise encumbered any of the Contributed Assets to any party other than the Company, or agreed to do so, and there are no outstanding options or rights granted to any third party in or to any of the Contributed Assets, or to acquire any rights or licenses to any of the Contributed Assets. Execution and delivery of this Agreement will convey to and vest in Company good and marketable title to the Contributed Assets, free

and clear of any liens, claims, security interests or other encumbrances, and will otherwise provide Company with unrestricted rights to use and exploit the Contributed Assets.

Section 3.8 Inventorship. The sole inventors of the Device Assets are BioValve and BTI employees, all of whom were acting within the scope of their employment with BioValve or BTI and are bound by valid and enforceable written assignments that are necessary and sufficient to irrevocably transfer all of their rights, title and interests therein to Bio Valve or BTI. Each current and former employee and contractor of BioValve and BTI has executed and delivered (and to the best of BioValve’s and BTI’s knowledge respectively, is in compliance with) an agreement in substantially the form of BioValve’s or BTI’s standard confidentiality and inventions assignment agreement, which agreements provide valid written assignments to BioValve or BTI of all rights, title and interests in and to any invention, work product or other intellectual property rights conceived or developed thereunder, in whole or in part, by such persons. The Intellectual Property Rights do not include, and operation of the business relating to the Device Assets does not require, any (i) invention of any past or present employee or contractor made prior to or outside the scope of their employment or engagement with BioValve or BTI or (ii) any confidential or proprietary information or trade secret of any former employer of any such person or any other third party.

Section 3.9 Quiet Enjoyment. There have been no threats, communications, claims, actions, proceedings or litigation, and there is no basis upon which a claim may be made against BioValve, BTI, the Company or any of their respective affiliates, that could give rise to any Assumed Liability or that challenges the inventorship, ownership, scope, validity or enforceability of any of the Intellectual Property Rights. There is no instance where it has been held, claimed or alleged, whether directly or indirectly, and there is no basis upon which a claim may be made, that the subject matter of any Intellectual Property Right infringes, misappropriates or otherwise violates any intellectual property right of a third party, or that any activity of a third party infringes or may infringe upon or is in violation of any of the Intellectual Property Rights.

Section 3.10 Confidentiality. BioValve and BTI have taken all commercially reasonable and appropriate steps to protect and preserve the confidentiality of all trade secrets and other proprietary information relating to the Device Assets and the Intellectual Property Rights therein (“Business Confidential Information”). All use by and disclosure to employees or others of Business Confidential Information by BioValve and BTI has been pursuant to the terms of valid and binding written confidentiality and nonuse/restricted-use agreements.”

9. Legal Fees. The following language shall be added to the end of Section 4.4:

“Company will pay 50% of the outstanding legal fees of Xxxxx Xxxx LLP, counsel to certain of BioValve’s investors, with the Company’s share of such fees not to exceed $87,500.”

10. Covenants. The following language shall be added to the end of Section 4 as a new Sections 4.5 through 4.11:

“Section 4.5 Indemnification. BioValve shall defend and indemnify certain investors in Company for any breach of its obligations, representations and warranties herein, as further specified in the Valeritas, Inc. Recapitalization and Preferred Stock Purchase Agreement dated August 26, 2008 (the “Stock Purchase Agreement”).

Section 4.6 Non-Competition. During the Restricted Period (as defined below), each party shall refrain from Competition (as defined below) with the other. For the purposes of this provision: “Competition” means (i) directly or indirectly, individually or in conjunction with others, engaging in activities that compete with the Business (as defined below) of the other party, (ii) causing or attempting to cause any existing or prospective customer, supplier, client or account of in the area of the Business to terminate, limit or in any manner modify, or fail to enter into, any actual or potential business relationship with the other party; “Business” means any business in which a party is engaged or has proposed to be engaged on the Amendment Effective Date (provided, that, without limiting the generality of the foregoing, the Business of the Company shall specifically include any business that is based upon or uses the Contributed Assets); “Restricted Period” means a period commencing as of the Amendment Effective Date and ending on the date five years following the Amendment Effective Date.”

Section 4.7 Company Employees. BioValve acknowledge and agrees that all employees on the attached Appendix 3 are Company employees. BioValve agrees that it will not, beginning as of the date of this Amendment and for a period of two years thereafter (the “Restricted Period”), and anywhere in the world, directly or indirectly, on behalf of BioValve or any affiliate, encourage or solicit any person who at the time of such encouragement or solicitation is an employee or consultant of, or advisor to, Company to terminate such person’s relationship with Company for any reason; or solicit or recruit, directly or by assisting others, or attempt to solicit or recruit to BioValve or to any other person or entity who is or was a Company employee or consultant within the Restricted Period.

