Prepared by R.R. Donnelley Financial -- EX-10.4


 Exhibit 10.4 

INTELLECTUAL PROPERTY LICENSE AGREEMENT 

BETWEEN 
 ALZA
CORPORATION 
 AND 

THE MACROFLUX CORPORATION 

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 TABLE OF CONTENTS 

 

					
	 	  	Page	 
	 ARTICLE 1 — DEFINITIONS
	  	 	2	  
		
	 1.1 “Active Clinical Development”
	  	 	2	  
	 1.2 “Active Early Development”
	  	 	2	  
	 1.3 “Affiliate”
	  	 	2	  
	 1.4 “Agreement”
	  	 	3	  
	 1.5 “ALZA Inventions”
	  	 	3	  
	 1.6 “ALZA Know-How”
	  	 	3	  
	 1.7 “[**] Agreement”
	  	 	3	  
	 1.8 “Commercialize” or “Commercialization”
	  	 	3	  
	 1.9 “Confidential Information”
	  	 	3	  
	 1.10 “Control” or “Controlled”
	  	 	4	  
	 1.11 “Derivative Information”
	  	 	5	  
	 1.12 “Development Agreements”
	  	 	5	  
	 1.13 “Dollars”
	  	 	5	  
	 1.14 “Effective Date”
	  	 	5	  
	 1.15 “FDA”
	  	 	5	  
	 1.16 “Field”
	  	 	5	  
	 1.17 “Financial Records”
	  	 	5	  
	 1.18 “Financing Transaction”
	  	 	5	  
	 1.19 “First Sale”
	  	 	5	  
	 1.20 “Future ALZA Inventions”
	  	 	6	  
	 1.21 “Future ALZA Patents”
	  	 	6	  
	 1.22 License”
	  	 	6	  
	 1.23 “Licensed Patent(s)”
	  	 	6	  
	 1.24 “NDA”
	  	 	7	  
	 1.25 “Microprojection System”
	  	 	7	  
	 1.26 “Natrecor® (nesiritide)”
	  	 	7	  
	 1.27 “Net Sales”
	  	 	7	  
	 1.28 “Nesiritide Product”
	  	 	7	  
	 1.29 “Patent(s)”
	  	 	7	  
	 1.30 “Product”
	  	 	7	  
	 1.31 “Product Payments”
	  	 	8	  
	 1.32 “PTH”
	  	 	8	  
	 1.33 “PTH Product”
	  	 	8	  
	 1.34 “Quarter”
	  	 	8	  
	 1.35 “Regulatory Approval”
	  	 	8	  
	 1.36 “Regulatory Authority”
	  	 	8	  
	 1.37 “Regulatory Documents”
	  	 	8	  
	 1.38 [**]
	  	 	8	  
	 1.39 “Sublicensee”
	  	 	8	  
	 1.40 “Term”
	  	 	8	  

  

  
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	 1.41 “Territory”
	  	 	8	  
	 1.42 “Third Party”
	  	 	8	  
	 1.43 “Third Party Product”
	  	 	9	  
	 1.44 “TMC Inventions”
	  	 	9	  
	 1.45 “TMC Patents”
	  	 	9	  
	 1.46 “Trademark”
	  	 	9	  
	 1.47 “Transitional Services Agreement”
	  	 	10	  
	 1.48 “Valid Patent Claim”
	  	 	10	  
		
	 ARTICLE 2 — GRANT OF LICENSE RIGHTS
	  	 	10	  
		
	 2.1 License to TMC
	  	 	10	  
	 2.2 License to ALZA
	  	 	12	  
		
	 ARTICLE 3 — DEVELOPMENT AND COMMERCIALIZATION
	  	 	13	  
		
	 3.1 Development Responsibility and Costs
	  	 	13	  
	 3.2 Regulatory Responsibilities and Costs
	  	 	13	  
	 3.3 Existing Agreements
	  	 	13	  
	 3.4 ALZA Know-How
	  	 	13	  
	 3.5 Future Vendor Agreements
	  	 	15	  
	 3.6 TMC Diligence
	  	 	16	  
	 3.7 Annual Development Activity Report
	  	 	16	  
	 3.8 Commercial Responsibilities
	  	 	17	  
		
	 ARTICLE 4 — TRADEMARK RIGHTS TO TMC
	  	 	18	  
		
	 4.1 Trademark Assignment
	  	 	18	  
	 4.2 Limited Continued Obligation
	  	 	18	  
	 4.3 Trademark Maintenance
	  	 	18	  
	 4.4 Trademark Enforcement
	  	 	18	  
	 4.5 Effect of Termination
	  	 	18	  
		
	 ARTICLE 5 — FINANCIAL PROVISIONS
	  	 	19	  
		
	 5.1 Purchase Price
	  	 	19	  
	 5.2 Product Payments
	  	 	19	  
	 5.3 Single Royalty, Product Payment Term
	  	 	19	  
	 5.4 Timing and Mode of Payment
	  	 	19	  
	 5.5 Product Payment Reports
	  	 	19	  
	 5.6 Financial Records
	  	 	20	  
	 5.7 Currency Exchange
	  	 	20	  
	 5.8 Audit
	  	 	20	  
	 5.9 Interest Due
	  	 	22	  
	 5.10 Tax Withholding
	  	 	22	  
		
	 ARTICLE 6 — CONFIDENTIAL INFORMATION
	  	 	22	  
		
	 6.1 Confidentiality Obligations
	  	 	22	  
	 6.2 Written Assurances and Permitted Uses of Confidential Information
	  	 	23	  


  
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	 6.3 Public Announcements
	  	 	24	  
	 6.4 Publications
	  	 	24	  
		
	 ARTICLE 7 — PATENTS AND INTELLECTUAL PROPERTY
	  	 	25	  
		
	 7.1 Ownership; Inventions
	  	 	25	  
	 7.2 Disclosure of Patentable Invention
	  	 	26	  
	 7.3 Prosecution of Licensed Patents
	  	 	26	  
	 7.4 Infringement Claims by Third Parties
	  	 	29	  
	 7.5 Infringement Claims Against Third Parties
	  	 	30	  
	 7.6 Regulatory Listings and Notices Relating to the Act
	  	 	33	  
	 7.7 Patent Term Extensions
	  	 	33	  
	 7.8 Marking
	  	 	34	  
	 7.9 Entitlement Action
	  	 	34	  
		
	 ARTICLE 8 — INDEMNIFICATION
	  	 	34	  
		
	 8.1 Indemnification
	  	 	34	  
	 8.2 Insurance Proceeds
	  	 	36	  
	 8.3 Insurance
	  	 	36	  
	 8.4 Future Litigation Regarding Development Agreements
	  	 	37	  
		
	 ARTICLE 9 — RIGHT OF FIRST NEGOTIATION FOR PTH PRODUCT
	  	 	37	  
		
	 9.1 ALZA Rights Regarding PTH Product
	  	 	37	  
	 9.2 TMC Notice Regarding PTH Product
	  	 	37	  
	 9.3 Decision Regarding PTH Product
	  	 	38	  
	 9.4 No Negotiation of PTH Product
	  	 	39	  
	 9.5 Good Faith Negotiation Regarding PTH Product
	  	 	39	  
	 9.6 No Agreement Regarding PTH Product
	  	 	39	  
	 9.7 Additional Rights Regarding PTH Product
	  	 	39	  
	 9.8 No Implied Rights
	  	 	41	  
		
	 ARTICLE 10 — OPTION FOR NESIRITIDE PRODUCT
	  	 	41	  
		
	 10.1 Option for Nesiritide Product
	  	 	41	  
	 10.2 Exercise Of Option
	  	 	42	  
		
	 ARTICLE 11 — TMC’S RIGHT OF FIRST NEGOTIATION FOR EXPANDED LICENSE
	  	 	42	  
		
	 11.1 ALZA Notice Regarding Expanded License
	  	 	42	  
	 11.2 Decision Regarding Expanded License Negotiations
	  	 	42	  
	 11.3 No Negotiation Regarding Expanded License
	  	 	42	  
	 11.4 Good Faith Negotiation Regarding Expanded License
	  	 	42	  
	 11.5 No Agreement Regarding Expanded License
	  	 	43	  
		
	 ARTICLE 12 — TMC’S RIGHT OF FIRST NEGOTIATION ON PRODUCTS UTILIZING MICROPROJECTION SYSTEMS OUTSIDE THE FIELD
	  	 	43	  
		
	 12.1 ALZA Notice Regarding Collaboration
	  	 	43	  
	 12.2 Decision Regarding Collaboration Negotiations
	  	 	43	  


  
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	 12.3 No Negotiation Regarding Collaboration
	 	 	44	  
	 12.4 Good Faith Negotiations Regarding Collaboration
	 	 	44	  
	 12.5 No Agreement Regarding Collaboration
	 	 	44	  
		
	 ARTICLE 13 — TMC’S RIGHT TO MEET
	 	 	44	  
		
	 13.1 TMC Proposal
	 	 	44	  
		
	 ARTICLE 14 — EXCLUSIVITY
	 	 	45	  
		
	 14.1 TMC Exclusivity
	 	 	45	  
	 14.2 ALZA Exclusivity
	 	 	45	  
		
	 ARTICLE 15 — TERM AND TERMINATION
	 	 	47	  
		
	 15.1 Term
	 	 	47	  
	 15.2 Termination of this Agreement by TMC for any Reason
	 	 	47	  
	 15.3 Termination by ALZA
	 	 	47	  
	 15.4 Termination By Either Party for Breach
	 	 	47	  
	 15.5 Effective Date of Termination
	 	 	47	  
	 15.6 Termination for Bankruptcy
	 	 	48	  
	 15.7 Effect of Termination
	 	 	48	  
	 15.8 No Waiver
	 	 	50	  
	 15.9 Consequences of Termination
	 	 	50	  
	 15.10 [**]
	 	 	51	  
	 15.11 Survival of Obligations
	 	 	51	  
	 15.12 Termination Not Sole Remedy
	 	 	51	  
		
	 ARTICLE 16 — REPRESENTATIONS AND WARRANTIES
	 	 	51	  
		
	 16.1 Authority
	 	 	51	  
	 16.2 No Conflicts
	 	 	51	  
	 16.3 ALZA Representations
	 	 	51	  
	 16.4 No Implication By ALZA
	 	 	53	  
	 16.5 TMC Representations
	 	 	54	  
	 16.6 Disclaimer of Warranties
	 	 	54	  
		
	 ARTICLE 17 — DISPUTE RESOLUTION
	 	 	54	  
		
	 17.1 Dispute Resolution and Arbitration
	 	 	54	  
	 17.2 Arbitration
	 	 	55	  
		
	 ARTICLE 18 — MISCELLANEOUS PROVISIONS
	 	 	55	  
		
	 18.1 Entire Agreement
	 	 	55	  
	 18.2 Further Actions
	 	 	55	  
	 18.3 Binding Effect
	 	 	55	  
	 18.4 Assignment
	 	 	55	  
	 18.5 No Implied Licenses
	 	 	56	  
	 18.6 No Waiver
	 	 	56	  
	 18.7 Force Majeure 
	 	 	56	  


  
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	 18.8 Independent Contractors
	 	 	56	  
	 18.9 Notices and Deliveries
	 	 	57	  
	 18.10 Headings
	 	 	58	  
	 18.11 Severability
	 	 	58	  
	 18.12 Applicable Law
	 	 	58	  
	 18.13 Advice of Counsel
	 	 	58	  
	 18.14 Counterparts
	 	 	58	  
	 18.15 Waiver
	 	 	58	  
	 18.16 Bankruptcy
	 	 	58	  
	 18.17 Compliance with Laws
	 	 	59	  
	 18.18 Certain Tax Matters
	 	 	59	  

  

			
	ATTACHMENT 1.5	  	CERTAIN ALZA INVENTIONS
	ATTACHMENT 1.6	  	ALZA KNOW-HOW
	ATTACHMENT 1.12	  	DEVELOPMENT AGREEMENTS
	ATTACHMENT 1.23	  	LICENSED PATENTS
	ATTACHMENT 1.46	  	TRADEMARK
	ATTACHMENT 2.1.4	  	NON-FIELD PATENTS/APPLICATIONS
	ATTACHMENT 3.3.1	  	EXISTING AGREEMENTS
	ATTACHMENT 4.1	  	GENERAL TRADEMARK ASSIGNMENT
	ATTACHMENT 4.5	  	TRADEMARK ASSIGNMENT FORM
	ATTACHMENT 6.3	  	PRESS RELEASE
	ATTACHMENT 10.1	  	TERM SHEET FOR NESIRITIDE PRODUCT
	ATTACHMENT 16.3.4	  	DISCLOSURES
	ATTACHMENT 17.2	  	ARBITRATION PROCEEDINGS


  
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 INTELLECTUAL PROPERTY LICENSE AGREEMENT 

This Intellectual Property License Agreement (the “Agreement”) is made and effective as of October 5, 2006 (the “Effective
Date”), by and between ALZA Corporation, a Delaware corporation (“ALZA”) and The Macroflux Corporation, a Delaware corporation (“TMC”). ALZA and TMC may be referred to individually herein as a “Party” or together
as the “Parties”. 
 RECITALS 

1. ALZA is the owner of certain inventions and know-how regarding transdermal drug delivery systems and technologies. 

2. TMC desires to acquire, certain know-how and patent licenses under ALZA’s technology from ALZA on the terms set forth herein. 

3. In consideration of (i) the issuance of shares of TMC Series A Convertible Participating Preferred Stock pursuant to the Asset
Transfer and Series A Convertible Participating Preferred Stock Purchase Agreement made on or about the Effective Date, by and between TMC and ALZA (the “Series A Agreement”) and (ii) the obligations of TMC hereunder, ALZA is
willing to grant certain intellectual property licenses to TMC, subject to the terms and conditions of this Agreement. 
 4. The Parties
hereto intend that the exchange of Licenses for TMC Series A Convertible Participating Preferred Stock (“Series A Preferred”) and Product Payments pursuant to the terms of this Agreement together with the transactions effected
pursuant to the terms of the Series A Agreement and with all purchases of Series B Convertible Participating Preferred Stock (“Series B Preferred”) under the Series B Convertible Participating Preferred Stock Purchase Agreement made
on or about the Effective Date, by and among TMC and certain investors (the “Series B Agreement”) will be treated as a contribution of property (or cash in the case of the Series B Preferred) to TMC in exchange for shares (and boot
in the case of 

  
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Product Payments) pursuant to Section 351 of the Internal Revenue Code of 1986, as amended (the “Code”) for federal income tax purposes. 

NOW, THEREFORE, in consideration of the various promises and undertakings set forth herein, the Parties agree as follows: 

ARTICLE 1 — DEFINITIONS 

The terms in this Agreement with initial letters capitalized, whether used in the singular or the plural, will have the meaning set forth
below or, if not listed below, the meaning designated where first used in this Agreement. 
 1.1 “Active Clinical
Development” of a Product means that at any given time TMC is diligently engaging in one or more of the following development activities for such Product in the Field: (a) awaiting protocol approval from an applicable institutional
review board, FDA or other Regulatory Authority; (b) patient recruitment, patient treatment, data analysis, or report writing for any clinical trial; (c) regulatory file(s) being drafted or pending; and (d) manufacturing scale-up and
validation. 
 1.2 “Active Early Development” of a Product means that at any given time TMC is diligently engaging in one
or more of the following development activities for such Product in the Field: (a) formulation development; (b) preclinical studies to evaluate delivery or the feasibility of a prototype Product; (c) preclinical studies to evaluate
pharmacokinetics, pharmacodynamics, and/or safety of a prototype Product; and (d) analytical development. 
 1.3
“Affiliate” means, with respect to any Party, any corporation or other business entity, which directly or indirectly controls, is controlled by, or is under common control with such Party. For the purposes of this definition, the
term “control” (including, with correlative meanings, the terms “controlled by” and “under common control with”) as used with respect to any Party, will mean 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 

  
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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. 

1.4 “Agreement” means this Intellectual Property License Agreement, including its Attachments, as the same may be amended
from time to time. 
 1.5 “ALZA Inventions” means any inventions arising out of work conducted by or on behalf of ALZA
prior to the Effective Date that both (i) relate primarily to Microprojection Systems (including the use or manufacture thereof) and (ii) that are described in Attachment 1.5. 

1.6 “ALZA Know-How” means all currently available and reasonably relevant tangible and written know-how, data, and reports
owned or Controlled by ALZA as of the Effective Date that (i) relate to Microprojection Systems and Products or the business operations and plans of the Macroflux Internal Venture unit of ALZA, or (ii) that is otherwise necessary or useful
for the development, manufacture, promotion or use of a Microprojection System or a Product, in each case to the extent such know-how, data, and reports are listed on Attachment 1.6 or on the Post-Closing List (as defined in Section 3.4),
together with tangible and written know-how, data and reports generated after the Effective Date pursuant to the Transitional Services Agreement; provided, however, that ALZA Know-How will not include any written documentation, data or reports, or
any portion thereof, relating solely to any compound proprietary to or Controlled by ALZA or any of its Affiliates (including but not limited to nesiritide) or consisting of Improperly Transferred Documents. 

1.7 “[**] Agreement” means [**] 

1.8 “Commercialize” or “Commercialization” means the ongoing process and activities (including pre-launch
activities) generally engaged in by a pharmaceutical company to sell and market a pharmaceutical product. When used as a verb, “Commercialize” means to engage in Commercialization. 

1.9 “Confidential Information” means, in the case of ALZA, ALZA Know-How, and other
business and technical information regarding ALZA and its Affiliates, including information relating to technologies, compounds and products (other than Products), whether in development or Commercialized, or the use, manufacturing or
Commercialization for any of the foregoing, or related clinical or regulatory affairs, and ALZA’s processes and procedures, and financial and other business information regarding ALZA and its Affiliates, in each case to the extent such
information has been disclosed to TMC by or on behalf of ALZA prior to or during 

  
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the Term for the purposes described in this Agreement or the purposes of ALZA and its Affiliates providing facilities or services to TMC (“ALZA Confidential Information”), and in
the case of TMC, business and technical information regarding TMC and its Affiliates, limited to (i) information included in TMC’s annual development activity reports, (ii) agreements between TMC and Sublicensees, (iii) financial
information regarding Net Sales of Products and payments due to TMC regarding Third Party Products, and (iv) data and information developed by or on behalf of TMC after the Effective Date regarding the PTH Product or any other Product, in each
case to the extent such information has been disclosed to ALZA by or on behalf of TMC during the Term for the purposes described in this Agreement (“TMC Confidential Information”), and in each case, which information is owned or
Controlled by a Party hereto or any of its Affiliates or generated pursuant to this Agreement; provided, however, that Confidential Information will not include information which: 

(a) is or becomes part of the public domain through no breach of this Agreement (or any other agreement between TMC and ALZA or its
Affiliates) by the recipient or any of its Affiliates and through no breach of any agreement between individual TMC employees and ALZA or its Affiliates which breach occurs any time after August 1, 2006 (provided that it is understood that TMC
will in no event be liable to ALZA with respect to any breach of a prior agreement between individual TMC employees and ALZA or its Affiliates); 

(b) is known by the recipient or any of its Affiliates (without an obligation to keep such information confidential) prior to the disclosure
thereof by the disclosing Party as demonstrated by the recipient’s written records; 
 (c) becomes available to the receiving Party or
its Affiliates on a nonconfidential basis, whether directly or indirectly, from a Third Party who has the right to make such disclosure; 

(d) is independently developed by employees of the recipient who did not have knowledge of or access to any of the Confidential Information of
the disclosing Party (as Confidential Information is defined without reference to this subsection (d)). 
 1.10 “Control” or
“Controlled” means possession of the ability to grant a license or sublicense of Patents, know-how or other intangible rights as provided for herein without violating the terms of any contract or other arrangements with any Third
Party. 

  
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 1.11 “Derivative Information” means information, data or know-how (unless and
until such information, data or know-how is part of the public domain) that (a) is generated while performing work on a product in the Field covered by a Valid Patent Claim of the Licensed Patents or (b) arises out of the use of or
reference to ALZA Know-How or ALZA Confidential Information. 
 1.12 “Development Agreements” means the agreements
described on Attachment 1.11. 
 1.13 “Dollars” means the legal currency of the United States. 

1.14 “Effective Date” means the date of this Agreement as set forth in the first paragraph above. 

1.15 “FDA” means the United States Food and Drug Administration or any successor agency to its responsibilities for
pharmaceutical products such as Products. 
 1.16 “Field” means (a) passive, diffusion-mediated delivery of one or
more therapeutic or prophylactic agents into or through the skin from a Microprojection System, which Microprojection System is coated with such therapeutic or prophylactic agents; or (b) diffusion-mediated delivery of one or more therapeutic
or prophylactic agents into or through the skin by way of pathways formed by a Microprojection System. For clarity, the Field does not include any other applications of Microprojection Systems, such as (i) delivery of therapeutic or
prophylactic agents into or through the skin utilizing a Microprojection System in combination with any delivery system that utilizes a driving source (including, but not limited to, delivery systems that utilize one or more driving sources such as
electrical potential gradients, sound waves, heating systems, laser energy, hydraulic systems or radio waves), other than as provided by the microprojections, the therapeutic or prophylactic agent itself or chemical permeation enhancers, or
(ii) the use of a Microprojection System for sampling or sensing. 
 1.17 “Financial Records” will have the meaning
ascribed thereto in Section 5.6. 
 1.18 “Financing Transaction” means a private equity financing transaction to fund
TMC raising a minimum of $75 million in cash from Third Parties reasonably acceptable to ALZA. 
 1.19 “First Sale” means
with respect to each Product, the first sale in an arms length transaction and shipment of such Product to a Third Party by or on behalf of TMC or its 

  
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Sublicensee in a country in the Territory following receipt of applicable Regulatory Approval for such Product in such country. 

1.20 “Future ALZA Inventions” means any inventions conceived or reduced to practice and arising out of work conducted by or
on behalf of ALZA or any of its licensees after the Effective Date and for so long as TMC holds a license to the ALZA Know-How under Section 2.1.2 that relate primarily to Microprojection Systems (including the use or manufacture thereof);
provided, however, that Future ALZA Inventions will not include (i) inventions arising out of work conducted independently by ALZA’s licensees outside of any agreement with ALZA by employees of such licensees without access to, use of or
reference to any ALZA Know-How, ALZA confidential information (including ALZA Confidential Information) or other Future ALZA Inventions, TMC Inventions or confidential information of TMC, (ii) inventions developed by ALZA’s licensees to
the extent made by employees of such licensee without access to, use of or reference to any ALZA Know-How, ALZA confidential information (including ALZA Confidential Information) or other Future ALZA Inventions, TMC Inventions or confidential
information of TMC, (iii) inventions that ALZA demonstrates by clear and convincing evidence were independently developed solely by ALZA employees without access to or knowledge of any ALZA Know-How, TMC Confidential Information or TMC
Inventions and (iv) any invention developed by a Third Party whom ALZA had engaged to develop an ALZA product utilizing such Third Party’s proprietary Microprojection System under an agreement with ALZA, provided that ALZA has not obtained
from such Third Party the right to grant TMC a license to such invention (although ALZA will be under no obligation to do so) and provided further that ALZA fulfilled its obligations under Article 12 prior to having entered into such agreement with
such Third Party. 
 1.21 “Future ALZA Patents” means Patents based on Future ALZA Inventions. 

1.22 “License” means the licenses granted in Sections 2.1.1, 2.1.2 and 2.1.4. 

1.23 “Licensed Patent(s)” means the patents and patent applications that are identified in Attachment 1.23, as well as all
Patents derived therefrom. Licensed Patents are divided into two categories, Category A and Category B, as described in Attachment 1.23. Additionally, Licensed Patents will include all Patents based on ALZA Inventions, which Patents will be deemed
to be included in Category B. 

  
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 1.24 “NDA” means, for a particular Product, its United States New Drug
Application, filed with the FDA, as such application may be amended or supplemented from time to time. 
 1.25 “Microprojection
System” means a microprojection array having a plurality of microprojections which pierce at least through the outmost layer (i.e., the stratum corneum layer) of the skin. 

1.26 “Natrecor® (nesiritide)” means any product incorporating
nesiritide. 
 1.27 “Net Sales” means [**] 

1.28 “Nesiritide Product” means a Product incorporating nesiritide or any analog or derivative thereof. 

1.29 “Patent(s)” means all multinational, foreign and domestic patents and patent applications, including any continuations,
continuations-in-part, divisions, provisionals or any substitute applications, as well as any patents throughout the world issuing with respect to any such patent applications, continuations, continuations-in-part, divisions, provisionals or
substitute applications, and any reissues, reexaminations, renewals and extensions (including any supplemental patent certificates) of any of the foregoing and any confirmation patent or registration patent or patent addition based on any such
patent. 
 1.30 “Product” means a product in the Field (i) the manufacture, sale or use of which would but for the
license granted herein, infringe a Valid Patent Claim of the Licensed Patents or (ii) that is developed, in whole or in part, by TMC employees or Third Party employees with access to or knowledge of any ALZA Know-How, ALZA Confidential
Information, TMC Inventions, TMC Confidential Information, (as defined without reference to whether such TMC Confidential Information is disclosed to ALZA) or Derivative Information; provided, however, that in the case of subsection (ii), Product
will not include (x) a product that TMC demonstrates by clear and convincing evidence was independently developed by TMC employees or Third Party employees without access to or knowledge of any ALZA Know-How, ALZA Confidential Information, TMC
Inventions, TMC Confidential Information (as defined without reference to whether such TMC Confidential Information is disclosed to ALZA), or Derivative Information, and (y) a product that TMC acquires from a Third Party provided that such
Third Party developed such product without access to or knowledge of any ALZA Know-How, ALZA Confidential Information, TMC Inventions, TMC Confidential Information (as defined without 

  
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reference to whether such TMC Confidential Information is disclosed to ALZA) or Derivative Information. 

1.31 “Product Payments” will have the meaning ascribed thereto in Section 5.2. 

1.32 “PTH” means a peptide commonly known as parathyroid hormone or any analog or derivative thereof (including PTH (1-34)
OH). 
 1.33 “PTH Product” means a Product incorporating PTH. 

1.34 “Quarter” or “Quarterly” means each three month period ending
March 31, June 30, September 30 or December 31 of each year during the term of this Agreement. 
 1.35
“Regulatory Approval” means in any country, written notice of required marketing approval (including pricing approval, if required) by the Regulatory Authority having jurisdiction in such country, which approval is required before a
product may be commercially sold in such country for the marketing, sale and/or use of a product on a commercial basis in the applicable country. 

1.36 “Regulatory Authority” means the national (e.g., the FDA) or supra-national (e.g., the European Commission, the Council
of the European Union, or the EMEA) agency, if any, with which a pharmaceutical or biological product must be registered or by which a pharmaceutical or biological product must be approved prior to its manufacture, use or sale in a country. 

1.37 “Regulatory Documents” means that certain IND No. 70,973 submitted to the FDA together with the associated Form FDA
1571 (IND Serial No. 0007) as well as all written communications between ALZA and the FDA and ALZA’s internal contact reports, in each case, relating to IND No. 70,973. 

1.38 [**] 
 1.39
“Sublicensee” means, with respect to a particular Product, a Third Party to whom TMC has granted a license or sublicense under the License to make, have made, use, import, sell, offer for sale or have sold any and sell such Product.

 1.40 “Term” will have the meaning ascribed thereto in Section 15.1. 

1.41 “Territory” means the entire world. 

1.42 “Third Party” means an individual, corporation or other entity other than a Party or any of its Affiliates. 

  
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 1.43 “Third Party Product” means any Product being developed by TMC for a
Sublicensee that (a) incorporates the Sublicensee’s proprietary compound(s), or (b) is a vaccine. A compound is considered proprietary to a Sublicensee if there is no generic equivalent of the compound commercially available to the
public or if the unauthorized manufacture, use or sale of the compound by a person or entity other than such Sublicensee would infringe one or more Patents owned or licensed by such Sublicensee. 

1.44 “TMC Inventions” means any inventions conceived or reduced to practice and arising out of work conducted by or on behalf
of TMC or any of its Affiliates or Sublicensees after the Effective Date and for so long as TMC holds a license to the ALZA Know-How under Section 2.1.2 that relate primarily to Microprojection Systems (including the use or manufacture
thereof); provided, however, that TMC Inventions will not include (i) inventions arising out of work conducted independently by TMC’s Sublicensees or other Third Parties outside of any agreement with TMC or its Affiliates by employees of
such Sublicensee or other Third Party without access to, use of or reference to any ALZA Know-How, ALZA confidential information (including ALZA Confidential Information), Future ALZA Inventions or other TMC Inventions, TMC Confidential Information
(as defined without reference to whether such TMC Confidential Information is disclosed to ALZA), or Derivative Information, (ii) inventions developed by TMC’s (or its Affiliates’) Sublicensees to the extent made by employees of such
Sublicensee without access to, use of or reference to any ALZA Know-How, ALZA confidential information (including ALZA Confidential Information), Future ALZA Inventions or other TMC Inventions or TMC Confidential Information (as defined without
reference to whether such TMC Confidential Information is disclosed to ALZA), or Derivative Information, and (iii) inventions that TMC demonstrates by clear and convincing evidence were independently developed solely by TMC employees without
access to or knowledge of any ALZA Know-How, ALZA Confidential Information, TMC Confidential Information (as defined without reference to whether such TMC Confidential Information is disclosed to ALZA) or TMC Inventions (as defined without reference
to this subsection (iii)) or Derivative Information. 
 1.45 “TMC Patents” means Patents based on TMC Inventions. 

1.46 “Trademark” means the trademark applications and registrations for the mark “MACROFLUX” as described in
Attachment 1.46, including the goodwill associated therewith. 

  
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 1.47 “Transitional Services Agreement” means the transitional services agreement
entered into between the Parties effective on the Effective Date. 
 1.48 “Valid Patent Claim” means a claim of an issued
patent in a country of the Territory or a claim of a pending application filed in good faith for a patent in a country of the Territory, provided that such claim has not expired, or been determined to be invalid or unenforceable by a final
unappealable decision of a court or other appropriate body of competent jurisdiction, and which has not been admitted to be invalid by the patent owner through public disclaimer or dedication to the public. 

ARTICLE 2 — GRANT OF LICENSE RIGHTS. 

2.1 License to TMC. Subject to the terms and conditions of this Agreement and contingent on and subject to TMC’s closing of the
Financing Transaction, ALZA hereby grants to TMC: 
 (a) an exclusive license (even as to ALZA) under the Licensed Patents to make, have
made, import, use, sell, offer for sale and have sold Products in the Field in the Territory, subject to rights already granted to [**] under the Development Agreement between ALZA and [**]; and 

(b) a non-exclusive royalty-free license under the Future ALZA Patents to make, have made, import, use, sell, offer for sale and have sold
Products in the Field in the Territory. 
 (c) Notwithstanding the foregoing license grant(s), ALZA reserves the right to use all Licensed
Patents and Future ALZA Patents to the extent necessary to fulfill its obligations under this Agreement and the Transitional Services Agreement. 

2.1.2 Subject to the terms and conditions of this Agreement and contingent on and subject to TMC’s closing of the Financing Transaction,
ALZA hereby grants to TMC an exclusive license to the ALZA Know-How to make, have made, import, use, sell, offer for sale and have sold Products in the Field in the Territory, subject to rights already granted to [**] under the [**] Agreement. 

2.1.3 To the extent the Licensed Patents, Future ALZA Patents or ALZA Know-How cover technologies or products outside the Field, or are
otherwise useful outside the Field, 

  
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ALZA grants no rights to TMC, and ALZA specifically retains any and all such rights, in each case to the extent outside the Field. 

2.1.4 To the extent any Patents issue from the patent applications listed in Attachment 2.1.4 and such Patents have a Valid Patent Claim
covering a Product or the use of a Product, ALZA hereby grants to TMC a non-exclusive royalty-free license under such Patents, to make, have made, use, import, sell, offer for sale and have sold Products in the Territory in the Field; provided,
however, that any such Patents will not become Licensed Patents. 
 2.1.5 TMC will have the right to grant and authorize sublicenses to Third
Parties and TMC Affiliates with respect to its rights under the License in accordance with the terms and conditions of this Agreement. Any sublicense granted to a Third Party will be on a Product-by-Product basis, or on a specific multi-Product
basis (e.g., based on specified sets or classes of compounds or multiple vaccines), provided that TMC does not sublicense all (or substantially all) of TMC’s rights under this Agreement to any single Sublicensee (alone or together with such
Sublicensee’s Affiliates). TMC will provide ALZA with notice of the identity of each Sublicensee and will ensure (i) that each such agreement with its Sublicensee will be subject and subordinate to, and consistent with, the terms and
conditions of this Agreement and (ii) that the rights of ALZA under this Agreement are not prejudiced or in any way reduced or limited by such sublicensing arrangement; and (iii) that any Sublicensee will not further sublicense except on
terms consistent with this Section 2.1.5. TMC will provide ALZA with a copy of each such sublicense agreement within thirty (30) days after the execution thereof. Such copy may be redacted to exclude any information not necessary for
assessing TMC’s compliance with its obligations to ALZA under this Agreement. 
 2.1.6 TMC may carry out its obligations under this
Agreement in whole or in part through its Affiliates, Sublicensees, consultants and contractors, provided that TMC will remain responsible to ALZA for the performance of each such obligation that it so delegates. 

2.1.7 TMC will not permit any Sublicensees, Affiliates or delegated parties to use ALZA Confidential Information without provisions
safeguarding confidentiality which are at least equivalent to those provided in this Agreement and TMC ensures the compliance by each of its Sublicensees, Affiliates and delegated parties with all such applicable provisions safeguarding
confidentiality in accordance with the terms and conditions of this Agreement. 

