Document:

Supply Agreement

 Exhibit 10.16 
  

	 	***	CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT (INDICATED BY ASTERISKS) HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A
REQUEST FOR CONFIDENTIAL TREATMENT UNDER 17 C.F.R. SECTIONS 200.80(B)(4), 200.83 AND 230.406. 

  
 EXECUTION COPY 
  

  
 SUPPLY AGREEMENT 
  
 Between 
  
 BRISTOL-MYERS SQUIBB COMPANY 
  

and 
  
 SKINMEDICA, INC. 
  
 for 
  
 VANIQA® 
  
 Dated as of May 14, 2004 
  

  

 TABLE OF CONTENTS 
  

					
	 SECTION 1.     DEFINITIONS
	  	1
			
	 Section 1.01.
	  	 Definitions
	  	1
	 Section 1.02.
	  	 Other Definitions
	  	4
	 Section 1.03.
	  	 Interpretations
	  	5
		
	 SECTION 2.     GENERAL TERMS OF SUPPLY
	  	5
			
	 Section 2.01.
	  	 Sale and Purchase of Product
	  	5
	 Section 2.02.
	  	 Forecasts
	  	7
	 Section 2.03.
	  	 Ordering
	  	7
	 Section 2.04.
	  	 Shipments
	  	8
	 Section 2.05.
	  	 Receipt of Product
	  	8
	 Section 2.06.
	  	 Quality Control; Change in Specifications or Supplier
	  	10
	 Section 2.07.
	  	 Material Safety Data Sheets
	  	12
	 Section 2.08.
	  	 BMS Supply Contracts
	  	12
	 Section 2.09.
	  	 Line Extension Product and New Product
	  	12
	 Section 2.10.
	  	 Maintenance of Manufacturing Facility Registrations
	  	13
	 Section 2.11.
	  	 Maintenance of Product Registrations
	  	13
	 Section 2.12.
	  	 Promotional and Advertising Materials
	  	14
	 Section 2.13.
	  	 Intellectual Property; License Grant
	  	14
		
	 SECTION 3.     PURCHASE PRICE FOR PRODUCT
	  	15
			
	 Section 3.01.
	  	 Purchase Price
	  	15
		
	 SECTION 4.     PAYMENTS AND REPORTS
	  	16
			
	 Section 4.01.
	  	 Payment; Books and Records
	  	16
	 Section 4.02.
	  	 Mode of Payment
	  	17
	 Section 4.03.
	  	 Taxes
	  	17
	 Section 4.04.
	  	 Late Payments
	  	17
		
	 SECTION 5.     COMPLIANCE WITH LAWS; REPRESENTATIONS AND WARRANTIES
	  	17
			
	 Section 5.01.
	  	 Compliance with Law; Cooperation
	  	17
	 Section 5.02.
	  	 BMS Representations, Warranties and Covenants
	  	18
	 Section 5.03.
	  	 The Company Representations, Warranties and Covenants
	  	19
	 Section 5.04.
	  	 Representations and Warranties of Each Party
	  	19
	 Section 5.05.
	  	 Disclaimer of Warranties
	  	20
	 Section 5.06.
	  	 No Reliance by Third Parties
	  	20
		
	 SECTION 6.     INDEMNIFICATION; REMEDIES FOR BREACH
	  	20
			
	 Section 6.01.
	  	 BMS Indemnity
	  	20
	 Section 6.02.
	  	 The Company Indemnity
	  	20
	 Section 6.03.
	  	 Limitations on Liability and Remedies
	  	21
	 Section 6.04.
	  	 Control of Proceedings
	  	21

  

 (i) 

 TABLE OF CONTENTS (continued) 
  

					
	 Section 6.05.
	  	 Insurance
	  	22
	 Section 6.06.
	  	 Other Limitations on Liability
	  	22
	 Section 6.07.
	  	 Calculation of Losses
	  	23
		
	 SECTION 7.     COMPLIANCE WITH GOVERNMENT REGULATIONS
	  	23
			
	 Section 7.01.
	  	 Government Communications
	  	23
	 Section 7.02.
	  	 Access to Records
	  	23
	 Section 7.03.
	  	 Governmental and Regulatory Inspections
	  	23
	 Section 7.04.
	  	 The Company Inspections
	  	24
	 Section 7.05.
	  	 Regulatory Matters
	  	24
		
	SECTION 8.     STABILITY; PRODUCT RECALLS; ADVERSE EXPERIENCES; PRODUCT QUALITY COMPLAINTS; AND MEDICAL INQUIRIES	  	25
			
	 Section 8.01.
	  	 Stability
	  	25
	 Section 8.02.
	  	 Product Recalls
	  	26
	 Section 8.03.
	  	 Adverse Experience
	  	26
	 Section 8.04.
	  	 Product Quality Complaints
	  	27
	 Section 8.05.
	  	 Medical Inquiries
	  	28
	 Section 8.06.
	  	 Disclosure Information
	  	29
		
	 SECTION 9.     CONFIDENTIALITY
	  	29
			
	 Section 9.01.
	  	 Confidentiality Requirement
	  	29
	 Section 9.02.
	  	 Use of Information
	  	30
	 Section 9.03.
	  	 Relief
	  	30
		
	 SECTION 10.     TERMINATION
	  	31
			
	 Section 10.01.
	  	 Term
	  	31
	 Section 10.02.
	  	 Breach
	  	31
	 Section 10.03.
	  	 Bankruptcy
	  	31
	 Section 10.04.
	  	 Effect of Termination
	  	31
	 Section 10.05.
	  	 Accrued Rights, Surviving Obligations
	  	32
		
	 SECTION 11.     FORCE MAJEURE
	  	32
		
	 SECTION 12.     TECHNICAL ASSISTANCE
	  	33
			
	 Section 12.01.
	  	 Technical Assistance
	  	33
		
	 SECTION 13.     NOTICES
	  	34
		
	 SECTION 14.     MISCELLANEOUS PROVISIONS
	  	35
			
	 Section 14.01.
	  	 Assignment
	  	35
	 Section 14.02.
	  	 Non-Waiver
	  	35
	 Section 14.03.
	  	 Dispute Resolution
	  	35
	 Section 14.04.
	  	 Entire Agreement
	  	36

  

 (ii) 

 TABLE OF CONTENTS (continued) 
  

					
	 Section 14.05.
	  	 Public Announcements
	  	36
	 Section 14.06.
	  	 Governing Law
	  	36
	 Section 14.07.
	  	 Relationship of the Parties
	  	36
	 Section 14.08.
	  	 Counterparts
	  	36
	 Section 14.09.
	  	 Severability
	  	37
	 Section 14.10.
	  	 Expenses
	  	37
	 Section 14.11.
	  	 Descriptive Headings
	  	37
	 Section 14.12.
	  	 Amendments and Waivers
	  	37
	 Section 14.13.
	  	 Specific Performance
	  	37
	 Section 14.14.
	  	 Successors and Assigns
	  	37
	 Section 14.15.
	  	 Waiver of Jury Trial
	  	38

  
 SCHEDULES 
  

			
	 Schedule 1.01
	  	 Product Information

		
	 Schedule 2.03(a)
	  	 Initial Firm Order for Months 1 to 6 after Effective Date

		
	 Schedule 2.04
	  	 Form of Certificate of Analysis

		
	 Schedule 3.01(a)
	  	 Initial Purchase Price and Batch Size

  

 (iii) 

 THIS SUPPLY AGREEMENT (this “Agreement”) dated as of May 14, 2004 (the
“Agreement Date”), is between Bristol-Myers Squibb Company, a Delaware corporation (“BMS”), and SkinMedica, Inc., a Delaware corporation (the “Company”). 
  
 RECITALS 
  
 WHEREAS, the Company has entered into that certain Asset Purchase Agreement (the “Asset Purchase
Agreement”) dated April 29, 2004 with Women First HealthCare, Inc. (“WFHC”) to purchase certain rights, title and interest in and to the Product; and 
  
 WHEREAS, the Company wishes to purchase the Product from BMS, and BMS wishes to supply the Product to the Company, pursuant
to the terms and conditions set forth in this Agreement. 
  
 NOW,
THEREFORE, in consideration of the premises and the mutual covenants and promises contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties (as defined below) hereby
agree as follows: 
  
 SECTION 1. 
  
 DEFINITIONS 
  
 Section 1.01. Definitions. 
  
 For purposes of this Agreement: 
  
 “Affiliate” means, with respect to any Person, any Person
which, directly or indirectly, controls, is controlled by, or is under common control with, the specified Person. For the purposes of this definition, the term “control”, as applied to any Person, means the possession, directly or
indirectly, of the power to direct or cause the direction of the management of that Person, whether through ownership of voting securities or otherwise. 
  
 “Agreement” means this agreement, together with all appendices, exhibits and schedules hereto, and as the same may be amended or
supplemented from time to time. 
  
 “BMS
Know-How” shall have the meaning set forth in the License Agreement. 
  
 “BMS Manufacturing Know-How” means the percentages and specification of ingredients, the manufacturing processes, specifications, technology, inventions, assays, quality control and testing
procedures, Know-How and trade secrets Controlled by BMS and used to manufacture, formulate, test, label or package the Product as of June 25, 2002 but not used exclusively for the Product. 
  
 “C.F.R.” means the U.S. Code of Federal Regulations.

  
 “Controlled by” shall have the meaning set
forth in the License Agreement. 
  
 “Effective
Date” means the date on which the Company and WFHC close the Company’s purchase of the Vaniqa® assets pursuant to that certain Asset Purchase Agreement, dated April 29,2004 entered into by the Company and WFHC (as amended from time to time). For the sake of clarity, in the event
that the United States Bankruptcy Court of the District of Delaware or any bankruptcy trustee 
  

 
related thereto modifies any obligation or duty in this Agreement, BMS reserves the right to void this Agreement immediately. 
  
 “EXW” means Ex Works as defined in the International Chamber
of Commerce Incoterms 2000. 
  
 “Facility” means
any manufacturing facility(ies), whether located within or outside the United States, that manufacture, finish, label or package the Product pursuant to this Agreement. 
  
 “FDA” means the United States Food and Drug Administration, or any successor entity. 
  
 “FD&C Act” means the United States Food, Drug and
Cosmetics Act, as amended. 
  
 “Firm Order” means
a written irrevocable firm purchase order for the Product, which order shall include a delivery schedule specifying the requested delivery date and quantity of the Product ordered, and the location to which shipment of the Product is to be
delivered. 
  
 “Fully-Burdened Cost” means: (a)
in connection with the manufacture, labeling and packaging of the Product, the cost of materials, labor and variable overhead incurred in manufacturing plus the fully absorbed allocation of fixed overhead (including without limitation a reasonable
allocation of idle plant charges), in each case with respect to the Facility at which such Product is manufactured; and (b) in connection with the performance or provision of a service, the direct and indirect costs incurred by a Party to perform or
provide the service (including without limitation reasonable overhead charges), determined in accordance with GAAP; in each case as evidenced by reasonably detailed supporting documentation and prepared consistently from period to period.

  
 “GAAP” means United States generally accepted
accounting principles consistently applied. 
  
 “Gillette
Know-How” shall have the meaning set forth in the License Agreement assigned to the Company by WFHC as of the Effective Date. 
  
 “Good Manufacturing Practices” or “cGMP” means current good manufacturing practices, as established by the FDA and all
other applicable Laws, as may be amended from time to time. 
  
 “Governmental Entity” means any court of competent jurisdiction, legislature, governmental agency, administrative agency, regulatory agency or commission or other governmental authority or other instrumentality of the
United States or any other country, any state, county, city or other political subdivision (including the FDA and the corresponding authorities in the jurisdictions where the Product is marketed, distributed or sold). 
  
 “Improvement” means any modification by the Purchaser or its
Affiliates to the Product, including, without limitation, any modification in its manufacture, composition, preparation, means of delivery or dosage but shall specifically exclude (a) any such modification by Gillette, BMS or any of their respective
Affiliates and (b) any modification to the Product that alters or substitutes the Product’s active ingredient. 
  
 “Laws” means all laws, rules, regulations, ordinances and other requirements of any Governmental Entity. 
  
 “License Agreement” means the License Agreement, dated as of
June 25, 2002, among the WFHC, BMS and Gillette that was assigned by WFHC to the Company as of the Effective Date. 
  
  

 - 2 - 

 “Losses” means losses, liabilities, claims, damages and expenses (including, until such
time as the indemnifying Party has notified the indemnified Party in writing that it will assume control of a given claim, reasonable attorneys fees and costs of litigation pertaining to such claim), and expenses paid or payable by an indemnified
party to a Third Party. 
  
 “MAA” or
“Marketing Approval Application” means a NDA or a Premarket Approval Application, as required under the FD&C Act and the regulations promulgated thereunder, or a comparable filing for marketing approval in a country. 

 
 “Manufacturing Facility Registrations” means the
approvals, permits, applications, licenses or registrations granted by the relevant Governmental Entity to a Facility for the manufacture of the Product or any other products at such Facility. For sake of clarity, Manufacturing Facility
Registrations do not include Product Registrations. 
  
 “Material Safety Data Sheet” means the material safety data sheet used to comply with the Occupational Safety and Health Administration’s Hazard Communication Standard, 29 C.F.R. 1910.1200. 
  
 “NDA” means any new drug application filed pursuant to the
requirements of the FDA, as more fully defined in 21 C.F.R. Part 314.5 et seq., and any equivalent application filed with any Governmental Entity. 
  
 “NDC” means the unique, identifying number assigned to a drug product, including the labeler code, product code and package code, in
connection with the drug listing requirements of Section 510(j) of the FD&C Act and applicable FDA rules and regulations. 
  
 “Partnership Manufacturing Know-How” means the percentages and specifications of ingredients, the manufacturing processes,
specifications, technology, inventions, assays, quality control and testing procedures, Know-How and trade secrets Controlled by the a Delaware general partnership created by BMS and The Gillette Company on October 7, 1996 and used exclusively to
manufacture, formulate, test, label or package the Product as of June 25, 2002 and owned by the Company as of the Effective Date. 
  
 “Party” means BMS or the Company and, when used in the plural, means BMS and the Company. 
  
 “Past Due Sums” means the *** that WFHC currently owes BMS.

  
 “Person” means any individual, group,
corporation, partnership or other organization or entity (including any Government Entity). 
  
 “Prime Rate” means the rate of interest from time to time announced as the prime commercial lending rate to the most creditworthy customers by a bank of national standing agreed to by the Parties.

  
 “Product” means the prescription form of
VANIQA® (eflornithine hydrochloride) Cream, 13.9% and further listed and described on Schedule 1.01, as the same is manufactured, packaged and labeled in accordance with applicable Laws and the applicable Product Registration and
Specifications, including all strengths and packaging configurations of the final finished dosage form presentation existing on the Effective Date or any new forms as agreed by the Parties. 
  
 “Product Registrations” means the approvals, permits,
applications, licenses or registrations (including but not limited to the NDA) and any amendments or supplements thereto for the Product which 
  

	***	Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

  

 - 3 - 

 
have been received in order to market or sell same (and related submissions to and correspondence with the relevant Governmental Entity). For the avoidance
of doubt, the Parties agree that Product Registrations do not include any Manufacturing Facility Registration, any NDC number or any drug listing required by 21 C.F.R. Part 207. 
  
 “Specifications” for the Product means the written specifications set forth in the applicable NDA as of the
Effective Date, as the same may be amended or supplemented from time to time hereafter by the Company in accordance with Section 2.06(b). 
  
 “Third Party” means any Person who or which is neither a Party nor an Affiliate of a Party. 
  
 “United States” and “U.S.” means the fifty
(50) states of the United States of America and the District of Columbia, Puerto Rico and any other territory or possession of the United States. 
  
 Section 1.02. Other Definitions. 
  
 The following terms have the meanings set forth in the Sections set forth below: 
  

			
	 Term

	  	 Section

	 Agreement Date
	  	Preamble
	 Asset Purchase Agreement
	  	Recitals
	 Audit
	  	7.04
	 BMS
	  	Preamble
	 BMS Party
	  	6.02
	 Company
	  	Preamble
	 Company Party
	  	6.01
	 Confidential Information
	  	9.01(a)
	 Facility Audit
	  	5.01(c)
	 Facility Technical Information
	  	2.10(b)
	 Force Majeure Event
	  	11
	 Forecast
	  	2.02
	 Initial Term
	  	10.01
	 Non-Serious Adverse Event
	  	8.03(b)
	 PDMA
	  	2.12
	 Product Quality Complaint
	  	8.04(a)
	 Purchase Price
	  	3.01(a)
	 Recall
	  	8.02
	 Renewal Term
	  	10.01
	 Retained Rights
	  	2.14
	 Serious Adverse Event
	  	8.03(b)
	 SKU
	  	2.02
	 Stability Study
	  	8.01(b)
	 Technical Information
	  	2.11(b)
	 Term
	  	10.01
	 WFHC
	  	Recitals

  

 - 4 - 

 Section 1.03. Interpretations. 
  
 (a) In the event an ambiguity or a question of intent or
interpretation arises, this Agreement shall be construed as if drafted jointly by the Parties and no presumption or burden of proof shall arise favoring or disfavoring any Party by virtue of the authorship of any provisions of this Agreement.

  
 (b) The definitions of the terms herein shall
apply equally to the singular and plural forms of the terms defined. Whenever the context may require, any pronoun shall include the corresponding masculine, feminine and neuter forms. The words “include”,
“includes” and “including” shall be deemed to be followed by the phrase “without limitation”. The word “will” shall be construed to have the same meaning and effect as the word
“shall”. Unless the context requires otherwise; (A) any definition of or reference to any agreement, instrument or other document herein shall be construed as referring to such agreement, instrument or other document or any addenda,
schedules, exhibits or amendments thereto, and as from time to time amended, supplemented or otherwise modified (subject to any restrictions on such amendments, supplements or modifications set forth herein or therein); (B) any reference to any Laws
herein shall be construed as referring to such Laws as from time to time enacted, repealed or amended; (C) any reference herein to any Person shall be construed to include the Person’s successors and assigns; (D) the words
“herein”, “hereof” and “hereunder”. and words of similar import, shall be construed to refer to this Agreement in its entirety and not to any particular provision hereof; (E) all references herein
to Sections, Exhibits or Schedules shall be construed to refer to Sections, Exhibits and Schedules of this Agreement; and (F) the singular number includes the plural number and vice versa. 
  
 Section 1.04. Effective Date/Past Due Sums. The terms and
conditions set forth in this Agreement shall not be binding on BMS until the Effective Date and receipt of the Past Due Sums from the Company. For the sake of clarity, in the event that the United States Bankruptcy Court of the District of Delaware
or any bankruptcy trustee related thereto modifies any obligation or duty in this Agreement, BMS reserves the right to void this Agreement immediately. 
  
 Section 1.05. Closing Under the WFHC/Company Asset Purchase Agreement. The Company shall keep BMS informed of the status and timing of the
closing under that certain Asset Purchase Agreement, dated April 29, 2004, entered into by the Company and WFHC (as amended from time to time). In addition, if the closing under such Asset Purchase Agreement occurs, the Company shall give BMS notice
of such closing within one (1) business day of such closing and if such Agreement is terminated without a closing, the Company shall give BMS notice of the termination of such Agreement within one (1) business day of such termination. This Agreement
shall be void and of no further force and effect on either of the Parties if that certain Asset Purchase Agreement, dated April 29, 2004, entered into by the Company and WFHC (as amended from time to time) terminates according to its terms or is
terminated pursuant to the applicable provisions of such Agreement, without the closing having occurred thereunder. The Parties further agree that if this Agreement is not effective within one hundred twenty (120) days of the Agreement Date, that
this Agreement shall be void and of no further force and effect, unless otherwise mutually agreed to by the Parties in writing. 
  
 SECTION 2. 
  
 GENERAL TERMS OF SUPPLY 
  
 Section 2.01. Sale and Purchase of Product. 
  
 (a) BMS (either itself or through its Affiliates) shall supply to the Company, and the Company shall, subject to the terms and conditions
of this Agreement, purchase from BMS, one 

  

 - 5 - 

 
hundred percent (100%) of the Company’s requirements (except for quantities necessary to keep the Company’s back-up supplier qualified) the Product
for marketing, distribution, sale and use during the Term, pursuant to Firm Orders submitted by the Company to BMS from time to time in accordance with Section 2.03, at the Purchase Price, and subject to Section 5.02. 
  
 (b) All quantities of the Product shall be supplied
hereunder by BMS in finished dosage form, filled, labeled, branded and packaged for commercial sale or distribution, or as samples, as the case may be, in accordance with the terms and conditions of this Agreement, the Specifications and applicable
Laws. BMS shall solely and exclusively supply the Product to the Company, its Affiliates and their respective designees. BMS shall be responsible for the purchase of all raw materials for the manufacture of the Product in accordance with the Product
Registrations as necessary to supply the finished Product to the Company under this Agreement. Company shall be responsible for all costs incurred by BMS relating to any Firm Orders placed by Company (including, any raw materials or working
inventory purchase by BMS on behalf of Company in connection with Firm Orders). 
  
