Document:

API Compound Supply Agreement between the Company and Girindus AG

 Exhibit 10.4 
  
 Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the
confidentiality request. Omissions are designated as **. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 
  
 EXECUTION VERSION 
  
 API COMPOUND SUPPLY AGREEMENT 
  
 between 
  
 ADOLOR CORPORATION 
  
 and 
  
 GIRINDUS AG

  
 dated 
  
 July 6, 2004 

 TABLE OF CONTENTS 
  

					
	 	  	 	  	Page

	ARTICLE 1	  	DEFINITIONS	  	1
			
	ARTICLE 2	  	SUPPLY BY SUPPLIER	  	6
			
	2.1    	  	Commitment to Supply	  	6
			
	2.2    	  	Facilities, Equipment and Materials	  	6
			
	2.3    	  	Responsibility	  	6
			
	ARTICLE 3	  	STANDARD TERMS OF SUPPLY OF BX7 AND API COMPOUND	  	6
			
	3.1    	  	Regulatory Matters	  	6
			
	3.2    	  	Manufacturing Matters	  	8
			
	3.3    	  	Storage Obligations, Containers and Inventories	  	10
			
	3.4    	  	Materials Suppliers	  	10
			
	3.5    	  	Facility	  	10
			
	3.6    	  	Monitoring and Recordkeeping; Operating Procedures	  	11
			
	3.7    	  	Inspection, Access and Documentation	  	11
			
	3.8    	  	Compliance and Quality	  	12
			
	3.9    	  	Provision of Information	  	12
			
	ARTICLE 4	  	PROVISION OF BX7 FROM ADOLOR TO SUPPLIER	  	12
			
	4.1    	  	Supply	  	12
			
	4.2    	  	Consignment Stock	  	13
			
	4.3    	  	Use of the BX7	  	13
			
	4.4    	  	Representations and Warranties for BX7	  	13
			
	4.5    	  	Inspection	  	13
			
	4.6    	  	Risk of Loss	  	13
			
	4.7    	  	Withdrawals of Stock	  	13
			
	ARTICLE 5	  	FORECASTING AND ORDERING	  	14
			
	5.1    	  	Forecast	  	14
			
	5.2    	  	Purchase Orders	  	14
			
	5.3    	  	Addressees for Correspondence	  	16
			
	ARTICLE 6	  	SHIPPING AND DELIVERY; STORAGE	  	16
			
	6.1    	  	Shipping and Delivery Dates	  	16
			
	6.2    	  	Terms of Delivery	  	16
			
	6.3    	  	Shipping Costs	  	16

  

 i 

 TABLE OF CONTENTS 
 (continued) 
  

					
	 	  	 	  	Page

	6.4    	  	Documentation and Release	  	16
			
	6.5    	  	Retention of Samples	  	17
			
	6.6    	  	Storage of BX7 and API Compound	  	17
			
	6.7    	  	Shortages	  	17
			
	ARTICLE 7	  	INSPECTION AND DEFECTIVE BX7 AND API COMPOUND; RECALL	  	17
			
	7.1    	  	Inspection by Adolor	  	17
			
	7.2    	  	Latent Defects	  	18
			
	7.3    	  	Defective BX7 or API Compound	  	18
			
	7.4    	  	Remedies	  	18
			
	7.5    	  	BX7 or API Compound Recall	  	19
			
	ARTICLE 8	  	FINANCIAL PROVISIONS	  	19
			
	8.1    	  	Supply Price	  	19
			
	8.2    	  	Process Improvements and Sharing of Cost Efficiencies	  	19
			
	8.3    	  	Manner of Payments	  	19
			
	8.4    	  	Invoices; Timing of Payments	  	20
			
	8.5    	  	Tax Withholding	  	20
			
	8.6    	  	Late Payment	  	20
			
	ARTICLE 9	  	CONFIDENTIALITY	  	20
			
	9.1    	  	Confidential Information	  	20-21
			
	9.2    	  	Public Announcements	  	21
			
	9.3    	  	Assignment of Inventions	  	21
			
	9.4    	  	Confidentiality of this Agreement	  	21
			
	9.5    	  	Survival	  	21
			
	ARTICLE 10	  	REPRESENTATIONS AND WARRANTIES	  	22
			
	10.1    	  	Representations of Supplier	  	22
			
	10.2    	  	Mutual Representations and Warranties	  	23
			
	10.3    	  	Disclaimer of Warranty	  	23
			
	ARTICLE 11	  	INDEMNIFICATION AND INSURANCE; LIMITATION OF LIABILITY	  	23
			
	11.1    	  	General Obligation	  	23
			
	11.2    	  	Indemnification by Supplier	  	23

  

 ii 

 TABLE OF CONTENTS 
 (continued) 
  

					
	 	  	 	  	Page

	11.3    	  	Indemnification by Adolor	  	24
			
	11.4    	  	Indemnification Procedure.	  	24
			
	11.5    	  	Assumption of Defense	  	25
			
	11.6    	  	Insurance	  	25
			
	11.7    	  	Limitation of Liability	  	26
			
	ARTICLE 12	  	TERM AND TERMINATION	  	26
			
	12.1    	  	Term	  	26
			
	12.2    	  	Termination	  	26
			
	ARTICLE 13	  	RIGHTS AND DUTIES UPON TERMINATION	  	27
			
	13.1    	  	Pending Purchase Orders	  	27
			
	13.2    	  	Outstanding Payment	  	27
			
	13.3    	  	Return of Materials	  	27
			
	13.4    	  	Accrued Rights; Surviving Obligations	  	27
			
	ARTICLE 14	  	GENERAL PROVISIONS	  	28
			
	14.1    	  	Relationship of the Parties	  	28
			
	14.2    	  	Covenant Not to Compete	  	28
			
	14.3    	  	Force Majeure	  	28
			
	14.4    	  	Governing Law	  	29
			
	14.5    	  	Jurisdiction	  	29
			
	14.6    	  	Assignment	  	29
			
	14.7    	  	Notices	  	30
			
	14.8    	  	Severability	  	30
			
	14.9    	  	Headings	  	31
			
	14.10  	  	Certain Conventions	  	31
			
	14.11  	  	Waiver; Remedies	  	31
			
	14.12  	  	Entire Agreement	  	31
			
	14.13  	  	No License	  	31
			
	14.14  	  	Third Party Beneficiaries	  	31
			
	14.15  	  	Counterparts	  	31

  

 iii 

 SCHEDULES 
  

			
	 SCHEDULE 1.41
	  	SPECIFICATIONS
	 SCHEDULE 3.2
	  	QUALITY AGREEMENT
	 SCHEDULE 4.7.4
	  	ALLOWABLE MANUFACTURING LINE LOSSES
	 SCHEDULE 5.1
	  	FIRST FORECAST
	 SCHEDULE 8.1
	  	SUPPLY PRICE

  

 iv 

 API COMPOUND SUPPLY AGREEMENT 
  
 This API COMPOUND SUPPLY AGREEMENT (this “Agreement”), made as of the 6th day of July, 2004 (the
“Effective Date”), between ADOLOR CORPORATION, a Delaware corporation having a principal place of business at 700 Pennsylvania Drive, Exton, Pennsylvania 19341 (“Adolor”), and GIRINDUS AG, a stock corporation
organized under the laws of Germany, with a principal place of business at Postfach 100 259, Buchenallee 20, D-51402 Bensberg, Germany (“Supplier”). Adolor and Supplier may be referred to as a “Party” or, together,
the “Parties”. 
  
 RECITALS

  
 WHEREAS, Supplier has manufactured in collaboration with
Adolor the BX7 and the API Compound (each as defined below); and 
  
 WHEREAS, the Parties desire that Supplier supplies Adolor with the BX7 and API Compound under this Agreement on the terms and subject to the conditions set forth below. 
  
 NOW, THEREFORE, in consideration of the mutual promises, covenants and agreements set forth herein, and for other good and
valuable consideration, the receipt and sufficiency of which are hereby acknowledged, and intending to be legally bound, the Parties hereby agree as follows: 
  
 ARTICLE 1 
 DEFINITIONS

  
 For purposes of this Agreement, the following initially
capitalized terms, whether used in the singular or plural, shall have the following meanings: 
  
 1.1 “Act” means the U.S. Federal Food, Drug and Cosmetic Act as amended from time to time. 
  
 1.2 “Adverse Drug Experience” means any of: an “adverse drug experience,” a “life-threatening adverse drug
experience,” a “serious adverse drug experience,” or an “unexpected adverse drug experience,” as those terms are defined at either 21 C.F.R. § 312.32 or 21 C.F.R. § 314.80. 
  
 1.3 “Affiliate” of a Party means any Person, whether de jure
or de facto, which directly or indirectly controls, is controlled by, or is under common control with such Person for so long as such control exists, where “control” means the decision-making authority as to such Person and, further, where
such control shall be presumed to exist where a Person owns more than fifty percent (50%) of the equity (or such lesser percentage which is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction) having the power to
vote on or direct the affairs of the entity. 
  
 1.4
“Allowable Manufacturing Line Losses” shall have the meaning set forth in Section 4.7.4. 
  

 1 

 1.5 “API Compound” means bulk quantities of Compound prior to the commencement of
secondary manufacturing resulting in Product. 
  
 1.6
“Breaching Party” shall have the meaning set forth in Section 12.2.1 
  
 1.7 “Business Day” means any day on which banking institutions in New York, New York are open for business. 
  
 1.8 “BX7” means the starting material for Compound, having the molecular formula (3R,4R)-3-(3,4-dimethyl-4-piperidinyl)phenol.

  
 1.9 “Calendar Quarter” means each successive
period of three calendar months commencing January 1, April 1, July 1 and October 1. 
  
 1.10 “Calendar Year” means, for the first calendar year, the period commencing on the Effective Date and ending on December 31 of the calendar year during which the Effective Date occurs, and each
successive period beginning on January 1 and ending twelve (12) consecutive calendar months later on December 31. 
  
 1.11 “Certificate of Analysis” means a document identified as such and provided by Supplier to Adolor or its designee that sets forth the
analytical test results against the Specifications for a specified lot of BX7 and/or API Compound shipped to Adolor or its designee hereunder. 
  
 1.12 “Certificate of Compliance” means a document identified as such and provided by Supplier to Adolor or its designee that certifies,
warrants and reflects that each batch of BX7 and/or API Compound was produced and tested in compliance with the Specifications, cGMPs, the Master Batch Record and all other applicable regulatory documents. 
  
 1.13 “Claims” means all charges, complaints, actions, suits,
proceedings, hearings, investigations, claims and demands. 
  
 1.14 “Compound” means the peripheral mu-antagonist having molecular formula [[2(S)-[[4(R)-(3-hydroxyphenyl)-3(R),4-dimethyl-1-piperidinyl]-methyl]-1-oxo-3-phenylpropyl]amino]acetic acid dihydrate, known generically as
“alvimopan”, and all pharmaceutically acceptable salts and solvates thereof. 
  
 1.15 “Confidential Information” means all secret, confidential or proprietary information or data, whether provided in written, oral, graphic, video, computer or other form, provided by one Party (the
“Disclosing Party”) to the other Party (the “Receiving Party”) pursuant to this Agreement or generated pursuant to this Agreement, including but not limited to, information relating to the Disclosing Party’s
existing or proposed research, development efforts, patent applications, business or products, the terms of this Agreement and any other materials that have not been made available by the Disclosing Party to the general public. Notwithstanding the
foregoing sentence, Confidential Information shall not include any information or materials that: 
  
 1.15.1 were already known to the Receiving Party (other than under an obligation of confidentiality), at the time of disclosure by the Disclosing Party to
the extent such Receiving Party has documentary evidence to that effect; 
  

 2 

 1.15.2 were generally available to the public or otherwise part of the public domain at the time of its
disclosure to the Receiving Party; 
  
 1.15.3 became generally
available to the public or otherwise part of the public domain after its disclosure or development, as the case may be, and other than through any act or omission of a Party in breach of such Party’s confidentiality obligations under this
Agreement; 
  
 1.15.4 were disclosed to a Party, other than under
an obligation of confidentiality, by a Third Party who had no obligation to the Disclosing Party not to disclose such information to others; or 
  
 1.15.5 were independently discovered or developed by or on behalf of the Receiving Party without the use of the Confidential Information belonging to the
other Party and the Receiving Party has documentary evidence to that effect. 
  
 1.16 “Consent” means any consent, authorization, permit, certificate, license or approval of, exemption by, or filing or registration with, any Governmental Authority or other person. 
  
 1.17 “Current Good Manufacturing Practices” or
“cGMPs” means all applicable standards relating to manufacturing practices for fine chemicals, active pharmaceutical ingredients, intermediates, bulk products or finished pharmaceutical products, including, without limitation, (i)
the principles detailed in the U.S. Current Good Manufacturing Practices, 21 C.F.R. Parts 210 and The Rules Governing Medicinal Products in the European Union, Volume IV, Good Manufacturing Practice for Medicinal Products as each may be amended from
time to time, or (ii) Laws promulgated by any Governmental Authority having jurisdiction over the manufacture of the BX7 and/or the API Compound, or (iii) guidance documents promulgated by any Governmental Authority having jurisdiction over the
manufacture of the BX7 and/or the API Compound (including but not limited to advisory opinions, compliance policy guides and guidelines) which guidance documents are being implemented within the pharmaceutical manufacturing industry for such BX7
and/or the API Compound and subject to any arrangements, additions or clarifications agreed to from time to time by the Parties in the Quality Agreement. 
  
 1.18 “Disclosing Party” shall have the meaning set forth in Section 1.15. 
  
 1.19 “Executed Batch Record” means the executed and completed Master Batch Record for each batch of BX7
and/or the API Compound manufactured pursuant to the terms of this Agreement. 
  
 1.20 “Facility” shall mean Supplier’s manufacturing facility located at Kantstrasse 2, 33790 Halle-Kuensebeck, Westphalia, Germany. 
  

 3 

 1.21 “FDA” means the United States Food and Drug Administration and any successor
thereto. 
  
 1.22 “File Retention Samples” shall
have the meaning set forth in Section 6.5. 
  
 1.23 “Force
Majeure Event” shall have the meaning set forth in Section 14.3. 
  
 1.24 “Forecast” shall have the meaning set forth in Section 5.1. 
  
 1.25 “Governmental Authority” means any court, tribunal, arbitrator, agency, legislative body, commission, official or other
instrumentality of (a) any government of any Country, (b) a federal, state, province, county, city or other political subdivision thereof or (c) any supranational body, including without limitation the European Agency for the Evaluation of Medicinal
Products. 
  
 1.26 “Indemnified Party” shall have
the meaning set forth in Section 11.4. 
  
 1.27
“Indemnifying Party” shall have the meaning set forth in Section 11.4. 
  
 1.28 “Laws” means all laws, statutes, rules, regulations (including, without limitation, cGMPs, Investigational New Marketing Authorization regulations at 21 C.F.R. § 312, NDA regulations at 21
C.F.R. § 314, relevant provisions of the Federal Food, Drug and Cosmetic Act, and other laws and regulations enforced by the FDA or other applicable Governmental Authority), ordinances and other pronouncements having the binding effect of law
of any Governmental Authority. 
  
 1.29 “Losses”
means any and all damages (including all incidental, consequential, statutory and treble damages), awards, deficiencies, settlement amounts, defaults, assessments, fines, dues, penalties, costs, fees, liabilities, obligations, taxes, liens, losses,
lost profits and expenses (including without limitation court costs, interest and reasonable fees of attorneys, accountants and other experts) incurred by or awarded to Third Parties and required to be paid to Third Parties with respect to a Claim
by reason of any judgment, order, decree, stipulation or injunction, or any settlement entered into in accordance with the provisions of this Agreement, together with all documented out-of-pocket costs and expenses incurred in complying with any
judgments, orders, decrees, stipulations and injunctions that arise from or relate to a Claim of a Third Party. 
  
 1.30 “Manufacturing Activities” shall mean the manufacturing, processing, testing, packaging, storing and other activities undertaken or
required to be undertaken by Supplier or its suppliers in order to manufacture at its Facility and supply Adolor with the BX7 and/or the API Compound. 
  
 1.31 “Marketing Authorization” means, with respect to a country, the regulatory authorization required to market and sell Product in such
country as granted by the relevant Governmental Authority. 
  

 4 

 1.32 “Master Batch Record” shall mean the current version of the master batch record
approved by the Parties, which may be amended in writing from time to time by mutual agreement of the Parties. 
  
 1.33 “Materials” means the raw materials, components and other ingredients required to manufacture the BX7 or API Compound, each as
specifically identified in the Marketing Authorization. 
  
 1.34
“Person” means any natural person, corporation, general partnership, limited partnership, joint venture, proprietorship or other business organization. 
  
 1.35 “Potential Contaminants” shall have the meaning set forth in Section 3.5.3. 
  
 1.36 “Product” means a prescription pharmaceutical product
that contains Compound as the sole active ingredient. 
  
 1.37
“Purchase Order” shall have the meaning set forth in Section 5.2. 
  
 1.38 “Receiving Party” shall have the meaning set forth in Section 1.15. 
  
 1.39 “Regulatory Standards” means (i) any and all permits, licenses, filings and certifications required by the FDA or other Governmental
Authorities, and compliance with cGMPs, applicable to the BX7 and/or the API Compound, any Manufacturing Activity or Facility, and (ii) any Laws (including the Environmental Protection Agency (EPA), the Occupational Safety and Health Administration
(OSHA), the Drug Enforcement Administration (DEA)), that apply to the BX7 and/or the API Compound, any Manufacturing Activity or Facility. 
  
 1.40 “Shipping Costs” shall have the meaning set forth in Section 6.3. 
  
 1.41 “Specifications” means all specifications for the BX7 and the API Compound as set forth on Schedule
1.41, as may be amended by the Parties from time to time. 
  
 1.42 “Taxes” shall have the meaning set forth in Section 8.5. 
  
 1.43 “Quality Agreement” shall have the meaning set forth in Section 3.2. 
  
 1.44 “Third Party” means a Person who is not a Party or an Affiliate of a Party. 
  
 1.45 “Validation Batch” means any one of three (3)
consecutive batches of API Compound which confirm the critical parameters described in the synthetic process which are manufactured by Supplier according to cGMP, are validated in accordance with the Act and meets the Specifications. 
  
 1.46 “Waste” shall mean any “Hazardous Substance”
and/or “Hazardous Material” as provided under the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), any “Hazardous Waste” as provided under the Resource Conservation and Recovery Act (RCRA), and/or
any other waste material, pollutant and/or contaminant of any kind including any routine process waste or any by-product arising from manufacture of the BX7 and/or the API Compound. 
  

 5 

 1.47 “Withholding Party” shall have the meaning set forth in Section 8.5. 
  
 ARTICLE 2 
 SUPPLY BY SUPPLIER 
  
 2.1 Commitment to Supply. Upon the terms and subject to the conditions of this Agreement and pursuant to Purchase Orders delivered from time to time by Adolor to Supplier in accordance with Section 5.2,
Supplier shall (a) use its best efforts to manufacture at its Facility, test, package, store, label, release and deliver the Validation Batches in accordance with the Specifications, cGMPs, the Master Batch Record and all applicable Laws and the
provisions of the Quality Agreement and supply the same exclusively to Adolor or its designee and (b) manufacture at its Facility, test, package, store, label, release and deliver the BX7 and/or API Compound in accordance with the Specifications,
cGMPs, the Master Batch Record and all applicable Laws and the provisions of the Quality Agreement and supply the same exclusively to Adolor or its designee. Supplier acknowledges that time is of the essence in accordance with the terms of this
Agreement. Supplier agrees that it shall not enter into any agreement with another Person that shall preclude it from meeting its obligations under this Agreement. 
  
 2.2 Facilities, Equipment and Materials. Supplier agrees to provide, at its own cost and expense, all facilities,
equipment, machinery, materials (other than as specifically set forth herein) in accordance with the Specifications and the Master Batch Records and labor necessary for the performance of the Manufacturing Activities. 
  
 2.3 Responsibility. Unless otherwise specified herein or expressly
consented to in writing by Adolor, as between the Parties, and except for activities including but not limited to the delivery of information or materials provided by Adolor or its designees under this Agreement, Supplier shall be solely responsible
for performance of all activities necessary for Adolor to be supplied with BX7, Validation Batches and/or API Compound as contemplated hereunder. Supplier shall not amend or modify the Specifications or Master Batch Record or any protocols,
processes or procedures used to perform the Manufacturing Activities without the express written approval from Adolor. Unless otherwise expressly agreed in writing in advance by Adolor, Supplier may not sublicense or subcontract the activities to be
performed by Supplier under this Agreement to an Affiliate, Third Party or other designee. 
  
 ARTICLE 3 
 STANDARD TERMS OF SUPPLY OF BX7 AND API COMPOUND 
  
 3.1 Regulatory Matters. 
  
 3.1.1 Consents. Supplier shall obtain all Consents for which it is
responsible that are required as of the Effective Date for the manufacture of the BX7, Validation Batches and the API Compound under the terms of this Agreement. At all times, Supplier shall maintain and comply with all the Consents which may from
time to time be required by any Governmental Authority having jurisdiction with respect to its manufacturing operations, the Manufacturing Activities and/or the Facility and otherwise to be obtained by Supplier to permit the performance 

 

 6 

 of its then current obligations under this Agreement. In the event any Consent held by Supplier relating to the Facility
or its ability to manufacture the BX7, Validation Batches and the API Compound in accordance with this Agreement is hereafter suspended or revoked, or Supplier has material restrictions imposed upon it by any Governmental Authority affecting the BX7
and the API Compound or the Facility, Supplier shall immediately notify Adolor and shall promptly provide a schedule of compliance and such other information related thereto as is reasonably requested by Adolor. 
  
 3.1.2 Notification of Adverse Manufacturing Activities. Supplier shall
advise Adolor of any information arising out of the Manufacturing Activities that has adverse regulatory compliance and/or reporting consequences concerning the BX7, Validation Batches and/or the API Compound or the Facility. 
  
