UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
______________________________________ 
FORM 10-Q
 _____________________________________
(Mark One)
x
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended March 31, 2018
Or
o
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
Commission file number: 001-35676
______________________________________ 
PROTHENA CORPORATION PUBLIC LIMITED COMPANY
(Exact name of registrant as specified in its charter)
______________________________________ 
Ireland
 
98-1111119
(State or other jurisdiction of
incorporation or organization)
 
(I.R.S. Employer
Identification Number)
 
Adelphi Plaza
Upper George's Street
Dún Laoghaire
Co. Dublin, A96 T927, Ireland
(Address of principal executive offices including Zip Code)
Registrant’s telephone number, including area code: 011-353-1-236-2500
 ______________________________________
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    Yes   x     No   o
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).    Yes   x     No   o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer
x
Accelerated filer
o
 
 
 
 
Non-accelerated filer
o (Do not check if a smaller reporting company)
Smaller reporting company
o
 
 
Emerging growth company
o
If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. o




Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).    Yes    o    No   x
The number of ordinary shares outstanding as of April 20, 2018 was 39,822,336 .




PROTHENA CORPORATION plc
Form 10-Q – QUARTERLY REPORT
For the Quarter Ended March 31, 2018
TABLE OF CONTENTS

 
Page
 
 
Condensed Consolidated Balance Sheets as of March 31, 2018 and December 31, 2017
Condensed Consolidated Statements of Operations for the three months ended March 31, 2018 and 2017
Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2018 and 2017
 
 
 
 
 
 





PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
Prothena Corporation plc and Subsidiaries
Condensed Consolidated Balance Sheets (unaudited)
(in thousands, except share and per share data)
 
March 31, 2018
 
December 31, 2017
Assets
 
 
 
Current assets:
 
 
 
Cash and cash equivalents
$
429,039

 
$
417,620

Receivable from Celgene
100,000

 

Receivable from Roche
12

 
240

Prepaid expenses and other current assets
8,102

 
8,467

Total current assets
537,153

 
426,327

Non-current assets:
 
 
 
Property and equipment, net
54,278

 
54,990

Deferred tax assets
8,320

 
8,113

Restricted cash
4,056

 
4,056

Other non-current assets
2,840

 
2,843

Total non-current assets
69,494

 
70,002

Total assets
$
606,647

 
$
496,329

Liabilities and Shareholders’ Equity
 
 
 
Current liabilities:
 
 
 
Accounts payable
$
11,590

 
$
13,633

Accrued research and development
15,693

 
13,509

Income taxes payable, current
481

 
311

Build-to-suit lease obligation, current
1,100

 
733

Other current liabilities
6,691

 
9,185

Total current liabilities
35,555

 
37,371

Non-current liabilities:
 
 
 
Deferred revenue
110,242

 

Deferred rent
243

 
254

Build-to-suit lease obligation, non-current
51,102

 
51,515

Total non-current liabilities
161,587

 
51,769

Total liabilities
197,142

 
89,140

Commitments and contingencies (Note 7)

 

Shareholders’ equity:
 
 
 
Euro deferred shares, €22 nominal value:

 

Authorized shares — 10,000 at March 31, 2018 and December 31, 2017
 
 
 
Issued and outstanding shares — none at March 31, 2018 and December 31, 2017
 
 
 
Ordinary shares, $0.01 par value:
398

 
385

Authorized shares — 100,000,000 at March 31, 2018 and December 31, 2017
 
 
 
Issued and outstanding shares — 39,821,799 and 38,482,764 at March 31, 2018 and December 31, 2017, respectively
 
 
 
Additional paid-in capital
900,200

 
849,154

Accumulated deficit
(491,093
)
 
(442,350
)
Total shareholders’ equity
409,505

 
407,189

Total liabilities and shareholders’ equity
$
606,647

 
$
496,329

  See accompanying Notes to Condensed Consolidated Financial Statements.

1



Prothena Corporation plc and Subsidiaries
Condensed Consolidated Statements of Operations
(in thousands, except per share data)
  (unaudited)

 
 
Three Months Ended
March 31,
 
 
2018
 
2017
Collaboration revenue
 
$
227

 
$
259

Total revenue
 
227

 
259

Operating expenses:
 
 
 
 
Research and development
 
34,706

 
25,698

General and administrative
 
14,229

 
10,832

Total operating expenses
 
48,935

 
36,530

Loss from operations
 
(48,708
)
 
(36,271
)
Other income (expense):
 
 
 
 
Interest income (expense), net
 
200

 
(364
)
Other expense, net
 
(272
)
 
(410
)
Total other expense, net
 
(72
)
 
(774
)
Loss before income taxes
 
(48,780
)
 
(37,045
)
Benefit from income taxes
 
(37
)
 
(1,661
)
Net loss
 
$
(48,743
)
 
$
(35,384
)
Basic and diluted net loss per share
 
$
(1.26
)
 
$
(0.99
)
Shares used to compute basic and diluted net loss per share
 
38,684

 
35,758

See accompanying Notes to Condensed Consolidated Financial Statements.



2



Prothena Corporation plc and Subsidiaries
Condensed Consolidated Statements of Cash Flows
(in thousands)
(unaudited)
 
Three Months Ended March 31,
 
2018
 
2017
Operating activities
 
 
 
Net loss
$
(48,743
)
 
$
(35,384
)
Adjustments to reconcile net loss to cash used in operating activities:
 
 
 
Depreciation and amortization
797

 
759

Share-based compensation
6,902

 
5,602

Deferred income taxes
395

 
737

Interest expense under build-to-suit lease obligation
908

 
916

Gain from early lease retirement

 
(2,096
)
Changes in operating assets and liabilities:
 
 
 
Accounts receivable
(99,772
)
 
(93
)
Prepaid and other assets
422

 
(5,452
)
Deferred revenue
110,242

 

Accounts payable, accruals and other liabilities
(2,735
)
 
(2,831
)
Net cash used in operating activities
(31,584
)
 
(37,842
)
Investing activities
 
 
 
Purchases of property and equipment
(181
)
 
(2,499
)
Proceeds from disposal of fixed assets

 
100

Net cash used in investing activities
(181
)
 
(2,399
)
Financing activities
 
 
 
Proceeds from issuance of ordinary shares in public offering, net

 
150,421

Proceeds from subscription of ordinary shares
39,758

 

Proceeds from issuance of ordinary shares upon exercise of stock options
4,380

 
9,948

Reduction of build-to-suit lease obligation
(954
)
 
(501
)
Net cash provided by financing activities
43,184

 
159,868

Net increase in cash, cash equivalents and restricted cash
11,419

 
119,627

Cash, cash equivalents and restricted cash, beginning of the year
421,676

 
390,979

Cash, cash equivalents and restricted cash, end of the period
$
433,095

 
$
510,606

 
 
 
 
Supplemental disclosures of cash flow information
 
 
 
Cash paid for income taxes, net of refunds
$

 
$

 
 
 
 
Supplemental disclosures of non-cash investing and financing activities
 
 
 
Acquisition of property and equipment included in accounts payable and accrued liabilities
$
79

 
$
88

Receivable from option exercises
$
19

 
$
311

Offering costs included in accounts payable and accrued liabilities
$

 
$
107

  See accompanying Notes to Condensed Consolidated Financial Statements.

3



The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the statement of financial position that sum to the total of the same such amounts shown in the Condensed Consolidated Statements of Cash Flows.
 
Three Months Ended March 31,
 
2018
 
2017
Cash and cash equivalents
429,039

 
506,550

Restricted cash
4,056

 
4,056

Total Cash, cash equivalents and restricted cash, end of the period
433,095

 
510,606



4



Notes to the Condensed Consolidated Financial Statements
(unaudited)
 
1.
Organization
Description of Business
Prothena Corporation plc and its subsidiaries (“Prothena” or the “Company”) is a global clinical-stage biotechnology company focused on the discovery and development of novel therapies in the neuroscience and orphan disease categories. Fueled by its deep scientific understanding built over decades of research in protein misfolding, Prothena seeks to fundamentally change the course of progressive, life-threatening diseases associated with this biology.
The Company is advancing a pipeline of antibody therapeutic candidates for a number of potential indications and novel targets including Parkinson’s disease and other related synucleinopathies (PRX002/RG7935) and ATTR amyloidosis (PRX004) as well as tau and Aβ (Amyloid beta) for the potential treatment of Alzheimer’s disease and other neurodegenerative disorders and TDP-43 for the potential treatment of ALS (amyotrophic lateral sclerosis) and FTD (frontotemporal dementia).
The Company was formed on September 26, 2012 under the laws of Ireland and re-registered as an Irish public limited company on October 25, 2012. The Company's ordinary shares began trading on The Nasdaq Global Market under the symbol “PRTA” on December 21, 2012 and currently trade on The Nasdaq Global Select Market.
Liquidity and Business Risks
As of March 31, 2018 , the Company had an accumulated deficit of $491.1 million and cash and cash equivalents of $429.0 million .
Based on the Company's business plans, management believes that the Company's cash and cash equivalents at March 31, 2018 are sufficient to meet its obligations for at least the next twelve months. To operate beyond such period, or if the Company elects to increase its spending on development programs significantly above current long-term plans or enters into potential licenses and or other acquisitions of complementary technologies, products or companies, the Company may need additional capital. The Company expects to continue to finance future cash needs that exceed its cash from operating activities primarily through its current cash and cash equivalents, its collaborations with Roche and Celgene, and to the extent necessary, through proceeds from public or private equity or debt financings, loans and other collaborative agreements with corporate partners or other arrangements.
The Company is subject to a number of risks, including but not limited to: the uncertainty of the Company's research and development (“R&D”) efforts resulting in future successful commercial products; obtaining regulatory approval for its product candidates; its ability to successfully commercialize its product candidates, if approved; significant competition from larger organizations; reliance on the proprietary technology of others; dependence on key personnel; uncertain patent protection; dependence on corporate partners and collaborators; and possible restrictions on reimbursement from governmental agencies and healthcare organizations, as well as other changes in the healthcare industry.
2.
Summary of Significant Accounting Policies
Basis of Preparation and Presentation of Financial Information
These accompanying Unaudited Interim Condensed Consolidated Financial Statements have been prepared in accordance with the accounting principles generally accepted in the U.S. (“GAAP”) and with the instructions for Form 10-Q and Regulation S-X statements. Accordingly, they do not include all of the information and notes required for complete financial statements. These interim Condensed Consolidated Financial Statements should be read in conjunction with the Consolidated Financial Statements and Notes thereto contained in the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (the “SEC”) on February 26, 2018 (the “2017 Form 10-K”). These Unaudited Interim Condensed Consolidated Financial Statements are presented in U.S. dollars, which is the functional currency of the Company and its consolidated subsidiaries. These Unaudited Interim Condensed Consolidated Financial Statements include the accounts of the Company and its consolidated subsidiaries. All intercompany balances and transactions have been eliminated in consolidation.

5



Unaudited Interim Financial Information
The accompanying Unaudited Interim Condensed Consolidated Financial Statements and related disclosures are unaudited, have been prepared on the same basis as the annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for a fair presentation of the results of operations for the periods presented. The year-end condensed consolidated balance sheet data was derived from audited financial statements, however certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted. The condensed consolidated results of operations for any interim period are not necessarily indicative of the results to be expected for the full year or for any other future year or interim period.
Use of Estimates
The preparation of the Condensed Consolidated Financial Statements in conformity with GAAP requires management to make judgments, estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosures. On an ongoing basis, management evaluates its estimates, including critical accounting policies or estimates related to revenue recognition, share-based compensation and research and development expenses. The Company bases its estimates on historical experience and on various other market specific and other relevant assumptions that management believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Because of the uncertainties inherent in such estimates, actual results may differ materially from these estimates.
Significant Accounting Policies
There were no significant changes to the accounting policies during the three months ended March 31, 2018, from the significant accounting policies described in Note 2 of the "Notes to Consolidated Financial Statements" in the 2017 Form 10-K, with the exception of those noted below.

Recently Adopted Accounting Pronouncement

In May 2014, the FASB issued Accounting Standards Update No. 2014-09, Revenue from Contracts with Customers, which is largely codified in Accounting Standards Codification Topic 606 (ASC 606). ASC 606 supersedes the revenue recognition requirement in ASC 605, Revenue Recognition, and supersedes nearly all existing revenue recognition guidance under GAAP. To date, the Company has derived its revenue from a license and collaboration agreement and a service agreement. The consideration the Company is eligible to receive under these agreements includes upfront payments, research and development funding, milestone payments and royalties. The core principle of ASC 606 is to recognize revenue when promised goods or services are transferred to customers in an amount that reflects the consideration that is expected to be received for those goods and services. The Company adopted ASC 606 as of January 1, 2018 using the modified retrospective transition method. As of January 1, 2018, the Company did not record any changes to the opening balance of the accumulated deficit since the cumulative effect of applying the new revenue standard was the same as applying ASC 605. Prior period amounts are not adjusted and continue to be reported in accordance with the Company’s historical accounting under ASC 605. Upon adoption of the new revenue standard, the Company will provide additional revenue-related disclosures in its notes to the Consolidated Financial Statements commencing this three months ended March 31, 2018.

Revenue Recognition

Revenue is recognized only when the Company satisfies an identified performance obligation by transferring a promised good or service to a customer.

Contracts with Multiple Performance Obligations

The Company’s License Agreement with Roche contains multiple performance obligations. The Company accounts for the individual performance obligations separately if they are distinct. Factors considered in the determination of whether the license performance obligations are distinct included, among other things, the research and development capabilities of Roche and Roche’s sublicense rights, and for the remaining performance obligations the fact that they are not proprietary and can be and have been provided by other vendors. The transaction price is allocated to the separate performance obligation on a relative standalone selling price basis.
The Company does not disclose the value of unsatisfied performance obligations for (i) contracts with an original expected length of one year or less and (ii) contracts for which the Company recognize revenue at the amount to which we have the right to invoice for services performed.

6




Collaboration Revenue

Upon adoption of ASC 606, the Company recognizes research and development reimbursements as collaboration revenue earned over time as services are performed. Prior to adoption of ASC 606, the Company recorded research reimbursement as collaboration revenue and development reimbursement as an offset to R&D expense once the license revenue cap was met.

Milestone Revenue

The Company generally classifies each of its milestones into one of three categories: (i) clinical milestones; (ii) regulatory and development milestones; and (iii) commercial milestones. Clinical milestones are typically achieved when a product candidate advances into or completes a defined phase of clinical research. For example, a milestone payment may be due to the Company upon the initiation of a clinical trial for a new indication. Regulatory and development milestones are typically achieved upon acceptance of the submission for marketing approval of a product candidate or upon approval to market the product candidate by the FDA or other regulatory authorities. For example, a milestone payment may be due to the Company upon submission for marketing approval of a product candidate by the FDA. Commercial milestones are typically achieved when an approved product reaches certain defined levels of net royalty sales by the licensee of a specified amount within a specified period.

In general, the Company considers such milestone payments as variable consideration with constraint and therefore recognizes the revenue from such milestone payments as collaboration revenue at point in time when the Company can conclude it is probable that a significant revenue reversal will not occur in future periods.

Profit Share Revenue

For agreements, with profit sharing arrangements, the Company will record its share of the pre-tax commercial profit as collaboration revenue when the profit sharing can be reasonably estimated and that a significant revenue reversal will not occur in future periods.

Royalty Revenue

The Company will recognize revenue from royalties based on licensees' sales of the Company's products or products using the Company's technologies. Royalties are recognized as earned in accordance with the contract terms when royalties from licensees can be reasonably estimated and that a significant revenue reversal will not occur in future periods. There were no royalties earned during the three months ended March 31, 2018 and 2017 , respectively.

Taxes, Shipping and Handling

The Company excludes from the measurement of the transaction price all taxes assessed by a governmental authority that are both imposed on and concurrent with a specific revenue-producing transaction and collected by the Company from a customer (e.g., sales, use, value added, some excise taxes). In addition, we account for shipping and handling as activities that are performed after our customers obtain control of the goods as activities to fulfill our performance obligation to transfer the goods.

Incremental Costs to Obtain or Fulfill a Contract

For costs to obtain a contract, the Company will capitalize such amounts if they are incremental and expected to be recovered. Sales commissions directly related to obtaining new contracts will be capitalized unless the amortization period is one year or less, at which these costs will be recorded within selling and general administrative expenses. As of March 31, 2018, the Company does not have such costs capitalized in its unaudited condensed consolidated balance sheet.

Share-based Compensation
To determine the fair value of share-based payment awards, the Company uses the Black-Scholes option-pricing model. The determination of fair value using the Black-Scholes option-pricing model is affected by the Company’s share price as well as assumptions regarding a number of complex and subjective variables. Share-based compensation expense is recognized on a straight-line basis over the requisite service period for each award. Further, share-based compensation expense recognized in the Consolidated Statements of Operations is based on awards expected to vest and therefore the amount of expense has been reduced for estimated forfeitures. If actual forfeitures differ from estimates at the time of grant they will be revised in subsequent periods. The Company uses its historical volatility for the Company's stock to estimate expected volatility. Through December 31, 2017, the expected volatility was based on a combination of historical volatility for the Company's stock and the historical volatilities

7



of several of the Company's publicly traded comparable companies. If factors change and different assumptions are employed in determining the fair value of share-based awards, the share-based compensation expense recorded in future periods may differ significantly from what was recorded in the current period (see Note 10 for further information).
The Company records any excess tax benefits or tax shortfalls from its equity awards in its Consolidated Statements of Operations in the reporting periods in which stock options are exercised.
Segment and Concentration of Risks
The Company operates in one segment. The Company’s chief operating decision maker (the “CODM”), its Chief Executive Officer, manages the Company’s operations on a consolidated basis for purposes of allocating resources. When evaluating the Company’s financial performance, the CODM reviews all financial information on a consolidated basis.
Financial instruments that potentially subject the Company to concentration of credit risk consist of cash and cash equivalents and accounts receivable. The Company places its cash equivalents with high credit quality financial institutions and by policy, limits the amount of credit exposure with any one financial institution. Deposits held with banks may exceed the amount of insurance provided on such deposits. The Company has not experienced any losses on its deposits of cash and cash equivalents and its credit risk exposure is up to the extent recorded on the Company's Consolidated Balance Sheet.
The receivable from Celgene Switzerland LLC (“Celgene”) as of March 31, 2018 relates to the upfront payment under the Master Collaboration Agreement that became effective March 20, 2018 . Celgene is wholly owned by Celgene Switzerland SA, a tax resident of Switzerland. The receivable from Roche as of March 31, 2018 and December 31, 2017 are amounts due from Roche entities located in the U.S. and Switzerland under the License Agreement that became effective January 22, 2014. Revenue recorded in the Statements of Operations consists of reimbursement from Roche for research and development services. The Company's credit risk exposure is up to the extent recorded on the Company's Condensed Consolidated Balance Sheet.
As of March 31, 2018 , $53.7 million of the Company's long-lived assets were held in the U.S. and $0.6 million were in Ireland. As of December 31, 2017 , $54.4 million of the Company's long-lived assets were held in the U.S. and $0.6 million were in Ireland.
The Company does not own or operate facilities for the manufacture, packaging, labeling, storage, testing or distribution of nonclinical or clinical supplies of any of its drug candidates, including for commercial supplies if the Company obtains regulatory approval to market any of its drug candidates. The Company instead contracts with and relies on third-parties to manufacture, package, label, store, test and distribute all pre-clinical development and clinical supplies of our drug candidates, and it plans to continue to do so for the foreseeable future, including for commercial supplies if the Company obtains regulatory approval to market any of its drug candidates. The Company also relies on third-party consultants to assist in managing these third-parties and assist with its manufacturing strategy.
Recent Accounting Pronouncements
In February 2016, the FASB issued Accounting Standards Update 2016-02 Topic 842, Leases (ASC 842), which will require lessees to recognize assets and liabilities for leases with lease terms of more than 12 months. Consistent with current GAAP, the recognition, measurement, and presentation of expenses and cash flows arising from a lease by a lessee primarily will depend on its classification as a finance or operating lease. However, unlike current GAAP, which requires only capital leases to be recognized on the balance sheet, the new guidance will require both types of leases to be recognized on the balance sheet. ASC 842 is effective for annual periods beginning after December 15, 2018, and interim periods within those years. Early adoption is permitted for all entities. The standard requires that entities use a modified retrospective approach for leases that exist or are entered into after the beginning of the earliest comparative period in the financial statements. Entities have the option to use certain relief. Full retrospective application is prohibited. Note 7, “Commitments and Contingencies” provides details on the Company's current lease arrangements. The Company continues to evaluate the provisions of ASC 842 to determine the impact the adoption will have on its consolidated financial statements; however, the Company anticipates recognition of additional assets and corresponding liabilities related to leases on its consolidated balance sheets. Additionally, the Company expects to derecognize its build-to-suit asset and liabilities upon adoption pending its final evaluation.

In December 2017, the SEC staff issued Staff Accounting Bulletin (SAB) 118, Income Tax Accounting Implications of the Tax Cuts and Jobs Act (the “TCJA”), to provide guidance for companies that are not able to complete their accounting for the income tax effects of the Act in the period of enactment. In doing so, the SEC staff acknowledged the challenges companies may face in accounting for the effects of the Act by their financial reporting deadlines and said the guidance is intended to help companies provide investors with timely, decision-useful information. The TCJA is effective in the first quarter of 2018 and, among other things, lowers the Company’s U.S. federal income tax rate from 34% to 21% . Accordingly, the Company has recorded a provisional tax benefit of $0.4 million as of December 31, 2017 related to the remeasurement of its U.S. deferred tax assets to reflect the lower

8



statutory tax rate. As of March 31, 2018 , no adjustments have been made to the provisional net tax benefit reported as of the year ended December 31, 2017. As of March 31, 2018 , the Company has not completed its accounting for the tax effects of the TCJA, and recorded a provisional net tax benefit based on the Company's best estimates. The provisional amounts incorporate assumptions made based upon the Company's current interpretation of the TCJA and are subject to revision as the Company receives and interprets any additional clarification and implementation guidance issued by the U.S. Treasury Department, Internal Revenue Service (the “IRS”), and other standard-setting bodies. Any adjustments to the provisional amounts recorded will be included as an adjustment to the provision for income taxes. Adjustments may materially impact the Company's provision for income taxes and effective tax rate in the period in which the adjustments are made. The Company anticipates its accounting for the tax effects of the TCJA will be completed in 2018.
3.
Fair Value Measurements
The Company measures certain financial assets and liabilities at fair value on a recurring basis, including cash equivalents. Fair value is an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability. A three-tier fair value hierarchy is established as a basis for considering such assumptions and for inputs used in the valuation methodologies in measuring fair value:
Level 1 —    Observable inputs such as quoted prices (unadjusted) for identical assets or liabilities in active markets.
Level 2 —
Include other inputs that are based upon quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active, and model-based valuation techniques for which all significant inputs are observable in the market or can be derived from observable market data. Where applicable, these models project future cash flows and discount the future amounts to a present value using market-based observable inputs including interest rate curves, foreign exchange rates, and credit ratings.
Level 3 —
Unobservable inputs that are supported by little or no market activities, which would require the Company to develop its own assumptions.
The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. The carrying amounts of certain financial instruments, such as cash equivalents, accounts receivable, accounts payable and accrued liabilities, approximate fair value due to their relatively short maturities, and low market interest rates, if applicable.
Based on the fair value hierarchy, the Company classifies its cash equivalents within Level 1. This is because the Company values its cash equivalents using quoted market prices. The Company’s Level 1 securities consisted of $336.9 million and $319.7 million in money market funds included in cash and cash equivalents at March 31, 2018 and December 31, 2017 , respectively.
4.
Composition of Certain Balance Sheet Items
Property and Equipment, net
Property and equipment, net consisted of the following (in thousands):
 
March 31, 2018
 
December 31, 2017
Machinery and equipment
$
9,084

 
$
9,078

Leasehold improvements
579

 
579

Purchased computer software
1,395

 
1,316

Build-to-suit property
51,760

 
51,760

 
62,818

 
62,733

Less: accumulated depreciation and amortization
(8,540
)
 
(7,743
)
Property and equipment, net
$
54,278

 
$
54,990

Depreciation expense was $0.8 million and $0.8 million for the three months ended March 31, 2018 and 2017 , respectively.

9



Other Current Liabilities
Other current liabilities consisted of the following (in thousands):
 
March 31, 2018
 
December 31, 2017
Payroll and related expenses
$
4,475

 
$
7,342

Professional services
654

 
438

Deferred rent
49

 
49

Other
1,513

 
1,356

Other current liabilities
$
6,691

 
$
9,185

5.
Net Loss Per Ordinary Share
Basic net income (loss) per ordinary share is calculated by dividing net income (loss) by the weighted-average number of ordinary shares outstanding during the period. Shares used in diluted net income per ordinary share would include the dilutive effect of ordinary shares potentially issuable upon the exercise of stock options outstanding. However, potentially issuable ordinary shares are not used in computing diluted net loss per ordinary share as their effect would be anti-dilutive due to the loss recorded during the three months ended March 31, 2018 and 2017 , and therefore diluted net loss per share is equal to basic net loss per share.
Net loss per ordinary share was determined as follows (in thousands, except per share amounts):
 
 
Three Months Ended March 31,
 
 
2018
 
2017
Numerator:
 
 
 
 
Net loss
 
$
(48,743
)
 
$
(35,384
)
Denominator:
 
 
 
 
Weighted-average ordinary shares outstanding
 
38,684

 
35,758

Net loss per share:
 
 
 
 
Basic and diluted net loss per share
 
$
(1.26
)
 
$
(0.99
)
The equivalent ordinary shares not included in diluted net loss per share because their effect would be anti-dilutive are as follows (in thousands):
 
Three Months Ended March 31,
 
2018
 
2017
Stock options to purchase ordinary shares
5,227

 
4,395

6. Build-to-Suit Lease

In March 2016 , the Company entered into a noncancelable operating sublease (the “Lease”) to lease 128,751 square feet of office and laboratory space in South San Francisco, California (the “Current SSF Facility”). Subsequently, in April 2016, the Company took possession of the Current SSF Facility. The Lease includes a free rent period and escalating rent payments and has a term that expires on December 31, 2023 , unless terminated earlier. The Company's obligation to pay rent commenced on August 1, 2016. The Company is obligated to make lease payments totaling approximately $39.2 million over the lease term. The Lease further provides that the Company is obligated to pay to the sublandlord and master landlord certain costs, including taxes and operating expenses. Expected future lease payments under the build-to-suit lease as of March 31, 2018 are included in Note 7, “Commitments and Contingencies.”

In connection with this Lease, the Company received a tenant improvement allowance of $14.2 million from the sublandlord and the master landlord, for the costs associated with the design, development and construction of tenant improvements for the Current SSF Facility. The Company is obligated to fund all costs incurred in excess of the tenant improvement allowance. The scope of the tenant improvements did not qualify as “normal tenant improvements” under the lease accounting guidance. Accordingly, for accounting purposes, the Company is the deemed owner of the building during the construction period and the Company capitalized $36.5 million within property and equipment, net, including $1.2 million for capitalized interest and

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recognized a corresponding build-to-suit obligation in other non-current liabilities in the Condensed Consolidated Balance Sheets as of March 31, 2018 . The Company has also recognized structural and non-structural tenant improvements totaling $15.3 million as of March 31, 2018 as an addition to the build-to-suit lease property for amounts incurred by the Company during the construction period, of which $14.2 million were reimbursed by the landlord during the year ended December 31, 2016 through the tenant improvement allowance. The Company increased its financing obligation for the additional building costs reimbursements received from the landlord during the construction period. In addition, for the three months ended March 31, 2018 and 2017 , the Company recorded rent expense associated with the ground lease of $0.1 million and $0.1 million , respectively, in its Condensed Consolidated Statements of Operations. Total interest, which represents the cost of financing obligation under the Lease agreement, was $0.9 million and $0.9 million for the three months ended March 31, 2018 and 2017 , respectively, which was recognized within the Condensed Consolidated Statement of Operations.

During the fourth quarter of 2016, construction on the build-to-suit lease property was substantially completed and the build-to-suit lease property was placed in service. As such, the Company evaluated the Lease to determine whether it had met the requirements for sale-leaseback accounting, including evaluating whether all risks of ownership have been transferred back to the landlord, as evidenced by a lack of continuing involvement in the build-to-suit lease property. The Company determined that the construction project did not qualify for sale-leaseback accounting and will instead be accounted for as a financing lease, given the Company’s expected continuing involvement after the conclusion of the construction period. The build-to-suit lease property remains on the Company’s Consolidated Balance Sheets as of March 31, 2018 at its historical cost of $51.8 million and is being depreciated over its estimated useful life. As of March 31, 2018 , the total amount of the build-to-suit lease obligation was $52.2 million , of which $1.1 million and $51.1 million were classified as current and non-current liability, respectively, on the Company's Condensed Consolidated Balance Sheets. The Company expects to derecognize the build-to-suit lease property and financing lease obligation at the end of the lease term.

The Company obtained a standby letter of credit in April 2016 in the initial amount of $4.1 million , which may be drawn down by the sublandlord in the event the Company fails to fully and faithfully perform all of its obligations under the Lease and to compensate the sublandlord for all losses and damages the sublandlord may suffer as a result of the occurrence of any default on the part of Company not cured within the applicable cure period. This standby letter of credit is collateralized by a certificate of deposit of the same amount which is classified as restricted cash. As of March 31, 2018 , none of the standby letter of credit amount has been used.

7. Commitments and Contingencies
Lease Commitments
The Company recognizes rent expense for its operating leases on a straight-line basis over the noncancelable lease term and records the difference between cash rent payments and the recognition of rent expense as a deferred rent liability. Where leases contain escalation clauses, rent abatements and/or concessions, such as rent holidays and landlord or tenant incentives or allowances, the Company applies them in the determination of straight-line rent expense over the lease term. The Company records the tenant improvement allowance for operating leases as deferred rent and associated expenditures as leasehold improvements that are being amortized over the shorter of their estimated useful life or the term of the lease. Rent expense was $0.2 million and $0.3 million for the three months ended March 31, 2018 and 2017 , respectively.

Dublin
In August 2015 , the Company entered into an agreement to lease 6,258 square feet of office space in Dún Laoghaire, Ireland. This lease has a term of 10 years from commencement and provides for an option to terminate the lease at the end of the fifth year of the term. It is also subject to a rent review every five years. As a result of this noncancelable operating lease, the Company is obligated to make lease payments totaling approximately €2.0 million , or $2.5 million as converted using an exchange rate as of March 31, 2018 , over the term of the lease, assuming current lease payments. Of this obligation, approximately $1.9 million remains outstanding as of March 31, 2018 .
Switzerland
In 2017, the Company entered into noncancelable operating subleases to lease office space in Zug, Switzerland. The lease terms expire in June 2018 and August 2018. As of March 31, 2018 , the Company is obligated to make lease payments of approximately CHF 56,000 , or $59,000 as converted using an exchange rate as of March 31, 2018 .