 (c) Subject to BMS Regulatory review and approval, and pursuant to applicable law, BMS and the Company shall take any and all actions
necessary to change, as expeditiously as possible, the NDC numbers for the Product and to apply new NDC numbers to the Product. Subject to BMS Regulatory review and approval, and pursuant to applicable law, for no more than six (6) months following
the Effective Date, the Product manufactured hereunder may continue to be labeled and packaged with the same labels and packaging that are used by BMS in connection with its previous manufacture of the Product for WFHC; provided, however,
that the Parties shall use their commercially reasonable efforts to complete the revision of all Product labeling and packaging sooner. Subject to BMS Regulatory review and approval, and pursuant to applicable law, after such time, the Product shall
be manufactured with labeling, branding, trade dress and packaging identifying BMS or any Affiliate thereof as the manufacturer of the Product and the Company (or the Company’s designee) as the distributor thereof and the labeling shall reflect
the Company’s NDC number. Promptly after the Effective Date, BMS shall provide to the Company samples and copies of all labeling, branding, trade dress and packaging for the Product as of the Effective Date. Within sixty (60) calendar days
following the delivery by BMS to the Company of the current labeling and packaging, the Company shall provide to BMS final specifications for the revised labeling, branding, trade dress and packaging of the Product, including all necessary
photo-ready art (or its substantial equivalent) reflecting such revisions. 
  
 (d) Subject to the provisions of Section 2.01 (c), the Company shall control and shall have sole responsibility for, the content and type of all labeling and packaging (and any changes or supplements thereto) for the
Product. All such activities related to any changes or supplements to the labeling and packaging shall be conducted at the Company’s sole cost and expense, including any *** in securing any approvals required by the FDA or other applicable
regulatory authorities for any such changes or supplements. BMS shall be responsible for obtaining such labels in accordance with the content specified by the Company. Any changes to the labeling and packaging shall be communicated to BMS in writing
at least one hundred twenty (120) calendar days (or, if shorter, the period required by applicable Laws or Government Entities) prior to the desired implementation date together with the documentation specifying the content to be included in the
labeling and packaging, including all necessary photo-ready art (or its substantial equivalent). BMS shall not be required to implement such changes until its first batch run after the expiration of such one hundred twenty (120) day (or shorter)
period. However, BMS shall endeavor to implement the changes as early as practicable. 
  
 (e) No terms and conditions contained in any Firm Order, acknowledgment, invoice, bill of lading, acceptance or other preprinted form
issued by either Party shall be effective to the extent they are inconsistent with or modify the terms and conditions contained herein. 
  

	 	***	Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

  

 - 6 - 

 Section 2.02. Forecasts. 
  
 The Company shall submit to BMS upon execution of this Agreement and thereafter no later than the first week
of each month during the Term hereof, a twenty-four (24) month rolling forecast (“Forecast”) organized by months and Product stock keeping units (“SKUs”) setting forth orders the Company expects to place for the
Product during such period commencing with the beginning of said calendar month. The Company shall make all Forecasts in good faith given market and other information available to the Company. All Forecasts are non-binding except as set forth in
Section 2.03 below. 
  
 Section 2.03. Ordering.

  
 (a) On the Effective Date (provided that
the Effective Date is no later than July 15, 2004), the Company shall provide BMS with a purchase order for *** batches of the 30 gram presentation of the Product priced at *** (the “Early Batches”). For the sake of clarity, each of
the Early Batches shall have a minimum theoretical batch size of *** tubes and minimum theoretical batch size of *** cases and the pricing thereto is based on the assumption that existing tubes as of the Effective Date can be utilized).
Notwithstanding the foregoing, if the purchase order for the Early Batches is received after July 15, 2004 or if, in BMS Regulatory’s opinion, the existing tubes cannot be utilized, the price for the Early Batches shall be set to the Purchase
Price set forth on Schedule 3.01(a). In addition to the foregoing, by December 1, 2004, the Company shall provide BMS with its initial Firm Order of Product at the Purchase Prices set forth on Schedule 3.01(a) for its requirements for
the *** batches requiring recrystallization of BMS’ existing inventory of the active pharmaceutical ingredient for the Product. The requested delivery date of the *** batches in the initial Firm Order shall not be sooner than March 31, 2005
(e.g., December 1, 2004 plus 120 calendar days). BMS and the Company understand and agree that the requested delivery date (March 31, 2005) for the *** batches in the initial Firm Order is a firm delivery date. The requested delivery date for the
subsequent *** batches of the initial Firm Order are set forth on Schedule 2.03(a) and represents the Company’s best forecast of Product requirements and such forecasted dates may change based on market conditions, provided that
the Company acknowledges and agrees that it is ultimately responsible for such *** batches. BMS will supply the quantities set forth in Schedule 2.03(a) for the Product in accordance with the delivery schedule set forth therein, and to the
extent such initial Firm Order is not sufficient to meet the Company’s actual requirements for the Product for such period, BMS will use its commercially reasonable efforts to supply the Company with its requirements beyond the amounts
specified in Schedule 2.03(a). The Company agrees to purchase such quantities of the Product as supplied by BMS in accordance with Schedule 2.03(a). 
  
 (b) Except as provided in Section 2.03(a), and subject to the terms and conditions of this Agreement, the
Company shall purchase the Product solely by Firm Orders for the Product. The terms and conditions of this Agreement shall be controlling over any conflicting terms and conditions in such Firm Order. The Company shall submit each such written Firm
Order (including the initial Firm Order) along with *** of the Purchase Price for such Product to BMS at least one hundred twenty (120) days in advance of the date specified in each Firm Order on which delivery of the Product is required. Each such
Firm Order shall be binding on the Company and on BMS once such Firm Order is accepted by BMS (it being understood that such Firm Order shall be deemed to be accepted by BMS if it: (i) meets the requirements as set forth in this Agreement; and (ii)
includes a minimum of *** of Product). In addition to the foregoing, BMS shall not be obligated to accept a Firm Order if (i) the Company does not pay its *** down payment along with such Firm Order and (ii) there are any outstanding balances for
previous orders. Prior to the placement of Firm Orders, the Parties shall communicate regarding BMS’ production schedules for the Product and the Company’s anticipated delivery requirements for the Product so that the Parties can
coordinate BMS’ production schedules and the Company’s delivery requirements to enable BMS to supply Product to the Company with the maximum practicable shelf life at the time of shipment. Notwithstanding the 
  

	 	***	Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

  

 - 7 - 

 
foregoing, BMS shall attempt to accommodate any request of the Company for delivery of the Product in less than ***, and further, BMS will attempt to
accommodate any changes requested by the Company in delivery schedules for the Product following BMS’ receipt of Firm Orders from the Company; provided, however, BMS shall not be liable for any failure or inability to do so.
Subject to the foregoing, upon receipt of each Firm Order by BMS hereunder, BMS shall supply the Product in such quantities (with any variances permitted hereunder) and deliver the Product to the Company on the requested delivery dates specified in
such Firm Order, unless otherwise mutually agreed in writing by the Parties. To the extent that such Firm Order is not sufficient to meet the Company’s actual requirements, BMS shall use commercially reasonable efforts to supply the Company
with its requirements beyond the amounts specified in its Firm Order; provided, however, BMS shall not be liable for any failure or inability to do so. BMS is not entitled to accept verbal orders of any kind for the production of the
Product hereunder. 
  
 (c) Quantities of the
Product actually shipped by BMS may vary from the quantities specified in any Firm Order by ***, or as mutually agreed upon by the Parties, and still be deemed to be in compliance with such Firm Order; provided, however, the Company
only shall be invoiced and required to pay for the quantities that BMS actually ships to the Company. 
  
 (d) Any Product ordered by the Company for delivery on each specified delivery date shall be consistent with BMS’ current minimum
batch sizes for the Product, or multiples thereof, as set forth in Schedule 3.01(a). BMS may change the batch size at any time; provided that BMS gives the Company no less than six months prior notice; and provided
further that such changes in batch size conform with Product Registrations and applicable Laws. 
  
 Section 2.04. Shipments. 
  
 BMS shall ship each Firm Order, EXW Facility for the Product (whether manufactured by BMS, an Affiliate of BMS or a Third Party) to the
Company or its designee to the destinations specified by the Company on the applicable Firm Order using the Company’s designated common carrier. Freight (including customs clearance costs) and insurance shall be for the account of the Company.
Title shall pass to the Company and the risk of loss, delay or damage in transit shall be with the Company, from and after the Company’s designated common carrier takes custody of the Product from BMS at the Facility (including, without
limitation any loss from an environmental impact arising from the release or consumption of the Product); provided, however, that such transfer of title and risk of loss, delay and damage shall not in any way otherwise obviate or limit the
representations and warranties or indemnification obligations of BMS hereunder. BMS shall package the Product for shipment in accordance with appropriate packaging and shipping containers agreed upon by the Parties, unless otherwise specified in
writing by the Company sixty (60) business days prior to such shipment, in which event any extra costs incurred by BMS on account of the packaging changes requested by the Company shall be promptly reimbursed by the Company. In the event that BMS
receives less than sixty (60) business days notice of a request for alternate packaging, BMS shall not be required to repackage any shipments that have already been packed for shipment. BMS shall include the following with each shipment of the
Product: (a) the Company purchase order number; (b) the BMS lot and batch numbers for the Product included; (c) the quantity of the Product; and (d) the Certificate of Analysis (the form of which is attached hereto as Schedule 2.04).

  
 Section 2.05. Receipt of Product. 
  
 (a) The Company shall be entitled to reject any portion or
all of any shipment of the Product that does not conform to the Specifications or otherwise fails to comply in any material respect with Section 5.02(a) (unless such non-conformity was attributable to an act or omission of the Company 
  

	 	***	Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

  

 - 8 - 

 
or the common carrier once such Product, packaged for shipment in accordance with Section 2.04, was accepted by such common carrier from BMS),
provided, that, (i) the Company shall notify BMS within *** calendar days after receipt of such shipment if it is rejecting a shipment due to obvious physical damage or quantity discrepancies that are evident upon visual inspection of
the packaged Product as shipped by BMS (unless caused by the common carrier or the Company), (ii) except as otherwise provided in Section 2.05(a)(iii), the Company shall notify BMS within *** calendar days after receipt of such shipment if it is
rejecting a shipment due to any defects other than those obvious visual defects, and (iii) the Company shall notify BMS within *** calendar days after the Company becomes aware of any defects in the case of Product having detects that are
attributable solely to BMS’ manufacture of such Product. Notwithstanding anything contained herein, the Company shall have no obligation to inspect the Product beyond a visual inspection of each shipment for obvious physical damage or quantity
discrepancies that are evident upon visual inspection of the packaged Product as shipped by BMS. Without in any way limiting BMS’ indemnity obligations as set forth in Section 6.01, if no notice is provided by the Company within the relevant
time periods set forth above, then the Company shall be deemed to have accepted the shipment. Any notice of rejection by the Company shall be accompanied by a reasonably detailed statement of its reasons for rejection and a report of any pertinent
analysis performed by the Company on the allegedly non-conforming Product, together with the methods and procedures used. BMS shall notify the Company as promptly and as reasonably possible, but in any event within *** calendar days after receipt of
such notice of rejection, whether or not it accepts the Company’s assertions of non-conformity. 
  
 (b) Whether or not BMS accepts the Company’s assertion of non-conformity, promptly upon receipt of a notice of rejection, unless
otherwise specified by the Company, BMS shall use commercially reasonable efforts to provide replacement Product for the Product that was rejected by the Company in the original shipment within *** calendar days of receipt of the Company’s
notice of non-conformity. If any such Product rejected by the Company from such original shipment ultimately is found to be non-conforming (whether pursuant to Section 2.05(c) or if BMS so acknowledges in writing), BMS shall bear all expenses for
such replacement Product (including all transportation and/or disposal charges and cost of manufacture for such non-conforming Product), to the extent the Company previously paid for any corresponding non-conforming Product. If it is determined
subsequently that such non-conforming Product was in fact conforming (whether pursuant to Section 2.05(c) or if the Company so acknowledges in writing), then the Company shall be responsible not only for the *** of the allegedly nonconforming
Product (including all transportation charges), but also, upon receipt and acceptance by the Company in accordance with the procedures (and at the same price charged in the original shipment) set forth above, ***. Replacement shipments shall also be
subject to the procedures contained in Section 2.05(a). BMS shall be under no obligation to accept a return of Product except as provided in this Section 2.05(b). 
  
 (c) If BMS disagrees wife any alleged non-conformity with respect to any Product it shall so notify the
Company in writing with *** calendar days of the Company’s notice of non-conformity and BMS and the Company shall promptly (and in no event longer than an additional *** calendar days) cooperate with one another to retain an independent
laboratory of recognized repute, reasonably acceptable to both Parties, which shall analyze an aliquot sample or such other portion of a shipment of such Product, furnished by the Company from the shipment received by the Company, as may be
necessary to substantiate whether the shipment rejected by the Company conformed to the Specifications or otherwise failed to comply in any material respect with Section 5.02(a) at the time of delivery to the Company or its designee. The laboratory
shall use such procedures and tests as the laboratory may consider necessary or appropriate to reach a conclusion. Both Parties agree to cooperate with the independent laboratory’s reasonable requests for assistance in connection with its
analysis hereunder. Both Parties shall be bound by the laboratory’s results of analysis, which, absent manifest error, shall be deemed final as to any dispute over compliance of the Product with the Specifications and/or compliance in any
material respect with Section 5.02(a) at the time of delivery to the Company or 
  

	 	***	Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

  

 - 9 - 

 
its designee. If the laboratory analysis shows that the Product does not conform to the Specifications and/or that it does not comply in all material
respects with Section 5.02(a), the costs of such analysis shall be paid by BMS. If the laboratory analysis shows that the Product does conform to the Specifications and/or that it does comply in all material respects with Section 5.02(a), the costs
of such analysis shall be paid by the Company. 
  
 (d) If BMS acknowledges an alleged non-conformity (or if the laboratory concludes that the Product was non-conforming), BMS shall promptly (and in any case within *** calendar days thereafter) make arrangements for the return and disposal
of the non-conforming Product. BMS shall pay, or reimburse the Company, for the *** incurred by the Company for such return shipment of such non-conforming Product in accordance with BMS’ instructions. 
  
 Section 2.06. Quality Control; Change in Specifications or
Supplier. 
  
 (a) BMS shall conduct all
quality control testing of the Product prior to shipment in accordance with the Product Registration and applicable Laws. BMS shall retain records and samples of the Product relating to such testing as required by applicable Law and shall provide
the Company with reasonable access during normal business hours to such records during any Audit in accordance with the procedures set forth in Section 7.04; provided, however, that such access does not unreasonably disrupt the normal
operations of BMS. If the Company conducts quality control testing of the Product after delivery thereof to the Company, the Company shall use a laboratory qualified by BMS to ensure consistency of testing with the BMS results. If reasonably
required by the Company, BMS shall promptly after the Effective Date (and in no event later than *** days provide all analytical methodology used by BMS for quality control testing of the Product. 
  
 (b) The Company shall have the right: (i) subject to
BMS’ prior written consent not to be unreasonably withheld, to change the Specifications with respect to the Product from time to time; (ii) subject to BMS’ prior written consent not to be unreasonably withheld, to change the tubes used
for the Product; (iii) to change the Specifications with respect to the Product without prior written consent, from time to time, as may be required by any Governmental Entity having jurisdiction over the Product; or (iv) to change the
Specifications with respect to the Product by mutual agreement of the Parties and in each case, on not less than *** calendar days prior written notice to BMS (or such shorter period as required by any Governmental Entity or mutually agreed by the
Parties). In such event, upon the reasonable request of the Company and at the Company’s sole expense, BMS shall assist with all analytical or experimental work to be performed in connection with making such change, but the Company shall be
responsible, at the Company’s expense, for filing all changes proposed by the Company to any Product Registration, and for seeking approval of any such change required by each applicable Governmental Entity. The Company shall reimburse BMS or
its Affiliates for *** in implementing any changes to the Specifications in accordance with this Section 2.06(b) requested by the Company in BMS’ or its Affiliates’ Facility, and for filing, amending or supplementing any Manufacturing
Facility Registration required thereby and shall not hold BMS responsible for any reasonable disruption of supply resulting from any such change in the Specifications. 
  
 (c) At any time and from time to time, BMS may, (i) in its sole discretion, without the consent of the
Company (but with *** prior written notice) change the manufacturer or source of manufacturing used in the manufacturing of the Product to an Affiliate of BMS, or to another BMS owned and operated facility, provided that BMS shall
remain responsible for all of its obligations set forth herein, and provided further that any such change which will result in a delay in BMS’ or such other party’s ability to meet the Company’s delivery
requirements for Products pursuant to Firm Orders made pursuant to Section 2.03 shall require the prior written consent of the Company (not to be unreasonably withheld or delayed), (ii) with the Company’s prior written consent (not to be

  

	 	***	Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

  

 - 10 - 

 
unreasonably withheld) change the manufacturer or source of manufacturing used in the manufacturing of the Product to a Third Party; provided
that BMS shall be responsible for the acts or omissions of such Third Party or (iii) without the consent of the Company (but with *** prior written notice) change the manufacturer or manufacturing source used in the manufacturing of the
Product to a successor (whether by merger, consolidation, reorganization or other similar event) or purchaser of the Facility and/or substantially all of its business assets relating to the Product, provided, that, such successor or
purchaser has agreed in writing to assume all of BMS’ rights and obligations hereunder and a copy of such assumption is provided to the Company, and provided further that any such change which will result in a delay in
BMS’ or such other party’s ability to meet the Company’s delivery requirements for Products pursuant to Firm Orders made pursuant to Section 2.03 shall require the prior written consent of the Company (not to be unreasonably withheld
or delayed). The Company shall cooperate with BMS (and such other manufacturer, if applicable) in any reasonable manner to effect such transfer to an Affiliate of BMS, Third Party or successor. BMS shall be responsible for making any required
Manufacturing Facility Registration with respect to such change in manufacturer and seeking approval from each applicable Governmental Entity. The Company shall be responsible for making any required filing with respect to any Product Registration
in connection with such change in manufacturer or source of manufacturing. BMS shall bear all costs incurred by either Party with respect to such change in manufacturer or source of manufacturing including without limitation any Product Registration
filings, and shall compensate the Company for *** incurred pursuant to any such change. 
  
 (d) At any time and from time to time, BMS in its sole discretion may change, without the consent of but with *** prior written notice to
and consultation with the Company, any manufacturing processes used in manufacturing the Product, any active pharmaceutical ingredient, intermediates, excipients, reagents or other compounds used in the manufacture of the Product, and any suppliers
of any components used in making the Product; provided that, any such change requiring approval of an amendment or supplement to any Product Registration will not be effected or implemented without the prior written consent of the
Company (not to be unreasonably withheld or delayed); and provided further that except where such change results from a manufacturing Improvement made in response to a pronouncement of a Governmental Entity (other than as a
result of non-compliance by BMS), a Force Majeure Event, or a change in applicable Law, no such change shall be effected in a manner that would result in or cause an interruption of supply of the Product to the Company. Each Party will fully
cooperate with the other in any reasonable manner to effect such change in a timely manner. The Company shall be responsible for all Product Registration filings needed to effect such change, and will use its commercially reasonable efforts to make
all such regulatory filings (subject to receipt of necessary information from BMS) and take such actions as may be required to implement and seek regulatory approval for such change on a timely basis. BMS shall be responsible for making any required
filing to any Manufacturing Facility Registration with respect to such change and seeking approval from each applicable Governmental Entity, BMS shall reimburse the Company for *** in seeking and obtaining or assisting BMS in seeking and obtaining
any qualification or regulatory approval of such change. However, if such change is required by a change in Law or by a Governmental Entity (other than as a result of non-compliance by BMS), or is requested by the Company, in which event the Company
shall reimburse BMS for *** to seek and obtain any regulatory approval for such change and to implement such change. 
  
 (e) With respect to any regulatory filings and approvals made or sought by either Party under this Section 2.06, each Party shall provide
reasonable cooperation to the other Party in connection therewith. If a change proposed to be made under this Section 2.06 requires prior approval by any applicable Governmental Entity before implementation, such change will not be implemented until
such change has been so approved. 
  

	 	***	Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

  

 - 11 - 

 Section 2.07. Material Safety Data Sheets. 
  
 BMS shall provide the Company with all information in the
applicable Material Safety Data Sheets as they exist as of the Effective Date for the Product provided by BMS and thereafter as reasonably requested by the Company. 
  
 Section 2.08. BMS Supply Contracts. 
  
 BMS shall have the sole right, but not the obligation, at its sole discretion and expense, to maintain and
enforce any contract entered into by BMS or its Affiliates covering the supply of any active pharmaceutical ingredient, compounds, intermediates, biomaterials, packaging components, containers and other materials used in the manufacture of the
Product. Upon termination of BMS’ supply obligation under this Agreement, BMS will assign, to the extent assignable and if requested by the Company, any contracts relating to the supply of any active pharmaceutical ingredient, compounds,
intermediates, biomaterials, packaging components, containers and other material used exclusively in the manufacture of the Product, and the Company shall be solely responsible for all obligations arising under such assigned contracts after the date
of assignment. Except as provided by Section 11, nothing contained in this Section 2.08 shall excuse BMS from performing its obligations under this Agreement. For the avoidance of doubt, termination without cause by BMS and/or expiration of a supply
contract by BMS, in itself, does not constitute a Force Majeure event; provided, however, BMS’ inability to obtain bulk supply shall constitute a Force Majeure event. 
  
 Section 2.09. Line Extension Product and New Product. 
  
 (a) BMS shall have no obligation, express or implied, to
develop or assist in the development or manufacture of new formulations, dosages, forms of administration or preparations for the Product. 
  
 (b) BMS and the Company acknowledge and agree that within *** days of the Effective Date they will enter into good faith negotiations on
the qualification of a *** as a new sample configuration for the Product. These negotiations will include but not be limited to: 
  
 (i) Cost and schedule for the creation, implementation and completion, of a production qualification/Validation protocol for the filling
of the *** on BMS’ equipment. Such protocol to be approved by both BMS and the company 
  
 (ii) Cost and schedule for BMS to perform all analytical work necessary for the Company to submit the *** to the FDA for approval as a
marketed package. 
  
