Document:

MDCO EX 10.1 03.31.2013

	
					
	 
	 
	 
	 
	Exhibit 10.1

	 
	 
	 
	 
	 

	 
	Confidential Materials omitted and filed separately with the
Securities and Exchange Commission.  Asterisks denote omissions.

	 

	 
	 

	 
	 

	 
	 

	 
	 
	 
	 
	 

Execution Copy

LICENSE AND ASSET TRANSFER AGREEMENT

BY AND BETWEEN

ALZA CORPORATION 

AND

INCLINE THERAPEUTICS, INC.

TABLE OF CONTENTS
Article 1 Definitions.  1
Article 2 License Grant.  9
		
	2.1.
	License Grants to Incline.    9

		
	2.2.
	Sublicensing.    10

		
	2.3.
	Right of First Negotiation for Other Opioid Products.    10

		
	2.4.
	Right of First Negotiation for Other Products.    11

		
	2.5.
	Retained Rights    12

		
	2.6.
	Diligence    12

		
	2.7.
	Development Reports    12

		
	2.8.
	Provision of Licensed Know-How    12

Article 3 Purchase and Sale of Assets; Assignment and Assumption of Liabilities.  12
		
	3.1.
	Sale of Transferred Assets    12

		
	3.2.
	Excluded Assets    14

		
	3.3.
	Assumed Liabilities    15

		
	3.4.
	Excluded Liabilities    15

		
	3.5.
	Product Liability    16

Article 4 The Closing; Post-Closing Covenants.  16
		
	4.1.
	Closing and Closing Conditions    16

		
	4.2.
	ALZA's Responsibilities at the Closing    17

		
	4.3.
	Incline's Responsibilities at the Closing    17

		
	4.4.
	Agreements Relating to Electronic Transfer, Delivery and Digitization

of Hard Copy Documents; Physical Delivery of Transferred Assets; 
and Transfer of Governmental Filings and Authorizations    17
		
	4.5.
	Improperly Transferred Documents    19

		
	4.6.
	No Continuing Obligations    20

		
	4.7.
	Costs and Taxes.    20

		
	4.8
	Allocation    21

		
	4.9.
	Risk of Loss    21

		
	4.10.
	Trademark and Domain Name Assignment, Recording and Other Obligations    21

		
	4.11.
	Incline's Post-Closing Covenants.    21

		
	4.12.
	ALZA's Post-Closing Covenant    23

		
	4.13.
	Pharmacovigalence Covenants    23

Article 5 Financial Provisions.  23
		
	5.1.
	Upfront Payment    23

		
	5.2.
	Milestone Payments    23

		
	5.3.
	Royalty Payments    25

		
	5.4.
	Adjustments in Royalty Rates.    26

		
	5.5.
	Royalty Reports    27

		
	5.6.
	Reimbursement of Payments Under ALZA Third Party Licenses    27

		
	5.7.
	Other Financial Provisions.    27

Article 6 Intellectual Property.  30
		
	6.1.
	Prosecution of Patents.    30

		
	6.2.
	Enforcement of Licensed Patents.    30

		
	6.3.
	Marking    31

Article 7 Confidential Information.  31
		
	7.1.
	Confidentiality Obligations    31

		
	7.2.
	Exceptions    31

		
	7.3.
	Authorized Disclosure and Use.    35

		
	7.4.
	SEC Filings and Other Disclosures    35

		
	7.5.
	Public Announcements    36

Article 8 Representations and Warranties.  36
		
	8.1.
	Representations and Warranties of Each Party    36

		
	8.2.
	Additional Representations and Warranties of ALZA.    37

		
	8.3.
	Additional Representations and Warranties of Incline    37

		
	8.4.
	Disclaimer of Warranties.    38

		
	8.5.
	No Implication    38

Article 9 Indemnification and Insurance.  38
		
	9.1.
	Survival    38

		
	9.2.
	Indemnification by ALZA    39

		
	9.3.
	Indemnification by Incline    39

		
	9.4.
	Scope of ALZA's Liability    39

		
	9.5.
	Claims    39

		
	9.6.
	Defense of Third Party Claims    40

		
	9.7.
	Exclusive Remedy.    40

		
	9.8.
	Calculation of Damages    41

		
	9.9.
	Mitigation    41

		
	9.10.
	No Limitation on Right to Contest    41

		
	9.11.
	Limitations of Indemnification    41

		
	9.12.
	Insurance    41

Article 10 Term and Termination.  41
		
	10.1.
	Term    41

		
	10.2.
	Termination for Cause    41

		
	10.3.
	Termination for Incline Bankruptcy    42

		
	10.4.
	Effects of Termination    42

		
	10.5.
	No Waiver    42

		
	10.6.
	Consequences of Termination    43

		
	10.7.
	Termination Not Sole Remedy    43

		
	10.8.
	Survival of Obligations    43

		
	10.9.
	Rights in Bankruptcy    43

Article 11 Dispute Resolution.  43
		
	11.1.
	Escalating; Decision Making Authority    43

		
	11.2.
	Mediation    44

		
	11.3.
	Arbitration    44

		
	11.4.
	Jury Trial.    47

		
	11.5.
	Termination    47

Article 12 Miscellaneous.  47
		
	12.1.
	No Reliance by Incline; Own Due Diligence    47

		
	12.2.
	Performance by Affiliates    47

		
	12.3.
	Entire Agreement    47

		
	12.4.
	Binding Effect    48

		
	12.5.
	Assignment    48

		
	12.6.
	No Third Party Beneficiaries    48

		
	12.7.
	Use of Names    48

		
	12.8.
	No Waiver    48

		
	12.9.
	Modifications and Amendments    48

12.10.  Independent Contractors  48
12.11.  Notices and Deliveries  48
12.12.  Severability  49
12.13.  Governing Law; Submission to Jurisdiction  49

12.14.  Specific Enforcement  50
12.15.  Advice of Counsel  50
12.16.  Counterparts  50
12.17.  Payment of Expenses  50
12.18.  Compliance with Laws  50
12.19.  Construction  50

Exhibits

Exhibit A - Form of Bill of Sale
Exhibit B - Form of Trademark Assignment
Exhibit C - Form of Domain Name Assignment
Exhibit D - Form of NDA and IND Assignments
Exhibit E - Form of Press Release

Schedules

Schedule 1.4 - ALZA Third Party Licenses
Schedule 1.18 - Fentanyl Analogs
Schedule 1.28 - Licensed Know-How
Schedule 1.29 - Licensed Patents
Schedule 1.44 - Product Domain Names
Schedule 1.45 - Product Trademarks
Schedule 3.1.2(a) - Clinical Trial Data
Schedule 3.1.2(b) and 3.1.2(c) - Manufacturing Data and Other Test Data
Schedule 3.1.4 - Manufacturing Equipment
Schedule 3.1.5 - Other Tangible Items
Schedule 3.1.6 - Market Research Materials
Schedule 3.1.7 - Governmental Filings and Authorizations
Schedule 4.5 - Third Party Confidentiality Obligations 
Schedule 4.7.3 - NDA and MAA Maintenance Reimbursements
Schedule 4.8 - Purchase Price Allocation
Schedule 4.11.5 - ALZA Employees Not Subject to Non-Solicit
Schedule 8.2 - ALZA Employees

    

LICENSE AND ASSET TRANSFER AGREEMENT

This License and Asset Transfer Agreement (this “Agreement”) is made as of June 21, 2010 (the “Execution Date”), by and between ALZA Corporation, a Delaware corporation (“ALZA”) and Incline Therapeutics, Inc., a Delaware corporation (“Incline”).  ALZA and Incline may each be referred to herein individually as a “Party” and collectively as the “Parties.”

BACKGROUND

		
	1.
	ALZA has developed the ALZA Product (as defined below) and owns or controls the rights to certain intangible assets relating to the ALZA Product, such as patents, patent applications and know-how, as well as certain tangible assets relating to the ALZA Product.

		
	2.  
	Incline desires to acquire from ALZA rights in and to such intangible and tangible assets, pursuant to and subject to the terms and conditions of this Agreement.

		
	3.  
	Contemporaneously with this Agreement, Incline completed a financing transaction made pursuant to that certain Series A Convertible Preferred Stock Purchase Agreement, effective as of the date hereof, by and among Incline, Frazier Healthcare VI, LP and certain other investors (the “Stock Purchase Agreement”) and entered into the Option Agreement, executed as of the date hereof, between Incline and Cadence Pharmaceuticals, Inc. (the “Option Agreement”). 

NOW, THEREFORE, in consideration of the various promises and covenants set forth herein, and other good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged, the Parties hereby agree as follows:

		
	Article 1
	

Definitions

The terms in this Agreement with initial letters capitalized shall have the meaning set forth below or, if not listed below, the meaning designated where first used in this Agreement, and capitalized plural/singular or other forms of defined words or phrases shall have the corresponding meaning.

1.1“Affiliate” means, with respect to a Party, any corporation or other business entity that directly or indirectly, through one or more intermediaries, controls or is controlled by, or is under common control with such Party, but only for so long as such control shall continue.  For the purposes of this definition, the term “control” as used with respect to any Party, means the possession of at least 50% of the voting stock or other ownership interest of the other corporation or entity, or the power to direct or cause the direction of the management and policies of the corporation or other entity or the power to elect or appoint at least 50% of the members of the governing body of the corporation or other entity through the ownership of the outstanding voting securities or by contract or otherwise.

1.2“ALZA Product” means the iontophoretic transdermal system providing delivery of fentanyl under the influence of an electric current which is from a source external to the human 

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body (i.e., non-naturally occurring) that was developed and Controlled by ALZA prior to the Execution Date, also known as IONSYSTM.

1.3“ALZA Proprietary Compound” means any active pharmaceutical compound or substance, other than a Fentanyl Analog, owned, licensed, or otherwise controlled by ALZA or its Affiliates as of the Execution Date or during the Term anywhere in the Territory.
  
1.4“ALZA Third Party Licenses” means the agreements between ALZA and a Third Party set forth on Schedule 1.4. 

1.5“ALZA-[**] License Agreement” means that certain [**], between ALZA and [**].

1.6“Bankruptcy” means, with respect to a Party, that: (a) the Party has been declared insolvent or bankrupt by a court of competent jurisdiction; or (b) a voluntary or involuntary petition in bankruptcy has been filed in any court of competent jurisdiction against the Party and such petition has not dismissed within one hundred twenty (120) days after filing; or (c) the Party has made or executed an assignment of substantially all of its assets for the benefit of creditors.

1.7 “Commercialization” means any activities directed toward or including marketing, promoting, distributing, offering for sale, and selling a product, including importing a product for such purposes.  When used as a verb, “Commercialize” shall mean to engage in Commercialization.

1.8“Commercially Reasonable Efforts” means, with respect to the efforts to be expended by Incline with respect to a specified objective, those reasonable, diligent, good faith efforts to accomplish such objective as a similarly capitalized pharmaceutical or medical device company, as the case may be, in the United States would normally use to accomplish a similar objective under similar circumstances with respect to a product owned by such company.

1.9“Competing Product” means [**].

1.10“Confidential Information” means, with respect to a Party, unpublished or proprietary information or material that is Controlled or developed, in whole or in part, by such Party, whether tangible or intangible, where such information or material is disclosed to the other Party hereunder or is information that is designated herein as Confidential Information of such Party.
  
1.11“Contract Year” means the twelve (12) month period beginning on January 1 and ending on December 31 of each calendar year, provided, however, that the first Contract Year shall be the period of time beginning on the Closing Date and ending on December 31, 2010.

1.12“Control” or “Controlled” means, with respect to an item of information or intellectual property right, including know-how or Patent Right, possession (whether by ownership or license, other than pursuant to this Agreement) of the ability to transfer or grant a license, sublicense or other right with respect to such item or right as provided for herein without violating the terms of any contract or other arrangements with any Third Party.

1.13“Damages” means losses, liabilities, damages, deficiencies, costs and expenses directly incurred or suffered (and, if applicable, reasonable attorneys' fees associated therewith).

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1.14“EMEA” means the European Regulatory Authority known as the European Medicines Agency and any successor agency thereto.

1.15“Encumbrance” means any charge, claim, condition, equitable interest, lien, license, option, pledge, security interest, mortgage, right of way, easement, encroachment, servitude, right of first offer or first refusal, buy/sell agreement and any other restriction or covenant with respect to, or condition governing the use, construction, voting (in the case of any security or equity interest), transfer, receipt of income or exercise of any other attribute of ownership which would, individually or in the aggregate, have a material adverse effect on Incline's ability to develop and Commercialize a Product.

1.16“Europe” means the countries of the European Union, and all other countries encompassed by the area bordered by the Ural Mountains, Ural River and Caspian Sea in the east, the Caucasus Mountains and the Black Sea with its outlets, Bosporus and Dardanelles in the south.  

1.17“FDA” means the United States Food and Drug Administration or any successor agency in the United States with responsibilities comparable to those of the United States Food and Drug Administration.

1.18“Fentanyl Analog” means fentanyl and those other compounds listed on Schedule 1.18 hereto, and any salt, polymorph, or any other bioequivalent form of any such compounds. 

1.19“First Commercial Sale” means, on a country-by-country basis, the first commercial sale of a Product to a Third Party in an arms' length transaction in the country in the Territory by or on behalf of Incline, its Affiliates or sublicensees following receipt of applicable Regulatory Approval of such Product in such country.

1.20“GAAP” means the generally accepted accounting principles in the United States applied on a consistent basis.

1.21“Generic Drug” means, as to any given pharmaceutical drug product approved by the FDA under a New Drug Application, a pharmaceutical drug product that (A) is not and will not be marketed under the approval of such New Drug Application and that (B) (i) contains as its active ingredient(s) the same active ingredient(s) as such approved product, and (ii) obtained or is intended to obtain, regulatory approval from the FDA under an Abbreviated New Drug Application or Section 505(b)(2) New Drug Application.

1.22“Hedge-able Currency” means [**].

1.23“Incline Compound” means any active pharmaceutical compound exclusively owned, licensed or otherwise controlled by Incline on a worldwide basis that is not (a) a Fentanyl Analog, (b) a Generic Drug owned, licensed or otherwise controlled by ALZA or its Affiliates during the Term anywhere in the Territory or (c) an ALZA Proprietary Compound.
  
1.24“Incline Combination” means a combination of (a) one or more Incline Compounds and (b) either (i) one or more Fentanyl Analogs or (ii) one or more Other Generic Compounds.
  

3

1.25“IND” means an effective Notice of Claimed Investigational Exemption for a New Drug or Investigational New Drug Application, as defined in Title 21, Part 312, of the Code of Federal Regulations, on file with the FDA before the commencement of clinical trials of a Product in humans, or any comparable filing with the Regulatory Authority of a country other than the United States.

1.26“Innovator Protection” means, with respect to a given Product in a given country in the Territory, that (a) at least one Valid Claim of a Licensed Patent in such country covers such Product, its manufacture, or use, and/or (b) such Product has Regulatory Exclusivity in such country.

1.27“Liability” means, with respect to any Person, any liability or obligation of such Person whether known or unknown, whether asserted or unasserted, whether determined, determinable or otherwise, whether absolute or contingent, whether accrued or unaccrued, whether liquidated or unliquidated, whether incurred or consequential, whether due or to become due and whether or not required under GAAP to be accrued on the financial statements of such Person.

1.28“Licensed Know-How” means the inventions and other know-how Controlled by ALZA and contained in the ALZA invention records set forth on Schedule 1.28, and related laboratory notebook records solely to the extent that such related laboratory notebook records relate to such ALZA invention records.  Incline understands and acknowledges that the inventions contained in the ALZA invention records set forth on Schedule 1.28 may be jointly owned with Third Parties and that such invention records are subject to such Third Party ownership interests.

1.29“Licensed Patents” means the patents and patent applications owned by ALZA and set forth on Schedule 1.29 and all Patent Rights arising therefrom, as well as any Patent Rights owned by ALZA arising from the Licensed Know-How. 

1.30“MAA” means (a) a marketing authorization application filed with (i) the EMEA under the centralized EMEA filing procedure or (ii) a Regulatory Authority in any European country if the centralized EMEA filing procedure is not used, to obtain marketing approval or (b) any other equivalent or related regulatory submission, such as a Type II variation, to gain approval to market a Product in any country in the European Union.

1.31“Major EU Countries” means the United Kingdom, France, Italy, Germany and Spain.

1.32“NDA” means (a) a New Drug Application submitted to the FDA to obtain marketing approval for a Product in the United States or (b) any other equivalent or related regulatory submission, such as an sNDA, ANDA or sANDA, to gain approval to market a Product in the United States.
 
1.33“Net Sales” means the gross invoiced amount of sales of all Products by Incline and its Affiliates, sublicensees and distributors to Third Parties, less the following deductions actually incurred, allowed, paid, accrued, or specifically allocated, provided that all such deductions shall be commercially reasonable and actually deducted and not recouped:

		
	(a)
	normal and customary trade, cash and quantity discounts, allowances and credits actually allowed or paid including cash coupons and retroactive price reductions; 

4

		
	(b)
	credits or allowances actually granted for damaged Products, returns or rejections of Products, price adjustments and billing errors;

		
	(c)
	rebates, chargebacks and discounts (or equivalents thereof) granted to managed health care organizations, pharmacy benefit managers (or equivalents thereof), federal, state/provincial, local and other governments, their agencies and purchasers and reimbursers or to trade customers that are directly attributable to the Products; 

		
	(d)
	commissions paid to Third Party distributors, brokers or agents;

		
	(e)
	sales taxes, VAT taxes and other Taxes directly linked to the sales of the Products to the extent included in the gross amount invoiced; 

		
	(f)
	transportation costs, including insurance, for outbound freight related to delivery of the Products directly chargeable to the Products, but only to the extent that such expenses are separately delineated in the applicable invoices; and

		
	(g)
	customs duties, surcharges and other governmental charges incurred in connection with the exportation or importation of the Products.

each as determined on a country by country basis, in each case as accounted for by Incline in accordance with GAAP, as consistently applied.  
Net Sales shall include the amount of fair market value of all other consideration in respect of the Products, whether such consideration is in kind or in other form and shall not include (i) any reimbursement received by Incline, its Affiliate, sublicensee or distributor, as applicable, in respect of the use of a Product in a country solely as part of a clinical trial prior to the receipt of marketing authorization required to commence commercial sales of such Product in such country, or (ii) any revenue generated under patient access or compassionate use programs prior to the receipt of marketing authorization required to commence commercial sales of such Product in a country. 
In the event that any discounts, reductions, payments or rebates are offered for a Product where such Product is sold to a customer as part of a grouped set of products, the applicable discount, reduction, payment or rebate for such Product in such arrangement shall be based on the weighted average discount, reduction, payment or rebate of such grouped set of products; each to the extent consistent with Incline's usual course of dealing for its products other than such Product, if any. 
		
	1.34
	“Other Generic Compound” means [**].  

1.35“Other Generic-Fentanyl Combination” means [**]. 

1.36“Other Product” means an iontophoretic transdermal system that [**].

1.37“Other Opioid Compound” means [**].
  
1.38“Other Opioid-Fentanyl Combination” means a combination of one or more Fentanyl Analogs and one or more Other Opioid Compounds. 

5

1.39“Other Opioid-Generic Combination” means a combination of one or more Other Opioid Compounds and one or more Other Generic Compounds.

1.40“Other Opioid Product” means an iontophoretic transdermal system that [**].

1.41“Patent Right(s)” means, with respect to a particular invention, any and all (a) United States or foreign patents claiming the invention, (b) U.S. or foreign patent applications claiming the invention, including all provisional applications, substitute applications, inventor's certificates, registration patents, confirmation patents, continuations, continuations-in-part, divisions, renewals, and all patents granted thereon, (c) all patents-of-addition, reissues, reexaminations and extensions or restorations by existing or future extension or restoration mechanisms, including supplementary protection certificates or the equivalent thereof, of the foregoing, and (d) any other form of government-issued right for the invention substantially equivalent to any of the foregoing.

1.42“Person” means any natural person, corporation, firm, business trust, joint venture, association, organization, company, partnership or other business entity, or any government, or any agency or political subdivisions thereof.

1.43“Product” means an iontophoretic transdermal system providing delivery under the influence of an electric current which is from a source external to the human body (i.e., non-naturally occurring) of one or more Fentanyl Analogs.

1.44“Product Domain Names” means the internet domain names set forth on Schedule 1.44.

1.45“Product Trademarks” means the registered trademarks “IONSYS” and “E-TRANS” or trademark applications for “IONSYS” and “E-TRANS” in certain countries in the Territory, as set forth in Schedule 1.45.

1.46“Prosecuting” means, with regard to a specified Patent Right, preparing, filing, prosecuting, maintaining, and defending such Patent Right, including with respect to any reexamination, reissue, interference, or opposition proceedings.  For the avoidance of doubt, “Prosecuting” excludes any infringement suits or other legal proceedings to enforce the specified Patent Right, regardless of whether or not such proceedings involve the defense of the Patent Right in suit. When used as a noun, “Prosecution” shall mean the act of Prosecuting.

1.47“Quarter” or “Quarterly” means each three month period ending March 31, June 30, September 30 or December 31 of each Contract Year during the Term.

1.48“Regulatory Approval” means the technical, medical and scientific licenses, registrations, authorizations and approvals (including approvals of NDAs and labeling approvals) of the applicable Regulatory Authority necessary for the commercial manufacture, distribution, marketing, promotion, offer for sale, use, import, export and sale of a Product in a regulatory jurisdiction.

1.49“Regulatory Authority” means any applicable supranational, European Union, federal, national, regional, state or local regulatory agency, department, bureau, commission, council or other government entity with authority over the development, manufacture, use, marketing and/

6

or sale (including approval of NDAs and other marketing authorization applications) of a pharmaceutical product in any regulatory jurisdiction throughout the world, including the FDA in the United States and the EMEA in the EU.

1.50“Regulatory Exclusivity” means any rights or protections which are recognized, afforded or granted by the FDA, EMEA or any other Regulatory Authority in any country or region of the Territory, in association with the Regulatory Approval of a Product, providing such Product:  (a) a period of marketing exclusivity, during which a Regulatory Authority recognizing, affording or granting such marketing exclusivity shall refrain from either reviewing or approving a marketing authorization application or similar regulatory submission, submitted by a Third Party seeking to market a Competing Product, or (b) a period of data exclusivity, during which a Third Party seeking to market a Competing Product is precluded from either referencing or relying upon, without an express right of reference from the dossier holder, such Product's clinical dossier or relying on previous Regulatory Authority findings of safety or effectiveness with respect to such Product to support the submission, review or approval of a marketing authorization application or similar regulatory submission before the applicable Regulatory Authority.  Regulatory Exclusivity shall include rights conferred in the United States pursuant to the Hatch-Waxman Amendments to the Federal Food, Drug and Cosmetic Act, the Orphan Drug Act or the Best Pharmaceuticals for Children Act or in the European Union pursuant to Section 10.1(a)(iii) of Directive 2001/EC/83.

1.51“Royalty Period” means, with respect to a given Product in a given country in the Territory, the period of time commencing on the date of First Commercial Sale of such Product in such country and extending until the later of (a) the date on which there is no Innovator Protection for such Product in such country and (b) twenty (20) years from the date of First Commercial Sale of such Product in such country.

1.52“Series A Financing” means the Series A financing of Incline in an amount up to $43,000,00 by Frazier Healthcare VI, LP, 5AM Ventures III, L.P., Technology Partners, Adams Street Partners, Saints Capital Partners, Emergent Medical Partners, Wilson Sonsini Goodrich & Rosati, and other investors.

1.53“Sublicensed Patent Rights” means [**].
  
1.54“Tax” and “Taxes” means all taxes, charges, duties, fees, levies or other assessments, including income, excise, property, business, goods and services, sales or use, value added, profits, license, withholding (with respect to compensation or otherwise), payroll, employment, net worth, capital gains, transfer, stamp, social security, environmental, occupation and franchise taxes, imposed by any government entity, and including any interest, penalties and additions attributable thereto.

1.55“Territory” means the world, including all countries, possessions, and jurisdictions; provided, however, that in the event this Agreement is terminated pursuant to Section 10.2 only with respect to a Region, such Region shall automatically be excluded from the Territory as of the effective date of such termination.

1.56“Third Party” means any Person other than a Party or any of its Affiliates.

1.57“Trademarks” means trademarks, servicemarks, trade dress, logos and all applications, 

7

registrations and renewals therefor.

1.58“Transferred IP” means the Product Trademarks, Transferred Know-How and Product Domain Names included as Transferred Assets pursuant to Sections 3.1.1, 3.1.2 and 3.1.3, respectively.

1.59“Valid Claim” means a claim (a) of any issued and unexpired patent that has not been dedicated to the public, disclaimed, revoked or held unenforceable or invalid by a decision of a court or governmental agency of competent jurisdiction (including a patent office, where applicable) from which no appeal can be taken, or with respect to which an appeal is not taken within the time allowed for appeal, and that has not been disclaimed or admitted to be invalid or unenforceable through reissue, disclaimer or otherwise.

1.60Additional Definitions.  Each of the following definitions are found in the body of this Agreement as indicated:
	
			
	 
	Section
	

	Adverse Event
	4.13
	

	Agreement
	Preamble
	

	ALZA Indemnitees
	9.3
	

	ALZA-Medtronic Agreement
	4.11.6
	

	ALZA ROFN Notice
	2.3.2
	

	Appeal Arbitrator
	11.3.6
	

	Assumed Liabilities
	3.3
	

	Claim
	9.5
	

	Closing
	4.1.1
	

	Closing Date
	4.1.1
	

	Controlling Party
	6.2.3
	

	CPR
	11.2
	

	[**]
	4.12
	

	Execution Date
	Preamble
	

	Excluded Assets
	3.2
	

	Excluded Liabilities
	3.4
	

	Expedited Arbitration Dispute
	11.3.1
	

	Financial Records
	5.7.4
	

	Financing Commitments
	8.3.1
	

	Improperly Transferred Documents
	4.5
	

	Incline Indemnitees
	9.2
	

	Incline Notice Period
	2.3.3
	

	Incline Notification
	2.3.3
	

	Incline ROFN Notice
	2.4.1
	

	Indemnified Party
	9.5
	

	Indemnifying Party
	9.5
	

	Indemnity Basket
	9.4
	

	Indemnity Cap
	9.4
	

	Infringer
	6.2.1
	

	Initial Selected Product Negotiation Period
	2.4.2
	

	Key Terms
	2.4.2
	

	Manufacturing Data
	3.1.2
	

	Market Research Materials
	3.1.6
	

8

	
			
	Milestone Three
	5.2.1
	

	Negotiation Period
	2.3.3
	

	Option Agreement
	Background
	

	Other Opioid Product License Agreement
	2.3.2
	

	Other Product License Agreement
	2.4.1
	

	Other Product Third Party Agreements
	2.4.6
	

	Privileged Information
	6.1.4
	

	Region
	10.2
	

	Right of First Negotiation
	2.3.3
	

	ROFN Period
	2.3.1
	

	ROW Countries
	10.2
	

	Second Selected Product Negotiation Period
	2.4.3
	

	Stock Purchase Agreement
	Background
	

	Term
	10.1
	

	Third Party Claim
	9.6
	

	Third Party Negotiation Period
	2.3.4
	

	Title 11
	10.9
	

	Total Relevant Sales
	5.4.2
	

	Transferred Assets
	3.1
	

	Transferred Know-How
	3.1.2
	

	Upfront Purchase Price
	5.1
	

		
	Article 2
	License Grant

2.1License Grants to Incline.  

2.1.1Subject to the terms and conditions of this Agreement and the terms and conditions of the ALZA Third Party Licenses, ALZA hereby grants to Incline, effective as of the Closing Date, an exclusive (including with regard to ALZA and its Affiliates) license under the Licensed Patents owned by ALZA and the Licensed Know-How owned by ALZA to make, have made, use, import, export, sell, offer for sale, have sold and otherwise exploit the Products in the Territory.

2.1.2Subject to the terms and conditions of this Agreement, ALZA hereby grants to Incline, effective as of the Closing Date, a non-exclusive sublicense under the Sublicensed Patent Rights, to make, have made, use, import, export, sell, offer for sale, have sold and otherwise exploit the Products (to the extent such Products are “ALZA Products” as such term is defined in the ALZA-[**] License Agreement) in the Territory.  Incline understands and acknowledges that such sublicense is at all times subject to the terms and conditions of the ALZA-[**] License Agreement and that ALZA has only non-exclusive rights to such Sublicensed Patent Rights.  ALZA agrees that it will not amend or modify the ALZA-[**] License Agreement in a manner that would adversely affect Incline's sublicense rights under this Section 2.1.2, nor will it terminate early the ALZA-[**] License Agreement, without prior consent from Incline, which consent shall not be unreasonably withheld.  ALZA shall promptly provide to Incline any notice from any Third Party to the ALZA-[**] License Agreement regarding any allegation of material breach by ALZA of the ALZA-[**] License Agreement. 

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2.1.3The Parties acknowledge that, as of the Execution Date, ALZA has provided to Incline (a) a complete and accurate copy of the ALZA-[**] License Agreement, including all amendments and (b) copies of the other ALZA Third Party Licenses.
  
2.2Sublicensing.
  
2.2.1Subject to the terms and conditions of the ALZA Third Party Licenses, Incline may sublicense the rights granted to it under Section 2.1 to one or more of its Affiliates or Third Parties at any time.  Each such sublicense (a) shall be subject and subordinate to, and consistent with, the terms and conditions of this Agreement, (b) shall not in any way diminish, reduce or eliminate any of Incline's obligations under this Agreement, (c) shall require each such sublicensee to comply with all applicable terms of this Agreement, including to keep books and records, and permit ALZA to audit (either directly or through an independent auditor) such books and records, and (d) shall provide that any such sublicensee shall not further sublicense except on terms consistent with this Section 2.2.  Incline shall provide ALZA with a complete copy of each such sublicense agreement within thirty (30) days after the execution thereof; provided that Incline may redact such portions of any such agreement that do not relate to such sublicense or the terms thereof.  

2.2.2Incline shall remain responsible for its obligations hereunder and for the performance of its sublicensees (including making all payments due to ALZA by reason of any Net Sales of the Products as provided in Section 5.2 and Section 5.3), and shall ensure that any such sublicensees comply with all relevant provisions of this Agreement.  In the event of any uncured material breach by any sublicensee under a sublicense agreement that would constitute a material breach of Incline's obligations under this Agreement, Incline shall promptly inform ALZA in writing and shall use Commercially Reasonable Efforts to address such default; provided, however, that any such uncured material breach by such sublicensee of an obligation that would constitute a material breach of Incline's obligations under this Agreement shall be deemed an uncured material breach of Incline hereunder unless Incline cures such material breach within the time and pursuant to the terms provided under Section 10.2 hereof.
  
2.2.3Upon an early termination of Incline's license rights under this Agreement, ALZA shall offer any Third Party sublicensee under a sublicense granted by Incline pursuant to Section 2.2.1 that was in effect on the effective date of termination of Incline's license rights under this Agreement the right to enter into a license agreement directly with ALZA on substantially the same terms and conditions under which such rights and licenses were granted to such sublicensee, provided that such sublicensee (a) is not then in breach of its sublicense, (b) agrees to comply with all the terms of this Agreement to the extent applicable to the rights sublicensed to it by Incline, and (c) such agreement does not include obligations upon ALZA that exceed the obligations of ALZA under this Agreement.

2.3Right of First Negotiation for [**].
  
2.3.1For purposes of this Agreement, the “ROFN Period” means the period beginning on the Closing Date and ending [**] years thereafter.

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2.3.2If, at any time during the ROFN Period, ALZA wishes to [**], then, prior to entering into any negotiations of the terms of such [**] with such Third Party, ALZA will give written notice to Incline of its desire to negotiate such [**] (the “ALZA ROFN Notice”).   The ALZA ROFN Notice shall be deemed ALZA's Confidential Information and shall identify [**].  Notwithstanding the foregoing, [**]”

2.3.3Incline shall have the first right to negotiate with ALZA with respect to the terms of the [**] described in the ALZA ROFN Notice (the “Right of First Negotiation”) on the terms and conditions set forth below in this Section 2.3.  In the event that Incline elects to exercise its Right of First Negotiation with respect to such [**], Incline will have [**] days after receipt of the ALZA ROFN Notice for such [**] (the “Incline Notice Period”) to so notify ALZA (the “Incline Notification”).  Upon receipt by ALZA of the Incline Notification, the Parties shall enter into good faith exclusive negotiations for a [**] day period following the receipt of the Incline Notification (the “Negotiation Period”).  The Negotiation Period can be extended by written agreement of ALZA and Incline.
  
2.3.4In the event that (a) Incline exercises its Right of First Negotiation with respect to such [**], but the Parties do not [**] within the Negotiation Period or (b) Incline does not exercise its Right of First Negotiation with respect to such [**] during the Incline Notice Period, then ALZA may, during the [**] month period following the end of the Negotiation Period or the Incline Notice Period, as the case may be (the “Third Party Negotiation Period”), negotiate and enter into an [**], provided that the [**].
  
2.3.5If no Other Opioid Product License Agreement with a Third Party is consummated during the Third Party Negotiation Period, ALZA's right to enter into an Other Opioid Product License Agreement with a Third Party with respect to such Other Opioid Product will again become subject to Incline's Right of First Negotiation pursuant to the terms and conditions provided above in this Section 2.3.
 
2.4Right of First Negotiation for Other Products.
 
2.4.1If, at any time during the ROFN Period, Incline wishes to [**], then Incline shall give written notice to ALZA of its desire to negotiate such [**] (the “Incline ROFN Notice”).   The Incline ROFN Notice shall be deemed Incline's Confidential Information, shall identify [**].  The Incline ROFN Notice shall identify no more than [**].

2.4.2Upon receipt of the Incline ROFN Notice, the Parties shall enter into good faith exclusive negotiations for a [**] day period following ALZA's receipt of the Incline ROFN Notice (the “[**] Negotiation Period”) to attempt to agree upon the key terms of [**] (the “Key Terms”).  The Key Terms shall include, at a minimum, [**] Negotiation Period can be extended by written agreement of ALZA and Incline.

2.4.3In the event the Parties agree upon a non-binding term sheet including the Key Terms by the end of the [**] Negotiation Period, then for an additional period of [**] days (the “[**] Negotiation Period”) the Parties shall proceed to conduct diligence with respect to the [**].  During the [**] Negotiation Period, ALZA shall review any [**].  At the conclusion of such review, ALZA shall determine in good faith, and promptly notify Incline, whether or not the rights under the [**] Negotiation Period can be extended by written agreement of ALZA and Incline.

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2.4.4In the event that the Parties do not (i) proceed to the [**] Product Negotiation Period or (ii) [**] Negotiation Period, then ALZA shall thereafter have no further obligation to Incline with respect to the [**].

2.4.5Incline shall not exercise its rights under Section 2.4 [**].  Each Incline ROFN Notice, whether it is the [**] election of a Right of First Negotiation under Section 2.4 with respect to a [**], shall count toward the limit under this Section 2.4.5.

2.4.6Incline acknowledges and understands that the [**] under Section 2.3 and Section 2.4 are subject to, among other things, [**].  Incline also acknowledges and understands that nothing in Section 2.3 or Section 2.4 obligates ALZA to [**] that might be granted pursuant to Section 2.3 or Section 2.4.  Incline further acknowledges and understands that [**] pursuant to Section 2.3 or Section 2.4 (a) might be [**].

2.5Retained Rights.  Any rights of ALZA not expressly granted to Incline under the provisions of this Agreement shall be retained by ALZA, including: (a) the rights to exploit the Licensed Patents and Licensed Know-How to the extent they cover technologies or products other than the Products (subject to Incline's rights under Section 2.3), including the right to develop and Commercialize products for the iontophoretic transdermal delivery of any ALZA Proprietary Compound; and (b) the right to develop and Commercialize an iontophoretic transdermal system providing delivery of any compound or substance other than a Product (subject to Incline's rights under Section 2.3). 

2.6Diligence.  During the Term, Incline, either itself or through one or more Affiliates or Third Party sublicensees, shall use Commercially Reasonable Efforts to develop, obtain Regulatory Approval for and Commercialize at least one Product (including a Product that delivers fentanyl) in the United States and the Major EU Countries.
  
2.7Development Reports.  With respect to any Product, on a semiannual basis no later than thirty (30) days following each June 30 and December 31 during each Contract Year until the First Commercial Sale of such Product in any country in the Territory, Incline shall submit to ALZA a written report describing in reasonable detail the development work conducted by Incline on such Product during the just-ended semiannual period and Incline's future development plans for such Product, which such report shall be the Confidential Information of Incline.

2.8Provision of Licensed Know-How.  At the Closing, ALZA shall, and shall cause its Affiliates to, provide Incline with copies of the invention records set forth on Schedule 1.28 and both (i) complete laboratory notebooks that contain information exclusively related to such invention records; and (ii) where laboratory notebooks contain information exclusively related to such invention records, as well as other information not subject to this Agreement, only those portions of such laboratory notebook records that exclusively relate to such invention records.

Article 3Purchase and Sale of Assets; Assignment and Assumption of Liabilities

3.1Sale of Transferred Assets.  Upon the terms and subject to the conditions of this Agreement and the ALZA Third Party Licenses, at the Closing, ALZA shall, and shall cause its Affiliates to, irrevocably sell, convey, assign and transfer to Incline, and Incline shall purchase, 

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receive and assume from ALZA and its Affiliates, all of ALZA's or its Affiliate's right, title and interest in and to the following as they exist as of the Closing Date (collectively, the “Transferred Assets”) free and clear of any Encumbrances, in exchange for the payment of the consideration described in Article 5 and the assumption by Incline of the Assumed Liabilities:

3.1.1Trademarks.  The Product Trademarks, including any goodwill associated with the Product Trademarks.

3.1.2Know-How.  The following reasonably relevant tangible and written know-how, data, information, including in any reports and records, to the extent relating exclusively to the ALZA Product, owned or Controlled by ALZA as of the Closing Date (collectively, the “Transferred Know-How”), in tangible or electronic form, subject to the terms of any written agreement with any Third Party relating to such Transferred Know-How or any applicable laws or regulations (such as those relating to health care compliance):

(a)Clinical Trial Data.  Clinical trial data and documentation (including protocols, investigator brochures, interim and final reports, case report forms, safety data, raw data, batch records, laboratory records, data tables, data files and summaries, original signed investigator financial disclosure forms, IRB approvals and SAS programs) exclusively related to the ALZA Product, as summarized on Schedule 3.1.2(a);

(b)Other Test Data.  Data and documentation, including study reports,  exclusively related to those non-clinical (including chemistry, manufacture and control) or preclinical tests conducted with respect to or using the ALZA Product, as summarized on Schedule 3.1.2(b) and 3.1.2(c); 

(c)Manufacturing Data.  Standard operating procedures, quality assurance, quality control and release protocols, qualification and validation reports, development reports, analytical methods, stability data and reports, batch records and environmental safety reports exclusively related to the manufacture, storage and release of the ALZA Product, as summarized on Schedule 3.1.2(b) and 3.1.2(c) (the “Manufacturing Data”); and

(d)Lab Notebooks.  Copies of laboratory notebook records to the extent such laboratory notebook records exclusively relate to the Licensed Patents and Licensed Know-How; to the extent transferable.

3.1.3Domain Names.  The Product Domain Names.

3.1.4Manufacturing Equipment.  To the extent transferable, the machinery, equipment, manuals, change control documents, drawings and tools owned by ALZA, including equipment related to the three manufacturing lines at ALZA's Vacaville facilities, exclusively related to the ALZA Product, as summarized on Schedule 3.1.4, together with ALZA's interest in respect of transferrable warranties relating thereto.

3.1.5Other Tangible Items.  Those tangible items exclusively related to the ALZA Product, including testing and research equipment, that are summarized on Schedule 3.1.5.

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3.1.6Business Records.  Subject to Section 4.11.2, the Third Party market research materials exclusively related to the ALZA Product and in ALZA's possession and Control (but excluding records or files not reasonably separable from market research documents or databases that do not exclusively relate to the ALZA Product) set forth on Schedule 3.1.6 (the “Market Research Materials”).

3.1.7Governmental Filings and Authorizations.  To the extent transferable and in ALZA's Control, (a) the NDAs and MAAs related exclusively to the ALZA Product and (b) the INDs filed with the FDA related exclusively to the ALZA Product, as identified on Schedule 3.1.7.  ALZA shall also provide copies of regulatory filings materially related to the NDAs and MAAs identified on Schedule 3.1.7 and copies of material correspondence relating thereto.
 
3.1.8Rights and Claims.  All rights, privileges, claims and causes of action of ALZA or its Affiliates (regardless of whether or not such claims or causes of action have been asserted by ALZA) arising out of or relating to the ownership, performance or use of the Transferred Assets or the ALZA Product.

3.2Excluded Assets.  Notwithstanding anything to the contrary set forth in this Agreement, Incline is not purchasing any asset of ALZA or its Affiliates that does not constitute a Transferred Asset, including the following (collectively, the “Excluded Assets”):

3.2.1Accounts Receivable.  All accounts receivable, notes receivable and similar rights to receive payments;

3.2.2Cash and Cash Equivalents.  All cash and cash equivalents (including marketable securities and other investment assets);

3.2.3Benefit Plans.  All the assets of and all the assets relating to and all rights under any employee benefit or welfare plan or any related contract between any Person and ALZA or any of its Affiliates;

3.2.4Certain Records.  (a) Any personnel records maintained by ALZA or any of its Affiliates, (b) records (including accounting records) relating to Taxes paid or payable by ALZA or any of its Affiliates with respect to the Transferred Assets or the ALZA Product, and (c) records prepared in connection with the transactions contemplated by this Agreement, including bids received from other Persons and analyses relating to the ALZA Product;

3.2.5Real Property.  (a) any real property and any buildings, improvements and fixtures thereon; and (b) any leasehold interests, including any prepaid rent, security deposits and options to renew or purchase in connection therewith, of ALZA or any of its Affiliates;

3.2.6Insurance.  All current and prior insurance policies arranged or maintained by ALZA or any of its Affiliates and all rights of any nature with respect thereto, including all rights to insurance recoveries thereunder and to assert claims with respect to any such insurance recoveries, whether arising before or after the Closing;

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3.2.7Tax Claims.  Refunds and credits, claims for refunds or credits and rights to receive refunds or credits from any taxing authority with respect to Taxes paid or to be paid by ALZA or any of its Affiliates;

3.2.8Intellectual Property.  Except for the intellectual property rights identified in Sections 3.1.1, 3.1.2 and 3.1.3, all other intellectual property rights owned or licensed by ALZA, including the Licensed Patents and the Licensed Know-How;

3.2.9IT Systems.  All property in the nature of databases, software programs, computer hardware, source code and object code owned or licensed by ALZA (including any obtained through its Affiliates), excluding the software included within the ALZA Product.

3.3Assumed Liabilities.  At the Closing, Incline will assume (and on and after the Closing, Incline will satisfy, perform and otherwise discharge when due, and on the terms and subject to the conditions of Article 9, will indemnify, defend and hold harmless the ALZA Indemnitees with respect to) the following specified obligations and liabilities of ALZA and its Affiliates (collectively, the “Assumed Liabilities”), and no other liabilities or obligations:

3.3.1all Liabilities that Incline has expressly agreed to reimburse, bear or pay pursuant to Section 4.7.

3.4Excluded Liabilities.  Incline is not assuming any Liabilities of ALZA or its Affiliates with respect to the ownership, possession, manufacture, research, development, Commercialization, use or operation of any Product, including the ALZA Product, or Transferred Assets or the exploitation of the inventions claimed by the Licensed Patents or Licensed Know-How by ALZA or its Affiliates prior to the Closing (collectively, the “Excluded Liabilities”).  All Excluded Liabilities shall be retained by and remain Liabilities of ALZA or its Affiliates.  Without limiting the generality of the foregoing, the Excluded Liabilities shall expressly include the following Liabilities of ALZA or its Affiliates:

3.4.1all Liabilities arising from any FDA, EMEA or other Regulatory Authority action or notification with respect to the development, administration, promotion or sale of any Product, including the ALZA Product, by ALZA or its Affiliates prior to the Closing;

3.4.2accounts payable or other Liabilities for goods and services with respect to the development, marketing, manufacture and distribution of any Product, including the ALZA Product, developed or sold by ALZA or its Affiliates prior to the Closing;

3.4.3all Taxes accruing prior to the Closing from the ownership, possession or use of any Product, including the ALZA Product, or Transferred Assets; and

3.4.4all Liabilities relating to the Transferred Assets or any Product, including the ALZA Product, and arising under, based upon, or relating to, any environmental law, environmental claim or hazardous substances, in each case, arising prior to the Closing.