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Future minimum payments under the above-described noncancelable operating leases as of March 31, 2018 are as follows (in thousands):
Year Ended December 31,
 
Operating Lease
2018 (9 months)
 
$
251

2019
 
255

2020
 
255

2021
 
255

2022
 
255

Thereafter
 
680

Total
 
$
1,951


Current SSF Facility

In March 2016 , the Company entered into a noncancelable operating sublease of the Current SSF Facility which expires in December 31, 2023 . The Company is considered the “accounting owner” of the Current SSF Facility as a build-to-suit property and has recorded a build-to-suit lease obligation on its consolidated balance sheet. Additional information regarding the build-to-suit lease is included in Note 6, “Build-To-Suit Lease.” Future minimum payments under build-to-suit lease obligation as of March 31, 2018 are as follows (in thousands):
Year Ended December 31,
 
Expected Cash Payments Under Build-To-Suit Lease Obligation
2018 (9 months)
 
$
3,832

2019
 
5,803

2020
 
5,979

2021
 
6,165

2022
 
6,350

Thereafter
 
6,535

Total
 
$
34,664

Indemnity Obligations
The Company has entered into indemnification agreements with its current and former directors and officers and certain key employees. These agreements contain provisions that may require the Company, among other things, to indemnify such persons against certain liabilities that may arise because of their status or service and advance their expenses incurred as a result of any indemnifiable proceedings brought against them. The obligations of the Company pursuant to the indemnification agreements continue during such time as the indemnified person serves the Company and continues thereafter until such time as a claim can be brought. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is unlimited; however, the Company has a director and officer liability insurance policy that limits its exposure and enables the Company to recover a portion of any future amounts paid. As a result of its insurance policy coverage, the Company believes the estimated fair value of these indemnification agreements is minimal. Accordingly, the Company had no liabilities recorded for these agreements as of March 31, 2018 and 2017 .
Other Commitments
In April 2017, the Company contracted with Boehringer Ingelheim Biopharmaceuticals GmbH to develop the capability to manufacture and supply drug substance of NEOD0001, and to so supply NEOD001 to use for worldwide commercial sale purposes if the Company applies for and obtains regulatory approval to market NEOD001.  No drug substance has been manufactured under this contract.  However, the commitments table below includes the Company’s purchase obligations under this contract.
In the normal course of business, the Company enters into various firm purchase commitments primarily related to research and development activities. As of March 31, 2018 , the Company had non-cancelable purchase commitments to suppliers for $43.4 million of which $7.5 million is included in accrued current liabilities, and contractual obligations under license agreements of $1.7 million of which $0.4 million is included in accrued current liabilities. The following is a summary of the Company's non-cancelable purchase commitments and contractual obligations as of March 31, 2018 (in thousands):

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Total
 
2018
 
2019
 
2020
 
2021
 
2022
 
Thereafter
Purchase Obligations
 
$
43,405

 
$
17,616

 
$
25,789

 
$

 
$

 
$

 
$

Contractual obligations under license agreements (1)
 
1,725

 
435

 
230

 
100

 
100

 
85

 
775

Total
 
$
45,130

 
$
18,051

 
$
26,019

 
$
100

 
$
100

 
$
85

 
$
775

                            
(1) Excludes future obligations pursuant to the cost-sharing arrangement under the Company's License Agreement with Roche. Amounts of such obligations, if any, cannot be determined at this time.
8. Significant Agreements
Roche License Agreement
In December 2013 , the Company through its wholly owned subsidiary Prothena Biosciences Limited and Prothena Biosciences Inc entered into a License, Development, and Commercialization Agreement (the “License Agreement”) F. Hoffmann-La Roche Ltd. and Hoffmann-La Roche Inc. (together, “Roche”) to develop and commercialize certain antibodies that target α - synuclein, including PRX002/RG7935, which are referred to collectively as “Licensed Products.” Upon the effectiveness of the License Agreement in January 2014, the Company granted to Roche an exclusive, worldwide license to develop, make, have made, use, sell, offer to sell, import and export the Licensed Products. The Company retained certain rights to conduct development of the Licensed Products and an option to co-promote PRX002/RG7935 in the U.S. During the term of the License Agreement, the Company and Roche will work exclusively with each other to research and develop antibody products targeting alpha-synuclein (or α - synuclein) potentially including incorporation of Roche’s proprietary Brain Shuttle™ technology to potentially increase delivery of therapeutic antibodies to the brain. The License Agreement provided for Roche making an upfront payment to the Company of $30.0 million , which was received in February 2014; making a clinical milestone payment of $15.0 million upon initiation of the Phase 1 study for PRX002/RG7935, which was received in May 2014; and making a clinical milestone payment of $30.0 million upon dosing of the first patient in the Phase 2 study for PRX002/RG7935, which was achieved in June 2017.
For PRX002/RG7935, Roche is also obligated to pay:
up to $380.0 million upon the achievement of development, regulatory and various first commercial sales milestones;
up to an additional $175.0 million upon achievement of ex-U.S. commercial sales milestones; and
tiered, high single-digit to high double-digit royalties in the teens on ex-U.S. annual net sales, subject to certain adjustments.
Roche bears 100% of the cost of conducting the research activities under the License Agreement. In the U.S., the parties share all development and commercialization costs, as well as profits, all of which will be allocated 70% to Roche and 30% to the Company, for PRX002/RG7935 in the Parkinson’s disease indication, as well as any other Licensed Products and/or indications for which the Company opts in to participate in co-development and co-funding. After the completion of specific clinical trial activities, the Company may opt out of the co-development and cost and profit sharing on any co-developed Licensed Products and instead receive U.S. commercial sales milestones totaling up to $155.0 million and tiered, single-digit to high double-digit royalties in the teens based on U.S. annual net sales, subject to certain adjustments, with respect to the applicable Licensed Product.
The Company filed an Investigational New Drug Application (“IND”) with the FDA for PRX002/RG7935 and subsequently initiated a Phase 1 study in 2014. Following the Phase 1 study, Roche became primarily responsible for developing, obtaining and maintaining regulatory approval for and commercializing Licensed Products. Roche also became responsible for the clinical and commercial manufacture and supply of Licensed Products.
In addition, the Company has an option under the License Agreement to co-promote PRX002/RG7935 in the U.S. in the Parkinson’s disease indication. If the Company exercises such option, it may also elect to co-promote additional Licensed Products in the U.S. approved for Parkinson’s disease. Outside the U.S., Roche will have responsibility for developing and commercializing the Licensed Products. Roche bears all costs that are specifically related to obtaining or maintaining regulatory approval outside the U.S. and will pay the Company a variable royalty based on annual net sales of the Licensed Products outside the U.S.
While Roche will record product revenue from sales of the Licensed Products, the Company and Roche will share in the net profits and losses of sales of the PRX002/RG7935 for the Parkinson's disease indication in the U.S. on a 70% / 30% basis with the Company receiving 30% of the profit and losses provided that the Company has not exercised its opt-out right.

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The License Agreement continues on a country-by-country basis until the expiration of all payment obligations under the License Agreement. The License Agreement may also be terminated (i) by Roche at will after the first anniversary of the effective date of the License Agreement, either in its entirety or on a Licensed Product-by-Licensed Product basis, upon 90 days’ prior written notice to the Company prior to first commercial sale and 180 days’ prior written notice to Prothena after first commercial sale, (ii) by either party, either in its entirety or on a Licensed Product-by-Licensed Product or region-by-region basis, upon written notice in connection with a material breach uncured 90 days after initial written notice, and (iii) by either party, in its entirety, upon insolvency of the other party. The License Agreement may be terminated by either party on a patent-by-patent and country-by-country basis if the other party challenges a given patent in a given country. The Company’s rights to co-develop Licensed Products under the License Agreement will terminate if the Company commences certain studies for certain types of competitive products. The Company’s rights to co-promote Licensed Products under the License Agreement will terminate if the Company commences a Phase 3 study for such competitive products.
The License Agreement cannot be assigned by either party without the prior written consent of the other party, except to an affiliate of such party or in the event of a merger or acquisition of such party, subject to certain conditions. The License Agreement also includes customary provisions regarding, among other things, confidentiality, intellectual property ownership, patent prosecution, enforcement and defense, representations and warranties, indemnification, insurance, and arbitration and dispute resolution.
Collaboration Accounting
The License Agreement was evaluated under ASC 808, Collaborative Agreements. At the outset of the License Agreement, the Company concluded that it did not qualify as collaboration under ASC 808 because the Company does not share significant risks due to the net profit and loss split (under which Roche incurs substantially more of the costs of the collaboration) and because of the Company’s opt-out provision. The Company believes that Roche will be the principal in future sales transactions with third parties as Roche will be the primary obligor bearing inventory and credit risk. The Company will record its share of pre-tax commercial profit generated from the collaboration as collaboration revenue once the Company can conclude it is probable that a significant revenue reversal will not occur in future periods. Prior to commercialization of a Licensed Product, the Company’s portion of the expenses related to the License Agreement reflected on its income statement will be limited to R&D expenses. After commercialization, if the Company opts-in to co-detail commercialization, expenses related to commercial capabilities, including expenses related to the establishment of a field sales force and other activities to support the Company’s commercialization efforts, will be recorded as sales, general and administrative (“SG&A”) expense and will be factored into the computation of the profit and loss share. The Company will record the receivable related to commercialization activities as collaboration revenue once the Company can conclude it is probable that a significant revenue reversal will not occur in future periods.
Adoption of ASC 606, Revenue from Contracts with Customers

The Company adopted ASC 606, Revenue from Contracts with Customers, as of January 1, 2018 using the modified retrospective transition method. The Company recognized the cumulative effect of applying the new revenue standard as an adjustment to the opening balance of the accumulated deficit as of January 1, 2018. Prior period amounts are not adjusted and continue to be reported in accordance with the Company’s historical accounting under ASC 605, Revenue Recognition.

As of January 1, 2018, the Company did not record any changes to the opening balance of the accumulated deficit since the cumulative effect of applying the new revenue standard was the same as applying ASC 605. The impact of the adoption of ASC 606 to revenues for the three months ended March 31, 2018 was an increase of $0.2 million , which represents the revenue recognized for the development services provided by the Company during the quarter that is reimbursable by Roche. Historically, the Company recorded such reimbursement as an offset against its R&D expenses under ASC 605. Upon the adoption of ASC 606, the reimbursement for development services is now included as part of the Company’s collaboration revenue.

Performance Obligations
The License Agreement was evaluated under ASC 606. The License Agreement includes the following distinct performance obligations: (1) the Company's grant of an exclusive royalty bearing license, with the right to sublicense to develop and commercialize certain antibodies that target á - synuclein, including PRX002/RG7935, and the initial know how transfer which was delivered at the effective date (the “Royalty Bearing License”); (2) the Company’s obligation to supply clinical material as requested by Roche for a period up to twelve months (the “Clinical Product Supply Obligation”); (3) the Company’s obligation to provide manufacturing related services to Roche for a period up to twelve months (the “Supply Services Obligation”); (4) the Company’s obligation to prepare and file the IND (the “IND Obligation”); and (5) the Company’s obligation to provide development activities under the development plan during Phase 1 clinical trials (the “Development Services Obligation”). Revenue allocated

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to the above performance obligations under the License Agreement are recognized when the Company has satisfied its obligations either at a point in time or over a period of time.
The Company concluded that the Royalty Bearing License and the Clinical Product Supply Obligation were satisfied at a point in time. The Royalty Bearing License is considered to be a functional intellectual property, in which the revenue would be recognized at the point in time since (a) the Company concluded that the license to Roche has a significant stand-alone functionality, (b) the Company does not expect the functionality of the intellectual property to be substantially changed during the license period as a result of activities of Prothena, and (c) Prothena’s activities transfer a good or service to Roche. The Clinical Product Supply Obligation does not meet criteria for over time recognition; as such, the revenue related to such performance obligation was recognized the point in time at which Roche obtained control of manufactured supplies, which occurred during the first quarter of 2014.
The Company concluded that the Supply Services Obligation, the IND Obligation and the Development Services Obligation were satisfied over time. The Company utilized an input method measure of progress by basing the recognition period on the efforts or inputs towards satisfying the performance obligation (i.e. costs incurred and the time elapsed to complete the related performance obligations). The Company determined that such input method provides an appropriate measure of progress toward compete satisfaction of such performance obligations.

As of March 31, 2018 and December 31, 2017, there were no remaining performance obligations under License Agreement since the obligations related to research and development activities were only for the Phase 1 clinical trial and the remaining obligations were delivered or performed.
Transaction Price

According to ASC 606-10-32-2, the transaction price is the amount of consideration to which an entity expects to be entitled in exchange for transferring promised goods or services to a customer, excluding amounts collected on behalf of third parties (for example, some sales taxes). The consideration promised in a contract with a customer may include fixed amounts, variable amounts, or both. Factors considered in the determination of the transaction price include, among other things, estimated selling price of the license and costs for clinical supply and development costs.

The initial transaction price under the License Agreement, pursuant to ASC 606, was $55.1 million , including $45.0 million for the Royalty Bearing License, $9.1 million for the IND and Development Services Obligations, and $1.1 million for the Supply Services Obligation. The $45.0 million for the Royalty Bearing License included the upfront payment of $30.0 million and the clinical milestone payment of $15.0 million upon initiation of the Phase 1 clinical trial of PRX002/RG7935, both of which were made in 2014. The remaining transaction price amounts the Company expected to receive as reimbursements were based on costs expected to be paid to third parties and other costs to be incurred by the Company in order to satisfy its performance obligations. They are considered to be variable considerations not subject to constraint. The Company did not incur any incremental costs, such as commissions, to obtain or fulfill the License Agreement.
Under ASC 606, the transaction price was allocated to the performance obligations as follows: $48.9 million to the Royalty Bearing License; $4.6 million to the IND and Development Services Obligations; $1.1 million to the Clinical Product Supply Obligation; and $0.6 million to the Supply Services Obligation. As of March 31, 2018, the aggregate amount of the transaction price allocated to the performance obligations that are unsatisfied is $nil . Prior to the adoption of ASC 606, the transaction price was allocated to the deliverables as follows: $35.6 million to the Royalty Bearing License; $3.3 million to the IND and Development Services Obligations; $0.8 million to the Clinical Product Supply Obligation; and $0.4 million to the Supply Services Obligation.
The Company allocated the initial transaction price to the Royalty Bearing License and other performance obligations using the relative selling price method based on its best estimate of selling price for the Royalty Bearing License and third party evidence for the remaining performance obligations. The best estimate of selling price for the Royalty Bearing License was based on a discounted cash flow model. The key assumptions used in the discounted cash flow model used to determine the best estimate of selling price for the Royalty Bearing License included the market opportunity for commercialization of PRX002/RG7935 in the U.S. and the royalty territory (for licensed products that are jointly funded the royalty territory is worldwide except for the U.S., and for all licensed products that are not jointly funded the Royalty Territory is worldwide), the probability of successfully developing and commercializing PRX002/RG7935, the estimated remaining development costs for PRX002/RG7935, and the estimated time to commercialization of PRX002/RG7935. The Company concluded that a change in the assumptions used to determine the best estimate of selling price (“BESP”) of the license deliverable would not have a significant effect on the allocation of arrangement consideration.

15



The Company’s discounted cash flow model included several market conditions and entity-specific inputs, including the likelihood that clinical trials for PRX002/RG7935 will be successful, the likelihood that regulatory approval will be obtained and the product commercialized, the appropriate discount rate, the market locations, size and potential market share of the product, the expected life of the product, and the competitive environment for the product. The market assumptions were generated using a patient-based forecasting approach, with key epidemiological, market penetration, dosing, compliance, length of treatment and pricing assumptions derived from primary and secondary market research, referenced from third-party sources.

Significant Payment Terms

Payments for development services are due within 45 days after receiving an invoice from the Company. Variable considerations related to clinical and regulatory milestone payments are constrained due to high likelihood of a revenue reversal. The payment term for all milestone payments are due within 45 days after the achievement of the relevant milestone and receipt by Roche of an invoice for such an amount from the Company.
According to ASC 606-10-32-17, a significant financing component does not exist if a substantial amount of the consideration promised by the customer is variable, and the amount or timing of that consideration varies on the basis of the occurrence or nonoccurrence of a future event that is not substantially within the control of the customer or the entity. Since a “substantial amount of the consideration” promised by Roche to the Company is variable (i.e., is in the form of either milestone payments or sales-based royalties) and the amount of such variable consideration varies based upon the occurrence or nonoccurrence of future events that are not within the control of either Roche or the Company (i.e., are largely subject to regulatory approval), the License Agreement does not have a significant financing component.

Optional Goods and Services
An option for additional goods or services exists when a customer has a present contractual right that allows it to choose the amount of additional distinct goods or services that are purchased. Prior to the customer’s exercise of that right, the vendor is not presently obligated to provide those goods or services. ASC 606-10-25-18(j) requires recognition of an option as a distinct performance obligation when the option provides a customer with a material right.
In addition to the distinct performance obligations noted above, the Company was obligated to provide indeterminate research services for up to three years ending in 2017 at rates that were not significantly discounted and fully reimbursable by Roche (the “Research Services”). The amount for any such Research Services was not fixed and determinable and was not at a significant incremental discount. There were no refund rights, concessions or performance bonuses to consider.
The Company evaluated the obligation to perform Research Services under ASC 606-10-55-42 and 55-43 to determine whether it gave Roche a “material right”. According to ASC 606-10-55-43, if a customer has the option to acquire an additional good or services at a price that would reflect the standalone selling price for that good or service, that option does not provide the customer with a material right even if the option can be exercised only by entering into a previous contract.
The Company concluded that Roche’s option to have the Company perform Research Services did not represent a “material right” to Roche that it would not have received without entering into the License Agreement. As a result, Roche’s option to acquire additional Research Services was not considered a performance obligation at the outset of the License Agreement under ASC 606. Accordingly, this deliverable will become new performance obligation for Prothena when Roche asks Prothena to conduct such Research Services. As of March 31, 2018, there were no remaining Research Services performance obligations. Prior to the adoption of ASC 606, the Company recognized Research Services as collaboration revenue as earned.
Post Contract Deliverables
Any development services provided by the Company after performance of the Development Service Obligation are not considered a contractual performance obligation under the License Agreement, since the License Agreement does not require the Company to provide any development services after completion of the Development Service Obligation. However, the collaboration’s Joint Steering Committee approved continued funding for additional development services to be provided by the Company (the “Additional Development Services”). Under the License Agreement and upon the adoption of ASC 606, the Company recognizes the reimbursements for Additional Development Services as collaboration revenue as earned.

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Revenue and Expense Recognition

The Company recognized 0.2 million as collaboration revenue for the three months ended March 31, 2018 , including $nil for Research Services and $0.2 million for Additional Development Services, as compared to $0.3 million of Research Services as collaboration revenue for the three months ended March 31, 2017 . The Company recorded $0.8 million of reimbursement for Additional Development Services from Roche for the three months ended March 31, 2017 as an offset to R&D expenses. Cost sharing payments to Roche are recorded as R&D expenses. The Company recognized $2.4 million in R&D expenses for payments made to Roche during the three months ended March 31, 2018 , as compared to $1.3 million for the three months ended March 31, 2017 .
Milestone Accounting

Under the License Agreement, only if the U.S. and or global options are exercised, the Company is eligible to receive milestone payments upon the achievement of development, regulatory and various first commercial sales milestones. Milestone payments are evaluated under ASC Topic 606. Factors considered in this determination included scientific and regulatory risk that must be overcome to achieve each milestone, the level of effort and investment required to achieve the milestone, and the monetary value attributed to the milestone. Accordingly, the Company estimates payments in the transaction price based on the most likely approach, which considers the single most likely amount in a range of possible amounts related to the achievement of these milestones. Additionally, milestone payments are included in the transaction price only when the Company can conclude it is probable that a significant revenue reversal will not occur in future periods when the milestone is achieved.
The Company excludes the milestone payments and royalties in the initial transaction price calculation because such payments are considered to be variable considerations with constraint. Such milestone payments and royalties will be recognized as revenue once the Company can conclude it is probable that a significant revenue reversal will not occur in future periods.
The clinical and regulatory milestones under the License Agreement after the point at which the Company could opt-out are considered to be variable considerations with constraint due to the fact that active participation in the development activities that generate the milestones is not required under the License Agreement, and the Company can opt-out of these activities. There are no refunds or claw-back provisions and the milestones are uncertain of occurrence even after the Company has opted out. Based on this determination, these milestones will be recognized when the Company can conclude it is probable that a significant revenue reversal will not occur in future periods.
The Company did not achieve any clinical and regulatory milestones under the License Agreement during the three months ended March 31, 2018 and 2017 .
Celgene Collaboration Agreement
Overview

On March 20, 2018 , the Company, through its wholly owned subsidiary, Prothena Biosciences Limited, entered into a Master Collaboration Agreement (the “Collaboration Agreement”) with Celgene Switzerland LLC (“Celgene”), a subsidiary of Celgene Corporation, pursuant to which Prothena granted to Celgene a right to elect in its sole discretion to exclusively license rights both in the U.S. (the “US Rights”) and on a global basis (the “Global Rights”), with respect to the Company’s programs to develop and commercialize antibodies targeting Tau, TDP-43 and an undisclosed target (the “Collaboration Targets”). For each such program, Celgene has an exclusive right to license clinical candidates in the U.S. at the IND filing and if exercised, would also have a right to expand the license to global rights at the completion of Phase 1. Following the exercise for global rights, Celgene would have decision making authority over all further global clinical development and commercialization. The Company is responsible for all research and development activity through completion of Phase 1 clinical studies of products in each such program, unless Celgene elects otherwise at its cost.
Under the terms of the Collaboration Agreement, Celgene is obligated to pay Prothena an upfront payment of $100.0 million , plus future potential license exercise payments and regulatory and commercial milestones for each program under the Collaboration Agreement, as well as royalties on net sales of any resulting marketed products. In connection with the Collaboration Agreement, the Company and Celgene entered into a Share Subscription Agreement on March 20, 2018 , under which Celgene subscribed to 1,174,536 of the Company’s ordinary shares for a price of $42.57 per share, for a total of approximately $50.0 million .

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Celgene U.S. and Global Rights and Licenses

On a program-by-program basis, following the Company’s filing of an IND application for any of the Company’s three collaboration programs to Celgene, Celgene may elect in its sole discretion to exercise its US Rights to receive an exclusive license to develop and commercialize antibodies targeting the applicable Collaboration Target in the U.S. If Celgene exercises its US Rights for a collaboration program, it is obligated to pay the Company an exercise fee of approximately $80.0 million per program. Thereafter, following Phase 1, Celgene would have decision making authority over development activities, and all regulatory, manufacturing and commercialization activities, for antibody products targeting the relevant Collaboration Target (the “Collaboration Products”) in the U.S.
On a program-by-program basis, following completion of a Phase 1 clinical trial for a collaboration program for which Celgene has previously exercised its US Rights, Celgene may elect in its sole discretion to exercise its Global Rights with respect to such collaboration program to receive a worldwide, exclusive license to develop and commercialize antibodies targeting the applicable Collaboration Target. If Celgene exercises its Global Rights, Celgene would be obligated to pay the Company an additional exercise fee of $55.0 million for such collaboration program. The Global Rights would then replace the US Rights for that collaboration program, and Celgene would have decision making authority over developing, obtaining and maintaining regulatory approval for, manufacturing and commercializing the Collaboration Products worldwide.
After Celgene's exercise of Global Rights for a collaboration program, the Company is eligible to receive up to $562.5 million in regulatory and commercial milestones per program. For obtaining either US Rights or Global Rights for such collaboration program by Celgene, the Company will also be eligible to receive tiered royalties on net sales of Collaboration Products ranging from high single digit to high teen percentages, on a weighted average basis depending on the achieving of certain net sales thresholds. Such exercise fees, milestones and royalty payments are subject to certain reductions as specified in the Collaboration Agreement, the agreement for US Rights and the agreement for Global Rights.
Celgene will continue to pay royalties on a Collaboration Product-by-Collaboration Product and country-by-country basis, until the latest of (i) expiration of certain patents covering the Collaboration Product, (ii) expiration of all regulatory exclusivity for the Collaboration Product, and (iii) an agreed period of time after the first commercial sale of the Collaboration Product in the applicable country (the “Royalty Term”).
Term and Termination
 
The research term under the Collaboration Agreement continues for a period of six years , which Celgene may extend for up to two additional 12 -month periods by paying an extension fee of $10.0 million per extension period. The term of the Collaboration Agreement continues until the last to occur of the following: (i) expiration of the research term; (ii) expiration of all US Rights terms; and (iii) expiration of all Global Rights terms.
The term of any US License or Global License would continue on a Licensed Product-by-Licensed Product and country-by-country basis until the expiration of all Royalty Terms under such agreement.
The Collaboration Agreement may be terminated (i) by either party on a program-by-program basis if the other party remains in material breach of the Collaboration Agreement following a cure period to remedy the material breach, (ii) by Celgene at will on a program-by-program basis or in its entirety, (iii) by either party, in its entirety, upon insolvency of the other party, or (iv) by Prothena, in its entirety, if Celgene challenges a patent licensed by Prothena to Celgene under the Collaboration Agreement.
Share Subscription Agreement
  
Pursuant to the terms of the Collaboration Agreement, the Company entered into a Share Subscription Agreement (the “SSA”) with Celgene, pursuant to which the Company issued, and Celgene subscribed for, 1,174,536 of the Company’s ordinary shares (the “Shares”) for an aggregate subscription price of approximately $50.0 million , pursuant to the terms and conditions thereof.
Under the SSA, Celgene is subject to certain transfer and standstill restrictions, including a restriction on acquiring more than 9.9% of the Company’s share capital for a specified period of time following the closing of the subscription of the Shares, or earlier upon announcement of the intent to consummate a change of control of the Company by the Company or a third party, or expiration or termination of the Collaboration Agreement. In addition, Celgene will be entitled to request the registration of the Shares with the U.S. Securities and Exchange Commission on Form S-3ASR or Form S-3 following termination of the transfer restrictions if the Shares cannot be resold without restriction pursuant to Rule 144 promulgated under the U.S. Securities Act of 1933, as amended (the “Securities Act”).

18



  
Collaboration Accounting

The Collaboration Agreement was evaluated under ASC 808, Collaborative Agreements. At the outset of the Collaboration Agreement, the Company concluded that it does not qualify as collaboration under ASC 808 because the Company does not share significant risks due to economics of the collaboration.
Performance Obligations

The Collaboration Agreement was evaluated under ASC 606. Per ASC 606, a performance obligation is defined as a promise to transfer a good or service or a series of distinct goods or services. At inception of the Collaboration Agreement, the Company concluded that it does not have material distinct performance obligation as the Company is not obligated to transfer the US or Global license to Celgene unless Celgene exercises its US Right or Global Right, respectively, and the Company is not obligated to perform development activities under the development plan during preclinical and Phase 1 clinical trials including the regulatory filing of the IND. The discovery, preclinical and clinical development activities performed by the Company are to be performed at the Company’s discretion and therefore are not considered distinct performance obligations under ASC 606. Per the terms of the Collaboration Agreement, the Company may conduct discovery activities to characterize, identify and generate antibodies to become collaboration candidates that target such Collaboration Target, and thereafter may pre-clinically develop collaboration candidates to identify lead candidates that target such Collaboration Target and file an IND with the U.S. Food and Drug Administration (the “FDA”) for a Phase 1 clinical trial for such lead candidates. The Company is solely responsible for any and all costs and expenses in connection with the performance, in its discretion, of any program prior to the exercise of the Global Right for such program. The Company is not obligated to perform manufacturing activities. Per the terms of the Collaboration Agreement, to the extent that the Company, at its discretion, conducts a program, the Company shall be responsible for the manufacture of collaboration candidates and collaboration products for use in such program, as well as the associated costs. Delivery of manufactured compound (clinical product supply) is not deemed a performance obligation under ASC 606 as the Company is not obligated to transfer supply of collaboration product to Celgene unless Celgene exercises its right to participate in the Phase 1 development.
Transaction Price

According to ASC 606-10-32-2, the transaction price is the amount of consideration to which an entity expects to be entitled in exchange for transferring promised goods or services to a customer, excluding amounts collected on behalf of third parties (for example, some sales taxes). The consideration promised in a contract with a customer may include fixed amounts, variable amounts, or both. Factors considered in the determination of the transaction price included, among other things, estimated selling price of the license and costs for clinical supply and development costs.
The initial transaction price under the Collaboration Agreement, pursuant to ASC 606, was $110.2 million , including the $100.0 million upfront payment and $10.2 million premium on the ordinary shares purchased under the SSA.
The Company evaluated the potential obligations to transfer the U.S. and global licenses to Celgene under ASC 606-10-55-42 and 55-43 to determine whether it gave Celgene a “material right”. According to ASC 606-10-55-43, if a customer has the option to acquire an additional good or services at a price that would reflect the standalone selling price for that good or service, that option does not provide the customer with a material right even if the option can be exercised only by entering into a previous contract. The Company concluded that Celgene’s options to exercise its US Rights or Global Rights did not represent a “material right” to Celgene that it would not have received without entering into the Collaboration Agreement. As a result, the obligations to transfer the U.S. and Global licenses to Celgene were not considered performance obligations at the outset of the Collaboration Agreement under ASC 606.
In addition, the Company did not include the option fees in the initial transaction price because such fees are variable consideration that are contingent on the options to the US Rights and the Global Rights being exercised. Upon the exercise of the US Rights and the Global Rights, the Company will have the obligation to deliver the U.S. and global licenses, respectively. The Company will include the option fees in the transaction price at a point in time when the Company can conclude that it is probable that a significant revenue reversal will not occur. In addition, the Company did not include in the initial transaction price certain clinical and regulatory milestone payments since these variable considerations are constrained due to high likelihood of a revenue reversal.

At the inception of the Collaboration Agreement, the Company did not transfer any goods or services to Celgene. Accordingly, the Company has concluded that the initial transaction price will be recognized as contract liability and will be deferred until the Company transfers control of goods or services to Celgene (which would be when Celgene exercises the US Right and receives

19



control of the US license for at least one of the programs) or at the termination of the Collaboration Agreement, whichever occurs first. The total transaction price will be allocated to each of the Company’s performance obligations on a relative standalone selling price basis at the point that Celgene receives the license for each program.

Significant Payment Terms

The upfront payment of $100.0 million is due within ten business days after the effective date of the Collaboration Agreement, while all option fees and milestone payments are due within 30 days after the achievement of the relevant milestone by Celgene or receipt by Celgene of an invoice for such an amount from the Company.
The Collaboration Agreement does not have a significant financing component since a substantial amount of consideration promised by Celgene to the Company is variable and the amount of such variable consideration varies based upon the occurrence or nonoccurrence of future events that are not within the control of either Celgene or the Company. Variable considerations related to clinical and regulatory milestone payments and option fees are constrained due to high likelihood of a revenue reversal.