 3.1.3 Governmental Authorities. Supplier shall provide to Adolor any
information reasonably requested by Adolor, and shall consult with Adolor before providing any information to any Governmental Authority, in connection with manufacture of the BX7, Validation Batches and the API Compound. Supplier shall immediately
advise Adolor of any requests by any Governmental Authority for inspections of the Facility or with respect to the BX7, Validation Batches and/or the API Compound. 
  
 3.1.4 Inspection of BX7, Validation Batches and API Compound Suppliers by Governmental Authorities. In the event
Supplier is audited or inspected by a Governmental Authority relating to the Manufacturing Activities, the BX7, Validation Batches or the API Compound, Supplier shall promptly (but in any event, within one Business Day) notify Adolor of such audit
or inspection as well as of any alleged violations or deficiencies relating to the Facility, process, the BX7, Validation Batches and/or API Compound, allow Adolor to be present during such audit or inspection, and shall promptly disclose to Adolor
all relevant portions of any notice of observations or potential violations, as well as a copy of Supplier’s response thereto. In addition, Supplier will provide Adolor with unredacted copies of any FDA 483(s) and Establishment Inspection
Reports (or their equivalents) issued as a result of said audit and any follow-up written communications between Supplier and the Governmental Authority. Supplier shall use its commercially reasonable best efforts to correct all identified
deficiencies in a timely manner and advise Adolor periodically of progress being made, as well as when all deficiencies have been corrected. 
  
 3.1.5 Generic Drug Enforcement Act. Supplier has not used and will not use in the manufacture of the BX7, Validation Batches or the API Compound in
any capacity the services of any person, including any firm or individual, debarred or subject to debarment under the Generic Drug Enforcement Act of 1992, amending the Act at 21 U.S.C. 335a. Supplier agrees to notify Adolor immediately in the event
any person providing services to Supplier relating to this Agreement is debarred or becomes subject to debarment. 
  
 3.1.6 Adverse Reaction Reporting. To the extent permitted under applicable Laws, including the Health Insurance Portability and Accountability Act
of 1996 and the European Union Privacy Directive (95/46/EC dated October 25, 1995 as supplemented with Directive 2002/58/EC of July 12, 2002, and Regulation No. 45/2001, dated December 18, 2001), each as amended, Supplier shall notify Adolor of all
information reported to Supplier relating to any Adverse Drug Experience, whether expected or unexpected, relating to the use of the BX7 or the API Compound. 
  

 7 

 3.2 Manufacturing Matters. 
  
 3.2.1 Quality Agreement. Adolor and Supplier shall enter into the Quality Agreement (the “Quality
Agreement”) appended to this Agreement as Schedule 3.2 as may be amended from time to time by mutual agreement of the Parties. To the extent there are any inconsistencies or conflicts between this Agreement and the Quality Agreement,
the terms and conditions of this Agreement shall control unless otherwise agreed to in writing by the Parties. 
  
 3.2.2 Master Batch Records. The Parties shall develop and agree upon the Master Batch Records no later than one (1) month before the start of the
manufacturing campaign for the commercial supply of the API Compound. 
  
 3.2.3 Specification Changes. Adolor shall be entitled to request changes to the Specifications from time to time. Supplier shall undertake commercially reasonable efforts to make all revisions to the Specifications requested by
Adolor, in accordance with this Section 3.2.3 and all applicable Laws. Adolor retains the right and responsibility for final written approval of the Specifications prior to implementation by Supplier. 
  
 (a) Required Manufacturing Changes. For changes to the Specifications
that are required by a Governmental Authority, the Marketing Authorization or applicable Laws (collectively “Required Manufacturing Changes”), Adolor and Supplier shall cooperate in making such changes and Supplier shall implement
such changes in compliance with such applicable Laws and as promptly as practicable; provided, however, it is understood that if it is not possible or practicable for Supplier to make such Required Manufacturing Changes, Supplier shall not be deemed
to be in breach of this Agreement but Adolor shall be entitled to terminate this Agreement. 
  
 (b) Discretionary Manufacturing Changes. For changes to the Specifications that are not Required Manufacturing Changes (collectively “Discretionary Manufacturing Changes”), Adolor shall submit
a request to Supplier for any such Discretionary Manufacturing Changes. Upon receipt of such request from Adolor, Supplier shall determine (i) estimated costs that would be incurred resulting from the Discretionary Manufacturing Changes, (ii) any
resulting planned changes in timing for the delivery of the BX7, Validation Batches and/or the API Compound and (iii) the estimated time of implementing any such Discretionary Manufacturing Changes (the “Cost and Time Statement”).
Supplier shall provide the Cost and Time Statement to Adolor setting forth the terms on which Supplier would be willing to make the Discretionary Manufacturing Changes. Upon Adolor’s written approval of the Cost and Time Statement, the parties
shall cooperate in making such Discretionary Manufacturing Changes and Supplier shall implement such Discretionary Manufacturing Changes. 
  

 8 

 (c) Cost and Payment for Changes to the Specifications.  
  
 (i) For all changes to the Specifications pursuant to Sections 3.2.3(a) or
3.2.3(b), except as otherwise set forth in this Section 3.2.3(c); 
  
 (ii) Adolor shall be responsible for and pay Supplier any and all amounts incurred in implementing a change to the Specifications. Supplier must provide such documentation of its costs and expenses as may be reasonably requested by Adolor.
Supplier agrees to use commercially reasonable efforts to minimize its costs associated with any Specification change. 
  
 (iii) For all changes that are necessitated because a change is required to the Facility generally or a class of products (and not specific to the API
Compound), Supplier shall be responsible for the costs and expenses of such changes. 
  
 3.2.4 Accident Reports. Supplier shall promptly notify Adolor of all material accidents related to the manufacture, handling, use or storage of the BX7, Validation Batches or the API Compound the Supplier
becomes aware of, including: (a) accidents resulting in significant personal injury requiring more than first aid treatment, (b) accidents resulting in chronic illness or loss of consciousness, (c) accidents resulting in material property damage,
(d) accidents resulting in material environmental release and (e) accidents that result in regulatory, safety, health or environmental audits. 
  
 3.2.5 Handling of Materials; Wastes. Adolor shall inform Supplier and Supplier shall inform its employees, contractors and other personnel of any
known or reasonably ascertainable chemical hazards associated with the BX7, Validation Batches and/or the API Compound or any Wastes generated through performance of the Manufacturing Activities, and to provide such persons with reasonable training
in the proper methods of handling and disposing of such items. In addition, Supplier shall handle, accumulate, label, package, ship and dispose of all Wastes generated through performance of the Manufacturing Activities in accordance with all
applicable Laws. 
  
 3.2.6 Documentation for Governmental
Authority Requirements. Supplier shall maintain complete and accurate documentation of all validation data, stability testing data, batch records, quality control and laboratory testing and any other data required under cGMPs and other
requirements of any relevant Governmental Authority in connection with the performance of any Manufacturing Activities hereunder. Supplier shall provide Adolor with a copy of such documentation promptly upon Adolor’s request. 
  
 3.2.7 Technical Information. Supplier, at its sole cost and expense
(except for translations), shall, upon receiving a written request from Adolor, supply technical information on the BX7, Validation Batches and/or the API Compound and methods of manufacture and testing to the extent that such information is
necessary both to enable Adolor to fulfill its obligations within this Agreement or in its agreements with its customers, including compliance with any statutory or regulatory requirements of, or a request by, any Governmental Authority. Adolor
shall bear the cost and expenses reasonably incurred by Supplier in connection with translating the documentation or information requested by Adolor pursuant to this Section. 
  

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 3.3 Storage Obligations, Containers and Inventories. 
  
 3.3.1 Records, Retained Samples and Storage. Supplier shall retain
samples and maintain records from each batch of BX7, Validation Batches and/or the API Compound for a period required by applicable Laws for record keeping, testing and regulatory purposes or specified in the Quality Agreement. When storing
Compound, nonconforming Compound or Wastes, Supplier shall comply with and maintain all storage facilities in compliance with Specifications and in accordance with cGMPs and applicable Laws. 
  
 3.3.2 Containers and Packaging. Supplier shall supply the BX7,
Validation Batches and/or the API Compound in such containers and packaging and with such container closure systems and labeling as set forth in the Specifications. 
  
 3.4 Materials Suppliers. In order to fulfill its obligations under this Article 3, and without prejudice to the terms
and conditions of this Article 3, Supplier shall be responsible for: (i) entering into appropriate supply agreements with suppliers of the materials necessary to manufacture the BX7, Validation Batches and/or the API Compound, provided that Adolor
has the right to approve any such supplier and once approved, Supplier may not change such suppliers without the prior written approval of Adolor; (ii) transferring any relevant specifications or technology to such suppliers and (iii) obtaining any
necessary regulatory approval for the use of such suppliers. Notwithstanding anything to the contrary contained herein, (a) to the extent a specific Material supplier is named in a Marketing Authorization, Supplier shall only obtain Materials from
such suppliers named in the relevant Marketing Authorization, (b) Supplier will perform periodic audits of its Material suppliers and (c) Supplier shall prepare all certifications as to any Materials required by cGMPs or Laws, (each, a
“Materials Certification”). Such Materials Certifications shall include, without limitation, all required certifications related to Materials derived from animal products. 
  
 3.5 Facility. 
  
 3.5.1 Sole Location. The Facility shall be the only location where
Supplier performs the Manufacturing Activities; provided that upon the reasonable request of Supplier, Supplier shall be entitled to switch the Manufacturing Activities to a different location if agreed to in writing by Adolor. If Adolor so agrees,
such new location shall be deemed the Facility for purposes of this Agreement. 
  
 3.5.2 Maintenance of Facility. During the Term of this Agreement, Supplier shall maintain the Facility, all personal property, equipment, machinery, BX7, Validation Batches, API Compound, systems, intangibles,
intellectual property and contract rights in use at the Facility during the Term in the ordinary course of business, and free of material defects, except for defects attributable to wear and tear consistent with the age and usage of such assets, and
except for such defects as do not and will not, in the aggregate, materially impair the ability to use such assets in connection with the manufacture, generation, processing, distribution, transport, treatment, storage, disposal or other handling of
the BX7, Validation Batches and/or the API Compound. 
  

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 3.5.3 Certain Prohibitions. Supplier shall not manufacture, store or process any BX7, Validation
Batches or API Compound in the same building in which Supplier manufactures, stores or processes genotoxics, penicillins, genetically modified organisms, cephalosporins, sex hormones, anabolic steroids, and infectious agents (e.g., spore-bearing and
live viruses), (collectively, “Potential Contaminants”) unless the Potential Contaminants are stored or manufactured in contained environments and in compliance with cleaning, validation and changeover standards of all cGMPs and all
applicable Laws. Supplier shall promptly notify Adolor if any of the Potential Contaminants are manufactured, processed or stored in any portion of the Facility which may result in the introduction of Potential Contaminants into the areas of the
Facility where Supplier manufactures, processes or stores the BX7, Validation Batches or the API Compound. Supplier shall notify Adolor by not later than the earlier to occur of (i) one hundred and eighty (180) days prior to such event or (ii)
Supplier’s knowledge of such event, if Supplier intends to change the nature or use of any portion of the Facility to include the use of any of the Potential Contaminants. Supplier shall not make such changes if the change could reasonably be
expected to result in a material adverse effect on the ability to fully perform the obligations under this Agreement and Supplier has not demonstrated to Adolor’s reasonable satisfaction that such Potential Contaminants shall be completely
segregated from the BX7, Validation Batches and/or the API Compound at all times and shall comply with all Regulatory Standards. 
  
 3.5.4 Representatives. In connection with the monitoring of this Agreement, Adolor and Glaxo Group Limited (“GSK”) shall be
allowed to have, at their cost, representatives on site at Supplier, access to the portions of Supplier’s facility used in the manufacture, generation, storage, testing, treatment, holding, transportation, distribution or other handling or
receiving of the Compound and all associated records for the purpose of observing, reporting on, and consulting as to such activities, and adequate temporary desk space and other reasonable resources available to these representatives during the
periods they are working at Supplier. In addition, Adolor and GSK shall have the right, subject to any Third Party confidentiality obligations and prior advance notice of at least ten (10) Business Days and approval by Supplier, not to be
unreasonably withheld, refused, conditioned or delayed, and during normal business hours, to examine those technical records made by Supplier that only relate to the manufacture of the BX7, Validation Batches and/or the API Compound. 
  
 3.6 Monitoring and Recordkeeping; Operating Procedures. Throughout the
term of this Agreement, and for so long thereafter as is required by applicable Laws, Supplier shall monitor and maintain reasonable records respecting its compliance with cGMPs, including through the establishment and implementation of such
operating procedures as are reasonably necessary to assure such compliance. Supplier shall notify Adolor in writing of any significant trend changes in the statistical process control data and/or quality testing results for batches of the BX7,
Validation Batches and/or the API Compound manufactured hereunder. 
  
 3.7 Inspection, Access and Documentation.  
  
 3.7.1 Audit Rights. For the purpose of permitting a quality and compliance audit, including to ascertain compliance with cGMPs, Specifications and applicable Laws and to audit due to an Adverse Drug Experience, emergency or
inspection by a Governmental Authority, Supplier shall grant to authorized representatives of Adolor and GSK (or a Third 
  

 11 

 Party hired on behalf of GSK or Adolor who is reasonably acceptable to Supplier), upon reasonable notice, access to the
Facility. GSK and/or Adolor shall provide Supplier at least ten (10) Business Days notice in writing of the desire to have such access; provided, however, that in the event of an Adverse Drug Experience or any proposed or actual inspection by a
Governmental Authority or other emergency involving the BX7, Validation Batches and/or the API Compound, GSK and Adolor shall have the right at any time upon oral or written notice to Supplier of one (1) Business Day to conduct an audit of
Supplier’s facility and more frequently than once per calendar year. Supplier shall promptly respond to GSK’s or Adolor’s request and the Parties shall agree on the time, scope and manner of the audit. 
  
 3.7.2 cGMP Documentation. Supplier shall maintain, in accordance with
and for the period required under cGMPs and applicable Laws, complete and adequate records pertaining to the methods and facilities used for the manufacture, processing, testing, packing, labeling, holding and distribution of the BX7, Validation
Batches and/or the API Compound. 
  
 3.7.3 Visits. Subject
to the provisions of Section 3.7.1, visits of representatives or agents of either Adolor or GSK to the Facility for the purposes mentioned above shall be mutually agreed between the Parties in advance as to the number of the participants and their
intended tasks at the Facility. Supplier may request that the participants agree to reasonable obligations of confidentiality to the Supplier before the start of any such visit. 
  
 3.8 Compliance and Quality. 
  

3.8.1 Compliance Standards. Supplier is solely responsible for the safety and health of its employees, consultants and visitors and compliance
with all Laws related to health, safety and the environment, including, without limitation, providing its employees, consultants and visitors with all required information and training concerning any potential hazards involved in the manufacture,
packaging, storage and supply of the BX7, Validation Batches and/or the API Compound and taking any precautionary measures to protect its employees from any such hazards. For avoidance of doubt it is stated that the foregoing shall not overrule the
indemnifications obligations of Adolor set forth in Article 11 of this Agreement. 
  
 3.8.2 Quality Assurance; Quality Control. Supplier shall implement and perform the quality control testing (including retesting and any validation, or stability tests that may be required) set forth on
Schedule 1.41 against the Specifications and such other quality assurance and quality control procedures as required by cGMPs and applicable Laws. 
  
 3.9 Provision of Information. Supplier shall provide to Adolor copies (in electronic or hard-copy form, as requested by Adolor) of all data
generated during the Term as may be reasonably requested from time to time by Adolor. 
  
 ARTICLE 4 
 PROVISION OF BX7 FROM ADOLOR TO SUPPLIER 
  
 4.1 Supply. The Parties may decide that in certain instances, Adolor
will provide Supplier with BX7, at no cost to Supplier, in sufficient quantity and quality to enable Supplier to perform the Manufacturing Activities and supply API Compound to Adolor provided, however, in the absence of such decision, Supplier
shall be responsible for procuring or manufacturing BX7. 
  

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 4.2 Consignment Stock. All BX7 supplied to Supplier by Adolor is supplied as consignment stock and
shall be clearly identified as the property of Adolor, shall be kept segregated and maintained in the Facility, and shall at all times be owned by Adolor. 
  
 4.3 Use of the BX7. Supplier shall use the BX7 only to perform the Manufacturing Activities to produce and supply the API Compound to Adolor.

  
 4.4 Representations and Warranties for BX7. Adolor
represents, warrants and covenants that the BX7 supplied by it or its designees to Supplier shall be manufactured, packed, labeled, stored and supplied in compliance with all applicable Laws and the relevant Specifications. Furthermore, Adolor
represents, warrants and covenants that the BX7 supplied by it or its designees to Supplier from sources other than Supplier shall be free of defects which would have an impact on the Manufacturing Activities and/or the Allowable Manufacturing Line
Losses. Supplier represents, warrants and covenants that BX7 will be held at the Facility only, unless otherwise agreed to by Adolor in writing, and that such Facility, at Supplier’s sole cost and expense, has and will, for such time as such
BX7 will be maintained meet the requirements established by applicable Governmental Authorities, and that the BX7 will always be maintained in accordance with cGMPs, the Quality Agreement (including storage conditions specified therein), the
Specifications and all applicable Laws (including, without limitation, the receipt and possession of all applicable permits and authorizations), as well as Adolor’s reasonable prior written instructions. 
  
 4.5 Inspection. Adolor shall, at its own cost, be entitled to inspect
the BX7 and its related records during normal business hours upon reasonable request and prior written notice and with the least reasonably possible interference with Supplier’s ordinary course of business. 
  
 4.6 Risk of Loss. The risks of loss, damage or destruction of the BX7
delivered to Supplier shall be borne by Supplier from the date of delivery to the Facility in accordance with INCOTERMS (2000) DDP. 
  
 4.7 Withdrawals of Stock. 
  
 4.7.1 Withdrawal. Supplier shall be entitled to withdraw BX7 for the performance of the Manufacturing Activities according to the terms and
conditions of this Agreement and respecting the procedure of first in/first out. 
  
 4.7.2 Statement of Use. Within fifteen (15) days after the end of each quarter during the Term, Supplier shall send Adolor a statement of usage and inventory showing the following items: (a) the quantities of
BX7 supplied by Adolor; (b) the quantities of BX7 in Supplier’s inventory at the beginning of the calendar quarter; (c) the quantities of BX7 withdrawn by Supplier; (d) the quantities of BX7 used by Supplier in performing the Manufacturing
Activities; (e) any quantities of BX7 lost or destroyed while held as consignment stock or following withdrawal from consignment stock; (f) any quantities of BX7 for which Supplier is unable to account; and (g) the quantities of BX7 in
Supplier’s inventory at the end of the calendar quarter. If, based upon its inspections of the BX7 pursuant to Section 4.5, Adolor disputes any of the items on the statement of usage and inventory, the Parties will promptly meet to attempt to
resolve such disagreement. 
  

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 4.7.3 Responsibility for BX7 Lost or Destroyed or Used Beyond Allowable Manufacturing Line Losses.
In addition to any other remedies available to Adolor at law or in equity, Supplier shall be entirely responsible for BX7 lost or destroyed while in the possession or control of Supplier for reasons other than nonconformance of BX7 with
Adolor’s warranties set forth in the forgoing Article 4.4., and for BX7 used in excess of Allowable Manufacturing Line Losses (as defined below), and shall compensate Adolor for any such quantities at a rate equal to Adolor’s reasonable
purchase price per kilogram for replacement BX7 multiplied by the Allowable Manufacturing Line Losses. If any amounts are owed to Adolor by Supplier pursuant to this Section 4.7.3, such amounts shall be payable within thirty (30) days following the
date of issuance of the statement of usage and inventory pursuant to Section 4.7.2. 
  
 4.7.4 Allowable Manufacturing Line Losses. Supplier agrees in performing the Manufacturing Activities to limit its yield losses to those specified in Schedule 4.7.4 (the “Allowable Manufacturing
Line Losses”). Within forty-five (45) days after the end of each Calendar Year, Supplier shall calculate the actual line losses. To the extent such actual line losses exceed the Allowable Manufacturing Line Losses, Supplier shall compensate
Adolor for the quantities of BX7 supplied or otherwise purchased by Adolor and used by Supplier in excess of the Allowable Manufacturing Line Losses in accordance with Schedule 4.7.4, provided that in lieu of compensating Adolor, Supplier may
elect to manufacture replacement BX7 at no additional cost to Adolor. 
  
 4.7.5 Late Delivery of BX7. If the Parties decide that Adolor should supply BX7 to Supplier hereunder, Adolor acknowledges that Supplier shall have no liability whatsoever towards Adolor in case of late delivery of the API Compound
due to late delivery of the BX7 by Adolor; provided, however, if Supplier has inventories of BX7, Supplier shall use such inventory to manufacture API Compound and this Section 4.7.5 shall not be deemed a reason for late delivery of API Compound. If
any such inventory was manufactured by Supplier itself, Adolor shall purchase such inventory from Supplier in accordance with the terms and provisions herein with respect to supply of BX7 by Supplier. 
  
 ARTICLE 5 
 FORECASTING AND ORDERING 
  
 5.1 Forecast. 
  
 5.1.1
Adolor Providing BX7. If Adolor provides Supplier with BX7 pursuant to Section 4.1, at the beginning of each Calendar Quarter during the term of this Agreement, Adolor shall provide Supplier with a rolling six (6) Calendar Quarter
non-binding, good faith estimate of the quantities of API Compound that Adolor foresees it have Supplier deliver during such six (6) Calendar Quarter period. 
  
 5.1.2 Supplier Manufacturing BX7. If Adolor does not provide Supplier with BX7 and Supplier itself manufactures BX7, then, during the term of this
Agreement, at the beginning of each Calendar Quarter, Adolor shall provide Supplier with a rolling three (3) year non-binding, good faith estimate of the quantities of API Compound that Adolor foresees it will order from Supplier during such three
(3) year period. 
  

