##### 



Execution Version
    
    Exhibit 10.1
  COLLABORATION AND LICENSE AGREEMENT
 This COLLABORATION AND LICENSE AGREEMENT Agreement Effective Date Edison Penwest
 BACKGROUND
 WHEREAS
 WHEREAS,
 WHEREAS,
 NOW THEREFORE,
 ARTICLE 1  DEFINITIONS
  A0001 Schedule 1.1 Schedule 1.1
 Activity Schedule 1.2
 Affiliate
 1




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##### 



Change in Control Event  Business Combination
 Collaboration
 Collaboration IP
 Collaboration Know-how
 Collaboration Patent
 Collaboration Term
 Commercially Reasonable Efforts
 2




---



##### 



Compound
 Confidential Information
 Controls Controlled
 Development Plan
 Early Success Candidate ESC
 Edison IP
 Edison Know-how
 Edison Patents Schedule 1.18
 3




---



##### 



Edison Product
 Exclusivity Period
 Executive Officers
 FDA
 Field
 First Commercial Sale
 FTE
 FTE Rate
 4




---



##### 



Future Compound(s)
 General Operating Committee GOC
 Good Laboratory Practices GLP
 Good Manufacturing Practices GMP
 IND
 Know-how
 Law
 Major Market
 Management Steering Committee MSC
 NDA
 Net Sales
 5




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##### 



6




---



##### 



Combination
Product
 Non-Orphan Field
 Party Parties
 Patent
 Penwest IP
 Person
 Phase IIa Study
 Phase IIb Study
 7




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##### 



Pivotal Study
 Product
 Regulatory Approval
 Regulatory Authority
 Regulatory Filings
 Replacement Compound
 Required Third Party Payments Required Third Party Patents
 Research Funding Amount
 8




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##### 



Research Funding Period Initial Funding Period
 Research Program
 Responsible Party
 Royalty-Bearing Product
 Specified Compound(s)
 Sublicensee
 Target Field
 Territory
 Third Party
 Valid Claim
 Additional Definitions
 9




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##### 



Definition
    
    Section
    
    Definition
    
    SectionAdverse Drug Reaction
    
    2.4.2(b)
    
    JAMS
    
    15.7.2Agreement Wind-Down Period
    
    14.4.1(g)
    
    Manufacturing Technology
    
    2.2.3(a)API
    
    2.2.3(a)
    
    Minimum ESC Requirement
    
    2.2.2Archetypal Plan
    
    2.1.2(b)
    
    Net IncomeBankruptcy Code
    
    4.7
    
    Non-Breaching Party
    
    14.2.2Breaching Party
    
    14.2.2
    
    Notice of Abandonment
    
    9.4.4Co-Chair
    
    3.1.3
    
    Penwest Indemnitees
    
    13.1Commercialization Update
    
    2.5.2
    
    Post-Funding Activities
    
    2.2.2Development Criteria
    
    2.2.1(b)
    
    Promissory Note
    
    5.3Disclosing Party
    
    10.1.1
    
    Pursuing Party
    
    9.6.2Initial Development Plan
    
    2.1.2(a)
    
    Receiving Party
    
    10.1.1Edison Indemnitees
    
    13.2
    
    Rejected Compound
    
    2.3.3Exclusivity Extension Period
    
    5.2.2
    
    Replacement Compound
    
    2.3.4Failed Compound
    
    6.2
    
    Representatives
    
    10.1.1Force Majeure
    
    15.9
    
    Required Third Party Patents
    
    1.51Foundation
    
    4.6
    
    Research Extension Period
    
    5.2.2Foundation Opportunity
    
    4.6
    
    Secondary Compound
    
    6.2Foundation Opportunity
Compound
    
    4.6
    
    Taxes
    
    8.4Generic Competition
    
    7.1.3
    
    Term
    
    14.1Infringing Product
    
    9.6.3
    
    Terminated Compound
    
    14.2Initial Development Plan
    
    2.1.2(a)
    