  
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 2.2 License to ALZA. Subject to the terms and conditions of this Agreement, TMC hereby
grants to ALZA an irrevocable, perpetual, royalty-free, worldwide, nonexclusive license, with the right to sublicense, under the TMC Patents to make, have made, use, import, sell, offer for sale and have sold products outside the Field. If the
License is terminated on or prior to the third anniversary of the Effective Date and TMC has made all payments due under the [**] Agreement which accrued on or before the effective date of such termination and TMC is not then in material default
under the [**] Agreement or which default is cured by TMC within the time frame set forth in the [**] Agreement, TMC hereby grants and ALZA will automatically receive an irrevocable, perpetual, worldwide, nonexclusive license, with the right to
sublicense, under TMC Patents, to make, have made, use, import, sell, offer for sale and have sold products in the Field to the extent the License is so terminated, and on a product-by-product basis, and country-by-country basis, ALZA will pay TMC a
royalty equal to [**] of ALZA’s (or its Affiliates or sublicensee’s) Net Sales (as such term is defined in this Agreement but with the terms TMC and ALZA being reversed for purposes of this Section 2.2) of each product covered by such
TMC Patents so long as there is a Valid Patent Claim of a TMC Patent covering such product in such country and the Parties will negotiate in good faith an agreement regarding the timing and mode of such payments, the requirement for ALZA to maintain
financial records related to such payments and the right of TMC to audit such financial records, on terms similar to those imposed on TMC herein. If the License is terminated on or prior to the third anniversary of the Effective Date and TMC has not
made all payments due under the [**] Agreement and which default is not cured within the time frame set forth in the [**] Agreement or is in material default under the [**] Agreement and which default is not cured within the time frame set forth in
the [**] Agreement or if the License is terminated at any time after the third anniversary of the Effective Date, TMC hereby grants and ALZA will automatically receive an irrevocable, perpetual, royalty-free, worldwide, nonexclusive license, with
the right to sublicense, under the TMC Patents to make, have made, use, import, sell, offer for sale and have sold products in the Field. If the License is terminated at any time, and at ALZA’s request, the Parties will negotiate in good faith,
on commercially reasonable terms, for ALZA to obtain an exclusive, royalty-bearing license under the TMC Patents to make, have made, use, import, sell, offer for sale and have sold products in the Field. 

  
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 ARTICLE 3 — DEVELOPMENT AND COMMERCIALIZATION. 

3.1 Development Responsibility and Costs. TMC will have the sole responsibility and right to develop Products and will bear the
cost of conducting development of Products (it being understood that TMC may satisfy such responsibilities and exercise such rights itself or through its Affiliates and Sublicensees); provided, however, ALZA will provide certain support services to
TMC for a limited transition period pursuant to the Transitional Services Agreement. 
 3.2 Regulatory Responsibilities and Costs.
TMC will have the sole responsibility for, and will bear the cost of preparing, all regulatory filings and related submissions with respect to Products (it being understood that TMC may satisfy such responsibilities itself or through its
Affiliates and Sublicensees). Promptly after the Effective Date, the Parties will work together to transfer and assign to TMC the Regulatory Documents. 

3.3 Existing Agreements. 

3.3.1 The Parties acknowledge that prior to the Effective Date, ALZA made available to TMC all current agreements between ALZA and Third
Parties relating to Microprojection Systems requested by TMC. For the agreements listed on Attachment 3.3.1 attached hereto, ALZA agrees that promptly after the Effective Date, it will assign such agreements to TMC, when possible, and, if required,
will request the consent of the relevant Third Party to such assignment. TMC will assume all ongoing responsibilities and obligations under such agreements as of the Effective Date. 

3.3.2 [**] 
 3.4 ALZA
Know-How. The Parties acknowledge that prior to the Effective Date, except as otherwise noted in Attachment 1.6, ALZA made available to TMC the ALZA Know-How listed on Attachment 1.6 as well as (i) the contents of the office files of TMC
employees (collectively, “Employee Office Files”), (ii) a copy of the contents of TMC employee’s folders on a shared hard drive designated for the Macroflux Internal Venture unit of ALZA (including a copy of each employee’s
archived e-mail) (collectively, “H-Drive Files”), and (iii) a copy of the contents of the Macroflux Technology Development Folder (collectively, “Tech Dev Files”) (the Employee Office Files, H-Drive Files and Tech Dev Files,
collectively the “Transferred Information”). The parties acknowledge that ALZA has retained an electronic copy of the H-Drive Files and Tech Dev Files and TMC will provide ALZA with a written inventory of the 

  
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Employee Office Files prior to the Effective Date. Promptly after the Effective Date, TMC will use commercially reasonable efforts to review the Transferred Information to confirm that it does
not contain ALZA documents or files that (A) do not relate to either the Microprojection Systems and Products or the business operations and plans of the Macroflux Internal Venture unit of ALZA, (B) are not otherwise necessary or useful
for the development, manufacture, promotion or use of a Microprojection System or a Product, (C) relate solely to any compound proprietary to or Controlled by ALZA or any of its Affiliates (including but not limited to nesiritide),
(D) include confidential information of a Third Party, (E) relate solely to technologies of ALZA or its Affiliates other than Microprojection Systems, or (F) include confidential information of ALZA or its Affiliates that applies
generally to ALZA’s or its Affiliate’s businesses and not specifically to the Macroflux Internal Venture unit of ALZA or any Transferred Employee (as defined in the Series A Agreement) (including but not limited to worldwide policies,
human resources forms and job descriptions, and financial policies) (any such documents or files, “Improperly Transferred Documents”). If any document or file in the Transferred Information contains both ALZA Know-How and any of the types
of information described in clauses (A) through (F) of the preceding sentence, the parties 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 clauses (A) through (F). In the event TMC discovers that it possesses any Improperly Transferred Documents, either during its review of the Transferred Information
described above or at any point in the future, TMC shall promptly notify ALZA, provide a general description of such confidential or proprietary information, and either promptly return to ALZA or destroy, at ALZA’s option, all tangible
materials that disclose or embody such confidential or proprietary information. Within seven (7) days of the Effective Date, TMC shall provide ALZA with (i) a list of any Improperly Transferred Documents identified by TMC in its review of
the Transferred Information, and (ii) an index of all other written know-how, data, and reports remaining in the Transferred Information after the removal of such Improperly Transferred Documents (such index, the “Post-Closing List”).
The parties acknowledge that other than the ALZA Know-How identified in Attachment 1.6 as remaining to be transferred (which know-how, data, and reports shall be transferred to TMC by the applicable transfer date specified for such item in
Attachment 1.6), ALZA has no obligations to provide any additional 

  
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Know-How generated prior to the Effective Date to allow TMC to practice under the License. Notwithstanding the foregoing, or anything in Section 18.2 to the contrary, for a period of six
(6) months following the Effective Date, in the event that TMC identifies a particular item of ALZA Know-How that was not made available to TMC, and TMC would be materially impeded in the development of the Microprojection System or the
development or Commercialization of Products by not having such item, ALZA will use commercially reasonable efforts to make such ALZA Know-How available to TMC in a timely manner. At the termination of the Transitional Services Agreement, ALZA will
make available to TMC all ALZA Know-How generated in the performance of the transitional services. Any duplication of the ALZA Know-How for TMC will be at TMC’s sole cost and expense. If TMC identifies additional Improperly Transferred
Documents or additional ALZA Know-How identified by TMC for a period of six (6) months following the Effective Date after the generation of the Post-Closing List, in either case, pursuant to this Section 3.4, TMC will amend the
Post-Closing List to exclude or include such information and will provide such revised list to ALZA. Following the termination of the Transitional Services Agreement, TMC will amend the Post-Closing List to include ALZA Know-How generated in the
performance of the transitional services, and will provide such revised list to ALZA. The parties will each maintain a copy of the most recent Post-Closing List. Notwithstanding anything in this Section 3.4 to the contrary, ALZA will not be
required to transfer or make available any ALZA Know-How that would require ALZA to breach any obligation it may have to a Third Party or violate any law, statute, ordinance or regulation. For the avoidance of doubt, the transfer of any tangible
manifestations of ALZA Know-How pursuant to this Section 3.4 will not alter the ownership or other rights of ALZA or its Affiliates with respect to such ALZA Know-How. In the event of a dispute between the Parties regarding the procedures in
this Section 3.4, the Parties will use the dispute resolution procedures described in Section 17.1, provided that the first sixty (60) day period described therein will be reduced to ten (10) business days and the second sixty
(60) day period will be reduced to thirty (30) days for such dispute. 
 3.5 Future Vendor Agreements. Neither TMC nor ALZA
will enter into any agreement with any Third Party vendor that prohibits such Third Party from providing services to the other Party or its Affiliates related to Microprojection Systems or the components, 

  
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manufacture, assembly or packaging thereof, for use in the Field, in the case of TMC, or for use outside the Field, in the case of ALZA. 

3.6 TMC Diligence. 
 3.6.1
General Diligence Obligations. During the Term, TMC will use diligent efforts to continue development of Microprojection Systems in the Field and to develop and obtain Regulatory Approval for Products within the Territory in a manner consistent with
the efforts United States-based, mid-sized, specialty pharmaceutical companies devote to products having similar market potential at a similar stage of development or life of such product based on conditions then prevailing with respect to the
applicable product and the relevant market. 
 3.6.2 Specific Diligence Obligations. In addition to TMC’s general development diligence
requirements set forth above, and in no way limiting them, at all times during the period of time beginning with the Effective Date and ending on the date of the First Sale of the second Product to be Commercialized, TMC will have at least two
Products in a combination of Active Early Development and/or Active Clinical Development (it being understood that this obligation will be satisfied if TMC has (i) two or more Products in Active Early Development, (ii) two or more Products
in Active Clinical Development, or (iii) one Product in Active Early Development and one Product in Active Clinical Development); provided, however, TMC will not be deemed to be in breach of this specific diligence obligation if TMC encounters
an adverse technical, clinical or other condition/event regarding a particular Product (and not a condition/event that applies generally to TMC) which, in TMC’s reasonable judgment, requires the termination or suspension of development work on
such particular Product, so long as TMC is engaged in Active Early Development on at least one additional Product within 6 months following the date TMC terminates or suspends such development program. 

3.6.3 Consequences of Default. If TMC does not fulfill its general diligence obligations set forth in Section 3.6.1 above, ALZA will be
entitled, but not obligated, to terminate the License and this Agreement, subject to the terms of Section 15.4 below. If TMC does not fulfill its specific diligence obligations set forth in Section 3.6.2 above, ALZA will be entitled, but
not obligated, to terminate the License and this Agreement immediately upon written notice to TMC. 
 3.7 Annual Development Activity
Report. Within ninety (90) days after the Effective Date, TMC will submit to ALZA a written development plan containing at least 

  
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development timelines and milestones for the PTH Product and for at least one other Product. Thereafter, on or before February 28th of
each calendar year, TMC will submit to ALZA a written, non-confidential annual report summarizing in reasonable detail the development work conducted by TMC during the prior calendar year and TMC’s development plans for the then-current year.
TMC will blind the identity of the active pharmaceutical ingredients in any Product that it is developing (or considering developing) that is not subject to the Exclusivity provisions of Article 14 below and which has not been previously publicly
disclosed when describing such Product in such annual reports and will limit the information disclosed in such annual reports to non-confidential information regarding the Products being developed provided that the information contained in such
reports is sufficiently detailed to allow ALZA to evaluate TMC’s compliance with the provisions of this Agreement. To the extent that TMC has entered into any agreements with Third Parties for the development or Commercialization of Third Party
Products, TMC will include in the development report the status of such programs including the work conducted on such programs and any milestones achieved in the previous year. To the extent necessary for assessing TMC’s compliance with its
obligations to ALZA under this Agreement, ALZA may request additional confidential information related to TMC’s development activities after receipt of such report, and, subject to the consent of any applicable Third Party, TMC will provide
such requested information subject to the terms of this Agreement, including, but not limited to, Article 6. TMC will provide such reports unless and until an authorized corporate officer of ALZA requests TMC to terminate such reports in whole or in
part and thereafter will provide such reports only to the extent requested. 
 3.8 Commercial Responsibilities. TMC agrees to use
commercially reasonable efforts to Commercialize Products, which efforts are consistent with the efforts and resources that TMC or a United States-based, mid-sized, specialty pharmaceutical company devotes to products of similar market potential and
in similar product lifecycle positions based on conditions then prevailing with respect to the applicable product and the relevant markets. If TMC does not fulfill its commercial diligence obligations set forth in this Article 3, ALZA will be
entitled, but not obligated, to terminate the License and this Agreement, subject to the terms of Section 15.4 below. 

  
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 ARTICLE 4 — TRADEMARK RIGHTS TO TMC. 

4.1 Trademark Assignment. ALZA will assign (and, if necessary, cause its Affiliates to assign) to TMC the Trademarks, including the
goodwill associated therewith. In connection with and in furtherance of the transfer of the Trademarks, the Parties (and, if necessary, ALZA’s Affiliates) will execute the trademark assignments in the forms attached hereto as Attachment 4.1, or
such equivalent form as may be required in any non-U.S. jurisdiction. As of the Effective Date, the costs of prosecution, issuance and maintenance of applications and registrations of the Trademarks incurred after the Effective Date will be paid by
TMC. 
 4.2 Limited Continued Obligations. For a period of up to one year following the Effective Date, ALZA will provide (and, if
necessary, cause its Affiliates to provide) the necessary information and original registration certificates, and will execute all reasonable documents necessary to permit TMC, at TMC’s expense, to effect and perfect the transfer of the
registrations of the Trademarks. Notwithstanding Section 18.2 below, after such one year period, ALZA (and its Affiliates) will have no further obligations in respect thereof. 

4.3 Trademark Maintenance. If TMC elects to abandon its use of the Trademarks then it will give at least 60 days advance notice to
ALZA. In such case, ALZA (or its designated Affiliate) may elect in its own discretion to continue the prosecution, issuance and maintenance of any such Trademarks and require TMC to assign such Trademarks to ALZA (or its designated Affiliate) and
any associated goodwill, without compensation to TMC. 
 4.4 Trademark Enforcement. For as long as TMC owns the Trademark in a
country, TMC will have the right, but not the obligation, to defend or enforce the Trademark in such country. 
 4.5 Effect of
Termination. In the event of termination under Sections 15.2, 15.3, 15.4 or 15.6: TMC will assign the Trademarks and any associated goodwill to ALZA (or its designated Affiliate), without compensation to TMC, and will execute a trademark
assignment in the form attached hereto as Attachment 4.5; provided, however, that if the Agreement is terminated (i) by ALZA due to TMC’s failure to meet its specific diligence obligations described in Section 3.5, and the License to
TMC is converted to a Product specific license in accordance with Section 15.7.3, or (ii) by either Party for any reason and one or more Sublicensees are 

  
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entitled to have their sublicenses survive such termination in accordance with 15.7.3, then ALZA will grant to TMC, and its Sublicensees and Affiliates, as applicable, the royalty-free right to
use the Trademarks in association with the Product developed and commercialized under the Product specific license, or with respect to the Products being developed under such surviving sublicense, as applicable, in the Territory in the Field under
terms of a Trademark License Agreement that will be negotiated by the Parties and that will contain appropriate quality control provisions. 

ARTICLE 5 — FINANCIAL PROVISIONS 

5.1 Purchase Price. In exchange for the Licenses granted hereunder and such other consideration as set forth in the Series A Agreement,
TMC will issue to ALZA shares of TMC Series A Preferred, as specified in the Series A Agreement. 
 5.2 Product Payments. In
addition to the purchase price described in Section 5.1, TMC will pay to ALZA product payments for each Product (“Product Payments”) as described in this Article 5. Product Payments, when made, will be non-refundable, non-recoupable
and non-creditable. 
 5.2.1 For each Product other than a Third Party Product, TMC will pay to ALZA Product Payments as follows: 

(a) With respect to each of the [**] such Product for which a First Sale occurs, TMC will pay to ALZA: 

(i) [**] of Net Sales of such Products by TMC and its Affiliates; and 

(ii) the greater of: [**] of Net Sales of such Products by Sublicensees, or [**] of all royalties received by TMC or its Affiliates from
Sublicensees based on commercial sales of such Products. 
 (b) With respect to the [**] and each subsequent Product for which a First Sale
occurs, TMC will pay to ALZA: 
 (i) [**] of Net Sales of such Products by TMC and its Affiliates; and 

(ii) the greater of: [**] of Net Sales of such Products by Sublicensees, or [**] of all royalties received by TMC or its Affiliates from
Sublicensees based on their commercial sales of such Products. 
 5.2.2 For each Third Party Product, TMC will pay to ALZA Product Payments
as follows: 
 (a) [**] of Nonroyalty Revenue received by TMC or its Affiliates from a Sublicensee prior to the receipt of Regulatory
Approval of such Third Party Product; and 
 (b) [**] of Nonroyalty Revenue received by TMC or its Affiliates from a Sublicensee with
respect to, and following the receipt of, Regulatory Approval of such Third Party Product; and 
 (c) [**] of all royalties received by TMC
or its Affiliates from Sublicensees based on sales of such Third Party Product. 
 (d) For purposes of this Section 5.2.2,
“Nonroyalty Revenue” will mean all upfront payments, milestone payments and all other consideration (other than royalties) received by TMC or its Affiliates from Sublicensees with respect to such Third Party Product. In case of
non-financial consideration of value, Nonroyalty Revenue will be calculated on a fair market value of the consideration received. Notwithstanding the foregoing, the following payments (if any) received by TMC or its Affiliates from such Sublicensees
will be specifically excluded from Nonroyalty Revenue: 
 (i) an equity investment by such Sublicensee (but solely to the extent that such
investment is at a price equal to or less than the fair market value of TMC’s stock sold in such investment), 
 (ii) a nonforgivable
loan (but solely to the extent that such loan is subject to commercially reasonable terms with respect to repayment (including conversion to equity at the fair market value of TMC’s stock)), 

(iii) reimbursement of TMC’s actual research and development costs directly related to the Third Party Product that is the subject of a
sublicense granted by TMC and only to the extent incurred by TMC after the effective date of such sublicense, 
 (iv) reimbursement of
TMC’s actual patent prosecution or maintenance expenses directly related to the Third Party Product that is the subject of a sublicense granted by TMC and only to the extent incurred by TMC after the Effective Date of this Agreement, and 

(v) payments directly attributable to TMC’s supplying such Third Party Product (or components of such Third Party Product) (at no more
than 100% of TMC’s actual manufacturing cost) to such Sublicensee. 
 (e) Notwithstanding the foregoing, for each Third Party Product,
if the compound in such Third Party Product or the vaccine comprising such Third Party Product becomes owned or Controlled by TMC or TMC becomes owned or Controlled by such Sublicensee, then as of such date the relevant Product will no longer be a
Third Party Product, and, going forward, TMC will pay Product Payments to ALZA as described in Section 5.2.1. Any Product Payments regarding such Third Party Product already due to ALZA pursuant to Section 5.2.2 will not be affected. 

5.3 Single Royalty, Product Payment Term. 

5.3.1 Single Product Payment. In no event will more than a single Product Payment be due under this Article 5 with respect to the sale of any
Product unit, unless TMC or its Affiliates receives, more than a single payment with respect to the sale of any Third Party Product unit. 

5.3.2 Non-Third Party Product Payment Term. 

(a) For each Product (excluding Third Party Products), the Product Payments will be payable on a Product-by-Product and country-by-country
basis until five (5) years after the expiration date of the last Valid Patent Claim of any Licensed Patent anywhere in the Territory; provided, however, that beginning on the date in a country that the Product is no longer covered by a Valid
Patent Claim of any Licensed Patent, the otherwise applicable Product Payment rate described in Section 5.2.1 for such Product in such country will be reduced by [**] going forward. For clarity, if there is no issued Licensed Patents in a
country, the Product Payment rate described in Section 5.2.1 for such Product in such country will be [**] of the rate described in Section 5.2.1 until five (5) years after the expiration date of the last Valid Patent Claim of any
Licensed Patent anywhere in the Territory. 
 (b) Notwithstanding Section 5.3.2(a) above, in cases where TMC enters into a sublicense
agreement with a Sublicensee for the Sublicensee to Commercialize a Product other than a Third Party Product, the foregoing Product Payments for each such Product sold by or on behalf of such Sublicensee will be payable on a Product-by-Product basis
until, on a country-by-country basis, the later of (i) the expiration date of the last Valid Patent Claim of any Licensed Patent covering such Product in such country, (ii) ten (10) years following the First Sale of such Product in
such country, or (iii) the last date on which the Sublicensee is required to make payments to TMC based on commercial sales of such Product in such country, provided that (A) beginning on the date in a country that the Product is no longer
covered by a Valid Patent Claim of any Licensed Patent in a country or (B) where there are no issued Licensed Patents in a country, the otherwise applicable Product Payment rate described in Section 5.2.1 for such Product in such country
will be reduced by [**] going forward; and provided further, however, that in no event shall any Product Payments be payable under this Section 5.3.2(b) after the date that is five (5) years after the expiration date of the last Valid
Patent Claim of any Licensed Patent anywhere in the Territory. If a Sublicensee has a non-exclusive right to Commercialize a Product in a country, or an exclusive right to Commercialize a Product only in certain countries, the Product Payments to
ALZA will be calculated separately for TMC pursuant to Section 5.2.1(a)(i) or 5.2.1(b)(i) and each such Sublicensee pursuant to Section 5.2.1(a)(ii) or 5.2.1(b)(ii). 

5.3.3 Third Party Product Payment Term. For each Third Party Product, the Product Payments will be payable for as long as TMC receives payments
from such Sublicensee; provided, however, that in no event shall any Product Payments be payable under this Section 5.3.3 after the date that is five (5) years after the expiration date of the last Valid Patent Claim of any Licensed Patent
anywhere in the Territory. 
 5.4 Timing and Mode of Payment. All payments to ALZA hereunder will be in Dollars and will be made by
wire transfer in the requisite amount to the account designated by ALZA. Product Payments pursuant to Sections 5.2.1(a)(i) and 5.2.1(b)(i) will be made within forty-five (45) days after the close of each Quarter. Product Payments pursuant to
Sections 5.2.1(a)(ii), 5.2.1(b)(ii) and Section 5.2.2 will be made within thirty (30) days after the date the payments on which they are based are due to TMC. 

5.5 Product Payment Reports. 

5.5.1 During the Term, TMC will notify ALZA each time it enters into an agreement with a Sublicensee regarding the development or
Commercialization of a Third Party Product pursuant to which TMC will receive Nonroyalty Revenue and/or royalties based on sales of such Third Party Product and will provide to ALZA a copy of such agreement within 30 days after the execution
thereof. Such copy may be redacted to exclude any information that is not necessary for assessing TMC’s compliance with its obligations to ALZA under this Agreement. Thereafter, TMC will furnish to ALZA a written report regarding Product
Payments due to ALZA pursuant to Section 5.2.2 within 30 days after the date the payment on which such Product Payment is based is due to TMC showing: (a) the amount due to TMC from such Third Party; (b) a description of the milestone
or event on which such payment is based; (c) the Product Payments, payable in Dollars, in respect of such payment; and (d) the exchange rates 

  
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used, if any, in converting into Dollars from the currencies in which the payments were made to TMC. 

5.5.2 During the Term and commencing with the First Sale of each Product, TMC will furnish or cause to be furnished to ALZA on a Quarterly
basis, a written report or reports covering each Quarter (each such Quarter being sometimes referred to herein as a “reporting period”) showing: (a) gross invoiced sales and total deductions used to calculate Net Sales of each Product
sold by TMC and its Sublicensees during the reporting period on a country-by-country basis; (b) the Product Payments, payable in Dollars, which will have accrued hereunder in respect of such Net Sales; (c) the exchange rates used, if any,
in converting into Dollars, from the currencies in which sales of Product were made; (d) dispositions of such Product other than pursuant to sale for cash; and (e) any withholding taxes required to be paid from such Product Payments. In
addition, with each such report on a Quarterly basis, TMC will furnish to ALZA a statement of the total amount due from TMC to [**] pursuant to the [**] Agreement and evidence to ALZA’s reasonable satisfaction that such payment was made to
[**]. 
 5.6 Financial Records. TMC will keep accurate records for three (3) years from the end of each reporting period,
including, without limitation, gross invoiced sales, Net Sales, and Product Payments, in accordance with United States generally accepted accounting principles, in sufficient detail to enable the amounts due hereunder to be determined and verified
by ALZA (“Financial Records”). 
 5.7 Currency Exchange. In the case of sales of any Product outside the United States or
payments received from Third Parties outside of the United States, for the purpose of calculating Net Sales and making Product Payments where the consideration is based in a currency other than Dollars, conversion from such foreign currency to
Dollars will be at the average rate of exchange published in the New York edition of The Wall Street Journal (or, if The Wall Street Journal is not then published, such other financial periodical of general circulation in the United States) with
respect to the currency of the country of origin of such Net Sales or other payments for the Quarter for which such Product Payments are being paid. 

5.8 Audit. Financial Records under this Agreement will be available during reasonable business hours for a period of three
(3) years from the end of the reporting period to which they relate for audit purposes. Upon the written request of ALZA but not more often than once each year, at ALZA’s expense, TMC will permit an independent public accounting firm of


  
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national prominence selected by ALZA and reasonably acceptable to TMC to have access during normal business hours to those records of TMC as may be reasonably necessary for the sole purpose of
verifying the accuracy of the Net Sales report and Product Payment calculation conducted by TMC pursuant to this Agreement. The aforementioned independent public accountant will execute an appropriate and customary confidentiality agreement with TMC
and its Sublicensees, as applicable. 
 5.8.1 TMC will include in each sublicense entered into by it pursuant to this Agreement; a provision
requiring, among others, the Sublicensee or commercialization partner to keep and maintain adequate Financial Records pursuant to such sublicense agreement and will use commercially reasonable efforts to cause such Sublicensee to grant access to
such Financial Records by the aforementioned independent public accountant for the reasons specified in this Agreement, provided that in the event that TMC is unable to obtain the consent of a Sublicensee to such an audit by ALZA’s auditors,
TMC will obtain for itself such right and, at the request of ALZA, TMC will exercise such audit right with respect to Sublicensees and provide the results of such audit for inspection by ALZA pursuant to this Section 5.8.1. It is understood and
agreed that this Section 5.8.1 shall not apply to Non-Stocking Distributors unless such Non-Stocking Distributor is maintaining Financial Records on behalf of TMC. 

5.8.2 In order to initiate an audit for a particular calendar year, ALZA will provide written notice to TMC. ALZA will provide TMC with notice
of one or more proposed dates of the audit not less than forty-five (45) days prior to the first proposed date and TMC will reasonably accommodate the scheduling of such audit. 

5.8.3 The report prepared by such independent public accounting firm, a copy of which will be sent or otherwise provided to TMC by such
independent public accountant at the same time as it is sent or otherwise provided to ALZA, will contain the conclusions of such independent public accountant regarding the audit and will specify that the amounts paid to ALZA pursuant thereto were
correct or, if incorrect, the amount of any underpayment or overpayment. 
 5.8.4 If such independent public accounting firm’s report
establishes any underpayment, TMC will remit to ALZA within 30 days after TMC’s receipt of such report, (i) the amount of such underpayment and (ii) if such underpayment exceeds [**] of the total amount owed for the calendar year then
being audited, the reasonable and necessary fees and expenses of 

  
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such independent public accountant performing the audit, subject to reasonable substantiation thereof. If such independent public accounting firm’s report establishes any overpayment, TMC
will receive a credit equal to such overpayment against the Product Payment otherwise payable to ALZA. 
 5.9 Interest Due. In
the case of any delay in payment by TMC to ALZA of any amounts due, interest on the overdue payment will 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 [**], assessed from the day payment was initially due. The foregoing interest will be due from TMC without any special notice. 

5.10 Tax Withholding. Any income or other taxes which TMC is required by law to pay or withhold on behalf of ALZA with respect
to Product Payments, and any interest thereon, payable to ALZA under this Agreement will be deducted from the amount of such Product Payments and interest due and paid or withheld, as appropriate, by TMC on behalf of ALZA. Any such tax required to
be paid or withheld will be an expense of, and be borne solely by, ALZA. TMC will furnish ALZA with reasonable evidence of such withholding payment in electronic or written form as soon as practicable after such payment is made. The Parties hereto
will reasonably cooperate 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 withholding payment, or any claim to a refund of
any such payment. 
 ARTICLE 6 — CONFIDENTIAL INFORMATION. 

6.1 Confidentiality Obligations. Each Party agrees that, for the Term of this Agreement and for ten (10) years thereafter,
it will keep confidential and will not publish or otherwise disclose and will not use for any purpose (except as expressly permitted hereunder) Confidential Information of the other Party; provided, however, that TMC can use ALZA Know-How to the
extent reasonably necessary to develop, manufacture or use Microprojection Systems in the Field and to develop and commercialize Products and TMC can disclose ALZA Know-How only to the extent relating primarily to Microprojection Systems (including
the manufacture or use thereof) in the Field and to Products. For clarity, TMC may not disclose any specific information relating to any agents or compounds proprietary to or Controlled by ALZA or its 

  
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Affiliates (including the identity or structure of such agents or compounds), in each case to the extent such information would not fall within any of exceptions (a)-(d) of Section 1.9.

 6.2 Written Assurances and Permitted Uses of Confidential Information. 

6.2.1 Each Party will inform its employees and consultants who perform work under this Agreement of the obligations of confidentiality
specified in Section 6.1, and all such persons will be bound by obligations of confidentiality substantially similar to those set forth herein. 

6.2.2 Each Party may disclose Confidential Information of the other Party to the extent necessary to comply with applicable governmental
regulations and/or submitting information to tax or other governmental authorities, or to the extent the receiving Party is compelled to disclose such information by a court or other tribunal of competent jurisdiction, provided, however, that in
such case the receiving Party will give prompt notice to the other Party so that the other Party may seek a protective order or other remedy from said court or tribunal. In any event, the receiving Party will disclose only that portion of the
Confidential Information that, in the opinion of its legal counsel, is legally required to be disclosed and will exercise reasonable efforts to ensure that any such information so disclosed will be accorded confidential treatment by said court or
tribunal. 
 6.2.3 To the extent it is reasonably necessary or appropriate to fulfill its obligations and exercise its rights under this
Agreement, either Party may use the Confidential Information of the other Party and may disclose such Confidential Information to its Affiliates, officers, employees, consultants, outside contractors, agents, clinical investigators, Sublicensees,
potential Sublicensees, financial investors, attorneys and others that have a need to know the Confidential Information in order for the receiving Party to exercise its rights and perform its obligations under this Agreement, on condition that those
individuals and entities to whom the receiving Party discloses such Confidential Information agree to keep the Confidential Information confidential for the same time periods and to the same extent as such Party is required to keep the Confidential
Information confidential under this Agreement, and to any regulatory authorities to the extent reasonably necessary to obtain Regulatory Approval. 

6.2.4 The terms and conditions of this Agreement will be treated by each Party as Confidential Information of the other Party and may be
disclosed solely as permitted under this Article 6. For clarity, either Party will have the right to disclose this Agreement to the extent 

  
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required by applicable law or regulation, including filing this Agreement with the United States Securities and Exchange Commission. If a Party discloses this Agreement because it is required by
law, it will give the other Party at least [**] advance notice, where possible, of the scope of the Agreement to be disclosed with any proposed redactions so that the other Party will have an opportunity to comment. To the extent the receiving Party
reasonably requests the redaction of any information in the Agreement, the disclosing Party will delete such information unless, in the opinion of the disclosing Party’s legal counsel, such information is legally required to be fully disclosed.

 6.3 Public Announcements. An initial press release will be agreed upon by the Parties promptly after the Effective Date.
Otherwise, neither Party will originate any publicity, news release or public announcements, written or oral, whether to the public or press, stockholders or otherwise, relating to the terms of this Agreement, performance under it or any of its
terms, to any amendment hereto or performances hereunder without the prior written consent of the other Party, save only such announcements that are required by law to be made or that are otherwise agreed to by the Parties. Such announcements will
be brief and factual. If a Party decides to make an announcement required by law, it will give the other Party at least [**] advance notice, where possible, of the text of the announcement so that the other Party will have an opportunity to comment
upon the announcement. To the extent that the receiving Party reasonably requests the deletion of any information in the materials, the disclosing Party will delete such information unless, in the opinion of the disclosing Party’s legal
counsel, such Confidential Information is legally required to be fully disclosed. For purposes of clarity, disclosures which have already been approved and made public will be exempted from the foregoing restrictions. 

6.4 Publications. Each Party recognizes that the publication of papers regarding the results of non-clinical scientific studies or
clinical trials related to the Products in the Field, including oral presentations and abstracts, may be beneficial to both Parties provided such publications are subject to reasonable controls to protect ALZA Confidential Information. Accordingly,
TMC will deliver to ALZA a complete copy of any proposed publication by TMC that relates to or discloses ALZA Confidential Information at least [**] prior to submitting such proposed publication. ALZA will review any such proposed publication and
give its comments to TMC within [**] of the delivery of such proposed publication to ALZA. With respect to oral 

  
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presentation materials, ALZA will make reasonable efforts to expedite review of such materials, and will return such items as soon as practicable to TMC with appropriate comments, if any, but in
no event later than [**] from the date of delivery to ALZA. TMC will comply with ALZA’s request to delete references to ALZA’s Confidential Information in any such proposed publication. Notwithstanding anything to the contrary herein, TMC
may publish information about clinical trials performed or to be performed on the Products in the Field, without the need to obtain ALZA’s prior written approval (provided, however, that TMC will use diligent efforts to inform ALZA and
to allow ALZA to comment on the disclosure), to the extent that such disclosure is required, in TMC’s reasonable opinion, to comply with applicable laws and regulations. 

ARTICLE 7 — PATENTS AND INTELLECTUAL PROPERTY. 

7.1 Ownership; Inventions. ALZA will own and retain and will continue to own and retain, all rights, title and interest to (i) any
inventions conceived and reduced to practice by employees of ALZA, or by or on behalf of ALZA by Third Parties, prior to the Effective Date, including the Licensed Patents, and (ii) all ALZA Inventions, even if conceived by or on behalf of
ALZA, prior to the Effective Date and reduced to practice by TMC after the Effective Date. Any invention conceived and reduced to practice and arising out of work conducted by or on behalf of a Party after the Effective Date that relates primarily
to Microprojection Systems (including the use or manufacture thereof), including, but not limited to, Future ALZA Inventions and TMC Inventions, will (i) be owned by that Party and that Party will retain all rights, title and interest to the
invention subject to the terms of this Agreement, including the right to file patent applications based on the invention and to prosecute; issue and maintain Patents that issue based on such Party’s invention, or (ii) if owned by a Third
Party, will be licensed to the applicable Party under terms permitting such Party to fulfill its obligations to the other Party under Sections 2.1.1(b) or 2.2, as applicable. For purposes of clarity, inventorship for patentable inventions will be
determined in accordance with United States patent laws for determining inventorship. In the event of a dispute regarding inventorship, if the Parties are unable to resolve such inventorship dispute, the Parties will establish a procedure to resolve
such dispute, which may include engaging a Third Party patent attorney jointly selected by the Parties to resolve such dispute. 

