Document:

Exhibit 10(a) 

CONSENT OF INDEPENDENT
REGISTERED PUBLIC ACCOUNTING FIRM 

We consent to the incorporation by
reference in this Amendment No. 24 to Registration Statement No. 811-21162 on Form N-1A
of our report dated December 26, 2007, relating to the financial statements and financial
highlights of BlackRock Core Principal Protected Fund of BlackRock Principal Protected
Trust (the “Fund”) appearing in the Annual Report on Form N-CSR of the Fund for the year
ended October 31, 2007, and of our report dated December 26, 2007, relating to the
financial statements and financial highlights of Master Large Cap Core Portfolio of
Master Large Cap Series LLC (the “Master LLC”) appearing in the Annual Report on Form
N-CSR of the Master LLC for the year ended October 31, 2007, and to the references to us
under the headings “Independent Registered Public Accounting Firm” and “Financial
Statements” in Part B of this Registration Statement. 

/s/ Deloitte & Touche LLP 

Princeton, New Jersey 

February 27, 2008Exhibit 10(b) 

CONSENT OF
INDEPENDENT REGISTERED ACCOUNTING FIRM 

The Board of Directors 

Ambac Assurance Corporation: 

We consent to the  incorporation  by
reference in the registration  statement on Form N-1A (Investment  Company Act No.
811-21162) of the Blackrock Core Principal  Protected  Fund (the  “Registrant”),  of our
report dated February 28, 2007 on the consolidated  financial  statements of Ambac
Assurance  Corporation and subsidiaries as of December 31, 2006 and 2005,  and for each
of the years in the three-year  period ended December 31, 2006,  which report appears in
the Annual Report on Form 10-K of Ambac  Financial  Group,  Inc.,  which was filed with
the Securities and Exchange  Commission on March 1, 2007.  Our report  refers to changes,
 in 2006, in Ambac  Assurance  Corporation’s  methods of accounting  for variable
interest entities and stock-based compensation. 

/s/ KPMG LLP 

New York, New York 
February 28, 2008exv4wxayx3y

 

Exhibit 4(a)(3)

RESEARCH, DEVELOPMENT AND

COMMERCIALIZATION AGREEMENT

by and among

AMERICAN HOME PRODUCTS CORPORATION

acting through

AMERICAN HOME PRODUCTS CORPORATION’S

WYETH-AYERST LABORATORIES DIVISION,

and

NEURALAB LIMITED

March 17, 2000

CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

 

 

Table of Contents

	 	 	 	 	 	 	 
	 	 	 	 	Page	 
	1. DEFINITIONS	 	 	1	 
	 
	 	 	 	 	 	 
	1.1.
	 	“Ab Peptide” or “Ab”	 	 	1	 
	1.2.
	 	“Affiliate(s)”	 	 	1	 
	1.3.
	 	“AHPC Forecasted Share of Pro-Forma Net Profits”	 	 	2	 
	1.4.
	 	“AHPC In-License”	 	 	2	 
	1.5.
	 	“AHPC Intellectual Property”	 	 	2	 
	1.6.
	 	“AHPC Know-How”	 	 	2	 
	1.7.
	 	“AHPC Manufacturing Profit”	 	 	2	 
	1.8.
	 	“AHPC Non-Collaboration Invention”	 	 	2	 
	1.9.
	 	“AHPC Patent Rights”	 	 	2	 
	1.10.
	 	“AHPC Pre-tax Profit”	 	 	3	 
	1.11.
	 	“AHPC Prior Invention”	 	 	3	 
	1.12.
	 	“AHPC Share of Pro-Forma Net Profit”	 	 	3	 
	1.13.
	 	“Assigned Sales Force Effort”	 	 	3	 
	1.14.
	 	“Base Price”	 	 	3	 
	1.15.
	 	“Betabloc”	 	 	3	 
	1.16.
	 	“Blocking Third Party Intellectual Property”	 	 	3	 
	1.17.
	 	“Calendar Quarter”	 	 	4	 
	1.18.
	 	“Change of Control”	 	 	4	 
	1.19.
	 	“Collaboration Intellectual Property”	 	 	4	 
	1.20.
	 	“Collaboration Inventions”	 	 	4	 
	1.21.
	 	“Collaboration Know-How”	 	 	4	 
	1.22.
	 	“Collaboration Patent Rights”	 	 	4	 
	1.23.
	 	“Commercialization”	 	 	4	 
	1.24.
	 	“Commercially Reasonable Efforts”	 	 	4	 
	1.25.
	 	“Confidential Information”	 	 	5	 
	1.26.
	 	“Control” or “Controlled”	 	 	5	 
	1.27.
	 	“Copyright”	 	 	6	 
	1.28.
	 	“Cost of Goods Manufactured for Sale”	 	 	6	 
	1.29.
	 	“Current Clinical Trials”	 	 	6	 
	1.30.
	 	“Detail”	 	 	6	 
	1.31.
	 	“Detail Cost”	 	 	6	 
	1.32.
	 	“Development”	 	 	6	 
	1.33.
	 	“Distribution Expenses”	 	 	6	 
	1.34.
	 	“Effective Date”	 	 	7	 
	1.35.
	 	“ELAN”	 	 	7	 
	1.36.
	 	“ELAN Forecasted Share of Pro Forma Net Profits”	 	 	7	 
	1.37.
	 	“ELAN In-Licenses”	 	 	7	 
	1.38.
	 	“ELAN Intellectual Property”	 	 	7	 
	1.39.
	 	“ELAN Know-How”	 	 	7	 

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	 	 	 	 	Page	 
	1.40.
	 	“ELAN/Lilly Litigation”	 	 	7	 
	1.41.
	 	“ELAN/Lilly Patent Rights”	 	 	7	 
	1.42.
	 	“ELAN Manufacturing Profit”	 	 	8	 
	1.43.
	 	“ELAN Non-Collaboration Invention”	 	 	8	 
	1.44.
	 	“ELAN Patent Rights”	 	 	8	 
	1.45.
	 	“ELAN Pre-tax Profit”	 	 	8	 
	1.46.
	 	“ELAN Prior Invention”	 	 	8	 
	1.47.
	 	“ELAN Share of Pro-Forma Net Profit”	 	 	8	 
	1.48.
	 	“Enhancing Third Party Intellectual Property”	 	 	8	 
	1.49.
	 	“Entry Into Pivotal Clinical Trials”	 	 	9	 
	1.50.
	 	“Exchange Product”	 	 	9	 
	1.51.
	 	“FDA”	 	 	9	 
	1.52.
	 	“FD&C Act”	 	 	9	 
	1.53.
	 	“Field”	 	 	9	 
	1.54.
	 	“First Commercial Sale”	 	 	9	 
	1.55.
	 	“FTE”	 	 	9	 
	1.56.
	 	“Fully-Absorbed Standard Cost”	 	 	9	 
	1.57.
	 	“Global Research and Development Plan”	 	 	9	 
	1.58.
	 	“Good Clinical Practice" or "GCP”	 	 	10	 
	1.59.
	 	“Good Laboratory Practice" or "GLP”	 	 	10	 
	1.60.
	 	“Good Manufacturing Practice" or "GMP”	 	 	10	 
	1.61.
	 	“HSR Act”	 	 	10	 
	1.62.
	 	“HSR Clearance Date”	 	 	10	 
	1.63.
	 	“Improvement Product”	 	 	10	 
	1.64.
	 	“IND”	 	 	11	 
	1.65.
	 	“Interim Clinical Evaluation" or "ICE”	 	 	11	 
	1.66.
	 	“Invention”	 	 	11	 
	1.67.
	 	“Know-How”	 	 	11	 
	1.68.
	 	“Lilly”	 	 	11	 
	1.69.
	 	***	 	 	11	 
	1.70.
	 	“Manufacture", "Manufactured" or "Manufacturing”	 	 	11	 
	1.71.
	 	***	 	 	11	 
	1.72.
	 	“Net Sales”	 	 	11	 
	1.73.
	 	“Non-Collaboration Invention”	 	 	12	 
	1.74.
	 	“Patent Rights”	 	 	12	 
	1.75.
	 	“Pivotal Clinical Study”	 	 	12	 
	1.76.
	 	“Post-Approval Research”	 	 	12	 
	1.77.
	 	“Post-Approval Research and Regulatory Expenses”	 	 	12	 
	1.78.
	 	“Pre-Marketing Expenses”	 	 	13	 
	1.79.
	 	“Pre-tax Profit”	 	 	13	 

CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

-ii-

 

	 	 	 	 	 	 	 
	 	 	 	 	Page	 
	1.80.
	 	“Prior Invention”	 	 	13	 
	1.81.
	 	“Product”	 	 	13	 
	1.82.
	 	“Product Sales Forecast”	 	 	13	 
	1.83.
	 	“Pro-Forma Net Profit”	 	 	13	 
	1.84.
	 	“Promotion”	 	 	13	 
	1.85.
	 	“R&D Expenses”	 	 	13	 
	1.86.
	 	“Regulatory Approval”	 	 	14	 
	1.87.
	 	“Regulatory Approval Filing”	 	 	14	 
	1.88.
	 	“Regulatory Authority”	 	 	14	 
	1.89.
	 	“Research”	 	 	14	 
	1.90.
	 	“Research Term”	 	 	14	 
	1.91.
	 	“Research and Development Candidate" or "R&D Candidate”	 	 	14	 
	1.92.
	 	“Sales and Marketing Expenses”	 	 	14	 
	1.93.
	 	“Sales Force Effort”	 	 	15	 
	1.94.
	 	“Sample”	 	 	15	 
	1.95.
	 	“Sample Receipt Forms”	 	 	15	 
	1.96.
	 	“Sublicensee”	 	 	15	 
	1.97.
	 	“Territory”	 	 	15	 
	1.98.
	 	“Third Part(y/ies)”	 	 	15	 
	1.99.
	 	“Third Party License”	 	 	15	 
	1.100.
	 	“Third Party License Fee”	 	 	16	 
	1.101.
	 	“Trademark”	 	 	16	 
	1.102.
	 	“Working Capital Charges”	 	 	16	 
	1.103.
	 	Additional Definitions	 	 	16	 
	 
	 	 	 	 	 	 
	2. LICENSES	 	 	17	 
	 
	 	 	 	 	 	 
	2.1.
	 	Licenses to AHPC	 	 	17	 
	2.2.
	 	Licenses to ELAN	 	 	18	 
	2.3.
	 	Licensing and Sublicensing to Third Parties	 	 	19	 
	2.4.
	 	Exclusive Working Relationship	 	 	20	 
	2.5.
	 	Right of Reference	 	 	20	 
	2.6.
	 	No Other Rights	 	 	20	 
	 
	 	 	 	 	 	 
	3. MANAGEMENT OF COLLABORATION	 	 	20	 
	 
	 	 	 	 	 	 
	3.1.
	 	Joint Steering Committee	 	 	20	 
	3.2.
	 	Authority	 	 	24	 
	3.3.
	 	Project Coordinators	 	 	24	 
	3.4.
	 	Meetings of Chief Executive Officers	 	 	24	 
	3.5.
	 	Compliance with Laws	 	 	24	 
	 
	 	 	 	 	 	 
	4. RESEARCH AND DEVELOPMENT	 	 	24	 
	 
	 	 	 	 	 	 
	4.1.
	 	The Research and Development Programs	 	 	24	 
	4.2.
	 	The Research and Development Plans	 	 	25	 
	4.3.
	 	Funding of the Global Research and Development Plan.	 	 	27	 

-iii-

 

	 	 	 	 	 	 	 
	 	 	 	 	Page	 
	4.4.
	 	Reporting and Disclosure	 	 	30	 
	4.5.
	 	Disclosure	 	 	30	 
	 
	 	 	 	 	 	 
	5. MANUFACTURING AND REGULATORY MATTERS	 	 	30	 
	 
	 	 	 	 	 	 
	5.1.
	 	Manufacture and Supply of Products	 	 	30	 
	5.2.
	 	Labeling	 	 	32	 
	5.3.
	 	Regulatory Matters	 	 	33	 
	 
	 	 	 	 	 	 
	6. COMMERCIALIZATION OF PRODUCTS	 	 	34	 
	 
	 	 	 	 	 	 
	6.1.
	 	Commercialization in the Territory	 	 	34	 
	6.2.
	 	Accounting Considerations	 	 	40	 
	6.3.
	 	Product Pricing	 	 	41	 
	6.4.
	 	Diligence	 	 	41	 
	 
	 	 	 	 	 	 
	7. CONSIDERATION	 	 	41	 
	 
	 	 	 	 	 	 
	7.1.
	 	Reimbursement of Expenditures for Previously Developed Intellectual Property	 	 	41	 
	7.2.
	 	Additional Payments	 	 	41	 
	7.3.
	 	Sales Bonus	 	 	44	 
	7.4.
	 	Reports and Payments	 	 	44	 
	7.5.
	 	Maintenance of Records; Audits	 	 	45	 
	7.6.
	 	Interest	 	 	46	 
	7.7.
	 	GAAP	 	 	46	 
	 
	 	 	 	 	 	 
	8. INTELLECTUAL PROPERTY	 	 	46	 
	 
	 	 	 	 	 	 
	8.1.
	 	Ownership	 	 	46	 
	8.2.
	 	Joint Patent Committee	 	 	47	 
	8.3.
	 	Prosecution and Maintenance of Patent Rights	 	 	47	 
	8.4.
	 	Trademarks	 	 	49	 
	8.5.
	 	Enforcement of Patent Rights	 	 	49	 
	8.6.
	 	Third Party Claims	 	 	50	 
	8.7.
	 	Third Party Licenses	 	 	51	 
	8.8.
	 	Patent Marking	 	 	52	 
	8.9.
	 	Patent Certifications	 	 	52	 
	8.10.
	 	Certain Actions	 	 	52	 
	8.11.
	 	Limitation	 	 	53	 
	 
	 	 	 	 	 	 
	9. CONFIDENTIALITY	 	 	53	 
	 
	 	 	 	 	 	 
	9.1.
	 	Confidentiality	 	 	53	 
	9.2.
	 	Terms of Agreement	 	 	53	 
	9.3.
	 	Permitted Disclosures	 	 	54	 
	9.4.
	 	Publications	 	 	54	 

-iv-

 

	 	 	 	 	 	 	 
	 	 	 	 	Page	 
	10. REPRESENTATIONS AND WARRANTIES	 	 	54	 
	 
	 	 	 	 	 	 
	10.1.
	 	Representations and Warranties of Each Party.	 	 	54	 
	10.2.
	 	Additional Representations and Warranties of ELAN.	 	 	55	 
	10.3.
	 	Additional Representations and Warranties of AHPC	 	 	56	 
	10.4.
	 	Representation by Legal Counsel.	 	 	56	 
	10.5.
	 	No Inconsistent Agreements.	 	 	56	 
	10.6.
	 	Disclaimer.	 	 	56	 
	 
	 	 	 	 	 	 
	11. ***
	 	 	 	 	56	 
	 
	 	 	 	 	 	 
	      *** Approximately 9 lines omitted ***	 	 	 	 
	 
	 	 	 	 	 	 
	12. GOVERNMENT APPROVALS.	 	 	56	 
	 
	 	 	 	 	 	 
	12.1.
	 	HSR Filing.	 	 	57	 
	12.2.
	 	ELAN’s and AHPC’s Obligations.	 	 	57	 
	12.3.
	 	Additional Approvals.	 	 	57	 
	12.4.
	 	Termination.	 	 	57	 
	 
	 	 	 	 	 	 
	13. TERM AND TERMINATION.	 	 	57	 
	 
	 	 	 	 	 	 
	13.1.
	 	Term.	 	 	57	 
	13.2.
	 	Termination for Cause.	 	 	58	 
	13.3.
	 	Termination for Convenience.	 	 	59	 
	13.4.
	 	Termination Pursuant to Section 11.2.	 	 	60	 
	13.5.
	 	Termination for Failure to Reach Certain Net Sales Levels.	 	 	60	 
	13.6.
	 	Provision for Insolvency.	 	 	60	 
	13.7.
	 	Provision for Certain Changes of Control.	 	 	62	 
	13.8.
	 	Survival of Certain Obligations.	 	 	63	 
	 
	 	 	 	 	 	 
	14. PRODUCT LIABILITY, INDEMNIFICATION AND INSURANCE.	 	 	63	 
	 
	 	 	 	 	 	 
	14.1.
	 	Sharing of Product Liability Expenses.	 	 	63	 
	14.2.
	 	Indemnification by AHPC.	 	 	63	 
	14.3.
	 	Indemnification by ELAN.	 	 	64	 
	14.4.
	 	Procedure.	 	 	64	 
	14.5.
	 	Insurance.	 	 	65	 
	 
	 	 	 	 	 	 
	15. EXCHANGE PRODUCT.	 	 	65	 
	 
	 	 	 	 	 	 
	15.1.
	 	Exchange Product Offerings.	 	 	65	 
	 
	 	 	 	 	 	 
	 
	 	CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY	 	 	 	 
	 
	 	WITH THE SECURITIES AND EXCHANGE COMMISSION.	 	 	 	 
	 
	 	ASTERISKS (*) DENOTE SUCH OMISSIONS.	 	 	 	 

-v-

 

	 	 	 	 	 	 	 
	 	 	 	 	Page	 
	16. ASSIGNMENTS; CHANGES OF CONTROL	 	 	66	 
	 
	 	 	 	 	 	 
	16.1.
	 	Assignments	 	 	66	 
	16.2.
	 	Anti-Takeover Covenant	 	 	66	 
	 
	 	 	 	 	 	 
	17. MISCELLANEOUS	 	 	66	 
	 
	 	 	 	 	 	 
	17.1.
	 	Further Actions	 	 	66	 
	17.2.
	 	Force Majeure.	 	 	66	 
	17.3.
	 	Notices	 	 	67	 
	17.4.
	 	Amendment	 	 	68	 
	17.5.
	 	Waiver	 	 	68	 
	17.6.
	 	Severability	 	 	68	 
	17.7.
	 	Descriptive Headings	 	 	68	 
	17.8.
	 	Governing Law; Venue.	 	 	68	 
	17.9.
	 	Entire Agreement of the Parties	 	 	68	 
	17.10.
	 	Independent Contractors	 	 	69	 
	17.11.
	 	Debarment	 	 	69	 
	17.12.
	 	Counterparts	 	 	69	 
	17.13.
	 	NO CONSEQUENTIAL DAMAGES	 	 	69	 

	 	 	 
	LIST OF EXHIBITS
	 
	 	 
	Exhibit 1.9
	 	AHPC Patent Rights
	Exhibit 1.29
	 	Current Clinical Trials
	Exhibit 1.41
	 	Elan/Lilly Patent Rights
	Exhibit 1.44
	 	Elan Patent Rights
	Exhibit 1.56
	 	Elements of Fully Absorbed Standard Costs
	Exhibit 4.1.1
	 	R&D Candidates
	Exhibit 4.2.2
	 	Annual Research Plan/Annual Development Plan
	Exhibit 5.3
	 	Adverse Event Reporting Procedures
	Exhibit 10.2(a)
	 	Certain ELAN Patent Rights
	Exhibit 10.2(b)
	 	Government Funding - ELAN Patent Rights
	Exhibit 10.3(a)
	 	Certain AHPC Patent Rights
	Exhibit 10.3(b)
	 	Government Funding - AHPC Patent Rights

-vi-

 

RESEARCH, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

     THIS RESEARCH, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT (the “Agreement”) is entered into
on this 17th day of March, 2000, by and among American Home Products Corporation, a Delaware
corporation, together with Affiliates of American Home Products Corporation, acting through
American Home Products Corporation’s Wyeth-Ayerst Laboratories Division (collectively, “AHPC”) and
Neuralab Limited, a Bermuda private limited company (“NEURALAB”). AHPC and ELAN (as defined below)
may each be referred to herein individually as a “Party” and collectively as the “Parties”.

BACKGROUND

	1.	 	AHPC is engaged in the research, development and commercialization of human pharmaceutical
products.
	 
	2.	 	ELAN is the owner of certain patent rights and know-how relating to the use of certain
peptide immunogens and antibodies for the treatment and prevention of neurodegenerative
conditions in humans associated with b amyloid deposition.
	 
	3.	 	AHPC and ELAN have agreed to collaborate, on the terms and conditions set forth in this
Agreement, on the research, development and commercialization of such peptide immunogens and
antibodies.

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

1. DEFINITIONS.

     1.1. “Ab Peptide” or “Ab”. Ab Peptide or Ab shall mean
b amyloid protein *** Approximately 3 lines omitted *** .

     1.2. “Affiliate(s)”. Affiliate(s) shall mean, with respect to any person or entity,
any other person or entity which controls, is controlled by or is under common control with such
person or entity. A person or entity shall be regarded as in control of another entity if it owns
or controls at least fifty percent (50%) of the equity securities of the subject entity entitled to
vote in the election of directors (or, in the case of an entity that is not a corporation, for the
election of the corresponding managing authority), provided, however, that the term “Affiliate”
shall not
include subsidiaries or other entities in which a Party or its Affiliates owns a majority of
the ordinary voting power necessary to elect a majority of the board of directors or other
governing

CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

 

 

board, but is restricted from electing such majority by contract or otherwise, until such
time as such restrictions are no longer in effect.

     1.3. “AHPC Forecasted Share of Pro-Forma Net Profits”. AHPC Forecasted Share of
Pro-Forma Net Profits shall mean, on a Product-by-Product and country by-country basis,
          ***          of the Pro-Forma Net Profits, subject to upward adjustment to
correspond with any upward adjustment in AHPC Share of Pro-Forma Net Profit as set forth in
Article11, forecasted to be obtained from the distribution and sale of such Product in such country
during a given calendar year.

     1.4. “AHPC In-License”. AHPC In-License shall mean any agreement between AHPC and any
Third Party pursuant to which AHPC Controls those AHPC Patent Rights which claim any R&D Candidate
or Product or are used in the Research, Development, Manufacture or Commercialization of any R&D
Candidate or Product, provided, however, that the Parties agree not to practice any such AHPC
Patent Right in the Research, Development, Manufacture or Commercialization of any R&D Candidate or
Product unless and until the JSC has reviewed such agreement and, after consideration of the terms
and conditions therein, elected to utilize such AHPC Patent Rights in the Research Development,
Manufacture or Commercialization of any R&D Candidate or Product.

     1.5. “AHPC Intellectual Property”. AHPC Intellectual Property shall mean AHPC’s
interest in (a) the AHPC Know-How, (b) the AHPC Patent Rights, (c) the Collaboration Know-How, (d)
the Collaboration Patent Rights, (e) the Copyrights and (f) the Trademarks.

     1.6. “AHPC Know-How”. AHPC Know-How shall mean Know-How, excluding the Collaboration
Know-How, that AHPC Controls as of the Effective Date or that comes into the Control of AHPC during
the term of this Agreement.

     1.7. “AHPC Manufacturing Profit”. AHPC Manufacturing Profit shall mean, on a
Product-by-Product basis, an amount (such amount not to be less than zero) per unit of such Product
to be determined and approved by the JSC at least ninety (90) days prior to the beginning of each
calendar year during which such Product is to be delivered to ELAN for supply by ELAN to the
Distributing Party for commercial sale hereunder, which amount shall not exceed ***
of the AHPC Forecasted Share of Pro-Forma Net Profits to be obtained from the sale of
such Product during such calendar year divided by the total number of units of such Product
included in the applicable Product Sales Forecast for such calendar year.

     1.8. “AHPC Non-Collaboration Invention”. AHPC Non-Collaboration Invention shall mean
a Non-Collaboration Invention Controlled by AHPC.

     1.9. “AHPC Patent Rights”. AHPC Patent Rights shall mean Patent Rights that AHPC
Controls as of the Effective Date or that come into the Control of AHPC during the

CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

- 2 -

 

term of this
Agreement, which Patent Rights claim any AHPC Prior Invention and/or AHPC Non-Collaboration
Invention. Those AHPC Patent Rights known to be existing as of the Effective Date are listed on
Exhibit 1.9 attached hereto.

     1.10. “AHPC Pre-tax Profit”. AHPC Pre-tax Profit shall mean, on a Product-by-Product
and country-by-country basis, AHPC’s share of the Pro Forma Net Profit from the sale of such
Product in such country during a given Calendar Quarter after deduction of any AHPC Manufacturing
Profit paid to AHPC in connection with the sale of such Product in such country during such
Calendar Quarter.

     1.11. “AHPC Prior Invention”. AHPC Prior Invention shall mean a Prior Invention
Controlled by AHPC.

     1.12. “AHPC Share of Pro-Forma Net Profit”. AHPC Share of Pro-Forma Net Profit shall
mean, on a Product-by-Product and country-by-country basis and subject to upward adjustment as set
forth in Article 11, *** of the Pro-Forma Net Profit obtained from
such Product in such country.

     1.13. “Assigned Sales Force Effort”. Assigned Sales Force Effort shall mean the
estimated number of Details to be performed by a Party in the Promotion of a Product in a country
of the Territory during any Calendar Quarter or calendar year, as applicable, as assigned by the
JSC under the then applicable Annual Commercialization Plan and in accordance with Section 6.1.2.

     1.14. “Base Price”. Base Price shall mean, in the case of either Party, on a
Product-by-Product basis, the actual cost to acquire such unit of Product, or components thereof,
from either the other Party or a Third Party pursuant to Section 5.1, plus its Fully-Absorbed
Standard Cost to produce or complete the production, as applicable, of such Product, plus (or
minus, as the case may be): (a) such Party’s costs for Product inventory adjustments and losses,
(b) any Manufacturing cost variances incurred by such Party and allocable to such Product, (c)
amortization of such Party’s new standard costs for such Product, and (d)such Party’s prior period
adjustments allocable to such Product. For the sake of clarity, the Base Price for such Product
shall be equal to such Party’s Cost of Goods Manufactured for Sale.

     1.15. “Betabloc”. Betabloc shall mean any therapeutic or prophylactic vaccine
*** .

     1.16. “Blocking Third Party Intellectual Property”. Blocking Third Party Intellectual
Property shall mean, with respect to any country in the Territory, on a country-by-country basis, a
valid patent or patent application in such country owned or otherwise controlled by a
Third Party, in the absence of a license to which, the Research and/or Development of an R&D

CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

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Candidate and/or the Manufacture and/or Commercialization of a Product would infringe such patent
or a patent that issues from such patent application.

          1.17. “Calendar Quarter”. Calendar Quarter shall mean the respective periods of three
(3) consecutive calendar months ending on March 31, June 30, September 30 or December 31, for so
long as this Agreement is in effect.

          1.18. “Change of Control”. Change of Control shall mean any of the following: (a) the
sale or disposition of all or substantially all of the assets of a Party to a Third Party, (b) the
acquisition by a Third Party, other than an employee benefit plan (or related trust) sponsored or
maintained by a Party or any of its Affiliates, of more than 50% of such Party’s outstanding shares
of voting capital stock, or (c) the merger or consolidation of a Party with or into another
corporation, other than, in the case of (b) or (c) of this Section, an acquisition or a merger or
consolidation of a Party in which holders of shares of such Party’s voting capital stock
immediately prior to the acquisition, merger or consolidation will have at least fifty percent
(50%) of the ownership of voting capital stock of the acquiring Third Party or the surviving
corporation in such merger or consolidation, as the case may be, immediately after the merger or
consolidation.

          1.19. “Collaboration Intellectual Property”. Collaboration Intellectual Property
shall mean the Collaboration Know-How and the Collaboration Patent Rights.