Milestone and Royalties Accounting

Under the Collaboration Agreement, the Company is eligible to receive milestone payments upon the achievement of development, regulatory and various first commercial sales milestones. Milestone payments are evaluated under ASC Topic 606. Factors considered in this determination included scientific and regulatory risk that must be overcome to achieve each milestone, the level of effort and investment required to achieve the milestone, and the monetary value attributed to the milestone. Accordingly, the Company estimates payments in the transaction price based on the most likely approach, which considers the single most likely amount in a range of possible amounts related to the achievement of these milestones. Additionally, milestone payments are included in the transaction price only when the Company can conclude it is probable that a significant revenue reversal will not occur in future periods.
The Company excluded the milestone payments and royalties in the initial transaction price because such payments are considered to be variable considerations with constraint. Such milestone payments and royalties will be recognized as revenue at a point in time when the Company can conclude it is probable that a significant revenue reversal will not occur in future periods.
The Company did not achieve any clinical and regulatory milestones under the Collaboration Agreement during the three months ended March 31, 2018 .
9. Shareholders' Equity
Ordinary Shares
As of March 31, 2018 , the Company had 100,000,000 ordinary shares authorized for issuance with a par value of $0.01 per ordinary share and 39,821,799 ordinary shares issued and outstanding. Each ordinary share is entitled to one vote and, on a pro rata basis, to dividends when declared and the remaining assets of the Company in the event of a winding up.
Euro Deferred Shares
As of March 31, 2018 , the Company had 10,000 Euro Deferred Shares authorized for issuance with a nominal value of €22  per share. No Euro Deferred Shares are outstanding at March 31, 2018 . The rights and restrictions attaching to the Euro Deferred Shares rank pari passu with the ordinary shares and are treated as a single class in all respects.
March 2017 Offering
In March 2017, the Company completed an underwritten public offering of an aggregate of 2,700,000 of its ordinary shares at a public offering price of $57.50 per ordinary share. The Company received aggregate net proceeds of approximately $150.3 million , after deducting the underwriting discount and offering costs.
Celgene Share Subscription Agreement
In connection with the Celgene Collaboration Agreement, the Company entered into a Share Subscription Agreement (the “SSA”) with Celgene, pursuant to which the Company issued, and Celgene subscribed for, 1,174,536 of the Company’s ordinary shares (the “Shares”) for an aggregate subscription price of approximately $50.0 million , of which the fair value of $39.8 million was recorded in shareholders' equity and the premium of $10.2 million was recorded as deferred revenue from Celgene.
Under the SSA, Celgene is subject to certain transfer and standstill restrictions, including a restriction on acquiring more than 9.9% of the Company’s share capital for a specified period of time following the closing of the subscription of the Shares,

20



or earlier upon announcement of the intent to consummate a change of control of the Company by the Company or a third party, or expiration or termination of the Collaboration Agreement. In addition, Celgene will be entitled to request the registration of the Shares with the SEC on Form S-3ASR or Form S-3 following termination of the transfer restrictions if the Shares cannot be resold without restriction pursuant to Rule 144 promulgated under the Securities Act.
10. Share-Based Compensation
Amended and Restated 2012 Long Term Incentive Plan (“LTIP”)
Employees and consultants of the Company, its subsidiaries and affiliates, as well as members of the Company's Board of Directors, are eligible to receive equity awards under the LTIP. The LTIP provides for the grant of stock (share) options, including incentive stock options and nonqualified stock options, stock appreciation rights (“SARS”), restricted shares, restricted share units (“RSUs”), cash or stock-based performance awards and other share-based awards to eligible individuals. Options under the LTIP may be granted for periods up to ten years. All options issued to date have had a ten year life.
The Company granted 1,093,100 and 854,800 share options during the three months ended March 31, 2018 and 2017 , respectively, under the LTIP. The Company's option awards generally vest over four years. In May 2017, the Company's shareholders approved an increase of 1,350,000 additional ordinary shares authorized for issuance under the LTIP. The aggregate number of ordinary shares authorized for issuance under the LTIP is 8,750,000 ordinary shares. As of March 31, 2018 , 1,276,912 ordinary shares remained available for grant, and options to purchase 5,227,086 ordinary shares under the LTIP were outstanding with a weighted-average exercise price of approximately $37.77 per share.
Share-based Compensation Expense
The Company estimates the fair value of share-based compensation on the date of grant using an option-pricing model. The Company uses the Black-Scholes model to value share-based compensation, excluding RSUs, which the Company values using the fair market value of its ordinary shares on the date of grant. The Black-Scholes option-pricing model determines the fair value of share-based payment awards based on the share price on the date of grant and is affected by assumptions regarding a number of complex and subjective variables. These variables include, but are not limited to, the Company’s share price, volatility over the expected life of the awards and actual and projected employee stock option exercise behaviors. Since the Company does not have sufficient historical employee share option exercise data, the simplified method has been used to estimate the expected life of all options. The Company uses its historical volatility for the Company's stock to estimate expected volatility starting January 1, 2018. Through December 31, 2017, the expected volatility was based on a combination of historical volatility for the Company's stock and the historical volatilities of several of the Company's publicly traded comparable companies due to insufficient historical employee share option exercise data. Although the fair value of share options granted by the Company is estimated by the Black-Scholes model, the estimated fair value may not be indicative of the fair value observed in a willing buyer and seller market transaction.
As share-based compensation expense recognized in the Consolidated Financial Statements is based on awards ultimately expected to vest, it has been reduced for estimated forfeitures. Forfeitures are estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from estimates. Forfeitures were estimated based on estimated future turnover and historical experience.
Share-based compensation expense will continue to have an adverse impact on the Company’s results of operations, although it will have no impact on its overall financial position. The amount of unearned share-based compensation currently estimated to be expensed from now through the year 2021 related to unvested share-based payment awards at March 31, 2018 is $77.8 million . The weighted-average period over which the unearned share-based compensation is expected to be recognized is 2.99 years . If there are any modifications or cancellations of the underlying unvested securities, the Company may be required to accelerate and/or increase any remaining unearned share-based compensation expense. Future share-based compensation expense and unearned share-based compensation will increase to the extent that the Company grants additional equity awards.
Share-based compensation expense recorded in these Consolidated Financial Statements for the three months ended March 31, 2018 and 2017 was based on awards granted under the LTIP. The following table summarizes share-based compensation expense for the periods presented (in thousands):

21



 
Three Months Ended March 31,
 
2018
 
2017
Research and development
$
2,258

 
$
2,308

General and administrative
4,644

 
3,294

Total share-based compensation expense
$
6,902

 
$
5,602

For the three months ended March 31, 2018 and 2017 , the Company recognized tax benefits from share-based awards of $1.1 million and $0.9 million , respectively.
The fair value of the options granted to employees and non-employee directors during the three months ended March 31, 2018 and 2017 was estimated as of the grant date using the Black-Scholes option-pricing model assuming the weighted-average assumptions listed in the following table:
 
Three Months Ended March 31,
 
2018
 
2017
Expected volatility
67.2%
 
73.1%
Risk-free interest rate
2.8%
 
2.1%
Expected dividend yield
—%
 
—%
Expected life (in years)
6.0
 
6.0
Weighted average grant date fair value
$20.67
 
$35.30
The fair value of employee stock options is being amortized on a straight-line basis over the requisite service period for each award. Each of the inputs discussed above is subjective and generally requires significant management judgment to determine.
The following table summarizes the Company’s stock option activity during the three months ended March 31, 2018 :
 
Options
 
Weighted
Average
Exercise
Price
 
Weighted
Average
Remaining
Contractual
Term (years)
 
Aggregate
Intrinsic
Value
(in thousands)
Outstanding at December 31, 2017
4,406,752

 
$
38.93

 
7.60
 
$
30,455

Granted
1,093,100

 
33.20

 
 
 
 
Exercised
(164,499
)
 
26.74

 
 
 
 
Canceled
(108,267
)
 
55.87

 
 
 
 
Outstanding at March 31, 2018
5,227,086

 
$
37.77

 
8.07
 
$
30,991

Vested and expected to vest at March 31, 2018
5,093,258

 
$
37.64

 
8.03
 
$
30,725

Vested at March 31, 2018
2,215,513

 
$
29.37

 
6.68
 
$
25,353

The total intrinsic value of options exercised was $2.1 million and $17.0 million during the three months ended March 31, 2018 and 2017 , respectively, determined as of the date of exercise.
11. Income Taxes
The major taxing jurisdictions for the Company are Ireland and the U.S. The Company recorded an income tax benefit of $37,000 for three months ended March 31, 2018 , as compared to an income tax benefit of $1.7 million for the three months ended March 31, 2017 . The provision for income taxes differs from the statutory tax rate of 12.5% applicable to Ireland primarily due to Irish net operating losses for which a tax provision benefit is not recognized and U.S. income taxed at different rates. The income tax provision reflects the estimate of the effective tax rate expected to be applicable for the full year and the Company re-evaluates this estimate each quarter based on its forecasted tax expense for the full year. Jurisdictions with a projected loss for the year where no tax benefit can be recognized are excluded from the estimated annual effective tax rate.
The Company adopted ASU 2016-09 on January 1, 2017. Pursuant to the adoption of ASU 2016-09, tax attributes previously tracked off balance sheet have been recorded as deferred tax assets, offset by a valuation allowance. Further, excess benefits of

22



stock compensation have been recorded as a benefit to the tax provision for all periods presented. For the three months ended March 31, 2018 and 2017 , the Company recorded a net tax shortfall of $0.3 million and excess tax benefits of $1.9 million , respectively, which were recorded as part of its income tax provision in the Condensed Consolidated Statements of Operations. The Company's income tax expense will continue to be impacted by fluctuations in stock price between the grant dates and the exercise dates of its option awards.
On December 22, 2017, the U.S. Tax Cuts and Jobs Act (the “TCJA”) was signed into law. It contains many significant changes to the U.S. income tax laws. The TCJA is effective in the first quarter of 2018 and, among other things, lowers the Company’s U.S. federal income tax rate from 34% to 21%. Accordingly, for the year ended December 31, 2017, the Company has recorded a provisional tax benefit of $0.4 million related to the remeasurement of its U.S. deferred tax assets to reflect the lower statutory tax rate. As of March 31, 2018, no adjustments have been made to the provisional net tax benefit reported as of the year ended December 31, 2017.

As of March 31, 2018 , the Company has not completed its accounting for the tax effects of the TCJA, but recorded a provisional net tax benefit based on the Company's best estimates. The provisional amounts incorporate assumptions made based upon the Company's current interpretation of the TCJA and are subject to revision as the Company receives and interprets any additional clarification and implementation guidance issued by the U.S. Treasury Department, IRS and other standard-setting bodies. Any adjustments to the provisional amounts recorded will be included as an adjustment to the provision for income taxes. Adjustments may materially impact the Company's provision for income taxes and effective tax rate in the period in which the adjustments are made. The Company anticipates its accounting for the tax effects of the TCJA will be completed in 2018.
The Company's deferred tax assets are composed primarily of its Irish subsidiaries' net operating loss carryovers, state net operating loss carryforwards available to reduce future taxable income of the Company's U.S. subsidiary, federal and California research and development credit carryforward, shared-based compensation and other temporary differences. The Company maintains a valuation allowance against its Irish and certain U.S. federal and state deferred tax assets. Each reporting period, the Company evaluates the need for a valuation allowance on its deferred tax assets by jurisdiction.
  No provision for income tax in Ireland has been recognized on undistributed earnings of the Company's U.S. and Swiss subsidiaries because the Company considers such earnings to be indefinitely reinvested.
12. Subsequent Events

In April 2018, in connection with the Collaboration Agreement with Celgene as discussed in Note 8 “Significant Agreements”, the Company received the $100.0 million upfront payment from Celgene.


23



ITEM 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
This Quarterly Report on Form 10-Q, including this Management’s Discussion and Analysis of Financial Condition and Results of Operations, contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. These statements relate to, among other things, our objective to fundamentally change the course of progressive, life-threatening diseases; our goal of advancing a pipeline of antibody therapeutic candidates for a number of potential indications and novel targets; the design, proposed mechanism of action and potential therapeutic benefits of PRX004; the design and objectives of our Phase 1 study for PRX004; the capabilities of our proprietary mis-TTR assay and our intention to use it in the Phase 1 study of PRX004; the possibility of future studies of PRX004; amounts we might receive under our collaboration with Celgene; the sufficiency of our cash and cash equivalents to meet our obligations; our anticipated need for additional capital; our estimates of certain future contractual obligations; and our plan and timing to develop a reorganization plan and provide an update on that plan and financial guidance for 2018. Forward-looking statements may include words such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. Forward-looking statements are subject to risks and uncertainties, and actual events or results may differ materially. Factors that could cause our actual results to differ materially include, but are not limited to, the risks and uncertainties listed below as well as those discussed under Part II Item 1A - Risk Factors of this Form 10-Q.
our ability to obtain additional financing in future offerings and/or obtain funding from future collaborations;
our operating losses;
our ability to successfully complete research and development of our drug candidates;
our ability to develop, manufacture and commercialize products;
our collaborations with third parties, including Roche and Celgene;
our ability to protect our patents and other intellectual property;
our ability to hire and retain key employees;
tax treatment of our separation from Elan and subsequent distribution of our ordinary shares;
our ability to maintain financial flexibility and sufficient cash, cash equivalents and investments and other assets capable of being monetized to meet our liquidity requirements;
potential disruptions in the U.S. and global capital and credit markets;
government regulation of our industry;
the volatility of our ordinary share price;
business disruptions; and
the other risks and uncertainties described in Item 1A - Risk Factors of this Form 10-K.
We undertake no obligation to revise or update any forward-looking statements to reflect any event or circumstance that arises after the date of this report.
This discussion should be read in conjunction with the Condensed Consolidated Financial Statements and Notes presented in this Quarterly Report on Form 10-Q and the Condensed Consolidated Financial Statements and Notes contained in our Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (the “SEC”) on February 26, 2018 (the “2017 Form 10-K”).

Overview

Prothena Corporation plc is a global clinical-stage biotechnology company focused on the discovery and development of novel therapies in the neuroscience and orphan disease categories. Fueled by its deep scientific understanding built over decades of research in protein misfolding, Prothena seeks to fundamentally change the course of progressive, life-threatening diseases associated with this biology.

We are advancing a pipeline of antibody therapeutic candidates for a number of potential indications and novel targets including Parkinson’s disease and other related synucleinopathies (PRX002/RG7935) and ATTR amyloidosis (PRX004), as well

24



as tau and Aβ for the potential treatment of Alzheimer’s disease and other neurodegenerative disorders and TDP-43 for the potential treatment of ALS (amyotrophic lateral sclerosis) and FTD (frontotemporal dementia).

We were formed on September 26, 2012 under the laws of Ireland and re-registered as an Irish public limited company on October 25, 2012. Our ordinary shares began trading on The Nasdaq Global Market under the symbol “PRTA” on December 21, 2012 and currently trade on The Nasdaq Global Select Market.
Recent Developments
NEOD001
In April 2018, we announced that we were discontinuing development of NEOD001, an investigational monoclonal antibody that was being evaluated for the treatment of AL amyloidosis. The decision was based on results from the Phase 2b PRONTO study and a futility analysis of the Phase 3 VITAL study. Based on the results from the Phase 2b PRONTO study, which did not meet its primary or secondary endpoints, we asked the independent data monitoring committee (the "DMC") of the Phase 3 VITAL study to review a futility analysis of the ongoing VITAL study. The DMC recommended discontinuation of the VITAL study for futility. We therefore decided to discontinue all development of NEOD001, including the VITAL study as well as the open label extension studies.

PRX004 for the Potential Treatment of ATTR Amyloidosis

PRX004 is an investigational monoclonal antibody that targets pathogenic, misfolded forms of TTR protein for the potential treatment of ATTR amyloidosis.

In March 2018, at the 16th International Symposium on Amyloidosis (ISA), we presented research relating to PRX004 for the potential treatment of ATTR amyloidosis, including a proprietary mis-TTR assay developed to measure the misfolded forms of transthyretin (TTR) protein present in plasma of patients with hereditary ATTR amyloidosis, as well as preclinical research demonstrating that conformation-specific antibodies target misfolded TTR and immune mediated clearance of amyloid through phagocytosis.

In May 2018, we announced first-in-human dosing in a Phase 1 clinical study of PRX04 in patients with ATTR amyloidosis. PRX004 is an investigational antibody designed to target and clear the pathogenic, misfolded forms of the TTR protein found in ATTR amyloidosis without affecting the native, or normal tetrameric form of the protein. The Phase 1 study will evaluate PRX004 in patients with ATTR amyloidosis to inform possible future studies and will include the use of our propriety mis-TTR assay as a pharmacodynamic measure of the levels of misfolded TTR species in plasma across multiple hereditary TTR mutations.

Discovery

We are advancing a discovery pipeline of novel investigational programs against targets such as tau, Aβ (Amyloid beta) and TDP-43.

In March 2018, we entered into a global neuroscience research and development collaboration with Celgene Switzerland LLC (a wholly owned subsidiary of Celgene Corporation) to develop new therapies for a broad range of neurodegenerative diseases. The collaboration is focused on three proteins implicated in the pathogenesis of several neurodegenerative diseases, inducing tau, TDP-43 and an undisclosed target. We received a $100 million upfront payment and a $50 million equity investment by Celgene, and are eligible to receive future potential exercise payments and regulatory and commercial milestones for each licensed program. We are also eligible to receive additional royalties on net sales of any resulting marketed products.

Critical Accounting Policies and Estimates
Management’s discussion and analysis of our financial condition and results of operations is based on our condensed consolidated financial statements, which have been prepared in accordance with the accounting principles generally accepted in the U.S. (“GAAP”). The preparation of these condensed consolidated financial statements requires us to make estimates and assumptions for the reported amounts of assets, liabilities, revenues, expenses and related disclosures.

Except for the accounting policies for revenue recognition that was updated as a result of adopting ASC 606, there were no significant changes to our critical accounting policies and estimates during the three months ended March 31, 2018 from the critical accounting policies and estimates disclosed in Management's Discussion and Analysis of Financial Condition and Results of Operations in our 2017 Form 10-K.
Recent Accounting Pronouncements

25



Except as described in Note 2 to the Condensed Consolidated Financial Statements under the heading “Recent Accounting Pronouncements”, there have been no new accounting pronouncements or changes to accounting pronouncements during the three months ended March 31, 2018 , as compared to the recent accounting pronouncements described in our 2017 Form 10-K, that are of significance or potential significance to us.
Results of Operations
Comparison of Three Months Ended March 31, 2018 and 2017
Revenue
 
Three Months Ended March 31,
 
Percentage Change
2018
 
2017
 
(Dollars in thousands)
 
 
Collaboration revenue
$
227

 
$
259

 
(12
)%
Total revenue
$
227

 
$
259

 
(12
)%

Total revenue was $0.2 million and $0.3 million for the three months ended March 31, 2018 and 2017 , respectively.
Collaboration revenue includes reimbursements under our License Agreement with Roche, which became effective January 2014. See Note 8 to the Condensed Consolidated Financial Statements regarding “Roche License Agreement” for more information.

Collaboration revenue for the three months ended March 31, 2018 and 2017 consisted of reimbursement for development and research services of $0.2 million and $0.3 million , respectively.
Operating Expenses
 
Three Months Ended March 31,
 
Percentage Change
2018
 
2017
 
(Dollars in thousands)
 
 
Research and development
$
34,706

 
$
25,698

 
35
%
General and administrative
14,229

 
10,832

 
31
%
Total operating expenses
$
48,935

 
$
36,530

 
34
%
Total operating expenses consist of research and development ("R&D") expenses and general and administrative ("G&A") expenses. Our operating expenses for the three months ended March 31, 2018 and 2017 were $48.9 million and $36.5 million , respectively.
With the recent discontinuation of the NEOD001 program, we are assessing our resources relative to our current pipeline and are developing a reorganization plan. We expect to provide an update during the second quarter on reorganization plans and financial guidance for 2018.
Our R&D expenses primarily consist of personnel costs and related expenses, including share-based compensation and external costs associated with nonclinical activities and drug development related to our drug programs, including NEOD001, PRX002/RG7935, PRX004 and our discovery programs. Pursuant to our License Agreement with Roche, we make payments to Roche for our share of the development expenses incurred by Roche related to PRX002/RG7935 program, which is included in our R&D expense. Prior to January 1, 2018, we recorded reimbursements from Roche for development as an offset to R&D expense.
Our G&A expenses primarily consist of professional service expenses and personnel costs and related expenses, including share-based compensation.
Research and Development Expenses
Our R&D expenses increased by $9.0 million , or 35% , for the three months ended March 31, 2018 as compared to the same periods in the prior year. The increase for the three months ended March 31, 2018 , compared to the same period in the prior year, was primarily due to higher consulting expenses, higher personnel costs (including share-based compensation expenses), higher

26



expense associated with PRX002/RG7935 and to a lesser extent higher clinical trial costs associated primarily with the NEOD001 program, which were partially offset by a decrease in external expenses related to product manufacturing.
Our research activities are aimed at developing new drug products. Our development activities involve the translation of our research into potential new drugs. R&D expenses include personnel costs and related expenses, external expenses associated with nonclinical and drug development and materials, equipment and facilities costs that are allocated to clearly related R&D activities.
The following table sets forth the R&D expenses for our major programs (specifically, any program with successful first dosing in a Phase 1 clinical trial, which were NEOD001, PRX002/RG7935 and PRX003) and other R&D expenses for the three months ended March 31, 2018 and 2017 , and the cumulative amounts to date (in thousands):

 
 
Three Months Ended March 31,
 
Cumulative to Date
 
 
2018
 
2017
 
NEOD001 (1)
 
$
25,596

 
$
18,220

 
$
277,804

PRX002/RG7935 (2)
 
2,607

 
1,978

 
53,355

PRX003 (3)
 
194

 
2,615

 
58,868

Other R&D (4)
 
6,309

 
2,885

 
 
 
 
$
34,706

 
$
25,698

 
 

 
(1)
Cumulative R&D costs to date for NEOD001 include the costs incurred from the date when the program has been separately tracked in preclinical development. Expenditures in the early discovery stage are not tracked by program and accordingly have been excluded from this cumulative amount.
(2)
Cumulative R&D costs to date for PRX002/RG7935 and related antibodies include the costs incurred from the date when the program has been separately tracked in nonclinical development. Expenditures in the early discovery stage are not tracked by program and accordingly have been excluded from this cumulative amount. PRX002/RG7935 cost include payments to Roche for our share of the development expenses incurred by Roche related to PRX002/RG7935 programs and , through December 31, 2017, is net of reimbursements from Roche for development and supply services recorded as an offset to R&D expense. For the three months ended March 31, 2018 , $0.2 million of reimbursements from Roche for development services was recorded as part of collaboration revenue as a result of the adoption of new revenue standard. For the three months ended March 31, 2017 , $0.8 million of reimbursements from Roche for development services was recorded as an offset to R&D expenses.
(3)
Cumulative R&D costs to date for PRX003 include the costs incurred from the date when the program has been separately tracked in nonclinical development. Expenditures in the early discovery stage are not tracked by program and accordingly have been excluded from this cumulative amount. Based on the Phase 1b multiple ascending dose study results announced in September 2017, we announced that we will not advance PRX003 into mid-stage clinical development for psoriasis or psoriatic arthritis as previously planned.
(4)
Other R&D is comprised of preclinical development and discovery programs that have not progressed to first patient dosing in a Phase 1 clinical trial.

General and Administrative Expenses
Our G&A expenses increase by $3.4 million , or 31% three months ended March 31, 2018 as compared to the same periods in the prior year. The increase for the three months ended March 31, 2018 , compared to the same period in the prior year, was primarily due to higher personnel costs, and to a lesser extent higher legal fees.

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Other Income (Expense)
 
Three Months Ended March 31,
 
Percentage Change
2018
 
2017
 
(Dollars in thousands)
 
 
Interest income
$
1,108

 
$
552

 
101
 %
Interest expense
(908
)
 
(916
)
 
(1
)%
Interest income (expense), net
200

 
(364
)
 
(155
)%
Other expense
(272
)
 
(410
)
 
(34
)%
Total Other Expense, net
$
(72
)
 
$
(774
)
 
(91
)%
Interest income (expense), net increased by $0.6 million , or 155% , for the three months ended March 31, 2018 compared to the same period in the prior year. The increase for the three months ended March 31, 2018 , compared to the same period in the prior year, was primarily due to higher interest income associated with higher balances in our cash and money market accounts.
Other expense, net for the three months ended March 31, 2018 and 2017 were primarily due to foreign exchange losses from transactions with vendors denominated in Euros.
Benefit from Income Taxes
 
Three Months Ended March 31,
 
Percentage Change
2018
 
2017
 
(Dollars in thousands)
 
 
Benefit from income taxes
$
(37
)
 
$
(1,661
)
 
(98
)%

The benefit from income taxes for the three months ended March 31, 2018 and 2017 were $37,000 and $1.7 million , respectively. The benefit from income taxes decreased by $1.6 million for the three months ended March 31, 2018 , compared to the same period in the prior year, primarily due to lower excess tax benefits in the three months ended March 31, 2018 .
For the three months ended March 31, 2018 and 2017 , we recorded a tax shortfall of $0.3 million and excess tax benefit of $1.9 million , respectively, as part of our income tax provision related to the adoption of ASU 2016-09, Improvements to Employee Share-Based Payment Accounting. Our income tax expense will continue to be impacted by fluctuations in stock price between the grant dates and the exercise dates of stock options.
The tax provisions for all periods presented reflect U.S. federal taxes associated with recurring profits attributable to intercompany services that our U.S. subsidiary performs for the Company and also include Swiss taxes associated with intercompany services that our Swiss subsidiary performed for the Company. No tax benefit has been recorded related to tax losses recognized in Ireland and any deferred tax assets for those losses are offset by a valuation allowance.
On December 22, 2017, the U.S. Tax Cuts and Jobs Act (the “TCJA”) was signed into law in the U.S. The TCJA significantly changed existing U.S. tax law and includes numerous provisions that will affect our business going forward, including changes to the U.S. federal statutory tax rate, the repeal of alternative minimum tax, and additional limits on the deductibility of executive compensation, among other things. The TCJA reduces the U.S. federal statutory tax rate from 34% to 21% effective January 1, 2018. Accordingly, for the year ended December 31, 2017, we have recorded a provision tax benefit of $0.4 million related to the remeasurement of our U.S. deferred tax assets to reflect the lower statutory tax rate. As of March 31, 2018 , no adjustments have been made to the provisional net tax benefit reported as of the year ended December 31, 2017.
As of March 31, 2018 , we have not completed our accounting for the tax effects of the TCJA, and have recorded provisional net tax benefit based on our best estimates. The provisional amounts incorporate assumptions made based upon our current interpretation of the TCJA and are subject to revision as we receive and interpret any additional clarification and implementation guidance issued by the U.S. Treasury Department, Internal Revenue Service (the “IRS”) and other standard-setting bodies. Any adjustments to the provisional amounts recorded will be included as an adjustment to the provision for income taxes. Adjustments may materially impact our provision for income taxes and effective tax rate in the period in which the adjustments are made. We anticipate our accounting for the tax effects of the TCJA will be completed in 2018.


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Liquidity and Capital Resources
Overview
 
March 31,
 
December 31,
 
2018
 
2017
Working capital
$
501,598

 
$
388,956

Cash and cash equivalents
429,039

 
417,620

Total assets
606,647

 
496,329

Total liabilities
197,142

 
89,140

Total shareholders’ equity
409,505

 
407,189

Working capital was $501.6 million as of March 31, 2018 , an increase of $112.6 million from working capital of $389.0 million as of December 31, 2017 . This increase in working capital during the three months ended March 31, 2018 was primarily due to $100.0 million receivable associated with the upfront payment from the Celgene Collaboration Agreement, and to a lesser extent a higher net cash and cash equivalents balance resulting from the proceeds of $50.0 million from our share subscription agreement with Celgene, which were partially offset by use of $48.9 million for operating expenses (adjusted to exclude non-cash charges).
As of March 31, 2018 , we had $429.0 million in cash and cash equivalents. Although we believe, based on our current business plans, that our existing cash and cash equivalents will be sufficient to meet our obligations for at least the next twelve months, we anticipate that we will require additional capital in the future in order to continue the research and development of our drug candidates and preparation for commercialization. As of March 31, 2018 , $71.2 million of our outstanding cash and cash equivalents related to U.S. operations that are considered permanently reinvested. We do not intend to repatriate these funds. However, if these funds were repatriated back to Ireland we would incur a withholding tax from the dividend distribution.
We have based this estimate on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. Because of the numerous risks and uncertainties associated with the development and commercialization of our product candidates, we are unable to estimate the amounts of increased capital outlays and operating expenses associated with completing the development of our product candidates. Our future capital requirements will depend on numerous factors, including, without limitation, the timing of initiation, progress, results and costs of our clinical trials; the results of our research and nonclinical studies; the costs of clinical manufacturing and of establishing commercial manufacturing arrangements; the costs of preparing, filing and prosecuting patent applications and maintaining, enforcing and defending intellectual property-related claims; the costs and timing of capital asset purchases; our ability to establish research collaborations, strategic collaborations, licensing or other arrangements; the costs to satisfy our obligations under current and potential future collaborations; and the timing, receipt, and amount of revenues or royalties, if any, from any approved drug candidates. Pursuant to the License Agreement with Roche, in the U.S., we and Roche share all development and commercialization costs, as well as profits, all of which will be allocated 70% to Roche and 30% to us, for PRX002/RG7935 in the Parkinson’s disease indication, as well as any other Licensed Products and/or indications for which we opt in to co-develop and co-fund. Pursuant to the Collaboration Agreement with Celgene the Company is eligible to receive payments for commercial and regulatory milestones and royalties on net sales of Collaboration Products payments. In order to develop and obtain regulatory approval for our potential products we will need to raise substantial additional funds. We expect to raise any such additional funds through public or private equity or debt financings, collaborative agreements with corporate partners or other arrangements. We cannot assume that such additional financings will be available on acceptable terms, if at all, and such financings may only be available on terms dilutive to our shareholders.
Cash Flows for the Three Months Ended March 31, 2018 and 2017
The following table summarizes, for the periods indicated, selected items in our Condensed Consolidated Statements of Cash Flows (in thousands):

29



 
Three Months Ended March 31,
 
2018
 
2017
Net cash used in operating activities
$
(31,584
)
 
$
(37,842
)
Net cash used in investing activities
(181
)
 
(2,399
)
Net cash provided by financing activities
43,184

 
159,868

Net increase in cash and cash equivalents and restricted cash
$
11,419

 
$
119,627

Cash Used in Operating Activities
Net cash used in operating activities was $31.6 million for the three months ended March 31, 2018 , primarily due to use of $48.9 million for operating expenses (adjusted to exclude non-cash charges), an increase in receivable from Celgene and a decrease in accounts payable and accrued liabilities, which were partially offset by an increase in deferred revenue.
Net cash used in operating activities was $37.8 million for the three months ended March 31, 2017 , primarily due to use of $36.5 million for operating expenses (adjusted to exclude non-cash charges), an increase in prepaid expenses and other current assets and a decrease in accounts payable.
Cash Used in Investing Activities
Net cash used in investing activities was $0.2 million and $2.4 million for the three months ended March 31, 2018 and 2017 , respectively. Net cash used in investing activities for the three months ended March 31, 2018 and 2017 primarily related to purchases of property and equipment.
Cash Provided by Financing Activities
Net cash provided by financing activities was $43.2 million for the three months ended March 31, 2018 , primarily from the $39.8 million proceeds from Celgene's subscription of ordinary shares at market value, and to a lesser extent, from the $4.4 million proceeds from issuances of ordinary shares upon exercises of stock options.
Net cash provided by financing activities was $159.9 million for the three months ended March 31, 2017 , primarily from the net proceeds from our March 2017 public offering and $9.9 million from issuances of ordinary shares upon exercises of stock options.
Off-Balance Sheet Arrangements
At March 31, 2018 , we were not a party to any off-balance sheet arrangements that have, or are reasonably likely to have, a current or future effect on our financial condition, changes in financial condition, revenue or expenses, results of operations, liquidity, capital expenditures or capital resources.
Contractual Obligations
Our contractual obligations as of March 31, 2018 consisted of minimum cash payments under a build-to-suit lease obligation of $34.7 million , operating leases of $2.0 million , purchase obligations of $43.4 million (of which $7.5 million is included in accrued current liabilities) and contractual obligations under license agreements of $1.7 million (of which $0.4 million is included in accrued current liabilities). Purchase obligations consist of non-cancelable purchase commitments to suppliers. Operating leases represent our future minimum rental commitments under our non-cancelable operating leases.
In August 2015 , we entered into an agreement to lease 6,258 square feet of office space in Dublin, Ireland. This lease has a term of 10 years from commencement and provides for an option to terminate the lease at the end of the fifth year of the term. It is also subject to a rent review every five years. As a result of this noncancelable operating lease, we are obligated to make lease payments totaling approximately €2.0 million , or $2.5 million as converted using an exchange rate as of March 31, 2018 , over the term of the lease, assuming current lease payments. Of this obligation, approximately $1.9 million remains outstanding as of March 31, 2018 .

In March 2016 , we entered into a noncancelable operating sublease to lease 128,751 square feet of office and laboratory space in South San Francisco, California. We are obligated to make lease payments totaling approximately $39.2 million over the lease term. Of this obligation, approximately $34.7 million remains outstanding as of March 31, 2018 .

30



In 2017, we entered into noncancelable operating subleases to lease office space in Zug, Switzerland. The lease terms expire in June 2018 and August 2018. We are obligated to make lease payments of approximately CHF 56,000 , or $59,000 as of March 31, 2018 , converted using an exchange rate as of March 31, 2018 .
The following is a summary of our contractual obligations as of the filing date (in thousands):
 
 
Total
 
2018
 
2019
 
2020
 
2021
 
2022
 
Thereafter
Operating leases (1)
 
$
1,951

 
$
251

 
$
255

 
$
255

 
$
255

 
$
255

 
$
680

Minimum cash payments under build-to-suit lease obligation (1)
 
34,664

 
3,832

 
5,803

 
5,979

 
6,165

 
6,350

 
6,535

Purchase obligations
 
20,312

 
10,702

 
9,610

 

 

 

 

Contractual obligations under license agreements (2)
 
1,725

 
435

 
230

 
100

 
100

 
85

 
775

Total
 
$
58,652

 
$
15,220

 
$
15,898

 
$
6,334

 
$
6,520

 
$
6,690

 
$
7,990

 
(1) See Note 7, "Commitments and Contingencies" to our condensed consolidated financial statements.
(2) Excludes future obligations pursuant to the cost-sharing arrangement under our License Agreement with Roche. Amounts of such obligations, if any, cannot be determined at this time.

ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Foreign Currency Risk
Our business is primarily conducted in U.S. dollars except for our agreements with contract manufacturers for drug supplies which are denominated in Euros. We recorded a loss on foreign currency exchange rate differences of approximately $0.3 million and $0.4 million during the three months ended March 31, 2018 and 2017 , respectively. If we continue or increase our business activities that require the use of foreign currencies, we may incur further losses if the Euro and other such currencies continue to strengthen against the U.S. dollar.
Interest Rate Risk
Our exposure to interest rate risk is limited to our cash equivalents, which consist of accounts maintained in money market funds. We have assessed that there is no material exposure to interest rate risk given the nature of money market funds. In general, money market funds are not subject to interest rate risk because the interest paid on such funds fluctuates with the prevailing interest rate. Accordingly, our interest income fluctuates with short-term market conditions.
In the future, we anticipate that our exposure to interest rate risk will primarily be related to our investment portfolio. We intend to invest any surplus funds in accordance with a policy approved by our board of directors which will specify the categories, allocations, and ratings of securities we may consider for investment. The primary objectives of our investment policy are to preserve principal and maintain proper liquidity to meet our operating requirements. Our investment policy also specifies credit quality standards for our investments and limits the amount of credit exposure to any single issue, issuer or type of investment.
Credit Risk
Our receivable from Celgene as of March 31, 2018 relates to the upfront payment under the Collaboration Agreement. Celgene is wholly owned by Celgene Switzerland SA, a tax resident of Switzerland. Our receivable from Roche as of March 31, 2018 and December 31, 2017 are amounts due from Roche entities located in the U.S. and Switzerland under the License Agreement with Roche.
Financial instruments that potentially subject us to concentration of credit risk consist of cash and cash equivalents and accounts receivable. We place our cash and cash equivalents with high credit quality financial institutions and pursuant to our investment policy, we limit the amount of credit exposure with any one financial institution. Deposits held with banks may exceed the amount of insurance provided on such deposits. We have not experienced any losses on our deposits of cash and cash equivalents.
ITEM 4. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our chief executive officer ("CEO") and chief financial officer ("CFO") evaluated the effectiveness of our disclosure controls and procedures pursuant to Rule 13a-15 under the U.S. Securities Exchange Act of 1934, as amended (the "Exchange Act"), as of the end of the period covered by this Form 10-Q.  Based on this evaluation, our CEO and CFO concluded that, as of March 31, 2018 , our disclosure controls and procedures are designed and are effective to provide reasonable assurance that information we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC's rules and forms, and that such

31



information is accumulated and communicated to our management, including our CEO and CFO, as appropriate, to allow timely decisions regarding required disclosure.
Changes in Internal Control over Financial Reporting
There were no changes in our internal control over financial reporting identified in management’s evaluation pursuant to Rules 13a-15(d) or 15d-15(d) of the Exchange Act during our fiscal quarter ended March 31, 2018 that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Limitations on Effectiveness of Controls and Procedures
Internal control over financial reporting has inherent limitations. Internal control over financial reporting is a process that involves human diligence and compliance and is subject to lapses in judgment and breakdowns resulting from human failures. Internal control over financial reporting also can be circumvented by collusion or improper management override. Because of such limitations, there is a risk that material misstatements will not be prevented or detected on a timely basis by internal control over financial reporting. However, these inherent limitations are known features of the financial reporting process. Therefore, it is possible to design into the process safeguards to reduce, though not eliminate, this risk.
Our management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures must reflect the fact that there are resource constraints and that management necessarily applies its judgment in evaluating the benefits of possible controls and procedures relative to their costs.