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 5.1.3 Adolor Ordering BX7. If Adolor intends to order supplies of BX7, during the term of this
Agreement, Adolor shall provide Supplier with a rolling six (6) Calendar Quarter non-binding, good faith estimate of the quantities of BX7 that Adolor foresees it will order from Supplier during such six (6) Calendar Quarter period

  
 5.1.4 Forecasts. Each forecast pursuant to Section
5.1.1, 5.1.2 or 5.1.3 shall be referred to as a “Forecast”. The first such Forecast shall be for the period from the Effective Date through the first Calendar Quarter of Calendar Year 2007 is attached hereto as Schedule 5.1.

  
 5.2 Purchase Orders. 
  
 5.2.1 Delivery of Purchase Order. 
  
 (a) If Adolor provides Supplier with BX7 pursuant to Section 4.1 or Supplier
uses BX7 previously manufactured for and purchased by Adolor, Adolor may, from time to time, place purchase orders with Supplier for quantities of API Compound to be delivered hereunder at least that number of months as set forth on Schedule
8.1 prior to the delivery date specified in each respective purchase order and Supplier shall deliver such quantities of API Compound on such delivery date. 
  

(b) If Adolor does not provide Supplier with BX7 and Supplier itself manufactures BX7, then Adolor may, from time to time, place purchase orders with
Supplier for quantities of API Compound to be delivered hereunder at least that number of months as set forth on Schedule 8.1 prior to the delivery date specified in each respective purchase order and Supplier shall deliver such quantities of
API Compound on such delivery date. 
  
 (c) If Adolor desires to
order BX7, Adolor may, from time to time, place purchase orders with Supplier for quantities of BX7 to be delivered hereunder at least that number of months as set forth on Schedule 8.1 prior to the delivery date specified in each respective
purchase order and Supplier shall deliver such quantities of BX7 on such delivery date. 
  
 (d) Each purchase order pursuant to Section 5.2.1(a), 5.2.1(b), or 5.2.1(c) shall be referred to as a “Purchase Order”. Supplier shall deliver BX7 and/or API Compound against each Purchase Order in
accordance with Article 5. Adolor shall purchase all such BX7 and/or API Compound ordered and delivered by the delivery date specified in a Purchase Order, provided that such BX7 and/or API Compound meets the Specifications. Supplier shall use
commercially reasonable efforts to supply any quantity of BX7 and/or API Compound ordered in the aggregate that exceeds the quantity in the Forecast. All Purchase Orders shall be for full batch quantities of BX7 and/or API Compound or multiples
thereof. 
  
 5.2.2 Acceptance of Purchase Order. Supplier
shall respond to each Purchase Order placed by Adolor in writing within ten (10) Business Days after receipt of each Purchase Order, setting out Suppliers acceptance or rejection of the Purchase Order. Supplier shall be 
  

 15 

 entitled to reject only that portion of any Purchase Order which Supplier will be unable to fill due to: (i) the
occurrence of a Force Majeure Event or (ii) which, when added to other Purchase Orders placed during a given twelve (12)-month period, exceed then current Forecast covering such period by more than twenty percent (20%). 
  
 5.2.3 Terms of Purchase Orders. Other than terms respecting quantity,
delivery date(s), shipment method and destination(s), the terms and conditions of any Purchase Order submitted by Adolor, or written acceptance thereof by Supplier, shall be of no force and effect, whether or not objected to by Supplier, and nothing
in any such Purchase Order or written acceptance shall supersede the terms and conditions of this Agreement or the Quality Agreement. 
  
 5.3 Addressees for Correspondence. All Forecasts, Purchase Orders, written acceptances of Purchase Orders and other notices contemplated under this
Article 4 shall be sent to the attention of such persons as each Party may identify to the other in writing from time to time. 
  
 ARTICLE 6 
 SHIPPING AND DELIVERY;
STORAGE 
  
 6.1 Shipping and Delivery Dates. On each
Purchase Order submitted by Adolor, Adolor shall specify the requested quantity, delivery date(s), shipment method and destination(s) of BX7 and/or API Compound being ordered. Supplier shall arrange for the delivery of BX7 and/or API Compound to
Adolor’s (or its designee’s) designated facilities as stated on the Purchase Order accepted by Supplier and in a manner consistent with good commercial practices, and in accordance with any agreed-upon shipping specifications, this
Agreement and Adolor’s or its designee’s reasonable instructions. Supplier shall not ship any BX7 or API Compound until Supplier receives a written release from Adolor in the form of a Certificate of Compliance which shall not be
unreasonably withheld or delayed by Adolor. 
  
 6.2 Terms of
Delivery. Once Adolor has released the API Compound in accordance with Section 6.4, Supplier shall ship BX7 and/or API Compound in accordance with Adolor’s instructions by a carrier selected by Adolor FCA (Incoterms 2000) Supplier’s
Facility. If Adolor does not timely indicate in writing its selection of a carrier to Supplier, Supplier shall be entitled to select an appropriate carrier. Supplier shall abide by the export procedures set forth in the Quality Agreement.

  
 6.3 Shipping Costs. Adolor shall pay all costs,
expenses, taxes, levies, tariffs, brokerage fees, insurance premiums and other costs and charges assessed or levied in connection with the transportation of BX7, Validation Batches and/or API Compound from Supplier’s Facility to Adolor pursuant
to Section 6.1 (the “Shipping Costs”). If Supplier pays any of the Shipping Costs on behalf of Adolor, then Supplier shall invoice such Shipping Costs to Adolor and Adolor shall pay such costs. 
  
 6.4 Documentation and Release. Prior to each shipment of BX7 and/or
API Compound, Supplier shall provide Adolor with a Certificate of Analysis and Certificate of Compliance, and, at Adolor’s request, Supplier shall provide Adolor with reasonable access to any applicable supporting data. Prior to release of the
BX7, Validation Batches and/or API 
  

 16 

 Compound, Supplier shall test the BX7 and/or API Compound in accordance with the testing procedures described in the
Specifications, and shall provide Adolor with a copy of the applicable Executed Batch Record for each batch shipped and a copy of the applicable deviation or other investigatory report, if any. Adolor shall review the Certificate of Analysis and
Certificate of Compliance, and indicate to Supplier, within fifteen (15) days after receipt of such certificates, whether to release each batch of API Compound, Validation Batch or BX7 for shipment. If Adolor does not provide notice to Supplier
within such fifteen (15) day period, Supplier shall be entitled to ship the API Compound, Validation Batch or BX7 to the designation indicated pursuant to Section 6.1. With each shipment of BX7, Validation Batch and/or API Compound, Supplier shall
provide Adolor with commercially appropriate shipping documentation, including bills of lading. 
  
 6.5 Retention of Samples. Supplier shall properly store and retain appropriate samples (identified by batch number) of BX7, Validation Batches
and/or API Compound that it supplies to Adolor in conditions and for times consistent with all applicable Regulatory Standards and to permit appropriate or required internal and regulatory checks and references (collectively, the “File
Retention Samples”). Supplier shall provide Adolor with reasonable access to and portions of the File Retention Samples for testing and other purposes upon Adolor’s request. 
  
 6.6 Storage of BX7 and API Compound. Notwithstanding anything to the contrary contained herein, Adolor may request
that Supplier, rather than ship BX7, Validation Batches and/or API Compound upon completion to a designated location, store the BX7 and/or the API Compound at the Facility until such time as Adolor requests that the BX7, Validation Batches and/or
API Compound be shipped to a designated location. In the event that Adolor requests that the BX7 and/or API Compound be stored at the Facility, the provisions of Sections 4.3, 4.4, 4.5 and 4.6 shall be applicable to any such BX7, Validation Batches
and/or API Compound. 
  
 6.7 Shortages. In the event that
Supplier is aware or anticipates that it will be unable to meet any Purchase Order, either in whole or in part, for whatever reason, Supplier shall promptly inform Adolor in writing of such inability. In particular, Supplier shall promptly inform
Adolor of any notice, written or oral, received from any materials supplier regarding a possible shortage or inability to supply. 
  
 ARTICLE 7 
 INSPECTION AND DEFECTIVE
BX7 AND API COMPOUND; RECALL 
  
 7.1 Inspection by
Adolor. 
  
 7.1.1 Inspection of BX7, Validation
Batches and API Compound. Within thirty (30) days following a shipment of BX7 and/or API Compound, Adolor or its designee may at its cost perform or have performed the quality control procedures described in the Specifications to determine if
such BX7, Validation Batches and/or API Compound conforms to the Specifications. Adolor shall promptly notify Supplier of any damages, shortage and other defects discovered by Adolor following Adolor’s discovery thereof. 
  

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 7.1.2 Acceptance of BX7 and API Compound. If notice is not given by Adolor or its designee
pursuant to Section 7.1.1 within the time period set forth therein, then the BX7, Validation Batches and/or API Compound shall be deemed accepted by Adolor for purposes of this Article 7 and, except as provided in Section 7.2, may not be rejected
pursuant to Section 7.3 or Section 7.4. 
  
 7.2 Latent
Defects. In the case of BX7, Validation Batches and/or API Compound with defects not readily discoverable prior to the shipment of any BX7, Validation Batches and/or API Compound to Adolor, or thereafter within the time period specified in
Section 7.1.1, each Party shall notify the other Party of any such defects discovered by such Party promptly following such Party’s discovery thereof. 
  
 7.3 Defective BX7 or API Compound. 
  
 7.3.1 Rejection by Adolor. In any case where Adolor or its designee expects to reject or otherwise make a claim against Supplier with respect to
damaged, non-conforming or otherwise defective BX7, Validation Batches and/or API Compound, Supplier shall be offered a reasonable opportunity to offer proof or evidence as to why such BX7, Validation Batches and/or API Compound should not be
rejected and to inspect and/or test such BX7, Validation Batches and/or API Compound. 
  
 7.3.2 Testing of File Retention Samples. In the event of any dispute as to whether BX7, Validation Batches and/or API Compound may be rightfully rejected by Adolor or its designee for failure to conform to the
Specifications or have been manufactured in accordance with cGMPs, such BX7, Validation Batches and/or API Compound shall be tested, using the File Retention Samples, for conformance with the applicable Specifications and acceptance criteria by an
independent testing organization mutually acceptable to both Parties, which analysis shall be binding on Supplier and Adolor solely for the purpose of determining whether such BX7, Validation Batches and/or API Compound may be rightfully rejected as
non-conforming, damaged or otherwise defective. The fees and expenses charged by such independent testing organization shall be paid by the Party in error. 
  
 7.3.3 Disposal of Rejected BX7, Validation Batches and API Compound. All or part of any shipment of BX7, Validation Batches and/or API
Compound determined to have been rightfully rejected by Adolor or its designee shall be held by Adolor or its designee for a period of thirty (30) days following notice to Supplier for proper disposal by Supplier, at Supplier’s expense. If
Supplier does not provide instructions for disposal of the BX7, Validation Batches and/or API Compound within such period, then Adolor or its designee may dispose of such BX7, Validation Batches and/or API Compound and Supplier shall either pay or
reimburse Adolor or its designee for all costs and expenses incurred by Adolor or its designee in connection with the disposal of such BX7, Validation Batches and/or API Compound. All or part of any shipment of BX7, Validation Batches and/or API
Compound determined to have been rightfully rejected by Adolor or its designee prior to its release for shipment shall be properly disposed of by Supplier, at Supplier’s expense. 
  
 7.4 Remedies. In the event Adolor or its designee receives BX7, Validation Batches and/or API Compound from Supplier
that was not manufactured by Supplier in accordance with 
  

 18 

 the Specifications, cGMPs or applicable Law, Adolor may, in addition to any other rights or remedies it may have under
Sections 7.5.2 and 11.1 elect for Supplier to (i) replace such non-conforming or otherwise defective BX7, Validation Batches and/or API Compound with an equal quantity of BX7, Validation Batches and/or API Compound that conforms to the
Specifications and is not otherwise defective as soon as is reasonably possible at no additional cost to Adolor, but in no event later than the time periods set forth in Section 5.1 after receipt of notification of non-conformity and the acceptance
of the same by Supplier, or otherwise after Supplier’s receipt of the results of testing pursuant to Section 7.3.2 stating the non-conformity or (ii) refund the purchase price for the quantity of such defective BX7, Validation Batches and/or
API Compound or credit the same to other invoices issued to Adolor hereunder. 
  
 7.5 BX7 or API Compound Recall. 
  
 7.5.1 Recall. Adolor, in its sole responsibility and discretion, shall be entitled to make all decisions with respect to any reasonable recall, market withdrawals or other corrective action related to the BX7 and/or API Compound.

  
 7.5.2 Costs Associated with BX7 or API Compound Recall.
The out-of-pocket costs associated with any such recall, including the cost of any BX7 supplied by Adolor, shall be borne by the Parties in proportion to which any such recall is required as a result of Supplier’s (or its suppliers’,
permitted subcontractors’ or Affiliates’) or Adolor’s (or its designees’, subcontractors’ or Affiliates’) breach of their respective obligations or representations or warranties under this Agreement, including the
Quality Agreement. If neither Party is in breach, Adolor shall be responsible for such costs. 
  
 ARTICLE 8 
 FINANCIAL PROVISIONS 
  
 8.1 Supply Price. Supplier shall supply BX7, Validation Batches and/or API Compound to Adolor at the price per unit
set forth on Schedule 8.1. 
  
 8.2 Process Improvements
and Sharing of Cost Efficiencies. Supplier shall be committed to developing and implementing, continuous cost, quality and customer service improvement programs by seeking productivity improvements, by minimizing waste and improving yields, by
purchasing quality materials at lower cost, by improving manufacturing processes, by streamlining organizational processes, by reducing cycle times and lead times and the like. In each June and each December during the term of this Agreement, the
Parties shall meet to discuss and set targets and goals of cost reductions and quality and customer service improvements for the following six (6)-month period, and to discuss the impact of any cost saving achieved during the previous six (6)-month
period on the BX7 and/or the API Compound pricing. The Parties agree to negotiate in good faith changes to BX7 and/or API Compound pricing to share equitably in any such cost savings so achieved. 
  
 8.3 Manner of Payments. All sums due to either Party under this
Agreement shall be payable in United States Dollars by bank wire transfer in immediately available funds to such bank account(s) as each of Supplier and Adolor shall from time to time designate, unless otherwise agreed by the Parties in writing.

  

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 8.4 Invoices; Timing of Payments. Supplier shall invoice Adolor for all BX7, Validation Batches
and/or API Compound manufactured under Purchase Orders hereunder on the date of provision by Supplier to Adolor of the documentation described in Article 8, last sentence of the Quality Agreement, and for all other amounts due to Supplier, if any,
hereunder monthly in arrears. Each invoice shall specify the Purchase Order number to which it corresponds. Unless otherwise specified in this Agreement, all amounts due to Supplier hereunder shall be paid by Adolor within [**] of receipt of
invoice. 
  
 8.5 Tax Withholding. Any taxes, levies or
other duties (“Taxes”) paid or required to be withheld under the appropriate tax Laws by one Party (“Withholding Party”) on account of monies payable to the other Party under this Agreement shall be deducted from
the amount of monies otherwise payable to the other Party under this Agreement. The Withholding Party shall secure and send to the other Party within a reasonable period of time proof of any such Taxes paid or required to be withheld by the
Withholding Party for the benefit of the other Party. The Parties shall cooperate reasonably with each other to ensure that any amounts required to be withheld by either Party are reduced in amount to the fullest extent permitted by applicable Laws.
No deduction shall be made, or a reduced amount shall be deducted, if the other Party furnishes a document from the appropriate tax Governmental Authorities to the Withholding Party certifying that the payments are exempt from Taxes or subject to
reduced tax rates, according to the applicable convention for the avoidance of double taxation. 
  
 8.6 Late Payment. In the event any payment by Adolor is not made when due, Supplier shall be entitled to interest on any such payment at the rate
of one and one quarter percent (1.25%) per month during the default period. In this case Supplier is also entitled, among its other rights, to cease work and stop deliveries or any other activities with respect to a Purchase Order, until such
payment, including any accrued interest, has been paid in full. 
  
 ARTICLE 9 
 CONFIDENTIALITY 
  
 9.1 Confidential Information. Each of Supplier and Adolor shall keep all Confidential Information received from the other Party with the same
degree of care it maintains the confidentiality of its own Confidential Information, but in no event less than a reasonable degree of care. Neither Party shall use such Confidential Information for any purpose other than in performance of this
Agreement or disclose the same to any other Person other than to such of its agents who have a need to know such Confidential Information to implement the terms of this Agreement or enforce its rights under this Agreement. A Receiving Party shall
advise any agent who receives such Confidential Information of the confidential nature thereof and of the obligations contained in this Agreement relating thereto, and the Receiving Party shall ensure that all such agents comply with such
obligations as if they had been a party hereto. Upon termination of this Agreement, the Receiving Party shall return or destroy all documents, tapes or other media containing Confidential Information of the Disclosing Party that remain in the
Receiving Party’s or its agents’ possession, except that the Receiving Party may keep one copy of the Confidential Information in the legal department files of the Receiving Party, solely for archival purposes. Such archival copy shall
continue to be subject to the provisions of this Article 9. Notwithstanding anything to the contrary in this Agreement, the Receiving Party shall have the right to disclose any Confidential Information provided hereunder if, in the reasonable

  

	[**]	=Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

  

 20 

 opinion of the Receiving Party’s legal counsel, such disclosure is necessary to comply with the terms of this
Agreement or the requirements of any Law. Where possible, the Receiving Party shall notify the Disclosing Party of the Receiving Party’s intent to make such disclosure of Confidential Information pursuant to the provision of the preceding
sentence sufficiently prior to making such disclosure so as to allow the Disclosing Party adequate time to take whatever action the Disclosing Party may deem to be appropriate to protect the confidentiality of the information. 
  
 9.2 Public Announcements. Except as may be required by applicable
Laws, neither Party will make any public announcement of any information regarding this Agreement or any agreement related hereto without the prior written approval of the other Party. Once any written statement is approved for disclosure by the
Parties or information is otherwise made public in accordance with the preceding sentence, either Party may make a subsequent public disclosure of the contents of such statement without further approval of the other Party. 
  
 9.3 Assignment of Inventions. All data, discoveries, inventions, [**],
new uses, [**], copyrights, trade secrets, [**], and compounds, whether patentable or not, arising from work performed under this Agreement, or the BX7 and/or the API Compound (collectively, the “Inventions”), shall be the sole and
exclusive property of Adolor with full right, title, and interest thereto. Throughout the term of this Agreement, Provider shall use the Inventions for the sole purpose of performing the Manufacturing Activities under this Agreement. Upon expiration
or termination of this Agreement, Supplier shall have no right or interest in or to the Inventions. Adolor may, at its sole option, incorporate any Inventions in any regulatory filings or patent applications based upon the inclusion of such findings
therein. Supplier shall promptly disclose to Adolor any and all Inventions. Supplier hereby agrees to unconditionally assign, and hereby does assign, to Adolor any and all right, title and interest in and to any Inventions. Supplier, its employees,
agents, and consultants shall fully cooperate with Adolor in obtaining and maintaining, at Adolor’s sole cost and expense, any applicable protection, including patent protection, as may be available with respect to such Inventions, and shall
execute all documents deemed necessary by Adolor for purposes of procuring and maintaining such protection, and all documents necessary for assigning Inventions to Adolor. Nothing contained in this Section shall override the effect of German labor
law including employee’s invention rights, as may be applicable resulting from the Manufacturing Activities rendered by Supplier under this Agreement. 
  
 9.4 Confidentiality of this Agreement. The terms of this Agreement shall be Confidential Information of each Party and, as such, shall be subject
to the provisions of this Article 9. Notwithstanding the foregoing, the Parties have the right to disclose the material financial terms of the Agreement to any potential acquirer, merger or commercial partner or significant investor, provided,
however, that prior to any such disclosure, the Party wishing to disclose such information (a) shall require the intended recipient to sign an undertaking agreeing to accord confidential treatment to such information and not use such information
except to evaluate the proposed acquisition, merger commercial arrangement or investment, and (b) shall take such other steps as reasonably necessary to secure confidential treatment of such information. 
  
 9.5 Survival. The obligations and prohibitions contained in this
Article 9 shall survive the expiration or termination of this Agreement [**] after the expiration date of this Agreement or [**], whatever time may be longer. 
  

	[**]	=Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

  

 21 

 ARTICLE 10 
 REPRESENTATIONS AND WARRANTIES 
  
 10.1 Representations of Supplier. Supplier represents and warrants to Adolor that: 
  
 10.1.1 Supplier shall conduct its services obligated under this Agreement in a competent, workmanlike fashion; 
  
 10.1.2 All BX7, Validation Batches and API Compound shall be in accordance
with Adolor’s labeling instructions, shall not be adulterated or misbranded within the meaning of the Act, and is not an article which may not, under the Act, be introduced into interstate commerce; 
  
 10.1.3 All BX7, Validation Batches and API Compound shall be manufactured in
accordance with the Specifications, cGMPs, all applicable Laws, the Quality Agreement and any further formulating, manufacturing, packaging or other standards agreed in writing by the Parties if any; 
  
 10.1.4 All BX7, Validation Batches and API Compound so sold and shipped shall
be manufactured in accordance with all applicable Laws in effect at the time and place of manufacture of such BX7, Validation Batches and API Compound, and all waste, including but not limited to all hazardous waste, generated at the time of
manufacture of BX7, Validation Batches and API Compound shall be disposed of in accordance with all applicable Laws; 
  
 10.1.5 All records as are necessary and appropriate to demonstrate compliance with applicable Laws shall be maintained by Supplier and such manufacture of
BX7, Validation Batches and API Compound shall be performed in a facility maintaining a current drug establishment registration with the FDA as set forth in 21 C.F.R. § 207, as applicable; 
  
 10.1.6 Supplier has provided and shall provide to Adolor all pertinent
information in its possession relative to physical, environmental and human health hazards involving the BX7 and API Compound; 
  
 10.1.7 The ownership and operation of the Facilities shall be in material compliance with cGMPs and all applicable Laws (including the receipt and
possession of all applicable permits and authorizations), including a current drug establishment registration with the FDA as set forth in 21 C.F.R. 207, as applicable), and any further formulating, manufacturing, packaging or other standards agreed
in writing by the Parties, and all Waste generated in connection with the manufacture of the BX7, Validation Batches and API Compound shall be disposed of in accordance with all applicable Laws. 
  