  
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 7.2 Disclosure of Patentable Inventions. ALZA will promptly notify TMC in writing of any
Future ALZA Patents. TMC will promptly notify ALZA in writing of any TMC Patents. 
 7.3 Prosecution of Licensed Patents. 

7.3.1 ALZA Prosecution and Enforcement of Future ALZA Patents. ALZA will own and retain all rights, title and interest to Future ALZA Patents,
subject to this Agreement. ALZA will be responsible for, and will bear the expenses for all filing, prosecution, issuance and maintenance of Future ALZA Patents. ALZA retains all rights to defend and enforce Future ALZA Patents at ALZA’s sole
cost and expense. 
 7.3.2 TMC Prosecution of Licensed Patents. 

(a) As of the Effective Date, TMC will be responsible for and will bear the expenses for all filing, prosecution, issuance and maintenance of
all Licensed Patents. 
 (b) TMC will use good faith efforts to file patent applications to protect and cover the ALZA Inventions. TMC will
file the patent applications based on such ALZA Inventions, and any additional Patents claiming priority to Licensed Patents that are filed by TMC, in ALZA’s name. Such patent applications will be assigned to ALZA or an Affiliate of ALZA, will
be approved in writing by ALZA prior to filing, and will be included in the Licensed Patents licensed hereunder, and TMC will bear all costs of preparation, filing, prosecution, issuance and maintenance thereof. TMC will use reasonable efforts to
file initially all such patent applications in the United States and as a Patent Cooperation Treaty application with the Worldwide Intellectual Property Organization (“WIPO”) designating all countries, filing at the very least in the
United States, France, Japan, United Kingdom, Germany, Italy and Spain. TMC agrees to use reasonable efforts to ensure that any such Patents filed outside of the United States prior to a United States filing will be in a form sufficient to establish
the date of original filing as a priority date for the purposes of a subsequent United States filing. All such Patent filings will be made in accordance with local foreign filing license requirements. In furtherance of and not in limitation of the
foregoing, TMC will provide ALZA with a draft copy of each United States, foreign and WIPO patent application to be filed by it relating to the ALZA Inventions or claiming priority to the Licensed Patents in order, and sufficiently in advance, to
obtain comments from ALZA’s patent counsel, as well as a list of countries in which such applications will be filed at least [**] in advance of TMC’s estimated filing date. TMC will provide to ALZA


  
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as filed copies of all such United States and WIPO patent applications promptly after the filing of such applications. 

(c) TMC will use good faith efforts to prosecute to allowance the Licensed Patents and to seek the broadest claims within and outside the
Field for all inventions described in the Licensed Patents and defend against oppositions filed against the grant of the Licensed Patents, and upon and after the grant of any letters patent based on any such ALZA Inventions or Licensed Patents in
any country where it files patent applications, maintain such letters patent in force by duly filing all necessary papers and paying any fees required for such purpose by the patent laws of the particular country in which such letters patent was
granted. TMC will consult with ALZA on all such Licensed Patents, in a timely manner so that ALZA’s comments can be duly considered and incorporated by TMC, and will disclose to ALZA the complete text of all such Licensed Patents and provide
ALZA with copies of all material correspondence with the applicable patent office and any agent working on TMC’s behalf that relate to such Licensed Patents. TMC will provide to ALZA a copy of each U.S. Patent and Trademark Office “Office
Action,” or its foreign equivalent, sufficiently in advance of the response due date, to obtain substantive comment of ALZA’s patent counsel. TMC will consider in good faith ALZA’s suggestions and recommendations regarding any such
ALZA Inventions and Licensed Patents (such suggestions and recommendations not to be unreasonably delayed) before any action is taken, and in any event will obtain ALZA’s prior approval for any filings, actions and decisions regarding such
Licensed Patents listed in Category B (such approval not to be unreasonably withheld or delayed). 
 (d) (i) If, on a country by country
basis in the Territory, TMC decides at any time to discontinue the prosecution or maintenance of any of the Licensed Patents, or has decided not to pursue the filing of any foreign counterpart of an existing Licensed Patent in a country where the
Licensed Patents are not already filed in as of the Effective Date of this Agreement, in each case, TMC will promptly notify ALZA in writing and will take no action to file a replacement patent application thereof. Such notification will be given at
least [**] prior to the date on which such patent application(s) or patent(s) will become abandoned. ALZA will then have the option to assume full responsibility, at its discretion and sole cost, for the filing, prosecution and maintenance of the
affected patent applications(s) or patent(s) in such country or countries. TMC will provide such reasonable assistance as is reasonably necessary to allow 

  
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ALZA to assume the filing, prosecution and maintenance of such affected patent application(s) or patent(s), including executing any documents to reflect ALZA’s interests therein. In the
event TMC elects not to proceed with the filing, prosecution or maintenance of any such patent application or patent, then such affected patent application(s) or patent(s) and inventions embodied in such patent application(s) or patent(s) will be
deemed to no longer be included as Licensed Patents with respect to those jurisdictions in which TMC has elected not to proceed with the filing, prosecution or maintenance of such patent application(s) or patent(s). 

(ii) TMC will use good faith efforts to file patent applications based on ALZA Inventions in accordance with Section 7.3.2(b). In the
event TMC elects not to proceed with the filing of any patent application for: 
 (A) any commercially significant patentable invention in
the Field contained in any ALZA Invention(s), ALZA will have the right to file and prosecute patent application(s) or patent(s) in respect of such ALZA Invention(s), to the extent set forth in subsection (iv) below, and such patent
application(s) or patent(s) will be deemed to no longer be included as Licensed Patents with respect to those jurisdictions in which ALZA has elected to proceed with the filing, prosecution or maintenance of such patent application(s) or patent(s).

 (B) any patentable invention outside the Field contained in any ALZA Invention(s), ALZA will have the right to file and prosecute patent
application(s) or patent(s) in respect of such ALZA Invention(s), and such patent application(s) or patent(s), to the extent not claiming inventions within the Field, will be deemed to no longer be included as Licensed Patents with respect to those
jurisdictions in which ALZA has elected to proceed with the filing, prosecution or maintenance of such patent application(s) or patent(s). 

(iii) Further, TMC will notify ALZA in writing prior to the issuance of any patent from the Licensed Patents and afford ALZA the opportunity
to seek protection by filing patent applications for: 
 (A) any commercially significant patentable inventions in the Field that are
embodied in the patent application from which the issued patent matures and for which TMC does not intend to seek protection, and any such ALZA-filed patent application will not be considered Licensed Patents to the extent set forth in subsection
(iv) below with respect to those jurisdictions in which the ALZA-filed patent applications are filed. 

  
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 (B) any patentable inventions outside the Field that are embodied in the patent application from
which the issued patent matures and for which TMC does not intend to seek protection, and any such ALZA-filed patent application, to the extent not claiming inventions within the Field, will not be considered Licensed Patents with respect to those
jurisdictions in which the ALZA-filed patent applications are filed. 
 (iv) In the event that (A) ALZA believes that TMC has failed to
file a patent application claiming any commercially significant ALZA Invention(s), or (B) ALZA believes there are additional commercially significant patentable inventions embodied in any patent application from which a patent is expected to
issue and for which TMC has elected not to file a subsequent patent application claiming priority to said patent application, then ALZA will so inform TMC, specifying with reasonable particularity the commercially significant invention that it
believes TMC has failed to file on. In the event that TMC agrees with ALZA’s assessment, TMC will proceed with the filing of a patent application claiming such invention and any resulting patent applications, and any patents issuing therefrom
shall be included in the Licensed Patents. In the event that TMC disagrees with ALZA’s assessment and elects not to file a patent application with respect to such invention in a particular jurisdiction, then ALZA will have the right to file for
patent protection with respect to such inventions in such jurisdiction, and any patent claims that issue in such jurisdiction for such invention shall not be included within the Licensed Patents. 

(e) In the event that a declaratory judgment action alleging invalidity of any of the Licensed Patents is brought against either Party, ALZA
will have the right, but not the obligation, to assume the sole defense of the action at its own expense. 
 7.3.3 TMC Prosecution of TMC
Patents. TMC will own and retain all rights, title and interest to TMC Patents, subject to the terms of this Agreement. TMC will be responsible for, and will bear the expenses for all filing, prosecution, issuance and maintenance of TMC Patents. TMC
retains all rights to defend and enforce TMC Patents at TMC’s sole cost and expense. 
 7.4 Infringement Claims by Third
Parties. 
 7.4.1 Notice. If the manufacture, use or sale of any Product results in a claim or a threatened claim by a Third Party
against a Party hereto for patent infringement or for inducing or contributing to patent infringement (“Infringement Claim”), the Party first having notice of an 

  
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Infringement Claim will promptly notify the other in writing. The notice will set forth the facts of the Infringement Claim in reasonable detail. 

7.4.2 Defense. TMC will have the right but not the obligation to defend any suit resulting from an Infringement Claim at its expense. Upon
TMC’s request and in connection with TMC’s defense of any such Infringement Claim, ALZA will provide reasonable assistance to TMC at TMC’s cost for such defense. TMC will keep ALZA reasonably informed on a Quarterly basis, in person
or by telephone, prior to and during the pendency of any such suit. 
 7.4.3 Settlement. In the event that the manufacture, use or sale of a
Product in a country would infringe a Third Party Patent and a license to such Third Party Patent is available, and TMC in its sole discretion seeks such a license, the Parties agree that TMC will be responsible for all costs associated with
acquiring such Third Party license. 
 7.5 Infringement Claims Against Third Parties. 

7.5.1 Cooperation. ALZA and TMC each agree to take reasonable actions to protect Licensed Patents from infringement in the Field. If one Party
brings any such action or proceeding, the other Party may be joined as a Party plaintiff if necessary for the action or proceeding to proceed and, in case of joining, the other Party agrees to give the first Party reasonable assistance (and to
execute all necessary and appropriate documents) and authority to file and to prosecute such suit. In the case of any such joinder, the other Party will be reimbursed for any costs associated with its participation.- The Parties will keep each other informed of the status of their respective activities regarding any litigation or settlement thereof concerning Products in the Field. 

7.5.2 Notice. If any Licensed Patent is infringed in the Field by a Third Party in any country in connection with the manufacture, use and/or
sale of a Product in such country, the Party to this Agreement first having knowledge of such infringement, or knowledge of a reasonable probability of such infringement, will promptly notify the other in writing. The notice will set forth the known
facts of such infringement in reasonable detail. 
 7.5.3 Institution of Proceedings. 

(a) ALZA has the first right, but not the obligation, to bring and control an action to enforce Licensed Patents, whether the infringement has
occurred in the Field or not; provided, however, that TMC will be entitled to join and participate in any such action to the extent the alleged infringement is in the Field, provided that ALZA will maintain control of


  
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 and direction of such action. If ALZA does not bring an action against the alleged infringer within 60 days after
written notice from TMC, TMC may bring and control such an action with respect to infringement in the Field; provided, however, that ALZA will be entitled to join and participate in any such action. If TMC enforces Licensed Patents, TMC will not
enter into any settlement that diminishes the rights or interests of ALZA outside of the Field or has an adverse effect on any Licensed Patent without ALZA’s written consent. ALZA and TMC will each be represented by their own counsel at their
own expense. The expense of the Parties in bringing suit will first be reimbursed out of any moneys recovered, with the Party bringing the suit being reimbursed first. The balance of any recovery for infringement in the Field will be distributed:
(a) to TMC in an amount equal to its lost profits or a reasonable royalty on the sales of the infringer (whichever measure of damages were applied) with respect to the portion (percentage) of the total recovery that is reasonably related to
infringement in the Field; provided, however, that TMC will pay to ALZA in an amount equal to the royalties and other fees due ALZA based on such sales (if a sales of the infringer measure of damages is applied) or a reasonable approximation of the
royalties and other fees that TMC would have owed to ALZA on sales of products that TMC lost to the infringer (if a lost profits measure of damages is applied) based upon the recovery distributed to TMC; and then (b) [**] to ALZA with respect
to the portion (percentage) of the total recovery that was reasonably related to infringement outside the Field. The balance, if any, remaining after TMC has been compensated for lost profits or lost sales within the Field and ALZA has been
compensated for lost royalties in respect of infringement within the Field and ALZA has recovered all direct damages in respect of infringement outside the Field will be divided as follows: [**] to ALZA and [**] to TMC with respect to the portion
(percentage) of the total recovery that is reasonably related to infringement in the Field and [**] to ALZA with respect to the portion (percentage) of the total recovery that is reasonably related to infringement outside the Field. 

(b) ALZA will have the right, but not the obligation, to bring and control an action to enforce Licensed Patents outside the Field for
ALZA’s sole recovery; provided, however, that to the extent the alleged infringement is due to a Third Party product comprising a Microprojection System utilizing one or more driving sources (including, but not limited to, delivery systems that
utilize one or more driving sources such as electrical potential gradients, sound waves, heating systems, laser energy, hydraulic systems, radio waves) for 

  
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delivery of a compound for which ALZA then has exclusivity obligations to TMC pursuant to Section 14.2, and at such time TMC is actively working on a Product for delivery of such compound
utilizing a Microprojection System, TMC will have the right to request that ALZA initiate an enforcement action against the alleged infringer to halt such infringement. TMC will be entitled to join and participate in any such action against such
alleged infringer provided that ALZA maintains control of and direction of such action. If ALZA does not bring an action against the alleged infringer within 60 days after a request by TMC to do so, TMC may bring and control such an action with
respect to such infringement. ALZA will be entitled to join and participate in any such action against the alleged infringer. TMC will not enter into any settlement that diminishes the rights or interests of ALZA outside of the Field or has an
adverse effect on any Licensed Patent without ALZA’s written consent. ALZA and TMC will each be represented by their own counsel at their own expense. The expense of the Parties in bringing suit against the alleged infringer will first be
reimbursed out of any moneys recovered, with the Party bringing the suit being reimbursed first. The balance of any recovery will be distributed: (a) to TMC in an amount equal to its lost profits or a reasonable royalty on the sales of the
infringer (whichever measure of damages is applied) with respect to the portion (percentage) of the total recovery that were reasonably related to the infringement; provided, however, that TMC would pay to ALZA an amount equal to the royalties and
other fees due ALZA based on such sales (if a sales of the infringer measure of damages is applied) or a reasonable approximation of the royalties and other fees that TMC would have owed to ALZA on sales of products that TMC lost to the infringer
(if a lost profits measure of damages is applied) based upon the recovery distributed to TMC; and then (b) [**] to ALZA with respect to the portion (percentage) of the total recovery that is reasonably related to the damages suffered by ALZA
(i.e., lost sales of ALZA products outside the Field). Any amount remaining from the recovery would be divided as follows: [**] to ALZA and [**] to TMC. 

(c) Notwithstanding anything in this Section 7.5.3 to the contrary, neither ALZA (or any of its licensees, Affiliates, or assignees) nor
TMC (or any of its Sublicensees, Affiliates, or assignees) will bring an action or join in any action to enforce certain Licensed Patents against [**] to the extent ALZA is so contractually obligated; provided, however, that ALZA will use
commercially reasonable efforts in its negotiations with [**] in connection with the agreement contemplated in Section 3.3.2 above to identify which Licensed 

  
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Patents are subject to the obligations described in Section 4.6 of the [**] Agreement and ALZA will keep TMC reasonably informed (as reasonably requested by TMC) regarding the progress and
substance of such negotiations with regard to such issue, and ALZA will consider in good faith TMC’s comments regarding the terms proposed for such issue but ALZA will not be obligated to incorporate TMC’s comments. If ALZA reaches
agreement with [**], ALZA will promptly notify TMC of the identity of the Licensed Patents that are subject to Section 4.6 of the [**] Agreement, if any. 

7.6 Regulatory Listings and Notices Relating to the Act . TMC will have the right to include the Licensed Patents in any list that TMC
provides in any regulatory filing worldwide relating directly to a Product, such as an NDA or 505(b)(2) filing in the United States, or their foreign equivalent, after receiving ALZA’s prior written approval. TMC will immediately, and in no
event later than five (5) business days, give written notice to ALZA of any certification filed under the “U.S. Drug Price Competition and Patent Term Restoration Act of 1984” (hereinafter the “Act”), including, but not
necessarily limited to, notices pursuant to §§101 and 103 of the Act from persons who have filed an abbreviated NDA (“ANDA”) or a “paper” NDA, based on an NDA filed by TMC relating to a Product, claiming that a Licensed
Patent is invalid or unenforceable or that infringement will not arise from the manufacture, use or sale of any Product by a Third Party. ALZA will have the first right, but not the obligation, to bring and control an action to enforce the Licensed
Patent; provided, however, that TMC will be entitled to join and participate in any such action to the extent any alleged infringement were in the Field so long as ALZA maintains control of and direction of such action. ALZA and TMC will each be
represented by their own counsel at their own expense. If ALZA does not bring an action against the alleged infringer within forty (40) days after written notice to TMC of the certification, then TMC will have the right to bring and control
such an action with respect to infringement in the Field in accordance with Section 7.5.3(a)(1) above. 
 7.7 Patent Term
Extensions . After filing an application for Regulatory Approval for a Product, TMC will provide to ALZA a written list specifying all Licensed Patents that it is in good faith considering to be the subject of a patent extension with respect to
such Product. After receiving Regulatory Approval for the Product, TMC will identify one Licensed Patent in the country in the Territory where the Product was approved and will have the right to request that ALZA file, at TMC’s expense, an
application and take all reasonable actions necessary to obtain 

  
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a patent extension pursuant to 35 USC 156, or like foreign statutes such as for a Supplementary Certificate of Protection of the Member States of the European Union, for such Licensed Patent and
ALZA agrees to respond to such request within ten (10) business days. If ALZA fails to respond to such request (or notifies TMC that it is declining to pursue such patent extension) within such ten (10) business day period, or if having
notified TMC that it intends to pursue such patent extension, fails to promptly take such action, then TMC will have the right on behalf of ALZA to file such application and take all such actions necessary to obtain such patent extension. For
purposes of clarity, TMC and ALZA agree that if such Licensed Patent selected by TMC for patent extension could be the subject of a patent extension with respect to a Product for which ALZA or any of its Affiliates has received Regulatory Approval
then ALZA will have the sole right to determine whether such Licensed Patent will be used to obtain a patent extension for such ALZA Product or for TMC’s Product. TMC and ALZA agree to cooperate with one another in obtaining such extension and
use reasonable efforts to take all such actions necessary to obtain such patent extension at TMC’s cost. 
 7.8 Marking .
TMC, and its Sublicensees and Affiliates, will mark all Products made under this Agreement with a notice in accordance with 35 USC 287 and similar marking provisions in countries other than the United States in the Territory. 

7.9 Entitlement Action. 

[**] 
 ARTICLE 8 —
INDEMNIFICATION. 
 8.1 Indemnification. 

. 
 8.1.1 Indemnification by TMC. TMC will
indemnify, defend and hold ALZA and its Affiliates and any of their agents, employees and directors (the “ALZA Indemnitees”) harmless from and against any and all liability, damage, claim, loss, cost or expense, including reasonable
attorneys’ fees (“Losses”) arising out of claims by Third Parties: (i) relating to the design, development, manufacture, use, handling, storage, sale or other disposition of any Microprojection System or any Product in the Field
if such claims arise from the use or application of Microprojection Systems or Products by or on behalf of TMC, its Affiliates or Sublicensees after the Effective Date; (ii) arising from TMC’s breach of the Agreement; (iii) arising
from activities occurring on or after the Effective Date with respect to agreements entered 

  
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into by ALZA and Third Parties (and transferred to TMC pursuant to this Agreement) regarding the development of any Microprojection System or Product; or (iv) arising from TMC’s
negligence or willful misconduct, except, in each case, to the extent such Losses arise from claims by Third Parties covered by ALZA’s indemnification obligations specified in Section 8.1.2. 

8.1.2 Indemnification by ALZA. ALZA will indemnify, defend and hold TMC and its Affiliates and any of their agents, employees and directors
(“TMC Indemnitees”) harmless from and against any and all Losses arising out of claims by Third Parties: (i) based on activities occurring prior to the Effective Date with respect to ALZA’s development of Microprojection Systems
or Products in the Field (other than claims relating to (x) product liability or patent infringement in the Field or (y) other matters relating to the design or development of Microprojection Systems or Products if in the case of either
clause (x) or (y) such claims arise from the use or application of Microprojection Systems or Products after the Effective Date (“Excluded Claims”)), (ii) arising from ALZA’s breach of this Agreement; or
(iii) arising from ALZA’s gross negligence or willful misconduct (other than Excluded Claims); except, in each case, to the extent such Losses arise from claims by Third Parties covered by TMC’s indemnification obligations specified
in Section 8.1.1. 
 8.1.3 Indemnification Procedure. 

(a) Whenever any Loss is asserted against or incurred by a TMC Indemnitee or ALZA Indemnitee (the “Indemnified Party”), the
Indemnified Party will give written notice thereof (a “Claim”) to ALZA or TMC, respectively (the “Indemnifying Party”). The Indemnified Party will furnish to the Indemnifying Party in reasonable detail such information as the
Indemnified Party may have with respect to the Claim. The failure to give such notice will not relieve the Indemnifying Party of its indemnification obligations under this Agreement, unless the failure to give such notice is materially prejudicial
to an Indemnifying Party’s ability to defend such action. 
 (b) Within [**] after delivery of such notification, the Indemnifying
Party may, upon written notice thereof to the Indemnified Party, and at its expense, undertake the defense of Claims with attorneys of its own choosing. In the event the Indemnifying Party does not assume control of such defense, the Indemnified
Party may undertake the defense of the Claim. 

  
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 (c) The Party not controlling such defense may participate therein at its own expense; provided
that if the Indemnifying Party assumes control of such defense and the Indemnified Party reasonably concludes, based on advice from counsel, that the Indemnifying Party and the Indemnified Party have conflicting interests with respect to such
action, suit, proceeding or claim, the Indemnifying Party will be responsible for the reasonable fees and expenses of counsel to the Indemnified Party solely in connection therewith; provided further, however, that in no event will the Indemnifying
Party be responsible for the fees and expenses of more than one counsel in any one jurisdiction for all Indemnified Parties. 
 (d) The
Party controlling such defense will keep the other Party advised of the status of such action, suit, proceeding or claim and the defense thereof and will consider recommendations made by the other Party with respect thereto. 

(e) The Indemnified Party will not agree to any settlement of such action, suit, proceeding or claim without the prior written consent of the
Indemnifying Party, which will not be unreasonably withheld. The Indemnifying Party will not consent to entry of any judgment or enter into any settlement that admits fault on the party of the Indemnified Party, except with the consent of the
Indemnified Party, which such consent will not be unreasonably withheld or delayed. In the event the Indemnified Party refuses to consent to the entry of a judgment or a settlement for which the Indemnifying Party is solely and entirely responsible
and has indicated its sole and entire responsibility in writing to the Indemnified Party, following such refusal, the liability of the Indemnifying Party to the Indemnified Party will be fixed at the amount of any money damages provided in the
proposed judgment or settlement. 
 8.2 Insurance Proceeds. Any indemnification hereunder will be made net of any insurance proceeds
recovered by the Indemnified Party; provided, however, that if, following the payment to the Indemnified Party of any amount under this Article 8, such Indemnified Party recovers any insurance proceeds in respect of the claim for which such
indemnification payment was made, the Indemnified Party will promptly pay an amount equal to the amount of such proceeds (but not exceeding the amount of such indemnification payment) to the Indemnifying Party. 

8.3 Insurance. TMC will use all commercially reasonable efforts to maintain insurance, including product liability insurance, with
respect to its activities hereunder. Such 

  
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insurance will be in such amounts and subject to such deductibles as the Parties may agree, based upon standards prevailing in the industry at the time. 

8.4 Future Litigation Regarding Development Agreements. In the event that any litigation arises with respect to any of the
Development Agreements, at ALZA’s request, TMC will cause former ALZA employees or consultants that are then employed by or consulting for TMC or its Affiliates to provide reasonable assistance to ALZA in connection with such litigation,
including giving testimony. ALZA will not be required to compensate TMC or such former employees or consultants for their time and expense in providing such assistance; provided, however, that ALZA will reimburse such employees or consultants for
travel costs incurred in connection with the provision of such assistance at ALZA’s request in accordance with the then-current Johnson & Johnson travel reimbursement policy. ALZA will cover its own expenses regarding such litigation
including meetings with and preparation of such TMC employees prior to such employees providing testimony. To the extent such employees want or require their own legal assistance, it will be at their sole cost and expense. 

ARTICLE 9 — RIGHT OF FIRST NEGOTIATION FOR PTH PRODUCT 

9.1 ALZA Rights Regarding PTH Product. On the terms set forth in this Article 9, ALZA (or its designated Affiliate) will have a right
of first negotiation to an agreement whereby ALZA (or its designated Affiliate) would obtain from TMC, for mutually agreed consideration, an exclusive, worldwide license, with the right to sublicense, to make, have made, use, import, sell, offer for
sale and have sold any PTH Product developed by or on behalf of TMC. TMC will not enter into, or enter into discussions or negotiations regarding, an agreement with a Third Party to make, have made, use, import, sell, offer for sale or have sold any
PTH Product unless and until TMC has provided notice to ALZA pursuant to Section 9.2 and complied with the other procedures set forth in Sections 9.2 – 9.7. 

9.2 TMC Notice Regarding PTH Product. At any time after the earlier of (i) TMC’s receipt of the FDA minutes from its End of
Phase I Meeting with the FDA regarding the PTH Product or (ii) equivalent written communication from the FDA responding to questions submitted in the TMC End of Phase I Meeting request regarding the PTH Product or (iii) the expiration of
thirty (30) days following the submission by TMC to the FDA of a protocol for the Phase II study of the PTH Product without a written response from the FDA (in the event that the 

  
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FDA does not hold an End of Phase I Meeting and does not respond to questions submitted by TMC in its request for an End of Phase I Meeting); provided that in no event shall the time determined
under Section 9.2(i)-(iv) be earlier than January 1, 2007, if TMC decides to seek a partner for further development or Commercialization of the PTH Product, TMC will provide notice in writing to ALZA of such intention. Together with
such notice, TMC will deliver to ALZA all final study reports of all preclinical and clinical studies regarding the PTH Product conducted prior to such date, and (ii) such other data or information, if any, which is then Controlled by TMC or
its Affiliates and which is, in TMC’s reasonable estimation, reasonably necessary to permit ALZA (or its Affiliates) to evaluate whether to enter into an agreement regarding the development or Commercialization of the PTH Product (the “PTH
Product Notice Package”). 
 9.3 Decision Regarding PTH Product. Within 10 calendar days of its receipt of the PTH Product
Notice Package, ALZA will inform TMC if it believes any additional information is required to reasonably evaluate the PTH Product opportunity. If ALZA believes additional information is required, it will provide TMC with a detailed list of such
additional item(s) of information it is requesting, and in the event that TMC agrees that such additional item(s) of information are reasonably required to evaluate the PTH Product opportunity (such agreement not to be unreasonably withheld or
delayed) and such additional items of information are reasonably accessible to TMC, TMC will promptly endeavor to provide such information to ALZA. Within 30 calendar days after ALZA’s receipt of the PTH Product Notice Package, or in the event
TMC agrees to provide ALZA additional information, within 20 days of TMC’s delivery of such additional information to ALZA, ALZA will provide TMC with notice either that (i) ALZA would not like to negotiate an agreement regarding the PTH
Product or (ii) ALZA would like to negotiate an agreement regarding the PTH Product. If ALZA fails to deliver any notice within such 30-day period, ALZA will be deemed to have provided notice that it would not like to negotiate an agreement
regarding the PTH Product. Notwithstanding anything in Article 9 to the contrary, TMC may not provide any information regarding the PTH Product that was available at the time TMC provided the PTH Product Notice to ALZA (or became available during
the period TMC was negotiating with ALZA pursuant to Section 9.5) and that was not included in the PTH Product Notice Package or provided to ALZA pursuant to Section 9.3 to any 

  
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Third Party for the purpose of discussing an agreement with such Third Party for the continued development or Commercialization of the PTH Product. 

9.4 No Negotiation of PTH Product. If ALZA notifies TMC that it would not like to negotiate with TMC for an agreement regarding the PTH
Product (or is deemed to have done so), ALZA will have no further rights to the PTH Product and TMC will have no further obligations to ALZA with respect to such PTH Product, in each case, except as provided in Section 9.7. 

9.5 Good Faith Negotiation Regarding PTH Product. If ALZA notifies TMC that ALZA or any of its Affiliates would like to negotiate with
TMC, the Parties will negotiate exclusively with each other in good faith for a period of [**] following such notice for a letter of intent covering an arrangement pursuant to which ALZA or its Affiliate will obtain worldwide rights for further
development, licensing and marketing of the PTH Product. The arrangement will include the transfer to ALZA or its Affiliate ownership of any and all data, results, regulatory filings or Regulatory Approvals relating to the PTH Product obtained or
Controlled by TMC. The [**] negotiation period may be extended by mutual agreement of the Parties. During any period of time in which the Parties are negotiating in good faith, TMC will provide ALZA with any additional material data and information
developed by or on behalf of TMC during such time pertaining to the PTH Product. 
 9.6 No Agreement Regarding PTH Product. If the
Parties are unable to reach an agreement upon the terms of such letter of intent within such [**] period despite good faith negotiations during the [**] period or, if after reaching agreement upon a letter of intent the Parties are unable to enter
into a definitive agreement regarding the PTH Product despite an additional [**] period of good faith negotiations (and any agreed extension thereof), TMC will have the right (i) to develop and market the PTH Product through its own in-house
marketing and sales organization (or that of its Affiliates) on a worldwide basis, or (ii) to pursue an agreement with a Third Party for the continued development or Commercialization of the PTH Product so long as such Third Party agreement is
not on terms which, when taken as a whole, are materially less favorable for TMC than the last proposal TMC made to ALZA (or its Affiliate) during the negotiation period (or any agreed extension thereof). 

9.7 Additional Rights Regarding PTH Product. In the event that TMC decides not to seek a partner for further development or
Commercialization of the PTH Product prior to the unblinding of data for the first Phase II clinical trial of the PTH Product, or in the event that 

  
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ALZA (or its Affiliate) and TMC do not enter into an agreement regarding the PTH Product following ALZA’s receipt of the PTH Product Notice Package and TMC does not enter into an agreement
with a Third Party for the continued development or Commercialization of the PTH Product prior to the unblinding of data for the first Phase II clinical trial of the PTH Product, then following completion of the first study report for the first
Phase II clinical trial of the PTH Product that includes statistical analysis showing the positive statistical significance of the PTH Product against the primary endpoint established in the protocol for such trial, TMC will be obligated to provide
to ALZA a PTH Product Notice Package, including all additional data developed regarding the PTH Product up to such date, and the provisions of this Article 9 will again apply to the PTH Product; provided that (i) if the final study report for
such Phase II clinical trial is not materially different in its conclusions or the data presented from the initial draft report provided to ALZA, the 30-day time period specified in Section 9.3(i)-(ii) for ALZA to provide notice to TMC
will be reduced to 15 days and will not commence with the receipt of such PTH Product Notice Package but will instead commence upon receipt by ALZA of the final study report for such Phase II clinical trial, or (ii) if the final study report
for such Phase II clinical trial is materially different in its conclusions or the data presented from the initial draft report provided to ALZA, the 30-day time period specified in Section 9.3(i)-(ii) for ALZA to provide notice to TMC
will remain 30 days and will not commence with the receipt of such PTH Product Notice Package but will instead commence upon receipt by ALZA of the final study report for such Phase II clinical trial. Similarly, in the event that TMC decides not to
seek a partner for further development or Commercialization of the PTH Product prior to the unblinding of data for the first Phase III clinical trial of the PTH Product, or in the event that ALZA (or its Affiliate) and TMC do not enter into an
agreement regarding the PTH Product following ALZA’s receipt of the PTH Product Notice Package and TMC does not enter into an agreement with a Third Party for the continued development or Commercialization of the PTH Product prior to the
unblinding of data for the first Phase III clinical trial of the PTH Product, then following completion of the first study report for the first pivotal Phase III clinical trial of the PTH Product that includes statistical analysis showing the
positive statistical significance of the PTH Product against the primary endpoint established in the protocol for such trial, TMC will be obligated to provide to ALZA a PTH Product Notice Package, including all additional data developed regarding
the PTH Product up to such date, and the provisions of this Article 9 will again apply 

  
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to the PTH Product; provided that (i) if the final study report for such Phase III clinical trial is not materially different in its conclusions or the data presented from the initial draft
report provided to ALZA, the 30-day time period specified in Section 9.3(i)-(ii) for ALZA to provide notice to TMC will be reduced to 15 days and will not commence with the receipt of such PTH Product Notice Package but will instead
commence upon receipt by ALZA of the final study report for such Phase III clinical trial, or (ii) if the final study report for such Phase III clinical trial is materially different in its conclusions or the data presented from the initial
draft report provided to ALZA, the 30-day time period specified in Section 9.3(i)-(ii) for ALZA to provide notice to TMC will remain 30 days and will not commence with the receipt of such PTH Product Notice Package but will instead
commence upon receipt by ALZA of the final study report for such Phase III clinical trial. 
 9.8 No Implied Rights. For purposes of
clarity, it is acknowledged and agreed that TMC need only provide one such initial notice and PTH Product Notice Package under Section 9.2, and that TMC is not obligated to provide any further notice if TMC subsequently engages in discussions
with more than one Third Party with respect to the PTH Product prior to the unblinding of data for the first Phase II clinical trial of the PTH Product. Similarly, it is acknowledged and agreed that in the event TMC is required to offer the PTH
Product to ALZA pursuant to Section 9.7 above, TMC need only provide one such notice and PTH Product Notice Package at the end of the first Phase II clinical trial with respect thereto, if applicable, and one such notice and PTH Product Notice
Package at the end of the first Phase III clinical trial with respect thereto, each as required under Section 9.7, and that TMC is not obligated to provide any further notice if TMC subsequently engages in discussions with more than one Third
Party with respect to the PTH Product. 
 ARTICLE 10 — OPTION FOR NESIRITIDE PRODUCT. 