32



PART II. OTHER INFORMATION

ITEM 1. LEGAL PROCEEDINGS
We are not currently a party to any material legal proceedings. We may at times be involved in litigation and other legal claims in the ordinary course of business. When appropriate in management’s estimation, we may record reserves in our financial statements for pending litigation and other claims.
ITEM 1A. RISK FACTORS
Investing in our ordinary shares involves a high degree of risk. Our Annual Report on Form 10-K for 2017 (filed with the SEC on February 26, 2018 ) includes a detailed discussion of our business and the risks to our business. You should carefully read that Form 10-K. You should also read and carefully consider the risks described below and the other information in this Quarterly Report on Form 10-Q. The occurrence of any of the events or developments described below could harm our business, financial condition, results of operations and/or growth prospects. In such an event, the market price of our ordinary shares could decline, and you may lose all or part of your investment. Additional risks and uncertainties not presently known to us or that we currently deem immaterial also may impair our business operations.
Risks Relating to Our Financial Position, Our Need for Additional Capital and Our Business
We anticipate that we will incur losses for the foreseeable future and we may never sustain profitability.
We may not generate the cash that is necessary to finance our operations in the foreseeable future. We incurred net losses of $153.2 million, $160.1 million and $80.6 million for the years ended December 31, 2017, 2016 and 2015, respectively. We expect to continue to incur substantial losses for the foreseeable future as we:
support the Phase 2 clinical trial for PRX002/RG7935 being conducted by Roche, conduct our Phase 1 clinical trial for PRX004 and possibly initiate additional clinical trials for these and other programs;
develop and commercialize our product candidates, including PRX002/RG7935 and PRX004;
undertake nonclinical development of other product candidates and initiate clinical trials, if supported by nonclinical data; and
pursue our early stage research and seek to identify additional drug candidates and potentially acquire rights from third parties to drug candidates through licenses, acquisitions or other means.
We must generate significant revenue to achieve and maintain profitability. Even if we succeed in discovering, developing and commercializing one or more drug candidates, we may not be able to generate sufficient revenue and we may never be able to achieve or sustain profitability.
We will require additional capital to fund our operations, and if we are unable to obtain such capital, we will be unable to successfully develop and commercialize drug candidates.
As of March 31, 2018 , we had cash and cash equivalents of $429.0 million . Although we believe, based on our current business plans, that our existing cash and cash equivalents will be sufficient to meet our obligations for at least the next twelve months, we anticipate that we will require additional capital in the future in order to continue the research and development, and eventually commercialization, of our drug candidates. Our future capital requirements will depend on many factors that are currently unknown to us, including, without limitation:
the timing of initiation, progress, results and costs of our clinical trials, including the Phase 2 clinical trial for PRX002/RG7935 and our Phase 1 clinical trial for PRX004;
the timing, initiation, progress, results and costs of these and our other research, development and commercialization activities;
the results of our research and nonclinical studies;
the costs of manufacturing our drug candidates for clinical development as well as for future commercialization needs;
the costs of preparing for commercialization of our drug candidates;

33



the costs of preparing, filing and prosecuting patent applications and maintaining, enforcing and defending intellectual property-related claims;
our ability to establish research collaborations, strategic collaborations, licensing or other arrangements;
the timing, receipt and amount of any payments or royalties that we might receive under current or potential future collaborations;
the costs to satisfy our obligations under current and potential future collaborations; and
the timing, receipt and amount of revenues or royalties, if any, from any approved drug candidates.
We have based our expectations relating to liquidity and capital resources on assumptions that may prove to be wrong, and we could use our available capital resources sooner than we currently expect. Because of the numerous risks and uncertainties associated with the development and commercialization of our product candidates, we are unable to estimate the amounts of increased capital outlays and operating expenses associated with completing the development and commercialization of our current product candidates.
In the pharmaceutical industry, the research and development process is lengthy and involves a high degree of risk and uncertainty. This process is conducted in various stages and, during each stage, there is a substantial risk that product candidates in our research and development pipeline will experience difficulties, delays or failures. This makes it difficult to estimate the total costs to complete our ongoing clinical trials and to estimate anticipated completion dates with any degree of accuracy, which raises concerns that attempts to quantify costs and provide estimates of timing may be misleading by implying a greater degree of certainty than actually exists.
In order to develop and obtain regulatory approval for our product candidates we will need to raise substantial additional funds. We expect to raise any such additional funds through public or private equity or debt financings, collaborative agreements with corporate partners or other arrangements. We cannot assure you that additional funds will be available when we need them on terms that are acceptable to us, or at all. General market conditions may make it very difficult for us to seek or obtain financing from the capital markets. If we raise additional funds by issuing equity securities, substantial dilution to existing shareholders would result. If we raise additional funds by incurring debt financing, the terms of the debt may involve significant cash payment obligations as well as covenants and specific financial ratios that may restrict our ability to operate our business. We may be required to relinquish rights to our technologies or drug candidates or grant licenses on terms that are not favorable to us in order to raise additional funds through strategic alliances, joint ventures or licensing arrangements.
If adequate funds are not available on a timely basis, we may be required to:
terminate or delay clinical trials or other development for one or more of our drug candidates;
delay arrangements for activities that may be necessary to commercialize our drug candidates;
curtail or eliminate our drug research and development programs that are designed to identify new drug candidates; or
cease operations.
In addition, if we do not meet our payment obligations to third parties as they come due, we may be subject to litigation claims. Even if we are successful in defending against these claims, litigation could result in substantial costs and distract management, and may have unfavorable results that could further adversely impact our financial condition.
The United Kingdom s announced withdrawal from the European Union could have a negative effect on global economic conditions and financial markets, EU regulatory procedures and our business.
In June 2016, a majority of voters in the United Kingdom (the “UK”) elected in a national referendum to withdraw from the European Union (the “EU”). In March 2017, the UK government formally initiated the withdrawal process. That pending withdrawal, currently scheduled to occur in or before March 2019, has created significant uncertainty about the future relationship between the UK and the EU, including with respect to the laws and regulations that will apply as the UK determines which EU laws to replace or replicate upon withdrawal. The pending withdrawal has also given rise to calls for the governments of other EU member states to consider withdrawal. These developments, or the perception that any of them could occur, have had and may continue to have a material adverse effect on global economic conditions and the stability of global financial markets, and may significantly reduce global market liquidity and restrict the ability of key market participants to operate in certain financial markets. Any of these factors could depress economic activity and restrict access to capital, which could have a material adverse effect on our business, financial condition, results of operations and growth prospects.

34



  Our future success depends on our ability to retain key personnel and to attract, retain and motivate qualified personnel.
We are highly dependent on key personnel, including Dr. Gene G. Kinney, our President and Chief Executive Officer. There can be no assurance that we will be able to retain Dr. Kinney or any of our key personnel. The loss of the services of Dr. Kinney or any other person on whom we are highly dependent might impede the achievement of our research, development and commercial objectives.
Recruiting and retaining qualified scientific and other personnel are critical to our growth and future success. Competition for qualified personnel in our industry is intense. We may not be able to attract and retain these personnel on acceptable terms given that competition. Failure to recruit and retain qualified personnel could have a material adverse effect on our business, financial condition, results of operations and growth prospects.
Our collaborators, prospective collaborators and suppliers may need assurances that our financial resources and stability on a stand-alone basis are sufficient to satisfy their requirements for doing or continuing to do business with us.
Some of our collaborators, prospective collaborators and suppliers may need assurances that our financial resources and stability on a stand-alone basis are sufficient to satisfy their requirements for doing or continuing to do business with us. If our collaborators, prospective collaborators or suppliers are not satisfied with our financial resources and stability, it could have a material adverse effect on our ability to develop our drug candidates, enter into licenses or other agreements and on our business, financial condition or results of operations.
The agreements we entered into with Elan involve conflicts of interest and therefore may have materially disadvantageous terms to us.
We entered into certain agreements with Elan in connection with our separation from Elan, which set forth the main terms of the separation and provided a framework for our initial relationship with Elan. These agreements may have terms that are materially disadvantageous to us or are otherwise not as favorable as those that might be negotiated between unaffiliated third parties. In December 2013, Elan was acquired by Perrigo Company plc (“Perrigo”), and in February 2014 Perrigo caused Elan to sell all of its shares of Prothena in an underwritten offering. As a result of the acquisition of Elan by Perrigo and the subsequent sale of all of its shares of Prothena, Perrigo may be less willing to collaborate with us in connection with the agreements to which we and Elan are a party and other matters.
We may be adversely affected by earthquakes or other natural disasters.
We have a key facility and operations in the San Francisco Bay Area of Northern California, which in the past has experienced severe earthquakes. If an earthquake, other natural disaster or similar event were to occur and prevent us from using all or a significant portion of those operations or local critical infrastructure, or that otherwise disrupts our operations, it could be difficult or, in certain cases, impossible for us to continue our business for a substantial period of time. We have disaster recovery and business continuity plans, but they may prove to be inadequate in the event of a natural disaster or similar event. We may incur substantial expenses if our disaster recovery and business continuity plans prove to be inadequate. We do not carry earthquake insurance. Furthermore, third parties upon which we are materially dependent upon may be vulnerable to natural disasters or similar events.  Accordingly, such a natural disaster or similar event could have an adverse effect on our business, financial condition or results of operations.
We may experience breaches or similar disruptions of our information technology systems or data.
Our business is increasingly dependent on critical, complex and interdependent information technology systems to support business processes as well as internal and external communications. The size and complexity of those systems make them vulnerable to breakdown, malicious intrusion and computer viruses. We have developed systems and processes that are designed to protect our information technology systems and prevent data loss and other security breaches, including systems and processes designed to reduce the impact of a security breach. However, such measures cannot provide absolute security. Any breakdown, malicious intrusion or computer virus could result in the impairment of key business processes or breach of data security, which could cause us to lose trade secrets or other intellectual property or lead to unauthorized disclosure of personal data of our employees, third parties with which we do business, clinical trial participants or others. Such an event could have an adverse effect on our business, financial condition or results of operations.
We are subject to increasingly complex data protection laws and regulations.
We are subject to various data protection laws and regulations, which are expanding and becoming more complex. In April 2016, the EU General Data Protection Regulation (the “GDPR”) was adopted in the EU and is intended to supersede the current EU Data Protection Directive in May 2018. Under the GDPR, enhanced data protection requirements as well as substantial fines for breaches of personal data will apply and increase our obligations and potential liabilities for the personal data that we process

35



or control. We may be required to implement additional controls to facilitate compliance with the GDPR and other new or evolving data protection laws and regulations. Ensuring our compliance with these laws and regulations involves substantial costs, and it is possible that governmental authorities or third parties will assert that our business practices fail to comply with these laws and regulations. If our operations are found to be in violation of any of such laws and regulations, we may be subject to significant civil, criminal and administrative damages, penalties and fines, as well as reputational harm, which could have a material adverse effect on our business, financial condition or results of operations.
We could be adversely impacted by tax reform in the United States.
The U.S. Tax Cuts and Jobs Act (the “TCJA”) was signed into law on December 22, 2017. The TCJA significantly changes U.S. tax law and includes numerous provisions that will impact our business going forward, including changes to the U.S. federal statutory tax rate, the repeal of alternative minimum tax and additional limits on the deductibility of executive compensation, among other things. Some of those effects are expected to be positive for us, such as the lower statutory tax rate and repeal of the alternative minimum taxes. However, other effects are expected to negative for us, such as the expanded limitations on the deductibility of compensation paid to certain of our executive officers. We have not yet completed an assessment of the impact on us of the TCJA. The actual net effect could be adverse.
Risks Related to the Discovery, Development and Regulatory Approval of Drug Candidates
Our success is largely dependent on the success of our research and development programs. Our drug candidates are in various stages of development and we may not be able to successfully discover, develop, obtain regulatory approval for or commercialize any drug candidates.
The success of our business depends substantially upon our ability to discover, develop, obtain regulatory approval for and commercialize our drug candidates successfully. Our research and development programs are prone to the significant and likely risks of failure inherent in drug development. We intend to continue to invest most of our time and financial resources in our research and development programs.
Although we have an ongoing Phase 2 clinical trial for PRX002/RG7935 and an ongoing Phase 1 clinical trial for PRX004, there is no assurance that this work will support further development of these drug candidates. In addition, we currently do not, and may never, have any other drug candidates in clinical trials and we have not identified drug candidates for many of our research programs.
Before obtaining regulatory approvals for the commercial sale of any drug candidate for a target indication, we must demonstrate with substantial evidence gathered in adequate and well-controlled clinical trials that the drug candidate is safe and effective for use for that target indication. In the U.S., this must be done to the satisfaction of the U.S. Food and Drug Administration (the “FDA”); in the EU this must be done to the satisfaction of the EMA; and in other countries this must be done to the satisfaction of comparable regulatory authorities.
Satisfaction of these and other regulatory requirements is costly, time consuming, uncertain, and subject to unanticipated delays. Despite our efforts, our drug candidates may not:
offer improvement over existing treatment options;
be proven safe and effective in clinical trials; or
meet applicable regulatory standards.
Positive results in nonclinical studies of a drug candidate may not be predictive of similar results in humans during clinical trials, and promising results from early clinical trials of a drug candidate may not be replicated in later clinical trials. Interim results of a clinical trial do not necessarily predict final results. A number of companies in the pharmaceutical and biotechnology industries have suffered significant setbacks in late-stage clinical trials even after achieving promising results in early-stage development. Accordingly, the results from completed nonclinical studies and clinical trials for our drug candidates may not be predictive of the results we may obtain in later stage trials or studies. Our nonclinical studies or clinical trials may produce negative or inconclusive results, and we may decide, or regulators may require us, to conduct additional nonclinical studies or clinical trials, or to discontinue clinical trials altogether.
Furthermore, we have not marketed, distributed or sold any products. Our success will, in addition to the factors discussed above, depend on the successful commercialization of our drug candidates, which may require:
obtaining and maintaining commercial manufacturing arrangements with third-party manufacturers;

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developing the marketing and sales capabilities, internal and/or in collaboration with pharmaceutical companies or contract sales organizations, to market and sell any approved drug; and
acceptance of any approved drug in the medical community and by patients and third-party payors.
Many of these factors are beyond our control. We do not expect any of our drug candidates to be commercially available for several years and some or all may never become commercially available. Accordingly, we may never generate revenues through the sale of products.
We have entered into collaborations and may enter into additional collaborations in the future, and we might not realize the anticipated benefits of such collaborations.
Research, development and/or commercialization collaborations, including those that we have with Roche and Celgene, are subject to numerous risks, which include the following:
collaborators have significant discretion in determining the efforts and resources that they will apply to a collaboration, and might not commit sufficient efforts and resources or might misapply those efforts and resources;
we may have limited influence or control over the approaches to development and commercialization of products candidates in the territories in which our collaboration partners lead development and commercialization;
collaborators might not pursue research, development and commercialization of collaboration product candidates or might elect not to continue or renew research, development or commercialization programs based on clinical trial results, changes in their strategic focus due to the acquisition of competing products, availability of funding or other factors, such as a business combination that diverts resources or creates competing priorities;
collaborators might delay, provide insufficient resources to, or modify or stop clinical trials for collaboration product candidates or require a new formulation of a product candidate for clinical testing;
collaborators could develop or acquire products outside of the collaboration that compete directly or indirectly with our product candidates or require a new formulation of a product candidate for clinical testing;
collaborators with sales, marketing and distribution rights to one or more product candidates might not commit sufficient resources to sales, marketing and distribution or might otherwise fail to successfully commercialize those product candidates;
collaborators might not properly maintain or defend our intellectual property rights or might use our intellectual property improperly or in a way that jeopardizes our intellectual property or exposes us to potential liability;
collaboration activities might result in the collaborator having intellectual property covering our activities or product candidates, which could limit our rights or ability to research, develop or commercialize our product candidates;
disputes might arise between us and a collaborator that could cause a delay or termination of the collaboration or result in costly litigation that diverts management attention and resources; and
collaborations might be terminated, which could result in a need for additional capital to pursue further development or commercialization of our product candidates.
In addition, funding provided by a collaborator might not be sufficient to advance product candidates under the collaboration. For example, although Celgene made a $100 million upfront payment to us and made a $50 million equity investment in us upon entering into the Collaboration Agreement, we might need additional funding to advance product candidates prior to when Celgene decides whether to exercise its license rights to those product candidates.
If a collaborator terminates a collaboration or a development program under a collaboration, including by failing to exercise a license or other option under the collaboration, whether because we fail to meet a milestone or otherwise, any potential revenue from the collaboration would be significantly reduced or eliminated. In addition, we will likely need to either secure other funding to advance research, development and/or commercialization of the relevant product candidate or abandon that program, the development of the relevant product candidate could be significantly delayed, and our cash expenditures could increase significantly if we are to continue research, development and commercialization of the relevant product candidates.
Any one or more of these risks, if realized, could reduce or eliminate future revenue from product candidates under our collaborations, and could have a material adverse effect on our business, financial condition, results of operations and/or growth prospects.

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If clinical trials of our drug candidates are prolonged, delayed, suspended or terminated, we may be unable to commercialize our drug candidates on a timely basis, which would require us to incur additional costs and delay our receipt of any revenue from potential product sales.
We cannot predict whether we will encounter problems with the Phase 2 clinical trial for PRX002/RG7935, our Phase 1 clinical trial for PRX004 or any other future clinical trials that will cause us or any regulatory authority to delay or suspend those clinical trials or delay the analysis of data derived from them. A number of events, including any of the following, could delay the completion of our ongoing or planned clinical trials and negatively impact our ability to obtain regulatory approval for, and to market and sell, a particular drug candidate:
conditions imposed on us by the FDA, the EMA or other comparable regulatory authorities regarding the scope or design of our clinical trials;
delays in obtaining, or our inability to obtain, required approvals from institutional review boards (“IRBs”) or other reviewing entities at clinical sites selected for participation in our clinical trials;
insufficient supply or deficient quality of our drug candidates or other materials necessary to conduct our clinical trials;
delays in obtaining regulatory agency agreement for the conduct of our clinical trials;
lower than anticipated enrollment and/or retention rate of subjects in our clinical trials, which can be impacted by a number of factors, including size of patient population, design of trial protocol, trial length, eligibility criteria, perceived risks and benefits of the study drug, patient proximity to trial sites, patient referral practices of physicians, availability of other treatments for the relevant disease and competition from other clinical trials;
slower than expected rates of events in trials with a composite primary endpoint that is event-based;
serious and unexpected drug-related side effects experienced by subjects in clinical trials; or
failure of our third-party contractors and collaborators to meet their contractual obligations to us or otherwise meet their development or other objectives in a timely manner.
We are dependent upon Roche with respect to further development of PRX002/RG7935. Under the terms of our collaboration with Roche, Roche is responsible for that further development, including the conduct of the ongoing Phase 2 clinical trial and any future clinical trial of that drug candidate.
Clinical trials may also be delayed or terminated as a result of ambiguous or negative data or results. In addition, a clinical trial may be suspended or terminated by us, the FDA, the EMA or other comparable regulatory authorities, the IRBs at the sites where the IRBs are overseeing a trial, or the safety oversight committee overseeing the clinical trial at issue due to a number of factors, including:
failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols;
inspection of the clinical trial operations or trial sites by the FDA, the EMA or other regulatory authorities resulting in the imposition of a clinical hold on or imposition of additional conditions for the conduct of the trial;
interpretation of data by the FDA, the EMA or other regulatory authorities;
requirement by the FDA, the EMA or other regulatory authorities to perform additional studies;
failure to achieve primary or secondary endpoints or other failure to demonstrate efficacy or adequate safety;
unforeseen safety issues; or
lack of adequate funding to continue the clinical trial.
Additionally, changes in regulatory requirements and guidance may occur and we may need to amend clinical trial protocols to reflect these changes. Amendments may require us to resubmit our clinical trial protocols to regulatory authorities and IRBs for reexamination, which may impact the cost, timing or successful completion of a clinical trial.
We do not know whether our clinical trials will be conducted as planned, will need to be restructured or will be completed on schedule, if at all. Delays in our clinical trials will result in increased development costs for our drug candidates. In addition, if we experience delays in the completion of, or if we terminate, any of our clinical trials, the commercial prospects for our drug candidates may be delayed or harmed and our ability to generate product revenues will be delayed or jeopardized. Furthermore,

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many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of a drug candidate.
The regulatory approval processes of the FDA, the EMA and other comparable regulatory authorities are lengthy, time consuming and inherently unpredictable, and if we are ultimately unable to obtain regulatory approval for our drug candidates, our business will be substantially harmed.
The time required to obtain approval by the FDA, the EMA and other comparable regulatory authorities is inherently unpredictable but typically takes many years following the commencement of clinical trials and depends upon numerous factors, including the substantial discretion of the regulatory authorities. In addition, approval policies, regulations, or the type and amount of clinical data necessary to gain approval may change during the course of a drug candidate’s clinical development and may vary among jurisdictions. We have not obtained regulatory approval for any drug candidate and it is possible that none of our existing drug candidates or any drug candidates we may seek to develop in the future will ever obtain regulatory approval.
Our drug candidates could fail to receive regulatory approval for many reasons, including the following:
the FDA, the EMA or comparable regulatory authorities may disagree with the design, implementation or conduct of our clinical trials;
we may be unable to demonstrate to the satisfaction of the FDA, the EMA or comparable regulatory authorities that a drug candidate is safe and effective for its proposed indication;
the results of clinical trials may not meet the level of statistical significance required by the FDA, the EMA or comparable regulatory authorities for approval;
we may be unable to demonstrate that a drug candidate’s clinical and other benefits outweigh its safety risks;
the FDA, the EMA or comparable regulatory authorities may disagree with our interpretation of data from nonclinical studies or clinical trials;
the data collected from clinical trials of our drug candidates may not be sufficient to support the submission of a Biologic License Application (“BLA”) to the FDA, a Marketing Authorization Application (“MAA”) to the EMA or similar applications to comparable regulatory authorities;
the FDA, the EMA or comparable regulatory authorities may fail to approve the manufacturing processes or facilities of third-party manufacturers with which we contract for clinical and commercial supplies; or
the approval policies or regulations of the FDA, the EMA or comparable regulatory authorities may significantly change in a manner rendering our clinical data insufficient for approval.
This lengthy approval process as well as the unpredictability of future clinical trial results may result in our failing to obtain regulatory approval to market our drug candidates, which would significantly harm our business, results of operations and prospects. In addition, even if we were to obtain approval, regulatory authorities may approve any of our drug candidates for fewer or more limited indications than we request, may grant approval contingent on the performance of costly post-marketing clinical trials, or may approve a drug candidate with a label that does not include the labeling claims necessary or desirable for the successful commercialization of that drug candidate. Any of the foregoing scenarios could materially harm the commercial prospects for our drug candidates.
Even if our drug candidates receive regulatory approval in one country or jurisdiction, we may never receive approval or commercialize our products in other countries or jurisdictions.
In order to market drug candidates in a particular country or jurisdiction, we must establish and comply with numerous and varying regulatory requirements of that country or jurisdiction, including with respect to safety and efficacy. Approval procedures vary among countries and can involve additional product testing and additional administrative review periods. The time required to obtain approval in other countries might differ from that required to obtain, for example, FDA approval in the U.S. or EMA approval in the EU. The regulatory approval process in other countries may include all of the risks detailed above regarding FDA approval in the U.S. and EMA approval in the EU as well as other risks. Regulatory approval in one country or jurisdiction does not ensure regulatory approval in another country or jurisdiction, but a failure or delay in obtaining regulatory approval in one country may have a negative effect on the regulatory process in others. Failure to obtain regulatory approval in one country or jurisdiction or any delay or setback in obtaining such approval would impair our ability to develop other markets for that drug candidate.

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Both before and after marketing approval, our drug candidates are subject to ongoing regulatory requirements and continued regulatory review, and if we fail to comply with these continuing requirements, we could be subject to a variety of sanctions and the sale of any approved products could be suspended.
Both before and after regulatory approval to market a particular drug candidate, adverse event reporting, manufacturing, labeling, packaging, storage, distribution, advertising, promotion, record keeping and reporting related to the product are subject to extensive, ongoing regulatory requirements. These requirements include submissions of safety and other post-marketing information and reports, as well as continued compliance with current good manufacturing practice (“cGMP”) requirements and current good clinical practice (“cGCP”) requirements for any clinical trials that we conduct post-approval. Any regulatory approvals that we receive for our drug candidates may also be subject to limitations on the approved indicated uses for which the product may be marketed or to the conditions of approval, or contain requirements for potentially costly post-marketing testing, including Phase 4 clinical trials, and surveillance to monitor the safety and efficacy of the drug candidate. Later discovery of previously unknown problems with a product, including adverse events of unanticipated severity or frequency, or not previously observed in clinical trials, or with our third-party manufacturers or manufacturing processes, or failure to comply with the regulatory requirements of the FDA, the EMA and other comparable regulatory authorities could subject us to administrative or judicially imposed sanctions, including:
restrictions on the marketing of our products or their manufacturing processes;
warning letters;
civil or criminal penalties;
fines;
injunctions;
product seizures or detentions;
import or export bans;
voluntary or mandatory product recalls and related publicity requirements;
suspension or withdrawal of regulatory approvals;
total or partial suspension of production; and
refusal to approve pending applications for marketing approval of new products or supplements to approved applications.
The FDA’s, the EMA’s or other comparable regulatory authorities’ policies may change and additional government regulations may be enacted that could prevent, limit or delay regulatory approval of our drug candidates. If we are slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if we are not able to maintain regulatory compliance, we may lose any marketing approval that we may have obtained, which would adversely affect our business, prospects and ability to achieve or sustain profitability.
If side effects are identified during the time our drug candidates are in development or after they are approved and on the market, we may choose to or be required to perform lengthy additional clinical trials, discontinue development of the affected drug candidate, change the labeling of any such products, or withdraw any such products from the market, any of which would hinder or preclude our ability to generate revenues.
Undesirable side effects caused by our drug candidates could cause us or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA, the EMA or other comparable regulatory authorities. Drug-related side effects could affect patient recruitment or the ability of enrolled patients to complete a trial or result in potential product liability claims. Any of these occurrences may harm our business, financial condition and prospects significantly. Even if any of our drug candidates receives marketing approval, as greater numbers of patients use a drug following its approval, an increase in the incidence or severity of side effects or the incidence of other post-approval problems that were not seen or anticipated during pre-approval clinical trials could result in a number of potentially significant negative consequences, including:
regulatory authorities may withdraw their approval of the product;

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regulatory authorities may require the addition of labeling statements, such as warnings or contraindications, or impose additional safety monitoring or reporting requirements;
we may be required to change the way the product is administered, conduct additional clinical trials;
we could be sued and held liable for harm caused to patients; and
our reputation may suffer.
Any of these events could substantially increase the costs and expenses of developing, commercializing and marketing any such drug candidates or could harm or prevent sales of any approved products.
We deal with hazardous materials and must comply with environmental laws and regulations, which can be expensive and restrict how we do business.
Some of our research and development activities involve the controlled storage, use, and disposal of hazardous materials. We are subject to U.S. federal, state, local and other countries’ and jurisdictions’ laws and regulations governing the use, manufacture, storage, handling and disposal of these hazardous materials. Although we believe that our safety procedures for the handling and disposing of these materials comply with the standards prescribed by these laws and regulations, we cannot eliminate the risk of accidental contamination or injury from these materials. In the event of an accident, state or federal authorities may curtail our use of these materials, and we could be liable for any civil damages that result, which may exceed our financial resources and may seriously harm our business. Because we believe that our laboratory and materials handling policies and practices sufficiently mitigate the likelihood of materials liability or third-party claims, we currently carry no insurance covering such claims. An accident could damage, or force us to shut down, our operations.
Risks Related to the Commercialization of Our Drug Candidates
Even if any of our drug candidates receives regulatory approval, if such approved product does not achieve broad market acceptance, the revenues that we generate from sales of the product will be limited.
Even if any drug candidates we may develop or acquire in the future obtain regulatory approval, they may not gain broad market acceptance among physicians, healthcare payors, patients and the medical community. The degree of market acceptance for any approved drug candidate will depend on a number of factors, including:
the indication and label for the product and the timing of introduction of competitive products;
demonstration of clinical safety and efficacy compared to other products;
prevalence and severity of adverse side effects;
availability of coverage and adequate reimbursement from managed care plans and other third-party payors;
convenience and ease of administration; 
cost-effectiveness;
other potential advantages of alternative treatment methods; and
the effectiveness of marketing and distribution support of the product.
Consequently, even if we discover, develop and commercialize a product, the product may fail to achieve broad market acceptance and we may not be able to generate significant revenue from the product.
The success of PRX002/RG7935 in the United States is dependent upon the strength and performance of our collaboration with Roche. If we fail to maintain our existing collaboration with Roche, such termination would likely have a material adverse effect on our ability to develop and commercialize PRX002/RG7935 and our business. Furthermore, if we opt out of profit and loss sharing with Roche, our revenues from PRX002/RG7935 will be reduced.
The success of sales of PRX002/RG7935 in the U.S. will be dependent on the ability of Roche to successfully develop in collaboration with us, and launch and commercialize PRX002/RG7935, if approved by the FDA, pursuant to the License Agreement we entered into in December 2013. Our collaboration with Roche is complex, particularly with respect to future U.S. commercialization of PRX002/RG7935, with respect to financial provisions, allocations of responsibilities, cost estimates and the respective rights of the parties in decision making. Accordingly, significant aspects of the development and commercialization of PRX002/RG7935 require Roche to execute its responsibilities under the arrangement, or require Roche’s agreement or approval,

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prior to implementation, which could cause significant delays that may materially impact the potential success of PRX002/RG7935 in the U.S. In addition, Roche may under some circumstances independently develop products that compete with PRX002/RG7935, or Roche may decide to not commit sufficient resources to the development, commercialization, marketing and distribution of PRX002/RG7935. If we are not able to collaborate effectively with Roche on plans and efforts to develop and commercialize PRX002/RG7935, our business could be materially adversely affected.
Furthermore, the terms of the License Agreement provide that Roche has the ability to terminate such arrangement for any reason after the first anniversary of the License Agreement at any time upon 90 days’ notice (if prior to first commercial sale) or 180 days’ notice (if after first commercial sale). For example, Roche may determine that the outcomes of clinical trials have made PRX002/RG7935 a less attractive commercial product and terminate our collaboration. If the License Agreement is terminated, our business and our ability to generate revenue from sales of PRX002/RG7935 could be substantially harmed as we will be required to develop, commercialize and build our own sales and marketing organization or enter into another strategic collaboration in order to develop and commercialize PRX002/RG7935 in the U.S. Such efforts may not be successful and, even if successful, would require substantial time and resources to carry out.
The manner in which Roche launches PRX002/RG7935, including the timing of launch and potential pricing, will have a significant impact on the ultimate success of PRX002/RG7935 in the U.S, and the success of the overall commercial arrangement with Roche. If launch of commercial sales of PRX002/RG7935 in the U.S. by Roche is delayed or prevented, our revenue will suffer and our stock price may decline. Further, if launch and resulting sales by Roche are not deemed successful, our business would be harmed and our stock price may decline. Any lesser effort by Roche in its PRX002/RG7935 sales and marketing efforts may result in lower revenue and thus lower profits with respect to the U.S. The outcome of Roche’s commercialization efforts in the U.S. could also have a negative effect on investors’ perception of potential sales of PRX002/RG7935 outside of the U.S., which could also cause a decline in our stock price.
Furthermore, pursuant to the License Agreement, we are responsible for 30% of all development and commercialization costs for PRX002/RG7935 for the treatment of Parkinson’s disease in the U.S., and for any future Licensed Products and/or indications that we opt to co-develop, in each case unless we elect to opt out of profit and loss sharing. If we elect to opt out of profit and loss sharing, we will instead receive sales milestones and royalties, and our revenue, if any, from PRX002/RG7935 will be reduced.
Our right to co-develop PRX002/RG7935 and other Licensed Products under the License Agreement will terminate if we commence certain studies for a competitive product that treats Parkinson’s disease or other indications that we opted to co-develop. In addition, our right to co-promote PRX002/RG7935 and other Licensed Products will terminate if we commence a Phase 3 study for a competitive product that treats Parkinson’s disease.
 Moreover, under the terms of the License Agreement, we rely on Roche to provide us estimates of their costs, revenue and revenue adjustments and royalties, which estimates we use in preparing our quarterly and annual financial reports. If the underlying assumptions on which Roche’s estimates were based prove to be incorrect, actual results or revised estimates supplied by Roche that are materially different from the original estimates could require us to adjust the estimates included in our reported financial results. If material, these adjustments could require us to restate previously reported financial results, which could have a negative effect on our stock price.
Our ability to receive any significant revenue from PRX002/RG7935 will be dependent on Roche’s efforts and our participation in profit and loss sharing, and may result in lower levels of income than if we marketed or developed our product candidates entirely on our own. Roche may not fulfill its obligations or carry out marketing activities for PRX002/RG7935 as diligently as we would like. We could also become involved in disputes with Roche, which could lead to delays in or termination of development or commercialization activities and time-consuming and expensive litigation or arbitration. If Roche terminates or breaches the License Agreement, or otherwise decides not to complete its obligations in a timely manner, the chances of successfully developing, commercializing or marketing PRX002/RG7935 would be materially and adversely affected.
Outside of the United States, we are solely dependent on the efforts and commitments of Roche, either directly or through third parties, to further develop and commercialize PRX002/RG7935. If Roche’s efforts are unsuccessful, our ability to generate future product sales from PRX002/RG7935 outside the United States would be significantly reduced.
Under our License Agreement, outside of the U.S., Roche has responsibility for developing and commercializing PRX002/RG7935 and any future Licensed Products targeting α- synuclein. As a consequence, any progress and commercial success outside of the U.S. is dependent solely on Roche’s efforts and commitment to the program. For example, Roche may delay, reduce or terminate development efforts relating to PRX002/RG7935 outside of the U.S., or under some circumstances independently develop products that compete with PRX002/RG7935, or decide not to commit sufficient resources to the commercialization, marketing and distribution of PRX002/RG7935.