 10.1.8 Other than the intellectual property provided or to be provided by
Adolor, Supplier owns or controls all the intellectual property necessary to manufacture the BX7, Validation Batches and API Compound in accordance with the terms of this Agreement, and, to the best of its knowledge, the use of such intellectual
property does not infringe the rights of any Third Party. 
  

 22 

 10.2 Mutual Representations and Warranties. Adolor and Supplier each represents and warrants to
the other as of the Effective Date that: 
  
 10.2.1
Organization and Authority. It has full corporate right, power and authority to enter into this Agreement and to perform its respective obligations under this Agreement; 
  
 10.2.2 No Conflicts or Violations. The execution and delivery of this Agreement by such Party and the performance of
such Party’s obligations hereunder (a) do not conflict with or violate any requirement of applicable laws or regulations existing as of the Effective Date and applicable to such Party and (b) do not conflict with, violate, breach or constitute
a default under, and are not prohibited or materially restricted by, any contractual obligations of such Party or any of its Affiliates existing as of the Effective Date; and 
  
 10.2.3 Valid Execution. Such Party is duly authorized, by all requisite corporate action, to execute and deliver this
Agreement and the execution, delivery and performance of this Agreement by such Party does not require any shareholder action or approval or the approval or consent of any Third Party, and the Person executing this Agreement on behalf of such Party
is duly authorized to do so by all requisite corporate action. 
  
 10.3 Disclaimer of Warranty. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, EACH PARTY EXPRESSLY DISCLAIMS, WAIVES, RELEASES, AND RENOUNCES ANY WARRANTY, EXPRESS OR IMPLIED, INCLUDING ANY WARRANTY OF MERCHANTABILITY OR
FITNESS FOR A PARTICULAR PURPOSE. 
  
 ARTICLE 11 

INDEMNIFICATION AND INSURANCE; LIMITATION OF LIABILITY 
  

11.1 General Obligation. The civil liability of Supplier for carrying the services and deliveries hereunder is governed by the applicable laws
related to such acts and omissions, but shall be subject to the terms of this Agreement and shall not in any way supersede Adolor’s and Supplier’s obligations to each other under this Agreement. 
  
 11.2 Indemnification by Supplier. Supplier hereby agrees to defend
Adolor and its Affiliates; and their respective, directors, officers, employees, agents, successors and assigns from and against any and all Claims of a Third Party and to indemnify and hold Adolor and its Affiliates, and their respective directors,
officers, employees, agents, successors and assigns, harmless from and against any and all Losses of a Third Party for: (a) bodily injury, personal injury, death and property damage caused by (i) defects in the BX7, Validation Batches or API
Compound (including any materials or samples thereof) at the time of dispatch by Supplier or Supplier’s permitted designee resulting from Supplier’s failure to manufacture the BX7, Validation Batches or the API Compound in accordance with
the Specifications, cGMPs, all applicable Laws, the Quality Agreement and any further formulating, manufacturing, packaging or other standards agreed in writing by the Parties or (ii) defective BX7, Validation Batches or API Compound information
(including any materials or samples thereof) submitted by Supplier 
  

 23 

 to Adolor; (b) gross negligence or willful misconduct or wrongdoing of Supplier or any Person for whose actions or
omissions Supplier is legally liable; or (c) a breach by Supplier of its representations, warranties and/or covenants hereunder; provided, however, that in all cases referred to in this Section 11.2, Supplier shall have no liability to Adolor for
any Losses of Adolor to the extent that such Losses of Adolor were caused by any item for which Adolor is required to indemnify Supplier pursuant to Section 11.3. 
  
 11.3 Indemnification by Adolor. Adolor hereby agrees to defend Supplier and its Affiliates and their respective
directors, officers, employees, agents, successors and assigns from and against any and all Claims and suits of a Third Party and to indemnify and hold Supplier and its Affiliates and their respective directors, officers, employees, agents,
successors and assigns, harmless from and against any and all Losses for: (a) bodily injury, personal injury, death and property damage caused by defective BX7, Validation Batches and/or API Compound information (including any materials or samples
thereof) submitted by Adolor to Supplier; (b) gross negligence or willful misconduct or wrongdoing of Adolor or any Person for whose actions or omissions Adolor is legally liable; (c) a breach by Adolor of its representations, warranties and/or
covenants hereunder; (d) infringements of any Third Party’s patents or other proprietary rights resulting from or in connection with the use or sale of BX7, Validation Batches and/or API Compound resulting from any intellectual property,
information or material provided by Adolor to Supplier; provided, however, that in all cases referred to in this Section 11.3, Adolor shall have no liability to Supplier for any Losses of Supplier to the extent that such Losses of Supplier were
caused by any item for which Supplier is required to indemnify Adolor pursuant to Section 11.2. 
  
 11.4 Indemnification Procedure.  
  
 11.4.1 Notice. Each Party will notify promptly the other if it becomes aware of a Claim (actual or potential) by any Third Party (a “Third
Party Claim”) for which indemnification may be sought by that Party and will give such information with respect thereto as the other Party shall reasonably request. If any proceeding (including any governmental investigation) is instituted
involving any Party for which such Party may seek an indemnity under Section 11.2 or 11.3, as the case may be (the “Indemnified Party”), the Indemnified Party shall not make any admission or statement concerning such Third Party
Claim, but shall promptly notify the other Party (the “Indemnifying Party”) orally and in writing and the Indemnifying Party and Indemnified Party shall meet to discuss how to respond to any Third Party Claims that are the subject
matter of such proceeding. The Indemnifying Party shall not be obligated to indemnify the Indemnified Party to the extent any admission or statement made by the Indemnified Party or any failure by such Party to notify the Indemnifying Party of the
claim materially prejudices the defense of such claim. 
  
 11.4.2
Defense of Claim. If the Indemnifying Party elects to defend or, if local procedural rules or laws do not permit the same, elects to control the defense of a Third Party Claim, it shall be entitled to do so provided it gives notice to the
Indemnified Party of its intention to do so within forty-five (45) days after the receipt of the written notice from the Indemnified Party of the potentially indemnifiable Third Party Claim (the “Litigation Condition”); provided,
that the Indemnifying Party expressly agrees the Indemnifying Party shall be responsible for satisfying and discharging any award made to the Third Party as a result of 
  

 24 

 such proceedings or settlement amount agreed with the Third Party in respect of the Third Party Claim without prejudice
to any provision in this Agreement or right at law which will allow the Indemnifying Party subsequently to recover any amount from the Indemnified Party to the extent the liability under such settlement or award was attributable to the Indemnified
Party. Subject to compliance with the Litigation Condition, the Indemnifying Party shall retain counsel reasonably acceptable to the Indemnified Party (such acceptance not to be unreasonably withheld, refused, conditioned or delayed) to represent
the Indemnified Party and shall pay the fees and expenses of such counsel related to such proceeding. In any such proceeding, the Indemnified Party shall have the right to retain its own counsel, but the fees and expenses of such counsel shall be at
the expense of the Indemnified Party. The Indemnified Party shall not settle any claim for which it is seeking indemnification without the prior consent of the Indemnifying Party which consent shall not be unreasonably withheld, refused, conditioned
or delayed. The Indemnified Party shall, if requested by the Indemnifying Party, cooperate in all reasonable respects in the defense of such claim that is being managed and/or controlled by the Indemnifying Party. The Indemnifying Party shall not,
without the written consent of the Indemnified Party (which consent shall not be unreasonably withheld, refused, conditioned or delayed), effect any settlement of any pending or threatened proceeding in which the Indemnified Party is, or based on
the same set of facts could have been, a party and indemnity could have been sought hereunder by the Indemnified Party, unless such settlement includes an unconditional release of the Indemnified Party from all liability on claims that are the
subject matter of such proceeding. If the Litigation Condition is not met, then neither Party shall have the right to control the defense of such Third Party Claim and the Parties shall cooperate in and be consulted on the material aspects of such
defense at the each Party’s own expense; provided that if the Indemnifying Party does not satisfy the Litigation Condition, the Indemnifying Party may at any subsequent time during the pendency of the relevant Third Party Claim irrevocably
elect, if permitted by local procedural rules or laws, to defend and/or to control the defense of the relevant Third Party Claim so long as the Indemnifying Party also agrees to pay the reasonable fees and costs incurred by the Indemnified Party in
relation to the defense of such Third Party Claim from the inception of the Third Party Claim until the date the Indemnifying Party assumes the defense or control thereof. 
  
 11.5 Assumption of Defense. Notwithstanding anything to the contrary contained herein, an Indemnified Party shall be
entitled to assume the defense of any Third Party Claim with respect to the Indemnified Party, upon written notice to the Indemnifying Party pursuant to this Section 11.5, in which case the Indemnifying Party shall be relieved of liability under
Section 11.2 or 11.3, as applicable, solely for such Third Party Claim and related Losses. 
  
 11.6 Insurance. During the term of this Agreement and for a period of five (5) years after its termination, each party shall obtain and/or maintain, respectively, at its sole cost and expense, liability
insurance in amounts, respectively, as are the greater of: (i) required by applicable Laws and (ii) reasonable and customary in the U.S. pharmaceutical industry for companies of comparable size and activities at the respective place of business of
each Party, [**]. Such liability insurance shall insure against all liability, including personal injury, physical injury, or property damage arising out of the manufacture, sale, distribution, or marketing of the API Compound. Each Party shall
provide written proof of the existence of such insurance to the other Party upon request. 
  

	[**]	=Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

  

 25 

 11.7 Limitation of Liability. EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, IN NO
EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER PARTY OR ANY OF ITS AFFILIATES FOR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT, SPECIAL, PUNITIVE OR EXEMPLARY DAMAGES (INCLUDING, WITHOUT LIMITATION, LOST PROFITS, BUSINESS OR GOODWILL) SUFFERED OR
INCURRED BY SUCH OTHER PARTY OR ITS AFFILIATES IN CONNECTION WITH A BREACH OR ALLEGED BREACH OF THIS AGREEMENT. THE FOREGOING SENTENCE SHALL NOT LIMIT THE OBLIGATIONS OF EITHER PARTY TO INDEMNIFY THE OTHER PARTY FROM AND AGAINST THIRD PARTY CLAIMS
UNDER THIS ARTICLE 11. 
  
 ARTICLE 12 
 TERM AND TERMINATION 
  
 12.1 Term. Unless terminated sooner as permitted hereunder, this Agreement shall commence on the Effective Date and shall expire on the seventh
(7th) anniversary thereof, provided that unless either Party gives written notice at least twenty-four (24) months prior to the expiration of the initial term or any renewal term, this Agreement shall continue for successive two year terms.

  
 12.2 Termination. [**]. In addition, this Agreement may
be terminated upon the written consent of both Parties, or by either Party upon the happening of one of the following events: 
  
 12.2.1 Termination for Breach. Either Party may, without prejudice to any other remedies available to it at law or in equity, terminate this
Agreement in the event that the other Party (as used in this subsection, the “Breaching Party”) shall have materially breached or defaulted in the performance of any of its obligations. The Breaching Party shall have thirty (30)
days after written notice thereof was provided to the Breaching Party by the non-breaching Party to remedy such default. Any such termination shall become effective at the end of such 30-day period unless the Breaching Party has cured any such
breach or default prior to the expiration of such 30-day period. 
  
 12.2.2 Termination for Force Majeure Event. Notwithstanding anything to the contrary contained in this Agreement, in the event a Force Majeure Event shall have occurred and be continuing for ninety (90) consecutive days, the Party
not suffering such Force Majeure Event shall be entitled to terminate this Agreement effective immediately upon written notice to the Party suffering such Force Majeure Event. 
  
 12.2.3 Termination for Reasons of Insolvency or Termination of Business Activities. Either Party shall be entitled to
terminate this Agreement if the other Party becomes insolvent or is the subject of a petition in bankruptcy whether voluntary or involuntary or of any other proceeding under bankruptcy, insolvency or similar laws, makes an assignment for the benefit
of creditors, is named in such a petition, or its property is subject to a suit for the appointment of a receiver, or is dissolved or liquidated. Such termination right may be exercised without the need for written notice within thirty (30) days
following the date as of which the Party entitled to terminate receives knowledge of such insolvency or termination of business activities by the other Party. 
  

	[**]	=Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

  

 26 

 ARTICLE 13 
 RIGHTS AND DUTIES UPON TERMINATION 
  
 13.1 Pending Purchase Orders. Except in cases of the termination of this Agreement for a Force Majeure Event or as otherwise expressly set forth in this Agreement, the termination of this Agreement shall not
affect Purchase Orders placed by Adolor and accepted by Supplier at the time notice of termination is given and until the time any such termination becomes effective. Except as expressly set forth in this Agreement, Adolor shall have no liability to
Supplier for any costs that Supplier may have incurred (or to which Supplier may be committed) in connection with materials used by Supplier in the manufacturing or packaging of BX7 and/or the API Compound prior to the effectiveness of any notice of
termination; provided that, except when Supplier is in default, Adolor shall reimburse Supplier for all unused raw materials not capable of resale or use elsewhere if such raw materials are being procured to satisfy the Forecasts. 
  
 13.2 Outstanding Payment. Payments of amounts owing to either Party
under this Agreement as of its expiration or termination shall be due and payable within the later of: (i) to the extent such amounts can be calculated and a fixed sum determined at the time of expiration or termination of this Agreement, sixty (60)
days after the date of such expiration or termination or (ii) ten (10) days after the date in which such amounts can be calculated and a fixed sum determined. 
  

13.3 Return of Materials. Within thirty (30) days following the effective date of termination of this Agreement, each Party shall destroy or
return to the other Party all tangible items bearing, containing or contained in any of the Confidential Information of the other Party, and shall provide the other Party written certification of such destruction or return. Supplier shall also
return to Adolor all unused quantities of BX7 and any work-in-progress being held by Supplier. Supplier shall transfer to Adolor or its designee Supplier’s existing inventory of materials and work-in-process as well as any inventory of BX7
and/or API Compound in Supplier’s possession or control, except for any samples Supplier may be required to retain by applicable Law. 
  
 13.4 Accrued Rights; Surviving Obligations. Termination, relinquishment or expiration of this Agreement for any reason shall be without prejudice
to any rights that shall have accrued to the benefit of any Party prior to such termination, relinquishment or expiration. Such termination, relinquishment or expiration shall not relieve any Party from obligations which are expressly or by
implication intended to survive termination, relinquishment or expiration of this Agreement and shall not affect or prejudice any provision of this Agreement which is expressly or by implication provided to come into effect on, or continue in effect
after, such termination, relinquishment or expiration. 
  

 27 

 ARTICLE 14 
 GENERAL PROVISIONS 
  
 14.1
Relationship of the Parties. Each Party shall bear its own costs incurred in the performance of its obligations hereunder without charge or expense to the other except as expressly provided in this Agreement. Neither Party shall have any
responsibility for the hiring, termination or compensation of the other Party’s employees or for any employee benefits of such employee. No employee or representative of a Party shall have any authority to bind or obligate the other Party to
this Agreement for any sum or in any manner whatsoever, or to create or impose any contractual or other liability on the other Party without such Party’s approval. For all purposes, and notwithstanding any other provision of this Agreement to
the contrary, Supplier’s legal relationship under this Agreement to Adolor shall be that of independent contractor. This Agreement is not a partnership agreement and nothing in this Agreement shall be construed to establish a relationship of
co-partners or joint venturers between the Parties. 
  
 14.2
Covenant Not to Compete. Supplier (whether on its own behalf or with or on behalf of any Person) shall not, and shall not permit any of its Affiliates to, until the fifth (5th) anniversary of the date following the expiration or termination
of this Agreement: 
  
 14.2.1 carry on or be engaged, concerned,
interested or in any way assist in the development or manufacture of (i) any prescription or over the counter formulation of the API Compound or Compound, or (ii) any generic or copycat versions of the API Compound or Compound, including any salts,
hydrates, polymorphs or anhydrous form thereof; 
  
 14.2.2 sell,
market, distribute or seek customers for or advertise (i) any prescription or over the counter formulation of API Compound or Compound, or (ii) any generic or copycat versions of the API Compound or Compound, including any salts, hydrates,
polymorphs or anhydrous form thereof; 
  
 14.2.3 license, consent
to or authorize or purport to license, consent to or authorize the doing or carrying out by any Person of any of the acts or matters referred to in either of subparagraphs (a) or (b) above; or 
  
 14.2.4 pursue any policy of doing or carrying out or of facilitating or
bringing about the doing or carrying out by any Person of any of the acts or matters referred to in any of the subparagraphs (a) through (c) above, for example, by providing technological assistance, expertise, manufacturing or supplies to any
Person. 
  
 14.3 Force Majeure. The occurrence of an event
which materially interferes with the ability of a Party to perform its obligations or duties hereunder which is not within the reasonable control of the Party affected or any of its Affiliates, not due to malfeasance by such Party or its Affiliates,
and which could not with the exercise of due diligence have been avoided (each, a “Force Majeure Event”), including but not limited to an injunction, order or action by a Governmental Authority, fire, floods, embargoes, accident,
labor difficulty, strike, lock outs, riot, civil commotion, act of God, inability to obtain materials, shortages of energy, delay or errors by shipping companies or change in applicable Laws, omissions or delays in acting by any Governmental
Authority shall not excuse such Party from the performance of its obligations or 
  

 28 

 duties under this Agreement, but shall merely suspend such performance during the continuation of the force majeure. The
Party prevented from performing its obligations or duties because of a Force Majeure Event shall promptly notify the other Party of the occurrence and particulars of such force majeure and shall provide the other Party, from time to time, with its
best estimate of the duration of such Force Majeure Event and with notice of the termination thereof. The Party so affected shall use commercially reasonable efforts to avoid or remove such causes of nonperformance as soon as is reasonably
practicable. Upon termination of the Force Majeure Event, the performance of any suspended obligation or duty shall promptly recommence. The Party subject to the Force Majeure Event shall not be liable to the other Party for any direct, indirect,
consequential, incidental, special, punitive, exemplary or other damages arising out of or relating to the suspension or termination of any of its obligations or duties under this Agreement by reason of the occurrence of a Force Majeure Event,
provided such Party complies in all material respects with its obligations under this Section 14.3. 
  
 14.4 Governing Law. This Agreement shall be construed, and the respective rights of the Parties determined, according to the substantive Law of the
Commonwealth of Pennsylvania notwithstanding the provisions governing conflict of Laws under such Pennsylvania Law to the contrary, except matters of intellectual property Law which shall be determined in accordance with the intellectual property
Laws relevant to the intellectual property in question. The UNCITRAL Convention for the International Sale of Goods, as well as any other unified Law relating to the conclusion and implementation of contracts for the international sale of goods,
shall not apply. 
  
 14.5 Jurisdiction. Any legal action or
proceeding with respect to this Agreement shall be brought in the courts of the Commonwealth of Pennsylvania or of the United States District Court for the Eastern District of Pennsylvania, and, by execution and delivery of this Agreement, each
Party hereby irrevocably accepts the exclusive jurisdiction of the aforesaid courts. Each Party hereby further irrevocably waives any claim that any such court lacks jurisdiction over it or to the laying of venue, and agrees not to plead or claim,
in any legal action or proceeding with respect to this Agreement brought in any of the aforesaid courts, that any such court lacks jurisdiction over it or any such action or proceeding has been brought in an inconvenient forum. 
  
 14.6 Assignment. This Agreement or any right, remedy, obligation or
liability hereunder may not be assigned by either Party without the prior consent of the other Party; provided, however, that Adolor may assign this Agreement, in whole or in part, to any of its Affiliates if Adolor guarantees the performance of
this Agreement by such Affiliate; and provided further, that Adolor may assign this Agreement to a purchaser of substantially all of its assets provided that Adolor shall remain liable in such event, or to a successor entity resulting from a merger
or other business consolidation between Adolor and another entity. This Agreement shall be binding upon, and subject to the terms of the foregoing sentence, inure to the benefit of the Parties hereto, their permitted successors, legal
representatives and assigns. 
  

 29 

 14.7 Notices. All demands, notices, consents, approvals, reports, requests and other
communications hereunder must be in writing and will be deemed to have been duly given only if delivered personally, by facsimile with confirmation of receipt, by mail (first class, postage prepaid), or by overnight delivery using a
globally-recognized carrier, to the Parties at the following addresses: 
  

			
	 Adolor:
	 	 Adolor Corporation
 700 Pennsylvania Drive
 Exton, Pennsylvania 19341
 Facsimile: 484-595-1520
 Attn: President

		
	 With a copy to:
	 	 Adolor Corporation
 700 Pennsylvania Drive

Exton, Pennsylvania 19341
 Facsimile: 484-595-1520
 Attn: General Counsel

		
	 and to:
	 	 Morgan, Lewis & Bockius LLP
 502 Carnegie
Center
 Princeton, NJ 08540
 Attn: Randall B. Sunberg

Facsimile: 609-919-6639

		
	 Supplier:
	 	 Girindus AG
 Kantstrasse 2
 33790 Halle-Kuensebeck, Westphalia
 Germany
 Attn.: Dr. Georg Ollmann
 Facsimile: +49-5201-711-5852

		
	and with a copy to:	 	 Girindus AG
 Buchenallee 20
 51402 Bensberg
 Germany
 Attn.: Dr. Harald Mothes
 Facsimile: +49-2204-926-972

  
 or to such other
address as the addressee shall have last furnished in writing in accord with this provision to the addressor. All notices shall be deemed effective upon receipt by the addressee. 
  
 14.8 Severability. In the event of the invalidity of any provisions of this Agreement or if this Agreement contains
any gaps, the Parties agree that such invalidity or gap shall not affect the validity of the remaining provisions of this Agreement. The Parties will replace an invalid provision or fill any gap with valid provisions which most closely approximate
the purpose and economic effect of the invalid provision or, in case of a gap, the Parties’ presumed intentions. In the event that the terms and conditions of this Agreement are materially altered as a result of the preceding sentences, the
Parties shall renegotiate the terms and conditions of this Agreement in order to resolve any inequities. Nothing in this Agreement shall be interpreted so as to require either Party to violate any applicable Laws. 
  

 30 

 14.9 Headings. The headings used in this Agreement have been inserted for convenience of reference
only and do not define or limit the provisions hereof. 
  