3.4.5Transferred Assets Subject to Third-Party Consent.  To the extent that the sale, assignment, transfer, conveyance or delivery or attempted sale, assignment, transfer, conveyance or delivery to Incline (or one of its Affiliates) of any Transferred Asset is prohibited by any 

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applicable law or would require any governmental or Third Party authorizations, approvals, consents or waivers and such authorizations, approvals, consents or waivers shall not have been obtained prior to the Closing, this Agreement shall not constitute a sale, assignment, transfer, conveyance or delivery, or any attempted sale, assignment, transfer, conveyance or delivery, thereof.  For a period of [**] months after the Closing, the Parties shall cooperate with each other to obtain promptly such authorizations, approvals, consents or waivers; provided, however, that ALZA shall not be required to pay any consideration or make any concession therefor.  If authorization, approval, consent or waiver is obtained, ALZA shall assign, transfer, convey or deliver any such Transferred Asset to Incline at no additional cost.  If not obtained, ALZA will be deemed to have fulfilled its obligations under this Agreement and under no circumstances shall any payments due pursuant to Article 5 be reduced or ALZA or its Affiliates be subject to any liability on account of the failure to obtain any such authorization, approval, consent or waiver.  Pending the earlier of obtaining such authorization, approval, consent or waiver or the expiration of such [**]-month period, the Parties shall cooperate with each other in any reasonable and lawful arrangements designed to provide to Incline the benefits of use of any such Transferred Asset.  Incline further agrees that no representation, warranty or covenant of ALZA contained in this Agreement shall be breached or deemed breached, and no condition to Incline's obligations to close the transactions contemplated by this Agreement shall be deemed not satisfied as a result of (i) the failure to obtain any such consent or as a result of any such default or termination; or (ii) any lawsuit, action, claim, proceeding or investigation commenced or threatened by or on behalf of any Person arising out of or relating to the failure to obtain any consent or any such default or termination.

3.5Product Liability.  Notwithstanding any other provision in this Agreement, (a) ALZA shall be responsible for any product liability claims arising from the ownership, possession, manufacture, research, development, Commercialization, use or operation of any Product, including the ALZA Product, by ALZA or its Affiliates or sublicensees, successors and assigns prior to the Closing and (b) Incline shall be responsible for any product liability claims arising from the ownership, possession, manufacture, research, development, Commercialization, use or operation of any Product by Incline, its Affiliates, sublicensees or successors and assigns on or after the Closing.

Article 4The Closing; Post-Closing Covenants

4.1Closing and Closing Conditions.  

4.1.1The Closing.  Except as provided in Section 4.4.3, the closing of the purchase and sale of the Transferred Assets and the assumption of the Assumed Liabilities (the “Closing”) shall take place on the third business day following the Execution Date or such other date as ALZA and Incline mutually agree (the “Closing Date”).  The Closing shall be deemed to occur and be effective at 11:59 P.M., local time, on the date of such closing.  The Closing will occur on the Closing Date so long as the conditions set forth in Section 4.1.2 and Section 4.1.3  have been satisfied or waived by or on such date.  Until the occurrence of the Closing, none of the assets or liabilities of ALZA shall be transferred to or assumed by Incline, as the case may be.

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4.1.2Condition Precedent to Incline's Obligations at the Closing.  All of the obligations of Incline hereunder are subject to fulfillment, prior to or at the Closing, of ALZA's obligations under Section 4.2.

4.1.3Conditions Precedent to ALZA's Obligations at the Closing.  All of the obligations of ALZA hereunder are subject to the fulfillment, prior to or at the Closing, of Incline's obligations under Section 4.3.

4.2ALZA's Responsibilities at the Closing.  At the Closing, ALZA shall execute and deliver to Incline a general assignment and bill of sale in the form of Exhibit A, general IND and NDA assignments in the form of Exhibit D and such other instruments of conveyance, assignment and transfer as may be necessary to sell, convey, assign and transfer to Incline good and valid title to the Transferred Assets free and clear of any Encumbrances; provided, that, notwithstanding the foregoing provisions of this Section 4.2, for any Transferred Assets that are Product Trademarks or Product Domain Names, ALZA shall as soon as practicable following the Closing execute and deliver to Incline a general trademark assignment in the form of Exhibit B and a general domain name assignment in the form of Exhibit C consistent with ALZA's obligations under Section 4.10.

4.3Incline's Responsibilities at the Closing.  At or following the Closing (as expressly provided below), Incline shall:

4.3.1execute and deliver to ALZA such agreements and instruments as may be necessary for Incline to assume and undertake to pay, perform and discharge as and when due the Assumed Liabilities;

4.3.2issue to ALZA the consideration specified in Section 5.1;

4.3.3reimburse ALZA for its expenses pursuant to Section 4.7.2 and Section 4.7.3;
 
4.3.4have received, from one or more Third Party investors, a minimum of $[**] (including the $[**] of initial seed capital paid to Incline in the form of a convertible note) of investment in the first tranche of the Series A Financing pursuant to the Stock Purchase Agreement; and

4.3.5have received not less than $[**] in connection with the grant of the Third Party option pursuant to the Option Agreement.

4.4Agreements Relating to Electronic Transfer, Delivery and Digitization of Hard Copy Documents; Physical Delivery of Transferred Assets; and Transfer of Governmental Filings and Authorizations.

4.4.1Delivery by Electronic Transfer.  ALZA and Incline agree that any of the Transferred Assets of the type that can be transmitted to Incline electronically (including the Transferred Know-How and copies of regulatory filings and approvals) shall be so delivered to Incline as soon as reasonably practicable following the Closing in intangible form as contained on hard drives or other data storage devices and shall not be delivered to Incline on any tangible medium. ALZA shall have no obligation to maintain or provide backup or duplicate copies of these and any other materials after the transfer contemplated herein.

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4.4.2Delivery and Digitization of Hard Copy Documents.  Transferred Assets that exist as hard copy or paper files shall be delivered to Incline upon transfer of the MAA from ALZA to Incline and assumption by Incline of the responsibilities under the MAA.  Upon such transfer and assumption, Incline shall make arrangements with a Third Party vendor reasonably acceptable to ALZA to create an electronic copy and database of the Transferred Assets that exist as hard copy or paper files and documents prior to the transfer of these documents from ALZA's facilities as soon as reasonably practicable following the Closing.  Incline shall provide ALZA, at Incline's expense, with a complete duplicate copy of the electronic database created by the activities contemplated herein, as soon as reasonably practicable following the Closing.  ALZA shall have no obligation to maintain or provide duplicate copies of these and any other materials after the transfer contemplated herein.

4.4.3Physical Delivery of Transferred Assets.  Incline shall make arrangements with a Third Party vendor reasonably acceptable to ALZA to remove from ALZA's facilities, upon terms and conditions acceptable to ALZA, and transport the Transferred Assets (except for those Transferred Assets to be delivered pursuant to Section 4.4.1 and except as provided below in this Section 4.4.3), as soon as reasonably practicable following the Closing (or, with respect to the documents referenced in Section 4.4.2 above, as soon as reasonably practicable following digitization), but in no event later than [**] days following the Execution Date for all Transferred Assets other than the manufacturing equipment referenced in Section 3.1.4.  Such delivery shall be made Ex Works (Incoterms 2000) ALZA's facilities.  ALZA shall reasonably cooperate with Incline to permit Incline to remove such Transferred Assets from ALZA's facilities.  If, despite ALZA's reasonable cooperation, such Transferred Assets located in ALZA's facilities are not completely removed by [**] days following the Execution Date, Incline shall incur a penalty fee of $[**] on the first day of each subsequent month that the Transferred Assets have not been removed.  ALZA shall have no obligation sixty (60) days following the Execution Date to retain such Transferred Assets.  With respect to the manufacturing equipment referenced in Section 3.1.4 (other than the [**] manufacturing line), ALZA shall make arrangements with a Third Party vendor reasonably acceptable to Incline, to remove from ALZA's facilities, no earlier than July 12, 2010 and no later than July 23, 2010, and ship such equipment to Incline's designated warehouse or delivery sites in [**], and all title and interest in and to such equipment shall remain with ALZA until delivery by the Third Party vendor, at which point title shall transfer to Incline.  All risk of loss of or damage to such equipment shall be borne entirely by Incline, and Incline shall be responsible for obtaining, at its own cost, insurance for such risk of loss during such transport .  Incline shall reimburse ALZA for all costs associated with such transport of such equipment within three (3) days of invoice therefor.  With respect to the [**] manufacturing line, Incline shall make arrangements with a Third Party vendor reasonably acceptable to ALZA to remove from ALZA's facilities, upon terms and conditions acceptable to ALZA, and transport such manufacturing line no earlier than July 12, 2010 and no later than July 23, 2010, and ship the [**] manufacturing line to a warehouse determined by Incline for no consideration and for the sole purpose of disposing of the equipment, with all title to and interest in such manufacturing line, and all risk of loss passing to Incline as of the Closing Date.    If, despite ALZA's reasonable cooperation, the manufacturing equipment referenced in Section 3.1.4 located in ALZA's facilities is not completely removed by July 23, 2010 for shipment, Incline shall incur a penalty fee of $[**] on the first day of each subsequent month that such equipment has not been removed for shipment.  ALZA shall have no obligation following July 23, 2010 to retain the manufacturing equipment referenced in Section 3.1.4.

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4.4.4Transfer of Governmental Filings and Authorizations.  Incline will use its best efforts to assume each of the IND, NDA and MAA as soon as possible after the Closing and ALZA shall cooperate with Incline to effectuate such transfer by using reasonable efforts to:  (1) provide Incline with available information within ALZA's Control; and/or (2) communicate as necessary with the Regulatory Authority responsible for the IND, NDA and MAA, including providing documentation controlled by ALZA in its sole discretion (which ALZA may direct Incline to prepare) and required by such Regulatory Authority to effect such transfer.  Incline shall deliver evidence of its assumption of the IND and NDA to the FDA within one business day of receipt of confirmation from ALZA that it has delivered evidence of its assignment of the IND and NDA to the FDA.  If, despite ALZA's reasonable cooperation, the IND or NDA or both are not assigned to Incline and the obligations thereunder are not assumed by Incline by September 1, 2010, Incline shall incur a penalty fee of $[**] on such day, and the first day of each subsequent month thereafter that such filings and obligations are not assigned and assumed.  ALZA shall have no obligation following December 31, 2010 to continue to maintain the IND or NDA and may after such date take any and all actions to terminate such filings.  If, despite ALZA's reasonable cooperation, the MAA is not assigned to Incline and the obligations thereunder are not assumed by Incline by January 1, 2011, Incline shall incur a penalty fee of $[**] on such day, and the first day of each subsequent month thereafter that such filings and obligations are not assigned and assumed.  ALZA shall have no obligation following April 30, 2011 to continue to maintain the MAA and may after such date take any and all actions to terminate such filings.  In addition to the foregoing and notwithstanding anything herein to the contrary, ALZA's cooperation shall not include responsibility for any operational activities such as those related to product development or supply chain that may be required to effect transfer and ALZA shall not have any Liability or be responsible for any Damages related to ALZA's maintenance of the IND, NDA or MAA prior to the assumption of such filings by Incline or for the inability of such filings to be transferred to Incline.

4.5Improperly Transferred Documents.  If at any point after the Closing, either Party (or its Affiliates and sublicensees) discovers that any portion of the Transferred Assets (a) does not relate to the Products, (b) is not otherwise necessary or useful for the development, manufacture, Commercialization or use of the Products, (c) relates solely to any technology proprietary to or Controlled by ALZA or any of its Affiliates (including technology employing microprojections or needles or transdermal delivery devices other than the Products) other than the technology described in the definition of “Product,” (d) includes, to the extent such Party can reasonably assess, the confidential information of a Third Party, (e) relates to ALZA Proprietary Compounds or compounds proprietary to any Third Party, or (f) includes Confidential Information of ALZA or its Affiliates that applies generally to ALZA's or its Affiliate's businesses and not exclusively and specifically to the Products (any such documents or files, “Improperly Transferred Documents”), then such Party shall promptly notify the other Party of such discovery and provide a general description of the Improperly Transferred Documents.  Promptly after such notification, Incline shall return to ALZA or destroy, at ALZA's direction and expense, all tangible materials that disclose or embody the information or know-how in the Improperly Transferred Documents described in subclauses (a) through (f) above.  Incline acknowledges that it (and its Affiliates and sublicensees) shall have no right to use the information or know-how contained in any Improperly Transferred Documents for any purpose, including the development and Commercialization of the Products and shall treat it as ALZA's Confidential Information.  Incline acknowledges that ALZA may have confidentiality obligations to certain Third Parties, including the Third Parties who are parties to the agreements set forth on Schedule 4.5 hereto, and that Incline has not been authorized to access or use any portion of the Transferred Assets 

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that may be subject to any confidentiality obligations to such Third Parties under such agreements, which will be considered Improperly Transferred Documents until such time if any as any consent of such Third Party to the use of such information by Incline is so obtained from such Third Party.  If any document or file in the Transferred Assets contains both information related to the Products and any of the types of information described in subclauses (a) through (f) above, Incline, with reasonable assistance from ALZA, will work together to separate such information or redact the improper portion of the information document or file to the extent practicable so that the document or file no longer contains the types of information described in subclauses (a) through (f).

4.6No Continuing Obligations.  After completion of the delivery of the Transferred Assets pursuant to Section 4.4, ALZA shall not have any obligation to provide any further information, documents, electronic files or assistance to Incline with respect to the Products. 

4.7Costs and Taxes.

4.7.1Incline shall reimburse ALZA for out-of-pocket expenses reasonably incurred by ALZA or its Affiliates after the Closing and until the delivery of all Transferred Assets in connection with the sale of the Transferred Assets, including (a) all reasonable out of pocket costs and fees associated with duplicating, digitizing, moving and transferring to Incline the Transferred Assets and (b) all reasonable out of pocket costs and fees associated with the [**] consultants that have been retained by ALZA to prepare for the transfer of the Transferred Assets to Incline.  Incline shall provide such reimbursement within [**] days after ALZA submits to Incline reasonable evidence that ALZA has incurred such costs and fees.
  
4.7.2Incline shall reimburse ALZA for out-of-pocket expenses incurred by ALZA or its Affiliates in connection with the maintenance of the Licensed Patents from August 2009 until the Closing, including its outside legal expenses.  Incline shall not be obligated to reimburse ALZA under this Section 4.7.2 unless and until Incline receives documentation from ALZA evidencing such expenses. 
 
4.7.3Incline shall reimburse ALZA for out-of-pocket expenses incurred by ALZA or its Affiliates from January 1, 2010 until the Closing related to annual maintenance fees paid with respect to the NDA and MAA related to the ALZA Product, as set forth in Schedule 4.7.3.

4.7.4The reimbursement amounts due and payable pursuant to Section 4.7.2 and Section 4.7.3 shall be paid to ALZA pursuant to Section 4.3.3 and shall be in addition to the Upfront Purchase Price.

4.7.5Any sales or use Taxes that are or may be payable by ALZA in connection with the sale (by ALZA) or purchase (by Incline) of the manufacturing equipment described in Section 3.1.4 or other tangible items described in Section 3.1.5 shall be borne and paid solely by Incline when due; provided, however, that if any such amount shall be paid by ALZA, Incline shall, subject to receipt of reasonably satisfactory evidence of ALZA's payment thereof, promptly reimburse ALZA.  ALZA and Incline shall file all necessary Tax returns and other documentation required to be filed by it with respect to all such Taxes, and, if required by applicable law, the Parties shall, and shall cause their Affiliates 

20

to, join in the execution of any such Tax returns and other documentation; provided, however, that for the purposes of preparing any sales Tax return, ALZA shall use the purchase price allocation prepared in accordance with Section 4.8 for such purpose.  Furthermore, ALZA agrees, to the extent possible, to reasonably cooperate with Incline to minimize any sales Tax payable.  Any transfer Taxes other than sales or use Taxes with respect to the items described in Sections 3.1.4 and 3.1.5 shall be borne [**] percent ([**]%) by ALZA and [**] percent ([**]%) by Incline.  Any property Taxes based on the value of the Transferred Assets payable with respect to a Taxable period that includes the Closing Date shall be borne by the Parties on a pro rated basis regardless of the date the Tax becomes due and payable as follows:  (a) ALZA shall bear the portion of the Tax equal to the Tax multiplied by a fraction with a numerator equal to the number of days in the Taxable period prior to the Execution Date and a denominator equal to the total number of days in the Taxable period and (b) Incline shall bear the remaining portion of such Tax.  For the avoidance of doubt, ALZA shall bear and pay any income or franchise Taxes incurred by ALZA as a result of the sale by ALZA of the Transferred Assets.  Except as provided in this Section 4.7.5 and Section 5.7.3, Incline shall be solely responsible for all Taxes accruing on or after the Closing Date from the ownership, possession or use of the Products or Transferred Assets. 

4.8Allocation.  ALZA has prepared an allocation of the purchase price, including the milestone and royalty payments, if any, paid pursuant to Article 5, among the Transferred Assets in accordance with Code Section 1060 and the Treasury regulations thereunder.  ALZA, Incline and their Affiliates shall be obligated to file Tax returns in all respects and for all purposes consistent with such allocation prepared by ALZA and set forth on Schedule 4.8.   
 
4.9Risk of Loss.  All risk of loss with respect to the Transferred Assets (whether or not covered by insurance) shall be on ALZA up to the time of the Closing, whereupon such risk of loss with respect to the Transferred Assets conveyed at such Closing shall pass to Incline.  Notwithstanding the foregoing, ALZA will use Commercially Reasonable Efforts until such time as delivery thereof has been completed pursuant to Section 4.4, to continue to maintain the Transferred Assets in the manner maintained by it or its Affiliates prior to the Closing.

4.10Trademark and Domain Name Assignment, Recording and Other Obligations.  Notwithstanding anything to the contrary set forth in this Agreement, it shall be Incline's responsibility (a) to prepare the applicable country trademark assignments and domain name assignments, to record such assignments following execution thereof by ALZA (or its applicable Affiliate) and to pay all costs associated with such recordations, provided, that ALZA shall, and shall cause its Affiliates to, execute and deliver to Incline such assignments as soon as practicable following the Closing in the forms set forth on Exhibit B and Exhibit C in order to effectuate the assignment of such trademarks and domain names to Incline, with such obligation of ALZA and its Affiliates continuing for one year following the Closing; (b) to apply for its own marketing authorizations for the Products to the relevant Regulatory Authorities where it is not within the power of ALZA to cause, by giving notice to the applicable Regulatory Authority, the transfer directly to Incline of the existing marketing authorizations identified as Transferred Assets and (c) to bear the fees and other costs in accordance with Section 4.7.

4.11Incline's Post-Closing Covenants.  

4.11.1No Use of Excluded Trademarks.  Incline hereby covenants that after the Closing, 

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neither Incline nor any of its Affiliates shall use in any manner any Trademark of ALZA or any of its Affiliates (other than the Product Trademarks), in connection with the research, development, manufacture or Commercialization of Products or any other product, including the names JOHNSON & JOHNSON and ALZA.

4.11.2Market Research Materials.  Incline hereby agrees and acknowledges that its use of any information in the Market Research Materials shall be entirely at Incline's own risk and that ALZA shall have no responsibility (financial or otherwise) with respect to Incline's use of the information in such Market Research Materials after the Closing.  Accordingly, Incline shall not, and shall cause its Affiliates not to, sue ALZA, whether at law or in equity, with respect to the contents of such Market Research Materials or the result of Incline's use of such Market Research Materials.

4.11.3Insurance.  The coverage under all insurance policies related to the Transferred Assets and Products arranged or maintained by ALZA or its Affiliates is only for the benefit of ALZA and its Affiliates, and not for the benefit of Incline.  As of the Closing, and in accordance with Section 9.12, Incline agrees to arrange for its own insurance policies with respect to the Transferred Assets and Products covering all periods and agrees not to seek, through any means, to benefit from any of ALZA's or its Affiliates' insurance policies which may provide coverage for claims relating in any way to the Transferred Assets or Products.

4.11.4Other Technologies.  Incline hereby agrees and acknowledges that nothing in this Agreement is intended to grant Incline any intellectual property rights related to microprojection delivery or other drug delivery owned or Controlled by ALZA or its Affiliates, including the Patent Rights granted to [**], between ALZA and [**]. 

4.11.5No Solicitation.  For two (2) years following the Closing Date, Incline shall not, and shall cause its Affiliates not to, solicit, recruit, offer employment to, employ, engage as a consultant, lure or entice away, or in any other manner persuade or attempt to persuade, any employee of ALZA or an Affiliate to leave the employ of ALZA or any of its Affiliates, provided, however, that this Section 4.11.5 does not preclude Incline or any of its Affiliates from employing any such employee who (a) seeks employment with Incline in response to a general advertisement or other similar method not specifically directed towards employees of ALZA or its Affiliates, (b) responds to a solicitation by an independent recruiting firm, (c) has first contacted Incline on his or her own initiative or (d) was terminated by ALZA or an Affiliate prior to commencement of subsequent employment discussions between Incline and such employee.  Nothing in this Section 4.11.5 shall prevent Incline from hiring the individuals listed on Schedule 4.11.5.  In the event that, subject to the terms and conditions of this Agreement (including this Section 4.11.5), Incline employs or otherwise engages any individual who is listed on Schedule 4.11.5, ALZA agrees to waive any confidentiality provision set forth in any employment agreement between ALZA and such individual to the extent that such provision would prevent such individual from disclosing information related solely to the Transferred Assets, inventions claimed in the Licensed Patents, or Licensed Know-How in exercise of Incline's rights under this Agreement.

4.11.6ALZA-[**] Agreement.  Incline hereby agrees to provide to ALZA the information, communications and notices that ALZA is required to provide to [**], by 

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and between ALZA and [**], as amended and supplemented (the “ALZA-[**] Agreement”), including the information, communications and notices required under Sections 3.2(c), 4.4 and 7.1 of the ALZA-[**] Agreement, with respect to Incline's activities related to or covered by the Licensed Patents that were transferred from [**] to ALZA under the ALZA-[**] Agreement.

4.12ALZA's Post-Closing Covenant.  If Incline enters into a consulting arrangement with [**] on or after the Closing Date, ALZA hereby agrees to waive any and all claims against [**] for breach of the Letter Agreement dated as of September 29, 2003 between ALZA and [**], as amended, arising from [**] disclosure of ALZA's Confidential Information related exclusively to the Transferred Assets to Incline pursuant to and during the term of such consulting arrangement.

4.13Pharmacovigilance Covenants.  Prior to transfer of the IND, NDA and MAA to Incline, Incline will ensure that it has access to adequate pharmacovigilance capabilities to support all regulatory safety reporting obligations associated with the transfer of the ALZA Product; in particular, having appointed a “Qualified Person” for pharmacovigilance in compliance with the requirements of Vol 9A of the Rules Governing Medicinal Products in the European Union.  Upon Incline's assumption of any of the IND, NDA or MAA, ALZA will provide Incline with copies of all regulatory reporting forms for any Adverse Event it receives within [**] calendar days for 7-day expedited reports and [**] calendar days for all other reports to allow Incline to comply with its obligations under applicable law. Upon acceptance of transfer of the IND, NDA and MAA from ALZA, Incline will acknowledge to ALZA in writing its acceptance and immediately assume regulatory safety reporting obligations under each filing.  If at any point ALZA holds one or more of the IND, NDA and MAA but has transferred one or more of the IND, NDA and MAA to Incline, Incline will provide ALZA with copies of all Adverse Event reports it receives within [**] calendar days to allow ALZA to continue to comply with its remaining obligations under applicable law.  For purposes of this Section 4.13, an “Adverse Event” means any untoward or undesirable occurrence in a patient or trial subject administered a pharmaceutical product, an event which is not necessarily causally related to the product- consistent with the corresponding term used in the ICH guidelines (E2A, E2C and E2D) relating to the collection, maintenance analysis and reporting of an adverse event or experience.  

Article 5Financial Provisions

5.1Upfront Payment.  Incline shall pay to ALZA $[**] million on or before the Closing Date (the “Upfront Purchase Price”).  Such payment shall be non-refundable and non-creditable.

5.2Milestone Payments.  Any milestone payment payable by Incline pursuant to this Section 5.2 shall be with respect to events occurring after the Closing Date and made no more than once with respect to the achievement of each such milestone event.

5..2.1Development and Commercial Milestone Payments.  Incline shall pay to ALZA the amounts set forth in the table below opposite the corresponding milestone event within thirty (30) days after the first occurrence of such event:

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	Milestone Event
	Payment

	First acceptance of the filing of an MAA in the European Union for approval to market a Product in the European Union.
	$[**] million

	First approval of an NDA by the FDA to market a Product in the United States.
	$[**] million

	First Commercial Sale of a Product in the United States (“Milestone Three”); provided, however, that payment upon achievement of this milestone is subject to Section 5.2.2.
	$[**] million

	First Commercial Sale of a Product in any country in the European Union.
	$[**] million

5.2.2Milestone Three.  In the event that either (i) the FDA requires that Incline, as a condition precedent to Regulatory Approval in the United States, conduct new clinical studies with a primary objective of demonstrating efficacy or safety in order to receive such Regulatory Approval, or (ii) Incline believes, in good faith and after exerting reasonable business judgment, that the conduct of one or more new clinical studies [**] are required to be conducted prior to Regulatory Approval in order to gain Regulatory Approval in the United States, based on written correspondence received from the FDA and provided to ALZA, and Incline on such basis of (i) or (ii) above so conducted such clinical trial(s) prior to receipt of Regulatory Approval and written evidence of the cost and conduct of such clinical trials is provided to ALZA, Incline shall have the right to offset against the amount otherwise due upon achievement of Milestone Three the amounts actually expended by Incline (internal and Third Party costs) on such clinical trials prior to receipt of Regulatory Approval, up to a limit of $[**] million.  For the avoidance of doubt, the minimum payment due upon achievement of Milestone Three shall be $[**] million.

5.2.3Sales Milestone Payments.  Incline shall pay to ALZA the amounts set forth in the table below opposite the corresponding milestone event within [**] days after the end of the Quarter in which Incline first achieves such milestone event: 

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	Milestone Event
	Payment

	United States
	 

	The first time cumulative Net Sales in the United States exceeds $[**] million during a period of four (4) consecutive Quarters
	$[**] million

	The first time cumulative Net Sales in the United States exceeds $[**] million during a period of four (4) consecutive Quarters
	$[**] million

	The first time cumulative Net Sales in the United States exceeds $[**] million during a period of four (4) consecutive Quarters
	$[**] million

	The first time cumulative Net Sales in the United States exceeds $[**] million during a period of four (4) consecutive Quarters
	$[**] million

	Outside the United States
	 

	The first time cumulative Net Sales outside the United States exceeds $[**] million during a period of four (4) consecutive Quarters
	$[**] million

	The first time cumulative Net Sales outside the United States exceeds $[**] million during a period of four (4) consecutive Quarters
	$[**] million

	The first time cumulative Net Sales outside the United States exceeds $[**] million during a period of four (4) consecutive Quarters
	$[**] million

	The first time cumulative Net Sales outside the United States exceeds $[**] million during a period of four (4) consecutive Quarters
	$[**] million

For the avoidance of doubt, Incline may achieve more than one of the milestone events described above in the same Quarter or period of four (4) consecutive Quarters in the same territory.

If any of the milestone events described above are achieved after less than a full period of four (4) consecutive Quarters, then the applicable milestone payment shall be due and payable to ALZA within [**] days after the end of the Quarter in which the milestone event was met, and shall not be withheld until the completion of the full period of four (4) consecutive Quarters.

For illustrative purposes only, Incline would pay milestones for sales of the Products in the United States as follows:

	
					
	Quarter
	Quarterly Net Sales                           (in millions)
	Cumulative Net Sales (in millions) in Prior 4 Quarters
	Milestone(s) Triggered
	Milestone Payment due to ALZA [**] days after end of Quarter (in millions)

	[**]
	[**]
	[**]
	[**]
	[**]

	[**]
	[**]
	[**]
	[**]
	[**]

	[**]
	[**]
	[**]
	[**]
	[**]

	[**]
	[**]
	[**]
	[**]
	[**]

	[**]
	[**]
	[**]
	[**]
	[**]

	[**]
	[**]
	[**]
	[**]
	[**]

		
	5.3
	Royalty Payments.  In consideration of the transfers and licenses (as the case may be) specified herein, including the sale of Transferred Assets and the license grant in Section 2.1, Incline shall pay royalties to ALZA as follows:

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5.3.1United States.  Subject to Section 5.4, during the Royalty Period applicable to the United States, Incline shall pay to ALZA the following royalties on Net Sales in the United States by Incline, its Affiliates and sublicensees:

(a)[**] percent ([**]%) of annual Net Sales in the United States during a Contract Year for that portion of the annual aggregate Net Sales in the United States that is less than or equal to $[**] million;

(b)[**] percent ([**]%) of annual Net Sales in the United States during a Contract Year for that portion of the annual aggregate Net Sales in the United States that is greater than $[**] million and less than or equal to $[**] million;

(c)[**] percent ([**]%) of annual Net Sales in the United States during a Contract Year for that portion of the annual aggregate Net Sales in the United States that is greater than $[**] million and less than or equal to $[**] million; and

(d)[**] percent ([**]%) of annual Net Sales in the United States during a Contract Year for that portion of the annual aggregate Net Sales in the United States that is greater than $[**] million.

5.3.2Outside of the United States.  Subject to Section 5.4, during the Royalty Period applicable to any country in the Territory other than the United States, Incline shall pay to ALZA the following royalties on Net Sales in such country by Incline, its Affiliates and sublicensees:

(a)[**] percent ([**]%) of annual Net Sales in all countries in the Territory other than the United States during a Contract Year for that portion of the annual aggregate Net Sales in all countries in the Territory other than the United States that is less than or equal to $[**] million;

(b)[**] percent ([**]%) of annual Net Sales in all countries in the Territory other than the United States during a Contract Year for that portion of the annual aggregate Net Sales in all countries in the Territory other than the United States that is greater than $[**] million and less than or equal to $[**] million;

(c)[**] percent ([**]%) of annual Net Sales in all countries in the Territory other than the United States during a Contract Year for that portion of the annual aggregate Net Sales in all countries in the Territory other than the United States that is greater than $[**] million and less than or equal to $[**] million; and

(d)[**] percent ([**]%) of annual Net Sales in all countries in the Territory other than the United States during a Contract Year for that portion of the annual aggregate Net Sales in all countries in the Territory other than the United States that is greater than $[**] million.

5.4Adjustments in Royalty Rates.

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5.4.1Absence of Innovator Protection.  On a country-by-country basis, if there is no Innovator Protection for a Product in a country, then Incline shall pay to ALZA during the Royalty Period applicable to such Product in such country a reduced royalty rate on Net Sales by Incline, its Affiliates and sublicensees in such country equal to [**] percent ([**]%) of the royalty rate applicable under Section 5.3.1 or 5.3.2.

5.4.2Product Competition.  In the event that, with respect to a Product in a country in the Territory, at least one Competing Product is sold by a Third Party, and the total unit sales of all Competing Products during a particular Quarter in such country are greater than [**] percent ([**]%) of the Total Relevant Sales (as defined below) for such Product in such country, then Incline shall pay to ALZA a royalty rate on Net Sales by Incline, its Affiliates or sublicensees in any such country at a rate equal to the product obtained by multiplying the royalty rate applicable to such country under Section 5.3.1 or 5.3.2 (as modified by Section 5.4.1) by the factor [**].  For the purposes of this Section 5.4.2, (a) “Total Relevant Sales” means, with respect to a particular Product in a particular country in the Territory in a Quarter, the total combined unit sales of such Product in such country in such Quarter by Incline, its Affiliates or sublicensees; and (b) no product sold illegally or without the applicable required regulatory approval shall be considered to be a Competing Product.  

5.4.3No Adjustment for Third Party Licenses.  If Incline enters into an agreement with a Third Party to obtain a license under a Patent Right or other right that Incline reasonably believes or expects to be necessary to Commercialize a Product in the Territory, then Incline shall be responsible for paying one hundred percent (100%) of the amounts owed to such Third Party pursuant to such agreement without any offset against the payments Incline is required to make to ALZA hereunder.

5.5Royalty Reports.  Commencing with the First Commercial Sale of a Product in any country in Territory, Incline shall deliver to ALZA, within [**] days after the last day of each Quarter (each such Quarter being sometimes referred to herein as a “reporting period”) a written report or reports setting forth for such reporting period the following information on a country-by-country basis:  (a) gross invoiced sales and total deductions used to calculate Net Sales of the Products sold by Incline, its Affiliates and its sublicensees during the reporting period; (b) the number of units of the Products sold by Incline, its Affiliates and its sublicensees during the reporting period; (c) the basis for any adjustments to the royalty payable for the sale of the Products; (d) currency exchange rates used in determining the royalties (e) the calculation of the royalty due hereunder for the sale of the Products; (f) any withholding Taxes required to be paid from such royalty payments and (g) the exchange rate used, if any, in determining the amount due or performing any necessary currency conversion.

5.6Reimbursement of Payments Under ALZA Third Party Licenses.  If ALZA is required to make any payment to a Third Party under an ALZA Third Party License as a result of the activities of Incline, its Affiliates or its Third Party sublicensees related to the Licensed Patents or any Product on or after the Closing Date (including payments to indemnify such Third Party), Incline shall reimburse ALZA [**] percent ([**]%) of such payment actually made by ALZA within [**] days after receiving written notice from ALZA that such reimbursement is due and owing.  Incline may not offset any payments made to ALZA pursuant to this Section 5.6 against any other payments Incline is required to make to ALZA under this Agreement.

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5.7Other Financial Provisions.  

5.7.1Currency, Timing and Mode of Payment.  

(a)The milestone payments owed pursuant to Section 5.2 shall be paid in U.S. dollars and the calculation of Net Sales outside the United States with respect to such milestone payments shall be made in U.S. dollars regardless of the countries in which the sales are made.  Net Sales made in currencies other than U.S. dollars shall be converted into U.S. dollars using a fixed exchange rate as described in Section 5.7.2.  The fixed exchange rate shall apply to all payments related to the Net Sales recognized during the period for which that fixed exchange rate applies, independent of the actual invoice date.

(b)All royalty payments to ALZA pursuant to Section 5.3 shall be paid in the same currencies in which sales of a Product were made (e.g., Incline shall pay royalties in U.S. Dollars for Net Sales in the United States or in Euros for Net Sales in the European Union); provided that if (a) sales of a Product were made in a currency other than a Hedge-able Currency, or (b) the equivalent value in U.S. Dollars of a royalty based on sales in any given currency, on a currency-by-currency basis, would be less than $1 million on an annual basis, then such amounts shall be converted into U.S. Dollars using a fixed exchange rate as described in Section 5.7.2. 

(c)Royalty payments by Incline under this Agreement shall be made within [**] days after the last day of each Quarter. 

5.7.2Payments and Exchange Rate.  All payments to ALZA pursuant to this Agreement shall be made by wire transfer in the requisite amount to the account designated by ALZA from time to time.  Whenever for the purposes of calculating Net Sales outside the United States for both milestone payments owed pursuant to Section 5.2 and the royalties payable under Section 5.3, conversion from any foreign currency shall be required, all amounts shall first be calculated in the currency of sale and then converted into United States dollars by applying the following: 

(a)    Exchange rates for calculating Net Sales outside of the United States during a given Contract Year shall be determined by the October preceding such Contract Year and shall be based upon the exchange rates set forth in Bloomberg, a Third Party service.
(b)    Exchange rates shall be reset annually using the procedure set forth in Section 5.7.2(a).  The exchange rates for each Contract Year shall apply to all Net Sales outside of the United States recognized during such Contract Year and in no event shall the exchange rates for a given Contract Year be applicable to payments based on Net Sales outside of the United States recognized in prior periods.
5.7.3Tax Withholding.  Incline shall make all payments to ALZA under this Agreement without deduction or withholding for Taxes except to the extent that any such deduction or withholding is required by law, rule or regulation in effect at the time of payment.  

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Any Tax required to be withheld on or deducted from amounts payable under this Agreement by Incline shall promptly be paid by Incline on behalf of ALZA to the appropriate governmental authority, and Incline shall furnish ALZA with proof of payment of such Tax.  Any such Tax required to be withheld or deducted shall be an expense of and borne by ALZA.  Incline and ALZA shall cooperate with respect to all documentation required by any taxing authority or reasonably requested by Incline to secure a reduction in the rate of applicable withholding Taxes.  

5.7.4Maintenance of Financial Records.  Incline shall keep and shall cause its Affiliates and sublicensees to keep books and accounts of record in connection with the sale of the Products, including records of gross invoiced sales, Net Sales, exchange rates and royalty payments (collectively, “Financial Records”), in accordance with GAAP, in sufficient detail to permit accurate determination of all figures necessary for verification of royalties to be paid hereunder.  Incline and its Affiliates and sublicensees shall maintain such Financial Records for a period of at least [**] years after the end of the Contract Year in which they were generated.

5.7.5Audit.  Upon [**] days prior written notice from ALZA, Incline shall permit an independent certified public accounting firm of internationally recognized standing selected by ALZA and reasonably acceptable to Incline, to examine, at ALZA's sole expense, the relevant Financial Records of Incline and its Affiliates and sublicensees as may be reasonably necessary to verify the accuracy of the royalty reports provided by Incline pursuant to Section 5.5 and the payment of royalties hereunder.  An examination by ALZA under this Section 5.7.5 shall occur not more than once in any calendar year and shall be limited to the pertinent Financial Records for any calendar year ending not more than [**] years before the date of the request.  The accounting firm shall be provided access to such Financial Records at Incline's facility(ies) where such Financial Records are normally kept and such examination shall be conducted during Incline's normal business hours.  Incline may require the accounting firm to sign a standard non-disclosure agreement before providing the accounting firm access to Incline's facilities or records.  Upon completion of the audit, the accounting firm shall provide both ALZA and Incline a written report disclosing any discrepancies in the royalty reports submitted by Incline or the royalties paid by Incline, if any, and, in each case, the specific details concerning any discrepancies.  Any information provided by Incline to the accounting firm and the written report of the accounting firm shall be the Confidential Information of Incline.

5.7.6Underpayments/Overpayments.  If such independent public accounting firm's written report shows any underpayment of royalties, Incline shall remit to ALZA within [**] days after Incline's receipt of such report so concluding (or, if later, within [**] days after resolution of a bona fide objection by Incline to the findings in such report), (a) the amount of such underpayment and (b) if such underpayment exceeds [**]percent ([**]%) of the total amount owed to ALZA for the Contract Year(s) then being examined, the reasonable fees and expenses of such independent public accountant performing the examination, subject to reasonable substantiation thereof.  If such independent public accounting firm's written report shows any overpayment of royalties, Incline shall receive a credit equal to such overpayment against the royalties otherwise payable to ALZA.

5.7.7Interest Due.  In case of any delay in payment by Incline to ALZA, interest on the 

29

overdue payment shall accrue at an annual interest rate, compounded monthly, equal to the prime rate as reported in The Wall Street Journal, as determined for each month on the last business day of that month, plus [**] percent ([**]%), assessed from the day payment was initially due.  The foregoing interest shall be due from Incline without any special notice.
 
5.7.8Form of Consideration for Convenience.  The Parties acknowledge that the value of rights assigned or licensed, as the case may be, by ALZA to Incline is comprised of many components, including intellectual property of various types, such as Licensed Patents, Licensed Know-How, trademarks, domain names, Transferred Know-How, manufacturing equipment, regulatory filings, and other non-financial consideration, and that in view of this and other terms of this Agreement, and for the convenience of the Parties, various of the royalty obligations set forth above are intended to account for such multi-component value as an aggregate.

Article 6    Intellectual Property

6.1Prosecution of Patents.

6.1.1Licensed Patents.  Incline acknowledges that the Licensed Patents are not Transferred Assets and that ALZA will retain ownership of the Licensed Patents.

(a)Incline, through counsel of its choosing, shall have primary responsibility for and control over obtaining and Prosecuting throughout the Territory the Licensed Patents in ALZA's name at Incline's sole cost.  ALZA shall promptly after the Closing provide Incline notice of the identity of its designated patent representative (or another designee upon notice to Incline) and, notwithstanding the foregoing, Incline shall keep ALZA's designated patent representative reasonably informed of such Prosecution and provide ALZA's patent representative with copies of material correspondence (including applications, office actions and responses) relating to Prosecution of any Licensed Patents.  ALZA's patent representative may provide comments and directions, and Incline shall reasonably consider all such comments and directions with respect to any Prosecution actions to be taken.  In addition, Incline shall not take any action that would have a materially adverse impact on the scope, validity and enforceability of any claim within the Licensed Patents without ALZA's prior written approval, which shall not be unreasonably withheld or delayed.

(b)In order to facilitate ALZA's right to comment and direct, Incline shall provide copies of all such material correspondence promptly after receipt by Incline and any proposed responses by Incline at least [**] business days prior to any filing or response deadlines, or within [**] business days of Incline's receipt of any official correspondence if such correspondence only allows for [**] days or less to respond, and ALZA shall provide any comments and directions in sufficient time to allow Incline to meet applicable filing requirements and deadlines.  In no event shall Incline be required to delay any submission, filing or response past any deadline that is not extendable.  Incline also authorizes ALZA's patent counsel to communicate directly with Incline's outside patent counsel.  

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Incline shall keep ALZA reasonably apprised (e.g., [**]) of the status of the Licensed Patents throughout the world.

(c)[**], and ALZA [**] in connection with this Section 6.1.1(c).

6.1.2Election Not to Continue Prosecution; Abandonment.  If Incline is no longer interested in Prosecuting a Licensed Patent in a particular country in the Territory, then Incline shall so notify ALZA promptly in writing of its intention in good time to transfer control of Prosecution and to enable ALZA to meet any deadlines by which an action must be taken to establish or preserve any such rights in such Licensed Patent in such country and ALZA shall have the right to file for, or continue to Prosecute, or otherwise pursue such Licensed Patents in such country, and Incline shall fully cooperate with ALZA in regard to transfer of Prosecution and provide all reasonable assistance as requested by ALZA.

6.1.3Patent Term Extensions.  Incline shall file all applications for patent term extensions of Licensed Patents and take all actions necessary to obtain patent extensions, to the extent reasonably expected to be available under advice of competent patent counsel, including: (a) patent term adjustments under 35 U.S.C. 154 to remedy U.S. Patent and Trademark Office delay during Prosecution; (b) patent extensions under 35 U.S.C. 156 to remedy delays due to Regulatory Approval; (c) interim term extensions; (d) extensions under the General Agreement on Tariffs and Trade Act; and (e) private extensions via Congressional legislation, or like statutes of any of the foregoing in countries other than the United States, such as for a Supplementary Certificate of Protection of the Member States of the European Union, for the Licensed Patents.  ALZA agrees to sign such further documents and take such further actions as may be reasonably requested by Incline in order for Incline to obtain such patent extensions.  If Incline reasonably declines to pursue such patent extensions, then Incline shall give sufficient written notice to allow ALZA, who, as owner of such Licensed Patents shall at all times retain the right, at its sole discretion, to file all such applications and take all such actions necessary to obtain such patent extensions and Incline shall fully cooperate with ALZA in regard thereto and provide all reasonable assistance as requested by ALZA, including execution of documents required for any such patent extensions.  ALZA may provide comments and directions with respect to any patent extensions filed by Incline, and Incline shall reasonably consider all such comments and directions.

6.1.4Common Interest.  All advice and communications exchanged between the Parties, including between Incline's outside patent counsel and patent counsel representing ALZA and patent counsel representing Incline, regarding the Licensed Patents or their Prosecution (“Privileged Information”), shall be deemed Confidential Information of both Parties.  In addition, the Parties acknowledge and agree that, with regard to such Prosecution of the Licensed Patents, the interests of the Parties as licensor and licensee are to obtain Valid Claims, and as such, are aligned and common.  The Parties agree and acknowledge that they have not waived, nor shall either Party waive or take any action to destroy, any legal privilege concerning such Privileged Information, including privilege under the common interest doctrine and similar or related doctrines.

6.1.5Orange Book Listing.  As of the Closing Date, Incline shall have the responsibility to list eligible Licensed Patents in the FDA “Approved Drug Products with 

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Therapeutic Equivalence Evaluations” (Orange Book), or like compilations of health authorities of any countries in the Territory, where such listing is available or required, and to make any updates or corrections to such listings.  Incline shall keep ALZA reasonably informed of such listings.  ALZA agrees to cooperate at Incline's reasonable request in connection with its listings required by applicable law.

6.1.6Access to Original Lab Notebooks.  Upon reasonable notice from Incline, ALZA shall permit Incline to access at Incline's sole cost, during normal business hours, the originals of any laboratory notebooks that contain information related exclusively to the inventions claimed in the Licensed Patents for purposes of Prosecuting such Licensed Patents or any Patent Rights arising from such Licensed Patents, including defending any patent interferences to which Incline is a party, directly or on behalf of ALZA.

6.2Enforcement of Licensed Patents.