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In the event that Roche does not diligently develop and commercialize PRX002/RG7935, the License Agreement provides us the right to terminate the License Agreement in connection with a material breach uncured for 90 days after notice thereof. However, our ability to enforce the provisions of the License Agreement so as to obtain meaningful recourse within a reasonable timeframe is uncertain. Further, any decision to pursue available remedies including termination would impact the potential success of PRX002/RG7935, including inside the U.S., and we may choose not to terminate as we may not be able to find another partner and any new collaboration likely will not provide comparable financial terms to those in our arrangement with Roche. In the event of our termination, this may require us to develop and commercialize PRX002/RG7935 on our own, which is likely to result in significant additional expense and delay. Significant changes in Roche’s business strategy, resource commitment and the willingness or ability of Roche to complete its obligations under our arrangement could materially affect the potential success of the product. Furthermore, if Roche does not successfully develop and commercialize PRX002/RG7935 outside of the U.S., our potential to generate future revenue outside of the U.S. would be significantly reduced.
If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell approved products, we may be unable to generate product revenue.
We do not currently have a fully-scaled organization for the sales, marketing and distribution of pharmaceutical products. In order to market any products that may be approved by the FDA, the EMA or other comparable regulatory authorities, we must build our sales, marketing, managerial and other non-technical capabilities or make arrangements with third parties to perform these services.
We have entered into the License Agreement with Roche for the development of PRX002/RG7935 and may develop our own sales force and marketing infrastructure to co-promote PRX002/RG7935 in the U.S. for the treatment of Parkinson’s disease and any future Licensed Products approved for Parkinson’s disease in the U.S. If we exercise our co-promotion option and are unable to develop our own sales force and marketing infrastructure to effectively commercialize PRX002/RG7935 or other Licensed Products, our ability to generate additional revenue from potential sales of PRX002/RG7935 or such products in the U.S. may be harmed. In addition, our right to co-promote PRX002/RG7935 and other Licensed Products will terminate if we commence a Phase 3 study for a competitive product that treats Parkinson’s disease.
For any other products that may be approved, if we are unable to establish adequate sales, marketing and distribution capabilities, whether independently or with third parties, we may not be able to generate product revenue and may not become profitable.
If government and third-party payors fail to provide coverage and adequate reimbursement rates for any of our drug candidates that receive regulatory approval, our revenue and prospects for profitability will be harmed.
In both U.S. and non-U.S. markets, our sales of any future products will depend in part upon the availability of reimbursement from third-party payors. Such third-party payors include government health programs such as Medicare, managed care providers, private health insurers, and other organizations. There is significant uncertainty related to the third-party coverage and reimbursement of newly approved drugs. Coverage and reimbursement may not be available for any drug that we or our collaborators commercialize and, even if these are available, the level of reimbursement may not be satisfactory. Third-party payors often rely upon Medicare coverage policy and payment limitations in setting their own reimbursement policies. Third-party payors are also increasingly attempting to contain healthcare costs by demanding price discounts or rebates limiting both coverage and the amounts that they will pay for new drugs, and, as a result, they may not cover or provide adequate payment for our drug candidates. We might need to conduct post-marketing studies in order to demonstrate the cost-effectiveness of any future products to such payors’ satisfaction. Such studies might require us to commit a significant amount of management time and financial and other resources. Our future products might not ultimately be considered cost-effective. Adequate third-party reimbursement might not be available to enable us to maintain price levels sufficient to realize an appropriate return on investment in product development. If coverage and adequate reimbursement are not available or reimbursement is available only to limited levels, we or our collaborators may not be able to successfully commercialize any product candidates for which marketing approval is obtained.
The regulations that govern marketing approvals, pricing, coverage and reimbursement for new drugs vary widely from country to country. Current and future legislation may significantly change the approval requirements in ways that could involve additional costs and cause delays in obtaining approvals. Some countries require approval of the sale price of a drug before it can be marketed. In many countries, the pricing review period begins after marketing or licensing approval is granted. In some countries, prescription pharmaceutical pricing remains subject to continuing governmental control even after initial approval is granted. As a result, we or our collaborators might obtain marketing approval for a drug in a particular country, but then be subject to price regulations that delay commercial launch of the drug, possibly for lengthy time periods, and negatively impact our ability to generate revenue from the sale of the drug in that country. Adverse pricing limitations may hinder our ability to recoup our investment in one or more drug candidates, even if our drug candidates obtain marketing approval.

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U.S. and other governments continue to propose and pass legislation designed to reduce the cost of healthcare. In the U.S., we expect that there will continue to be federal and state proposals to implement similar governmental controls. In addition, recent changes in the Medicare program and increasing emphasis on managed care in the U.S. will continue to put pressure on pharmaceutical product pricing. For example, in 2010, the U.S. Patient Protection and Affordable Care Act, as amended by the U.S. Health Care and Education Reconciliation Act (collectively, the “Healthcare Reform Law”), was enacted. The Healthcare Reform Law substantially changed the way healthcare is financed by both governmental and private insurers and significantly affects the pharmaceutical industry. Among the provisions of the Healthcare Reform Law of importance to the pharmaceutical industry are the following:
an annual, nondeductible fee on any entity that manufactures or imports certain branded prescription drugs and biologic agents, apportioned among these entities according to their market share in certain government healthcare programs;
an increase in the minimum rebates a manufacturer must pay under the U.S. Medicaid Drug Rebate Program to 23.1% and 13.0% of the average manufacturer price for branded and generic drugs, respectively;
expansion of healthcare fraud and abuse laws, including the U.S. False Claims Act and the U.S. Anti-Kickback Statute, new government investigative powers and enhanced penalties for non-compliance;
a new Medicare Part D coverage gap discount program, under which manufacturers must agree to offer 50 percent point-of-sale discounts off negotiated prices of applicable brand drugs to eligible beneficiaries during their coverage gap period, as a condition for the manufacturer’s outpatient drugs to be covered under Medicare Part D;
extension of manufacturers’ Medicaid rebate liability to covered drugs dispensed to individuals who are enrolled in Medicaid managed care organizations;
expansion of eligibility criteria for Medicaid programs by, among other things, allowing states to offer Medicaid coverage to additional individuals and by adding new mandatory eligibility categories for certain individuals with income at or below 133% of the federal poverty level, thereby potentially increasing a manufacturer’s Medicaid rebate liability;
a licensure framework for follow-on biologic products;
expansion of the entities eligible for discounts under the Public Health Service pharmaceutical pricing program;
new requirements under the federal Open Payments program and its implementing regulations;
a new requirement to annually report drug samples that manufacturers and distributors provide to physicians; and
a new Patient-Centered Outcomes Research Institute to oversee, identify priorities in, and conduct comparative clinical effectiveness research, along with funding for such research.
In addition, other legislative changes have been proposed and adopted since the Healthcare Reform Law was enacted. These changes include aggregate reductions to Medicare payments to providers of up to 2% per fiscal year, which went into effect in 2013 and will stay in effect through 2024 unless additional congressional action is taken. In 2013, the U.S. American Taxpayer Relief Act of 2012, among other things, further reduced Medicare payments to several types of providers and increased the statute of limitations period for the government to recover overpayments to providers from three to five years. These new laws may result in additional reductions in Medicare and other healthcare funding, which could have a material adverse effect on customers for our drugs, if approved, and, accordingly, our financial operations.
We expect that the Healthcare Reform Law, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and in additional downward pressure on the price that we receive for any approved drug. Legislation and regulations affecting the pricing of pharmaceuticals might change before our drug candidates are approved for marketing. Any reduction in reimbursement from Medicare or other government healthcare programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability or commercialize our drugs.
 There can be no assurance that our drug candidates, if they are approved for sale in the U.S. or in other countries, will be considered medically reasonable and necessary for a specific indication, that they will be considered cost-effective by third-party payors, that coverage or an adequate level of reimbursement will be available, or that third-party payors’ reimbursement policies will not adversely affect our ability to sell our drug candidates profitably if they are approved for sale.

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The markets for our drug candidates are subject to intense competition. If we are unable to compete effectively, our drug candidates may be rendered noncompetitive or obsolete.
The research, development and commercialization of new drugs is highly competitive. We will face competition with respect to all drug candidates we may develop or commercialize in the future from pharmaceutical and biotechnology companies worldwide. The key factors affecting the success of any approved product will be its indication, label, efficacy, safety profile, drug interactions, method of administration, pricing, coverage, reimbursement and level of promotional activity relative to those of competing drugs.
Furthermore, many large pharmaceutical and biotechnology companies, academic institutions, governmental agencies and other public and private research organizations are pursuing the development of novel drugs that target the same indications we are targeting with our research and development program. We face, and expect to continue to face, intense and increasing competition as new products enter the market and advanced technologies become available. Many of our competitors have:
significantly greater financial, technical and human resources than we have and may be better equipped to discover, develop, manufacture and commercialize drug candidates;
more extensive experience in nonclinical testing and clinical trials, obtaining regulatory approvals and manufacturing and marketing pharmaceutical products;
drug candidates that have been approved or are in late-stage clinical development; and/or
collaborative arrangements in our target markets with leading companies and research institutions.
Competitive products may render our research and development program obsolete or noncompetitive before we can recover the expenses of developing and commercializing our drug candidates. Furthermore, the development of new treatment methods and/or the widespread adoption or increased utilization of any vaccine or development of other products or treatments for the diseases we are targeting could render any of our drug candidates noncompetitive, obsolete or uneconomical. If we successfully develop and obtain approval for a drug candidate, we will face competition based on the safety and effectiveness of the approved product, the timing of its entry into the market in relation to competitive products in development, the availability and cost of supply, marketing and sales capabilities, coverage, reimbursement, price, patent position and other factors. Even if we successfully develop drug candidates but those drug candidates do not achieve and maintain market acceptance, our business will not be successful.
Our drug candidates for which we intend to seek approval as biologic products may face competition sooner than anticipated.
Our drug candidates are regulated by the FDA as biologic products and we intend to seek approval for these products pursuant to the BLA pathway. The U.S. Biologics Price Competition and Innovation Act of 2009 (the “BPCIA”) created an abbreviated pathway for the approval of biosimilar and interchangeable biologic products. The abbreviated regulatory pathway establishes legal authority for the FDA to review and approve biosimilar biologics, including the possible designation of a biosimilar as “interchangeable” based on its similarity to an existing brand product. Under the BPCIA, an application for a biosimilar product cannot be approved by the FDA until 12 years after the original branded product was approved under a BLA. The law is complex and is still being interpreted and implemented by the FDA. As a result, its ultimate impact, implementation, and meaning are subject to uncertainty. While it is uncertain when such processes intended to implement BPCIA may be fully adopted by the FDA, any such processes could have a material adverse effect on the future commercial prospects for our biologic products.
We believe that any of our drug candidates approved as a biologic product under a BLA should qualify for the 12-year period of exclusivity. However, there is a risk that this exclusivity could be shortened due to congressional action or otherwise, or that the FDA will not consider our drug candidates to be reference products for competing products, potentially creating the opportunity for generic competition sooner than anticipated. Moreover, the extent to which a biosimilar, once approved, will be substituted for any one of our reference products in a way that is similar to traditional generic substitution for non-biologic products is not yet clear, and will depend on a number of marketplace and regulatory factors that are still developing.

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We are subject to healthcare and other laws and regulations, including anti-bribery, anti-kickback, fraud and abuse, false claims, physician payment transparency and health information privacy and security laws and regulations, which could expose us to criminal, civil and/or administrative sanctions and penalties, exclusion from governmental healthcare programs or reimbursements, contractual damages and reputational harm.
Our operations and activities are directly, or indirectly through our service providers and collaborators, subject to numerous healthcare and other laws and regulations, including, without limitation, those relating to anti-bribery, anti-kickback, fraud and abuse, false claims, physician payment transparency and health information privacy and security, in the U.S., the EU and other countries and jurisdictions in which we conduct our business. These laws include:
the U.S. Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering or paying remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase or recommendation of an item or service reimbursable under a federal healthcare program, such as the Medicare and Medicaid programs;
U.S. federal and state false claims laws, including the False Claims Act, which impose criminal and civil penalties, including civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented, claims for payment from Medicare, Medicaid, or other third-party payors that are false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;
the U.S. Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), which imposes criminal and civil liability for executing a scheme to defraud any healthcare benefit program and making false statements in connection with the delivery of or payment for healthcare benefits, items or services, and under the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH”) imposes obligations, including mandatory contractual terms, on certain types of individuals and entities with respect to safeguarding the privacy, security and transmission of individually identifiable health information and places restrictions on the use of such information for marketing communications;
the U.S. Physician Payment Sunshine Act, which requires applicable manufacturers of drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to the Centers for Medicare & Medicaid Services (“CMS”) information related to “payments or other transfers of value” made to physicians and teaching hospitals and applicable manufacturers and applicable group purchasing organizations to report annually to CMS ownership and investment interests held by the physicians and their immediate family members;
laws and regulations that apply to sales or marketing arrangements; apply to healthcare items or services reimbursed by non-governmental third-party payors, including private insurers; require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines; that restrict payments that may be made to healthcare providers; require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; and
similar and other laws and regulations in the U.S. (federal, state and local), in the EU (including member countries) and other countries and jurisdictions.
Further, the Healthcare Reform Law, among other things, amended the intent requirements of the U.S. Anti-Kickback Statute and the criminal statutes governing healthcare fraud. A person or entity can now be found guilty of violating the statute without actual knowledge of the statute or specific intent to violate it. In addition, the Healthcare Reform Law provided that the government may assert that a claim including items or services resulting from a violation of the U.S. Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the U.S. False Claims Act.
Ensuring our compliance with applicable healthcare and other laws and regulations involves substantial costs, and it is possible that governmental authorities or third parties will assert that our business practices fail to comply with these laws and regulations. If our operations are found to be in violation of any of such laws and regulations, we may be subject to significant civil, criminal and administrative damages, penalties and fines, as well exclusion from participation in government healthcare programs, curtailment or restructuring of our operations and reputational harm, any of which could have a material adverse effect on our business, financial condition or results of operations.

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If a successful product liability or clinical trial claim or series of claims is brought against us for uninsured liabilities or in excess of insured liabilities, we could incur substantial liability.
The use of our drug candidates in clinical trials and the sale of any products for which we obtain marketing approval will expose us to the risk of product liability and clinical trial liability claims. Product liability claims might be brought against us by consumers, healthcare providers or others selling or otherwise coming into contact with our products. Clinical trial liability claims may be filed against us for damages suffered by clinical trial subjects or their families. If we cannot successfully defend ourselves against product liability claims, we could incur substantial liabilities. In addition, regardless of merit or eventual outcome, product liability claims may result in:
decreased demand for any approved drug candidates;
impairment of our business reputation;
withdrawal of clinical trial participants;
costs of related litigation;
distraction of management’s attention;
substantial monetary awards to patients or other claimants; and
loss of revenues; and the inability to successfully commercialize any approved drug candidates.
We currently have clinical trial liability insurance coverage for all of our clinical trials. However, our insurance coverage may not be sufficient to reimburse us for any expenses or losses we may suffer. Moreover, insurance coverage is becoming increasingly expensive, and, in the future, we may not be able to maintain insurance coverage at a reasonable cost or in sufficient amounts to protect us against losses due to liability. If and when we obtain marketing approval for any of our drug candidates, we intend to expand our insurance coverage to include the sale of commercial products; however, we may be unable to obtain this product liability insurance on commercially reasonable terms. On occasion, large judgments have been awarded in class action lawsuits based on drugs that had unanticipated side effects. A successful product liability claim or series of claims brought against us could cause our ordinary share price to decline and, if judgments exceed our insurance coverage, could decrease our cash and adversely affect our business.
Risks Related to Our Dependence on Third Parties
We rely on third parties to conduct our clinical trials, and those third parties may not perform satisfactorily, including failing to meet established deadlines for the completion of any such clinical trials.
We do not have the ability to independently conduct clinical trials for our drug candidates, and we rely on third parties, such as consultants, contract research organizations, medical institutions and clinical investigators, to assist us with these activities. Our reliance on these third parties for clinical development activities results in reduced control over these activities. Furthermore, these third parties may also have relationships with other entities, some of which may be our competitors. Although we have and will enter into agreements with these third parties, we will be responsible for confirming that our clinical trials are conducted in accordance with their general investigational plans and protocols. Moreover, the FDA, the EMA and other comparable regulatory authorities require us to comply with regulations and standards, commonly referred to as cGCPs, for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the trial participants are adequately protected. Our reliance on third parties does not relieve us of these responsibilities and requirements. If we or any of our third-party contractors fail to comply with applicable cGCPs, the clinical data generated in our clinical trials may be deemed unreliable and the FDA, the EMA or other comparable regulatory authorities may require us to perform additional clinical trials before approving our marketing applications. We cannot assure you that upon inspection by a given regulatory authority, such regulatory authority will determine that any of our clinical trials complies with cGCP regulations. In addition, our clinical trials must be conducted with product produced under cGMP regulations. Our failure to comply with these regulations may require us to repeat clinical trials, which would delay the regulatory approval process.
 To date, we believe our consultants, contract research organizations and other third parties with which we are working have performed well; however, if these third parties do not successfully carry out their contractual duties, meet expected deadlines, or comply with applicable regulations, we may be required to replace them. Although we believe that there are a number of other third-party contractors we could engage to continue these activities, we may not be able to enter into arrangements with alternative third-party contractors or to do so on commercially reasonable terms, which may result in a delay of our planned clinical trials. Accordingly, we may be delayed in obtaining regulatory approvals for our drug candidates and may be delayed in our efforts to successfully develop our drug candidates.

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In addition, our third-party contractors are not our employees, and except for remedies available to us under our agreements with such third-party contractors, we cannot control whether or not they devote sufficient time and resources to our ongoing clinical and nonclinical programs. If third-party contractors do not successfully carry out their contractual duties or obligations or meet expected deadlines, if they need to be replaced or if the quality or accuracy of the clinical data they obtain is compromised due to the failure to adhere to our clinical protocols, regulatory requirements or for other reasons, our clinical trials may be extended, delayed or terminated and we may not be able to obtain regulatory approval for or successfully commercialize our drug candidates. As a result, our results of operations and the commercial prospects for our drug candidates would be harmed, our costs could increase and our ability to generate revenues could be delayed.
If we do not establish additional strategic collaborations, we may have to alter our research and development plans.
Our drug research and development programs and potential commercialization of our drug candidates will require substantial additional cash to fund expenses. Our strategy includes potentially collaborating with additional leading pharmaceutical and biotechnology companies to assist us in furthering development and potential commercialization of some of our drug candidates, in some or all geographies. It may be difficult to enter into one or more of such collaborations in the future. We face significant competition in seeking appropriate collaborators and these collaborations are complex and time-consuming to negotiate and document. We may not be able to negotiate collaborations on acceptable terms, or at all, in which case we may have to curtail the development of a particular drug candidate, reduce or delay its development program or one or more of our other development programs, delay its potential commercialization or increase our expenditures and undertake development or commercialization activities at our own expense. If we elect to increase our expenditures to fund development or commercialization activities on our own, we will need to obtain additional capital, which may not be available to us on acceptable terms, or at all. If we do not have sufficient funds, we will not be able to bring our drug candidates to market and generate product revenue.
We have no manufacturing capacity and depend on third-party manufacturers to supply us with nonclinical and clinical trial supplies of all of our drug candidates, and we will depend on third-party manufacturers to supply us with any drug products for commercial sale if we obtain marketing approval from the FDA, the EMA or any other comparable regulatory authority for any of our drug candidates.
We do not own or operate facilities for the manufacture, packaging, labeling, storage, testing or distribution of nonclinical or clinical supplies of any of our drug candidates. We instead contract with and rely on third parties to manufacture, package, label, store, test and distribute nonclinical and clinical supplies of our drug candidates, and we plan to continue to do so for the foreseeable future. We also rely on third-party consultants to assist us with managing these third-parties and with our manufacturing strategy. If any of these third-parties fail to perform these activities for us, nonclinical or clinical development of our drug candidates could be delayed, which could have an adverse effect on our business, financial condition, results of operations and growth prospects.
If the FDA, the EMA or any other comparable regulatory authority approves any of our drug candidates for commercial sale, we expect to continue to rely, at least initially, on third-parties to manufacture, package, label, store, test and distribute commercial supplies of such approved drug product. Significant scale-up of manufacturing may require additional comparability validation studies, which the FDA, the EMA or other comparable regulatory authorities must review and approve. Our third-party manufacturers might not be able to successfully establish such comparability or increase their manufacturing capacity in a timely or economic manner, or at all. If our third-party manufacturers are unable to successfully establish comparability or increase their manufacturing capacity for any drug product, and we are unable to timely establish our own manufacturing capabilities, the commercial launch of that drug product could be delayed or there could be a shortage in supply, which could have an adverse effect on our business, financial condition, results of operations and growth prospects.
Our third-party manufacturers’ facilities could be damaged by fire, power interruption, information system failure, natural disaster or other similar event, which could cause a delay or shortage in supplies of our drug candidates, which could have an adverse effect on our business, financial condition, results of operations and growth prospects.
Our drug candidates require, and any future drug product will require, precise, high quality manufacturing, packaging, labeling, storage and testing that meet stringent cGMP, other regulatory requirements and other standards. Our third-party manufacturers are subject to ongoing periodic and unannounced inspections by the FDA, the EMA and other comparable regulatory authorities to ensure compliance with these cGMPs, other regulatory requirements and other standards. We do not have control over, and are dependent upon, our third-party manufacturers’ compliance with these cGMPs, regulations and standards. Any failure by a third-party manufacturer to comply with these cGMPs, regulations or standards or that compromises the safety of any of our drug candidates or any drug product could cause a delay or suspension of production of nonclinical or clinical supplies of our drug candidates or commercial supplies of drug products, cause a delay or suspension of nonclinical or clinical development, product approval and commercialization of our drug candidates or drug products, result in seizure or recall of clinical or commercial supplies, result in fines and civil penalties, result in liability for any patient injury or death or otherwise increase our costs, any of

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which could have an adverse effect on our business, financial condition, results of operations and growth prospects. If a third-party manufacturer cannot or fails to perform its contractual commitments, does not have sufficient capacity to meet our nonclinical, clinical or eventual commercial requirements or fails to meet cGMPs, regulations or other standards, we may be required to replace it or qualify an additional third-party manufacturer. Although we believe there are a number of potential alternative manufacturers, the number of manufacturers with the necessary manufacturing and regulatory expertise and facilities to manufacture biologics like our antibodies is limited. In addition, we could incur significant additional costs and delays in identifying and qualifying any new third-party manufacturer, due to the technology transfer to such new manufacturer and because the FDA, the EMA and other comparable regulatory authorities must approve any new manufacturer prior to manufacturing our drug candidates. Such approval would require successful technology transfer, comparability and other testing and compliance inspections. Transferring manufacturing to a new manufacturer could therefore interrupt supply, delay our clinical trials and any commercial launch and/or increase our costs for our drug candidates, any of which could have an adverse effect on our business, financial condition, results of operations and growth prospects.
Roche, with whom we are collaborating on development of PRX002/RG7935, is manufacturing clinical supplies for the Phase 2 clinical trial for PRX002/RG7935 and is expected to do so for any subsequent clinical trials of PRX002/RG7935. We are dependent on Roche to continue to manufacture these clinical supplies.
Rentschler Biotechnologie GmbH (“Rentschler”) is our third-party manufacturer of clinical supplies of our drug candidate PRX004. We are dependent on Rentschler to manufacture these clinical supplies in order to continue our Phase 1 and initiate any other clinical trials for PRX004.
We depend on third-party suppliers for key raw materials used in our manufacturing processes, and the loss of these third-party suppliers or their inability to supply us with adequate raw materials could harm our business.
We rely on third-party suppliers for the raw materials required for the production of our drug candidates. Our dependence on these third-party suppliers and the challenges we may face in obtaining adequate supplies of raw materials involve several risks, including limited control over pricing, availability, quality and delivery schedules. We cannot be certain that our suppliers will continue to provide us with the quantities of these raw materials that we require or satisfy our anticipated specifications and quality requirements. Any supply interruption in limited or sole sourced raw materials could materially harm our ability to manufacture our products until a new source of supply, if any, could be identified and qualified. Although we believe there are currently several other suppliers of these raw materials, we may be unable to find a sufficient alternative supply channel in a reasonable time or on commercially reasonable terms. Any performance failure on the part of our suppliers could delay the development and potential commercialization of our drug candidates, including limiting supplies necessary for clinical trials and regulatory approvals, which would have a material adverse effect on our business.
Risks Related to Our Intellectual Property
If we are unable to adequately protect or enforce the intellectual property relating to our drug candidates our ability to successfully commercialize our drug candidates will be harmed.
Our success depends in part on our ability to obtain patent protection both in the U.S. and in other countries for our drug candidates. Our ability to protect our drug candidates from unauthorized or infringing use by third parties depends in substantial part on our ability to obtain and maintain valid and enforceable patents. Due to evolving legal standards relating to the patentability, validity and enforceability of patents covering pharmaceutical inventions and the scope of claims made under these patents, our ability to obtain, maintain and enforce patents is uncertain and involves complex legal and factual questions. Accordingly, rights under any issued patents may not provide us with sufficient protection for our drug candidates or provide sufficient protection to afford us a commercial advantage against competitive products or processes.
In addition, we cannot guarantee that any patents will issue from any pending or future patent applications owned by or licensed to us or our affiliates. Even if patents have issued or will issue, we cannot guarantee that the claims of these patents are or will be valid or enforceable or will provide us with any significant protection against competitive products or otherwise be commercially valuable to us. Patent applications in the U.S. are maintained in confidence for up to 18 months after their filing. In some cases, however, patent applications remain confidential in the U.S. Patent and Trademark Office (the “USPTO”) for the entire time prior to issuance as a U.S. patent. Similarly, publication of discoveries in the scientific or patent literature often lags behind actual discoveries. Consequently, we cannot be certain that we or our licensors or co-owners were the first to invent, or the first to file patent applications on, our drug candidates or their use as drugs. In the event that a third party has also filed a U.S. patent application relating to our drug candidates or a similar invention, we may have to participate in interference or derivation proceedings declared by the USPTO to determine priority of invention in the U.S. The costs of these proceedings could be substantial and it is possible that our efforts would be unsuccessful, resulting in a loss of our U.S. patent position. Furthermore, we may not have identified all U.S. and non-U.S. patents or published applications that affect our business either by blocking our ability to commercialize our drugs or by covering similar technologies. Composition-of-matter patents on the biological or chemical active

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pharmaceutical ingredient are generally considered to be the strongest form of intellectual property protection for pharmaceutical products, as such patents provide protection without regard to any method of use. We cannot be certain that the claims in our patent applications covering composition-of-matter of our product candidates will be considered patentable by the USPTO and courts in the U.S. or by the patent offices and courts in other countries, nor can we be certain that the claims in our issued composition-of-matter patents will not be found invalid or unenforceable if challenged. Method-of-use patents protect the use of a product for the specified method. This type of patent does not prevent a competitor from making and marketing a product that is identical to our product for an indication that is outside the scope of the patented method. Moreover, even if competitors do not actively promote their product for our targeted indications, physicians may prescribe these products “off-label.” Although off-label prescriptions may infringe or contribute to the infringement of method-of-use patents, the practice is common and such infringement is difficult to prevent or prosecute.
Recent patent reform legislation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents. In 2011, the U.S. Leahy-Smith America Invents Act (the “Leahy-Smith Act”) was signed into law. The Leahy-Smith Act includes a number of significant changes to U.S. patent law. These include provisions that affect the way patent applications are prosecuted, redefine prior art, may affect patent litigation, and switch the U.S. patent system from a “first-to-invent” system to a “first-to-file” system. Under a “first-to-file” system, assuming the other requirements for patentability are met, the first inventor to file a patent application generally will be entitled to the patent on an invention regardless of whether another inventor had made the invention earlier. The USPTO subsequently developed new regulations and procedures to govern administration of the Leahy-Smith Act, and many of the substantive changes to patent law associated with the Leahy-Smith Act, and in particular, the first-to-file provisions, only became effective in 2013. Accordingly, it is not clear what, if any, impact the Leahy-Smith Act will have on the operation of our business. However, the Leahy-Smith Act and its implementation could increase the uncertainties and costs surrounding the prosecution of our patent applications and the enforcement or defense of our issued patents, all of which could have a material adverse effect on our business and financial condition.
We may be subject to a third-party preissuance submission of prior art to the USPTO, or become involved in opposition, derivation, reexamination, inter partes review, post-grant review, or other patent office proceedings or litigation, in the U.S. or elsewhere, challenging our patent rights or the patent rights of others. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate, our patent rights, allow third parties to commercialize our technology or products and compete directly with us, without payment to us, or result in our inability to manufacture or commercialize products without infringing third-party patent rights.
We may not be able to protect our intellectual property rights throughout the world.
The laws of some jurisdictions do not protect intellectual property rights to the same extent as in the U.S. and many companies have encountered significant difficulties in protecting and defending such rights in other jurisdictions. If we encounter such difficulties in protecting or are otherwise precluded from effectively protecting our intellectual property rights in other jurisdictions, our business prospects could be substantially harmed.
We license patent rights from third-party owners. Such licenses may be subject to early termination if we fail to comply with our obligations in our licenses with third parties, which could result in the loss of rights or technology that are material to our business.
We are a party to licenses that give us rights to third-party intellectual property that is necessary or useful for our business, and we may enter into additional licenses in the future. Under these license agreements we are obligated to pay the licensor fees, which may include annual license fees, milestone payments, royalties, a percentage of revenues associated with the licensed technology and a percentage of sublicensing revenue. In addition, under certain of such agreements, we are required to diligently pursue the development of products using the licensed technology. If we fail to comply with these obligations and fail to cure our breach within a specified period of time, the licensor may have the right to terminate the applicable license, in which event we could lose valuable rights and technology that are material to our business.
If the licensor retains control of prosecution of the patents and patent applications licensed to us, we may have limited or no control over the manner in which the licensor chooses to prosecute or maintain its patents and patent applications and have limited or no right to continue to prosecute any patents or patent applications that the licensor elects to abandon.
Litigation regarding patents, patent applications and other proprietary rights may be expensive and time consuming. If we are involved in such litigation, it could cause delays in bringing drug candidates to market and harm our ability to operate.
Our success will depend in part on our ability to operate without infringing the proprietary rights of third parties. Although we are not currently aware of any litigation or other proceedings or third-party claims of intellectual property infringement related to our drug candidates, the pharmaceutical industry is characterized by extensive litigation regarding patents and other intellectual

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property rights. Other parties may hold or obtain patents in the future and allege that the use of our technologies infringes these patent claims or that we are employing their proprietary technology without authorization.
In addition, third parties may challenge or infringe upon our existing or future patents. Proceedings involving our patents or patent applications or those of others could result in adverse decisions regarding:
the patentability of our inventions relating to our drug candidates; and/or
the enforceability, validity or scope of protection offered by our patents relating to our drug candidates.
Even if we are successful in these proceedings, we may incur substantial costs and divert management time and attention in pursuing these proceedings, which could have a material adverse effect on us.
If we are unable to avoid infringing the patent rights of others, we may be required to seek a license, defend an infringement action or challenge the validity of the patents in court. Patent litigation is costly and time consuming. We may not have sufficient resources to bring these actions to a successful conclusion. In addition, if we do not obtain a license, develop or obtain non-infringing technology, fail to defend an infringement action successfully or have infringed patents declared invalid, we may:
incur substantial monetary damages;
encounter significant delays in bringing our drug candidates to market; and/or
be precluded from participating in the manufacture, use or sale of our drug candidates or methods of treatment requiring licenses.
If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets of interest and our business may be adversely affected.
Our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks. We may not be able to protect our rights to these trademarks and trade names, which we need to build name recognition by potential partners or customers in our markets of interest. Over the long term, if we are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively and our business may be adversely affected.
We may be unable to adequately prevent disclosure of trade secrets and other proprietary information.
We rely on trade secrets to protect our proprietary technologies, especially where we do not believe patent protection is appropriate or obtainable; however, trade secrets are difficult to protect. We rely in part on confidentiality agreements with our employees, consultants, outside scientific collaborators, sponsored researchers, and other advisors to protect our trade secrets and other proprietary information. These agreements may not effectively prevent disclosure of confidential information and may not provide an adequate remedy in the event of unauthorized disclosure of confidential information. In addition, others may independently discover our trade secrets and proprietary information. Costly and time-consuming litigation could be necessary to enforce and determine the scope of our proprietary rights, and failure to obtain or maintain trade secret protection could adversely affect our competitive business position.
We may be subject to claims that our employees have wrongfully used or disclosed alleged trade secrets of their former employers.
Many of our employees were previously employed at universities, Elan or Elan subsidiaries, or other biotechnology or pharmaceutical companies, including our competitors or potential competitors. Although we try to ensure that our employees do not use the proprietary information or know-how of others in their work for us, we may be subject to claims that we or these employees have used or disclosed intellectual property, including trade secrets or other proprietary information, of any such employee’s former employer. Litigation may be necessary to defend against these claims. If we fail in defending any such claims, in addition to paying monetary damages, we may lose valuable intellectual property rights or personnel. Even if we are successful in defending against such claims, litigation could result in substantial costs and be a distraction to management.