Section 4.8 Intercompany Note. BioValve and Company will agree that all existing intercompany notes, accounts payable and receivable, and other accounts shall be, and hereby are, canceled in consideration of the issuance by Company of a note in the form attached as Annex I in the principal amount of $1,771,508, which Company shall issue on or prior to the date of this Amendment, which note provides that Company shall pay BioValve $1 million of the amounts outstanding under the note within seven (7) days of the issuance date

and all remaining amounts outstanding under the note in equal monthly installments on or prior to February 26, 2009 (or the date of the Subsequent Closing (as such term is defined in the Stock Purchase Agreement), if earlier).

Section 4.9 Rapid Infuser Payments. In the event that Company enters into licensing or partnering agreements with any third party on an exclusive or non-exclusive basis, granting the third party a right to use the Rapid Infuser Technology in the development and/or commercialization of such Rapid Infuser Technology alone or in combination with a pharmaceutical agent, Company shall pay BioValve an amount equal to nine percent (9%) of any cash upfront license or signing fees which Company actually receives from such third party and nine percent (9%) of any cash development milestone payments, with a development milestone defined as any milestone payment for any purpose other than those described below as payments that are excluded (“License Payments”). Such payments will be made to BioValve within thirty days after receipt by Company of such License Payments from the third party licensee. For clarity, Company’s payments to BioValve under this Section 4.9 shall not include (and will not be based on) any (a) amounts that are payable directly in connection with the sale of a product incorporating the Rapid Infuser Technology, including royalties, profit shares or sales milestones, (b) payments for equity or debt of Company, (c) payments for the manufacture or supply of products by Company, including research support or research reimbursement payments, (d) payment or reimbursement for services performed by Company, (e) payment on account of costs associated with the prosecution, maintenance, enforcement, defense or suits with respect to intellectual property (the “Excluded Payments”). For payments in connection with licensing or partnering agreements related to a combination of a pharmaceutical agent and the Rapid Infuser Technology in which Company has invested greater than $2 million in direct development costs prior to such licensing or partnering agreement (a “Combination Product”), ten (10%) percent of the Licensing Payments from the Combination Product shall be deemed allocatable to the Rapid Infuser Technology and the baseline for the nine (9%) percent payments hereunder. Payment or consideration received by Company in any form other than cash that directly relates to the Rapid Infuser Technology and is made in lieu of cash Licensing Payments shall be considered Licensing Payments for purposes of this Agreement. This provision shall survive a change of control. On the signing of each new licensing agreement with a third party and on each February 1 following the Amendment Effective Date, Company will provide BioValve a written summary of the Licensing Payments agreed to including any revisions in a third party agreement that affect BioValve’s payments and an updated status on the expected timing of those payments for the sole purpose of BioValve’s business planning.

Section 4.10 Waiver and Release. BioValve hereby stipulates and agrees that it has and will have no rights, claims or causes of action against Company with respect to any Excluded Assets and Excluded Liabilities, and hereby waives, releases and agrees not to assert or exercise any such rights, claims or causes of action, whether known or unknown, contingent or accrued.

11. Device Assets and other Intellectual Property. Schedule 1.1 of the Disclosure Schedule is hereby deleted and replaced in its entirety by the new Schedule 1.1 in the form attached hereto as Appendix 1.

12. Schedule 2.2(c). Schedule 2.2(c) of the Disclosure Schedule is hereby deleted and replaced in its entirety by the new Schedule 2.2(c) in the form attached hereto as Appendix 2.

13. BioValve Assets. Appendix 4 hereto contains a true and complete list all BioValve assets and property currently located on Company’s premises. BioValve hereby covenants and agrees that it shall use commercially reasonable efforts to remove all such assets and property from Company’s premises on or before September 30, 2008.

14. Scope of Amendment. This Amendment shall be effective and binding upon the parties as of the Amendment Effective Date. Except and only to the extent specifically modified herein, all of the terms and conditions of the Agreement are hereby ratified and confirmed and shall remain in full force and effect. In case of any conflict or inconsistency between the provisions of this Amendment and the Agreement, this Amendment shall control. This Amendment may be executed in multiple counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument. In making proof of this Amendment, it shall not be necessary to produce or account for more than one such counterpart.

IN WITNESS WHEREOF, intending to be legally bound, the parties have caused their duly authorized officers to execute this Amendment as an instrument under seal, as of the Amendment Effective Date.


	COMPANY:

	VALERITAS, INC.