          1.20. “Collaboration Inventions”. Collaboration Inventions shall mean all Inventions
Controlled by either Party, either alone or jointly with the other Party, which Inventions are made
(meaning that they are conceived prior to or during the Research Term and experimentation has been
initiated in the course of the Research Program) by either Party’s employees, agents or
subcontractors in the performance of such Party’s obligations under the Research Program and
Development Program or in performing any Post-Approval Research, regardless of whether such
Inventions are made solely by such Party’s employees, agents or subcontractors or jointly with the
employees, agents or subcontractors of the other Party.

          1.21. “Collaboration Know-How”. Collaboration Know-How shall mean that Know-How that
is created or developed by or on behalf of either Party, either alone or jointly with the other
Party, in performing its obligations under the Research Program and Development Program or in
performing any Post-Approval Research.

          1.22. “Collaboration Patent Rights”. Collaboration Patent Rights shall mean those
Patent Rights that claim Collaboration Inventions.

          1.23. “Commercialization”. Commercialization shall mean any and all activities of
using, importing, marketing, promoting, distributing, offering for sale and selling a Product in
the Field and shall include Promotion. When used as a verb, “Commercialize” shall mean to engage
in Commercialization.

          1.24. “Commercially Reasonable Efforts”. Commercially Reasonable Efforts shall mean,
in the conduct of the Research Program and the Development Program, those efforts and resources
normally used by a Party for a product or compound owned by it or to which it has rights, which is
of similar market potential at a similar stage in its development or product life,
taking into account, without limitation, issues of safety and efficacy, product profile, the
proprietary

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position of the R&D Candidate or Product, the regulatory environment and status of the
R&D Candidate or Product, and other relevant scientific factors. Without limiting the foregoing,
Commercially Reasonable Efforts as it applies to the clinical development of R&D Candidates and
Products hereunder shall mean adherence to the activities and time lines (to the extent adherence
to such activities and time lines is controllable by the Party responsible for performing such
activities) set forth in the Global Research and Development Plan prepared by the JSC, as may be
amended from time to time based on the results of studies conducted with an R&D Candidate or
Product, and regulatory factors. In all other instances, “Commercially Reasonable Efforts” shall
mean those efforts and resources normally used by a Party for a product or compound owned by it or
to which it has rights, which is of similar market potential at a similar stage in its development
or product life, taking into account, without limitation, issues of safety and efficacy, product
profile, competitiveness of the marketplace, the proprietary position of the R&D Candidate or
Product, the regulatory environment and status of the R&D Candidate or Product, the profitability
of the Product and other relevant scientific and commercial factors. Notwithstanding the
foregoing, to the extent that the performance of a Party’s obligations hereunder is adversely
affected by the other Party’s failure to perform its obligations hereunder, such Party shall not be
deemed to have failed to use its Commercially Reasonable Efforts in performing such obligations.

          1.25. “Confidential Information”. Confidential Information shall mean, with respect
to a Party, all information (and all tangible and intangible embodiments thereof), which is
Controlled by such Party, is disclosed by such Party to the other Party pursuant to this Agreement,
and is designated as confidential in writing by the disclosing Party whether by letter or by use of
an appropriate stamp or legend, prior to or at the time any such information is disclosed by the
disclosing Party to the other Party. In addition, any information which is orally, electronically
or visually disclosed by a Party, or is disclosed in writing without an appropriate letter, stamp
or legend, shall constitute Confidential Information if the disclosing Party, within thirty (30)
days after such disclosure, delivers to the receiving Party a written document or documents
describing the information disclosed and referencing the place and date of such oral, visual,
electronic or written disclosure and the names of the person(s) to whom such disclosure was made,
provided, however, that any technical information disclosed at a meeting of the JSC shall
constitute Confidential Information unless otherwise specified. Notwithstanding the foregoing,
Confidential Information of a Party shall not include information which, and only to the extent,
the receiving Party can establish by written documentation (a) has been publicly known prior to
disclosure of such information by the disclosing Party to the receiving Party, (b) has become
publicly known, without breach of this Agreement on the part of the receiving Party, subsequent to
disclosure of such information by the disclosing Party to the receiving Party, (c) has been
received by the receiving Party at any time from a source, other than the disclosing Party,
rightfully having possession of and the right to disclose such information free of confidentiality
obligations, (d) has been otherwise known by the receiving Party free of confidentiality
obligations to the disclosing Party prior to disclosure of such information by the disclosing Party
to the receiving Party, or (e) has been independently developed by employees or others on behalf of
the receiving Party without the aid, application or use of such information disclosed by the
disclosing Party to the receiving Party.

          1.26. “Control” or “Controlled”. Control or Controlled shall mean with respect to any
(a) item of information, including, without limitation, Know-How, or (b) intellectual

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property
right, the possession (whether by ownership or license, other than pursuant to this Agreement) by a
Party of the ability to grant to the other Party access and/or a license as provided herein under
such item or right without violating the terms of any agreement or other arrangements with any
Third Party existing before or after the Effective Date.

          1.27. “Copyright”. Copyright shall mean any copyright Controlled by a Party or by
both Parties, which copyright pertains to the promotional materials and literature that is selected
for use by the JSC in connection with the Promotion of Products in the Territory pursuant to
Section 6.1.7.

          1.28. “Cost of Goods Manufactured for Sale”. Cost of Goods Manufactured for Sale
shall mean a Party’s actual cost to acquire Product from a Third Party, or its Fully-Absorbed
Standard Cost to produce the Product, plus (or minus, as the case may be): (a)the Party’s costs for
Product inventory adjustments and losses, (b) any Manufacturing cost variances allocable to such
Product, (c) amortization of new standard costs for such Product, and (d) prior period adjustments
allocable to such Product.

          1.29. “Current Clinical Trials”. Current Clinical Trials shall mean the clinical
trials underway as of the Effective Date, as more fully described in Exhibit 1.29.

          1.30. “Detail”. Detail shall mean a face-to-face meeting between one or more
physicians and one or more professional sales representatives, made in compliance with the target
market allocation of the JSC under Section 6.1.2 during which a complete Product presentation, as
defined from time to time by the JSC, is communicated, which Product presentation is either the
first or second product-related information communicated by such professional sales representative
during such meeting. When used as a verb, “Detail” shall mean to perform a Detail.

          1.31. “Detail Cost”. Detail Cost shall mean, on a Product-by-Product and country-by
country basis, the cost per Detail agreed to by the JSC, which shall be consistent with industry
standards for similar types of products (if available), which agreement shall be reached at least
ninety (90) days prior to the beginning of each calendar year.

          1.32. “Development”. Development shall mean, on an R&D Candidate-by-R&D Candidate and
country-by-country basis, all activities performed by or on behalf of either Party pursuant to the
Global Research and Development Plan on such R&D Candidate in the Field from the date on which the
JSC designates such R&D Candidate for further pre-clinical development toward IND filing until
Regulatory Approval of such R&D Candidate is obtained in such country for the indication under
study. Development shall include, without limitation, all activities related to preclinical
testing, test method development and stability testing, toxicology, formulation, process
development, manufacturing scale-up, quality assurance/quality control, clinical studies,
regulatory affairs, statistical analysis and report writing. When used as a verb, “Develop” shall
mean to engage in Development.

          1.33. “Distribution Expenses”. Distribution Expenses shall mean a Party’s actual
distribution costs (other than those deducted as part of the calculation of Net Sales), warehousing

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costs and billing, receiving, collection and other miscellaneous costs incurred by the Party as
they relate to distribution of the Products.

          1.34. “Effective Date”. Effective Date shall mean the date two (2) business days
after the HSR Clearance Date.

          1.35. “ELAN”. ELAN shall mean Neuralab Limited, a Bermuda private limited company,
and its Affiliates, which Neuralab Limited designates to carry out its rights and obligations under
this Agreement.

          1.36. “ELAN Forecasted Share of Pro Forma Net Profits”. ELAN Forecasted Share of Net
Profits shall mean, on a Product-by-Product and country-by-country basis,          ***           of the Pro-Forma Net Profits, subject to downward adjustment to correspond with any
downward adjustment in ELAN Share of Pro-Forma Net Profit as set forth in Article11, forecasted to
be obtained from the distribution and sale of such Product in such country during a given calendar
year.

          1.37. “ELAN In-Licenses”. ELAN In-Licenses shall mean *** Approximately 5 lines
omitted *** .

          1.38. “ELAN Intellectual Property”. ELAN Intellectual Property shall mean ELAN’s
interest in (a) the ELAN Know-How, (b) the ELAN Patent Rights, (c) the Collaboration Know-How, (d)
the Collaboration Patent Rights, (e) the Copyrights and (f) the Trademarks.

          1.39. “ELAN Know-How”. ELAN Know-How shall mean Know-How, excluding the Collaboration
Know-How and any Invention claimed in the ELAN/Lilly Patent Rights, that ELAN Controls as of the
Effective Date or that comes into the Control of ELAN during the term of this Agreement.

          1.40. “ELAN/Lilly Litigation”. ELAN/Lilly Litigation shall mean ELAN Pharmaceuticals,
Inc. and Neuralab Limited v. Eli Lilly and Company, Civil Action No. C 99-04222 WHA, pending in the
United States District Court for the Northern District of California — San Francisco Division.

          1.41. “ELAN/Lilly Patent Rights”. ELAN/Lilly Patent Rights shall mean the patent
rights listed on Exhibit 1.41 attached hereto as well as any patents and patent
applications from which such patent rights claim priority, and all provisional applications,
substitutions, continuations, continuations-in-part, divisions, renewals, and all patents granted
thereon, and all patents-of-addition, reissues, reexaminations and extensions or restorations by
existing or future extension or restoration mechanisms, including, without limitation, supplementary protection
certificates or the equivalent thereof.

CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

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          1.42. “ELAN Manufacturing Profit”. ELAN Manufacturing Profit shall mean, on a
Product-by-Product basis, an amount (such amount not to be less than zero) per unit of such Product
to be determined and approved by the JSC at least ninety (90) days prior to the beginning of each
calendar year during which such Product is to be delivered to the Distributing Party for commercial
sale hereunder, which amount shall not exceed           ***           of the ELAN
Forecasted Share of Pro-Forma Net Profits to be obtained from the sale of such Product during such
calendar year divided by the total number of units of such Product included in the applicable
Product Sales Forecast for such calendar year.

          1.43. “ELAN Non-Collaboration Invention”. ELAN Non-Collaboration Invention shall mean
a Non-Collaboration Invention Controlled by ELAN.

          1.44. “ELAN Patent Rights”. ELAN Patent Rights shall mean Patent Rights that ELAN
Controls as of the Effective Date or that come into the Control of ELAN during the term of this
Agreement, which Patent Rights claim any ELAN Prior Invention and/or ELAN Non-Collaboration
Invention. Those ELAN Patent Rights known to be existing as of the Effective Date are listed on
Exhibit 1.44 attached hereto.

          1.45. “ELAN Pre-tax Profit”. ELAN Pre-tax Profit shall mean, on a Product-by-Product
and country-by-country basis, ELAN’s share of the Pro Forma Net Profit from the sale of such
Product in such country during a given Calendar Quarter after deduction of any ELAN Manufacturing
Profit paid to ELAN in connection with the sale of such Product in such country during such
Calendar Quarter.

          1.46. “ELAN Prior Invention”. ELAN Prior Invention shall mean a Prior Invention
Controlled by ELAN, provided, however, that ELAN Prior Invention shall not include any Invention
claimed in the ELAN/Lilly Patent Rights.

          1.47. “ELAN Share of Pro-Forma Net Profit”. ELAN Share of Pro-Forma Net Profit shall
mean, on a Product-by-Product and country-by-country basis and subject to downward adjustment as
set forth in Article 11,           ***           of the Pro Forma Net Profit obtained from such
Product in such country.

          1.48. “Enhancing Third Party Intellectual Property”. Enhancing Third Party
Intellectual Property shall mean, with respect to any country in the Territory, on a
country-by-country basis, a valid patent or patent application in such country owned or otherwise
controlled by a Third Party that covers an invention, which if utilized by the Parties under this
Agreement would facilitate the Research, Development and/or Manufacture of an R&D Candidate or
Product, as the case may be, and/or if included in a Product would materially enhance the
commercial value of such Product. For purposes of clarity, Enhancing Third Party Intellectual Property
shall not include Blocking Third Party Intellectual Property.

CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

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          1.49. “Entry Into Pivotal Clinical Trials”. Entry Into Pivotal Clinical Trials shall
mean, with respect to Betabloc, the earliest point in time when all of the following shall have
occurred: (i) the JSC has determined that the Current Clinical Trials have been successfully
completed with respect to safety and the absence of need to conduct any additional study prior to
pivotal study(ies), and (ii) the FDA has accepted pivotal study protocols; (iii) the JSC has
determined that the data expected to be generated under such pivotal study protocols, when taken
together with any other completed studies, would be accepted as “fileable” as the basis for
Regulatory Approval by the FDA; and (iv) the first dosing of a patient in the pivotal study for
which such protocols have been accepted has occurred.

          1.50. “Exchange Product”. Exchange Product shall mean a pharmaceutical product, of
AHPC’s sole choosing, which product is Controlled by AHPC and is marketed or, within the one (1)
year period following an Exchange Product Offering made to Elan for such product, is expected to be
marketed in the United States, provided, however, that Elan shall have no right to require AHPC to
designate any particular product as an Exchange Product.

          1.51. “FDA”. FDA shall mean the United States Food and Drug Administration or any
successor agency thereto.

          1.52. “FD&C Act”. FD&C Act shall mean the United States Federal Food, Drug, and
Cosmetic Act, as amended, and the regulations promulgated thereunder.

          1.53. “Field”. Field shall mean the treatment and/or prevention of neurodegenerative
conditions in humans associated with [$]-amyloid deposition, including, without limitation,
Alzheimer’s disease (“AD”) *** Approximately 4 lines omitted ***.

          1.54. “First Commercial Sale”. First Commercial Sale shall mean, with respect to any
Product and any country of the world, the first sale of such Product under this Agreement, for use
in the Field, to a Third Party in such country, after such Product has been granted Regulatory
Approval for use in the Field by the competent Regulatory Authorities in such country.

          1.55. “FTE”. FTE shall mean a total of           ***           per year of scientific work on the Research Program carried out by
employees of a Party having the appropriate scientific expertise to conduct such activities.

          1.56. “Fully-Absorbed Standard Cost”. Fully-Absorbed Standard Cost shall mean the
cost for those items specified in Exhibit 1.56 attached hereto, which costs have been
incurred by a Party in Manufacturing and/or distributing Products.

          1.57. “Global Research and Development Plan”. Global Research and Development Plan
shall mean the comprehensive plan for the Research and Development of an R&D Candidate which is
created and updated periodically by the JSC in accordance with Section

CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

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4.2.1, and designed to
generate the preclinical, clinical and regulatory information required for regulatory filings for
such R&D Candidate in the Major Market Countries and in such other countries of the Territory where
the JSC elects to seek Regulatory Approval for such R&D Candidate.

          1.58. “Good Clinical Practice” or “GCP”. Good Clinical Practice or GCP shall
mean the then current standards for clinical trials for pharmaceuticals, as set forth in the FD&C
Act and applicable regulations promulgated thereunder, as amended from time to time, and such
standards of good clinical practice as are required by the European Union and other organizations
and governmental agencies in countries in which the Products are intended to be sold, to the extent
such standards are not less stringent than United States GCP.

          1.59. “Good Laboratory Practice” or “GLP”. Good Laboratory Practice or GLP
shall mean the then current standards for laboratory activities for pharmaceuticals, as set forth
in the FD&C Act and applicable regulations promulgated thereunder, as amended from time to time,
and such standards of good laboratory practice as are required by the European Union and other
organizations and governmental agencies in countries in which the Products are intended to be sold,
to the extent such standards are not less stringent than United States GLP.

          1.60. “Good Manufacturing Practice” or “GMP”. Good Manufacturing Practice or
GMP shall mean the then current standards for manufacturing activities for pharmaceuticals, as set
forth in the FD&C Act and applicable regulations promulgated thereunder, as amended from time to
time, and such standards of good manufacturing practice as are required by the European Union and
other organizations and governmental agencies in countries in which the Products are intended to be
manufactured or sold, to the extent such standards are not less stringent than United States GMP.

          1.61. “HSR Act”. HSR Act shall mean the Hart-Scott-Rodino Antitrust Improvements Act
of 1976, as amended, and the rules and regulations promulgated thereunder.

          1.62. “HSR Clearance Date”. HSR Clearance Date shall mean the earliest date on which
the Parties have actual knowledge that all applicable waiting periods under the HSR Act with
respect to the transactions contemplated hereunder have expired or have been terminated.

          1.63. “Improvement Product”. Improvement Product shall mean any therapeutic and/or
preventative pharmaceutical product, other than Betabloc, within the Field that has previously been
Developed as an R&D Candidate. Improvement Product shall include, without limitation, ***
Approximately 6 lines omitted *** .

CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

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          1.64. “IND”. IND shall mean an Investigational New Drug Application, as defined in
the FD&C Act, that is required to be filed with the FDA before beginning clinical testing of a
Product in human subjects, or an equivalent foreign filing.

          1.65. “Interim Clinical Evaluation” or “ICE”. Interim Clinical Evaluation or
ICE shall mean the determination by the JSC that an R&D Candidate, having entered the Development
Program, meets JSC criteria with respect to Phase I safety, and, if so designed, initial evidence
of efficacy in a Phase I/II study. In addition, in order to meet such criteria for ICE, such R&D
Candidate must demonstrate a clinically acceptable side effect profile, and the cost of goods,
expected formulation and dosing schedule must remain commercially reasonable in order to warrant
further Development.

          1.66. “Invention”. Invention shall mean any discovery or other finding that relates
to the Field, to any R&D Candidate and/or Product, the Research and/or Development of any R&D
Candidate and/or Product, any method of making an R&D Candidate and/or Product or any method of
using an R&D Candidate and/or Product.

          1.67. “Know-How”. Know-How shall mean all Inventions, discoveries, data, information,
processes, methods, techniques, materials, technology, results or other know-how, whether or not
patentable but which are not generally known, that (a) are Controlled by either Party as of the
Effective Date or come into the Control of either Party or of both Parties during the term of this
Agreement and (b) relate to the Field, any R&D Candidate and/or Product, the Research and/or
Development of any R&D Candidate and/or Product, any method of making any R&D Candidate and/or
Product and/or any method of using an R&D Candidate and/or Product.

          1.68. “Lilly”. Lilly shall mean Eli Lilly and Company, an Indiana corporation.

          1.69. *** Approximately 2 lines omitted ***

          1.70. “Manufacture”, “Manufactured” or “Manufacturing”. Manufacture,
Manufactured or Manufacturing shall mean all activities involved in the production of an R&D
Candidate or Product to be Developed and/or Commercialized under this Agreement.

          1.71. *** Approximately 4 lines omitted ***

          1.72. “Net Sales”. Net Sales shall mean the gross amounts charged for sales of
Products by a Party and/or its Sublicensees, as appropriate, to Third Parties, less the sum of (a)
and (b) where (a) is a provision for (i) reasonable trade, cash and quantity discounts or rebates
(other than price discounts granted at the time of the sale), reasonable service allowances and
reasonable broker’s or agent’s commissions, if any, actually allowed or paid, (ii) credits or
allowances actually given or made for rejection or return of, previously sold products or for
retroactive price reductions (including Medicaid, Medicare, government, commercial and similar

CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

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types of rebates), (iii) taxes, duties or other governmental charges levied on or measured by
the billing amount (excluding income and franchise taxes), as adjusted for rebates and refunds,
(iv) charges actually incurred for freight and insurance directly related to the distribution of
the Product (excluding amounts reimbursed by Third Party customers), (v)reasonable credits or
allowances actually given or made for wastage replacement, and (vi) taxes paid by a Party and/or
its Sublicensees, as appropriate, to the United States Government or an instrumentality thereof
under 42 U.S.C. 300 aa-1 et seq. or other similar legislation, or to a State of the United States
or to a government of any other country or portion thereof insuring against liability arising out
of the manufacture, use or sale of Products by a Party and/or its Sublicensees; and (b) is a
periodic adjustment of the provision determined in (a) to reflect amounts actually incurred for
(i), (ii), (iii), (iv), and (v). A “sale” of a Product is deemed to occur upon the invoicing, or
if no invoice is issued, upon the earlier of shipment or transfer of title in the Product to a
Third Party.

          1.73. “Non-Collaboration Invention”. Non-Collaboration Invention of a Party shall
mean an Invention Controlled by either Party, which Invention (a) is made by such Party’s
employees, agents or subcontractors during the term of this Agreement or otherwise comes into the
Control of such Party during the term of this Agreement and (b) is not made in the performance of
the Research Program, the Development Program or any Post-Approval Research.

          1.74. “Patent Rights”. Patent Rights shall mean any and all (a) patents, (b)pending
patent applications, including, without limitation, all provisional applications, substitutions,
continuations, continuations-in-part, continued prosecution applications, requests for continued
examination, divisions, renewals, and all patents granted thereon, and (c) all patents-of-addition,
reissues, reexaminations and extensions or restorations by existing or future extension or
restoration mechanisms, including, without limitation, supplementary protection certificates or the
equivalent thereof, that (i) are Controlled by either Party as of the Effective Date or come into
the Control of either Party or of both Parties during the term of this Agreement and (ii) claim any
Invention.

          1.75. “Pivotal Clinical Study”. Pivotal Clinical Study shall mean a pivotal study in
patients, conducted in accordance with a protocol approved by the JSC, which protocol is designed
to ascertain efficacy and safety of an R&D Candidate for the purpose of preparing and submitting
applications for Regulatory Approval to the competent Regulatory Authorities in a country of the
world.

          1.76. “Post-Approval Research”. Post-Approval Research shall mean ongoing research
and development of a Product, pursuant to this Agreement, after such Product has received
Regulatory Approval in a country of the Territory, including, without limitation, Phase IV clinical
studies and clinical studies in support of additional indications within the Field or labeling
changes for such Product in such country during the term of this Agreement.

          1.77. “Post-Approval Research and Regulatory Expenses”. Post-Approval Research and
Regulatory Expenses shall mean those costs incurred, on a Product-by-Product and country-by-country
basis, by either Party directly attributable to (a) Post-Approval Research and/or (b) complying
with its regulatory reporting obligations in the Territory in accordance with Section 5.3.3 and
5.3.4.

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          1.78. “Pre-Marketing Expenses”. Pre-Marketing Expenses shall mean those expenses
incurred on a Product-by-Product and country-by-country basis, by either Party, other than R&D
Expenses, before Regulatory Approval of the Product in such country, directly attributable to the
carrying out of such Party’s obligations under the Commercialization Plan or an Annual
Commercialization Plan, as applicable, in preparation for the Commercialization of such Product in
such country. Such expenses may include, without limitation, costs incurred for professional
education, Product-related public relations, relationships with opinion leaders and professional
societies, market research, health care economics studies, and establishment of the supply chain
for the distribution and sale of such Product in such country. Such expenses may include both
internal expenses incurred by a Party, excluding costs of field sales force personnel (i.e.,
excluding salaries, bonus, benefits, sales force automation, and personnel expenses — telephone,
supplies, postage, meetings, travel and voice mail including all information technology) but
including costs of other Product marketing personnel, as well as out-of-pocket expenses paid to
Third Parties by a Party at reasonable rates preapproved by the JSC.

          1.79. “Pre-tax Profit”. Pre-tax Profit shall mean on a country-by-country and
Product-by-Product basis, the Pro-Forma Net Profit less the AHPC Manufacturing Profit and the ELAN
Manufacturing Profit.

          1.80. “Prior Invention”. Prior Invention of a Party shall mean an Invention
Controlled by either Party, which Invention is made by the Party’s employees, agents or
subcontractors before the Effective Date or which otherwise came into the Control of such Party
before the Effective Date.

          1.81. “Product”. Product shall mean Betabloc or an Improvement Product.

          1.82. “Product Sales Forecast”. Product Sales Forecast shall mean, on a
Product-by-Product basis, a forecast, to be approved by the JSC no later than ninety (90) days
prior to the beginning of each calendar year, of the amount of such Product (excluding Samples)
anticipated to be distributed and sold by the Distributing Party, in each country of the Territory,
during such calendar year.

          1.83. “Pro-Forma Net Profit”. Pro-Forma Net Profit shall mean, on a
Product-by-Product and country-by-country basis, the Net Sales obtained from the sale of such
Product in such country less the Cost of Goods Manufactured for Sale, the Third Party License Fees,
the Sales and Marketing Expenses, the Assigned Sales Force Adjustment Payment, the Distribution
Expenses, the Working Capital Charges and the Post-Approval Research and Regulatory Expenses for
such Product.

          1.84. “Promotion”. Promotion shall mean those activities, including, without
limitation, Detailing and distributing Samples of a Product, normally undertaken by a
pharmaceutical company’s sales force to implement marketing plans and strategies aimed at
encouraging the appropriate use of a particular Product. When used as a verb, “Promote” shall mean
to engage in such activities.

          1.85 “R&D Expenses”. R&D Expenses shall mean, on an R&D Candidate-by-R&D Candidate
basis, the expenses (other than Third Party License Fees) of the Parties incurred

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in performing the Research Program, the Development Program and in obtaining Regulatory
Approval for such R&D Candidate pursuant to the Global Research and Development Plan. Payments
made under Section 7.1 or 7.2 shall not be R&D Expenses.

          1.86. “Regulatory Approval”. Regulatory Approval shall mean the technical, medical
and scientific licenses, registrations, authorizations and approvals (including, without
limitation, approvals of BLAs or their foreign equivalents, supplements and amendments, pre- and
post- approvals, pricing and third party reimbursement approvals, and labeling approvals) of any
national, supra-national, regional, state or local regulatory agency, department, bureau,
commission, council or other governmental entity, necessary for the commercial manufacture,
distribution, marketing, promotion, offer for sale, use, import, export and sale of Product(s) in a
regulatory jurisdiction. For the sake of clarity, Regulatory Approval shall not be achieved for a
Product in a country until any applicable pricing and governmental third party reimbursement
approvals (other than those required by Medicaid or Medicare) have also been obtained in such
country.

          1.87. “Regulatory Approval Filing”. Regulatory Approval Filing shall mean, on a
country by country basis, the submission of an application for Regulatory Approval of a Product to
the appropriate Regulatory Authorities in such country and the acceptance, by such Regulatory
Authorities, of such application for review.

          1.88. “Regulatory Authority”. Regulatory Authority shall mean any national (e.g., the
FDA), supra-national (e.g., the European Commission, the Council of the European Union, or the
European Agency for the Evaluation of Medicinal Products), regional, state or local regulatory
agency, department, bureau, commission, council or other governmental entity in each country of the
world involved in the granting of Regulatory Approval for a Product.

          1.89. “Research”. Research shall mean, on an R&D Candidate-by-R&D Candidate basis,
those preclinical activities undertaken by or on behalf of either Party prior to Development of
such R&D Candidate, including, without limitation, medicinal chemistry, immunochemistry,
immunology, cell biology, pharmacology, preclinical toxicology, and formulation of such R&D
Candidate in the Field.

          1.90. “Research Term”. Research Term shall mean the Initial Research Term and any
extensions thereof.

          1.91. “Research and Development Candidate” or “R&D Candidate”. Research and
Development Candidate or R&D Candidate shall mean any compound, molecule or macromolecule that the
JSC, in accordance with Section 4.1.1, selects or otherwise designates for evaluation under the
Research Program and/or the Development Program.