10.1 Option for Nesiritide Product. On the terms set forth in this Article 10, TMC hereby grants to ALZA and its Affiliates an
exclusive, irrevocable option for a period commencing on the Effective Date and ending on a date that is the third anniversary of the Effective Date (the “Option Period”), to enter into good faith negotiations with TMC for a separate
development and commercialization agreement with TMC, upon the terms and conditions set forth in Attachment 10.1, and such additional reasonable terms and conditions as 

  
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the Parties agree, covering the development, manufacture and commercialization of a Nesiritide Product. 

10.2 Exercise Of Option. ALZA (or its Affiliates) may exercise its option by providing TMC with written notice within the Option Period
of its desire to exercise such option. If ALZA (or its Affiliates) exercises its option within the Option Period described in Section 10.1, the Parties will commence good faith negotiations for a development and commercialization agreement upon
the terms and conditions set forth in Attachment 10.1, and such additional reasonable terms and conditions as the Parties mutually agree, covering the development, manufacture and commercialization of a Nesiritide Product. 

ARTICLE 11 — TMC’S RIGHT OF FIRST NEGOTIATION FOR EXPANDED LICENSE. 

11.1 ALZA Notice Regarding Expanded License. Prior to entering into negotiations with or offering to any Third Party a license outside
the Field under the Licensed Patents for delivery of therapeutic or prophylactic agents into or through the skin utilizing Microprojection Systems in combination with delivery systems that utilize a driving source (and such license were not related
to a specific product or products or a specific energy based delivery system), ALZA will deliver notice to TMC of ALZA’s intent to offer such license together with a description of the rights it is proposing to license in sufficient detail, in
ALZA’s reasonable estimation, to permit TMC to evaluate its interest in such opportunity. 
 11.2 Decision Regarding Expanded
License Negotiations. Within 30 calendar days of TMC’s receipt of such notice and description of rights, TMC will provide ALZA with notice either that (i) TMC would not like to negotiate such license or (ii) TMC would like to
negotiate for the rights to such license. If TMC fails to deliver any notice within such 30-day period, TMC will be deemed to have provided notice that it would not like to negotiate such license. 

11.3 No Negotiation Regarding Expanded License. If TMC notifies ALZA that it would not like to negotiate with ALZA for an agreement
regarding such license (or is deemed to have done so), TMC will have no further rights to such license and ALZA will have no further obligations to TMC with respect to such license. 

11.4 Good Faith Negotiation Regarding Expanded License. If TMC notifies ALZA within the 30 calendar day period that it would like to
negotiate with ALZA for such license, the Parties will negotiate exclusively with each other in good faith for a period of [**] following 

  
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such notice for a letter of intent covering an arrangement pursuant to which TMC will obtain such license. The [**] negotiation period may be extended by mutual agreement of the Parties. 

11.5 No Agreement Regarding Expanded License. If the Parties are unable to reach an agreement upon the terms of such letter of intent
within such [**] period despite good faith negotiations during the [**] period or if after reaching agreement upon a letter of intent the Parties are unable to enter into a definitive license agreement despite an additional [**] period of good faith
negotiations (or any agreed extension thereof), ALZA will have the right to pursue an agreement with a Third Party for such license so long as for a period of [**] following the termination of the negotiations between ALZA and TMC, such Third Party
license is not on terms which, when taken as a whole, are materially less favorable for ALZA than the last proposal ALZA had made to TMC during the negotiation period (or any agreed extension thereof). 

ARTICLE 12 — TMC’S RIGHT OF FIRST NEGOTIATION ON PRODUCTS UTILIZING MICROPROJECTION SYSTEMS OUTSIDE THE FIELD. 

12.1 ALZA Notice Regarding Collaboration. Prior to entering into a collaboration with a Third Party to develop an ALZA product
utilizing a Microprojection System in combination with any delivery system that utilizes an energy-based driving source, ALZA will deliver notice to TMC of its intent to enter into such collaboration together with a description of the proposed
collaboration in sufficient detail, in ALZA’s reasonable estimation, to permit TMC to evaluate its interest in such opportunity. Notwithstanding the foregoing, if after consulting with TMC regarding the proposed collaboration, ALZA reasonably
determines that TMC’s Microprojection Systems are not at such time suitable for ALZA’s intended application, ALZA will so inform TMC and will meet with TMC to discuss the basis of its decision. Thereafter, TMC will have no further rights
regarding such collaboration and ALZA will have no further obligations to TMC with respect to such collaboration. 
 12.2 Decision
Regarding Collaboration Negotiations. Within 30 calendar days of TMC’s receipt of such notice and written description of proposed collaboration, and if ALZA has not informed TMC that TMC’s Microprojection Systems are not suitable for
ALZA’s intended application, TMC will provide ALZA with notice either that (i) TMC would not like to negotiate with ALZA for an agreement regarding such collaboration or (ii) TMC would like to negotiate with ALZA for an agreement
regarding such collaboration. If TMC fails to deliver any notice 

  
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 within such 30-day period, TMC will be deemed to have provided notice that it would not like to negotiate for an
agreement regarding such collaboration. 
 12.3 No Negotiation Regarding Collaboration. If TMC notifies ALZA that it would not like
to negotiate with ALZA for an agreement regarding such collaboration (or is deemed to have done so), TMC will have no further rights regarding such collaboration and ALZA will have no further obligations to TMC with respect to such collaboration.

 12.4 Good Faith Negotiations Regarding Collaboration. If TMC notifies ALZA within the 30 calendar day period that it would like to
negotiate with ALZA for an agreement regarding such collaboration, the Parties will negotiate exclusively with each other in good faith for a period of [**] following such notice for a letter of intent covering such collaboration. The [**]
negotiation period may be extended by mutual agreement of the Parties. 
 12.5 No Agreement Regarding Collaboration. If the
Parties are unable to reach an agreement upon the terms of such letter of intent within such [**] period despite good faith negotiations during the [**] period or if after reaching agreement upon a letter of intent the Parties are unable to enter
into a definitive collaboration agreement despite an additional [**] period of good faith negotiations (or any agreed extension thereof), ALZA will have the right to pursue an agreement with a Third Party for such collaboration so long as for a
period of [**] following the termination of the negotiations between ALZA and TMC, such Third Party license is not on terms which, when taken as a whole, are materially less favorable for ALZA than the last proposal ALZA had made to TMC during the
negotiation period (or any agreed extension thereof). 
 ARTICLE 13 — TMC’S RIGHT TO MEET. 

13.1 TMC Proposal. Beginning on a date that is 18 months after the Effective Date, TMC may notify ALZA on a nonconfidential
basis that TMC would like to initiate good faith negotiations with ALZA to obtain a nonexclusive license of the Licensed Patents for the delivery of a specific therapeutic or prophylactic agent into or through the skin utilizing a Microprojection
System in combination with a delivery system that utilizes a driving source other than iontophoresis. ALZA and TMC will meet at ALZA’s facilities at a mutually agreeable time and date that is within 45 days of ALZA’s receipt of such
notice. At the meeting, TMC may present its proposal for such arrangement to ALZA on a nonconfidential basis. ALZA will not have any 

  
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additional obligations of any kind regarding such proposal or such product, including but not limited to, any obligation to negotiate in good faith or to respond in any way to such proposal or to
agree to any form of additional license. 
 ARTICLE 14 — EXCLUSIVITY. 

14.1 TMC Exclusivity. Notwithstanding anything in this Agreement to the contrary, beginning on the Effective Date and continuing
until a date that is the later of (i) December 31, 2014, or (ii) the end of the period that ALZA, its Affiliates or sublicensees, have a Valid Patent Claim covering Natrecor®
(nesiritide) or regulatory exclusivity (including any data package or marketing exclusivity) from any Regulatory Authority regarding Natrecor® (nesiritide) (collectively, the “Exclusivity
Period”), or (iii) the date on which Natrecor® (nesiritide) is no longer being sold by ALZA or any ALZA Affiliate, TMC will not conduct (itself or with an Affiliate or a Third Party)
any material development or Commercialization activities with respect to any Product (other than the Nesiritide Product with ALZA or its Affiliate as described in Section 10.2) incorporating nesiritide or any analog or derivative thereof. 

In addition, beginning on the Effective Date and continuing until a date that is the later of (i) December 31, 2014, or
(ii) the end of the Exclusivity Period anywhere in the Territory, TMC will not conduct (itself or with an Affiliate or a Third Party) any material development or Commercialization activities with respect to any Product (other than the
Nesiritide Product with ALZA or its Affiliate as described in Section 10.2) incorporating any natriuretic peptide, stresscopin, urocortin, or any analog or derivative of a natriuretic peptide, stresscopin or urocortin in the Field. 

14.2 ALZA Exclusivity. 

14.2.1 Notwithstanding anything in this Agreement to the contrary, during such time as TMC is actively working on a PTH Product, ALZA will not
conduct any material development or Commercialization activities with respect to any product for delivery of PTH into or through the skin via a Microprojection System in combination with a driving source (including, but not limited to, delivery
systems that utilize one or more driving sources such as electrical potential gradients, sound waves, heating systems, laser energy, hydraulic systems or 

  
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radio waves), unless ALZA and TMC have entered into a separate agreement regarding such product. 

14.2.2 Notwithstanding anything in this Agreement to the contrary, during the time beginning on the Effective Date and ending on the six month
anniversary of the Effective Date (or such earlier date that TMC notifies ALZA of its selection of no more than two compounds as described below), ALZA will not conduct (itself or with an Affiliate or Third Party) any material development or
Commercialization activities with respect to any product for delivery of human growth hormone (hGH), alpha-interferon (alpha-IFN), beta-interferon (beta-IFN), granulocyte colony stimulating factor (G-CSF), or desmopressin or any analog of any of the
foregoing into or through the skin via a Microprojection System in combination with a driving source (including but not limited to, delivery systems that utilize one or more driving sources such as electrical potential gradients, sound waves,
heating systems, laser energy, hydraulic systems or radio waves), unless ALZA and TMC have entered into a separate agreement regarding such product. On or prior to the six month anniversary of the Effective Date, TMC will notify ALZA that it has
selected up to two compounds from the compounds listed above for which ALZA’s exclusivity obligations to TMC as described above will continue thereafter for a period of two years from the Effective Date provided that such obligations will only
remain in effect with respect to each compound selected by TMC pursuant to this Section 14.2.2 during the period when TMC is actively working on a Product for delivery of such compound. ALZA will have no continuing exclusivity obligations to
TMC for the compounds not so selected. 
 14.2.3 TMC will inform ALZA of the status of its development projects pursuant to the annual
development reports described in Section 3.6. If TMC terminates the active development of the PTH Product, it will so notify ALZA within 30 days of the termination of such program. If TMC begins active work on a Product for delivery of any of
the compounds listed in Section 14.2.2 or terminates active work on a Product for delivery of any of the compounds listed in Section 14.2.2, it will so notify ALZA within 30 days of such initiation or termination of such work. If, at any
time, TMC is not actively working on a Product for delivery of any of PTH, or one of the compounds listed in Section 14.2.2 (or TMC has not notified ALZA that it has commenced active work on such compound) and ALZA begins work on a product
outside the Field for the delivery of such compound, ALZA will no longer have any obligation 

  
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under Section 14.2 regarding such compound, even if TMC later begins working on a Product for delivery of such compound in the Field. 

ARTICLE 15 — TERM AND TERMINATION. 

15.1 Term. This Agreement will commence on the Effective Date and will remain in effect until the expiration of TMC’s
obligation to make Product Payments for all Products, unless earlier terminated as provided in this Article 15 (the “Term”). TMC’s license with respect to the ALZA Know-How will survive the expiration, (but not an earlier termination)
of this Agreement. 
 15.2 Termination of this Agreement by TMC for any Reason. TMC may terminate this Agreement for any
reason upon ninety (90) days advance written notice to ALZA. 
 15.3 Termination by ALZA. ALZA may terminate this Agreement if
TMC or any of its Affiliates or Sublicensees initiates or voluntarily maintains, or participates in or, in the absence of a subpoena or other court order (a copy of which subpoena or court order will be promptly provided to ALZA if not prohibited
under such subpoena or order), cooperates with any Third Party to initiate or maintain, any action or proceeding seeking a declaration or judgment of invalidity with respect to any of the Licensed Patents or to challenge the ownership or
inventorship of any of the Licensed Patents. This clause is not intended to create any rights for TMC or any of its Affiliates or Sublicensees to participate in any actions not authorized by law. 

15.4 Termination By Either Party for Breach. Either Party may terminate this Agreement in the event the other Party commits a
material breach of any obligation of this Agreement. A material breach by TMC will include, but not be limited to, TMC’s failure to satisfy any of its diligence obligations described in Sections 3.5 and 3.7. 

15.5 Effective Date of Termination. For any breach other than a failure by TMC to pay when due any amount due hereunder,
termination will become effective either (i) sixty (60) calendar days after the date of such notice unless TMC cures such material breach or withdraws or terminates such action or proceeding described in Section 15.3 during such sixty
(60) day period (or, if such material breach, by its nature, is a curable breach that is not curable within such 60 day period, such longer period as would be reasonably necessary for a diligent party to cure such material breach), or
(ii) immediately if such material breach, by its nature, is incurable or if TMC has failed to engage in Active Early Development on at least one additional Product 

  
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within 6 months following the date TMC terminates or suspends a development program, as described in Section 3.5. 

For any breach consisting of a failure by TMC to pay when due any amount due hereunder, termination will become effective twenty
(20) calendar days after the date of such notice unless ALZA receives all undisputed amounts due, together with all interest due and payable thereon, within such twenty (20) day period and, if any of the amount is in dispute, a notice
specifying the disputed amount, together with a reasonably detailed explanation of the basis for such dispute. 
 15.6 Termination for
Bankruptcy. This Agreement will terminate automatically without any notice to TMC in the event: (i) TMC is declared insolvent or bankrupt by a court of competent jurisdiction, (ii) a voluntary or involuntary petition in
bankruptcy is filed in any court of competent jurisdiction against TMC and such petition is not dismissed within ninety (90) days after filing, or (iii) TMC makes or executes an assignment of substantially all of its assets for the benefit
of creditors. 
 15.7 Effect of Termination. 

15.7.1 Subject to Sections 15.7.2 and 15.7.3, in the event of termination under Section 15.2, Section 15.3, Section 15.4 or
Section 15.6: all rights licensed herein will revert to ALZA and the license to ALZA in Section 2.2 will remain in full force and effect. 

15.7.2 Notwithstanding Section 15.7.1, if the Agreement is terminated by ALZA due to TMC’s failure to meet its specific diligence
obligations described in Section 3.6.2 prior to the First Sale of the second Product to be Commercialized, the License and Agreement will be terminated with respect to all Products except (i) any Product that, on the effective date of
termination, TMC is diligently Commercializing or that TMC is diligently developing and that has been introduced into a patient in a human clinical study and (ii) any Third Party Product in Active Early Development, Active Clinical Development
or any later stage of development or Commercialization by TMC or its Sublicensee. 
 15.7.3 Upon termination of this Agreement for any
reason following the First Sale of the second Product, any sublicense granted by TMC to a Sublicensee will survive termination only if all of the following conditions are met: (a) the Sublicensee is not then in default under the terms of its
sublicense agreement; (b) the Sublicensee has a sublicense which was not granted by TMC in violation of this Agreement; (c) the Sublicensee has, at the time this 

  
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Agreement is terminated, at least one Third Party Product or other Product in Active Early Development, Active Clinical Development, or Commercialization and (d) the Sublicensee agrees in
writing that: (i) ALZA will be entitled to enforce all relevant provisions of such sublicense agreement directly against such Sublicensee; (ii) ALZA will not assume, and will not be responsible to such Sublicensee for, any representations,
warranties, or obligations of TMC to such Sublicensee (including, but not limited to, any obligations to manufacture for, or provide technology transfer to, the Sublicensee), other than to permit such Sublicensee to make, have made, import, use,
sell, offer for sale and have sold Products under the Licensed Patents and ALZA Know-How to the extent such rights are sublicensed to such Sublicensee under the applicable sublicense agreement; (iii) ALZA will be responsible for the direction
of the filing, prosecution, issuance and maintenance of all Licensed Patents and ALZA Inventions and the extension and maintenance of any such Patents, and the handling of such matters will be in ALZA’s reasonable discretion; (iv) the
royalties and non-royalty payments to ALZA by such Sublicensee in respect of each applicable Product and Third Party Product will be the greater of (x) what ALZA would have received from TMC under this Agreement in respect of such
Sublicensee’s activities with respect to such applicable Product or Third Party Product or (y) what such Sublicensee would have owed to TMC under its sublicense agreement; (v) the Sublicensee will pay its portion of ALZA’s patent
filing, prosecution, issuance and maintenance expenses related to the Licensed Patents which would otherwise have been borne by TMC under Section 7.3.2(a) of this Agreement, which expenses will be apportioned pro rata among each surviving
Sublicensee; (vi) the Sublicensee will be subject to the same diligence obligations as TMC under Sections 3.6.1 and 3.8 of this Agreement with respect to Sublicensee’s Product(s); and (vii) the Sublicensee may not exercise its rights
to make, have made, import, use, sell, offer for sale and have sold Products under the Licensed Patents and ALZA Know-How (to the extent such rights are sublicensed to such Sublicensee under the applicable sublicense agreement) for any Products that
are not in Active Early Development, Active Clinical Development or Commercialization at the time this Agreement is terminated. ALZA may require any Sublicensee that is a party to a sublicense agreement that survives termination of this Agreement
pursuant to this Section 15.7.3 to enter into a direct license with ALZA to replace such sublicense agreement on terms that are substantially identical to the terms set forth in such sublicense agreement with such changes as are necessary to
implement the standards set forth in this Section 15.7.3(c)(i)-

  
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(vii). If ALZA desires to enter into a direct license with a Sublicensee, ALZA will provide written notification to such Sublicensee and will, for a period of ninety (90) days after
providing such notice, negotiate in good faith with such Sublicensee for a direct license under the Licensed Patents, Future ALZA Patents, and ALZA Know-How, in each case, to the extent such rights were sublicensed from TMC to such Sublicensee in
the sublicensed field. It is understood and agreed that the sublicense agreements held by any such Sublicensee will survive commencing on termination of this Agreement and, should ALZA desire to enter into a direct license with such Sublicensee, end
after the 90 day negotiation period described above. 
 15.7.4 Also in the event of termination under Section 15.2, Section 15.3,
Section 15.4, or Section 15.6, for any Products (excluding Third Party Products and any Products sublicensed to Sublicensees whose sublicenses survive in accordance with Section 15.7.3) for which TMC’s rights have terminated, TMC
will, at ALZA’s request, negotiate in good faith, on commercially reasonable terms, for ALZA to obtain (i) the right and license, with the right to sublicense, to use, cross-reference and access all regulatory submissions and Regulatory
Approvals regarding such Products and all preclinical data, clinical data and regulatory information regarding such Products, and (ii) a worldwide, sublicensable exclusive license to TMC Patents and know-how, in each case, solely to the extent
required by ALZA (or its designated Affiliate) to make, have made, use, sell, have sold, offer to sell and import such Products. TMC will execute and deliver further instruments and the Parties will take such other actions as may be reasonably
required to carry out the intent and purposes of this Section 15.7.4, including assignment to ALZA (or its designated Affiliate). 

15.8 No Waiver. The right of a Party to terminate this Agreement, as provided in this Article 15 will not be affected in any way
by its waiver or failure to take action with respect to any prior default. 
 15.9 Consequences of Termination. Except as otherwise
provided herein, upon expiration or termination of this Agreement, all remaining records and materials in its possession or control containing the other Party’s Confidential Information and to which the former Party does not retain rights
hereunder, will promptly be returned or destroyed, at the other Party’s request. Notwithstanding the foregoing, (i) one copy of such records may be retained by legal counsel for the former Party solely for evidentiary purposes,
(ii) TMC will have no obligation to return ALZA Confidential Information to the extent such information (x) is necessary to develop 

  
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and Commercialize a Product for which TMC has a Product-specific license under this Agreement, or (y) TMC has previously sublicensed the right to develop and Commercialize a Product to a
Sublicensee and such sublicense survives the termination of this Agreement pursuant to Section 15.7.3. 
 15.10 [**] 

15.11 Survival of Obligations. The termination or expiration of this Agreement will not relieve the Parties of any
obligations accruing prior to such termination, and any such termination will be without prejudice to the rights of either Party against the other. The provisions of Sections 2.2, 4.5, 5.6, 5.7, 5.8, 5.9, 7.5.3(a)-(b) (with respect solely to
the allocation of any recovery and not with respect to the institution of proceedings for infringement actions (i) filed prior to termination or expiration of this Agreement or (ii) pertaining to the acts of infringement occurring during
the Term), 15.7, 15.9 – 15.12, 16.5.2, 16.6 and Articles 1, 6, 8, 17 and 18 will survive any termination of this Agreement. 
 15.12
Termination Not Sole Remedy. Termination is not the sole remedy under this Agreement and, whether or not termination is effected, all other remedies will remain available except as expressly agreed to otherwise herein. 

ARTICLE 16 — REPRESENTATIONS AND WARRANTIES. 
  

16.1 Authority. Each Party represents and warrants that as of the Effective Date, it has the full right, power and authority to
enter into this Agreement and that 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. 

16.2 No Conflicts. Each Party represents and warrants that 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 violate any material law or regulation of any court, governmental body or administrative or other
agency having jurisdiction over it. 
 16.3 ALZA Representations. TMC and ALZA acknowledge and agree that Pete Daddona, [**]
(the “Former ALZA Business Managers”) were employees of ALZA or ALZA Affiliates and were closely involved in the management and operations of the Macroflux® group at ALZA.
Accordingly, ALZA will in no event be liable to TMC, TMC Indemnitees or any other 

  
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party for any breach of ALZA’s representations and warranties contained in the Agreement to the extent that any such Former ALZA Business Managers had, or reasonably should have had as a
result of their involvement with the Macroflux® business prior to the Effective Date, knowledge of any material fact or facts which reasonably gives rise to such breach or knowledge, as of the
Effective 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. The Parties agree that in any dispute or legal
proceeding, TMC will bear the burden of proof that no such Former ALZA Business Manager had knowledge (or should not reasonably have had such knowledge) of such breach or of the material facts giving rise to such breach. Subject to the foregoing,
ALZA hereby represents and warrants to TMC, as of the Effective Date. 
 16.3.1 ALZA has the lawful right to grant the License. 

16.3.2 Except as disclosed in Attachment 1.10, ALZA has not previously assigned, transferred, conveyed or otherwise encumbered its rights,
title and interest in the Licensed Patents and Trademarks and there are currently no existing license agreements for the Licensed Patents and Trademarks that are in conflict with the Licenses. 

16.3.3 To ALZA’s actual knowledge as of the Effective Date (without any inference or duty of investigation), it owns and Controls all
right, title and interest in and to the ALZA Know-How and the patents and patent applications listed on Attachment 1.22, subject to rights granted in the [**] Agreement. 

16.3.4 Except for the matters disclosed in Attachment 16.3.4, ALZA has received no written notice of any claim by any Third Party that
(a) such Third Party has any rights to the Licensed Patents in the Field that prevent ALZA from granting to TMC the License or (b) the Licensed Patents (to the extent representing issued Patents) are invalid or unenforceable. 

16.3.5 To ALZA’s actual knowledge as of the Effective Date (without any inference or duty of investigation), ALZA has not received any
written notice or other written communication from any Third Party regarding any breach by ALZA of its obligations under any of the agreements listed on Attachment 3.3.1. 

16.3.6 Except for the matters disclosed in Attachment 16.3.4, to ALZA’s actual knowledge as of the Effective Date (without any inference
or duty of investigation), there is no 

  
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litigation threatened, impending or existing against ALZA or to which ALZA is a party relating to the Licensed Patents or Trademarks. 

16.3.7 ALZA has made available to TMC true and correct copies of the Product Development Agreements and the [**] Agreement. 

16.3.8 To ALZA’s actual knowledge as of the Effective Date (without any inference or duty of investigation) there have been no FDA
inspections of clinical studies conducted by ALZA or manufacturing facilities for the manufacture of clinical supplies, in each case, regarding the PTH Product and ALZA’s activities regarding the PTH Product have been and are being conducted in
substantial compliance with all applicable laws and regulations. 
 16.3.9 To ALZA’s actual knowledge as of the Effective Date (without
any inference or duty of investigation), neither ALZA nor any of its officers, employees or agents has made an untrue statement of a material fact or fraudulent statement to the FDA or any other Regulatory Authority or failed to disclose a material
fact required to be disclosed to the FDA or any other Regulatory Authority regarding the PTH Product. 
 16.3.10 To ALZA’s actual
knowledge, in the course of the clinical development of the PTH Product over the past [**], ALZA has not used any employee or consultant who (at the time such employee or consultant provided services to ALZA with respect to such products) was
debarred by the FDA or the subject of pending disbarment proceedings by the FDA. 
 16.4 No Implication By ALZA. Except as
expressly stated herein, nothing in the Agreement will be construed as: 
 16.4.1 A warranty or representation by ALZA as to the validity or
patentability or scope of any of the Licensed Patents or the ALZA Know-How; 
 16.4.2 A warranty or representation by ALZA that anything that
has been or will be made, used, sold, offered for sale, or imported under the License provided herein is or will be free from infringement of patents of Third Parties; 

16.4.3 An obligation on the part of ALZA to bring or prosecute actions or suits against Third Parties for infringement of any of the Licensed
Patents or for entitlement of any patents or applications that relate to the [**]; or 

  
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 16.4.4 A grant by implication, estoppel, or otherwise, any licenses or rights under patents or
other intellectual property of ALZA or an Affiliate of ALZA other than that expressly included in the License. 
 16.5 TMC
Representations. During this Agreement, TMC will: 
 16.5.1 comply in all material respects with all applicable laws and
regulations concerning the development, manufacture, use and sale of Microprojection Systems and Products; 
 16.5.2 comply with the terms
and conditions of the [**] Agreement and will notify ALZA promptly of any claim or notice received by TMC asserting that TMC is in breach of the [**] Agreement; and 

16.5.3 have adequate terms and conditions in its sublicense agreements to allow TMC to comply with all relevant terms and conditions of the
Agreement. 
 16.6 Disclaimer of Warranties. ALZA MAKES NO REPRESENTATIONS AND EXTENDS NO WARRANTIES OR CONDITIONS OF ANY
KIND, EITHER EXPRESS OR IMPLIED, WITH RESPECT TO THE LICENSED PATENTS OR KNOW-HOW LICENSED HEREUNDER, INCLUDING, BUT NOT LIMITED TO, WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. ANY INFORMATION PROVIDED BY ALZA TO TMC IS MADE
AVAILABLE ON AN “AS IS” BASIS WITHOUT WARRANTY WITH RESPECT TO COMPLETENESS, COMPLIANCE WITH REGULATORY STANDARDS OR REGULATIONS OR FITNESS FOR A PARTICULAR PURPOSE OR ANY OTHER KIND OF WARRANTY WHETHER EXPRESS OR IMPLIED. 

ARTICLE 17 — DISPUTE RESOLUTION 

17.1 Dispute Resolution and Arbitration. In the case of any disputes between the Parties arising from this Agreement, and in
case this Agreement does not provide a solution for how to resolve such disputes, the Parties will discuss and negotiate in good faith a solution acceptable to both 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 [**], then the President of ALZA and the Chief Executive Officer of TMC will discuss in good faith an appropriate resolution to the dispute. If these executives fail,
after good faith discussions, to 

  
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reach an amicable agreement within [**], then either Party may upon written notice to the other submit the dispute to binding arbitration pursuant to Section 17.2. 

17.2 Arbitration. Any claim, dispute or controversy arising out of or in connection with or relating to this Agreement
(including, without limitation, disputes with respect to the rights and obligations of the Parties following termination) not settled by the procedures set forth in Section 17.1 above, or the breach or alleged breach of a material provision of
this Agreement, will be adjudicated by arbitration in accordance with the Arbitration Proceedings as set forth in Attachment 17.2. 

ARTICLE 18 — MISCELLANEOUS PROVISIONS. 

18.1 Entire Agreement. This Agreement and each of the Attachments hereto constitute and contain the entire understanding and
agreement of 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. 
 18.2 Further Actions. Each Party agrees to execute, acknowledge and deliver such further
instruments and to do all such other acts as may be necessary or appropriate in order to carry out the purposes and intent of this Agreement. 

18.3 Binding Effect. This Agreement and the rights granted herein will be binding upon, and will inure to the benefit of, ALZA,
TMC and their respective lawful successors and permitted assigns. 
 18.4 Assignment. Neither Party will assign this Agreement
without the prior written consent of the other Party (such consent not to be unreasonably withheld) except that a Party may assign this Agreement to an Affiliate or to a successor in connection with the merger, consolidation or sale of all or
substantially all of its assets or that portion of its business pertaining to the subject matter of this Agreement. The sublicense of all (or substantially all) of TMC’s rights under this Agreement will be deemed to be an assignment under this
Section 18.4. Any permitted assignee will assume all obligations of its assignor under this Agreement. No assignment will have the effect of relieving any Party to this Agreement of any of its obligations hereunder. It is understood and agreed
that any Third Party excluding any “person” or “group” (within the meaning of Section 13(d) or 14(d) of the Securities Exchange Act of 1934, as 

  
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amended) that is controlled directly or indirectly by ALZA or TMC or such Party’s present officers or directors, (a) that directly or indirectly acquires all or substantially all of the
stock or assets of ALZA or TMC or (b) into which ALZA or TMC is consolidated or merged, shall not be required to provide the other Party with rights under Section 2.1.1(b) or Section 2.2, as the case may be, in the event and to the
extent that those provisions would require such acquiring Third Party to grant licenses to the other Party covering inventions conceived and reduced to practice by such Third Party prior to the date it acquires ALZA or TMC, without access to or
knowledge of any ALZA Know-How, ALZA Confidential Information, TMC Confidential Information (as defined without reference to whether such TMC Confidential Information is disclosed to ALZA), TMC Inventions or Derivative Information (unless such
access to or knowledge of was provided to such Third Party by the non-acquired Party). In each case, the burden of establishing such exception to the Section 2.1.1(b) or Section 2.2 license will fall upon the acquiring Third Party. 

18.5 No Implied Licenses. No rights to any other patents, know-how or technical information, or other intellectual property
rights, other than as explicitly identified herein, are granted or deemed granted by this. Agreement. No right, expressed or implied, is granted by this Agreement to a Party to use in any manner the name or any other trade name or trademark of the
other Party or its Affiliates in connection with the performance of this Agreement. 
 18.6 No Waiver. No waiver, modification
or amendment of any provision of this Agreement will 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 will not constitute a waiver of that right or excuse a similar subsequent failure to perform any such term or condition. 

18.7 Force Majeure. The failure of a Party to perform any obligation under this Agreement by reason of force majeure, limited to
acts of God, acts of governments, riots, wars, strikes, accidents or deficiencies in materials or transportation or other causes of a similar magnitude beyond its control, will not be deemed to be a breach of this Agreement, for so long as the
affected Party is using diligent efforts to remedy the force majeure event and perform its obligations as soon as practicable. The Party which is affected by any force majeure will contact the other Party for discussion of possible emergency
measures. 
 18.8 Independent Contractors. Both Parties are independent contractors and not agents or employees of the other
Party under this Agreement. Nothing contained in this 

  
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Agreement is intended nor is to be construed so as to constitute ALZA or TMC as partners or joint venturers with respect to this Agreement. Neither Party will have any express or implied right or
authority to assume or create any obligations on behalf of or in the name of the other Party or to bind the other Party to any other contract, agreement or undertaking with any Third Party except as may be explicitly provided for herein or
authorized in writing. 
 18.9 Notices and Deliveries . Any notices, request, delivery, approval or consent required or
permitted to be given under this Agreement will be in writing and will be deemed to have been sufficiently given when it is received, whether delivered in person, transmitted by facsimile with contemporaneous confirmation, or delivery by registered
letter (or its equivalent) or delivery by certified overnight courier service, to the Party to which it is directed at its address shown below or such other address as such Party will have last given by notice to the other Parties. 

If to TMC: 
 The Macroflux
Corporation 
 2000 Charleston Road, M12-2A 

Mountain View, CA 94043 

Attention: Chief Executive Officer 

Facsimile: [**] 
 With a copy to:

 Wilson Sonsini Goodrich & Rosati 

650 Page Mill Road 
 Palo Alto, CA
94304 
 Attention: [**] 

Facsimile: [**] 
 If to ALZA:

 ALZA Corporation 
 1900
Charleston Road 
 Mountain View, CA 94043 

Attention: Legal Department 

Facsimile: [**] 
 with a copy to:

 Office of General Counsel 

Johnson & Johnson 

  
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 One Johnson & Johnson Plaza 

New Brunswick, NJ 08933 

Facsimile: [**] 
 18.10
Headings. The captions to the sections and articles in this Agreement are not a part of this Agreement, and are included merely for convenience of reference only and will not affect its meaning or interpretation. 

18.11 Severability. In the event that any provision of this Agreement will, for any reason, be held to be invalid or
unenforceable in any respect, such invalidity or unenforceability will not affect any other provision hereof, and this Agreement will be construed as if such invalid or unenforceable provision had not been included herein. 

18.12 Applicable Law. This Agreement will be governed by and interpreted in accordance with the laws of the State of Delaware
without reference to its choice of laws or conflicts of laws provisions. 
 18.13 Advice of Counsel. TMC and ALZA have each
consulted with counsel of their choice regarding this Agreement, and each acknowledges and agrees that this Agreement will not be deemed to have been drafted by one Party or another and will be construed accordingly. 

18.14 Counterparts. This Agreement may be executed in two or more counterparts, or facsimile versions, each of which will be deemed to
be an original, and all of which together will be deemed to be one and the same agreement. 
 18.15 Waiver. Except as
specifically provided for herein, the waiver from time to time by either of the Parties of any of their rights or their failure to exercise any remedy will not operate or be construed as a continuing waiver of same or of any other of such
Party’s rights or remedies provided in this Agreement. 
 18.16 Bankruptcy. All rights and licenses granted under or
pursuant to this Agreement by TMC or ALZA are, and will otherwise be deemed to be, for purposes of Section 365(n) of Title II, U.S. Code (the “Bankruptcy Code”), licenses of right to “Intellectual Property” as defined under
Section 101(35A) of the Bankruptcy Code. The Parties agree that the Parties as licensees of such rights under this Agreement, will retain and may fully exercise all of their rights and elections they would have in the case of a licensor
bankruptcy under the Bankruptcy Code. Each Party agrees during the term of this Agreement to create or maintain current copies, 

  
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or if not amenable to copying, detailed descriptions or other appropriate embodiments, of all such intellectual property licensed to the other Party. 