 (iii) Pricing for BMS to
produce the *** for the Company in quantities previously quoted on by BMS for the current *** blend sample tube. 
  
 Costs and expenses relating to the protocol and any analytical work necessary pursuant to this Section 2.09(b) shall be the Company’s
sole responsibility. 
  

	***	Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

  

 - 12 - 

 Section 2.10. Maintenance of Manufacturing Facility Registrations. 
  
 For so long as BMS is manufacturing the Product for the
Company: 
  
 (a) BMS shall have sole
responsibility at its expense for maintaining, and shall use commercially reasonable efforts to maintain, each Manufacturing Facility Registration covering the manufacture of the Product. 
  
 (b) The Company agrees to provide to BMS all material
manufacturing and supply information (the “Facility Technical Information”) necessary to enable BMS (i) to make any filings required by applicable Law in connection with any Manufacturing Facility Registration, (ii) to otherwise
maintain each such Manufacturing Facility Registration, and (iii) to include complete and accurate information in reports required to be made by BMS to any applicable Governmental Entity with respect to any Product with respect to such Manufacturing
Facility Registration. BMS shall, to the extent it is not required to be reported to BMS by the Company under applicable Laws, provide written notice to Company setting forth in reasonable detail the nature of the Facility Technical Information in
respect of the Product and the date by which such Facility Technical Information shall be provided to BMS in respect of the Product. Any such written notice shall allow the Company reasonable time to accumulate such Facility Technical Information
requested. The Company shall use its commercially reasonable efforts to provide such Facility Technical Information to BMS on or before the date set forth in any such written request. The Company will use its commercially reasonable efforts to do
all such other acts, as promptly as reasonably possible, which may be necessary or appropriate to make all necessary reports to BMS to allow appropriate and timely filings required by Law to the Manufacturing Facility Registration. BMS shall
reimburse the Company *** to provide such information and reports. 
  
 (c) Each Party shall keep the other informed on a timely basis as to any developments that would have a material adverse effect on a Manufacturing Facility Registration. BMS shall have the final decision-making
authority in every case on how to maintain each Manufacturing Facility Registration and any other issues in connection therewith; provided, that, BMS will not, except where required by, or to fulfill its obligations under, applicable
Laws or except where required by a Governmental Entity acting within the scope of its authority, supplement, amend or otherwise alter a Manufacturing Facility Registration so as to breach this Agreement or to materially and adversely alter the
rights granted to, or the obligations imposed upon, the Company hereunder that are derived from such Manufacturing Facility Registration. 
  
 Section 2.11. Maintenance of Product Registrations. 
  
 (a) As between the Parties, the Company shall retain all rights, title and interests in and to, and all
obligations under, the Product Registration. The Company shall have sole responsibility for maintaining, and shall use commercially reasonable efforts to maintain, the Product Registration, including filing NDA annual reports. 
  
 (b) BMS agrees to provide all material information (the
“Technical Information”) necessary to enable the Company (i) to make any filings required by applicable Law in connection with any Product Registrations anywhere in the world, (ii) to otherwise maintain any Product Registrations
anywhere in the world (including any Supplemental Registrations), and (iii) to include complete and accurate information in the annual reports required to be made by the Company to the FDA in relation to the Product. The Company shall, to the extent
it is not required to be reported to the Company by BMS under applicable Laws and/or as listed on Form FDA 2252, provide written notice to BMS setting forth in reasonable detail the nature of the Technical Information in respect of the Product and
the date by which such Technical Information shall be provided to the Company in respect of the Product. Any such 
  

	***	Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

  

 - 13 - 

 
written notice shall allow BMS reasonable time to accumulate such Technical Information requested. BMS shall use its commercially reasonable efforts to
provide such Technical Information to the Company on or before the date set forth in any such written request. BMS will use its commercially reasonable efforts to do all such other acts, as promptly as reasonably possible, which may be necessary or
appropriate to make all necessary reports to the Company, including reports of Serious and Non-Serious Adverse Events in accordance with Section 8.03, that are required by Law to allow appropriate and timely filings to the Product Registration.
Except as otherwise provided in the Asset Purchase Agreement, the Company shall reimburse BMS *** to provide such information and reports with respect to Product Registrations outside U.S. 
  
 (c) Each Party shall keep the other informed on a timely
basis as to any developments that would have a material adverse effect on the Product Registrations. Where the Company may lawfully do so and subject to any confidentiality obligations it may have to Third Parties with respect to Third Party
information included therein, the Company shall provide BMS, upon request after reasonable notice from BMS, with access to copies of all filings submitted by the Company based on any information submitted by BMS or that relate to any Facility. The
Company shall have the final decision-making authority in every case on how to maintain each Product Registration and any other issues in connection therewith, provided, however, the Company shall consult with BMS, on whether and how
to communicate with the applicable Governmental Entity with respect to decisions on Recall of the Product. The Company will not, except where required by, or to fulfill its obligations under, applicable Law or except where required by a Governmental
Entity acting within the scope of its authority, supplement, amend or otherwise alter any Product Registration so as to breach this Agreement or to materially and adversely alter the rights granted to, or the obligations imposed upon, BMS hereunder
or under the Asset Purchase Agreement that are derived from such Product Registration. 
  
 (d) The Company shall pay all fees arising on or after the Effective Date with respect to the Product Registrations that the Company
initiates, including NDA user and filing fees. 
  
 Section
2.12. Promotional and Advertising Materials. 
  
 The Company shall be solely responsible for designing, preparing and distributing at its sole expense all promotional materials and advertisements used by or on its behalf of it in the promotion and marketing of the
Product. The Company shall be solely responsible for submitting, without BMS review, all promotional and advertising materials prepared by or for it to Governmental Entity for review and approval (as applicable). Notwithstanding any review or use of
any promotional or advertising materials by BMS prior to the Effective Date, the Company will be solely responsible and liable for any failure arising after the Effective Date of such materials to comply with the applicable labeling and Product
Registration and with applicable Law (including the Prescription Drug Marketing Act of 1987 (“PDMA”) and any amendments thereto), unless the failure to so comply is a result of BMS’ or its Affiliate’s act or omission with
respect to such promotional and advertising materials, including packaging errors and omissions, in which case BMS shall be solely responsible and liable. 
  
 Section 2.13. Intellectual Property; License Grant. 
  
 (a) The Company hereby grants to BMS a non-exclusive, fully paid-up and royalty-free, irrevocable, worldwide
and sublicensable right and license under its rights, title and interests in and to the Partnership Manufacturing Know-How, the Gillette Know-How and the BMS Know-How, in each case solely for purposes of manufacturing and supplying the Product
exclusively to the Company during the Term and under the provisions of this Agreement. 
  

	***	Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

  

 - 14 - 

 (b) As between the Parties, the Company shall own all right, title and interest in and to
the Partnership Manufacturing Know-How, including, without limitation, to any Improvements thereto. 
  
 (c) BMS hereby grants to Company a non-exclusive, fully paid-up and royalty-free, irrevocable, worldwide and sublicensable right and
license under its rights, title and interests in and to the BMS Manufacturing Know-How solely for the purpose of manufacturing or having manufactured the Product and any Improvements thereto for the Company’s manufacturing, marketing, sale and
distribution. 
  
 SECTION 3. 
  
 PURCHASE PRICE FOR PRODUCT 
  
 Section 3.01. Purchase Price. 
  
 (a) Except for the purchase price for the Early Batches
ordered pursuant to 2.03(a), the purchase price for commercial and sample supplies of the Product sold to the Company during the Term pursuant to Firm Orders submitted by Company shall be equal to the price set forth in Schedule
3.01(a) (as adjusted from time to time at BMS’ discretion in the event that any of the assumptions on Schedule 3.01 (a) are not satisfied and pursuant to Sections 3.01(b) and 3.01(c), the “Purchase Price”).

  
 (b) The Purchase Price for the Product shall
be fixed at the beginning of the Term, and thereafter shall be adjusted on January 1, 2005 and on each January 1 thereafter during the Term (to take effect for orders to be delivered after January 1) to be equal to *** for such calendar year as
calculated by BMS in accordance with its standard accounting procedures in or about September of the preceding calendar year. The Purchase Price may not be increased in any annual adjustment pursuant to this Section 3.01(b) in excess of *** of the
Purchase Price in effect for the immediately preceding calendar year. For the avoidance of doubt, this limitation shall not apply to any increase to the Purchase Price pursuant to an adjustment under Section 3.01(c). 
  
 (c) In addition to any Purchase Price adjustment pursuant to
Section 3.01(b), BMS shall be entitled to increase the Purchase Price for the Product at any time during the Term (to take effect for orders to be delivered after the date of such event) by giving *** prior written notice to the Company solely to
take into account, to the extent not reimbursed by the Company: (i) any increase in the *** of manufacturing the Product occasioned by a change in Specifications requested by the Company pursuant to Section 2.06(b); (ii) changes in its manufacturing
processes in response to a pronouncement of a Governmental Entity (other than as a result of non-compliance by BMS); (iii) changes resulting from a Force Majeure Event, or a change in applicable Law pursuant to Sections 2.06(c) and 2.06(d); or (iv)
to reflect unanticipated, significant, additional costs incurred upon renewal or replacement of any contract or arrangement with a Third Party for the supply of any materials or services used in the manufacture or supply of the finished Product, but
excluding for purposes of this clause (iv) any costs incurred in connection with the change of the manufacturer or source of manufacturing of the Product. In connection with any increase of the Purchase Price pursuant to the preceding sentence, BMS
shall provide reasonable documentation to the Company supporting the basis for the increase and shall use its commercially reasonable efforts to locate an alternative lower cost supplier for materials or provider of services utilized to manufacture
the Product. Since such increases may not be immediately known at the Effective Date of the price increase, the Purchase Price for any deliveries made after the Effective Date of such price increase will be invoiced and initially paid based

  

	***	Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

  

 - 15 - 

 
on the Purchase Price then in effect, with an adjustment of the Purchase Price and payment of any difference to be made once the adjustment is finally
determined. 
  
 (d) Not more frequently than once
with respect to any year in which BMS has elected to adjust the Purchase Price under Section 3.01(b) or Section 3.01(c), the Company shall have the right within twelve (12) months of such Purchase Price adjustment, to have an independent accounting
firm audit BMS’ books and records relating to such price adjustment, for the sole purpose of verifying BMS’ determination of the adjustment. Such audit shall be at reasonable times during normal business hours and upon reasonable notice to
BMS. Concurrently with the auditing firm’s furnishing of its conclusions to the Company, a copy of such conclusions shall be furnished to BMS to allow BMS an opportunity to review the accuracy of the auditing firm’s conclusions. The
parties shall cooperate with one another in good faith to resolve any disputes concerning the auditing firm’s conclusions in accordance with Section 14.03. The Company shall bear the full cost of such audit unless such audit discloses a
variance of more than *** from the amount due, in which event, BMS shall bear the full cost of such audit. Any amounts that are determined to be due and owing by BMS to the Company following such audit shall be paid within thirty (30) days
thereafter, together with any interest due thereon from the date of overpayment by the Company at the *** per annum; provided that in no event shall such rate exceed the maximum legal annual interest rate. The payment of such interest
shall not limit the Company from exercising any other rights or remedies it may have. If such audit right is not exercised by the Company within the twelve (12) month time period, then such price increase shall be deemed accepted. 
  
 SECTION 4. 
  
 PAYMENTS AND REPORTS 
  
 Section 4.01. Payment; Books and Records. 
  
 (a) BMS shall submit invoices to the Company for the Product
promptly after shipment. Each invoice shall reflect the Purchase Price less a pro-rata portion of the initial *** paid pursuant to Section 2.03 applicable to the number of batches being delivered by BMS pursuant to such invoice as compared to the
entire Firm Order. In accordance with Section 2.03, the Company shall pay *** of the Purchase Price upon ordering and the remaining balance shall be made by the Company within thirty (30) calendar days of receipt of the invoice or shipment,
whichever occurs later. In addition, BMS, in its sole discretion, shall determine, and may from time to time change without the consent of, but with notice to, the Company, the identity of the party that shall invoice the Company for any Product
supplied hereunder which shall be BMS or an Affiliate of BMS. 
  
 (b) BMS shall maintain complete and accurate books, records and accounts that, in reasonable detail, fairly reflect the calculation of *** of the Product supplied hereunder, in sufficient detail to permit (i) BMS to
prepare financial statement for the supply of Product to the Company for each calendar quarter and calendar year in conformity with GAAP and as required by Section 3.01 and (ii) the Company to confirm the accuracy of the calculation of any Purchase
Price invoiced hereunder. BMS shall retain such books, records and account for a period of not less than three (3) calendar years after the calendar year in which they are prepared. 
  
 (c) Within sixty (60) days after the end of each calendar quarter, BMS shall provide the Company with the
financial statements prepared by BMS pursuant to Section 4.0 l (b). 
  

	***	Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

  

 - 16 - 

 Section 4.02. Mode of Payment. 
  
 The Company shall make all payments required under this
Agreement by electronic transfer of immediately available United States dollars to a bank account designated by BMS. The wire transfer information for BMS is as follows: 
  
 *** 
  
 Section 4.03. Taxes. 
  
 Any and all transfer, sales, use, and other taxes imposed upon or with respect to or measured by the sale or delivery by BMS to the
Company of any Product hereunder shall be the responsibility of and for the account of the Company. Such amounts shall be included on BMS’ invoices to the Company for the Product. If BMS obtains any credit for the amounts of the tax, such
amount shall be repaid by BMS to the Company when it is received by BMS. Anything to the contrary notwithstanding, the Company shall have no obligation to pay any income tax imposed on BMS or any of its Affiliates which may arise from the
transactions contemplated by this Agreement. 
  
 Section 4.04.
Late Payments. 
  
 In the event that
any payment due hereunder (including without limitation any down payment) is not made when due, the payment shall accrue interest from the date due *** per annum, provided, that, in no event shall such rate exceed the maximum legal annual
interest rate. The payment of such interest shall not limit BMS from exercising any other rights it may have as a consequence of the lateness of any payment. 
  
 Section 4.05. Additional Payment/Past Due Sums. 
  
 In accordance with Section 4.02 and subject to Section 4.04, the Company agrees to pay BMS the Past Due Sums within *** of the Effective
Date. For the sake of clarity, BMS shall be under no obligation hereunder until the Past Due Sums are received by BMS. 
  
 SECTION 5. 
  
 COMPLIANCE WITH LAWS; REPRESENTATIONS AND WARRANTIES 
  
 Section 5.01. Compliance with Law; Cooperation. 
  
 (a) Compliance with Law. Each Party shall maintain in full force and effect all necessary licenses, permits and other
authorizations required by applicable Law to carry out its duties and obligations under this Agreement. Each Party shall comply with all Laws applicable to its activities under this Agreement, including, without limitation, any requirements of any
product license applicable to the Product and all applicable U.S. federal, state and local environmental health and safety laws then in effect. The Company shall store, market, promote, advertise and sell the Product sold to it by BMS in compliance
with all applicable Laws, including the PDMA. BMS and the Company each shall keep all records and reports required to be kept by applicable Laws. The Parties will reasonably cooperate with 
  

	***	Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

  

 - 17 - 

 
one another with the goal of ensuring fall compliance with Laws. Each Party will cooperate with the other to provide such letters, documentation and other
information on a timely basis as the other Party may reasonably require to fulfill its reporting and other obligations under applicable Laws to applicable Governmental Entity. 
  
 (b) Reasonable Cooperation. Without limiting any obligation expressly imposed on either Party
pursuant to the other provisions of this Agreement, BMS and the Company each hereby agrees to co-operate in good faith with one another, particularly with respect to unanticipated problems or contingencies, and shall perform its respective
obligations in good faith and in a commercially reasonable, diligent and workmanlike manner, and use its commercially reasonable efforts to take, or cause to be taken, all actions and to do, or cause to be done, all things necessary or proper to
make effective the transactions contemplated by this Agreement, including such actions as may be reasonably necessary to obtain approvals and consents of Governmental Entities and other Persons, provided, that, no Party shall be required to (i) pay
money (other than as expressly required pursuant to the terms and conditions of this Agreement), or (ii) assume any other material obligation not otherwise required to be assumed by this Agreement. 
  
 (c) Right to Audit. Not more frequently than
once in any calendar year, the Company shall afford BMS or BMS’ representatives, upon not less than *** prior written notice and during normal business hours of Company, reasonable access to (i) the premises where the Product is being handled
and stored, and (ii) the personnel dedicated to the handling and storing of such Product, to the extent necessary to inspect and conduct a reasonable audit thereof (the “Facility Audit”) with respect to the performance of
Company’s obligations under all applicable Laws and compliance with the handling and storing requirements of the Specifications; provided, that, such access does not unreasonably disrupt the normal operations of Company. BMS, in
its sole discretion, may make recommendations regarding the handling or storage of the Product, which may be implemented by the Company in its sole discretion. Notwithstanding this provision, all responsibility regarding the handling and storage of
the Product is with the Company once the Product is shipped from BMS’ Facility in accordance with the terms set forth in Section 2.04. 
  
 Section 5.02. BMS Representations, Warranties and Covenants. 
  
 (a) BMS represents, warrants and covenants to the Company that the Product manufactured by or for BMS and
sold to the Company under this Agreement will, at the time it is tendered to the common carrier for delivery to the Company, except to the extent such non-compliance is attributable to specific instructions received from the Company: 
  
 (i) not be adulterated or misbranded under applicable Law;

  
 (ii) meet the Specifications therefor;

  
 (iii) be manufactured, tested, labeled,
packaged, stored, handled, and shipped, in compliance in all material respects with cGMP and with any other applicable Laws, including all applicable U.S. federal, state and local environmental health and safety laws in effect at the time and place
of manufacture of the Product; 
  
 (iv) will be
free from defects in material, manufacturing and workmanship when delivered to the common carrier, provided that BMS makes no representation or warranty in this clause (iv) with respect to any defects or non-conformity that can not be
readily tested or seen; 
  

	***	Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

  

 - 18 - 

 (v) have a shelf life of not less than *** of the shelf . life set forth in Schedule
1.01. In the event that the shelf life of any Product is approved to be extended, then the Parties will discuss in good faith an adjustment to this representation to fairly reflect such extension. 
  
 (b) BMS represents and warrants to the Company that, as of
the Effective Date, there is no claim, suit or proceeding, or other investigation pending, or to the actual knowledge of BMS, threatened in writing against BMS which is likely to prevent or materially interfere with BMS’ performance under this
Agreement or materially adversely affect the rights and interests of the Company hereunder. 
  
 (c) BMS represents, warrants and covenants to the Company that BMS, its Affiliates, licensees and contractors shall adhere in all material
respects to all applicable Laws relating to the manufacture, handling, storage, and disposal by any of them of the Product. 
  
 (d) BMS represents and warrants to the Company that the prices set forth on Schedule 3.01 (a) do not exceed *** for calendar year 2002 as
calculated by BMS in accordance with its standard accounting procedures in or about September of 2001. 
  
 Section 5.03. The Company Representations, Warranties and Covenants. 
  
 The Company represents, warrants and covenants to BMS that the Company, its Affiliates, licensees and
contractors shall adhere in all material respects to all applicable Laws relating to the handling, storage, sale, distribution and disposal by any of them of the Product except to the extent such non-compliance is attributable to specific
instruction received from BMS. 
  
 Section 5.04.
Representations and Warranties of Each Party. 
  
 (a) Each Party hereby represents and warrants to the other Party as of the Effective Date as follows: 
  
 (i) such Party (A) has the power and authority and the legal right to enter into this Agreement and perform its obligations hereunder, and
(B) has taken all necessary action on its part required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder. This Agreement has been duly executed and delivered on behalf of such Party and
constitutes a legal, valid, binding obligation of such Party and is enforceable against it in accordance with its terms subject to the effects of bankruptcy, insolvency, or other laws of general application affecting the enforcement of creditor
rights and judicial principles affecting the availability of specific performance and general principles of equity, whether enforceability is considered a proceeding at law or equity. 
  
 (ii) such Party is not aware of any pending or threatened litigation (and has not received any
communication) that alleges that such Party’s activities related to this Agreement have violated, or that by conducting the activities as contemplated herein such Party would violate, any of the intellectual property rights of any other Person.

  
 (iii) all necessary consents, approvals and
authorizations of all governmental authorities and other Persons required to be obtained by such Party in connection with this Agreement have been obtained. 
  

	***	Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

  

 - 19 - 

 (iv) the execution and delivery of this Agreement and the performance of such
Party’s obligations hereunder (A) do not conflict with or violate any requirement of applicable law or regulation or any provision of articles of incorporation, bylaws or limited partnership agreement of such Party, as applicable, in any
material way, and (B) do not conflict with, violate, or breach or constitute a default or require any consent under, any contractual obligation or court or administrative order by which such Party is bound. 
  
 Section 5.05. Disclaimer of Warranties. 
  
 EXCEPT AS EXPRESSLY PROVIDED IN THIS AGREEMENT, THE ASSET
PURCHASE AGREEMENT OR ANY RELATED AGREEMENT, THERE ARE NO OTHER REPRESENTATIONS OR WARRANTIES, EXPRESS OR IMPLIED, MADE OR GIVEN BY EITHER PARTY HEREUNDER, INCLUDING, WITHOUT LIMITATION, ANY WARRANTIES OF QUALITY, PERFORMANCE, MERCHANTABILITY AND
FITNESS FOR A PARTICULAR USE OR PURPOSE OF A PRODUCT OR ABSENCE OF INFRINGEMENT OF THIRD PARTY RIGHTS WITH RESPECT TO THE MANUFACTURE, USE OR SALE OF A PRODUCT. 
  

Section 5.06. No Reliance by Third Parties. 
  