6.2.1Notification.  Each Party shall promptly report in writing to the other Party during the Term any known infringement or suspected infringement of any of the Licensed Patents in the Territory by a Third Party (an “Infringer”), and shall provide the other Party with all available details or evidence supporting said infringement or suspected infringement, including the identity of the Infringer and a description of the alleged infringement.  Each Party shall promptly notify the other of any Third Party communications pertaining to any Licensed Patent that the Party receives pursuant to the Drug Price Competition and Patent Term Restoration Act of 1984 or similar such notice (including under any laws in countries in the Territory other than the United States), including notices pursuant to Sections 101 and 103 of such act from persons who have filed an abbreviated NDA (ANDA) or a NDA under Section 505(b)(2) of the Federal Food, Drug and Cosmetic Act.

6.2.2Institution of Proceedings.  Incline shall have the first right, but not the obligation, to take any reasonable measures it deems appropriate to stop such infringing activities by any Infringer manufacturing, using or Commercializing a Competing Product in any part of the Territory, including initiating or prosecuting an infringement or other appropriate suit or action against such Infringer.  In the event Incline elects not to take action pursuant to this Section 6.2.2, Incline shall so notify ALZA promptly in writing of its intention in good time to enable ALZA to meet any deadlines by which an action must be taken to establish or preserve any enforcement rights and ALZA shall have the right, but not the obligation, to take any such reasonable measures to stop such infringing activities by such Infringer

6.2.3Procedures.  Each Party shall give the other Party sufficient advance notice of its intent to file any suit pursuant to Section 6.2.2 and the reasons therefore and each Party shall provide the other Party with a sufficient opportunity to provide comments and directions regarding such filings, provided, however, that the commenting Party shall provide any such comments and directions promptly and sufficiently in advance of any filing dates, to the extent reasonably possible, to allow for consideration by the Party filing the suit (the “Controlling Party”), and further provided that it shall be within the Controlling Party's reasonable discretion whether to incorporate such comments or directions.  The Parties shall keep each other reasonably and timely informed of the status and progress of the litigation, including furnishing copies of communications, 

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pleadings, and other documents and keeping each Party informed of settlement efforts, and shall obtain comments, directions and strategy from the other Party, including during pre-trial motions and discovery, provided, however, that it shall be within the Controlling Party's reasonable discretion whether to incorporate such comments, directions or strategy.  The Controlling Party has a right to enter into any settlement, provided that (a) the Controlling Party shall not enter into any settlement, consent, judgment or other disposition without the prior written consent of the other Party (which consent shall not unreasonably be withheld or delayed) if such settlement includes a finding or agreement that any Patent Right is invalid or unenforceable, and (b) if any rights are granted in such settlement, consent, judgment, or other disposition to a Third Party to continue any activity upon which the suit was based, such rights shall be limited to the product or activity that was the subject of the suit.  The Controlling Party shall have the sole and exclusive right to select counsel for any such suit and action and shall pay all expenses of the suit, including attorneys' fees and court costs.  Upon request by the Controlling Party, the other Party shall give the Controlling Party all reasonable information, documents and assistance in connection with such suit for infringement.  If necessary for the Controlling Party to prosecute any legal action, the other Party shall join the legal action as a party, using the Controlling Party's counsel, at the Controlling Party's cost.

6.2.4Recoveries.  Any amounts recovered by either Party pursuant to Section 6.2.2 or Section 6.2.5, whether by settlement or judgment, shall be used to reimburse the Parties for their reasonable, documented out-of-pocket costs and expenses (including attorneys' fees) incurred in making such recovery (which amounts shall be allocated pro rata if insufficient to cover the totality of such expenses), with any remainder being paid to the Controlling Party, provided that in the event a court awards Incline any damages to compensate for lost sales, Incline shall owe ALZA a portion of such damages paid in the form of a royalty, at a rate as determined in accordance with Section 5.3 based on the deemed Net Sales attributable to any received award of lost profits or other compensation for lost sales.  The Controlling Party pursuing any action under Section 6.2.2 shall bear all payments awarded against or agreed to be paid by such Party pursuant to such action or in connection with the underlying infringement, including any costs or expenses incurred that exceed the amounts recovered by the Controlling Party.

6.2.5Declaratory Judgments.  Each Party shall provide the other Party with immediate written notice of any declaratory judgment action or other claim or action brought by a Third Party in any jurisdiction that alleges the invalidity, unenforceability or non-infringement of any Licensed Patent.  For any such declaratory judgment action or other claim or action brought by a Third Party manufacturing, using or Commercializing a Competing Product in any part of the Territory, Incline shall have the first right, but not the obligation, at its own expense, to control the defense of the Licensed Patents in any such declaratory judgment action.  Incline shall notify ALZA within fifteen (15) business days of receiving written notice of such declaratory judgment action as to whether it intends to elect to control the defense of such declaratory judgment action (or if appropriate such lesser period as is necessary so as to give ALZA a reasonable period in which to respond to such declaratory judgment action).  If, after the expiration of such period, Incline has not notified ALZA of its intent to control the defense of such declaratory judgment action, then ALZA shall have the right, but not the obligation, to control such defense of such declaratory judgment action, provided that Incline shall fully cooperate with ALZA in the event that ALZA determines to control the defense of 

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such declaratory judgment action.  Such cooperation shall include being a named party where reasonably requested by ALZA in any action so defended by ALZA.  Neither Party shall make any admission, consent to the entry of any judgment or enter into any settlement with respect to any declaratory judgment action involving any Licensed Patent without the prior written consent of the other Party (which consent shall not unreasonably be withheld or delayed) if such admission, judgment or settlement includes a finding or agreement that any Licensed Patent is invalid or unenforceable, or would enjoin or grant other equitable relief against the other Party.  Each Party shall cooperate (including by executing any documents required to enable the other Party to participate in such litigation) with the other Party in the defense of any declaratory judgment action brought by a Third Party relating to the Licensed Patents in accordance with this Section 6.2.5 and shall have the right to consult with the other Party and to participate in and be represented by counsel of its choosing in such litigation at its own expense. 

		
	6.3
	Marking.  Incline, its Affiliates and its sublicensees shall mark the Products with a notice in accordance with 35 U.S.C. § 287 and similar marking provisions in countries other than the United States in the Territory    -

Article 7Confidential Information

7.1Confidentiality Obligations.  During the Term of this Agreement and for a period of [**] years thereafter, each Party shall treat as confidential all Confidential Information of the other Party, shall not use such Confidential Information except as set forth in this Agreement, and shall not disclose, directly or indirectly, such Confidential Information to any Third Party except as expressly provided for herein.  Without limiting the foregoing, each of the Parties shall use at least the same degree of care which it uses to prevent the disclosure of its own Confidential Information of like importance to prevent the disclosure of Confidential Information disclosed to it by the other Party under this Agreement.  Each Party shall disclose Confidential Information of the other Party only to its directors, officers, employees, consultants and advisors and those of its Affiliates who, in such Party's sole discretion, have a need to know such information in order for such Party to carry out the activities and transactions contemplated by this Agreement, and shall ensure that such Persons comply with the restrictions on use and disclosure set forth in this Article 7.  Each Party shall promptly notify the other Party of any misuse or unauthorized disclosure of the other Party's Confidential Information.  With respect to Confidential Information pertaining to the subject matter of this Agreement, the confidentiality provisions hereof will govern and supersede as of the Execution Date any confidentiality provisions under prior agreements between the Parties with respect to such Confidential Information.  For the avoidance of doubt, the confidentiality agreements between Frazier Healthcare VI, LP and Cadence Pharmaceuticals, Inc. and ALZA, dated February 10, 2009, shall remain in effect and shall not be superseded by the confidentiality provisions contained herein.  This Section 7.1 shall not prohibit Incline from publishing papers containing information related to Incline's use of the Licensed Know-How owned by ALZA as permitted under Section 2.1.1, including oral presentations and abstracts, in scientific and medical journals, publications, meetings and conferences, provided however, that Incline files a patent application to protect any patentable subject matter prior to such publication.  

7.2Exceptions.  Notwithstanding Section 7.1, neither Party shall have liability to the other with regard to any Confidential Information of the other which (a) was generally available to the 

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public or otherwise part of the public domain at the time of its disclosure to the receiving Party, (b) became generally available to the public or otherwise part of the public domain after its disclosure or development, as the case may be, other than through any act or omission of the receiving Party, (c) was known by the receiving Party, without an obligation to the other Party to keep such information confidential, at the time of disclosure by the disclosing Party and the receiving Party has documentary or other competent evidence to that effect, (d) was disclosed to the receiving Party, without restriction, by a Third Party who, to the knowledge of the receiving Party, had no obligation to the disclosing Party not to disclose such information to others, or (e) was independently discovered or developed by or on behalf of the receiving Party without the use of or reference to any Confidential Information belonging to the disclosing Party and the receiving Party has documentary or other competent evidence to that effect.

7.3Authorized Disclosure and Use.

7.3.1Disclosure.  Notwithstanding the foregoing provisions of Section 7.1, each Party may disclose Confidential Information belonging to the other Party solely to the extent such disclosure is reasonably necessary to (a) file or Prosecute patent applications as contemplated by this Agreement, (b) prosecute or defend litigation, and (c) comply with applicable laws and regulations, including to the extent reasonable necessary to obtain Regulatory Approval and pricing and reimbursement approval.  In addition, Incline shall have the right to disclose to Cadence Pharmaceuticals, Inc. (“Cadence”) during the term of the Option Agreement, this Agreement, including its terms and subject matter (including activities and the results of activities conducted hereunder) to the extent necessary to comply with Incline's obligations under the Option Agreement or as necessary for Cadence to conduct its diligence with respect to Incline in its deliberations as to whether or not to exercise its option to acquire Incline under the Option Agreement, under terms of confidentiality no less strict than those contained in this Agreement.

7.3.2Advanced Notice.  In the event a Party deems it reasonably necessary to disclose Confidential Information belonging to the other Party pursuant to Section 7.3.1 above, or is otherwise compelled to disclose Confidential Information belonging to the other Party by a court or other tribunal of competent jurisdiction, the receiving Party shall (a) give prompt notice of such disclosure to the other Party so that the other Party may seek a protective order or other remedy from said court or tribunal and (b) disclose only that portion of the Confidential Information that, in the opinion of its legal counsel, is legally required to be disclosed.  The receiving Party shall exercise reasonable efforts to ensure that any such information so disclosed shall be accorded confidential treatment by said court or tribunal.  

7.3.3Use.  Notwithstanding the foregoing provisions of Section 7.1 but subject to Section 4.5, each Party shall have the right to use the other Party's Confidential Information in carrying out its responsibilities or exercising its rights under this Agreement, or as otherwise expressly authorized by this Agreement. 

7.4SEC Filings and Other Disclosures.  Either Party may disclose the terms of this Agreement only (a) to the extent required, in the reasonable opinion of such Party's outside legal counsel, to comply with the rules and regulations promulgated by the United States Securities and Exchange Commission or similar security regulatory authorities in other countries, or the rules and regulations of any national exchange on which it is listed, (b) in connection with a 

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prospective acquisition, merger, financing or license for such Party, to prospective acquirers or merger candidates or to existing or potential investors or licensees, (c) in the case of ALZA, to its directors, officers, employees, consultants and advisors and those of its Affiliates who, in such ALZA's sole discretion, have a need to know such information in order for ALZA to carry out the activities and transactions contemplated by this Agreement, or (d) in the case of Incline, to its shareholders holding information rights, provided that prior to such disclosure each such prospective acquirer, candidate, investor, licensee or shareholder receiving disclosure pursuant to clause (b) or (d) shall agree in writing to be bound by obligations of confidentiality and non-use at least equivalent in scope to those set forth in this Article 7.  If a Party must disclose this Agreement or any of the terms hereof in accordance with Section 7.4(a), such Party agrees, at its own expense, to seek confidential treatment of portions of this Agreement or such terms, as may be reasonably requested by the other Party.  Notwithstanding the foregoing, ALZA shall have the right to review and comment (provided such comments are received within five (5) business days) on the contents of any Incline registration statement or other offering document (e.g., a prospectus) to the extent it contains the name of or any information about ALZA or any of its Affiliates in connection with this Agreement; it being understood and agreed that, except in the case such disclosure may, upon advice of counsel acceptable to both Incline and ALZA, be required by applicable law, ALZA's reasonable approval shall be required for any disclosure referring to it or any of its Affiliates.

7.5Public Announcements.  A press release, deemed agreed upon by the Parties, is attached to this Agreement as Exhibit E.  Except for issuing such press release, and except as provided in Section 7.4, no Party shall originate any publicity, news release or public announcements, written or oral, whether to the public, press, stockholders or otherwise, relating to the execution of this Agreement or any of the terms of this Agreement or any amendment hereto without the prior written consent of the other Party.

Article 8    Representations and Warranties

8.1Representations and Warranties of Each Party.  Each Party hereby represents and warrants to the other Party as follows:

8.1.1Organization and Good Standing.  As of the Execution Date, it is a legal entity duly organized, validly existing and in good standing under the laws of its jurisdiction of incorporation.

8.1.2Authority.  As of the Execution Date, it has the full right, power and authority to enter into this Agreement and this Agreement has been duly executed by such Party and constitutes a legal, valid and binding obligation of such Party, enforceable in accordance with its terms, subject to (a) laws of general application relating to bankruptcy, insolvency and the relief of debtors; and (b) rules of law governing specific performance, injunctive relief and other equitable remedies.

8.1.3No Conflicts.  The execution, delivery and performance of this Agreement by such Party does not conflict with any material agreement, instrument or understanding, oral or written, to which it is a party or by which it is bound, nor to the knowledge of such Party, violate any material law or regulation of any court, governmental body or administrative or other agency having jurisdiction over it.

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8.2Additional Representations and Warranties of ALZA.  

8.2.1Transferred Assets.  Subject to Section 8.2.2 below, in addition to the representations and warranties made by ALZA under Section 8.1, ALZA hereby represents and warrants to Incline as of the Execution Date that ALZA owns good and valid title to, or otherwise has the right to transfer (or cause to be transferred), the Transferred Assets as provided for herein, free and clear of all Encumbrances.

8.2.2Limitation.  Incline and ALZA acknowledge and agree that the employees listed in Schedule 8.2 were employees of ALZA and were closely involved in the management and operations relating to the ALZA Product and certain other Products, and Incline has had a reasonable opportunity to interview such employees.  ALZA shall in no event be liable to Incline, any other Incline Indemnitee or any other Person for any breach of ALZA's representations and warranties contained in this Agreement to the extent that any such employees had, or reasonably should have had as a result of their involvement with ALZA prior to the Execution Date, (a) knowledge of any material fact or facts which reasonably gives rise to such breach or (b) knowledge, as of the Execution Date, that ALZA was making a material misstatement, omission, misrepresentation, or inaccuracy herein, or was in breach of any of the representations or warranties contained in the Agreement.  Incline and ALZA agree that, in any dispute or legal proceeding, Incline shall bear the burden of proof that no such former employee had knowledge (or should not reasonably have had such knowledge) of such breach or of the material facts giving rise to such breach.

8.2.3Licensed Patents.  ALZA hereby represents and warrants to Incline that, to the best of ALZA's knowledge as of the Execution Date, certain of the Licensed Patents set forth on Schedule 1.29 constitute all of the Patent Rights owned or Controlled by ALZA or its Affiliates as of the Execution Date [**].

8.3Additional Representations and Warranties of Incline.  In addition to the representations and warranties made by Incline under Section 8.1, Incline hereby represents and warrants to ALZA as of the Execution Date that:

8.3.1Financing.  Incline has delivered to ALZA true and complete copies of all agreements relating to the Series A Financing and the Option Agreement (such agreements, the “Financing Commitments”).  Each of the Financing Commitments, in the form so delivered, is in full force and effect and is a legal, valid and binding obligation of Incline and the other parties thereto.  The Series A Financing, when funded in accordance with the Financing Commitments, and the Option Agreement shall provide Incline with funds sufficient to satisfy Incline's obligation under Section 5.1 (Upfront Payment).

8.3.2Diligence.  Incline acknowledges that it has had conducted, under the advice of counsel of its own selection, its independent due diligence evaluation in connection with the transactions contemplated by this Agreement, and that all rights transferred hereunder, licensed or assigned, are accepted as is, without any warranties except as expressly provided for in this Agreement.

8.3.3Commercialization.  Incline acknowledges that it is solely responsible on and 

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after the Closing for (a) all research, development and Commercialization activities related to the Products and (b) acquiring the Regulatory Approvals with the relevant Regulatory Authorities as necessary to Commercialize the Products in the Territory.  Incline also acknowledges that ALZA provides no warranty with respect to the success of the Products, including whether or not Incline will be successful in acquiring the relevant Regulatory Approvals to Commercialize the Products in the Territory.

8.4Disclaimer of Warranties.

8.4.1EXCEPT AS OTHERWISE EXPRESSLY SET FORTH IN THIS AGREEMENT, ALZA AND ITS AFFILIATES MAKE NO REPRESENTATIONS AND EXTEND NO WARRANTIES OR CONDITIONS OF ANY KIND, EITHER EXPRESS OR IMPLIED, WITH RESPECT TO THE PRODUCTS, TRANSFERRED ASSETS, LICENSED KNOW-HOW OR LICENSED PATENTS INCLUDING WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT, AND ANY SUCH OTHER REPRESENTATIONS OR WARRANTIES ARE HEREBY EXPRESSLY DISCLAIMED.  ALZA AND ITS AFFILIATES HEREBY DISCLAIM ANY REPRESENTATION OR WARRANTY THAT THE DEVELOPMENT, MANUFACTURE OR COMMERCIALIZATION OF ANY PRODUCT WILL BE SUCCESSFUL.

8.4.2INCLINE HEREBY ACKNOWLEDGES AND AGREES THAT IT IS PURCHASING THE TRANSFERRED ASSETS AND LICENSING THE LICENSED KNOW-HOW AND LICENSED PATENTS ON AN "AS IS, WHERE IS" BASIS WITHOUT WARRANTY WITH RESPECT TO COMPLETENESS, ACCURACY, VALIDITY, NON-INFRINGEMENT, COMPLIANCE WITH REGULATORY STANDARDS OR REGULATIONS OR FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER KIND OF WARRANTY WHETHER EXPRESS OR IMPLIED.

8.5No Implication.  Except as expressly stated herein, nothing in the Agreement shall be construed as:

(a)     A warranty or representation by ALZA as to the validity or patentability or scope of any of the Licensed Patents or Licensed Know-How; 

(b)    A warranty or representation by ALZA that anything that has been or shall be made, used, sold, offered for sale, or imported under the licenses granted under Section 2.1 is or shall be free from infringement of patents of Third Parties; and

(c)    A grant by implication, estoppel, or otherwise, of any licenses or rights under patents or other intellectual property of ALZA (including such licenses or rights granted to ALZA through its Affiliates and/or Third Parties) other than that expressly included in this Agreement.

Article 9     Indemnification and Insurance

9.1Survival.  Except for the representations and warranties set forth in Sections 8.1.1 (Organization and Good Standing) and 8.1.2 (Authority), all representations and warranties 

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contained in this Agreement shall survive the Execution Date until the date that is [**] months from the Execution Date, and shall then expire and be of no force or effect.  The representations and warranties set forth in Sections 8.1.1 (Organization and Good Standing) and 8.1.2 (Authority) and the covenants contained in this Agreement shall survive [**] except as otherwise specified herein.

9.2Indemnification by ALZA.  Subject to Section 8.2.2 and Section 9.4, ALZA hereby agrees to indemnify, defend and hold harmless Incline and its Affiliates, and their respective directors, officers, employees, agents and representatives (collectively, the “Incline Indemnitees”) from and against any and all Damages which any Incline Indemnitee may incur or suffer to the extent such arise out of or result from (a) any of the Excluded Liabilities or Excluded Assets or (b) the breach of any representation, warranty, covenant or agreement made by ALZA in this Agreement, in each case except to the extent caused by the gross negligence or willful misconduct of an Incline Indemnitee

9.3Indemnification by Incline.  Incline hereby agrees to indemnify, defend and hold harmless ALZA and its Affiliates, and their respective directors, officers, employees, agents and representatives (collectively, the “ALZA Indemnitees”) from and against any and all Third Party Claims and related Damages which any ALZA Indemnitee may incur or suffer to the extent such arise or result from (a) the ownership, possession, manufacture, research, development, Commercialization, use or operation of any Product or the Transferred Assets, including the use of any information in the Market Research Materials, or exploitation of the inventions claimed by the Licensed Patents, by Incline, its Affiliates, sublicensees or successors and assigns on or after the Closing, (b) any of the Assumed Liabilities or (c) the breach of any representation, warranty, covenant or agreement made by Incline in this Agreement (including the use of any Improperly Transferred Documents by Incline or any of its Affiliates or sublicensees in breach of Section 4.5), except to the extent caused by the gross negligence or willful misconduct of an ALZA Indemnitees.

9.4Scope of ALZA's Liability.  Indemnification shall be available to the Incline Indemnitees under Section 9.2 only to the extent the aggregate amount of Damages otherwise due to the Incline Indemnitees for all claims for such indemnification exceeds $200,000 (the “Indemnity Basket”) and then indemnification shall be available to the Incline Indemnitees for the amount of all payments due to the Incline Indemnitees in excess of such amount, but only for all such Damages up to $3,750,000 (the “Indemnity Cap”).  In addition, Incline agrees and acknowledges that in no event shall ALZA be liable for any loss of or damage to any of the manufacturing equipment set forth in Schedule 3.1.4 during transport from ALZA to Incline's warehouse or facility, as provided in Section 4.4.3, and that Incline's sole remedy in event of such loss or damage shall be as provided under the relevant insurance obtained by Incline with respect to such risk of loss or damage during such transport.  

9.5Claims.  Any Incline Indemnitee or ALZA Indemnitee claiming it may be entitled to indemnification under this Article 9 (the “Indemnified Party”) shall give prompt written notice to the other Party (the “Indemnifying Party”) of each matter, action, cause of action, claim, demand, fact or other circumstances upon which a claim for indemnification (a “Claim”) hereunder may be based.  Such notice shall contain, with respect to each Claim, such facts and information as are then reasonably available, the estimated amount of Damages and the specific basis for indemnification hereunder.  Failure to give prompt notice of a Claim hereunder shall not affect the Indemnifying Party's obligations hereunder, except to the extent the Indemnifying 

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Party is prejudiced by such failure.

9.6Defense of Third Party Claims.  The Indemnified Party shall permit the Indemnifying Party, at the Indemnifying Party's option and expense, to assume the complete defense of any Claim based on any action, suit, proceeding, claim, demand or assessment by any Third Party (a “Third Party Claim”) with full authority to conduct such defense and to settle or otherwise dispose of the same and the Indemnified Party shall reasonably cooperate with the Indemnifying Party at the Indemnifying Party's request and expense in such defense; provided the Indemnifying Party shall not, in defense of any Third Party Claim, except with the consent of the Indemnified Party (which consent shall not be unreasonably withheld or delayed), consent to the entry of any judgment or enter into any settlement (a) which provides for any relief other than the payment of monetary damages and/or (b) which does not include as an unconditional term thereof the giving by the Third Party claimant to the Indemnified Party of a release from all liability in respect thereof.  After notice to the Indemnified Party of the Indemnifying Party's election to assume the defense of any Third Party Claim, the Indemnifying Party shall be liable to the Indemnified Party only for such legal or other expenses subsequently incurred by the Indemnified Party in connection with the defense thereof at the request of the Indemnifying Party.  As to those Third Party Claims with respect to which the Indemnifying Party does not elect to assume control of the defense, the Indemnified Party shall afford the Indemnifying Party an opportunity to participate in such defense, at its cost and expense, and shall consult with the Indemnifying Party prior to settling or otherwise disposing of any of the same.

9.7Exclusive Remedy.

9.7.1Subject to Section 9.7.2, except in the event of fraud or intentional misrepresentation, (a) the sole and exclusive remedy of Incline and any other Incline Indemnitee with respect to any claims arising out of or relating to this Agreement, whether arising in contract, tort or otherwise, shall be the right of Incline or such Incline Indemnitee, as the case may be, to make claims of indemnification for Damages pursuant to the provisions of Section 9.2, and (b) the sole and exclusive remedy of ALZA and any other ALZA Indemnitee with respect to any Third Party Claims arising out of or relating to this Agreement, whether arising in contract, tort or otherwise, shall be the right of ALZA or such ALZA Indemnitee, as the case may be, to make claims of indemnification for Damages pursuant to the provisions of Section 9.3.   In furtherance of the foregoing, each Party hereby waives, to the fullest extent permitted under applicable law, any and all other rights, remedies, claims and causes of action it or any of its Affiliates may have (excluding rights, claims or causes of action of any Party for fraud and intentional misrepresentation), from and after the Execution Date, against the other Party or its Affiliates.

9.7.2The provisions of Section 9.7.1 shall not restrict the right of any Party to seek specific performance or other equitable remedies in connection with any breach of any of the covenants contained herein.  In addition to the foregoing and notwithstanding anything herein to the contrary, ALZA shall not have any Liability or be responsible for any Damages arising out of or with respect to the manner in which Incline operates the Transferred Assets after the Closing.

9.7.3With respect to any Damages arising under this Agreement, Incline agrees that it shall only seek such Damages from ALZA, and Incline hereby waives the right to seek 

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Damages from or equitable remedies, such as injunctive relief, against any Affiliate of ALZA or any director, officer or employee of ALZA (or any of its Affiliates).

9.8Calculation of Damages.  Except as otherwise provided in this Article 9, in any case where the Indemnified Party subsequently recovers from Third Parties any amount in respect of a matter with respect to which an Indemnifying Party has indemnified it pursuant to this Article 9, such Indemnified Party shall promptly pay over to the Indemnifying Party the amount so recovered (after deducting therefrom the full amount of the expenses incurred by it in procuring such recovery), but not in excess of any amount previously so paid by the Indemnifying Party to or on behalf of the Indemnified Party in respect of such matter.

9.9Mitigation.  Each Party agrees that it shall, and it shall cause its Affiliates to, use its or their reasonable efforts to mitigate any Damages to be indemnified under this Article 9.

9.10No Limitation on Right to Contest.  Nothing in this Article 9 shall be construed as a limitation on the Indemnifying Party's right to contest in good faith whether the Indemnified Party is entitled to indemnification pursuant to this Article 9 with respect to a particular claim.

9.11Limitations of Indemnification.  SUBJECT TO AND WITHOUT LIMITING THE INDEMNIFICATION OBLIGATIONS OF EACH PARTY WITH RESPECT TO THIRD PARTY CLAIMS, NO PARTY OR ANY OF ITS AFFILIATES SHALL BE LIABLE TO THE OTHER PARTY UNDER ANY CONTRACT, WARRANTY, NEGLIGENCE, TORT, STRICT LIABILITY OR OTHER LEGAL OR EQUITABLE THEORY FOR ANY SPECIAL, INDIRECT, INCIDENTAL, PUNITIVE, EXEMPLARY OR CONSEQUENTIAL DAMAGES OR FOR LOST PROFITS, MILESTONES OR ROYALTIES, ARISING OUT OF OR IN CONNECTION WITH THIS AGREEMENT OR ITS SUBJECT MATTER.

9.12Insurance.  During the Term of this Agreement and for a period of at least [**] years following the termination of this Agreement, Incline shall maintain, at its sole cost and expense, general liability insurance, including product liability coverage, with bodily injury, death and property damage limits, in such amounts and with such scope of coverage as is consistent with drug industry standards for Products of a similar nature.  Incline shall have its insurance carrier furnish to ALZA certificates stating that all insurance required under this Agreement is in force.  Such certificates shall indicate any deductible and self-insured retention and the effective expiration dates of the policies.  All certificates are to stipulate that ALZA shall be given [**] days written notice of all cancellation, non-renewal or material changes in policy.  ALZA shall be named as an additional insured on all insurance policies obtained by Incline in accordance with this Section 9.12.  

Article 10    Term and Termination

10.1Term.  The term of this Agreement shall commence on the Execution Date and shall continue until the expiration and satisfaction of all payment obligations hereunder (including under Article 5), unless this Agreement is terminated earlier in accordance with this Article 10 (the “Term”).  This Agreement may be terminated by ALZA, by written notice to Incline, if the Closing shall not have occurred on or before [**] business days after the Execution Date.  

10.2Termination for Cause.  In the event that a Party commits a material breach of its 

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obligations under this Agreement that is not cured within the [**] day period (or such other time period as mutually agreed by the Parties) after receipt of written notice from the non-breaching Party, the non-breaching Party may terminate this Agreement upon written notice to the breaching Party; provided, however, that (a) a breach of this Agreement that solely relates to the United States shall give rise to a termination right only as to the United States, (b) a breach of this Agreement that relates solely to any country in Europe shall give rise to a termination right only as to Europe and (c) a breach of this Agreement that relates solely to any country in the Territory that is not the United States or any country in Europe (the “ROW Countries”) shall give rise to a termination right in all of the ROW Countries (the United States, Europe and the ROW Countries each referred to hereinafter as a “Region”).  To the extent the allegedly breaching Party disputes a claim of material breach pursuant to Article 11 following receipt of written notice from the non-breaching Party, any effectiveness of the termination of this Agreement as a result of such material breach shall be tolled until such dispute is resolved pursuant to Article 11.  Termination of this Agreement by a Party pursuant to this Section 10.2 shall be without prejudice to any of its other rights conferred on it by this Agreement, and in addition to any other remedies that may be available to it under law. 

10.3Termination for Incline Bankruptcy.  ALZA may terminate this Agreement at any time during the Term in the event of an Incline Bankruptcy.

10.4Effects of Termination.  In the event of termination by either Party under Section 10.2 or a termination by ALZA under Section 10.3, the following shall apply:

10.4.1Termination of License.  All rights to the Licensed Patents and Licensed Know-How licensed herein shall revert to ALZA, and all licenses granted herein by ALZA to Incline with respect to the Products and all rights of first negotiation set forth in Section 2.3 and Section 2.4 shall terminate.

10.4.2Assignment of Government Filings.  At no expense to ALZA or any of its Affiliates, Incline shall assign and promptly transfer to ALZA or its Affiliates, as requested by ALZA, all Regulatory Approvals (including government authorizations) that were included as part of the Transferred Assets.  

10.4.3Assignment of Trademarks and Domain Names.  At no expense to ALZA or any of its Affiliates, Incline shall assign and promptly transfer to ALZA or its Affiliates, as requested by ALZA, the Product Trademarks and Product Domain Names that were included as part of the Transferred Assets.

10.4.4License to Know-How.  Incline hereby grants to ALZA a non-exclusive, fully paid-up, royalty-free, irrevocable license, with the right to sublicense through multiple tiers, under the Transferred Know-How.

10.4.5Termination by Region.  In the event of termination by ALZA pursuant to Section 10.2 solely with respect to a Region, the effects of termination described in this Section 10.4 shall apply solely with respect to the relevant Region.  

10.5No Waiver.  The right of a Party to terminate this Agreement, as provided in this Article 10, shall not be affected in any way by its waiver or failure to take action with respect to any prior default by the other Party.

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10.6Consequences of Termination.  Except as otherwise provided herein, upon termination of this Agreement, each Party shall promptly return to the other Party all remaining records and materials in its possession or control containing the other Party's Confidential Information.  Notwithstanding the foregoing, one copy of such records may be retained by legal counsel solely for evidentiary purposes.

10.7Termination Not Sole Remedy.  Termination is not the sole remedy under this Agreement and, whether or not termination is effected, all other remedies shall remain available except as expressly agreed to otherwise herein.

10.8Survival of Obligations.  The termination of this Agreement shall not relieve the Parties of any obligations accruing prior to such termination, and any such termination shall be without prejudice to the rights of either Party against the other. 
 
10.8.1Termination for Cause or Termination for Incline Bankruptcy.  If this Agreement is terminated by either Party pursuant to Section 10.2 or by ALZA pursuant to Section 10.3, the following provisions, as well as (a) any other Sections or defined terms referred to in such provisions or necessary to give them effect and (b) any other provision that by its terms expressly survives termination of this Agreement, shall survive any termination of this Agreement:  Section 4.11 (Incline's Post-Closing Covenants), Article 7 (Confidential Information), including Section 7.5 (Public Announcements), Article 9 (Indemnification and Insurance), Section 10.4 (Effects of Termination), this Section 10.8 (Survival of Obligations), Article 11 (Dispute Resolution) and Article 12 (Miscellaneous). 

10.8.2Termination for Failure to Close.  If this Agreement is terminated by ALZA pursuant to Section 10.1, the following provisions, as well as (a) any other Sections or defined terms referred to in such provisions or necessary to give them effect and (b) any other provision that by its terms expressly survives termination of this Agreement, shall survive any termination of this Agreement: Article 7 (Confidential Information), including Section 7.5 (Public Announcements), this Section 10.8 (Survival of Obligations), Article 11 (Dispute Resolution) and Article 12 (Miscellaneous).

10.9Rights in Bankruptcy.  All rights and licenses granted to Incline and ALZA under or pursuant to this Agreement, for all purposes of Section 365(n) of Title 11 of the United States Code (“Title 11”), are licenses of rights to “intellectual property” as defined in Title 11, and, in the event that a case under Title 11 is commenced by or against ALZA, its Affiliates or successors, on the one hand, or Incline, its Affiliates or successors, on the other hand, the Party licensed hereunder shall have all of the rights set forth in Section 365(n) of Title 11 to the maximum extent permitted thereby.  All rights of Incline and ALZA under this Section 10.9 and under Section 365(n) of Title 11 are in addition to and not in substitution of any and all other rights, powers, and remedies that it may have under this Agreement, Title 11, and any other applicable law.  

Article 11    Dispute Resolution

11.1Escalating; Decision Making Authority.  In the case of any disputes between the Parties 

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arising from this Agreement, the Parties shall discuss and negotiate in good faith a solution acceptable to the Parties and in the spirit of this Agreement.  If, after negotiating in good faith pursuant to the foregoing sentence, the Parties fail to reach agreement within [**] days, then the matter shall be referred to the President of ALZA and the Chief Executive Officer of Incline for resolution at the request of either Party.  If these executives fail, after good faith discussions, to reach an amicable agreement on the matter within [**] business days of submission to the executives, then either Party may upon written notice to the other submit the dispute to non-binding mediation pursuant to Section 11.2.

11.2Mediation.  Any dispute, controversy or claim arising out of or related to this Agreement, or the interpretation, application, breach, termination or validity thereof, including any claim of inducement by fraud or otherwise, which claim would, but for this provision, be submitted to arbitration shall, before submission to arbitration, first be mediated through non‐binding mediation in accordance with The CPR Mediation Procedure then in effect of the International Institute for Conflict Prevention & Resolution or its successor (“CPR”) available at www.cpradr.org, except where that procedure conflicts with the following provisions, in which case these provisions control.  

11.2.1The mediation shall be conducted in New York, New York and shall be attended by a senior executive with authority to resolve the dispute from each of the Parties. 

11.2.2The mediator shall be neutral, independent, disinterested and shall be selected from a professional mediation firm such as ADR Associates, JAMS or CPR. 

11.2.3The Parties shall promptly confer in an effort to select a mediator by agreement.  In the absence of such an agreement within [**] days of initiation of the mediation, the mediator shall be selected by [**] as follows:  [**].

11.2.4The mediator shall confer with the Parties to design procedures to conclude the mediation within no more than [**] days after initiation.  Under no circumstances may the commencement of arbitration under Section 11.3 be delayed more than [**] days from the date of written notice by a Party under Section 11.1 to submit such issue to mediation absent contrary agreement of the Parties.

11.2.5Each Party agrees not to use the period or pendency of the mediation to disadvantage the other Party procedurally or otherwise.  No statements made by either side during the mediation may be used by the other or referred to during any subsequent proceedings.

11.2.6Each Party has the right to pursue provisional relief from any court, such as attachment, preliminary injunction, replevin, etc., to avoid irreparable harm, maintain the status quo, or preserve the subject matter of the arbitration, even though mediation has not been commenced or completed.

11.3Arbitration.  Any claim, dispute or controversy arising from or related to this Agreement or to the interpretation, application, breach, termination or validity of this Agreement, including any claim of inducement of this Agreement by fraud or otherwise, that is not settled by the procedures set forth in Section 11.1 or Section 11.2 above, shall be submitted for resolution to arbitration pursuant to the CPR Rules for Non-Administered Arbitration (available at 

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www.cpradr.org), except where those rules conflict with these provisions, in which case these provisions control.  Expedited Arbitration Disputes (as defined below) shall be handled under the provisions of this Section 11.3 procedure.  The arbitration shall be held in New York City, New York.

11.3.1Other than with respect to Expedited Arbitration Disputes, the panel shall consist of three (3) arbitrators chosen from the [**].  However, if the aggregate of all amounts in dispute is less than $[**] (any such dispute, an “Expedited Arbitration Dispute”), then [**].  Each arbitrator shall be neutral, independent, disinterested, impartial, shall abide by The CPR-Georgetown Commission Proposed Model Rule for the Lawyer as Third Party Neutral available at www.cpradr.org/cpr-george.html and shall be able to make a commitment to dedicate sufficient time to the arbitration to enable the arbitration to be conducted within the time limits set forth in Section 11.3.2 below.

11.3.2The Parties agree to (a) discuss within [**] days of initiation of the arbitration whether they can select the arbitrator(s) by mutual agreement, after which [**] day period either Party shall be free to refer the selection of the arbitrator(s) to the CPR as provided in Section 11.3.3 below if such Party is not satisfied that the Parties shall be able to select the arbitrator(s) by mutual agreement in a timely manner, (b) to meet with the arbitrator(s) within [**] days of selection and (c) to agree at that meeting or before upon procedures for discovery and as to the conduct of the hearing which shall result in the hearing being concluded within no more than [**] months after selection of the arbitrator(s) and in the award being rendered within [**] days of any post-hearing briefing, which briefing shall be completed by both sides within [**] days after the conclusion of the hearings, or within [**] days of the conclusion of the hearings if there is no post-hearing briefing.

11.3.3In the event the Parties cannot agree upon selection of the arbitrators and the disputed matter is an Expedited Arbitration Dispute, the CPR shall select the arbitrator based on the rankings each Party gives the slate proposed by the CPR and any challenges for cause, which the rankings and challenges shall be provided by the Parties to the CPR [**] business days following receipt of the CPR's slate.  The CPR shall endeavor to make the selection [**] business days following receipt of the Parties' rankings and challenges.  In the event the Parties cannot agree upon selection of the arbitrators and the disputed matter is not an Expedited Arbitration Dispute, the Parties shall select arbitrators as follows:  [**].

11.3.4In the event the Parties cannot agree upon procedures for conduct of the hearing meeting on the schedule set forth in Section 11.3.2 above, then the arbitrator(s) shall set dates for the hearing, any post-hearing briefing and the issuance of the award in accordance with the Section 11.3.2 schedule.  In addition, in the event the Parties cannot agree upon procedures for discovery as set forth in Section 11.3.2 above, the arbitrator(s) shall provide that discovery be limited so that the Section 11.3.2 schedule may be met without difficulty and so that neither side obtains more than a total of [**].  In no event shall the arbitrator(s), absent agreement of the Parties, allow more than [**] days per side for the hearing or more than a total of [**] days for the hearing.  Multiple hearing days shall be scheduled consecutively to the greatest extent possible.

11.3.5The arbitrator(s) must render their award by application of the substantive law of 

45

the State of New York and are not free to apply “amiable compositeur” or “natural justice and equity.”  The arbitrator(s) shall render a written opinion setting forth findings of fact and conclusions of law with the reasons therefor stated.  A transcript of the evidence adduced at the hearing shall be made and shall, upon request, be made available to either Party.  The arbitrator(s) shall have power to exclude evidence on grounds of hearsay (subject to all hearsay exceptions set forth in the United States Federal Rules of Evidence), prejudice beyond its probative value, redundancy, or irrelevance and no award shall be overturned by reason of such ruling on evidence.  To the extent possible, the arbitration hearings and award shall be maintained in confidence.  Except as set forth below, the decision of the arbitrator(s) shall be final and not subject to further review, except pursuant to the Federal Arbitration Act.

11.3.6In the event the panel's award with respect to a disputed matter other than an Expedited Arbitration Dispute exceeds $[**] in monetary damages, then the losing Party may obtain review of the arbitrators' award or decision by a single appellate arbitrator (the “Appeal Arbitrator”) selected from the CPR Panels of Distinguished Neutrals by agreement or, failing agreement within [**] business days, pursuant to the selection procedures specified in Section 11.3.3 above for Expedited Arbitration Disputes, except that the Parties may [**].  If CPR cannot provide such services, the Parties shall together select another provider of arbitration services that can.  No Appeal Arbitrator shall be selected unless he or she can commit to rendering a decision within [**] days following oral argument as specified in this Section 11.3.6.  Any such review must be initiated within [**] days following the rendering of the award referenced in Section 11.3.5 above.

11.3.7In any arbitration appeal pursuant to Section 11.3.6, the Appeal Arbitrator shall make the same review of the arbitration panel's ruling and its bases that the U.S. Court of Appeals of the Circuit where the arbitration hearings are held would make of findings of fact and conclusions of law rendered by a district court after a bench trial and then modify, vacate or affirm the arbitration panel's award or decision accordingly, or remand to the panel for further proceedings.  The Appeal Arbitrator shall consider only the arbitration panel's findings of fact and conclusions of law, pertinent portions of the hearing transcript and evidentiary record as submitted by the Parties, opening and reply briefs of the Party pursuing the review, and the answering brief of the opposing Party, plus a total of no more than [**] hours of oral argument evenly divided between the Parties.  The Party seeking review must submit its opening brief and any reply brief within [**] and [**] days, respectively, following the date of the award under review, whereas the opposing Party must submit its responsive brief within [**] days of that date.  Oral argument shall take place within [**] months after the date of the award under review, and the Appeal Arbitrator shall render a decision within [**] days following oral argument.  That decision shall be final and not subject to further review, except pursuant to the Federal Arbitration Act.

11.3.8The Parties consent to the non-exclusive jurisdiction of the Federal District Court for the district in New York, New York for the enforcement of these provisions and the entry of judgment on any award rendered hereunder (including after review of the Appeal Arbitrator where such an appeal is pursued).  

11.3.9Each Party has the right before or, if the arbitrator(s) cannot hear the matter within an acceptable period, during the arbitration to seek and obtain from the 

46

appropriate court provisional remedies such as attachment, preliminary injunction and replevin, to avoid irreparable harm, maintain the status quo, or preserve the subject matter of the arbitration.

11.4Jury Trial.  EACH PARTY HERETO WAIVES ITS RIGHT TO TRIAL OF ANY ISSUE BY JURY. 

11.5Termination.  Notwithstanding the foregoing, the provisions of Article 11 shall not prevent the Parties from terminating this Agreement in accordance with Article 10, provided that the arbitrators may settle any dispute in respect of the circumstances and validity of a termination of this Agreement.

Article 12    Miscellaneous

12.1No Reliance by Incline; Own Due Diligence.  Incline is relying on its own investigation, examination and valuation of the Products and Transferred Assets in effecting the transactions covered and intended by this Agreement.  Incline has made all inspections and investigations of the Products and the Transferred Assets deemed necessary or desirable by Incline.  Incline is purchasing the Transferred Assets based on the results of its inspections and investigations, and not on any representation or warranty of ALZA or any of its Affiliates not expressly set forth in this Agreement.  In light of these inspections and investigations and the representations and warranties made to Incline by ALZA herein, Incline is relinquishing any right to any claim based on any representations and warranties other than those expressly set forth in this Agreement.

12.2Performance by Affiliates.  To the extent that this Agreement imposes obligations on Affiliates of a Party, such Party agrees to cause its Affiliates to perform such obligations.  Any obligation of a Party to the other Party under this Agreement, which obligation is performed, satisfied or fulfilled by an Affiliate of such Party, shall be deemed to have been performed, satisfied or fulfilled by such Party.

12.3Entire Agreement.  This Agreement, together with the Exhibits and Schedules expressly contemplated hereby and attached hereto, constitutes and contains the entire understanding and agreement between the Parties respecting the subject matter of this Agreement and cancels and supersedes any and all prior or contemporaneous negotiations, correspondence, understandings and agreements between the Parties, whether oral or written, regarding such subject matter.  Before signing this Agreement, the Parties have had numerous conversations including preliminary discussions, formal negotiations and informal conversations at meals and social occasions, and have generated correspondence and other writings, in which the Parties discussed the transaction which is the subject of this Agreement and their aspirations for success.  In such conversations and writings, individuals representing the Parties may have expressed their judgments and beliefs concerning the intentions, capabilities, and practices of the Parties, and may have forecasted future events.  The Parties recognize that such conversations and writings often involve an effort by both sides to be positive and optimistic about the prospects for the transaction.  However, it is also recognized that all business transactions contain an element of risk, as does the transaction contemplated by this Agreement, and that it is normal business practice to limit the legal obligations of contracting Parties to only those promises and representations which are essential to their transaction so as to provide certainty as to their respective future rights and remedies.  Accordingly, this Agreement is intended to define the full 

47

extent of the legally enforceable undertakings and representations of the Parties hereto, and no promise or representation, written or oral, which is not set forth explicitly in such agreements is intended by either Party to be legally binding.  Each of the Parties acknowledge that in deciding to enter into this Agreement and to consummate the transaction contemplated hereby and thereby, none of them has relied upon any statements or representations, written or oral, other than those explicitly set forth herein or therein.