18.17 Compliance with Laws. The Parties will comply with all applicable laws, rules, regulations and orders of the United States
and applicable European countries and supra-governmental organizations and all jurisdictions and any agency or court thereof in connection with this Agreement and the transactions contemplated thereby. 

18.18 Certain Tax Matters. The Parties will, for all federal, state and local income tax purposes, treat the exchange of
Licenses for Series A Preferred and Product Payments as part of the transaction under Section 351 of the Code described in Section 7.4 of the Series A Agreement and will not take any position or action contrary thereto or inconsistent
therewith. For the avoidance of doubt, the parties agree to treat the Product Payments as boot pursuant to Section 351 of the Code. 

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

			
	ALZA CORPORATION
		
	By:	 	/s/ Erik Wiberg
	Name:	 	Erik Wiberg
	Title:	 	VP Pharmaceuticals Group
		 	  Business Development

  

			
	THE MACROFLUX CORPORATION
		
	By:	 	/s/ Peter Daddona
	Name:	 	Peter Daddona


  
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	Title:	 	Chief Scientific Officer


  
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 Attachment 1.5 - Certain ALZA Inventions 

[**] 

  
 CONFIDENTIAL MATERIALS
OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND 
 EXCHANGE COMMISSION. DOUBLE ASTERISKS [**] DENOTE OMISSIONS. 







 Attachment 1.6 - ALZA Know-How 

  
 CONFIDENTIAL MATERIALS
OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND 
 EXCHANGE COMMISSION. DOUBLE ASTERISKS [**] DENOTE OMISSIONS. 







 Attachment 1.6 - ALZA Know-How Index 

Note: ALZA Know-How will also include data and documents that will be generated under the Transitional Services Agreement. These data and documents will be
transferred at the end of the Transition Period. Requirements: 
  

	(1)	Electronic copies of all documents 

  

	(2)	Controlled copies must have a hardcopy that is updated per GPSG - Macroflux® Corporation Agreement 


# denotes data and documents that will be transferred to TMC after the Effective Date 

 

			
	 Document Type
	  	 Schedule

		
	Regulatory Documents	  	 IND No. 70,973, Form FDA 1571 (IND Serial No.

0007), as well as all written communications between ALZA and the FDA and ALZA’s internal contact reports, in each case, relating to IND No.

70,973

		
	Laboratory Notebooks	  	Schedule A
		
	Employee Training Records	  	Schedule B
		
	SOPs	  	Schedules C-1 and C-2
		
	Forms	  	Schedule D
		
	Technical reports	  	Schedule E
		
	Toxicology Reports	  	Schedule F
		
	Design History Files	  	Schedule G
		
	Training Modules	  	Schedule H
		
	ALZA Analytical Methods (AAM)	  	Schedule I
		
	ALZA Quality Specification (AQS)	  	Schedule J
		
	Clinical Production Record (CPR)	  	Schedule K
		
	Packaging Material Specifications (PMS)	  	Schedule L
		
	Clinical Files	  	Schedule M
		
	Bioanalytical CRO documentation	  	Schedule N
		
	Vendor Fifes	  	Schedule 0
		
	Completed Batch Records	  	Schedule P
		
	Equipment Files	  	
		
	Equipment Manuals	  	
		
	Drawing files (CAD)	  	


  
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 Attachment 1.6 – ALZA Know-How Index 

Schedule A: Lab Notebooks 

Note: transfer of Notebooks to be completed by October 31, 2006 

 

											
	[**]	  	8953#	  		  	6156	  	[**]	  	7220
	[**]	  	7136#	  		  	6580	  	[**]	  	3890
		  	7188#	  		  	7144	  		  	7256
		  	7312#	  		  	7737	  		  	7219
		  	7405#	  	[**]	  	8805	  	[**]	  	8743
		  	7528#	  	[**]	  	8301	  	[**]	  	5097
		  	7679#	  		  	8409	  	[**]	  	8380
		  	7929#	  		  	8593	  	[**]	  	6586
	[**]	  	8415#	  	[**]	  	7739	  		  	6675
		  	8414#	  		  	8060	  		  	6796
		  	8422#	  		  	8067	  		  	6960
		  	8484#	  		  	8066	  		  	7190
		  	8485#	  		  	8304	  		  	7290
	[**]	  	6844#	  		  	8305	  		  	7374
		  	7344#	  		  	8335	  		  	7537
		  	8157#	  		  	8334	  		  	7650
	[**]	  	7304#	  		  	8421	  		  	7667
		  	7425#	  		  	8423	  		  	7668
		  	7456#	  		  	8580	  		  	7922
		  	7457#	  		  	8647	  		  	8138
		  	7641#	  		  	8694	  		  	8507
		  	7822#	  	[**]	  	6055	  		  	8644
		  	8144#	  		  	6995	  		  	8645
		  	8269#	  		  	7488	  		  	8646
		  	8520#	  	[**]	  	8381	  	[**]	  	7182
		  	8702#	  		  	8549	  	[**]	  	8705
		  	8952#	  		  	8554	  		  	8591
	[**]	  	7577#	  		  	8797	  	[**]	  	7533
		  	8052#	  	[**]	  	7261	  		  	7619
	[**]	  	8248#	  		  	7262	  		  	8136
	[**]	  	5128#	  		  	7263	  		  	8331
		  	5129#	  		  	8972	  	[**]	  	7646


  
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		  	5756#	  	[**]	  	8607	  		  	7647


  
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	[**]	  	7648#	  	[**]	  	6830	  		  	7876
		  	7649#	  	[**]	  	7901	  		  	7913
	[**]	  	8980#	  		  	8234	  		  	8013
	[**]	  	8456#	  		  	8827	  		  	8010
		  	8629#	  	[**]	  	6709	  	[**]	  	6435
		  	8786#	  		  	7410	  		  	6824
		  	8806#	  	[**]	  	7814	  		  	7993
		  	8961#	  		  	8065	  		  	8468
	[**]	  	8729#	  		  	8495	  		  	8552
	[**]	  	7771#	  		  	8870	  	[**]	  	8253
	[**]	  	5585#	  	[**]	  	7639	  		  	7429
		  	7826#	  		  	7671	  		  	8137
		  	8007#	  		  	7704	  	[**]	  	7421
		  	8673#	  		  	7777	  		  	7422
	[**]	  	8804#	  		  	7811	  		  	


  
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 Attachment 1.6 - ALZA Know-How Index 

Schedule B; Employee Training Records 
  

							
	
        Employee Name        
	  	WWID	 	  	  

	 [**]
	  	 	701089503	  	  	
	 [**]
	  	 	332708	  	  	
	 [**]
	  	 	128009636	  	  	
	 [**]
	  	 	181837	  	  	
	 [**]
	  	 	128009768	  	  	
	 [**]
	  	 	701090331	  	  	
	 [**]
	  	 	341136	  	  	
	 [**]
	  	 	180920	  	  	
	 [**]
	  	 	333305	  	  	
	 [**]
	  	 	191935	  	  	
	 [**]
	  	 	365850	  	  	
	         Daddona, Pete        
	  	 	180405	  	  	
	 [**]
	  	 	340710	  	  	
	 [**]
	  	 	128009326	  	  	
	 [**]
	  	 	104759	  	  	
	 [**]
	  	 	128008889	  	  	
	 [**]
	  	 	366617	  	  	
	 [**]
	  	 	701084297	  	  	
	 [**]
	  	 	701093113	  	  	
	 [**]
	  	 	174510	  	  	
	 [**]
	  	 	701085092	  	  	
	 [**]
	  	 	701084298	  	  	
	 [**]
	  	 	701088378	  	  	
	 [**]
	  	 	128005057	  	  	
	 [**]
	  	 	197229	  	  	
	 [**]
	  	 	128011652	  	  	
	 [**]
	  	 	128005078	  	  	
	 [**]
	  	 	182026	  	  	
	 [**]
	  	 	181643	  	  	
	 [**]
	  	 	332715	  	  	
	 [**]
	  	 	701077855	  	  	


  
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[**]                         
   
	  	194628	  	
	 [**]
	  	181971	  	


  
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[**]                         
   
	  	701091650	  	
	 [**]
	  	180601	  	
	 [**]
	  	333306	  	
	 [**]
	  	180442	  	
	 [**]
	  	701086157	  	
	 [**]
	  	332717	  	


  
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 Attachment 1.6 - ALZA Know-How Index 

Schedule B: Employee Training Records 
  

					
	         Employee Name    
	  	WWID	  	 
	 [**]
	  	358707	  	
	 [**]
	  	195876	  	
	 [**]
	  	366468	  	
	 [**]
	  	332726	  	.
	 [**]
	  	180233	  	
	 [**]
	  	701086391	  	
	 [**]
	  	104560	  	
	 [**]
	  	701085629	  	
	 [**]
	  	83251	  	
	 [**]
	  	357636	  	
	 [**]
	  	180060	  	
	 [**]
	  	161600	  	
	 [**]
	  	330872	  	
	 [**]
	  	191534	  	
	 [**]
	  	701087267	  	
	 [**]
	  	701091073	  	
	 [**]
	  	172542	  	
	 [**]
	  	336464	  	
	 [**]
	  	701084448	  	
	 [**]
	  	104528	  	
	 [**]
	  	337092	  	
	 [**]
	  	334826	  	
	 [**]
	  	338021	  	
	 [**]
	  	128005503	  	
	 [**]
	  	128005055	  	
	 [**]
	  	201135	  	
	 [**]
	  	198594	  	
	 [**]
	  	103974	  	
	 [**]
	  	701085359	  	
	 [**]
	  	701091773	  	
	 [**]
	  	180181	  	


  
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[**]                        

	  	181545]	 	


  
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 Attachment 1.6 - ALZA Know-How Index 

Schedule C-1: Controlled SOPs 
  

					
	 SOP Number
	  	 SOP Title
	  	  

	 Manufacturing
	  	
	0-005	  	ALZA Corporate Document Control	  	
	0-006	  	Document Change Order Procedure	  	
	0-017	  	Guidelines For Cleaning Manufacturing Equipment and Cleaning Validation	  	
	0-018	  	Employee Training	  	
	0-103	  	First Article Inspection Procedure	  	
	0-301	  	Facility, Equipment, and System Qualification	  	
	0-302	  	Guidelines for Determining if a Computer System Requires Computer Validation	  	
	0-500	  	Quality Organization and Scope of Responsibilities	  	
	0-501	  	Line Sign-Off and Materials Verification	  	
	0-502	  	ALZA Quality Specifications	  	
	0-503	  	Dispositioning Materials	  	
	0-550	  	Clinical Packaging Sample Retains Handling	  	
	0-551	  	Periodic Review of Quality Standards	  	
	0-554	  	Process Change Request	  	
	0-704	  	Facility Equipment Logbook Procedures	  	
	22-000            	  	[**]	  	
	22-001	  	[**]	  	
	22-002	  	Operating and Cleaning Procedures for the Allegra 6 Beckman Centrifuge	  	
	22-003	  	Operating and Cleaning the Glas-Col Rotator	  	
	22-004	  	[**]	  	
	22-005	  	Operating and Cleaning of Mettler Toledo Balances	  	
	22-006	  	Cleaning, Sanitization, and Operation Procedure for Unidirectional Air Flow Hoods	  	
	22-007	  	Operating and Cleaning Procedure for the Van der Sthal Heat Sealer	  	
	22-009	  	[**]	  	
	22-010	  	REVCO Refrigerator Model REL 404	  	
	22-011	  	REVCO Freezer Model ULT350-3-A31	  	
	22-012	  	[**]	  	


  
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 Attachment 1.6 - ALZA Know-How Index 

Schedule C-1: Controlled SOPS 
  

					
	 SOP Number
	  	 SOP Title
	  	 
	22-013            	  	[**]	  	
	22-014	  	Operating and Cleaning Procedures for the Bransonic Sonicators (Model 5510-MT and 8510-MT)	  	
	22-015	  	Gowning Requirements and Personnel Practices in the Macroflux® Pilot Plant	  	
	22-016	  	Personnel, Equipment, and Material Flow for the Macroflux® Pilot Plant	  	
	22-017	  	Sanitization and Use of the M-12 Macroflux® Pilot Plant Pass Through	  	
	22-018	  	Cleaning and Sanitization of the Macroflux® Pilot Plant	  	
	22-021	  	Operation of the Vortex Genie 2 Mixer	  	
	22-022	  	Operating and Cleaning Procedure for the Despatch SDC2-30 Oven	  	
	22-026	  	Setup, Operation, and Cleaning Procedures for Macroflux® Dew Point Control System (DPCS)	  	
	22-027	  	Setup, Operation, and Cleaning of the Macroflux® Tangential Flow Filtration System	  	
	22-028	  	Setup, Operation, and Cleaning of the Fuji Heat Sealer (MS-350NP)	  	
	22-029	  	Operation and Cleaning of the Macroflux® Applicator Test Stand	  	
	22-030	  	Operation and Cleaning for the Macroflux® Leica L2 Microscope	  	
	22-031	  	Operation of MANOSTAT Peristaltic Pump for Macroflux® Manufacturing	  	
	22-032	  	Operating and Cleaning Procedure for Macroflux® Labconco Freeze Drying Equipment	  	
	22-033	  	Operation and Cleaning of Hudson Clicker Press	  	
	22-034	  	Operation and Cleaning of Chaffee Rotor Sealer	  	
	22-035	  	Operation and Cleaning Procedure for the Blue M Mechanical Convection Oven	  	
	22-037	  	Vacuum Chamber for Pouch Seal Integrity	  	
	22-041	  	Operating and Cleaning Procedures for the Multivac C-400 Heat Sealer	  	
	22-043	  	 Calibration and Operation of 10 Scientific Instrument

(Model miniLab 1Q125) pH Meter
	  	
	22-044	  	Personnel Flow within the Macroflux® Pilot Plant	  	
	22-045	  	Setup, Cleaning and Operation of the Macroflux® Resistance Cutter	  	
	22-046	  	Operating and Cleaning Procedures for the Macroflux® Subassembly & Outer Ring Tube Loader	  	


  
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	22-049            	  	Issuance and Control of Parts Production Record for Macroflux® Aseptic Manufacturing	  	


  
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 Attachment 1.6 - ALZA Know-How Index 

Schedule C-1: Controlled SOPs 
  

					
	 SOP Number
	  	 SOP Title
	  	 
	22-050            	  	Procedure For Sanitization of Carts in Macroflux® Pilot Plant	  	
	5-005	  	QED Line Audits	  	
	5-039	  	Retain Sample File In Mountain View	  	
	7-001	  	Guidelines for the Preparation, Review and Approval of Master Clinical Production and Control Records	  	
	7-002	  	Audit of Clinical Production Records for Disposition	  	
	7-003	  	Guidelines For The Preparation Of A Clinical Batch Record For Clinical Production	  	
	7-004	  	Guidelines for the Preparation and Approval of Phase I Clinical Supplies used in IND or Ex-US, IND Exempt, or Non-Drug Demonstrator Placebo Studies	  	,
	7-009	  	Accountability of Materials in Clinical Production	  	
	7-013	  	Guidelines For Two Or More Operations In A Manufacturing Area At The Same Time	  	
	7-019	  	Handling and Flow of Material In Clinical Production	  	
	7-034	  	Mountain View Research Inventory Control Shipping Procedure	  	
	7-048	  	Material Dispensing from Mountain View Research Inventory	  	
	7-049	  	Approval, Preparation and Use of Clinical and Non-Clinical Labels	  	
	7-053	  	Solvent Handling And Dispensing	  	
	7-056	  	In-Process Inspections for Pouching/Labeling Operations in Clinical Production	  	
	7-057	  	Cleaning Supply Solvents	  	
	7-061	  	Controlled Substances Accountability	  	
	7-064	  	Review and Release Procedures for Incoming Materials Used in Clinical Manufacture	  	
	7-086	  	Clinical Packaging Record Review and Release Checklist	  	
	7-095	  	Guidelines for Completing Clinical Production Paperwork	  	
	7-096	  	Guidelines For The Preparation Of Aseptic Process Simulation Test Protocol	  	
	7-097	  	Evaluation of Drug Actives for Dispensing in M5 Warehouse	  	
	7-099	  	M5 Weighing and Dispensing Isolator Operating and Cleaning Procedure	  	
	7-100	  	Lot Characterization For Clinical Products	  	


  
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	7-101              	  	Mountain View-inventory Cycle Counting Program	  	


  
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 Attachment 1.6 - ALZA Know-How Index 

Schedule C4: Controlled SOPs 
  

					
	 SOP Number
	  	 SOP Title
	  	 
	Formulation & Analytical	  	
	0-005	  	ALZA Corporate Document Control	  	
	0-006	  	Document Change Order Procedure	  	
	0-018	  	Employee Training	  	
	0-047	  	GMP Training Program	  	
	0-053	  	Guidance for Using Plateau Training Management System	  	
	0-109	  	Departure Notice Procedure	  	
	10-212	  	Good Laboratory Practices Audit Program	  	
	10-213	  	GLP Internal Facility and Process-based Inspections	  	
	130-0000	  	Calibration, Test Equipment and Work Orders	  	
	14-005	  	Bioanalytical Method Validation	  	
	14-006	  	Method Validation Requirements for Transferring LC/MS/MS Assays	  	
	14-008	  	Bioanalytical Sample Analysis	  	
	150-0010	  	HPLC Systems	  	
	150-1007        	  	Waters 2690/2695 HPLC and GPC Separations Module	  	
	150-1011	  	ALZA Metrology HPLC Systems	  	
	150-1115	  	HPLC Column Heaters	  	
	150-1117	  	Preventive Maintenance, Performance Verification, and Performance Qualification SOP for HPLC System Vacuum Degasser	  	
	150-1122	  	Beckman Coulter Capillary Electrophoresis	  	
	150-1202	  	Preventive Maintenance, Performance Verification, and Performance Qualification SOPs for HP 1100 HPLC Autosampler G1313A	  	
	150-1402	  	Preventive Maintenance, Performance Verification, and Performance Qualification SOPs for the HP1100 HPLC Column Heater G1316A	  	
	150-1601	  	Preventive Maintenance, Performance Verification, and Performance Qualification SOPs for the HP/Agilent 1100 Vacuum Degasser G1322A, G1379A	  	
	151-1010	  	Thermo-Nicolet FT-IR	  	
	151-2003	  	Agilent 8452A and 8453 Diode Array UV-VIS Spectrophotometers	  	
	151-2010	  	Molecular Devices SPECTRAmax Plus Microplate Spectrophotometers	  	
	151-3202	  	Waters Micromass Mass Spectrometer System	  	


  
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 Attachment 1.6 - ALZA Know-How Index 

Schedule C-1: Controlled SOPs 
  

					
	 SOP Number
	  	 SOP Title
	  	 
	152-0011	  	Calibration of Scales and Balances	  	
	154-0022	  	Simple Measurement Instruments	  	
	154-0050	  	Liquid Volume Dispensers	  	
	154-0080	  	Procedure for pH and Conductivity Meters	  	
	154-0091	  	Haake RheoStress RS100 Rheometer	  	
	154-0098	  	Simple Laboratory Equipment	  	
	154-0101	  	Thermometers	  	
	154-0102	  	Reference Standard Laboratory Desiccators	  	
	154-0105	  	WESCOR 5520 Vapor Pressure Osmometer	  	
	155-1103	  	Brookfield Viscometers	  	
	155-3101	  	Differential Scanning Calorimeter 2920 and Thermogravimetric Analyzer 2950	  	
	156-0025	  	General Purpose Water, Steam, and Oil Temperature Baths	  	
	156-0031	  	Refrigerators and Freezers	  	
	156-0051	  	Ovens	  	
	156-0062	  	Dessicators	  	
	156-0067	  	Temperature and Humidity Environmental Test Chambers	  	
	158-0010	  	Purified Water Systems in the Laboratory	  	
	158-1002	  	Millipore Academic and Synthesis Purified Water Systems	  	
	159-0020        	  	Preventive Maintenance, Performance Verification, Calibration and Performance Qualification of Centrifuges	  	
	159-0032	  	Qualification of Shakers	  	
	159-1008	  	Analytical Laboratory Glassware Washers/Dryers	  	
	16-0013	  	Differential Scanning Calorimeter 2920 and Thermogravimetric Analyzer 2950	  	
	16-0023	  	Amersham Biosciences Personal Densitometer SI Laser Densitometer	  	
	16-0024	  	Amersham Personal Densitometer SI System Software	  	
	16-01105	  	HP 1100 Binary Pump	  	
	16-01202	  	HP 1100 Autosampler	  	
	16-01306	  	HP 1100 Diode Array Detector	  	
	16-01402	  	HP 1100 Thermostatted Column Compartment	  	


  
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 Attachment 1.6 - ALZA Know-How Index 

Schedule C-1: Controlled SOPs 
  

					
	 SOP Number
	  	 SOP Title
	  	 
	16-01601	  	HP 1100 Vacuum Degasser	  	
	16-12011	  	Operation of Agilent 8453 UV-visible Spectrophotometer	  	
	16-40080	  	Radiometer/Copenhagen PHM220 Lab pH Meter	  	
	16-48001      	  	Operation Manual for Benchtop pH/ISE Meters Model 420A	  	
	2-016	  	Hazardous Waste Disposal	  	
	9-003	  	cGMP Operations in Analytical Laboratories	  	
	9-004	  	Content of Analytical Data Set	  	
	9-012	  	Procedures For Sample Documentation Log-in, and Handling	  	
	9-016	  	Validation of Analytical Methods For Drug Analysis From Swabs of Cleaned Equipment	  	
	9-028	  	Worksheet Tracking Forms	  	
	9-030	  	Format of Laboratory Instrument Specific Operation Manual	  	
	9-038	  	ALZA Analytical Laboratory Training/Retraining Procedures	  	
	9-040	  	Archive and Restoration of Electronic Test Data In Analytical Sciences	  	
	9-041	  	Laboratory Procedures for Handling Controlled Substances	  	
	9-042	  	Procedures for the Issuance and Use of Instrument Usage Logbooks	  	
	9-043	  	Laboratory Reagent Preparation and Maintenance	  	
	9-047	  	Procedure for Certification, Handling, and Distribution of Analytical Reference Standards	  	
	9-048	  	Qualification for Laboratory Analytical Instrument/Equipment Hardware	  	
	9-049	  	Handling Hazardous Chemicals and Solvents in Analytical Testing Laboratories	  	
	9-050	  	Qualification of IR Reference Spectra	  	
	9-051	  	Determination of Stability of Solutions	  	
	9-402	  	Laboratory Data Documentation, Review, and Approval Procedures in Analytical Sciences	  	
	9-406	  	NDA-Level Method Validation Protocols for Chromatographic and UV-Spectroscopic Quantitative Analytical Methods for Small Molecules	  	
	9-407	  	Analytical Method Documentation System	  	
	9-408	  	Analytical Method Transfer	  	
	9-409	  	Validation of Quantitative Analytical Methods	  	


  
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 Attachment 1.6 - ALZA Know-How Index 

Schedule C-1: Controlled SOPs 
  

					
	 SOP Number
	  	 SOP Title
	  	  

	9-410	  	Preparation, Labeling and Expiration Dating for Laboratory Solutions, Samples and Standards	  	
	9-412	  	Procedure for Calculating, Recording and Reporting Impurities and Degradation Products	  	
	9-413	  	Handling “Lost” Samples	  	
	9-417	  	Validation of Qualitative Analytical Methods	  	
	9-418	  	Validation of Instrumental Measurement Analytical Methods	  	
	9-419	  	IND-Phase 11 and Phase III Clinical Studies Method Validation Protocols for Chromatographic and UV-Spectroscopic Quantitative Analytical Methods for Small Molecules	  	
	9-423	  	Access Control for Computerized Systems in Analytical Sciences	  	
	9-424            	  	 Audit Trail Requirements for Computerized Laboratory Instruments

in Analytical Sciences
	  	
	9-425	  	Changing Date and Time Stamps for Computerized Systems in Analytical Sciences	  	
	9-426	  	Definition of Electronic Records for Computerized Systems in Analytical Sciences	  	
	9-427	  	Resetting Forgotten Passwords for Computerized Systems in Analytical Sciences	  	
	9-429	  	Data Record and Signature Linking for Hybrid Systems in Analytical Sciences	  	
	9-430	  	Use of Electronic Signatures in Analytical Sciences	  	
	9-431	  	Daily Calibration Procedure for pH meters	  	
	9-432	  	Daily Temperature Check for Refrigerators/Freezers	  	
	9-433	  	Analytical Sciences Area Policy	  	
	9-439	  	Validation of Qualitative Near Infrared Spectroscopy Methods	  	
	9-440	  	NIR Test Procedure	  	
	9-441	  	Investigations for Laboratory Testing in Analytical Sciences	  	
	9-442	  	Procedural Deviation Investigation for Analytical Sciences	  	
	9-443	  	Computer System Validation of Analytical Laboratory Instruments	  	
	9-445	  	Analytical Sciences LIMS Policy	  	
	9-446	  	Day Of Use Balance Verification in Analytical Sciences	  	


  
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	9-448            	  	Daily Use Verification of Milli-Q Water System	  	


  
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 Attachment 1.6 - ALZA Know-How Index 

Schedule C-1: Controlled SOPs 
  

					
	 SOP Number
	  	 SOP Title
	  	  

	9-449	  	Analytical Sciences Empower CDS - System Security	  	
	9-450	  	Analytical Sciences Empower CDS - System Administration	  	
	9-451	  	Analytical Sciences Empower CDS - General Use	  	
	9-452	  	Analytical Sciences Empower CDS - Empower Change Requests	  	
	9-453	  	Analytical Sciences Empower Chromatography Data System Development and Validation of Custom Fields	  	
	9-454	  	Administration of the ExRx Origin for Analytical Sciences Investigations	  	
	9-455	  	HIAC Royco Particle Counter with PharmSpec Software	  	
	9-466	  	Analytical Sciences Document Control Process	  	
	9-468	  	ALZA R&D LabWare LIMS System Security	  	
	9-469	  	ALZA R&D LIMS Configuration Control within a Validated Database	  	
	Design Control        	  		  	
	0-15001	  	Design and Development Planning (D&DP)	  	
	0-15002	  	Design Input (User/Stakeholder Needs)	  	
	0-15003	  	Product Design Risk Management	  	
	0-15004	  	Design Output	  	
	0-15005	  	Design Review	  	
	0-15006	  	Design Verification	  	
	0-15007	  	Design Validation	  	
	0-15008	  	Design Change	  	
	0-15009	  	Design History File	  	
	0-15010	  	Manufacturing Risk Assessment	  	
	0-15011	  	Manufacturing Launch Strategy	  	
	0-15013	  	Design Transfer	  	
	0-15014	  	Design Master Record (DMR)	  	


  
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 Attachment 1.6 - ALZA Know-How Index 

Schedule C-2: Additional SOPs 
  

					
	 SOP Number
	  	 SOP Title
	  	 
	Scientific Writing	  	
	0-054	  	Procedure for Completing and Amending Clinical Study Reports	  	
	0-055	  	Procedure for Completing and Updating Investigator’s Brochures	  	
	Clinical Operations    	  		  	
	11-002	  	Central Files	  	
	11-003	  	Training Program	  	
	11-100	  	Preparation and Approval of Protocols and Protocol Amendments	  	
	11-101	  	Informed Consent	  	
	11-106	  	Monitoring Clinical Trials	  	
	11-107	  	Planning, Documenting and Conducting a Pre-study Visit	  	
	11-108	  	Preparing for Study Initiation	  	
	11-109	  	Planning, Documenting and Conducting a Initiation Visit	  	
	11-110	  	Planning, Documenting and Conducting a In Progress Visit	  	
	11-111	  	Planning, Documenting and Conducting a Termination Visit	  	
	11-114	  	Accountability and Reconciliation of Investigational Drug Supplies	  	
	11-115	  	Contract Manufacture and Packaging of Clinical Supplies	  	
	11-117	  	Procurement of Clinical Packaging Components	  	
	11-210	  	Shipment of Clinical Materials from 3rd Party Contractor to an Investigational Site	  	
	11-211	  	Retrieval of Investigational Drug Product from Clinical Sites	  	
	11-212	  	Reassignment of Marketed Product for Clinical Use	  	
	11-213	  	Reporting Serious Adverse Events Originating from Pharmaceutical Clinical Trials	  	
	11-214	  	Procedures for Handling Complaints for Clinical Trial Material at Clinical Study Sites	  	
	11-216	  	[**]	  	
	11-217	  	Guidelines for the Development, Review and Approval of Clinical Development Plans	  	
	11-218	  	Mapping Adverse Events	  	
	Statistics and Data Management	  		  	
	23-001	  	Volume Structure of Clinical Studies and Access Rights	  	
	23-002	  	Creation of Study Case Report Forms within DataFax for Clinical Pharmacology Studies	  	


  
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	23-003            	  	DataFax Database Setup and Testing	  	


  
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 Attachment 1.6 - ALZA Know-How Index 

Schedule C-2: Additional SOPs 
  

			
	 SOP Number
	  	 SOP Title

	23-004	  	Study Edit Checks: Document, Programs and Processing
		
	23-005	  	Validation of DataFax Records
		
	23-006	  	Query Process for DataFax Database Data
		
	23-007	  	DataFax Router Management
		
	23-008	  	Quality Assurance Procedure Performed on Clinical Databases
		
	23-009	  	DataFax Training
		
	23-010	  	Access Restrictions to DataFax Databases
		
	23-011	  	Electronic Transfer of Data
		
	23-012	  	Employee Training for Computerized Systems Within the Clinical Division
		
	23-017	  	Physical Security for Clinical Computer System Servers
		
	23-027	  	Study Randomizations
		
	23-030	  	Guidelines for SAS Coding Conventions
		
	23-031	  	Guideline for SAS Log Review
		
	23-032	  	Guideline for Volume Structure and Access Rights
		
	23-037	  	Study Data Access Restriction and Finalization
		
	23-039	  	Use of Statistics and Data management Study Process Checklist
		
	23-040	  	Guidelines for Quality Assurance Sampling and Auditing
		
	23-041	  	Guidelines for Quality Assurance Error Number Calculation
		
	23-042	  	Guidelines for Randomization Programs
		
	23-042	  	Guidelines for Making CRF Changes
		
	23-044	  	Guidelines for Emergency Shutdown Procedure for the DataFax Server
		
	23-048	  	Guideline for Exporting Electronic Data From DataFax
		
	23-050	  	Guideline for SAS Names
		
	23-052	  	Guideline for SAS Volume Directories
		
	23-053	  	Guideline for the Production of Quality Assurance of Case Report Form Tabulations
		
	23-056	  	Security Access and Control of dsNavigator
		
	539-000	  	DataFax User Study Access Form
		
	539-001	  	DataFax Database Change Control Form
		
	539-002	  	Clinical Systems Hardware and Software Change Control Documentation


  
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	539-003	  	[**]


  
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 Attachment 1.6 - ALZA Know-How Index 

Schedule C-2: Additional SOPs 
  

			
	 SOP Number
	  	 SOP Title

	539-004	  	Study Volume Access Form
		
	539-006	  	Security Questionnaire
		
	539-007	  	Event Qualification Form
		
	539-008	  	Study Volume Freeze Form
		
	539-009	  	dsNavigator User Access Form
		
	539-011	  	dsNavigator Database Change Control Form
		
	Preclinical	  	
		
	0-018	  	Employee Training
		
	0-027	  	Records Retention
		
	8-108	  	Toxicology Department Training
		
	8-109	  	Animal Welfare/USDA Employee Training
		
	8-202	  	Protocol Approval Procedures
		
	8-203	  	Protocol Amendments and Protocol Deviations for Nonclinical Good Laboratory Practice Studies
		
	8-205	  	Raw Data Procedures
		
	8-212	  	Biological Research (BIO) Studies: Protocols, Study Conduct, and Reports
		
	8-300	  	Documenting Animal Orders and Receipt
		
	8-301	  	Husbandry of Rats and Mice
		
	8-302	  	Husbandry of Rabbits and Guinea Pigs
		
	8-303	  	Animal Husbandry of Dogs and Pigs
		
	8-305	  	Laboratory Animal Identification Procedures
		
	8-307	  	Verifying Animal Identification Upon Cage Transfer and Manipulation
		
	8-311	  	Daily Animal Health Evaluations and Documentation
		
	8-312	  	Euthanasia and Disposal of Laboratory Animals
		
	8-314	  	Environmental Conditions of Animal Rooms and Support Areas
		
	8-315	  	Cage Cleaning and Room Maintenance
		
	8-316	  	Animal Feed, Water, and Bedding
		
	8-320	  	Animal Vendor and Intermediate Handler Qualification
		
	8-338	  	Veterinary Resource Center Dress and Protection Procedures
		
	8-405	  	Controlled Substances


  
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	8-500	  	Skin Irritation Evaluations


  
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 Attachment 1.6 - ALZA Know-How Index 

Schedule C-2: Additional SOPs 
  

			
	 SOP Number
	  	 SOP Title

	8-509	  	Blood Collection from Rats and Mice
		
	8-510	  	Blood Collection in Rabbits and Guinea Pigs
		
	8-515	  	Administration of Fluids Via Hypodermic Syringe
		
	8-517	  	Disposal of Sharps, and Biohazardous, Drug, Chemical, and Radioactive Waste
		
	8-518	  	Anesthesia and Analgesia of Laboratory Animals
		
	8-543	  	Gross Pathology Procedure
		
	8-547	  	Animal Randomization
		
	8-555	  	Implantation of Catheters in Laboratory Rodents
		
	8-564	  	Blood Collection — Swine
		
	8-571	  	Clinical Observations
		
	8-572	  	Survival Surgery and Perioperative Care
		
	8-573	  	Delivery of Inhalation Agents to Laboratory Animals
		
	9-041	  	Laboratory Procedures for Handling Controlled Substances


  
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 Attachment 1.6 - ALZA Know-How Index 

Schedule D: Forms 
  

			
	 Form Number
	  	 Form Title

	Process Development and Manufacturing
		
	05-001-007	  	Supplement material and Equipment Received and In Process Data Sheet
		
	231-502	  	Screening Study Plan Approval and Release
		
	531-1039	  	Microbiology Report for Test for indicator Organisms .
		