 14.10
Certain Conventions. Unless the context of this Agreement otherwise requires: (i) words of any gender include each other gender, (ii) words such as “herein”, “hereof”, and “hereunder” refer to this Agreement as a
whole and not merely to the particular provision in which such words appear, (iii) words using the singular shall include the plural, and vice versa, and (iv) the words “include,” “includes” and “including” shall be
deemed to be followed by the phrase “but not limited to”, “without limitation”, “inter alia”, “among other things” or words of similar import. 
  
 14.11 Waiver; Remedies. Any term or condition of this Agreement may be waived at any time by the Party that is
entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of the Party waiving such term or condition. No waiver by any Party of any term or condition of this
Agreement, in any one or more instances, shall be deemed to be or construed as a waiver of the same or any other term or condition of this Agreement on any future occasion. Except as expressly set forth in this Agreement, all rights and remedies
available to a Party, whether under this Agreement or afforded by Law or otherwise, will be cumulative and not in the alternative to any other rights or remedies that may be available to such Party. 
  
 14.12 Entire Agreement. This Agreement (including the exhibits and
schedules hereto) constitute the entire agreement between the Parties, and supersede all previous agreements and understandings between the Parties, whether written or oral, with respect to the within subject matter. This Agreement may be altered,
amended or changed only by a writing making specific reference to this Agreement and signed by duly authorized representatives of Adolor and Supplier. 
  
 14.13 No License. Nothing in this Agreement shall be deemed to constitute the grant of any license or other right in either Party, to or in respect
of any BX7 or API Compound, patent, trademark, Confidential Information, trade secret or other data or any other intellectual property of the other Party, except as expressly set forth herein. 
  
 14.14 Third Party Beneficiaries. None of the provisions of this
Agreement shall be for the benefit of or enforceable by any Third Party, including any creditor of either Party. No such Third Party shall obtain any right under any provision of this Agreement or shall by reasons of any such provision make any
Claim in respect of any debt, liability or obligation (or otherwise) against either Party. 
  
 14.15 Counterparts. This Agreement may be executed in any two counterparts, each of which, when executed, shall be deemed to be an original and both of which together shall constitute one and the same document;
and such counterparts may be delivered to the other Party by facsimile. 
  
 [Remainder of this page intentionally blank] 
  

 31 

 IN WITNESS WHEREOF, Adolor and Supplier, by their duly authorized officers, have executed this Agreement
as of the Effective Date. 
  

			
	 ADOLOR CORPORATION

		
	 By:
	 	 /s/ Michael R. Dougherty

	 	 	Name: Michael R. Dougherty
	 	 	Title: Senior Vice President, Chief Operating Officer and Chief Financial Officer
	
	 GIRINDUS AG

		
	 By:
	 	 /s/ Robert F. Link

	 	 	Name: Robert F. Link
	 	 	Title: Executive Vice President—Marketing
		
	 By:
	 	 /s/ K. Leineweber

	 	 	Name: K. Leineweber
	 	 	Title: Chief Financial Officer

 SCHEDULE 1.41 
  
 Specifications 
  
 [**] 
  

	[**]	=Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 SCHEDULE 3.2 
  
 Quality Agreement 

 SCHEDULE 4.7.4 
  
 Allowable Manufacturing Line Losses 
  
 [**] 
  

	[**]	=Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 SCHEDULE 5.1 
  
 First Forecast 
 (Kg’s) 
  
 [**] 
  

	[**]	=Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

 SCHEDULE 8.1 
  
 Supply Price 
  
 [**] 
  

	[**]	=Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.Drug Product Supply Agreement

 Exhibit 10.5 
  
 Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the
confidentiality request. Omissions are designated as **. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission. 
  
 EXECUTION VERSION 
  
 DRUG PRODUCT SUPPLY AGREEMENT 
  
 between 
  
 ADOLOR CORPORATION 
  
 and 
  
 PHARMACEUTICS
INTERNATIONAL, INC. 
  
 dated 
  
 July 1, 2004 

 TABLE OF CONTENTS 
  

					
	 	  	 	  	Page

	ARTICLE 1	  	 DEFINITIONS
	  	1
			
	ARTICLE 2	  	 SUPPLY BY PII
	  	5
			
	2.1    	  	 Commitment to Supply
	  	5
			
	2.2    	  	 Facilities, Equipment and Materials
	  	5
			
	2.3    	  	 Responsibility
	  	5
			
	ARTICLE 3	  	 STANDARD TERMS OF SUPPLY OF DRUG PRODUCT
	  	6
			
	3.1    	  	 Regulatory Matters
	  	6
			
	3.2    	  	 Manufacturing Matters
	  	7
			
	3.3    	  	 Storage Obligations, Containers and Inventories
	  	9
			
	3.4    	  	 Materials Suppliers
	  	9
			
	3.5    	  	 Facility
	  	9
			
	3.6    	  	 Monitoring and Recordkeeping; Operating Procedures
	  	10
			
	3.7    	  	 Inspection, Access and Documentation
	  	10
			
	3.8    	  	 Compliance and Quality
	  	11
			
	3.9    	  	 Provision of Information
	  	11
			
	ARTICLE 4	  	 SUPPLY OF API COMPOUND
	  	11
			
	4.1    	  	 Supply
	  	11
			
	4.2    	  	 Consignment Stock
	  	11
			
	4.3    	  	 Use of the API Compound
	  	11
			
	4.4    	  	 Representations and Warranties of PII for API Compound
	  	11
			
	4.5    	  	 Inspection
	  	12
			
	4.6    	  	 Risk of Loss
	  	12
			
	4.7    	  	 Withdrawals of Stock
	  	12
			
	ARTICLE 5	  	 FORECASTING AND ORDERING
	  	12
			
	5.1    	  	 Forecast
	  	12
			
	5.2    	  	 Ordering Under the Forecast
	  	13
			
	5.3    	  	 Addressees for Correspondence
	  	13
			
	ARTICLE 6	  	 SHIPPING AND DELIVERY; STORAGE
	  	13
			
	6.1    	  	 Shipping and Delivery Dates
	  	13
			
	6.2    	  	 Terms of Delivery
	  	14

  

 i 

 TABLE OF CONTENTS 
 (continued) 
  

					
	 	  	 	  	Page

			
	6.3    	  	 Shipping Costs
	  	14
			
	6.4    	  	 Documentation and Release
	  	14
			
	6.5    	  	 Retention of Samples
	  	14
			
	6.6    	  	 Storage of Drug Product
	  	14
			
	ARTICLE 7	  	 INSPECTION AND DEFECTIVE DRUG PRODUCT; RECALL
	  	15
			
	7.1    	  	 Inspection by Adolor
	  	15
			
	7.2    	  	 Latent Defects
	  	15
			
	7.3    	  	 Defective Drug Product
	  	15
			
	7.4    	  	 Remedies
	  	16
			
	7.5    	  	 Drug Product Recall
	  	16
			
	7.6    	  	 Shortages
	  	16
			
	7.7    	  	 Costs Incurred as a Result of PII’s Failure to Supply
	  	16
			
	ARTICLE 8	  	 FINANCIAL PROVISIONS
	  	17
			
	8.1    	  	 Supply Price
	  	17
			
	8.2    	  	 Process Improvements and Sharing of Cost Efficiencies
	  	17
			
	8.3    	  	 Manner of Payments
	  	17
			
	8.4    	  	 Invoices; Timing of Payments
	  	17
			
	ARTICLE 9	  	 CONFIDENTIALITY
	  	17
			
	9.1    	  	 Confidential Information
	  	17
			
	9.2    	  	 Public Announcements
	  	18
			
	9.3    	  	 Inventions
	  	18
			
	9.4    	  	 Confidentiality of this Agreement
	  	19
			
	9.5    	  	 Survival
	  	19
			
	ARTICLE 10	  	 REPRESENTATIONS AND WARRANTIES
	  	19
			
	10.1    	  	 Representations of PII
	  	19
			
	10.2    	  	 Mutual Representations and Warranties
	  	19
			
	10.3    	  	 Disclaimer of Warranty
	  	20
			
	ARTICLE 11	  	 INDEMNIFICATION AND INSURANCE
	  	20
			
	11.1    	  	 Indemnification by PII
	  	20
			
	11.2    	  	 Indemnification by Adolor
	  	21

  

 ii 

 TABLE OF CONTENTS 
 (continued) 
  

					
	 	  	 	  	Page

	11.3    	  	 Indemnification Procedure
	  	21
			
	11.4    	  	 Assumption of Defense
	  	22
			
	11.5    	  	 Limitation of Liability
	  	22
			
	11.6    	  	 Insurance
	  	22
			
	ARTICLE 12	  	 TERM AND TERMINATION
	  	23
			
	12.1    	  	 Term
	  	23
			
	12.2    	  	 Termination
	  	23
			
	ARTICLE 13	  	 RIGHTS AND DUTIES UPON TERMINATION
	  	24
			
	13.1    	  	 Pending Purchase Orders
	  	24
			
	13.2    	  	 Outstanding Payment
	  	24
			
	13.3    	  	 Return of Materials
	  	24
			
	13.4    	  	 Access to Records/Maintenance of Critical Samples and Test Programs
	  	24
			
	13.5    	  	 Accrued Rights; Surviving Obligations
	  	24
			
	ARTICLE 14	  	 GENERAL PROVISIONS
	  	25
			
	14.1    	  	 Relationship of the Parties
	  	25
			
	14.2    	  	 Covenant Not to Compete
	  	25
			
	14.3    	  	 Force Majeure
	  	26
			
	14.4    	  	 Governing Law
	  	26
			
	14.5    	  	 Jurisdiction
	  	26
			
	14.6    	  	 Assignment
	  	26
			
	14.7    	  	 Notices
	  	27
			
	14.8    	  	 Severability
	  	27
			
	14.9    	  	 Headings
	  	28
			
	14.10  	  	 Certain Conventions
	  	28
			
	14.11  	  	 Waiver; Remedies
	  	28
			
	14.12  	  	 Entire Agreement
	  	28
			
	14.13  	  	 No License
	  	28
			
	14.14  	  	 Third Party Beneficiaries
	  	28
			
	14.15  	  	 Counterparts
	  	28

  

 iii 

 SCHEDULES 
  

			
	 SCHEDULE 1.4
	 	API COMPOUND
	 SCHEDULE 1.42
	 	SPECIFICATIONS
	 SCHEDULE 2.3
	 	CURRENT APPROVED SUBCONTRACTORS
	 SCHEDULE 3.2
	 	QUALITY AGREEMENT
	 SCHEDULE 3.5.2
	 	POTENTIAL CONTAMINANTS CURRENTLY BEING MANUFACTURED AT THE FACILITY
	 SCHEDULE 5.1
	 	FIRST FORECAST
	 SCHEDULE 8.1
	 	SUPPLY PRICE

  

 iv 

 DRUG PRODUCT SUPPLY AGREEMENT 
  
 This DRUG PRODUCT SUPPLY AGREEMENT (this “Agreement”), made as of the 1st day of July, 2004 (the
“Effective Date”), between ADOLOR CORPORATION, a Delaware corporation having a principal place of business at 700 Pennsylvania Drive, Exton, Pennsylvania 19341 (“Adolor”), and PHARMACEUTICS INTERNATIONAL, INC., a
Maryland corporation having a principal place of business at 10819 Gilroy Road, Hunt Valley, Maryland 21031 (“PII”). Adolor and PII may be referred to as a “Party” or, together, the “Parties”.

  
 RECITALS 
  
 WHEREAS, PII has the capability to manufacture the Drug Product (as defined
below); and 
  
 WHEREAS, the Parties desire that PII supply Adolor
with the Drug Product under this Agreement on the terms and subject to the conditions set forth below. 
  
 NOW, THEREFORE, in consideration of the mutual promises, covenants and agreements set forth herein, and for other good and valuable consideration, the
receipt and sufficiency of which are hereby acknowledged, and intending to be legally bound, the Parties hereby agree as follows: 
  
 ARTICLE 1 
 DEFINITIONS

  
 For purposes of this Agreement, the following initially
capitalized terms, whether used in the singular or plural, shall have the following meanings: 
  
 1.1 “Act” means the U.S. Federal Food, Drug and Cosmetic Act as amended from time to time. 
  
 1.2 “Adverse Drug Experience” means any of: an “adverse drug experience,” a “life-threatening adverse drug
experience,” a “serious adverse drug experience,” or an “unexpected adverse drug experience,” as those terms are defined at either 21 C.F.R. § 312.32 or 21 C.F.R. § 314.80. 
  
 1.3 “Affiliate” of a Party means any Person, whether de jure
or de facto, which directly or indirectly controls, is controlled by, or is under common control with such Person for so long as such control exists, where “control” means the decision-making authority as to such Person and, further, where
such control shall be presumed to exist where a Person owns more than fifty percent (50%) of the equity (or such lesser percentage which is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction) having the power to
vote on or direct the affairs of the entity. 
  
 1.4 “API
Compound” means an intermediate of Drug Product meeting the specifications set forth on Schedule 1.4 and made a part hereof. 

 1.5 “Breaching Party” shall have the meaning set forth in Section 12.2.1 
  
 1.6 “Business Day” means any day on which banking
institutions in New York, New York are open for business. 
  
 1.7
“Calendar Quarter” means each successive period of three calendar months commencing January 1, April 1, July 1 and October 1. 
  
 1.8 “Calendar Year” means, for the first calendar year, the period commencing on the Effective Date and ending on December 31 of the
calendar year during which the Effective Date occurs, and each successive period beginning on January 1 and ending twelve (12) consecutive calendar months later on December 31. 
  
 1.9 “Certificate of Analysis” means a document identified as such and provided by PII to Adolor or its
designee that sets forth the analytical test results against the Specifications for a specified lot of Drug Product shipped to Adolor or its designee hereunder. 
  

1.10 “Certificate of Compliance” means a document identified as such and provided by PII to Adolor or its designee that certifies,
warrants and reflects that each batch of Drug Product was produced and tested in compliance with the Specifications, cGMPs, the Master Batch Record and all other applicable regulatory documents. 
  
 1.11 “Claims” means all charges, complaints, actions, suits,
proceedings, hearings, investigations, claims and demands. 
  
 1.12 “Compound” means the peripheral mu antagonist having molecular formula [[2(S)-[[4(R)-(3-hydroxyphenyl)-3(R),4-dimethyl-1-piperidinyl]-methyl]-1-oxo-3-phenylpropyl]amino]acetic acid dihydrate, known generically as
“alvimopan”, and all pharmaceutically acceptable salts and solvates thereof. 
  
 1.13 “Confidential Information” means all secret, confidential or proprietary information or data, whether provided in written, oral, graphic, video, computer or other form, provided by one Party (the
“Disclosing Party”) to the other Party (the “Receiving Party”) pursuant to this Agreement or generated pursuant to this Agreement, including but not limited to, information relating to the Disclosing Party’s
existing or proposed research, development efforts, patent applications, business or products, the terms of this Agreement and any other materials that have not been made available by the Disclosing Party to the general public. Notwithstanding the
foregoing sentence, Confidential Information shall not include any information or materials that: 
  
 1.13.1 were already known to the Receiving Party (other than under an obligation of confidentiality), at the time of disclosure by the Disclosing Party to
the extent such Receiving Party has documentary evidence to that effect; 
  
 1.13.2 were generally available to the public or otherwise part of the public domain at the time of its disclosure to the Receiving Party; 
  

 2 

 1.13.3 became generally available to the public or otherwise part of the public domain after its
disclosure or development, as the case may be, and other than through any act or omission of a Party in breach of such Party’s confidentiality obligations under this Agreement; 
  
 1.13.4 were disclosed to a Party, other than under an obligation of confidentiality, by a Third Party who had no obligation
to the Disclosing Party not to disclose such information to others; or 
  
 1.13.5 were independently discovered or developed by or on behalf of the Receiving Party without the use of the Confidential Information belonging to the other Party and the Receiving Party has documentary evidence to that effect.

  
 1.14 “Consent” means any consent,
authorization, permit, certificate, license or approval of, exemption by, or filing or registration with, any Governmental Authority or other person. 
  
 1.15 “Current Good Manufacturing Practices” or “cGMPs” means all applicable standards relating to manufacturing
practices for fine chemicals, active pharmaceutical ingredients, intermediates, bulk products or finished pharmaceutical products, including (i) the principles detailed in the U.S. Current Good Manufacturing Practices, 21 C.F.R. Parts 210 as may be
amended from time to time, (ii) Laws promulgated by any Governmental Authority having jurisdiction over the manufacture of the Drug Product, and (iii) guidance documents promulgated by any Governmental Authority having jurisdiction over the
manufacture of the Drug Product, in (including but not limited to advisory opinions, compliance policy guides and guidelines) which guidance documents are being implemented by PII or within the pharmaceutical manufacturing industry for such Drug
Product and specifically identified by Adolor to be applicable to this Agreement, subject to, with respect to clause (iii) only, any arrangements, additions or clarifications agreed to from time to time by the Parties in the Quality Agreement.

  
 1.16 “Disclosing Party” shall have the
meaning set forth in Section 1.13. 
  
 1.17 “Drug
Product” means a prescription pharmaceutical product that contains Compound as the sole active ingredient supplied in bulk capsules for final labeling and packaging by Adolor or its designee. 
  
 1.18 “Executed Batch Record” means the executed and
completed Master Batch Record for each batch of Drug Product manufactured pursuant to the terms of this Agreement. 
  
 1.19 “Facility” shall mean PII’s manufacturing facility located at 10819 Gilroy Road, Hunt Valley, Maryland. 
  
 1.20 “FDA” means the United States Food and Drug
Administration and any successor thereto. 
  
 1.21 “File
Retention Samples” shall have the meaning set forth in Section 6.5. 
  
 1.22 “Force Majeure Event” shall have the meaning set forth in Section 14.3. 
  

 3 

 1.23 “Forecast” shall have the meaning set forth in Section 5.1. 
  
 1.24 “Governmental Authority” means (a) any court, tribunal,
arbitrator, agency, legislative body, commission, official or other instrumentality of the United States or (b) a federal, state, county, city or other political subdivision thereof. 
  
 1.25 “ICH” means the International Conference on Harmonisation of Technical Requirements for Registration
of Pharmaceuticals for Human Use. 
  
 1.26 “Indemnified
Party” shall have the meaning set forth in Section 11.3. 
  
 1.27 “Indemnifying Party” shall have the meaning set forth in Section 11.3. 
  
 1.28 “Laws” means all United States applicable laws, statutes, rules, regulations (including, without limitation, cGMPs, the ICH
guidelines, Investigational New Marketing Authorization regulations at 21 C.F.R. § 312, NDA regulations at 21 C.F.R. § 314, the applicable regulations and guidelines of the FDA or other applicable Governmental Authority), ordinances and
other pronouncements having the binding effect of law of any Governmental Authority. 
  
 1.29 “Losses of Adolor or GSK” shall have the meaning set forth in Section 11.1. 
  
 1.30 “Losses of PII” shall have the meaning set forth in Section 11.2. 
  
 1.31 “Manufacturing Activities” shall mean the manufacturing, processing, testing, packaging, storing and
other activities undertaken or required to be undertaken by PII or its suppliers in order to manufacture and supply Adolor with the Drug Product. 
  
 1.32 “Marketing Authorization” means, with respect to a country, the regulatory authorization required to market and sell Product in such
country as granted by the relevant Governmental Authority. 
  
 1.33 “Master Batch Record” shall mean the current version of the master batch record approved by the Parties, which may be amended in writing from time to time by mutual agreement of the Parties. 
  
 1.34 “Materials” means the raw materials, components and
other ingredients required to manufacture the Drug Product, each as specifically identified in a Marketing Authorization. 
  
 1.35 “Person” means any natural person, corporation, general partnership, limited partnership, joint venture, proprietorship or other
business organization. 
  
 1.36 “Potential
Contaminants” shall have the meaning set forth in Section 3.5.2. 
  
 1.37 “Product” means a prescription pharmaceutical product that contains Compound as the sole active ingredient. 
  
 1.38 “Purchase Order” shall have the meaning set forth in Section 5.2.1(a). 
  
 1.39 “Receiving Party” shall have the meaning set forth in
Section 1.13. 
  

 4 

 1.40 “Regulatory Standards” means (i) any and all permits, licenses, filings and
certifications required by the FDA or other Governmental Authorities, and compliance with cGMPs, applicable to the Drug Product, any Manufacturing Activity or Facility, and (ii) any Laws (including the Environmental Protection Agency (EPA), the
Occupational Safety and Health Administration (OSHA), the Drug Enforcement Administration (DEA)), that apply to the Drug Product, any Manufacturing Activity or Facility. 
  
 1.41 “Shipping Costs” shall have the meaning set forth in Section 6.3. 
  
 1.42 “Specifications” means all specifications for the Drug
Product as set forth on Schedule 1.42, as may be amended by the Parties from time to time. 
  
 1.43 “Quality Agreement” shall have the meaning set forth in Section 3.2. 
  
 1.44 “Third Party” means a Person who is not a Party or an Affiliate of a Party. 
  
 1.45 “Waste” shall mean any “Hazardous Substance”
and/or “Hazardous Material” as provided under the Comprehensive Environmental Response, Compensation and Liability Act (CERCLA), any “Hazardous Waste” as provided under the Resource Conservation and Recovery Act (RCRA), and/or
any other waste material, pollutant and/or contaminant of any kind including any routine process waste or any by-product arising from manufacture of the Drug Product. 
  
 ARTICLE 2 
 SUPPLY BY PII 
  
 2.1 Commitment to Supply.
Upon the terms and subject to the conditions of this Agreement and pursuant to Purchase Orders delivered from time to time by Adolor to PII in accordance with Section 5.2, PII shall manufacture, test, package in bulk, store, label, release and
deliver and supply to Adolor or its designee the Drug Product in accordance with the Specifications, cGMPs, the Master Batch Record and all applicable Laws and the provisions of the Quality Agreement. PII acknowledges that time is of the essence in
accordance with the terms of this Agreement. 
  