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Risks Related to Our Ordinary Shares
The market price of our ordinary shares may fluctuate widely.
Our ordinary shares commenced trading on The Nasdaq Global Market on December 21, 2012 and currently trade on The Nasdaq Global Select Market. We cannot predict the prices at which our ordinary shares may trade. The market price of our ordinary shares may fluctuate widely, depending upon many factors, some of which may be beyond our control, including:
our ability to obtain financing as needed;
progress in and results from our ongoing or future clinical trials;
our collaborations with third parties, including with Roche and Celgene;
failure or delays in advancing our nonclinical drug candidates or other drug candidates we may develop in the future into clinical trials;
results of clinical trials conducted by others on drugs that would compete with our drug candidates;
issues in manufacturing our drug candidates;
regulatory developments or enforcement in the U.S. and other countries;
developments or disputes concerning patents or other proprietary rights;
introduction of technological innovations or new commercial products by our competitors;
changes in estimates or recommendations by securities analysts, if any, who cover our company;
public concern over our drug candidates;
litigation;
future sales of our ordinary shares;
general market conditions;
changes in the structure of healthcare payment systems;
failure of any of our drug candidates, if approved, to achieve commercial success;
economic and other external factors or other disasters or crises;
period-to-period fluctuations in our financial results;
overall fluctuations in U.S. equity markets;
our quarterly or annual results, or those of other companies in our industry;
announcements by us or our competitors of significant acquisitions or dispositions;
the operating and ordinary share price performance of other comparable companies;
investor perception of our company and the drug development industry;
natural or environmental disasters that investors believe may affect us;
changes in tax laws or regulations applicable to our business or the interpretations of those tax laws and regulations by taxing authorities; or
fluctuations in the budgets of federal, state and local governmental entities around the world.
These and other external factors may cause the market price and demand for our ordinary shares to fluctuate substantially, which may limit or prevent investors from readily selling their ordinary shares and may otherwise negatively affect the liquidity of our ordinary shares. In particular, stock markets in general have experienced volatility that has often been unrelated to the operating performance of a particular company. These broad market fluctuations may adversely affect the trading price of our

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ordinary shares. In the past, when the market price of a stock has been volatile, some holders of that stock have instituted securities class action litigation against the company that issued the stock. If any of our shareholders brought a lawsuit against us, we could incur substantial costs defending the lawsuit. Such a lawsuit could also divert the time and attention of our management.
Your percentage ownership in Prothena may be diluted in the future.
As with any publicly traded company, your percentage ownership in us may be diluted in the future because of equity issuances for acquisitions, capital raising transactions or otherwise. We may need to raise additional capital in the future. If we are able to raise additional capital, we may issue equity or convertible debt instruments, which may severely dilute your ownership interest in us. In addition, we intend to continue to grant option awards to our directors, officers and employees, which would dilute your ownership stake in us. As of March 31, 2018 , the number of ordinary shares available for issuance pursuant to outstanding and future equity awards under our equity plan was 5,227,086 .
If we are unable to maintain effective internal controls, our business could be adversely affected.
We are subject to the reporting and other obligations under the U.S. Securities Exchange Act of 1934, as amended, including the requirements of Section 404 of the U.S. Sarbanes-Oxley Act, which require annual management assessments of the effectiveness of our internal control over financial reporting. The rules governing the standards that must be met for management to assess our internal control over financial reporting are complex and require significant documentation, testing and possible remediation to meet the detailed standards under the rules. During the course of its testing, our management may identify material weaknesses or deficiencies which may not be remedied in time to meet the deadline imposed by the Sarbanes-Oxley Act. These reporting and other obligations place significant demands on our management and administrative and operational resources, including accounting resources.
Our management is responsible for establishing and maintaining adequate internal control over financial reporting. Our internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of our financial statements for external purposes in accordance with accounting principles generally accepted in the U.S. During the course of our review and testing of our internal controls, we may identify deficiencies and be unable to remediate them before we must provide the required reports. Furthermore, if we have a material weakness in our internal controls over financial reporting, we may not detect errors on a timely basis and our condensed consolidated financial statements may be materially misstated. We or our independent registered public accounting firm, when required, may not be able to conclude on an ongoing basis that we have effective internal control over financial reporting, which could harm our operating results, cause investors to lose confidence in our reported financial information and cause the trading price of our stock to fall.
        We cannot provide assurance that a material weakness will not occur in the future, or that we will be able to conclude on an ongoing basis that we have effective internal controls over financial reporting in accordance with Section 404 and the related rules and regulations of the SEC when required. A material weakness in internal control over financial reporting is a deficiency, or a combination of deficiencies, in internal control over financial reporting, such that there is a reasonable possibility that a material misstatement of a company’s annual or interim consolidated financial statements will not be prevented or detected on a timely basis by the company’s internal controls. If we cannot in the future favorably assess, or our independent registered public accounting firm, when required, is unable to provide an unqualified attestation report on, the effectiveness of our internal controls over financial reporting, investor confidence in the reliability of our financial reports may be adversely affected, which could have a material adverse effect on our share price. In addition, any failure to report our financial results on an accurate and timely basis could result in sanctions, lawsuits, delisting of our shares from the Nasdaq Global Select Market or other adverse consequences that would have an adverse effect on our business, financial position and results of operations.
If we were treated as a passive foreign investment company for U.S. federal income tax purposes, it could result in adverse U.S. federal income tax consequences to United States holders of our ordinary shares .
Significant potential adverse U.S. federal income tax implications generally apply to U.S. investors owning shares of a passive foreign investment company (“PFIC”), directly or indirectly. In general, we would be a PFIC for a taxable year if either (i) 75% or more of our income constitutes passive income (the “income test”), or (ii) 50% or more of our assets produce passive income (the “asset test”). Changes in the composition of our active or passive income, passive assets or fair market value may cause us to become a PFIC. A separate determination must be made each taxable year as to whether we are a PFIC (after the close of each taxable year).
We do not believe we were a PFIC for U.S. federal income tax purposes for our taxable years ended December 31, 2017, 2016 or 2015. However, the application of the PFIC rules is subject to uncertainties in a number of respects, and we cannot assure that the U.S. Internal Revenue Service (the “IRS”) will not take a contrary position. We also cannot assure that we will not be a PFIC for U.S. federal income tax purposes for any future taxable year.

53



We may not be able to successfully maintain our tax rates, which could adversely affect our business and financial condition, results of operations and growth prospects.
We are incorporated in Ireland and maintain subsidiaries or offices in Ireland, the U.S. and other jurisdictions. We are able to achieve a low average tax rate through the performance of certain functions and ownership of certain assets in tax-efficient jurisdictions, together with intra-group service agreements. However, changes in tax laws in any of these jurisdictions could adversely affect our ability to do so in the future. Taxing authorities, such as the IRS, actively audit and otherwise challenge these types of arrangements, and have done so in our industry. We are subject to reviews and audits by the IRS and other taxing authorities from time to time, and the IRS or other taxing authority may challenge our structure and inter-group arrangements. Responding to or defending against challenges from taxing authorities could be expensive and time consuming, and could divert management’s time and focus away from operating our business. We cannot predict whether and when taxing authorities will conduct an audit, challenge our tax structure or the cost involved in responding to any such audit or challenge. If we are unsuccessful, we may be required to pay taxes for prior periods, interest, fines or penalties, and may be obligated to pay increased taxes in the future, all of which could have an adverse effect on our business, financial condition, results of operations or growth prospects.
Future changes to the tax laws relating to multinational corporations could adversely affect us.
Under current law, we are treated as a foreign corporation for U.S. federal tax purposes. However, changes to the U.S. Internal Revenue Code, U.S. Treasury Regulations or other IRS guidance thereunder could adversely affect our status as a foreign corporation or otherwise affect our effective tax rate. In addition, the U.S. Congress, the IRS, the Organization for Economic Co-operation and Development and other governments and agencies in jurisdictions where we do business have recently focused on issues related to the taxation of multinational corporations, and specifically in the area of “base erosion and profit shifting,” where payments are made between affiliates from a jurisdiction with high tax rates to a jurisdiction with lower tax rates. As a result, the tax laws in the U.S. and other countries in which we do business could change on a prospective or retroactive basis, and any such changes could have an adverse effect on our business, financial condition, results of operations or growth prospects.
Irish law differs from the laws in effect in the United States and may afford less protection to holders of our ordinary shares.
It may not be possible to enforce court judgments obtained in the U.S. against us in Ireland based on the civil liability provisions of the U.S. federal or state securities laws. In addition, there is uncertainty as to whether the courts of Ireland would recognize or enforce judgments of U.S. courts obtained against us or our directors or officers based on the civil liabilities provisions of the U.S. federal or state securities laws or hear actions against us or those persons based on those laws. We have been advised that the U.S. currently does not have a treaty with Ireland providing for the reciprocal recognition and enforcement of judgments in civil and commercial matters. Therefore, a final judgment for the payment of money rendered by any U.S. federal or state court based on civil liability, whether or not based solely on federal or state securities laws, would not automatically be enforceable in Ireland.
As an Irish incorporated company, we are governed by the Irish Companies Act 2014 (the “Companies Act”), which differ in some material respects from laws generally applicable to U.S. corporations and shareholders, including, among others, differences relating to interested director and officer transactions and shareholder lawsuits. Likewise, the duties of directors and officers of an Irish company generally are owed to the company only. Shareholders of Irish companies generally do not have a personal right of action against directors or officers of the company and may exercise such rights of action on behalf of the company only in limited circumstances. Accordingly, holders of our ordinary shares may have more difficulty protecting their interests than would holders of securities of a corporation incorporated in a jurisdiction of the U.S.
Irish law differs from the laws in effect in the United States with respect to defending unwanted takeover proposals and may give our board of directors less ability to control negotiations with hostile offerors.
We are subject to the Irish Takeover Panel Act, 1997, Takeover Rules, 2013. Under those Irish Takeover Rules, our Board is not permitted to take any action that might frustrate an offer for our ordinary shares once our Board has received an approach that may lead to an offer or has reason to believe that such an offer is or may be imminent, subject to certain exceptions. Potentially frustrating actions such as (i) the issue of ordinary shares, options or convertible securities, (ii) material acquisitions or disposals, (iii) entering into contracts other than in the ordinary course of business, or (iv) any action, other than seeking alternative offers, which may result in frustration of an offer, are prohibited during the course of an offer or at any earlier time during which our Board has reason to believe an offer is or may be imminent. These provisions may give our Board less ability to control negotiations with hostile offerors and protect the interests of holders of ordinary shares than would be the case for a corporation incorporated in a jurisdiction of the U.S.
Irish law requires that our shareholders renew every five years the authority of our Board of Directors to issue shares and to do so for cash without applying the statutory pre-emption right, and if our shareholders do not renew these authorizations by

54



May 17, 2022 (or any renewal is subject to limitations), our ability to raise additional capital to fund our operations would be limited.
As an Irish incorporated company, we are governed by the Companies Act. The Companies Act requires that every five years our shareholders renew the separate authorities of our Board to (a) allot and issue shares, and (b) opt out of the statutory pre-emption right that otherwise applies to share issuances for cash (which pre-emption right would require that shares issued for cash be offered to our existing shareholders on a pro rata basis before the shares may be issued to new shareholders). Our Constitution currently authorizes our Board to issue ordinary shares up to the amount of our authorized share capital, and to opt out of the statutory pre-emption right for such issuances, and our shareholders renewed those authorizations at our shareholders' annual general meeting held on May 17, 2017. Under Irish law, these authorizations will expire on May 17, 2022, five years after our shareholders last renewed these authorizations. Irish law requires that our shareholders renew the authority for our Board to issue ordinary shares by a resolution approved by not less than 50% of the votes cast at a general meeting of our shareholders. Irish law requires that our shareholders renew the authority of our Board to opt out of the statutory pre-emption right in share issuances for cash by a resolution approved by not less than 75% of the votes cast at a general meeting of our shareholders. If these authorizations are not renewed before May 17, 2022, or are renewed with limitations, our Board would be limited in its ability to issue shares, which would limit our ability to raise additional capital to fund our operations, including the research, development and potential commercialization of our product candidates.
Transfers of our ordinary shares may be subject to Irish stamp duty.
Irish stamp duty may be payable in respect of transfers of our ordinary shares (currently at the rate of 1% of the price paid or the market value of the shares acquired, if greater).
Under the Irish Stamp Duties Consolidation Act, 1999 (the “Stamp Duties Act”), a transfer of our ordinary shares from a seller who holds shares through DTC to a buyer who holds the acquired shares through DTC should not be subject to Irish stamp duty. Shareholders may also transfer their shares into or out of DTC without giving rise to Irish stamp duty provided that there is no change in the beneficial ownership of such shares and the transfer into or out of DTC is not effected in contemplation of a subsequent sale of such shares to a third party; in order to benefit from this exemption from Irish stamp duty, the seller must confirm to us that there is no change in the ultimate beneficial ownership of the shares as a result of the transfer and there is no agreement for the sale of the shares by the beneficial owner to a third party being contemplated.
A transfer of our ordinary shares (i) by a seller who holds shares outside of DTC to any buyer, or (ii) by a seller who holds the shares through DTC to a buyer who holds the acquired shares outside of DTC, may be subject to Irish stamp duty. Payment of any Irish stamp duty is generally a legal obligation of the transferee.
Any Irish stamp duty payable on transfers of our ordinary shares could adversely affect the price of those shares.
We do not anticipate paying cash dividends, and accordingly, shareholders must rely on ordinary share appreciation for any return on their investment.
We anticipate losing money for the foreseeable future and, even if we do ever turn a profit, we intend to retain future earnings, if any, for the development, operation and expansion of our business. Thus, we do not anticipate declaring or paying any cash dividends for the foreseeable future. Therefore, the success of an investment in our ordinary shares will depend upon appreciation in their value and in order to receive any income or realize a return on your investment, you will need to sell your Prothena ordinary shares. There can be no assurance that our ordinary shares will maintain their price or appreciate in value.
Dividends paid by us may be subject to Irish dividend withholding tax.
Although we do not currently anticipate paying cash dividends, if we were to do so in the future, a dividend withholding tax (currently at a rate of 20%) may arise. A number of exemptions from dividend withholding tax exist such that shareholders resident in the U.S. and shareholders resident in other countries that have entered into a double taxation treaty with Ireland may be entitled to exemptions from dividend withholding tax subject to the completion of certain dividend withholding tax declaration forms.
Shareholders entitled to an exemption from Irish dividend withholding tax on any dividends received from us will not be subject to Irish income tax in respect of those dividends, unless they have some connection with Ireland other than their shareholding (for example, they are resident in Ireland). Shareholders who receive dividends subject to Irish dividend withholding tax will generally have no further liability to Irish income tax on those dividends.

55



Prothena ordinary shares received by means of a gift or inheritance could be subject to Irish capital acquisitions tax.
Irish capital acquisitions tax (“CAT”) could apply to a gift or inheritance of our ordinary shares irrespective of the place of residence, ordinary residence or domicile of the parties. This is because our ordinary shares will be regarded as property situated in Ireland. The person who receives the gift or inheritance has primary liability for CAT. Gifts and inheritances passing between spouses are exempt from CAT. It is recommended that each shareholder consult his or her own tax advisor as to the tax consequences of holding our ordinary shares or receiving dividends from us.
ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
None.
ITEM 4. MINE SAFETY DISCLOSURES
Not Applicable.
ITEM 5. OTHER INFORMATION
None.
ITEM 6. EXHIBITS
See the Exhibit Index following the signature page to this Quarterly Report on Form 10-Q for a list of exhibits filed or furnished with this report, which Exhibit Index is incorporated herein by reference.


56



SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, as amended, the Registrant has duly caused this Quarterly Report on Form 10-Q to be signed on its behalf by the undersigned, thereunto duly authorized.

Dated:
May 8, 2018
Prothena Corporation plc
(Registrant)
 
 
 
 
 
/s/ Gene G. Kinney
 
 
Gene G. Kinney
 
 
President and Chief Executive Officer
 
 
 
 
 
/s/ Tran B. Nguyen
 
 
Tran B. Nguyen
 
 
Chief Financial Officer



57



EXHIBIT INDEX

 
 
 
 
Previously Filed
 
Exhibit
No.
 
Description
 
Form
 
File No.
Filing Date
Exhibit
Filed Herewith
10.1(a)
 
 
 
 
 
 
 
X
 
 
 
 
 
 
 
 
 
 
10.1(b)
 
 
 
 
 
 
 
X
 
 
 
 
 
 
 
 
 
 
10.2
 
 
 
 
 
 
 
X
 
 
 
 
 
 
 
 
 
 
10.3
 
 
 
 
 
 
 
X
 
 
 
 
 
 
 
 
 
 
10.4
 
 
 
 
 
 
 
X
 
 
 
 
 
 
 
 
 
 
31.1
 
 
 
 
 
 
 
X
 
 
 
 
 
 
 
 
 
 
31.2
 
 
 
 
 
 
 
X
 
 
 
 
 
 
 
 
 
 
32.1*
 
 
 
 
 
 
 
X
 
 
 
 
 
 
 
 
 
 
101.INS+
 
XBRL Instance Document
 
 
 
 
 
 
X
 
 
 
 
 
 
 
 
 
 
101.SCH+
 
XBRL Taxonomy Extension Schema Document
 
 
 
 
 
 
X
 
 
 
 
 
 
 
 
 
 
101.CAL+
 
XBRL Taxonomy Extension Calculation Linkbase Document
 
 
 
 
 
 
X
 
 
 
 
 
 
 
 
 
 
101.DEF+
 
XBRL Taxonomy Extension Definition Linkbase Document
 
 
 
 
 
 
X
 
 
 
 
 
 
 
 
 
 
101.LAB+
 
XBRL Taxonomy Extension Label Linkbase Document
 
 
 
 
 
 
X
 
 
 
 
 
 
 
 
 
 
101.PRE+
 
XBRL Taxonomy Extension Presentation Linkbase Document
 
 
 
 
 
 
X
_______________
#
Indicates management contract or compensatory plan or arrangement.
Portions of this exhibit (indicated by asterisks) have been omitted pursuant to a request for confidential treatment and this exhibit has been filed separately with the SEC.

58



*
Exhibit 32.1 is being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall such exhibit be deemed to be incorporated by reference in any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise specifically stated in such filing.
+
XBRL information is furnished and not filed for purposes of Sections 11 and 12 of the Securities Act of 1933 and Section 18 of the Securities Exchange Act of 1934, and is not subject to liability under those sections, is not part of any registration statement or prospectus to which it relates and is not incorporated or deemed to be incorporated by reference into any registration statement, prospectus or other document.



59
Exhibit 10.1(a)

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.









LICENSE AGREEMENT
BETWEEN
NEOTOPE BIOSCIENCES LIMITED
AND
THE REGENTS OF THE UNIVERSITY OF CALIFORNIA
FOR
CASE NO. SD2002-035








TABLE OF CONTENTS
ARTICLE 1. DEFINITIONS
2
ARTICLE 2. GRANTS
4
ARTICLE 3. CONSIDERATION
6
ARTICLE 4. REPORTS, RECORDS AND PAYMENTS
8
ARTICLE 5. PATENT MATTERS
11
ARTICLE 6. GOVERNMENTAL MATTERS
14
ARTICLE 7. TERMINATION OR EXPIRATION OF THE AGREEMENT
14
ARTICLE 8. LIMITED WARRANTY AND INDEMNIFICATION
15
ARTICLE 9. USE OF NAMES AND TRADEMARKS
17
ARTICLE 10. MISCELLANEOUS PROVISIONS
17


[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.



LICENSE AGREEMENT
This agreement (“Agreement”) is made by and between NEOTOPE BIOSCIENCES LIMITED, a private limited company incorporated under the laws of Ireland with offices at 25- 28 North Wall Quay, Dublin 1, Ireland (“LICENSEE”) and The Regents of the University of California, a California corporation having its statewide administrative offices at 1111 Franklin Street, Oakland, California 94607-5200 (“UNIVERSITY”), represented by its San Diego campus having an address at University of California, San Diego, Technology Transfer Office, Mail Code 0910, 9500 Gilman Drive, La Jolla, California 92093-0910 (“UCSD”).
This Agreement is effective on the date of the last signature (“Effective Date”).
RECITALS
WHEREAS, the inventions disclosed in UCSD Disclosure Docket No. SD2002-035 and titled “DEVELOPMENT OF AN ANTI-PARKINSON'S VACCINE IN TRANSGENIC MICE” (“Invention”), was made in part by employees of Elan Pharmaceuticals, Inc. (“Elan”), predecessor in interest to Licensee, and arose in part from research at UCSD by Dr. Eliezer Masliah and his associates (hereinafter and collectively, the “Inventors”) and are covered by Patent Rights as defined below;
WHEREAS, the development of the Invention was sponsored in part by Elan and as a consequence this license is subject to overriding obligations to the same under the sponsorship agreement;
WHEREAS, the sponsorship agreement referred to above included the transfer of sponsor’s material to UNIVERSITY and provisions limiting the use of said material;
WHEREAS, Elan assigned its rights in the Invention to Licensee;
WHEREAS, the Inventors are employees of UCSD, and they are obligated to assign all of their right, title and interest in the Invention to UNIVERSITY;
WHEREAS, LICENSEE entered into a secrecy agreement (UC Control No. 2012-20-0615) with UNIVERSITY, effective 5/15/2012, for the purpose of evaluating the Invention (the “Secrecy Agreement”);
WHEREAS, LICENSEE entered into Option Agreements (UC Control No. 2004-12-0016 and 2007-12-0032) with UNIVERSITY, effective 4/1/2003 and 7/11/2006 respectively, arising from the sponsorship agreement;
WHEREAS, UNIVERSITY is desirous that the Invention be developed and utilized to the fullest possible extent so that its benefits can be enjoyed by the general public;
WHEREAS, LICENSEE is desirous of obtaining certain rights from UNIVERSITY for commercial development, use, and sale of the Invention, and the UNIVERSITY is willing to grant such rights; and

1
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.



WHEREAS, LICENSEE understands that UNIVERSITY may publish or otherwise disseminate information concerning the Invention at any time and that LICENSEE is paying consideration thereunder for its early access to the Invention not continued secrecy therein.
NOW, THEREFORE, the parties agree:
ARTICLE 1. DEFINITIONS
The terms, as defined herein, shall have the same meanings in both their singular and plural forms.
1.1      “Affiliate” means any corporation or other business entity which is bound in writing by LICENSEE to the terms set forth in this Agreement and in which LICENSEE owns or controls, directly or indirectly, at least fifty percent (50%) of the outstanding stock or other voting rights entitled to elect directors, or in which LICENSEE is owned or controlled directly or indirectly by at least fifty percent (50%) of the outstanding stock or other voting rights entitled to elect directors; but in any country where the local law does not permit foreign equity participation of at least fifty percent (50%), then an “Affiliate” includes any company in which LICENSEE owns or controls or is owned or controlled by, directly or indirectly, the maximum percentage of outstanding stock or voting rights permitted by local law.
1.2      “Combination Product” means any product which is a Licensed Product (as defined below) and contains other product(s) or product component(s) that is not an excipient, diluent, adjuvant, buffer and the like and (i) does not use Invention, or Patent Rights (as defined below); (ii) the sale, use or import by itself does not contribute to or induce the infringement of Patent Rights; (iii) is sold separately by LICENSEE, its Sublicensee (as defined below) or an Affiliate; and (iv) enhances the market price of the final product(s) sold, used or imported by LICENSEE, its Sublicensee, or an Affiliate.
1.3      " Commercially Reasonable Efforts" means that the LICENSEE will use the efforts of a similarly situated company in its industry entrusted with the exercise of rights under an exclusive patent license but the level of effort will be no less than: (a) marketing Licensed Products in quantities calculated to address anticipated market demand once marketing has begun and (b) seeking needed governmental approvals for marketing Licensed Products with diligence in supplying indicated information to, and replying to, appropriate governmental offices in the process. Commercially Reasonable Efforts shall in no case involve a shelving of the development, marketing or sale of Licensed Products or a suspension of the diligent pursuit of needed governmental approval for Licensed Products.
1.4      “Field” means diagnostic, therapeutic and prophylactic uses, excluding [***].
1.5      "Licensed Method" means any method that is covered by a Valid Claim the use of which would constitute, but for the license granted to LICENSEE under this Agreement and Licensee’s co-ownership interest, an infringement, an inducement to infringe or contributory infringement, of any pending or issued claim within Patent Rights, had LICENSEE not had rights in patents and patent applications claiming Invention.
1.6      "Licensed Product" means any service, composition or product that is covered by a Valid Claim and the manufacture, use, sale, offer for sale, or importation of which would

2
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.



constitute, but for the license granted to LICENSEE under this Agreement and Licensee’s co-ownership interest, an infringement, an inducement to infringe or contributory infringement, of any pending or issued claim within the Patent Rights, had LICENSEE not had rights in patents and patent applications claiming Invention.
1.7      “Net Sales” means the gross amount charged for Licensed Products sold by LICENSEE, Sublicensees and/or Affiliates to third parties, less the sum of (a) and (b) where applicable and if reasonable, separately listed, (a) is a provision for (i) reasonable cash, trade, and quantity discounts or rebates other than price discounts granted at the time of the sale (as allowed under applicable law), 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 retroactive price reductions (including Medicaid, Medicare, government, commercial and similar types of rebates), (iii) sales tax, use tax, tariff, import/export duties or other excise taxes or other governmental charges levied on, attributable to or measured by the billing amount (excluding income, franchise, and value added taxes except to the extent that value added taxes have actually been paid and are not reimbursable), as adjusted for rebates and refunds, (iv) transportation, freight and insurance charges actually incurred and directly related to the distribution of the Licensed Products (excluding amounts reimbursed by third party customers), (v) reasonable credits or allowances actually given or made for wastage replacement, and (vi) taxes paid by LICENSEE, Sublicensees and/or Affiliates 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 Licensed Products by LICENSEE, Sublicensees and/or Affiliates; 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 Licensed 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 Licensed Product to a third party. For purposes of calculating Net Sales, transfers to a Sublicensee or an Affiliate of Licensed Product under this Agreement for (i) end use (but not resale) by the Sublicensee or Affiliate shall be treated as sales by LICENSEE at list price of LICENSEE, or (ii) resale by a Sublicensee or an Affiliate shall be treated as sales at the list price of the Sublicensee or Affiliate.
1.8      “Patent Costs” means all expenses for the preparation, filing, prosecution, and maintenance of all United States and foreign patents included in Patent Rights. Patent Costs shall also include out-of-pocket expenses for patentability opinions, inventorship determination, preparation and prosecution of patent application, re-examination, re-issue, interference, and opposition activities related to patents or applications in Patent Rights.
1.9      “Patent Rights” means UNIVERSITY’s rights in any the US and foreign patent applications described un Exhibit A disclosing and claiming the Invention, filed by Inventors and assigned to UNIVERSITY; and continuing applications thereof including divisions, substitutions, and continuations-in-part (but only to the extent the claims thereof are entirely supported in the specification and entitled to the priority date of the parent application); any patents issuing on said applications including reissues, reexaminations and extensions; and any corresponding foreign applications or patents.

3
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.



1.10      “Sublicense” means an agreement into which LICENSEE enters with a third party that is not an Affiliate for the purpose of (i) granting certain rights; (ii) granting an option to certain rights; or (iii) forbearing the exercise of any rights, granted to LICENSEE under this Agreement.
1.11      Sublicense Fees” means all issue fees, milestone payments and similar license fees received by LICENSEE from its Sublicensees in consideration for the grant of a Sublicense, but excluding: (i) earned royalties based on sales of Licensed Products; (ii) research payments and reimbursement of research or development costs or expenses which are explicitly earmarked for research and development activities in a specific contract (entered into after the Effective Date of this Agreement) with a Sublicensee towards the commercialization of Licensed Products; (iii) amounts paid for purchase of stock or other equity or debt interests in LICENSEE, provided that if such equity investments are at a price greater than fair market value, the premium shall be included in Sublicense Fees; (iv) reimbursement of patent costs and other out-of-pocket costs incurred in connection with filing, prosecuting, and/or maintaining the Patent Rights; and (v) payments received for the supply of goods (including Licensed Products) or services, which is subject to the provisions of Paragraph 3.1d or 3.1f (as applicable).
1.12      “Term” means the period of time beginning on the Effective Date and ending on the expiration date of the longest-lived Patent Rights.
1.13      “Territory” means worldwide where Patent Rights exist.
1.14      “Valid Claim” means any claim of an issued and unexpired patent within Patent Rights that has not been held unenforceable, unpatentable or invalid by a decision of a court or governmental agency of competent jurisdiction, which decision is unappealable or unappealed within the time allowed for appeal.
ARTICLE 2. GRANTS
2.1      License. Subject to the limitations set forth in this Agreement, UNIVERSITY hereby grants to LICENSEE and Affiliates, and LICENSEE hereby accepts, a exclusive license, with the right of Sublicense, under UNIVERSITY’s rights in Patent Rights to make and have made, to use and have used, to sell and have sold, to offer for sale, and to import and have imported Licensed Products and to practice Licensed Methods in the Field within the Territory and during the Term. LICENSEE agrees to be responsible for Affiliates performance of and compliance with the terms of this Agreement.
The license granted herein is exclusive for University’s interests in the Patent Rights.
2.2      Sublicense .
(a)      The license granted in Section 2.1 includes the right of LICENSEE to grant Sublicenses of UNIVERSITY’s interest in the Patent Rights to third parties during the Term but only for as long as this license is exclusive.
(b)      With respect to Sublicense granted pursuant to Paragraph 2.2(a), LICENSEE shall:

4
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.