	531-1041	  	Microbiology Report
		
	531-1075	  	Micro Report for LAL
		
	531-1230	  	Microbiology Report for Microbial Content Assay
		
	531-1251	  	Microbiology Report for Final Rinse Water Bioburden Assay
		
	531-1305	  	Macroflux® Cleaning In Process Sheet
		
	531-1306	  	Macroflux® Forming In Process Sheet
		
	531-507	  	ALZA Clinical Batch Review
		
	531-514	  	Pre Production Checklist
		
	531-524	  	Label Accountability Log
		
	531-796	  	Macroflux® Housing In Process Sheet


  
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 Attachment 1.6 - ALZA Know-How Index 

Schedule E: Technical Reports 
  

			
	 Report No.
	  	 Report Title

	Preclinical
		
	TR-1340	  	[**]
		
	TR-1347	  	[**]
		
	TR-1364	  	[**]
		
	TR-1367	  	[**]
		
	TR-1379	  	[**]
		
	TR-1380	  	[**]
		
	TR-1409	  	[**]
		
	TR-1547	  	[**]
		
	TR-1557	  	[**]
		
	TR-1583	  	[**]
		
	TR-1607	  	Determination of Transdermal Delivery of human Parathyroid Hormone (hPTH) 1-34 in [**].
		
	TR-1635	  	[**]
		
	TR-1636	  	Pharmacokinetic Profiles of hPTH (1-34) (TH0229) and Forteo Administered in [**]
		
	TR-2191	  	[**]
		
	TR-2205	  	[**]
		
	TR-2236	  	[**]
		
	TR-2332	  	Optimization of Commercial Human PTH (1-34) EIA From Peninsula Laboratories For Use with [**] Plasma


  
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	TR-2405	  	Transdermal Delivery of hPTH 1-34 with Macroflux® in [**]


  
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 Attachment 1.6 - ALZA Know-How Index 

Schedule E: Technical Reports 
  

			
	 Report No.
	  	 Report Title

	TR-2467	  	[**]
		
	TR-2702	  	Testing of Physical Stability of Macroflux® PTH Systems in [**] Model
		
	TR-2703	  	Effect of Patch Wearing Time of Macroflux® PTH Systems In Vivo Using [**] Model
	
	Formulation & Analytical
		
	TR-1331	  	Formulation Development Report
		
	TR-1348	  	Oxidation of PTH(1-34) in the solid state
		
	TR-1349	  	Solution Stability of PTH(1-34)
		
	TR-1350	  	Solid State Stability of PTH
		
	TR-1479	  	[**]
		
	TR-1483	  	[**]
		
	TR-1511	  	[**]
		
	TR-1512	  	[**]
		
	TR-1531	  	hPTH(1-34) Macroflux® formulation development report
		
	TR-1584	  	Determination of Coating Variability
		
	TR-1709	  	[**]
		
	TR-2192	  	Macroflux® Human B-type Naturetic Peptide (hBNP) Formulation Development Report
		
	TR-2326	  	IVP-1 Packaging Configuration Long Term Stability: 6 Month Data Summary
		
	TR-2510	  	Determination of Residual Human Parathyroid Hormone (hPTH) 1-34 on [**] Skin
	
	Process Development and Manufacturing
		
	TR-1454	  	Identification and Handling of Dedicated Equipment for PDP-1 In Phase I Clinical Builds
		
	TR-1555	  	PDP-09: Macroflux® hPTH (1-34) Phase I Process Development Report
		
	TR-1568	  	PDP-09 (hPTH) Coating Process Development


  
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 Attachment 1.6 - ALZA Know-How Index 

Schedule F: Toxicology Reports 
  

					
	 Study Number
	  	 Toxicology Study Title
	  	 
	 TR-06-0576-

003#
	  	4-Week Subcutaneous Injection Toxicity and Toxicokinetic Study with Teriparatide (Human Parathyroid Hormone, 1-34) in Rats	  	transfer to occur by 12/31/06
			
	 TR-05-7106-

021#
	  	Chromosomal Aberrations in Chinese Hamster Ovary (CHO) Cells	  	transfer to occur by 12/31/06
			
	 TR-05-7106-

022#
	  	Salmonella-Escherichia coli/Mammalian-Microsome Reverse Mutation Assay with a Confirmatory Assay	  	transfer to occur by 12/31/06
			
	TR-05-016	  	A Primary and Cumulative Irritation Study of Macroflux® (hPTH) [**]	  	
			
	TR-05-003	  	A Primary and Cumulative Irritation Study of Macroflux® (hBNP) [**]	  	
			
	TR-03-035	  	[**]	  	
			
	TR-03-026	  	A Primary Skin Irritation Study of Macroflux® (Parathyroid Hormone) in [**]	  	
			
	TR-02-034	  	A Primary Skin Irritation Study of Macroflux® (desmopressin) in [**]	  	
			
	TR-02-031	  	In Vitro Evaluation of Macroflux® Circular Array, 2B200LS, 2cm2, 321/cm2, Unformed, Code No. 0012734, Control No. MV0214344: ISO Cytotoxicity Testing	  	
			
	TR-02-029	  	A Primary Skin Irritation Study of Macroflux® (Desmopressin) Systems in [**]	  	
			
		  	[**]	  	
	TR-02-027	  		  	
			
		  	[**]	  	
	TR-02-026	  		  	
			
		  	[**]	  	
	TR-02-003	  		  	


  
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	TR-02-002	  	[**]


  
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 Attachment 1.6 ALZA Know-How Index 

Schedule G: Design History Files 
  

			
	 Report Number
	  	 Report Title

	DHF - Applicator - All Sections
		
	TR-1510-DHF	  	Macroflux® Gen 3i Applicator (code no. 0013490) Design and Development Plan
		
	TR-1525-DHF	  	Development Team and Approval Matrix for the Macroflux® Applicator (Code No. 0013490)
		
	TR-1292-DHF	  	Macroflux® Applicator (Code No. 0011864) User / Stakeholder Needs
		
	TR-1294-DHF	  	Hold-down Force Criterion
		
	TR-1295-DHF	  	Impact Criterion
		
	TR-1497-DHF	  	Macroflux® Applicator (Code No. 0013490) User/Stakeholder Needs
		
	TR-1511-DHF	  	Macroflux® Gen 3i Applicator (Code No. 0013490) System Requirements
		
	TR-1293-DHF	  	Process Validation
		
	TR-1296-DHF	  	Macroflux® Applicator Code No. 0011864 Technical File
		
	TR-1297-DHF	  	 Evaluation of the Conformity with the Essential Requirements

(Directive 93/42/EEC, Annex 1)

		
	TR-1454-DHF -	  	Macroflux® Identification and Handling of Dedicated Equipment for PDP-1 in Phase I Clinical Builds
		
	TR-1508-DHF	  	Macroflux® Gen3i Applicator (Code No. 0013490) Material Selection
		
	TR-1509-DHF	  	Macroflux® Gen3i Applicator (Code No. 0013490) FEA Report
		
	TR-1513-DHF	  	Macroflux® Gen3i Applicator (Code No. 0013490) Tooling
		
	TR-1519-DHF	  	Macroflux® Gen3i Applicator Tolerance Analysis and Geometry Check
		
	TR-1769-DHF	  	Macroflux® Gen3i Applicator Component First Article Inspection Report (Code No. 0013490)
		
	TR-1795-DHF	  	Hold Down Force Generation and Tolerability Measurements in Healthy Elderly Volunteers for Macroflux® Applicator Design (C-2003-014)
		
	TR-2039-DHF	  	Biocompatibility Assessment of Macroflux® Applicator (code no. 0013490) and Retainer (code no. 0013491)
		
	TR-2041-DHF	  	Clinical Performance of the Gen. 3 Macroflux® Applicator (Code No. 0011864)
		
	TR-2046-DHF	  	Macroflux® Gen4 Applicator Market Research by Timely Data Resources in 2003
		
	TR-2074-DH F	  	The Effect of Applicator Piston Angle on Macroflux® System Performance
		
	TR-1505-DHF	  	Macroflux® Gen3i Applicator - Technical Development Review
		
	TR-1774-DHF	  	Macroflux® Gen3i Applicator


  
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EXCHANGE COMMISSION. DOUBLE ASTERISKS [**] DENOTE OMISSIONS. 







 Attachment 1.6 - ALZA Know-How Index 

Schedule G: Design History Files 
  

			
	 Report Number
	  	 Report Title

	TR-1284-DHF	  	Macroflux® Applicator (Code No. 0011864) Impact Energy
		
	TR-1285-DHF	  	Macroflux® Applicator (Code No. 0011864) Hold-down Force
		
	TR-1286-DHF	  	Macroflux® Applicator (Code No. 0011864) Cycle Life
		
	TR-1287-DHF	  	Macroflux® Applicator (Code No. 0011864) Retainer Attachment Cycle Life
		
	TR-1288-DHF	  	Macroflux® Applicator (Code No. 0011864) Retainer Detachment Force
		
	TR-1289-DHF	  	Macroflux® Applicator (Code No. 0011864) Temperature Cycling
		
	TR-1290-DHF	  	Macroflux® Applicator (Code no 0011864) Chemical Resistance
		
	TR-1291-DHF	  	Macroflux® Applicator (Code No. 0011864) Shipping
		
	TR-1299-DHF	  	Declaration of Conformity - Macroflux® Applicator
		
	TR-1780-DHF	  	Macroflux® Gen3i Applicator (Code No. 0013490) Design Verification Testing General Tests
		
	TR-1781-DHF	  	Macroflux® Gen3i Applicator (Code No. 0013490) Design Verification Testing Environmental Tests
		
	TR-1782-DHF	  	Macroflux® Gen3i Applicator (Code No. 0013490) Design Verification Testing Life Cycle Tests
		
	TR-1794-DHF	  	Macroflux® Gen3i Applicator (Code No. 0013490) Design Verification Testing Video Protocol
		
	TR-1796-DHF	  	Macroflux® Gen3i Applicator Design Verification Report Code No. 0013490
		
	TR-1797-DHF	  	Macroflux® Gen3i Applicator Design Verification Matrix Code No. 0013490
		
	TR-2049-DHF	  	Macroflux® Gen4 Applicator (0013490) Design for the Environment
		
	TR-2058-DHF	  	Macroflux® Gen3i Applicator (Code No. 0013490) Design Verification Testing Audible and Tactile
		
	TR-1418-DHF	  	Non-Drug Macroflux® Manufacturing
		
	TR-2050-DHF	  	Macroflux® Applicator Code No. 0011864 Design History File Index
		
	TR-1300-DHF	  	Risk Analysis Worksheet (RAW) Form
		
	TR-1504-DHF	  	Risk Analysis for Macroflux® Applicator (Code 0013490)
		
	TR-1770-DHF	  	Macroflux® Gen3i Applicator (Code No. 0013490) Risk Analysis Meeting Minutes
	
	DHF Array - Design Output
		
	TR-1503-DHF	  	The Effect of Number of Passes on Coating of 0012907
		
	TR-1507-DHF	  	Evaluation of 2cm2 Macroflux® Array Designs: MF1004, MF1033, MF1034, MF1035, MF1037, MF1039, MF1040, S250


  
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 Attachment 1.6 - ALZA Know-Haw Index 

Schedule G: Design History Files 
  

			
	 Report Number
	  	 Report Title

	TR-1783	  	Coating Linearity to Array Size
	TR-1814-DHF	  	MF1035 Depth of Penetration Sensitivity to Coating
		
	TR-1815-DHF	  	Acceptability of Tecomet as a Macroflux® Array Supplier
	
	DHF - Housing - Design Output
		
	TR-1536-DHF	  	Identification of Macroflux® Product Contacting Equipment
		
	TR-1537-DH F	  	Process Parameters that Effect Film Thickness on the Macroflux® Center
		
	DHF - IVP-1	  	
		
	TR-2598-DHF	  	Film Thickness Measurement Using the Keyence LT-900, LS-7030
		
	TO-1205-DHF	  	[**]
		
	TR-2529-DHF	  	[**]
		
	TO-1208-DHF	  	[**]
		
	TD-1212-DHF	  	[**]
		
	TR-2299-DHF	  	[**]
		
	TR-2314-TR	  	Macroflux® Identification and Handling of Dedicated Equipment for IVP-1 (hBNP) in Phase I Clinical Builds
		
	TR-2530-TR	  	Macroflux® IVP-1 Package. Integrity Protocol
		
	TD-1223-DHF	  	[**]
		
	TD-1226-TR	  	[**]
		
	TR-2192-DHF	  	[**]
		
	TR-2321-DHF	  	Macroflux® Forming Elastomer Life Expectancy
		
	TR-2326-DHF	  	IVP-1 Final Product Packaging Configuration Long Term Stability - 6 Month Data Summary
		
	TR-2538-DHF	  	Macroflux® IVP-1 Package Integrity Report
		
	TR-2539-DHF	  	[**]
		
	TR-2595-DHF	  	RAM Optical Formed Length/Angle Inspection Gage R&R
		
	TR-2629-DHF	  	Film Thickness Measurement Using the Keyence LT-900, LS-7030


  
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	TR-2598-DHF	  	[**]


  
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EXCHANGE COMMISSION. DOUBLE ASTERISKS [**] DENOTE OMISSIONS. 







 Attachment 1.6 - ALZA Know-How Index 

Schedule G: Design History Files 
  

			
	 Report Number
	  	 Report Title

	TD-1209-DHF	  	[**]
		
	TD-1215-DHF	  	[**]
		
	TD-1227-DHF	  	[**]
		
	DHF - IVP-6	  	
		
	TD-1302-DHF	  	Dose Mapping Protocol for Irradiated Macroflux® Aseptic Processing Components—Equipment
		
	TD-1303-DHF	  	Mapping Protocol for Irradiated Macroflux® Aseptic Processing Components—Product Components
		
	TR-2871-DHF	  	Dose Mapping Report for Irradiated Macroflux® Aseptic Processing Components—Equipment
		
	TR-2332-DHF	  	[**]
		
	TR-2510-DHF	  	[**]
		
	TR-2874-DHF	  	RAM Optical Sprint CNC 200 Formed Length/Angle Inspection Gage R&R
		
	DHF - PDP-1	  	
		
	03102000-060702	  	Change Document No. 31020000-060702, Amendment No. 1
		
	03102000-101503	  	Change Document 31020000-101503, Amendment #3
		
	03102000-112603	  	Change Document 3102000-112603, Amendment 4
		
	PDP-1, 2/16/01	  	[**]
		
	TR-1340-DHF	  	[**]
		
	TR-1347-DH F	  	[**]
		
	TR-1364-DHF	  	[**]
		
	TR-1367-DHF	  	[**]
		
	TR-1379-DHF	  	[**]


  
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EXCHANGE COMMISSION. DOUBLE ASTERISKS [**] DENOTE OMISSIONS. 







 Attachment 1.6 - ALZA Know-How Index 

Schedule G: Design History Files 
  

			
	 Report Number
	  	 Report Title

	TR-1380-DHF	  	[**]
		
	TR-1409-DHF	  	[**]
		
	TR-1523-DHF	  	Formulation and Macroflux® Delivery System Development
		
	TR-1547-DHF	  	[**]
		
	TR-1557-DHF	  	[**]
		
	TR-1583-DHF	  	[**]
		
	TR-1635-DHF	  	[**]
		
	DHF - PDP-9	  	
		
	5112-121102	  	Change Document 5112-121102, Amendment 1
		
	PDP-9, 10/12/01	  	Macroflux® PTH Analog Delivery System
		
	TR-1573	  	PDP-09: Macroflux® hPTH (1-34) Phase I Process Development Report
		
	TR-1791-DHF	  	Macroflux® PDP-9 Human Parathyroid hormone (1-34) User/Stakeholder Needs
		
	TR-2042-DHF	  	Penetration of hPTH Coated Macroflux® Systems in Excised [**]
		
	TR-1348-DHF	  	Oxidation of PTH(1-34) in the Solid State
		
	TR-1349-DHF	  	Solution Stability of PTH(1-34)
		
	TR-1350-DHF	  	Solid State Stability of PTH
		
	TR-1351-DHF	  	hPTH(1-34) Macroflux® Formulation Development Report
		
	TR-1803-DHF	  	Macroflux® hPTH Microbiological Control Program


  
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 Attachment 1.6 ALZA Know-How Index 

Schedule H: Training Modules 
  

			
	 TM Number
	  	 TM Title

	02-012-004	  	ExRx Reporting System Training Module: Overview
		
	03-032-017	  	ExRx ANA Investigation Origin for Laboratory Testing and Procedural Deviation
		
	03-032-018	  	Laboratory Glassware and Utensils Pre-cleaning Procedure in Analytical Sciences
		
	03-032-019	  	Cleaning Procedure for Analytical Sciences Laboratory Glassware and Lab Ware
		
	03-032-020	  	Analytical Laboratory Safety Orientation
		
	03-032-022	  	Analytical Sciences Empower CDS - Getting Started
		
	03-032-023	  	Analytical Sciences Empower CDS - Creating a New Project
		
	03-032-024	  	Analytical Sciences Empower CDS - The Instrument Method
		
	03-032-025	  	Analytical Sciences Empower CDS - The Processing Method
		
	03-032-026	  	Analytical Sciences Empower CDS - The Method Set
		
	03-032-027	  	Analytical Sciences Empower CDS - The Sample Set Method
		
	03-032-028	  	Analytical Sciences Empower CDS - Running Samples
		
	03-032-029	  	Analytical Sciences Empower CDS - Viewing Data and Optimizing Methods
		
	03-032-030	  	Analytical Sciences Empower CDS - Data Processing
		
	03-032-031	  	Analytical Sciences Empower CDS - Reports and Electronic Signatures
		
	03-032-037	  	Operation of Advanced Software for the Agilent ChemStation with Security Pack for UV-visible Spectroscopy
		
	03-032-039	  	Administration of The Analytical Sciences Reference Standard Program
		
	03-032-045	  	Handling Analytical Records in Analytical Sciences Document Control Center


  
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 Attachment 1.6 - ALZA Know-How Index 

Schedule I: ALZA Analytical Methods (AAM) 
  

			
	 AAM No.
	  	 AAM Title

	1.710	  	identity and Purity of Parathyroid Hormone (PTH 1-34) by Reversed Phase High Performance Liquid Chromatography (RP-HPLC)
		
	1,760	  	[**]
		
	1.775	  	Determination of Parathyroid Hormone (hPTH 1-34) Content of Macroflux® Finished Product and In-Process Control Sample by Liquid Chromatography
		
	3.305	  	Identification by IR Spectroscopy (ATR Technique)
		
	3.307	  	Identification by Infrared Spectroscopy—Film from Chlorinated Solvent Solution
		
	3.339	  	Determination of PTH (1-34) in Swabbing Material by Micro BCA
		
	3.340	  	Determination of (1-34) Human Parathyroid Hormone Content of Macroflux® hPTH In-Process Samples by UV Spectrophotometry
		
	5.102	  	Physical Dimensions
		
	5.104	  	Thickness
		
	5.141	  	Appearance of Injection Molded Parts
		
	5.639	  	Activation Force Measurement of Macroflux® Applicator
		
	5.640	  	Impact Peak Force and Duration Measurement of Macroflux® Applicator
		
	5.719	  	Dimensional Inspection of Macroflux® Arrays with View Voyager
		
	6.441	  	USP Microbial Content Assay for Polysorbate 20
		
	6.443	  	Kinetic LAL Bacterial Endotoxins Test for Polysorbate 20
		
	6.444	  	USP Test for Staphylococcus aureus and Pseudomonas aeruginosa from Polysorbate 20
		
	6.483	  	Kinetic LAL Bacterial Endotoxins Test for Sucrose
		
	6.484	  	USP Microbial Content Assay for Sucrose
		
	6.523	  	USP Test for Staphylococcus aureus and Pseudomonas aeruginosa from Sucrose
		
	6.550	  	USP Microbial Content Assay for Edetate Disodium
		
	6.552	  	Kinetic LAL Bacterial Endotoxins Test for Edetate Disodium


  
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	6.553	  	USP Test for Staphylococcus aureus and Pseudomonas aeruginosa from Edetate Disodium


  
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 Attachment 1.6 - ALZA Know-How Index 

Schedule I: ALZA Analytical Methods (AAM) 
  

					
	 AAM No.
	  	 AAM Title
	  	 
			
	 6.576
	  	USP Microbial Content Assay for Human Parathyroid Hormone	  	
			
	 6.577
	  	Kinetic LAL Bacterial Endotoxins Test for Human Parathyroid Hormone	  	
			
	 6.578
	  	USP Test for Staphylococcus aureus and Pseudomonas aeruginosa from Human Parathyroid Hormone	  	
			
	 6.586
	  	USP Microbial Content Assay for Macroflux® Sucrose Placebo	  	
			
	 6.587
	  	Kinetic LAL Bacterial Endotoxins Test for Macroflux® Sucrose Placebo	  	
			
	 6.588
	  	USP Test for Staphylococcus aureus and Pseudomonas aeruginosa from Macroflux® Sucrose Placebo	  	
			
	 6.589
	  	[**]	  	
			
	 6.591
	  	Bioburden Testing of Final Rinse Water	  	
			
	 6.592
	  	USP Microbial Content Assay for Macroflux® Human Parathyroid Hormone	  	
			
	 6.593
	  	Kinetic LAL Bacterial Endotoxins Test for Macroflux® Human Parathyroid Hormone	  	
			
	 6.594
	  	USP Test for Staphylococcus aureus and Pseudomonas aeruginosa from Macroflux® Human Parathyroid Hormone	  	
			
	 6.595
	  	[**]	  	
			
	 6.596
	  	[**]	  	
			
	 6.597
	  	[**]	  	
			
	 6.599
	  	USP Microbial Content Assay for Macroflux® Adhesive Patch	  	
			
	 6.600
	  	USP Microbial Content Assay for Macroflux® Polyurethane Disk	  	
			
	 6.601
	  	Kinetic LAL Bacterial Endotoxins Test for Macroflux® Polyurethane Disk	  	
			
	 6.602
	  	USP Test for Staphylococcus aureus and Pseudomonas aeruginosa from Macroflux® Polyurethane Disk	  	
			
	 8.001
	  	Amino Acid Composition Analysis of Proteins and Peptides	  	
			
	 8.003
	  	Molecular Weight Determination of Peptides by Electrospray Mass Spectrometry .	  	
			
	 8.010
	  	[**]	  	
			
	 8.016
	  	[**]	  	
			
	 9.001
	  	Appearance	  	
			
	 9.002
	  	Certificate Verification	  	
			
	 9.003
	  	Attribute Verification	  	


  
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 Attachment 1.6 - ALZA Know-How Index 

Schedule I: ALZA Analytical Methods (AAM) 
  

					
	 AAM No.
	  	 AAM Title
	  	 
			
	 9.004
	  	Document Review	  	
			
	 9.030
	  	Certificate Verification for Reference Standards	  	
			
	 9.038
	  	Appearance of Components	  	
			
	 9.045
	  	Appearance of Raw Material Powders or Granules	  	


  
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EXCHANGE COMMISSION. DOUBLE ASTERISKS [**] DENOTE OMISSIONS. 







 Attachment 1.6 - ALZA Know-How Index 

Schedule J: ALZA Quality Specification (AQS) 
  

					
	 AQS Number
	  	 AQS Title
	  	 
			
	 0002654
	  	[**]	  	
			
	 0008541
	  	[**]	  	
			
	 0009083
	  	Hydrochloric Acid, NF, Ph Eur	  	
			
	 0009895
	  	Water for Injection, USP, (Bulk Package)	  	
			
	 0011513
	  	[**]	  	
			
	 0012191
	  	[**]	  	
			
	 0012490
	  	[**]	  	
			
	 0012512
	  	[**]	  	
			
	 0012514
	  	[**]	  	
			
	 0012602
	  	Centrifuge Tubes, 250 mL, Polypropylene	  	
			
	 0012608
	  	Pipette tip, 1000uL, positive displacement, sterile	  	
			
	 0012636
	  	Centrifuge tube, 15 ml, Sterile	  	
			
	 0012663
	  	Pipette tip, 10mL, sterile	  	
			
	 0012664
	  	Pipette tip, 100uL, positive displacement, sterile	  	
			
	 0013359
	  	[**]	  	
			
	 0013379
	  	Edetate Disodium, USP, Ph Eur, Dihydrate, (Low Endotoxin)	  	
			
	 0013429
	  	[**]	  	
			
	 0013430
	  	[**]	  	
			
	 0013431
	  	[**]	  	
			
	 0013490
	  	[**]	  	
			
	 0013652
	  	Parathyroid Hormone (1-34) Human, Acetate Salt	  	
			
	 0013673
	  	Detergent CIP-100 (1 gallon)	  	
			
	 0013712
	  	[**]	  	
			
	 0013854
	  	Pipette Tip, 10uL, Positive Displacement, Steri	  	
			
	 0013882
	  	[**]	  	
			
	 0013889
	  	Centrifuge Tubes, 2.0mL sterile/non-pyrogenic	  	
			
	 0013911
	  	[**]	  	
			
	 0013933
	  	Tubing, Polypropylene, 1/8 in ID x 1/4 in OD	  	


  
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 Attachment 1.6 - ALZA Know-How Index 

Schedule J: ALZA Quality Specification (AQS) 
  

					
	 AQS Number
	  	 AQS Title
	  	 
			
	 0014056
	  	[**]	  	
			
	 0014360
	  	[**]	  	
			
	 0014793
	  	[**]	  	
			
	 0014859
	  	[**]	  	
			
	 0014860
	  	[**]	  	
			
	 0014889
	  	[**]	  	
			
	 0014941
	  	Sucrose, NF (low endotoxin), Beet Derived	  	
			
	 0015010
	  	[**]	  	
			
	 0015011
	  	[**]	  	
			
	 0015029
	  	[**]	  	
			
	 0015081
	  	HOPE, Separator	  	
			
	 0015186
	  	[**]	  	
			
	 0015187
	  	[**]	  	
			
	 0015188
	  	[**]	  	
			
	 0015189
	  	[**]	  	
			
	 0015207
	  	[**]	  	
			
	 0015340
	  	[**]	  	
			
	 0015346
	  	[**]	  	
			
	 0015403
	  	[**]	  	
			
	 0015540
	  	[**]	  	
			
	 0015594
	  	[**]	  	
			
	 0015618
	  	Bag, Unprinted, Nylon/LLDPE 14.5 x 7”	  	
			
	 0015619
	  	Bag, Unprinted, Tyvek/film 15 x 19.5	  	
			
	 0015620
	  	Shipper, Corrugated, RSC, 16 x 10 x 8”	  	
			
	 0015621
	  	Bag, Unprinted, Tyvek/film, 15.5 x 13.25”	  	
			
	 0015634
	  	[**]	  	
			
	 0015662
	  	[**]	  	


  
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EXCHANGE COMMISSION. DOUBLE ASTERISKS [**] DENOTE OMISSIONS. 







 Attachment L6 - ALZA Know-How Index 

Schedule J: ALZA Quality Specification (AQS) 
  

					
	 AQS Number
	  	 AQS Title
	  	 
			
	 0015663
	  	Bag, Unprinted, Nylon/LLDPE, 9 x 14”	  	
			
	 0015664
	  	Shipper, Corrugated, RSC, 22 x 15 x 10”	  	
			
	 0015665
	  	Bag, Unprinted, Nylon/LLDPE, 7 x 6.5”	  	
			
	 0015666
	  	Bag, Unprinted, Nylon/LLDPE, 19 x 16 “	  	
			
	 0015667
	  	Shipper, Corrugated, RSC, 20 x 12 x 8”	  	
			
	 0015668
	  	Bag, Unprinted, Tyvek/film, 12 x 8.75”	  	
			
	 0015669
	  	Bag, Unprinted, Tyvek/film 16 x 37”	  	
			
	 0015670
	  	Bag, Unprinted, Nylon/LLDPE 16 x 8.5”	  	
			
	 0015671
	  	Shipper, Corrugated, RSC, 36 x 16 x 7”	  	
			
	 0015672
	  	Label, Identification, Process 3” x 2”	  	
			
	 0015691
	  	Polypropylene filter disk, 7.5”	  	
			
	 0015692
	  	Autoclave Indicator, 1/2” Circle	  	
			
	 0015693
	  	Polyethylene Foam Cushioning and Mailer	  	
			
	 0015694
	  	Poly Cushion/Shipper Macroflux® Reservoir	  	
			
	 0015695
	  	Poly Cushion/Shipper 16x10x8”	  	
			
	 0015696
	  	Carton, Folding, Plastic, 5 Side	  	
			
	 0015697
	  	Indicator, Irradiation, 1/2” Circle	  	
			
	 0015698
	  	Poly Cushion/Shipper,Macroflux® Filters	  	
			
	 0015699
	  	Poly Cushion/Shipper for Macroflux® Tubes	  	
			
	 0015708
	  	[**]	  	
			
	 0015712
	  	[**]	  	
			
	 0015713
	  	[**]	  	
			
	 0015781
	  	Cap, Protective, Plastisol, Black 1/2” x 1 3/4”	  	
			
	 0015782
	  	Tray, Thermoformed, PETG	  	
			
	 0015783
	  	Poly Cushion/Shipper, MFL Metal Tube	  	
			
	 0015803
	  	Bag, Unprinted, Tyvek/Film, 6 1/4 x 9 5/8 inch	  	
			
	 0015804
	  	Lid, Tyvek, 13 1/2 x 7 1/4 inch	  	
			
	 0015805
	  	Bag, Unprinted, Tyvek/Film, 18 x 23 1/2 inch	  	
			
	 0015806
	  	Pouch, Unprinted, Tyvek 3 7/8 x 5 7/8”	  	


  
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EXCHANGE COMMISSION. DOUBLE ASTERISKS [**] DENOTE OMISSIONS. 