12.4Binding Effect.  This Agreement and the rights and obligations hereunder shall be binding upon and inure solely to the benefit of the Parties hereto, their respective successors and permitted assigns.

12.5Assignment.  Neither Party may assign its rights or delegate its duties under this Agreement without the prior written consent of the other Party, provided that ALZA may transfer this Agreement to an Affiliate without the prior written consent of Incline and further provided that any Party may transfer this Agreement to a successor in connection with the merger or consolidation of such Party with or into a Third Party or the sale of all or substantially all of its assets or that portion of its business pertaining to the subject matter of this Agreement, in each case without the prior written consent of the other Party.  Any permitted assignee shall assume all obligations of its assignor under this Agreement.

12.6No Third Party Beneficiaries.  Other than as explicitly set forth herein, nothing contained herein is intended to confer upon any Person, other than the Parties to this Agreement and their respective successors and permitted assigns, any rights or remedies under or by reason of this Agreement.  

12.7Use of Names.  Except as expressly provided, no right is granted by this Agreement to a Party to use in any manner the name or any other trade name of the other Party or its Affiliates in connection with this Agreement.

12.8No Waiver.  No waiver, modification or amendment of any provision of this Agreement shall be valid or effective unless made in writing and signed by a duly authorized officer of each Party.  The failure of either Party to assert a right hereunder or to insist upon compliance with any term or condition of this Agreement shall not constitute a waiver of that right or excuse a similar subsequent failure to perform any such term or condition.

12.9Modifications and Amendments.  This Agreement shall not be altered or otherwise amended except pursuant to an instrument in writing executed and delivered by each of the Parties hereto.

12.10Independent Contractors.  Each Party is an independent contractor and not an agent or employee of the other Party under this Agreement.  Nothing contained in this Agreement is intended nor is to be construed so as to constitute ALZA or Incline as partners or joint venturers with respect to this Agreement.  No Party shall have any express or implied right or authority to assume or create any obligations on behalf of or in the name of the other Parties or to bind the other Parties to any other contract, agreement or undertaking with any Third Party except as may be explicitly provided for herein or authorized in writing.

12.11Notices and Deliveries.  Any notice, request, instruction or other communication to be given hereunder by either Party to the other Party shall be in writing and shall be deemed to have 

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been sufficiently given when it is received, whether delivered in person, transmitted by facsimile with contemporaneous confirmation of successful transmission, delivered by registered letter postage prepaid (or its equivalent) or delivered by postage prepaid certified overnight by an internationally recognized courier service, to the Party to which it is directed at its address shown below or such other address as such Party shall have last given by notice to the other Parties.

If to Incline:

Incline Therapeutics, Inc.
601 Union, Two Union Square, Suite 3200
Seattle, WA 98101
Facsimile:  206-621-1848
Attention:  Chief Executive Officer

with a copy to:

Cooley LLP
3175 Hanover St.
Palo Alto, CA  94306
Facsimile:  650-849-7400
Attention:  Barbara Kosacz, Esq.

If to ALZA:

ALZA Corporation
6500 Paseo Padre Parkway
Fremont, CA  94555
Facsimile:  510-248-2366
Attention:  Legal Department

with a copy to:

Office of General Counsel
Johnson & Johnson
One Johnson & Johnson Plaza
New Brunswick, NJ  08933
Facsimile:  732-524-2788

12.12Severability.  It is the desire and intent of the Parties hereto that the provisions of this Agreement shall be enforced to the fullest extent permissible under the laws in each jurisdiction in which enforcement is sought.  Accordingly, if any particular provision of this Agreement shall be determined to be invalid or unenforceable, such provision shall be deemed amended to delete therefrom the portion thus determined to be invalid or unenforceable, such deletion to apply to the extent of such invalidity or unenforceability, without affecting in any way the remaining provisions hereof only with respect to the operation of such provision in the particular jurisdiction in which such determination is made.

12.13Governing Law; Submission to Jurisdiction.  This Agreement shall be governed by and 

49

interpreted in accordance with the laws of the State of New York without reference to its choice of laws or conflicts of law provisions.  Each Party (a) submits to the exclusive jurisdiction of the state and federal courts sitting in New York, New York, with respect to actions or proceedings arising out of or relating to this Agreement in which a Party brings an action in aid of arbitration, (b) agrees that all claims in respect of such action or proceeding may be heard and determined only in any such court, and (c) agrees not to bring any action or proceeding arising out of or relating to this Agreement in any other court, other than an action or proceeding seeking injunctive relief or brought to enforce an arbitration ruling issued pursuant to Section 11.3.  Each Party waives any defense of inconvenient forum to the maintenance of any action or proceeding so brought and waives any bond, surety or other security that might be required of the other Party with respect thereto.  Each Party may make service on the other Party by sending or delivering a copy of the process to the Party to be served at the address and in the manner provided for the giving of notices in Section 12.11.  Nothing in this Section 12.13, however, shall affect the right of any Party to serve legal process in any other manner permitted by New York law.
  
12.14Specific Enforcement.  The Parties agree that irreparable damage would occur and that the Parties would not have any adequate remedy at law if any of the provisions of this Agreement were not performed in accordance with their specific terms or were otherwise breached.  It is accordingly agreed that the Parties shall be entitled to an injunction or injunctions to prevent breaches of this Agreement and to enforce specifically the terms and provisions of this Agreement, this being in addition to any other remedy to which any Party is entitled at law or in equity.

12.15Advice of Counsel.  Each Party acknowledges and agrees it has participated in the drafting of this Agreement.  In interpreting and applying the terms and provisions of this Agreement, the Parties agree that no presumption shall exist or be implied against the Party which drafted such terms and provisions.

12.16Counterparts.  This Agreement may be executed in any number of counterparts (including by facsimile or electronic transmission), each of which need not contain the signature of more than one Party, but all such counterparts taken together shall constitute one and the same agreement.

12.17Payment of Expenses.  Except as otherwise set forth in this Agreement, all costs and expenses associated with this Agreement and the transactions contemplated thereby shall be borne by the Party incurring such expenses.

12.18Compliance with Laws.  Each Party shall comply with all applicable laws, rules, regulations and orders of the United States and applicable foreign countries and supra-governmental organizations and all jurisdictions and any agency or court thereof in connection with this Agreement and the transactions contemplated thereby.

12.19Construction.  Except where the context requires otherwise, whenever used the singular includes the plural, the plural includes the singular, the use of any gender is applicable to all genders and the word “or” has the inclusive meaning represented by the phrase “and/or”.  Whenever this Agreement refers to a number of days, unless otherwise specified, such number refers to calendar days.  The headings of this Agreement and any descriptions of Attachments and Exhibits or descriptions of cross‐references are for convenience of reference only and do not 

50

define, describe, extend or limit the scope or intent of this Agreement or the scope or intent of any provision contained in this Agreement.  The terms “including,” “include(s),” “such as,” and “for example” as used in this Agreement mean including the generality of any description preceding such term and shall be deemed to be followed by “without limitation”.

[Signature Page Follows]

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IN WITNESS WHEREOF, the Parties have caused this Agreement to be executed by their respective duly authorized officers as of the Execution Date, each copy of which shall for all purposes be deemed to be an original.

ALZA CORPORATION

By:    ___/s/ Luis E. Toca_____________________

Name:    ______ Luis E. Toca ____________________

Title:    ______Treasurer______________________

INCLINE THERAPEUTICS, INC.

By:    ___/s/ Alan Levy___________________

Name:    Alan Levy, PhD

Title:    Chief Executive Officer

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EXHIBIT A
BILL OF SALE 
THIS BILL OF SALE, is made as of [CLOSING DATE], 2010, by and between ALZA Corporation, a Delaware corporation (“Assignor”) and Incline Therapeutics, Inc., a Delaware corporation (“Assignee”).
RECITALS
WHEREAS, Assignor and Assignee are parties to a License and Asset Transfer Agreement dated as of [CLOSING DATE], 2010 (the “Agreement”); and 
WHEREAS, Assignor and Assignee now desire to carry out the intent and purpose of the Agreement by Assignor's execution and delivery to Assignee of this instrument evidencing the sale, conveyance, assignment, transfer and delivery to Assignee of the Transferred Assets; provided, that the Excluded Liabilities shall not be assumed pursuant to the Agreement; 
NOW, THEREFORE, in consideration of the foregoing premises and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties agree as follows:
1.Definitions.  All capitalized terms not otherwise defined herein shall have the meaning ascribed to them in the Agreement.

2.Sale of the Transferred Assets.  Upon the terms and subject to the conditions of the Agreement and the ALZA Third Party Licenses, Assignor and its Affiliates do hereby irrevocably sell, convey, assign and transfer to Assignee, and Assignee does hereby purchase, receive and assume from Assignor and its Affiliates, all of Assignor's or its Affiliate's right, title and interest in and to the Transferred Assets free and clear of any Encumbrances TO HAVE AND TO HOLD the Transferred Assets unto Assignee, its successors and assigns, FOREVER.  Notwithstanding the foregoing sentence, as provided under the Agreement, with respect to the manufacturing equipment referenced in Section 3.1.4 which is other than the [**] manufacturing line, Assignor shall make arrangements with a Third Party vendor reasonably acceptable to Assignee, to remove from Assignor's facilities, no earlier than July 12, 2010 and no later than July 23, 2010, and ship such equipment to Assignee's designated warehouse or delivery sites in [**] at the following addresses:
[**]
All right, title and interest in and to such equipment shall remain with Assignor until delivery by the Third Party vendor to such delivery sites, at which point all of Assignor's rights, title and interest in and to such equipment shall transfer to Assignee free and clear of any Encumbrances TO HAVE AND TO HOLD such equipment unto Assignee, its successors and assigns, FOREVER.  
3.Appointment.  Assignor hereby constitutes and appoints Assignee and its successors and assigns as its true and lawful attorney in fact in connection with the transactions contemplated by this instrument, with full power of substitution, in the name and stead of 

53

Assignor but on behalf of and for the benefit of Assignee and its successors and assigns, to demand and receive any and all of the assets, properties, rights and business hereby conveyed, assigned, and transferred or intended so to be, and to give receipt and releases for and in respect of the same and any part thereof, and from time to time to institute and prosecute, in the name of Assignor or otherwise, for the benefit of Assignee or its successors and assigns, proceedings at law, in equity, or otherwise, which Assignee or its successors or assigns reasonably deem proper in order to collect or reduce to possession or endorse any of the Transferred Assets and to do all acts and things in relation to the assets which Assignee or its successors or assigns reasonably deem desirable.

4.Governing Law.  This Bill of Sale shall be construed and enforced in accordance with the laws (other than the conflict of law rules) of the State of New York.
  
5.General.  In the event that any provision of this Bill of Sale be construed to conflict with a provision in the Agreement, the provision in the Agreement shall control.  This instrument shall be binding upon and shall inure to the benefit of the respective successors and assigns of Assignee and Assignor.  This Bill of Sale may be executed in one or more counterparts, each of which shall be deemed an original but all of which together will constitute one and the same instrument.

IN WITNESS WHEREOF, the undersigned has executed this instrument under seal of Assignee on the date first above written.

	
	
	ALZA CORPORATION, as Assignor

	 

	By:______________________________
        Name:
Title:

	
	
	INCLINE THERAPEUTICS, INC., as Assignee

	 

	By:______________________________
Name:
Title:

EXHIBIT B
FORM OF TRADEMARK ASSIGNMENT

This Trademark Assignment is made as of [CLOSING DATE], by and between [ALZA Corporation] [______], a [Delaware corporation] [_____], and Incline Therapeutics, Inc. a Delaware corporation (the “Assignee”).  
RECITALS
WHEREAS, pursuant to the License and Asset Transfer Agreement, dated as of [EXECUTION DATE], 2010, by and between [the Assignor] [ALZA Corporation] and the Assignee (the "Agreement"), the Assignor wishes to transfer to the Assignee, and the Assignee wishes to acquire from the Assignor, the Trademarks set forth on Schedule A hereto; and
WHEREAS, the Assignor has agreed to execute this Trademark Assignment at the Closing.
NOW, THEREFORE, in consideration of the foregoing premises and for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged by Assignee, the parties agree as follows:
1.Definitions. All capitalized terms not otherwise defined herein shall have the meaning ascribed to them in the Agreement.

2.Assignment of Rights in Trademarks.  The Assignor does hereby transfer and assign to the Assignee, and the Assignee hereby accepts the transfer and assignment of, all of the Assignor's right, title, and interest in and to the Trademarks, together with (i) the material relevant supporting documents, such as registration and renewal confirmations, if any; (ii) all the goodwill associated with the Trademarks; and (iii) all claims for damages by reason of past infringement of the Trademarks with the right to sue and collect for the same; the same to be held and enjoyed by the said Assignee, and its successors and assigns from and after the date hereof as fully and entirely as the same would have been held and enjoyed by the said Assignor had this Trademark Assignment not been made.

3.Governing Law.  Except to the extent that U.S. federal law preempts state law with respect to the matters covered hereby, this Trademark Assignment shall be governed by and construed in accordance with the laws of the State of New York without regard to any choice of law principle that would dictate the laws of another jurisdiction.

4.General.  This instrument shall be binding upon and shall inure to the benefit of the respective successors and assigns of Assignee and Assignor.  This Trademark Assignment may be executed in one or more counterparts, each of which shall be deemed an original but all of which together will constitute one and the same instrument.

[Signature Pages Follow]

IN WITNESS WHEREOF, the undersigned has caused its duly authorized officer to execute this Trademark Assignment as of the date first written above.            	
	
	[ALZA CORPORATION] [______], as Assignor

	 

	By:______________________________
Name:
Title:

[STATE]
COUNTY OF                 
This instrument was executed before me on this ___ day of ___________, 200_, by ____________________(name), the _____________________ (title) of ALZA Corporation, a Delaware corporation, on behalf of said corporation.
WITNESS my hand and official seal.
	
	
	_______________________________

	Notary Public in and for [STATE]

	 

	 

	_______________________________

	Printed or Typed Name of Notary

	 

	My Commission Expires ______________

IN WITNESS WHEREOF, the undersigned has caused its duly authorized officer to execute this Trademark Assignment as of the date first written above.    
                    
	
	
	INCLINE THERAPEUTICS, INC., as Assignee

	 

	By:______________________________
Name:
Title:

[STATE]
COUNTY OF                 
This instrument was executed before me on this ___ day of ___________, 200_, by ____________________(name), the _____________________ (title) of Incline Therapeutics Inc., a Delaware corporation, on behalf of said corporation.
WITNESS my hand and official seal.
	
	
	_______________________________

	Notary Public in and for [STATE]

	 

	 

	_______________________________

	Printed or Typed Name of Notary

	 

	My Commission Expires ______________

	 

Schedule A
Trademarks
[_____________]

        

EXHIBIT C
FORM OF DOMAIN NAME ASSIGNMENT

This Domain Name Assignment is made as of [CLOSING DATE], 2010 by and between [ALZA Corporation] [______], a [Delaware corporation] [_____] (“Assignor”), and Incline Therapeutics, Inc., a Delaware corporation (“Assignee”).

WHEREAS, pursuant to the License and Asset Transfer Agreement, dated as of [EXECUTION DATE], 2010, by and between the Assignee and [Assignor] [ALZA Corporation] (the “Agreement”), the Assignor wishes to transfer and assign to the Assignee, and the Assignee wishes to acquire from the Assignor, the Domain Names set forth on Schedule A hereto; and

WHEREAS, the Assignor has agreed to execute this Domain Name Assignment (the “Assignment”) at the Closing.

NOW, THEREFORE, in consideration of the foregoing premises and for good and valuable consideration, the receipt and sufficiency of which is hereby acknowledged by Assignee, the parties agree as follows:

1.Definitions.  All capitalized terms not otherwise defined herein shall have the meaning ascribed to them in the Agreement.

2.Assignment of Rights in Domain Names.  Assignor hereby transfers and assigns all of the Assignor's right, title and interest to the Domain Names to Assignee.

3.Further Assurances. For a period of two (2) years following the Closing, Assignor shall execute and deliver to Assignee such documents and take such actions as requested by Assignee to register, evidence or perfect Assignee's rights under this Agreement. Without limiting the above, with respect to the Domain Names, Assignor shall on request of Assignee, (i) in the presence of a notary public, sign and complete any documentation required by the [Registrar] to change the name of the registrant of the Domain Names from the Assignor to the Assignee; (ii) have a notary public notarize such document(s) as designated therein, and (iii) send Assignee original executed copies of such agreement(s) via overnight courier.

4.Governing Law.  This Domain Name Assignment shall be governed by and construed in accordance with the laws of the State of New York without regard to any choice of law principle that would dictate the laws of another jurisdiction.

5.General.  This instrument shall be binding upon and shall inure to the benefit of the respective successors and assigns of Assignee and Assignor.  This Domain Name Assignment may be executed in one or more counterparts, each of which shall be deemed an original but all of which together will constitute one and the same instrument.  

IN WITNESS WHEREOF, the undersigned has caused its duly authorized officer to execute this Domain Name Assignment as of the date first written above.
                    
	
	
	[ALZA CORPORATION] [_______], as Assignor

	 

	By:______________________________
Name:
Title:

	
	
	INCLINE THERAPEUTICS, INC., as Assignee

	 

	By:______________________________
Name:
Title:

Schedule A
Domain Names
[_____________]

EXHIBIT D
FORM OF NDA AND IND ASSIGNMENTS
[Incline Letterhead]

	
		
	 
	[Effective Date, 2010]

	Bob A. Rappaport, MD
Director
Food and Drug Administration 
Center for Drug Evaluation and Research
Division of Anesthesia and Analgesia Products
5901-B Ammendale Road
Beltsville, MD 20705-1266
	IND 41,574 Serial No.: 
E-TRANS® (fentanyl HCl) System

General Correspondence
Transfer of IND Ownership

Dear Dr. Rappaport,

Effective with the date of this letter, Incline Therapeutics, Inc. accepts sponsorship and responsibility, as outlined in 21 CFR 312 for Investigational New Drug Application (IND) 41,574 for E-TRANS® (fentanyl HCl) System. A copy of the transfer letter from Johnson & Johnson Pharmaceutical Research & Development, L.L.C (J&JPRD) on behalf of ALZA Corporation is included for reference.

All future correspondence relating to the IND should be directed to:

[_____________]
Incline Therapeutics, Inc. 
601 Union, Two Union Square, Suite 3200
Seattle, WA 98101
Phone:  [_____________]
Facsimile:  206-621-1848

Incline Therapeutics Inc. has received a complete copy of the IND, including amendments and all official correspondence to date from J&JPRD.

Incline Therapeutics will adhere to all appropriate regulations (including 21 CFR 312.33) to submit timely updates to the IND including pharmacovigilance reporting  and IND annual reports.

All future submissions to the IND will be in paper format.  Under separate cover, Incline will request a waiver for the eCTD format.

If you have any questions or require any additional information, please do not hesitate to contact [INCLINE CONTACT] at [INCLINE CONTACT PHONE].

Sincerely, 

Incline Therapeutics Inc.

Name:____________________

Title: _____________________

[Incline Letterhead]

	
		
	 
	[Effective Date, 2010]

	Bob A. Rappaport, MD
Director
Food and Drug Administration 
Center for Drug Evaluation and Research
Division of Anesthesia and Analgesia Products
5901-B Ammendale Road
Beltsville, MD 20705-1266
	NDA 21-388:
IONSYSTM (fentanyl iontophoretic transdermal system)

General Correspondence
Transfer of NDA Ownership

Dear Dr. Rappaport,

In accordance with the provisions of 21 CFR § 314.72, we are notifying you of acceptance of a transfer in ownership of the New Drug Application (NDA) 21-388 for IONSYSTM  (fentanyl iontophoretic transdermal system). Effective as of the close of business on [EFFECTIVE DATE], 2010, ownership of, and all rights to, the NDA have been transferred from ALZA Corporation to Incline Therapeutics, Inc. Incline Therapeutics, Inc. commits to all agreement, promises and conditions made by the former owner and contained in the NDA. A copy of the transfer letter from Johnson & Johnson Pharmaceutical Research & Development, L.L.C (J&JPRD) on behalf of ALZA Corporation is included for reference.

All future correspondence relating to the NDA should be directed to:

[_____________]
Incline Therapeutics, Inc. 
601 Union, Two Union Square, Suite 3200
Seattle, WA 98101
Phone:  [_____________]
Facsimile:  206-621-1848

Incline Therapeutics has been provided a complete copy of the NDA including all supplements, safety reports, annual reports and correspondence pertaining thereto.

Incline Therapeutics will adhere to all appropriate regulations (including 21 CFR 314.70 and 314.72) to submit timely updates and changes to the NDA including pharmacovigilance reporting, annual reports and changes to the labeling and branding, as appropriate.  

All future submissions to the NDA will be in paper format.  Under separate cover, Incline will request a waiver for the eCTD format.

If you have any questions or require any additional information, please do not hesitate to contact [INCLINE CONTACT] at [INCLINE CONTACT PHONE].

Sincerely, 

Incline Therapeutics Inc.

Name:____________________

Title: _____________________

	
				
	 

	

	 

	 
	[Effective Date, 2010]
	 

	Bob A. Rappaport, MD
Director
Food and Drug Administration 
Center for Drug Evaluation and Research
Division of Anesthesia and Analgesia Products
5901-B Ammendale Road
Beltsville, MD 20705-1266
	IND 41,574 Serial No.: 
E-TRANS® (fentanyl HCl) System

General Correspondence
Transfer of IND Ownership
	 

Dear Dr. Rappaport:

Reference is made to Investigational New Drug Application (IND) 41,574 for E-TRANS® (fentanyl HCl) System. Effective as of the date of this letter, Johnson & Johnson Pharmaceutical Research & Development, L.L.C (J&JPRD) on behalf of ALZA Corporation, is transferring ownership of the above-cited IND to Incline Therapeutics, Inc. As of that date Incline Therapeutics Inc. will assume all responsibilities related to the IND and the development of E-TRANS System. Incline Therapeutics has been provided a complete copy of the IND and all amendments, safety reports, annual reports and correspondence pertaining thereto.

All future correspondence relating to the IND should be directed to:

[_____________]
Incline Therapeutics, Inc. 
601 Union, Two Union Square, Suite 3200
Seattle, WA 98101
Phone:  [_____________]
Facsimile:  206-621-1848

Incline Therapeutics will submit a letter of acknowledgement and acceptance of responsibility for the IND. Incline Therapeutics will also state that they have received a complete copy of the IND.

This submission is being provided in electronic format. J&JPRD utilizes either McAfee VirusScan Enterprise or Microsoft ForeFront Client Security to ensure that this submission is free of computer viruses and spyware. J&JPRD authorizes the CDER to use similar software as appropriate.

Should you have any questions and/or comments, please contact me directly at (908) 704-4756. 

Sincerely,
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Michael H. Kaufman
Director, Regulatory Affairs

 

	
					
	 
	[Effective Date, 2010]
	 

	Bob A. Rappaport, MD
Director
Food and Drug Administration 
Center for Drug Evaluation and Research
Division of Anesthesia and Analgesia Products
5901-B Ammendale Road
Beltsville, MD 20705-1266
	NDA 21-388:
IONSYSTM (fentanyl iontophoretic transdermal system)

General Correspondence
Transfer of NDA Ownership
	 

Dear Dr. Rappaport:

Reference is made to New Drug Application (NDA) 21-388 for IONSYSTM (fentanyl iontophoretic transdermal system). In accordance with 21 CFR §314.72 we herewith notify the Agency that effective as of the date of this letter, Johnson & Johnson Pharmaceutical Research & Development, L.L.C (J&JPRD) on behalf of ALZA Corporation, is transferring ownership of, and all rights to, the above-cited NDA to Incline Therapeutics, Inc. Incline Therapeutics has been provided a complete copy of the NDA including all supplements, safety reports, annual reports and correspondence pertaining thereto.

All future correspondence relating to the NDA should be directed to:

[_____________]
Incline Therapeutics, Inc. 
601 Union, Two Union Square, Suite 3200
Seattle, WA 98101
Phone:  [_____________]
Facsimile:  206-621-1848

Incline Therapeutics will submit a letter of acknowledgement and acceptance of responsibility for the NDA. Incline Therapeutics will also state that they have received a complete copy of the NDA.

This submission is being provided in electronic format. J&JPRD utilizes either McAfee VirusScan Enterprise or Microsoft ForeFront Client Security to ensure that this submission is free of computer viruses and spyware. J&JPRD authorizes the CDER to use similar software as appropriate.

Should you have any questions and/or comments, please contact me directly at (908) 704-4756. 

Sincerely,
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Michael H. Kaufman
Director, Regulatory Affairs

EXHIBIT E
FORM OF PRESS RELEASE
Incline Therapeutics Announces Acquisition of IONSYSTM and $43 Million Series A Financing

REDWOOD CITY, CA - June [Day], 2010 - Incline Therapeutics, Inc., a privately-held, hospital-focused specialty pharmaceutical company, announced today that it has entered into an agreement to acquire the rights to IONSYSTM (fentanyl iontophoretic transdermal system) from ALZA Corporation and completed a $43 million Series A financing.

IONSYSTM Acquisition

Under the terms of the agreement, Incline will receive an exclusive, worldwide license to IONSYS and will acquire certain other assets related to IONSYS.

IONSYSTM (fentanyl iontophoretic transdermal system) is an investigational product candidate intended to provide patient-controlled analgesia for adult inpatients requiring opioids following surgery.  IONSYS is a compact, needle-free, self-contained, pre-programmed system designed to be applied to the skin on the upper arm or chest and activated by patients double clicking a button on the system.  A generally imperceptible electrical current then actively delivers a small dose of the short-acting opioid analgesic fentanyl directly through the skin and into the systemic circulation.  

IONSYS was approved by both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) in 2006; however, IONSYS is not currently marketed anywhere in the world.  Before marketing IONSYS, regulatory approval must be sought from both the FDA and EMA for new patient safety features being developed into the system.  Additionally, FDA approval will require an acceptable Risk Evaluation and Mitigation Strategy (REMS) to manage risks associated with fentanyl contained in IONSYS, which is subject to potential abuse and misuse.
 
“We believe IONSYS is an exceptional asset around which to form Incline Therapeutics,” said Alan Levy, Ph.D., Chief Executive Officer and Director of Incline.  “We look forward to building upon the product to accelerate the development of IONSYS toward potential approval and launch.”

Series A Financing

The $43 million Series A equity financing was led by Frazier Healthcare Ventures.  The venture syndicate also includes 5AM Ventures, Technology Partners, Adams Street Partners, Saints Capital Partners, and Emergent Medical Partners.  In connection with the financing, James Topper, M.D., Ph.D., General Partner of Frazier Healthcare Ventures, James Young, Ph.D., Venture Partner of 5AM Ventures, Jim Glasheen, Ph.D., General Partner of Technology Partners, and Terry Gould, Partner and Head of Direct Investments of Adams Street Partners, have joined the Incline board of directors.  

“Incline represents a unique investment opportunity around a late-stage product candidate with seven completed Phase III clinical trials, prior regulatory approvals, and substantial manufacturing capacity,” said Dr. Topper of Frazier Healthcare Ventures.  “Further, we are pleased to join such an experienced management team, several of whom we have worked closely with in previous ventures.”

Cadence Option Agreement

Separately, Cadence Pharmaceuticals, Inc. announced today that Incline has granted Cadence an option to acquire the company.  In connection with the transaction, Ted Schroeder, President and CEO of Cadence, has been appointed as Cadence's representative on the Incline board of directors.

About Inpatient Post-Operative Pain Management
More than 20 million inpatient surgical procedures requiring pain management are estimated to occur in the United States each year.  Current treatment methods include bolus injections, regional nerve blockade, epidural infusions, and intravenous patient-controlled analgesia (IV PCA).  IV PCA systems are controlled infusions pumps that deliver a prescribed amount of an intravenous opioid when a patient activates a button connected to the pump.  Although it is estimated that approximately 50% of patients receive IV PCA after surgery, IV PCA has been associated with programming, medication, and pump errors, IV line infections, needlestick injuries, and limited patient mobility.

About Incline Therapeutics, Inc.
Incline Therapeutics is a hospital-focused specialty pharmaceutical company focused on the development of IONSYS (fentanyl iontophoretic transdermal system).  Incline is financed by leading life science venture capital firms and led by a management team with significant pharmaceutical and medical device industry experience.  The company is based in Redwood City, California.

InclineTM is a trademark of Incline Therapeutics, Inc.  
CadenceTM is a trademark of Cadence Pharmaceuticals, Inc.

# # #

Contact:     David Socks
President and Chief Operating Officer
Incline Therapeutics, Inc.     
Phone: 858-436-1414        
        

Schedule 1.4

ALZA Third Party Licenses

Confidential treatment omitted and filed separately with the Securities and Exchange Commission. A total of one page was omitted. 
[**].

Schedule 1.18

Fentanyl Analogs

Confidential treatment omitted and filed separately with the Securities and Exchange Commission. A total of two pages were omitted. 
[**].

Schedule 1.28
Licensed Know-How

The following invention records with respect to the ALZA Product, in each case only to the extent available and applicable.  It is expressly understood by Incline that ALZA makes no representation that the invention records provided to Incline are comprehensive or complete individually or in aggregate.  Incline agrees and acknowledges that ALZA shall be obligated to provide to Incline only those records which ALZA has identified as of the Closing Date as contained within its storage sites and pertaining to the items listed below.

Confidential treatment omitted and filed separately with the Securities and Exchange Commission. A total of one page was omitted. 
[**].

Schedule 1.29
Licensed Patents
Patents

	
						
	Country
	Filing Date
	Filing No.
	Grant Date
	Grant No.
	Short Title

Confidential Materials omitted and filed separately with the Securities and Exchange Commission. A total of 29 pages were omitted.
[**]

    

Schedule 1.44
Product Domain Names

	
				
	Domain Name
	Registry
	Registration Date
	Expiration Date

 
Confidential treatment omitted and filed separately with the Securities and Exchange Commission. A total of three pages were omitted. 
[**].

Schedule 1.45
Product Trademarks

Confidential treatment omitted and filed separately with the Securities and Exchange Commission. A total of ten pages were omitted. 
[**].

Schedule 3.1.2(a)

Clinical Trial Data

The following Clinical Trial Data with respect to the ALZA Product, in each case only to the extent available and applicable.  It is expressly understood by Incline that ALZA makes no representation that the Clinical Trial Data is comprehensive or complete individually or in aggregate.  Incline agrees and acknowledges that ALZA shall be obligated to provide to Incline only those records and documents which ALZA has identified as of the Closing Date as contained within its storage sites and pertaining to the items listed below.

Confidential treatment omitted and filed separately with the Securities and Exchange Commission. A total of two pages were omitted. 
[**].

Schedule 3.1.2(b) and 3.1.2(c)

Manufacturing Data and Other Test Data

The following Manufacturing and Other Test Data with respect to the ALZA Product, in each case only to the extent available and applicable.  It is expressly understood by Incline that ALZA makes no representation that the Manufacturing Data and Other Test Data is comprehensive or complete, individually or in aggregate.  Incline agrees and acknowledges that ALZA shall be obligated to provide to Incline only those records and documents which ALZA has identified as of the Closing Date as contained within its storage sites and pertaining to the items listed below.

Confidential treatment omitted and filed separately with the Securities and Exchange Commission. A total of one page was omitted. 
[**].

Schedule 3.1.4

Manufacturing Equipment

Confidential treatment omitted and filed separately with the Securities and Exchange Commission. A total of one page was omitted. 
[**].

Schedule 3.1.5

Other Tangible Items

The following Other Tangible Items to the extent available and applicable.  It is expressly understood by Incline that ALZA makes no representation that the Other Tangible Items are available or functional.

Confidential treatment omitted and filed separately with the Securities and Exchange Commission. A total of one page was omitted. 
[**].

Schedule 3.1.6

Market Research Materials

The following Market Research Materials with respect to the ALZA Product, in each case only to the extent available and applicable.  It is expressly understood by Incline that ALZA makes no representation that the Market Research Materials are comprehensive or complete, individually or in aggregate.  Incline agrees and acknowledges that ALZA shall be obligated to provide to Incline only those records and documents which ALZA has identified as of the Closing Date as contained within its storage sites and pertaining to the items listed below.

Confidential treatment omitted and filed separately with the Securities and Exchange Commission. A total of one page was omitted. 
[**].

Schedule 3.1.7

Governmental Filings and Authorizations

[**]

The following Governmental Filings and Authorizations and related materials with respect to the ALZA Product IND, NDA and MAA, in each case only to the extent available and applicable.  It is expressly understood by Incline that ALZA makes no representation that the Governmental Filings and Authorizations documentation is comprehensive or complete, individually or in aggregate.  Incline agrees and acknowledges that ALZA shall be obligated to provide to Incline only those records and documents which ALZA has identified as of the Closing Date as contained within its storage sites and pertaining to the items listed below.

Confidential treatment omitted and filed separately with the Securities and Exchange Commission. A total of one page was omitted. 
[**].

Schedule 4.5

Third Party Confidentiality Obligations 

Confidential treatment omitted and filed separately with the Securities and Exchange Commission. A total of two pages were omitted. 
[**].

Schedule 4.7.3

NDA and MAA Maintenance Reimbursements

		
	•
	€[**] for MAA Annual Maintenance Fees paid in 2010.

Schedule 4.8

Purchase Price Allocation

Machinery & Equipment            $[**]

Patents, Trademarks and Other   
		
	 Intangible Property
	Any milestone and royalty payments made pursuant to Article 5 of this Agreement.

Schedule 4.11.5

ALZA Employees Not Subject to Non-Solicit

[**]

Schedule 8.2

ALZA Employees

[**]MDCO EX 10.2 03.31.2013

	
					
	 
	 
	 
	 
	Exhibit 10.2

	 
	Confidential Materials omitted and filed separately with the
Securities and Exchange Commission.  Asterisks denote omissions.
	 

	 
	 
	 
	 
	 

Execution Version

LICENSE AND COLLABORATION AGREEMENT
by and between
ALNYLAM PHARMACEUTICALS, INC.
and
THE MEDICINES COMPANY

LICENSE AND COLLABORATION AGREEMENT

THIS LICENSE AND COLLABORATION AGREEMENT (this “Agreement”), effective as of February 3, 2013 (the “Effective Date”), by and between Alnylam Pharmaceuticals, Inc., a corporation organized and existing under the laws of the State of Delaware (“Alnylam”) and, The Medicines Company, a corporation organized and existing under the laws of Delaware (“MedCo”).
RECITALS: 
WHEREAS, Alnylam owns or controls certain fundamental intellectual property relating to RNA interference, and is developing proprietary therapeutic products in the Field Targeting the human PCSK9 gene, including ALN-PCS02 and ALN-PCSsc (all as defined below); 
WHEREAS, MedCo desires to develop and commercialize such products in the Territory (as defined below);
WHEREAS, Alnylam desires to collaborate with MedCo in the further development of such products in the Territory as set forth herein; and
 WHEREAS, Alnylam and MedCo believe that a license and collaboration for such purpose on the terms and conditions of this Agreement would be desirable.
NOW, THEREFORE, in consideration of the foregoing premises and the mutual covenants herein contained, the Parties hereby agree as follows:
1.DEFINITIONS

Unless specifically set forth to the contrary herein, the following terms, whether used in the singular or plural, shall have the respective meanings set forth below:
		
	1.1
	[Intentionally Omitted]. 

1.2“Acquired Party” has the meaning set forth in Section 6.7.

1.3“Acquirer” has the meaning set forth in Section 6.7.

1.4“Additional Alnylam In-Licenses” means the agreements set forth in Section C of  Schedule D.

1.5“Affiliate” means, with respect to a Person, any other Person which controls, is controlled by, or is under common control with the applicable Person.  For purposes of this definition, “control” shall mean: (a) in the case of corporate entities, direct or indirect ownership of at least fifty percent (50%) of the stock or shares (or such lesser percentage which is the maximum allowed to be owned by a foreign corporation in a particular jurisdiction) entitled to vote for the election of directors, or otherwise having the power to control or direct the affairs of such Person; and (b) in the case of non-corporate entities, direct or indirect ownership of at least fifty percent (50%) of the equity interest or the power to direct the management and policies of such non-corporate entities.  

2

1.6“ALN-PCS02” means the siRNA Product Controlled by Alnylam comprising the siRNA [**]) formulated in a lipid-based nanoparticle, as further described on Schedule A.  

1.7“ALN-PCSsc” means an siRNA Product Controlled by Alnylam comprising an siRNA conjugated with a triantennary Ga1NAc molecule, as further described on Schedule B.

1.8“Alnylam Collaboration IP” means (a) any improvement, discovery or Know-How, patentable or otherwise, first conceived or reduced to practice or, with respect to inventions and discoveries other than patentable inventions, otherwise identified, discovered, made or developed, solely by individuals who are employees, agents or consultants of Alnylam or its Affiliates and Controlled by Alnylam at any time during the Term, in each case in the conduct of the Collaboration, and (b) any Patent Rights which claim such improvements, discoveries or Know-How.  Alnylam Collaboration IP excludes Alnylam's interest in Joint Collaboration IP.  Patent Rights constituting Alnylam Collaboration IP are either Alnylam Core Technology Patent Rights or Alnylam Product-Specific Patent Rights, as the case may be.

1.9“Alnylam Core Technology Patent Rights” means Patent Rights Controlled by Alnylam at any time during the Term that are reasonably necessary or useful to Develop, Manufacture or Commercialize Licensed Products, in each case other than Alnylam Product-Specific Patent Rights and Patent Rights comprising Joint Collaboration IP.  Alnylam Core Technology Patent Rights includes the Patent Rights set forth on Schedule C-1 and may include Patent Rights that constitute Alnylam Collaboration IP.

1.10“Alnylam Indemnitees” has the meaning set forth in Section 10.1.

1.11“Alnylam In-Licenses” means (a) the Existing Alnylam In-Licenses and (b) any agreement between Alnylam (or its Affiliates) and a Third Party entered into after the Effective Date pursuant to which Alnylam acquires Control of Know-How or Patent Rights that are reasonably necessary or useful to Develop, Manufacture or Commercialize Licensed Products in the Field in the Territory, but in the case of any such agreement described in clause (b), solely to the extent that such agreement is designated as an Alnylam In-License pursuant to Section 6.4.2.2.

1.12“Alnylam Know-How” means Know-How Controlled by Alnylam at any time during the Term that is reasonably necessary or useful to Develop, Manufacture and/or Commercialize Licensed Products in the Field in the Territory.  

1.13“Alnylam Patent Rights” means Alnylam Core Technology Patent Rights and Alnylam Product-Specific Patent Rights.

1.14“Alnylam Product-Specific Patent Rights” means Patent Rights Controlled by Alnylam at any time during the Term that solely claim (a) an siRNA Targeting the human PCSK9 gene contained in a Licensed Product, and pharmaceutical compositions thereof; (b) an siRNA Product or specific components thereof to the extent that such components are unique to said siRNA Products; (c) methods of using the compositions described in clause (a) or (b) above as a human therapeutic or prophylactic, or to Target the human PCSK9 gene, or to inhibit expression of human PCSK9, and foreign equivalents of such method claims; (d) methods and compositions directed to the synthesis or analysis of the compositions described in clause (a) or (b); or (e) Alnylam Collaboration IP that is applicable solely to a Licensed Product; provided, however, that (y) any such patents that include claims that are directed to subject matter applicable to siRNA or siRNA delivery in general will not be considered Alnylam Product-Specific Patent Rights but will be considered Alnylam Core Technology Patent Rights.  Alnylam Product-Specific Patent Rights 

3

excludes Joint Collaboration IP, includes the Patent Rights set forth on Schedule C-2 and may include Patent Rights that constitute Alnylam Collaboration IP. 

1.15“Alnylam Technology” means, collectively, Alnylam Know-How, Alnylam Patent Rights, Alnylam Collaboration IP and Alnylam's interest in Joint Collaboration IP. 

1.16“Bankrupt Party” has the meaning set forth in Section 6.5.

1.17“Breaching Party” has the meaning set forth in Section 12.2.2.

1.18“Bulk Drug Product” means formulated Bulk Drug Substance in bulk form prior to filling and finishing.

1.19“Bulk Drug Substance” means an siRNA (including chemical modifications and covalent conjugates) or other active ingredient in bulk form manufactured for use as an active pharmaceutical ingredient in a Licensed Product.

1.20“Business Day” means a day on which banking institutions in Boston, Massachusetts, USA and Parsippany, New Jersey, USA are open for business, excluding any Saturday or Sunday.
  
1.21“Calendar Quarter” means the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31 of each Calendar Year; provided, that (a) the first Calendar Quarter of the Term shall begin on the Effective Date and end on the first to occur of March 31, June 30, September 30 or December 31 thereafter and the last Calendar Quarter of the Term shall end on the last day of the Term, and (b) the first Calendar Quarter of a Royalty Term for a Licensed Product in a country shall begin on the First Commercial Sale of such Licensed Product in such country and end on the first to occur of March 31, June 30, September 30 or December 31 thereafter and the last Calendar Quarter of a Royalty Term shall end on the last day of such Royalty Term.

1.22“Calendar Year” means each successive period of twelve (12) months commencing on January 1 and ending on December 31; provided, that (a) the first Calendar Year of the Term shall begin on the Effective Date and end on the first December 31 thereafter and the last Calendar Year of the Term shall end on the last day of the Term, and (b) the first Calendar Year of a Royalty Term for a Licensed Product in a country shall begin on the First Commercial Sale of such Licensed Product in such country and end on the first December 31 thereafter and the last Calendar Year of the Term shall end on the last day of such Royalty Term.

1.23“Challenge” has the meaning set forth in Section 12.2.4.

1.24“Challenging Party” has the meaning set forth in Section 12.2.4.

1.25“Change of Control” means, with respect to a Party, any of the following:  (a) the sale or disposition of all or substantially all of the assets of such Party or its direct or indirect controlling Affiliate to a Third Party, other than to an entity of which more than fifty percent (50%) of the voting capital stock are owned after such sale or disposition by shareholders of such Party or its direct or indirect controlling Affiliate (in either case, whether directly or indirectly through any parent entity); or (b) (i) the acquisition by a Third Party, alone or together with any of its Affiliates, other than an employee benefit plan (or related trust) sponsored or maintained by such Party or any of its Affiliates, of more than fifty percent (50%) of the outstanding shares of voting capital stock of such Party or its direct or indirect controlling Affiliate, or 

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(ii) the acquisition, merger or consolidation of such Party or its direct or indirect controlling Affiliate with or into another Person, other than, in the case of this clause (b), an acquisition or a merger or consolidation of such Person or its controlling Affiliate in which the holders of shares of voting capital stock of such Person or its controlling Affiliate, as the case may be, immediately prior to such acquisition, merger or consolidation will beneficially own, directly or indirectly, at least fifty percent (50%) of the shares of voting capital stock of the acquiring Third Party or the surviving corporation in such acquisition, merger or consolidation, as the case may be, immediately after such acquisition, merger or consolidation.

1.26“Clinical Study” means a Phase I Study, Phase II Study, Phase III Study, or Pivotal Study, as applicable; but excluding any Post-Approval Studies.

1.27“Collaboration” means the activities of the Parties in the Development and Manufacture of Licensed Products under this Agreement and/or the Development Supply Agreement.

1.28“Combination Product” has the meaning set forth in Section 1.89.

1.29“[**]” has the meaning set forth in Section 7.4.4.

1.30“[**]” has the meaning set forth in Section 7.4.4. 

1.31“Commercialization” or “Commercialize” means any and all activities directed to marketing, promoting, distributing, importing, exporting, offering to sell and/or selling a product, including the conduct of Post-Approval Studies, and activities directed to obtaining pricing and reimbursement approvals, as applicable.

1.32“Commercially Reasonable Efforts” means (a) with respect to the obligations of a Party under this Agreement that relate to the Development, Manufacture or Commercialization of a Licensed Product, the carrying out of such obligations in a diligent, expeditious and sustained manner using efforts and resources, including reasonably necessary personnel and financial resources, that biopharmaceutical companies of comparable size to, and comparable resources of, such Party typically devote to their own products of similar market potential at a similar stage in development or product life, taking into account the following factors to the extent reasonable and relevant:  issues of safety and efficacy, product profile, competitiveness of such Licensed Product and alternative Third Party products (but not alternative products Controlled by the Party to which the efforts obligation applies which are not Licensed Products) in the marketplace, the patent or other proprietary position of such Licensed Product, the regulatory structure involved and the potential profitability of such Licensed Product marketed or to be marketed, but excluding from consideration any financial considerations of MedCo to Alnylam under this Agreement; provided, however, that  to the extent the obligations of MedCo under this Agreement relate to the Development, Manufacture or Commercialization of a Licensed Product for China, such efforts and resources shall instead be those that MedCo typically devotes to its own products of similar market potential at a similar stage in development or product life, taking into account the factors set forth above; and (b) with respect to other obligations under this Agreement, the carrying out of such obligations in a diligent, expeditious and sustained manner using efforts and resources, including reasonably necessary personnel and financial resources, that biopharmaceutical companies of comparable size and resources typically devote to similar obligations.