(i)      not receive, or agree to receive, anything of value in lieu of cash as consideration from a third party under a Sublicense granted to a Sublicensee without the express written consent of UNIVERSITY.
The supply of goods, services, or leased space between the Licensee and Sublicensee shall not be considered non-cash consideration under this paragraph to the extent the supply of goods, services, or leased space are at fair market value for dealings with unrelated third parties and with no premium due to the sublicensed rights in the Patent Rights.
(ii)      to the extent applicable, include in any Sublicense all of the rights of and obligations due to UNIVERSITY and contained in this Agreement;
(iii)      promptly provide UNIVERSITY with a copy of each Sublicense issued, which shall be LICENSEE’s Confidential Information and shall be held in confidence as set forth in Section 10.2. LICENSEE may redact those portions of a Sublicense that do not relate to this Agreement.
(iv)      collect and guarantee payment of all payments due, directly or indirectly, to UNIVERSITY from any Sublicensees and summarize and deliver all reports due, directly or indirectly, to UNIVERSITY from Sublicensees.
(c)      Upon termination of this Agreement for any reason, UNIVERSITY, at its sole discretion, shall determine whether LICENSEE shall cancel or assign to UNIVERSITY any and all Sublicenses.
(d)      If LICENSEE grants a license to a third party under its own interest in any Patent Rights, LICENSEE shall also concurrently grant a Sublicense under Patent Rights to said third party under this Section 2.2.
2.3      Reservation of Rights . Subject to Sections 2.3(d) and (e), UNIVERSITY reserves the right to:
(a)      use the Invention and Patent Rights for educational and research purposes; and
(b)      publish or otherwise disseminate any information about the Invention at any time; and;
(c)      allow other nonprofit institutions to use and publish or otherwise disseminate any information about Invention and Patent Rights for educational and research purposes.
(d)      For the avoidance of doubt, the provisions of that certain Research Agreement dated September 1, 2001 between UNIVERSITY and Elan Pharma International Limited, predecessor in interest to LICENSEE, and its seven amendments, limiting use and transfer of the material continue to apply under this Agreement.
(e)      UNIVERSITY shall request Dr. Eliezer Masliah to notify the UNIVERSITY’s licensing professional responsible for the administration of this Agreement who

5
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.



agrees to provide notice to any corporate sponsor that approaches him with a similar antibody for work in the same therapeutic area that (i) UNIVERSITY’s Patent Rights have been exclusively licensed, and (ii) LICENSEE has patent rights solely owned by LICENSEE , including compositions that may be relevant to the material the potential sponsor is proposing to use in the research project. LICENSEE agrees that UNIVERSITY may provide any such potential sponsor notified under this paragraph 2.3e contact information of LICENSEE.
ARTICLE 3. CONSIDERATION
3.1      Fees and Royalties. The parties hereto understand that the fees and royalties payable by LICENSEE to UNIVERSITY under this Agreement are partial consideration for the license granted herein to LICENSEE and Affiliates under Patent Rights. LICENSEE shall pay UNIVERSITY:
(a)      a license issue fee of [***], within [***] days after the Effective Date;
(b)      license maintenance fees of [***] per year and payable on the first anniversary of the Effective Date and annually thereafter on each anniversary; provided however, that LICENSEE’s obligation to pay this fee shall end on the date when LICENSEE is commercially selling a Licensed Product;
(c)      one-time milestone payments in the amounts payable according to the following schedule or events for each Licensed Product, each payment being due and payable one time only and within [***] days after the occurrence of the corresponding event:
Amount
Date or Event
(i)      [***]

[***]
(ii)      [***]
[***]
(iii)      [***]
[***]
(iv)      [***]
[***]
(v)      [***]
[***]
(vi)      [***]
[***]
(vii)      [***]
[***]
(viii)      [***]
[***]
(ix)      [***]
[***]


(d)      an earned royalty of one percent (1%) on Net Sales of Licensed Products by LICENSEE, Sublicensees and/or its Affiliate(s); provided, however, that the earned

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royalty due on Net Sales of Combination Product by LICENSEE, Sublicensees and/or its Affiliate(s) shall be calculated as below:
Earned Royalties due UNIVERSITY = [A/(A+B)] x Royalty Rate on Net Sales of the Licensed Products x Net Sales of Combination Product, where:
A is the separately listed Net Sale unit price of the Licensed Product or Licensed Product components; and
B is the separately listed sale prices of the individual products or product components, respectively, that satisfy the requirements outlined in Paragraph 1.3 (“Combination Products”).
In the event LICENSEE is required to pay royalties to one or more third parties for rights necessary to make, use or sell Licensed Products, LICENSEE may deduct [***] from the earned royalties payable to UNIVERSITY for every [***] LICENSEE actually pays to said third parties; provided, however, in no event shall the amount payable to UNIVERSITY be less than [***] of the amount otherwise due (Abatement”).
(e)      A percentage of all Sublicense fees received by LICENSEE from its Sublicensees, according to the following schedule:
Percentage
Timing of Sublicense
[***]
[***]
[***]
[***]
[***]
[***]

(f)      Beginning the calendar year of commercial sales of the first Licensed Product by LICENSEE, its Sublicensee, or an Affiliate and if the total earned royalties paid by LICENSEE under Paragraphs 3.1(d) and (f) to UNIVERSITY cumulatively amounts to less than:
(i)      [***];
(ii)      [***];
(iii)      [***],
LICENSEE shall pay to UNIVERSITY the above amounts as a minimum annual royalty on or before February 28 following the last quarter of such year the difference between amount noted above and the total earned royalty paid by LICENSEE for such year under Paragraphs 3.1(d) and (f); provided, however, that for the year of commercial sales of the first Licensed Product, the amount of minimum annual royalty payable shall be pro-rated for the number of months remaining in that calendar year.
(g)      All fees and royalty payments specified in Paragraphs 3.1(a) through 3.1(f) above shall be paid by LICENSEE pursuant to Paragraph 4.3 and shall be delivered by LICENSEE to UNIVERSITY as noted in Paragraph 10.1.

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(h)      The royalties under Sections 3.1(d) and 3.1(e) continue, on a
country-by-country basis, until the expiration of the last to expire patent containing a Valid Claim covering the applicable Licensed Product or Licensed Method.
3.2      Due Diligence .
(a)      LICENSEE shall use Commercially Reasonable Efforts, either directly or through its Affiliate(s) or Sublicensee(s) to:
(i)      diligently proceed with the development, manufacture and sale of Licensed Products;
[***]
(b)      If LICENSEE should reasonably believe it may fail to meet any of its obligations specified in Paragraphs 3.3(a)(iii)-(iv) and provides UNIVERSITY with notice of its concern at least [***] months prior to the relevant date of such obligation, LICENSEE and UNIVERSITY shall enter into good faith negotiations to amend this Agreement to extend the dates for satisfaction of such obligation and, if applicable, the remaining obligations.
(c)      If LICENSEE fails to perform its obligations specified in Paragraphs 3.3(a)(i)-(ii) or the negotiations pursuant to Paragraph 3.3(b) fail to result in an amendment to this Agreement and LICENSEE fails to perform any of its obligations specified in Paragraphs 3.3(a)(iii)-(iv), then UNIVERSITY shall have the right and option to terminate this Agreement. This right, if exercised by UNIVERSITY, supersedes the rights granted in Article 2.
ARTICLE 4. REPORTS, RECORDS AND PAYMENTS
4.1      Reports .
(a)      Progress Reports .
If requested, six months after the Effective Date, UNIVERSITY may request a progress report, and then on the subsequent anniversary after Effective Date and ending on the date of first commercial sale of a Licensed Product in the United States, within [***] days after receipt of UNIVERSITY’s progress report form, LICENSEE will provide an annual progress report relating to LICENSEE’s (and Affiliate’s and Sublicensee’s) activities for the preceding twelve months to develop and test all Licensed Products and obtain governmental approvals necessary for marketing the same (the “Progress Report”). Such Progress Reports shall be due within [***] days after the anniversary of the Effective Date of this Agreement and include a summary of work completed, summary of work in progress, current schedule of anticipated events or milestones, market plans for introduction of Licensed Products, and summary of resources (dollar value) spent in the reporting period. The Progress Reports referred to in this Section 4.1 (a) should be marked with the following title and case number: “License Agreement between UCSD and Neotope, Inc. for case 2002-035.” Progress Reports shall be submitted as attachment to UCSD’s email address: tto-reports@ucsd.edu .

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(b)      Royalty Reports
After the first commercial sale of a Licensed Product anywhere in the world, LICENSEE shall submit to UNIVERSITY semi-annual royalty reports on or before each of May 31 and November 30 of each year. Each May and November royalty report shall cover LICENSEE’S (and each Affiliate’s and Sublicensee’s) activities October through March and April through August, respectively, and shall show:
(i)      the date of first commercial sale of a Licensed Product in each country;
(ii)      the gross sales, deductions as provided in Paragraph 1.6 (Net Sales), and Net Sales during the most recently completed calendar quarter and the royalties, in US dollars, payable with respect thereto;
(iii)      the number of each type of Licensed Product sold;
(iv)      Sublicense fees and royalties received during the most recently completed calendar quarter in US dollars, payable with respect thereto;
(v)      the method used to calculate the royalties; and
(vi)      the exchange rates used.
If no sales of Licensed Products have been made and no Sublicense revenue has been received by LICENSEE during any reporting period, LICENSEE shall so report. The reports referred to in this Section 4.1(b) should be marked with the following title and case number: “License Agreement between UCSD and PROTHENA BIOSCIENCES for case 2002-035” and shall be submitted as attachment to UCSD’s email address: tto-reports@ucsd.edu.
4.2      Records & Audits .
(a)      LICENSEE shall keep, and shall require its Affiliates and Sublicensees to keep, accurate and correct records of all Licensed Products manufactured, used, and sold, and Sublicense fees received under this Agreement. Such records shall be retained by LICENSEE for at least [***] years following a given reporting period.
(b)      All records shall be available during normal business hours for inspection at the expense of UNIVERSITY by UNIVERSITY’s Internal Audit Department or by a Certified Public Accountant selected by UNIVERSITY and in compliance with the other terms of this Agreement for the sole purpose of verifying reports and payments or other compliance issues. Such inspector shall not disclose to UNIVERSITY any information other than information relating to the accuracy of reports and payments made under this Agreement or other compliance issues. In the event that any such inspection shows an under reporting and underpayment in excess of [***] for any twelve-month (12-month) period, UNIVERSITY shall provide LICENSEE with a report of such inspector’s findings and conclusions. If LICENSEE does not dispute the report, then LICENSEE shall pay the cost of the audit as well as any additional sum that would have been payable to UNIVERSITY had the LICENSEE reported correctly, plus an interest charge at a rate of [***] per year. Such interest shall be

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calculated from the date the correct payment was due to UNIVERSITY up to the date when such payment is actually made by LICENSEE. For underpayment not in excess of [***] for any twelve-month (12-month) period, LICENSEE shall pay the difference within [***] days without interest charge or inspection cost. Any unresolved dispute between the parties regarding the report shall first be referred to the Chief Financial Officer of LICENSEE and UNIVERSITY’s Assistant Vice Chancellor, Technology Transfer. If the dispute has not been resolved within [***] days after such referral, then the parties may pursue any and all remedies that may be available under this Agreement, at law and in equity.
4.3      Payments .
(a)      All fees, reimbursements and royalties due UNIVERSITY shall be paid in United States dollars and all checks shall be made payable to “The Regents of the University of California”, referencing UNIVERSITY’s taxpayer identification number, 95-6006144, and sent to UNIVERSITY according to Paragraph 10.1 (Correspondence). When Licensed Products are sold in currencies other than United States dollars, LICENSEE shall first determine the earned royalty in the currency of the country in which Licensed Products were sold and then convert the amount into equivalent United States funds, using the exchange rate quoted in the Wall Street Journal on the last business day of the applicable reporting period.
(b)      Royalty Payments
(i)      Royalties shall accrue when Licensed Products are invoiced, or if not invoiced, when delivered to a third party or Affiliate.
(ii)      LICENSEE shall pay earned royalties quarterly [***]. Each such payment shall be for earned royalties accrued within LICENSEE’s most recently completed calendar quarter.
(iii)      Royalties earned on sales occurring in any country outside the United States (“Ex-US”) or royalty income arising from any Sublicense granted pursuant to this Agreement Ex-US shall not be reduced by LICENSEE for any taxes, fees, or other charges imposed by the government of such country affecting the payment of royalty income to UNIVERSITY, except as allowed under Paragraph 1.7. Payments are actually made by LICENSEE or SUBLICENSEE in fulfillment of UNIVERSITY’s tax liability in any particular country may be credited against earned royalties or fees due UNIVERSITY for that country. LICENSEE shall pay all bank charges resulting from the transfer of such royalty payments. LICENSEE shall deliver to UNIVERSITY, upon UNIVERSITY’s request, proof of payment of all such taxes. Each party shall provide assistance to the other party in seeking any benefits available to such party with respect to government tax withholdings by any relevant law or double tax treaty.
(iv)      If at any time legal restrictions prevent the prompt remittance of part or all royalties by LICENSEE with respect to any country where a Licensed Product is sold or a Sublicense is granted pursuant to this Agreement,

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LICENSEE shall convert the amount owed to UNIVERSITY into US currency and shall pay UNIVERSITY directly from its US sources of funds for as long as the legal restrictions apply.
(v)      In the event that any patent or patent claim within Patent Rights is held invalid in a final decision by a patent office from which no appeal or additional patent prosecution has been or can be taken, or by a court of competent jurisdiction and last resort and from which no appeal has or can be taken, all obligation to pay royalties based solely on that patent or claim or any claim patentably indistinct therefrom shall cease as of the date of such final decision. LICENSEE shall not, however, be relieved from paying any royalties that accrued before the date of such final decision, that are based on another patent or claim not involved in such final decision.
(vi)      Royalty payments under Article 3, recoveries and settlements under Article 5, and royalty reports under 4.1(b) shall be rendered for any and all Licensed Products even if due after expiration of the Agreement. If no utilization of Technology and no applicable Patent Rights existed in the Territory at the time of any making, use, sale, offer for sale, or import, then no royalty payments or royalty reports shall be due.
(c)      Late Payments. In the event royalty, reimbursement and/or fee payments are not received by UNIVERSITY when due, LICENSEE shall pay to UNIVERSITY the interest charges at a rate of [***] per year. Such interest shall be calculated from the date payment was due until actually received by UNIVERSITY.
ARTICLE 5. PATENT MATTERS
5.1      Patent Prosecution and Maintenance .
(a)      LICENSEE agrees to diligently prosecute and maintain the patents and patent applications described under the Patent Rights. LICENSEE shall provide UNIVERSITY with copies of all relevant documentation relating to such prosecution and UNIVERSITY shall keep this documentation confidential. The counsel shall take instructions only from LICENSEE. Additional filings related to the Invention shall determine inventorship in accordance with US patent law and ownership shall follow inventorship. All patent filings and all patent prosecution decisions and related filings (e.g. responses to office actions) shall be at LICENSEE’s final discretion (prosecution includes, but is not limited to, interferences, oppositions and any other inter partes matters originating in a patent office).
(b)      LICENSEE shall consider amending any patent application in Patent Rights to include claims reasonably requested by UNIVERSITY to protect the products contemplated to be sold by LICENSEE under this Agreement.
(c)      If LICENSEE decides to discontinue prosecution or maintenance of any Patent Right, LICENSEE agrees to notify UNIVERSITY in sufficient time for UNIVERSITY to decide whether they wish to assume responsibility for that patent or application. UNIVERSITY will notify LICENSEE of their decision in a timely manner. If UNIVERSITY reasonably disagrees with the abandonment of said Patent

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Right LICENSEE shall continue prosecution or maintenance of such Patent Right as set forth in Sections 5.1(a) and (b).
(d)      Should LICENSEE in its sole discretion decide to apply for an extension of the term of any patent in Patent Rights if appropriate under the Drug Price Competition and Patent Term Restoration Act of 1984 and/or European, Japanese and other foreign counterparts of this law., LICENSEE shall prepare all documents for such application, and UNIVERSITY shall execute such documents and take any other additional action as LICENSEE reasonably requests in connection therewith.
5.2      Patent Infringement .
(a)      In the event that UNIVERSITY (to the extent of the actual knowledge of the licensing professional responsible for the administration of this Agreement) or LICENSEE (to the extent of the actual knowledge of LICENSEE’s employee(s) responsible for the administration of this Agreement) learns of infringement of potential commercial significance in the Field of any Valid Claim, the knowledgeable party will provide the other (i) with written notice of such infringement and (ii) with any evidence of such infringement available to it (the “Infringement Notice”). During the period in which, and in the jurisdiction where, LICENSEE has exclusive rights under this Agreement, neither UNIVERSITY nor LICENSEE will notify a third party (including the infringer) of infringement or put such third party on notice of the existence of any Patent Rights without first obtaining consent of the other. If LICENSEE notifies a third party of infringement or puts such third party on notice of the existence of any Patent Rights with respect to such infringement without first obtaining the written consent of UNIVERSITY and UNIVERSITY is sued in declaratory judgment, UNIVERSITY shall have the right to terminate this Agreement immediately without the obligation to provide [***] days’ notice as set forth in Paragraph 7.1. Both UNIVERSITY and LICENSEE will use their reasonably diligent efforts to cooperate with each other to abate such infringement without litigation.
(b)      If infringing activity of potential commercial significance by the infringer has not been abated within [***] days following the date the Infringement Notice takes effect, LICENSEE shall have the first right to institute suit for patent infringement against the infringer. UNIVERSITY may voluntarily join such suit, but may not thereafter commence suit against the infringer for the acts of infringement that are the subject of LICENSEE’s suit or any judgment rendered in that suit. LICENSEE may not join UNIVERSITY in a suit initiated by LICENSEE without UNIVERSITY’s prior written consent. Since UCSD does not have the authority to commit UNIVERSITY to joining such suit, UCSD shall request and recommend that UNIVERSITY, if deemed to be a necessary party by a court of competent jurisdiction and in the absence of a conflict that would prevent UNIVERSITY from doing so, join such suit at LICENSEE’S expense. LICENSEE will pay any costs incurred by UNIVERSITY arising out of such suit, including but not limited to, any legal fees of counsel that UNIVERSITY selects and retains to represent it in the suit.
(c)      If, within [***] days following the date the Infringement Notice takes effect, infringing activity of potential commercial significance by the infringer has not been abated and if LICENSEE has not brought suit against the infringer, UNIVERSITY

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may institute suit for patent infringement against the infringer. If UNIVERSITY institutes such suit, LICENSEE may not join such suit without UNIVERSITY’s consent and may not thereafter commence suit against the infringer for the acts of infringement that are the subject of UNIVERSITY’s suit or any judgment rendered in that suit. UNIVERSITY shall not admit the invalidity or unenforceability of any Patent Rights without LICENSEE’s prior written consent.
(d)      Notwithstanding anything to the contrary in this Agreement:
(A)    in the event that the infringement or potential infringement pertains to an issued patent included within the Patent Rights and written notice is given under any statute expediting litigation (e.g. the Drug Price Competition and Patent Term Restoration Act of 1984 and/or foreign counterparts of this Law) ("Act"), then the party in receipt of such notice under the Act (in the case of UNIVERSITY to the extent of the actual knowledge of the licensing officer responsible for the administration of this Agreement) shall provide the Infringement Notice to the other party promptly. If the time period is such that the LICENSEE will lose the right to pursue legal remedy for infringement by not notifying a third party or by not filing suit, the notification period and the time period to file suit will be accelerated to within [***] days of the date of such notice under the Act to either party.
(B)    The parties shall cooperate to comply with the provisions of the Patient Protection and Affordable Care Act (H.R. 3590) required to protect and enforce Patent Rights including without limitation the Public Health Service Act (42 U.S.C. 262) Sections 351 (1)(1 )-(6), (8) and (9).
(e)      Any recovery or settlement received in connection with any suit will first be shared by UNIVERSITY and LICENSEE proportionately to cover the litigation costs each incurred except as to those of its costs paid by the other party to this Agreement. In any suit initiated by LICENSEE, any recovery in excess of litigation costs will be shared between LICENSEE and UNIVERSITY as follows: (A) UNIVERSITY will receive [***] of the recovery if UNIVERSITY was not a party in the; or (B) UNIVERSITY will receive [***] of the recovery if UNIVERSITY was a party in the litigation. In any suit initiated by UNIVERSITY, any recovery in excess of litigation costs will be shared between LICENSEE and UNIVERSITY as follows: (A) LICENSEE will receive fifteen percent (15%) of the recovery if LICENSEE was not a party in the suit; or (B) LICENSEE will receive [***] of the recovery if LICENSEE was a party in the litigation. UNIVERSITY and LICENSEE agree [***]. LICENSEE and UNIVERSITY will [***].
(f)      Any agreement made by LICENSEE for purposes of settling litigation or other dispute shall comply with the requirements of Section 2.2 (Sublicenses) of this Agreement.
(g)      Each party will cooperate with the other in litigation proceedings instituted hereunder but at the expense of the party who initiated the suit (unless such suit is being jointly prosecuted by the parties).

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(h)      Any litigation proceedings will be controlled by the party bringing the suit, except that UNIVERSITY may be represented by counsel of its choice in any suit brought by LICENSEE.
5.3      Patent Marking. LICENSEE shall mark all Licensed Products made, used or sold under the terms of this Agreement, or their containers, in accordance with the applicable patent marking laws. LICENSEE shall be responsible for all monetary and legal liabilities arising from or caused by (i) failure to abide by applicable patent marking laws and (ii) any type of incorrect or improper patent marking.
ARTICLE 6. GOVERNMENTAL MATTERS
6.1      Governmental Approval or Registration. If this Agreement or any associated transaction is required by the law of any nation to be either approved or registered with any governmental agency, LICENSEE shall assume all legal obligations to do so. LICENSEE shall notify UNIVERSITY if it becomes aware that this Agreement is subject to a United States or foreign government reporting or approval requirement. LICENSEE shall make all necessary filings and pay all costs including fees, penalties, and all other out-of-pocket costs associated with such reporting or approval process.
6.2      Export Control Laws. LICENSEE shall observe all applicable United States and foreign laws with respect to the transfer of Licensed Products and related technical data to foreign countries, including, without limitation, the International Traffic in Arms Regulations and the Export Administration Regulations.
ARTICLE 7. TERMINATION OR EXPIRATION OF THE AGREEMENT
7.1      Termination by UNIVERSITY .
(a)      If LICENSEE fails to perform or violates any term of this Agreement, then UNIVERSITY may give written notice of default (“Notice of Default”) to LICENSEE. If LICENSEE fails to cure the default within sixty (60) days of the Notice of Default, UNIVERSITY may terminate this Agreement and the license granted herein by a second written notice (“Notice of Termination”) to LICENSEE. If a Notice of Termination is sent to LICENSEE, this Agreement shall automatically terminate on the effective date of that notice. Termination shall not relieve LICENSEE of its obligation to pay any fees owed at the time of termination and shall not impair any accrued right of UNIVERSITY. During the term of any such Notice of Default or period to cure, to the extent the default at issue is a failure to pay past or ongoing Patent Costs as provided for under this Agreement, UNIVERSITY shall have no obligation to incur any new Patent Costs under this Agreement and shall have no obligation to further prosecute Patent Rights or file any new patents under Patent Rights.
(b)      This Agreement will terminate immediately, without the obligation to provide sixty (60) days’ notice as set forth in Paragraph 7.1(a), if LICENSEE files a claim including in any way the assertion that any portion of UNIVERSITY’s Patent Rights is invalid or unenforceable where the filing is by the LICENSEE, a third party on behalf of the LICENSEE, or a third party at the written urging of the LICENSEE.

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(c)      This Agreement shall automatically terminate without the obligation to provide sixty (60) days’ notice as set forth in Paragraph 7.1(a) upon the filing of a petition for relief under the United States Bankruptcy Code by or against the LICENSEE as a debtor or alleged debtor.
7.2      Termination by LICENSEE .
(a)      LICENSEE shall have the right at any time and for any reason to terminate this Agreement upon a ninety (90) day written notice to UNIVERSITY. Said notice shall state LICENSEE’s reason for terminating this Agreement.
(b)      Any termination under Paragraph 7.2(a) shall not relieve LICENSEE of any obligation or liability accrued under this Agreement prior to termination or rescind any payment made to UNIVERSITY or action by LICENSEE prior to the time termination becomes effective. Termination shall not affect in any manner any rights of UNIVERSITY arising under this Agreement prior to termination.
7.3      Survival on Termination or Expiration. The following Paragraphs and Articles shall survive the termination or expiration of this Agreement:
(a)      Article 4 (REPORTS, RECORDS AND PAYMENTS), to the extent by their nature the applicable provisions of Article 4 would be reasonably expected to survive.
(b)      Article 8 (LIMITED WARRANTY AND INDEMNIFICATION);
(c)      Article 9 (USE OF NAMES AND TRADEMARKS); and
(d)      Article 10.
ARTICLE 8. LIMITED WARRANTY AND INDEMNIFICATION
8.1      Limited Warranty .
(a)      UNIVERSITY warrants that it has the lawful right to grant this license. This warranty does not include Patent Rights to the extent assigned, or otherwise licensed, by UNIVERSITY’s inventors to third parties.
(b)      The license granted herein are is provided “AS IS” and without WARRANTY OF MERCHANTABILITY or WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE or any other warranty, express or implied. UNIVERSITY makes no representation or warranty that the Licensed Product, Licensed Method or the use of Patent Rights will not infringe any other patent or other proprietary rights.
(c)      NEITHER PARTY WILL BE LIABLE FOR ANY LOST PROFITS, COSTS OF PROCURING SUBSTITUTE GOODS OR SERVICES, LOST BUSINESS, ENHANCED DAMAGES FOR INTELLECTUAL PROPERTY INFRINGEMENT, OR FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, PUNITIVE, OR OTHER SPECIAL DAMAGES SUFFERED BY THE OTHER PARTY, SUBLICENSEES, OR AFFILIATES ARISING OUT OF OR RELATED TO THIS AGREEMENT FOR ALL CAUSES OF ACTION OF ANY KIND (INCLUDING

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TORT, NEGLIGENCE, STRICT LIABILITY AND BREACH OF WARRANTY) EVEN IF UNIVERSITY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. ALSO, UNIVERSITY WILL NOT BE LIABLE FOR ANY DIRECT DAMAGES SUFFERED BY LICENSEE, SUBLICENSEES, JOINT VENTURES, OR AFFILIATES ARISING OUT OF OR RELATED TO PATENT RIGHTS TO THE EXTENT ASSIGNED, OR OTHERWISE LICENSED, BY UNIVERSITY’S INVENTORS TO THIRD PARTIES.
(d)      Nothing in this Agreement shall be construed as:
(i)      a warranty or representation by UNIVERSITY as to the validity or scope of any Patent Rights;
(ii)      a warranty or representation that anything made, used, sold or otherwise disposed of under any license granted in this Agreement is or shall be free from infringement of patents of third parties;
(iii)      an obligation to bring or prosecute actions or suits against third parties for patent infringement except as provided in Section 5.2 hereof;
(iv)      conferring by implication, estoppel or otherwise any license or rights under any patents of UNIVERSITY other than Patent Rights as defined in this Agreement, regardless of whether those patents are dominant or subordinate to Patent Rights; or
(v)      an obligation to furnish any know-how not provided in Patent Rights.
8.2      Indemnification .
(a)      LICENSEE will, and will require Sublicensees to, indemnify, hold harmless, and defend UNIVERSITY and its officers, employees, and agents; the sponsors of the research that led to the Invention; and the inventors of patents or patent applications under Patent Rights, and their employers; against any and all product liability claims, suits, losses, damages, costs, fees, and expenses resulting from, or arising out of, the exercise of this license or any Sublicense.
(b)      LICENSEE, at its sole cost and expense, shall insure its activities in connection with the work under this Agreement and obtain, keep in force and maintain insurance or an equivalent program of self-insurance as follows:
comprehensive or commercial general liability insurance (contractual liability included) with limits of at least:
(i)      [***]
(ii)      [***]
(iii)      Worker’s Compensation as legally required in the jurisdiction in which the LICENSEE is doing business; and

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(iv)      the coverage and limits referred to above shall not in any way limit the liability of LICENSEE.
(c)      UNIVERSITY shall notify LICENSEE in writing of any claim or suit brought against UNIVERSITY in respect of which UNIVERSITY intends to invoke the provisions of this Article. LICENSEE shall keep UNIVERSITY informed on a current basis of its defense of any claims under this Article. LICENSEE will not settle any claim against UNIVERSITY without UNIVERSITY’s written consent, where (a) such settlement would include any admission of liability or admission of wrong doing on the part of the indemnified party, (b) such settlement would impose any restriction on UNIVERSITY/indemnified party’s conduct of any of its activities, or (c) such settlement would not include an unconditional release of UNIVERSITY/indemnified party from all liability for claims that are the subject matter of the settled claim.
ARTICLE 9. USE OF NAMES AND TRADEMARKS
9.1      Except as provided in 9.3, nothing contained in this Agreement confers any right to use in advertising, publicity, or other promotional activities any name, trade name, trademark, or other designation of either party hereto (including contraction, abbreviation or simulation of any of the foregoing). Unless required by law, and except for investor presentations and in connection with due diligence, the use by LICENSEE of the name, “The Regents of the University of California” or the name of any campus of the University of California in advertising, publicity, or other promotional activities is prohibited, without the express written consent of UNIVERSITY.
9.2      UNIVERSITY may disclose to the Inventors the terms and conditions of this Agreement upon their request. If such disclosure is made, UNIVERSITY shall request the Inventors not disclose such terms and conditions to others.
9.3      The parties may acknowledge the existence of this Agreement and the extent of the grant in Article 2 to third parties, but shall not, without the prior written consent of the other party, such consent not to be unreasonably withheld, conditioned, or delayed, disclose the financial terms of this Agreement to third parties, except where required by law to do so, such as under the California Public Records Act.
LICENSEE does not grant UNIVERSITY (including UCSD) permission to include LICENSEE’s name and a link to LICENSEE’s website in UNIVERSITY’s and UCSD’s annual reports and on UNIVERSITY’s (including UCSD’s) websites that showcase technology transfer related stories.
ARTICLE 10. MISCELLANEOUS PROVISIONS
10.1      Correspondence. Any notice or payment required to be given to either party under this Agreement shall be deemed to have been properly given and effective:
(a)      on the date of delivery if delivered in person, or
(b)      five (5) days after mailing if mailed by first-class or certified mail, postage paid, to the respective addresses given below, or to such other address as is designated by written notice given to the other party.

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If sent to LICENSEE:
Notices:
Neotope Biosciences Limited
25-28 North Wall Quay
Dublin 1 Ireland
Attention: Director
With a copy to:
Prothena Biosciences Inc,
650 Gateway Boulevard
South San Francisco, CA 94080
Attn: Tara Nickerson
Invoices:     accounting@prothena.com
If sent to UNIVERSITY by mail:
University of California, San Diego
Technology Transfer Office
9500 Gilman Drive, Mail Code 0910
La Jolla, CA 92093-0910 Attention:
Assistant Vice Chancellor
If sent to UNIVERSITY by courier:
University of California, San Diego
Technology Transfer Office
10300 North Torrey Pines Road
Torrey Pines Center North, Third Floor
La Jolla, CA 92037
Attention: Assistant Vice Chancellor
10.2      Secrecy .
(a)      “Confidential Information” shall mean information, relating to the Invention and the Patent Rights, and information disclosed by a party to the other party in connection with negotiation, terms and performance of this Agreement which if disclosed in writing shall be marked “Confidential”, or if first disclosed otherwise, shall within [***] days of such disclosure be reduced to writing by UNIVERSITY and sent to LICENSEE:
(b)      The receiving party shall:
(i)      use the Confidential Information for the sole purpose of performing under the terms of this Agreement;
(ii)      safeguard Confidential Information against disclosure to others with the same degree of care as it exercises with its own data of a similar nature;

18
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.



(iii)      except as otherwise permitted herein, not disclose Confidential Information to others (except to its employees (not applicable to UNIVERSITY’s employees, except to the extent related to the terms of this Agreement), agents, Sublicensees, Affiliates or consultants who are bound to the receiving party by a like obligation of confidentiality) without the express written permission of the disclosing party, except that the receiving party shall not be prevented from using or disclosing any of the Confidential Information that:
(A)      the receiving party can demonstrate by written records was previously known to it;
(B)      is now, or becomes in the future, public knowledge other than through acts or omissions of the receiving party;
(C)      is lawfully obtained by the receiving party from sources independent of disclosing party; or
(D)      is required to be disclosed by law or a court of competent jurisdiction; and
(c)      The secrecy obligations of the parties with respect to Confidential Information shall continue for a period ending [***] years from the termination date of this Agreement.
(d)      Notwithstanding the foregoing, LICENSEE may, without UNIVERSITY’s prior consent, disclose this Agreement to potential Sublicensees in connection with due diligence.
10.3      Assignability. This Agreement shall be binding upon and inure to the benefit of LICENSEE and UNIVERSITY and their respective successors and permitted assigns. Neither party may delegate its obligations under this Agreement or assign or otherwise transfer this Agreement without the prior written consent of the other party; provided, however, that either party may, without prior consent, assign this Agreement and/or the rights and obligations thereunder to an Affiliate, or to a third party who acquires all, or substantially all of the business relating to the subject matter of this Agreement. The parties agree to notify the other party of any such assignment.
10.4      No Waiver. No waiver by either party of any breach or default of any covenant or agreement set forth in this Agreement shall be deemed a waiver as to any subsequent and/or similar breach or default.
10.5      Governing Laws. THIS AGREEMENT SHALL BE INTERPRETED AND CONSTRUED IN ACCORDANCE WITH THE LAWS OF THE STATE OF CALIFORNIA, but the scope and validity of any patent or patent application shall be governed by the applicable laws of the country of the patent or patent application.
10.6      Force Majeure. A party to this Agreement may be excused from any performance required herein if such performance is rendered impossible or unfeasible due to any catastrophe or other major event beyond its reasonable control, including, without limitation,

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[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.



war, riot, and insurrection; laws, proclamations, edicts, ordinances, or regulations; strikes, lockouts, or other serious labor disputes; and floods, fires, explosions, or other natural disasters. When such events have abated, the non-performing party’s obligations herein shall resume.
10.7      Headings. The headings of the several sections are inserted for convenience of reference only and are not intended to be a part of or to affect the meaning or interpretation of this Agreement.
10.8      Entire Agreement. This Agreement embodies the entire understanding of the parties and supersedes all previous communications, representations or understandings, either oral or written, between the parties relating to the subject matter hereof; provided, however, that the Secrecy Agreement shall remain in full force and effect for all disclosures between the parties prior to the Effective Date of this Agreement.
10.9      Amendments. No amendment or modification of this Agreement shall be valid or binding on the parties unless made in writing and signed on behalf of each party.
10.10      Severability. In the event that any of the provisions contained in this Agreement is held to be invalid, illegal, or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect any other provisions of this Agreement, and this Agreement shall be construed as if the invalid, illegal, or unenforceable provisions had never been contained in it.
IN WITNESS WHEREOF , both UNIVERSITY and LICENSEE have executed this Agreement, in duplicate originals, by their respective and duly authorized officers on the day and year written.
NEOTOPE BIOSCIENCES LTD.
THE REGENTS OF THE UNIVERSITY OF CALIFORNIA:
By: /s/ Shane Cooke    
By: /s/ Jane Moores       
(Signature)
(Signature)
Name:     Shane Cooke    
Jane Moores, PH.D.
Title:     Director    
Assistant Vice Chancellor-Technology Transfer
Date:     04 November 2013   
Date:     10/21/13             

I concur in Sections 2.3(e) and 10.2 (subject to UNIVERSITY's rights in Sections 2.3a-c) only as they exist on the date of my signature. I am not a party to this Agreement.
By: /s/ Eliezer Masliah        
(Signature)
Dr. Eliezer Masliah
    

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[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.