    Termination Notice
    
    14.2Initial Funding Period
    
    1.53
    
    United States Dollar or  US$
    
    8.1Unreimbursed Edison Costs
    
    4.6
 10




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##### 



Interpretation
 ARTICLE 2  PERFORMANCE OF THE COLLABORATION
 Collaboration
 General
    Development Plan
 Schedule 2.1A Initial
Development Plan
 11




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##### 



Schedule 2.1B Archetypal Plan
 th
  Resource Commitments
 12




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##### 



Research Responsibilities of Edison
 Generally
  Development Criteria
  Minimum ESC Requirement Minimum ESC Requirement Post-Funding Activities
 Manufacture
 API API provided that
 13




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##### 



Manufacturing Technology
 CMC
 Other
 Delivery of A0001; Right of First Refusal on Future Compounds
 A0001
 Presentation of ESC
 Designation of Future Compound
 14




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##### 



Rejected Compound
 Replacement Compounds Replacement Compound
 Development Responsibilities of Penwest
 Generally
   15




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##### 



Regulatory Matters
 Filings
 Clinical Safety Reporting; Pharmacovigilance
 16




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Adverse Drug Reaction
 Commercialization
    provided that
 Commercialization Update
 Development Costs
 17




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##### 



Affiliates and Subcontractors
 Records
 Reporting
 ARTICLE 3  GOVERNANCE OF THE COLLABORATION
 General Operating Committee
 Establishment GOC
 18




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##### 



Responsibilities
 Membership Schedule 3.1.3 Co-Chair
 Meetings
 19




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##### 



Decision-Making
 Management Steering Committee
 Establishment MSC
 Responsibilities
 Membership Schedule 3.2.3
 Meetings
 Decision Making
 20




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##### 



provided however
 Input from other Personnel
 Exigent Circumstances
 ARTICLE 4  LICENSES, EXCLUSIVITY AND FOUNDATION OPPORTUNIITIES
 License Grant to Penwest
    21




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##### 



Edison Retained Rights
 Limited Grants to Edison
   Sublicense Right provided that
 22




---



##### 



Exclusivity
 Foundation Opportunity Foundation Opportunity Compound Foundation Foundation Opportunity provided however that Unreimbursed Edison Costs
 23




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##### 



Terminated Compound
 Rights in Bankruptcy Bankruptcy Code
 No Implied Licenses
 ARTICLE 5  TECHNOLOGY ACCESS FEE; RESEARCH FUNDING; EQUITY INVESTMENT
 Technology Access Fee
 Research Funding
    Research Extension Period
 24




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##### 



Exclusivity Extension Period
   Financial Accommodation Promissory Note
 ARTICLE 6  MILESTONE PAYMENTS
 Milestone Payments
  25




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##### 



[Note: milestone events are required to be disclosed so an
investor can see when payment is due.]
 Milestone
    
    Amount (US$)First dosing in humans
    
    $
    [**]Successful completion of a Pivotal Study
    
    $
    [**]Regulatory Approval of an NDA in a Major Market
    
    $
    [**]
  Milestone
    
    Amount (US$)Penwests selection of a Future Compound for development
under the Collaboration pursuant to Section 2.3.3
    
    $
    [**]Successful completion of a Pivotal Study
    
    $
    [**]Regulatory Approval of an NDA in a Major Market
    
    $
    [**]
  26




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Milestone
    
    Amount (US$)Successful completion of a Phase IIb Study for such indication
    
    $
    [**]Successful completion of a Pivotal Study for such indication
    
    $
    [**]Regulatory Approval of an NDA in first Major Market for such
indication
    
    $
    [**]Regulatory Approval of an NDA in second Major Market for such
indication
    
    $
    [**]
    Credit for Failed Compound Failed Compound Secondary Compound
 27




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##### 



ARTICLE 7  ROYALTY PAYMENTS
 Penwest Royalty Payment Obligation
 Royalties
    Required Third Party Payments provided however
 Generic Competition Generic Competition
 28




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##### 



Edison Royalty Payment Obligation Net Income
 Royalty Term
 Paid-Up License
 Royalties Payable Only Once
 Royalty Reports and Accounting
 Royalty Report
 29




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##### 



Records Retention; Audits
 ARTICLE 8  PAYMENT TERMS
 United States Dollars United States Dollar
 Currency Exchange
 Late Payments The Wall Street Journal provided however
 30