1.33“Competitive Infringement” has the meaning set forth in Section 11.4.1. 

1.34“Confidential Information” means with respect to a Party but subject to Section 8.1(a)(i)-(iv), any and all confidential or proprietary information and data, including (with respect to Alnylam as the 

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disclosing Party) Alnylam Technology, (with respect to MedCo as the disclosing Party) MedCo Technology, and all other scientific, pre-clinical, clinical, regulatory, manufacturing, marketing, financial and commercial information or data, whether communicated in writing or orally or by any other method, which is provided by one Party to the other Party in connection with this Agreement.  Alnylam Technology is Confidential Information of Alnylam.  MedCo Technology is Confidential Information of MedCo.  Joint Collaboration IP is the Confidential Information of both Parties, with each Party being considered both the disclosing Party and the receiving Party.  

1.35“Control”, “Controls” or “Controlled by” means, with respect to any Know-How, Patent Right or other intellectual property right and a Party, the ability of such Party or its Affiliates (whether by ownership or license, other than pursuant to a license granted under this Agreement) to assign, transfer, or grant access to, or a license or sublicense of, such item or right as provided for herein without violating the terms of any agreement or other arrangement with any Third Party; provided that, with respect to rights to any Third Party Know-How, Patent Rights or other intellectual property right that are licensed to, or otherwise obtained by, (i) a Party or its Affiliates pursuant to an agreement entered into by such Party or any of its Affiliates after the Effective Date or (ii) Alnylam or its Affiliates pursuant to any Additional Alnylam In-License, such Third Party Know-How, Patent Rights or other intellectual property right shall be deemed not to be under the Control of such Party or its Affiliates, or Alnylam or its Affiliates, respectively, unless and until the agreement pursuant to which such rights are obtained becomes an In-License pursuant to Section 6.4.2.

1.36“Costs” means (a) with respect to the Development, (i) the direct and documented out-of-pocket costs and expenses incurred by a Party or its Affiliates in conducting activities under the Transaction Agreements, and (ii) FTE Costs of internal personnel that are attributable or reasonably allocable to such activities, in each case as determined in accordance with GAAP, and (b) with respect to the supply of Licensed Product by Alnylam pursuant to Sections 5.1(a)(i) and (ii), the reasonable internal and external costs of Alnylam incurred in Manufacturing or having Manufactured such Licensed Product (i) to the extent that such Licensed Product is Manufactured by Alnylam, the fully allocated cost of Manufacture of such Licensed Product, consisting of direct material and direct labor costs, plus Manufacturing overhead attributable to such Licensed Product (including facilities start-up costs, all directly incurred Manufacturing variances and a reasonable allocation of related Manufacturing administrative and facilities costs for such Licensed Product, but excluding corporate administrative overhead and/or costs associated with excess capacity), all calculated strictly in accordance with GAAP consistently applied by Alnylam, and (ii) to the extent that such Licensed Product is Manufactured by a Third Party manufacturer, the actual fees paid by Alnylam to the Third Party for the Manufacture, supply and packaging of such Licensed Product and any reasonable costs, including direct labor costs, actually incurred by Alnylam in managing or overseeing the Third Party relationship.

1.37“Cover,” “Covering” or “Covers” means, as to a product and Patent Rights, that, in the absence of a license granted under, or ownership of, such Patent Rights, the research, development, manufacture, use, offer for sale, sale, or importation of such product would infringe such Patent Rights or, as to a pending claim included in such Patent Rights, the research, development, manufacture, use, offer for sale, sale, or importation of such product would infringe such Patent Rights if such pending claim were to issue in an issued patent.

1.38 “Development,” “Developing” or “Develop” means the research and development of Licensed Products, including activities related to the generation, characterization, optimization, construction, expression, use and production of Licensed Products, any other research and development activities related to the testing and qualification of Licensed Products, including toxicology studies, 

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statistical analysis and report writing, pre-clinical testing, Clinical Studies and regulatory affairs, product approval and registration activities, but excluding Post-Approval Studies.  

1.39“Development Costs Cap” has the meaning set forth in Section 2.3.1.

1.40“Development Supply Agreement” has the meaning set forth in Section 5.1.

1.41“Dispute” has the meaning set forth in Section 13.12.

1.42“Effective Date” has the meaning set forth in the preamble.

1.43“EMA” means the European Medicines Agency and any successor governmental authority having substantially the same function.
 
1.44“EU” means the European Union, as its membership may be altered from time to time, and any successor thereto.  

1.45“[**]” has the meaning set forth in Section 7.4.4.

1.46[Intentionally Omitted]. 

1.47“Existing Alnylam In-Licenses” means (a) the Third Party agreements identified as such in Section A of Schedule D and (b) any Additional Alnylam In-License included within the definition of Existing Alnylam In-Licenses pursuant to Section 6.4.2.3. 
 
1.48“Existing Alnylam Third Party Agreements” means the Third Party agreements identified as such in Section B of Schedule D.

1.49“Extra Early Development Costs” has the meaning set forth in Section 2.3.1.

1.50“FDA” means the United States Food and Drug Administration and any successor governmental authority having substantially the same function.

1.51“Field” means the treatment, palliation and/or prevention of all human diseases. 
 
1.52“Finished Product” means the finished product formulation of a Licensed Product, containing Bulk Drug Product, filled into unit packages (but excluding, in the case of supply by Alnylam or its Affiliates, any automated delivery device such as an “autoinjector”) for final labeling and packaging.

1.53“First Commercial Sale” means, with respect to a Licensed Product in a country, the first sale by MedCo or its Related Parties for end use or consumption of such Licensed Product in such country after all Regulatory Approvals legally required for such sale have been granted by the Regulatory Authority of such country.   

1.54“FTE” means [**] hours of work devoted to or in support of the Development or Manufacture of a Licensed Product, that is carried out by one or more qualified scientific or technical employees or contract personnel of a Party or its Affiliates.  

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1.55“FTE Cost” means, for any period, the FTE Rate multiplied by the number of FTEs in such period; provided, however, that for purposes of such calculation, no individual may account for more than one FTE in any Calendar Year.  

1.56“FTE Rate” means [**] U.S. Dollars ($[**]) per FTE, increased annually beginning on January 1, 2014 and thereafter on January 1 of each succeeding year by the percentage increase in the CPI as of December 31 of the then most recently ended calendar year over the level of the CPI on December 31, 2012.  As used in this definition, “CPI” shall mean the Consumer Price Index - Urban Wage Earners and Clerical Workers, U.S. City Average, All Items, 1982-84 = 100, published by the United States Department of Labor, Bureau of Labor Statistics (or its successor equivalent index) in the United States. 

1.57“GAAP” means generally accepted accounting principles as practiced in the United States or, to the extent applicable, IFRS (International Financial Reporting Standards).

1.58“Generic Competition” has the meaning set forth in Section 7.4.3.

1.59“Generic Product” means, with respect to a Licensed Product in a country, another pharmaceutical product that (a) is sold by a Third Party other than a Related Party of MedCo under license from Medco in such country, (b) is authorized for use in such country in one or more of the indications for which such Licensed Product has Regulatory Approval in such country, (c) contains the same active ingredient(s) as such Licensed Product or a bioequivalent thereof, and (d) was approved for sale in such country by reference to the same or a subset of the same information that was used for obtaining the Regulatory Approval for such Licensed Product in such country without such Third Party being granted a license to such information by MedCo or its Related Parties.

1.60“Governmental Authority” means any applicable government authority, court, tribunal, arbitrator, agency, legislative body, commission or other instrumentality of (a) any government of any country or territory, (b) any state, province, county, city or other political subdivision thereof or (c) any supranational body.

1.61 “IND” means an Investigational New Drug application, Clinical Trial Application or similar application or submission for approval to conduct human clinical investigations filed with or submitted to a Regulatory Authority in conformance with the requirements of such Regulatory Authority.

1.62“Indemnitee” has the meaning set forth in Section 10.3. 

1.63“Initial Development Budget” has the meaning set forth in Section 2.2.1.

1.64“Initial Development Plan” has the meaning set forth in Section 2.2.1.

1.65“In-Licenses” means, collectively, the Alnylam In-Licenses and the MedCo In-Licenses.

1.66“Joint Collaboration IP” means, collectively, (a) any improvement, discovery or Know-How, patentable or otherwise, first conceived or reduced to practice or, with respect to inventions and discoveries other than patentable inventions, otherwise identified, discovered, made or developed, jointly by individuals who are employee(s), agent(s) or consultant(s) of Alnylam or its Affiliates, on the one hand, and individuals who are employee(s), agent(s) or consultant(s) of MedCo or its Affiliates, on the other hand, in the conduct of the Collaboration, and (b) any Patent Rights which claim such improvements, discoveries or Know-How during the Term.

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1.67 “Joint Steering Committee” or “JSC” means the joint steering committee as more fully described in Section 4.1.

1.68 “Know-How” means any biological materials and other tangible materials or intangible information, including inventions, practices, methods, protocols, formulas, knowledge, know-how, trade secrets, processes, assays, skills, experience, techniques, governmental or regulatory correspondence (including conversation logs), and results of experimentation and testing, including pharmacological, toxicological and pre-clinical and clinical test data and analytical and quality control data, patentable or otherwise.

1.69“Laws” means all applicable laws, statutes, rules, regulations, orders, judgments, injunctions, ordinances or other pronouncements having the binding effect of law of any Governmental Authority.  

1.70“Lead Product” has the meaning set forth in Section 2.2.2.

1.71“Licensed Compound” has the meaning set forth in Section 1.89.

1.72“Licensed Product” means any siRNA Product, including ALN-PCS02 and ALN-PCSsc.

1.73“Licensing Party” has the meaning set forth in Section 6.4.2.2.

1.74“Licensor Party” has the meaning set forth in Section 12.2.4.

1.75“Losses” has the meaning set forth in Section 10.1. 

1.76“Major Market Country” means the United States, the United Kingdom, France, Germany, Italy, Spain, Japan, or China.

1.77“Manufacturing” or “Manufacture” means, as applicable, all activities associated with the production, manufacture, processing, filling, finishing, packaging, labeling, shipping, and storage of a Licensed Product (including Bulk Drug Substance, Bulk Drug Product and Finished Product), including process and formulation development, process validation, stability testing, manufacturing scale-up, pre-clinical, clinical and commercial manufacture and analytical development, product characterization, quality assurance and quality control development, testing and release.  

1.78“MedCo Collaboration IP” means (a) any improvement, discovery or Know-How, patentable or otherwise, first conceived or reduced to practice or, with respect to inventions and discoveries other than patentable inventions, otherwise identified, discovered, made or developed, solely by individuals who are employees, agents or consultants of MedCo or its Affiliates and Controlled by MedCo at any time during the Term, in each case in the conduct of the Collaboration or otherwise under this Agreement, and (b) any Patent Rights which claim such improvements, discoveries or Know-How.  MedCo Collaboration IP excludes MedCo's interest in Joint Collaboration IP.

1.79“MedCo Commercialization Plan” has the meaning set forth in Section 3.2. 

1.80“MedCo Development Plan” has the meaning set forth in Section 2.2.3.

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1.81“MedCo Improvements” means any improvement, discovery or Know-How, patentable or otherwise, that (a) is first conceived or reduced to practice, or with respect to inventions and discoveries other than patentable inventions, otherwise identified, discovered, made or developed, solely by individuals who are employees, agents or consultants of MedCo or its Affiliates in the course of conducting Development, Manufacturing or Commercialization activities with respect to Licensed Products under this Agreement, (b) is Controlled by MedCo or its Affiliates, and (c) constitutes (i) a new use or method of use of, or a new indication for, a Licensed Product, or (ii) an improvement that would otherwise be dominated by Alnylam Technology, including, as applicable, formulation technology.  For clarity, MedCo Improvements excludes device technology for the administration of a pharmaceutical product to a human.

1.82“MedCo Indemnitees” has the meaning set forth in Section 10.2.

1.83“MedCo In-License” means any agreement between MedCo (or its Affiliates) and a Third Party pursuant to which MedCo Controls Know-How or Patent Rights that are reasonably necessary or useful for the Development, Manufacture and/or Commercialization of Licensed Products in the Territory, but solely to the extent, if any, that such agreement is designated as a MedCo In-License pursuant to Section 2.4(b).

1.84“MedCo Know-How” means Know-How in MedCo Collaboration IP and MedCo's rights in Know-How comprising Joint Collaboration IP. 

1.85“MedCo Patent Rights” means Patent Rights in MedCo Collaboration IP (other than MedCo's rights in Patent Rights comprising Joint Collaboration IP).

1.86“MedCo Technology” means, collectively, MedCo Know-How, MedCo Patent Rights, MedCo Collaboration IP and MedCo's interest in Joint Collaboration IP. 

1.87“MicroRNA Mimic” means a double-stranded or single-stranded oligonucleotide or analog thereof with a substantially similar base composition as a particular microRNA and which is designed to mimic the activity of such microRNA.

1.88“NDA” means a New Drug Application, Biologics License Application, Marketing Authorization Application or similar application or submission filed with a Regulatory Authority in a country or group of countries to obtain marketing approval for a biological, pharmaceutical or other therapeutic or prophylactic product in that country or in that group of countries.

1.89“Net Sales” means, for any period and for any country in the Territory, the total aggregate amount billed during such period in such country by MedCo, its Affiliates and its Sublicensees in such country for all sales of the Licensed Products to Third Parties (other than to a Sublicensee of MedCo or its Affiliates) after deducting, if not previously deducted, from the amount invoiced or received, the following deductions to the extent actually applied or taken with respect to such sales of Licensed Products:

(a)discounts (including trade, cash and quantity discounts), cash and non-cash coupons, charge back payments and rebates granted to managed health care organizations or to federal, state and local governments, their agencies, and purchasers and reimbursers or to customers; 

(b)actually granted credits, allowances, discounts to and chargebacks for claims, spoiled, damaged or outdated goods, rejections or returns of the Licensed Products, including Licensed Products returned in connection with recalls or withdrawals;

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(c)taxes and duties paid, absorbed or allowed which are directly related to the sale of the Licensed Product; 

(d)actual freight and insurance costs incurred in transporting the Licensed Product to customers;

(e)discounts or rebates or other payments required by applicable Law, including any governmental special medical assistance programs; 

(f)customs duties, surcharges and other governmental charges incurred in connection with the exportation or importation of the Licensed Product; 

(g)fee-for-service wholesaler fees, GPO administrative fees, inventory management fees paid to wholesalers, and any similar fees reasonably allocated to the Licensed Product, to the extent consistent with the usual course of dealing of MedCo or the applicable Related Party for its products other than a Licensed Product; 

(h)amounts that are written off as uncollectible in accordance with the accounting procedures of MedCo or the applicable Related Party, consistently applied; provided, that if any such written-off amounts are subsequently collected, such collected amounts shall be included in Net Sales in the period in which they are subsequently collected; and

(i)any other deduction to revenue that is not described above which is required to be recorded as an adjustment to gross revenue for financial reporting purposes.

Such amounts shall be determined from the books and records of MedCo or its Related Parties, maintained in accordance with GAAP, consistently applied.  
If any Licensed Product is sold as a Combination Product (as defined below), the Net Sales from the Combination Product, for the purposes of determining milestones and royalties, shall be determined by multiplying the Net Sales of the Combination Product during the applicable Calendar Quarter, by the fraction, A/(A+B), where A is the average sale price of a Sole Compound Product (as defined below) when sold separately in finished form and B is the average sale price of the other active compounds or active ingredients included in the Combination Product when sold separately in finished form, in each case during the applicable Calendar Quarter or, if sales of both the Sole Compound Product and the other active compounds or active ingredients did not occur in such period, then in the most recent Calendar Quarter in which sales of both occurred.  If such average sale price cannot be determined for both the Sole Compound Product and all other active compounds or active ingredients included in the Combination Product, Net Sales for the purposes of determining milestones and royalties shall be calculated by multiplying the Net Sales of the Combination Product by the fraction of C/(C+D) where C is the fair market value of the Sole Compound Product and D is the fair market value of all other active compounds or active ingredients included in the Combination Product.  In such event, MedCo shall in good faith make a determination of the respective fair market values of the Sole Compound Product and all other active compounds or active ingredients included in the Combination Product, and shall notify Alnylam of such determination and provide Alnylam with MedCo's basis for such determination.  If Alnylam in good faith does not agree with such determination, Alnylam shall give MedCo written notice of its disagreement within thirty (30) days after receiving the relevant report pursuant to Sections 7.3 or 7.4, and the provisions of Section 13.12 shall apply.  “Licensed Compound” means an siRNA Product subject to a license granted by Alnylam to MedCo 

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under Section 6.1.  “Combination Product” means a product that contains one or more Licensed Compounds and one or more therapeutically active compounds or active ingredients that are not Licensed Compounds. “Sole Compound Product” means a product containing no active compounds or active ingredients other than a Licensed Compound. 
In the case of any sale or other disposal for value, such as barter or counter-trade, of Licensed Product, or part thereof, other than in an arm's length transaction exclusively for cash, Net Sales shall be calculated as above on the value of the non-cash consideration received or the fair market price (if higher) of the Licensed Product in the country of sale or disposal, as determined in accordance with GAAP.
Sales between or among MedCo and its Related Parties shall be excluded from the computation of Net Sales, but Net Sales shall include sales to the first Third Party (other than a Sublicensee of MedCo or its Affiliate) thereafter by MedCo or its Related Parties.
1.90Non-Acquired Party” has the meaning set forth in Section 6.7.

1.91“Non-Bankrupt Party” has the meaning set forth in Section 6.5. 

1.92“Non-Breaching Party” has the meaning set forth in Section 12.2.2.

1.93“Party” means MedCo and/or Alnylam.

1.94“Patent Rights” means all patents (including all reissues, extensions, substitutions, confirmations, re-registrations, re-examinations, supplementary protection certificates and patents of addition) and patent applications (including all provisional applications, requests for continuation, continuations, continuations-in-part and divisionals) and all equivalents of the foregoing in any country of the world. 

1.95“Payee” has the meaning set forth in Section 7.9.1. 

1.96“Paying Party” has the meaning set forth in Section 7.9.1.
 
1.97“[**]” means the [**].

1.98“Person” shall mean any natural person, corporation, unincorporated organization, partnership, association, joint stock company, joint venture, limited liability company, trust, Governmental Authority, or any other entity.

1.99“Pharmacovigilance Agreement” has the meaning set forth in Section 2.6.3.

1.100“Phase I Completion” means [**].  

1.101“Phase I Study” means a study in humans which provides for the introduction into humans of a product, conducted in healthy volunteers or patients, to obtain initial information on product safety, tolerability, pharmacological activity or pharmacokinetics, as more fully defined in 21 C.F.R. § 312.21(a) (or the equivalent thereof outside the United States).

1.102“Phase I/II Study” means a single study in humans that includes a Phase I Study and a Phase II Study.

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1.103“Phase II Study” means a study in humans of the safety, dose ranging or efficacy of a product, as further defined in 21 C.F.R. § 312.21(b) (or the equivalent thereof outside the United States).

1.104“Phase III Study” means a study in humans of the efficacy and safety of a product, which is prospectively designed to demonstrate statistically whether such product is effective and safe for use in a particular indication in a manner sufficient (alone or together with one or more other such studies) to file an application for Regulatory Approval for such product, as further defined in 21 C.F.R. § 312.21(c) (or the equivalent thereof outside the United States).  

1.105“Pivotal Study” means a controlled pivotal clinical study of a product that is prospectively designed to demonstrate statistically whether such product is effective and safe for use in a particular indication in a manner sufficient to obtain Regulatory Approval to market such product in a Major Market Country.

1.106“Post-Approval Study” means a clinical study of a Licensed Product initiated in a country after receipt of Regulatory Approval for such Licensed Product in such country.

1.107“Pre-Existing Affiliates” has the meaning set forth in Section 6.7.

1.108“Product Trademark(s)” means the trademark(s) and service mark(s) for use in connection with the distribution, marketing, promotion and sale of Licensed Products, and/or accompanying logos, trade dress and/or indicia of origin.  Product Trademarks specifically excludes the corporate names and logos of the Parties and their Related Parties.

1.109“Regulatory Approval” means any and all approvals, licenses, registrations or authorizations of any Regulatory Authority that are necessary for the marketing and sale of a pharmaceutical product in a country or group of countries, including pricing and/or reimbursement approval in any country in which pricing and/or reimbursement approval is required by applicable Laws.

1.110“Regulatory Authority” means any applicable government regulatory authority involved in granting approvals for the Development, Manufacturing and/or Commercialization of any Licensed Product, including the FDA and the EMA.

1.111“Regulatory Lead” has the meaning set forth in Section 2.6.1. 

1.112“Regulatory Exclusivity” means, with respect to a Licensed Product in a country, any exclusive marketing right, data exclusivity right, orphan drug designation, or another exclusive right which would prevent a Generic Product version of such Licensed Product from being marketed or sold in such country, conferred by any Governmental Authority with respect to such Licensed Product in such country, other than a Patent Right.

1.113“Related Party” means, with respect to a Party, such Party's Affiliates and permitted Sublicensees. 

1.114“Royalty Term” has the meaning set forth in Section 7.4.2. 

1.115“Sales Milestone” has the meaning set forth in Section 7.3. 

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1.116“Selection Date” has the meaning set forth in Section 2.2.2.

1.117“siRNA” means a double-stranded ribonucleic acid (RNA) composition designed to act primarily through an RNA interference mechanism that consists of either (a) two separate oligomers of native or chemically modified RNA that are hybridized to one another along a substantial portion of their lengths, or (b) a single oligomer of native or chemically modified RNA that is hybridized to itself by self-complementary base-pairing along a substantial portion of its length to form a hairpin.

1.118“siRNA Product” means an siRNA composition designed to Target the human PCSK9 gene through an RNA interference mechanism, and which is not a microRNA, microRNA antagonist or MicroRNA Mimic.

1.119“Sole Compound Product” has the meaning set forth in Section 1.89.

1.120“Sublicensed Party” has the meaning set forth in Section 6.4.1.2.

1.121“Sublicensee” means, with respect to MedCo or Alnylam, as the case may be, a Third Party to whom such Party grants a sublicense under any Alnylam Technology or MedCo Technology, respectively, to Develop, Manufacture or Commercialize a Licensed Product in the Field pursuant to Section 6.1.3 or Section 6.2.3, and, with respect to Alnylam, a Third Party to whom Alnylam grants a sublicense pursuant to Section 6.2.3 under any MedCo Improvements licensed to Alnylam pursuant to Section 6.2.2.

1.122“Sublicensor Party” has the meaning set forth in Section 6.4.1.2.

1.123“Target” or “Targeting” means, with respect to an siRNA and a target gene, that such siRNA antagonizes the expression of the messenger RNA of such target gene, and with respect to a product and a target gene, that such product contains an siRNA that antagonizes the expression of the messenger RNA of such target gene.  

1.124“Term” has the meaning set forth in Section 12.1.

1.125“Territory” means all countries of the world.

1.126“Third Party” means an entity other than the Parties and their Affiliates.

1.127“Third Party License Payment” means royalties, upfront fees, milestones or other amounts payable under an In-License.

1.128“Transaction Agreements” means, collectively, this Agreement, the Development Supply Agreement, any quality agreement between the Parties with respect to the supply of Licensed Product and the Pharmacovigilance Agreement.  

1.129“United States” means the United States of America and its territories, possessions and commonwealths.

1.130“Valid Claim” means a claim of:  (a) an issued and unexpired Patent Right, which claim has not been (i) revoked or held unenforceable, unpatentable or invalid by a decision of a court or other governmental agency of competent jurisdiction, which is not appealable or has not been appealed within the time allowed for appeal, or (ii) abandoned, disclaimed, denied or admitted to be invalid or unenforceable 

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through reissue, re-examination or disclaimer or otherwise, or (b) a patent application that has been pending less than [**] from the date of filing of the earliest patent application from which such patent application claims priority, which claim has not been cancelled, withdrawn or abandoned, or finally rejected by an administrative agency action from which no appeal can be taken.  

		
	2.
	DEVELOPMENT COLLABORATION

2.1Overview. Prior to the Effective Date, Alnylam has been engaged in the Development of Licensed Products.  Under this Agreement, the Parties will collaborate in the further Development of Licensed Products, with Alnylam retaining all responsibility for the Development of Licensed Products until Phase I Completion as set forth in the Initial Development Plan, and MedCo assuming all other responsibility for the Development of Licensed Products.  Initially the Collaboration will include the Development of both ALN-PCS02 and ALN-PSCsc in parallel.  In accordance with the process described below, the Parties intend to select one of ALN-PCS02 or ALN-PSCsc for ongoing Development prior to the initiation of IND-enabling studies described in the Initial Development Plan.  

2.2Development Plans.  

2.2.1Initial Global Development Plan.  The Development activities to be undertaken by Alnylam with respect to Licensed Products in the Territory prior to Phase I Completion will be set forth in a written workplan and timetable (the “Initial Development Plan”), which plan includes the Development activities to be undertaken (and all of which will be conducted by Alnylam) with respect to Licensed Products prior to Phase I Completion, and an estimated budget for such Development activities (“Initial Development Budget”).  A draft of the Initial Development Plan is attached hereto as Schedule E.   Alnylam shall submit an update to the Initial Development Plan for review and approval by the JSC of any material modifications or updates within forty-five (45) days of the Effective Date and thereafter on at least a semi-annual basis.  The JSC shall have the right to modify the Initial Development Plan during such review and approval but only to the extent consistent with the budget and timelines contained in the Initial Development Plan attached hereto as Schedule E or as otherwise agreed by the Parties.

2.2.2Selection of Lead Product.  Within thirty (30) days after the Selection Date (as defined below), the JSC shall designate one of ALN-PCS02 and ALN-PCSsc as the product to continue to Develop under the Collaboration (the designated product, the “Lead Product”). “Selection Date” means [**].

2.2.3MedCo Development Plan. The global Development activities to be undertaken with respect to Licensed Products by MedCo, or, to the extent agreed upon by the Parties in writing, by Alnylam following Phase I Completion, will be set forth in a rolling [**] written workplan and timetable (the “MedCo Development Plan”) to be prepared, subject to JSC approval, by MedCo.  Within [**] days after filing of the IND for the Lead Product in accordance with the Initial Development Plan, MedCo shall provide the initial MedCo Development Plan to the JSC for review and approval. The MedCo Development Plan shall subsequently be updated by MedCo from time to time and no less frequently than twice per Calendar Year, subject to JSC approval.

2.3Responsibilities for Development Activities. 

2.3.1Initial Development Plan.  Alnylam shall be responsible for the global Development of Licensed Products and all Development activities with respect thereto through Phase I Completion as set forth in the Initial Development Plan.  Alnylam shall be responsible for one hundred percent (100%) of all Costs for the Development activities that are conducted by Alnylam for the Licensed Product in the Territory 

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pursuant to the Initial Development Plan up to a total of (a) [**] dollars ($[**]), prior to the receipt by Alnylam of the Milestone Payment in Section 7.2(a)(i), or (b) [**] ($[**]), upon receipt by Alnylam of the Milestone Payment in Section 7.2(a)(i) (such amount in (a) or (b), the relevant “Development Costs Cap”); provided, however, that, Alnylam shall also bear any Costs for Development activities conducted by Alnylam pursuant to the Initial Development Plan that exceed such amount to the extent such excess Costs [**].  MedCo shall be responsible for all Costs with respect to Development activities for the Licensed Product pursuant to the Initial Development Plan that (a) are conducted by Alnylam, (b) are in excess of the then-applicable Development Costs Cap, and (c) are approved by the JSC (the “Extra Early Development Costs”).

2.3.2MedCo Development Plan.  MedCo shall be responsible for all Development activities with respect to Licensed Products under the MedCo Development Plan and, as and to the extent mutually agreed by the Parties in writing, Alnylam will assist MedCo in such Development activities under the MedCo Development Plan.  MedCo shall be responsible for one hundred percent (100%) of all costs and expenses with respect to such Development activities that are conducted by or on behalf of MedCo and, if agreed upon in writing by the Parties, all Costs with respect to such Development activities that are conducted by Alnylam after Phase I Completion pursuant to the MedCo Development Plan. 

2.3.3Development and Certain Supply Costs.  Within thirty (30) days following the end of each Calendar Quarter in which Costs are incurred by Alnylam under the Initial Development Plan or the MedCo Development Plan or pursuant to Section 5.1(a), Alnylam shall prepare and deliver to MedCo a quarterly report summarizing such Costs incurred during such period.  Alnylam shall submit any additional information reasonably requested by MedCo related to such Costs included in its report within [**] Business Days after its receipt of such request.  Alnylam shall issue concurrently an invoice to MedCo for any Extra Early Development Costs incurred by Alnylam and/or any Costs incurred by Alnylam pursuant to the MedCo Development Plan in conducting activities to be conducted by Alnylam as agreed upon in writing by the Parties, and MedCo shall pay all amounts within [**] days after its receipt of the invoice.  Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined.  Commencing after Alnylam first issues such an invoice, MedCo shall have the right to audit the records of Alnylam with respect to any such Costs included in such reports, in accordance with Section 7.5.

2.4Diligence. 

(a)     After the JSC's selection of the Lead Product, MedCo will use Commercially Reasonable Efforts to (i) Develop at least one Licensed Product and obtain Regulatory Approval of at least one Licensed Product in each Major Market Country and (ii) subject to Section 2.3.2, perform the Development activities under the MedCo Development Plan.
(b)       Alnylam will use Commercially Reasonable Efforts to perform the Development activities under the Initial Development Plan and, subject to Section 2.3.2, those activities under the MedCo Development Plan which Alnylam has agreed in writing to undertake; provided, however, that except as expressly provided in this Agreement or otherwise agreed to in writing by Alnylam, in no event will Alnylam be required to perform any activities under the Initial Development Plan or the MedCo Development Plan with respect to Licensed Products that would require Alnylam to incur Costs in excess of the then-applicable Development Costs Cap, unless paid or payable by MedCo as Extra Early Development Costs.  Alnylam will be excused from its obligation to perform its affected Development and Manufacturing obligations with respect to Licensed Products under the Transaction Agreements during any period of time with respect to which Alnylam cannot perform such obligations to the extent that, (i) Alnylam becomes aware that the 

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performance of such obligations would infringe Patent Rights that MedCo Controls and are reasonably necessary for such performance by Alnylam, and (ii) Alnylam is not protected by any safe harbor provisions with respect to claims that it would infringe such Patent Rights.  The Parties agree to promptly discuss in good faith a mutually agreed resolution to such a situation.  If the Parties agree in writing that MedCo will grant Alnylam a license or sublicense under such Patent Rights, then unless otherwise agreed by the Parties in writing, such Patent Rights will be considered MedCo Patent Rights, and if such Patent Rights are licensed to MedCo or its Affiliate by a Third Party, such sublicense shall be subject to the relevant license agreement to MedCo or its Affiliate from such Third Party and such agreement shall be designated a MedCo In-License.
2.5Records and Reports.  

2.5.1Prior to the date that is [**] days after Phase I Completion, Alnylam shall prepare and deliver to the JSC a quarterly written report summarizing Alnylam's Development activities for Licensed Products performed to date (or updating such report for activities performed since the last such report submitted hereunder, as applicable).  Within [**] days after Phase I Completion Alnylam shall deliver to the JSC a final report of Alnylam's Development activities for the Licensed Products.  After Phase I Completion, MedCo shall prepare and deliver to the JSC, by no later than each [**] (for the period ending December 31 of the prior Calendar Year), written reports summarizing Development activities for Licensed Products performed to date (or updating such report for activities performed since the last such report submitted hereunder, as applicable), with Alnylam providing to MedCo, in accordance with the MedCo Development Plan, written reports summarizing Alnylam's activities (if any) under the MedCo Development Plan.  Each Party will provide the members of the JSC with written copies of all materials they intend to present at a JSC meeting.  The JSC may also request at any time specific material data or information related to Collaboration activities or that a written report be prepared in advance of any meeting summarizing certain material data and information arising out of the conduct of the Collaboration activities, and the Party or appropriate committee to whom such request is made shall promptly provide to the other Party or JSC such report, data or information.   

2.5.2Each Party will maintain scientific records, in sufficient detail and in good scientific manner appropriate for patent and regulatory purposes, which will fully and properly reflect all work done and results achieved in the performance of the Development activities with respect to Licensed Products by such Party.  Each Party will have the right, during normal business hours and upon reasonable notice, to inspect and copy (or request the other Party to copy) all records of the other Party maintained in connection with the work done and results achieved in the performance of such Development activities, but solely to the extent access to such records is necessary for such Party to exercise its rights under this Agreement.  All such records, and the information disclosed therein, will be maintained as Confidential Information by the recipient Party in accordance with Article 8.  

2.6Regulatory Matters.   

2.6.1Regulatory Filings and Interactions.  Alnylam shall be the “Regulatory Lead” with respect to Licensed Products through Phase I Completion and MedCo shall be the Regulatory Lead with respect to Licensed Products thereafter.  Except as otherwise provided in the Initial Development Plan or Section 2.6.2, (a) each Party will own the INDs, the NDAs and related regulatory documents submitted to the applicable Regulatory Authorities by it with respect to Licensed Products and (b) the Regulatory Lead will, as to Licensed Products, (i) oversee, monitor and coordinate all regulatory actions, communications and filings with, and submissions to, each Regulatory Authority, (ii) be responsible for interfacing, corresponding and meeting with each Regulatory Authority, and (iii) be responsible for maintaining all 

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regulatory filings.  Alnylam will promptly notify the JSC in writing of all material communications received by it from Regulatory Authorities regarding the Licensed Products and of all filings and submissions made by it to Regulatory Authorities regarding the Licensed Products; provided, however, that after Phase I Completion, Alnylam shall not communicate with any Regulatory Authority regarding any Licensed Product without MedCo's prior written consent, except as required by Law or as requested or required by a Regulatory Authority.  MedCo shall provide Alnylam with written notice of (x) all filings and submissions for Regulatory Approval regarding any Licensed Product in the Territory in a timely manner; and (y) all Regulatory Approvals obtained or denied and the filing of any IND for any Licensed Product within fifteen (15) days after such event; provided, however, that in all circumstances except as required by Law, MedCo shall inform Alnylam of such event prior to public disclosure of such event by MedCo. 

2.6.2IND Transfer; Right of Reference.  Upon MedCo's written request Alnylam will use Commercially Reasonable Efforts to promptly transfer to MedCo, at Alnylam's expense, Alnylam's IND for the Lead Product after Phase I Completion, and any other Alnylam Know-How reasonably requested by MedCo with respect to any such IND.  During the Term, each Party will have the right to reference the other Party's INDs, NDAs and other filings with and submissions to Regulatory Authorities with respect to Licensed Products for the purpose of conducting its Development activities under the Initial Development Plan and the MedCo Development Plan, and in the case of MedCo, to otherwise obtain Regulatory Approval of Licensed Products in the Territory.  

2.6.3Pharmacovigilance.  Within [**] months after the Effective Date, the Parties will develop and agree in writing upon a pharmacovigilance agreement (“Pharmacovigilance Agreement”) that will include safety data exchange procedures governing the coordination of collection, investigation, reporting, and exchange of information concerning any adverse experiences, and any product quality and product complaints involving adverse experiences, related to Licensed Products, sufficient to enable each Party to comply with its legal and regulatory obligations.  

2.7Information Exchange.   Prior to Phase I Completion, Alnylam shall provide, and shall have its Affiliates provide, to MedCo, without additional compensation, all material Know-How Controlled by Alnylam and/or its Related Parties (as applicable) relating to Licensed Products, including copies of (a) pre-clinical and clinical safety and efficacy data, (b) protocols and investigator brochures, and (c) regulatory filings, that are reasonably necessary or useful for MedCo (or its Related Parties) to perform its obligations or exploit its rights under this Agreement with respect to such Licensed Products.   Promptly after Phase I Completion and on an ongoing basis throughout the Term, as requested by the JSC and to the extent not already provided to MedCo, Alnylam shall provide, and shall have its Affiliates provide, to MedCo, without additional compensation, all material Alnylam Know-How that relates to the Licensed Products, including copies of (i) pre-clinical and clinical safety and efficacy data, (ii) protocols and investigator brochures and (iii) regulatory filings, in each case that are reasonably necessary or useful for MedCo (or its Related Parties) to perform its obligations or exploit its rights under this Agreement with respect to such Licensed Products.  The transfer of Alnylam Know-How reasonably necessary or useful for the Manufacture of Licensed Products by Alnylam and its Affiliates to MedCo will also be subject to the provisions of Section 5.2 and the Development Supply Agreement. 

2.8Third Parties. The Parties shall be entitled to utilize the services of Third Party contract research and contract manufacturing organizations to perform their respective Development and Manufacturing activities under this Agreement; provided, that (a) each Party shall ensure that such Third Parties it utilizes operate in a manner consistent with the terms of this Agreement and (b) each Party shall remain at all times fully liable for its responsibilities under this Agreement.  Each Party shall ensure that any agreements with such Third Parties shall include confidentiality and non-use provisions that are no 

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less stringent than those set forth in Section 8.1 of this Agreement and shall use Commercially Reasonable Efforts to obtain ownership of, and/or a fully sublicenseable license under and to, any Know-How and Patent Rights that are developed or used by such Third Parties in the performance of such agreement and are reasonably necessary or useful to Develop, Manufacture and/or Commercialize Licensed Products in the Field. 
 
3.COMMERCIALIZATION OF THE LICENSED PRODUCTS

3.1Responsibility and Diligence.   As between the Parties, MedCo shall have the sole right and be solely responsible, at its expense, for all Commercialization activities relating to Licensed Products in the Field in the Territory.  MedCo shall use Commercially Reasonable Efforts, through itself or its Related Parties, to Commercialize at least one Licensed Product in the Field in at least each Major Market Country after receipt of Regulatory Approval of such Licensed Product in the Field in such Major Market Country. 

3.2MedCo Commercialization Plan.  No less than [**] months in advance of the reasonably expected first Regulatory Approval in the Territory with respect to a Licensed Product, and on an annual basis thereafter, MedCo shall prepare and deliver to Alnylam, a written non-binding plan that summarizes the Commercialization activities to be undertaken with respect to Licensed Products in the Territory in the next Calendar Year and, to the extent commercially reasonable, MedCo's plans to obtain further Regulatory Approvals and Commercialize Licensed Products in countries in the Territory in which MedCo is not then Commercializing Licensed Products, and the dates by which such activities are targeted to be accomplished (the “MedCo Commercialization Plan”).  The MedCo Commercialization Plan shall subsequently be updated and modified by MedCo, from time to time and no less frequently than once per Calendar Year.
  
3.3Advertising and Promotional Materials.  MedCo will be responsible for the creation, preparation, production, reproduction and filing with the applicable Regulatory Authorities, of relevant written sales, promotion and advertising materials relating to Licensed Products for use in the Territory.  All such promotional materials will be compliant with all Laws, and substantially consistent with the MedCo Commercialization Plan.  To the extent permitted by Law, MedCo and its Related Parties shall use Commercially Reasonable Efforts to include Alnylam's (or its designee's) name with reasonable prominence on Licensed Product promotional materials related to the Licensed Product in the Territory in acknowledgement of Alnylam's contributions to the Licensed Product.

3.4Reporting Obligations.  MedCo shall prepare and deliver to Alnylam, by no later than each [**] following the first Regulatory Approval of a Licensed Product in the Field in the Territory (for the period ending December 31 of the prior Calendar Year), written reports summarizing MedCo's Commercialization activities for Licensed Products performed to date (or updating such report for activities performed since the last such report submitted hereunder, as applicable).  In addition, MedCo shall provide Alnylam with written notice of the First Commercial Sale of each Licensed Product in the Territory within [**] days after such event; provided, however, that in all circumstances except as required by Law, MedCo shall inform Alnylam of such event prior to public disclosure of such event by MedCo.  MedCo shall also provide such other information to Alnylam as Alnylam may reasonably request with respect to MedCo's Commercialization activities with respect to Licensed Products.  

3.5Sales and Distribution.  MedCo and its Related Parties shall have the sole right and shall be responsible for the pricing of Licensed Products, booking sales, warehousing and distribution of Licensed Products in the Territory.  Moreover, MedCo and its Related Parties shall have the sole right and shall be solely responsible for handling all returns of commercialized Licensed Product, as well as all aspects of 

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Licensed Product order processing, invoicing and collection, distribution, inventory and receivables, in the Territory. 
 
3.6Recalls, Market Withdrawals or Corrective Actions.   In the event that any Regulatory Authority issues or requests a recall or takes a similar action in connection with the Licensed Product in the Territory, or in the event MedCo determines that an event, incident or circumstance has occurred that may result in the need for a recall or market withdrawal in the Territory, MedCo shall, within [**] hours after it receives such information from such Regulatory Authority or makes such determination, advise Alnylam thereof by telephone, facsimile or e-mail.

3.7Commercialization Expenses.  As between the Parties, MedCo shall bear all costs and expenses incurred in connection with the Commercialization of Licensed Products in the Territory.

4.COLLABORATION MANAGEMENT

4.1Joint Steering Committee.  The Parties hereby establish a joint steering committee (the “JSC”) to facilitate the Collaboration as follows:

4.1.1Composition of the Joint Steering Committee.  The Development of Licensed Products hereunder shall be conducted under the direction of the JSC, which shall comprise [**] representatives of MedCo and [**] representatives of Alnylam.  Each Party shall appoint its respective representatives to the JSC from time to time, and may substitute one or more of its representatives, in its sole discretion, effective upon notice to the other Party of such change.  Each Party shall have at least one JSC representative who is a senior employee (vice president level or above), and all JSC representatives shall be employees of the relevant Party and have appropriate expertise and ongoing familiarity with the Collaboration.  Additional non-voting representatives or consultants may from time to time, by mutual consent of the Parties, be invited to attend JSC meetings, subject to all representatives (including the designated voting representatives) and consultants undertaking confidentiality obligations in a written agreement (which may have been executed prior to the Effective Date) that are substantially comparable to the requirements of Section 8.1.  All proceedings for the JSC shall take place in English.  Each Party shall bear its own expenses relating to attendance at such meetings by its representatives. 

4.1.2JSC Chairperson.  The JSC chairperson shall be an employee of Alnylam prior to Phase I Completion and an employee of MedCo thereafter.  The JSC chairperson's responsibilities shall include (a) scheduling meetings at least once per Calendar Quarter, but more frequently if the JSC determines it necessary; (b) setting agendas for meetings with solicited input from other members; (c) coordinating the delivery of draft minutes to the JSC for review and final approval; and (d) conducting meetings, including ensuring that objectives for each meeting are set and achieved.  The JSC chairperson shall have no greater authority on the JSC than any other representative of the JSC.

4.1.3JSC Responsibilities.  The JSC shall have the following responsibilities with respect to the Collaboration:

(a)reviewing reports and updates provided by Alnylam regarding the Development of Licensed Products under the Initial Development Plan, including material modifications and updates to the Initial Development Plan provided by Alnylam in accordance with Section 2.2.1, providing Alnylam with feedback regarding same and approving such updates and modifications to the Initial Development Plan in accordance with Section 2.2.1;

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(b)[**];

(c)approving Extra Early Development Costs in accordance with Section 2.3.1(c);

(d)reviewing reports and updates provided by MedCo regarding the Development of Licensed Products in the Territory, including reviewing and approving the MedCo Development Plan and updates thereto in accordance with Section 2.2.3;

(e)ensuring coordination between the Parties with respect to Development activities in the Territory for Licensed Products under the MedCo Development Plan (to the extent the Parties have agreed in writing that Alnylam should perform any such activities), and regulatory and pharmacovigilance requirements and matters to the extent necessary for the Parties to perform their duties or exercise their rights hereunder and for the Parties to comply with the Pharmacovigilance Agreement and the requirements of Law and Regulatory Authorities, respectively;

(f)regularly assessing the progress of Alnylam in its conduct of the Initial Development Plan and the progress of MedCo in its conduct of the MedCo Development Plan, against the respective timelines contained therein;

(g)reviewing Alnylam Technology that would be reasonably helpful to MedCo's Development of Licensed Products and determine which of such Alnylam Technology should be transferred to MedCo; and

(h)performing such other activities as the Parties agree in writing shall be the responsibility of the JSC.

For purposes of clarity, the JSC shall not have the authority to modify the terms of this Agreement.
4.1.4Meetings.  The first JSC meeting shall be held within [**] months after the Effective Date, and the JSC shall thereafter meet in accordance with a schedule established by mutual written agreement of the Parties, but no less frequently than [**] per Calendar Quarter, with the location for such meetings alternating between Alnylam's and MedCo's US facilities (or such other locations as are mutually agreed by the Parties).  Alternatively, the JSC may meet by means of teleconference, videoconference or other similar communications equipment, but at least [**] meetings per Calendar Year shall be conducted in person.