          1.92. “Sales and Marketing Expenses”. Sales and Marketing Expenses shall mean those
expenses (other than those deducted as part of the calculation of Net Sales) directly allocable, on
a Product-by-Product and country-by-country basis, to the Parties’ market development and/or
Promotion of such Product in the Territory, consistent with the Commercialization Plan for such
Product. Sales and Marketing Expenses shall include: (a) costs for Promotion of the Product,
excluding costs of the field sales force personnel (i.e., excluding Detailing expenses,

-14-

 

including, without limitation, salaries, bonus, benefits, sales force automation, and
personnel expenses — telephone, supplies, postage, meetings, travel and voice mail including all
information technology and out-of-pocket expenses paid to a Contract Sales Organization) but
including costs of other Product marketing personnel; (b) out-of-pocket payments to Third Parties
incurred by such Party and specifically attributable to such Party’s performance under the
Commercialization Plan, excluding Third Party License Fees, (c) costs for activities related to
obtaining reimbursement from payers, (d) market research costs (including, without limitation,
actual costs of sales and marketing data), (e) marketing and advertising costs (including, without
limitation, cost for preparing and reproducing detail aids and other promotional materials), (f)
professional education, (g) Product related public relations, (h) costs of pharmacoeconomics
studies, (i) costs for Manufacturing and distributing Samples, and (j) costs for conducting
seminars, attending conventions and industry meetings, and establishing relationships with opinion
leaders and professional societies in connection with the Product. Such costs enumerated above
will include both internal costs (e.g., salaries, benefits, supplies and materials, etc.) as well
as the actual amounts paid to outside service providers (e.g., consultants, agency fees, meeting
costs, etc.). Sales and Marketing Expenses will specifically exclude the cost of activities that
promote either Party’s business as a whole without being Product specific (such as corporate image
advertising).

          1.93. “Sales Force Effort”. Sales Force Effort, with respect to a Party, shall mean,
on a Product-by-Product and country-by-country basis, the actual number of Details provided during
a given calendar year by such Party.

          1.94. “Sample”. Sample shall mean a unit of a Product that is not intended to be sold
and is intended to promote the sale of such Product. When used as a verb, “Sample” shall mean to
provide Samples to health care providers.

          1.95. “Sample Receipt Forms”. Sample Receipt Forms shall mean those multi-part paper
forms (or an electronic version thereof) supplied by the Distributing Party for the purpose of
recording Detail and Sample activity performed by each Party’s sales representatives during
Details. These forms are also used as Sample receipts on which to obtain a physician’s signature
in acknowledgment of the physician’s receipt of Samples.

          1.96. “Sublicensee”. Sublicensee shall mean a Third Party that is granted a license
and/or sublicense under this Agreement pursuant to Section 2.3 to both make and sell Products.
“Sublicensee” shall also include a Third Party that is granted the right to distribute Product,
provided that such Third Party is also responsible for marketing and promotion of the Product
within the applicable territory. “Sublicense” shall mean an agreement or arrangement pursuant to
which such a sublicense or distribution right has been granted.

          1.97. “Territory”. Territory shall mean the entire world.

          1.98. “Third Part(y/ies)”. Third Part(y/ies) shall mean any person(s) or entit(y/ies)
other than AHPC or ELAN.

          1.99. “Third Party License”. Third Party License shall mean any agreement with a
Third Party for a license under intellectual property rights or technology necessary or useful

-15-

 

for the Research, Development, Manufacture or Commercialization of an R&D Candidate or a
Product, which license is entered into, during the term of this Agreement, by a Party pursuant to
Section 8.7.

          1.100. “Third Party License Fee”. Third Party License Fee shall mean license fees,
royalties and other amounts paid to any Third Party under each Third Party License, AHPC
In-License, or ELAN In-License.

          1.101. “Trademark”. Trademark shall mean any trademark Controlled by a Party or by
both Parties, that is selected for use by the JSC in connection with the Commercialization of any
Product hereunder, provided, however, that the term “Trademark” shall not include the tradename of
either Party or any trademark or trade dress of either Party which is not used exclusively in
connection with the Products Commercialized under this Agreement.

          1.102. “Working Capital Charges”. Working Capital Charges shall mean a Party’s
internal finance charges for carrying Product in inventory and receivables in respect of Products.
The cost of capital used by a Party in calculating such charges shall be no greater than the lowest
cost of capital routinely used by such Party in calculating internal working capital charges for
products carried in inventory that are not Products and receivables in respect of such products.

          1.103. Additional Definitions. Each of the following definitions is set forth in the
section of this Agreement indicated below:

	 	 	 	 	 
	 	 	Definition	 	Section
	 
	 	***	 	10.2(g)
	 
	 	***	 	16.2
	 
	 	AD	 	1.51
	 
	 	Adverse Event Reporting Procedures	 	5.3.3
	 
	 	Agreement	 	Introduction
	 
	 	AHPC	 	Introduction
	 
	 	AHPC Indemnified Party	 	14.3
	 
	 	American	 	16.2
	 
	 	Annual Commercialization Plan	 	6.1.2
	 
	 	Annual Development Plan	 	4.2.2
	 
	 	Annual Research Plan	 	4.2.2
	 
	 	Antitrust Division	 	12.1
	 
	 	Assigned Sales Force Adjustment Payment	 	6.1.4
	 
	 	Athena	 	10.2(f)
	 
	 	Audited Party	 	4.3.6 and 7.5.2
	 
	 	Auditing Party	 	4.3.6 and 7.5.2
	 
	 	Contract Sales Organization	 	2.3.1
	 
	 	Commercialization Plan	 	6.1.2
	 
	 	Development Program	 	4.1.1
	 
	 	Development Term	 	4.1.3

CONFIDENTIAL
INFORMATION OMITTED AND

FILED SEPARATELY WITH THE SECURITIES AND
EXCHANGE COMMISSION.

ASTERISKS(*) DENOTE SUCH OMISSIONS.

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	 	 	Definition	 	Section
	 
	 	Distributing Party	 	6.1.1
	 
	 	        ***	 	13.7.2
	 
	 	ELAN	 	Introduction
	 
	 	ELAN Indemnified Party	 	14.2
	 
	 	Exchange Act	 	16.2
	 
	 	Exchange Product Offering	 	15.1
	 
	 	FTC	 	12.1
	 
	 	Indemnified Party	 	14.4
	 
	 	Indemnifying Party	 	14.4
	 
	 	Initial Research Term	 	4.1.2
	 
	 	Joint Patent Committee/JPC	 	8.2.1
	 
	 	Joint Steering Committee/JSC	 	3.1
	 
	 	Liability	 	14.2
	 
	 	Licensing Party	 	8.7.1
	 
	 	Manufacturing Subcontractor	 	5.1.1
	 
	 	Marketing Account	 	6.1.6(b)
	 
	 	Parties	 	Introduction
	 
	 	Party	 	Introduction
	 
	 	Product Liability Expenses	 	14.1
	 
	 	R&D Account	 	4.3.2
	 
	 	Report	 	12.1
	 
	 	Research Program	 	4.1.1
	 
	 	Right of Reference	 	2.5
	 
	 	Section 13.5 Terminating Party	 	13.5.1
	 
	 	Section 13.7 Party	 	13.7.1
	 
	 	Section 13.7 Terminating Party	 	13.7.3
	 
	 	Sued Party	 	8.6.3
	 
	 	Terminating Party	 	13.2.2
	 
	 	Termination for Convenience	 	13.3.1
	 
	 	Title 11	 	13.6.2
	 
	 	Title 11 Party	 	13.6.2

2. LICENSES.

          2.1. Licenses to AHPC.

          (a) Subject to the terms and conditions of this Agreement, including, without limitation,
Section 2.4, ELAN hereby grants to AHPC

     (i) a worldwide, exclusive (except to the extent necessary for ELAN to exercise its
rights and perform its activities under this Agreement in the conduct of the

CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

-17-

 

Research Program, the Development Program and any Post-Approval Research) license or
sublicense, as the case may be, without the right to grant sublicenses except pursuant to
the terms set forth in Section 2.3, under the ELAN Intellectual Property, to practice the
ELAN Know-How and the Collaboration Know-How to the extent necessary for AHPC to exercise
its rights and perform its activities, under this Agreement, in the conduct of the Research
Program, the Development Program and any Post-Approval Research;

     (ii) a worldwide, non-exclusive license or sublicense, as the case may be, without the
right to grant sublicenses except pursuant to the terms set forth in Section 2.3, under
ELAN’s interest in the ELAN/Lilly Patent Rights, to practice any invention claimed in the
ELAN/Lilly Patent Rights to the extent necessary for AHPC to exercise its rights and perform
its activities, under this Agreement, in the conduct of the Research Program, the
Development Program and any Post-Approval Research;

     (iii) a worldwide, exclusive (except to the extent necessary for ELAN to Manufacture
and/or Commercialize Products pursuant to this Agreement) license or sublicense, as the case
may be, without the right to grant sublicenses except pursuant to the terms set forth in
Section 2.3, under the ELAN Intellectual Property, to Manufacture and Commercialize Products
in the Territory; and

     (iv) a worldwide, non-exclusive license or sublicense, as the case may be, without the
right to grant sublicenses except pursuant to the terms set forth in Section 2.3, under
ELAN’s interest in the ELAN/Lilly Patent Rights, to Manufacture and Commercialize Products
in the Territory.

          (b) In the event that the Research and Development of R&D Candidates under this Agreement
and/or the Manufacture and/or Commercialization of Products in the Territory by AHPC and/or its
Sublicensees would, during the term of this Agreement, misappropriate any know-how and/or infringe
any patent rights Controlled by ELAN that are not covered by the licenses and sublicenses granted
to AHPC in Section 2.1(a), ELAN hereby grants to AHPC, to the extent ELAN is legally able to do so,
a worldwide, nonexclusive, non-royalty bearing license, under such know-how and patent rights, to
enable AHPC and/or its Sublicensees to Research and Develop R&D Candidates under this Agreement and
to Manufacture and/or Commercialize Products in the Territory in accordance with the licenses and
sublicenses granted in Section 2.1(a).

          2.2. Licenses to ELAN. Subject to the terms and conditions of this Agreement, AHPC
hereby grants to ELAN

          (a) a worldwide, exclusive (except to the extent necessary for AHPC to exercise its rights and
perform its activities under this Agreement in the conduct of the Research Program, the Development
Program and any Post-Approval Research) license or sublicense, as
the case may be, without the right to grant sublicenses except pursuant to the terms set forth
in Section 2.3, under the AHPC Intellectual Property, to practice the AHPC Know-How and the
Collaboration Know-How to the extent necessary for ELAN to exercise its rights and perform its
activities under this Agreement in the conduct of the Research Program, the Development
Program and any Post-Approval Research; and

-18-

 

          (b) a worldwide, exclusive (except to the extent necessary for AHPC to Manufacture and/or
Commercialize Products pursuant to this Agreement) license or sublicense, as the case may be,
without the right to grant sublicenses except pursuant to the terms set forth in Section 2.3, under
the AHPC Intellectual Property, to Manufacture and/or Commercialize Products in the Territory.

          In the event that the Research and Development of R&D Candidates under this Agreement and/or
the Manufacture and/or Commercialization of Products in the Territory by ELAN and/or its
Sublicensees would, during the term of this Agreement, misappropriate any know-how and/or infringe
any patent rights Controlled by AHPC that are not covered by the licenses and sublicenses granted
to ELAN in Sections 2.2(a) and/or (b), AHPC hereby grants to ELAN, to the extent AHPC is legally
able to do so, a worldwide, non-exclusive, non-royalty bearing license, under such know-how and
patent rights, to enable ELAN and/or its Sublicensees to Research and Develop R&D Candidates under
this Agreement and to Manufacture and/or Commercialize Products in the Territory in accordance with
the licenses and sublicenses granted in Sections 2.2(a) and/or (b).

     2.3. Licensing and Sublicensing to Third Parties.

     2.3.1. Right to Grant Licenses and Sublicenses. Subject to Section 2.3.2, is
pursuant to Section 4.2.3, the JSC approves the utilization of one or more Third Parties to
perform certain tasks in the conduct of the Research Program, the Development Program or any
Post-Approval Research, the Party entering into a contract with such Third Party for the
performance of such services, may, as part of such contract, grant to such Third Party a
nonexclusive, nontransferable license or sublicense, as applicable, without the right to
grant sublicenses, under the AHPC Intellectual Property, the ELAN Intellectual Property or
ELAN’s interest in the ELAN/Lilly Patent Rights, as applicable, only to the extent and only
for so long as such license or sublicense is necessary for such Third Party to perform such
tasks. All such contracts and sublicenses entered into by either party with any such Third
Party shall be subject to the prior written approval of the JSC with the prior review of
each Party’s legal department, which approval shall not be unreasonably withheld or delayed.
Subject to Section 2.3.2, if pursuant to Section 6.1.1, the JSC approves the utilization of
one or more professional sales organizations (each a “Contract Sales Organization”) to
perform all or part of a Party’s activities in Promoting Products pursuant to this
Agreement, such Party may, as part of such contract, grant to such Contract Sales
Organization a nonexclusive, nontransferable, license or sublicense, as applicable, without
the right to grant sublicenses, under the AHPC Intellectual Property, the ELAN Intellectual
Property or ELAN’s interest in the ELAN/Lilly Patent Rights, as applicable, only to the
extent and only for so long as such license or sublicense is necessary for such Contract
Sales Organization to perform such Promotion. All such contracts and sublicenses entered
into by either Party with a Contract Sales Organization
shall be subject to the prior written approval of the JSC with the prior review of each
Party’s legal department, which approval shall not be unreasonably withheld or delayed.

-19-

 

          2.3.2. Limitations.

          (a) Elan hereby agrees to not grant to Lilly and/or any Affiliate of Lilly, any license or
sublicense, as applicable, under the AHPC Intellectual Property or ELAN’s interest in the
Collaboration Intellectual Property or the Copyrights or the Trademarks, as applicable, without the
express written consent of AHPC.

          (b) AHPC hereby agrees to not grant to Lilly and/or any Affiliate of Lilly, any license or
sublicense, as applicable under the AHPC Intellectual Property or AHPC’s interest in the
Collaboration Intellectual Property or the Copyrights or the Trademarks, as applicable, without the
express written consent of ELAN.

          2.4. Exclusive Working Relationship. Except as expressly set forth in this Agreement,
it is understood and agreed by the Parties that: (a) *** the
Parties shall work exclusively with each other in the Field under the terms of this Agreement,
(b)                                                                ***
                                                          the Parties shall have the right, alone
but not in collaboration with or through the grant of rights to any Third Party, to research,
develop, manufacture and commercialize, in the Field, product candidates and products, as
applicable, other than R&D Candidates and Products under this Agreement, (c)
                                                               ***
                                                          the Parties shall have the right, either
alone or in collaboration with or through the grant of rights to any Third Party, to research,
develop, manufacture and commercialize, in the Field, product candidates and products, as
applicable, other than R&D Candidates and Products under this Agreement, and (d)                  
***                  the Parties shall work exclusively with each other to Research, Develop,
Manufacture and Commercialize R&D Candidates and Products, and shall not, either alone or in
collaboration with or through the grant of rights to any Third Party, develop, make, import,
export, distribute, offer for sale, sell, or otherwise commercialize, outside of the Field, such
R&D Candidate or Product in any country in the Territory.

          2.5. Right of Reference. Each Party hereby grants the other a “Right of Reference,”
as that term is defined in 21 C.F.R. § 314.3(b), to any data developed under this Agreement, and a
Party shall provide a signed statement to this effect, if requested by the other, in accordance
with 21 C.F.R. § 314.50(g)(3).

          2.6. No Other Rights. No rights, other than those expressly set forth in this
Agreement are granted to either Party hereunder, and no additional rights shall be deemed granted
to either Party by implication, estoppel or otherwise.

3. MANAGEMENT OF COLLABORATION.

          3.1. Joint Steering Committee.

CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

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     3.1.1. Formation, Membership. Within thirty (30) days after the Effective
Date, ELAN and AHPC shall establish a “Joint Steering Committee” or “JSC” to oversee and
direct the conduct of the Research and Development of each R&D Candidate and to oversee and
coordinate those activities that are necessary for the successful Commercialization for a
Product in the Territory, as further described below in this Agreement. The JSC shall be
comprised of four (4) representatives from each Party as appointed by such Party, which
representatives shall be senior representatives of each Party (i.e., vice president or
higher) and shall have expertise suitable to the then-current activities of the
collaboration. The JSC may change its size from time to time by mutual consent of its
members. A Party may replace one (1) or more of its representatives from time to time upon
written notice to the other Party. The JSC may establish subcommittees to oversee specific
projects or activities or to perform certain of its functions, and such subcommittees shall
be constituted as the JSC shall determine, but shall always include equal representation
from each Party. The JSC will exist until the termination of this Agreement unless the
Parties otherwise agree in writing.

     3.1.2. Chairperson; Secretary. The chairperson and secretary of the JSC shall
rotate on an annual basis between the Parties. The chairperson and secretary shall not be
from the same Party at the same time. The first chairperson shall be designated by AHPC.
The chairperson will be responsible for scheduling meetings of the JSC, preparing agendas
for meetings, sending to all JSC members notices of all regular meetings and agendas for
such meetings at least five (5) business days before such meetings. The secretary shall
record the minutes of the meeting, circulate copies of meeting minutes to the Parties and
each JSC member promptly following the meeting for review, comment and approval, and shall
finalize approved meeting minutes. The chairperson shall be a member of the JSC but the
secretary need not be a member of the JSC.

     3.1.3. Meetings. The JSC shall meet at least once each Calendar Quarter during
the term of this Agreement, unless otherwise mutually agreed by the Parties. Either Party
may call a special meeting of the JSC on fifteen (15) days written notice to the other Party
and each of the JSC members. Such written notice shall include an agenda for the special
meeting. Meetings, including without limitation, special meetings, of the JSC will
alternate between the offices of the Parties, unless otherwise agreed by the members of the
JSC, or may be held telephonically or by video-conference. Meetings of the JSC shall be
effective only if at least one (1) representative of each Party is in attendance or
participating in the meeting. Members of the JSC shall have the right to participate in and
vote at meetings by telephone. The most senior attending representative of each Party on
the JSC shall have the right to vote on behalf of any members of the JSC from such Party not
attending a JSC meeting in person or by telephone. Each Party shall be responsible for
expenses incurred by its employees and its members of the JSC in attending or otherwise
participating in JSC meetings.

     3.1.4. Decision Making. All decisions of the JSC shall be made by majority
vote, with at least one representative from each Party voting with the majority. In the
event that the JSC is unable to reach a decision with respect to any scientific matter under
its consideration, such matter shall be referred for resolution to the President, Wyeth-

-21-

 

Ayerst Research and the Executive Vice President, Elan Pharmaceuticals (who shall be
the most senior individual within ELAN’s research and development organization). In the
event that the JSC is unable to reach a decision with respect to any commercial matter under
its consideration, such matter shall be referred for resolution to the President,
Wyeth-Ayerst Global Pharmaceuticals and the President, Elan Pharmaceuticals. A matter shall
be considered referred by the JSC as of the date that either Party or the JSC provides each
decision-making individual a written description of the disputed matter, which written
description shall include the positions taken by each member of the JSC as to such matter,
all other information relevant to such matter and a copy of the minutes of each JSC meeting
at which such matter was discussed. Within ten (10) days after such matter is so presented
by the JSC, the Parties’ decision-making individuals noted above shall determine the date,
time and location of the meeting to address such matter. Such decision-making meetings will
alternate between the offices of the Parties, unless otherwise agreed by the Parties, or may
be held telephonically or by video-conference. Each Party shall be responsible for expenses
incurred by its decision-making individual in attending or otherwise participating in such
meetings. If any of such referred matters cannot be resolved by such individuals, either
Party may elect to bring the matter to the attention of the Executive Vice President, AHPC
and the President, Elan Corporation, plc (or such other officer exercising the duties of
this office) and thereafter should a dispute not be resolved, to the Chief Executive
Officers of said corporations. If disputes are not resolved at this level, then subject to
Section 3.1.5 either Party may seek any remedy, at law or in equity, that may be available.

     3.1.5. Mediation. If a dispute arises between the Parties, and if such dispute
cannot be resolved pursuant to Section 3.1.4 above, the Parties agree to try in good faith
to resolve any dispute, controversy or claim (except as to any issue relating to
intellectual property) arising out of or relating to this Agreement, or the breach,
termination or invalidity thereof by non-binding mediation administered by the American
Arbitration Association in accordance with its commercial mediation rules. Unless otherwise
mutually agreed upon by the Parties, the mediation proceedings shall be conducted at the
location chosen by the Party not originally requesting the resolution of the dispute. The
Parties agree that they shall share equally the cost of the mediation, including filing and
hearing fees, and the cost of the mediator(s). Each Party shall bear its own attorneys’
fees and associated costs and expenses.

     3.1.6. Responsibilities of the JSC. In addition to its general responsibility
to oversee and coordinate Research and Development according to the Research Program and the
Development Program, ensure a regular flow of Research and Development information between
the Parties and to oversee and coordinate the Commercialization of Products in the
Territory, the JSC shall in particular:

          (a) prepare the Global Research and Development Plan pursuant to Section 4.2.1;

          (b) review and update as necessary the Global Research and Development Plan;

-22-

 

          (c) approve the Annual Research Plan for the period from the Effective Date through calendar
year 2001 in accordance with Section 4.2.2, and prepare and approve an updated Annual Research Plan
during each subsequent year in which the Parties engage in Research activities;

          (d) review and approve any substantive departure from any Annual Research Plan pursuant to
Section 4.2.2;

          (e) approve the Annual Development Plan for the period from the Effective Date through
calendar year 2001 in accordance with Section 4.2.2, and prepare and approve an updated Annual
Development Plan during each subsequent year in which the Parties engage in Development activities;

          (f) review and approve any substantive departure from any Annual Development Plan pursuant to
Section 4.2.2;

          (g) oversee the activities of the project team(s) that is/are performing the Party’s
activities under the Research Program and the Development Program;

          (h) facilitate the flow of information between the Parties with respect to all Research and
Development work being conducted for each R&D Candidate in the Field on a worldwide basis;

          (i) ascertain, at least on an annual basis, what, if any intellectual property owned by,
licensed to or developed by each Party would be useful for the Research, Development and
Commercialization of R&D Candidates and Products;

          (j) determine whether an R&D Candidate has or has not met the criteria for payment of
milestones;

          (k) review and approve any recommendations by the Joint Patent Committee that a Third Party
License should be entered pursuant to Section 8.7;

          (l) review and approve all scientific and clinical protocols, which shall provide that all
preclinical and clinical development work under this Agreement shall be conducted in accordance
with GLPs and GCPs;

          (m) review and approve the contents and filings of INDs, applications for Regulatory Approval,
and related and supporting submissions to Regulatory Authorities;

          (n) prepare and approve a Commercialization Plan pursuant to Section 6.1.2;

          (o) prepare an Annual Commercialization Plan pursuant to Section 6.1.2; and

          (p) at least ninety (90) days prior to the beginning of each calendar year, prepare an
estimate of Pro Forma Net Profits on a Product-by-Product and country-by-country basis.

-23-

 

     3.1.7. Guiding Principle. The Parties’ intent is to Develop and Commercialize
Products as expeditiously as possible with resources and responsibilities allocated on the
basis of the Parties’ respective capabilities and availability of adequate capacities,
either internally or through subcontractors obtained in accordance with Sections 4.2.3
and/or 6.1.1. Subject to the foregoing, the guiding principle to be followed by the JSC is
to allocate such resources and responsibilities                    ***
                   .

          3.2. Authority. The Parties agree that, in voting on matters as described in this
Article 3, it shall be conclusively presumed that each voting member of the JSC has the authority
and approval of such member’s respective senior management in casting his or her vote and that
decisions of the JSC made in accordance with this Article 3 shall be binding upon each of the
Parties; provided, however, that the JSC shall not have the authority to amend or modify this
Agreement.

          3.3. Project Coordinators. Each Party shall designate one (1) or two (2) of its
employees as project coordinator(s) for all of the activities contemplated under this Agreement.
Such project coordinators will be responsible for the day-to-day coordination of the collaboration
contemplated by this Agreement and will serve to facilitate communication between the Parties. A
Party may, from time to time, replace its designated project coordinator(s) upon providing the
other Party with written notice to that effect.

          3.4. Meetings of Chief Executive Officers. The Chief Executive Officers (CEOs) of
AHPC and Elan Corporation, plc, or their designated direct-reporting representative, shall meet two
(2) times per year during the term of this Agreement, unless otherwise agreed upon in writing by
the Parties. In such meetings, the CEOs shall review the progress of the collaboration and shall
discuss any current issues of the collaboration with the intent of proposing resolutions for such
issues. Meetings, including without limitation, special meetings called pursuant to Section 3.1.4,
shall alternate between the offices of the Parties, unless otherwise agreed by the CEOs or their
respective representatives, or may be held telephonically or by videoconference.

          3.5. Compliance with Laws. Each Party agrees that, in conducting its activities under
this Agreement, it shall at all times comply with all applicable material laws and regulations.

4. RESEARCH AND DEVELOPMENT.

     4.1. The Research and Development Programs.

     4.1.1. Conduct of the Research and Development Programs. Under the terms and
conditions set forth herein, AHPC and ELAN shall collaborate through one or more joint
project teams in the conduct of a collaborative research program (the “Research

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Program”) and a collaborative development program (the “Development Program”) for the
pre-clinical and clinical Research and Development of R&D Candidates in the Field. The JSC
shall identify R&D Candidates for Research under the Research Program. The R&D Candidates
as of the Effective Date include, without limitation, those listed on Exhibit 4.1.1.
Each R&D Candidate shall be advanced from the Research Program into the Development Program
on the date that the JSC designates such R&D Candidate for further pre-clinical development
toward IND filing. An R&D Candidate shall remain in the Development Program until such time
as (i) the JSC determines that such R&D Candidate should be returned to the Research Program
for the conduct of further pre-clinical studies, (ii) such R&D Candidate is dropped from the
Research Program and Development Program or (iii) such R&D Candidate receives Regulatory
Approval in the Territory at which time such R&D Candidate shall be deemed a Product. Each
of the Research Program and Development Program shall be conducted in accordance with the
Global Research and Development Plan as described in Section 4.2.

     4.1.2. The Research Program. The Research Program shall be conducted for an
initial term of      ***       (the “Initial Research Term”). The Research Term shall be
extended for a period of        ***        if, during the Initial Research Term, the JSC
determines that there exists an approach on which either Party has initiated Research, other
than *** Approximately 5 lines omitted ***. The Initial Research Term may also be
extended upon mutual agreement of the Parties, which extension shall be agreed upon at least
four (4) months in advance of the end of the initial term or the then current extension. At
the first JSC meeting following the end of each calendar year during the Research Term, and
within thirty (30) days after the end of the Research Term, the JSC shall meet to prepare a
list identifying all R&D Candidates and Products which were Researched or Developed during
the calendar year or the Research Term, as applicable, and which remain subject to the terms
and conditions of this Agreement, which lists shall be provided in writing to each Party.

     4.1.3. The Development Program. The Development Program shall have a term (the
“Development Term”) which commences on the Effective Date and shall continue until the JSC
agrees to cease the clinical development of the final R&D Candidate or until all Regulatory
Approvals for all R&D Candidates have been received in the Territory.

     4.2. The Research and Development Plans.

     4.2.1. Global Research and Development Plan. Within sixty (60) days following
its formation, the JSC shall prepare and approve a Global Research and Development Plan
which shall set forth the goals and objectives of the Research Program and the Development
Program. The Global Research and Development Plan shall set forth

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generally (i) the research activities that shall be undertaken by the Parties in the
identification of R&D Candidates under the Research Program, (ii) the pre-clinical
activities to be undertaken with any R&D Candidate toward an IND filing under the Research
Program, (iii) the target date for submission of any IND other than the IND for the Current
Clinical Trials, (iv) the clinical development activities that shall be undertaken after
such IND is filed to obtain Regulatory Approval of an R&D Candidate under the Development
Program, (iv) date of first enrollment and completion of patient accrual for clinical
trials, (v) global regulatory filing strategy, (vi) global manufacturing strategy, and (vii)
target submission dates for applications for Regulatory Approval of an R&D Candidate in the
Major Market Countries. The Global Research and Development Plan shall be kept current by
the JSC, updated on such schedule as the JSC may determine but not less often than once per
calendar year. The Global Research and Development Plan may only be modified or amended
upon written approval of the JSC.