 The representations and warranties of a Party set forth in this Agreement are intended for the sole and exclusive benefit of the other
Party hereto, and may not be relied upon by any Third Party. 
  
 SECTION 6. 
  
 INDEMNIFICATION; REMEDIES FOR
BREACH 
  
 Section 6.01. BMS Indemnity.

  
 Subject to the Company’s indemnity
obligations under Section 6.02, BMS shall defend, indemnify and hold harmless the Company, its Affiliates, and its and their employees, agents, officers, and directors (a “Company Party”) from and against any and all Losses that
result from or arise in connection with any claim (including, product liability claims, strict liability or tort claims), action, suit or other proceeding made or brought by or on behalf of a Third Party against a Company Party (including claims,
actions, suits or proceedings for bodily injury, death or property damage), in any such case, based on the breach of any representation or warranty of BMS contained in Section 5.02 or breach of any material obligation of BMS of this Agreement;
provided, however, that BMS shall not be obligated to indemnify a Company Party for any Losses incurred by such Company Party to the extent attributable to any breach of this Agreement by the Company, a Company Party or the
Company’s contractors/licensees, or to any act or omission constituting gross negligence or willful misconduct on the part of the Company, a Company Party or the Company’s contractors/licensees, or any action taken by BMS or its Affiliate
upon the direction of the Company (including pursuant to amendments or modifications made to the Specifications by the Company) or to any failure of a Company Party to identify or bring to BMS’ attention a Product defect or non-conformity
actually known by such Company Party prior to the use of such Product by a Third Party. 
  
 Section 6.02. The Company Indemnity. 
  
 Subject to BMS’ indemnity obligations under Section 6.01, the Company shall defend, indemnify and hold harmless BMS, its Affiliates,
and its and their employees, agents, officers, and directors (a “BMS Party”) from and against any and all Losses that result from or arise in connection with 

  

 - 20 - 

 
(a) any claim (including product liability claims, strict liability or tort claims), action or proceeding made or brought against such BMS Party by or on
behalf of a Third Party for bodily injury, death or property damage to the extent such injury, death or damage is based on (i) the Company’s use, promotion, advertising, handling, disposal or supply of the Product after the Effective Date
(regardless of which Party manufactured it) or (ii) the Company’s breach of this Agreement; or (b) any claim, action, suit or other proceeding made or brought by a Third Party based on (i) the breach by the Company of any of its representations
or warranties contained in Section 5.03 or breach of any material obligation of Company under this Agreement, including breach of applicable Law; or (ii) infringement of a Third Party’s trademarks or copyrights by reason of Company’s
specified labeling of the Products or any materials used in promoting or advertising the Product, or (iii) in the event that any changes are made to the Product (including, without limitation, changes to the Specifications, formulation or
manufacturing process used to manufacture the Product) after the Effective Date, infringement of a Third Party’s patent rights by reason of the manufacture, use, import, export, or sale of the Product after the Effective Date of such change;
provided, however, that the Company shall not be obligated to indemnify a BMS Party for any Losses incurred by such BMS Party to the extent attributable to a breach by BMS of this Agreement, or to any act or omission
constituting gross negligence or willful misconduct on the part of BMS or a BMS Party. 
  
 Section 6.03. Limitations on Liability and Remedies. 
  
 Notwithstanding any other provision in this Agreement, no Party shall in any event be liable to the other Party or its Affiliates,
officers, directors, employees, stockholders, agents or representatives on account of any breach hereof or any indemnity obligation set forth herein for any indirect, special, consequential or punitive damages (including, but not limited to, lost
profits, loss of use, damage to goodwill or loss of business that maybe incurred or claimed by such other Party or its Affiliates, officers, directors, employees, stockholders, agents or representatives or by a Third Party for which indemnification
is sought hereunder. 
  
 Section 6.04. Control of
Proceedings. 
  
 (a) To receive the
benefits of the indemnity under Sections 6.01 or 6.02, as applicable, an indemnified Party must (i) give the indemnifying Party written notice of any claim or potential claim promptly after the indemnified Party receives written notice of any such
claim and (ii) allow the indemnifying Party to assume exclusive control of the defense and settlement (including all decisions relating to litigation, defense and appeal) of any such claim, provided, that, (i) the controlling Party has
confirmed its indemnification obligation to such indemnified Party under this Section 6.04 with respect to a given claim), and (ii) such controlling Party may not settle such claim or enter into any voluntary consent judgment in any manner that
would (w) require payment by the other Party, (x) materially adversely affect the rights granted to the other Party hereunder, (y) make any admission of wrongdoing or fault of any Party without such Party’s prior written consent, or (z)
materially conflict with the terms of this Agreement, without first obtaining the other Party’s prior written consent. 
  
 (b) The indemnified Party shall (so long as such cooperation does not vitiate any legal privilege to which it is entitled) reasonably
cooperate with the indemnifying Party in its defense of the claim (including making documents and records available for review and copying and making persons within its/his/her control available for pertinent testimony). If the indemnifying Party
defends the claim, an indemnified Party may participate in, but not control, the defense of such claim using attorneys of its/his/her choice and at its/his/her sole cost and expense. An indemnifying Party shall have no obligation or liability under
this Section 6 as to any claim for which settlement or compromise of such claim is made by an indemnified Party without the prior written consent of the indemnifying Party. 
  

 - 21 - 

 (c) If the indemnifying Party notifies the other in writing that it will not defend the
other Party against such claim asserted against the other Party, or if the indemnifying Party fails to defend or take other reasonable, timely action, in response to such claim asserted against the other Party, the indemnified Party shall have the
right, but not the obligation, to defend or take other reasonable action to defend its interests in such proceedings, and shall have the right to litigate, settle or otherwise dispose of any such claim without limiting its rights to indemnification
under this Section 6; provided, however, that the Party shall not have the right to settle such claim or enter into a consent judgment in a manner that adversely affects the rights granted to the indemnifying Party hereunder, or would
materially conflict with this Agreement, or would require a payment by the indemnifying Party without the prior written consent of the Party entitled to control the defense. 
  
 Section 6.05. Insurance. 
  
 (a) The Company will maintain comprehensive general liability insurance on a claims-made basis, with
endorsements for contractual liability and product liability with coverage limits of not less than (i) *** per occurrence or in the aggregate, at all times commencing on the Effective Date and continuing through the date that is *** following the
Effective Date, and (ii) *** per occurrence or in the aggregate, at all times from and after the date that is *** following the Effective Date and continuing during the period that any Product is being distributed or sold by or through the Company
hereunder, and for *** thereafter. The minimum level of insurance set forth herein shall not be construed to create a limit on the Company’s liability hereunder. On each of the Effective Date and the date that is sixty (60) days following the
Effective Date, the Company shall furnish to BMS a certificate of insurance evidencing such coverage as of such date. Each such certificate of insurance, as well as any certificates evidencing new or modified coverages of the Company, shall include
a provision whereby sixty (60) days written notice must be received by BMS prior to coverage modification or cancellation by either the Company or the insurer. In addition, the Company shall promptly notify BMS of any cancellation or modification of
such insurance coverage and of any new or modified coverage. In the case of a modification or cancellation of such coverage, the Company shall promptly provide BMS with a new certificate of insurance evidencing that the Company’s coverage meets
the requirements in the first sentence of this Section. 
  
 (b) BMS will maintain at all times during the period that any Product is being supplied to the Company by BMS, and is being manufactured by or for BMS, and for *** thereafter, a commercially reasonable program of
self-insurance and insurance consistent with, or more comprehensive than, industry standards on a claims-made basis with respect to its obligations under this Agreement. BMS further agrees that the Company shall have the benefit of an additional
insured party of not less than the first *** per occurrence or in the aggregate in any policies of insurance maintained by BMS with respect to product liability relating to the Product, including the equivalent of such status as an additional named
insured party for purposes of BMS’ self- insurance. 
  
 Section 6.06. Other Limitations on Liability. 
  
 (a) Any action for breach of this Agreement by a Party arising during the Term must be commenced within twelve (12) months after the end of the Term, provided nothing in this Section 6.06(a) shall apply to any claim
by either Party for indemnification under Section 6.01 or 6.02, or to any claim by either Party for breach of the other Party’s indemnity obligation. 
  
 (b) BMS and the Company shall cooperate with each other in resolving any claim or liability with respect to which a Party is obligated to
indemnify the other under this Agreement, 
  

	***	Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

  

 - 22 - 

 
including without limitation, by making commercially reasonable efforts to mitigate or resolve any such claim or liability. 
  
 Section 6.07. Calculation of Losses. 
  
 The amount of any Loss for which indemnification is provided
under Section 6.01 or Section 6.02 shall be net of any amounts actually recovered by the indemnified party under insurance policies (after reduction for any costs or expenses incurred in connection therewith, including, retrospective and prospective
premium adjustments, experience-based premium adjustments) with respect to such Loss, and shall be reduced to take account of any net tax benefit of the indemnified party arising from the occurrence or payment of any such Loss which is actually
recognized via a reduction of income tax liability that would have otherwise been due in the tax year such Loss is claimed (or, if applicable, in a prior year as a result of a carryback) on the indemnified party’s federal and state income tax
returns or within the four (4) succeeding tax years of the indemnified party. In computing the amount of such net tax benefit, the indemnified party shall be deemed to recognize all other items of income, gain, loss, deduction or credit before
recognizing any item arising from the receipt or accrual of the right to receive any indemnity payment under Section 6.01 or Section 6.02 or the incurrence or payment of any indemnified Loss. Further, if a net tax benefit results in a tax year after
the tax year the loss was originally claimed by the indemnified party, the net tax benefit shall be computed by computing the present value thereof using a discount rate of ***. Any indemnity payment under Section 6.01 or Section 6.02 shall be
treated as an adjustment to the Purchase Price for tax purposes, unless a final determination with respect to the indemnified party or any of its Affiliates causes any such payment not to be treated as an adjustment to such price for federal income
tax purposes. 
  
 SECTION 7. 
  
 COMPLIANCE WITH GOVERNMENT REGULATIONS 
  
 Section 7.01. Government Communications. 
  
 BMS shall be responsible for all communications with any
Governmental Entity relating to BMS’ manufacturing activities, including Facility inspections by Governmental Entities, under this Agreement and the Company shall be responsible for all communication with any Governmental Entity concerning the
marketing, distribution, or sale of the Product; provided that the parties agree that the Company and not BMS shall be responsible for and shall engage in all communications with Governmental Entities with respect to the Product Registrations,
unless BMS is required to participate in any communications by any Governmental Entity. 
  
 Section 7.02. Access to Records. 
  
 The Company shall have, in connection with any Audit under Section 7.04, reasonable access to BMS’ files, during normal business
hours, from time to time upon reasonable prior notice, to review all such records, correspondence, notices, documents, and other materials (including warning letters and letters of adverse findings) relating to the manufacture of the Product;
provided, however, that such access does not unreasonably disrupt the normal operation of BMS. 
  
 Section 7.03. Governmental and Regulatory Inspections. 
  
 BMS shall notify the Company immediately by telephone and in writing of any inspections conducted by any
Governmental Entity of the premises where the Product is being manufactured, to the extent such inspection relates to the manufacture of the Product, and shall provide to 
  

	***	Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

  

 - 23 - 

 
the Company copies of all correspondence, reports, notices, findings and other material pertinent to such inspections and that specifically relate to the
Product. BMS may redact portions that do not specifically relate to the Product. 
  
 Section 7.04. The Company Inspections. 
  
 BMS shall, or if BMS is not manufacturing the Product, BMS shall use its commercially reasonable efforts to cause the Person manufacturing
such Product to afford the Company or the Company’s representatives, upon not less than *** prior written notice and during normal business hours for BMS or such Person, and not more than *** per calendar year (such Audit to cover all Products
and all Facilities), reasonable access to (i) the premises where the Products are being tested and/or manufactured, and (ii) the personnel dedicated to the manufacturing, processing, analytical testing, packaging, labeling and storing of such
Product, to the extent necessary to inspect and conduct a reasonable audit (“Audit”) thereof with respect to the performance of BMS’ obligations hereunder; provided, that, such access does not unreasonably disrupt
the normal operations of BMS or such other manufacturer. Such Audit shall be carried out in a manner that ensures the continued confidentiality of BMS’ business and technical information, including the execution of such appropriate
confidentiality agreements as BMS may reasonably request in advance of any such Audit. Within *** calendar days of completing any such Audit hereunder, the Company shall submit to BMS a written report outlining its findings and/or observations from
any such Audit. If deficiencies are discovered during an Audit that could, in the Company’s opinion, prevent BMS from satisfying its supply obligations hereunder, and BMS in good faith disputes the observations or conclusions of the Company,
then the Parties shall promptly enter into good faith discussions to resolve their differences. 
  
 Section 7.05. Regulatory Matters. 
  
 (a) General Compliance. BMS will, at its sole expense, comply with all Laws applicable to production, testing,
storage, shipment, and record keeping by BMS of the Product and its performance of its obligations hereunder, including all applicable Laws or requirements under any applicable Product Registrations or Manufacturing Facility Registrations. During
any period that BMS manufactures the Product for the Company, except as otherwise expressly set forth in this Agreement, (i) BMS will pay any fees necessary to obtain and maintain Manufacturing Facility Registrations and any other licenses,
registrations, permits, exemptions, allowances, authorizations, or approvals from a Governmental Entity which are applicable to a Facility used by BMS to manufacture the Product, and (ii) the Company shall pay all other fees, costs or expenses
necessary to maintain or obtain licenses, registrations, permits, exemptions, allowances, authorizations, or approvals from a Governmental Entity which are applicable to the use, promotion, advertising or sale of such Product, including all NDA user
fees (or similar or substitute fees) applicable to the Product, other than facilities or establishment fees not specific to the Product. During any period that the Company maintains the Product Registration and manufactures the Product, the Company
will, at its sole expense, comply with all Laws applicable to it with respect to the production, testing, storage, shipment, and recordkeeping of the Product, including all applicable Laws or requirements under any applicable Product Registrations
or Manufacturing Facility Registrations and will, except as otherwise expressly set forth in this Agreement, pay all filing, user and similar (or substitute) fees required in connection with obtaining, maintaining, changing or supplementing any
applicable Product Registration or Manufacturing Facility Registration. At the Company’s request, BMS shall cooperate with the Company in (i) maintaining any applicable Product Registration, including cooperation in the preparation of NDA
annual reports with respect to the Product, and (ii) responding to any Governmental Entity inquiry or request for inspection. 
  
 (b) Validations and Qualifications. BMS will perform, ***, process and cleaning validation, analytical methods validation,
installation/operating qualification, and calibration of all equipment and Facilities utilized in the manufacture, packaging, labeling, testing, 
  

	***	Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

  

 - 24 - 

 
storing, and release of finished Product in accordance with all Laws. The Parties acknowledge and agree that BMS will ***. The Company will have right to
review the results thereof during an Audit or in conjunction with a new process or equipment. In general, BMS will, at all times in the performance of its obligations hereunder, comply with its standard operating procedures for the Product and will
make copies of such standard operating procedures available to the Company for review during Company Audits permitted hereunder. 
  
 (c) Batch Records. Batch records, including information relating to the manufacturing, packaging, labeling, and quality
control testing and analysis for each lot of finished Product produced hereunder, will be prepared as and when BMS performs any such tasks, in accordance with applicable Laws and BMS’ then current standard operating procedures. Batch records
and all other records relating to production hereunder shall be retained by BMS for the period required by applicable Laws. Batch records for any SKU of the Product, as well as updates to the validation package for the Product, will be made
available during an Audit. Upon request of the Company not more than once every calendar quarter, BMS will copy and provide to the Company batch records for each SKU of the Product. 
  
 SECTION 8. 
  
 STABILITY; PRODUCT RECALLS; ADVERSE EXPERIENCES; 
 PRODUCT QUALITY COMPLAINTS; AND MEDICAL INQUIRIES 
  
 Section 8.01. Stability and Quality Control. 
  
 (a) Except as otherwise provided in Section 8.01(b), BMS will be responsible, ***, for taking and maintaining quality control and stability samples in support of the Product Registrations for the Product, and for
testing stability samples on a timely basis in accordance with applicable Law, the Product Registrations and BMS’ then current standard operating procedures. The Parties acknowledge and agree that BMS will ***. BMS will make available the
stability data (i) for the Product for review by the Company during any Audit (if the Company gives BMS reasonable notice to collect and organize same), (ii) in a form suitable for inclusion in the Company’s NDA annual reports with respect to
the Product, and as otherwise reasonably requested by the Company upon the occurrence of an event that may reasonably be expected to materially and adversely affect the quality or validity of the stability data. BMS further agrees to maintain all
stability data with respect to the Product in accordance with applicable Laws. BMS will notify the Company promptly (but at least within at least three (3) business days of BMS’ initiation) of an internal investigation of a stability failure
with regard to the Product. 
  
 (b) The Parties
acknowledge that, pursuant to a requirement made by the FDA, BMS conducted a post-marketing stability study with respect to the Product (the “Stability Study”). Notwithstanding any other provision in the Agreement, BMS will be
responsible, ***, to complete the Stability Study, to prepare all reports required to be submitted to the FDA with respect to the Stability Study, and to handle all communications with the FDA relating to the Stability Study and changes to the
Specifications resulting therefrom which ***; provided that BMS shall consult with the Company with respect thereto and shall not agree to any changes to the Specifications without the Company’s consent, which shall not be unreasonably withheld
or delayed. In the event that any changes to the Specifications are required by the FDA, the Company shall reimburse BMS for *** to implement such change. 
  

	***	Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

  

 - 25 - 

 Section 8.02. Product Recalls. 
  
 In the event that the Company obtains information that a
Product or any portion thereof should be alleged or proven not to meet the Specifications, labeling or Product Registration for such Product, Company shall notify BMS immediately after the Company obtains such information and both Parties shall
cooperate fully regarding the investigation and disposition of any such matter. BMS and the Company shall each maintain such traceability records as are sufficient and as may be necessary to permit a recall, product withdrawal or field correction of
any Product. In the event (a) any applicable regulatory authority should issue a request, directive or order that a Product be recalled or withdrawn, (b) a court of competent jurisdiction orders such a recall or withdrawal or (c) (i) the Company
determines that any Product already in interstate or international commerce presents a risk of injury or deception or is otherwise defective and that recall or withdrawal of such Product is appropriate or (ii) BMS determines that any Product already
in interstate or international commerce presents a risk of injury or deception or is otherwise defective and that recall or withdrawal of such Product is appropriate and such determination is consented to in writing by the Company (each of the
events in (a), (b) and (c), a “Recall”), each Party shall give telephonic notice (to be confirmed in writing) to the other within twenty-four (24) hours of the receipt of notice of any such event. The Company shall have sole
responsibility for carrying out the Recall, and shall consult with BMS in determining, and thereafter use commercially reasonable efforts in taking, all corrective action in connection with a Recall. Each Party will provide full cooperation and
assistance to the other Party in connection therewith as may be requested by the other Party, including, in the case of the Company, providing BMS within two (2) business days of receipt by the Company of notice of the Recall a list of customers who
received any recalled or withdrawn Product. The Company shall be responsible *** except to the extent such Recall is attributable to BMS’ failure to manufacture the Product in accordance with Section 5.02(a) in which event BMS shall *** that are so attributable to such actions by BMS. Otherwise, all Recalls or withdrawals shall be solely the responsibility of
the Company. 
  
 Section 8.03. Adverse Experience.

  
 During the Term, each Party shall
promptly notify the other Party of any significant adverse events that relate to the Product or are required in accordance with the regulations of relevant Governmental Entities, including adverse drug experiences and governmental inquiries, and
each Party shall cooperate with the other Party in connection therewith as reasonably requested by the other Party and as follows: 
  
 (a) Serious Adverse Events for the Product of which one (1) Party becomes aware shall be submitted to the other Party within three (3)
business days but no more than four (4) calendar days from the date the first-mentioned Party first became aware of such Serious Adverse Event. Non-Serious Adverse Events for the Product that are reported to one (1) Party shall be submitted to the
other Party no more than one (1) month from the date received by the first-mentioned Party; provided, however, that medical and scientific judgment should be exercised in deciding whether expedited reporting is appropriate in other
situations, such as important medical events that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the patient or may require intervention to prevent a Serious Adverse Event outcome. BMS shall timely
provide to the Company any and all data in BMS’ possession relating to the Product manufactured for the Company by BMS or its Affiliate which is necessary for the Company to timely complete and submit any adverse event report. 
  

	***	Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

  

 - 26 - 

 (b) Until the reporting procedures referenced in Section 8.03(d) herein have been
instituted by the Parties, a “Serious Adverse Event” for the Product shall have the meaning set forth in 21 C.F.R. § 314.80(a), as amended from time to time, and a “Non-Serious Adverse Event” for the Product is
defined as an untoward medical occurrence at any dose of the Product that is not a Serious Adverse Event. 
  
 (c) The Company shall have the reporting responsibility for such events as provided under applicable Laws to applicable regulatory health
authorities. The Company shall report all Serious Adverse Events and all Non-Serious Adverse Event involving the Product learned by it to: 
  
 Director of Quality and Compliance Consolidated Services 
 Bristol-Myers Squibb Company 
 P.O. Box 5400 
 Mail Stop HW19-1.01 
 Princeton, New Jersey 08543-5400 
 U.S.A. 
 Email address: worldwide.safety@bms.com 
 Facsimile No.: (609) 818-3804 
 Telephone No.: (609) 818-3737 
  
 BMS shall report all Serious Adverse Events and all Non-Serious Adverse Events involving the Product learned by it to: 
  
 SkinMedica, Inc. 
 5909 Sea Lion Place, Suite H 
 Carlsbad, CA 92008 
 Facsimile No.: (760) 448-3603 
 Telephone No.: (760) 448-3660 
 Attention: Dennie W. Dyer, Vice President, Operations

  
 A CIOMS-I form or a form that contains the
data elements of a CIOMS-I form is recommended. 
  