 Attachment 1.6 - ALZA Know-How Index 

Schedule J: ALZA Quality Specification (AQS) 
  

					
	 AQS Number
	  	 AQS Title
	  	 
			
	 0015819
	  	Bag, Unprinted, Tyvek/film, 4 3/4 x 6 1/4 inch	  	
			
	 0015820
	  	Pouch, Unprinted, 5 1/4 x 8 1/2 inch	  	
			
	 0015821
	  	Letter Opener, White	  	
			
	 0015860
	  	Tubing, Silicone 0.030 I.D. x 0.066 O.D.	  	
			
	 0015863
	  	[**]	  	
			
	 0015864
	  	Syringe, 3mI Sterile	  	
			
	 0015865
	  	Syringe, 10 ml Sterile	  	
			
	 0015866
	  	Syringe, 5 ml Sterile	  	
			
	 0015868
	  	Gasket, Viton	  	
			
	 0015884
	  	[**]	  	
			
	 0015885
	  	Shipper, Corrugated, RSC, 14 1/2 x 11x110”	  	
			
	 0015886
	  	Bag, Unprinted, Nylon/LLDPE, 20 1/2 x 18”	  	
			
	 0015887
	  	Poly Cushion/Shipper, Media Filter	  	
			
	 0015888
	  	Shipper, Corrugated, RSC 27 x 7 1/2 x 5”	  	
			
	 0015889
	  	Bag, Unprinted, Nylon/LLDPE, 8 1/2 x 12”	  	
			
	 0015890
	  	Bag, Unprinted, Nylon/LLDPE, 8 x 27”	  	
			
	 0015891
	  	Bag, Unprinted, Nylon/LLDPE, 12 1/2 x 17”	  	
			
	 0016086
	  	Tapered Y Connector	  	
			
	 0016109
	  	Cable Tie, Nylon, 5 1/2”	  	
			
	 0016162
	  	[**]	  	
			
	 0016163
	  	[**]	  	
			
	 0016164
	  	[**]	  	
			
	 0016165
	  	[**]	  	
			
	 0016166
	  	[**]	  	
			
	 0016167
	  	[**]	  	
			
	 0016180
	  	Bag, Unprinted, Tyvek/Film, 22 x 29-1/2”	  	
			
	 0016181
	  	Poly Cushion/Mailer/Shipper	  	
			
	 0016182
	  	Bag, Unprinted, Tyvek/Film, 15.5 x 10.625”	  	
			
	 0016256
	  	[**]	  	


  
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 Attachment 1.6 - ALZA Know-How Index 

Schedule J: ALZA Quality Specification (AQS) 
  

					
	 AQS Number
	  	 AQS Title
	  	 
			
	 0016262
	  	Argon	  	
			
	 0016397
	  	Pouch, Unprinted, Foil Pouch, 5.50 x 8.50”	  	
			
	 0016404
	  	Plastic Box, PS, Hinged 5 1/8“x 3 1/8 “x 1 5/16”	  	
			
	 0016497
	  	Tip Cap, Sterile	  	
			
	 0016498
	  	Tube, PETG 1 1/2 x 9 inch	  	
			
	 0016524
	  	Sodium Hydroxide Pellets, NF	  	
			
	 0016527
	  	Pouch, Printed, Tyvek 3 7/8” x 5 7/8”	  	
			
	 0016528
	  	Syringe Filter Connector, Stainless Steel	  	
			
	 0016536
	  	MFL Subassemblies in MACAP Infeed Tube	  	
			
	 0016545
	  	Needle, 16 gauge x 1.5 inch Sterile	  	
			
	 0016668
	  	Tyvek Pouch, Irr 3 7/8 inch x 5 7/8 inch	  	
			
	 0016669
	  	[**]	  	
			
	 0016670
	  	[**]	  	
			
	 0016671
	  	[**]	  	
			
	 0016707
	  	[**]	  	
			
	 00319
	  	Nitrogen, NF (liquid)	  	
			
	 009895
	  	Water for Injection, USP, (Bulk Package)	  	


  
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 Attachment 1.6 - ALZA Know-How Index 

Schedule K: CPR 
  

					
	 CPR Number
	  	 CPR Title
	  	 
			
	 0002654
	  	Foil Pouch, 3 718 x 5 7/8 inch	  	
			
	 0012191
	  	[**]	  	
			
	 0012514
	  	Polyurethane Disk, 70A, 5/8” Diameter, 1/8” Thick, Amber	  	
			
	 0013359
	  	[**]	  	
			
	 0013372
	  	[**]	  	
			
	 0013432
	  	[**]	  	
			
	 0013433
	  	[**]	  	
			
	 0013434
	  	[**]	  	
			
	 0013911
	  	[**]	  	
			
	 0015186
	  	Polyurethane DiSk, 54A, 0.8 inch diameter	  	
			
	 0015634
	  	Polyurethane Disk, 54A 5/8 inch Diameter	  	
			
	 0015708
	  	[**]	  	
			
	 0016536
	  	[**]	  	


  
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 Attachment 1.6 - ALZA Know-How Index 

Schedule L: Packaging Material Specifications (PMS) 
  

							
	 PMS Number
	  	 PMS Title
	  	 	 
			
	 0015692
	  	Autoclave Indicator, 1/2” Circle	  			
			
	 0015891
	  	Bag, Unprinted, Nylon/LLDPE, 12 1/2 x 17”	  			
			
	 0015886
	  	Bag, Unprinted, Nylon/LLDPE, 20 1/2.x 18”	  			
			
	 0015889
	  	Bag, Unprinted, Nylon/LLDPE, 8 1/2 x 12”	  			
			
	 0015890
	  	Bag, Unprinted, Nylon/LLDPE, 8 x 27”	  			
			
	 0016182
	  	Bag, Unprinted, Tyvek/Film, 15.5 x 10.625”	  			
			
	 0016180
	  	Bag, Unprinted, Tyvek/Film, 22 x 29-1/2’	  			
			
	 0015803
	  	Bag, Unprinted, Tyvek/Film, 6 1/4 x 9 5/8 inch	  			
			
	 0015805
	  	Bag, Unprinted, Tyvek/Film, 18 x 23 1/2 inch	  			
			
	 0015819
	  	Bag, Unprinted, Tyvek/Film, 4 3/4 x 6 1/4 inch	  			
			
	 0013164
	  	Box, Polystyrene, Hinged	  			
			
	 0016109
	  	Cable Tie, Nylon, 5 1/2”	  			
			
	 0015781
	  	Cap, Protective, Plastisol, Black 1/2” x 1 3/4”	  			
			
	 0015696
	  	Carton, Folding, Plastic, 5 Side	  			
			
	 0015697
	  	Indicator, Irradiation, 1/2” Circle	  			
			
	 0013163
	  	Interleaving, High Impact Polystyrene	  			
			
	 0015821
	  	Letter Opener, White	  			
			
	 0015804
	  	Lid, Tyvek, 13 1/2 x 7 1/4 inch	  			
			
	 0016181
	  	Poly Cushion/Mailer/Shipper	  			
			
	 0015695
	  	Poly Cushion/Shipper 16x10x8”	  			
			
	 0015699
	  	Poly Cushion/Shipper for Macroflux® Tubes	  			
			
	 0015694
	  	[**]	  			
			
	 0015884
	  	[**]	  			
			
	 0015887
	  	Poly Cushion/Shipper, Media Filter	  			
			
	 0015783
	  	Poly Cushion/Shipper, MFL Metal Tube	  			
			
	 0015698
	  	Poly Cushion/Shipper, Macroflux® Filters	  			
			
	 0015693
	  	Polyethylene Foam Cushioning and Mailer	  			
			
	 0015691
	  	Polypropylene filter disk, 7.5”	  	 	,	  


  
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 Attachment 1.6 - ALZA Know-How Index 

Schedule L: Packaging Material Specifications (PMS) 
  

					
	 PMS Number
	  	 PMS Title
	  	 
			
	 0015820
	  	Pouch, Unprinted, 5 1/4 x 8 112 inch	  	
			
	 0015806
	  	Pouch, Unprinted, Tyvek 3 7/8 x 5 718”	  	
			
	 0015888
	  	Shipper, Corrugated, RSC, 27 x 7 1/2 x 5”	  	
			
	 0015885
	  	Shipper, Corrugated, RSC, 14 1/2 x 11x110”	  	
			
	 0016497
	  	Tip Cap, Sterile	  	
			
	 0015782
	  	Tray, Thermoformed, PETG	  	
			
	 0016498
	  	Tube, PETG 1 1/2 x 9 inch	  	
			
	 000783
	  	Pouch Stock, Unprinted, 12”	  	
			
	 0016527
	  	Pouch, Printed, Tyvek 3 7/8” x 5 7/8”	  	
			
	 0016397
	  	Pouch, Unprinted, Foil Pouch, 5.50 x 8.50”	  	


  
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 Attachment 1.6 - ALZA Know-How Index 

 

			
	Schedule M: Clinical Files
		
	 Clinical Study Number and Title
	  	
		
	 [**] - Tolerability of Skin Interface Technology Designs and Application Methods in Healthy Volunteers
	  	
		
	 [**] - Assessment of Tolerability and Penetration of Macroflux®
Non-Drug Systems in Healthy Volunteers
	  	
		
	 [**] - Assessment of Penetration and Tolerability of Macroflux®
Non-Drug Systems in Healthy Volunteers
	  	
		
	 [**] - Assessment of Safety and Bioavailability of Macroflux® TH0229 in
Healthy Volunteers
	  	
		
	 [**] # - Pharmacokinetics, Pharmacodynamics and Tolerability of Macroflux®
hPTH via Three Application Sites in Healthy, Postmenopausal Women
	  	[**]
		
	 [**] # - Dose-Finding Study of Macroflux® hPTH in Healthy
Postmenopausal Women
	  	[**]
		
	 [**]
	  	

 The documents from each clinical study must, at a minimum, include the following (except as noted for study
[**] above: 
  

	
	Raw data
	
	Final study report
	
	Approved Final Protocol
	
	All Protocol Amendments
	
	Protocol Signature Pages
	
	All Protocol Amendment(s) Signature Pages
	
	If not included in protocol, a document describing unblinding procedure in case of an emergency, (if applicable)
	
	Institutional Review Board (IRB)/ Independent Ethics Committee (IEC) approved Informed Consent Forms (original and amended versions)
	
	Signed FDA Form 1572 (and all updated 1572s)
	
	Curricula vitae (CV) for the principal investigator, subinvestigators, and others listed on the 1572.


  
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	One page CV summaries for investigator and sub investigators


  
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 Attachment 1.6 - ALZA Know-How Index 

Schedule M: Clinical Files 
 The
documents from each clinical study must, at a minimum, include the following (except as noted for study [**] above): 
  

	
	Financial Disclosure Forms (if applicable)
	
	Insurance statement (if applicable)
	
	Declaration of Helsinki, (if applicable)
	
	DEA forms (if applicable)
	
	IRB/IEC membership list or Department of Health and Human Services (DHHS) ID number
	
	Initial IRB/IEC approval letter for the protocol, consent form and any subsequent amendments
	
	IRB/IEC approval for advertisements and copy of advertisement (if applicable)
	
	IRB/IEC approval for any other written information given to subjects and copy of information (if applicable)
	
	IRB/IEC continuing review and reapproval (if applicable)
	
	Each edition of the Investigator’s Brochure
	
	Package Insert/Summary of Product Characteristics, (if applicable)
	
	Clinical laboratory information (certifications, accreditation, normal ranges, CV of laboratory director)
	
	Documents concerning investigational drug shipments and accountability
	
	Documentation concerning disposition of any unused investigational drug at study termination
	
	Monitoring Log
	
	Subject Screening/Enrollment Log
	
	Signature Verification Form/Staff Delegation Log
	
	Contact reports, correspondence, monitoring reports
	
	Serious Adverse Event Report Form (if applicable)
	
	Notification to investigators of IND safety reports (if applicable)
	
	IRB/IEC notification of IND safety reports (if applicable)
	
	Clinical Safety Team Checklist
	
	Approved version of Case Report Forms (CRFs)
	
	DataFax QC reports (returned by sites) documenting CRF corrections
	
	Subjects’ completed signed and dated CRFs
	
	Case Reports
	
	Clinical Research Organization (CRO) file, (if applicable)
	
	CRO Audit reports
	
	Protocol specific training manuals, (if applicable)


  
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	Any other study related documents except for financial records


  
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 Attachment 1.6 - ALZA Know-How Index 

Schedule N: Bioanalytical - CRO documents 
  

	
	 Per provision 3.4 of the License Agreement, ALZA will not be required to transfer or make available any ALZA Know-How that would require
ALZA to breach any obligation it may have to a Third Party or violate any law, statute, ordinance or regulation.
  

Note: Audit reports and quotes required for all CROs listed

 
 Data and documents in this Section N to be transferred at the end of the transition
services period

	  
 CRO Name

 
 [**]



  
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 Attachment 1.6 - ALZA Know-How Index 

Schedule O: Vendor Files 
 Per
provision 3.4 of the License Agreement, ALZA will not be required to transfer or make available any ALZA Know-How that would require ALZA to breach any obligation it may have to a Third Party or violate any law, statute, ordinance or regulation.
ALZA agrees to transfer to TMC any equipment files, equipment manuals; drawing files and vendor audit files in its possession for the vendors listed in this Schedule O at the end of the transition services period provided that TMC has obtained any
permission required from such vendors for such transfers. 
  

							
	 Item Number(s)
	  	 Vendor Name
	  	 GMP PO Number
	  	  

				
	 11696
	  	[**]	  	None	  	
				
	 None
	  	[**]	  	None	  	
				
	 None
	  	[**]	  	None	  	
				
	 None
	  	[**]	  	None	  	
				
	 15708
	  	[**]	  	Various (4)	  	
				
	 12512
	  	[**]	  	70110457	  	
				
	 None
	  	[**]	  	None	  	
				
	 13164
	  	[**]	  	Various (2)	  	
				
	 13712
	  	[**]	  	70110041	  	
				
	 14793
	  	[**]	  	70110604	  	
				
	 15863, 16669, 16670
	  	[**]	  	70110687	  	
				
	 15010 & 15011
	  	[**]	  	Various (3)	  	
				
	 15340
	  	[**]	  	Various (2)	  	
				
	 15619 & 15621
	  	[**]	  	None	  	
				
	 13827
	  	[**]	  	Pending	  	
				
	 16523
	  	[**]	  	70110650	  	
				
	 13163 & 15081
	  	[**]	  	70110546	  	
				
	 14941
	  	[**]	  	Various	  	
				
	 None
	  	[**]	  	Pending	  	
				
	 14889
	  	[**]	  	70110631	  	
				
	 13827
	  	[**]	  	None	  	
				
	 13827
	  	[**]	  	Various	  	
				
	 15618, 15663, 15665, 15666,

15670, 15886, 15889, 15891
	  	[**]	  	Various (2)	  	
				
	 15699, 15693, 15694, 15695

15696, 15698, 15884, 15887
	  	[**]	  	70110494	  	


  
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	 15696
	  	[**]	  	Various (3)	  	


  
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	 15668, 15669, 15804, 16527
	  	[**]	  	Various (8)	  	
				
	 4657, 4661, 8556, 9083

9895, 13673, 14977, 15403
	  	[**]	  	Various (11)	  	


  
 CONFIDENTIAL MATERIALS
OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND 
 EXCHANGE COMMISSION. DOUBLE ASTERISKS [**] DENOTE OMISSIONS. 







 Attachment 1.6 - ALZA Know-How Index 

Schedule P: Completed Batch Records 

Requirements: Completed Batch Records for the following programs listed below. 

 
  

			
	 Program name
	  	 
		
	Macroflux® PTH	  	
		
	Macroflux® Desmopressin	  	
		
	[**]	  	


  
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 Attachment 1.12 - Development Agreements 

 

	1.	Interim Development Agreement between ALZA Corporation and [**]. 

  

	2.	Interim Development Agreement between ALZA Corporation and [**]. 

  

	3.	Interim Development Agreement between ALZA Corporation and [**]. 

  

	4.	Termination Agreement between ALZA Corporation and [**] terminating all three of the above [**]. 

  

	5.	Interim Development Agreement between ALZA Corporation and [**]. 

  

	6.	Material Evaluation Agreement between ALZA Corporation and [**]. 


  
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 Attachment 1.23 - Licensed Patents 

 

			
	 CATEGORY A
	  	 
	 6,050,988 ARC2758R1
 AU, CA, CN, EP, JP, KR,
MX
	  	Device for Enhancing Transdermal Agent Flux
		
	 6,230,051 ARC2466CIP1
 CA, EP, JP, KR
	  	Device and Method for Enhancing Transdermal Sampling
		
	6,855,372 ARC3116R1	  	Method and Apparatus for Coating Skin Piercing Microprojections
		
	 6,855,131 ARC3014R1
 AU, BR, CA, CZ, EP, HU, HK,
IL, IN, JP, KR, MA, MX, NO,
 NZ, PL, RU, VN, ZA
	  	Microprotrusion Member Retainer for Impact Applicator
		
	6,953,589 ARC2685N1	  	Device For Enhancing Transdermal Agent Flux
		
	 09/733,305 ARC2864R1
 AU, CA, CN, EP, HK, HU,
IL, JP, KR, MX, NO, NZ, ZA
	  	Skin Treatment Method and Apparatus for Sustained Transdermal Drug Delivery
		
	10/794,637 ARC2864N1	  	Skin Treatment Method and Apparatus for Sustained Transdermal Drug Delivery
		
	 09/733,506 ARC2877R1
 EP, HK
	  	Device and Method for Enhancing skin Piercing by Microprotrusions
		
	10/984,499 ARC2877DIV I	  	Device and Method for Enhancing skin Piercing by Microprotrusions
		
	 09/976,763 ARC2972R1
 AU, BR, CA, CN, CZ, EP,
HK, HU, IL, IN, JP, KR, MA, MX,
 NO, NZ, PL, RU, VN, ZA
	  	Microblade Array Impact Applicator
		
	11/251,488 ARC2972USCNT	  	Microblade Array Impact Applicator
		
	10/978,807 ARC3014CON1	  	Microprotrusion Member Retainer for Impact Applicator
		
	 10/045,842 ARC3036R1
 AU, BR, CA, CN, CZ, EP,
HK, HU, IL, IN, JP, KR, MA, MX,
 NO, NZ, PL, RU, VN, ZA
	  	Transdermal Drug Delivery Devices Having Coated Microprotrusions
		
	11/347,779 ARC3036USD1V	  	Transdermal Drug Delivery Devices Having Coated Microprotrusions
		
	10/984,510 ARC3116D1V1	  	Method and Apparatus for Coating Skin Piercing Microprojections
		
	 10/127,171 ARC3092R1
 AU, BR, CA, CN. EP, IL,
JP, KR, MX, NO, NZ, ZA
	  	Microprojection Array Immunization Patch and Method


  
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	11/267,563 ARC3092USCNT	  	Microprojection Array Immunization Patch and Method
		
	 10/127,108 ARC3056R1
 AU, BR, CA, CN, EP, EP
DIV, IL, JP, KR, MX, NO, NZ, NZ DIV, ZA
	  	Microprojection Array Having a Beneficial agent Containing Coating
		
	 10/305,641 ARC3089R1
 EP
	  	Method and Apparatus for Forming Microprojection Arrays
		
	10/327,330 ARC2909R1 AU, EP, HU, IN, NO, RU, ZA	  	Skin-Piercing Microprojections Having Piercing Depth Control
		
	10/674,626 ARC3061R1 CA, EP	  	Drug Delivery Device and Method Having Coated Microprojections Incorporating Vasoconstrictors
		
	 10/608,304 ARC3074R1
 AR, AU, BR, CA, CN, EP,
JP, KR, MX, SG, TW
	  	Transdermal Drug Delivery Devices Having Coated Microprotrusions
		
	 10/637,909 ARC3149R1
 AR, AU, BR, CA, CN, EP,
HK, JP, KR, MX, SG, TW
	  	Transdermal Vaccine Delivery Device Having Coated Microprotrusions
		
	 10/745,995 ALZ5103R1
 AR, AU, BR, CA, CL, CN,
EP, HK, JP, KR, MX, SG, TW, VE
	  	Active Agent Delivery Device Having Composite Members
		
	 10/884,603 ARC3077USANP
 AR, AU, BR, CA, CL, CN,
EP, JP, KR, MX, MY, NZ, PE, PK, SG, TH, TW, UY, VE
	  	Microprojection Array Immunization Patch and Method
		
	 10/880,702 ALZ5049USNP
 AR, AU, BR, CA, CN, EP,
JP, KR, TH, MX, MY, NZ, SG, TW, VE
	  	Formulations for Coated Microprotrusions Containing Non-Volatile Counterions
		
	 11/034,891 ALZ5049CIP1
 WO, AR, MY, TH, TW,
VE
	  	Formulations for Coated Microprojections Having Controlled Solubility
		
	 10/880,701 ALZ5050USANP
 AR, AU, BR, CA, CN, EP,
JP, KR, MX, MY, NZ, SG, TH, TW, VE
	  	Method for Coating Skin Piercing Microprojections
		
	 10/925,518 ALZ5056USANP
 AR, AU, BR, CA, CN, EP,
JP, KR, MX, MY, NZ, SG, TW, TH, VE
	  	Device and Method For Intradermal cell Implantation
		
	 10/910,889 ALZ5037USANP
 AR, AU, BR, CA, CN, EP,
JP, KR, MY, MX, NZ, SG, TH, TW, VE
	  	Device For Enhancing Transdermal Agent Flux
		
	 10/910,915 ALZ5037USANP2
 AR, AU, BR, CA, CN,
EP, JP, KR, MY, MX, NZ, SG, TH, TW, VE
	  	Device For Enhancing Transdermal Agent Flux
		
	10/911,299 ALZ5037USANP3	  	Device For Enhancing Transdermal Agent Flux
		
	 10/972,230 ALZ5074NP
 AR, MY, TH, TW, VE, AU,
BR, CA, CN, EP, JP, KR, MX, SG
	  	Compositions of Stabilized DNA for Coating Microprojections
		
	 10/971,224 ALZ5075NP
 AR, MY, TH, TW, VE, AU,
BR, CA, CN, EP, JP, KR, MX, SG
	  	Method and Apparatus for Reducing the Incidence of Tobacco Use


  
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EXCHANGE COMMISSION. DOUBLE ASTERISKS [**] DENOTE OMISSIONS. 








			
		
	 10/972,231 ALZ5076NP
 AR, MY, TH, TW, VE, AU,
BR, CA, CN, EP, KR JP, MX, SG
	  	Delivery of Polymer Conjugates of Therapeutic Peptides and Proteins via a Microprojection Apparatus
		
	 10/971,871 ALZ5084NP
 AR, MY, TH, VE, AU, BR,
CA, CN, EP, KR, JP, MX, SG
	  	Self-Actuating Applicator for Microprojection Array
		
	 10/970,890 ALZ5095NP
 AR, MY, TH, TW, VE, AU,
BR, CA, CN, EP, KR, JP, MX, SG
	  	Composition and Apparatus for Transdermal Delivery
		
	 11/084,631 ALZ5123NP
 AR, AU, BR, CA, CN, EP,
JP, KR, MY, MX, SG, TH, TW, VE
	  	Apparatus and Method for Transdermal delivery of Influenza Vaccine
		
	 11/084,635 ALZ5 I 24NP
 WO, AR, MY, TH, TW,
VE
	  	Apparatus and Method for Transdermal Delivery of Multiple Vaccines
		
	 11/084,634 ALZ5133NP
 WO, AR, MY, TH, TW,
VE
	  	Method and Apparatus for Transdermal Delivery of hPTH(1-34)
		
	 11/222,297 ALZ5154USNP
 WO, AR, MY, TH, TW,
VE
	  	Microprojection Array with Improved Skin Adhesion and Compliance
		
	11/259,010 ALZ5159USNP	  	Method and Apparatus for Transdermal Delivery of Desmopressin
		
	 11/341,832 ALZ5170USNP
 WO, AR, MY, TH, TW,
VE
	  	Coated Microprojections Having Reduced Variability and Method for Producing Same
		
	 11/391,609 ALZ5171USNP
 WO
	  	Microprojections with Capillary Control Features and Method
		
	 11/446,530 ALZ5 I 93USANP
 WO
	  	Method for Terminal Sterilization of Transdermal Delivery Devices
		
	 11/446,487 ALZ5194USANP
 WO
	  	Method for Terminal Sterilization of Transdermal Delivery Devices
		
	 11/472,165 ALZ5173USANP
 WO
	  	Method And Device for Coating a Continuous Strip of Microprojections Members
		
	11/ ALZ5216USAPSP	  	Coatable Transdermal Delivery Microprojection Assembly
	WO	  
		
	60/754,948 ALZ5234USPSP	  	Therapeutic Formulations With Improved Stability
		
	60/781,049 ALZ5237USPSP	  	Microprojection Array Application with High Barrier Retainer
		
	60/782,939 ALZ5240USPSP	  	Apparatus and Methods for Transdermal Delivery of Parathyroid Hormone Agents to Prevent or Treat Osteopenia
		
	60/784,883 ALZ5243USPSP	  	Apparatus and Methods for Transdermal Delivery of a Triptan Agonist


  
 - 127 - 

CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND 

EXCHANGE COMMISSION. DOUBLE ASTERISKS [**] DENOTE OMISSIONS. 








			
		
	60/784,743 ALZ5244USPSP	  	Apparatus and Methods for Transdermal Delivery of a 5-Hydroxytritamine Antagonist
		
	60/784,850 ALZ5245USPSP	  	Apparatus and Methods for Transdermal Delivery of a Benzodiazepine
		
	60/817,499 ALZ5259USPSP	  	Apparatus and Methods for Transdermal Delivery of Insulin
		
	60/817,563 ALZ5260USPSP	  	Apparatus and Methods for Transdermal Delivery of Gonadotropins
		
	60/795,009 ALZ5247USPSP	  	Microprojection Array Application with Sculptured Microprojections for High Drug Loading
		
	60/794,941 ALZ5251 U SPSP	  	Microprojection Array Application with Grouped Microprojections for High Drug Loading
		
	60/794,960 ALZ5252USPSP	  	Microprojection Array Application with Multilayered Microprojection Member for High Drug Loading
		
	11/477,045 ALZ5084USCNT	  	Self-Actuating Applicator for Microprojection Array


  
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EXCHANGE COMMISSION. DOUBLE ASTERISKS [**] DENOTE OMISSIONS. 








			
	 CATEGORY B
	  	 
	 6083196 ARC2685R2 AU,
 CA, CN, EP, JP, KR,
MX
	  	Device for Enhancing Transdermal Agent Flux
		
	 6322808 ARC2685RI
 AU, CA, CN, EP, JP, MX DIV,
KR, MX
	  	Device for Enhancing Transdermal Agent Flux
		
	 08/877,155 ARC2466R1
 AR, AR DIV, CA, EP, JP,
KR, TW
	  	Device and Method for Enhancing Transdermal Flux
		
	 6,918.901 ARC2600R1
 AU, CA, CN, EP, JP, KR,
MX
	  	Device and Method for Enhancing Transdermal Agent Flux
		
	10/881,440 ARC2600N1	  	Device and Method for Enhancing Transdermal Agent Flux
		
	 09/950,436 ARC2911
 AU, BR, CA, CN, CZ, EP, IL,
JP, KR, MA, MX, NO, NZ, RU, VN, ZA
	  	Methods for Inhibiting Decrease in Transdermal Drug Flux by Inhibition of Pathway Closure
		
	 09/976,798 ARC3043R1
 AU, BR, CA, CN, CZ, EP,
HK, HU, IL, IN, JP, KR, MA, MX, NO, NZ,
 PL, RU, VN, ZA
	  	Apparatus and Method for Piercing Skin with Microprotrusions
		
	11/092,800 ARC3043CIP	  	Apparatus and Method for Piercing Skin with Microprotrusions
		
	11/092,202 ARC3043DIV1	  	Apparatus and Method for Piercing Skin with Microprotrusions
		
	 10/971,430 ALZ5070NP
 IAR, MY, TH, TW, VE, AU,
BR, CA, CN, EP, KR, JP, MX, SG
	  	Apparatus and Method for Enhancing Transdermal Drug Delivery
		
	 10/970,901 ALZ5071NP
 AR, MY, TH, TW, VE, AU,
BR, CA, CN, EP, KR, JP, MX, SG
	  	Pretreatment Method and System for Enhancing Transdermal Drug Delivery
		
	 11/084,636 ALZ5125NP
 WO, AR, MY, TH, TW,
VE
	  	Apparatus and Method for Transdermal Delivery of FentanylBased Agents
		
	 11/201,617 ALZ5150NP
 WO, AR, MY, TH, TW,
VE
	  	Microprojection Apparatus and System with Low Infection Potential
		
	 I 1/237,200 ALZ5156NP
 WO, AR, MY, TH, TW,
VE
	  	Method and Formulation for Stabilizing Alum-Adsorbed Vaccines
		
	 11/336,134 ALZ5169NP
 WO, AR, MY, TH, TW,
VE
	  	Therapeutic Peptide Formulations With Improved Stability
		
	 11/355,729 ALZ5174NP
 WO, AR, MY, TH, TW,
VE
	  	Microprojection Arrays with Improved Biocompatibilty
		
	 11/112,311 ALZ5134NP
 WO, AR, MY, TH, TW,
VE
	  	Method and formulation for Transdermal Delivery of Immunologically Active Agents


  
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 Attachment 1.46 - Trademark 

 

							
	 TRADEMARK
	  	 COUNTRY
	  	 FILING NO,
	  	 REGISTRATION NO.

				
	MACROFLUX	  	ARGENTINA	  	2648182	  	
				
	MACROFLUX	  	ARGENTINA	  	2648183	  	
				
	MACROFLUX	  	ARGENTINA	  	2648184	  	
				
	MACROFLUX	  	AUSTRALIA	  	1050824	  	
				
	MACROFLUX	  	AUSTRALIA	  	1099430	  	
				
	MACROFLUX	  	BENELUX	  	1102532	  	790811
				
	MACROFLUX	  	BRAZIL	  	828132097	  	
				
	MACROFLUX	  	BRAZIL	  	828132062	  	
				
	MACROFLUX	  	BRAZIL	  	828132070	  	
				
	MACROFLUX	  	BULGARIA	  	880221	  	880221
				
	MACROFLUX	  	CANADA	  	875880	  	
				
	MACROFLUX	  	EUROPEAN COMMUNITY (EUROPEAN UNION)	  	819730	  	819730
				
	MACROFLUX	  	HONG KONG	  	300572751	  	
				
	MACROFLUX	  	INDIA	  	1419150	  	
				
	MACROFLUX	  	INDIA	  	1419151	  	
				
	MACROFLUX	  	INDIA	  	1419152	  	
				
	MACROFLUX	  	- ISRAEL	  	187772	  	
				
	MACROFLUX	  	ISRAEL	  	187773	  	
				
	MACROFLUX	  	ISRAEL	  	187774	  	
				
	MACROFLUX	  	JAPAN	  	52553/98	  	4410279
				
	MACROFLUX	  	KOREA (NORTH)	  	880221	  	880221
				
	MACROFLUX	  	KOREA (SOUTH)	  	0450	  	
				
	MACROFLUX	  	MALAYSIA	  	04863	  	
				
	MACROFLUX	  	MALAYSIA	  	04864	  	
				
	MACROFLUX	  	MALAYSIA	  	04865	  	
				
	MACROFLUX	  	MEXICO	  	768540	  	
				
	MACROFLUX	  	NEW ZEALAND	  	741896	  	
				
	MACROFLUX	  	NORWAY	  	01277	  	
				
	MACROFLUX	  	NORWAY	  	02451	  	
				
	MACROFLUX	  	RUSSIAN FEDERATION (formerly USSR)	  	880221	  	880221
				
	MACROFLUX	  	SINGAPORE	  	028591	  	
				
	MACROFLUX	  	SINGAPORE	  	02858J	  	02858J


  
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CONFIDENTIAL MATERIALS OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND 

EXCHANGE COMMISSION. DOUBLE ASTERISKS [**] DENOTE OMISSIONS. 








							
	MACROFLUX	  	SINGAPORE	  	02860B	  	
				
	MACROFLUX	  	SOUTH AFRICA	  	02108	  	
				
	MACROFLUX	  	SOUTH AFRICA	  	02109	  	
				
	MACROFLUX	  	SOUTH AFRICA	  	02110	  	
				
	MACROFLUX	  	SWITZERLAND	  	880221	  	880221
				
	MACROFLUX	  	TAIWAN	  	5192	  	
				
	MACROFLUX	  	TAIWAN	  	5193	  	
				
	MACROFLUX	  	TAIWAN	  	5194	  	
				
	MA CROFLUX	  	THAILAND	  	624920	  	
				
	MACROFLUX	  	THAILAND	  	616583	  	
				
	MACROFLUX	  	THAILAND	  	616584	  	
				
	MACROFLUX	  	UNITED STATES OF AMERICA	  	76/232982	  	2872091
				
	MACROFLUX	  	VENEZUELA	  	01523	  	
				
	MACROFLUX	  	VENEZUELA	  	01522	  	
				
	MACROFLUX	  	VENEZUELA	  	01524	  	
				
	MACROFLUX	  	VIETNAM	  	01518	  	

 www.macroflux.com and www.macroflux.info 

  
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 Attachment 2.1.4 — Non-Field Patents/Applications 

 

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


  
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 Attachment 3.3.1 — Existing Agreements 

Service and Consulting Agreements 
  

	1.	Service Agreement between ALZA Corporation and [**] regarding Contract #20060455, dated July 25, 2006 

  

	2.	Service Agreement between ALZA Corporation and [**] regarding Contract #20060120, dated March 9, 2006 

  

	3.	Service Agreement between ALZA Corporation and [**] regarding Contract #20050611, dated September 6, 2005 

  

	4.	Service Agreement between ALZA Corporation and [**] regarding Contract #20060046 and Purchase Order #991532361, dated February 2, 2006 


 

	5.	Service Agreement between ALZA Corporation and [**] regarding Contract #20060215 and Purchase Order #991595923, dated April 20, 2006 


 

	6.	Service Agreement between ALZA Corporation and [**] regarding Contract #20060353, dated May 22, 2006. 

  

	7.	Service Agreement between ALZA Corporation and [**] regarding Contract #20060192, dated April 21, 2006 

  

	8.	Master Services Agreement between ALZA Corporation and [**], regarding Contract #20060346, dated May 2, 2006; Clinical Agreement Request dated May 9, 2006; Work Order regarding Work Order #20060346-1,
dated May 9, 2006 

  

	9.	Service Agreement between ALZA Corporation and [**] regarding Contract #20050949 and Purchase Order #991520371, dated December 20, 2005 


  
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EXCHANGE COMMISSION. DOUBLE ASTERISKS [**] DENOTE OMISSIONS. 







 Attachment 3.3.1 — Agreements Transferring to TMC 

 

	10.	Service Agreement between ALZA Corporation and [**] regarding Contract #20060365, and Purchase Order #991618313, dated May 25, 2006 


 

	11.	Consultant Agreement between ALZA Corporation and Lane, Nancy E., M.D. regarding Contract #20050556, dated August 25, 2005, as amended on August 24, 2006. 


 

	12.	Consultant Agreement between ALZA Corporation and [**] regarding Contract #20060330 and Purchase Order #991622895, dated May 22, 2006 


 

	13.	Service Agreement between ALZA Corporation and [**] regarding Contract #20060191, dated March 30, 2006 

  

	14.	Service Agreement between ALZA Corporation and [**] regarding Contract #20060108, dated May 3, 2006 

  

	15.	Service Agreement between ALZA Corporation and [**] regarding Contract #20060034, dated January 23, 2006 

  

	16.	Service Agreement between ALZA Corporation and [**] regarding Contract #20050869, dated December 12, 2005, as amended on September 14, 2006 


 

	17.	Service Agreement between ALZA Corporation and [**] regarding Contract #20060388 and Purchase Order #991638161, dated June 7, 2006 


 

	18.	Service Agreement between ALZA Corporation and [**] regarding Contract #20050858 and Purchase Order #991489623, dated November 18, 2005, as amended on February 16, 2006 


 

	19.	Service Agreement between ALZA Corporation and [**] regarding Contract #20060467, dated August 8, 2006 


  
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EXCHANGE COMMISSION. DOUBLE ASTERISKS [**] DENOTE OMISSIONS. 







 Attachment 3.3.1 — Agreements Transferring to TMC 

Secrecy/Confidentiality Agreements 
  

	1.	Confidentiality Agreement between ALZA Corporation and ACE USA regarding Contract #20060382, dated June 12, 2006 

  

	2.	Secrecy Agreement between ALZA Corporation and Alliance Capital Ventures regarding Contract #20060234, dated April 11, 2006 

  

	3.	Secrecy Agreement between ALZA Corporation and [**] regarding Contract #20060422, dated June 22, 2006 

  

	4.	Secrecy Agreement between ALZA Corporation and Babington Consulting, LLC regarding Contract #20060538 dated September 6, 2006. 

  


	5.	Secrecy Agreement between ALZA Corporation and [**] regarding Contract #20050444, dated August 1, 2005 

  

	6,	Secrecy Agreement between ALZA Corporation and [**] regarding Contract #20060172, dated May 2, 2006 

  

	7.	Secrecy Agreement between ALZA Corporation and Continental Casualty Company regarding Contract #20060381, dated June 19, 2006 

  

	8.	Secrecy Agreement between ALZA Corporation and CRESA Partners, LLC regarding Contract #20060390, dated June 12, 2006 

  

	9.	Secrecy Agreement between ALZA Corporation and [**] regarding Contract #20060516, dated September 1, 2006. 

  

	10.	Secrecy Agreement between ALZA Corporation and [**] regarding Contract #20060077, dated February 14, 2006 


  
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EXCHANGE COMMISSION. DOUBLE ASTERISKS [**] DENOTE OMISSIONS. 