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##### 



Tax Matters Taxes
 ARTICLE 9  INTELLECTUAL PROPERTY MATTERS
 Ownership of Intellectual Property
 Inventorship
 Disclosure by Employees, Agents or Independent Contractors
 Patent Prosecution and Related Activities
 Edison IP
 31




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##### 



Penwest IP
 Collaboration IP
 Prosecution by Penwest
 Prosecution by Edison
 Cooperation; Request to Responsible Party
 32




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##### 



Procedure on Uncertainty to Prosecute.
 Notice
 Permitted Disclosures
 Enforcement
 Collaboration IP
 Failure to Enforce Collaboration IP
 33




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##### 



Pursuing Party
 Edison IP Infringing Product
 Failure to Enforce Edison Patents
  34




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##### 





Cooperation


Division of Recoveries


Infringement Claims by Third Parties


No Settlement Without Consent


Patent Term Restoration


ARTICLE 10  CONFIDENTIALITY


Confidentiality


Term of Confidentiality Receiving
Party Disclosing Party Representatives


35




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##### 



Ownership of Confidential Information
 Exceptions
     Legal Disclosure
 Public Domain
 Confidential Terms
 36




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##### 



Publication
 ARTICLE 11  REPRESENTATIONS AND WARRANTIES OF EDISON
  Organization
 Authority
 Enforceability
 Approvals and Consents.
 No Conflicts
 37




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Non-Infringement


Pending Claims


Title


Sufficient Rights


No Prior Grant or Patents


Disclaimer


ARTICLE 12  REPRESENTATIONS AND WARRANTIES OF PENWEST




Organization


38




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##### 





Authority


Enforceability


Approvals and Consents.


No Conflicts


Title


Disclaimer


ARTICLE 13  INDEMNIFICATION


Indemnification by Edison Penwest Indemnitees 39




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##### 







Indemnification by Penwest Edison Indemnitees


Notices provided however


ARTICLE 14  TERM; TERMINATION


Term of Agreement Term 40




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##### 







Termination Termination Notice Terminated Compound


Termination by Penwest


Termination For Material Breach Non-Breaching
Party Breaching Party


Termination for Bankruptcy


Rights in Law or Equity 41




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General Effects of Termination


Accrued Obligations


Non-Exclusive Remedy


General Survival


Effects of Certain Terminations


Termination by Penwest for Convenience; Termination by Edison for Breach or Penwest
Bankruptcy


Ongoing Trials


Regulatory Filings 42




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Technology Licenses


Trademarks


Sublicensees


Governance


Transition Assistance 43




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##### 





Agreement Wind-Down
Period


Return of Materials


Termination by Penwest for Breach or Edison Bankruptcy


Termination of License Grant to Edison


Foundation Opportunity provided however that


44



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##### 



Retention of License Grant to Penwest
 Confidential
Information
 No Other Rights
 Termination Press Releases
 ARTICLE 15  MISCELLANEOUS
 Notices
 If to Edison:
    
    If to Penwest:5941 Optical Court, Suite 228
    
    39 Old Ridgebury Road, Suite 11San Jose, CA 95138
    
    Dansbury, CT 06810-5120Attn:
    
    Attn: Chief Executive Officer
 45




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##### 



Fax:
    
    Fax: (203) 794-1393With a copy to:
    
    With a copy to:Wilson Sonsini Goodrich & Rosati
    
    Wilmer Cutler Pickering Hale and Dorr LLP650 Page Mill Road
    
    60 State StreetPalo Alto, CA 94304
    
    Boston, MA 02109Attn: Ian Edvalson, Esq.
    
    Attn:  Steven D. Singer, Esq.Fax: (650) 493-6811
    
    Fax: (617) 526-5000
 Amendments
 Waiver
 Headings
 Applicable Law
 Severability
 Assignment; Binding Effect provided however
 46




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##### 



Further Assurances
 Force Majeure Force
Majeure
 Independent Contractors
 Publicity
 47




---



##### 



Registration and Filing of the Agreement
 Entire Agreement
 Beneficiaries
 Compliance with Laws
 Limitation of Liability
 Dispute Resolution
 Resolution
 Binding Arbitration JAMS
 48




---



##### 



Written Notice
 Selection of Arbitrators
 Hearings
 Discovery
 Proposed Ruling
 Time; Testimony
 Representation by an Attorney
 Location
 49




---



##### 



Costs
 Written Decision
 Remedy
 Final Decision
 Remainder of This Page Intentionally Left Blank
 50




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##### 



IN WITNESS WHEREOF
 PENWEST PHARMACEUTICALS CO.
    