     4.2.2. Annual Research and Development Plans. Within sixty (60) days after the
Effective Date, the Parties shall prepare an annual research plan (the “Annual Research
Plan”) and shall prepare an annual development plan for each R&D candidate in the
Development Program (each an “Annual Development Plan”) each of which shall address the
specific collaborative Research and Development activities of the Parties from the Effective
Date through calendar year 2001 pursuant to this Agreement. The initial Annual Research
Plan and Annual Development Plan shall address the elements set forth in Exhibit
4.2.2 to this Agreement, as well as other elements that may be appropriate for inclusion
therein. The JSC shall review and approve such initial Annual Research Plan and Annual
Development Plan within sixty (60) days following its formation. Thereafter, on or before
October 31 of each year (commencing in 2001), the JSC shall prepare and approve an Annual
Research Plan and an Annual Development Plan addressing the collaborative Research and
Development activities (as applicable) to be undertaken by the Parties during the following
calendar year pursuant to this Agreement and the then current Global Research and
Development Plan. Each Annual Research Plan and each Annual Development Plan shall include,
without limitation, detailed plans for, as applicable, the collaborative Research and
Development activities, Manufacturing and scale-up tasks, and clinical studies of R&D
Candidates for use in the Field, designation of which Party is responsible for each task,
staffing levels required to carry out such activities (which levels shall be reasonably
necessary for the attainment of the Annual Research Plan or Annual Development Plan, as
applicable), and a budget setting forth the estimated expenditures required to carry out
such activities. Should the JSC determine that a specific activity would best be undertaken
by a Third Party contractor, the JSC shall indicate which Party shall manage such Third
Party contractor. The Annual Research Plan and Annual Development Plan may only be modified
or amended upon written approval of the JSC.

     4.2.3. Conduct of the Annual Research Plan and Annual Development Plans. ELAN
and AHPC shall each use Commercially Reasonable Efforts to perform its
respective activities under the then current Annual Research Plan and Annual
Development Plan and each Party shall perform such activities in accordance with applicable
GLPs and GCPs. All activities to be undertaken in the performance of an Annual Research
Plan or Annual Development Plan shall be carried out by employees of

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the Parties and/or their respective Affiliates, provided, however, that if either Party
is able to reasonably demonstrate, and the JSC agrees, that (a) it would be in the best
interests of both Parties to contract with one (1) or more Third Parties to perform certain
tasks under either an Annual Research Plan or Annual Development Plan, and (b) any such
Third Party is capable of performing such tasks in a manner competitive with the Parties in
terms of cost and quality, then, the Party responsible for such task may enter into a
contract with a Third Party to perform such task, which contract shall be subject to the
prior written approval of the JSC. In determining whether to utilize the services of any
Third Party in conducting activities under an Annual Research Plan or Annual Development
Plan, the Parties shall consider, inter alia, what would be the most efficient and cost
effective means for accomplishing the proposed activity, any relevant intellectual property
issues that may impede a Third Party’s ability to perform the proposed activity or that may
warrant limiting the performance of the proposed activity to one of the Parties, and other
relevant factors. The responsibility for performing clinical studies of each R&D Candidate
will be assigned to AHPC, ELAN and/or Third Party contractors selected by the JSC in
accordance with this Section.

     4.2.4. Periodic Inspections. With respect to any facility or site at which a
Party conducts Research, Development or Manufacturing pursuant to this Agreement, including,
where commercially reasonable and within the control of the other Party, Third Party
facilities or sites, each Party shall have the right, at its expense, upon reasonable
written notice and during normal business hours, to inspect such site and facility and any
records relating thereto as is reasonably necessary to verify the other Party’s compliance
with the terms of this Agreement relating to GLP, GCP and GMP. Such inspection shall be
subject to the confidentiality provisions of this Agreement. Each Party agrees to, to the
maximum extent possible, to include in any agreement with a Third Party relating to such
facilities and sites a clause permitting the other Party to exercise its rights under this
Section.

     4.3. Funding of the Global Research and Development Plan.

     4.3.1. Research and Development Expenses. From the Effective Date forward, the
Parties shall share all R&D Expenses     ***    .

     4.3.2. Payment of Expenses; R&D Accounts. Subject to reconciliation as
provided in Section 4.3.4, each Party shall be responsible and pay for all expenses incurred
by it in performing its activities under the Research Program and the
Development Program. Subject to the limitations set forth in Section 4.3.3, each Party
shall charge all such expenses so incurred by it or its Affiliates to a separate account
created by such Party on its books and records solely for the purpose of tracking expenses
incurred in connection with the Research Program and Development Program (each, an

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“R&D Account”). Within thirty (30) days after the end of each Calendar Quarter, each
Party shall submit to the other Party a written summary of all expenses charged to its R&D
Account during such Calendar Quarter, which summary shall be accompanied by reasonable
supporting documentation for such expenses. The Parties will work together to report to
each other estimates of the amounts to be included in such reports prior to the expiration
of such thirty (30) day period.

     4.3.3. Expense Limitations. The expenses charged by either Party to its R&D
Account in accordance with Section 4.3.2, shall not be in an amount in excess of          
***           of the amount included for such expenses in the then current Annual Research
Plan or Annual Development Plan, as appropriate, unless the JSC recommends and each Party
approves such excess expenses. Additionally, the Parties hereby agree that efforts of the
employees of a Party or its Affiliates in performing its activities hereunder shall be
charged to such Party’s R&D Account at the applicable FTE rate set forth in the applicable
Annual Research Plan or Annual Development Plan, provided, however, that only those efforts
that are contemplated by the Global Research and Development Plan and/or the applicable
Annual Research Plan or Annual Development Plan shall be chargeable by a Party to its R&D
Account, except as otherwise approved in writing by the JSC. The FTE rates set forth in any
Annual Research Plan or Annual Development Plan shall be based upon direct costs plus a
minimum overhead allocation established by the JSC. All payments made by a Party to a Third
Party in connection with the performance of its activities under an Annual Research Plan or
Annual Development Plan shall be charged to such Party’s R&D Account at such Party’s actual
out-of-pocket cost. Expenses incurred by each Party for equipment, materials and supplies
utilized in performing its activities under an Annual Research Plan or Annual Development
Plan shall not be separately charged to such Party’s R&D Account, except for those expenses
incurred by a Party, with the prior written consent of the JSC, in the purchase or making of
equipment, materials or supplies (other than common laboratory supplies, e.g., pipettes,
test tubes, petri dishes, reagents, and the like) that are to be used exclusively in
connection with the performance of such Party’s activities under an Annual Research Plan or
Annual Development Plan (e.g., laboratory animals, compounds that are R&D Candidates,
Products, placebo supplies, etc.), which expenses shall be charged to such Party’s R&D
Account at such Party’s actual out-of-pocket expense incurred in purchasing or making such
equipment, materials or supplies. Notwithstanding the foregoing, in the case of materials
supplied to the Parties by either Party for use in clinical trials of R&D Candidates or
Products, the supplying Party shall charge to its
R&D Account its Fully Absorbed Standard Cost for such materials, as adjusted to account
for manufacturing cost variances allocable to such materials.

     4.3.4. Reconciliation of Expenses. Within sixty (60) days after the end of
each calendar year, AHPC shall prepare a reconciliation report, accompanied by reasonable

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supporting documents and calculations, which reconciles the amounts charged to each
Party’s R&D Account during such calendar year pursuant to Section 4.3.2, including, without
limitation, making any necessary adjustments for prior period manufacturing cost variances
allocable to Products utilized in Development, and the share of the Parties’ aggregate R&D
Expenses to be allocated to each of the Parties for such calendar year in accordance with
Section 4.3.1. Within thirty (30) days after AHPC delivers such reconciliation report to
ELAN, the net amount shown as being due either AHPC or ELAN will be paid by the Party owing
such amount.

     4.3.5. Third Party License Fees. Until such date as a Product is
Commercialized in the Territory the Parties shall           ***           the costs of any
Third Party License Fees for such Product. The Party paying any Third Party License Fee
shall invoice the other Party for its share of such Third Party License Fee within         
***          days after the end of each calendar year. The Party receiving such invoice
shall reimburse the other Party for its share of such Third Party License Fees within
         ***          days after receiving the invoice therefor.

     4.3.6. Records and Audits. During the term of this Agreement, each Party shall
keep and maintain accurate and complete records showing the expenses incurred by it in
performing its activities under the Annual Research Plans and Annual Development Plans
during the                          ***                          which books and records
shall be in sufficient detail such that R&D Expenses can accurately be determined. Upon
fifteen (15) days prior written notice from a Party (the “Auditing Party”), the other Party
(the “Audited Party”) shall permit an independent certified public accounting firm of
nationally recognized standing selected by the Auditing Party and reasonably acceptable to
the Audited Party, to examine the relevant books and records of the Audited Party and its
Affiliates as may be reasonably necessary to verify the reports submitted by the Audited
Party in accordance with Section 4.3.2 and the accuracy of the reconciliation report
prepared in accordance with Section 4.3.4. An examination by a Party under this Section
4.3.6 shall occur not more than once in any calendar year and shall be limited to the
pertinent books and records for any calendar year ending not more than            ***
           before the date of the request. The accounting firm shall be provided access to
such books and records at the Audited Party’s facility(ies) where such books and records are
normally kept and such examination shall be conducted during the Audited Party’s normal
business hours. The Audited Party may require the accounting firm to sign a standard
non-disclosure agreement before providing the accounting firm access to the
Audited Party’s facilities or records. Upon completion of the audit, the accounting
firm shall provide both AHPC and ELAN a written report disclosing whether the reports
submitted by the Audited Party are correct or incorrect and the specific details concerning
any discrepancies. No other information shall be provided to the Auditing Party. If the
accountant determines that, based on errors in the reports so submitted, the reconciliation

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report prepared in accordance with Section 4.3.4 is incorrect, the Parties shall
promptly revise the reconciliation report and any additional amount owed by one Party to the
other shall be paid within thirty (30) days after receipt of the accountant’s report, along
with interest at the annual interest rate of    ***   , compounded monthly from the date
that such additional amount should have first been paid, provided, however, that no such
interest shall be payable if the errors leading to the reconciliation report being incorrect
were in the reports provided by the Party to receive such additional amount. Additionally,
if the accountant determines that the reports submitted by the Audited Party overstate the
Audited Party’s expenses by more than           ***          , the Audited Party shall
reimburse the Auditing Party for the expenses incurred by the Auditing Party in conducting
the audit.

     4.4. Reporting and Disclosure.

     4.4.1. Reports. Before each quarterly meeting of the JSC, ELAN and AHPC will
each provide the other with written copies of all materials they intend to present at the
JSC meeting plus, to the extent not set forth in the JSC materials, a written report
summarizing any other material data and information arising out of the conduct of the
Research Program and/or Development Program including, without limitation, data and
information relating to any Inventions made by such Party. If after receipt of any such
report, either Party shall request additional data or information relating to an Annual
Research Plan or Annual Development Plan or Collaboration Intellectual Property licensed
hereunder, the Party to whom such request is made shall promptly provide to the other Party
such data or information that such Party reasonably believes is necessary for the continued
conduct of the Research Program or the Development Program.

     4.4.2. Quarterly Meeting. At the quarterly meeting of the JSC, AHPC and ELAN
will review in reasonable detail (i) all data and information generated in the conduct of
the Annual Research Plan and Annual Development Plan by each Party, and (ii) all
Collaboration Intellectual Property licensed hereunder developed by the Parties.

     4.5. Disclosure. During the term of this Agreement, the Parties will promptly
disclose to one another all data, information, Inventions, techniques and discoveries (whether
patentable or not) arising out of the conduct of the Research Program and the Development Program,
and all Inventions, techniques and discoveries (whether patentable or not) included in
Collaboration Intellectual Property licensed hereunder. Such disclosures may take the form of limited visits by ELAN and AHPC personnel to the facilities being utilized for the Research
Program and the Development Program to permit observation of the procedures being employed.

5. MANUFACTURING AND REGULATORY MATTERS.

          5.1. Manufacture and Supply of Products.

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     5.1.1. Responsible Party. ELAN shall be responsible for the Manufacture and
supply to AHPC of Products for worldwide sale and distribution by AHPC, provided however,
ELAN will distribute Products in those countries designated by the JSC under Section 6.1.1.
ELAN can elect to Manufacture the entire Product or a component thereof, including without
limitation its packaging or formulations, provided that, ELAN is competitive with Third
Parties in Cost of Goods Manufactured for Sale and quality. In the event that ELAN does not
elect to Manufacture, then AHPC shall have the option to be the Contract Manufacturer for
ELAN of that portion of Product Manufacturing which ELAN declined to Manufacture, provided
that, AHPC is competitive with Third Parties in Cost of Goods Manufactured for Sale and
quality. Should neither AHPC nor ELAN elect to Manufacture Products, then ELAN shall choose
a Third Party to be a Contract Manufacturer, subject to AHPC’s prior approval, which shall
not be unreasonably withheld. In the event that either AHPC or a Third Party (each a
“Manufacturing Subcontractor”) is to Manufacture Product or a component thereof, ELAN shall,
in accordance with Section 5.1.3 below, negotiate in good faith and enter into a supply
agreement with such Manufacturing Subcontractor.

     5.1.2. Agreement for Supply of Product to AHPC. Within           ***
          after the Effective Date (or such later time upon which the Parties may mutually
agree), ELAN and AHPC shall negotiate, in good faith, and enter into a written supply
agreement which sets forth the rights and obligations of the Parties in connection with
ELAN’s exclusive supply of Product to AHPC for worldwide sale and distribution by AHPC
(except for those countries in which Elan is designated as the Distributing Party in
accordance with Section 6.1.1), provided that the Parties shall on a semi-annual basis,
prior to the second anniversary of the Effective Date, consider whether the timetable for
negotiating and entering into such supply agreement should be accelerated. Such supply
agreement shall not be inconsistent with the terms and conditions of this Agreement and
shall include provisions to ensure the timely Manufacture and supply of Product for sale and
distribution by the Distributing Party hereunder, including, without limitation,
forecasting, ordering and delivery schedules and procedures, product warranties, and
procedures to address periods of supply shortages, including, without limitation, providing
AHPC the right to Manufacture Product to meet its requirements during supply shortages and
allocation of Product inventories during such supply shortages. The purchase price, on a
country-by-country basis, to be paid to ELAN (or ELAN’s Affiliate)
by AHPC for each unit of Product delivered to AHPC under such supply agreement for
distribution in such country shall be equal to the Base Price (on a per unit of Product
basis) plus the ELAN Manufacturing Profit for such country, provided, however, that the
purchase price for any units of Product to be distributed in such country as Samples shall
be the Base Price and shall not include any ELAN Manufacturing Profit. The Base Price
portion of the purchase price shall be payable within thirty (30) days after such Product is
delivered to AHPC and the ELAN Manufacturing Profit portion of such purchase price

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shall be paid within sixty (60) days after the end of the Calendar Quarter during which
such Product is sold by AHPC. Upon ELAN’s request, AHPC shall supply such technical
assistance and expertise as may be reasonably necessary to permit ELAN to discharge its
Manufacturing responsibilities.

     5.1.3. Agreement for Supply of Product to ELAN. In the event that ELAN
determines that a Manufacturing Subcontractor shall Manufacture and supply Product to ELAN,
ELAN shall, as soon as practicable after such determination, but in no event longer than
                                ***                               , negotiate, in good
faith, and enter into a written supply agreement with such Manufacturing Subcontractor,
which written agreement shall be subject to the prior review and written approval of the JSC
and, if the Manufacturing Subcontractor is a Third Party, AHPC. Such supply agreement shall
not be inconsistent with the terms and conditions of this Agreement and shall include
provisions to ensure the timely Manufacture and supply of Product so that ELAN is able to
meet its obligations under the supply agreement entered into with AHPC under Section 5.1.2
above, including, without limitation, forecasting, ordering and delivery procedures and
schedules, product warranties, and procedures to address periods of supply shortages,
including, without limitation, providing ELAN and/or AHPC the right to Manufacture Product
to meet the Distributing Party’s requirements during supply shortages and allocation of
Product inventories during such supply shortages. In the event that the Manufacturing
Subcontractor is AHPC, the purchase price to be paid by ELAN, on a country-by-country basis,
for each unit of Product supplied by AHPC for ultimate distribution in such country, shall
be the Base Price (on a per unit of Product basis) plus the AHPC Manufacturing Profit for
such country, provided, however, that the purchase price for any units of Product to be
distributed as Samples shall be the Base Price and shall not include any AHPC Manufacturing
Profit. The Base Price portion of the purchase price shall be payable within thirty (30)
days after such Product is delivered to ELAN and the AHPC Manufacturing Profit portion of
such purchase price shall be paid within sixty (60) days after the end of the Calendar
Quarter during which such Product is sold by the Distributing Party.

          5.2. Labeling. To the extent permitted by applicable laws and regulations, as may be
reasonably requested by the other Party, the Manufacturing Party shall include in all Product
Labels, Labeling, and Packaging, as those terms are use in the FD&C Act, a statement
indicating that such Product was developed in collaboration with the other Party. Should
either Party believe that any change in a Label relating to a Product be necessary, such Party
shall notify the other Party in writing, specifying the proposed change. The Parties shall
thereafter consult with each other regarding the proposed change, and the Party which is
responsible for regulatory matters in the relevant country shall not unreasonably refuse to submit
such proposed change to the Regulatory Authorities in such country. The Parties shall seek to
include uniform

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Labeling for each Product in all countries to the extent permitted by applicable laws and
regulations.

     5.3. Regulatory Matters.

     5.3.1. International Regulatory Approvals. AHPC shall file, in its own name,
all applications for Regulatory Approval for Products in all countries of the Territory
other than the United States. AHPC shall have the primary responsibility for communicating
with any Regulatory Authority regarding any such application for Regulatory Approval or any
Regulatory Approval once granted, provided, however, that ELAN shall (a) provide AHPC with
advice and reasonable assistance in (i) developing a Regulatory Approval filing strategy for
Products, (ii) reviewing study reports from clinical trials of Products, (iii) preparing
applications for Regulatory Approval for Products, (iv) preparing supplements to
applications for Regulatory Approval for Products, (v) responding to questions from
Regulatory Authorities regarding applications for Regulatory Approval or any supplement
thereto and (b) participate in interactions with Regulatory Authorities concerning the
Products.

     5.3.2. United States Regulatory Approvals. ELAN shall file, in its own name,
all applications for Regulatory Approval for Products in the United States. ELAN shall have
the primary responsibility for communicating with any Regulatory Authority regarding any
such application for Regulatory Approval or any Regulatory Approval once granted, provided,
however, that AHPC shall (a) provide ELAN with advice and reasonable assistance in (i)
developing a Regulatory Approval filing strategy for Products, (ii) reviewing study reports
from clinical trials of Products, (iii) preparing applications for Regulatory Approval for
Products, (iv) preparing supplements to applications for Regulatory Approval for Products,
(v) responding to questions from Regulatory Authorities regarding applications for
Regulatory Approval or any supplement thereto and (b) participate in interactions with
Regulatory Authorities concerning the Products.

     5.3.3. International Regulatory Reporting. AHPC shall be responsible for
filing all reports required to be filed in order to maintain any Regulatory Approvals
granted for Products in all countries of the Territory other than the United States,
including, without limitation, adverse drug experience reports. ELAN shall cooperate with
AHPC in preparing and filing all such reports and, upon AHPC’s request, provide AHPC with
any information in ELAN’s possession or Control which AHPC reasonably deems to be relevant
to any such reports. Notwithstanding the foregoing, to the extent ELAN has or receives any
information regarding any adverse drug experience which may be related to the use of any
Product, ELAN shall promptly provide AHPC with all such information in accordance with the
adverse event reporting procedures (as may be amended from time to time upon mutual
agreement of the Parties) set forth in Exhibit 5.3 attached hereto (the
“Adverse Event Reporting Procedures”). Expenses (both internal expenses and
out-of-pocket costs paid to a Third Party) incurred by a Party in performing its regulatory
reporting obligations under this Section in connection with Regulatory Approvals in the
Territory shall be charged by such Party to such Party’s Marketing Account for such Product
as a Post-Approval Research and Regulatory Expense.

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     5.3.4. United States Regulatory Reporting. ELAN shall be responsible for
filing all reports required to be filed in order to maintain any Regulatory Approvals
granted for Products in the United States, including, without limitation, adverse drug
experience reports. AHPC shall cooperate with ELAN in preparing and filing all such reports
and, upon ELAN’s request, provide ELAN with any information in AHPC’s possession or Control
which ELAN reasonably deems to be relevant to any such reports. Notwithstanding the
foregoing, to the extent AHPC has or receives any information regarding any adverse drug
experience which may be related to the use of any Product, AHPC shall promptly provide ELAN
with all such information in accordance with the Adverse Event Reporting Procedures.
Expenses (both internal expenses and out-of-pocket costs paid to a Third Party) incurred by
a Party in performing its regulatory reporting obligations under this Section in connection
with Regulatory Approvals in the Territory shall be charged by such Party to such Party’s
Marketing Account for such Product as a Post-Approval Research and Regulatory Expense.

     5.3.5. Regulatory Processes and Procedures. Within sixty (60) days after the
approval of the Global Research and Development Plan, the Parties’ respective regulatory
affairs or other applicable departments shall meet and agree upon processes and procedures
for sharing information needed to support each Party’s respective regulatory
responsibilities, including without limitation, a global safety database relating to R&D
Candidates and Products.

     5.3.6. Coordination. To the extent practical, the other Party shall be given
the opportunity to participate in substantive discussions and meetings with Regulatory
Authorities which relate to R&D Candidates or Products, including, but not limited to, with
respect to any IND or Regulatory Approval Filings. The Parties shall cooperate in good
faith with respect to the conduct of any inspections by any Regulatory Authority of a
Party’s site and facilities related to R&D Candidates or Products, and each Party shall at a
minimum be given the opportunity to attend the summary, or wrap up, meeting related to R&D
Candidates or Products with such Regulatory Authority at the conclusion of such site
inspection. Each Party shall consider the attendance of the other Party at any such
regulatory inspections, but shall not be obligated to accept the other Party’s attendance at
such inspections if such attendance would result in the disclosure to the other Party of
confidential information or trade secrets unrelated to the R&D Candidates or Products. To
the extent either Party receives written or material oral communication from the Regulatory
Authority relating to the R&D Candidates or Products, the Party receiving
such communication shall notify the other Party and provide a copy of any written
communication as soon as reasonably practicable.

6. COMMERCIALIZATION OF PRODUCTS.

     6.1. Commercialization in the Territory.

     6.1.1. Principles of Copromotion and Distribution. Subject to the terms of
this Agreement, the Parties shall Commercialize each Product in the Territory during the
term of this Agreement exclusively with the other Party and under the same brand name, using
professional sales representatives who are full time employees of the Parties, provided,

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however, that if either Party is able to reasonably demonstrate, and the JSC agrees, that it
would be in the best interest of both Parties to contract with one (1) or more Contract
Sales Organizations to perform all or part of such Party’s Product Promotion obligations
hereunder, then such Party may enter into a contract with such Contract Sales Organization
to perform such Product Promotion activities, which contract shall be subject to the prior
written approval of the JSC. In the event that, under applicable laws or regulations,
copromotion of a Product is not permitted in a country of the Territory, the JSC shall
determine which Party shall be responsible for the Commercialization of such Product in such
country, taking into account the respective resources and expertise of each Party.
Notwithstanding the foregoing, AHPC shall be responsible for distributing Products in each
country of the Territory and collecting revenues from the sale of such Products unless,
pursuant to the preceding sentence, ELAN is designated by the JSC to assume such
responsibilities in a country. The Party distributing Product and collecting revenues from
the sale of such Product in a country shall be the “Distributing Party” in such country with
respect to such Product.

     6.1.2. Commercialization Plan. On a Product-by-Product
basis,                                                              ***
                                                            the JSC shall prepare and
approve a rolling multiyear (                       ***                      ) plan for
Commercializing such Product in the Territory (the “Commercialization Plan”), which plan
includes a comprehensive market development, marketing, sales, supply and distribution
strategy for such Product in the Territory. The Commercialization Plan shall be updated by
the JSC at least once each calendar year such that it addresses no less than the
                     ***                    . Not later than thirty (30) days after the
filing of the first application for Regulatory Approval of a Product in the Territory and
thereafter on or before September 30 of each calendar year, the JSC shall prepare an annual
commercialization plan (the “Annual Commercialization Plan”), which plan is based on the
then current Commercialization Plan and includes a comprehensive market development,
marketing, customer support, sales, supply and distribution strategy, including an overall
budget for anticipated marketing, promotion and sales efforts in the
upcoming calendar year (the first such Annual Commercialization Plan shall cover the
remainder of the calendar year in which such Product is anticipated to be approved plus the
first full calendar year thereafter). The Annual Commercialization Plan will specify which
audiences and distribution channels each Party shall devote its respective Promotion efforts
towards, the personnel and other resources to be devoted by each Party to such efforts, the
number and positioning of Details to be performed by each Party (which as much as is
reasonably possible shall represent an equal effort on the part of each Party), as well as
market and sales forecasts and related operating expenses, for the Product in each country
of the Territory, and budgets for projected Pre-Marketing Expenses, Distribution Expenses,
Third Party License Fees, Assigned Sales Force Adjustment Payment, Working Capital Charges,
Sales and Marketing Expenses and Post-

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Approval Research and Regulatory Expenses. In
preparing and updating the Commercialization Plan and each Annual Commercialization Plan,
the JSC will take into consideration factors such as market conditions, regulatory issues
and competition. The number of Details assigned to a Party by the JSC in accordance with
this Section shall be such Party’s Assigned Sales Force Effort.

     6.1.3. Performance Metrics. The number of Details actually performed by either
Party as part of its Assigned Sales Force Effort shall be determined according to Detail
reporting mechanisms and methodology that are approved and applied consistently by the JSC.

     6.1.4. Assigned Sales Force Adjustment. If, on a Product-by-Product and
country-by-country basis, a Party’s Assigned Sales Force Effort during a given Calendar
Quarter is greater than              ***              of both Parties’ combined Assigned
Sales Force Effort during such Calendar Quarter for such Product in such country, such Party
shall be considered to have provided an excess Assigned Sales Force Effort during such
Calendar Quarter with respect to such Product in such country and shall be entitled to
charge to its Marketing Account and to receive, as part of the reimbursement made under
Section 6.1.6(d), an “Assigned Sales Force Adjustment Payment” which will be in the amount
of either:

     (i)     in the event that, during a given Calendar Quarter, the other Party’s Assigned
Sales Force Effort for such Product in such country is less than or equal to
                  ***                  of the Parties’ combined Assigned Sales Force
Effort for such Product in such country, the sum of

     *** Approximately 6 lines omitted***

     (ii)     in the event that, during a given Calendar Quarter, the other Party’s Assigned
Sales Force Effort for such Product in such country is greater than           ***

                   but less than           ***               of the Parties’ combined
Assigned Sales Force Effort for such Product in such country, the sum of

     *** Approximately 5 lines omitted***

     6.1.5. Recalls; Customer Support.

          (a) Recalls. The determination of whether a Product recall is required shall, to the
extent feasible, be made jointly by the Parties, provided that, to the extent required by
regulatory time frames or public safety considerations, the Distributing Party shall have the right
to make the Product recall decision. During the term of this Agreement, the Distributing Party
shall be responsible for handling and implementing all recalls and market withdrawals of any

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Product in the Territory. The other Party will make available to the Distributing Party, upon
request, all of the other Party’s pertinent records that the Distributing Party may reasonably
request to assist it in effecting any recall or market withdrawals. The Parties shall share
equally all costs of a recall or marketing withdrawal of a Product in the Territory. A Party shall
have no obligation to reimburse or otherwise compensate the other Party for any lost profits or
income that may arise in connection with any such recall or market withdrawal. Any investigation
conducted in connection with a Product recall shall be undertaken jointly by the Parties.