	By:	/s/ Xxxxx Xxxxxx

	Name:	XXXXX XXXXXX

	Title:	Interim CEO

Address:	0 Xxxxxx Xxxxx

	Xxxxxxxxxx XX 00000

	PARENT:

	BIOVALVE TECHNOLOGIES INC.

	By:

	Name:

	Title:

Address:

IN WITNESS WHEREOF, intending to be legally bound, the parties have caused their duly authorized officers to execute this Amendment as an instrument under seal, as of the Amendment Effective Date.


	COMPANY:

	VALERITAS, INC.

	By:

	Name:

	Title:

Address:



	PARENT:

	BIOVALVE TECHNOLOGIES INC.

	By:	/s/ Xxxxxx X. Xxxxxxxx

	Name:	Xxxxxx X. Xxxxxxxx

	Title:	President & CEO

Address:	0 Xxxxxx Xxxxx

	Xxxxxxxxxx XX 00000

APPENDIX 1

Schedule 1.1 – Intellectual Property

Trademarks: h-Patch, e-Patch, Micro-Trans, Mini-Ject, V-Go

* * *

As used in the Agreement, the Patch Technology, Microneedle Technology, Needle-free Technology, and Rapid Infuser Technology shall have the following meanings and shall include, without limitation, the technologies and intellectual property disclosed or claimed in the patents or patent applications listed in Table 1 below, as well as the inventions which are not yet the subject of any patent filing listed in Table 2 below, including methods of making or using the same.

1. Patch Technology shall encompass: infusion devices in which drug delivery is controlled by controlling displacement of a medicinal reservoir via hydraulic fluid flow controlled by a restrictor between the fluid and the medicinal cartridge with or without a floating needle fluid path into the skin; skin-mounted infusion pumps with floating needles; spring-driven hydraulic infusers utilizing highly-viscous hydraulic fluid in which the contents of a drug reservoir can be expelled with minimum extension of the spring from it’s fully compressed length, so that the force applied by the spring remains relatively constant throughout the infusion; electrochemically-controlled gas generation displacement infusers; wearable mechanically driven infusers having basal delivery capability and patient controlled bolus delivery capability intended for, or capable of, the same or a similar use as other Company technologies and that are intended to be or are researched, developed or commercialized by Company; infusion devices known as h-Patch; infusion devices known as e-Patch; infusion devices known as V-Go; methods of making or using any of the foregoing; and ancillary devices and methods for use with any of the foregoing.

2. Microneedle Technology shall encompass: delivery or sampling devices using microneedle arrays applied to a body surface; microneedles, either hollow or solid structures, having integrated drug reservoirs; microneedles combined with a membrane; microneedle structures filled or coated with dissolvable solids; products known as Micro-Trans; methods of making or using any of the foregoing; and ancillary devices and methods for use with any of the foregoing.

3. Needle-free Technology shall encompass: devices using multi-stage energetic materials for dynamically propelling compounds or compositions across a biological barrier into the body; devices known as Mini-Ject; methods of making or using any of the foregoing; and ancillary devices and methods for use with any of the foregoing.

4. Rapid Infusion Technology shall encompass: devices that deliver solutions across the skin using a displacement method driven by a controlled slip anchor producing forces large enough to deliver compounds with viscosity ranging from 1 cps to 50 cps intended to deliver low to high volumes (i.e., less than one milliliter to about 20 milliliters). These devices include

devices intended for large volume subcutaneous administration by the patient for formulations of peptides, proteins, small molecules and antibodies that are most often administered by IV infusion. The Rapid Infusion Technology shall also include any work created by Company as part of the services performed by Company for “BioValve that is owned by BioValve under that certain Agreement For Service between the parties and dated May 23, 2008.

TABLE 1: Patents and Patent Applications:

Valeritas Ref.

No.

Country

Title

Priority
Appl. No.

Priority

Date

Application
No.

Filing Date

Status

Patent No.

Issue Date

BVTP-P01-002

Injection Devices

60/112,805

18-Dec-98

09/465,573

17-Dec-99

Granted

US 6,406,455 B1

18-Jun-02

BVTP-P02-002

Injection Devices

60/112,805

18-Dec-98

10/175,541

18-Jun-02

Granted

US 6,960,184

1-Nov-05

BVTP-P03-002

Injection Devices

60/112,805

18-Dec-98

11/063,500

22-Feb-05

Published

BVTP-PWO-002

Injection Devices

Same as above

US99/30172

17-Dec-99

Closed (entry into national stage

completed)