 Attachment 3.3.1— Agreements Transferring to TMC 

 

	11.	Secrecy Agreement between ALZA Corporation and [**] regarding Contract #20060497, dated August 18, 2006 

  

	12.	Secrecy Agreement between ALZA Corporation and Frazier Management LLC regarding Contract # 20060071, dated January 31, 2006 

  

	13.	Secrecy Agreement between ALZA Corporation and [**] regarding Contract #20050960, dated March 10, 2006 

  

	14.	Secrecy Agreement between ALZA Corporation and [**] regarding Contract #20060479, dated August 9, 2006 

  

	15.	Secrecy Agreement between ALZA Corporation and [**] regarding Contract #20060424, dated June 22, 2006 

  

	16.	Secrecy Agreement between ALZA Corporation and [**]regarding Contract #20060341, dated May 17, 2006 

  

	17.	Secrecy Agreement between ALZA Corporation and [**] regarding Contract #20060533, dated September 6, 2006. 

  

	18.	Secrecy Agreement between ALZA Corporation and Kleiner Perkins Caufield & Byers regarding Contract #20060075, dated March 6, 2006 


 

	19.	Secrecy Agreement between ALZA Corporation and [**] regarding Contract #20060344, dated May 17, 2006 

  

	20.	Secrecy Agreement between ALZA Corporation and Marsh Risk and Insurance, Inc. regarding Contract #20060354, dated May 22, 2006 


  
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EXCHANGE COMMISSION. DOUBLE ASTERISKS [**] DENOTE OMISSIONS. 







 Attachment 3.3.1 — Agreements Transferring to TMC 

 

	21.	Mutual Non-Disclosure Agreement between ALZA Corporation and [**], regarding Contract #20060379, dated September 16, 2004 

  

	22.	Secrecy Agreement between ALZA Corporation and Mercer Health Resource Consulting, Inc. regarding Contract #20060235, dated April 12, 2006, as amended on May 9, 2006 


 

	23.	Secrecy Agreement between ALZA Corporation and [**] regarding Contract #20060039, dated February 10, 2006 

  

	24.	Secrecy Agreement between ALZA Corporation and National Union Fire Insurance Company regarding Contract #20060425, dated June 21, 2006 


 

	25.	Secrecy Agreement between ALZA Corporation and New Enterprise Associates regarding Contract #20060460, dated July 24, 2006 

  

	26.	Secrecy Agreement between ALZA Corporation and Nomura Phase 4 Ventures LP regarding Contract #20060076, dated February 7, 2006 

  


	27.	Secrecy Agreement between ALZA Corporation and [**] regarding Contract #20060036, dated January 18, 2006 

  

	28.	Secrecy Agreement between ALZA Corporation and [**] regarding Contract #20060271, dated May 3, 2006 

  

	29,	Secrecy Agreement between ALZA Corporation and OrbiMed Advisors, LLC regarding Contract #20060095, dated February 16, 2006 

  

	30.	Secrecy Agreement between ALZA Corporation and [**] regarding Contract #20060366, dated May 2006 


  
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EXCHANGE COMMISSION. DOUBLE ASTERISKS [**] DENOTE OMISSIONS. 







 Attachment 3.3.1 — Agreements Transferring to TMC 

 

	31.	Secrecy Agreement between ALZA Corporation and [**] regarding Contract #20040368, dated May 4, 2004 

  

	32.	Secrecy Agreement between ALZA Corporation and [**] regarding Contract # 20050053, dated January 27, 2005 

  

	33.	Secrecy Agreement between ALZA Corporation and Robust Network Solutions regarding Contract #20060378, dated June 6, 2006 

  

	34.	Secrecy Agreement between ALZA Corporation and [**] regarding Contract #20060302, dated May 17, 2006 

  

	35.	Secrecy Agreement between ALZA Corporation and [**] regarding Contract #20050929, dated January 9, 2006 

  

	36.	Confidentiality Agreement between ALZA Corporation and St. Paul Travelers regarding Contract #20060395, dated June 7, 2006 

  

	37.	Secrecy Agreement between ALZA Corporation and The Tech Group regarding Contract #20060423, dated June 22, 2006 

  

	38.	Secrecy Agreement between ALZA Corporation and [**] regarding Contract #20050430, dated August 10, 2005 

  

	39.	Secrecy Agreement between ALZA Corporation and Warburg Pincus, LLC regarding Contract #20060088, dated February 28, 2006 


  
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 Attachment 4.1 - GENERAL TRADEMARK ASSIGNMENT 

WHEREAS, ALZA CORPORATION, a Delaware corporation, having its place of business at 1900 Charleston Road, Mountain View, California
94043 (hereinafter called “Assignor”), has established certain rights in various countries in and to the trademarks identified in the attached Exhibit A (together with any registrations and applications for registration therefor,
hereinafter “Trademarks”); and 
 WHEREAS, THE MACROFLUX CORPORATION, a Delaware Corporation, (hereinafter called
“Assignee”), desires to acquire all of Assignor’s right, title and interest in and to the Trademarks; and 
 NOW THEREFORE,
for good and valuable consideration, receipt of which is hereby acknowledged, Assignor does hereby assign and transfer unto Assignee, and Assignee does hereby accept, all of Assignor’s rights, title and interest in and to the Trademarks in all
countries where such rights exist together with the goodwill of the business symbolized by the Trademarks, Assignor undertakes within two years hereof to duly execute, or have duly executed by its subsidiaries, any further documents reasonably
necessary to record the transfer of title effected hereby, as prepared by Assignee. 
 IN WITNESS WHEREOF, Assignor and Assignee have caused
these presents to be executed by their duly authorized officers or agents on this             day of             , 2006. 

 

	
	ASSIGNOR: ALZA CORPORATION
	
	BY:                                     
                                         
           
	
	TITLE:                                     
                                         
    
	
	NOTARIZATION


  
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	ASSIGNEE: THE MACROFLUX CORPORATION
	
	BY:                                     
                                         
                   
	
	TITLE:                                     
                                         
             
	
	NOTARIZATION


  
 CONFIDENTIAL MATERIALS
OMITTED AND FILED SEPARATELY WITH THE SECURITIES AND 
 EXCHANGE COMMISSION. DOUBLE ASTERISKS [**] DENOTE OMISSIONS. 







 EXHIBIT A 
  


									
	 Mark
	  	Class	  	Country	  	App./Reg. No.	  	App./Reg. Date
	 MACROFLUX
	  	05	  	ARGENTINA	  	2648182	  	May 17, 2006
					
	 MACROFLUX
	  	10	  	ARGENTINA	  	2648183	  	May 18, 2006
					
	 MACROFLUX
	  	42	  	ARGENTINA	  	2648184	  	May 19, 2006
					
	 MACROFLUX
	  	05,10,42	  	AUSTRALIA	  	1099430	  	February 16, 2006
					
	 MACROFLUX
	  	05,10	  	AUSTRALIA	  	1050824	  	February 16, 2006
					
	 MACROFLUX
	  	05	  	BRAZIL	  	828132097	  	February 07, 2006
					
	 MACROFLUX
	  	10	  	BRAZIL	  	828132070	  	February 07, 2006
					
	 MACROFLUX
	  	42	  	BRAZIL	  	828132062	  	February 07, 2006
					
	 MACROFLUX
	  		  	CANADA	  	875880	  	April 22, 1998
					
	 MACROFLUX
	  	05,10,42	  	E.U.	  	819730	  	April 19, 2006
					
	 MACROFLUX
	  	05,10,42	  	HONG KONG	  	300572751	  	January 26, 2006
					
	 MACROFLUX
	  	05	  	INDIA	  	1419150	  	February 06, 2006
					
	 MACROFLUX
	  	42	  	INDIA	  	1419152	  	February 06, 2006
					
	 MACROFLUX
	  	10	  	INDIA	  	1419151	  	February 06, 2006
					
	 MACROFLUX
	  	05	  	ISRAEL	  	187772	  	February 22, 2006
					
	 MACROFLUX
	  	10	  	ISRAEL	  	187773	  	February 22, 2006
					
	 MACROFLUX
	  	42	  	ISRAEL	  	187774	  	February 22, 2006
					
	 MACROFLUX
	  	05,10,42	  	JAPAN	  	4410279	  	August 01, 2000
					
	 MACROFLUX
	  	05,10,42	  	S. KOREA	  	0450	  	February 08, 2006
					
	 MACROFLUX
	  	05	  	MALAYSIA	  	04863	  	March 28, 2006
					
	 MACROFLUX
	  	42	  	MALAYSIA	  	04865	  	March 28, 2006
					
	 MACROFLUX
	  	10	  	MALAYSIA	  	04864	  	March 28, 2006


  
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	 MACROFLUX
	  	42	  	MEXICO	  	924368	  	February 28, 2006
					
	 MACROFLUX
	  	05,10,42	  	NEW ZEALAND	  	741896	  	January 25, 2006
					
	 MACROFLUX
	  	05,10,42	  	NORWAY	  	01277	  	February 7, 2006
					
	 MACROFLUX
	  	05,10,42	  	NORWAY	  	02451	  	March 9, 2006
					
	 MACROFLUX
	  	05	  	SINGAPORE	  	02858J	  	February 14, 2006
					
	 MACROFLUX
	  	10	  	SINGAPORE	  	028591	  	February 14, 2006
					
	 MACROFLUX
	  	42	  	SINGAPORE	  	02860B	  	February 14, 2006
					
	 MACROFLUX
	  	05	  	SOUTH AFRICA	  	02108	  	February 01, 2006
					
	 MACROFLUX
	  	10	  	SOUTH AFRICA	  	02109	  	February 01, 2006
					
	 MACROFLUX
	  	42	  	SOUTH AFRICA	  	02110	  	February 01, 2006
					
	 MACROFLUX
	  	05	  	TAIWAN	  	5192	  	February 03, 2006
					
	 MACROFLUX
	  	10	  	TAIWAN	  	5193	  	February 03, 2006
					
	 MACROFLUX
	  	42	  	TAIWAN	  	5194	  	February 03, 2006
					
	 MACROFLUX
	  	05	  	THAILAND	  	624920	  	March 28, 2006
					
	 MACROFLUX
	  	10	  	THAILAND	  	616583	  	January 31, 2006
					
	 MACROFLUX
	  	42	  	THAILAND	  	616584	  	January 31, 2006
					
	 MACROFLUX
	  	05,10	  	U.S.	  	2872091	  	August 10, 2004
					
	 MACROFLUX
	  	05	  	VENEZUELA	  	01523	  	January 30, 2006
					
	 MACROFLUX
	  	10	  	VENEZUELA	  	01524	  	January 30, 2006
					
	 MACROFLUX
	  	42	  	VENEZUELA	  	01522	  	January 30, 2006
					
	 MACROFLUX
	  	05,10,42	  	VIETNAM	  	01518	  	February 06, 2006


  
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 TRADEMARK ASSIGNMENT 

WHEREAS, JANSSEN PHARMACEUTICA N.V., a Belgium corporation, having its place of business at Turnhoutseweg 30 B-2340 Beerse, Belgium
(hereinafter called “Assignor”), has established certain rights in various countries in and to the trademarks identified in the attached Exhibit A (together with any registrations and applications for registration therefor, hereinafter
“Trademarks”); and 
 WHEREAS, THE MACROFLUX CORPORATION, a Delaware Corporation, (hereinafter called
“Assignee”), desires to acquire all of Assignor’s right, title and interest in and to the Trademarks; and 
 NOW THEREFORE,
for good and valuable consideration, receipt of which is hereby acknowledged, Assignor does hereby assign and transfer unto Assignee, and Assignee does hereby accept, all of Assignor’s rights, title and interest in and to the Trademarks in all
countries where such rights exist together with the goodwill of the business symbolized by the Trademarks. Assignor undertakes within two years hereof to duly execute, or have duly executed by its subsidiaries, any further documents reasonably
necessary to record the transfer of title effected hereby, as prepared by Assignee. 
 IN WITNESS WHEREOF, Assignor and Assignee have caused
these presents to be executed by their duly authorized officers or agents on this              day of
                    , 2006. 
  

	
	ASSIGNOR: JANSSEN PHARMACEUTICA N.V.
	
	BY:                                     
                                         
                
	
	TITLE:                                     
                                         
          
	
	NOTARIZATION:


  
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	ASSIGNEE: THE MACROFLUX CORPORATION
	
	BY:                                     
                                         
                   
	
	TITLE:                                     
                                         
             
	
	NOTARIZATION:


  
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 EXHIBIT A 
  

									
	 Mark
	  	 Class
	  	 Country
	  	 App./Reg. No.
	  	 App./Reg. Date

	 MACROFLUX
	  	05, 10, 42	  	BENELUX	  	1102532	  	 February 1,

2006

					
	 MACROFLUX
	  	05, 10, 42	  	INTERNATIONAL	  	880221	  	March 1, 2006
		  		  	REGISTRATION	  		  	
		  		  	(Valid in Bulgaria,
N. Korea, Russia,
Switzerland)	  		  	


  
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 Attachment 4.5 - Trademark Assignment Form 

THIS TRADEMARK ASSIGNMENT (the “Assignment”) is made and entered into as of this
             day of                     , 2006 and is made effective as of
                    , 2006 (“Effective Date”, from ASSIGNOR NAME AND ADDRESS (“Assignor”) to ASSIGNEE NAME AND
ADDRESS (“Assignee”). 
 WHEREAS, Assignor is the sole and exclusive owner of the entire right, title and interest in, to and
under the trademarks and the trademark registration set forth on the Exhibit A (collectively, the “Trademark”), and the goodwill of the business associated therewith; 

WHEREAS, Assignee wishes to acquire and Assignor wishes to assign all right, title and interest in and to the Trademark, together with the
goodwill of the business in connection with which the Trademark is used; 
 NOW, THEREFORE, for the good and valuable consideration, the
receipt and sufficiency of which are hereby expressly acknowledged, the Assignor hereby sells, assigns and transfers to Assignee, all of the Assignor’s right, title and interest in and to said Trademark, together with the good will of the
business symbolized by said Trademark, and the Assignor’s entire right, title and interest in and to any and all claims and demands it may have, at law or in equity, for past infringement of Trademark. 

  
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 IN WITNESS WHEREOF, the Assignor and Assignee have caused this Assignment of Trademarks to be
executed and sealed by their respective duly authorized officers as of the dates noted below. 
  

			
	ASSIGNOR
		
	By:	 	  

		
	Name:	 	  

		
	Title:	 	  

		
	Date:	 	  

	
	ASSIGNEE
		
	By:	 	  

		
	Name:	 	  

		
	Title:	 	  

		
	Date:	 	  




  
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 EXHIBIT A — TRADEMARKS 

 

					
	 Title
	  	Issue Date	  	Registration
No.
		  		  	


  
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 Attachment 10.1 - Key Terms for a 

Product Development and Commercialization Agreement 

Macroflux® Nesiritide 

 

			
		
	Parties:	  	ALZA Corporation or its affiliated company designated by ALZA (“ALZA”) and NewCo (“NewCo”).
		
	Agreement:                                   
                     	  	A Product Development and Commercialization Agreement (the “Agreement”) incorporating the terms and conditions set forth herein, and other terms and conditions as the parties may agree, governing the development and
commercialization of a Macroflux® nesiritide product.
		
	Drug:	  	Nesiritide, or any analog or derivative thereof, in its pure form or in the formulation(s) provided to NewCo by ALZA.
		
	System:	  	NewCo’s proprietary system for the passive, diffusion-mediated delivery of therapeutic or prophylactic agents into or through the skin from a microprojection array having a plurality of microprojections which pierce at least
through the outmost layer (i.e., the stratum corneum layer) of the skin (a “Microprojection System”), which array is coated with such therapeutic or prophylactic agents; or (b) NewCo’s proprietary system for diffusion-mediated
delivery of therapeutic or prophylactic agents into or through the skin by way of pathways formed by a Microprojection System.
		
	Product:	  	A product combining the Drug with the System developed by NewCo pursuant to the Agreement.
		
	License Grant:	  	NewCo would grant ALZA an exclusive license under any and all intellectual property, patents, trade secrets and know-how now or hereafter owned or controlled by NewCo which are reasonably necessary or useful to make, have made, use,
import, offer for sale and sell the Product, solely for purposes of making, having made, using (including performing development work), importing, offering for sale and selling the Product in the Territory during the term of, and in accordance with,
the Agreement.
		
	Territory:	  	Worldwide.


  
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	 Product Development: 
	NewCo would undertake the technical development of the Product in accordance with work plans and cost estimates prepared by NewCo and pre-approved by ALZA. ALZA would supply Drug to NewCo at no cost, and would reimburse NewCo on a monthly basis
for its internal development costs at the NewCo FTE Rate plus [**] of any out-of-pocket costs incurred by NewCo in connection with such development activities. 

  

	 	“NewCo FTE Rate” would mean an annual FTE rate of [**] (which would be adjusted on an annual basis in accordance with the U.S. Department of Labor, Bureau of Labor Statistics Consumer Price Index-Urban Wage
Earners and Clerical Workers for the San Francisco-Oakland-San Jose, CA metropolitan area). 

  

	 	ALZA would be responsible for clinical development and regulatory activities for the Product in the Territory, and would bear related expenses. ALZA would use commercially reasonable efforts to perform the Product
development activities consistent with the efforts ALZA devotes to products of similar market potential and in similar product lifecycle positions and based on conditions then prevailing with respect to the applicable Product and the relevant
markets. 

 Commercialization 

	 Rights and Term: 
	ALZA would be granted the exclusive right (including the right to sublicense such right to a third party) to market the Product in the Territory. Upon receipt of regulatory approvals, ALZA would use commercially reasonable efforts (consistent
with the efforts ALZA devotes to products of similar market potential and in similar product lifecycle positions and based on conditions then prevailing with respect to the applicable Product and the relevant markets) to commence and continue
diligent commercialization of the Product during the term of the Agreement. The term of the Agreement would be for the commercial life of the Product. 

  

	 Exclusivity: 
	During the term of the Agreement, NewCo would not conduct (itself or with a third party) any material development or commercialization activities with respect to any product (other than the Product) incorporating a natriuretic peptide,
stresscopin, urocortin, or any analog or derivative of a natriuretic peptide, stresscopin, or urocortin, into any System. 

  

	 Upfront Payment: 
	None. 


  
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	 Milestone Payments: 
	ALZA would pay NewCo the following one-time Milestone Payments within forty five (45) days of each noted occurrence: 

  

	 	[**] 

  

	*	“Net Sales” would mean the total amount billed or invoiced in United States dollars (or converted thereto in accordance with the Agreement) on sales of the Product by ALZA, its affiliates or sublicensees to
independent, unrelated third parties (other than sublicensees) such as wholesalers in bona fide arm’s length transactions, less the following deductions, in each case related specifically to the Product and actually allowed and taken by such
third parties or accrued in accordance with generally accepted accounting principles as consistently applied across ALZA’s and its 


  
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	 Product Payments: 
	ALZA would make quarterly payments (“Product Payments”) to NewCo within 45 days after the end of each calendar quarter, until, on a country-by-country basis, the date of expiry of the last to expire of patents owned or licensed
by NewCo having a valid claim covering the Product in such country, at which point ALZA would have a fully paid-up license in such country. Product Payments would be determined by multiplying the aggregate worldwide Net Sales of the Product during
each calendar year by the applicable percentage rates, determined based on the cumulative, aggregate worldwide Net Sales of the Product for the then current calendar year as follows: 


 

					
	 For cumulative, aggregate
 worldwide Net
Sales of the
 Product in the then current
 calendar year within
the
 respective intervals below

($U.S. Million):
	  	The Product Payment Rate as a
percentage of worldwide,
aggregate Net Sales within
such intervals during the then
current
calendar year would
be:	 
	 [**]
	  	 	[	**] 
	 [**]
	  	 	[	**] 
	 [**]
	  	 	[	**] 

  

	 	The total Product Payment for each calendar quarter would be the sum of the amounts calculated in each interval set forth above. For example, if in the first quarter in a calendar year, aggregate worldwide Net Sales
were [**], the Product Payment percentage rate for such quarter would be [**], resulting in a quarterly Product Payment of [**]. If in the second quarter of such calendar year, 


affiliates’ products (as adjusted from time to time to reflect amounts actually incurred) and not otherwise recovered by or reimbursed to ALZA: [**] In
the case of any sale or other disposal for value, such as barter or counter-trade, of any Product other than in an arm’s length transaction exclusively for money, Net Sales would be calculated as above on a fair market price of the Product in
the country of sale or disposal. For clarity, Net Sales would not include the value of Product provided by ALZA for clinical trials, or donations. 

  
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	 	aggregate worldwide Net Sales were [**], the Product Payment percentage rates for such quarter would be as follows: [**] for [**] of such Net Sales, and [**] for [**] of such Net Sales, resulting in a quarterly Product
Payment of [**]. If in the third quarter of such calendar year, aggregate worldwide Net Sales were [**], the Product Payment percentage rates for such quarter would be as follows: [**] for [**] of such Net Sales, and [**] for [**] of such Net Sales,
resulting in a quarterly Product Payment of [**]. 

  

	 	Net Sales of the Product would be excluded from the aggregate worldwide net sales of products used to calculate the product payments paid to ALZA by NewCo under the terms of the Macroflux® technology licensing agreement. 

  

	 Manufacture and Supply:  
	NewCo would use commercially reasonable efforts to manufacture ALZA’s requirements of the Product through completion of Phase II clinical studies. ALZA would supply Drug to NewCo at no cost, and would reimburse NewCo on a monthly basis for
NewCo’s costs associated with manufacture of ALZA’s Preclinical, and Phase I and Phase II clinical requirements of the Product with such costs calculated as the sum of the NewCo FTE Rate plus [**] of any out-of-pocket costs
plus [**] of the cost of any new capital assets acquired by NewCo specifically for, and exclusively dedicated to the manufacture of Product (collectively, the “Manufacturing Costs”). Any capital assets (i) acquired by NewCo
specifically for, and exclusively dedicated to the manufacture of Product, and (ii) for which ALZA had reimbursed NewCo would be owned by ALZA. 

  

	 	At ALZA’s request, NewCo also would be responsible for manufacturing ALZA’s Phase III clinical requirements of the Product, provided that such manufacturing could be accomplished using NewCo’s existing
manufacturing facilities and without compromising NewCo’s ability to manufacture its existing requirements of its own products or to satisfy its prior manufacturing obligations to third parties (if any). ALZA would supply Drug to NewCo at no
cost, and would reimburse NewCo on a monthly basis for its Manufacturing Costs associated with manufacture of ALZA’s Phase III clinical requirements of the Product. In the event that manufacture of ALZA’s Phase III clinical requirements of
Product could not be accomplished using NewCo’s existing manufacturing facilities, the parties would discuss in good faith commercially reasonable alternative 


  
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 arrangements for manufacturing the Product including the following options: 

 

	 	(A)	NewCo would be responsible for development and scale-up of manufacturing processes for the Product and would transfer to a third party contract manufacturing organization (“CMO”) selected by ALZA and
reasonably acceptable to NewCo, such manufacturing technology and know-how as would be necessary or reasonably useful to enable such CMO to manufacture ALZA’s Phase III clinical requirements and commercial requirements of the Product. ALZA
would be responsible for all costs associated with the manufacture of its Phase III clinical requirements of the Product and its commercial requirements of the Product by such CMO and would reimburse NewCo for all internal costs incurred by NewCo in
connection with the transfer of manufacturing technology and know-how to such CMO at the NewCo FTE Rate plus [**] of any out-of-pocket costs incurred by NewCo in connection with such activities; and, 


 

	 	(B)	ALZA would provide capital and infrastructure investments required for any necessary incremental expansion of NewCo’s existing Phase III and/or commercial-scale manufacturing facilities, and NewCo would be
responsible for manufacturing ALZA’s Phase III clinical and/or commercial requirements of the Product. ALZA would supply Drug to NewCo at no cost, and would reimburse NewCo on a monthly basis for its Manufacturing Costs associated with
manufacture of Phase III clinical requirements of the Product. The parties would negotiate in good faith commercially reasonable terms for the manufacture and supply of ALZA’s commercial requirements of the Product. Until the parties agreed
upon fixed supply prices (which would be negotiated promptly after the manufacture and acceptance of three ICH batches of the Product, and which would include annual price increases in accordance with the U.S. Producers’ Price Index), the
supply price would be [**] of NewCo’s fully allocated manufacturing cost. ALZA would supply Drug to NewCo at no cost. 


Proprietary 

	 Rights: 
	Inventions arising out of the Agreement would be the property of ALZA if and to the extent related to the Drug itself, or the manufacture 


  
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	 	or use thereof (including the use of the Drug with the System). All other inventions arising out of the Agreement would be the property of NewCo, including those related to the System, or the manufacture or use thereof
without the Drug (including the use of the System with drugs other than the Drug). 

  

	 Indemnification: 
	ALZA would indemnify NewCo for claims arising from the manufacture, use or sale of the Product, except to the extent due to NewCo’s negligence or intentional misconduct. NewCo would warrant that, at the time of shipment, Product
manufactured by NewCo would meet the then agreed-upon specifications, would be manufactured in accordance with cGMP, and would not be adulterated or misbranded due to any action, or failure to act, of NewCo. NewCo would indemnify ALZA for breach of
this warranty; provided, however, that NewCo would not be liable for (i) misbranding with respect to any Product labeling or package insert text provided or used by ALZA or its Affiliates, subcontractors or agents, or any translation thereof;
or (ii) any adulteration, misbranding, failure to meet agreed-upon specifications or GMP violation due to handling or packaging of the Product by ALZA or its Affiliates, subcontractors or agents. NewCo’s warranty would not apply to or
cover any Product that had not been stored under the required conditions after leaving NewCo or to any product handling by anyone other than NewCo, or any adulteration occurring after the Product leaves NewCo. 


 

	 Termination: 
	ALZA would be able to terminate the Agreement at any time upon 90 days’ written notice to NewCo. NewCo would be able to terminate the Agreement on 30 days’ written notice to ALZA for ALZA’s material breach of the Agreement. If
NewCo notified ALZA that it was terminating the Agreement due to breach, ALZA would have the rights to cure the breach or, if such breach could not be cured within such notification period, such additional reasonable amount of time, prior to the
termination becoming effective. 

 THIS DOCUMENT OUTLINES THE GENERAL BUSINESS TERMS FOR THE AGREEMENT. OTHER TERMS AND CONDITIONS WOULD
APPLY. ALL TERMS ARE SUBJECT TO APPROVAL BY ALZA AND JOHNSON & JOHNSON MANAGEMENT, AND NEGOTIATION AND EXECUTION OF A DEFINITIVE AGREEMENT. 

  
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 Attachment 16.3.4- 

Disclosures 
  

	1.	Interactions and communications relating to the Interim Development Agreement between ALZA Corporation and [**] and its affiliates [**] and [**] regarding Contract [**], and any research and development conducted
pursuant to such agreement. 

  

	2.	Interactions and communications relating to the Material Evaluation Agreement between ALZA Corporation and [**] dated [**], and any research and development conducted pursuant to such Agreement. 


 

	3.	Interactions and communications relating to the opposition filed by [**] in connection with [**]. 


  
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 Attachment 17.2 - Arbitration Proceedings 

(a) Any dispute, claim or controversy arising from or related in any way to this Agreement or the interpretation, application, breach,
termination or validity thereof, including any claim of inducement of this Agreement by fraud or otherwise, will be submitted for resolution to arbitration pursuant to the rules then pertaining of the CPR Institute for Dispute Resolution for
Non-Administered Arbitration (available at www.cpradr.org/arb-rules.htm), or successor (“CPR”), except where those rules conflict with these provisions, in which case these provisions control. The arbitration will be held in Los Angeles,
California. 
 (b) The panel will consist of three arbitrators chosen from the CPR Panels of Distinguished Neutrals (or, by agreement, from
another provider of arbitrators) each of whom is a lawyer with at least 15 years experience with a law firm or corporate law department of over 25 lawyers or who was a judge of a court of general jurisdiction. In the event the aggregate damages
sought by the claimant are stated to be less than $5 million, and the aggregate damages sought by the counter claimant are stated to be less than $5 million, and neither side seeks equitable relief, then a single arbitrator will be chosen, having
the same qualifications and experience specified above. Each arbitrator will be neutral, independent, disinterested, impartial and will abide by The CPR-Georgetown Commission Proposed Model Rule for the Lawyer as Neutral available at
www.cpradr.org/cpr-george.html. 
 (c) The parties agree to cooperate (1) to attempt to select the arbitrator(s) by agreement
within 45 days of initiation of the arbitration, including jointly interviewing the final candidates, (2) to meet with the arbitrator(s) within 45 days of selection and (3) to agree at that meeting or before upon procedures for discovery
and as to the conduct of the hearing which will result in the hearing being concluded within no more than nine (9) months after selection of the arbitrator(s) and in the award being rendered within 60 days of the conclusion of the hearings, or
of any post hearing briefing, which briefing will be completed by both sides within 45 days after the conclusion of the hearings. 
 (d) In
the event the parties cannot agree upon selection of the arbitrator(s), the CPR will select arbitrator(s) as follows: CPR will provide the parties with a list of no less than 25 proposed arbitrators (15 if a single arbitrator is to be selected)
having the credentials referenced above. Within 25 days of receiving such list, the parties will rank at least 65% of the proposed arbitrators on the initial CPR list, after exercising cause challenges. The parties may then interview the five
candidates (three if a single arbitrator is to be selected) with the highest combined rankings for no more than one 

  
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hour each and, following the interviews, may exercise one peremptory challenge each. The panel will consist of the remaining three candidates (or one, if one arbitrator is to be selected) with
the highest combined rankings. In the event these procedures fail to result in selection of the required number of arbitrators, CPR will select the appropriate number of arbitrators from among the members of the various CPR Panels of Distinguished
Neutrals, allowing each side challenges for cause and three peremptory challenges each. In the event the dispute, claim or controversy relates to the validity or infringement of the Licensed Patents, Future ALZA Patents and TMC Patents, the
arbitrator will be registered before the United States Patent and Trademark Office and have experience in patent litigation. 
 (e) In the
event the parties cannot agree upon procedures for discovery and conduct of the hearing meeting the schedule set forth in paragraph c above, then the arbitrator(s) will set dates for the hearing, any post hearing briefing, and the issuance of the
award in accord with the paragraph c schedule. The arbitrator(s) will provide for discovery according to those time limits, giving recognition to the understanding of the parties that they contemplate reasonable discovery, including document demands
and depositions, but that such discovery be limited so that the paragraph c schedule may be met without difficulty. In no event will the arbitrator(s), absent agreement of the parties, allow more than a total of ten days for the hearing or permit
either side to obtain more than a total of 40 hours of deposition testimony from all witnesses, including both fact and expert witnesses, or serve more than 20 individual requests for documents, including subparts, or 20 individual requests for
admission or interrogatories, including subparts. Multiple hearing days will be scheduled consecutively to the greatest extent possible. 

(f) The arbitrator(s) must render their award by application of the substantive law of Pennsylvania and are not free to apply “amiable
compositeur” or “natural justice and equity.” The arbitrator(s) will 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
will be made and will, upon request, be made available to either party. The arbitrator(s) will have power to exclude evidence on grounds of hearsay, prejudice beyond its probative value, redundancy, or irrelevance and no award will be overturned by
reason of such ruling on evidence. To the extent possible, the arbitration hearings and award will be maintained in confidence. 
 (g) In the
event the panel’s award exceeds $5 million in monetary damages or includes or consists of equitable relief, or rejects a claim in excess of that amount or for that relief, 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, 

  
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failing agreement within seven working days, pursuant to the selection procedures specified in paragraph d above. If CPR cannot provide such services, the parties will together select another
provider of arbitration services that can. No Appeal Arbitrator will be selected unless he or she can commit to rendering a decision within forty five days following oral argument as provided in this paragraph. Any such review must be initiated
within thirty (30) days following the rendering of the award referenced in f above. 
 (h) The Appeal Arbitrator will 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 will 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 four
(4) hours of oral argument evenly divided between the parties. The party seeking review must submit its opening brief and any reply brief within seventy five (75) and one hundred thirty (130) days, respectively, following the date of
the award under review, whereas the opposing party must submit its responsive brief within one hundred ten (110) days of that date. Oral argument will take place within five (5) months after the date of the award under review, and the
Appeal Arbitrator will render a decision within forty five (45) days following oral argument. That decision will be final and not subject to further review, except pursuant to the Federal Arbitration Act. 

(i) The parties consent to the jurisdiction of the Federal District Court for the district in which the arbitration is held for the enforcement
of these provisions and the entry of judgment on any award rendered hereunder (including after review by the Appeal Arbitrator where such an appeal is pursued). Should such court for any reason lack jurisdiction, any court with jurisdiction will act
in the same fashion. 
 (j) Each 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 appropriate court provisional remedies such as attachment, preliminary injunction, replevin, etc. to avoid irreparable harm, maintain the status quo, or preserve the subject matter of the
arbitration. 
 (k) EACH PARTY HERETO WAIVES ITS RIGHT TO TRIAL OF ANY ISSUE BY JURY. 

  
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 (1) EACH PARTY HERETO WAIVES ANY CLAIM TO PUNITIVE, EXEMPLARY OR MULTIPLIED DAMAGES FROM THE
OTHER. 
 (m) EACH PARTY HERETO WAIVES ANY CLAIM OF CONSEQUENTIAL DAMAGES FROM THE OTHER. 

(n) EACH PARTY HERETO WAIVES ANY CLAIM FOR ATTORNEYS’ FEES AND COSTS AND PREJUDGMENT INTEREST FROM THE OTHER. 

13.2 Mediation. 
 (a) 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 will, before submission to arbitration, first be mediated through non binding mediation in accordance with The CPR Mediation Procedure then in effect of the CPR Institute for Dispute Resolution (CPR) available
at www.cpradr.org/m_proced.htm, except where that procedure conflicts with these provisions, in which case these provisions control. The mediation will be conducted in Philadelphia, Pennsylvania and will be attended by a senior executive with
authority to resolve the dispute from each of the operating companies that are parties. 
 (b) The mediator will be neutral, independent,
disinterested and will be selected from a professional mediation firm such as ADR Associates or JAMS/ENDISPUTE or CPR. 
 (c) The parties
will promptly confer in an effort to select a mediator by agreement. In the absence of such an agreement within 10 days of initiation of the mediation, the mediator will be selected by CPR as follows: CPR will provide the parties with a list of at
least 15 names from the CPR Panels of Distinguished Neutrals. Each party will exercise challenges for cause, two peremptory challenges, and rank the remaining candidates within 5 working days of receiving the CPR list. The parties may together
interview the three top ranked candidates for no more than one hour each and, after the interviews, may each exercise one peremptory challenge. The mediator will be the remaining candidate with the highest aggregate ranking. 

(d) The mediator will confer with the parties to design procedures to conclude the mediation within no more than 45 days after initiation.
Under no circumstances may the commencement of arbitration above be delayed more than 45 days by the mediation process specified herein absent contrary agreement of the parties. 

(e) Each 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. 

  
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 (f) Each 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. 

  
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