4.2Appointment of Subcommittees, Project Teams and Collaboration Managers.  The JSC shall be empowered to create such subcommittees of itself and project teams as it may deem appropriate or necessary.  Each such subcommittee and project team shall report to the JSC, which shall have authority to approve or reject recommendations or actions proposed thereby subject to the terms of this Agreement.  The provisions of Sections 4.1.1 and 4.1.4 shall apply to each subcommittee, mutatis mutandis, unless otherwise determined by the JSC.

4.3Minutes.  A secretary shall be appointed for each meeting and shall prepare minutes of the meeting, which shall provide a description in reasonable detail of the discussions held at the meeting and a list of any actions, decisions or determinations approved by the JSC.  The JSC secretary shall have no greater authority on the JSC than any other representative of the JSC.

4.4Decision-Making.  

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4.4.1With respect to decisions of the JSC, the representatives of each Party shall have collectively one vote on behalf of such Party.  For each meeting of the JSC, at least one (1) representative of each Party shall constitute a quorum and each Party shall use Commercially Reasonable Efforts to have its representative(s) participate in each JSC meeting.  Action on any matter may be taken at a meeting, by teleconference, videoconference or by written agreement.  The JSC shall attempt to resolve any and all disputes before it for decision by consensus.  

4.4.2If the JSC is unable to reach a consensus with respect to a dispute for a period in excess of [**] days, then the dispute shall be submitted to the Chief Executive Officers of Alnylam and MedCo for resolution.  
4.4.3If such escalated dispute cannot be resolved for a period in excess of [**] days, then:
[**].
4.4.4Notwithstanding the foregoing, MedCo may not exercise its final decision-making authority (i) to require Alnylam to undertake obligations beyond those for which it is responsible, or forgo any rights, under this Agreement, (ii) to cause Alnylam to incur any Costs above the then-applicable Development Costs Cap with respect to which MedCo has not otherwise agreed to reimburse Alnylam under this Agreement, (iii) to require Alnylam to take or decline to take any action that would result in a violation of any Law or any agreement with any Third Party or the infringement of intellectual property rights of Third Parties, (iv) in a manner that excuses MedCo from any of its obligations specifically enumerated under this Agreement, or (v) to expand or narrow the responsibilities of the JSC.

4.5Dissolution of JSC.  The JSC shall be dissolved upon the First Commercial Sale of the last Licensed Product that is expected to be Developed in the Territory; provided, that after the fifth (5th) anniversary of the Effective Date Alnylam shall have the right, but not the obligation, to dissolve the JSC.  Upon the dissolution of the JSC, MedCo shall have the sole rights and authority to take any action that had been within the JSC's purview.

5.MANUFACTURE AND SUPPLY OF THE LICENSED PRODUCT

5.1Responsibilities for Licensed Product Supply.  

(a)Alnylam will be solely responsible for (i) obtaining supply of Finished Product reasonably required for the conduct of Alnylam's obligations under the Initial Development Plan through Phase I Completion, and (ii) supplying MedCo with the quantity of Finished Product reasonably required for the first Phase II Study of the Lead Product conducted under the MedCo Development Plan (which, for clarity, may be the Phase II Study portion of a Phase I/II Study of the Lead Product initiated pursuant to the Initial Development Plan), in each case at Alnylam's expense for the Costs of such Licensed Product, but only to the extent that such Costs, when added to the Development Costs incurred by Alnylam pursuant to the Initial Development Plan, do not exceed the then-applicable Development Costs Cap, unless paid or payable by MedCo as Extra Early Development Costs. 
 
(b)MedCo will have the sole right and responsibility to Manufacture and supply Licensed Product for Development and Commercialization in the Territory under the MedCo Development Plan (except that Alnylam shall be responsible for supplying Licensed Product as described in clause (a)(ii) above), subject to the successful completion of the transfer of Alnylam Know-How to MedCo or its designated Third Party(ies) contract manufacturers pursuant to Section 5.3 and the Development Supply Agreement.  

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5.2Development Supply Agreement.  Within [**] months after the Effective Date, the Parties will negotiate in good faith and enter into a supply and technical transfer agreement (the “Development Supply Agreement”) pursuant to which Alnylam will (a) subject to the terms of Section 5.3, promptly provide MedCo or Third Party contract manufacturer(s) selected by MedCo and reasonably acceptable to Alnylam with Alnylam Know-How reasonably necessary or useful for the Manufacture of the Bulk Drug Substance, Bulk Drug Product and Finished Product, as the case may be, and shall make available its personnel on a reasonable basis to consult with MedCo with respect thereto, all at MedCo's expense for the Costs reasonably incurred by Alnylam in connection with such technology transfer activities; and (b) supply Finished Product to MedCo as set forth in Section 5.1(a)(ii).  The terms and conditions of the Development Supply Agreement shall be commercially reasonable and consistent with industry standards, as well as, if applicable, Alnylam's agreements with its Third Party contract manufacturers.  

5.3Technology Transfer.  Subject to the terms of the Development Supply Agreement, as soon as reasonably practicable, but in no event later than the fifth (5th) anniversary of the Effective Date, Alnylam shall initiate a technology transfer to MedCo, or to its Third Party manufacturer(s) of Licensed Product, selected by MedCo and reasonably acceptable to Alnylam, of Alnylam Know-How that is reasonably necessary or useful for the Manufacture of the Licensed Product, and shall make available its personnel on a reasonable basis to consult with MedCo or such Third Party manufacturer(s) with respect thereto, all at MedCo's expense, including the Costs reasonably incurred by Alnylam in connection with such technology transfer activities. MedCo shall reimburse Alnylam such Costs incurred with respect to such Manufacturing technology transfer within [**] days after receipt of an invoice therefor.  Alnylam and its Affiliates shall keep complete and accurate records in sufficient detail to enable the payments payable hereunder to be determined.  Alnylam shall not be required to perform technology transfer to more than one Third Party manufacturer for each stage of the Licensed Product supply chain (i.e., Bulk Drug Substance, Bulk Drug Product and Finished Product).  Promptly after MedCo's written request, Alnylam shall use Commercially Reasonable Efforts to assign to MedCo any manufacturing agreement between Alnylam and a Third Party that is solely related to the manufacture of Licensed Products.  Such assignment shall be subject to the terms and conditions of such agreement, including any required consents of such Third Party and MedCo's written agreement to assume all the obligations of Alnylam under such agreement to be undertaken after such assignment, but Alnylam shall remain solely responsible for its obligations under such agreement arising prior to such assignment.  Except as provided in the immediately preceding sentence, MedCo shall be solely responsible for contracting with such Third Party manufacturer (and any other Third Party manufacture to whom Alnylam has initiated technology transfer as set forth in this Section 5.3) for the supply of such Licensed Product and Alnylam shall have no obligations under such agreement between MedCo and such Third Party manufacturer.  Alnylam shall use Commercially Reasonable Efforts to obtain any such consent in a form reasonably acceptable to MedCo.

5.4Additional Licensed Product Supply.   MedCo agrees to consider, and the Parties agree to discuss in good faith, the manufacture and supply of Bulk Drug Substance, Bulk Drug Product and/or Finished Product by Alnylam (or its designee) to MedCo for MedCo's further Development activities and/or for Commercial sale in the Territory; provided, however, that nothing in the foregoing sentence shall be construed to require the Parties to agree to such an arrangement. 

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6.LICENSES 

6.1License Grants to MedCo.

6.1.1Development and Commercialization License. Subject to the terms and conditions of this Agreement, including Section 6.1.4, Alnylam hereby grants MedCo a non-transferable (except as provided in Section 13.1), sublicenseable (subject to Section 6.1.3), exclusive license under Alnylam Technology to Develop and Commercialize Licensed Products in the Field in the Territory.  Such license shall be royalty-bearing for the Royalty Term applicable to each Licensed Product in each country in the Territory, and, after the expiration of the Royalty Term applicable to such Licensed Product in such country, shall convert to a fully paid-up, irrevocable, perpetual, non-exclusive, sublicenseable (subject to Section 6.1.3) license to Develop and Commercialize such Licensed Product in the Field in such country. 
 
6.1.2Manufacturing License.  Subject to the terms and conditions of this Agreement, including those set forth in Article 5 and Section 6.1.4, Alnylam hereby grants MedCo a non-transferable (except as provided in Section 13.1), sublicenseable (subject to Section 6.1.3), worldwide, royalty-bearing, exclusive license under Alnylam Technology to Manufacture Licensed Products for Development of Licensed Products after Phase I Completion and for Commercialization in the Field in the Territory.  Such license shall be royalty-bearing for the Royalty Term applicable to each Licensed Product in each country in the Territory, and, after the expiration of the Royalty Term applicable to such Licensed Product in such country, shall convert to a fully paid-up, irrevocable, perpetual, non-exclusive, sublicenseable (subject to Section 6.1.3) license to Manufacture such Licensed Product for Development of Licensed Products after Phase I Completion and for Commercialization in the Field in such country.  

		
	6.1.3
	Sublicensing Terms.  

(a)MedCo shall have the right to sublicense any of its rights under Section 6.1.1 and 6.1.2 to any of its Affiliates or to any Third Party without the prior written consent of Alnylam, subject to the requirements of this Section 6.1.3, except that Alnylam's prior written consent shall be required for any sublicense to a Third Party of either (i) all or substantially all of MedCo's rights under this Agreement, or (ii) all or substantially all of MedCo's rights to Develop and Commercialize Licensed Products in the United States.  

(b)Each sublicense granted by MedCo pursuant to this Section 6.1.3 shall be subject to the terms and conditions of this Agreement and shall contain terms and conditions consistent with those in this Agreement.  MedCo shall promptly provide Alnylam with a copy of the fully executed sublicense agreement covering any Commercialization sublicense granted hereunder, and each such sublicense agreement shall contain the following provisions:  (i) a requirement that the Sublicensee comply with confidentiality and non-use provisions that are no less stringent than Section 8.1 with respect to Alnylam's Confidential Information; provided, however, that if such sublicense agreement contains a sublicense of Licensed Product sales rights, such sublicense agreement shall also contain the following provisions:  (x) a requirement that the Sublicensee submit applicable sales or other reports to MedCo to the extent necessary or relevant to the reports required to be made or records required to be maintained under this Agreement; and (y) the audit requirement set forth in Section 7.5; and (ii) subject to Section 6.4, any other provisions applicable to a Sublicensee required under any Alnylam In-License or necessary to allow Alnylam or its Affiliates to comply with its obligations thereunder, to the extent that MedCo had been made aware of such provisions prior to entering into such sublicense, including any such provision regarding diligence, insurance, indemnification, confidentiality, reporting, audits, publication, data sharing or regulatory matters.

24

(c)If MedCo becomes aware of a material breach of any sublicense by a Sublicensee of the rights granted to MedCo under this Section 6.1, MedCo shall promptly notify Alnylam of the particulars of the same and use Commercially Reasonable Efforts to cause the Sublicensee to comply with all the terms of the sublicense necessary for MedCo's compliance with the terms of this Agreement.  In the event that (i) the Sublicensee has failed to cure a material breach of such obligations within [**] days after notice of such breach and (ii) such material breach also constitutes a breach of this Agreement, MedCo shall terminate the sublicense at the request of Alnylam; provided, however, that, if such Sublicensee disputes that it has materially breached such obligations, or disputes that it has not timely cured a breach of such obligations, MedCo shall not be obligated to terminate such sublicense until such dispute is resolved by settlement, or in a final, non-appealable decision of a court or arbitrator, finding that such Sublicensee had materially breached such sublicense and had not timely cured such material breach.  Notwithstanding any sublicense, MedCo shall remain primarily liable to Alnylam for the performance of all of MedCo's obligations under, and MedCo's compliance with all terms and conditions of, this Agreement.

6.1.4Retained Rights.  Notwithstanding the license grants in Sections 6.1.1 and 6.1.2, Alnylam retains the rights under Alnylam Technology (a) to Develop and Manufacture Licensed Products in the Field in the Territory solely for the purpose and only to the extent necessary for the performance of its obligations under the Transaction Agreements, and (b) for all internal basic and preclinical research purposes, in each case including the right to collaborate with and issue sublicenses to academic collaborators and/or Third Party contractors involved in such research activities.  

		
	6.2
	License Grants to Alnylam. 

6.2.1Development and Manufacturing License. Subject to the terms and conditions of this Agreement, MedCo hereby grants Alnylam a non-transferable (except as provided in Section 13.1), sublicenseable (subject to Section 6.2.3), non-exclusive, worldwide, royalty-free license, under MedCo Technology, to perform Alnylam's Development and Manufacturing obligations with respect to Licensed Products under the Transaction Agreements.

6.2.2MedCo Improvements License.  Subject to the terms and conditions of this Agreement, MedCo hereby grants Alnylam a non-transferable (except as provided in Section 13.1), sublicenseable (subject to Section 6.2.3), worldwide, non-exclusive, royalty-free license under any MedCo Improvements to research, develop, manufacture and/or commercialize products containing siRNA molecules in the Field and in the Territory.  Such license is subject to the exclusive license grants to MedCo under Section 6.1 and the terms of Section 9.5.1. 

6.2.3Sublicensing Terms.  

(a)Alnylam shall have the right to sublicense any of its rights under Section 6.2.1 to any of its Affiliates or to any Third Party contractor without the prior written consent of MedCo, subject to the requirements of this Section 6.2.3.  Alnylam shall have the right to sublicense any of its rights under Section 6.2.2 or Section 12.3(b) to any of its Affiliates or to any Third Party without the prior written consent of MedCo, subject to the requirements of this Section 6.2.3.

(b)Each sublicense granted by Alnylam pursuant to this Section 6.2.3 shall be subject to the terms and conditions of this Agreement and shall contain terms and conditions consistent with those in this Agreement.  Each such sublicense agreement shall contain the following provisions:  (i) a requirement that the Sublicensee comply with confidentiality and non-use provisions that are no less stringent than 

25

Section 8.1 with respect to MedCo's Confidential Information, and (ii) subject to Section 6.4, any other provisions applicable to a Sublicensee required under any MedCo In-License or necessary to allow MedCo or its Affiliates to comply with its obligations thereunder, to the extent that Alnylam had been made aware of such provisions prior to entering into such sublicense, including any such provision regarding diligence, insurance, indemnification, confidentiality, reporting, audits, publication, data sharing or regulatory matters.  

(c)If Alnylam becomes aware of a material breach of any sublicense by a Sublicensee of the rights granted to Alnylam under this Section 6.2 or Section 12.3(b), Alnylam shall promptly notify MedCo of the particulars of the same and use Commercially Reasonable Efforts to cause the Sublicensee comply with all the terms of the sublicense necessary for Alnylam's compliance with the terms of this Agreement.  In the event that (i) the Sublicensee has failed to cure a material breach of such obligations within [**] days after notice of such breach and (ii) such material breach also constitutes a breach of this Agreement, Alnylam shall terminate the sublicense at the request of MedCo; provided, however, that, if such Sublicensee disputes that it has materially breached such obligations, or disputes that it has not timely cured a breach of such obligations, Alnylam shall not be obligated to terminate such sublicense until such dispute is resolved by settlement, or in a final, non-appealable decision of a court or arbitrator, finding that such Sublicensee had materially breached such sublicense and had not timely cured such material breach.  Notwithstanding any sublicense, Alnylam shall remain primarily liable to MedCo for the performance of all of Alnylam's obligations under, and Alnylam's compliance with all terms and conditions of, this Agreement.

6.3Joint Collaboration IP.  Subject to the rights and licenses granted to, and the obligations of, each Party under this Agreement, including MedCo's obligations under Section 7.4 during the Term, each Party shall have the right to exploit its interest in Joint Collaboration IP without the consent of and without accounting to the other Party.

6.4In-Licenses and Existing Alnylam Third Party Agreements.  

6.4.1Compliance with In-Licenses. 

6.4.1.1All licenses and other rights granted to MedCo under this Article 6 (including any sublicense rights) are subject to the rights and obligations of Alnylam and its Affiliates under the Alnylam In-Licenses and the Existing Alnylam Third Party Agreements.  All licenses and other rights granted to Alnylam under this Article 6 and Section 12.3(b) (including any sublicense rights) are subject to the rights and obligations of MedCo and its Affiliates under the MedCo In-Licenses.
  
6.4.1.2Subject to Section 6.4.1.3, (a) each Party (the “Sublicensed Party”) granted a sublicense under any of the In-Licenses of the other Party (the “Sublicensor Party”) shall comply with all applicable terms and conditions of the In-Licenses of the Sublicensor Party to the extent (i) required by the terms of such In-Licenses with respect to a sublicense under the terms of such In-License to the extent applicable to (A) the Sublicensed Party's rights or obligations relating to the Development, Manufacture or Commercialization of Licensed Products under any of the Transaction Agreements or (B) the filing, prosecution, maintenance, extension, defense, enforcement, patent challenge or the further sublicensing of the Alnylam Technology (if Alnylam is the Sublicensor Party) or the MedCo Technology (if MedCo is the Sublicensor Party) to the extent relevant to the Sublicensed Party's rights or obligations relating to the Development, Manufacture or Commercialization of Licensed Products under any of the Transaction Agreements, and (ii) the Sublicensed Party has been given written notice or provided a copy of such provisions 

26

on or prior to the later of (x) the Effective Date or (y) the date on which such In-License is first required to have been provided to the Sublicensed Party hereunder (provided that, with respect to an amendment thereto, such amendment is consistent with the last sentence of Section 6.4.4), and (b) each Sublicensed Party shall perform and take such actions as may be required to allow the Sublicensor Party to comply with its obligations under the Sublicensor Party's In-Licenses, to the extent (i) applicable to (A) the Sublicensed Party's rights or obligations relating to the Development, Manufacture or Commercialization of Licensed Products under any of the Transaction Agreements or (B) the filing, prosecution, maintenance, extension, defense, enforcement, patent challenge or the further sublicensing of the Alnylam Technology (if Alnylam is the Sublicensor Party) or the MedCo Technology (if MedCo is the Sublicensor Party) to the extent relevant to the Sublicensed Party's rights or obligations relating to the Development, Manufacture or Commercialization of Licensed Products under any of the Transaction Agreements and (ii) that the Sublicensed Party had been given written notice or provided a copy of such provisions on or prior to the later of (x) the Effective Date or (y) the date on which such In-License is first required to have been provided to the Sublicensed Party hereunder (provided that, with respect to an amendment thereto, such amendment is consistent with the last sentence of Section 6.4.4), including any such obligations relating to sublicensing, patent matters, confidentiality, reporting, audit rights, indemnification and diligence.  Without limiting the foregoing, each Sublicensed Party shall prepare and deliver to the Sublicensor Party any additional reports required under the applicable In-Licenses of the Sublicensor Party, in each case reasonably sufficiently in advance to enable the Sublicensor Party to comply with its obligations under the applicable In-Licenses, to the extent that the Sublicensed Party had been made aware of such provisions with reasonably sufficient time prior to the date on which such compliance is required in order for such Sublicensed Party, or its Related Parties, to properly prepare such reports, using Commercially Reasonable Efforts, including reasonably sufficient time to gather, analyze, format and review the relevant information (to the extent not already required to be provided to the Sublicensor Party under any Transaction Agreement other than pursuant to an In-License Agreement of the Sublicensor Party).  

6.4.1.3The Parties acknowledge that the terms of any In-License may be subject to interpretation.  The Parties shall cooperate with each other in good faith to support each Sublicensed Party in complying with its obligations, in accordance with this Section 6.4, under an In-License pursuant to which such Sublicensed Party has been granted a sublicense pursuant to this Agreement.  Without limitation to the foregoing, the Parties shall, from time to time, upon the reasonable request of either Party, discuss the terms of any In-License and agree upon, to the extent reasonably possible, a consistent interpretation of the terms of such In-License in order to, as fully as possible without imposing an unreasonable burden on the normal business activities of any Party, allow the Sublicensor Party and the Sublicensed Party to comply with the terms of such In-License, without imposing an unreasonably higher burden on one Party than the other with respect to compliance with the terms of such In-License.  Promptly after a Party reaches a conclusion or obtains information that such interpretation is or may be incorrect, it shall share such conclusion or information with the other Party and the Parties shall discuss such conclusion or information.

6.4.1.4Each Sublicensor Party shall ensure that, to the fullest extent permitted under the relevant In-License, any Confidential Information of the Sublicensed Party disclosed to the relevant Third Party as required by such In-License shall be protected as confidential information of the Sublicensor Party in accordance with such In-License.

6.4.1.5Each Sublicensor Party agrees, upon the Sublicensed Party's request, to provide the Sublicensed Party with copies of any In-Licenses to which the Sublicensed Party is a party (other 

27

than any amendments or side letters thereto which are not materially relevant to the rights granted to, and the obligations imposed on, the Sublicensed Party under this Agreement).  Each Sublicensor Party shall promptly provide the Sublicensed Party with a copy of any amendment, including any side letter, to any In-License of the Sublicensor Party, to the extent relevant in any way to the rights or obligations of the Sublicensed Party and whether or not such amendment is consistent with the obligations of the Sublicensor Party under the last sentence of Section 6.4.4.  Confidential Information of the Sublicensor Party or its counterparty may be redacted from such copies, except to the extent that such information is required in order to enable the Sublicensed Party to comply with its obligations to the Sublicensor Party under this Agreement with respect to such In-License or in order to enable the Sublicensor Party to ascertain compliance with the provisions of this Agreement.

6.4.1.6If the Sublicensor Party receives written notice from the relevant Third Party that the Sublicensor Party is in material breach of its In-License such that it would materially adversely affect the rights of the Sublicensed Party under this Agreement, and if the Sublicensor Party determines that it cannot or chooses not to cure or otherwise resolve any such alleged breach or default, then the Sublicensor Party shall so notify the Sublicensed Party within ten (10) Business Days of such determination.  

6.4.1.7To the extent that the Sublicensor Party receives written notice from the relevant Third Party that the Sublicensed Party is in material breach of an obligation imposed on the Sublicensed Party under an In-License of the Sublicensor Party pursuant to this Section 6.4, the Sublicensor Party shall promptly provide the Sublicensed Party with a copy of such breach notice, and any other relevant documents, received from such Third Party, but in no event more than five (5) Business Days after the Sublicensor Party's receipt thereof.  

6.4.2New In-Licenses; Additional Alnylam In-Licenses.  

6.4.2.1Alnylam Negotiation of Future Alnylam In-Licenses. Subject to Section 6.4.2.4, in the event that Alnylam or its Affiliate determines to enter into an agreement with a Third Party after the Effective Date pursuant to which Alnylam or its Affiliate would acquire a license under Patent Right(s) that Covers the development, manufacture or commercialization of pharmaceutical products comprised of siRNA compositions (other than microRNAs, microRNA antagonists or MicroRNA Mimics) in the Field and the Territory, and if such a license with respect to Licensed Products in the Field is available, then Alnylam shall use best efforts to ensure that the terms of such license applicable to Licensed Products in the Field are not materially less favorable than the terms applicable to other pharmaceutical products containing siRNA compositions in the Field under such license agreement.  

6.4.2.2Acceptance of Future Alnylam In-Licenses.  In the event that Alnylam (the “Licensing Party”) or its Affiliate enters into an agreement with a Third Party after the Effective Date that meets the criteria set forth in clause (b) of the definition of Alnylam In-License, then Alnylam will promptly provide MedCo with notice and a copy of the applicable Third Party agreement.  Within thirty (30) days following receipt of such notice, MedCo will decide, in its sole discretion, whether to accept the applicable Third Party agreement as an Alnylam In-License, and provide notice of such decision to Alnylam.  In the event that MedCo declines to accept such agreement as an Alnylam In-License, any rights granted to MedCo thereunder will not be deemed to be “Controlled” by Alnylam or licensed to MedCo under this Agreement, and will not be subject to the payment provisions under this Agreement relating to In-Licenses.  In the event that MedCo 

28

accepts such Third Party agreement as an Alnylam In-License, such agreement will thereafter be included within the definition of Alnylam In-License, and any rights granted to Alnylam thereunder will be deemed to be “Controlled” by Alnylam and sublicensed to MedCo pursuant to the terms of this Agreement. 

6.4.2.3Additional Alnylam In-Licenses.  MedCo shall have the option, exercisable during the Term upon written notice to Alnylam, and on an Additional Alnylam In-License by Additional Alnylam In-License basis, to expand the definition of Alnylam Patent Rights under this Agreement to include the Patent Rights Controlled by Alnylam under such Additional Alnylam In-License.  Upon receipt of such written notice from MedCo, then such agreement will thereafter be included within the definition of Existing Alnylam In-Licenses, and all rights granted to Alnylam thereunder will be deemed to be “Controlled” by Alnylam and sublicensed to MedCo under this Agreement effective as of the date of such written notice, and Schedule D will be updated accordingly.

6.4.2.4Product-Specific Rights.  As between the Parties, MedCo and its Affiliates shall have the sole right to enter into an agreement with a Third Party after the Effective Date to acquire a license with respect to Licensed Products in the Field under any Patent Right that (a) Covers the Development, Manufacture or Commercialization of any Licensed Product and (b) if such license had been acquired by Alnylam, would be an Alnylam Product-Specific Patent Right.

6.4.3Payments Under In-Licenses.  

6.4.3.1Alnylam shall bear [**] percent ([**]%) of any Third Party License Payments under the Alnylam In-Licenses, other than the payments described in Section 6.4.3.2, that become payable based on the licensing or sublicensing to MedCo of rights thereunder, or the exercise by MedCo of rights hereunder, with respect to Licensed Products.  

6.4.3.2Subject to Sections 6.1.3(a), and 7.4.5 (to the extent applicable), MedCo shall bear [**] percent ([**]%) of, and shall reimburse Alnylam for:

		
	(a)
	[**], and, if MedCo exercises its option pursuant to Section 6.4.2.3 with respect to [**], under the [**], that become payable based on the Manufacture or Commercialization by MedCo or its Related Parties of Licensed Products; provided, however, that (i) such [**], as the case may be, shall not [**] as set forth as of the Effective Date in such [**], as applicable, and (ii) the [**] taken together shall not exceed (x) with respect to [**], (A) on or prior to [**], and (B) after [**] (as defined on Schedule D), [**] (as defined on Schedule D) and, [**], which cover [**], [**]; and (y) with respect to [**], (A) on or prior to [**], and (B) after [**], which cover [**],

		
	(b)
	[**], other than the [**], that become payable based on the Manufacture or Commercialization by MedCo or its Related Parties of Licensed Products [**]; provided, however, that the [**] under each [**] shall not [**] as set forth as of the Effective Date in such [**],

		
	(c)
	[**], other than the [**], that become payable based on the Development, Manufacturing or Commercialization by MedCo or its Related Parties of Licensed Products, not to exceed [**] provided by Alnylam to MedCo pursuant to Section 6.4.2.2, and

29

		
	(d)
	[**] that become payable based on [**] thereunder, or [**] hereunder, with respect to Licensed Products. 

6.4.3.3With respect to the calculation of royalties payable by MedCo pursuant to Section 6.4.3.2(a), (b) or (c), if any such royalties are calculated based on the total sales during any relevant period of any Licensed Product(s) and any other products which are not Licensed Products, then the royalties shall be allocated pro rata to such Licensed Product(s) and other products such that MedCo, on the one hand, and Alnylam and its Affiliates and other licensees, on the other hand, bear their pro rata portion of such royalties based on the total sales of such Licensed Product(s) and such other products during the relevant time period.  Subject to the confidentiality and non-use obligations of Article 8, the Parties shall share any reasonably necessary information in order to properly calculate the royalty payments due from MedCo in accordance with this Section 6.4.3.3 and any overpayment by MedCo hereunder shall be promptly refunded to MedCo.  Schedule H provides a non-limiting example of the calculations with respect to this Section 6.4.3.3.
  
6.4.3.4With respect to any milestone payments payable by MedCo pursuant to Section 6.4.3.2(c), if any such milestone payments are due only on the first product to achieve the relevant milestone event under the relevant Alnylam In-License, and a Licensed Product is the first such product, then, upon the achievement of such milestone event by each of the next two (2) products which are not Licensed Products to achieve such milestone event, Alnylam shall pay to MedCo [**] of the milestone payment paid by MedCo with respect to such milestone event.  If a Licensed Product is not the first product to achieve the relevant milestone event, but is the second or third product to achieve the relevant milestone event, then MedCo agrees to reimburse Alnylam for [**] of such milestone payment.

6.4.3.5Alnylam shall invoice MedCo for amounts payable by MedCo pursuant to Sections 6.4.3.2 and 6.4.3.4, and MedCo shall pay all such amounts to Alnylam within thirty (30) days after its receipt of the invoice.   Alnylam and its Affiliates and sublicensees shall keep complete and accurate records in sufficient detail to enable the calculation of royalty payments by MedCo in accordance with Section 6.4.3.3, and the payments to or from MedCo pursuant to Section 6.4.3.4, to be determined.  MedCo shall have the right to audit such records of Alnylam in accordance with Section 7.5.

6.4.4Maintenance of In-Licenses. Each Sublicensor Party and its Affiliates shall use its Commercially Reasonable Efforts to maintain its good standing under each of its In-Licenses (including by not initiating any patent challenges which could result in the termination of any such In-License in accordance with its terms and promptly forwarding to the relevant Third Party all reports, payments and other information and material provided by the Sublicensed Party to the Sublicensor Party which, in accordance with the terms of such In-License, are to be forwarded or paid to the relevant Third Party).  Without the prior written consent of the Sublicensed Party, neither Sublicensor Party nor its Affiliates shall (a) breach any of its material obligations or waive any of its rights under any of its In-Licenses, (b) amend any of its In-Licenses in any manner that would be materially adverse to the rights granted to the Sublicensed Party under this Agreement, or (c) terminate any of its In-Licenses, including by failure to satisfy any of its diligence obligations thereunder.  

6.5Bankruptcy.  All rights and licenses granted under or pursuant to this Agreement by a Party to the other, including those set forth in Sections 6.1 and 6.2, are and shall otherwise be deemed to be, for purposes of Section 365(n) of the U.S. Bankruptcy Code, licenses of right to “intellectual property” as defined under Section 101 of the U.S. Bankruptcy Code.  The Parties agree that the Parties and their 

30

respective Related Parties, as sublicensees of such rights under this Agreement, shall retain and may fully exercise all of their rights and elections under the U.S. Bankruptcy Code and any foreign counterpart thereto.  The Parties further agree that that upon commencement of a bankruptcy proceeding by or against a Party (the “Bankrupt Party”) under the Bankruptcy Code, the other Party (the “Non-Bankrupt Party”) will be entitled to a complete duplicate of, or complete access to (as the Non-Bankrupt Party deems appropriate), all such intellectual property and all embodiments of such intellectual property.  Such intellectual property and all embodiments of such intellectual property will be promptly delivered to the Non-Bankrupt Party (a) upon any such commencement of a bankruptcy proceeding and upon written request by the Non-Bankrupt Party, unless the Bankrupt Party elects to continue to perform all of its obligations under this Agreement, or (b) if not delivered under (a) above, upon the rejection of this Agreement by or on behalf of the Bankrupt Party and upon written request by the Non-Bankrupt Party.  The Bankrupt Party (in any capacity, including debtor-in-possession) and its successors and assigns (including any trustee) agrees not to interfere with the exercise by Non-Bankrupt Party or its Related Parties of its rights and licenses to such intellectual property and such embodiments of intellectual property in accordance with this Agreement, and agrees to assist the Non-Bankrupt Party and its Related Parties in obtaining such intellectual property and such embodiments of intellectual property in the possession or control of Third Parties as reasonably necessary or desirable for the Non-Bankrupt Party to exercise such rights and licenses in accordance with this Agreement. The foregoing provisions are without prejudice to any rights the Non-Bankrupt Party may have arising under the Bankruptcy Code or other Laws. 

6.6No Other Rights.  Except as otherwise expressly provided in this Agreement, under no circumstances shall a Party, as a result of this Agreement, obtain any ownership interest or other right in any Know-How, Patent Rights or other intellectual property rights of the other Party, including items owned, controlled or devel-oped by the other Party, or provided by the other Party to the receiving Party at any time pursuant to this Agreement.  

6.7No Reach Through to Acquirer IP.  Notwithstanding anything in this Agreement to the contrary, following the closing of a Change of Control of a Party (the “Acquired Party”), the Parties agree that the other Party (the “Non-Acquired Party”) shall not obtain rights or access to the Patent Rights or Know-How controlled by the Acquirer (as defined below) or any of the Affiliates of such Acquirer (other than the Acquired Party and its Affiliates which exist immediately prior to the closing of such Change of Control (such Affiliates, the “Pre-Existing Affiliates”)); and the Acquirer and its Affiliates (other than the Acquired Party and its Pre-Existing Affiliates) shall not obtain rights or access to the Patent Rights or Know-How controlled by the Non-Acquired Party or any of its Affiliates pursuant to this Agreement, or be bound by the restrictions set forth in Section 9.5.1.  For clarity but without limitation, the Non-Acquired Party's rights in all Patent Rights and Know-How Controlled by the Acquired Party or any of its Pre-Existing Affiliates, which Patent Rights and Know-How exist as of the date of the closing of such Change of Control and are then licensed hereunder to the Non-Acquired Party, shall remain licensed to such Non-Acquired Party after the date of the closing of such Change of Control in accordance with and subject to the terms and conditions of this Agreement and shall not be affected in any manner by virtue of such Change of Control. “Acquirer” means, with respect to the Acquired Party, the Third Party that acquires such Acquired Party or its direct or indirect controlling Affiliate, or that acquires all or substantially all of the assets of the Acquired Party or its direct or indirect controlling Affiliate.

7.CERTAIN FINANCIAL TERMS

7.1Upfront Fee.  As partial consideration for the licenses and other rights granted by Alnylam to MedCo under this Agreement, and to fund Alnylam's Development Costs under the Initial Development Plan up to the Development Costs Cap under this Agreement, within five (5) days after the Effective Date, 

31

MedCo shall pay Alnylam a non-refundable, non-creditable initial payment of Twenty-Five Million U.S. Dollars ($25,000,000).

7.2Development Milestone Fees.  

(a)    As partial consideration for the licenses and other rights granted in this Agreement, and to fund Alnylam's Development Costs under the Initial Development Plan up to the Development Costs Cap under this Agreement, MedCo shall make the non-refundable, non-creditable milestone payments to Alnylam set forth below no later than [**] days after the earliest date on which MedCo becomes aware that the corresponding milestone event has first been achieved with respect to a Licensed Product.   
	
		
	Milestone Event
	Milestone Payment

	(i) First dosing of a subject in a Phase I Study of a Licensed Product
	$10,000,000

	[**]
	[**]

	[**]
	[**]

	[**]
	[**]

	[**]
	[**]

(b)     Each milestone payment by MedCo to Alnylam hereunder shall be payable only once, regardless of the number of times achieved with respect to a Licensed Product or the Licensed Products and in no event shall the total milestone payments under this Section 7.2 exceed [**] dollars ($[**]).  
(d)    MedCo shall provide Alnylam with written notice of the achievement by MedCo or any of its Related Parties of any milestone event set forth in Section 7.2(a)(ii)-(v) within [**] days after MedCo becomes aware of such event; provided, however, that, except as required by Law, MedCo shall inform Alnylam of such event prior to any public disclosure of such event by MedCo.  
(e)    Alnylam shall provide MedCo with written notice of the achievement by Alnylam or any of its Related Parties of any milestone event set forth in Section 7.2(a)(i) within [**] after Alnylam becomes aware of such event; provided, however, that, except as required by Law, Alnylam shall inform MedCo of such event prior to any public disclosure of such event by Alnylam.

7.3Sales Milestone Fees.  As partial consideration for the licenses and other rights granted in this Agreement, MedCo shall make the non-refundable, non-creditable milestone payments to Alnylam set forth below no later than [**] after the end of the Calendar Year in which the corresponding milestone event (a “Sales Milestone”) has first been achieved with respect to the Licensed Products.  

	
		
	Aggregate Calendar Year Net Sales of the Licensed Products in the Territory Equals or Exceeds (in U.S. Dollars):
	Milestone Payment

	[**]
	[**]

	[**]
	[**]

	[**]
	[**]

32

With respect to the foregoing Sales Milestones, payment shall be made only once for each milestone regardless of the number of times aggregate Calendar Year Net Sales for Licensed Products in the Territory reach a particular dollar threshold and in no event shall the total milestone payments under this Section 7.3 exceed [**] dollars ($[**]).  If Licensed Products achieve a higher Sales Milestone in a Calendar Year without having first achieved a lower Sales Milestone in any previous Calendar Year, then the milestone payment(s) for the lower Sales Milestone(s) shall be due and payable to Alnylam concurrently with the milestone payment for the higher Sales Milestone that has been achieved.  For example, if aggregate Net Sales of the Licensed Products in the Territory are $[**] in the first Calendar Year, and then $[**] in the next Calendar Year, then MedCo will owe Alnylam a milestone payment of $[**] with respect to the second Calendar Year ($[**] for the $[**] milestone and $[**] for the $[**] milestone).

7.4Royalties.

7.4.1Royalties Payable on Licensed Products. Subject to the terms and conditions of this Agreement, as partial consideration for the licenses and other rights granted in this Agreement MedCo shall pay to Alnylam royalties on aggregate Net Sales by MedCo and its Related Parties of all Licensed Products in the Territory, as follows:
	
		
	Aggregate Calendar Year 
Net Sales of all Licensed Products in the Territory
	Royalty
 (as a percentage of Net Sales)

	[**]
	[**]

	[**]
	[**]

	[**]
	[**]

	[**]
	[**]

Royalties on aggregate Net Sales shall be paid at the rate applicable to the portion of such aggregate Net Sales within each of the Net Sales levels above during such Calendar Year.  
7.4.2Royalty Term.  The period during which the royalties set forth in Section 7.4.1 shall be payable, on a Licensed Product-by-Licensed Product and country-by-country basis, shall commence with the First Commercial Sale of such Licensed Product in such country and continue until the latest of (a) the expiration of the last Valid Claim of any Patent Right that is (i) included in Alnylam Technology or MedCo Improvements, and (ii) Covers the manufacture, use, offer for sale, sale or importation of the Licensed Product in such country of sale, (b) the expiration of Regulatory Exclusivity for such Licensed Product in such country, and (c) the twelfth (12th) anniversary of the First Commercial Sale of the Licensed Product in such country (each such period, a “Royalty Term”).
 
7.4.3Royalty Adjustment for Generic Competition.  Subject to Section 7.4.6, the royalties to be paid by MedCo to Alnylam pursuant to this Section 7.4 shall be reduced by [**] percent ([**]%) with respect to Net Sales in a country of the Territory of any Licensed Product as to which Generic Competition exists. “Generic Competition” means, with respect to a Licensed Product in any country in the Territory in a given Calendar Quarter, that, during such Calendar Quarter, one or more Generic Products are commercially available in such country and such Generic Products have a combined market share (calculated on the basis of the number of units sold) of at least [**] percent ([**]%) of the aggregate market share of Licensed Products and Generic Products (based on data provided by IMS International, or if such data is not available, such other reliable data source as reasonably agreed by the Parties).

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7.4.4[**].

7.4.5Royalty Adjustment for Necessary Third Party IP.  Subject to Section 7.4.6, (a) if MedCo or any of its Related Parties is required to obtain a license or similar right from any Third Party under any Patent Rights that would be infringed by the practice of the Alnylam Patent Rights with respect to Licensed Products in the Field, and if MedCo or any of its Related Parties is required to pay to such Third Party a royalty, license fees or milestone payments to obtain such license or similar right with respect to the Development, Manufacture or Commercialization of Licensed Products in the Field, then the royalties to be paid by MedCo to Alnylam on Net Sales of a Licensed Product pursuant to this Section 7.4 in a Calendar Quarter shall be reduced by [**] percent ([**]%) of the amount of such royalty, license fees or milestone payments reasonably attributable to the Development, Manufacture or Commercialization of such Licensed Product and actually paid to such Third Party to the extent MedCo, directly or indirectly, bears the cost of such payment in such Calendar Quarter, and (b) the royalties to be paid by MedCo to Alnylam on Net Sales of a Licensed Product pursuant to this Section 7.4 in a Calendar Quarter shall be reduced by [**] percent ([**]%) of the amount of any payments made by MedCo to Alnylam pursuant to Section 6.4.3.2(c) reasonably attributable to the Development, Manufacture or Commercialization of such Licensed Product and actually paid to such Third Party to the extent MedCo, directly or indirectly, bears the cost of such payment in such Calendar Quarter. 

7.4.6Royalty Floor.  Notwithstanding the foregoing provisions of this Section 7.4, in no event during the applicable Royalty Term for a Licensed Product in a country of the Territory shall the royalties payable to Alnylam hereunder for such Licensed Product in such country for any Calendar Quarter be reduced pursuant to Sections 7.4.3, 7.4.4, and 7.4.5 to less than [**] percent ([**]%) of the royalties payable pursuant to Section 7.4.1 as to such Licensed Product in such country for such Calendar Quarter.

7.4.7Reports; Payment of Royalty.  During the Term, following the First Commercial Sale of the Licensed Product in the Territory, MedCo shall furnish to Alnylam a written report within [**] days after the end of each Calendar Quarter showing, on a Licensed Product-by-Licensed Product and country-by-country basis, the gross sales of each Licensed Product in each country of the Territory, deductions from gross sales (itemized by deduction category) for each Licensed Product for each country of the Territory included in the calculation of Net Sales, the Net Sales in each country of the Territory of Licensed Product during the reporting period, a calculation of royalty adjustments pursuant to Section 7.4 (if any) for such period and the royalties payable under this Agreement.  Quarterly reports shall be due no later than the [**] day following the end of each Calendar Quarter.  In addition, to the extent required under Sections 6.1.3(b) or 6.4.1, MedCo shall prepare and deliver to Alnylam any additional reports as required under the Alnylam In-Licenses and to determine any payments due under Section 6.4.  Royalties shown to have accrued by each royalty report shall be due and payable on the date such royalty report is due.  Along with the last report for a Calendar Year provided hereunder, MedCo will provide a final report for such entire Calendar Year that includes a calculation of [**] (if any) for such period, and a statement on whether any reconciling payments must be made at such time to effect the intent of Section 7.4.4.  Within [**] days after such statement is provided, the Party that owes any amounts to the other Party to effect such reconciliation will pay the relevant amount to the other Party.  MedCo and its Related Parties shall keep complete and accurate records in sufficient detail to enable the royalties and other payments payable hereunder, and, to the extent required under Sections 6.1.3(b) or 6.4.1, by Alnylam to Third Parties under the Alnylam In-Licenses, to be determined.

7.4.8Blended Royalty Rates. The Parties acknowledge and agree that the Patent Rights and Know-How licensed pursuant to this Agreement justify royalty rates of differing amounts with respect to the sales of Licensed Products, which rates could be applied separately to Licensed Products involving the 

34

exercise of such Licensed Patents and/or the incorporation of such Know-How, and that, if such royalties were calculated separately, royalties relating to Patent-Rights and royalties relating to Know-How would last for different terms.  Notwithstanding the foregoing, the Parties have determined, for reasons of convenience, that blended royalty rates for the Patent Rights and the Know-How licensed hereunder, as set forth above, will apply during a single Royalty Term.
  
7.5Audits.

7.5.1Upon the written request of a Party and not more than [**], the other Party and its Related Parties shall permit an independent certified public accounting firm of internationally-recognized standing selected by the requesting Party and reasonably acceptable to the other Party, at the requesting Party's expense except as set forth below, to have access during normal business hours to such of the records of the other Party as may be reasonably necessary to verify the accuracy of the royalty, Cost reimbursement and other reports hereunder for any Calendar Year ending not more than [**] Calendar Years prior to the date of such request for the sole purpose of verifying the basis and accuracy of costs incurred under Section 2.3.1, to the extent Alnylam has provided notice thereof to MedCo pursuant to Section 2.3.3, and payments made under Sections 2.3.3, 6.4 and, if applicable, 12.3 and Articles 5, 7 and 11.  The records for any Calendar Year may be audited no more than once.

7.5.2If such accounting firm identifies a discrepancy made during such period, the appropriate Party shall pay the other Party the amount of the discrepancy, together with late-payment interest in accordance with Section 7.7, within [**] days after the date the requesting Party delivers to the other Party such accounting firm's written report so concluding, or as otherwise agreed by the Parties in writing.  The fees charged by such accounting firm shall be paid by the requesting Party, unless such discrepancy results from a reporting error by the other Party and represents an underpayment by such other Party of at least five percent (5%) of the total amounts due from such other Party hereunder, or represents an overpayment to such other Party of at least five percent (5%) of the total amounts due to such other Party hereunder, in a Calendar Year, in which case such fees, to the extent reasonable, shall be paid by the other Party.