BVTP-PEP-002

Injection Devices

Same as above

99968496.2

17-Dec-99

Granted

1144031

26-Oct-05

BVTP-P01-003

Electroactive Pore

60/120,879

18-Feb-99

09/507,317

18-Feb-00

Granted

US 6,314,317 B1

6-Nov-01

BVTP-P02-003

Electroactive Pore

60/120,879

18-Feb-99

09/878,573

11-Jun-01

Granted

US 6,490,483 B2

3-Dec-02

BVTP-P03-003

Electroactive Pore

60/120,879

18-Feb-99

10/306,767

26-Nov-02

Granted

US 7,187,969 B2

6-Mar-07

BVTP-PWO-003

Electroactive Pore

Same as above

US00/04273

18-Feb-00

Closed (entry into national stage

completed)

BVTP-PJP-003

Electroactive Pore

Same as above

2000-599456

18-Feb-00

Abandoned

BVTP-PIL-003

Electroactive Pore

Same as above

144948

18-Feb-00

Pending

BVTP-PHK-003

Electroactive Pore

Same as above

2102212.6

18-Feb-00

Abandoned

BVTP-PEP-003

Electroactive Pore

Same as above

00914640.8

18-Feb-00

Granted

1161277

11-Oct-06

BVTP-PDE-003

Electroactive Pore

Same as above

00914640.8

18-Feb-00

EP patent validated In DE

1161277

2-Feb-07

BVTP-PGB-003

Electroactive Pore

Same as above

00194640.8

18-Feb-00

EP patent validated in GB

1161277

11-Oct-06

BVTP-PCA-003

Electroactive Pore

Same as above

2362814

18-Feb-00

Abandoned

BVTP-PAU-003

Electroactive Pore

Same as above

36003/00

18-Feb-00

Granted

767510

26-Feb-04

BVTP-P01-004

Injection Device

60/174,876

7-Jan-00

09/755,906

5-Jan-01

Granted

US 6,616,627 B2

9-Sep-03

BVTP-P02-004

Injection Device

60/174,876

7-Jan-00

10/658,116

8-Sep-03

Published

BVTP-PWO-004

Injection Device

Same as above

US01/00346

4-Jan-01

Closed (entry into national stage

completed)

BVTP-PEP-004

Injection Device

Same as above

1908589.3

4-Jan-01

Published

BVTP-PCA-004

Injection Device

Same as above

2396569

4-Jan-01

Pending

BVTP-PAU-004

Injection Device

Same as above

36441/01

4-Jan-01

Granted

783680

9-Mar-06

BVTP-PA1-004

Injection Device

Same as above

2006200790

24-Feb-06

Pending

Valeritas Ref.

No.

Country

Title

Priority
Appl. No.

Priority

Date

Application

No.

Filing Date

Status

Patent No.

Issue Date

BVTP-P01-007

Injection Systems

60/250,410

60/250,425

60/250,537

60/250,573

30-Nov-00

10/001,002

30-Nov-01

Published

BVTP-P02-007

Dermal Drug Injection Systems

same as above

09/999,549

30-Nov-01

Published

BVTP-P03-007

Dermal Drug Injection Systems

same as above

10/007,061

30-Nov-01

Granted

US 7,150,409

19-Dec-06

BVTP-PWO-007

Dermal Drug Injection Systems

Same as above

same as above

US01/46029

30-Nov-01

Closed (entry into national stage

completed)

BVTP-PKR-007

Dermal Drug Injection Systems

Same as above

same as above

2003-7007279

00-Xxx-00

Xxxxxxxxx

XXXX-XXX-000

Dermal Drug Injection Systems

Same as above

same as above

2002-552611

30-Nov-01

Published

BVTP-PEP-007

Dermal Drug Injection Systems

Same as above

same as above

01994145.9

30-Nov-01

Published

BVTP-PCA-007

Dermal Drug Injection Systems

Same as above

same as above

2430499

30-Nov-01

Pending

BVTP-PAU-007

Dermal Drug Injection Systems

Same as above

same as above

2002246572

00-Xxx-00

Xxxxxxxxx

XXXX-XX0-000

Dermal Drug Injection Systems

Same as above

same as above

2007202665

8-Jun-07

Pending

BVTP-P01-011

Fluid Delivery and Measurement Systems and Methods

60/250,538

60/250,408

60/250,295

60/250,927

60/250,422

60/250,413

60/250,403

60/324,412

30-Nov-00

24-Sep-01

10/006,526

30-Nov-01

Granted

US 6,939,324 B2

6-Sep-05

BVTP-P02-011

Fluid Delivery and Measurement Systems and Methods

same as above

11/219944

6-Sep-05

Pending

(Allowed)