 2.2
Facilities, Equipment and Materials. Except for the equipment provided to PII by Adolor under the existing Equipment Agreement between the Parties, dated August 10, 2001, PII agrees to provide, at its own cost and expense, all facilities,
equipment, machinery, materials (other than as specifically set forth herein) in accordance with the Specifications and the Master Batch Records and labor necessary for the performance of the Manufacturing Activities. 
  
 2.3 Responsibility. Unless otherwise specified herein or expressly
consented to in writing by Adolor, as between the Parties, PII shall be solely responsible for performance of all activities necessary for Adolor to be supplied with Drug Product as contemplated hereunder. PII shall not amend or modify the
Specifications or Master Batch Record or any protocols, processes or procedures used to perform the Manufacturing Activities without the express written approval from Adolor. Unless otherwise expressly consented in writing in advance by Adolor, PII
may not sublicense or subcontract the activities to be performed by PII under this Agreement to an Affiliate, Third Party or other designee, except for the subcontractors of PII as listed on Schedule 2.3. 
  

 5 

 ARTICLE 3 
 STANDARD TERMS OF SUPPLY OF DRUG PRODUCT 
  
 3.1 Regulatory Matters. 
  
 3.1.1 Consents. PII shall obtain all Consents for which it is responsible that are required as of the Effective Date for the manufacture of the Drug Product under the terms of this Agreement. At all times, PII shall maintain and
comply with all the Consents which may from time to time be required by any Governmental Authority having jurisdiction with respect to its manufacturing operations, the Manufacturing Activities and/or the Facility and otherwise to be obtained by PII
to permit the performance of its then current obligations under this Agreement. Notwithstanding the foregoing, Adolor shall obtain, maintain and comply with all Marketing Authorizations required in connection with the sale of the Drug Product. In
the event any Consent held by PII relating to the Facility or its ability to manufacture the Drug Product in accordance with this Agreement is hereafter suspended or revoked, or PII has material restrictions imposed upon it by any Governmental
Authority affecting the Drug Product or the Facility, PII shall immediately notify Adolor and shall promptly provide a schedule of compliance and such other information related thereto as is reasonably requested by Adolor. 
  
 3.1.2 Notification of Adverse Manufacturing Activities. PII shall
advise Adolor of any information arising out of the Manufacturing Activities that to PII’s knowledge has adverse regulatory compliance and/or reporting consequences concerning the Drug Product or the Facility. 
  
 3.1.3 Governmental Authorities. PII shall provide to Adolor any
information reasonably requested by Adolor, and shall consult with Adolor before providing any information to any Governmental Authority, in connection with manufacture of Drug Product. PII shall immediately advise Adolor of any requests by any
Governmental Authority for inspections of the Facility with respect to the Drug Product. 
  
 3.1.4 Inspection of Drug Product Suppliers by Governmental Authorities. In the event PII is audited or inspected by a Governmental Authority relating to the Manufacturing Activities for the Drug Product, PII
shall promptly (but in any event, within one business day) notify Adolor of such audit or inspection as well as of any alleged violations or deficiencies relating to the Facility, process, and/or Drug Product, allow Adolor to be present during such
audit or inspection, and shall promptly disclose to Adolor all relevant portions of any notice of observations or potential violations, as well as a copy of PII’s response thereto. In addition, PII will provide Adolor with unredacted (subject
to Third Party confidentiality obligations) copies of any FDA 483(s) and Establishment Inspection Reports (or their equivalents) issued as a result of said audit and any follow-up written communications between PII and the Governmental Authority.
PII shall use its commercially reasonable best efforts to correct all identified deficiencies in a timely manner and advise Adolor periodically of progress being made, as well as when all deficiencies have been corrected. 
  

 6 

 3.1.5 Generic Drug Enforcement Act. PII has not used and will not use in the manufacture of Drug
Product in any capacity the services of any person, including any firm or individual, debarred or subject to debarment under the Generic Drug Enforcement Act of 1992, amending the Act at 21 U.S.C. 335a. PII agrees to notify Adolor immediately in the
event any person providing services to PII relating to this Agreement is debarred or becomes subject to debarment. 
  
 3.1.6 Adverse Reaction Reporting. To the extent permitted under applicable Laws, including the Health Insurance Portability and Accountability Act
of 1996 and the European Union Privacy Directive, each as amended, each Party shall promptly notify the other Party of all information reported to it relating to any Adverse Drug Experience, whether expected or unexpected, relating to the use of the
Drug Product. 
  
 3.1.7 Notice of Changes to Marketing
Authorization. Adolor shall provide PII with sufficient advance notice of any changes to any Marketing Authorization that results in a change to the Materials or to PII’s obligations hereunder. 
  
 3.2 Manufacturing Matters. 
  
 3.2.1 Quality Agreement. Adolor and PII shall enter into the Quality
Agreement (the “Quality Agreement”) appended to this Agreement as Schedule 3.2. To the extent there are any inconsistencies or conflicts between this Agreement and the Quality Agreement, the terms and conditions of this
Agreement shall control unless specifically otherwise agreed to in writing by the Parties. In the event that the Quality Agreement contains material provisions that substantially differ from applicable comparable Regulatory Standards, the Regulatory
Standards shall control. 
  
 3.2.2 Specification Changes.
Adolor shall be entitled to request changes to the Specifications from time to time. PII shall endeavor to make all revisions to the Specifications requested by Adolor, in accordance with this Section 3.2.2 and all applicable Laws. Adolor retains
the right and responsibility for final written approval of the Specifications prior to implementation by PII. 
  
 (a) Required Manufacturing Changes. For changes to the Specifications that are required by a Governmental Authority, the Marketing Authorization
or applicable Laws (collectively “Required Manufacturing Changes”), Adolor and PII shall cooperate in making such changes and PII shall implement such changes in compliance with such applicable Laws and as promptly as practicable.

  
 (b) Discretionary Manufacturing Changes. For changes
to the Specifications that are not Required Manufacturing Changes (collectively “Discretionary Manufacturing Changes”), Adolor shall submit a request to PII for any such Discretionary Manufacturing Changes. Upon receipt of such
request from Adolor, PII shall determine (a) one-time and/or ongoing costs that would be incurred resulting from the Discretionary Manufacturing Changes, (b) any resulting planned changes in timing for the delivery of the Drug Product and (c) the
estimated time of implementing any such Discretionary Manufacturing Changes (the “Cost and Time Statement”). PII shall provide the Cost and Time Statement to Adolor setting 
  

 7 

 forth the terms on which PII would be willing to make the Discretionary Manufacturing Changes. Upon Adolor’s written
approval of the Cost and Time Statement, the parties shall cooperate in making such Discretionary Manufacturing Changes and PII shall implement such Discretionary Manufacturing Changes. 
  
 (c) Cost and Payment for Changes to the Specifications. 
  
 (i) For all changes to the Specifications pursuant to Sections 3.2.2(a) or
3.2.2(b), Adolor shall be responsible for and pay PII any and all amounts incurred in implementing a change to the Specifications. PII must provide such documentation of its costs and expenses as may be reasonably requested by Adolor. PII agrees to
use commercially reasonable efforts to minimize its costs associated with any Specification change. 
  
 (ii) For all changes to the Specifications that are necessitated because a change is required to the Facility generally, PII shall be responsible for the
costs and expenses of such changes. 
  
 3.2.3 Accident
Reports. Each Party shall promptly notify the other of all material accidents related to the manufacture, handling, use or storage of Drug Product, including: (a) accidents resulting in significant personal injury requiring more than first aid
treatment, (b) accidents resulting in chronic illness or loss of consciousness, (c) accidents resulting in material property damage, (d) accidents resulting in material environmental release and (e) accidents that result in regulatory, safety,
health or environmental audits. 
  
 3.2.4 Handling of
Materials; Wastes. PII shall inform its employees, contractors and other personnel of any known or reasonably ascertainable chemical hazards associated with the Drug Product or any Wastes generated through performance of the Manufacturing
Activities, and to provide such persons with reasonable training in the proper methods of handling and disposing of such items. In addition, PII shall handle, accumulate, label, package, ship and dispose of all Wastes generated through performance
of the Manufacturing Activities in accordance with all applicable Laws. In connection herewith, Adolor shall provide PII with data on the chemical and physical properties, toxicity and handling, storing and shipping information for the Drug Product,
including Material Safety Data Sheets (MSDS) or equivalent, and agree to provide updates to PII as new related information becomes available to Adolor. 
  
 3.2.5 Documentation for Governmental Authority Requirements. PII shall maintain complete and accurate documentation of all validation data,
stability testing data, batch records, quality control and laboratory testing and any other data required under cGMPs and other requirements of any relevant Governmental Authority in connection with the performance of any Manufacturing Activities
hereunder. PII shall provide Adolor with such documentation promptly upon Adolor’s request. 
  
 3.2.6 Technical Information. As set forth in the Quality Agreement, PII, at its sole cost and expense, shall, upon receiving a written request from
Adolor, supply technical information on the Drug Product and methods of manufacture and testing to the extent that such information is necessary both to enable Adolor to fulfill its obligations within this Agreement or in its agreements with its
customers, including compliance with any statutory or regulatory 
  

 8 

 requirements of, or a request by, any Governmental Authority. To the extent Adolor requests technical information that is
not contemplated in the Quality Agreement, PII, at its standard hourly rates, shall supply such information to Adolor. 
  
 3.3 Storage Obligations, Containers and Inventories. 
  
 3.3.1 Records, Retained Samples and Storage. PII shall retain samples and maintain records from each batch of Drug Product for a period required by
applicable Laws for record keeping, testing and regulatory purposes or specified in the Quality Agreement. When storing Compound, nonconforming Compound or Wastes, PII shall comply with and maintain all storage facilities in compliance with
Specifications and in accordance with cGMPs and applicable Laws. 
  
 3.3.2 Containers and Packaging. PII shall supply the Drug Product in such containers and packaging and with such container closure systems and labeling as set forth in the Specifications. 
  
 3.4 Materials Suppliers. Notwithstanding anything to the contrary
contained herein, (a) PII shall only obtain Materials from such suppliers named in the relevant Marketing Authorization, (b) PII will perform periodic audits of its Material suppliers as provided in the Quality Agreement, and (c) PII shall prepare
all certifications as to any Materials required by cGMPs or Laws, (each, a “Materials Certification”). Such Materials Certifications shall include, without limitation, all certifications required by Laws related to Materials derived
from animal products. 
  
 3.5 Facility. 
  
 3.5.1 Sole Location. The Facility shall be the only location where
PII performs the Manufacturing Activities unless otherwise agreed to in writing by Adolor. 
  
 3.5.2 Certain Prohibitions. PII shall not manufacture, store or process any Drug Product in the same building in which PII manufactures, stores or processes genotoxics, penicillins, genetically modified
organisms, cephalosporins, sex hormones, anabolic steroids, and infectious agents (e.g., spore-bearing and live viruses), (collectively, “Potential Contaminants”) unless the Potential Contaminants are stored or manufactured in
contained environments and in compliance with cleaning, validation and changeover standards of all cGMPs and all applicable Laws; provided, however, Adolor acknowledges that as of the Effective Date, PII is manufacturing the Potential Contaminants
set forth on Schedule 3.5.2 at the Facility. PII shall promptly notify Adolor if any of the Potential Contaminants are manufactured, processed or stored in any portion of the Facility which would result in the introduction of Potential
Contaminants into the areas of the Facility where PII manufactures, processes or stores the Drug Product. PII shall notify Adolor by not later than the earlier to occur of (i) sixty (60) days prior to such event or (ii) PII’s knowledge of such
event, if PII intends to change the nature or use of any portion of the Facility to include the use of any of the Potential Contaminants other than those set forth on Schedule 3.5.2. PII shall not make such changes if the change could reasonably be
expected to result in a material adverse effect on the ability to fully perform the obligations under this Agreement and PII has not demonstrated to Adolor’s reasonable satisfaction that such Potential Contaminants shall be segregated from the
Drug Product at all times consistent with current practices and shall comply with all Regulatory Standards. 
  

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 3.5.3 Representatives. In connection with the monitoring of this Agreement, subject to reasonable
advance notice and compliance with PII’s policies for visitors to the Facility, Adolor and Glaxo Group Limited (“GSK”) shall be allowed to have, at their cost, representatives on site at PII, access to the portions of
PII’s Facility used in the manufacture, generation, storage, testing, treatment, holding, transportation, distribution or other handling or receiving of the Compound and all associated records for the purpose of observing, reporting on, and
consulting as to such activities, and adequate temporary desk space and other reasonable resources available to these representatives during the periods they are working at PII. In addition, Adolor and GSK shall have the right, subject to any Third
Party confidentiality obligations and prior advance notice of at least ten (10) Business Days and approval by PII, not to be unreasonably withheld, refused, conditioned or delayed, and during normal business hours, to examine those technical records
made by PII that only relate to the manufacture of Drug Product and PII’s operations generally. 
  
 3.6 Monitoring and Recordkeeping; Operating Procedures. Throughout the term of this Agreement, and for so long thereafter as is required by
applicable Laws, PII shall monitor and maintain reasonable records respecting its compliance with cGMPs, including through the establishment and implementation of such operating procedures as are reasonably necessary to assure such compliance. PII
shall notify Adolor in writing of any significant trend changes in the statistical process control data and/or quality testing results for batches of Drug Product manufactured hereunder. 
  
 3.7 Inspection, Access and Documentation. 
  
 3.7.1 Audit Rights. For the purpose of permitting a quality and compliance audit, including to ascertain compliance
with cGMPs, Specifications and applicable Laws and to audit due to an Adverse Drug Experience, emergency or inspection by a Governmental Authority, PII shall grant to authorized representatives of Adolor and GSK (or a Third Party hired on behalf of
GSK or Adolor who is reasonably acceptable to PII), upon reasonable notice, access to the Facility for one (1) two (2)-day period annually. GSK and/or Adolor shall provide PII at least ten (10) Business Days notice in writing of the desire to have
such access; provided, however, that in the event of an Adverse Drug Experience or any proposed or actual inspection by a Governmental Authority or other emergency involving the Product, GSK and Adolor shall have the right at any time upon oral or
written notice to PII of one (1) Business Day to conduct an audit of PII’s facility without reference to the annual limitation described above. PII shall promptly respond to GSK’s or Adolor’s request and the Parties shall agree on the
time, scope and manner of the audit. 
  
 3.7.2 cGMP
Documentation. PII shall maintain, in accordance with and for the period required under cGMPs and applicable Laws, complete and adequate records pertaining to the methods and facilities used for the manufacture, processing, testing, packing,
labeling, holding and distribution of the Drug Product. 
  

 10 

 3.8 Compliance and Quality. 
  
 3.8.1 Compliance Standards. PII is solely responsible for the safety and health of its employees, consultants and
visitors and compliance with all Laws related to health, safety and the environment, including, without limitation, providing its employees, consultants and visitors with all required information and training concerning any potential hazards
involved in the manufacture, packaging, storage and supply of the Drug Product and taking any precautionary measures to protect its employees from any such hazards. In connection herewith, Adolor shall provide PII with data on the chemical and
physical properties, toxicity and handling, storing and shipping information for the Drug Product, including Material Safety Data Sheets (MSDS) or equivalent, and agrees to provide updates to PII as new related information becomes available to
Adolor. 
  
 3.8.2 Quality Assurance; Quality Control. PII
shall implement and perform testing (including retesting and any validation or stability tests that may be required) set forth on Schedule 1.42 against the Specifications and such other quality assurance and quality control procedures as
required by cGMPs and applicable Laws. 
  
 3.9 Provision of
Information. PII shall provide to Adolor copies (in electronic or hard-copy form, as requested by Adolor) of all data generated during the Term as may be reasonably requested from time to time by Adolor. 
  
 ARTICLE 4 
 SUPPLY OF API COMPOUND 
  
 4.1 Supply. At least one hundred five (105) days prior to the requested delivery date of the Drug Product to Adolor, Adolor will provide PII with API Compound, at no cost to PII, in sufficient quantity to
enable PII to perform the Manufacturing Activities and supply Drug Product to Adolor. Upon receipt of the API Compound by PII, PII shall test the API Compound against the Specifications as indicated on Schedule 1.42. 
  
 4.2 Consignment Stock. All API Compound supplied to PII by Adolor is
supplied as consignment stock and shall be clearly identified as the property of Adolor, shall be kept segregated and maintained in the Facility, and shall at all times be owned by Adolor. 
  
 4.3 Use of the API Compound. PII shall use the API Compound only to
perform the Manufacturing Activities to produce and supply the Drug Product to Adolor. 
  
 4.4 Representations and Warranties of PII for API Compound. PII represents, warrants and covenants that API Compound will be held at the Facility only, unless otherwise consented by Adolor in writing (which
consent shall not be unreasonably withheld), and that such Facility, at PII’s sole cost and expense, has and will, for such time as such API Compound will be maintained meet the requirements established by applicable Governmental Authorities,
and that the API Compound will always be maintained in accordance with cGMPs, the Quality Agreement (including storage conditions specified therein), the Specifications and all applicable Laws (including, without limitation, the receipt and
possession of all applicable permits and authorizations), as well as Adolor’s reasonable prior written instructions. 
  

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 4.5 Inspection. At no additional cost to Adolor, Adolor shall be entitled to inspect the API
Compound and its related records during normal business hours upon reasonable request and prior written notice and with the least reasonably possible interference with PII’s ordinary course of business. 
  
 4.6 Risk of Loss. The risks of loss, damage or destruction of the API
Compound delivered to PII shall be borne by PII from the date of delivery to the Facility until delivery in accordance with Section 6.2 below. 
  
 4.7 Withdrawals of Stock. 
  
 4.7.1 Withdrawal. PII shall be entitled to withdraw API Compound for the performance of the Manufacturing Activities according to the terms and
conditions of this Agreement and respecting the procedure of first in/first out, except for API Compound that is beyond re-test. 
  
 4.7.2 Statement of Use. Within fifteen (15) days after the end of each quarter during the Term, PII shall send Adolor a statement of usage and
inventory showing the following items: (a) the quantities of API Compound supplied by Adolor; (b) the quantities of API Compound in PII’s inventory at the beginning of the calendar quarter; (c) the quantities of API Compound withdrawn by PII;
(d) the quantities of API Compound used by PII in performing the Manufacturing Activities; (e) any quantities of API Compound lost or destroyed while held as consignment stock or following withdrawal from consignment stock; (f) any quantities of API
Compound for which PII is unable to account; (g) API Compound that is no longer useable because of degradation due to stability or that is beyond re-test; and (h) the quantities of API Compound in PII’s inventory at the end of the calendar
quarter. If, based upon its inspections of the API Compound pursuant to Section 4.5, Adolor disputes any of the items on the statement of usage and inventory, the Parties will promptly meet to attempt to resolve such disagreement. 
  
 4.7.3 Responsibility for API Compound Lost or Destroyed; Allowable
Manufacturing Line Losses. In addition to any other remedies available to Adolor at law or in equity, PII shall be entirely responsible for API Compound lost or destroyed for reasons other than nonconformance of API Compound with the
Specifications or used by PII in the Manufacturing Activities. After completion of the validation batches of the API Compound, the Parties in good faith shall negotiate a mechanism to account for allowable manufacturing line losses and associated
payments or reimbursements based on the actual usage. 
  
 4.7.4
Late Delivery of API Compound. Adolor acknowledges that PII shall have no liability whatsoever in case of late delivery of the Drug Product due to late delivery of the API Compound by Adolor. 
  
 ARTICLE 5 
 FORECASTING AND ORDERING 
  
 5.1 Forecast. At the beginning of each Calendar Quarter during the term of this Agreement, Adolor shall provide PII with a rolling six (6) Calendar Quarter non-binding, good faith estimate of the quantities of
Drug Product that Adolor foresees it will order from PII during such six (6) Calendar Quarter period, including any validation batches (each, a “Forecast”), with quarterly updates. The first such Forecast shall be for the period
from June 2004 through December 2005 is attached hereto as Schedule 5.1. 
  

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 5.2 Ordering Under the Forecast. 
  
 5.2.1 Purchase Orders. 
  
 (a) Delivery of Purchase Order. The volume requirements for Drug Product as set forth for each of the first Calendar Quarter of each Forecast will
be a binding commitment to purchase the specified volumes of Drug Product. Adolor may from time to time place purchase orders with PII for quantities of Drug Product at least ninety (90) days prior to the delivery date specified in each respective
purchase order (each, a “Purchase Order”). The Purchase Order must be consistent with the binding portion of each Forecast. PII shall deliver Drug Product against each Purchase Order in accordance with Article 5. Adolor shall
purchase all such Drug Product ordered and delivered by the delivery date specified in a Purchase Order, provided that such Drug Product meets the Specifications. PII shall use commercially reasonable efforts to supply any quantity of Drug Product
ordered in the aggregate that exceeds the quantity in the Forecast. All Purchase Orders shall be for full batch quantities of Drug Product or integral multiples thereof. 
  
 (b) Acceptance of Purchase Order. PII shall acknowledge and provide Adolor with a written acceptance of each
Purchase Order within five (5) Business Days following PII’s receipt thereof. PII shall be entitled to reject only that portion of any Purchase Order which PII will be unable to fill due to: (i) the occurrence of a Force Majeure Event, (ii) the
failure of Adolor to timely supply or cause to be supplied the API Compound as required in Section 4.1 above, or (iii) such portion of the Purchase Order, when added to other Purchase Orders placed during a given twelve (12)-month period, exceeds
then current Forecast covering such period by more than twenty percent (20%). 
  
 (c) Terms of Purchase Orders. Other than terms respecting quantity, delivery date(s), shipment method and destination(s), the terms and conditions of any Purchase Order submitted by Adolor, or written
acceptance thereof by PII, shall be of no force and effect, whether or not objected to by PII, and nothing in any such Purchase Order or written acceptance shall supersede the terms and conditions of this Agreement or the Quality Agreement.

  
 5.3 Addressees for Correspondence. All Forecasts,
Purchase Orders, written acceptances of Purchase Orders and other notices contemplated under this Article 5 shall be sent to the attention of such persons as each Party may identify to the other in writing from time to time. 
  