          (b) Customer Support. The Distributing Party shall, using Commercially Reasonable
Efforts, perform, and in consultation with the other Party, be responsible for all customer support
services necessary to discharge its Distribution and Commercialization obligations hereunder,
except that any customer support services which require regulatory approval, acquiescence or
oversight, including, without limitation, pharmacovigilance, responding to physician inquiries, or
professional education, shall be conducted by the Party with regulatory responsibility in the
country in which the Product is distributed.

          6.1.6. Commercialization Expenses.

          (a) Premarketing Expenses. On a Product by Product and country by country basis,
before Regulatory Approval of such Product in such country of the Territory, the Pre-Marketing
Expenses incurred by the Parties with respect to such Product in anticipation of obtaining
Regulatory Approval of such Product in such country shall be shared                       ***
           consistent with plans and budgets established in the applicable Annual Development Plan.
As such Pre-Marketing Expenses are incurred they shall be paid for by the Party incurring such
expenses, subject to reimbursement as set forth in Section 4.3.4.

          (b) Payment of Expenses, Marketing Accounts. Subject to reconciliation as provided in
Sections 6.1.6(d) and 6.1.6(e), as applicable, each Party shall be responsible and pay for the
Sales and Marketing Expenses, Third Party License Fees, Assigned Sales Force Adjustment Payment,
Distribution Expenses, Post-Approval Research and Regulatory Expenses and Working Capital Charges incurred by it in performing its activities in connection with the
Commercialization of Products in the Territory. Subject to the limitations set forth in Section
6.1.6(c), each Party shall charge all such expenses so incurred by it or its Affiliates to a
separate account created by such Party on its books and records solely for the purpose of tracking
expenses incurred in connection with the Commercialization of Products in the Territory (each, a
“Marketing Account”). Within thirty (30) days after the end of each Calendar Quarter, each Party
shall submit to the other Party a written summary of all Sales and Marketing Expenses, Third Party
License Fees, Assigned Sales Force Adjustment Payment, Distribution Expenses, Post-Approval
Research and Regulatory Expenses and Working Capital Charges incurred by it in performing its
activities in connection with the Commercialization of Products in the Territory,

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charged to its
Marketing Account during such Calendar Quarter, which summary shall be accompanied by reasonable
supporting documentation for such expenses.

          (c) Expense Limitations. The Sales and Marketing Expenses, Distribution Expenses,
Post-Approval Research and Regulatory Expenses and Working Capital Charges charged by either Party
to its Marketing Account in accordance with this Section 6.1.6, shall not be in an amount in excess
of                         ***                      of the amount included for such expenses in
the then current Annual Commercialization Plan, unless the JSC approves such excess expenses. All
payments made by a Party to any Third Party in connection with the performance of its activities in
connection with the Commercialization of a Product in the Territory shall be charged to such
Party’s Marketing Account at such Party’s actual out-of-pocket cost incurred in accordance with the
JSC approved contract entered into with such Third Party.

          (d) Reimbursement of Certain Expenses. At the time the Distributing Party, pursuant
to Section 7.4.1, distributes to the other Party, such other Party’s share of Pre-tax Profits
obtained from the sale of a Product in a country of the Territory during any Calendar Quarter, the
Distributing Party shall also reimburse each of AHPC and ELAN for those Sales and Marketing
Expenses, Assigned Sales Force Adjustment Payments, Distribution Expenses, Post-Approval Research
and Regulatory Expenses and Working Capital Charges that are (i) directly allocable to the
Commercialization of such Product in such country during such Calendar Quarter, (ii)properly
charged by such Party to its Marketing Account and (iii)reported to the other Party in accordance
with this Section. Such reimbursements shall be made solely from revenues obtained by the
Distributing Party which are attributable to the Net Sales of such Product in such country of the
Territory, with each Party receiving such reimbursement simultaneously in an amount proportional to
the expenditures actually made by such Party *** Approximately 10 lines omitted *** . If the
Net Sales are insufficient in any Calendar Quarter to fully reimburse the Parties proportionately
as set forth above, reimbursement payments shall be made in a sequential manner first for the Cost
of Goods Manufactured for Sale, second for the Third Party License Fees and third for the summed
Sales and Marketing Expenses, Assigned Sales Force Adjustment Payments, Distribution Expenses,
Post-Approval
Research and Regulatory Expenses and Working Capital Charges charged to a Party’s Marketing
Account with respect to such Calendar Quarter. After such sequential reimbursement payments have
been made, the Party having the lower amount remaining in its Marketing Account shall pay to the
other Party            ***           of the difference between the amount in such Party’s
Marketing Account and the other Party’s Marketing Account.

     (e) Extra Sales Force Effort Reconciliation. Within sixty (60) days after the end of
each calendar year, the JSC shall meet to review the Sales Force Effort provided by each of the
Parties on a Product-by-Product and country-by-country basis during such calendar year. If, with
respect to any Product in any country, a Party’s actual Sales Force Effort during such

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calendar
year is materially different from such Party’s Assigned Sales Force Effort for such Product in such
country during such calendar year, the JSC shall determine whether it is necessary for either Party
to make an adjustment payment to the other Party, which adjustment payment shall be equivalent to:

     *** Approximately 11 lines omitted***

     The Party obligated to make such adjustment payment shall make such payment to the other
Party within thirty (30) days after the JSC determines such adjustment payment is necessary.

     6.1.7. Marketing and Promotional Materials. The JSC shall determine the
content, quantity and method of distribution of any promotional materials related to the
Product in the Territory, provided, however, that all such marketing and promotional
materials shall be subject to the approval of AHPC’s and ELAN’s legal, medical affairs,
marketing and regulatory affairs departments before any use thereof by either Party. The
JSC shall determine which Party will be responsible for preparing and duplicating such
marketing and promotional materials and shall provide reasonable quantities of the same to
each Party for use by such Party in connection with its Promotion of the Product in the
Territory hereunder. Each Party shall use only marketing and promotional materials approved
by the JSC. All Copyright and other intellectual property rights in said promotional
materials shall remain vested in the Party that owns such promotional materials. Neither
Party may independently create, distribute or use sales, promotion or other similar material
relating to a Product in the Territory without the prior written consent of either the JSC
or the other Party.

     6.1.8. Promotional Claims. Each Party shall limit the claims of safety and
efficacy that such Party or its sales force makes for a Product in the Territory to those
that are consistent with the approved labeling for such Product in such country of the
Territory. Neither Party may add, delete or modify claims of efficacy or safety in its
Promotion of any Product in the Territory nor make any changes in Promotion materials
and literature approved by the JSC. Each Party’s Detailing and Promotion of a Product
in the Territory shall be in strict adherence to all regulatory, professional and legal
requirements including, without limitation, FDA’s regulations and guidelines concerning the
advertising of prescription drug products, the American Medical Association’s Guidelines on
Gifts to Physicians, the PhRMA Guidelines for Marketing Practices, the ACCME Standards for
Commercial Support of Continuing Medical Education, the then current Annual
Commercialization Plan for the Product and any updates thereto.

     6.1.9. Samples. When Detailing and Sampling the Product, each Party’s
professional sales representative shall complete Sample Receipt Forms provided by the

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Distributing Party. A copy of the completed Sample Receipt Forms shall be left with the
physician receiving the Detail. Such professional sales representative shall mail to the
Distributing Party, in pre-addressed, postage-paid envelopes provided by the Distributing
Party, at the close of each business day the original completed Sample Receipt Forms for all
Details performed by such professional sales representative that day. A copy of all such
Sample Receipt Forms shall be kept by each such professional sales representative. Each
Party shall ensure that each of its professional sales representatives fills out the Sample
Receipt Forms accurately, completely and timely. The Fully-Absorbed Standard Cost incurred
by the Distributing Party in providing and processing Sample Receipt Forms shall be charged
by the Distributing Party to its Marketing Account as a Sales and Marketing Expense.

     6.1.10. Communications. Each Party shall be fully responsible for
disseminating accurate information regarding a Product to its professional sales
representatives based on the Product’s approved labeling and information provided by the
JSC.

     6.1.11. Training. Each Party shall be responsible for the training of its own
professional sales representatives, in accordance with the training requirements and
training programs and using training materials approved by the JSC and shall require each of
its professional sales representatives to attend sales training for a Product before their
Promotion of such Product in the Territory hereunder. After the initial training meeting,
each Party shall periodically provide additional training, in accordance with the training
requirements and training programs and using training materials approved by the JSC, to each
of its professional sales representatives Promoting Products hereunder. The expenses
incurred by each Party in training its professional sales representatives shall be borne by
the Party.

     6.1.12. Compliance. In connection with its Promotion of the Product in the
Territory, each Party shall comply and shall cause each of its employees, representatives
and agents, including, without limitation, each of its professional sales representatives,
to comply with all laws and regulations of the Territory and shall do nothing which such
Party knows or reasonably should know would jeopardize the goodwill or reputation of either
Party or the reputation of any Product.

          6.2. Accounting Considerations
        . The Parties have structured the Manufacturing and Commercialization provisions of this
Agreement with a view to permitting *** Approximately 3 lines omitted ***. The Parties will
use reasonable efforts to cause the current Manufacturing and Commercialization provisions to
satisfy the foregoing accounting objectives. Notwithstanding any provision of this Agreement, if
ELAN at any time can reasonably demonstrate to AHPC that the Manufacturing and Commercialization
provisions do not achieve the foregoing accounting objectives, the Parties agree to negotiate in
good faith to achieve these accounting objectives (subject to the provisions of Article 11), which
shall, if required, include, but not be limited to, modification of responsibility for Product
Distribution in some countries.

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          6.3. Product Pricing. At regular intervals consistent with the preparation of the
Commercialization Plan and Annual Commercialization Plan, AHPC shall conduct studies relating to
the optimal Product pricing or reimbursement strategies on a country-by-country, or as applicable,
regional basis. AHPC shall have sole discretion with respect to the manner, nature and conduct of
such studies, but shall consult with and permit ELAN to comment on and provide guidance thereto.
AHPC shall present its findings and any recommendations relating to pricing and reimbursement
strategies to the JSC in order to permit it to prepare the Commercialization Plan and the Annual
Commercialization Plans. No recommendation made by AHPC or discussed by the JSC shall be binding
on either Party. AHPC shall have sole decision authority and discretion with respect to all
pricing decisions relating to Products in the United States, its territories and possessions, and
ELAN shall have sole decision authority and discretion with respect to all pricing decisions
relating to Products in all countries of the Territory except the United States, its territories
and possessions provided, however, that on a country-by-country basis, in the event that the
Parties cannot agree that it would be lawful for AHPC or ELAN to have pricing authority in such
country (where confirmed in writing by a mutually acceptable independent outside counsel), the
Distributing Party in such country shall have sole decision authority and discretion with respect
to all pricing decisions relating to Products in such country.

          6.4. Diligence. Each Party shall use its respective Commercially Reasonable Efforts
in carrying out all of its obligations in connection with the Manufacture, Distribution and
Commercialization of Products under the then current Annual Commercialization Plan.

7. CONSIDERATION.

          7.1. Reimbursement of Expenditures for Previously Developed Intellectual Property.

          7.1.1. To NEURALAB. On the Effective Date, AHPC shall pay NEURALAB ***
Approximately 5 lines omitted *** .

          7.1.2. To AHPC. On the Effective Date, NEURALAB shall pay to AHPC ***
Approximately 2 lines omitted*** .

          7.1.3. No Refunds or Credits. The payments set forth in Section 7. 1.1 and
7.1.2 shall not be refundable or creditable and shall not be subject to or create future
performance obligations upon either AHPC or ELAN.

          7.2. Additional Payments.

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     7.2.1. One-Time Payments. In consideration of NEURALAB’s contributions to the
Research Program and the Development Program, subject to Article 11, AHPC shall pay to
NEURALAB the following additional Research and Development expense reimbursement payments,
each such payment being due and payable one time only and within thirty (30) days after the
occurrence of the corresponding event:

	 	 	 
	Event	 	Additional Payment
	*** Approximately 10 lines omitted ***

	 	      ***Approximately 3 lines omitted ***

     7.2.2. Pre-Approval Payments. In consideration of NEURALAB contributions to
the Research Program and the Development Program, subject to Article 11, AHPC shall pay to
NEURALAB the following additional Research and Development expense reimbursement payments,
each such payment being due and payable within thirty (30) days after the occurrence of the
corresponding event:

	 	 	 
	Event	 	Additional Payment
	*** Approximately 25 lines
omitted ***

	 	*** Approximately 13 lines
omitted ***

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     7.2.3. Approval Payments. Subject to Article 11, AHPC shall pay to NEURALAB
the following payments based on specific approvals set forth below. These payments are for
past Research and Development efforts. Each such payment shall be due and payable within
thirty (30) days after the occurrence of the corresponding event:

	 	 	 
	Event	 	Additional Payment
	*** Approximately 24 lines
omitted ***

	 	*** Approximately 12 lines
omitted ***

     7.2.4. Additional Products. Subject to Article 11, each of the additional
payments set forth in this Section 7.2 are payable only once with respect to any Product and
shall be non-refundable and non-creditable. Notwithstanding the immediately preceding
sentence, subject to Article 11, additional payments equal to           ***            of the
payment indicated above in Section 7.2.2 and 7.2.3 shall be payable for up to           ***          
      R&D Candidates or Products, as applicable, with respect to which each event set forth
above occurs; provided that such    ***    additional payments shall only be payable

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if subsequent occurrences of any event result from R&D Candidates or Products, as applicable,
that *** Approximately 8 lines omitted ***.

          7.3. Sales Bonus. Subject to Article 11, AHPC shall pay to NEURALAB a one-time sales
bonus payment in the amount of                 ***                  within thirty (30) days after
the first occasion on which aggregate world-wide Net Sales of a Product or Products under this
Agreement, *** Approximately 2 lines omitted ***.

     7.4. Reports and Payments.

     7.4.1. Pre-tax Profit Statements and Payments. After the First Commercial Sale
of a Product in the Territory, the Distributing Party, within sixty (60) days after the end
of each Calendar Quarter, shall deliver to the other Party a report setting forth for such
Calendar Quarter the following information, on a Product-by-Product and country-by-country
basis: (i) the Net Sales of such Product in each country of the Territory, (ii) the
Pro-Forma Net Profit obtained from the sale of such Product in each country of the
Territory, (iii) the deductions made from Net Sales in calculating such Pro-Forma Net
Profit, including, without limitation, the computation of Cost of Goods Manufactured for
Sale in such detail as the Distributing Party customarily uses for its own internal
reporting purposes, or as reasonably requested by the other Party, each Party’s Sales and
Marketing Expenses, Third Party License Fees, Assigned Sales Force Adjustment Payments,
Distribution Expenses, Post-Approval Research and Regulatory Expenses and Working Capital
Charges, and (iv) the amount of the AHPC Pre-tax Profit and the ELAN Pre-tax Profit. No
such reports shall be due with respect to any Product before the First Commercial Sale of
such Product in the Territory. At the time such report is made, the Distributing Party
shall, after reimbursement under Section 6.1.6(d) has been made, remit to the other Party
the amount of the AHPC Pre-tax Profit or ELAN Pre-tax Profit, as applicable, if any,
allocated to such other Party for such Calendar Quarter after any deductions made in
accordance with this Section. The Parties will work together to report to each other
estimates of the amounts to be included in such reports prior to the expiration of such
sixty (60) day period.

     7.4.2. Taxes and Withholding. All payments under this Agreement will be made
without any deduction or withholding for or on account of any tax unless such deduction
or withholding is required by applicable laws or regulations. As of the Effective
Date, the Parties believe that, under applicable laws and regulations, withholding of taxes
on payments made under Section 7.1 and 7.2 is not required, provided, however, that if due
to any change in the applicable laws or regulations, or either Party’s interpretation
thereof, withholding is required, the provisions of this Section 7.4.2 shall govern. If the
paying Party is so required to deduct or withhold such Party will (i) promptly notify the
other Party of such requirement, (ii) pay to the relevant authorities the full amount

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required to be deducted or withheld promptly upon the earlier of determining that such
deduction or withholding is required or receiving notice that such amount has been assessed
against the other Party, (iii) promptly forward to the other Party an official receipt (or
certified copy) or other documentation reasonably acceptable to the other Party evidencing
such payment to such authorities.

     7.4.3. Currency. All amounts payable and calculations hereunder shall be in
United States dollars. As applicable, Net Sales, Pre-tax Profits and any expenses incurred
by either Party shall be translated into United States dollars in accordance with the paying
Party’s customary and usual currency conversion procedures, consistently applied. If, due
to restrictions or prohibitions imposed by national or international authority, payments
cannot be made as provided in this Article 7, the Parties shall consult with a view to
finding a prompt and acceptable solution, and the paying Party will deal with such monies as
the other Party may lawfully direct at no additional out-of-pocket expense to the paying
Party.

     7.5. Maintenance of Records; Audits.

     7.5.1. Record Keeping for the Territory. Each Party shall keep and maintain
accurate and complete records in connection with the sale by it of Products in the Territory
hereunder and each Party shall keep and maintain accurate and complete records showing the
expenses incurred and efforts employed by or on behalf of it in Promoting Products in the
Territory hereunder, which books and records shall be in sufficient detail to permit the
accurate determination of Net Sales, Pre-tax Profits and all other figures necessary for the
verification of the allocation of Pre-tax Profits. Each Party shall maintain and cause its
Affiliates to maintain such records for a period of at least                 ***
               after the end of the calendar year in which they were generated.

     7.5.2. Audits. Upon thirty (30) days prior written notice from a Party (the
“Auditing Party”), the other Party (the “Audited Party”) shall permit an independent
certified public accounting firm of nationally recognized standing selected by the Auditing
Party and reasonably acceptable to the Audited Party, to examine, at the Auditing Party’s
sole expense, the relevant books and records of the Audited Party as may be reasonably
necessary to verify the accuracy of the reports submitted by the
Audited Party in accordance with Section 7.4.1 and the calculation and allocation of
Pre-tax Profits. An examination by a Party under this Section 7.5.2 shall occur not more
than once in any calendar year and shall be limited to the pertinent books and records for
any calendar year ending not more than            ***             before the date of the
request. The accounting firm shall be provided access to such books and records at the
Audited Party’s facility(ies) where such books and records are normally kept and such
examination shall be conducted during the Audited Party’s normal business hours. The

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Audited Party may require the accounting firm to sign a standard non-disclosure agreement
before providing the accounting firm access to the Audited Party’s facilities or records.
Upon completion of the audit, the accounting firm shall provide both AHPC and ELAN a written
report disclosing whether the reports submitted by the Audited Party are correct or
incorrect, whether the calculation and allocation of Pre-tax Profits are correct or
incorrect, and, in each case, the specific details concerning any discrepancies. No other
information shall be provided to the Auditing Party.

     7.5.3. Underpayments/Overpayments. If such accounting firm correctly concludes
that additional Pre-tax Profits were due to a Party, the other Party shall pay to such Party
such additional Pre-tax Profits together with any interest that may be due thereon as
provided in Section 7.6 within thirty (30) days of the date the Parties receives such
accountant’s written report so correctly concluding. If an underpayment to an Auditing
Party exceeds                 ***                of the Pre-tax Profits that were to be
distributed to such Auditing Party, the other Party also shall reimburse the Auditing Party
for the out-of-pocket expenses incurred in conducting the audit, except in the event that
such underpayment was due to any inaccurate information provided by the Auditing Party.

     7.5.4. Confidentiality. All financial information of a Party which is subject
to review under this Section 7.5 shall be deemed to be Confidential Information subject to
the provisions of Article 9, and such Confidential Information shall not be disclosed to any
Third Party or used for any purpose other than verifying payments to be made by one Party to
the other hereunder, provided, however, that such Confidential Information may be disclosed
to Third Parties only to the extent necessary to enforce a Party’s rights under this
Agreement.

          7.6. Interest. Any payment under this Article 7 that is more than            ***
            past due shall thereafter be subject to interest at an annual percentage rate of   
          ***           . Likewise, any overpayment that is not refunded within            ***             after
the date such overpayment was identified shall thereafter be subject to interest at an annual
percentage rate of           ***           , provided, however, that if the overpayment is due to errors in reports provided by the overpaid
Party, such interest shall accrue from the date the overpayment was made.

          7.7. GAAP. The calculation of all expenditures, payments and reimbursements made by
either Party under this Agreement shall be made in accordance with United States generally accepted
accounting procedures.

8. INTELLECTUAL PROPERTY.

          8.1. Ownership. All Collaboration Inventions shall be owned jointly by the Parties. All
patent applications and patents covering any Collaboration Invention shall be owned

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jointly by the
Parties. Nothing in this Section 8.1 shall affect the ownership of Prior Inventions or
Non-Collaboration Inventions.

     8.2. Joint Patent Committee.

     8.2.1. Membership. Within thirty (30) days after the Effective Date, ELAN and
AHPC shall establish a “Joint Patent Committee” or “JPC” to oversee and direct the continued
prosecution of ELAN Patent Rights and the preparation and filing of new patent applications
covering Collaboration Inventions. The JPC shall be comprised of one (1) senior patent
attorney from each Party as appointed by such Party. A Party may replace its representative
from time to time upon written notice to the other Party. The JPC shall exist until the
termination of this Agreement.

     8.2.2. Decisions. All decisions of the JPC shall be unanimous, and in the
event that a decision cannot be reached by the JPC, the matter shall be referred to the
Associate General Counsel – Patents and Trademarks for AHPC and the Vice President,
Intellectual Property, ELAN Pharmaceuticals for further review and resolution. In the event
that such officers are unable to reach a decision with respect to any such matter, then such
matter shall be resolved in accordance with Section 3.1.4.

     8.3. Prosecution and Maintenance of Patent Rights.

     8.3.1. ELAN Patent Rights. Decisions as to whether to file, prosecute and
maintain, and in which countries to do so, ELAN Patent Rights licensed to AHPC hereunder,
along with other strategic decisions relating thereto, shall be made by the JPC. Based on
such decisions, ELAN shall use diligent efforts to prepare, file, prosecute and maintain all
of the ELAN Patent Rights which are licensed to AHPC hereunder, using patent counsel that is
reasonably acceptable to AHPC. With respect to any such ELAN Patent Right, ELAN shall give
AHPC an opportunity to review and comment upon the text of the applications before filing,
shall consult with AHPC with respect to such application, and shall supply AHPC with a copy
of the applications as filed, together with notice of its filing date and serial number
whether such ELAN Patent Rights are filed prior to or after the Effective Date, as well as
full copies of the prosecution history for
those ELAN Patent Rights filed prior to the Effective Date. ELAN shall keep AHPC
advised of the status of the actual and prospective patent filings, including, without
limitation, the grant of any ELAN Patent Rights, and shall provide advance copies of any
official correspondence related to the filing, prosecution and maintenance of such patent
filings for review and comment by AHPC. If ELAN, on a country-by-country basis, elects not
to file a patent application or to cease the prosecution and/or maintenance of any such ELAN
Patent Right in such country, ELAN shall provide AHPC with written notice immediately upon
the decision to not file or continue the prosecution of such patent application or
maintenance of such patent and at least sixty (60) days before ceasing prosecution and/or
maintenance of such ELAN Patent Right and, in such case, shall permit AHPC, at AHPC’s sole
discretion, to file and/or continue prosecution and/or maintenance of such Patent Right in
such country at AHPC’s own expense. If AHPC elects to continue prosecution or maintenance,
ELAN, upon AHPC’s request, shall assign such Patent Right to AHPC and execute such documents
and perform such acts, at 

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 AHPC’s expense, as may be reasonably necessary to permit AHPC to
file, prosecute and/or maintain such ELAN Patent Right in such country. Notwithstanding the
foregoing, the rights of AHPC under this Section 8.3.1 shall not apply where the exercise of
such rights would violate applicable law or any agreement between ELAN and a Third Party.

     8.3.2. Collaboration Patent Rights.

          (a) Upon the identification of a Collaboration Invention, the JPC shall (i) promptly discuss
such Collaboration Invention, (ii) promptly discuss the desirability of filing a United States
patent application covering such Collaboration Invention, as well as any foreign counterparts,
(iii) make the final decision with respect to any such filings as soon as practicable, and (iv)
designate the Party to be responsible for the supervision of the preparation, filing and
prosecution of such patent application by outside patent counsel reasonably acceptable to the JPC.
Such outside patent counsel shall be instructed to act in the best interests of both Parties taking
into consideration their relative interests under this Agreement.

          (b) The Party responsible for the preparation, filing and prosecution of a patent application
covering a Collaboration Invention shall provide the other Party with a copy of any patent
application which first discloses such Collaboration Invention prior to filing the first of such
applications in any jurisdiction, if possible, for review and comment by the other Party. The
Party responsible for each patent application shall keep the other Party advised of the status of
the actual and prospective patent filings, including, without limitation, the grant of any
Collaboration Patent Rights, and shall provide advance copies of any official correspondence
related to the filing, prosecution and maintenance of such patent filings for review and comment by
the other Party. The Party receiving any such patent application and official correspondence shall
maintain such information in confidence.

          (c) Subject to (i) the grant of licenses to AHPC and ELAN under Article 2, and (ii) the
exclusivity provisions of Section 2.4, each Party shall be free to exploit Collaboration Patent
Rights within the Territory without restriction and without payment of any compensation to the
other Party.

     8.3.3. Patent Term Extensions. The Parties shall cooperate, if necessary and
appropriate, with each other in gaining patent term extension, including without limitation,
supplementary protection certificates and any other extensions that are now or become
available in the future wherever applicable to Patent Rights covering Products. The Parties
shall, if necessary and appropriate, use reasonable efforts to agree upon a joint strategy
relating to patent term extensions, but, in the absence of mutual agreement with respect to
any extension issue, a patent shall be extended if either Party elects to extend such
patent. All filings for such extension shall be made by the Party to whom the patent is
assigned, provided, however, that in the event that the Party to whom the patent is assigned
elects not to file for an extension, such Party shall (i) inform the other Party of its
intention not to file and (ii) grant the other Party the right to file for such extension.

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     8.3.4. Costs and Expenses. The Parties shall                 ***
               all costs and expenses of filing, prosecuting, maintaining and extending the
Collaboration Patent Rights. AHPC shall reimburse ELAN for            ***             of
the reasonable costs associated with the ELAN Patent Rights incurred after the Effective
Date. Notwithstanding the foregoing, any expenses regarding intellectual property within
the ELAN Patent Rights that is not limited to Betabloc or Improvement Products or the Field,
as well as any expenses regarding intellectual property that is non-exclusively licensed to
AHPC, shall be paid solely by ELAN.

     8.4. Trademarks.

     8.4.1. Product Trademark. All Products shall be sold in the Territory under
Trademarks selected by the JSC. AHPC shall own such Trademarks and shall be responsible for
the filing, prosecution and maintenance of such Trademarks in each country of the Territory.
The JSC shall use its best efforts to select a world-wide Trademark for each Product. The
costs of obtaining and maintaining said Trademarks shall be shared equally by the Parties.