7.5.3To the extent required under Sections 6.1.3(b) or 6.4.1, and subject to Section 6.4, MedCo shall comply with all applicable audit requirements in the Alnylam In-Licenses and shall include in each sublicense granted by it pursuant to this Agreement a provision requiring its Sublicensees to make reports to Alnylam, to keep and maintain records of sales made pursuant to such sublicense and to grant access to such records by the independent accountants of the Person(s) that are also party to such Alnylam In-Licenses to the same extent required of MedCo under this Agreement.

7.5.4Unless an audit for a Calendar Year has been commenced prior to the [**] anniversary of the end of such Calendar Year, the calculation of royalties, Cost reimbursement and other payments payable with respect to such Calendar Year shall be binding and conclusive upon both Parties, and each Party and its Related Parties shall be released from any further liability or accountability with respect to such royalties or expense reimbursement for such Calendar Year, upon such [**] anniversary.  If an audit for a Calendar Year has been commenced prior to the [**] anniversary of the end of such Calendar Year, the calculation of royalties, Cost reimbursement and other payments payable with respect to such Calendar Year shall be binding and conclusive upon both Parties, and each Party and its Related Parties shall be released from any further liability or accountability with respect to such royalties or expense reimbursement for such Calendar Year, following the conclusion of such audit.  

7.5.5Each Party shall treat all financial information subject to review under this Section 7.5 or under any sublicense agreement as the audited Party's Confidential Information in accordance with the 

35

confidentiality and non-use provisions of this Agreement, and shall cause its accounting firm to enter into an acceptable confidentiality agreement with the audited Party and/or its Related Parties obligating it to retain all such information in confidence pursuant to such confidentiality agreement.

7.6Payment Exchange Rate.  All payments to be made under this Agreement shall be made in United States dollars and shall be paid by bank wire transfer in immediately available funds to such bank account in the United States as may be designated in writing by the receiving Party from time to time. In the case of Net Sales made or expenses incurred by a Party and its Related Parties in currencies other than United States dollars, the rate of exchange to be used in computing the amount of United States dollars due shall be the rate of exchange utilized by such Party in its worldwide accounting system and calculated in accordance with generally accepted accounting principles in the United States consistently applied, prevailing on the last day of each Calendar Quarter for royalty payments. 
 
7.7Late Payments.  Any amount owed by a Party to the other Party under this Agreement that is not paid on or before the date such payment is due shall bear interest at a rate per annum equal to the lesser of (a) the then current one (1) month London Inter-Bank Offering Rate for US Dollars, as quoted on the British Banker's Association's website currently located at www.bba.org.uk (or such other source as may be mutually agreed by the Parties), plus [**] percentage points, per annum or (b) the highest rate permitted by Law, calculated on the number of days such payments are paid after such payments are due and compounded monthly.
  
7.8Blocked Payments.  If, by reason of Laws in any jurisdiction in the Territory, it becomes impossible or illegal for a Party to transfer milestone payments, royalties or other payments under this Agreement to the other Party, the payor shall promptly notify the payee.  During any such period described above, the payor shall deposit such payments in local currency in the relevant jurisdiction to the credit of the payee in a recognized banking institution designated by the payee or, if none is designated by the payee within a period of [**] days, in a recognized banking institution selected by the payor and identified in a written notice given to the payee.

7.9Taxes.   

7.9.1The Parties acknowledge and agree that, as of the Effective Date, no deduction for any tax withholding shall be required with respect to the payments due under this Agreement.  Each Party (the “Paying Party”) shall use reasonable efforts to minimize tax withholding on payments made to the other Party (the “Payee”).  Notwithstanding such efforts, if the Paying Party concludes that tax withholdings under the Laws of any country are required with respect to payments to the Payee, the Paying Party shall promptly notify the Payee and allow the Payee [**] Business Days to determine whether there are actions the Payee can lawfully undertake to avoid such withholding.  The Paying Party shall refrain from making such payment until the earliest to occur of:  (a) such [**] Business Day period has expired; (b) the Payee instructs the Paying Party that the Payee intends to take actions that will reduce, or obviate the need for, such withholding, in which case the Paying Party shall make such payment (and future payments subject to the same or similar treatment), subject to no or such reduced withholding of tax, only after (i) it is instructed to do so by the Payee and (ii) it has received written advice from  the Payee's counsel, in form and substance reasonably satisfactory to the Paying Party, that such actions have been taken, are lawful and are effective to so reduce or eliminate such withholding; or (c) the Payee instructs the Paying Party to make such payment and withhold the required amount of tax and pay it to the appropriate Governmental Authority in accordance with applicable Laws, in which case, the Paying Party shall take such actions and shall promptly thereafter provide the Payee with copies of receipts or other evidence of such withheld amount and such payment, including to the extent reasonably available to the Paying Party, such evidence 

36

as is reasonably required and sufficient to allow the Payee to document such tax withholdings adequately for purposes of claiming foreign tax credits and similar benefits.  The Parties will cooperate reasonably in completing and filing documents required under the provisions of any applicable tax Laws or under any other applicable Law, in connection with the making of any required tax withholding payment, or in connection with any claim to a refund of, or credit for, any such payment.  Each Party will reasonably cooperate with the other Party (at such other Party's expense and request) to minimize such taxes imposed on such other Party in accordance with applicable Laws.  

7.9.2Notwithstanding the foregoing, if, as a result of (a) the assignment of this Agreement by the Paying Party to an Affiliate or a Third Party outside of the United States or (b) the exercise by the Paying Party of its rights under this Agreement through an Affiliate or Third Party outside of the United States, foreign withholding tax in excess of the foreign withholding tax amount that would have been payable in the absence of such assignment or exercise of rights becomes payable with respect to amounts due to the Payee hereunder, such amount due to the Payee will be increased so that the amount actually paid to the Payee (after withholding of the excess withholding tax) equals the amount that would have been payable to the Payee in the absence of such excess withholding.

7.9.3For clarity, the provisions of Sections 7.9.1 and 7.9.2 shall not apply to taxes imposed on a Party's net income.

7.10Invoices.  To the extent necessary for the Paying Party to comply with applicable Law or GAAP, the Paying Party may require the other Party to issue an invoice to the Paying Party for any amount due by the Paying Party hereunder prior to the Paying Party paying such amount.

7.11Good Faith Disputes Over Payment Obligations,  With respect to any payment due or purported to be due hereunder, the portion of any such payment which is disputed in good faith shall not be owed until the dispute is resolved, and the Parties shall use good faith efforts to promptly resolve such dispute; provided, however, that any such amount finally determined to be due shall be paid with interest pursuant to Section 7.7 from the date originally due (without regard to this Section 7.11).

		
	8.
	CONFIDENTIALITY AND PUBLICATION 

8.1Nondisclosure Obligation.  

(a) All Confidential Information disclosed by one Party to the other Party hereunder shall be maintained in confidence by the receiving Party and shall not be disclosed to a Third Party or used for any purpose except as set forth herein without the prior written consent of the disclosing Party, except that no information or data shall be considered Confidential Information to the extent that such information or data:
		
	(i)
	is known by the receiving Party at the time of its receipt, and not through a prior disclosure by the disclosing Party, as documented by the receiving Party's business records;

		
	(ii)
	is in the public domain or publicly known by use and/or publication before its receipt from the disclosing Party (or, with respect to Joint Collaboration IP, before its development hereunder), or thereafter enters the public domain or becomes publicly known through no fault of the receiving Party;

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	(iii)
	is subsequently disclosed to the receiving Party by a Third Party who may lawfully do so and is not under an obligation of confidentiality to the disclosing Party; or

		
	(iv)
	is developed by the receiving Party independently of Confidential Information received from the disclosing Party (including any Joint Collaboration IP), as documented by the receiving Party's business records.

(b)    Notwithstanding the obligations of confidentiality and non-use set forth above and in Section 8.2 below, a receiving Party may provide Confidential Information disclosed to it, and disclose the existence and terms of this Agreement, as may be reasonably required in order to perform its obligations and to exploit its rights under this Agreement, to (i) Related Parties, and their employees, directors, agents, consultants, advisors and/or other Third Parties for the performance of its obligations hereunder (or for such entities to determine their interest in performing such activities) in accordance with this Agreement, in each case who are obligated to keep such Confidential Information confidential on terms no less stringent than those in this Section 8.1; (ii) Governmental Authorities or other Regulatory Authorities in order to obtain patents in accordance with this Agreement, or otherwise perform its obligations or exploit its rights under this Agreement; provided, that such Confidential Information shall be disclosed only to the extent reasonably necessary to do so; (iii) the extent required by Law, including by the rules or regulations of the United States Securities and Exchange Commission or similar regulatory agency in a country other than the United States or of any stock exchange or listing entity; (iv) any bona fide actual or prospective underwriters, investors, lenders, other financing sources, acquirers, permitted sublicensees, collaborators or strategic partners and to consultants and advisors of such Party, in each case who are obligated to keep such Confidential Information confidential on terms no less stringent than those in this Section 8.1; and (v) Third Parties to the extent a Party is required to do so pursuant to the terms of an In-License. 
If a Party is required by Law to disclose Confidential Information that is subject to the non-disclosure provisions of this Section 8.1 or Section 8.2, such Party shall, to the extent permitted by Law, promptly inform the other Party of the disclosure that is being sought in order to provide the other Party an opportunity to challenge or limit the disclosure obligations.  Confidential Information that is required to be disclosed by Law shall remain otherwise subject to the confidentiality and non-use provisions of this Section 8.1 and Section 8.2.  If either Party concludes that a copy of this Agreement must be filed with the United States Securities and Exchange Commission or similar regulatory agency in a country other than the United States, such Party will provide the other Party with a copy of this Agreement showing any provisions hereof as to which the Party proposes to request confidential treatment, will provide the other Party with an opportunity to comment on any such proposed redactions and to suggest additional redactions, and will take such Party's reasonable and timely comments into consideration before filing the Agreement.
8.2Publication and Publicity.  

8.2.1Publication.  MedCo and Alnylam each acknowledge the other Party's interest in publishing the results of the Collaboration.  Each Party also recognizes the mutual interest in obtaining valid patent protection and in protecting trade secret information.  Consequently, except for disclosures permitted pursuant to Section 8.1, 8.2.2(b) or 8.2.2(c), either Party wishing to make a publication or public presentation of Development results that contains the Confidential Information of the other Party shall deliver to the other Party a copy of the proposed written publication or presentation at least [**] days prior to submission for publication or presentation.  The reviewing Party shall have the right (a) to propose modifications to the publication or presentation for patent reasons, trade secret reasons or business reasons, which proposals the publishing Party may accept or reject in its discretion, and (b) to request a reasonable delay in publication or presentation in order to protect patentable information in accordance with Article 11.  If the reviewing 

38

Party requests a delay pursuant to clause (b), the publishing Party shall delay submission or presentation for a period of an additional [**] days to enable the non-publishing Party to file patent applications protecting such Party's rights in such information in accordance with Article 11.  With respect to any proposed publications or disclosures by clinical investigators or academic or non-profit collaborators, such materials shall be subject to review under this Section 8.2 to the extent that MedCo or Alnylam, as the case may be, has the right and ability (after using Commercially Reasonable Efforts to obtain such right and ability) to do so. 

8.2.2Publicity.  

(a)    Except as set forth in Section 8.1 above and clause (b) below, the terms of this Agreement may not be disclosed by either Party, and no Party shall use the name, trademark, trade name or logo of the other Party or its employees in any publicity, news release or disclosure relating to this Agreement or its subject matter, without the prior express written permission of the other Party, except as may be required by Law or expressly permitted by the terms of the Transaction Agreements. 
(b)    Following the execution of this Agreement, the Parties shall issue a joint press release agreed to by the Parties and substantially in the form set forth in Schedule F.  After such initial press release, except as provided in Sections 8.1, 8.2.2(a), or 8.2.2(c), neither Party shall issue a press release or public announcement relating to this Agreement without the prior written approval of the other Party, which approval shall not be unreasonably withheld, conditioned or delayed, except that a Party may (i) once a press release or other public statement is approved in writing by both Parties, make subsequent public disclosure of the information contained in such press release or other written statement without the further approval of the other Party, and (ii) issue a press release or public announcement as required, in the reasonable judgment of such Party, by Law, including by the rules or regulations of the United States Securities and Exchange Commission or similar regulatory agency in a country other than the United States or of any stock exchange or listing entity. 
(c)    Either Party may issue a press release or make a public disclosure relating to this Agreement or the Parties' activities under this Agreement to the extent that such disclosure describes the commencement and/or  “top-line” results of Clinical Trials of a Licensed Product conducted by such Party, the achievement by such Party of any material Development events with respect to a Licensed Product or the filing for or receipt of Regulatory Approval with respect to the Licensed Product by such Party or its Related Parties in the Territory, or amounts paid to either Party in respect of the achievement of any milestone events.  Prior to making any such disclosure, the Party making the disclosure shall provide the other Party with a draft of such proposed disclosure at least five (5) Business Days (or, to the extent faster timely disclosure of a material event is required by Law or stock exchange or stock market rules, such shorter period of time sufficiently in advance of the disclosure so that the other Party will have the opportunity to comment upon the disclosure and the disclosing Party will be able to comply with its obligations) prior to making any such disclosure, for the other Party's review and comment, which shall be considered in good faith by the disclosing Party. 
(d)    Subject to Sections 8.2.1 and 8.2.2(c), MedCo and its Related Parties may make public announcements or disclosures reasonably necessary or useful to Develop or Commercialize the Licensed Products in the Field in the Territory, including disclosures necessary to recruit subjects to clinical trials and disclosures to advertise, promote and otherwise Commercialize the Licensed Products.

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9.REPRESENTATIONS, WARRANTIES AND COVENANTS; INDEMNIFICATION 

9.1Mutual Representations and Warranties.  Each Party represents and warrants to the other Party that as of the Effective Date: 

9.1.1It is duly organized and validly existing under the laws of its jurisdiction of incorporation or formation, and has full corporate or other power and authority to enter into this Agreement, and to carry out the provisions hereof.  

9.1.2It is duly authorized to execute and deliver this Agreement, and to perform its obligations hereunder, and the person or persons executing this Agreement on its behalf has been duly authorized to do so by all requisite corporate action.

9.1.3This Agreement is legally binding upon it and enforceable in accordance with its terms. The execution, delivery and performance of this Agreement by it does not conflict with any agreement, instrument or understanding, oral or written, to which it is a party and by which it may be bound, or with its charter or by-laws.

9.1.4It has not granted, and will not grant, during the Term, any right to any Affiliate or Third Party that would conflict with the rights granted to the other Party hereunder. 
 
9.1.5Neither it nor any of its Affiliates has been debarred or is subject to debarment. 

9.2Representations and Warranties of Alnylam.  Except as provided in Schedule G, Alnylam represents and warrants to MedCo that as of the Effective Date: 

9.2.1 (a) Alnylam is the sole and exclusive owner of, or otherwise has the right to license to MedCo as set forth in this Agreement, pursuant to an Alnylam In-License (or will Control pursuant to an Additional Alnylam In-License at such time that such Additional Alnylam In-License is included as an Alnylam In-License pursuant to Section 6.4.2.3), the Alnylam Technology.  (b) All of the Alnylam Technology licensed to MedCo hereunder in the Territory that is solely and exclusively owned by Alnylam or its Affiliates is free and clear of liens, charges or encumbrances, other than licenses granted to Third Parties that are not inconsistent with the rights and licenses granted to MedCo under this Agreement.  (c) The Alnylam Technology and the Patent Rights licensed by Alnylam pursuant to the Additional Alnylam In-Licenses constitute all the intellectual property that Alnylam or its Affiliates own or have rights under that are or may be reasonably necessary or useful for the Development, Manufacturing and Commercialization of the Licensed Products. 

9.2.2 Alnylam has sufficient legal and/or beneficial title and ownership of, or sufficient license rights under, the Alnylam Patent Rights listed in Schedule C to grant the licenses to such Alnylam Patent Rights granted to MedCo pursuant to this Agreement.

9.2.3 (a) To Alnylam's knowledge, Schedule C-1 sets forth a complete and accurate list of the Alnylam Core Technology Patent Rights.  (b) To Alnylam's knowledge, Schedule C-2 sets forth a complete and accurate list of the Alnylam Product-Specific Patent Rights.  (c) Schedules C-1 and C-2 collectively set forth a complete and accurate list of the Alnylam Patent Rights owned, either solely or jointly, by Alnylam or its Affiliates.  (d) To Alnylam's knowledge, Schedules C-1and C-2 collectively set forth a complete and accurate list of the Alnylam Patent Rights licensed, either exclusively or nonexclusively, to Alnylam or its Affiliates. (e) To Alnylam's knowledge, each issued Alnylam Patent Right remains in full 

40

force and effect.  (f) Alnylam or its Affiliates have timely paid all filing and renewal fees payable with respect to such Alnylam Patent Rights for which Alnylam controls prosecution and maintenance.  (g) Schedules C-1 and C-2 indicate whether each Alnylam Patent Right is owned exclusively by Alnylam or its Affiliates, is owned jointly by Alnylam and one or more Affiliates or Third Parties, or is licensed to Alnylam or its Affiliates.  (h) For each Alnylam Patent Right that is owned, but not owned exclusively, by Alnylam or its Affiliates, or that is licensed to Alnylam or its Affiliates, Schedules C-1 and C-2 identify the Third Party owner(s) and, if applicable, the Alnylam In-License pursuant to which Alnylam Controls such Alnylam Patent Right.  (i) For each Alnylam Product-Specific Patent Right that is licensed, but not exclusively licensed, to Alnylam or its Affiliates, Schedule C-2 indicates the non-exclusive nature of the license.  (j) For each Alnylam Core Technology Patent Right family (other than Patent Rights licensed from Isis Pharmaceuticals, Inc.) that is licensed, but not exclusively licensed, to Alnylam or its Affiliates, Schedule C-1 indicates the non-exclusive nature of the license.  (k) Alnylam or its Affiliates is/are the sole and exclusive owner(s) of all Patent Rights identified in Schedules C-1 or C-2 as being owned exclusively by Alnylam or its Affiliates and Alnylam Controls all other Patent Rights identified on such schedules.  (l) To Alnylam's knowledge, Schedule C-3 sets forth a complete and accurate list of the Patent Rights licensed to Alnylam pursuant to the Additional Alnylam In-Licenses and which, if MedCo exercises its option pursuant to Section 6.4.2.3 with respect to the relevant Additional Alnylam In-License on the Effective Date, would be considered “Controlled” by Alnylam. 

9.2.4(a) To Alnylam's knowledge, the Alnylam Product-Specific Patent Rights, are, or, upon issuance, will be, valid and enforceable patents and no Third Party has challenged or threatened to challenge the scope, validity or enforceability of any Alnylam Product-Specific Patent Right (including, by way of example, through opposition or the institution or written threat of institution of interference, nullity or similar invalidity proceedings before the United States Patent and Trademark Office or any analogous foreign Governmental Authority).  (b) Alnylam has complied with all applicable Laws, including any duties of candor to applicable patent offices, in connection with its filing, prosecution and maintenance of the Alnylam Patent Rights for which Alnylam controls filing, prosecution and maintenance.  

9.2.5 (a) Section A and Section C of Schedule D sets forth a complete and accurate list of all agreements between Alnylam or any of its Affiliates, on the one hand, and a Third Party(ies), on the other hand, entered into on or prior to the Effective Date and pursuant to which Alnylam or any of its Affiliates licenses or acquires any intellectual property rights owned or controlled by Alnylam or its Affiliates which are reasonably necessary or useful to Develop, Manufacture or Commercialize Licensed Products in the Field.  (b) Alnylam and its Affiliates have not granted any Third Party, and are not under any obligation to grant any Third Party, any right to Develop, Manufacture or Commercialize Licensed Products in the Field in the Territory, except for the non-exclusive licenses granted to the Third Parties pursuant to the Existing Alnylam Third Party Agreements.  (c) Alnylam Controls all Know-How and Patent Rights licensed to Alnylam under the Existing Alnylam In-Licenses that are necessary or useful for MedCo to Develop, Manufacture and/or Commercialize Licensed Products in the Field in the Territory.  (d) Without limiting the generality of the foregoing, (i) Alnylam has obtained all necessary consents (if any) and fulfilled all necessary conditions (if any) to sublicense to MedCo under this Agreement such Know-How and Patent Rights licensed to Alnylam or its Affiliates under the Existing Alnylam In-Licenses, and (ii) Alnylam has obtained all necessary consents (if any) under the Existing Alnylam Third Party Agreements to grant the licenses to MedCo to Alnylam Technology that are purported to be granted to MedCo pursuant to this Agreement.  (e) At such time that an Additional Alnylam In-License is included as an Alnylam In-License pursuant to Section 6.4.2.3, Alnylam will Control all Know-How, if any, and Patent Rights licensed to Alnylam or its Affiliates under such Additional Alnylam In-License that is necessary or useful for MedCo to Develop, Manufacture and/or Commercialize Licensed Products in the Field in the Territory.

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9.2.6 To Alnylam's knowledge, neither Alnylam nor its Affiliates are in breach or default under any Existing Alnylam In-License or Additional Alnylam In-License, and neither Alnylam nor its Affiliates have received any written notice of breach or default with respect to any Existing Alnylam In-License or Additional Alnylam In-License.

9.2.7Alnylam has provided MedCo with true and complete copies of all Existing Alnylam In-Licenses, Additional Alnylam In-Licenses and Existing Alnylam Third Party Agreements; provided, however, that, (a) to the extent that the terms of any such agreements require Alnylam to redact any provisions thereof before providing such agreements, or relevant portion thereof, to MedCo, Alnylam has provided MedCo with copies of such agreements, which are true and complete to the fullest extent possible under such agreements and that any provisions or portions which have not been provided to MedCo either (i) are not relevant to any obligations owed by MedCo, or rights granted to MedCo, under such agreement or any Transaction Agreement or (ii) have been summarized by Alnylam to MedCo in writing, and such summary is true and complete in all material respects; and (b) Alnylam is not required by this Section 9.2.7 to provide to MedCo copies of any amendment or side letter to any Existing Alnylam In-License, Additional Alnylam In-License or Existing Alnylam Third Party Agreement which is not materially relevant to the rights granted to, and the obligations imposed on, MedCo under this Agreement.

9.2.8To Alnylam's knowledge, the use, Development, Manufacture or Commercialization by Alnylam or MedCo (or their respective Related Parties) of any Licensed Product as formulated and manufactured as of the Effective Date, or as intended to be formulated and manufactured as of the Effective Date, (a) does not and will not infringe any issued, valid and enforceable patent of any Third Party or (b) will not infringe the claims of any published Third Party patent application when and if such claims were to issue in scope that was valid and enforceable.

9.2.9 There is no (a) claim, demand, suit, proceeding, arbitration, inquiry, investigation or other legal action of any nature, civil, criminal, regulatory or otherwise, pending or, to Alnylam's knowledge, threatened against Alnylam or any of its Affiliates or (b) judgment or settlement against or owed by Alnylam or any of its Affiliates, in each case in connection with the Alnylam Technology or any Licensed Product.

9.2.10To Alnylam's knowledge, the Development of Licensed Product in the Territory to date has been conducted by Alnylam and its Affiliates and its subcontractors, in compliance (in all material respects) with all applicable Laws.

9.3[Intentionally Omitted]. 

9.4Warranty Disclaimer.  EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATION OR EXTENDS ANY WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED, TO THE OTHER PARTY WITH RESPECT TO ANY TECHNOLOGY, LICENSED PRODUCT, GOODS, SERVICES, RIGHTS OR OTHER SUBJECT MATTER OF THIS AGREEMENT AND HEREBY DISCLAIMS ALL IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE AND NON-INFRINGEMENT WITH RESPECT TO ANY AND ALL OF THE FOREGOING.  EACH PARTY HEREBY DISCLAIMS ANY REPRESENTATION OR WARRANTY THAT THE DEVELOPMENT, MANUFACTURE OR COMMERCIALIZATION OF THE LICENSED PRODUCTS PURSUANT TO THIS AGREEMENT WILL BE SUCCESSFUL OR THAT ANY PARTICULAR SALES LEVEL WITH RESPECT TO THE LICENSED PRODUCTS WILL BE ACHIEVED.

9.5Certain Covenants.

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9.5.1.Exclusivity. During the Term but subject to this Agreement including Sections 6.1.4 and 6.7, neither Party or its Affiliates will, without the prior written agreement of the other Party, alone or with or for an Affiliate or Third Party, or grant any Third Party a license to, research, develop, manufacture or commercialize in any country any product directed to the human PCSK9 gene, other than a Licensed Product pursuant to this Agreement.  For purposes of this Section 9.5.1, “directed to” means, with respect to a compound, molecule or siRNA and a target, that such compound, molecule or siRNA modulates the expression or activity of such target, influences the expression or activity of such target or otherwise antagonizes or inhibits the expression or activity of such target, and with respect to a product and a target, that such product contains a compound, molecule or siRNA that modulates the expression or activity of such target, influences the expression or activity of such target or otherwise antagonizes or inhibits the expression or activity of such target.

9.5.2.Compliance. Each Party and its Related Parties shall conduct the Collaboration and the Development, Manufacture and Commercialization of the Licensed Product in material accordance with all Laws and industry standards, including current governmental regulations concerning good laboratory practices, good clinical practices and good manufacturing practices. 

9.5.3.Debarment.  Neither Party nor any of its Affiliates will use in any capacity, in connection with the Collaboration or the performance of its obligations under this Agreement, any person or entity that has been debarred pursuant to Section 306 of the United States Federal Food, Drug, and Cosmetic Act, as amended, or that is the subject of a conviction described in such section.  Each Party agrees to inform the other Party in writing immediately if it learns that (a) it or any person or entity that is performing activities in the Collaboration or under this Agreement, is debarred or is subject to debarment or is the subject of a conviction described in Section 306, or (b) any action, suit, claim, investigation or legal or administrative proceeding is pending or, to the notifying Party's knowledge, is threatened, relating to the debarment or conviction of the notifying Party or any person or entity used in any capacity by such Party or any of its Affiliates in connection with the Collaboration or the performance of its other obligations under this Agreement

10.INDEMNIFICATION; LIMITATION OF LIABILITY; INSURANCE

10.1General Indemnification by MedCo.  MedCo shall indemnify, hold harmless, and defend Alnylam, its Related Parties, and their respective directors, officers, employees and agents (“Alnylam Indemnitees”) from and against any and all Third Party claims, suits, losses, liabilities, damages, costs, fees and expenses (including reasonable attorneys' fees) (collectively, “Losses”) to the extent such Losses arise out of or result from, directly or indirectly, (a) any breach of, or inaccuracy in, any representation or warranty made by MedCo in the Transaction Agreements or any breach or violation of any covenant or agreement of MedCo in the Transaction Agreements, (b) the negligence or willful misconduct by or of MedCo and its Related Parties, and their respective directors, officers, employees and agents, in the performance of MedCo's obligations under the Transaction Agreements, or (c) the Development, Manufacture or Commercialization of Licensed Products by MedCo or its Related Parties.  MedCo shall have no obligation to indemnify the Alnylam Indemnitees to the extent that the Losses arise out of or result from, directly or indirectly, any breach of, or inaccuracy in, any representation or warranty made by Alnylam in the Transaction Agreements, or any breach or violation of any covenant or agreement of Alnylam in the Transaction Agreements, or the negligence or willful misconduct by or of any of the Alnylam Indemnitees. 

10.2General Indemnification by Alnylam.  Alnylam shall indemnify, hold harmless, and defend MedCo, its Related Parties and their respective directors, officers, employees and agents (“MedCo Indemnitees”) from and against any and all Losses to the extent such Losses arise out of or result from, 

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directly or indirectly, (a) any breach of, or inaccuracy in, any representation or warranty made by Alnylam in the Transaction Agreements or any breach or violation of any covenant or agreement of Alnylam in the Transaction Agreements, (b) the negligence or willful misconduct by or of Alnylam and its Related Parties, and their respective directors, officers, employees and agents, in the performance of Alnylam's obligations under the Transaction Agreements, (c) the Development, Manufacture or Commercialization of Licensed Products by Alnylam or its Related Parties pursuant to the Initial Development Plan, the Development Supply Agreement or Section 12.3, or (d) the exercise by Alnylam or its Related Parties of its rights in Section 6.2.2.  Alnylam shall have no obligation to indemnify the MedCo Indemnitees to the extent that the Losses arise out of or result from, directly or indirectly, any breach of, or inaccuracy in, any representation or warranty made by MedCo in the Transaction Agreements, or any breach or violation of any covenant or agreement of MedCo in the Transaction Agreements, or the negligence or willful misconduct by or of any of the MedCo Indemnitees.

10.3Indemnification Procedure.  In the event of any such claim against any MedCo Indemnitee or Alnylam Indemnitee (individually, an “Indemnitee”), the indemnified Party shall promptly notify the other Party in writing of the claim once the indemnified Party learns of it, and the indemnifying Party shall manage and control, at its sole expense, the defense of the claim and its settlement.  The Indemnitee shall cooperate with the indemnifying Party, at the indemnifying Party's reasonable request and expense, and may, at its option and expense, be represented in any such action or proceeding.  The indemnifying Party shall not be liable for any settlements, litigation costs or expenses incurred by any Indemnitee without the indemnifying Party's written authorization.  The indemnifying Party shall not settle any such claim without the Indemnitee's consent, unless such settlement requires only payments by the indemnifying Party.  Notwithstanding the foregoing, if the indemnifying Party believes that any of the exceptions to its obligation of indemnification of the Indemnitees set forth in Sections 10.1 or 10.2 may apply, the indemnifying Party shall promptly notify the Indemnitees, which shall then have the right to be represented in any such action or proceeding by separate counsel at their expense; provided, that the indemnifying Party shall be responsible for payment of such expenses if the Indemnitees are ultimately determined to be entitled to indemnification from the indemnifying Party for the matters to which the indemnifying Party notified the Indemnitees that such exception(s) may apply.  To the extent that an indemnification obligation hereunder results in payments to a Third Party which are described in Section 6.4.3, the provisions of Sections 10.1 through 10.3 shall be subject to the provisions of Section 6.4.3 to the extent Section 6.4.3 is applicable.

10.4Limitation of Liability.  NEITHER PARTY HERETO WILL BE LIABLE FOR SPECIAL, INCIDENTAL, CONSEQUENTIAL OR PUNITIVE DAMAGES ARISING OUT OF THIS AGREEMENT OR THE EXERCISE OF ITS RIGHTS HEREUNDER, INCLUDING LOST PROFITS ARISING FROM OR RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF SUCH DAMAGES, EXCEPT AS A RESULT OF A PARTY'S WILLFUL MISCONDUCT, A MATERIAL BREACH OF THE CONFIDENTIALITY AND NON-USE OBLIGATIONS IN ARTICLE 8, OR A BREACH OF THE EXCLUSIVITY PROVISION IN SECTION 9.5.1.  NOTHING IN THIS SECTION 10.4 IS INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF EITHER PARTY.

10.5Insurance. Each Party shall maintain insurance during the Term and for a period of at least [**] years after the last commercial sale of any Licensed Product under this Agreement by such Party or its Related Parties, with a reputable, solvent insurer in an amount appropriate for its business and products of the type that are the subject of this Agreement, and for its obligations under this Agreement.  Specifically, each Party shall maintain product liability insurance of at least [**] U.S. Dollars ($[**]) per occurrence. Upon reasonable request, each Party shall provide the other Party with evidence of the existence and maintenance of such insurance coverage.

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10.6Obligations with Respect to IP Representations, Warranties and Covenants.  In the event that Alnylam has materially breached any of its representations, warranties or covenants under Sections 9.2 or 6.4.4 and such breach has a material adverse effect on the rights of MedCo under this Agreement, then Alnylam shall use Commercially Reasonable Efforts to remedy such breach and obtain the right from the relevant Affiliate or Third Party in order to Control the relevant intellectual property such that it is considered Alnylam Technology and licensed or sublicensed to MedCo hereunder, and Alnylam shall bear any additional incremental payments that may be owed to such Affiliate or Third Party with respect to such remedy and such rights, license and sublicense, including any costs and expenses that might otherwise reasonably be imposed on MedCo or its Related Parties with respect to such consent or such rights, license or sublicense, other than the payment of royalties in accordance with Section 6.4.3 as set forth as of the Effective Date under any Existing Alnylam In-License (or any Additional Alnylam In-License, as the case may be) with respect to sales of Licensed Products by MedCo or its Related Parties.  For clarity, the foregoing shall not be deemed to be MedCo's sole remedy with respect to such breach.

11.INTELLECTUAL PROPERTY OWNERSHIP, PROTECTION AND RELATED MATTERS

11.1Inventorship.  Inventorship for patentable inventions conceived or reduced to practice during the course of the performance of activities pursuant to this Agreement shall be determined in accordance with United States patent laws for determining inventorship.  

11.2 Ownership. Alnylam shall own the entire right, title and interest in and to all inventions and discoveries (and Patent Rights claiming patentable inventions therein) first conceived or reduced to practice or, with respect to inventions and discoveries other than patentable inventions, otherwise identified, developed, made or discovered, solely by employees or consultants of Alnylam or acquired solely by Alnylam in the course of conducting the Collaboration.  MedCo shall own the entire right, title and interest in and to all inventions and discoveries (and Patent Rights claiming patentable inventions therein) first conceived or reduced to practice or, with respect to inventions and discoveries other than patentable inventions, otherwise identified, developed, made or discovered, solely by employees or consultants of MedCo or acquired solely by MedCo in the course of conducting the Collaboration.  The Parties shall jointly own any inventions and discoveries (and Patent Rights claiming patentable inventions therein) first conceived or reduced to practice or, with respect to inventions and discoveries other than patentable inventions, otherwise identified, developed, made or discovered, jointly in the course of conducting the Collaboration.

11.3Prosecution and Maintenance of Patent Rights.  

11.3.1MedCo Technology and Product-Specific Technology.  MedCo has the sole right and responsibility to, at MedCo's discretion, file, conduct prosecution, and maintain (including the defense of any interference, opposition or any other pre- or post-grant proceedings or challenges), all Patent Rights comprising MedCo Technology (other than Joint Collaboration IP), in MedCo's name.

11.3.2 Alnylam Technology. 

(a)Subject to Sections 11.3.2(b) and 11.3.2(c), Alnylam has the sole right and responsibility to, at Alnylam's discretion, file, conduct prosecution, and maintain (including the defense of any interference, opposition or any other pre- or post-grant proceedings or challenges), all Patent Rights comprising Alnylam Technology (other than Joint Collaboration IP), in Alnylam's name.  Alnylam agrees to use Commercially Reasonable Efforts to prosecute and maintain such Alnylam Patent Rights in the 

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Major Market Countries, and to prosecute and maintain Alnylam Product-Specific Patent Rights in all other countries reasonably requested by MedCo.  

(b)Alnylam shall provide MedCo, sufficiently in advance for MedCo to comment, with copies of all patent applications and other material submissions and correspondence intended to be filed with any patent counsel or patent authorities pertaining to Patent Rights comprising Alnylam Product-Specific Patent Rights, and Alnylam shall consider in good faith MedCo's reasonable and promptly provided comments and advice with respect to the prosecution or maintenance strategy with respect to such Patent Rights; provided, however, that if Alnylam determines that MedCo's comments or advice are not reasonable, Alnylam shall promptly notify MedCo thereof and the Parties shall promptly discuss such determination.  If the Parties cannot promptly reach agreement with respect to such issue, the Parties shall hire an outside patent attorney, mutually agreeable to the Parties, to determine which Party's approach is more likely to obtain the broadest enforceable patent coverage for the Licensed Products in the Field, and the Parties shall implement such approach.  In the event that MedCo fails to provide any such comments or advice reasonably in advance of a patent office deadline, Alnylam shall in good faith file a response designed to obtain the broadest enforceable patent coverage for the Licensed Products in the Field.  Alnylam shall promptly provide MedCo with copies of all material correspondence received from any patent counsel or patent authorities pertaining to Patent Rights comprising Alnylam Product-Specific Patent Rights.

(c)In the event that Alnylam elects not to seek or continue to seek or maintain patent protection on any Alnylam Product-Specific Patent Rights, subject to the terms and conditions of any applicable Alnylam In-License or Existing Alnylam Third Party Agreement, Alnylam shall notify MedCo of such decision in sufficient time so as to permit MedCo to decide whether to seek, prosecute and maintain such Patent Right and to take any necessary actions without losing patent protection, and MedCo shall have the right (but not the obligation), at its expense, to seek, prosecute and maintain in any country patent protection on such Alnylam Product-Specific Patent Rights in the name of Alnylam.  Alnylam shall use Commercially Reasonable Efforts to make available to MedCo its documentation, and its authorized attorneys, agents or representatives, and such of its employees, as are reasonably necessary to assist MedCo in obtaining and maintaining the patent protection described under this Section 11.3.2(c).  Alnylam shall sign or use Commercially Reasonable Efforts to have signed all legal documents necessary to file and prosecute such patent applications or to obtain or maintain such patents.  

11.3.3Joint Collaboration IP.
  
(a)Alnylam shall have the first right to, at Alnylam's discretion, file, prosecute and maintain (including the defense of any interference, opposition or any other pre- or post-grant proceedings or challenges), all Patent Rights comprising Joint Collaboration IP, in the names of both Alnylam and MedCo.  Alnylam shall provide MedCo, sufficiently in advance for MedCo to comment, with copies of all patent applications and other material submissions and correspondence intended to be filed with any patent counsel or patent authorities pertaining to Patent Rights comprising Joint Collaboration IP, and Alnylam shall consider in good faith MedCo's reasonable and promptly provided comments and advice with respect to the prosecution or maintenance strategy with respect to such Patent Rights; provided, however, that if Alnylam determines that MedCo's comments or advice are not reasonable, Alnylam shall promptly notify MedCo thereof and the Parties shall promptly discuss such determination.  If the Parties cannot promptly reach agreement with respect to such issue, the Parties shall hire an outside patent attorney, mutually agreeable to the Parties, to determine which Party's approach is more likely to obtain the broadest enforceable patent coverage for the Licensed Products in the Field, and the Parties shall implement such approach.  In the event that MedCo fails to provide any such comments or advice reasonably in advance of a patent office deadline, Alnylam shall in good faith file a response designed to obtain the broadest 

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enforceable patent coverage for the Licensed Products in the Field.  Alnylam shall promptly provide MedCo with copies of all material correspondence received from any patent counsel or patent authorities pertaining to Patent Rights comprising Joint Collaboration IP.  Each Party shall sign, or use Commercially Reasonable Efforts to have signed, all legal documents necessary to file and prosecute patent applications or to obtain or maintain patents in respect of such Joint Collaboration IP, at its own cost.

(b)In the event that Alnylam elects not to file or continue to prosecute or maintain patent protection on any Joint Collaboration IP in the Territory, Alnylam shall notify MedCo of such decision in sufficient time so as to permit MedCo to decide whether to seek, prosecute and maintain such Patent Right and to take any necessary actions without losing patent protection, and MedCo shall have the right (but not the obligation), to file, prosecute and maintain in any country Patent Rights comprising Joint Collaboration IP in the names of both Alnylam and MedCo.  Alnylam shall use Commercially Reasonable Efforts to make available to MedCo its documentation, and its authorized attorneys, agents or representatives, and such of its employees, as are reasonably necessary to assist MedCo in obtaining and maintaining the patent protection described under this Section 11.3.3(b).  Alnylam shall sign or use Commercially Reasonable Efforts to have signed all legal documents necessary to file and prosecute such patent applications or to obtain or maintain such patents. 

11.3.4Cooperation.  With respect to the rights granted to a Party under Sections 11.3.2 or 11.3.3, each Party hereby agrees:  (a) to make its employees, agents and consultants reasonably available to the other Party (or to the other Party's authorized attorneys, agents or representatives), to the extent reasonably necessary to enable such Party to undertake patent prosecution; (b) to provide the other Party with copies of all material correspondence pertaining to prosecution with the patent offices; (c) to cooperate, if necessary and appropriate, with the other Party in gaining patent term extensions wherever applicable to Patent Rights licensed under this Agreement; and (d) to endeavor in good faith to coordinate its efforts with the other Party to minimize or avoid interference with the prosecution and maintenance of the other Party's patent applications. 

11.3.5Patent Expenses.  Except as provided below with respect to Alnylam Product-Specific Patent Rights and Patent Rights comprising Joint Collaboration IP in the Territory, the patent filing, prosecution and maintenance expenses incurred after the Effective Date with respect to Patent Rights comprised of Alnylam Technology and MedCo Technology shall be borne by each Party having the right to file, prosecute and maintain such Patent Rights under this Section 11.3.  MedCo shall reimburse Alnylam on a Calendar Quarter basis (and within thirty (30) days after receipt of an invoice) with respect to the out-of-pocket patent filing, prosecution and maintenance expenses incurred by Alnylam after the Effective Date with respect to the Alnylam Product-Specific Patent Rights in the Territory, up to [**] ($[**]) of such expenses per Calendar Year.  The Parties shall share equally the out-of-pocket patent filing, prosecution and maintenance expenses incurred with respect to Patent Rights comprising Joint Collaboration IP.  Each Party shall keep complete and accurate records with respect to such amount required to be paid by the other Party, and such other Party shall have the right to audit such records in accordance with Section 7.5.

11.3.6Patent Term Extension.  MedCo will determine, in its sole discretion, a strategy of seeking available patent term extension, restorations and supplementary protection certificates (“SPC”) and other extensions from among Alnylam Product-Specific Patent Rights, MedCo Patent Rights and Patent Rights comprising Joint Collaboration IP, to the extent applicable, that will be designed to maximize patent protection and commercial value for the Licensed Products in the Field in the Territory, and the Parties, subject to the provisions of any In-License, will seek patent term extensions, restorations, SPCs and other extensions in all relevant countries in the Territory for such Patent Rights as selected by MedCo in accordance with that strategy.  If MedCo determines not to so file for any extension, restoration or SPC 

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for any of such Patent Rights in any relevant country of the Territory, it will give notice of such determination to Alnylam at least [**] days prior to the date on which such a filing must be made or the right to do so is lost, and Alnylam will have the right to make such filing.  Where required under national law, Alnylam will make the filings for such extensions, restorations and SPCs for Alnylam Product-Specific Patents and, as applicable, will make, or cooperate with MedCo to make, the filing for Patent Rights comprising Joint Collaboration IP in the Territory, in each case as directed by MedCo.  Each Party will execute such authorizations and other documents and take such other actions as may be reasonably requested by the other Party to obtain any such extensions, restorations and SPCs in the Territory.  

11.4Third Party Infringement.

11.4.1Notices. Each Party shall promptly report in writing to the other Party any (a) known or suspected infringement of any Alnylam Technology, MedCo Technology or Joint Collaboration IP or (b) unauthorized use or misappropriation of any Confidential Information or Know-How of a Party by a Third Party of which it becomes aware, in each case to the extent such infringing, unauthorized or misappropriating activities involve, as to a Licensed Product, a Generic Product or competing product in the Field (“Competitive Infringement”), and shall provide the other Party with all available evidence of such infringement, unauthorized use or misappropriation.

11.4.2Rights to Enforce.  