BVTP-PWO-011

Fluid Delivery and Measurement Systems and Methods

Same as above

same as above

US01/46028

30-Nov-01

Closed (entry into national stage

completed)

BVTP-PEP-011

Fluid Delivery and Measurement Systems and Methods

Same as above

same as above

01988242.2

30-Nov-01

Published

BVTP-PCA-011

Fluid Delivery and Measurement Systems and Methods

Same as above

same as above

2430590

30-Nov-01

Pending

BVTP-P01-023

Microneedle, Microneedle arrays, and systems and methods relating to same

60/323,417

19-Sep-01

10/251,480

19-Sep-02

Published

BVTP-P01-025

Gas Pressure Actuated Microneedle Arrays, and Systems and methods relating to same

60/323,852

21-Sep-01

10/252,739

23-Sep-02

Published

Valeritas Ref.

No.

Country

Title

Priority
Appl. No.

Priority

Date

Application
No.

Filing Date

Status

Patent No.

Issue Date

BVTP-PWO-025

Gas Pressure Actuated Microneedle Arrays, and Systems and methods relating to same

Same as above

same as above

US02/30117

23-Sep-02

Closed (entry into national stage

completed)

BVTP-PEP-025

Gas Pressure Actuated Microneedle Arrays, and Systems and methods relating to same

Same as above

same as above

2766341.8

23-Sep-02

Published

BVTP-PCA-025

Gas Pressure Actuated Microneedle Arrays, and Systems and methods relating to same

Same as above

02499838

23-Sep-02

Pending

BVTP-P01-027

Stacked Microneedle Systems

60/174,023

30-Dec-99

09/747,768

22-Dec-00

Published

BVTP-PWO-027

Stacked

Microneedle

Systems

Same as above

US00/35144

22-Dec-00

Closed (entry into national stage

completed) Pending

BVTP-PEP-027

Stacked

Microneedle

Systems

Same as above

00990324.6

22-Dec-00

Published

BVTP-PCA-027

Stacked

Microneedle

Systems

Same as above

2396767

00-Xxx-00

Xxxxxxx

XXXX-XX0-000

Stacked

Microneedle

Systems

Same as above

0000000000

13-Oct-05

Pending

BVTP-P02-028

Microneedle Adapter

60/247,571

9-Nov-00

10/412,384

11-Apr-03

Abandoned

BVTP-P03-028

Microneedle Adapter

60/247,571

9-Nov-00

11/977,158

22-Oct-07

Pending

Abandoned

BVTP-PWO-028

Microneedle Adapter

Same as above

US01/46845

8-Nov-01

Closed (entry into national stage

completed)

BVTP-P01-029

Microneedle Array Systems

60/257,757

21-Dec-00

10/027,115

20-Dec-01

Granted

US 7,027,478 B2

11-Apr-06

BVTP-PW0-029

Microneedle Array Systems

Same as above

US01/49797

20-Dec-01

Closed (no entry into national stage)

BVTP-P01-030

Switchable Microneedle Arrays and Systems and Methods relating to same

60/325,522

28-Sep-01

10/260,711

30-Sep-02

Abandoned

BVTP-P02-030

Switchable Microneedle Arrays and Systems and Methods relating to same

60/325,522

28-Sep-01

11/975,353

18-Oct-07

Pending

BVTP-PWO-030

Switchable Microneedle Arrays and Systems and Methods relating to same

Same as above

US02/30993

30-Sep-02

Closed (entry into national stage

completed)

Valeritas Ref.

No.

Country

Title

Priority
Appl. No.

Priority

Date

Application
No.

Filing Date

Status

Patent No.

Issue Date

BVTR-PEP-030

Switchable Microneedle Arrays and Systems and Methods relating to same

Same as above

02780401.2

30-Sep-02

Abandoned

BVTP-PCA-030

Switchable Microneedle Arrays and Systems and Methods relating to same

Same as above

2500452

30-Sep-02

Pending

BVTP-P02-032

Microneedle with Membrane

60/325,736

28-Sep-01

10/993,927

19-Nov-04

Abandoned

BVTP-P03-032

Microneedle with Membrane

60/325,736

28-Sep-01

12/152,138

12-May-08

Pending

BVTP-PWO-032

Microneedle with Membrane

Same as above

US02/31153

30-Sep-02

Closed (entry into national stage

completed)