     8.4.2. Party Name on Product Promotional Material. To effectuate the purposes
of this Agreement, AHPC shall grant to Elan an exclusive, royalty free license in a separate
written agreement, to use Trademarks in connection with the Commercialization of a Product
in a country where ELAN is the Distributing Party. With respect to Product promotional
materials, packaging, labels or package inserts, to the extent such items identify or
otherwise make reference to either of the Parties, ELAN and AHPC shall both be presented and
described with equal prominence and emphasis as having joined and participated in the joint
Development and Commercialization of the Product (subject to compliance with the applicable
laws and regulations of each country in which such Product is to be presented). All
documentary information and oral presentations (where practical) regarding the Detailing and
Promotion of Products shall state this arrangement and display the names, logos and company trademarks of ELAN and AHPC with equal
prominence.

     8.5. Enforcement of Patent Rights.

     8.5.1. Notice. If ELAN or AHPC becomes aware that any ELAN Intellectual
Property, AHPC Intellectual Property or Collaboration Patent Rights is infringed or
misappropriated by a Third Party or is subject to a declaratory judgment action arising from
such infringement, ELAN or AHPC, as the case may be, shall promptly notify the other Party.

     8.5.2. Enforcement by AHPC. AHPC shall have the first right (but not the
obligation), at its sole expense, to enforce the Collaboration Patent Rights, AHPC Patent

CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

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     Rights and ELAN Patent Rights; provided, however, that (i)ELAN shall have the right to join
such proceeding at any time at its own expense and will do so at any time if it is deemed to
be a necessary Party, and (ii)AHPC shall not admit the invalidity or unenforceability of any
Collaboration Patent Rights or ELAN Patent Rights without ELAN’s prior written consent.
AHPC shall keep ELAN reasonably informed on a quarterly basis, in person or by telephone,
prior to and during any such enforcement. ELAN shall assist AHPC, upon request and at
ELAN’s expense in taking any action to enforce the Collaboration Patent Rights or ELAN
Patent Rights and shall join in any such action if deemed to be a necessary party. AHPC
shall incur no liability to ELAN as a consequence of such litigation or any unfavorable
decision resulting therefrom, including any decision holding any of the Collaboration Patent
Rights or ELAN Patent Rights invalid, not infringed or unenforceable.

     8.5.3. Enforcement by ELAN. If AHPC fails to abate an infringement of the
Collaboration Patent Rights or ELAN Patent Rights, or to file an action to abate such
infringement, within six (6) months after a written request from ELAN to do so, or if AHPC
discontinues the prosecution of any such action, ELAN at its expense may, in its discretion,
undertake such action as it determines appropriate (other than the grant of a license to the
allegedly infringing Third Party) to enforce such Collaboration Patent Rights or ELAN Patent
Rights. ELAN shall keep AHPC reasonably informed on a quarterly basis, in person or by
telephone, prior to and during any such enforcement. In such case, AHPC shall assist ELAN,
upon request and at AHPC’s sole expense, in taking any action to enforce the Collaboration
Patent Rights or ELAN Patent Rights.

     8.5.4. Recoveries. All monies recovered upon the final judgment or settlement
of any such action shall be used first to reimburse the costs and expenses (including
reasonable attorneys’ fees and costs) of AHPC and ELAN and thereafter the Parties
shall                ***               .

     8.6. Third Party Claims.

     8.6.1. Third Party Claims — Course of Action. If the Commercialization of a
Product, under this Agreement, is alleged by a Third Party to infringe a Third Party’s
patent or misappropriate a Third Party’s trade secret, the Party becoming aware of such
allegation shall promptly notify the other Party thereof, in writing, reasonably detailing
the claim.

     8.6.2. Negotiation with Third Party. The JSC shall determine which Party shall
negotiate with said Third Party for a suitable license or assignment and execute such
license or assignment, provided, however, that such Party shall enter into no such agreement
unless it has first obtained the other Party’s written approval of the terms of

CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

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such agreement, including the amounts of any royalties or payments, which approval shall not be
unreasonably withheld. If such negotiation results in a consummated agreement, such Party
shall make all payments to the Third Party and such payments shall *** Approximately 4
lines omitted *** .

     8.6.3. Third Party Suit. If a Third Party sues a Party (the “Sued Party”)
alleging that the Sued Party’s or the Sued Party’s Sublicensees’ Research, Development,
Manufacture or Commercialization of any R&D Candidate and/or Product infringes or will
infringe said Third Party’s patent or misappropriates said Third Party’s trade secret, then
upon the Sued Party’s request and in connection with the Sued Party’s defense of any such
Third Party suit, the other Party shall provide reasonable assistance to the Sued Party for
such defense and shall join such suit if deemed a necessary party. The Sued Party shall
keep the other Party, if such other Party has not joined in such suit, reasonably informed
on a quarterly basis, in person or by telephone, prior to and during the pendency of any
such suit. The Sued Party shall not admit the invalidity of any patent within the
Collaboration Patent Rights, the ELAN Patent Rights or the AHPC Patent Rights, nor settle
any such suit, without written consent of the other Party. The Parties shall ***
Approximately 3 lines omitted ***.

     8.7. Third Party Licenses.

     8.7.1. General. If either Party believes that there exists Third Party
intellectual property that constitutes Blocking Third Party Intellectual Property or
Enhancing Third Party Intellectual Property, as the case may be, it shall notify the JSC and
the JPC. The JPC shall then determine whether or not such Third Party intellectual property
constitutes Blocking Third Party Intellectual Property or Enhancing Third Party Intellectual
Property, as the case may be. If the determination of the JPC is affirmative, the JSC shall
determine whether, on what terms (economic or otherwise), and by which Party (the “Licensing
Party”) such Blocking Third Party Intellectual Property or Enhancing Third
Party Intellectual Property, as the case may be, shall be licensed for the purposes of
this Agreement. Prior to entering into a license agreement with respect to such Blocking
Third Party Intellectual Property or Enhancing Third Party Intellectual Property, as the
case may be, the Licensing Party shall submit the proposed license agreement to the JSC for
approval. If the JSC approves the proposed license agreement, the Licensing Party shall
enter into such license agreement and shall pay the Third Party License Fees due thereunder,
subject to reimbursement in accordance with Section 4.3.5 or 6.1.6(d), as applicable. Any
agreement entered into pursuant to this Section 8.7.1 and any ELAN In-License or other
agreements between a Party and any Third Party existing as of the Effective Date and
relating to either Elan Intellectual Property or AHPC Intellectual Property, shall not be
amended without the prior written consent of the JSC.

CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

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     8.7.2. Failure to Obtain a Third Party License. If, within ninety (90) days
after a Licensing Party has been instructed by the JSC, pursuant to Section 8.7.1, to
attempt to enter into a license agreement with respect to Blocking Third Party Intellectual
Property or Enhancing Third Party Intellectual Property, as the case may be, it is
determined by the JSC that no license is obtainable on commercially reasonably terms despite
a good faith attempt by such Licensing Party to obtain such license, then (a) neither Party
shall practice the Third Party intellectual property that was the subject of the proposed
license agreement and (b) in the case of Blocking Third Party Intellectual Property only,
neither Party shall proceed with the Research, Development, Manufacture and/or
Commercialization of an R&D Candidate or Product, as the case may be, to the extent doing so
would infringe such Blocking Third Party Intellectual Property.

     8.7.3. Resolution of Disputes. If the JPC is unable to reach a determination
under Section 8.7.1 with respect to whether Third Party intellectual property constitutes
Blocking Third Party Intellectual Property or Enhancing Third Party Intellectual Property,
as the case may be, then such issue shall be presented to the JSC for determination. If the
JSC is unable to resolve such issue, or is unable to reach a determination under Section
8.7.1 or 8.7.2 with respect to any issue relating to a proposed license agreement, then such
issue shall be evaluated in accordance with the procedures set forth in Section 3.1.4. If
such issue cannot be resolved, pursuant to Section 3.1.4, then *** Approximately 6 lines
omitted ***.

          8.8. Patent Marking. Each Party agrees to mark and have its Affiliates and all
Sublicensees mark all Products (or their containers or labels) sold pursuant to this Agreement in
accordance with the applicable statutes or regulations in the country or countries of manufacture
and sale thereof.

          8.9. Patent Certifications. Each Party shall immediately give written notice to the
other of any certification of which it becomes aware filed pursuant to 21 U.S.C.
§ 355(b)(2)(A), or § 355(j)(2)(A)(vii) (or any amendment or successor statute thereto)
claiming that the ELAN Patent Rights, AHPC Patent Rights or Collaboration Patent Rights covering
any Product are invalid or that infringement will not arise from the manufacture, use or sale of
such Product by a Third Party.

     8.10. Certain Actions.

     8.10.1. ELAN. During the term of this Agreement, ELAN shall use reasonable
efforts not to diminish the rights under ELAN Intellectual Property or ELAN/Lilly Patent
Rights granted to AHPC under this Agreement, including without limitation by not committing
or permitting any actions or omissions which would cause the breach of any agreements
between itself and Third Parties (including ELAN In-Licenses) which

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WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

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provide for intellectual
property rights applicable to the Research, Development, Manufacture or Commercialization of
any R&D Candidate or Product and shall provide AHPC with prompt written notice of any
alleged breach of any such agreements.

     8.10.2. AHPC. During the term of this Agreement, AHPC shall use reasonable
efforts not to diminish the rights under AHPC Intellectual Property granted to ELAN under
this Agreement, including without limitation by not committing or permitting any actions or
omissions which would cause the breach of any agreements between itself and Third Parties
which provide for intellectual property rights applicable to the Research, Development,
Manufacture or Commercialization of any R&D Candidate or Product and shall provide ELAN with
prompt written notice of any alleged breach of any such agreements.

          8.11. Limitation. Notwithstanding any other provision in this Article 8, the Parties
acknowledge and understand that ELAN shall not be obligated to prepare, file, prosecute, and
maintain patents and patent applications, or to bring or pursue enforcement proceedings or defend
declaratory judgment actions regarding the ELAN Patent Rights if, and to the extent that, ELAN is
not entitled to do so under applicable agreements with Third Parties.

9.  CONFIDENTIALITY.

          9.1. Confidentiality. During the term of this Agreement and for a period of
                ***                following the expiration or earlier termination thereof, each
Party shall maintain in confidence the Confidential Information of the other Party, and shall not
disclose, use or grant to a Third Party the right to use any of the Confidential Information of the
other Party except on a need-to-know basis to such Party’s directors, officers and employees, and
to such

          Party’s consultants working on such Party’s premises, to the extent such disclosure is
reasonably necessary in connection with such Party’s activities as expressly authorized by this
Agreement. To the extent that disclosure to any person is authorized by this Agreement, prior to
disclosure, a Party shall obtain written agreement of such person to hold in confidence and not
disclose, use or grant the use of the Confidential Information of the other Party except as
expressly permitted under this Agreement. Each Party shall notify the other Party promptly upon
discovery of any unauthorized use or disclosure of the other Party’s Confidential Information.

          9.2. Terms of Agreement. Neither Party shall disclose any terms or conditions of this
Agreement to any Third Party without the prior written consent of the other Party; provided,
however, that a Party may disclose the terms or conditions of this Agreement, (a) on a need-to-know
basis to its legal and financial advisors, who are obligated to maintain such information in
confidence, and (b) to a Third Party (who is obligated to maintain such information in confidence)
in connection with (i) an equity investment in ELAN by such Third Party, which investment is in
excess of                 ***                of ELAN’s market capitalization at such time,

CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

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(ii) a merger, consolidation or similar transaction by such Party, or (iii) the sale of all or
substantially all of the assets of such Party relating to the subject matter of this Agreement.
Notwithstanding the foregoing, prior to execution of this Agreement, the Parties have agreed upon
the substance of information that can be used to describe the terms and conditions of this
transaction, and each Party may disclose such information, as modified by mutual written agreement
the Parties, without the consent of the other Party.

          9.3. Permitted Disclosures. The confidentiality obligations under this Article 9
shall not apply (a) to the extent that a Party is required to disclose information by applicable
law, regulation or order of a governmental agency or a court of competent jurisdiction, or (b) to
the extent necessary or desirable to allow either Party (where possible, with adequate safeguards
for confidentiality) to defend against litigation or to file and prosecute patent applications;
provided, however, in either such case that such Party shall provide written notice thereof to the
other Party, consult with the other Party with respect to such disclosure and provide the other
Party sufficient opportunity to object to any such disclosure or to request that the disclosing
Party seek confidential treatment thereof, in which event the disclosing Party shall use all
reasonable efforts to accommodate the other Party’s requests.

          9.4. Publications. During the term of this Agreement, each Party will submit to the
other Party for review and approval all proposed academic, scientific and medical publications and
public presentations relating to Collaboration Intellectual Property, the Research Program,
Development Program, R&D Candidates and/or Products for review in connection with preservation of
exclusive Patent Rights and/or to determine whether Confidential Information should be modified or
deleted, provided, however that after the approval of an academic, scientific or medical
publication and/or public presentation has been given, then such Party shall not have to resubmit
any such information for re-approval should it be republished or publicly disclosed in another
form. Written copies of such proposed publications and presentations shall be submitted to the
other Party no later than sixty (60) days before submission for publication or presentation and
such other Party shall provide its comments with respect to such publications and presentations
within thirty (30) days following its receipt of such written copy. Notwithstanding the foregoing,
no such publication or presentation shall be made until such publication or presentation has been
approved by each Party’s respective patent counsel. ELAN and AHPC will each comply with standard
academic practice regarding authorship of scientific publications and recognition of contribution
of other parties in any publications relating to the Research Program, the Development Program, R&D
Candidates, Products and/or Collaboration Intellectual Property.

10. REPRESENTATIONS AND WARRANTIES

          10.1. Representations and Warranties of Each Party. As of the Effective Date, each of
ELAN and AHPC hereby represents and warrants to the other Party hereto as follows:

     (a) it is a corporation or entity duly organized and validly existing under the laws of
the state or other jurisdiction of its incorporation or formation;

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     (b) the execution, delivery and performance of this Agreement by such Party has been
duly authorized by all requisite corporate action and does not require any shareholder
action or approval;

     (c) it has the power and authority to execute and deliver this Agreement and to perform
its obligations hereunder;

     (d) the execution, delivery and performance by such Party of this Agreement and its
compliance with the terms and provisions does not and will not conflict with or result in a
breach of any of the terms and provisions of or constitute a default under (i) a loan
agreement, guaranty, financing agreement, agreement affecting a product or other agreement
or instrument binding or affecting it or its property; (ii) the provisions of its charter or
operative documents or bylaws; or (iii) any order, writ, injunction or decree of any court
or governmental authority entered against it or by which any of its property is bound;

     (e) its Patent Rights and Know-How are existing and, to the best of its knowledge, are
not invalid or unenforceable, in whole or in part; and

     (f) it has the full right, power and authority to grant all of the right, title and
interest in the licenses granted to the other Party under this Agreement.

          10.2. Additional Representations and Warranties of ELAN. ELAN hereby represents and
warrants to AHPC that as of the Effective Date:

     (a) ELAN has the sole right, title and interest in and to the ELAN Patent Rights listed
in Exhibit 10.2(a) to this Agreement;

     (b) no ELAN Patent Rights are subject to, or were developed pursuant to, any funding
agreement with any government or government agency, except as provided on Exhibit
10.2(b) to this Agreement;

     (c) to ELAN’s knowledge, the use of Ab in the Field does not infringe any issued
U.S. or European patents owned or controlled by any Third Party (except as licensed to ELAN
by such Third Party);

     (d) ELAN is not in breach of any material provisions of any agreements with Third
Parties (including without limitation the ELAN In-Licenses) relating to the ELAN Patent
Rights;

     (e) ELAN has neither represented nor conceded that Lilly has rights to the use of
Ab in the Field;

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            *** Approximately 3 lines omitted ***           

           *** Approximately 3 lines omitted ***            

The outcome of the ELAN/Lilly Litigation shall not be determinative as to the absence or presence
of a breach of the foregoing representations and warranties in Sections 10.1 and 10.2.

          10.3. Additional Representations and Warranties of AHPC. AHPC hereby represents and
warrants to ELAN that as of the Effective Date:

     (a) AHPC has the sole right, title and interest in and to the AHPC Patent Rights listed
in Exhibit 10.3(a) to this Agreement;

     (b) No AHPC Patent Rights are subject to, or were developed pursuant to any funding
agreement with any government or government agency, except as provided in Exhibit
10.3(b) to this Agreement; and

     (c) AHPC is not in breach of any material provisions of any agreements with Third
Parties relating to the AHPC Patent Rights.

          10.4. Representation by Legal Counsel. Each Party hereto represents that it has been
represented by legal counsel in connection with this Agreement and acknowledges that it has
participated in the drafting. In interpreting and applying the terms and provisions of this
Agreement, the Parties agree that no presumption shall exist or be implied against the Party which
drafted such terms and provisions.

          10.5. No Inconsistent Agreements. Neither Party has in effect and after the Effective
Date neither Party shall enter into any oral or written agreement or arrangement that would be
inconsistent with its obligations under this Agreement.

          10.6. Disclaimer. THE FOREGOING WARRANTIES OF EACH PARTY ARE IN LIEU OF ANY OTHER
WARRANTIES, EXPRESS OR IMPLIED, INCLUDING, WITHOUT LIMITATION, ANY IMPLIED WARRANTIES OF
NONINFRINGEMENT, ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR ANY IMPLIED WARRANTIES OF FITNESS FOR
A PARTICULAR PURPOSE, ALL OF WHICH ARE HEREBY SPECIFICALLY EXCLUDED AND DISCLAIMED.

11. *** Approximately 185 lines omitted ***

12. GOVERNMENT APPROVALS.

CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

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          12.1. HSR Filing. Each of ELAN and AHPC shall file, as soon as practicable after the date this Agreement is
signed by each of the Parties, with the Federal Trade Commission (the “FTC”) and the Antitrust
Division of the United States Department of Justice (the “Antitrust Division”) the notification and
report form (the “Report”) required under the HSR Act with respect to the transactions as
contemplated hereby and shall reasonably cooperate with the other Party to the extent necessary to
assist the other Party in the preparation of its Report and to proceed to obtain necessary
approvals under the HSR Act, including but not limited to the expiration or earlier termination of
any and all applicable waiting periods required by the HSR Act. Each Party shall bear its own
expenses, including, without limitation, legal fees incurred in connection with preparing such
filings, except that AHPC shall pay any HSR filing fees required of either Party.

          12.2. ELAN’s and AHPC’s Obligations. Each of ELAN and AHPC shall use its good faith
efforts to eliminate any concern on the part of any court or government authority regarding the
legality of the proposed transaction, including, if required by federal or state antitrust
authorities, promptly taking all steps to secure government antitrust clearance, including, without
limitation, cooperating in good faith with any government investigation including the prompt
production of documents and information demanded by a second request for documents and of witnesses
if requested.

          12.3. Additional Approvals. ELAN and AHPC will cooperate and use respectively all
reasonable efforts to make all other registrations, filings and applications, to give all notices
and to obtain as soon as practicable all governmental or other consents, transfers, approvals,
orders, qualifications authorizations, permits and waivers, if any, and to do all other things
necessary or desirable for the consummation of the transactions as contemplated hereby. Neither
Party shall be required, however, to divest or out-license products or assets or materially change
its business if doing so is a condition of obtaining approval under the HSR Act or other
governmental approvals of the transactions contemplated by this Agreement.

          12.4. Termination. If a Report is required to be filed under the HSR Act, either
Party may, before the Effective Date, terminate this Agreement by written notice to the other
Party, if, within one hundred fifty (150) days after the Report is filed in accordance with Section
12.1, approval of the transactions contemplated by this Agreement under the HSR Act has not been
obtained or the notice and waiting period, as may be extended by the FTC, under the HSR Act has not
expired without adverse action regarding this Agreement or the transactions contemplated hereby.
If this Agreement is terminated pursuant to this Section 12.4, then, notwithstanding any provision
in this Agreement to the contrary, neither Party shall have any further obligation to the other
Party with respect to the subject matter of this Agreement except for the obligations set forth in
Article 9, which obligations shall survive any termination of this Agreement.

13. TERM AND TERMINATION.

          13.1. Term. The term of this Agreement will commence on the Effective Date and,
unless earlier terminated as provided in Article 11, this Article13 or in Section 12.4, shall
continue in full force and effect on a Product-by-Product and country-by-country basis for so long
as any R&D Candidate is being Developed or any Product is being sold under this

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Agreement.
Notwithstanding the foregoing, the Research Term shall be as set forth in Section 4.1.2, unless
this Agreement is terminated as provided in Article11, this Article 13 or in Section 12.4.

          13.2. Termination for Cause.

          13.2.1. Termination for Cause. This Agreement may be terminated effective immediately
by written notice by either Party at any time during the term of this Agreement for a continuing
material breach or recurring material breaches by the other Party, which breach or breaches remain
uncured for            ***           in the case of nonpayment of any amount due (unless there
exists a bona fide dispute as to whether such payment is owing, in which case the            ***
            period shall be tolled pending resolution of such dispute) and               ***
              for all other breaches, each measured from the date written notice of such breach is
given to the breaching Party, provided, however, that if such breach is not susceptible of cure
within the stated period and the breaching Party uses diligent good faith efforts to cure such
breach, the stated period will be extended by an additional            ***            .

     13.2.2. Effect of Termination for Cause on Licenses. If a Party (the
“Terminating Party”) terminates this Agreement pursuant to this Section 13.2 or pursuant to
Section 13.7.3:

     (a) all licenses granted by the Terminating Party to the other Party hereunder will
automatically terminate;

     (b) all licenses granted by the other Party to the Terminating Party will become fully
paid up, irrevocable, perpetual, royalty-free licenses;

     (c) the other Party will assign to the Terminating Party all right, title and interest
in and to: (i) all regulatory filings and Regulatory Approvals pertaining to any Product
which regulatory filings and Regulatory Approvals, if any, are Controlled by the other
Party, (ii) all of the other Party’s interest in any Trademark, including, without
limitation, the goodwill symbolized by such Trademark used for Products, and (iii) all of
the other Party’s interest in any Copyrights necessary or useful for Commercializing
Products;

     (d) the other Party will grant to the Terminating Party a worldwide, exclusive (even as
to the other Party) license to practice any invention claimed in the Collaboration Patent
Rights and to practice the Collaboration Know-How for all research and commercial purposes
in the Field; and

     (e) the other Party will have no right to receive a share of Pre-tax Profits or any
other payments which may result from the sale of any Product, the occurrence of any event or
the conduct of any activity after the effective date of such termination, provided,

CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

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however,
that the other Party shall remain entitled to receive any payments that accrued before the
effective date of such termination.

     13.3. Termination for Convenience.

     13.3.1. Right to Terminate. Subject to adjustment as set forth in Section
13.7.3, at any time                                                                  ***
                                                    , AHPC may terminate this Agreement
upon one hundred eighty (180) days prior written notice to ELAN (a “Termination for
Convenience”).

     13.3.2. Effect of Termination for Convenience. If AHPC elects to effect a
Termination for Convenience:

     (a) the licenses under AHPC Intellectual Property granted by AHPC to ELAN shall be
limited in scope so that they only permit ELAN to continue Research, Development,
Manufacture and Commercialization of R&D Candidates and Products created by the Parties
prior to such termination, and as so limited will become fully paid up, irrevocable,
perpetual, royalty-free licenses, and all other licenses granted by AHPC to ELAN will
automatically terminate;

     (b) all licenses granted by ELAN to AHPC will automatically terminate;

     (c) AHPC will assign to ELAN all right, title and interest in and to: (i) all
regulatory filings and Regulatory Approvals pertaining to any Product created by the Parties
prior to such termination, which regulatory filings and Regulatory Approvals, if any, are
Controlled by AHPC, (ii) all of AHPC’s interest in any Trademark, including, without
limitation, the goodwill symbolized by such Trademark used for Products created by the
Parties prior to such termination, and (iii) all of AHPC’s interest in any Copyrights
necessary or useful for Commercializing Products created by the Parties prior to such
termination;

     (d) AHPC will grant to ELAN a worldwide, exclusive (even as to AHPC) license to
practice any invention claimed in the Collaboration Patent Rights and to practice the
Collaboration Know-How for all research and commercial purposes in the Field; and

     (e) AHPC will have no right to receive a share of Pre-tax Profits or any other payments
which may result from the sale of any Product, the occurrence of any event or the conduct of
any activity after the effective date of such termination, provided, however, that AHPC
shall remain entitled to receive any payments that accrued before the effective date of such
termination.

CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

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          13.4. Termination Pursuant to Section 11.2. In the event of a termination under Section 11.2, then, notwithstanding any provision of this
Agreement to the contrary, neither Party shall have any further obligation to the other Party with
respect to the subject matter of this Agreement except for the obligations set forth in Article 9,
which obligations shall survive any termination of this Agreement.

          13.5. Termination for Failure to Reach Certain Net Sales Levels.

     13.5.1. Right to Terminate. If Net Sales of Products during a calendar year
fail to reach *** Approximately 3 lines omitted *** then either Party (the “Section 13.5
Terminating Party”) may terminate this Agreement upon one hundred eighty (180) days prior
written notice to the other Party.

     13.5.2. Effect on Other Rights and Obligations. If a Party terminates this
Agreement in accordance with Section 13.5.1, then: (a) all rights to Research, Develop,
Manufacture and Commercialize R&D Candidates and Products shall vest in the other Party; (b)
all licenses granted to the Section 13.5 Terminating Party hereunder shall terminate; (c)
the Section 13.5 Terminating Party shall assign to the other Party all right, title and
interest in and to: (i) all regulatory filings and Regulatory Approvals pertaining to any
Product which regulatory filings and Regulatory Approvals, if any, are owned or otherwise
controlled by the Section 13.5 Terminating Party, (ii) all of the Section 13.5 Terminating
Party’s interest in any Trademark, including, without limitation, the goodwill symbolized by
such Trademark used for Products, and (iii) all of the Section 13.5 Terminating Party’s
interest in any copyrights necessary or useful for Commercializing Products; (d) the Section
13. 5 Terminating Party shall grant to the other Party a worldwide, exclusive (even as to
the Section 13.5 Terminating Party) license to practice any invention claimed in the
Collaboration Patent Rights and to practice the Collaboration Know-How for all research and
commercial purposes in the Field; and (e) no further payments shall be required under
Article 7, except that the other Party shall thereafter pay the Section 13.5 Terminating
Party a Trademark and Know-How royalty on its Net Sales of each Product (on a
Product-by-Product basis) as follows:

*** Approximately 5 lines omitted ***

     13.6. Provision for Insolvency.

     13.6.1. Termination. This Agreement may be terminated by written notice by
either Party at any time during the term of this Agreement upon the declaration by a court
of competent jurisdiction that the other Party is bankrupt and, pursuant to the U.S.
Bankruptcy Code such other Party’s assets are to be liquidated, the filing or institution of
bankruptcy, liquidation or receivership proceedings (other than reorganization proceedings
under Chapter 11 of the U.S. Bankruptcy Code), or upon an assignment of a

CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

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substantial portion of the assets for the benefit of creditors by the other Party, or
in the event a receiver or custodian is appointed for such Party’s business, or if a
substantial portion of such Party’s business is subject to attachment or similar process;
provided, however, that in the case of any involuntary bankruptcy proceeding such right to
terminate shall only become effective if the proceeding is not dismissed within sixty (60)
days after the filing thereof.