 (d) As soon as reasonably practicable after the Effective Date, the Parties shall discuss and develop mutually acceptable guidelines and procedures for the receipt, recordation, reporting, communication (as between the parties) and exchange
of Serious Adverse Event and Non- Serious Adverse Event information, as applicable, to the other Party; provided that the Company shall have exclusive responsibility for communications with Governmental Entities concerning Serious
Adverse Event and Non-Serious Adverse Event information related to the Product. The Parties shall bear their respective costs incurred in connection with receiving, recording, reviewing, reporting, communicating and exchanging with each other
regarding and, as applicable, reporting and responding to Adverse Events. 
  
 (e) At the request of BMS, the Company shall cease reporting all Serious Adverse Events and all Non-Serious Adverse Events involving the Product to BMS. BMS shall continue to make such reports to the Company in
accordance with Section 8.03. 
  
 Section 8.04. Product
Quality Complaints. 
  
 (a) The Company
shall have sole responsibility, at its expense, for responding to all Product Quality Complaints received from Third Parties. BMS shall reimburse the Company for *** incurred by the Company for any Product Quality Complaint solely due to a

  

	***	Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

  

 - 27 - 

 
breach of BMS’ representations and warranties set forth in Section 5.02; otherwise the Company shall bear its own expense of responding to Product
Quality Complaints. BMS shall cooperate to effect any resolutions with respect to the Product Quality Complaint. “Product Quality Complaint” is defined as any complaint that questions the purity, identity, potency or quality of the
Product, its packaging, or labeling, or any complaint that concerns any incident that causes the drug product or its labeling to be mistaken for, or applied to, another article or any bacteriological contamination, or any significant chemical,
physical, or other change or deterioration in the distributed drug product, or any failure of one or more distributed batches of the drug product to meet the specifications therefor in the Product Registration. 
  
 (b) Where the subject matter of the Product Quality
Complaint relates in any way to the responsibilities of a Party under this Agreement or the duties performed by a Party hereunder, such Party will, within three (3) business days from receipt of written notice from the other Party or receipt by such
Party of any other information from a Third Party constituting the Product Quality Complaint, initiate a complaint investigation at such Party’s expense. Such Party will conduct such investigation expeditiously. The investigating Party will
report its findings to the other Party’s contact listed in Section 8.04(c) or (d) below, as the case may be, within thirty (30) calendar days. 
  
 (c) The Company shall inform BMS’ contact of any Product Quality Complaint received by it within three (3) business days from the
receipt date by the Company. Such information shall be sent to BMS as set forth below: 
  
 Director of Quality and Compliance Consolidated Services 
 Bristol-Myers Squibb Company 
 P.O. Box 5400 
 Mail Stop HW19-1.01

 Princeton, New Jersey 08543-5400 
 U.S.A. 
 Email address: worldwide.safety@bms.com 
 Facsimile No.: (609) 818-3804 
 Telephone No.: (609) 818-3737 
  
 (d) BMS shall inform the Company’s contact of any
Product Quality Complaint received by it within three (3) business days from the receipt date by BMS. Such information shall be sent to the Company as set forth in Section 8.03(c) below: 
  
 SkinMedica, Inc. 
 5909 Sea Lion Place, Suite H 
 Carlsbad, CA 92008 
 Facsimile No.: (760) 448-3603 
 Telephone No.: (760) 448-3660 
 Attention: Dennie W. Dyer, Vice President, Operations 
  
 (e) Nothing in this Section 8.04 is intended to limit, alter or restrict a Party’s reporting obligations under applicable Law.

  
 Section 8.05. Medical Inquiries. 
  
 The Company shall have sole responsibility, at its expense,
for handling all medical inquiries concerning the Product. BMS shall provide to the Company all medical inquiry files and shall refer all routine medical information requests in writing to the Company and all urgent medical 

  

 -28- 

 
information requests to the Company by telephone within three (3) business days of receipt by BMS. Such information shall be sent to the Company as set forth
below: 
  
 SkinMedica, Inc. 
 5909 Sea Lion Place, Suite H 
 Carlsbad, CA
92008 
 Facsimile No.: (760) 448-3603 
 Telephone No.: (760)448-3660 
 Attention: Dennie W. Dyer, Vice President, Operations 
  
 Section 8.06. Disclosure Information. 
  
 Both Parties shall be entitled to share information reported
to one another under Sections 8.03, 8.04 and 8.05 with their Affiliates and licensees to the extent required to meet reporting requirements under applicable Laws with respect to the marketing, use and sale of any Product. In addition, such
information may be disclosed by one Party upon the prior written consent of the other Party to any Third Party who manufactured a pertinent component of the applicable Product for BMS in connection with an investigation of an adverse event or
Product Quality Complaint. 
  
 SECTION 9. 
  
 CONFIDENTIALITY 
  
 Section 9.01. Confidentiality Requirement. 
  
 (a) Each Party acknowledges that it may receive confidential
or proprietary information of the other Party in the performance of this Agreement Each Party shall use commercially reasonable efforts to safeguard and to hold such information received by it from the other Party in confidence, and shall limit
disclosure of the furnishing Party’s information to those employees and consultants of the receiving Party and its Affiliates who are bound by a written obligation of confidentiality to the receiving Party that is consistent with the terms of
this Section 9. Each Party shall not, directly or indirectly, disclose, publish or use for the benefit of any Third Party or itself, except in carrying out its duties hereunder or as otherwise provided in Section 9.02, any confidential or
proprietary information of the other Party, without first having obtained the furnishing Parry’s written consent to such disclosure or use. “Confidential Information” shall include know-how, scientific information, clinical
data, efficacy and safety data, adverse event information, formulas, methods and processes, specifications, pricing information (including discounts, rebates and other price adjustments) and other terms and conditions of sales, customer information,
business plans, and all other intellectual property. This restriction shall not apply to any information within the following categories: 
  
 (i) information that is known to the receiving Party or its Affiliates prior to the time of disclosure to it, to the extent evidenced by
written records or other competent proof; 
  
 (ii) information that is independently developed by employees, agents, or independent contractors of the receiving Party or its Affiliates without reference to or reliance upon the information furnished by the disclosing Party, as evidenced
by written records or other competent proof; 
  

 -29- 

 (iii) information disclosed to the receiving Party or its Affiliates by a Third Party
that has a right to make such disclosure; or 
  
 (iv) any other information that becomes part of the public domain through no fault or negligence of the receiving Party. 
  
 The receiving Party shall also be entitled to disclose the other Party’s Confidential Information (1) that is required to be
disclosed in compliance with applicable Laws (including to comply with SEC, NYSE or stock exchange disclosure requirements) or by order of any Governmental Entity, (2) as may be necessary or appropriate in connection with the enforcement of this
Agreement or (3) as may be necessary for the conduct of clinical studies, provided that the Party disclosing such information shall promptly notify the other Party and shall use commercially reasonable efforts to obtain confidential treatment
of such information by the agency or court or other disclosee, and that, in the case of disclosures under (1), shall (i) provide the other Party with prompt prior notice of the proposed disclosure such that the other Party may seek a protective
order or other appropriate remedy and (ii) provide the other Party with a copy of the proposed disclosure in sufficient time to allow reasonable opportunity to comment thereon. 
  
 (b) The obligations set forth in this Section 9.01 shall survive the termination or expiration of this
Agreement. Nothing in this Section 9 shall be construed to create or imply any right or license under any patent rights, trademarks, copyrights or other intellectual property rights owned or controlled by a Party or its Affiliates except as may be
expressly set forth in the other Sections of this Agreement. 
  
 (c) The confidentiality obligations set forth in this Section 9 shall supercede the confidentiality obligations set forth in the confidentiality agreement dated as of February 18, 2002 between the Company and BMS, and
shall govern any and all information disclosed by either Party to the other pursuant thereto and shall be retroactively effective to the date of such confidentiality agreement. 
  
 Section 9.02. Use of Information. 
  
 Each Party shall use, and cause each of its Affiliates to use, any Confidential Information obtained by it
from the other Party or their respective Affiliates, pursuant to this Agreement or otherwise, solely in connection with the transactions contemplated hereby. The Company may use any chemistry, manufacturing and controls information and any
information set forth in any registration dossier held by BMS relating to any Product for the purpose of enabling and assisting the Company to commence manufacturing any such Product. 
  
 Section 9.03. Relief. 
  
 Each Party shall be entitled, in addition to any other right or remedy it may have, at law or in equity, to
an injunction, without the posting of any bond or other security, enjoining or restraining any other Party from any violation or threatened violation of this Section 9. 
  

 -30- 

 SECTION 10. 
  
 TERMINATION 
  
 Section 10.01. Term. 
  
 This Agreement shall become effective as of the Effective Date and shall expire, if not earlier terminated, on the earlier of (i) the date
when no Party has any further obligations or rights hereunder; or (ii) upon the third anniversary of the Agreement Date with respect to supply of the Product for marketing, distribution, sale and use in the Territory (the “Initial
Term”). The Initial Term shall automatically be extended for successive one-year periods unless either Party has given written notice of non-extension to the other Party twelve (12) months prior to the end of the Initial Term or any such
successive one-year period (each, a “Renewal Term”). The Initial Term and each Renewal Term shall be collectively referred to as the “Term”. 
  
 Section 10.02. Breach. 
  
 Failure by either Party to comply in any material respect with any of its material obligations contained in
this Agreement shall entitle the other Party, if it is not in material default hereunder, to give to the Party in default written notice specifying the nature of the default and requiring it to cure such default. If such default is not cured within
*** after the receipt of such notice (or, if such default cannot be cured within such *** period, if the Party in default does not commence and diligently continue substantive actions to cure such default), the notifying Party shall be entitled,
without prejudice to any of its other rights conferred on it by this Agreement and in addition to any other remedies available to it by law or in equity (except as provided in Section 6), to terminate this Agreement by giving written notice to take
effect immediately upon delivery of such notice. 
  
 Section
10.03. Bankruptcy. 
  
 In the event
that a Party shall have become insolvent or bankrupt, or shall have made an assignment for the benefit of its creditors, or there shall have been appointed a trustee or receiver of such Party for all or a substantial part of its property, or any
case or proceeding shall have been commenced or other action taken by or against such Party (as to which, if involuntarily commenced against such Party, such Party would not be able to obtain dismissal within ninety (90) days after commencement
thereof) in bankruptcy or seeking reorganization, liquidation, dissolution, winding-up, arrangement, composition or readjustment of its debts or any other relief under any bankruptcy, insolvency, reorganization or other similar act or Law now or
hereafter in effect, then such Party shall not be relieved in any respect of its obligations hereunder, and, in addition to any other remedies available to it by law or in equity, the other Party may terminate this Agreement, in whole or in part as
the terminating Party may determine, by written notice to such Party. 
  
 Section 10.04. Effect of Termination. 
  
 (a) Upon expiration or termination of the Term, BMS shall manufacture and ship, and the Company shall purchase from BMS any quantities of Product which have been ordered pursuant to Section 2.03(a) or Firm Ordered through the effective date
of termination, including any raw materials and working inventory costs that have been incurred by BMS in connection with such Firm Orders. In addition the Company shall have the right, by giving notice to BMS of its exercise of such right within
*** after the effective date of such expiration or termination, to purchase. from BMS (i) any additional quantities of Product in BMS’ inventory that are in finished form within *** after such effective date of termination, at the Purchase
Price as of such date in accordance with 
  

	***	Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

  

 -31- 

 
Section 3.01; (ii) any bulk drug substance inventory at *** therefor; and (iii) BMS’ inventory of any materials used in the manufacture of Product in
finished form other than bulk drug substance at *** therefore. 
  
 (b) Without limiting either Party’s right to damages for any breach of this Agreement, neither BMS nor the Company shall incur any liability to the other by reason of the expiration or termination of the Term or
this Agreement as provided herein, whether for loss of goodwill, anticipated profits or otherwise, and, subject to Section 10.05, BMS and the Company shall accept all rights granted and all obligations assumed hereunder, including those in
connection with such expiration or termination in full satisfaction of any claim resulting from such expiration or termination. 
  
 (c) Any acceptance by BMS of any Firm Order from the Company or the sale of the Product by BMS to the Company after the delivery of notice
of termination or after the expiration or termination of the Term for such Product shall not be construed as a renewal or extension of this Agreement or as a waiver of termination thereof. 
  
 (d) The license granted to BMS pursuant to Section 2.13(a)
shall immediately terminate upon termination or expiration of the Term and BMS and its Affiliates and their agents shall cease any and all use of the Company Confidential Information relating thereto. 
  
 Section 10.05. Accrued Rights, Surviving Obligations.

  
 (a) Termination, relinquishment or
expiration of the Term or of this Agreement for any reason shall be without prejudice to any rights which shall have accrued to the benefit of either Party prior to such termination, relinquishment or expiration, and such termination, relinquishment
or expiration shall not relieve either Party from obligations which are expressly indicated to survive termination or expiration of the Term or of this Agreement. 
  
 (b) Without limiting Section 10.05(a), termination, relinquishment or expiration of this Agreement, in whole
or in part, shall not terminate the Company’s obligation to pay the Purchase Price for, and BMS’ obligation to supply, Product which has been sold to the Company or Product which has been ordered by Firm Order prior to the effective date
of termination. All the Parties’ rights and obligations under Sections 4, 5,6,7,8, 9,12,13 and 14, Sections 2.13(b), 3.01(b) and this Section 10.05 (as applicable) shall survive termination or expiration hereof. 
  
 SECTION 11. 
  
 FORCE MAJEURE 
  
 Any delays in performance by any Parry under this Agreement shall not be
considered a breach of this Agreement if and to the extent caused by occurrences beyond the reasonable control of the Party affected, including acts of God, embargoes, governmental restrictions, inability to obtain material, fire, flood, earthquake,
hurricanes, storms, tornadoes, explosion, riots, wars, civil disorder, failure of public utilities or common carriers, labor disturbances, rebellion or sabotage (each, a “Force Majeure Event”). The Party suffering the
occurrence of a Force Majeure Event shall immediately notify the other Party as soon as practicable of such inability and of the period for which such inability is expected to continue, and any time for performance hereunder shall be extended by the
actual time of delay caused by such Force Majeure Event, provided, that, the Party suffering such Force Majeure Event uses commercially reasonable efforts to mitigate any such delay. The Party giving such notice shall thereupon be
excused from such of its obligations under this Agreement as it is thereby disabled from performing, and shall have no liability for such non-performance, for so long as it is so disabled and the thirty (30) 
  

	***	Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

  

 -32- 

 
calendar days thereafter. Where a Force Majeure Event is reasonably foreseeable, the Party affected by the event shall use commercially reasonable efforts to
mitigate or prevent the effects of such foreseeable Force Majeure Event in light of the nature of the Force Majeure Event and the amount of time reasonably available to it to prepare for same. 
  
 In the event of BMS’ inability to supply the Company due to a Force
Majeure Event, the Company shall have the right to obtain its supply of the Product from an alternate supplier and, in the event a Force Majeure Event prevents BMS’ performance under this Agreement for ninety (90) consecutive calendar days, the
Company may terminate this Agreement immediately upon written notice to BMS; provided that in such event, the Company: (a) shall purchase from BMS any additional quantities of Product in BMS’ inventory that are in finished form and meet the minimum shelf life requirements set forth in Section 5.02(a)(v), within thirty (30) calendar days after
the effective date of such termination, at the Purchase Price as of such date in accordance with Section 3.01; (b) shall purchase BMS’ inventory of any materials used in the manufacture of Product in finished form other than bulk drug substance
at BMS’ acquisition cost therefor, as indicated by supporting documentation reasonably satisfactory to the Company; and (c) shall have the right, by giving notice to BMS of its exercise of such right within thirty (30) days after the effective
date of such termination, to purchase from BMS any bulk drug substance inventory at BMS’ acquisition cost therefor, as indicated by supporting documentation reasonably satisfactory to the Company. 
  
 SECTION 12. 
  
 TECHNICAL ASSISTANCE 
  
 Section 12.01. Technical Assistance. 
  
 (a) During the Term and the six (6) month period immediately
following the expiration or termination of this Agreement, upon request of the Company, BMS shall provide the Company (and/or the Company’s designee), at Company’s expense, with the assistance of its employees and access to its other
internal resources to provide the Company with a reasonable level of technical assistance and consultation in connection with the transfer of the Product to, and regulatory qualification of, a finished goods supplier of the Company’s election.
BMS and the Company shall arrange a meeting within six (6) months after the Effective Date to begin discussions concerning such transfer and qualification. 
  
 (b) During the Term and promptly after termination or expiration of the Term, upon request of the Company, BMS shall provide the Company
(and/or the Company’s designee) with copies of all standard operating procedures, technology, documents, data, or other information that constitutes BMS Manufacturing Know-How, including (i) any Manufacturing Know-How identify by the Company as
not being conveyed pursuant to that certain Asset Purchase Agreement between the Company and WFHC; and (ii) all BMS Manufacturing Know-How that was not previously provided to the Company pursuant to the License Agreement. Following termination or
expiration of the Term, BMS and its Affiliates shall not use any Manufacturing Know-How other than BMS Manufacturing Know-How, for any purpose, and shall keep it confidential to the extent required by Section 9. With respect to all documents, data
and other information provided in accordance with the preceding sentence; (i) BMS shall be responsible for the cost of providing a reasonable number of sets of copies only; and (ii) in addition to paper and other tangible copies, BMS shall, upon the
Company’s request, also provide to the Company electronic copies of such documents, data and other information, provided, that, BMS or its Affiliates have electronic copies thereof, and provided, further, that BMS
shall have no obligation to reformat or otherwise alter or modify any such materials in order to provide them to the Company (or the Company’s designee). 
  

 -33- 

 (c) Any Third Party manufacturer the Company may designate to manufacture the Product
shall be required to sign a customary and appropriate confidentiality agreement with BMS with respect to the nondisclosure and use of any Manufacturing Know-How that constitutes BMS Know-How. 
  
 (d) During the period referred to in Section 12.01(a), BMS
will use its commercially reasonable efforts to provide up to *** man-hours of on-site consulting advice (including travel time) at the facilities of the Company or its designees with respect to manufacturing sites and the conduct of tests, studies
and assays required for the transfer of manufacturing of the Product to the Company or its designee at BMS’ ***. BMS and the Company shall negotiate in good faith a separate fee to be paid by the Company to BMS in the event additional man-hours
of such consulting advice is required by the Company or its designee. 
  
 SECTION 13. 
  
 NOTICES 
  
 All notices and other communications required or permitted to be given under
this Agreement shall be in writing and shall be delivered personally or sent by (a) registered or certified mail, return receipt requested; (b) a nationally recognized courier service guaranteeing next-day delivery, charges prepaid; or (c) facsimile
(with original promptly sent by any of the foregoing manners). Any such notices shall be addressed to the receiving Party at such Parry’s address set forth below, or at such other address as may from time to time be furnished by similar notice
by either Party: 
  

	 	(a)	if to BMS, to: 

  
 Bristol-Myers Squibb Company 
 1 Squibb
Drive 
 New Brunswick, NJ 08901 
 Telephone: (732) 227-7758 
 Facsimile: (732) 227-3874 
 Attention: Senior Counsel, Technical Operations 
  

	 	(b)	if to the Company, to: 

  
 SkinMedica, Inc. 
 5909 Sea Lion Place, Suite
H 
 Carlsbad, CA 92008 
 Facsimile No.: (760) 448-3603 
 Telephone No.: (760) 448-3660 
 Attention: Dennie W. Dyer, Vice President, Operations 
  

	***	Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

  

 -34- 

 with a copy to: 
  
 Morrison & Foerster LLP 
 1290 Avenue of the Americas 
 New York, New York 10104-0050 
 Facsimile No.: (212) 468-7900 
 Telephone No.:
(212) 468-8233 
 Attention: Priscilla Hughes, Esq. 
  

All notices shall be effective upon such personal delivery or delivery to such courier, upon transmission by facsimile, or three (3) days after it is
sent by such registered or certified mail, as the case may be. Copies shall be sent in the same manner as originals. 
  
 SECTION 14. 
  
 MISCELLANEOUS PROVISIONS 
  
 Section 14.01.
Assignment. 
  
 Except as expressly
permitted by Section 2.06 of this Agreement, neither Party shall assign or otherwise transfer this Agreement or any interest herein or right hereunder without the prior written consent of the other Party, and any such purported assignment, transfer
or attempt to assign or transfer any interest herein or right hereunder shall be void and of no effect; provided, however, each Party (i) may assign its rights and obligations hereunder to one of its Affiliates without the prior
consent of the other Party (although, in such event, the assigning Party shall remain primarily responsible for all of its obligations and agreements set forth herein, notwithstanding such assignment); and (ii) may assign its rights and obligations
to a successor (whether by merger, consolidation, reorganization or other similar event) or purchaser of the Facilities and/or all or substantially all its business assets relating to the Product, provided, that, such successor or
purchaser has agreed in writing to assume all such Party’s rights and obligations hereunder and a copy of such assumption is provided to the other Party. Notwithstanding the foregoing, the Company may pledge and grant a security interest in any
of the Company’s rights and interests in the Products, including under this Agreement. 
  
 Section 14.02. Non-Waiver. 
  
 Any failure on the part of a Party to enforce at any time or for any period of time any of the provisions of this Agreement shall not be deemed or construed to be a waiver of such provisions or of any right of such
Party thereafter to enforce each and every such provision on any succeeding occasion or breach thereof. 
  
 Section 14.03. Dispute Resolution. 
  