    
    
    EDISON PHARMACEUTICALS, INC.By:
    
    /s/ Jennifer L. Good
    
    
    
    By:
    
    /s/ Guy MillerName:
    
    Jennifer L. Good
    
    
    
    Name:
    
    Guy MillerTitle:
    
    President & CEO
    
    
    
    Title:
    
    CEO
 51




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##### 



Schedule 1.1
 Description of EPI-A0001
 [**]
 [**]




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##### 



Schedule 1.2
 Criteria for Determining Activity
 Studies
    
    Test
    
    Advancement Criteria
    
    Action upon no-pass
    
    APIQuantity
    
    Cost(Vendor)
    
    Resp.(Consult)Lead Selection : Edison to conduct with input from PW (PW* indicate that PW will conduct Physico-chemical/formulation)1
    
    [**]
    
    [**]
    
    [**]
    
    [**]
    
    [**]
    
    [**]2
    
    [**]
    
    [**]
    
    [**]
    
    [**]
    
    [**]
    
    [**]3
    
    [**]
    
    [**]
    
    [**]
    
    [**]
    
    [**]
    
    [**]4
    
    [**]
    
    [**]
    
    [**]
    
    [**]
    
    [**]
    
    [**]5
    
    [**]
    
    [**]
    
    [**]
    
    [**]
    
    [**]
    
    [**]6
    
    [**]
    
    [**]
    
    [**]
    
    
    
    [**]
    
    [**]7
    
    [**]
    
    [**]
    
    [**]
    
    [**]
    
    [**]
    
    [**]8
    
    [**]
    
    [**]
    
    [**]
    
    [**]
    
    [**]
    
    [**]9
    
    [**]
    
    [**]
    
    [**]
    
    [**]
    
    [**]
    
    [**]10
    
    [**]
    
    [**]
    
    [**]
    
    
    
    
    
    [**]
 Schedule 1.2




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Schedule 2.1A
 Initial Development Plan
 EPI A0001 PROGRAM : OVERVIEW OF SCOPE, OBJECTIVES AND BUDGET
 OVERALL SCOPE :
 A.
    
    DEVELOPMENT GOAL:Demonstrate safety and establish proof-of-concept of EPI-A0001 in patient population by
conducting clinical studies in healthy volunteers and patients[**]
 EPI-A0001 Development Timelines and Milestones are presented in TABLE 1.
  Schedule 2.1A




---



##### 



B. MAJOR ACTIVITIES & MILESTONES 1
 [**]
 
 [**]  Schedule 2.1A




---



##### 



TABLE 1 : EPI-A0001 Development Timelines and Milestones
   Schedule 2.1A




---



##### 



Schedule 1.18
 Certain Edison Patents
   Schedule 1.18




---



##### 



Schedule 2.1B
 Archetypal Plan
 EDISON NCE PROGRAM :
OVERVIEW OF SCOPE, OBJECTIVES, AND BUDGET
 OVERALL SCOPE :
 A.
    
    DEVELOPMENT GOAL: Select a new NCE back-up compound for EPI-A0001.[**]Selection and Development Timelines are presented in the attached TABLE 1-NCE:
  Schedule 2.1B




---



##### 



ARTICLE 16B. MAJOR ACTIVITIES & MILESTONES
 [**]
  Schedule 2.1B




---



##### 



TABLE 1-NCE: EDISON ESC Selection and Development Timelines
   Schedule 2.1B




---



##### 



Schedule 3.1.3
 GOC Members
 Penwest
   Edison
   Schedule 3.1.3




---



##### 



Schedule 3.2.3
 MSC Members
 Penwest
   Edison
   Schedule 3.2.3