BVTP-PEP-032

Microneedle with Membrane

Same as above

02773681.8

30-Sep-02

Published

BVTP-PCA-032

Microneedle with Membrane

Same as above

2500453

30-Sep-02

Pending

BVTP-P01-034

Microneedle Array Patch

60/416,740

7-Oct-02

10/681,777

7-Oct-03

Abandoned

BVTP-P02-034

Microneedle Array Patch

60/416,740

7-Oct-02

11/975,717

19-Oct-07

Pending

BVTP-PEP-034

Microneedle Array Patch

Same as above

03808167.5

7-Oct-03

Published

BVTP-PWO-034

Microneedle Array Patch

Same as above

US03/31847

7-Oct-03

Closed (entry into national stage

completed)

BVTP-P01-035

Hydraulically Actuated Pump for Long Duration Medicament Administration

60/465,070

23-Apr-03

10/831,354

23-Apr-04

Published

BVTP-PWO-035

Hydraulically Actuated Pump for Long Duration Medicament Administration

60/465,070

23-Apr-03

US04/12797

23-Apr-04

Closed (entry into national stage

completed)

BVTP-PEP-035

Hydraulically Actuated Pump for Long Duration Medicament Administration

60/465,070

23-Apr-03

04760179.4

23-Apr-04

Published

BVTP-PJP-035

Hydraulically Actuated Pump for Long Duration Medicament Administration

60/465,070

23-Apr-03

2006-513327

23-Apr-04

Published

BVTP-PCA-035

Hydraulically Actuated Pump for Long Duration Medicament Administration

60/465,070

23-Apr-03

2523267

23-Apr-04

Pending

BVTP-PAU-035

Hydraulically Actuated Pump for Long Duration Medicament Administration

60/465,070

23-Apr-03

200423285.8

23-Apr-04

Pending

Valeritas Ref.

No.

Country

Title

Priority
Appl. No.

Priority

Date

Application

No.

Filing Date

Status

Patent No.

Issue Date

BVTP-P01-037

Methods and Devices for Delivering Agents Across Biological Barriers

11/198,024

5-Aug-05

Published

BVTP-PAU-037

Methods and Devices for Delivering Agents Across Biological Barriers

11/198,024

5-Aug-05

2006278258

7-Aug-06

Pending

BVTP-PJP-037

Methods and Devices for Delivering Agents Across Biological Barriers

Same as above

2008-525284

7-Aug-06

Pending

BVTP-PEP-037

Methods and Devices for Delivering Agents Across Biological Barriers

Same as above

06801016.4

7-Aug-06

Pending

BVTP-PWO-037

Methods and Devices for Delivering Agents Across Biological Barriers

Same as above

US06/030981

7-Aug-06

Published

BVTP-P01 -038

Methods and Devices for Delivering GLP-1 and Uses Thereof

60/585,330

2-Jul-04

11/175990

5-Jul-05

Published

BVTP-PWO-038

Methods and Devices for Delivering GLP-1 and Uses Thereof

Same as above

US05/023818

5-Jul-05

Abandoned

BVTP-P60-1000

Multi-Cartridge Fluid Delivery Device

60/787,616

30-Mar-06

Abandoned

BVTP-PWO-1000

Multi-Cartridge Fluid Delivery Device

60/787,616

US2007/065363

30-Mar-07

Pending

Table 2: Inventions Relating to h-Patch Not Yet the Subject of Patent Applications

•

Coating for rubber components to control or reduce static friction

•

Hydraulic fluid rate control using restrictor control methods with viscosity ranges from 20 cps to 100,000 cps

•

Precision manufacturing method of molding medicinal cartridge to control diameter accuracy

•

Live action adhesive to allow relative movement of device versus skin and needle assembly increasing skin comfort

•

Filling system adapter for V-Go system

•

User interface; audible and tactile click

•

Method of needle release and safety lockout

•

Method of manufacture for viscous manifold

APPENDIX 2

Schedule 2.2(c) – Scheduled Contracts

2.2(c) — Scheduled Contracts.

The Scheduled Contracts shall include all agreements pertaining to the Contributed Assets, including without limitation those included in the Contract Table below.

CONTRACT TABLE


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 000 Xxxxxx Xxxxxxxx, Xxxxxxxxxx, XX for a period of ten (10) years and three (3) months effective November 1, 2006.



X. Xxxxxxxx-Xx Xxxxx Ltd.	November 14, 2007	BioValve agrees to conduct a study to develop new technology based on existing BioValve and Roche proprietary technology and assign any newly developed technology arising from the Study to Roche.

Ferring	November 28, 2007	For performance of a feasibility study of desmopressin with BioValve’s proprietary transdermal delivery system.

FM Healthcare Solutions LLC	June 1, 2006	FM Healthcare to provide recruiting and general human resources services.