     13.6.2. Effect on Licenses. All rights and licenses granted under or pursuant
to this Agreement by one Party to the other Party are, for all purposes of Section 365(n) of
Title 11 of the United States Code (“Title 11”), licenses of rights to “intellectual
property” as defined in Title 11. Each Party agrees that the other Party, as licensee of
such rights under this Agreement shall retain and may fully exercise all of its rights and
elections under Title 11. Each Party agrees during the term of this Agreement to create and
maintain current copies or, if not amenable to copying, detailed descriptions or other
appropriate embodiments, to the extent feasible, of all such intellectual property. If a
case is commenced by or against a Party under Title 11 (the “Title 11 Party”), such Party
(in any capacity, including debtor-in-possession) and its successors and assigns (including,
without limitation, a Title 11 Trustee) shall, as the other Party may elect in a written
request, immediately upon such request:

     (i) perform all of the obligations provided in this Agreement to be performed by the
Title 11 Party including, where applicable and without limitation, providing to the other
Party portions of such intellectual property (including embodiments thereof) held by the
Title 11 Party and such successors and assigns or otherwise available to them; or

     (ii) provide to the other Party all such intellectual property (including all
embodiments thereof) held by the Title 11 Party and such successors and assigns or otherwise
available to them; and

     (iii) not interfere with the rights of the other Party under this Agreement, or any
agreement supplemental hereto, to such intellectual property (including such embodiments),
including any right to obtain such intellectual property (or such embodiments) from another
entity.

     13.6.3. Rights to Intellectual Property. If a Title 11 case is commenced by or
against the Title 11 Party, and this Agreement is rejected as provided in Title 11, and the
other Party elects to retain its rights hereunder as provided in Title 11, then the Title 11
Party (in any capacity, including debtor-in-possession) and its successors and assigns
(including, without limitation, a Title 11 Trustee) shall provide to the other Party all
such intellectual property (including all embodiments thereof) held by the Title 11 Party
and such successors and assigns, or otherwise available to them, immediately upon the other
Party’s written request. Whenever the Title 11 Party or any of its successors or assigns
provides to the other Party any of the intellectual property licensed hereunder (or any
embodiment thereof) pursuant to this Section 13.6, the other Party shall have the right to
perform the obligations of the Title 11 Party hereunder with respect to such intellectual
property, but neither such provision nor such performance by the other Party shall release
the Title 11 Party from any such obligation or liability for failing to perform it.

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     13.6.4. Additional Rights. All rights, powers and remedies of a Party provided
herein are in addition to and not in substitution for any and all other rights, powers and
remedies now or hereafter existing at law or in equity (including, without limitation, Title
11) in the event of the commencement of a Title 11 case by or against the Title 11 Party. A
non-Title 11 Party, in addition to the rights, power and remedies expressly provided herein,
shall be entitled to exercise all other such rights and powers and resort to all other such
remedies as may now or hereafter exist at law or in equity (including, without limitation,
Title 11) in such event. The Parties agree that they intend the foregoing rights to extend
to the maximum extent permitted by law, including, without limitation, for purposes of Title
11:

     (a) the right of access to any intellectual property (including all embodiments
thereof) of the Title 11 Party, or any Third Party with whom the Title 11 Party contracts to
perform an obligation of the Title 11 Party under this Agreement, and, in the case of the
Third Party, which is necessary for the Research, Development, Manufacture and
Commercialization of Products; and

     (b) the right to contract directly with any Third Party described in Section 2.3 to
complete the contracted work.

     13.7. Provision for Certain Changes of Control.

     13.7.1 Change of Control Notice. A Party subject to a Change of Control shall
provide, where possible, written notice to the other Party (the “Section 13.7 Party”) at
least sixty (60) days prior to the Change of Control.

     13.7.2 *** Approximately 20 lines omitted ***

     13.7.3 Right to Terminate. This Agreement may be terminated effective
immediately by written notice by either Party (the “Section 13.7 Terminating Party”) at any
time within sixty (60) days after the Section 13.7 Terminating Party learns or is notified
in writing of a Change of Control of the other Party, if, within such sixty (60) day period
such other Party does not provide written confirmation reasonably satisfactory to the
Section 13.7 Terminating Party to the effect that: (i) after such Change of Control, the
Research Program and Development Program contemplated by this Agreement will have a priority
which is equal to or greater than the priority that the Research Program and Development
Program had in such other Party’s overall business organization prior to such Change in
Control and (ii) such other Party will continue to meet its obligations under this Agreement
          ***           . If applicable, in order to prevent the Section 13.7 Terminating Party from exercising
its right of termination under this Section 13.7.3, the Party undergoing a Change of Control
will, in addition to providing the written confirmation specified in the preceding sentence,
*** Approximately 3 lines

CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

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omitted ***. In the event of a termination pursuant to this Section, the effects of
termination set forth in Section 13.2.2 shall apply.

     13.8. Survival of Certain Obligations. Expiration or termination of this
Agreement shall not relieve the Parties of any obligation accruing before such expiration or
termination, and the provisions of the last sentence of Section 4.1.2, Section 7.5, Article
9 and Article 13 shall survive the expiration of the Agreement. Any expiration or early
termination of this Agreement shall be without prejudice to the rights of either Party
against the other accrued or accruing under this Agreement before termination, including,
without limitation, the obligation to distribute Pre-tax Profits for Product(s) sold before
such termination.

14. PRODUCT LIABILIlTY, INDEMNIFICATION AND INSURANCE.

     14.1. Sharing of Product Liability Expenses. Except where proximately caused
by the gross negligence or willful misconduct of a Party seeking reimbursement, the Parties
shall *** Approximately 2 lines omitted *** arising out of or caused by (a) the Manufacture
of a Product; (b) the death or bodily injury of any person on account of the use of a
Product; and/or (c) any recall or withdrawal of a Product (collectively, “Product Liability
Claims”).

     14.2. Indemnification by AHPC. AHPC will indemnify, defend and hold harmless
ELAN, its Affiliates, and each of its and their respective employees, officers, directors
and agents (each, an “ELAN Indemnified Party”) from and against any and all liability, loss,
damage, expense (including reasonable attorneys’ fees and expenses) and cost (collectively,
a “Liability”) that the ELAN Indemnified Party may be required to pay to one or more Third
Parties resulting from or arising out of:

     (a) any claims of any nature, other than Product Liability Claims or claims by Third
Parties relating to patent infringement, arising out of the conduct of the Research Program
and Development Program by, on behalf of, or under the authority of AHPC (other than by
ELAN);

     (b) any AHPC representation or warranty set forth herein being untrue in any material
respect when made; and/or

     (c) any Product Liability Claims proximately caused by the gross negligence or willful
misconduct of AHPC;

except in each case, to the extent caused by the gross negligence or willful misconduct of ELAN or
any ELAN Indemnified Party. Notwithstanding the foregoing, AHPC shall have no obligation

CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

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to defend, indemnify or hold harmless any ELAN Indemnified Party from and against any Liability
arising out of or resulting from the infringement of a Third Party patent.

     14.3. Indemnification by ELAN. ELAN will indemnify, defend and hold harmless
AHPC, its Affiliates, sublicensees, distributors and each of its and their respective
employees, officers, directors and agents (each, an “AHPC Indemnified Party”) from and
against any and all Liabilities that the AHPC Indemnified Party may be required to pay to
one or more Third Parties arising out of:

     (a) any claims of any nature, other than Product Liability Claims or claims by Third
Parties relating to patent infringement, arising out of the conduct of the Research Program
by, on behalf of, or under the authority of ELAN (other than by AHPC);

     (b) any ELAN representation or warranty set forth herein being untrue in any material
respect when made; and/or

     (c) any Product Liability Claims proximately caused by the gross negligence or willful
misconduct of ELAN;

except in each case, to the extent caused by the gross negligence or willful misconduct of AHPC or
any AHPC Indemnified Party. Notwithstanding the foregoing, ELAN shall have no obligation to
defend, indemnify or hold harmless any AHPC Indemnified Party from and against any Liability
arising out of or resulting from the infringement of a Third Party patent.

     14.4. Procedure. Each Party will notify the other in the event it becomes
aware of a claim for which indemnification may be sought hereunder. In case any proceeding
(including any governmental investigation) shall be instituted involving any Party in
respect of which indemnity may be sought pursuant to this Article 14, such Party (the
“Indemnified Party”) shall promptly notify the other Party (the “Indemnifying Party”) in
writing and the Indemnifying Party and Indemnified Party shall meet to discuss how to
respond to any claims that are the subject matter of such proceeding. The Indemnifying
Party, upon request of the Indemnified Party, shall retain counsel reasonably satisfactory
to the Indemnified Party to represent the Indemnified Party and shall pay the fees and
expenses of such counsel related to such proceeding. In any such proceeding, the
Indemnified Party shall have the right to retain its own counsel, but the fees and expenses
of such counsel shall be at the expense of the Indemnified Party unless (i) the Indemnifying
Party and the Indemnified Party shall have mutually agreed to the retention of such counsel
or (ii) the named parties to any such proceeding (including any impleaded parties) include
both the Indemnifying Party and the Indemnified Party and representation of both Parties by
the same counsel would be inappropriate due to actual or potential differing interests
between them. All such fees and expenses shall be reimbursed as they are incurred. The
Indemnifying Party shall not be liable for any settlement of any proceeding effected without
its written consent, but if settled with such consent or if there be a final judgment for
the plaintiff, the Indemnifying Party agrees to indemnify the Indemnified Party from and
against any loss or liability by reason of such settlement or judgment. The Indemnifying
Party shall not, without the written consent of the Indemnified

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Party, effect any settlement
of any pending or threatened proceeding in respect of which the Indemnified Party is, or arising out of the same set of facts could have been, a party and indemnity
could have been sought hereunder by the Indemnified Party, unless such settlement includes
an unconditional release of the Indemnified Party from all liability on claims to which the
indemnity relates that are the subject matter of such proceeding.

     14.5. Insurance. Each Party further agrees to use its reasonable efforts to
obtain and maintain, during the term of this Agreement, Commercial General Liability
Insurance, including Products Liability Insurance, with reputable and financially secure
insurance carriers to cover its indemnification obligations under Sections 14.2 or 14.3, as
applicable, or self-insurance, with limits of not less than *** Approximately 2 lines
omitted *** .

15. EXCHANGE PRODUCT.

     15.1. Exchange Product Offerings. During the         ***          period
following the         ***         , AHPC shall make up to         ***          offers
(each, an “Exchange Product Offering”) to Elan for Elan to copromote, along with AHPC, an
Exchange Product of AHPC’s sole choosing to a specialty (niche) market segment (i.e., to a
particular class of target physicians other than general practitioners) in the United
States. Each such Exchange Product Offering shall be presented to Elan by written notice,
which notice shall specify the Exchange Product that is the subject of the Exchange Product
Offering, the market segment within the United States that AHPC proposes Elan would market
such Exchange Product to, if such Exchange Product has previously been sold in the United
States by AHPC, United States sales data for such Exchange Product for the most recent
calendar year, if such Exchange Product is currently marketed, and AHPC’s proposed financial
terms for Elan’s copromotion of such Exchange Product. Within thirty (30) days of receiving
such notice, Elan shall notify AHPC in writing as to whether or not it desires to negotiate
a copromotion agreement for such Exchange Product. If Elan either fails to respond to such
notice within such thirty (30) day period or notifies AHPC that it does not desire to
negotiate a copromotion agreement for such Exchange Product Offering, Elan shall be deemed
to have rejected such Exchange Product Offering, and AHPC thereafter shall be free to market
the Product itself or pursuant to a copromotion agreement or other agreement with any Third
Party. If Elan notifies AHPC that it desires to negotiate a copromotion agreement for such
Exchange Product, the Parties shall promptly initiate good faith negotiations of such a
copromotion agreement, provided, however, that if the Parties fail to enter into a
copromotion agreement within three (3) months (unless extended at AHPC’s sole discretion)
after AHPC’s receipt of such notice from Elan, Elan shall be deemed to have rejected such
Exchange Product Offering and AHPC thereafter shall be free to market the Exchange Product
itself or pursuant to a copromotion agreement or other agreement with any Third Party. If
Elan has accepted an Exchange Product Offering and the Parties, in accordance with this
Section 15.1 have

CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

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negotiated and entered into a copromotion agreement for the Exchange Product that is the
subject of the Exchange Product Offering, AHPC shall have no obligation to make any further
Exchange Product Offerings to Elan. Likewise, if AHPC has made        ***         
Exchange Product Offerings to Elan and Elan has rejected all        ***          of such
Exchange Product Offerings, AHPC shall have no obligation to make any further Exchange
Product Offerings to Elan.

16. ASSIGNMENTS; CHANGES OF CONTROL.

     16.1. Assignments. Neither this Agreement nor any right or obligation
hereunder may be assigned or delegated, in whole or part, by either Party without the prior
express written consent of the other, except as expressly set forth below in this
Section16.1. Notwithstanding the foregoing, either Party may, without the written consent
of the other Party, assign this Agreement and its rights and delegate its obligations
hereunder to any of its Affiliates or to a Third Party in connection with the transfer or
sale of all or substantially all of its business relating to the subject matter of this
Agreement (provided that any such assignment to a Third Party shall be deemed a Change in
Control of the assigning Party for purposes of Section 13.7).

          16.2 Anti-Takeover Covenant. From the Effective Date until the earlier of (a) ***
Approximately 2 lines omitted ***, neither American Home Products Corporation (“American”) nor any
of its subsidiaries (as defined in Rule 1-02(x) of Regulation S-X under the Securities Exchange Act
of 1934, as amended (the “Exchange Act”)), will or will assist or encourage others to, directly or
indirectly, without the prior approval of ELAN’s Board of Directors: (i) acquire or agree, offer,
seek or propose to acquire beneficial ownership (as defined in Rule 13d-3 under the Exchange Act)
of any voting securities of ELAN or direct or indirect rights to acquire any voting securities of
ELAN or any subsidiaries of ELAN or substantially all of the assets or businesses of ELAN; (ii)
seek or propose to influence or control ELAN’s management or policies; or (iii) make, or in any way
participate in, directly or indirectly, any “solicitation” of “proxies” (as such terms are used in
the rules of the Exchange Act) to vote, or seek to advise or influence any person or entity with
respect to the voting of, any voting securities of ELAN.  *** Approximately 20 lines omitted ***
        .

17. MISCELLANEOUS.

     17.1. 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.

     17.2. Force Majeure. Nonperformance of a Party (other than for the payment of
money) shall be excused to the extent that performance is rendered impossible by strike,
fire, earthquake, flood, governmental acts or orders or restrictions, failure of suppliers,
or

CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

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any other reason where failure to perform, is beyond the reasonable control and not
caused by the negligence, intentional conduct or misconduct of the nonperforming Party. The
nonperforming Party shall notify the other Party promptly should such circumstances arise,
giving an indication of the likely extent and duration thereof, and shall use all reasonable
efforts to resume performance of its obligations as soon as practicable, provided, however,
that neither Party shall be required to settle any labor dispute or disturbance.

     17.3. Notices. All requests and notices required or permitted to be given to
the Parties hereto shall be given in writing, shall expressly reference the section(s) of
this Agreement to which they pertain, and shall be delivered to the other Party, and shall
be deemed given if delivered personally or by facsimile transmission (receipt verified),
mailed by registered or certified mail (return receipt requested), postage prepaid, or sent
by nationally recognized express courier service, to the Parties, at the appropriate address
as set forth below or to such other addresses as may be designated in writing by the Parties
from time to time during the term of this Agreement:

All correspondence to AHPC shall be addressed as follows:

Wyeth-Ayerst Laboratories

555 East Lancaster Avenue

St. Davids, Pennsylvania 19087

Attn: Senior Vice President, Global Business Development

Fax: (610) 688-9498

with a copy to:

American Home Products Corporation

5 Giralda Farms

Madison, New Jersey 07940

Attn: Senior Vice President and General Counsel

Fax: (973) 660-7156

All correspondence to ELAN shall be addressed as follows:

Neuralab Limited

102 St. James Court

Flatts, Smiths, FL-04

Bermuda

Attn: President

Fax: (441) 292-2224

with a copy to:

Elan Corporation, plc

2 Lincoln House

Lincoln Place

Dublin, Ireland

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Attn: Chief Executive Officer

Fax: 011-35-31-709-4810

and

Elan Pharmaceuticals, Inc.

800 Gateway Blvd.

South San Francisco, CA 94080

Attn: General Counsel

Fax: (650) 875-3620

     17.4. Amendment. No amendment, modification or supplement of any provision of
this Agreement shall be valid or effective unless made in writing and signed by a duly
authorized officer of each Party.

     17.5. Waiver. No provision of this Agreement shall be waived by any act,
omission or knowledge of a Party or its agents or employees except by an instrument in
writing expressly waiving such provision and signed by a duly authorized officer of the
waiving Party.

     17.6. Severability. If any clause or portion thereof in this Agreement is for
any reason held to be invalid, illegal or unenforceable, the same shall not affect any other
portion of this Agreement, as it is the intent of the Parties that this Agreement shall be
construed in such fashion as to maintain its existence, validity and enforceability to the
greatest extent possible. In any such event, this Agreement shall be construed as if such
clause or portion thereof had never been contained in this Agreement, and there shall be
deemed substituted therefor such provision as will most nearly carry out the intent of the
Parties as expressed in this Agreement to the fullest extent permitted by applicable law
unless doing so would have the effect of materially altering the rights and obligations of
the Parties in which event this Agreement shall terminate and all the rights and obligations
granted to the Parties hereunder shall cease and be of no further force and effect.

     17.7. Descriptive Headings. The descriptive headings of this Agreement are for
convenience only, and shall be of no force or effect in construing or interpreting any of
the provisions of this Agreement.

     17.8. Governing Law; Venue. This Agreement shall be governed by and
interpreted in accordance with the substantive laws of the State of New York, except matters
of intellectual property law, which shall be governed by and interpreted in accordance with
the national intellectual property laws relevant to the intellectual property in question,
without regard to conflict of law principles thereof. Venue for any action brought under
this Agreement shall lie exclusively in the United States of America and both Parties hereby
consent to such venue.

     17.9. Entire Agreement of the Parties. This Agreement constitutes and contains
the complete, final and exclusive understanding and agreement of the Parties and cancels and
supersedes any and all prior negotiations, correspondence, understandings and

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agreements, whether oral or written, among the Parties respecting the subject matter
hereof.

     17.10. Independent Contractors. Both Parties are independent contractors under
this Agreement. Nothing herein contained shall be deemed to create an employment, agency,
joint venture or partnership relationship between the Parties or any of their agents or
employees, or any other legal arrangement that would impose liability upon one Party for the
act or failure to act of the other Party. Neither Party shall have any express or implied
power to enter into any contracts or commitments or to incur any liabilities in the name of,
or on behalf of, the other Party, or to bind the other Party in any respect whatsoever.

     17.11. Debarment. Each Party agrees that it will not use, in any capacity, in
connection with any of its obligations to be performed under the Research Program or the
Development Program any individual who has been debarred under the FD&C Act or the Generic
Drug Enforcement Act.

     17.12. Counterparts. This Agreement may be executed in any number of
counterparts, each of which need not contain the signature of more than one Party but all
such counterparts taken together shall constitute one and the same agreement.

     17.13. NO CONSEQUENTIAL DAMAGES. IN NO EVENT SHALL A PARTY HERETO BE LIABLE
FOR SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES ARISING OUT OF THIS AGREEMENT OR THE
EXERCISE OF ITS RIGHTS HEREUNDER, INCLUDING, WITHOUT LIMITATION LOST PROFITS ARISING FROM OR
RELATING TO ANY BREACH OF THIS AGREEMENT, REGARDLESS OF ANY NOTICE OF SUCH DAMAGES. NOTHING
IN THIS SECTION 17.13 IS INTENDED TO LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR
OBLIGATIONS OF EITHER PARTY.

          IN WITNESS WHEREOF, duly authorized representatives of the Parties have duly executed this
Agreement to be effective as of the Effective Date.

	 	 	 	 	 	 	 	 	 
	AMERICAN HOME PRODUCTS 
CORPORATION	 	 	 	NEURALAB LIMITED
	 
	 	 	 	 	 	 	 	 
	By:

	 	/s/ Kenneth Martin 	 	 	 	By:	 	/s/ Kevin Insley 
	 

	 	 
	 	 	 	 	 	 
	 

	 	Name: Kenneth Martin
	 	 	 	 	 	Name: Kevin Insley
	 

	 	Title: Senior Vice President and
Chief Financial Officer
	 	 	 	 	 	Title: Vice President

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GUARANTEE

          In consideration of AHPC entering into the foregoing Research, Development and
Commercialization Agreement (the “Agreement”), Elan Corporation, plc, an Irish public limited
company (“ELAN”) hereby irrevocably and unconditionally guarantees to AHPC as principal and not as
surety the performance by Neuralab Limited (“NEURALAB “) and any Affiliate of ELAN or NEURALAB of
all of NEURALAB’s obligations under the Agreement, including, without limitation, the obligation to
make all payments to AHPC and grant all licenses to AHPC required under the Agreement.

          AHPC may enforce its rights under this Guarantee without first seeking to obtain performance
from NEURALAB or exercising any other remedy or right that AHPC may have. If AHPC decides to
proceed first to exercise any other remedy or right, or to proceed against another party, AHPC
retains all of its rights under this Guarantee.

          ELAN hereby consents to the non-exclusive jurisdiction of the state and federal courts of New
York with respect to any and all disputes, claims, actions or proceedings arising out of the
execution, delivery or performance of this Guarantee and waives all rights it might otherwise have
to object to venue before and the jurisdiction of such courts.

          This Guarantee shall survive the expiration or other termination of the Agreement and shall
survive and apply regardless of any amendments, waivers, extensions, modifications or other changes
in the obligations of NEURALAB under the Agreement.

	 	 	 	 	 	 	 
	 	 	ELAN CORPORATION, PLC	 	 
	 
	 	 	 	 	 	 
	 

	 	By	 	/s/ Seamus Mulligan 	 	 
	 

	 	 	 	 	 	 
	 

	 	 	 	Seamus Mulligan	 	 
	 
	 	 	 	 	 	 
	 

	 	Its:
	 	Executive Vice President, Corporate
	 	 
	 

	 	 	 	Development	 	 
	 
	 	 	 	 	 	 
	 

	 	Date:
	 	March 17, 2000	 	 

 

 

EXHIBIT 1.9

AHPC PATENT RIGHTS

          The following are those patent applications and patents Controlled by AHPC which AHPC, as of
the Effective Date, has identified as potentially being useful in connection with the Research
Program and the Development Program.

 *** Approximately 70 lines omitted ***

CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

 

 

EXHIBIT 1.29

CURRENT CLINICAL TRIALS

*** Approximately 6 lines omitted ***

CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

 

 

EXHIBIT 1.41

ELAN-LILLY PATENT RIGHTS

*** Approximately 55 lines omitted ***

CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

 

 

EXHIBIT 1.44

ELAN PATENT RIGHTS

*** Approximately 72 lines omitted ***

CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY

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ASTERISKS (*) DENOTE SUCH OMISSIONS.

 

 

EXHIBIT 1.56

ELEMENTS OF FULLY-ABSORBED STANDARD COSTS

*** Approximately 48 lines omitted ***

CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY

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EXHIBIT 4.1.1

R&D CANDIDATES

*** Approximately 3 lines omitted ***

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EXHIBIT 4.2.2

ELEMENTS OF ANNUAL RESEARCH PLAN

AND ANNUAL DEVELOPMENT PLAN

*** Approximately 29 lines omitted ***

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EXHIBIT 5.3

ADVERSE EVENT REPORTING PROCEDURES

          The Parties hereby agree that the following terms will govern disclosures of each Party to the
other with respect to adverse event reporting relating to any R&D Candidate or Product as
clinically tested or marketed by or on behalf of either Party.

1. DEFINITIONS.

          1.1. Adverse Experience or Event (AE): An AE is defined as any untoward, undesired, or
unplanned event in the form of signs, symptoms, disease, or laboratory or physiological
observations occurring in a human being in a temporal relationship to use of a Product regardless
of causal relationship. This includes:

	 	•	 	any clinically significant worsening of a pre-existing condition;
	 
	 	•	 	an AE occurring from overdose (i.e., a dose higher than that prescribed by a health
care professional for clinical reasons) of a Product, whether accidental or
intentional;
	 
	 	•	 	an AE occurring from abuse (i.e., use for non-clinical reasons) of a Product;
	 
	 	•	 	an AE that has been associated with the discontinuation of the use of a Product;
	 
	 	•	 	any failure of expected pharmacological action (for spontaneous reports).

          If there is any doubt whether the information constitutes an AE, the information will be
treated as an AE.

          1.2. Serious AE: A serious AE is defined as an AE occurring at any dose that: results in
death; is life-threatening (see below); requires inpatient hospitalization or prolongation of an
existing hospitalization; results in a persistent or significant disability or incapacity (see
below); results in cancer; results in a congenital anomaly or birth defect. Additionally,
important medical events that may not result in death, be life-threatening, or require
hospitalization may be considered a serious AE when, based upon appropriate medical judgment, they
may jeopardize the patient or subject and may require medical or surgical intervention to prevent
one of the outcomes listed in this definition. Examples of such medical events include allergic
bronchospasm requiring intensive treatment in an emergency room or at home; blood dyscrasias or
convulsions that do not result in hospitalization; or the development of drug dependency or abuse.

          1.2.1. Life-threatening refers to immediate risk of death as the event occurred. A
life-threatening experience does not include an experience that, had it occurred in a more severe
form, might have caused death but as it actually occurred did not create an immediate risk of
death. For example, hepatitis that resolved without evidence of hepatic failure would not be
considered life-threatening even though hepatitis of a more severe nature can be fatal. Similarly,

 

 

an allergic reaction resulting in angioedema of the face would not be life-threatening, even
though angioedema of the larynx, allergic bronchospasm, or anaphylaxis can be fatal.

          1.2.2. Disability is defined as a substantial disruption in a person’s ability to conduct
normal life functions.

          1.2.3. For studies, all pregnancies and all overdoses will be reported to GSSE in the same
time frame as serious AEs.

          1.2.4. A serious AE obtained from tests in laboratory animals includes any experience
suggesting a significant risk for human subjects, including any findings of mutagenicity,
teratogenicity, or carcinogenicity.

          1.2.5. If there is any doubt whether the information constitutes a serious AE, the information
will be treated as a serious AE.

          1.3. Non-Serious AE: is any AE which does not meet the criteria for a serious AE.

          1.4. Unexpected AE: An unexpected AE is one that is not listed in the current product
labeling. The current product labeling is either the package insert (for marketed Products) or the
current investigator’s brochure (for investigational Products). An unexpected AE includes any
event that may be symptomatically and pathophysiologically related to an event listed in the
labeling, but differs from the labeled event because of greater severity or specificity. For
example, hepatic necrosis would be unexpected (by virtue of greater severity) if the product
labeling referred only to elevated hepatic enzymes or hepatitis. Similarly, cerebral
thromboembolism and cerebral vasculitis would be unexpected (by virtue of greater specificity) if
the labeling only listed cerebral vascular accidents.

          1.5. Product (Drug, Vaccine, Biological, Device)-Related: For the purposes of regulatory
reporting for investigational products, an AE will be considered “product-related” (i.e.,
drug-related, vaccine-related, etc.) for studies if either the investigator, the Medical Monitor,
the CR&D Clinical Project Team Medical Monitor (or designee), or the Local Monitor (if applicable)
assesses the AE(s) as possibly, probably, or definitely related.

          1.6. An AE will be considered “not product-related” for studies if the investigator and the
medical monitor(s) and the local monitor (if applicable) assess the AE(s) as probably not related
or definitely not related, or “relationship remote.”

          1.7. Whenever the investigator’s or monitor’s assessment is unknown or unclear, the AE(s) will
be treated as product-related for the purposes of reporting to regulatory authorities.