 The Parries recognize that a bona fide dispute as to certain matters may from time to time arise during the Term which relates to either
Party’s rights and/or obligations hereunder. In the event of the occurrence of such a dispute, either Party may, by notice to the other Party, have such dispute referred to their respective officers designated below, or their successors, for
attempted resolution by good faith negotiations within thirty (30) days after such notice is received. Such designated officers are as follows: 
  
 For the Company: Rex Bright, President and CEO 
  

For BMS: Ashley Readshaw, Senior Vice President 
  

 -35- 

 In the event the designated officers are not able to resolve such dispute within such
thirty (30) day period, or such other period of time as the Parties may mutually agree in writing, the Parties agree to have the dispute finally settled by arbitration in accordance with the Commercial Arbitration Rules of the American Arbitration
Association. The arbitration shall be governed by the United States Arbitration Act, 9 U.S.C. §§ 1-16, 201-208. The arbitration shall be held in New York City. The arbitration proceedings shall be conducted, and the award shall be
rendered, in the English language. Each Party shall select one arbitrator who shall be an experienced lawyer and fluent in English. The two arbitrators appointed by the Parties shall select a third arbitrator from among arbitrators designated by the
American Arbitration Association. 
  
 Section 14.04. Entire
Agreement. 
  
 This Agreement, the
Schedules and Exhibits hereto and thereto, contain the entire agreement and understanding between the Parties hereto with respect to the subject matter hereof and supersede all prior agreements and understandings relating to such subject matter.

  
 Section 14.05. Public Announcements. 

 
 The form and content of any public announcement to be
made by one (1) Party regarding this Agreement, or the subject matter contained herein, shall be subject to the prior written consent of the other Party (which consent may not be unreasonably withheld), except as may be required by applicable Laws
(including disclosure requirements of the SEC, NYSE, or any stock exchange) in which event the other Party shall use commercially reasonable efforts to give the other Party reasonable advance notice and reasonable opportunity to review any such
disclosure. 
  
 Section 14.06. Governing Law.

  
 THIS AGREEMENT SHALL BE GOVERNED BY
AND CONSTRUED IN ACCORDANCE WITH THE INTERNAL LAWS OF THE STATE OF NEW YORK APPLICABLE TO AGREEMENTS MADE AND TO BE PERFORMED ENTIRELY WITHIN SUCH STATE, WITHOUT REGARD TO THE CONFLICTS OF LAW PRINCIPLES OF SUCH STATE. 
  
 Section 14.07. Relationship of the Parties. 
  
 In making and performing this Agreement, the Parties are
acting, and intend to be treated, as independent entities and nothing contained in this Agreement shall be construed or implied to create an agency, partnership, joint venture, or employer and employee relationship between BMS and the Company.
Except as otherwise provided herein, neither Party may make any representation, warranty or commitment, whether express or implied, on behalf of or incur any charges or expenses for or in the name of the other Party. No Party shall be liable for the
act of any other Party unless such act is expressly authorized in writing by both Parties hereto. 
  
 Section 14.08. Counterparts. 
  
 This Agreement may be executed in one or more counterparts, all of which shall be considered one and the same agreement, and shall become
effective when one or more such counterparts have been signed by each of the Parties and delivered to the other Party. 
  

 -36- 

 Section 14.09. Severability. 
  
 In the event that any one or more of the provisions contained herein, or the application thereof in any
circumstances, is held invalid, illegal or unenforceable in any respect for any reason, the Parties shall negotiate in good faith with a view to the substitution therefor of a suitable and equitable solution in order to carry out, so far as may be
valid and enforceable, the intent and purpose of such invalid provision; provided, however, that the validity, legality and enforceability of any such provision in every other respect and of the remaining provisions contained herein
shall not be in any way impaired thereby, it being intended that all of the rights and privileges of the Parties hereto shall be enforceable to the fullest extent permitted by law. 
  
 Section 14.10. Expenses. 
  
 Each of BMS and the Company shall bear its own direct and indirect expenses incurred in connection with the
negotiation and preparation of this Agreement and, except as set forth in this Agreement, the performance of the obligations contemplated hereby and thereby. 
  
 Section 14.11. Descriptive Headings. 
  
 The descriptive headings herein are inserted for convenience only and are not intended to be part of or to affect the meaning or
interpretation of this Agreement. 
  
 Section 14.12.
Amendments and Waivers. 
  
 This
Agreement may not be amended except by an instrument in writing signed on behalf of each of the Parties. By an instrument in writing either Party may waive compliance by the other Party with any term or provision of this Agreement that such other
Party was or is obligated to comply with or perform. No delay or failure on the part of any Party hereto in exercising any right, power, or privilege under this Agreement shall impair such right, power or privilege or be construed as a waiver of any
default or any acquiescence therein. No single or partial exercise of any such right, power or privilege shall preclude the further exercise of such right, power or privilege, or the exercise of any other right, power or privilege. 
  
 Section 14.13. Specific Performance. 
  
 The Parties hereto agree that if any of the provisions of
this Agreement were not performed in accordance with their specific terms or were otherwise breached, irreparable damage would occur, no adequate remedy at law would exist and damages would be difficult to determine, and that the Parties shall be
entitled to specific performance of the terms hereof, in addition to any other remedy at law or equity. 
  
 Section 14.14. Successors and Assigns. 
  
 This Agreement shall be binding upon and inure solely to the benefit of the Parties hereto, their successors and permitted assigns, and
nothing in this Agreement, express or implied, is intended to or shall confer upon any other Person or Persons any right, benefits or remedies of any nature whatsoever under or by reason of this Agreement. 
  

 -37- 

 Section 14.15. Waiver of Jury Trial. 
  
 EACH PARTY HERETO HEREBY WAIVES, TO THE FULLEST EXTENT
PERMITTED BY APPLICABLE LAW, ANY RIGHT IT MAY HAVE TO A TRIAL BY JURY IN RESPECT TO ANY LITIGATION DIRECTLY OR INDIRECTLY ARISING OUT OF, UNDER OR IN CONNECTION WITH THIS AGREEMENT. EACH PARTY HERETO (A) CERTIFIES THAT NO REPRESENTATIVE, AGENT OR
ATTORNEY OF ANY OTHER PARTY HAS REPRESENTED, EXPRESSLY OR OTHERWISE, THAT SUCH OTHER PARTY WOULD NOT, IN THE EVENT OF LITIGATION, SEEK TO ENFORCE THAT FOREGOING WAIVER AND (B) ACKNOWLEDGES THAT IT AND THE OTHER PARTIES HERETO HAVE BEEN INDUCED TO
ENTER INTO THIS AGREEMENT, AS APPLICABLE, BY, AMONG OTHER THINGS, THE MUTUAL WAIVERS AND CERTIFICATIONS IN THIS SECTION 14.15. 
  
 [The remainder of this page has been left blank intentionally.] 
  

 -38- 

 IN WITNESS WHEREOF, each of the Parties has caused this Supply Agreement for the Product to be
executed in multiple counterparts by its duly authorized representative. 
  

					
	BRISTOL-MYERS SQUIBB COMPANY
			
	 By:
	 	 	 	/s/    ASHLEY READSHAW        
	 	 	 Name:
	 	Ashley Readshaw
	 	 	 Title:
	 	 Senior Vice President
 Americas Finishing and
 Strategic Operations Planning

  

					
	SKINMEDICA, INC.
			
	 By:
	 	 	 	/s/    REX BRIGHT        
	 	 	 Name:
	 	Rex Bright
	 	 	 Title:
	 	President and Chief Executive OfficerManufacturing and Supply Agreement

 Exhibit 10.17 
  

	 	***	CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT (INDICATED BY ASTERISKS) HAS BEEN OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND EXCHANGE COMMISSION PURSUANT TO A
REQUEST FOR CONFIDENTIAL TREATMENT UNDER 17 C.F.R. SECTIONS 200.80(B)(4), 200.83 AND 230.406. 

  
 MANUFACTURING AND 
 SUPPLY AGREEMENT 
  
 THIS MANUFACTURING AND SUPPLY
AGREEMENT is entered into effective as of June 30, 2002 (“Effective Date”), by and between ENHANCED DERM TECHNOLOGIES, INC., a
Delaware corporation (“EDT”) and SKINMEDICA, INC., a California corporation (“SM”). EDT and SM are each referred to as a “Party” to this
Agreement, and collectively as the “Parties.” 
  
 BACKGROUND 
  

	A.	SM desires to use EDT’s facilities, resources and expertise to manufacture the Product, as defined below. 

  

	B.	EDT desires to act as developer and contract manufacturer of the Product in accordance with the terms and conditions set forth in this Agreement. 

  

	C.	EDT desires to grant to SM an exclusive license to market and sell the Product for the purpose of the treatment of diseases in the Field in the Territory, as both terms are defined
below. 

  
 NOW, THEREFORE, in consideration of these premises and
the mutual covenants set forth below, EDT and SM agree as follows: 
  
 AGREEMENT 
  
 ARTICLE 1

 DEFINITIONS 
  
 For the purposes of this Agreement, the following capitalized terms shall have the following meanings: 
  
 “Acceptance Notice” shall have the meaning set forth in Section 14.1
of this Agreement. 
  
 “Affiliate” means any
corporation or other business entity controlled by, controlling or under common control with a Party hereto. For this purpose “control” shall mean direct or indirect beneficial ownership of fifty percent (50%) or more of the voting stock,
or a fifty percent (50%) or more interest in the income of, such corporation or other business entity. 
  
 “Arbitrator” shall have the meaning set forth in Section 15.2 of this Agreement. 
  
 “Certificate of Analysis” means a summary of the quality control testing, as described in the Product Specifications, performed by the Contract
Manufacturer for Finished Product supplied under this Agreement. 

 “cGMP” means current Good Manufacturing Practices of the U.S. Food and Drug Administration, as may be
amended from time to time. 
  
 “Claim” shall have the meaning set
forth in Section 15.2 of this Agreement. 
  
 “Commercially
Reasonable Efforts” means the effort by EDT or SM to deploy, in light of prevailing circumstances and taking into account obligations and commitments to third parties, sufficient resources, capital equipment, material and labor as might
reasonably be expected to achieve in an appropriate time-scale, the benefits which are anticipated to accrue to EDT and SM from the commercial exploitation of the Products, and if the Commercially Reasonable Efforts are to be directed to a specific
goal, then that goal. 
  
 “Confidential Information” shall have
the meaning set forth in Section 8.2.1 of this Agreement. 
  
 “Contract Manufacturer” shall mean DPT Laboratories, Ltd. or such other manufacturer of the Product selected by EDT and approved by SM. 
  

	“DelPouch	Product” shall have the meaning set forth in Section 14.1 of this Agreement. 

  
 “Effective Date” shall have the meaning set forth in the preamble to this Agreement. 
  
 “FDA” means the U.S. Food and Drug Administration. 
  
 “Field” means the treatment of pigmentation disorders. 
  
 “Finished Product” shall mean the Product together with all Labeling,
branding, trade dress and packaging set forth in the Product Specifications. 
  
 “Initial Term” shall have the meaning set forth in Section 11.1 of this Agreement. 
  
 “Know-How” means unpatented technical and other information, including without limitation, ideas, concepts, expertise, designs, inventions, discoveries,
data, formulae, specifications, procedures for experiments, patent and legal data or descriptions, marketing, sales and manufacturing data, tests and other protocols and techniques, which is necessary or useful to make, have made, use, have used,
offer for sale, sell and import the Product in the Field in the Territory. 
  
 “Labeling” means the primary container label, secondary packaging, package insert, shelf pack and shipper label specific to a Finished Product manufactured in accordance with the Product Specifications. 

 
 “Losses” shall have the meaning set forth in Article 12 of this
Agreement. 
  

 2 

 “Manufacturing Standards” means the specifications for manufacturing, packaging, labeling and storing
the Products set forth in the Product Specifications, the master batch record, cGMPs, “material safety data sheets,” and all other applicable U.S. federal and state laws and regulations. 
  
 “Minimum Purchase Requirements” shall have the meaning set forth in
Section 3.4.1 of this Agreement. 
  

	“Offer	Notice” shall have the meaning set forth in Section 14.1 of this Agreement. 

  
 “Party” and “Parties” shall have the meanings set forth in the preamble to this Agreement. 
  
 “Patents” means all patents and patent applications in which EDT has rights
covering the Product and the Field, and any divisions, provisionals, renewals, continuations, continuations-in-part, extensions or substitutions thereof, including those patents set forth on Schedule I. 
  
 “Placebo” means a Product adjusted to be formulated without the active
ingredient. 
  
 “Product” means the product described on
Exhibit A to this Agreement, as it may be amended from time to time, and which is incorporated by this reference as though fully set forth in this paragraph. 
  
 “Product Specifications” means the specifications agreed to by both Parties for the manufacture of any Product and attached
hereto as Exhibit C. 
  
 “Regulatory Authority” means the
FDA or any equivalent or additional governmental or regulatory agencies having authority over EDT, EDT’s facilities, or the Products. 
  
 “Samples” means the Product size intended for distribution without charge to medical professionals.  
  
 “SM Improvements” shall have the meaning set forth in Section 4.4 of
this Agreement. 
  
 “Term” shall mean the Initial Term and any
extensions or renewals of the Initial Term in accordance with Section 11.1 of this Agreement. 
  
 “Territory” means the United States of America, including its territories, commonwealths and possessions. 
  
 “Unique Materials” shall have the meaning set forth in Section 3.12 of this Agreement. 
  
 ARTICLE 2 
 MANUFACTURE 
  

	2.1	 Exclusive Supply of Products. EDT shall supply, or cause to be supplied, and SM shall purchase all of SM’s Minimum Purchase Requirements of Finished
Product, including 

  

 3 

	 	 
Samples, for use in the Field in the Territory on the terms, and subject to the conditions, of this Agreement. EDT agrees that, during the Term of this
Agreement, SM shall have the exclusive right to purchase the Product from EDT and its Affiliates for resale in the Field and the Territory until such time as SM fails to satisfy the Minimum Purchase Requirements specified in Section 3.4.1
below and forfeits its exclusive right to purchase the Product in accordance with Section 3.4.3 below. 

  

	2.2	General Responsibilities. EDT will be responsible *** for all scale-up, validation, stability, formulation, Finished Product testing, and fill and finish work related to the
manufacture of the Product. 

  

	2.3	Conformance to Specifications. During the Term of this Agreement, and subject to the terms and conditions of this Agreement, EDT shall cause Contract Manufacturer to
formulate, fill and package the Product in accordance with the Product Specifications and Labeling requirements of SM. The Product shall conform to the Product Specifications. 

  

	2.4	Labeling. 

  

	 	2.4.1	EDT will label and package, or cause to be labeled and packaged, the Product in finished form (i.e., Finished Product), pursuant to a firm purchase order accepted by EDT as
described in Section 3.7, provided, however, that SM shall provide all specifications and artwork for packaging and trade dress for the Labeling and, and shall be responsible for the accuracy and final approval of Labeling before
manufacture. 

  

	 	2.4.2	SM shall determine the trademarks and trade names owned or licensed by SM to be used in connection with the Product and which trademarks and trade names will appear on the labels,
labeling, and any promotional materials for the Products. SM shall advise EDT as to the trademarks and trade names SM has selected for the Product. EDT shall use these trademarks and trade names and no other trademarks and trade names on the labels
and labeling for the Product. EDT shall have no right to use said trademarks and trade names other than in connection with its manufacturing and packaging Products for sale to SM under this Agreement. Upon expiration or termination of this
Agreement, EDT shall not use any of these trademarks or trade names, whether or not said trademarks or trade names have been registered with the U.S. Patent and Trademark Office. SM shall have the right to change trademarks and trade names and will
reimburse EDT for any costs incurred for labels or labeling bearing a trademark or trade name that SM has determined it no longer wants to use. 

  

	2.5	Raw Materials. EDT and/or Contract Manufacturer shall have the sole responsibility to source all raw materials used in the manufacture of the Product.

  

	2.6	Batch Testing; Certificate of Analysis. EDT shall test, or cause to be tested, in accordance with the Product Specifications, each batch of Product manufactured pursuant to
this Agreement before delivery to SM. Prior to each shipment of Product, EDT shall 

  

	***	Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

  

 4 

	 	 
provide, or cause to be provided, to SM a Certificate of Analysis in customary form attesting to the quality of each batch contained within the shipment,
including review and approval by the appropriate quality control unit of all batch production and control records. EDT shall maintain or cause to be maintained and provide SM with such batch records and documentation, including information relating
to the manufacturing, packaging, labeling, and quality control testing and analysis for each lot of Finished Product produced hereunder as may be required by the FDA and under all applicable federal, state and local laws and regulations.

  

	2.7	Good Manufacturing Practices. EDT shall ensure that Contract Manufacturer and any other contractors/affiliates shall manufacture, store and prepare all Product and related
raw materials for shipping in accordance with the cGMPs, in a facility to be agreed upon by EDT and SM. EDT may not change manufacturing of the Product to an alternate facility without first obtaining SM’s written approval.

  

	2.8	Inspections. EDT authorizes SM to make reasonable inspections at Contract Manufacturer’s plant on the same terms as are available to EDT under its agreement with
Contract Manufacturer in order for SM to satisfy itself that the Contract Manufacturer manufactures and documents the Product according to current cGMPs. In furtherance of, and not limited by, the foregoing, SM shall use its Commercially Reasonable
Efforts to cause Contract Manufacturer to permit SM, at any time during the Term of this Agreement, upon reasonable prior notice and during reasonable business hours, to inspect the facility where the Product has been or is being manufactured or
stored, or the raw materials to be incorporated into the Products have been or are being manufactured or stored. The provisions of this Section 2.8 are subject to the confidentiality provisions of Article 8. SM shall be responsible for
its costs of travel and accommodation for such inspections. 

  

	2.9	Changes to Specifications. 

  

	 	2.9.1	The Product Specifications or manufacturing process shall not be supplemented, modified or amended in any respect without the prior written agreement of the Parties. If SM requests
a change to a Product Specification, including the manufacturing process, and EDT agrees that such change is feasible, such change shall be incorporated within the Product Specification pursuant to a written amendment to this Agreement which shall
specify the change and resulting increase in price agreed to by each of the Parties. 

  

	 	2.9.2	EDT may provide additional services in conjunction with the manufacture of the Products, such as additional formulation, process development or stability testing, at the request of
SM and pursuant to SM’s purchase order. 

  

	2.10	Placebos. If required for clinical trial work in the future, EDT shall also supply all of SM’s needs for Placebos, on terms to be agreed upon at that time.

  

 5 

 ARTICLE 3 
 PLANNING AND SUPPLY 
  

	3.1	Supply of Product. EDT will produce, or cause to be produced, Finished Product to meet the mutually agreed upon forecasts, subject to the provisions of this Article 3.
EDT shall have the sole responsibility, financially and otherwise, for manufacturing the Product, either directly or through Contract Manufacturer or one or more Affiliates of EDT, receiving and processing orders and shipping the Finished Product to
SM. EDT shall bear all costs of the foregoing activities, including without limitation ***. EDT may utilize contractors to carry out its obligations hereunder, including Affiliates of EDT, only with the prior written consent of SM (provided that SM
is deemed to have hereby consented to the appointment of the initial Contract Manufacturer). EDT shall ensure, but cannot guarantee, that sufficient stock of the Product will be available in its inventory, or set aside by Contract Manufacturer, to
promptly fill orders from the trade based on the rolling non-binding forecasts provided by SM pursuant to Section 3.5. 

  

	3.2	Production. EDT will keep SM informed of all scheduled production activity for the Products. 

  

	3.3	Initial Supply of Product and Samples. EDT shall make available and SM shall purchase for commercial sale an initial supply of *** units of Product no later than ***;
provided however, that if the expiration date on Product is less than twenty (20) months, the initial supply required to be purchased by SM shall be *** units. The expiration dating shall be calculated as of the date that Product is
manufactured. For the avoidance of any doubt, the definition of “available” in this Section 3.3 shall mean that the initial supply of Product must be released from quarantine and ready for shipping by ***. 

 

	3.4	Minimum Purchase Requirements. 

  

	 	3.4.1	SM agrees to purchase a minimum of *** units of the Product per twelve (12) month period commencing with the first purchase of Product hereunder (the “Minimum Purchase
Requirements”). Subject to Section 11.2, any failure of SM to deliver firm purchases orders meeting the Minimum Purchase Requirements shall not be deemed to be a breach of this Agreement and shall result only in the loss by SM of its
exclusive right to purchase Product from EDT as set forth in Section 3.4.3 below.  

  

	 	3.4.2	If the FDA removes (or requires the removal) of the Product from the market, the Parties shall negotiate in good faith new minimum quantities. 

  

	 	3.4.3	If SM fails to purchase the Minimum Purchase Requirement in any given twelve (12) month period, EDT shall notify SM that it has failed to comply with this Section 3.4. If
within the *** following such notice, SM fails to order sufficient quantities of Product to bring it into compliance with Section 3.4.1, 

  

	***	Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

  

 6 

	 	 
then SM shall be deemed to have forfeited its exclusive right to purchase the Product hereunder and EDT may proceed to sell the Product to third parties in
the Territory. 

  

	3.5	Forecasts. SM shall provide an initial production forecast for 2002 by July 1, 2002. Thereafter SM shall provide a twelve (12) month rolling production forecast every three
(3) months. Forecasts shall be submitted in the format set out as Exhibit D. Forecasts shall include the amounts of each Product and Samples to be manufactured and supplied by EDT and the expected timing for the delivery of each
shipment during the forecast period. 