APPENDIX 3

Valeritas Employees

Barowich, Xxxxxxx

Xxxxxxxxxx, Xxxxxxx

Xxxxx, Xxxxxx

Xxxxxxxxx, Xxxxx

Xxxxxx, Xxxxxxx

Xxxxxxx, Xxx

Xxxxxxxxxx, Xxxx

Xxxxxx, Xxxx

Xxxx, Xxxxxx

Xxxx, Xxxxx

Xxxxxxx, Xxxxxxx

Xxxxxxxx, Xxxxxxx

Xxxxx, Xxxx

Xxxxxxxx, Xxxxxx

Xxxxx, Xxxxxx

XxXxxxxxxx, Xxxxx

XxXxxxxxxx, Xxxx

Xxxx, Xxxxxxx

Xxxx, Xxxxx

Xxxxxx, Xxxx

Xxxxxxxx, Xxxx

Xxxx, Xxx

Xxxxx, Xxxxx

Sisu, Xxxxxxxx

Xxxxxxxx, Xxxxxx

Xxxxxx, Xxxxx

Xxxxxx, Xxxx

Xxxxxx, Xxxxxxxx

Xxxxx, Xxxxx “Xxxxx”

Xxxxxx, Xxxxxxx

Xxxxxxx, Xxxx X.

XxXxxxx, Xxxxxx

Xxxxxxxx, Xxxxxx

Xxxx, Xxxxxxxx

Xxxxxxxx, Xxxxxxxx

Xxxxxxx, Xxxxxx

Xxxxx, Xxxxxx

Xxxxxx, Xxxxxxx

Xxxxx, Xxxxx X.

Xxxx, Xxxxxx

Xxxxxx, Xxxxx

Xxxxx, Xxxx

Xxxxxxxxxx, Xxxx

Xxxx, Xxxxx

APPENDIX 4

BioValve Assets on Company Premises

BioValve Technologies Inc. Lab Equipment

Number

Description

Model

Serial #

Location

Department

Status

Varian ProStar HPLC Column Valve Module

320

560

Shrewsbury

microneedle lab.

not in use

Varian ProStar HPLC Solvent Delivery Module

210

1114

Shrewsbury

microneedle lab.

not in use

Varian ProStar HPLC Solvent Delivery Module

210

1116

Shrewsbury

microneedle lab.

not in use

Varian ProStar HPLC UV VIS Detector

500

134

Shrewsbury

microneedle lab.

not in use

VWR Thermo -80° C Freezer

5416

802199

Shrewsbury

fridge area

in use

Amana Refrigerator

DRB2101A

11306610AC

Shrewsbury

fridge area

in use

Xxxxxxx Balance

AG245

1117461638

Shrewsbury

clean room

in use

NuAire CO2 Incubator

NU5500

15358092500

Shrewsbury

warehouse

not in use

Forma Scientific Incubator

3158

30861-2272

unknown

DuPont Sorvall Refrigerated High Speed Centrifuge

RC-5B

unknown

Forma Scientific Class IIA/B3 Biological Safety Cabinet

1184

14486-269

Shrewsbury

microneedle lab.

in use

Packard Top Count NXT Microplate Scintillation and Luminescence Counter

C990600

428654

Purdue

Packard Top Count NXT Microplate Scintillation and Luminescence Counter Base

A7401279

Purdue

Jouan Centrifuge

CR4-22

49311011

Purdue

Packard Multiprobe Liex Robotic Liquid Handling System

AMP11E1

A28655

Purdue

Scotsman Ice Cooler

AFE400 A-1A

564246-09D

Shrewsbury

warehouse

not in use

Xxxxxx Xxxxx GeneAmp

PCR9600

N15115

unknown

BioValve Technologies Inc. Lab Equipment

Number

Description

Model

Serial #

Location

Department

Status

Xxxxxxx Balance

AG 204

unknown

Xxxxxxx Top Loading Balance

PG2002-5

unknown

Xxxxxxx Vacuum Pump

RV5

27254982

Shrewsbury

clean room

in use

VWR Vacuum Oven

1400E

1203501

Shrewsbury

clean room

in use

Xxxxxx BioSystems Fluorometer

Modulus

PP#1

Shrewsbury

microneedle

lab.

in use

Motic Digital Microscope

DM 143

Shrewsbury

microneedle

lab.

in use

Cavro Syringe Pump

XLP 6000

XLP

0508231604

Shrewsbury

microneedle

lab.

in use

DryVac System

unknown

4X4 Cimaric Stirrer

unknown

1 set

Balance Standards 2100g to 0.01g

unknown

RV2 Stage w/LN Cord

unknown

7X7 Cimaric Stirrer

unknown

Rotary Evaporator

Purdue

Recirculating Water Aspirator

unknown

Xxxxxx Xxxxxxx Xxxx

Xxxxxxxxxx

various

in use

Tank Dolly

Shrewsbury

warehouse

not in use

Hydrogenation Apparatus

unknown

HPLC System

unknown

ph Meter

Shrewsbury

microneedle

lab.