          1.8. Protocol-Related: AEs from studies that are not product-related may nevertheless be
considered by the investigator or the medical monitor(s) or the local monitor (if applicable) to be
protocol-related. For purposes of reporting to GSSE and regulatory authorities, these will be
reported in the same manner as product-related events.

-2-

 

          1.9. BLA Holder is defined as: An “Applicant” as defined in 21 C.F.R. Section 3 14.3(b), for
regulatory approval of a Product in any regulatory jurisdiction, including a holder of a foreign
equivalent thereto.

          1.10. IND Holder is defined as: A “Sponsor” as defined in 21 C.F.R. Section 312.3(b) of an
investigational new drug in any regulatory jurisdiction, including a holder of a foreign equivalent
thereto.

          1.11. Capitalized terms not defined in this Exhibit shall have the meaning assigned thereto in
the Agreement.

With respect to any R&D Candidate or Product, the Parties agree as follows:

     a. All initial reports and any follow-up information (oral or written) for any and all
Serious AEs as defined above, (other than with respect to animal studies) which become known
to either Party (other than from disclosure by or on behalf of the other Party) must be
communicated by telephone, telefax or electronically directly to the other Party and/or the
BLA Holder, IND Holder (individually and collectively referred to as “Holders”) within
forty-eight (48) hours of receipt of the information. Written confirmation of the Serious
AE received by such Party should be sent to the other Party and/or the Holders as soon as it
becomes available, but in any event within forty-eight (48) hours of initial report of the
Serious AE by such Party.

     b. Both Parties shall exchange Medwatch and/or CIOMs forms and other health authority
reports within forty-eight (48) hours of submission to any Regulatory Authority.

     c. All initial reports and follow-up information received for all Non-Serious AEs for
marketed Product which become known to a Party (other than from disclosure by or on behalf
of the other Party) must be communicated in writing, by telefax or electronically to the
other Party within the required time frame to meet the regulatory obligations of either
Party, on Medwatch or CIOMs forms (where possible).

     d. Each Party shall coordinate and cooperate with the other whenever practicable to
prepare a single written report regarding all Serious and/or Non-Serious AEs, provided,
however, that neither Party shall be obligated to delay reporting of any AE in violation of
applicable law or regulations regarding the reporting of AEs.

2. THE PARTIES FURTHER AGREE THAT:

     a. A written report be forwarded to the other Party within forty-eight (48) hours of
receipt by the Party making the report, for AEs for animal studies which suggest a potential
significant risk for humans;

     b. Each Party will give the other Party a report via a print-out or computer disk of
all AEs reported to it and its Affiliates relating to any R&D Candidate or Product

-3-

 

within the last year, within thirty (30) days of receipt of a request from the other
Party but not more often than four (4) times a year;

     c. If either Party wishes access to AE Reports of the other Party relating to an R&D
Candidate or Product, upon request of that Party, the other Party shall make available its
AE records relating to the Product or Substance (including computer files) for viewing and
copying by the other Party. The Parties may discuss the transfer of AE Reports by computer
disk.

     d. Disclosure of information hereunder by a Party to the other Party shall continue as
long as either Party and/or its Affiliates or designees continue to clinically test or
market an R&D Candidate or Product.

	3.	 	Each Party shall diligently undertake the following further obligations where both Parties
are or will be commercializing the R&D Candidate or product pursuant to the Agreement and/or
performing clinical trials with respect to the R&D Candidate or Product:

     a. Upon the Effective Date, each Party shall identify individuals who shall be
responsible for identifying all AE reporting requirements in all countries of the world as
set forth in the Agreement, and any amendments thereto;

     b. To immediately consult with the other Party, with respect to the investigation and
handling of any Serious AE disclosed to it by the other Party or by a third Party and to
allow the other Party to review the Serious AE and to participate in the follow-up
investigation;

     c. To immediately advise the other Party of any R&D Candidate and/or Product safety
communication received from a health authority and consult with the other Party with respect
to any Product and/or Substance warning, labeling change or change to an investigator’s
brochure involving safety issues proposed by the other Party, including, but not limited to
the safety issues agreed to by the Parties;

     d. To diligently handle in a timely manner the follow-up investigation and resolution
of each AE reported to it;

     e. To provide the other Party mutually agreed upon audit rights of its AE reporting
system and documentation as related to any R&D Candidate and/or Product, upon prior notice,
during normal business hours, at the expense of the auditing Party and under the
confidentiality obligations set forth in the Agreement;

     f. To meet in a timely fashion from time to time as may be reasonably required to
implement the adverse event reporting and consultation procedures described in this Exhibit
5.3, including identification of those individuals in each Party’s Drug Safety group who
will be responsible for reporting to and receiving AE information from the other Party, and
the development of a written standard operating procedure with respect to adverse event
reporting responsibilities, including reporting responsibilities to investigators;

-4-

 

     g. Where possible, to transmit all data electronically;

     h. To report to each other any addenda, revisions or changes to the Agreement (e.g.,
change in territories, local regulations, addition of new licensors/licensees to the
Agreement, etc.) which might alter the adverse event reporting responsibilities hereunder;

     i. To utilize English as the language of communication and data exchange between the
Parties;

     j. To develop a system of exchange of documents and information if the Agreement
involves more than two Parties;

     k. To work together to develop an electronic system to transmit AE data.

	4.	 	The Parties shall meet within ninety (90) days after the Effective Date of the Agreement to
review this Exhibit and, if necessary, make modifications hereto, (which modifications need
only be approved by each Party’s head of regulatory affairs) or to establish a separate
agreement for adverse event exchange which will supersede this Exhibit.

-5-

 

EXHIBIT 10.2(a)

CERTAIN ELAN PATENT RIGHTS

*** Approximately 30 lines omitted ***

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EXHIBIT 10.2(b)

GOVERNMENT FUNDING — ELAN PATENT RIGHTS

*** Approximately 18 lines omitted ***

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EXHIBIT 10.3(a)

CERTAIN AHPC PATENT RIGHTS

*** Approximately 35 lines omitted ***

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EXHIBIT 10.3(b)

GOVERNMENT FUNDING — AHPC PATENT RIGHTS

          The AHPC Patent Rights listed below were developed, at least in part, under a government
funding agreement.

          *** Approximately 17 lines omitted ***

CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

 

 

AMENDMENT NO. 1

to

RESEARCH, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

This is Amendment No. 1, dated as of April 4, 2000 (“Amendment No. 1”), to the Research,
Development and Commercialization Agreement dated as of March 17, 2000 (the “Agreement”) by and
among American Home Products Corporation, a Delaware corporation, together with its Affiliates,
acting through its Wyeth-Ayerst Laboratories Division (collectively, “AHPC”) and Neuralab Limited,
a Bermuda private limited company (“Neuralab”).

INTRODUCTION

The Parties have determined that it is in their mutual best interests to amend the Agreement in the
manner set forth below.

Accordingly, in accordance with Section 17.4 of the Agreement, the Parties agree to amend the
Agreement as follows:

     1. Use of Terms. Capitalized terms used herein and not defined herein shall have the
respective meanings ascribed to such terms in the Agreement.

     2. Section 10.2. Section 10.2 of the Agreement is hereby amended by deleting the word
“and” at the end of subsection (f) thereof and by inserting the following new subsections (h) and
(i) immediately after subsection (g) thereof:

	 	“(h)	 	 Neither ELAN nor any of its employees or agents has at any time made any
misrepresentation, omitted to make any disclosure, or concealed any information
relating to Betabloc or to any Invention, which misrepresentation, omission or
concealment supports a finding of fraud by the trier of fact in the ELAN/Lilly
Litigation; and
	 
	 	(i)	 	ELAN is not aware of any information in the possession of Lilly that could
provide material support for any claim by Lilly to any right, title or interest in or
to Betabloc or in or to any Invention disputed in the ELAN/Lilly Litigation.”

     Section 10.2 of the Agreement is hereby further amended by deleting the final sentence thereof
in its entirety and inserting the following sentence in its place:

“The outcome of the ELAN/Lilly Litigation shall not be determinative as to the absence or
presence of a breach of the foregoing representations and warranties in Sections 10.1 and
10.2; provided, however, that any unappealed or unappealable final decision by a court of
competent jurisdiction based upon a record containing an explicit finding by the court or
jury of facts sufficient to establish the presence of a breach of the representations and
warranties set forth in Section 10.2(h) shall be determinative of the presence of such
breach unless the parties to the ELAN/Lilly Litigation have entered into a settlement
agreement that (x)

Page 1 of 3

 

compromises any appeal of such decision, (y)     ***      and (z) results in the termination of the ELAN/Lilly
Litigation (including any appeal therein).”

     3. *** Approximately 4 lines omitted ***

     4. *** Approximately 3 lines omitted ***

     5. *** Approximately 19 lines omitted ***

     6. Section 13.4. Section 13.4 of the Agreement is hereby amended by
deleting Section 13.4 in its entirety and by substituting the following in its place:

     “13.4 Section 13.4. Reserved.”

     7. Section 17.9. Section 17.9 of the Agreement is hereby amended by
deleting Section 17.9 in its entirety and by substituting the following in its place:

	 	“17.9 	 	Entire Agreement of the Parties. This Agreement constitutes and
contains the complete, final and exclusive understanding and agreement of the Parties
and, except for the Joint Defense Letter dated as of January 21, 2000 by and between
American Home Products Corporation and Elan Pharmaceuticals, Inc., cancels and
supersedes any and all prior negotiations, correspondence, understandings and
agreements, whether oral or written, among the Parties respecting the subject matter
hereof.”

     8. General. In all other respects, the Agreement is hereby ratified and
confirmed.

     IN WITNESS WHEREOF, the Parties have executed this Amendment No. 1 as of the date set forth
above.

AMERICAN HOME PRODUCTS CORPORATION

By:
/s/ Louis Hoynes

Title: Senior Vice President and General Counsel

NEURALAB LIMITED

By:
/s/ Kevin Insley

Title: Vice President

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WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

Page 2 of 3

 

GUARANTEE

The undersigned, an Irish public limited company, hereby guarantees the performance of Neuralab and
any Affiliate of Neuralab of all of Neuralab’s obligations under the foregoing Amendment No. 1 to
the same extent and in the same manner as the undersigned guaranteed the performance of Neuralab
and any Affiliate of Neuralab of all of Neuralab’s obligations under the Agreement, as set forth in
the Guarantee dated March 17, 2000 executed by the undersigned in connection with the Agreement.

	 	 	 	 	 
	 	 	ELAN CORPORATION, plc
	 
	 	 	 	 
	 

	 	By:
	 	/s/ Seamus Mulligan
	 
	 	 	 	 
	 

	 	Title:
	 	Executive Vice President

Page 3 of 3

 

 

AMENDMENT NO. 2

to

RESEARCH, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

     This Amendment (“Amendment No. 2”), dated as of April 4, 2002 (“the Amendment Effective
Date”), to the Research, Development and Commercialization Agreement dated as of March 17, 2000 (as
previously amended, the “Agreement”) is entered into by and among Wyeth (formerly known as
“American Home Products Corporation”), a Delaware corporation, together with its Affiliates, acting
through its Wyeth Pharmaceuticals Division (formerly known as its “Wyeth-Ayerst Laboratories
Division”) (collectively, “Wyeth”) and Neuralab Limited, a Bermuda private limited company
(“Neuralab”). Wyeth and Neuralab may each be referred to herein individually as a “Party” and
collectively as the “Parties”.

     WHEREAS, on November 16, 2000, Wyeth, Neuralab and Elan Pharmaceuticals, Inc. (together, with
Neuralab, “Elan”) entered into a letter agreement (the “Consent Letter”) pursuant to which Wyeth
provided its consent for Elan to enter into a Settlement Agreement and Release (the “Settlement
Agreement”) with Eli Lilly and Company (“Lilly”), to settle the ELAN/Lilly Litigation;

     WHEREAS, pursuant to the Consent Letter, Wyeth’s provision of such consent was conditioned
upon the Parties amending the Agreement to address (i) the responsibilities of the Parties for
          ***           under the Settlement Agreement, (ii) the mechanisms for
          ***           and (iii) adjustments to certain payments to be made by
Wyeth to Neuralab under the Agreement;

     WHEREAS, Elan has entered into the Settlement Agreement with Lilly and the Parties now desire
to enter into this Amendment No. 2 to satisfy the above stated condition of the Consent Letter; and

     WHEREAS, the Parties had a dispute as to whether the first payment set forth in Section 7.2.1
of the Agreement had become due and now also wish to amend the Agreement in settlement of such
dispute.

     NOW THEREFORE, in consideration of the foregoing premises, the following mutual promises and
covenants and other good and valuable consideration, the receipt and sufficiency of which is hereby
acknowledged, the Parties hereby agree as follows:

	 	1.	 	Capitalized terms used herein and not defined herein shall have the respective
meanings ascribed to such terms in the Agreement.
	 
	 	2.	 	Due to the change of the name of Wyeth, which name change became effective on
March 11, 2002, the name “Wyeth” is hereby substituted for the name “American Home
Products Corporation” or “AHPC” each time it appears in the Agreement

CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY

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ASTERISKS (*) DENOTE SUCH OMISSIONS.

Page 1 of 4

 

 

	 	 	 	and the name “Wyeth Pharmaceuticals” is hereby substituted for the name
“Wyeth-Ayerst Laboratories” each time it appears in the Agreement.

	 	3.	 	Section 1.47 of the Agreement is hereby amended by deleting Section 1.47 in its
entirety and replacing it with the following:

	 	“1.47	 	“ELAN Share of Pro-Forma Net Profit”. ELAN Share of Pro-Forma
Net Profit shall mean, on a Product-by-Product and country by country basis and
subject to upward or downward adjustment as set forth in Article 11,
          ***            of the Pro-Forma Net Profit obtained from such
Product in such country.”

	 	4.	 	As, under the Settlement Agreement,     *** Approximately 3 lines omitted ***     ,
the Parties agree that Section           ***            of the Agreement became applicable as of
the date of the Settlement Agreement, and hereby agree, that, notwithstanding any
provision to the contrary in Section           ***            or any other provision of the
Agreement, the application of Section           ***           shall have the following effects on
the Agreement:

	 	(a)	 	Under Section    *** Approximately 11 lines omitted ***    .
	 
	 	(b)	 	As the     *** Approximately 18 lines omitted ***    of the
Agreement. 
	 
	 	(c)	 	As the *** Approximately 4 lines omitted ***   , such that

	 	(i)	 	pursuant to Section *** Approximately 4 lines
omitted ***     ; and
	 
	 	(ii)	 	pursuant to Section    *** Approximately 20
lines omitted *** of the Agreement.

	 	5.	 	The Parties agree that, as of the Amendment Effective Date, no event that would
trigger a payment under Section 7.2.1 of the Agreement has occurred. In settlement of
the dispute between the Parties as to whether any such event has occurred the Parties
hereby agree that the payment to be made within thirty (30) days after ***
Approximately 4 lines omitted ***   . Additionally, the Parties hereby agree to amend
Section 7.2.1 of the Agreement by adding the following additional payment events to
Section 7.2.1 of the Agreement:

	 	 	 
	Event	 	Additional Payment
	*** Approximately 7 lines omitted ***

	 	***
	*** Approximately 3 lines omitted ***

	 	***

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Page 2 of 4

 

 

	 	 	 	provided, however, that (i) such additional payments will only be made if, prior to
the corresponding triggering event,
          ***            such that the first payment required under
Section 7.2.1, as amended hereby, has become due and (ii) if either of such
additional payments are made,     *** Approximately 3 lines omitted ***     . It is
understood and agreed that the amounts set forth in the table above reflect the
adjustments made pursuant to Section 3(c) of this Amendment No. 2.
	 
	 	6.	 	For the sake of clarity, the payments to be made under Sections 7.2 and 7.3 of
the Agreement, as reduced and otherwise modified by this Amendment No. 2, are set forth
in Exhibit A attached hereto and Sections 7.2 and 7.3 of the Agreement are hereby
replaced by the Sections 7.2 and 7.3 set forth in Exhibit A attached hereto.
	 
	 	7.	 	In all other respects, the Agreement is hereby ratified and confirmed.

     IN WITNESS WHEREOF, the Parties have executed this Amendment No. 2 as of the date set forth
above.

	 	 	 	 	 
	 	 	WYETH
	 
	 	 	 	 
	 

	 	By:
	 	/s/ Jeffrey S. Sherman
	 
	 	 	 	 
	 

	 	Title:
	 	Vice President
	 
	 	 	 	 
	 	 	NEURALAB LIMITED
	 
	 	 	 	 
	 

	 	By:
	 	/s/ Kevin Insley
	 
	 	 	 	 
	 

	 	Title:
	 	Vice President

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WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

Page 3 of 4

 

 

GUARANTEE

The undersigned, an Irish public limited company, hereby guarantees the performance of Neuralab and
any Affiliate of Neuralab of all of Neuralab’s obligations under the foregoing Amendment No. 2 to
the same extent and in the same manner as the undersigned guaranteed the performance of Neuralab
and any Affiliate of Neuralab of all of Neuralab’s obligations under the Agreement, as set forth in
the Guarantee dated March 17, 2000 executed by the undersigned in connection with the Agreement.

	 	 	 	 	 
	 	 	ELAN CORPORATION, plc
	 
	 	 	 	 
	 

	 	By:
	 	/s/ Seamus Mulligan
	 
	 	 	 	 
	 

	 	Title:
	 	Executive Vice President

Page 4 of 4

 

 

EXHIBIT A

     The amounts payable under Sections 7.2 and 7.3 of the Agreement, as adjusted in accordance
with Section 11.4 of the Agreement as implemented by this Amendment shall be as follows:

	7.2	 	Additional Payments.

	 	7.2.1	 	One-Time Payments.

	 	(a)	 	In consideration of NEURALAB’s contributions to the Research
Program and the Development Program, subject to Article 11, Wyeth shall pay to
NEURALAB the following additional Research and Development expense
reimbursement payments, each such payment being due and payable one time only
and within thirty (30) days after the occurrence of the corresponding event:

	 	 	 
	Event	 	Additional Payment
	*** Approximately 15 lines omitted ***

	 	*** Approximately 5 lines omitted ***

	 	(b)	 	Additionally, in the event that *** Approximately 3 lines
omitted ***, Wyeth also shall pay to NEURALAB the following additional Research
and Development expense reimbursement payments, each such payment being due and
payable one time only and within thirty (30) days after the occurrence of the
corresponding event:

	 	 	 
	Event	 	Additional Payment
	*** Approximately 10 lines omitted ***

	 	*** Approximately 2 lines omitted ***

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ASTERISKS (*) DENOTE SUCH OMISSIONS.

Exhibit A — Page 1 of 3

 

 

	 	 	 	provided, however, that if either of such additional payments are made, they
shall each be *** Approximately 3 lines omitted ***     .
	 
	 	(c)	 	For the sake of clarity, in no event shall the total amount
paid to NEURALAB as a result of the first event listed in Section 7.2.1(a) and
the events listed in Section 7.2.1(b) exceed           ***           .

	 	7.2.2	 	Pre-Approval Payments. In consideration of NEURALAB contributions to the
Research Program and the Development Program, subject to Article 11, Wyeth shall pay to
NEURALAB the following additional Research and Development expense reimbursement
payments, each such payment being due and payable within thirty (30) days after the
occurrence of the corresponding event:

	 	 	 
	Event	 	Additional Payment
	*** Approximately 23 lines omitted ***

	 	*** Approximately 13 lines omitted ***

	 	7.2.3	 	Approval Payments. Subject to Article 11, Wyeth shall pay to NEURALAB the
following payments based on specific approvals set forth below. These payments are for
past Research and Development efforts. Each such payment shall be due and payable
within thirty (30) days after the occurrence of the corresponding event:

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ASTERISKS (*) DENOTE SUCH OMISSIONS.

Exhibit A — Page 2 of 3

 

 

	 	 	 
	Event	 	Additional Payment
	*** Approximately 23 lines omitted ***

	 	*** *** Approximately 12 lines omitted ***

	 	7.2.4	 	Additional Products. Subject to Article 11, each of the additional payments
set forth in this Section 7.2 are payable only once with respect to any Product and
shall be non-refundable and non-creditable. Notwithstanding the immediately preceding
sentence, subject to Article 11, additional payments equal to           ***          
of the payment indicated above in Section 7.2.2 and 7.2.3 shall be payable
for up to           ***            R&D Candidates or Products, as applicable, with
respect to which each event set forth above occurs; provided that such additional
payments shall only be payable if subsequent occurrences of any event result from R&D
Candidates or Products, as applicable, that     *** Approximately 10 lines omitted ***
        .

	7.3	 	Sales Bonus. Subject to Article 11, Wyeth shall pay to NEURALAB a one-time sales bonus
payment in the amount of           ***            within thirty (30) days after the first
occasion on which aggregate world-wide Net Sales of a Product or Products under this
Agreement, *** Approximately 2 lines omitted *** .

CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY

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ASTERISKS (*) DENOTE SUCH OMISSIONS.

Exhibit A — Page 3 of 3

 

 

AMENDMENT NO. 3

to

RESEARCH, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

     This Amendment (“Amendment No. 3”), dated as of May 1, 2005 (“the Amendment Effective Date”),
to the Research, Development and Commercialization Agreement dated as of March 17, 2000 (as
previously amended, the “Agreement”) is entered into by and among Wyeth (formerly known as
“American Home Products Corporation”), a Delaware corporation, together with its Affiliates, acting
through its Wyeth Pharmaceuticals Division (formerly known as its “Wyeth-Ayerst Laboratories
Division”) (collectively, “Wyeth”) and Neuralab Limited, a Bermuda private limited company
(“Neuralab”). Wyeth and Neuralab may each be referred to herein individually as a “Party” and
collectively as the “Parties”.

     WHEREAS, under the Agreement the Parties have been conducting a Research Program and the
Initial Term of such Research Program expires on           ***            unless extended by the
Parties; and

     WHEREAS, the Parties now desire to extend the Initial Research Term under the Agreement.

     NOW THEREFORE, in consideration of the foregoing premises, the following mutual promises and
covenants and other good and valuable consideration, the receipt and sufficiency of which is hereby
acknowledged, the Parties hereby agree as follows:

	 	1.	 	Capitalized terms used herein and not defined herein shall have the respective
meanings ascribed to such terms in the Agreement.
	 
	 	2.	 	The Parties hereby agree to extend the Initial Research Term under the
Agreement by a period of           ***            such that the Research Term now will
expire on           ***           , unless further extended pursuant to the provisions
of Section 4.1.2.
	 
	 	3.	 	In all other respects, the Agreement is hereby ratified and confirmed.

     IN WITNESS WHEREOF, the Parties have executed this Amendment No. 2 as of the date set forth
above.

	 	 	 	 	 	 	 	 	 
	WYETH	 	 	 	NEURALAB LIMITED
	 
	 	 	 	 	 	 	 	 
	By:

	 	/s/ Mark L. Lee 	 	 	 	By:	 	/s/ Kevin Insley 
	 

	 	 
	 	 	 	 	 	 
	Name:

	 	Mark L. Lee
	 	 	 	Name:
	 	Kevin Insley
	Title:

	 	Sr. VP. Business Devp.
	 	 	 	Title:
	 	President

CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

 

 

GUARANTEE

The undersigned, an Irish public limited company, hereby guarantees the performance of Neuralab and
any Affiliate of Neuralab of all of Neuralab’s obligations under the foregoing Amendment No. 3 to
the same extent and in the same manner as the undersigned guaranteed the performance of Neuralab
and any Affiliate of Neuralab of all of Neuralab’s obligations under the Agreement, as set forth in
the Guarantee dated March 17, 2000 executed by the undersigned in connection with the Agreement.

	 	 	 	 	 
	 	 	ELAN CORPORATION, plc
	 
	 

	 	By:	 	/s/ William Daniel 
	 

	 	 	 	 
	 
	 	 	 	 
	 

	 	Title:
	 	 EVP, Company Secretary

Page 2 of 2

 

 

AMENDMENT NO. 4

to

RESEARCH, DEVELOPMENT AND COMMERCIALIZATION AGREEMENT

     This Amendment (“Amendment No. 4”), dated as of May 1, 2007 (“the Amendment Effective Date”),
to the Research, Development and Commercialization Agreement dated as of March 17, 2000 (as
previously amended, the “Agreement”) is entered into by and among Wyeth (formerly known as
“American Home Products Corporation”), a Delaware corporation, together with its Affiliates, acting
through its Wyeth Pharmaceuticals Division (formerly known as its “Wyeth-Ayerst Laboratories
Division”) (collectively, “Wyeth”) and Elan Pharma International Limited, a private limited company
incorporated under the laws of Ireland and having its registered office at Monnksland, Athlone,
County Westmeath, Ireland (“EPIL”), successor in interest to Neuralab Limited. Wyeth and EPIL may
each be referred to herein individually as a “Party” and collectively as the “Parties”.

     WHEREAS, under the Agreement the Parties have been conducting a Research Program and the Term
of such Research Program as extended by Amendment No. 3 expires on           ***            unless
extended by the Parties; and

     WHEREAS, the Parties now desire to further extend the Research Term under the Agreement.

     NOW THEREFORE, in consideration of the foregoing premises, the following mutual promises and
covenants and other good and valuable consideration, the receipt and sufficiency of which is hereby
acknowledged, the Parties hereby agree as follows:

	 	1.	 	Capitalized terms used herein and not defined herein shall have the respective
meanings ascribed to such terms in the Agreement.
	 
	 	2.	 	The Parties hereby agree to further extend the Research Term under the
Agreement by a period of           ***            such that the Research Term now will
expire on           ***          , unless further extended pursuant to the provisions
of Section 4.1.2.
	 
	 	3.	 	In all other respects, the Agreement is hereby ratified and confirmed.

CONFIDENTIAL INFORMATION OMITTED AND FILED SEPARATELY

WITH THE SECURITIES AND EXCHANGE COMMISSION.

ASTERISKS (*) DENOTE SUCH OMISSIONS.

Page 1 of 3

 

 

     IN WITNESS WHEREOF, the Parties have executed this Amendment No. 4 as of the date set forth
above.

	 	 	 	 	 	 	 	 	 
	WYETH	 	 	 	ELAN PHARMA INTERNATIONAL LIMITED
	 	 	 	 	 	 	 	 	 
	By:

	 	/s/ Robert J. Smith 	 	 	 	By:	 	/s/ Shane Cooke 
	 

	 	 
	 	 	 	 	 	 
	Name:

	 	Robert J. Smith
	 	 	 	Name:
	 	Shane Cooke
	Title:

	 	Senior Vice President
	 	 	 	Title:
	 	CFO, Director
	 

	 	Global Licensing	 	 	 	 	 	 
	 
	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	By:	 	/s/ William Daniel 
	 

	 	 	 	 	 	 	 	 
	 

	 	 	 	 	 	Name:
	 	William Daniel
	 

	 	 	 	 	 	Title:
	 	Director

Page 2 of 3

 

 

GUARANTEE

The undersigned, an Irish public limited company, hereby guarantees the performance of EPIL and any
Affiliate of EPIL of all of EPIL’s obligations under the foregoing Amendment No. 4 to the same
extent and in the same manner as the undersigned guaranteed the performance of EPIL and any
Affiliate of EPIL of all of EPIL’s obligations under the Agreement, as set forth in the Guarantee
dated March 17, 2000 executed by the undersigned in connection with the Agreement.

	 	 	 	 	 
	 	 	ELAN CORPORATION, plc
	 
	 	 	 	 
	 

	 	By:	 	/s/ William Daniel 
	 

	 	 	 	 
	 
	 	 	 	 
	 

	 	Name:
	 	William Daniel
	 
	 	 	 	 
	 

	 	Title:
	 	 EVP & Company Secretary

Page 3 of 3

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