(a)    MedCo Technology. Subject to the provisions of any In-License, MedCo shall have the sole and exclusive right to initiate an infringement or other appropriate suit anywhere in the world against any Third Party as to any infringement, or suspected infringement of, any Patent Rights, or of any use or suspected use without proper authorization of any Know-How, comprising MedCo Patent Rights, MedCo Know-How (other than MedCo's interest in Joint Collaboration IP), or MedCo Collaboration IP.  MedCo will consider in good faith any request from Alnylam to initiate an infringement or other appropriate suit against any Third Party with respect to a Competitive Infringement in the Territory of MedCo Patent Rights, MedCo Know-How (other than MedCo's interest in Joint Collaboration IP) or MedCo Collaboration IP; provided, however, that MedCo shall not be required to initiate any such suit or permit Alnylam to initiate any such suit.
(b)    Alnylam Technology and Joint Collaboration IP. Subject to the provisions of any In-License or Existing Alnylam Third Party Agreement, MedCo shall have the first right to initiate an infringement or other appropriate suit or action anywhere in the world against any Third Party with respect to any Competitive Infringement in the Territory of any Alnylam Product-Specific Patent Rights, Joint Collaboration IP (with respect to which MedCo shall consider Alnylam's input in good faith), or, with Alnylam's prior written consent, Alnylam Core Technology Patent Right or Alnylam Know-How (other than Alnylam's interest in Joint Collaboration IP).  Alnylam will consider in good faith any request from MedCo to initiate an infringement or other appropriate suit against any Third Party with respect to a Competitive Infringement in the Territory of any Alnylam Core Technology Patent Right or such Alnylam Know-How (other than Alnylam's interest in Joint Collaboration IP); provided, however, that Alnylam shall not be required to initiate any such suit or permit MedCo to initiate any such suit.
(c)    Step-In Right.  If within [**] days after MedCo's receipt of a notice of a Competitive Infringement with respect to any Alnylam Product-Specific Patent Right or Joint Collaboration IP (or at least ten (10) days before the loss of the right to take an action as described in Section 11.4.2(b) and permitted hereunder with respect to such Competitive Infringement, except if MedCo has notified Alnylam in writing that it intends to, and actually does, take action as described in Section 11.4.2(b) and permitted hereunder 

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against such Competitive Infringement), MedCo does not take any action as described in Section 11.4.2(b) and permitted hereunder against such Competitive Infringement in the relevant country in the Territory, Alnylam may in its sole discretion, bring and control any legal action in connection therewith at its sole expense.  
11.4.3Procedures; Expenses and Recoveries.  The Party having the right to initiate any infringement suit under Section 11.4.2 above shall have the sole and exclusive right to select counsel for any such suit and shall pay all expenses of the suit, including attorneys' fees and court costs and reimbursement of the other Party's reasonable out-of-pocket expense in rendering assistance requested by the initiating Party.  If required under applicable Law in order for the initiating Party to initiate and/or maintain such suit, or if either Party is unable to initiate or prosecute such suit solely in its own name or it is otherwise advisable to obtain an effective legal remedy, in each case, the other Party shall join as a party to the suit and will execute and cause its Affiliates to execute all documents, and take all actions, reasonably necessary for the initiating Party to initiate litigation  and maintain such action.  In addition, at the initiating Party's request, the other Party shall provide other reasonable assistance to the initiating Party in connection with an infringement suit at no charge to the initiating Party except for reimbursement by the initiating Party of reasonable out-of-pocket expenses incurred in rendering such assistance.  The non-initiating Party shall have the right to participate and be represented in any such suit under Section 11.4.2(b) or 11.4.2(c) by its own counsel at its own expense.  If the Parties obtain from a Third Party, in connection with any such suit under Section 11.4.2(b) or 11.4.2(c), any damages, license fees, royalties or other compensation (including any amount received in settlement of such litigation), such amounts shall be allocated in all cases as follows:

		
	(i)
	first, to reimburse each Party for all out-of-pocket expenses of the suit incurred by the Parties, including attorneys' fees and disbursements, court costs and other litigation expenses and, to the extent that such recovery is insufficient to fully reimburse each Party, each Party will be reimbursed pro rata in accordance with each Party's out-of-pocket expenses; and

		
	(ii)
	second, the balance shall be paid as follows:  (A) damages designated by the relevant court as multiple or punitive damages shall be paid [**] percent ([**]%) to the Party initiating the suit and [**] percent ([**]%) to the other Party; and (B) any other amounts shall be paid to MedCo, but, to the extent that MedCo would otherwise owe a royalty to Alnylam if MedCo or its Related Parties had sold the relevant Licensed Product subject to the Competitive Infringement in the Field in the relevant country in the Territory, such balance shall be considered “Net Sales” for purposes of determining royalties owed to Alnylam hereunder.

11.5Trademarks.     MedCo and its Related Parties have the sole right to use any trademark it owns or controls for Licensed Products in the Territory at its sole discretion, and each Party and its Related Parties shall retain all right, title and interest in and to its and their respective corporate names and logos.  MedCo will develop one or more Product Trademark(s) for use by MedCo and its Related Parties in the Territory to Commercialize Licensed Products which have received Regulatory Approval in the Field in the Territory.  MedCo (or its Related Parties, as appropriate) shall own all rights to such Product Trademarks and all goodwill associated therewith, throughout the Territory, and the rights to any Internet domain names incorporating the applicable Product Trademarks or any variation or part of such Product Trademarks used as its URL address or any part of such address.  For the avoidance of doubt, neither Party shall have any right to use the other Party's or the other Party's Related Parties' corporate names or logos in connection with Commercialization of Licensed Products without the prior written consent of the other Party.

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12.TERM AND TERMINATION

12.1Term. This Agreement shall be effective as of the Effective Date and, unless terminated earlier pursuant to Section 12.2, this Agreement shall continue in effect on a Licensed Product-by-Licensed Product and country-by-country basis until expiration of the last Royalty Term to expire under this Agreement (“Term”).  Upon expiration of the Term, all licenses of MedCo granted by Alnylam under Article 6 shall become fully paid-up, irrevocable, perpetual, non-exclusive, sublicenseable licenses.

12.2Termination Rights.

12.2.1Termination for Convenience.   MedCo shall have the right to terminate this Agreement at any time after the Effective Date on four (4) months prior written notice to Alnylam.
  
12.2.2Termination for Cause.  This Agreement may be terminated at any time during the Term upon written notice by either Party (the “Non-Breaching Party”) if the other Party (the “Breaching Party”) is in material breach of its obligations hereunder and has not cured such breach within ten (10) days in the case of a payment breach, or within sixty (60) days in the case of all other breaches, after notice requesting cure of the breach, or, if cure of such breach other than non-payment cannot reasonably be effected within such sixty (60) day period, to deliver to the Non-Breaching Party a plan reasonably calculated to cure such breach within a timeframe that is reasonably prompt in light of the circumstances then prevailing, but in no event more than [**].  Following delivery of such a plan, the Breaching Party will carry out the plan and cure the breach.  If the Breaching Party fails to cure a material breach of this Agreement as provided above, then the Non-Breaching Party may terminate this Agreement upon written notice to the Breaching Party.

12.2.3Termination for Failure to Designate a Lead Product.  Alnylam shall have the right to terminate this Agreement upon thirty (30) days prior written notice to MedCo in the event that a Lead Product has not been designated by the JSC (or by the Chief Executive Officer of MedCo pursuant to Section 4.4.3) prior to the earlier of: (a) thirty (30) days after Alnylam reaches the Development Costs Cap described in Section 2.3.1(a) and provides notice thereof to MedCo pursuant to Section 2.3.3, unless MedCo has agreed to pay or has paid the relevant Extra Early Development Costs; and (b) on or prior to June 30, 2015.
   
12.2.4Challenges of Patent Rights.   In the event that a Party (the “Challenging Party”) or any of its Related Parties (a) commences or participates in any action or proceeding (including any patent opposition, re-examination or any other pre- or post-grant challenge or proceeding), or otherwise asserts any claim, challenging or denying the validity or enforceability (such an action or proceeding, a “Challenge”) of any of the Patent Rights licensed to such Challenging Party by the other Party (the “Licensor Party”) under this Agreement or any claim thereof or (b) actively assists any other person or entity in bringing or prosecuting any action or proceeding (including any patent opposition, re-examination or any other pre- or post-grant challenge or proceeding) challenging or denying the validity or enforceability of any of such Patent Rights or any claim thereof, then (i) such Challenging Party shall give notice thereof to such Licensor Party within [**] days of taking such action or of learning that its Related Party has taken such action, and (ii) such Licensor Party will have the right, in its sole discretion, to give notice to such Challenging Party that this Agreement will terminate thirty (30) days following such notice (or such longer period as such Licensor Party may designate in such notice), and, unless, with respect to a challenge brought by such Challenging Party, such Challenging Party withdraws, or, with respect to a challenge brought by 

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its Affiliates, causes, or, with respect to a challenge brought by its Sublicensee, uses Commercially Reasonable Efforts to cause, to be withdrawn, all such challenge(s) within such thirty (30)-day (or longer) period, this Agreement will so terminate.  Notwithstanding the foregoing, in such event, MedCo, as the Licensor Party under this Agreement, may only terminate the licenses it has granted under this Agreement to Alnylam as the Challenging Party with respect to the Patent Rights that are the subject of the Challenge.  In the event that such Licensor Party is not permitted under Law to terminate this Agreement such that the licenses with respect to all the Patent Rights under this Agreement are terminated, then the Parties agree to construe this provision to permit such Licensor Party to terminate only the licenses to that portion of such Patent Rights with respect to which such Licensor Party may terminate consistent with Law. 

12.3Effect of Termination. Without limiting any other legal or equitable remedies that either Party may have, if this Agreement is terminated by Alnylam, or by MedCo in accordance with Section 12.2.1, then: 

		
	(a)
	If this Agreement is terminated by MedCo pursuant to Section 12.2.1, then MedCo's obligation under Section 9.5.1 shall survive for a period of eight (8) months after the effective date of termination, and if this Agreement is terminated by Alnylam pursuant to Sections 12.2.2 or 12.2.4, then MedCo's obligations under Section 9.5.1 shall survive for a period of twelve (12) months after the effective date of termination.

		
	(b)
	Subject to the terms and conditions of this Agreement (including Sections 6.4.1 and 6.4.4 with respect to the MedCo In-Licenses (if any) applicable to the rights granted to Alnylam pursuant to this Section 12.3(b)), MedCo shall and hereby does grant Alnylam a non-transferable (except as provided in Section 13.1), sublicenseable (subject to Section 6.2.3), worldwide, non-exclusive, royalty-bearing license, under any MedCo Technology that is produced, generated, conceived and/or reduced to practice as a result of the Development, Manufacturing or Commercialization activities of MedCo under this Agreement to Develop, Manufacture and Commercialize Licensed Products in the Field in the Territory.  The Parties shall negotiate in good faith the royalty to be paid to MedCo by Alnylam in exchange for, and reflecting the then net present value of, the foregoing license, and, in the event that the Parties cannot mutually agree upon such amount within [**] days following the effective date of termination, the Parties will, as soon as reasonably practicable and in no event later than [**] days following the expiration of such [**]-day period, mutually decide upon an independent Third Party valuation firm with substantial experience in valuing licenses of intellectual property rights for the commercialization of pharmaceutical and biotechnology products, which shall make a final and binding determination of the net value of such license and both Parties shall promptly provide all reasonable materials and information requested by such valuation firm and shall share equally in the expenses of such valuation firm.

		
	(c)
	MedCo shall use Commercially Reasonable Efforts to as promptly as practicable transfer to Alnylam or Alnylam's designee (i) possession and ownership of all governmental or regulatory correspondence, conversation logs, filings and approvals (including all Regulatory Approvals and pricing and reimbursement approvals) in MedCo's or its Affiliates' possession and Control relating to the Development, Manufacture or Commercialization of the Licensed Products and all Product Trademarks, (ii) copies of all data, reports, records and materials, and other sales and marketing related information in MedCo's or its Affiliates' possession and Control to the extent that such data, reports, records, materials or other information relate to the Development, Manufacture or Commercialization of Licensed Products, including all non-clinical and clinical data relating to Licensed Products, and 

51

customer lists and customer contact information and all adverse event data in MedCo's possession and Control, and (iii) all records and materials in MedCo's possession and Control containing Confidential Information of Alnylam.  MedCo shall further appoint Alnylam as MedCo's and/or MedCo's Affiliates' agent for all Licensed Product-related matters involving Regulatory Authorities in the Territory until all such Regulatory Approvals and other regulatory filings have been transferred to Alnylam or its designee, 

		
	(d)
	if the effective date of termination is after First Commercial Sale, then MedCo shall appoint Alnylam as its exclusive distributor of the Licensed Product in the Territory and grant Alnylam the right to appoint sub-distributors, until such time as all such Regulatory Approvals in the Territory have been transferred to Alnylam or its designee, 

		
	(e)
	if MedCo or its Affiliates are Manufacturing Licensed Product, then at Alnylam's option, MedCo shall supply the Licensed Product to Alnylam in the Territory on commercially reasonable terms to be negotiated in good faith by the Parties, until such time as all such Regulatory Approvals in the Territory have been transferred to Alnylam or its designee, Alnylam has obtained all necessary manufacturing approvals or Alnylam has procured or developed its own source(s) of Licensed Product supply, 

		
	(f)
	if Alnylam so requests, MedCo shall use Commercially Reasonable Efforts to assign to Alnylam any Third Party agreements solely relating to the Development, Manufacture or Commercialization of the Licensed Product to which MedCo is a party, subject to any required consents of such Third Party, which MedCo shall use Commercially Reasonable Efforts to obtain promptly, 

		
	(g)
	MedCo shall promptly transfer and assign to Alnylam all of MedCo's and its Affiliates' rights, title and interests in and to the Product Trademark(s) owned by MedCo or its Affiliates and used for the Licensed Products in the Field in the Territory,

		
	(h)
	MedCo shall transfer to Alnylam any inventory of Licensed Products Controlled by MedCo or its Affiliates as of the termination date, on commercially reasonable terms to be negotiated in good faith by the Parties,

 
		
	(i)
	MedCo shall use Commercially Reasonable Efforts to provide, at Alnylam's reasonable expense, any other assistance reasonably requested by Alnylam for the purpose of allowing Alnylam or its designee to proceed expeditiously with the Development, Manufacture and Commercialization of Licensed Products in the Territory, and

		
	(j)
	MedCo shall execute all documents and take all such further actions as may be reasonably requested by Alnylam in order to give effect to the foregoing clauses.

12.4Effect of Expiration or Termination; Survival.  Expiration or termination of this Agreement shall not relieve the Parties of any obligation accruing prior to such expiration or termination.  Any expiration or termination of this Agreement shall be without prejudice to the rights of either Party against the other accrued or accruing under this Agreement prior to expiration or termination, including the obligation to pay royalties for the Licensed Product sold prior to such expiration or termination.  The provisions of Articles 10 (other than Section 10.6) and 13, Sections 6.1.4(b), 6.3, 6.5, 6.6, 6.7, 8.1, 8.2.2, 9.4, 11.1, 11.2, 11.3.3, 11.3.4 (with respect to the rights granted to each Party under Section 11.3.3), 11.3.5 (with respect to Joint Collaboration IP), 12.3 (if applicable) and 12.4, Section 7.4.7 (with respect to any 

52

royalty report for the last Calendar Quarter), Sections 7.5 through 7.11 (with respect to amounts owed prior to expiration or termination of this Agreement or amounts due thereafter pursuant to Section 12.4), and the last sentences of Sections 6.1.1, 6.1.2 or 12.1 (with respect to the licenses which have converted as set forth therein on or before the expiration or termination of this Agreement) shall survive any expiration or termination of this Agreement.  Except as set forth in this Article 12, upon termination or expiration of this Agreement all other rights and obligations of the Parties under this Agreement cease. 

13.MISCELLANEOUS 

13.1Assignment.  Except as provided in this Section 13.1, this Agreement may not be assigned or otherwise transferred, nor may any right or obligation hereunder be assigned or transferred, by either Party without the written consent of the other Party.  However, either Party may, without the other Party's written consent, assign this Agreement and its rights and obligations hereunder in whole or in part to an Affiliate or to a Person that acquires, by merger, sale of assets or otherwise, all or substantially all of the business of the assigning Party to which the subject matter of this Agreement relates.  The Parties acknowledge that MedCo is considering the potential assignment of all or a significant portion of its obligations under this Agreement to a Third Party joint venture in which MedCo may hold a non-controlling equity interest, and Alnylam agrees to discuss in good faith with MedCo such an assignment together with appropriate financial and other protections for Alnylam; provided, however, that nothing in the foregoing sentence shall be construed to require Alnylam to agree to such an assignment.  The assigning Party shall remain responsible for the performance by its assignee of this Agreement or any obligations hereunder so assigned.  Any assignment of the rights or obligations of this Agreement not in accordance with the foregoing shall be void.

13.2Governing Law.  This Agreement shall be construed and the respective rights of the Parties determined in accordance with the substantive laws of the State of New York, notwithstanding any provisions of New York law governing conflicts of laws to the contrary, and the patent laws of the relevant jurisdiction without reference to any rules of conflict of laws.

13.3Entire Agreement; Amendments.  This Agreement and, when executed, the other Transaction Agreements, contain the entire understanding of the Parties with respect to the subject matter hereof, and supersedes all previous arrangements with respect to the subject matter hereof, whether written or oral, including the Mutual Confidential Disclosure Agreement made as of January 16, 2012 by the Parties.  This Agreement (including the Schedules hereto) may be amended, or any term hereof modified, only by a written instrument duly-executed by authorized representatives of both Parties.

13.4Severability. If any provision hereof should be held invalid, illegal or unenforceable in any respect in any jurisdiction, the Parties shall substitute, by mutual consent, valid provisions for such invalid, illegal or unenforceable provisions, which valid provisions in their economic effect are sufficiently similar to the invalid, illegal or unenforceable provisions that it can be reasonably assumed that the Parties would have entered into this Agreement with such valid provisions.  In case such valid provisions cannot be agreed upon, the invalid, illegal or unenforceable of one or several provisions of this Agreement shall not affect the validity of this Agreement as a whole, unless the invalid, illegal or unenforceable provisions are of such essential importance to this Agreement that it is to be reasonably assumed that the Parties would not have entered into this Agreement without the invalid, illegal or unenforceable provisions.

13.5Headings.  The captions to the Articles and Sections hereof are not a part of this Agreement, but are merely for convenience to assist in locating and reading the several Articles and Sections hereof.

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13.6Interpretation.  Whenever the context may require, any pronoun shall include the corresponding masculine, feminine and neuter forms and any noun shall include the corresponding singular and plural forms.  The words “include”, “includes” and “including” shall be deemed to be followed by the phrase “but not limited to.”  The word “will” shall be construed to have the same meaning and effect as the word “shall.”  “$” or “(D)(d)ollar” means U.S. Dollars.  With respect to any license grant, “exclusive” means exclusive as between the licensor Party and the licensed Party to the fullest extent possible, in light of any rights already granted by the licensor Party to Third Parties prior to the date on which such license is first granted and in light of any limitations on the rights granted to the licensor Party by its licensors.  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 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 permitted 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 Articles, Sections or Schedules shall be construed to refer to Articles, Sections and Schedules of this Agreement, (f) the word “or” shall be construed to have the same meaning and effect as “and/or”, and (g) a term not defined herein but reflecting a different part of speech than a term which is defined herein shall be interpreted in a correlative manner. 

13.7Waiver of Rule of Construction.  Each Party has had the opportunity to consult with counsel in connection with the review, drafting and negotiation of this Agreement.  Accordingly, the rule of construction that any ambiguity in this Agreement shall be construed against the drafting Party shall not apply.

13.8No Implied Waivers; Rights Cumulative.  No failure on the part of Alnylam or MedCo to exercise, and no delay in exercising, any right, power, remedy or privilege under this Agreement, or provided by statute or at law or in equity or otherwise, shall impair, prejudice or constitute a waiver of any such right, power, remedy or privilege or be construed as a waiver of any breach of this Agreement or as an acquiescence therein, nor shall any single or partial exercise of any such right, power, remedy or privilege preclude any other or further exercise thereof or the exercise of any other right, power, remedy or privilege.  Except as expressly provided in this Agreement, no right or remedy herein conferred upon or reserved to either Party is intended to be exclusive of any other right or remedy.

13.9Notices.  All notices which are required or permitted hereunder shall be in writing and sufficient if delivered personally, sent by facsimile (and promptly confirmed by personal delivery, registered or certified mail or overnight courier), sent by nationally-recognized overnight courier or sent by registered or certified mail, postage prepaid, return receipt requested, addressed as follows:

If to Alnylam, to:    Alnylam Pharmaceuticals, Inc. 
300 Third Street
Cambridge, MA  02142
Attention:  Legal Department
Facsimile No.: (617) 551-8101 
    

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With a copy to:    Faber Daeufer Itrato & Cabot PC
950 Winter Street
Waltham, MA 02451
Attention: Sumy C. Daeufer, Esq.
Facsimile No.: (781) 795-4747

		
	If to MedCo, to:  
	The Medicines Company

8 Sylvan Way
Parsippany, NJ 07054
Attention:  President
Facsimile No.:  (862) 207-6119

With a copy to:    The Medicines Company
8 Sylvan Way
Parsippany, NJ 07054
Attention:  General Counsel
Facsimile No.:  (862) 207-6062    

or to such other address as the Party to whom notice is to be given may have furnished to the other Party in writing in accordance herewith.  Any such notice shall be deemed to have been given: (a) when delivered if personally delivered or sent by facsimile on a Business Day (or if delivered or sent on a non-Business Day, then on the next Business Day); (b) on receipt if sent by overnight courier; and/or (c) on receipt if sent by mail.
13.10Compliance with Export Regulations.  Neither Party shall export any technology licensed to it by the other Party under this Agreement except in compliance with U.S. export laws and regulations.

13.11Force Majeure.  Neither Party shall be held liable to the other Party nor be deemed to have defaulted under or breached this Agreement for failure or delay in performing any obligation under this Agreement to the extent that such failure or delay is caused by or results from causes beyond the reasonable control of the affected Party, potentially including embargoes, war, acts of war (whether war be declared or not), insurrections, riots, civil commotions, strikes, lockouts or other labor disturbances, fire, floods, or other acts of God, or acts, omissions or delays in acting by any Governmental Authority or the other Party.  The affected Party shall notify the other Party of such force majeure circumstances as soon as reasonably practical, and shall promptly undertake all reasonable efforts necessary to cure such force majeure circumstances.

13.12Dispute Resolution.  In the event that the Parties do not resolve any dispute, controversy or claim arising from, or related to, this Agreement or to the breach hereof (collectively, “Dispute”) and neither Party has final decision-making authority as to such Dispute pursuant to Section 4.4, and a Party wishes to pursue the matter, such Party may file suit to have such Dispute adjudicated in a court of competent jurisdiction.

13.13Independent Contractors.  It is expressly agreed that Alnylam and MedCo shall be independent contractors and that the relationship between Alnylam and MedCo shall not constitute a partnership, joint venture or agency.  Alnylam shall not have the authority to make any statements, representations or commitments of any kind, or to take any action, which shall be binding on MedCo, 

55

without the prior written consent of MedCo, and MedCo shall not have the authority to make any statements, representations or commitments of any kind, or to take any action, which shall be binding on Alnylam without the prior written consent of Alnylam.

13.14Counterparts.  The Agreement may be executed in two or more counterparts, each of which shall be deemed an original, but all of which together shall constitute one and the same instrument.  Facsimile signatures and signatures transmitted via PDF shall be treated as original signatures.

13.15Performance by Affiliates.  Each Party shall have the right to have any of its obligations hereunder performed by, any of its Affiliates and the performance of such obligations by any such Affiliate(s) shall be deemed to be performance by such Party; provided, however, that such Affiliate shall be bound by the corresponding obligations of such Party and such Party shall be responsible for ensuring the performance of its obligations under this Agreement and that any failure of any Affiliate performing obligations of such Party hereunder shall be deemed to be a failure by such Party to perform such obligations.

13.16Binding Effect; No Third Party Beneficiaries.  As of the Effective Date, this Agreement shall be binding upon and inure to the benefit of the Parties and their respective successors and permitted assigns.  Except as expressly set forth in this Agreement, no person or entity other than the Parties and their respective permitted assignees hereunder shall be deemed an intended beneficiary hereunder or have any right to enforce any obligation of this Agreement.

[THE REMAINDER OF THIS PAGE HAS BEEN LEFT INTENTIONALLY BLANK]

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IN WITNESS WHEREOF, the Parties have executed this Agreement as of the Effective Date.

		
	THE MEDICINES COMPANY
	ALNYLAMPHARMACEUTICALS, INC.

BY:/s/ Glenn Sblendorio        BY:/s/ John M. Maraganore    
NAME: Glenn Sblendorio            NAME: John M. Maraganore, Ph.D.
TITLE: President and CFO            TITLE: Chief Executive Officer

57

SCHEDULE A
ALN-PCS02
ALN-PCS02 is an investigational ribonucleic acid interference (RNAi) therapeutic agent that is comprised of active pharmaceutical ingredient [**] (see sequence & diagram below), a synthetic small interfering RNA (siRNA) that is Targeted to the PCS messenger RNA (mRNA) in a [**] lipid nanoparticle formulation (see description below).

Confidential Materials omitted and filed separately with the Securities and Exchange Commission.      A total of 5 pages were omitted. [**]

58

SCHEDULE B
ALN-PCSsc

ALN-PCSsc is an investigational ribonucleic acid interference (RNAi) therapeutic agent that is comprised of an active pharmaceutical ingredient which is a synthetic small interfering RNA (siRNA) that is Targeted to the PCS messenger RNA (mRNA) and covalently linked on the 3′ end of the sense strand to a triantennary N-acetylgalactosamine (GalNAc3) ligand (see diagram below). The active pharmaceutical ingredient may be [**] (see sequence & diagram below).

Confidential Materials omitted and filed separately with the Securities and Exchange Commission.      A total of 2 pages were omitted. [**]

59

SCHEDULE C
Alnylam PATENT RIGHTS
SCHEDULE C-1
ALNYLAM CORE TECHNOLOGY PATENT RIGHTS
See attached.

Confidential Materials omitted and filed separately with the Securities and Exchange Commission.  A total of 183 pages were omitted. [**]

60

SCHEDULE C-2
ALNYLAM PRODUCT-SPECIFIC PATENT RIGHTS
See attached.

Confidential Materials omitted and filed separately with the Securities and Exchange Commission.  A total of 8 pages were omitted. [**]

61

SCHEDULE C-3
PATENT RIGHTS IN ADDITIONAL ALNYLAM IN-LICENSES
See attached.

Confidential Materials omitted and filed separately with the Securities and Exchange Commission.  A total of 16 pages were omitted. [**]

62

SCHEDULE D
EXISTING Alnylam IN-LICENSES, 
EXISTING ALNYLAM THIRD PARTY AGREEMENTS AND ADDITIONAL ALNYLAM IN-LICENSES
A.    As of the Effective Date, Existing Alnylam In-Licenses are the following Third Party agreements:
1.    Co-Exclusive License Agreement between Max Planck Innovation GmbH (formerly Garching Innovation GmbH) and Alnylam Pharmaceuticals, Inc., dated December 20, 2002, as amended by Amendment dated July 2, 2003, the Requirements Amendment effective June 15, 2005, the Waiver Amendment effective August 9, 2007 and the Amendment to the Alnylam Co-Exclusive License Agreement dated as of March 14, 2011, by and between Alnylam Pharmaceuticals, Inc., on the one hand, and Whitehead Institute for Biomedical Research, Massachusetts Institute of Technology and Max-Planck-Innovation GmbH, on the other hand; and Co-Exclusive License Agreement between Max Planck Innovation GmbH (formerly Garching Innovation GmbH) and Alnylam Europe AG (formerly Ribopharma AG), dated July 30, 2003 (collectively, the “Garching Agreements”)
2.    Amended and Restated Strategic Collaboration & License Agreement between Isis Pharmaceuticals, Inc. and Alnylam Pharmaceuticals, Inc., dated April 28, 2009, as amended by letter agreement dated August 27, 2012 (“Isis Agreement”)
3.    Sponsored Research Agreement dated as of July 27, 2009 by and among Alnylam, The University of British Columbia (“UBC”) and AlCana Technologies, Inc. (“AlCana”)
4.    Supplemental Agreement among Tekmira Pharmaceuticals Corporation (“Tekmira”), Protiva Biotherapeutics Inc. (“Protiva”), UBC and AlCana
5.    Sublicense Agreement dated January 8, 2007 between Alnylam and Tekmira (as successor in interest to Inex Pharmaceuticals Corporation)  
6.    Cross-License Agreement by and among Alnylam, Tekmira and Protiva dated November 12, 2012 and Settlement Agreement and General Release dated November 12, 2012 by and among Tekmira, Protiva, Alnylam and AlCana

B.    As of the Effective Date, Existing Alnylam Third Party Agreements are the following Third Party agreements:  
1.    License and Collaboration Agreement among F. Hoffmann-La Roche Ltd, Hoffman-La Roche Inc., and Alnylam Pharmaceuticals, Inc., dated July 8, 2007, as amended by letter amendment dated May 29, 2008 (assigned to Arrowhead Research Corporation in October 2011)
2.    License and Collaboration Agreement between Takeda Pharmaceutical Company Limited and Alnylam Pharmaceuticals, Inc., dated May 27, 2008, as supplemented or amended by letter agreements dated August 18, 2009 and March 16, 2011
C.    As of the Effective Date, the Additional Alnylam In-Licenses are the following Third Party agreements:  
[**]

63

SCHEDULE E
INITIAL DEVELOPMENT PLAN

Confidential Materials omitted and filed separately with the Securities and Exchange Commission.  A total of 5 pages were omitted. [**]

64

SCHEDULE F
JOINT PRESS RELEASE

Contacts: 
	
		
	The Medicines Company
	Alnylam Pharmaceuticals, Inc.

	Michael Mitchell
Head of Global Communications
973-290-6097
michael.mitchell@themedco.com
	Cynthia Clayton
Vice President, Investor Relations and                              
Corporate Communications
617-551-8207

Amanda Sellers (Media)
Spectrum
202-955-6222 x2597

DRAFT - Not for Release

The Medicines Company and Alnylam Form Strategic Alliance to 
Develop and Commercialize RNAi Therapeutics Targeting PCSK9 for the 
Treatment of Hypercholesterolemia

 The Medicines Company Obtains Exclusive Global License to Advance ALN-PCS 
RNAi Therapeutic Program 

 Alnylam to Receive $25 Million in Upfront Payment in Addition to Milestone Payments and Royalties on Product Sales 

 Companies to Host Conference Call Today at 8:30 a.m. ET to Discuss Collaboration 

Parsippany, N.J. and Cambridge, Mass., February 4, 2013 - The Medicines Company (Nasdaq: MDCO) and Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), a leading RNAi therapeutics company, announced today that they have formed an exclusive global alliance for the development and commercialization of Alnylam's ALN-PCS RNAi therapeutic program for the treatment of hypercholesterolemia.  

“This new alliance unites two organizations with a shared culture and commitment to innovation.  In my view and past experience, there could be no stronger partner for our ALN-PCS program than The Medicines Company, which has demonstrated industry-wide leadership in the advancement of cardiovascular medicines to patients and remarkable success in its strategy of in-licensing, developing, and 

65

commercializing breakthrough products,” said John Maraganore, Ph.D., Chief Executive Officer of Alnylam.  “For Alnylam, this new partnership enables the advancement of ALN-PCS, an important program within our 'Alnylam 5x15' product development and commercialization strategy focused on RNAi therapeutics directed toward genetically validated targets.  We believe that the ALN-PCS program holds great promise for the development of a significant therapeutic option for patients with hypercholesterolemia, and that the unique mechanism of action for ALN-PCS could provide a differentiated and potentially best-in-class strategy for PCSK9 antagonism.”  
 
“Our focus on acute and intensive care medicine has led us to a leadership position with Angiomax and potentially with cangrelor in the management of patients in extreme risk as a consequence of the rupture of their vulnerable coronary artery plaque at and around the time of acute coronary syndromes.  Meantime, we have made progress with MDCO-216 (ApoA-1 Milano), a turbocharged form of HDL-C ('good cholesterol') which has the potential to modify disease through reverse cholesterol transport,” said Clive Meanwell, M.D., Ph.D., Chairman and Chief Executive Officer of The Medicines Company.  “Now, this exciting collaboration with Alnylam  leaders in their field of RNAi  adds a second potentially disease modifying approach and more cutting edge technology to our portfolio.  We have seen that PCSK9 gene silencing can substantially reduce LDL-cholesterol in patients and has epidemiological and disease mechanisms studies suggest this can further reduce the risks of the world's number one killer, coronary artery disease.  Clearly we see the complementarity of approaches which increase 'good cholesterol' (HDL-C) and decrease 'bad cholesterol' (LDL-C).  We look forward to working with our colleagues at Alnylam for whom we have the greatest respect and admiration based upon earlier collaborations particularly around Angiomax, which was invented by John Maraganore.” 
 
PCSK9 (proprotein convertase subtilisin/kexin type 9) is a protein that regulates low-density lipoprotein (LDL) receptor levels on hepatocytes; gain-of-function human mutations in PCSK9 are associated with hypercholesterolemia while loss-of-function mutations are associated with lower levels of LDL cholesterol and a reduced risk of cardiovascular disease.  ALN-PCS is a PCSK9 synthesis inhibitor that reduces intracellular and extracellular levels of PCSK9 resulting in lowered plasma levels of LDL-C.  MDCO-216 is a naturally occurring variant of a protein found in high-density lipoprotein, or HDL.  It is a reverse cholesterol transport agent designed to reduce atherosclerotic plaque burden development and thereby reduce the risk of adverse thrombotic events.

Under this alliance, The Medicines Company and Alnylam intend to collaborate on the advancement of the ALN-PCS program.  Alnylam's ALN-PCS program includes ALN-PCS02  an intravenously administered RNAi therapeutic which has completed a Phase I trial, and ALN-PCSsc  a subcutaneously administered RNAi therapeutic currently in pre-clinical development.  Alnylam will continue the program while funded by The Medicines Company for an estimated one to two years to complete certain pre-clinical and Phase I clinical studies.  The Medicines Company will then lead and fund development from Phase II forward and commercialize the ALN-PCS program if successful.  Under the terms of the agreement, The Medicines Company will make an upfront cash payment of $25 million to Alnylam.  Alnylam may also receive potential development and commercial milestone payments of up to $180 million.  Alnylam will be eligible to receive scaled double-digit royalties on global products sales of ALN-PCS products.

Alnylam has completed a Phase I trial of ALN-PCS02 in healthy volunteer subjects with elevated baseline LDL-C.  Results showed that administration of a single intravenous dose of drug, in the absence of concomitant lipid-lowering agents such as statins, resulted in statistically significant and durable reductions of PCSK9 plasma levels of up to 84% and lowering of LDL-C of up to 50%.  ALN-PCS02 was shown to be generally safe and well tolerated in this study and there were no serious adverse events related to study drug administration.  Alnylam has also presented pre-clinical data from its ALN-PCSsc program 

66

demonstrating potent knockdown of the PCSK9 target gene with an ED50 of less than 0.3 mg/kg after a single subcutaneous dose.  

“Cardiovascular disease remains the leading cause of mortality worldwide, with elevated LDL-C a major modifiable risk factor.  New strategies are needed to dramatically and rapidly reduce LDL-C and prevent acute cardiovascular events that result from the rupture of cholesterol rich plaque when patients are at their most vulnerable,” said Daniel J. Rader, M.D., professor of Medicine and chief, Division of Translational Medicine and Human Genetics, at the Perelman School of Medicine at the University of Pennsylvania.  “As a key regulator of the LDL receptor, liver-expressed PCSK9 is one of the most important and best validated new targets in molecular medicine for the treatment of hypercholesterolemia.  The ALN-PCS data generated to date are very encouraging and I look forward to continued clinical studies that highlight the unique mechanistic approach of PCSK9 synthesis inhibitors.”

Dr. Rader serves as a member of Alnylam's Scientific Advisory Board and as a consultant on Alnylam's ALN-PCS program, and Alnylam and Dr. Rader collaborate on research for which Alnylam provides materials.

Conference Call Information
The Medicines Company and Alnylam will host a conference call today at 8:30 a.m. ET to discuss this new collaboration.  To access the call, please dial 877-312-7507 (domestic) or 631-813-4828 (international) five minutes prior to the start time and refer to conference ID 96998933.  A replay of the call will be available beginning at 11:30 a.m. ET.  To access the replay, please dial 855-859-2056 (domestic) or 404-537-3406 (international) and refer to conference ID 96998933.  A live audio webcast of the presentation will be available on The Medicines Company website at www.themedicinescompany.com, and on the News & Investors section of the Alnylam's website, www.alnylam.com

About Hypercholesterolemia
Hypercholesterolemia is a condition characterized by very high levels of cholesterol in the blood which is known to increase the risk of coronary artery disease, the leading cause of death in the U.S.  Some forms of hypercholesterolemia can be treated through dietary restrictions, lifestyle modifications (e.g., exercise and smoking cessation) and medicines such as statins.  However, a large proportion of patients with hypercholesterolemia are not achieving target LDL-C goals with statin therapy, including genetic familial hypercholesterolemia patients, acute coronary syndrome patients, high-risk patient populations (e.g., patients with coronary artery disease, diabetics, symptomatic carotid artery disease, etc.) and other patients that are statin intolerant.  Severe forms of hypercholesterolemia are estimated to affect more than 500,000 patients worldwide, and as a result, there is a significant need for novel therapeutics to treat patients with hypercholesterolemia whose disease is inadequately managed by existing therapies.

About ALN-PCS
ALN-PCS is a systemically delivered RNAi therapeutic targeting the gene proprotein convertase subtilisin/kexin type 9 (PCSK9), a target validated by human genetics that is involved in the metabolism of low-density lipoprotein cholesterol (LDL-C, or “bad” cholesterol).  ALN-PCS therapies are PCSK9 synthesis inhibitors that lower levels of both intracellular and extracellular PCSK9, thereby phenocopying the human genetics observed in loss of function or null human PCSK9 mutations (N. Engl. J. Med. (2006) 354:1264-1272; Am. J. Hum. Genet. (2006) 79: 514-523).  PCSK9 synthesis inhibition through an RNAi mechanism has the potential to lower tissue and circulating plasma PCSK9 protein levels resulting in higher LDL receptor levels in the liver, and subsequently lower LDL-C levels in the blood stream.  Lower LDL-C is associated with a decreased risk of cardiovascular disease, including myocardial infarction and stroke. 

About RNA Interference (RNAi)

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RNAi (RNA interference) is a revolution in biology, representing a breakthrough in understanding how genes are turned on and off in cells, and a completely new approach to drug discovery and development.  Its discovery has been heralded as “a major scientific breakthrough that happens once every decade or so,” and represents one of the most promising and rapidly advancing frontiers in biology and drug discovery today which was awarded the 2006 Nobel Prize for Physiology or Medicine.  RNAi is a natural process of gene silencing that occurs in organisms ranging from plants to mammals.  By harnessing the natural biological process of RNAi occurring in our cells, the creation of a major new class of medicines, known as RNAi therapeutics, is on the horizon.  Small interfering RNA (siRNA), the molecules that mediate RNAi and comprise Alnylam's RNAi therapeutic platform, target the cause of diseases by potently silencing specific mRNAs, thereby preventing disease-causing proteins from being made.  RNAi therapeutics have the potential to treat disease and help patients in a fundamentally new way.

About The Medicines Company
The Medicines Company (Nasdaq: MDCO) provides medical solutions to improve health outcomes for patients in acute and intensive care hospitals worldwide.  These solutions comprise medicines and knowledge that directly impact the survival and well being of critically ill patients.

The Medicines Company Forward-Looking Statement 
Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995.  Without limiting the foregoing, the words “believes,” “anticipates” and “expects” and similar expressions are intended to identify forward-looking statements.  These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements.  Important factors that may cause or contribute to such differences include whether the Company's products will advance in the clinical trials process on a timely basis or at all, whether the Company will make regulatory submissions for product candidates on a timely basis, whether its regulatory submissions will receive approvals from regulatory agencies on a timely basis or at all, whether physicians, patients and other key decision makers will accept clinical trial results, and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Quarterly Report on Form 10-Q filed on November 9, 2012, which are incorporated herein by reference.  The Company specifically disclaims any obligation to update these forward-looking statements. 

About Alnylam Pharmaceuticals
Alnylam is a biopharmaceutical company developing novel therapeutics based on RNA interference, or RNAi.  The company is leading the translation of RNAi as a new class of innovative medicines with a core focus on RNAi therapeutics for the treatment of genetically defined diseases, including ALN-TTR for the treatment of transthyretin-mediated amyloidosis (ATTR), ALN-AT3 for the treatment of hemophilia and rare bleeding disorders (RBD), ALN-AS1 for the treatment of acute intermittent porphyria (AIP), ALN-PCS for the treatment of hypercholesterolemia, and ALN-TMP for the treatment of hemoglobinopathies.  As part of its “Alnylam 5x15TM” strategy, the company expects to have five RNAi therapeutic products for genetically defined diseases in clinical development, including programs in advanced stages, on its own or with a partner by the end of 2015.  Alnylam has additional partnered programs in clinical or development stages, including ALN-RSV01 for the treatment of respiratory syncytial virus (RSV) infection and ALN-VSP for the treatment of liver cancers.  The company's leadership position on RNAi therapeutics and intellectual property have enabled it to form major alliances with leading companies including Merck, 

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Medtronic, Novartis, Biogen Idec, Roche, Takeda, Kyowa Hakko Kirin, Cubist, Ascletis, Monsanto, Genzyme, and The Medicines Company.  In addition, Alnylam holds a significant equity position in Regulus Therapeutics Inc., a company focused on discovery, development, and commercialization of microRNA therapeutics. Alnylam has also formed Alnylam Biotherapeutics, a division of the company focused on the development of RNAi technologies for applications in biologics manufacturing, including recombinant proteins and monoclonal antibodies.  Alnylam's VaxiRNATM platform applies RNAi technology to improve the manufacturing processes for vaccines; GlaxoSmithKline is a collaborator in this effort.  Alnylam scientists and collaborators have published their research on RNAi therapeutics in over 100 peer-reviewed papers, including many in the world's top scientific journals such as Nature, Nature Medicine, Nature Biotechnology, and Cell.  Founded in 2002, Alnylam maintains headquarters in Cambridge, Massachusetts.  For more information, please visit www.alnylam.com.

About “Alnylam 5x15TM”
The “Alnylam 5x15” strategy, launched in January 2011, establishes a path for development and commercialization of novel RNAi therapeutics directed toward genetically defined targets for diseases with high unmet medical need.  Products arising from this initiative share several key characteristics including: a genetically defined target and disease; the potential to have a major impact in a high unmet need population; the ability to leverage the existing Alnylam RNAi delivery platform; the opportunity to monitor an early biomarker in Phase I clinical trials for human proof of concept; and the existence of clinically relevant endpoints for the filing of a new drug application (NDA) with a focused patient database and possible accelerated paths for commercialization.  By the end of 2015, the company expects to have five such RNAi therapeutic programs in clinical development, including programs in advanced stages, on its own or with a partner.  The “Alnylam 5x15” programs include ALN-TTR for the treatment of transthyretin-mediated amyloidosis (ATTR), ALN-AT3 for the treatment of hemophilia and rare bleeding disorders (RBD), ALN-AS1 for the treatment of acute intermittent porphyria (AIP), ALN-PCS for the treatment of hypercholesterolemia, ALN-TMP for the treatment of hemoglobinopathies, and other programs.  Alnylam intends to focus on developing and commercializing certain programs from this product strategy itself in North and South America, Europe, and other parts of the world; these include ALN-TTR, ALN-AT3, and ALN-AS1; the company will seek global development and commercial alliances for other programs.

Alnylam Forward-Looking Statements
Various statements in this release concerning Alnylam's future expectations, plans and prospects, including without limitation, statements regarding Alnylam's views with respect to the potential for RNAi therapeutics, including the potential for the ALN-PCS program, including ALN-PCS02 and ALN-PCSsc, its expectations regarding the receipt of upfront and potential development and commercialization milestones and royalty payments on worldwide net sales, if any, under The Medicines Company agreement, and Alnylam's expectations regarding its “Alnylam 5x15” product strategy, constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, Alnylam's ability to successfully demonstrate the efficacy and safety of its drug candidates and the pre-clinical and clinical results for these product candidates, including ALN-PCS02 and ALN-PCSsc, which may not support further development of such product candidates, both our and The Medicines Company's ability to successfully advance ALN-PCS02 and/or ALN-PCSsc resulting in the potential payment of milestones and royalties to us, actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials for such product candidates, obtaining, maintaining and protecting intellectual property, obtaining regulatory approval for products, competition from others using technology similar to Alnylam's and others developing products for similar uses, and Alnylam's ability to establish and maintain strategic business alliances, including its collaboration with The Medicines Company, and new business initiatives, as well as those risks more fully 

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discussed in the “Risk Factors” filed with Alnylam's current report on Form 8-K filed with the Securities and Exchange Commission (SEC) on January 14, 2013 and in other filings that Alnylam makes with the SEC. In addition, any forward-looking statements represent Alnylam's views only as of today and should not be relied upon as representing its views as of any subsequent date. Alnylam does not assume any obligation to update any forward-looking statements.

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SCHEDULE G

DISCLOSURE SCHEDULE

Section 9.2.1(a):
- Reference is made to certain claims alleged by the plaintiffs in the action entitled:

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Section 9.2.2:
- Reference is made to certain claims alleged by the plaintiff in the [**] Litigation.

Section 9.2.5(c):
- Reference is made to certain claims alleged by the plaintiff in the [**] Litigation.

Section 9.2.8:
- [**]

Section 9.2.9(a):
- Reference is made to certain claims alleged by the plaintiff in the [**] Litigation.

Section 9.2.9(b):
- Reference is made to the [**]

- Reference is made to the [**]

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SCHEDULE H
EXAMPLE FOR SECTION 6.4.3.3
If, with respect to a particular Alnylam In-License, royalties are payable with respect to aggregate net sales of all products covered by such Alnylam In-License, and are not determined on a product-by-product basis, according to the following tiered royalty rates:
	
		
	 Aggregate Calendar Year 
net sales by Alnylam, its Affiliates or any of its sublicensees of all products
	Royalty
 (as a percentage of such net sales)

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And if sales are made during each of the four Calendar Quarters of the relevant Calendar Year as shown in the table below, then royalties owed by MedCo pursuant to such Alnylam In-License shall be as shown in such table:  
	
					
	Sales By
	Calendar Quarter 1
	Calendar Quarter 2
	Calendar Quarter 3
	Calendar Quarter 4

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