not in use

Chiracel System

unknown

79 feet

VWR Lab Casework and Epoxy Table Tops

Shrewsbury

quality

in use

VWR 6” Fume Hood with Fan

Shrewsbury

quality

in use

VWR Oven

1000799

Shrewsbury

microneedle

lab.

in use

VWR Refrigerator

Shrewsbury

fridge area

in use

Kenmore Freezer

Shrewsbury

fridge area

in use

Thermolyne Furnace

FB1415M

1.05E+12

Shrewsbury

microneedle

lab.

in use

Branson Ultrasonic Cleaner

1510R

RKB05038481

Shrewsbury

process lab.

in use

Xxxxxxx Balance

AG 245

119130501

Shrewsbury

engineering

lab.

in use

YSI Glucose Analyzer

2300D

01G0908AA

Shrewsbury

analytical lab.

not in use

BioValve Technologies Inc. Lab Equipment

Number

Description

Xxxxx

Xxxxxx #

Xxxxxxxx

Xxxxxxxxxx

Xxxxxx

XXXXX Balance

E12140

F0541120072 983

Shrewsbury

microneedle

lab.

in use

Dell Computer and Monitor for Lab

Shrewsbury

microneedle

lab.

not in use

Medica Ion Analyzer

Easylyte

00000XXXX

Xxxxxxxxxx

analytical lab.

not in use

Barnstead Nanopure Diamond

D11901

1.19001E+12

Shrewsbury

analytical lab.

not in use

National Glassware Washer

MLW661E

80947

Shrewsbury

autoclave rm.

not in use

National Oven

NL141D

80826

Shrewsbury

autoclave rm.

not in use

Geltinge Castle Autoclave

133LS

99J60370

Shrewsbury

mechanical

rm.

not in use

Several

Microneedle Sheets

Shrewsbury

microneedle

lab.

in use

Several

Microneedles on Reels

Shrewsbury

microneedle

lab.

in use

Several

Microneedle Launcher Prototypes

Shrewsbury

microneedle

lab.

in use

Canon Copier

NP6050

XXX00000

Xxxxxxxxxx

process eng.

not in use

Minolta Color Laser Printer

QMSMC 2200

90251968

Shrewsbury

front office

not in use

Desk and Side Chairs

Shrewsbury

various

unknown

24 feet

VWR lab casework and epoxy table tops.

Shrewsbury

warehouse

not in use

Desktop computers and monitors

Shrewsbury

warehouse

not in use

Small bags of vials containing drug compound and or cell lines (stored in the freezer)

Shrewsbury

- 80 Freezer

not in use

17g

Dar100

Lot#911.H.94.5 05

unknown

200g

Dar 200A

Lot#01 DAR09-01 (DR-05-522)-18

Shrewsbury

27.6 grms. Lot # 0309073 20 35 grms. Lot # 0309073 20

- 80 Freezer

not in use

1 kg. batches of DAR 100A

Shrewsbury

fridge area

not in use

BioValve Technologies Inc. Office Equipment

Description

Canon D860 Copier

Brother Intellifax 2820

Executive Machine Shredder

ATT Phones

Motorola SB V1250 Cable Modem

Mac Airport Extreme Router A1034

GE Water Cooler

Sharp Carousel Microwave

Cusinart Coffee Maker

Global Horizon Filing Cabinets

Steelcase Desks

Steelcase Credenzas

Office Star Swivel Desk Chairs

Office Star Guest Chairs

Boardroom Table

Boardroom Chairs

Boardroom Credenza

Framed Whiteboard

Boardroom Partition Screens

8 ft. cubicles with built in desks and cupboards

Small Conference Table

Chairs

Vacuum

5-Drawer Yawnee Xxxx File Cabinet

5-Drawer Steelcase Horizontal File Cabinets

Bookshelves

Potted Plants

Acer 15” Plasma Screen

Dell Docking Station

Dell Latitude D600 Laptop Computer

Mac G5 Desktop Computer

Mac 21” Plasma Screen

i-Mac 20” Computer

HP 240 All-in-One Printer

HP 3550 Printer and wireless network

Highlighted items sold when Xxxxxx office closed in 2007

ANNEX 1

Intercompany Note

Document Metadata

Table of Contents

FIRST AMENDMENT TO FORMATION AGREEMENT

Document Metadata