 ARTICLE 6 
 SHIPPING AND DELIVERY; STORAGE 
  
 6.1 Shipping and Delivery Dates. On each Purchase Order submitted by Adolor, Adolor shall specify the requested quantity, delivery date(s), shipment method and destination(s) of Drug Product being ordered. PII
shall arrange for the delivery of Drug Product to Adolor’s (or its designee’s) designated facilities in the United States as stated on the Purchase Order and in a manner consistent with good commercial practices, and in accordance with any
agreed-upon 
  

 13 

 shipping specifications, this Agreement and Adolor’s or its designee’s reasonable instructions. PII shall not
ship any Drug Product until PII receives a written release from Adolor as provided in the Quality Agreement. 
  
 6.2 Terms of Delivery. Once Adolor has released the Drug Product in accordance with Section 6.4, PII shall ship Drug Product in accordance with
Adolor’s instructions by a carrier selected by Adolor FCA (Incoterms 2000) PII’s Facility to a location designated by Adolor in the United States. If Adolor does not timely indicate in writing its selection of a carrier to PII, PII shall
be entitled to select an appropriate carrier. 
  
 6.3 Shipping
Costs. Adolor shall pay all costs, expenses, taxes, levies, tariffs, brokerage fees, insurance premiums and other costs and charges assessed or levied in connection with the transportation of Drug Product from PII’s Facility to Adolor
pursuant to Section 6.1 (the “Shipping Costs”). If PII pays any of the Shipping Costs on behalf of Adolor, then PII shall invoice such Shipping Costs to Adolor and Adolor shall pay such costs. 
  
 6.4 Documentation and Release. Prior to each shipment of Drug Product,
PII shall provide Adolor with a Certificate of Analysis and a Certificate of Compliance, as required by the Quality Agreement, and, at Adolor’s request, PII shall provide Adolor with reasonable access to any applicable supporting data. Prior to
release of the Drug Product, PII shall test the Drug Product in accordance with the testing procedures described in Schedule 1.42 and against the Specifications, and shall provide Adolor with a copy of the applicable Executed Batch Record for
each batch shipped and a copy of the applicable deviation or other investigatory report, if any. Adolor shall review the Certificate of Analysis and the Certificate of Compliance and indicate to PII, within fifteen (15) days after receipt of such
certificates, whether to release each batch of Drug Product for shipment. If Adolor does not provide notice to PII within such fifteen (15) day period, PII shall be entitled to ship the Drug Product to the designated location indicated pursuant to
Section 6.1. With each shipment of Drug Product, PII shall provide Adolor with commercially appropriate shipping documentation, including bills of lading. 
  
 6.5 Retention of Samples. PII shall properly store and retain appropriate samples (identified by batch number) of Drug Product that it supplies to
Adolor in conditions and for times consistent with all applicable Regulatory Standards and to permit appropriate or required internal and regulatory checks and references (collectively, the “File Retention Samples”). PII shall
provide Adolor with reasonable access to and portions of the File Retention Samples for testing and other purposes upon Adolor’s request. 
  
 6.6 Storage of Drug Product. Notwithstanding anything to the contrary contained herein, Adolor may request that PII, rather than ship Drug Product
upon completion to a designated location, store the Drug Product at the Facility until such time as Adolor requests that the Drug Product be shipped to a designated location. In the event that Adolor requests that the Drug Product be stored at the
Facility, (i) the provisions of Sections 4.3, 4.4, 4.5 and 4.6 shall be applicable to any such Drug Product, (ii) Adolor shall pay the storage cost (including insurance) mutually agreed upon by the Parties in connection with the storage, and (iii)
the amount of Drug Product stored shall be limited to an amount as reasonably agreed to by the Parties. 
  

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 ARTICLE 7 
 INSPECTION AND DEFECTIVE DRUG PRODUCT; RECALL 
  
 7.1 Inspection by Adolor. 
  
 7.1.1 Inspection of Drug Product. Within thirty (30) days following its receipt of a shipment of Drug Product, Adolor or its designee may perform or have performed the quality control procedures described in Schedule 1.42 to
determine if such Drug Product conforms to the Specifications. Adolor shall promptly notify PII of any damages, shortage and other defects discovered by Adolor following Adolor’s discovery thereof. 
  
 7.1.2 Acceptance of Drug Product. If notice is not given by Adolor or
its designee pursuant to Section 7.1.1 within the time period set forth therein, then the shipment shall be deemed accepted by Adolor for purposes of this Article 7 and, except as provided in Section 7.2, may not be rejected pursuant to Section 7.3
or Section 7.4. 
  
 7.2 Latent Defects. In the case of Drug
Product with defects not readily discoverable prior to the shipment of any Drug Product to Adolor, or thereafter within the time period specified in Section 7.1, each Party shall notify the other Party of any such defects discovered by such Party
promptly following such Party’s discovery thereof. Notwithstanding anything to the contrary contained herein, in the case of latent defects that are not readily ascertainable by inspection or analysis, Adolor shall have thirty (30) days from
the earlier of: (a) date of discovery of such latent defect or (b) expiration of the shelf life of the Drug Product to notify PII of such latent defect. 
  
 7.3 Defective Drug Product. 
  
 7.3.1 Rejection by Adolor. In any case where Adolor or its designee expects to reject or otherwise make a claim against PII with respect to
damaged, non-conforming or otherwise defective Drug Product, PII shall be offered a reasonable opportunity to offer proof or evidence as to why such Drug Product should not be rejected and to inspect and/or test such Drug Product. Adolor shall at
all times supply PII with any evidence it or its designee has that relates to whether any Drug Product delivered to Adolor by PII is non-conforming as contemplated hereunder. 
  
 7.3.2 Testing of File Retention Samples. In the event of any dispute as to whether Drug Product may be rightfully
rejected by Adolor or its designee for failure to conform to the Specifications or have been manufactured in accordance with cGMPs, such Drug Product shall be tested, using the File Retention Samples, for conformance with the applicable
Specifications and cGMPs and acceptance criteria by an independent testing organization mutually acceptable to both Parties, which analysis shall be binding on PII and Adolor solely for the purpose of determining whether such Drug Product may be
rightfully rejected as non-conforming, damaged or otherwise defective. The fees and expenses charged by such independent testing organization shall be paid by the Party in error. 
  
 7.3.3 Disposal of Rejected Drug Product. All or part of any shipment of Drug Product determined to have been
rightfully rejected by Adolor or its designee shall be held by Adolor or its designee for a period of thirty (30) days following notice to PII for proper disposal 
  

 15 

 by PII, at PII’s expense. If PII does not provide instructions for disposal of the Drug Product within such period,
then Adolor or its designee may dispose of such Drug Product and PII shall either pay or reimburse Adolor or its designee for all costs and expenses incurred by Adolor or its designee in connection with the disposal of such Drug Product. All or part
of any shipment of Drug Product determined to have been rightfully rejected by Adolor prior to its release for shipment shall be properly disposed of by PII, at PII’s expense. 
  
 7.4 Remedies. In the event Adolor or its designee receives Drug Product from PII that is non-conforming or otherwise
defective, Adolor may, in addition to any other rights or remedies it may have under Sections 7.5.2 and 11.1 elect for PII to replace such non-conforming or otherwise defective Drug Product with an equal quantity of Drug Product that conforms to the
Specifications and is not otherwise defective or refund the purchase price for the quantity of such defective Drug Product. If Adolor requests PII to replace such non-conforming or otherwise defective Drug Product as set forth above, PII shall
replace such Drug Product as soon as is reasonably possible at no additional cost to Adolor, but in no event later than forty-five (45) days after receipt of notification of nonconformity, subject to availability of API Compound. 
  
 7.5 Drug Product Recall. 
  
 7.5.1 Recall. Adolor, in its sole responsibility and discretion,
shall be entitled to make all decisions with respect to any recall, market withdrawals or other corrective action related to the Drug Product. 
  
 7.5.2 Costs Associated with Drug Product Recall. The out-of-pocket costs associated with any such recall, including the cost of replacement API
Compound, shall be borne by the Parties in proportion to which any such recall is required as a result of PII’s (or its suppliers’, permitted subcontractors’ or Affiliates’) or Adolor’s (or its designees’,
subcontractors’ or Affiliates’) breach of their respective obligations or representations or warranties under this Agreement, including the Quality Agreement. If neither Party is in breach, Adolor shall be responsible for such costs.

  
 7.6 Shortages. In the event that PII is aware or
anticipates that it will be unable to meet any Purchase Order, either in whole or in part, for whatever reason, PII shall promptly inform Adolor in writing of such inability. In particular, PII shall promptly inform Adolor of any notice, written or
oral, received from any materials supplier regarding a possible shortage or inability to supply. 
  
 7.7 Costs Incurred as a Result of PII’s Failure to Supply. To the extent Adolor incurs any additional costs or expenses as a result of a
failure by PII to supply, PII shall promptly reimburse Adolor for such additional costs and expenses upon written invoice therefor with reasonable supporting documentation; provided, however, if Adolor is required to obtain Drug Product from an
alternate source, PII shall not be required to reimburse Adolor for more than one hundred ten percent (110%) of the supply price charged by PII pursuant to Section 8.1 for such alternate supply of Drug Product. 
  

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 ARTICLE 8 
 FINANCIAL PROVISIONS 
  
 8.1 Supply Price. PII shall supply Drug Product to Adolor at the price per unit set forth on Schedule 8.1; provided, however, if the cost of materials, supplies, utilities or labor used to manufacture the Drug Product
increases or decreases by more than fifteen percent (15%), the Parties shall renegotiate in good faith an increase or decrease in the supply price. 
  
 8.2 Process Improvements and Sharing of Cost Efficiencies. PII shall be committed to developing and implementing, continuous cost, quality and
customer service improvement programs by seeking productivity improvements, by minimizing waste and improving yields, by purchasing quality materials at lower cost, by improving manufacturing processes, by streamlining organizational processes, by
reducing cycle times and lead times and the like. In each December during the term of this Agreement, the Parties shall meet to discuss and set targets and goals of cost reductions and quality and customer service improvements for the following
twelve (12)-month period, and to discuss the impact of any cost saving achieved during the previous twelve (12)-month period on the Drug Product pricing. The Parties agree to negotiate in good faith changes to Drug Product pricing to share equitably
in any such cost savings so achieved. 
  
 8.3 Manner of
Payments. All sums due to either Party under this Agreement shall be payable in United States Dollars by bank wire transfer in immediately available funds to such bank account(s) as each of PII and Adolor shall from time to time designate,
unless otherwise agreed by the Parties in writing. 
  
 8.4
Invoices; Timing of Payments. PII shall invoice Adolor for all Drug Product supplied hereunder on the date of shipment, and for all other amounts due to PII, if any, hereunder monthly in arrears. Each invoice shall specify the Purchase Order
number to which it corresponds. Unless otherwise specified in this Agreement, all amounts due to PII hereunder shall be paid by Adolor within thirty (30) days following the invoice date; provided, that the invoice shall be sent upon the earlier of
(i) the date of shipment of the Drug Product or (ii) three (3) days after Adolor is notified that the Drug Product is available for release in accordance with the Quality Agreement. Each PII invoice or portion thereof that is not the subject of a
bona fide dispute shall be payable within such time period described in the preceding sentence and thereafter unpaid balances shall bear interest at a rate of 18% per annum (or the highest rate allowed by Law) unless determined not to be properly
payable hereunder. 
  
 ARTICLE 9 
 CONFIDENTIALITY 
  
 9.1 Confidential Information. Each of PII and Adolor shall keep all Confidential Information received from the other Party with the same degree of
care it maintains the confidentiality of its own Confidential Information, but in no event less than a reasonable degree of care. Neither Party shall use such Confidential Information for any purpose other than in performance of this Agreement or
disclose the same to any other Person other than to such of its agents who have a need to know such Confidential Information to implement the terms of this Agreement or enforce its rights under this Agreement. A Receiving Party shall advise any
agent 
  

 17 

 who receives such Confidential Information of the confidential nature thereof and of the obligations contained in this
Agreement relating thereto, and the Receiving Party shall ensure that all such agents comply with such obligations as if they had been a party hereto. Upon termination of this Agreement, the Receiving Party shall return or destroy all documents,
tapes or other media containing Confidential Information of the Disclosing Party that remain in the Receiving Party’s or its agents’ possession, except that the Receiving Party may keep one copy of the Confidential Information in the legal
department files of the Receiving Party, solely for archival purposes. Such archival copy shall be deemed to be the property of the Disclosing Party, and shall continue to be subject to the provisions of this Article 9. Notwithstanding anything to
the contrary in this Agreement, the Receiving Party shall have the right to disclose any Confidential Information provided hereunder if, in the reasonable opinion of the Receiving Party’s legal counsel, such disclosure is necessary to comply
with the terms of this Agreement or the requirements of any Law. Where possible, the Receiving Party shall notify the Disclosing Party of the Receiving Party’s intent to make such disclosure of Confidential Information pursuant to the provision
of the preceding sentence sufficiently prior to making such disclosure so as to allow the Disclosing Party adequate time to take whatever action the Disclosing Party may deem to be appropriate to protect the confidentiality of the information.

  
 9.2 Public Announcements. Except as may be required by
applicable Laws, neither Party will make any public announcement of any information regarding this Agreement or any agreement related hereto without the prior written approval of the other Party. Once any written statement is approved for disclosure
by the Parties or information is otherwise made public in accordance with the preceding sentence, either Party may make a subsequent public disclosure of the contents of such statement without further approval of the other Party. 
  
 9.3 Inventions. All data, information, reports and any and all related
documentation, which are developed, generated or derived, directly or indirectly, by PII (or by any subcontractor of agent of PII) for Adolor during the term of this Agreement (the “Data”), and all inventions, discoveries, formulae,
procedures, any other intellectual property, and any improvements thereto, whether patentable or not, which result or evolve directly or as a result of the services provided hereunder by PII (or by any subcontractor or agent of PII) (the
“Inventions”) shall be and remain the sole and exclusive property of Adolor; provided, however, any Invention made, developed or discovered solely by PII (or by any subcontractor or agent of PII) that constitutes an invention,
improvement or other intellectual property relating to drug delivery technology, formulation, analysis or manufacturing process of pharmaceutical products generally, and not specifically related solely to the Product (“PII
Invention”, with Data relating thereto, “PII Data”) shall be and remain the property of PII, and PII hereby grants to Adolor a worldwide, royalty-free, exclusive license, with right to sublicense, upon written notice to
PII, to develop, use, manufacture and sell such PII Invention and PII Data in connection with the development, use, manufacture, offer for sale, import and sale of the Product. Except as specifically set forth herein, neither PII nor its employees
or agents shall have or acquire any right, title or interest in Data or Inventions. If related to the Drug Product, PII shall promptly disclose in writing to Adolor any Data and Inventions. If related to Drug Product and to the extent not PII
Inventions or PII Data, PII shall assign, and hereby does assign, any and all rights in any Data and Inventions to Adolor and shall assist Adolor in perfects its rights in such Data and Inventions. 
  

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 9.4 Confidentiality of this Agreement. The terms of this Agreement shall be Confidential
Information of each Party and, as such, shall be subject to the provisions of this Article 9. 
  
 9.5 Survival. The obligations and prohibitions contained in this Article 9 shall survive the expiration or termination of this Agreement. 
  
 ARTICLE 10 
 REPRESENTATIONS AND WARRANTIES 
  
 10.1
Representations of PII. PII represents and warrants to Adolor that: 
  
 10.1.1 All Drug Product shall be packaged and shipped in accordance with Adolor’s labeling instructions and shall not be adulterated or misbranded within the meaning of the Act, and is not an article which may
not, under the Act, be introduced into interstate commerce; 
  
 10.1.2 All Drug Product shall be manufactured, generated, processed, transported, treated, stored, disposed and handled by PII in accordance with and conform to the Specifications, cGMPs, the Master Batch Record, all applicable Laws, the
Quality Agreement and any further formulating, manufacturing, packaging or other standards agreed in writing by the Parties; and in accordance with and conform to any applicable standards specified by the United States Pharmacopeia; 
  
 10.1.3 All Drug Product so sold and shipped shall be manufactured in
accordance with all applicable Laws in effect at the time and place of manufacture of such Drug Product, and all waste, including but not limited to all hazardous waste, generated at the time of manufacture of Drug Product shall be disposed of in
accordance with all applicable Laws; 
  
 10.1.4 All records as are
necessary and appropriate to demonstrate compliance with applicable Laws shall be maintained by PII and such manufacture of Drug Product shall be performed in a facility maintaining a current drug establishment registration with the FDA as set forth
in 21 C.F.R. § 207; 
  
 10.1.5 The ownership and operation of
the Facilities shall be in material compliance with cGMPs and all applicable Laws (including the receipt and possession of all applicable permits and authorizations, including a current drug establishment registration with the FDA as set forth in 21
C.F.R. 207, if applicable), and any further formulating, manufacturing, packaging or other standards agreed in writing by the Parties, and all Waste generated in connection with the manufacture of the Drug Product shall be disposed of in accordance
with all applicable Laws; and 
  
 10.1.6 The Drug Product
delivered to Adolor will be free and clear of all liens and encumbrances. 
  

 19 

 10.2 Mutual Representations and Warranties. Adolor and PII each represents and warrants to the
other as of the Effective Date that: 
  
 10.2.1 Organization
and Authority. It has full corporate right, power and authority to enter into this Agreement and to perform its respective obligations under this Agreement; 
  

10.2.2 No Conflicts or Violations. The execution and delivery of this Agreement by such Party and the performance of such Party’s
obligations hereunder (a) do not conflict with or violate any requirement of applicable laws or regulations existing as of the Effective Date and applicable to such Party and (b) do not conflict with, violate, breach or constitute a default under,
and are not prohibited or materially restricted by, any contractual obligations of such Party or any of its Affiliates existing as of the Effective Date; and 
  
 10.2.3 Valid Execution. Such Party is duly authorized, by all requisite corporate action, to execute and deliver this Agreement and the execution,
delivery and performance of this Agreement by such Party does not require any shareholder action or approval or the approval or consent of any Third Party, and the Person executing this Agreement on behalf of such Party is duly authorized to do so
by all requisite corporate action. 
  
 10.3 Disclaimer of
Warranty. EXCEPT AS SPECIFICALLY SET FORTH IN THIS AGREEMENT, NEITHER PARTY MAKES ANY EXPRESS OR IMPLIED WARRANTIES OR COVENANTS, STATUTORY OR OTHERWISE, CONCERNING THE DRUG PRODUCT. WITHOUT LIMITING THE FOREGOING, NEITHER PARTY MAKES ANY
IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE REGARDING THE DRUG PRODUCT. IN NO EVENT WILL PII BE RESPONSIBLE FOR STABILITY OF THE DRUG PRODUCT MANUFACTURED IN ACCORDANCE WITH THE SPECIFICATIONS. 
  
 ARTICLE 11 
 INDEMNIFICATION AND INSURANCE 
  
 11.1 Indemnification by PII. PII hereby agrees to defend Adolor and GSK and their respective Affiliates, directors, officers, employees, agents, successors and assigns from and against any and all Claims of a
Third Party and to indemnify and hold Adolor and GSK and their respective Affiliates, directors, officers, employees, agents, successors and assigns, harmless from and against any and all losses, damages, costs, penalties, liabilities (including
strict liabilities), judgments, amounts paid in settlement, fines and expenses (including court costs and reasonable fees of attorneys and other professionals) (individually and collectively, the “Losses of Adolor or GSK”) arising
out of or in connection with: (a) the negligence or willful misconduct of PII or any Person for whose actions or omissions PII is legally liable; (b) a breach by PII of its representations, warranties and/or covenants hereunder; or (c) any claim
asserted by a Third Party that PII, in performing the services hereunder, has infringed or misappropriated any proprietary or confidential information or intellectual property rights of such Third Party, except as relate to any materials,
specifications or instructions provided to PII by Adolor; provided, however, that in all cases referred to in this Section 11.1, PII shall have no liability to Adolor for any Losses of Adolor or GSK to the extent that such Losses of Adolor or GSK
were caused by any item for which Adolor is required to indemnify PII pursuant to Section 11.2. 
  

 20 

 11.2 Indemnification by Adolor. Adolor hereby agrees to defend PII and its Affiliates and their
respective directors, officers, employees, agents, successors and assigns from and against any and all Claims of a Third Party and to indemnify and hold PII and its Affiliates and their respective directors, officers, employees, agents, successors
and assigns, harmless from and against any and all losses, damages, costs, penalties, liabilities (including strict liabilities), judgments, amounts paid in settlement, fines and expenses (including court costs and reasonable fees of attorneys and
other professionals) (individually and collectively, the “Losses of PII”) arising out of or in connection with: (a) defective Drug Product information (including any materials or samples thereof) submitted by Adolor to PII; (b) the
negligence or willful misconduct of Adolor or any Person for whose actions or omissions Adolor is legally liable or of any other Person other than PII with respect to the advertising, labeling or improper handling or storage of the Drug Product; (c)
a breach by Adolor of its representations, warranties and/or covenants hereunder; (d) injuries and/or death to humans resulting from the use of any API Compound provided to PII by Adolor or the use of the Drug Product; (e) the Specifications or
other written instructions provided by Adolor; or (f) patent infringement relating to any API Compound; provided, however, that in all cases referred to in this Section 11.2, Adolor shall have no liability to PII for any Losses of PII to the extent
that such Losses of PII were caused by any item for which PII is required to indemnify Adolor pursuant to Section 11.1. 
  
 11.3 Indemnification Procedure. 
  
 11.3.1 Notice. Each Party will notify promptly the other if it becomes aware of a Claim (actual or potential) by any Third Party (a “Third
Party Claim”) for which indemnification may be sought by that Party and will give such information with respect thereto as the other Party shall reasonably request. If any proceeding (including any governmental investigation) is instituted
involving any Party for which such Party may seek an indemnity under Section 11.1 or 11.2, as the case may be (the “Indemnified Party”), the Indemnified Party shall not make any admission or statement concerning such Third Party
Claim, but shall promptly notify the other Party (the “Indemnifying Party”) orally and in writing and the Indemnifying Party and Indemnified Party shall meet to discuss how to respond to any Third Party Claims that are the subject
matter of such proceeding. The Indemnifying Party shall not be obligated to indemnify the Indemnified Party to the extent any admission or statement made by the Indemnified Party or any failure by such Party to notify the Indemnifying Party of the
claim materially prejudices the defense of such claim. 
  