  

	3.6	Purchase Orders. SM will place written purchase orders directly or through its designated representatives with EDT at least *** prior to requested shipment date, including
the following details: number of units, requested shipping date, shipping instructions and SM’s order reference number including the price calculated according to this Agreement. Each Purchase Order issued pursuant to this Agreement shall be
governed by the terms and conditions of this Agreement. 

  

	3.7	Acceptance of Purchase Order by EDT. EDT shall promptly acknowledge its receipt of purchase orders and inform SM of the anticipated dates of manufacture and delivery of each
Product presentation to SM. EDT shall respond in writing as to its acceptance of each firm purchase order within *** of receipt of such order In each twelve (12) month period commencing after December 20, 2002, EDT must accept each purchase order
from SM until such time as EDT has accepted purchase orders representing the Minimum Purchase Requirements in such period. All purchase orders which are accepted by EDT (or required to be accepted by EDT pursuant to this Section 3.7) shall be deemed
binding on both of the parties. 

  

	3.8	Shipment; Delays. EDT shall ship the Product to SM or the location designated by SM by the delivery date specified in the accepted purchase order. 

 

	3.9	Change Orders. The time of delivery and quantities specified in a purchase order accepted by EDT pursuant to Section 3.7 above shall be binding upon the Parties and
may not be changed or canceled. 

  

	3.10	Increased Demand. EDT will use Commercially Reasonable Efforts to accommodate SM’s requests for units in excess of those forecasted pursuant to Section 3.5;
provided, however, that EDT shall not be in breach of this Agreement if EDT, despite its Commercially Reasonable Efforts, is unable to supply quantities of Product to SM in excess of *** of the amount forecast for that year pursuant to
Section 3.5. 

  

	***	Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

  

 7 

	3.11	Shipment; Inspection; Rejection 

  

	 	3.11.1	Shipment of Product. EDT shall ship, or cause to be shipped, at SM’s expense, the Product to SM or such destination(s) as SM may designate in writing. Product will be
shipped FOB SM’s designated delivery location, and all risk of loss or damage therein shall pass to SM when each such order of the Product is delivered to SM’s designated facility. Title to the Product supplied to SM by EDT pursuant to an
applicable purchase order shall remain in EDT until delivery to the SM’s designated facility, at which time title shall pass to the SM and SM shall assume all risk of loss or damage. All invoices and other shipping documents shall be sent via
first class mail or by fax to SM’s address for notices under this Agreement. 

  

	 	3.11.2	Non-Conforming Product. SM may reject any batch of Product that does not conform to the Manufacturing Standards, subject to the terms of this Section. Within *** after
SM’s receipt of Product and batch documents, SM shall inspect the Product and notify EDT whether it will accept or reject the Product. No inspection under this Section shall relieve EDT of its obligations and warranties under this Agreement. If
SM rejects all or any part of any shipment of Product, the procedures to be followed are: 

  

	 	(a)	SM shall submit to EDT in writing any claim that Product does not conform with the Specifications or Manufacturing Standards (including conformance to cGMPs), accompanied by a
report of SM’s analysis (which analysis shall be conducted in good faith) and a sample of the Product at issue, explaining in reasonable detail the basis on which the allegedly nonconforming Product does not meet the Specifications or
Manufacturing Standards. Until any dispute concerning nonconformance is resolved pursuant to (b) (ii) below, ***. Only those tests listed in the Specifications may be used to demonstrate nonconformance of Product from the
Specifications. 

  

	 	(b)	EDT shall conduct its own analysis of the Sample in good faith within *** after the receipt by EDT of the report and Sample from SM, and provide the results to SM.

  

	 	(i)	If after EDT’s own analysis of the Sample EDT agrees with the claim of nonconformity, SM shall promptly inform EDT if SM wishes to have EDT replace the nonconforming Product
with conforming Product. If SM wishes to receive such replacement Product, EDT shall provide such replacement as soon as reasonably practicable thereafter, in which case SM shall be obligated to pay only for such replacement Product. SM shall not be
obligated to pay for the nonconforming Product, and EDT shall: 

  

	 	(A)	credit SM for the amount paid by SM to EDT for the nonconforming Product if SM has already paid for such nonconforming Product or 

  

	***	Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

  

 8 

	 	(B)	cancel its invoice to SM for such nonconforming Product if SM has not yet paid for such nonconforming Product, and SM shall not be obligated to pay such canceled invoiced amount.

  

	 	(ii)	If, after its own analysis, EDT does not agree with the claim of nonconformity or determines that SM is responsible for the nonconformity, such Product shall be tested for
conformance with the applicable Specifications or Manufacturing Standards by an independent third party testing laboratory mutually acceptable to both parties. The independent analysis shall be binding on both Parties solely for the purpose of
determining whether such Product may be rightfully rejected. 

  

	 	(c)	After a final determination that the Product shipment is nonconforming, and if EDT is responsible for the nonconformity, SM shall return or destroy it at EDT’s request and cost
in the most cost effective and environmentally safe and appropriate manner available, consistent with federal, state and local laws and regulations. 

  

	 	3.11.3	Notwithstanding the other provisions of this Section 3.11, SM shall have no right to reject any Product that fails to conform with the Manufacturing Standards if the
nonconformance is attributable to (a) events outside of EDT’s control that occurred after delivery to SM’s designated facility, or (b) processes, procedures or Product components specified by SM in the Specifications, provided that
EDT followed or used such processes, procedures and Product components substantially in accordance with the Specifications and cGMPs. 

  

	3.12	Unique Materials. SM shall reimburse EDT for *** of “Unique Materials” (i.e., artwork, printed materials, labels, and cartons) purchased by EDT
expressly to meet its performance obligations under this Agreement in reliance upon a firm Purchase Order accepted pursuant to Section 3.7 and which later are made obsolete, or to the extent that such Unique Materials remain on hand at the
expiration or termination of this Agreement as provided under Article 11 unless terminated (i) by SM for breach by EDT or (ii) by EDT pursuant to Section 11.5. For purposes of this Section 3.12, material is obsolete if it cannot
be incorporated into the Product due to changes mandated by a Regulatory Authority, changes directed by SM, or SM-mandated cancellation or postponement. EDT may invoice SM for *** of Unique Materials after they are made obsolete. EDT’s invoices
shall identify the material in question and shall be accompanied by a statement of the cause of such obsolescence and a certification that EDT has disposed of such materials in accordance with the terms of this Agreement. 

 

	***	Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

  

 9 

	3.13	Insurance. EDT and SM shall at their own expense obtain and maintain workers’ compensation and comprehensive general liability insurance with respect to performance
under this Agreement, in the amount of ***. 

  
 ARTICLE 4 
 PROMOTION & PRODUCT DEVELOPMENT

  

	4.1	Promotional Materials. SM shall create and develop at SM’s own expense, promotional materials relating to the Product for distribution to independent third parties. SM
will establish the copy platform for all promotional materials and develop tactical programs. 

  

	4.2	Training Materials. SM shall bear the expenses associated with training its sales force. SM shall develop programs to monitor, test and otherwise ensure that the SM’s
sales force is sufficiently knowledgeable about the Product and other information contained in SM’s training materials. 

  

	4.3	Clinical Studies. EDT shall provide SM with full access to all data generated by EDT on the Product, including clinical, regulatory and marketing data. In addition, SM, at
its expense, shall have the right to conduct pre-clinical or clinical studies with the Product for regulatory and commercial purposes. SM will own all data and results from such studies which have been paid for in full by SM; provided, however, that
EDT shall have the right to access such data/results for the purpose of making external presentations, with SM’s prior written consent. 

  

	4.4	Product Improvements. Product improvements, including but not limited to formulations improvements, identified, initiated or made by SM (“SM Improvements”)
shall be the property of SM. SM Improvements may not be used by EDT or any of its Affiliates without the prior written consent of SM, except with Products sold to SM hereunder. SM Improvements will be incorporated in the Product, covered under this
Agreement only by mutual and written agreement by both EDT and SM. 

  
 ARTICLE 5 
 PRICE AND PAYMENT
TERMS 
  

	5.1	Development Fee. SM shall pay EDT *** upon execution of this Agreement. SM shall pay EDT an additional *** prior to June 30, 2002. 

  

	5.2	Price for Products. SM shall pay EDT for Products the amounts for each Product and for each size or formulation set forth in Exhibit B to this Agreement, which Exhibit
may be amended from time to time by the mutual written agreement of the Parties. Prices for Products may be increased by EDT, not more than once each year, in order to reflect increases in *** for the relevant period. 

  

	***	Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

  
  

 10 

	5.3	Invoices. EDT shall submit to SM an invoice with each shipment of Product. SM shall pay each invoice within *** of the date of each accurate invoice. SM shall not be
obligated to pay for any non-conforming shipment of Product. 

  
 ARTICLE 6 
 WARRANTIES 
  

	6.1	Quality. To facilitate quality control inspections by the Parties, EDT shall identify each Product shipment with a vendor lot number that is traceable to raw materials and/or
components used to manufacture such Product. 

  

	6.2	Representations and Warranties. 

  

	 	6.2.1	Product. EDT warrants that Product delivered to SM pursuant to this Agreement shall, at the time of delivery: 

  

	 	(a)	have been manufactured, filled, packaged and stored in accordance with all applicable laws, rules, regulations or requirements, including without limitation all FDA regulations;

  

	 	(b)	have been manufactured, filled, packaged and stored in accordance with, and will conform to, the Product Specifications and Manufacturing Standards; 

  

	 	(c)	will be free from defects in material, manufacturing and workmanship when delivered to SM’s designated facility; 

  

	 	(d)	will not have been adulterated or misbranded within the meaning of the Food, Drug and Cosmetic Act or be an article which may not, under the provisions of Sections 404 and 505 of
the Food, Drug and Cosmetic Act, be introduced into interstate commerce; 

  

	 	(e)	does not infringe upon the rights of any third party, including without limitation rights under (i) U.S. Patent 5,932,612 or (ii) any other patents that directly pertain to the
Product, and, in each case, any continuations or divisions of U.S. Patent 5,932,612 or such other patents; 

  

	 	(f)	have a *** from the date of manufacture. 

  

	***	Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

  

 11 

 With respect to the representation in clause (f) above, EDT agrees to cause the Product to be delivered
to SM reasonably promptly after the manufacture of the applicable Product batch. 
  

	 	6.2.2	Licensing. EDT represents and warrants that it has obtained and will maintain on a current basis and will comply with all licenses, permits and approvals of applicable
governmental agencies as may be required to manufacture, test and store the Product pursuant to this Agreement and perform its other obligations under this Agreement. EDT shall be responsible for obtaining and maintaining licenses and permits for
manufacture, testing and storage of the Product and ensuring that the facilities used in the manufacture of the Product meet cGMPs in all respects. 

  

	 	6.2.3	Compliance with Laws. EDT represents and warrants that it shall comply in all respects with all federal, state, local and foreign laws, regulations and other requirements
applicable to the manufacture, testing and storage of the Product and the performance of EDT’s obligations under this Agreement. EDT shall have sole responsibility for adopting and enforcing safety procedures for the handling and manufacture of
the Product at its facilities and the proper handling and proper disposal of waste relating to the Product. 

  

	 	6.2.4	Binding Effect. Each Party hereby represents and warrants that this Agreement is a legal and valid obligation binding upon it and is enforceable in accordance with its terms,
except that the enforcement of the rights and remedies created hereby is subject to bankruptcy, insolvency, reorganization and similar laws of general application affecting the rights and remedies of creditors and that the availability of the remedy
of specific performance or of injunctive relief is subject to the discretion of the court before which any proceeding therefor may be brought. The execution, delivery and performance of this Agreement by such Party does not conflict with any
agreement, instrument or understanding, oral or written, to which it is a party or by which it may be bound, nor violate any law or regulation of any court, governmental body or administrative or other agency having authority over it.

  

	6.3	Limitations. 

  

	 	6.3.1	Limitations on Warranty. The warranties furnished in Section 6.2.1 shall not apply to defects caused by accident or willful damage, abuse, misuse, neglect, improper
testing, handling, storage or use after delivery by EDT or the common carrier of the Product in question to SM’s designated facility. 

  

	 	6.3.2	 No Implied Representations, Warranties or Conditions. EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER EDT NOR SM MAKES ANY REPRESENTATIONS
OR WARRANTIES AND THERE ARE NO CONDITIONS, EXPRESS OR IMPLIED, STATUTORY OR OTHERWISE, WITH RESPECT TO PRODUCT SUPPLIED UNDER THIS 

  

 12 

	 	 
AGREEMENT, INCLUDING, WITHOUT LIMITATION, ANY REPRESENTATIONS, WARRANTIES OR CONDITIONS WITH RESPECT TO NONINFRINGEMENT, MERCHANTABILITY OR FITNESS FOR A
PARTICULAR PURPOSE OF SUCH PRODUCT, OR ARISING FROM A COURSE OF DEALING OR USAGE OF TRADE PRACTICE. 

  

	 	6.3.3	Limitation of Liability. EXCEPT FOR ANY LOSS, LIABILITY, DAMAGE OR OBLIGATION ARISING OUT OF OR RELATING TO THE DISCLOSURE OF CONFIDENTIAL INFORMATION PURSUANT TO ARTICLE
8 OR AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, IN NO EVENT SHALL EITHER PARTY HAVE ANY LIABILITY TO THE OTHER PARTY OR ANY OTHER THIRD PARTY FOR ANY LOST OPPORTUNITY, COSTS OF PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES, OR FOR ANY
INDIRECT, INCIDENTAL, CONSEQUENTIAL, PUNITIVE OR SPECIAL DAMAGES ARISING OUT OF THIS AGREEMENT, UNDER ANY CAUSE OF ACTION OR THEORY OF LIABILITY (INCLUDING NEGLIGENCE), AND WHETHER OR NOT SUCH PARTY TO THIS AGREEMENT HAS BEEN ADVISED OF THE
POSSIBILITY OF SUCH DAMAGE. THESE LIMITATIONS SHALL APPLY NOTWITHSTANDING ANY FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY. 

  
 ARTICLE 7 
 TECHNOLOGY TRANSFER 
  

	7.1	If for any reason EDT is unable to manufacture Product or provide sufficient quantity of Product to meet SM’s Minimum Purchase Requirements under this Agreement, after advance
written notice to EDT from SM and an opportunity to cure not to exceed an additional ***, SM shall have the right to manufacture, or have manufactured by any substitute manufacturer, the Product, in addition to its other rights and privileges under
this Agreement. In such event, EDT shall assist SM in qualifying a second source for the active ingredients in Product (excluding microsponge), providing technical assistance and documentation as necessary, including such manufacturing
technology and know-how so as to permit another entity to manufacture such active ingredients, and EDT agrees to cooperate with SM to facilitate any technology transfer (excluding microsponge) required in furtherance of the foregoing. SM’s
Minimum Purchase Requirements, and payment obligations to EDT pursuant to this Agreement, shall be temporarily suspended until EDT or the Contract Manufacturer can resume its manufacturing obligations or the expiration of any substitute
manufacturing or supply agreement entered into by SM with the substitute manufacturer 

  

	7.2	EDT shall provide SM with data on the chemical and physical properties, toxicity, and handling, storing, and shipping information for any materials supplied to SM by EDT and any
other information available to EDT that is necessary for the safe conduct of the manufacturing of the Product by SM or the substitute manufacturer. EDT shall supply SM with pertinent information regarding health or safety hazards to workers relating
to materials supplied to SM by EDT. EDT shall update all of such information provided to SM as such information becomes available to EDT. 

  

	***	Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

  

 13 

	7.3	In the event of any transfer of manufacturing responsibilities pursuant to this Article 7, EDT shall make available to SM, and SM shall purchase, SM’s minimum
requirements of microsponge components. The Parties shall negotiate in good faith with respect to the appropriate price for such microsponge components, and, in any event, EDT shall offer such microsponge components to SM on terms no less favorable
than the price attributable to the microsponge components included in Product previously supplied pursuant to this Agreement. 

  

	7.4	At such time as SM shall have the right to manufacture, or have manufactured, the Product in accordance with this Article 7, EDT shall be deemed to have granted to SM a
license, under the Patents and Know-How (and any improvement in or modification thereof) to make, have made, use, have used, offer for sale, sell and import the Product for the Field in the Territory. Such license shall ***, other than payments for
microsponge components in accordance with Section 7.3 above. 

  
 ARTICLE 8 
 CONFIDENTIALITY 
  

	8.1	Public Relations and Announcements. Neither Party shall make any representations concerning the other without the prior consent from the other Party. Except for such
disclosure as is required by applicable law and/or stock exchange regulation, neither Party shall make any announcement, news release, public statement, publication or presentation relating to the existence of this Agreement or the arrangements
referred to in this Agreement without the other Party’s prior written consent, which consent will not be unreasonably withheld. The Parties agree to coordinate the initial announcement and/or press release relating to this Agreement.
Notwithstanding the foregoing, each Party consents to references to it in reports or documents or other disclosures sent to stockholders or filed with or submitted to any governmental authority or stock exchange. The Parties agree that once approval
for disclosure of information has been obtained in accordance with the provisions of this Section 8.1, the Party that requested such approval shall be entitled to use such information without any obligation to seek further approval.

  

	8.2	Confidentiality. 

  

	 	8.2.1	Confidential Information. The Parties acknowledge that by reason of their relationship to each other under this Agreement, each will have access to certain information
and materials concerning the other’s business, plans, trade secrets, customers (including, but not limited to, customer lists), technology, and/or products that is confidential and of substantial value to that Party, which value would be
impaired if such information were disclosed to Third Parties (“Confidential Information”). Each Party agrees that it will not use in any way other than expressly authorized or contemplated under this Agreement, nor

  

	***	Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

  

 14 

	 	 
disclose to any third party, any such Confidential Information revealed to it by the other Party (except that Confidential Information may be disclosed, as
required for the purposes of this Agreement, to any Regulatory Authority, an Affiliate, assignee, distributor, consultant or third party contractor or research and development organization under similar written obligations of non-disclosure and
non-use), and will take every reasonable precaution to protect the confidentiality of such information and with no less restrictive precautions than it takes to protect its own confidential information. If Confidential Information is required to be
disclosed in response to a valid order by a court, Regulatory Authority or other government body of competent jurisdiction, or if otherwise required to be disclosed by law, or if necessary to establish the rights of either Party under this
Agreement, the receiving Party shall use Commercially Reasonable Efforts to provide the disclosing Party with advance notice of such required disclosure to give the disclosing Party sufficient time to seek a protective order or other protective
measures, if any are available, for such Confidential Information. 

  

	 	8.2.2	Exceptions. For purposes of this Agreement, information shall be deemed Confidential Information if such information, by its nature or due to the context within which
it is disclosed, is obviously intended by the disclosing Party to be kept confidential even if not identified as such in writing or with legends or other markings. Upon request by either Party, the other Party will advise whether or not it considers
any particular information or materials to be Confidential Information. Confidential Information does not include information, technical data or know-how that: 

  

	 	(a)	is or becomes publicly available through no fault of the receiving Party or its individual employees, agents or members amounting to a breach of this Agreement;

  

	 	(b)	is lawfully obtained on a non-confidential basis by the receiving Party from a third party who is not obligated to retain such information in confidence; 

 

	 	(c)	the receiving Party can demonstrate, by competent evidence, was known to it or any of its Affiliates from a source other than the disclosing Party or any of its Affiliates prior to
the disclosure under this Agreement; 

  

	 	(d)	the receiving Party can demonstrate by its written records is independently developed by employees of the receiving Party or an Affiliate of the receiving Party, which employees
were neither privy to nor had access to the Confidential Information and which is developed without use in any way of the Confidential Information; 

  

	 	(e)	 must be disclosed to governmental agencies, provided that: (A) this exception shall only apply to disclosure to such agencies, and not to any other person or
entity; and (B) the disclosing Party shall (1) provide the 

  

 15 

 
other Party with prompt notice (including copies of all written requests or demands) of any proposed disclosure to any governmental agency, with an
explanation of the Confidential Information of the other Party to be disclosed; and (2) cooperate in any lawful effort by the other Party to prevent, limit or restrict disclosure of its Confidential Information to such government agency. 

 
 In addition, in the event EDT is unable to manufacture Product or
provide sufficient quantity of Product and the provisions of Article 7 above permit SM to obtain a substitute manufacturer, SM may disclose Confidential Information to such substitute manufacturer to facilitate the manufacture of the Product
(except microsponge) in accordance with Article 7; provided that the substitute manufacturer enters into similar written obligations of non-disclosure and non-use as set forth in this Article 8. 
  

	8.3	Remedy. If either Party breaches any of its obligations with respect to this Article 8, or if such a breach is likely to occur, the other Party shall be
entitled to seek equitable relief, including specific performance or an injunction, in addition to any other rights or remedies, including money damages, provided by law, without posting a bond. 

  

	8.4	Return of Confidential Information. Within ten (10) days following the termination of any agreement between the Parties with respect to the subject matter the receiving Party
agrees to promptly return all tangible items relating to the Confidential Information, including all written material, photographs, models, compounds, compositions and the like made available or supplied by the disclosing Party to receiving Party,
and all copies thereof, upon the request of the disclosing Party, except such records as may be required to be kept for FDA or other government regulatory compliance. Recipient further agrees to identify those persons to whom the Confidential
Information that is the subject of this Agreement was disclosed upon request of the disclosing Party. 

  
 ARTICLE 9 
 ASSIGNMENT 
  

	9.1	Assignment. Neither Party shall have the right or authority to assign the Agreement or any portion of the Agreement, to sublet or subcontract in whole or in part, or
otherwise delegate its performance under this Agreement, except as contemplated hereunder or with the other Party’s prior written consent. Notwithstanding the foregoing, nothing in this Agreement shall prohibit EDT from assigning this Agreement
to any Affiliate of EDT that may from time to time own or operate the facility at Lafayette, Louisiana. No such assignment shall relieve EDT of primary liability for the performance of its obligations under this Agreement. 

 

 16 

 ARTICLE 10 
 FORCE MAJEURE 
  

	10.1	Force Majeure. Neither Party shall be considered in default of performance of its obligations under this Agreement, except any obligation under this Agreement to make
payments when due, to the extent that performance of such obligations is delayed by contingencies or causes beyond the reasonable control and not caused by the negligence or willful misconduct of such Party, including but not limited to strike,
fire, flood, earthquake, windstorm, governmental acts or orders or restrictions, or force majeure, to the extent that the failure to perform is beyond the reasonable control of the nonperforming Party, if the Party affected shall give prompt
written notice of any such cause to the other Party. The Party giving such notice shall thereupon be excused from such of its obligations under this Agreement for the period of time that it is so disabled, but the Agreement shall otherwise remain in
full force and effect. 

  
 ARTICLE
11 
 TERM AND TERMINATION 
  

	11.1	Term. This Agreement shall expire ten (10) years after the Effective Date (the “Initial Term”). At the end of the Initial Term, this Agreement shall
automatically renew for successive one (1) year periods under the same terms and conditions set forth under this Agreement (or such other terms agreed in writing by the Parties) until terminated in writing in accordance with the provisions of this
Agreement. 

  

	11.2	Termination for Material Breach. Either Party may terminate this Agreement upon written notice if the other Party has breached any of its material obligations under this
Agreement, and such breach has not been cured within *** after written notice of the breach. Additionally, EDT may terminate this Agreement, at its sole option, if SM fails to meet the Minimum Purchase Requirement in *** periods.

  

	11.3	Termination upon Insolvency. Either Party may, in addition to any other remedies available to it by law or in equity, terminate this Agreement immediately by written notice
to the other Party upon (i) the filing by the other Party of a voluntary petition in bankruptcy or seeking reorganization, liquidation, dissolution, winding-up, arrangement, composition or readjustment of its debts or any other relief under any
bankruptcy, insolvency, reorganization or other similar act or law of any jurisdiction now or hereafter in effect, (ii) the filing against such other Party of an involuntary petition in bankruptcy which is not dismissed within sixty (60) days, (iii)
the appointment of a receiver or trustee of any of such other Party’s property if such appointment is not vacated within sixty (60) days, (iv) the adjudication of such other Party as insolvent, or (v) the assignment of such other Party’s
property for the benefit of its creditors. 

  

	11.4	Termination for Force Majeure. Either Party may terminate this agreement upon thirty (30) days prior written notice in the event of the other Party’s inability to
substantially perform its obligations under this Agreement for more than one hundred eighty (180) days due to an event of force majeure as described in Article 10. 

  

	***	Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

  

 17 

	11.5	Termination without Cause. SM may terminate this Agreement upon six (6) months’ written notice to EDT. EDT may terminate this Agreement after the expiration of the
Initial Term upon six (6) months’ written notice to SM. 

  

	11.6	Accrued Liabilities. The termination of this Agreement for any reason shall not discharge either Party’s liability for obligations incurred under this Agreement and
amounts unpaid at the time of such termination. SM shall be liable to pay EDT for any Product, work in progress and materials purchased by EDT to fulfill its obligations under firm purchase orders under this Agreement, provided however that
EDT shall take all commercially reasonable steps to mitigate its damages under such circumstances. 

  

	11.7	Return and Disposition of Property. Upon the termination of this Agreement for any reason, each Party shall return to the other Party or its designee all of such other
Party’s property, including, but not limited to, all proprietary information in its possession. To the extent required by law or to comply with such Party’s continuing obligations under this Agreement, each Party may keep a single copy of
tangible property belonging to the other Party. EDT shall dispose of all bulk active ingredients, raw materials, containers, and Labeling not necessary to complete work in progress at SM’ expense in accordance with SM’ instructions.

  
 ARTICLE 12 
 INDEMNIFICATION 
  

	12.1	Indemnification by EDT. 

  

	 	12.1.1	EDT shall indemnify SM, its Affiliates and their respective directors, officers, employees and agents, and defend and save each of them harmless, from and against any and all suits,
losses, actions, demands, investigations, claims, damages, liabilities, costs and expenses (including, without limitation, reasonable attorneys’ fees and expenses) incurred by or rendered against any of them for personal injury, sickness,
disease or death or other damages (collectively, “Losses”) brought by third parties arising from or occurring as a result of: 

  

	 	(a)	a nonconformity of Product with the warranties under Sections 6.1 and 6.2 except for any damages attributable to the negligence of SM, its employees or agents;

  

	 	(b)	EDT’s failure to comply with the Product Specifications; 

  

	 	(c)	any willful act or omission or negligence of EDT or its employees, agents or other contractors in the manufacturing and testing of the Product; 

  

	***	Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

  

 18 

	 	(d)	any breach (or alleged breach) by EDT of its representations, warranties, or obligations under this Agreement; or 

  

	 	(e)	the manufacture or the storage of the Product prior to the delivery of Product to SM’s designated facility by EDT or its Affiliates; 

  
 all except to the extent caused by the negligence or willful misconduct of
SM or its officers, agents, employees, Affiliates, sublicensees or customers. 
  

	 	12.1.2	EDT shall indemnify, defend and hold harmless SM, its Affiliates and their respective directors, officers, employees and agents, and defend and save each of them harmless, from and
against any and all Losses incurred by or rendered against any of them related to any charge of infringement by a third party for the use, marketing or sale of any Product, including specifically with respect to United States Patent 5,932,612 and
any continuations and divisions thereof; except that such indemnity shall not apply to any marketing claims by SM that are materially inconsistent with those made by EDT prior to the Effective Date. 

  

	12.2	Indemnification by SM. SM shall indemnify EDT, its Affiliates and their respective directors, officers, employees and agents, and defend and save each of them
harmless, from and against any and all Losses brought by third parties arising from or occurring as a result of: 

  

	 	(a)	the use, sale or other distribution of the Product; 

  

	 	(b)	any willful act or omission or negligence of SM or its employees, agents or other contractors 

  

	 	(c)	any breach (or alleged breach) by SM of its representations, warranties, or obligations under this Agreement; or 

  

	 	(d)	the storage of Product after its delivery to the SM’s designated facility; 

  
 all except to the extent caused by the negligence or willful misconduct of EDT or its officers, agents, employees,
Affiliates, sublicensees or customers or the breach of any covenant, representation, warranty or agreement hereunder. 
  

	12.3	Process. If either Party expects to seek indemnification from the other pursuant to the provisions of this Article 12, it shall promptly give notice to the
indemnifying Party of any such Claim. The indemnifying Party shall have the right to control the defense of such Claim and the indemnified Party shall cooperate with the indemnifying Party in the defense of such Claim. No settlement or compromise of
any Claim shall be binding on a Party hereto without its prior written consent. 

  

 19 

 ARTICLE 13 
 AUDIT RIGHTS; INSPECTIONS 
  

	13.1	Inspections. SM, upon its own discretion and at its own cost and expense, is entitled during ordinary business hours and at dates acceptable to EDT to inspect or to have
inspected, EDT’s plant and procedures used for manufacture and storage of the Products as well as the books and records referred to in Section 13.2 below. 

  

	13.2	Books and Records. EDT agrees to maintain and cause its Affiliates to maintain complete and accurate books and records of account so as to enable SM to verify amounts due and
payable under this Agreement. In particular, EDT shall preserve and maintain all such records and accounts required for audit for a period of *** years after the calendar quarter for which the record applies. 

  

	13.3	Communications with Government Agencies. SM shall have the sole right and responsibility and shall bear all costs related to communications with any government
agencies to satisfy their requirements regarding the authorization and/or continued authorization to market the Product in commercial quantities in the Territory. EDT shall promptly notify SM of any inquiry or other communication that it receives
from the FDA concerning the Product. If required, SM shall be primarily responsible for all communications with the FDA (and state equivalent agencies) concerning the Product, including but not limited to reporting adverse events and responding to
any inquiries concerning advertising, detailing or promotional materials. EDT, however, shall be able to communicate with the any such governmental agency regarding the Product if: 

  

	 	(a)	such communication is necessary to comply with the terms of this Agreement or the requirements of any law, governmental order or regulation; or 

  

	 	(b)	EDT, if practical, made a request of such agency to communicate with SM instead, and such agency refused such request; provided, however, that before making any communication under
this Section 13.4, EDT shall, if practical, give SM notice as soon as possible of EDT’s intention to make such communications, and SM shall, if practical, be permitted to accompany EDT, take part in any such communications and receive
copies of all such communications. 

  

	13.4	Government Inspection. EDT agrees to advise SM by telephone and facsimile immediately of any proposed or announced visit or inspection, and as soon as possible but in any
case within *** of any unannounced visit or inspection, by any Regulatory Authority of any facilities owned by EDT in the performance of its obligations under this Agreement. EDT shall provide SM with a reasonable description of each such visit or
inspection promptly (but in no event later than five (5) calendar days) thereafter, and with copies of any letters, reports or other documents (including Form 483’s) issued by any such authorities that relate to the Products, or such
facilities, processes or procedures. SM may review EDT’s responses to any such reports and communications, and if practicable, and, insofar as timely received, SM’ reasonable views and requests shall be taken into account prior to
submission of such reports and communications to the relevant Regulatory Authority. 

  

	***	Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

  

 20 

	13.5	Notification and Recall. If any Regulatory Authority issues or requests a recall or takes similar action in connection with the Product, or if either Party determines
that an event, incident or circumstance has occurred which may result in the need for a recall or market withdrawal, the Party notified of or wishing to call such recall or similar action shall, within ***, advise the other Party of notification or
its determination by telephone or facsimile, after which the Parties shall promptly discuss and work together to effect an appropriate course of action; provided, however, that either Party may initiate a recall or market withdrawal
thereafter if it deems such action necessary or appropriate. SM shall be responsible for notification to FDA and compliance with applicable laws in conducting such recall. 

  

	13.6	Recall Expense. If a recall results from the breach of a Party’s warranties or obligations under this Agreement, the breaching Party shall bear the full expense
of both Parties incurred in any such recall. Such expenses of recall shall include, without limitation, the expenses of notification and destruction or return of the recalled Product and the sum paid for the recalled Product. If, however, a recall
is partially caused by SM’s actions or omissions and partially caused by EDT’s actions or omissions, then each Party shall be responsible for its proportionate share of the recall expenses based on its proportionate share of causation.

  
 ARTICLE 14 
 DELPOUCH PRODUCT 
  

	14.1	Right to Product in DelPouch Form. EDT hereby grants to SM the right to purchase the Product in DelPouch form (the “DelPouch Product”) from EDT on an
exclusive basis in the Field in the Territory prior to EDT’s offer of the DelPouch Product to any third party. In furtherance of the foregoing, EDT shall use Commercially Reasonable Efforts to offer the DelPouch Product as soon as reasonably
practicable and shall provide prompt written notice (the “Offer Notice”) to SM specifying the terms on which the DelPouch is available. SM may elect to exercise its right of first refusal hereunder by providing an affirmative notice
(the “Acceptance Notice”) to EDT within *** of the receipt of the Offer Notice. In such event, the Parties shall negotiate in good faith the definitive terms and agreements providing for the manufacture, purchase and supply of the
DelPouch Product. EDT agrees that SM shall not be required to pay *** with respect to the DelPouch Product and that the fees payable by SM pursuant to Section 5.1 above shall be deemed in full satisfaction of *** that EDT would otherwise
charge third parties with respect to the DelPouch Product. 

  

	14.2	Sale of DelPouch Product to Other Parties. In the event (i) SM does not provide an Acceptance Notice to EDT within such *** period or (ii) the Parties fail to agree on the
definitive terms and agreements for the manufacture, purchase and supply of 

  

	***	Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

  

 21 

	 	 
the DelPouch Product within *** of EDT’s receipt of the Acceptance Notice from SM, EDT shall have the right to offer the DelPouch Product to any other
third party on no more favorable terms than those offered to SM in the Offer Notice or, if applicable, the draft of the definitive agreements last offered by EDT to SM. 

  

	14.3	Certification of Terms. In the event that EDT enters into any definitive agreement with respect to DelPouch Product with a third party in accordance with the foregoing, it
shall provide SM with a certificate signed by an officer of EDT setting forth the material commercial terms of the definitive agreement and certifying that EDT has complied with the provisions of this Article 14.

  
 ARTICLE 15 
 DISPUTES 
  

	15.1	Governing Law. This Agreement shall be governed, controlled, interpreted and defined by and under the laws of the State of California and the United States without
regard to that body of law known as conflicts of law; provided that issues relating to the validity and enforceability of patents shall be governed by the laws of the jurisdiction under which such patent was granted. 

 

	15.2	Arbitration. Any claim, dispute, or controversy of whatever nature arising out of or relating to this Agreement, including, without limitation, any action or claim based on
tort, contract, or statute or concerning the interpretation, effect, termination, validity, performance and/or breach of this Agreement (“Claim”), shall be resolved by final and binding arbitration before a single arbitrator
(“Arbitrator”) who is knowledgeable in the subject matter at issue in the dispute. The Arbitrator will be selected by mutual agreement of the parties. The arbitration shall be held in Los Angeles County, California. Arbitration of
Claims between the parties shall be conducted in accordance with Sections 1282 through 1288 of the California Code of Civil Procedure. The Arbitrator shall, within 15 calendar days after the conclusion of the arbitration hearing, issue a written
award and statement of decision describing the essential findings and conclusions on which the award is based, including the calculation of any damages awarded. The Arbitrator shall be authorized to award compensatory damages, but shall NOT be
authorized (i) to award non-economic damages, such as for emotional distress, pain and suffering or loss of consortium, (ii) to award punitive damages, or (iii) to reform, modify or materially change this Agreement or any other agreements
contemplated hereunder; provided, however, that the damage limitations described in parts (i) and (ii) of this sentence will not apply if such damages are statutorily imposed. The Arbitrator also shall be authorized to grant any temporary,
preliminary or permanent equitable remedy or relief he or she deems just and equitable and within the scope of this Agreement, including, without limitation, an injunction or order for specific performance. Each Party shall bear its own
attorney’s fees, costs, and disbursements arising out of the arbitration, and shall pay an equal share of the fees and costs of the Arbitrator; provided, however, the Arbitrator shall be authorized to determine whether a Party is the
prevailing Party, and if so, to award to that prevailing Party reimbursement for its reasonable attorneys’ 

  

	***	Portions of this page have been omitted pursuant to a request for Confidential Treatment and filed separately with the Commission. 

  

 22 

 
fees, costs and disbursements (including, for example, expert witness fees and expenses, photocopy charges, travel expenses, etc.), and/or the fees and costs
of the Arbitrator. Each Party shall fully perform and satisfy the arbitration award within 15 days of the service of the award. By agreeing to this binding arbitration provision, the parties understand that they are waiving certain rights and
protections which may otherwise be available if a Claim between the parties were determined by litigation in court, including, without limitation, the right to seek or obtain certain types of damages precluded by this provision, the right to a jury
trial, certain rights of appeal, and a right to invoke formal rules of procedure and evidence. 
  
 Notwithstanding the foregoing, either Party shall have the right to pursue an action in a court of competent jurisdiction to obtain injunctive or other
equitable remedy, in order to preserve the status quo during the resolution of any dispute under this provision. 
  
 ARTICLE 16 
 NOTICES 
  

	16.1	Notices. Any notice required or permitted by this Agreement shall be in writing and shall be sent by prepaid registered or certified mail, return receipt requested; by
facsimile; by internationally recognized courier; or by personal delivery, in each case addressed to the other Party at the address below or at such other address for which such Party gives notice under this Agreement. 

  
 If to SM, at: 
  
 SkinMedica, Inc. 
 2380 Camino Vida Roble, Suite C 
 Carlsbad,
CA 92009 
 Attn: Rex Bright, President and Chief Executive Officer 
  
 If to EDT, at: 
  
 Enhanced Derm Technologies, Inc. 
 123
Saginaw Drive 
 Redwood City, CA 94063 
 Attn: David O’Hara 
  
 Such notice shall be deemed to have been
given when delivered or, if delivery is not accomplished by some fault of the addressee, when tendered. Either Party may change its address for notice by delivering a written notice of the new address in accordance with this Article 16.

  

 23 

 ARTICLE 17 
 ADDITIONAL PROVISIONS 
  

	17.1	No Agency; Independent Contractor. Each Party is and shall be considered to be an independent contractor of the other Party. Neither Party shall be the legal agent of the
other for any purpose whatsoever and neither Party has any right or authority to make or underwrite any promise, warranty or representation, to execute any contract or otherwise to assume any obligation or responsibility in the name of or on behalf
of the other Party. Neither Party shall be bound by or liable to any third persons for any act or for any obligation or debt incurred by the other toward such third party, except to the extent specifically agreed to in writing by the Party so to be
bound. 

  

	17.2	Headings. Article and section headings contained in this Agreement are included for convenience of reference only and shall not affect in any way the meaning or
interpretation of this Agreement. 

  

	17.3	Partial Invalidity. If any provision of this Agreement is held to be invalid, illegal, or unenforceable by a court of competent jurisdiction, then: (a) such provision will be
deemed amended to conform to applicable laws of such jurisdiction so as to be valid and enforceable, or, if it cannot be so amended without materially altering the intention of the parties, it will be stricken; (b) the validity, legality and
enforceability of such provision will not in any way be affected or impaired thereby in any other jurisdiction; and (c) the remaining provisions of this Agreement will remain in full force and effect. 

  

	17.4	Survival. The covenants and agreements set forth in Articles 7, 8, 12 and 15 shall survive any termination or expiration of this Agreement and remain in full
force and effect regardless of the cause of termination. 

  

	17.5	Entire Agreement. This Agreement, including the attached Exhibits, constitutes the entire agreement of the Parties with respect to the subject matter, and supersedes all
prior or contemporaneous understandings or agreements, whether written or oral, between SM and EDT with respect to such subject matter. In particular, (a) this Agreement specifically supercedes and replaces the Mutual Confidential Disclosure
Agreement dated July 2, 2001 and the Hydroquinone/Retinol Cream Term Sheet dated July 30, 2001 in their entirety, and (b) in the event of conflict between this Agreement and the terms and conditions of any purchase order or other form generated in
performance of this Agreement, then the terms and conditions of this Agreement shall control, and (c) in the event of conflict between this Agreement and the Quality Agreement (as it may be amended from time to time), the terms of this Agreement
shall govern all aspects of the relationship between the Parties except that the Quality Agreement shall govern with respect to quality matters. 

  

	17.6	 Waivers. No waiver of any term or condition of this Agreement shall be valid or binding on either Party unless agreed in writing by the Party to be charged.
The failure of either Party to enforce at any time, or for any period of time, any provision of this Agreement, or the failure to require at any time performance by the other Party of any provision of 

  

 24 

 
this Agreement, shall in no way be construed to be a present or future waiver of such provisions or of the right of such Party thereafter to enforce that
provision or other provisions of this Agreement. 
  

	17.7	Restrictions; Ability to Subcontract. Insofar as EDT anticipates using contract laboratories for any activity contemplated by this Agreement, EDT shall notify SM when use of
such contract laboratories becomes necessary. EDT may not use any such contract laboratories without the prior written consent of SM. EDT shall be responsible for assuring that any contract laboratories comply with the terms of this Agreement and
applicable laws and regulations. 

  

	17.8	Amendment. No amendment or modification of this Agreement shall be valid or binding upon the Parties unless made in writing and signed by the duly authorized representatives
of both Parties. 

  

	17.9	Conflicting Terms and Conditions. All sales under this Agreement shall be subject to the provisions of this Agreement (including, without limitation, the
Specifications) and shall not be subject to the terms and conditions contained on any purchase order of SM or confirmation of EDT, except insofar as any such purchase order or confirmation establishes: 

  

	 	(a)	the quantity and form of any Product ordered; 

  

	 	(b)	the shipment date; 

  

	 	(c)	the shipment routes and destinations; or 

  

	 	(d)	the carrier. 

  

	17.10	Binding Effect and Assignment. Each Party agrees that its rights and obligations under this Agreement may not be transferred or assigned directly or indirectly, except as
follows: (a) either Party may transfer or assign this Agreement to an Affiliate of such Party which agrees in writing to undertake the obligations under this Agreement, (b) either Party may transfer or assign this Agreement in connection with the
sale of all or substantially all of the assigning Party’s related business, and (c) either Party may transfer or assign this Agreement to a non-Affiliate Third Party with the prior written consent of the other Party, which consent shall not be
unreasonably withheld. Subject to the foregoing, this Agreement shall be binding upon and inure to, the benefit of the Parties, their successors and assigns. Any attempted assignment contrary to the provisions of this Section 17.10 shall be
deemed ineffective, and either Party shall have the right to terminate this Agreement, with the effect described in Section 11.2. 

  

	17.11	Counterparts. This Agreement may be executed in two or more counterparts, each of which shall be deemed an original and all of which together shall constitute one and the
same agreement. 

  

 25 

 IN WITNESS WHEREOF, the Parties have caused this Agreement to be duly executed by their respective duly authorized
officers as of the date first written above. 
  

							
	SKINMEDICA, INC.	 	ENHANCED DERM TECHNOLOGIES, INC.
	(“SM”)	 	(“EDT”)
				
	By:	 	 /s/ Rex Bright

	 	By:	 	 /s/ David O’Hara

	Name:	 	Rex Bright	 	Name:	 	David O’Hara
	Title:	 	President and Chief Executive Officer	 	Title:	 	 

  

 26

Source: [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00088-of-00352.parquet"}, [{"source": "alea-institute/alea-institute/kl3m-data-edgar-agreements/train-00088-of-00352.parquet"}]]