 11.3.2
Defense of Claim. If the Indemnifying Party elects to defend or, if local procedural rules or laws do not permit the same, elects to control the defense of a Third Party Claim, it shall be entitled to do so provided it gives notice to the
Indemnified Party of its intention to do so within thirty (30) days after the receipt of the written notice from the Indemnified Party of the potentially indemnifiable Third Party Claim (the “Litigation Condition”); provided, that
the Indemnifying Party expressly agrees the Indemnifying Party shall be responsible for satisfying and discharging any award made to the Third Party as a result of such proceedings or settlement amount agreed with the Third Party in respect of the
Third Party Claim without prejudice to any provision in this Agreement or right at law which will allow the Indemnifying Party subsequently to recover any amount from the Indemnified Party to the extent the liability under such settlement or award
was attributable to the Indemnified Party. Subject to compliance with the Litigation Condition, the Indemnifying Party shall retain counsel reasonably 
  

 21 

 acceptable to the Indemnified Party (such acceptance not to be unreasonably withheld, refused, conditioned or delayed) to
represent the Indemnified Party and shall pay the fees and expenses of such counsel related to such proceeding. In any such proceeding, the Indemnified Party shall have the right to retain its own counsel, but the fees and expenses of such counsel
shall be at the expense of the Indemnified Party. The Indemnified Party shall not settle any claim for which it is seeking indemnification without the prior consent of the Indemnifying Party which consent shall not be unreasonably withheld, refused,
conditioned or delayed. The Indemnified Party shall, if requested by the Indemnifying Party, cooperate in all reasonable respects in the defense of such claim that is being managed and/or controlled by the Indemnifying Party. The Indemnifying Party
shall not, without the written consent of the Indemnified Party (which consent shall not be unreasonably withheld, refused, conditioned or delayed), effect any settlement of any pending or threatened proceeding in which the Indemnified Party is, or
based on the same set of facts could have been, a party and indemnity could have been sought hereunder by the Indemnified Party, unless such settlement includes an unconditional release of the Indemnified Party from all liability on claims that are
the subject matter of such proceeding. If the Litigation Condition is not met, then neither Party shall have the right to control the defense of such Third Party Claim and the Parties shall cooperate in and be consulted on the material aspects of
such defense at the each Party’s own expense; provided that if the Indemnifying Party does not satisfy the Litigation Condition, the Indemnifying Party may at any subsequent time during the pendency of the relevant Third Party Claim irrevocably
elect, if permitted by local procedural rules or laws, to defend and/or to control the defense of the relevant Third Party Claim so long as the Indemnifying Party also agrees to pay the reasonable fees and costs incurred by the Indemnified Party in
relation to the defense of such Third Party Claim from the inception of the Third Party Claim until the date the Indemnifying Party assumes the defense or control thereof. 
  
 11.4 Assumption of Defense. Notwithstanding anything to the contrary contained herein, an Indemnified Party shall be
entitled to assume the defense of any Third Party Claim with respect to the Indemnified Party, upon written notice to the Indemnifying Party pursuant to this Section 11.4, in which case the Indemnifying Party shall be relieved of liability under
Section 11.1 or 11.2, as applicable, solely for such Third Party Claim and related Losses. 
  
 11.5 Limitation of Liability. IN NO EVENT SHALL EITHER PARTY BE LIABLE TO THE OTHER OR ANY OF ITS AFFILIATES, INCLUDING GSK AND ITS AFFILIATES, FOR ANY CONSEQUENTIAL, INCIDENTAL, INDIRECT, SPECIAL, PUNITIVE OR
EXEMPLARY DAMAGES (INCLUDING, WITHOUT LIMITATION, LOST PROFITS, BUSINESS OR GOODWILL) SUFFERED OR INCURRED BY SUCH OTHER PARTY OR ITS AFFILIATES, INCLUDING GSK AND ITS AFFILIATES, AND ANY PERSON IN PRIVITY WITH ANY OF THE FOREGOING, IN CONNECTION
WITH A BREACH OR ALLEGED BREACH OF THIS AGREEMENT. FOR AVOIDANCE OF DOUBT, THE FOREGOING SENTENCE SHALL NOT LIMIT THE OBLIGATIONS OF EITHER PARTY TO INDEMNIFY THE OTHER PARTY OR GSK UNDER THIS ARTICLE 11 FROM AND AGAINST CLAIMS OF THIRD PARTIES,
OTHER THAN ANY PERSON IN PRIVITY WITH ANY PARTY, GSK OR ANY OF THEIR AFFILIATES. 
  
 11.6 Insurance. During the term of this Agreement and for a period of five (5) years after its termination, each Party shall obtain and/or maintain, respectively, at its sole cost and 
  

 22 

 expense, liability insurance in amounts, respectively, required by applicable Laws, but in no event less than
$10,000,000. Such liability insurance shall insure against all liability, including personal injury, physical injury, or property damage arising out of the manufacture, sale, distribution, or marketing of the Drug Product. Each Party shall provide
written proof of the existence of such insurance to the other Party upon request. 
  
 ARTICLE 12 
 TERM AND TERMINATION 
  
 12.1 Term. Unless terminated sooner as permitted hereunder, this Agreement shall commence on the Effective Date and
shall expire on the seventh (7th) anniversary of the launch date of the Product, provided that unless either Party gives written notice at least twenty-four (24) months prior to the expiration of the initial term or any renewal term, this Agreement
shall continue for successive two year terms. 
  
 12.2
Termination. This Agreement may be terminated by Adolor upon six (6) months prior written notice to PII in the event Adolor withdraws the Drug Product from the United States. In addition, this Agreement may be terminated upon the written
consent of both Parties, or by either Party upon the happening of one of the following events: 
  
 12.2.1 Termination for Breach. Either Party may, without prejudice to any other remedies available to it at law or in equity, terminate this
Agreement in the event that the other Party (as used in this subsection, the “Breaching Party”) shall have materially breached or defaulted in the performance of any of its obligations. The Breaching Party shall have sixty (60) days
(ten (10) days if solely monetary defaults) after written notice thereof was provided to the Breaching Party by the non-breaching Party to remedy such default. Any such termination shall become effective at the end of such 60-day period (10-day
period if solely monetary defaults) unless the Breaching Party has cured any such breach or default prior to the expiration of such 60-day period (10-day period if solely monetary defaults). 
  
 12.2.2 Termination for Force Majeure Event. Notwithstanding anything
to the contrary contained in this Agreement, in the event a Force Majeure Event shall have occurred and be continuing for one hundred eighty (180) consecutive days, either Party shall be entitled to terminate this Agreement effective immediately
upon written notice to the Party suffering such Force Majeure Event; provided, that such termination shall not be deemed a breach by the Party suffering such Force Majeure Event. 
  
 12.2.3 Termination for Reasons of Insolvency or Termination of Business Activities. Either Party shall be entitled to
terminate this Agreement if the other Party becomes insolvent or is the subject of a petition in bankruptcy whether voluntary or involuntary or of any other proceeding under bankruptcy, insolvency or similar laws, makes an assignment for the benefit
of creditors, is named in such a petition, or its property is subject to a suit for the appointment of a receiver, or is dissolved or liquidated. Such termination right may be exercised without the need for written notice within thirty (30) days
following the date as of which the Party entitled to terminate receives knowledge of such insolvency or termination of business activities by the other Party. 
  

 23 

 ARTICLE 13 
 RIGHTS AND DUTIES UPON TERMINATION 
  
 13.1 Pending Purchase Orders. Except in cases of the termination of this Agreement for a Force Majeure Event or as otherwise expressly set forth in this Agreement, the termination of this Agreement shall not
affect Purchase Orders placed by Adolor and accepted by PII at the time notice of termination is given and until the time any such termination becomes effective. Except as expressly set forth in this Agreement, Adolor shall have no liability to PII
for any costs that PII may have incurred (or to which PII may be committed) in connection with materials used by PII in the manufacturing or packaging of Drug Product prior to the effectiveness of any notice of termination. 
  
 13.2 Outstanding Payment. Payments of amounts owing to either Party
under this Agreement as of its expiration or termination shall be due and payable within the later of: (i) to the extent such amounts can be calculated and a fixed sum determined at the time of expiration or termination of this Agreement, forty-five
(45) days after the date of such expiration or termination or (ii) ten (10) days after the date in which such amounts can be calculated and a fixed sum determined. Notwithstanding anything to the contrary contained in this Agreement, except when
Adolor has terminated this Agreement as the result of PII’s breach pursuant to Section 12.2.1, Adolor shall (a) compensate PII for all services performed hereunder prior to termination of this Agreement and (b) reimburse PII for all unused raw
materials not capable of resale or use elsewhere if such raw materials were or are being procured to satisfy the Forecasts. 
  
 13.3 Return of Materials. Within thirty (30) days following the of termination of this Agreement, each Party shall destroy or return to the other
Party all tangible items bearing, containing or contained in any of the Confidential Information of the other Party, and shall provide the other Party written certification of such destruction or return. PII shall also return to Adolor all unused
quantities of API Compound and any work-in-progress being held by PII. PII shall transfer to Adolor or its designee PII’s existing inventory of materials and work-in-process as well as any inventory of Drug Product in PII’s possession or
control. 
  
 13.4 Access to Records/Maintenance of Critical
Samples and Test Programs. Upon termination of this Agreement, PII shall provide Adolor or its designee access for a period up to one (1) year after the latest expiry date of Drug Product batches produced under the Agreement to records, reports
and master files relating to the Drug Products, to enable Adolor or its designee (i) to answer complaints, (ii) to answer queries from Governmental Authorities or (iii) to conduct investigations necessary to ensure the safety, efficacy and
compliance of the Drug Products. PII shall maintain all retention samples and stability programs for a period up to one (1) year after the latest expiry date of Drug Product batches produced under this Agreement. Adolor shall reimburse PII for the
time of PII’s personnel, at their standard hourly rates, for their time in connection with PII’s obligations under this Section 13.4. 
  
 13.5 Accrued Rights; Surviving Obligations. Termination or expiration of this Agreement for any reason shall be without prejudice to any rights
that shall have accrued to the benefit of any Party prior to such termination or expiration. Such termination or expiration shall not relieve any Party from obligations which are expressly or by implication intended to survive termination or
expiration of this Agreement and shall not affect or prejudice any provision of this Agreement which is expressly or by implication provided to come into effect on, or continue in effect after, such termination or expiration. 
  

 24 

 ARTICLE 14 
 GENERAL PROVISIONS 
  
 14.1
Relationship of the Parties. Each Party shall bear its own costs incurred in the performance of its obligations hereunder without charge or expense to the other except as expressly provided in this Agreement. Neither Party shall have any
responsibility for the hiring, termination or compensation of the other Party’s employees or for any employee benefits of such employee. No employee or representative of a Party shall have any authority to bind or obligate the other Party to
this Agreement for any sum or in any manner whatsoever, or to create or impose any contractual or other liability on the other Party without such Party’s approval. For all purposes, and notwithstanding any other provision of this Agreement to
the contrary, PII’s legal relationship under this Agreement to Adolor shall be that of independent contractor. This Agreement is not a partnership agreement and nothing in this Agreement shall be construed to establish a relationship of
co-partners or joint venturers between the Parties. 
  
 14.2
Covenant Not to Compete. In the event that Adolor, in its sole discretion, agrees to purchase at least eighty percent (80%) of Adolor’s United States Drug Product requirements for a given Calendar Year from PII, PII agrees that for such
Calendar Year (whether on its own behalf or with or on behalf of any Person) it shall not, and shall not permit any of its Affiliates to: 
  
 14.2.1 carry on or be engaged, concerned, interested or in any way assist in the development or manufacture of (i) any prescription or over the counter
formulation of the Drug Product, API Compound or Compound, or (ii) any generic or copycat versions of the Drug Product, API Compound or Compound, including any salts, hydrates, polymorphs or anahydrous form thereof; 
  
 14.2.2 sell, market, distribute or seek customers for or advertise (i) any
prescription or over the counter formulation of Drug Product, API Compound or Compound, or (ii) any generic or copycat versions of the Drug Product, API Compound or Compound, including any salts, hydrates, polymorphs or anahydrous form thereof;

  
 14.2.3 license, consent to or authorize or purport to license,
consent to or authorize the doing or carrying out by any Person of any of the acts or matters referred to in either Section 14.2.1 or Section 14.2.2; or 
  
 14.2.4 pursue any policy of doing or carrying out or of facilitating or bringing about the doing or carrying out by any Person of any of the acts or
matters referred to in Section 14.2.1, Section 14.2.2 or Section 14.2.3, for example, by providing technological assistance, expertise, manufacturing or supplies to any Person. 
  
 Nothing contained in this Section 14.2 is intended to be an implied license to or waiver of any patent or other intellectual
property right. 
  

 25 

 14.3 Force Majeure. The occurrence of an event which materially interferes with the ability of a
Party to perform its obligations or duties hereunder which is not within the reasonable control of the Party affected or any of its Affiliates, not due to malfeasance by such Party or its Affiliates, and which could not with the exercise of due
diligence have been avoided (each, a “Force Majeure Event”), including an injunction, order or action by a Governmental Authority, fire, accident, labor difficulty, strike, riot, civil commotion, act of God, inability to obtain
materials, delay or errors by shipping companies or change in applicable Laws, shall not excuse such Party from the performance of its obligations or duties under this Agreement, but shall merely suspend such performance during the continuation of
the Force Majeure Event. The Party prevented from performing its obligations or duties because of a Force Majeure Event shall promptly notify the other Party of the occurrence and particulars of such Force Majeure Event and shall provide the other
Party, from time to time, with its best estimate of the duration of such Force Majeure Event and with notice of the termination thereof. The Party so affected shall use commercially reasonable efforts to avoid or remove such causes of nonperformance
as soon as is reasonably practicable. Upon termination of the Force Majeure Event, the performance of any suspended obligation or duty shall promptly recommence. The Party subject to the Force Majeure Event shall not be liable to the other Party or
any Third Party for any direct, indirect, consequential, incidental, special, punitive, exemplary or other damages arising out of or relating to the suspension or termination of any of its obligations or duties under this Agreement by reason of the
occurrence of a Force Majeure Event, provided such Party complies in all material respects with its obligations under this Section 14.3. 
  
 14.4 Governing Law. This Agreement shall be construed, and the respective rights of the Parties determined, according to the substantive Law of the
State of Delaware notwithstanding the provisions governing conflict of Laws under such Delaware Law to the contrary, except matters of intellectual property Law which shall be determined in accordance with the intellectual property Laws relevant to
the intellectual property in question. The UNCITRAL Convention for the International Sale of Goods, as well as any other unified Law relating to the conclusion and implementation of contracts for the international sale of goods, shall not apply.

  
 14.5 Jurisdiction. Any legal action or proceeding with
respect to this Agreement shall be brought in the courts of the State of Delaware or of the United States District Court for District of Delaware, and, by execution and delivery of this Agreement, each Party hereby irrevocably accepts the exclusive
jurisdiction of the aforesaid courts. Each Party hereby further irrevocably waives any claim that any such court lacks jurisdiction over it or to the laying of venue, and agrees not to plead or claim, in any legal action or proceeding with respect
to this Agreement brought in any of the aforesaid courts, that any such court lacks jurisdiction over it or any such action or proceeding has been brought in an inconvenient forum. 
  
 14.6 Assignment. This Agreement may not be assigned by either Party without the prior consent of the other Party;
provided, however, that Adolor may assign this Agreement, in whole or in part, to any of its Affiliates if Adolor guarantees the performance of this Agreement by such Affiliate; and provided further, that Adolor may assign this Agreement to a
successor to all or substantially all of the assets or line of business to which this Agreement relates whether by merger, sale of stock, sale of assets or other similar transaction. This Agreement shall be binding upon, and subject to the terms of
the foregoing sentence, inure to the benefit of the Parties hereto, their permitted successors, legal representatives and assigns. 
  

 26 

 14.7 Notices. All notices hereunder must be in writing and will be deemed to have been duly given
only if delivered personally, by facsimile with confirmation of receipt, by mail (first class, postage prepaid), or by overnight delivery using a globally-recognized carrier, to the Parties at the following addresses: 
  

			
	 Adolor:
	 	 Adolor Corporation

	 	 	 700 Pennsylvania Drive

	 	 	 Exton, Pennsylvania 19341

	 	 	 Facsimile: 484-595-1520

	 	 	 Attn: President

		
	 With a copy to:
	 	 Adolor Corporation

	 	 	 700 Pennsylvania Drive

	 	 	 Exton, Pennsylvania 19341

	 	 	 Facsimile: 484-595-1520

	 	 	 Attn: General Counsel

		
	 and to:
	 	 Morgan, Lewis & Bockius LLP

	 	 	 502 Carnegie Center

	 	 	 Princeton, NJ 08540

	 	 	 Attn: Randall B. Sunberg

	 	 	 Facsimile: 609-919-6639

		
	 PII:
	 	 Pharmaceutics International, Inc.

	 	 	 10819 Gilroy Road

	 	 	 Hunt Valley, Maryland 21031

	 	 	 Attn: Steve King, Senior V.P.

	 	 	 Facsimile: 410-584-0007

		
	 and with a copy to:
	 	 Jacobs & Dembert, P.A.

	 	 	 One South Street – Suite 1910

	 	 	 Baltimore, Maryland 21202

	 	 	 Attn: James S. Jacobs, Esquire

	 	 	 Facsimile: 410-752-8105

  
 or to such other
address as the addressee shall have last furnished in writing in accord with this provision to the addressor. All notices shall be deemed effective upon receipt by the addressee. 
  
 14.8 Severability. In the event of the invalidity of any provisions of this Agreement or if this Agreement contains
any gaps, the Parties agree that such invalidity or gap shall not affect the validity of the remaining provisions of this Agreement. The Parties will replace an invalid provision or fill any gap with valid provisions which most closely approximate
the purpose and economic effect of the invalid provision or, in case of a gap, the Parties’ presumed intentions. In 
  

 27 

 the event that the terms and conditions of this Agreement are materially altered as a result of the preceding sentences,
the Parties shall renegotiate the terms and conditions of this Agreement in order to resolve any inequities. Nothing in this Agreement shall be interpreted so as to require either Party to violate any applicable Laws. 
  
 14.9 Headings. The headings used in this Agreement have been inserted
for convenience of reference only and do not define or limit the provisions hereof. 
  
 14.10 Certain Conventions. Unless the context of this Agreement otherwise requires: (i) words of any gender include each other gender, (ii) words such as “herein”, “hereof”, and
“hereunder” refer to this Agreement as a whole and not merely to the particular provision in which such words appear, (iii) words using the singular shall include the plural, and vice versa, and (iv) the words “include,”
“includes” and “including” shall be deemed to be followed by the phrase “but not limited to”, “without limitation”, “inter alia”, “among other things” or words of similar import.

  
 14.11 Waiver; Remedies. Any term or condition of this
Agreement may be waived at any time by the Party that is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of the Party waiving such term or condition. No
waiver by any Party of any term or condition of this Agreement, in any one or more instances, shall be deemed to be or construed as a waiver of the same or any other term or condition of this Agreement on any future occasion. Except as expressly set
forth in this Agreement, all rights and remedies available to a Party, whether under this Agreement or afforded by Law or otherwise, will be cumulative and not in the alternative to any other rights or remedies that may be available to such Party.

  
 14.12 Entire Agreement. This Agreement (including the
exhibits and schedules hereto) constitute the entire agreement between the Parties, and supersede all previous agreements and understandings between the Parties, whether written or oral, with respect to the within subject matter. This Agreement may
be altered, amended or changed only by a writing making specific reference to this Agreement and signed by duly authorized representatives of Adolor and PII. 
  
 14.13 No License. Nothing in this Agreement shall be deemed to constitute the grant of any license or other right in either Party, to or in respect
of any Drug Product, patent, trademark, Confidential Information, trade secret or other data or any other intellectual property of the other Party, except as expressly set forth herein. 
  
 14.14 Third Party Beneficiaries. None of the provisions of this Agreement shall be for the benefit of or enforceable
by any Third Party, including any creditor of either Party. No such Third Party shall obtain any right under any provision of this Agreement or shall by reasons of any such provision make any Claim in respect of any debt, liability or obligation (or
otherwise) against either Party. 
  
 14.15 Counterparts.
This Agreement may be executed in any two counterparts, each of which, when executed, shall be deemed to be an original and both of which together shall constitute one and the same document; and such counterparts may be delivered to the other Party
by facsimile. 
  

 28 

 IN WITNESS WHEREOF, Adolor and PII, by their duly authorized officers, have executed this Agreement as of
the Effective Date. 
  

			
	ADOLOR CORPORATION
		
	 By:
	 	 /s/ Michael R. Dougherty

	 Name:
	 	 Michael R. Dougherty

	 Title:
	 	 Senior Vice President, Chief Operating Officer, Chief Financial Officer

	
	PHARMACEUTICS INTERNATIONAL, INC.
		
	 By:
	 	 /s/ Syed E. Abidi

	 Name:
	 	 Syed E. Abidi

	 Title:
	 	 President and Chief Executive Officer

  

 29 

 SCHEDULE 1.4 
  
 API COMPOUND 
  
 [**] 
  

	[**]	=Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

  

 30 

 SCHEDULE 1.42 
  
 SPECIFICATIONS 
  
 [**] 
  

	[**]	=Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

  

 31 

 SCHEDULE 2.3 
  
 CURRENT APPROVED SUBCONTRACTORS 
  
 [**] 
  

	[**]	=Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

  

 32 

 SCHEDULE 3.2 
  
 QUALITY AGREEMENT 
  

 33 

 SCHEDULE 3.5.2 
  
 POTENTIAL CONTAMINANTS CURRENTLY BEING MANUFACTURED AT THE FACILITY 
  
 [**] 
  

	[**]	=Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

  

 34 

 SCHEDULE 5.1 
  
 FIRST FORECAST 
  
 [**] 
  

	[**]	=Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

  

 35 

 SCHEDULE 8.1 
  
 SUPPLY PRICE 
  
 [**] 
  

	[**]	=Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portions.

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