Exhibit A
Created 10/23/2012
[***]


1
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

Exhibit 10.1(b)

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

LICENSE AGREEMENT
AMENDMENT NUMBER ONE
This License Agreement Amendment Number One (the “Amendment”) is made as of January 15, 2014 (the “Amendment Effective Date”) by and between Neotope Biosciences Limited, a private limited company incorporated under the laws of Ireland with offices at 25-28 North Wall Quay, Dublin 1, Ireland (“LICENSEE”) and The Regents of the University of California, a California corporation having its statewide administrative offices at 1111 Franklin Street, Oakland, California 94607-5200 (“UNIVERSITY”), represented by its San Diego campus having an address at University of California, San Diego, Technology Transfer Office, Mail Code 0910, 9500 Gilman Drive, La Jolla, California 92093-0910 (“UCSD”).
RECITALS
WHEREAS, LICENSEE and UNIVERSITY have previously entered a license agreement effective November 4, 2013 (the “Agreement”);
WHEREAS, LICENSEE wishes to sublicense its rights under the Agreement to F. HOFFMANN-LA ROCHE LTD, a Swiss corporation with a principal place of business at Grenzacherstrasse 124, 4070 Basel, Switzerland (“Roche Basel”) and HOFFMANN-LA ROCHE INC., a New Jersey corporation with a principal place of business at 340 Kingsland Street, Nutley, New Jersey, U.S.A. 07110 (“Roche Nutley”, and together with Roche Basel, “Roche”);
WHEREAS, LICENSEE and Roche have entered into a separate research, development and commercialization agreement relating to Licensed Products and Patent Rights and other products and patent rights (the “Collaboration Agreement”);
WHEREAS, Roche wishes to enter into a Sublicense on terms that differ in some respects from the terms of the Agreement [***] and consistent with terms in the Collaboration Agreement; and
WHEREAS, LICENSEE and UNIVERSITY mutually desire to amend the Agreement to modify certain terms acceptable to Roche; such modifications are applicable only to the Roche Sublicense unless otherwise agreed between the parties;
NOW, THEREFORE, the parties agree as follows, effective as of the Amendment Effective Date:
TERMS AND CONDITIONS
1.    Section 1.2 of the Agreement shall be amended to read as follows:
“1.2 “Combination Product” means a single pharmaceutical formulation containing as its active ingredients both a Licensed Compound and one or more other therapeutically or prophylactically active ingredients or a combination therapy comprised of a Licensed Compound and one or more




other therapeutically or prophylactically active products, priced and sold in a single package containing such multiple products or packaged separately but sold together for a single price in each case, including all dosage forms, formulations, presentations, line extensions, and package configurations. All references to a Licensed Product in this Agreement shall be deemed to include a Combination Product.
2.    Section 1.3 of the Agreement shall be amended to add the following sentence:
“Notwithstanding the foregoing, the definition of Commercially Reasonable Efforts during the term of the Collaboration Agreement shall be as set forth in Schedule 1.3.”
3.
Section 1.7 of the Agreement shall be amended to add the following paragraph:
“Notwithstanding the foregoing, with respect to Licensed Products sold by Roche, its affiliates or sublicensees during the term of the Collaboration Agreement, the foregoing provisions of this Section 1.7 shall not apply and instead the terms set forth in Schedule 1.7 shall apply.”
4.
Article 1 of the Agreement shall be amended to add the following sections:
“1.15    “Collaboration Agreement” means the License, Development, and Commercialization Agreement between LICENSEE and Prothena Biosciences Inc, on the one hand, and Roche, on the other hand, dated December 11, 2013.”
1.16     “Roche” means F .Hoffman-La Roche Ltd and Hoffmann-La Roche Inc.”
5.    Section 2.2(b)(iii) of the Agreement shall be amended to add the following sentence:
“For the avoidance of doubt, LICENSEE shall have no obligation to provide UNIVERSITY with a copy of any sublicense entered into between Roche and its Affiliates or subcontractors. The obligation to provide UNIVERSITY with a copy of any sublicense with a non-affiliated third party for the commercial development of Licensed Products shall remain.”
6.    Section 2.2(b)(iv) of the Agreement shall be amended to add the following sentence:
“For the avoidance of doubt, LICENSEE shall have no obligation to collect payments from any sublicensee of Roche. The obligation to guarantee such payments shall remain a provision of the Agreement.”
7.
Section 3.2(b) of the Agreement shall be amended to read as follows:
“If LICENSEE should reasonably believe it may fail to meet any of its obligations specified in Paragraph 3.2(a)(iii)-(iv) or 3.2(d), as applicable, and provides

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


UNIVERSITY with notice of its concern at least [***] months prior to the relevant date of such obligation, LICENSEE and UNIVERSITY shall enter into good faith negotiations to amend this Agreement to extend the dates or otherwise modify the conditions for satisfaction of such obligations.”
8.    Section 3.2(c) of the Agreement shall be amended to read as follows:
“If LICENSEE fails to perform its obligations specified in Paragraph 3.2(a)(i)-(ii) or 3.2(d), as applicable, or the negotiations pursuant to Paragraph 3.2(b) fail to result in an amendment to this Agreement and LICENSEE fails to perform any of its obligations specified in Paragraphs 3.2(a)(iii)-(iv) or 3.2(d), as applicable, then UNIVERSITY shall have the right and option to terminate this Agreement. This right, if exercised by UNIVERSITY, supersedes the rights granted in Article 2.”
9.    Section 3.2 of the Agreement shall be amended to add new Section 3.2(d) as follows:
“(d)
Notwithstanding the foregoing, during the term of the Collaboration Agreement, Roche’s and LICENSEE’s and its Affiliates’ obligations of due diligence shall be subject to Schedule 3.2(d).”
10.     Article 4 of the Agreement shall be amended to add the following introductory paragraph:
“Except with respect to activities performed pursuant to the Collaboration Agreement during the term of the Collaboration Agreement, Sections 4.1, 4.2 and 4.3 shall apply. In the case of activities performed pursuant to the Collaboration Agreement, the provisions set forth in Schedule 4 shall apply.”

11.    Schedules 1.3, 1.7, 3.2(d) and 4 appended hereto as Exhibits A, B, C and D respectively, shall be added to the Agreement.
12.    Except as modified herein, the Agreement remains in full force and effect and is hereby incorporated by this reference. Capitalized terms not otherwise defined herein shall have the meanings contained in the Agreement.

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.



Accepted and Agreed:

NEOTOPE BIOSCIENCES LIMITED
THE REGENTS OF THE UNIVERSITY
OF CALIFORNIA


By:
/s/ Shane Cook         By:     /s/ Jane C. Moores    

Name:
Shane Cooke         Name:    Jane C. Moores, Ph.D

Title:
Director         Title:    Assistant Vice Chancellor,
    Technology Transfer

Date:
17 January 2014         Date:     1/14/14    

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.



EXHIBIT A
Schedule 1.3
Commercially Reasonable Efforts by Roche
“Commercially Reasonable Efforts” means such level of efforts required to carry out such obligation in a sustained manner consistent with the efforts that Roche devotes at the same stage of development or commercialization, as applicable, for its own internally developed pharmaceutical products in a similar area with similar market potential, at a similar stage of their product life taking into account the existence of other competitive products in the market place or under development, the proprietary position of the product, the regulatory structure involved, the anticipated profitability of the product and other relevant factors. It is understood that such product potential may change from time to time based upon changing scientific, business and marketing and return on investment considerations. The parties acknowledge that Roche (and its Affiliates) does not always seek to market its own products in every country or seek to obtain regulatory approval in every country or for every potential indication. [***]

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


EXHIBIT B
Schedule 1. 7
Net Sales Definition Applicable to Roche
“Net Sales” means, for a Licensed Product in a particular period, the amount calculated by subtracting from the Sales of such Licensed Product for such period: (a) a lump sum deduction of [***] in lieu of those deductions that are not accounted for on a Licensed Product-by­Licensed Product basis, including without limitation freight, postage charges, transportation insurance, packing materials for dispatch of goods, custom duties; (b) uncollectible amounts accrued during such period based on [***] in accordance with the then-currently used IFRS in the calculation of Sales of such Licensed Product for such period; and (c) government mandated fees and taxes (excluding income or franchise taxes) and [***] in accordance with the then-currently used IFRS in the calculation of Sales of such Licensed Product for such period, including, for example, any fees, taxes or other charges that become due in connection with [***]. For clarity, any given deduction shall be taken only under one of subsections (a) and (b), and only once in calculating Net Sales.
[***]
“Sales” means, for a Licensed Product in a particular period, the sum of (a) and (b) below:
(a)    The amount [***] with respect to such Licensed Product for such period [***]. This amount reflects the [*** ] taken in accordance with the then-currently used IFRS. By way of example, the gross-to-net deductions taken in accordance with IFRS as of the Effective Date include the following:
[***]
For clarity, any given deduction shall be taken only under one of subsections (i) through (v), and only once in calculating Sales. For purposes of clarity, sales by Roche and its Affiliates to any sublicensees that are not Affiliates of Roche shall be excluded from “Sales”, unless such sublicensees are end users of such Licensed Product.
(b)    For sublicensees that are not Affiliates of Roche and not end users of such Licensed Product [***], the sales amounts in the Territory reported to Roche and its Affiliates in accordance with [***]. For purposes of clarity, [***].

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.



EXHIBIT C
Schedule 3.2(d)
Due Diligence Obligations During Term of Collaboration Agreement
[***]

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.



EXHIBIT D
Schedule 4
Reports, Records and Payments under Roche Sublicense
4.1
Royalty Accounting and Reporting.
(a)    Timing of Payments. Roche shall calculate royalties on Net Sales quarterly as of March 31, June 30, September 30 and December 31 (each being the last day of an “Accounting Period”) and shall pay royalties on Net Sales to LICENSEE within [***] after the end of each Accounting Period in which such Net Sales occur. LICENSEE shall pay UNIVERSITY an amount equal to such royalties received within [***] after receipt of such royalties from Roche.
(b)    Currency Conversion. When calculating the Sales by Roche of any Licensed Product that occur in currencies other than the Payment Currency, Roche and LICENSEE shall convert the amount of such Sales into Swiss Francs and then into the Payment Currency using Roche’s then-current internal foreign currency translation method actually used on a consistent basis in preparing its audited financial statements (at the Effective Date, YTD average rate as reported by Reuters).
(c)    Royalty Reporting. Within [***] after the end of each Accounting Period, Roche shall provide to LICENSEE for such Accounting Period, on a Licensed Product-by-Licensed Product and country-by-country basis, a written report with the following information, [***]:
(i)    the gross amount invoiced in Swiss Francs;
(ii)    Sales in Swiss Francs, and the specific deductions applied in the calculation of Sales pursuant to Schedule 1.7 ;
(iii)    Net Sales in Swiss Francs, and the specific deductions applied in the calculation of Net Sales pursuant to Schedule 1.7 ;
(iv)    exchange rate used for the conversion of Net Sales from Swiss Francs to the Payment Currency;
(v)
Net Sales in the Payment Currency;
(vi)
total royalty payable in the Payment Currency.
[*** ]

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


4.2    Late Payment. Any payment under this Agreement that is not paid on or before the date such payment is due shall bear interest, to the extent permitted by Applicable Law, at [***] percentage points above the average one-month Euro Interbank Offered Rate, as reported by Reuters from time to time, calculated on the number of days such payment is overdue.
4.3    Currency and Method of Payment. Royalties on Net Sales and all other amounts payable by Roche under this Agreement shall be paid by Roche in Dollars (the “Payment Currency”) to account(s) designated by LICENSEE.
4.4
Records & Audits.
(a)    Roche shall keep, and shall require its Affiliates and sublicensees to keep, accurate and correct records of all Licensed Products manufactured, used, and sold, and sublicense fees received under this Agreement in sufficient detail to permit the other Party to confirm the accuracy of calculations of all payments made under this Agreement. Such records shall be retained by Roche for at least [***] following a given reporting period.
(b)    At the expense of LICENSEE, LICENSEE has the right to engage an internationally recognized independent public accountant (which shall not be deemed to be limited to the “Big Four” accounting firms) reasonably acceptable to Roche to perform, on behalf of LICENSEE, an audit of such books and records of Roche and its Affiliates, that are deemed necessary by the independent public accountant for the period or periods requested by the auditing Party and the correctness of any financial report or payments made under this Agreement. Upon timely request and at least [***] prior written notice from LICENSEE to Roche, such audit shall be conducted during regular business hours in such a manner as to not unnecessarily interfere with Roche’s normal business activities, and shall be limited to results in the [***] prior to audit notification. Such audit shall not be performed more frequently than [***]. All information, data, documents and abstracts herein referred to shall be used only for the purpose of verifying reports and payments made, and shall be treated as Roche’s confidential information.


[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.
Exhibit 10.2
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

EXCLUSIVE LICENSE AGREEMENT
This Exclusive License Agreement (“ Agreement ”; and as further defined herein) is made effective as of July 25, 2016 (the “ Effective Date ”) between:
UNIVERSITY HEALTH NETWORK , an Ontario corporation incorporated by special statute under the University Health Network Act, 1997, having a principal office at 190 Elizabeth Street, R. Fraser Elliott Building – Room 1S-417, Toronto, Ontario M5G 2C4 (“ UHN ”)
-AND-
PROTHENA BIOSCIENCES LIMITED , an Irish private limited company, having a principal office at Adelphi Plaza, Upper George’s Street, Dun Laoghaire, Co. Dublin A96 T927, Ireland (“ Prothena ”)
(In this Agreement, UHN and Prothena may be referred to individually as a “ Party ”, or collectively as the “ Parties ”.)
BACKGROUND :
Whereas:
A.
UHN under the guidance of UHN principal investigator Dr. Avi Chakrabartty is engaged in research relating to misfolded Transthyretin (“TTR”) in disease (the “ Technology ”), and owns UHN Background IP (defined below), which relates to the Technology;
B.
UHN and Prothena have been jointly conducting collaborative research activities relating to the Technology pursuant to two separate sponsored research agreements dated April 1, 2013 and April 1, 2014 (the “SRAs”) pursuant to which the Parties generated the Foreground IP (as defined below), which is jointly owned.
C.
Prothena wishes to license the UHN Background IP and UHN’s interest in the Foreground IP in accordance with the following terms and conditions stated in this Agreement; and
NOW, THEREFORE, THIS AGREEMENT WITNESSES that in consideration for the mutual promises, representations, covenants and agreements of the Parties contained herein, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties agree as follows:

1


ARTICLE 1 – INTERPRETATION
1.1
Defined Terms . For the purposes of this Agreement, unless the context otherwise requires, the following terms shall have the respective meanings set out below and grammatical variations of such terms shall have corresponding meanings:
(a)
Asset Transfer shall have the meaning provided in Section 14.3.
(b)
Affiliate means any corporation or other entity that controls, is controlled by, or is under common control a Party. An entity shall be regarded as in control of another corporation or entity if it owns or directly or indirectly controls more than fifty percent (50%) of the voting securities or other ownership interest of the other corporation or entity.
(c)
Agreement means this Exclusive License Agreement, and all of its Schedules, and the terms “herein”, “hereunder”, “hereto” and such similar expressions shall refer to this Agreement.
(d)
Claims shall have the meaning provided in Section 10.1.
(e)
Confidential Information of a Party means any and all information of and disclosed by, a Party and/or any of its Affiliates (a “ Disclosing Party ”) which has or does come into the possession or knowledge of the other Party and/or any of its Affiliates (a “ Receiving Party ”) in connection with or as a result of entering into this Agreement and which is (1) marked as confidential or identified as confidential at the time of disclosure, or (2) given the nature of the information or circumstances of disclosure, would be recognized as confidential or proprietary by a reasonable person, in each case including information concerning the Disclosing Party’s past, present and future business, research and development, technology, customers and suppliers. Information shall not be considered “Confidential Information” to the extent that the information:
(i)
is part of the public domain at the time of disclosure,
(ii)
subsequently becomes part of the public domain through no act or fault of the Receiving Party or its agents or employees in violation of this Agreement,
(iii)
can be demonstrated by the Receiving Party’s written records to have been known or otherwise available to the Receiving Party prior to the disclosure by the Disclosing Party,
(iv)
can be demonstrated by the Receiving Party’s written records to have been provided to the Receiving Party, without restriction, by a Third Party who is

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[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


not under a duty of confidentiality respecting the information disclosed and who has a legal right to disclose it,
(v)
can be demonstrated by the Receiving Party’s written records to have been independently developed by or on behalf of the Receiving Party without use of or reference to the Confidential Information disclosed hereunder, or
(vi)
is identified in writing by the Disclosing Party as no longer constituting Confidential Information.
(f)
Disclosing Party shall have the meaning provided in Section 1.1(e).
(g)
Diagnostics means use for prognosis, or diagnosis of medical risk or conditions in humans or animals, including companion diagnostics.
(h)
Field means all fields of use including, without limitation, Diagnostics, Therapeutics and any other uses.
(i)
Foreground IP or Foreground Intellectual Property means (a) the Patents and Patent Applications listed in Schedule B, (b) any Patents that issue from the Patent Applications listed in Schedule B, and (c) any Patents and/or Patent Applications that claim priority to a Patent or Patent Application listed in Schedule B; and all foreign or international equivalents, including supplementary protection certificates, of any of the foregoing in any country.
(j)
Gross Sales means the gross amount received by Prothena and its Affiliate(s) and any permitted Sublicensee(s), where such gross amount is received in respect of the sale of a Licensed Product(s) or Licensed Services. Any Licensed Products and Licensed Services transferred by Prothena to an Affiliate and/or permitted Sublicensee for (i) end use (but not resale) by the Affiliate or Sublicensee shall be treated as sales made by Prothena based on gross amounts received by Prothena, or (ii) resale by the Affiliate or Sublicensee shall be treated as sales made by the Affiliate or Sublicensee based on gross amounts received by the Affiliate or Sublicensee.
(k)
Infringement Suit shall have the meaning provided in Section 6.4.
(l)
License shall have the meaning provided in Section 2.1.
(m)
Licensed Product means any product or composition, the manufacture, use, sale, offer for sale, import, export of which would constitute, but for the license(s) granted herein, infringement of a Valid Claim.

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[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


(n)
Licensed Intellectual Property means the UHN Background IP and the Foreground IP.
(o)
Licensed Services means a method or process utilizing a Licensed Product, or is otherwise a service which would constitute, but for the license(s) granted herein, an infringement of a Valid Claim.
(p)
License Transfer Fee shall have the meaning provided in Section 14.4.
(q)
Litigating Party shall have the meaning provided in Section 6.4(d).
(r)
Net Sales means, the Gross Sales net of any of the following charges or expenses that are incurred with respect to the Licensed Products or Licensed Services:
(i)
reasonable trade or cash allowance/discounts, credits or volume discounts;
(ii)
credits, rebates or allowances because of damaged goods or returns or retroactive price reductions (including Medicaid, Medicare, government, commercial and similar types of rebates);
(iii)
freight, postage, shipping and insurance charges incurred in transporting the Licensed Products to the end customer;
(iv)
taxes, duties or other governmental charges (other than income taxes) levied on, absorbed or otherwise imposed on sales of products or services;
(v)
reasonable allowances actually given or made for wastage replacement; and
(vi)
taxes paid by Prothena, Affiliates and/or Sublicensees 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 another country or portion thereof.
with (i) – (vi) to be as determined from the books and records of Prothena, and/or its Affiliates, and/or Sublicensee(s), maintained in accordance with generally accepted accounting principles.
(s)
Notice(s) shall have the meaning provided in Section 13.1.
(t)
Patent means (a) letters patent (or other equivalent legal instrument), including without limitation utility and design patents, extensions, substitutions, registrations, confirmations, reissues, re-examinations or renewals thereof listed in Schedule A or Schedule B, as the case may be, (b) any patents that issue from the patent applications listed in Schedule A or Schedule B, as the case may be, (c) any patents that claim

4
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


priority to any of the foregoing, and (d) all foreign or international equivalents, including supplementary protection certificates, of any of the foregoing in any country.
(u)
Patent Application means (a) an application, for letters patent listed in Schedule A or Schedule B, as the case may be, including without limitation a provisional application, a non-provisional application, a reissue application, a re-examination application, a continuation application, a continued prosecution application, a continuation-in-part application, a divisional application or any equivalent thereof that is pending at any time during the Term before a government patent agency, (b) any patent applications that claim priority to any of the foregoing, and (c) all foreign or international equivalents of any of the foregoing in any country.
(v)
Phase 1 Clinical Trial means a human clinical trial of a Licensed Product that would satisfy the requirements of 21 C.F.R. 312.21(a) or corresponding foreign regulations.
(w)
Phase 2 Clinical Trial means a human clinical trial of a Licensed Product that would satisfy the requirements of 21 C.F.R. 312.21(b) or corresponding foreign regulations.
(x)
Phase 3 Clinical Trial means a human clinical trial of a Licensed Product that would satisfy the requirements of 21 C.F.R. 312.21(c) or corresponding foreign regulations.
(y)
Phase 2/3 Clinical Trial means a human clinical trial of a Licensed Product that is not a Phase 2 Clinical Trial or a Phase 3 Clinical Trial, but some combination thereof.
(z)
Phase 1/2 Clinical Trial means a human clinical trial of a Licensed Product that is not a Phase 1 Clinical Trial or a Phase 2 Clinical Trial, but some combination thereof.
(aa)
Prothena Insurance shall have the meaning provided in Section 11.1.
(bb)
Publication means any means of making available to the public of any information by way of speech, talk, paper, drawing, photograph, printed work, tape, video recording or other electronic means, or any other disclosure given or distributed.
(cc)
Quarterly Period means each successive three calendar month period during the Term ending March 31, June 30, September 30 and December 31. The first and last Quarterly Periods may be less than three (3) calendar months and will commence

5
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.


on the Effective Date of this Agreement and terminate on the date this Agreement expires or is earlier terminated, respectively.
(dd)
Receiving Party shall have the meaning provided in Section 1.1(e).
(ee)
Regulatory Approval shall mean authorization(s) by the appropriate governmental entity or entities in a country necessary for commercial sale of a Licensed Product or Licensed Services in said country in the Territory.
(ff)
Representatives shall have the meaning provided in Section 7.1.
(gg)
Royalty shall have the meaning provided in Section 3.4(a).
(hh)
Sponsored Research Agreements or “ SRAs means the agreements between UHN and Prothena dated April 1, 2013 and April 1, 2014, by which Prothena provided financial support to conduct specific and defined research at UHN.
(ii)
Sublicense(s) shall have the meaning provided in Section 2.3.
(jj)
Sublicensee(s) shall have the meaning provided in Section 2.3.
(kk)
Sublicensing Revenue means all revenue(excluding taxes) received by Prothena and/or its Affiliates from Sublicensees in consideration for sublicensing of the Licensed Intellectual Property including issue fees and milestone payments, but excluding earned royalties based on sales of Licensed Products, investments, loans and reimbursement for research and development activities, and reimbursement of patent costs. Notwithstanding the foregoing, exclusions are only to the extent such remuneration is a bona fide payment in respect of such matters, and not being made in order to reallocate what is otherwise intended to be upfront payments, milestones and royalties).
(ll)
Sublicensing Fee shall have the meaning provided in Section 3.5.
(mm)
Term shall have the meaning provided in Section 9.1.
(nn)
Territory means the world.
(oo)
Therapeutics means use as a therapeutic agent in humans or animals.
(pp)
Third Party means any person or entity who is not a Party or an Affiliate of a Party.
(qq)
UHN Background IP or “ UHN Background Intellectual Property means (a) the Patents and Patent Applications listed in Schedule A, (b) any Patents that issue

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from the Patent Applications listed in Schedule A, and (c) any Patents and/or Patent Applications that claim priority to a Patent or Patent Application listed in Schedule A, and all foreign or international equivalents, including supplementary protection certificates, of any of the foregoing in any country.
(rr)
UHN Indemnitees shall have the meaning provided in Section 10.1.
(ss)
Valid Claim in respect of a Licensed Product or Licensed Service shall mean a claim of (i) any issued, unexpired Patent within the Licensed Intellectual Property that has not been revoked or held unenforceable or invalid by a court or governmental agency or other body of competent jurisdiction, or (ii) any patent application within the Licensed Intellectual Property that has not been cancelled, withdrawn or abandoned, or pending for more than [***] years, with the exception that if a claim that has been pending for more than [***] years becomes issued, that claim shall thereafter be considered a Valid Claim.
(tt)
Yearly Period means each calendar year period during the Term ending December 31 st . The first and last Yearly Periods may be less than a full calendar year and will commence on the Effective Date of this Agreement and terminate on the date this Agreement terminates, respectively.
1.2
Other Defined Terms . All other defined terms in this Agreement shall have the meanings as otherwise specifically set out within the body of this Agreement.
1.3
Sections and Headings . The division of this Agreement into articles, sections and subsections and the insertion of headings are for reference purposes only and shall not affect the interpretation of this Agreement. Unless otherwise indicated, any reference herein to a particular Article, Section, Subsection or Schedule refers to the specified Article, Section or Subsection of, or Schedule to, this Agreement.
1.4
Number, Gender and Language . Except where the context otherwise requires, words importing the singular number shall include the plural and vice versa, words importing gender shall include all. The language of this Agreement shall be deemed to be the language mutually chosen by the Parties and no rule of strict construction shall be applied against either Party hereto.
1.5
Currency . All monetary amounts in this Agreement are in U.S. funds.
1.6
Schedules . The following Schedules are annexed to and form part of this Agreement:
Schedule “A” – UHN Background IP
Schedule “B” – Foreground IP

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1.7
Accounting Principles . Any reference in this Agreement to “generally accepted accounting principles” refers to accounting principles generally accepted in the United States (“GAAP”).
1.8
Best of Knowledge . “To the best of the knowledge” or “to the knowledge”, unless otherwise qualified hereunder means a statement of the declaring Party’s knowledge of the actual facts or circumstances to which such phrase relates without having made any inquiries or investigations outside of its own incorporated organization in connection with such facts and/or circumstances.
ARTICLE 2 – GRANT OF RIGHTS
2.1
License Grant . Subject to the terms and conditions of this Agreement, UHN grants to Prothena an exclusive, royalty bearing license, with the further right to grant Sublicenses, in and to the Licensed Intellectual Property to research, develop, make, have made, use, have used, sell or have sold, offer for sale, import, have imported, export and otherwise exploit Licensed Product(s) and Licensed Services in the Field in the Territory (the “ License ”). The License includes the ability for Prothena to engage Third Parties to assist in research, development manufacturing, distribution, sales, importing, exporting and other exploitation of Licensed Product(s) and Licensed Services.
2.2
UHN Retention of Right . UHN reserves its right to use (i) Licensed Intellectual Property for non-commercial research, academic and/or teaching purposes, with the further retention of its rights to grant noncommercial licenses to Third Party non-profit academic or research institutions for the same purposes, subject to Articles 7 and 8. UHN further retains the right to use the Licensed Intellectual Property for internal diagnostic purposes, excluding companion diagnostics. Nothing in this retention of rights is intended to prevent the Agreement being regarded overall as an exclusive license for litigation purposes. For the avoidance of doubt, neither UHN nor any other non-profit academic or research institution shall have any rights in any Licensed Intellectual Property for Therapeutics without written permission from Prothena.
2.3
Sublicenses . Prothena shall have the right to grant sublicense(s) to the Licensed Intellectual Property (the “ Sublicense(s) ”) to one or more sublicensees (the “ Sublicensee(s) ”); provided, however, that the Sublicense shall not have any terms which are inconsistent with this Agreement.
Unless otherwise indemnified by Prothena directly, the Sublicense shall provide that the Sublicensee will directly indemnify UHN on terms at least as favourable as those in Article 10 hereof unless approved otherwise in writing by UHN.
Upon termination of this Agreement for any reason, provided that a Sublicensee is not in material breach of its Sublicense, UHN shall grant to such Sublicensee license rights and

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terms equivalent to the sublicense rights and terms which Prothena previously granted to such Sublicensee.
ARTICLE 3 – CONSIDERATION
3.1
Payment of Funds . Payments to be made by Prothena to UHN hereunder shall be made by wire transfer, account details for which shall be included on the applicable invoice, and shall reference the following address:
University Health Network
Technology Development & Commercialization
College Street – Suite 150
Heritage Building – MaRS Centre
Toronto, Ontario, Canada, M5G 1L7
Attention: [***]
Invoices shall be sent to:
Accounting@Prothena.com
with a copy to:
[***]
3.2
Upfront License Fee . Upon execution of this Agreement by both Parties, and within [***] days after receipt by Prothena of an invoice from UHN, Prothena shall pay UHN a non-refundable and non-creditable license fee payment of [***], net of all transfer and transaction fees.
3.3
License Maintenance Fee.
(a)
Commencing on the first anniversary of the Effective Date, and on each anniversary thereafter, up to and including the year in which the first dosing of a subject in a Phase 1 Clinical Trial with a Licensed Product is made, Prothena shall pay UHN a yearly license maintenance fee payment of [***] dollars.
(b)
Commencing on the first anniversary of the Effective Date immediately following the first dosing of a subject in a Phase 1 Clinical Trial with a Licensed Product, and up to and including the anniversary of the Effective Date in which the first dosing of a subject in a study which prior to the first dosing has been deemed as a registrational study for purposes of Regulatory Approval (e.g., a Phase 2 Clinical Trial, a Phase 2/3 Clinical Trial or a Phase 3 Clinical Trial) is made, Prothena shall pay UHN a yearly license maintenance fee payment of [***] dollars.

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(c)
Commencing on the first anniversary of the Effective Date immediately following the first dosing of a subject in a study which has been deemed as a registrational study for purposes of Regulatory Approval, up to and terminating following the first sale of a Licensed Product in the Territory, Prothena shall pay UHN a yearly maintenance fee payment of [***] dollars.
All license maintenance fee payments are due and payable within [***] days of receipt by Prothena of an invoice from UHN issued after the applicable anniversary and are non-refundable and non-creditable as against future royalty payments. No payments are due under this Section 3.3 for any anniversary of the Effective Date following the first commercial sale of a Licensed Product.
3.4
Royalties.
(a)
Prothena shall, on a country-by-country basis, and on a Licensed Product by Licensed Product basis, or Licensed Service by Licensed Service basis (as the case may be) pay UHN a running royalty in the amount of:
(i)
[***] of Net Sales of Licensed Product(s) and Licensed Services sold by Prothena, its Affiliates or Sublicensees in the United States in the Field of Diagnostics and Therapeutics;
(ii)
[***] of Net Sales of Licensed Product(s) and Licensed Services sold by Prothena, its Affiliates or Sublicensees outside of the United States in the Field of Diagnostics and Therapeutics; and
(iii)
[***] of Net Sales of Licensed Product(s) and Licensed Services sold by Prothena, its Affiliates or Sublicensees in the Territory in a Field which is not Diagnostics or Therapeutics, collectively (“ Royalty ”) .
(b)
Royalties will be payable from the date of first commercial sale of the applicable Licensed Product(s) or Licensed Services in a country until the expiration of the last Valid Claim that covers the sale of of the applicable Licensed Product(s) or Licensed Services in that country.
(c)
In the event that Prothena is required to pay royalties to one or more Third Party(ies) in order to commercialize a Licensed Product or Licensed Service, the Royalty for such Licensed Product or Licensed Services will be reduced by the amount of royalties payble to said Third Party; provided, however, that the Royalty shall not be decreased in any instance to less than than [***] of the Royalty stated above.

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3.5
Sublicensing Fees . In further consideration of the license granted hereunder, Prothena shall pay to UHN the following percentage of Sublicensing Revenue received in consideration for Sublicense(s) of the Licensed Intellectual Property:
(a)
[***] of all Sublicensing Revenue received by Prothena and Affiliate(s) under any Sublicense [***];
(b)
[***] of all Sublicensing Revenue received by Prothena and Affiliate(s) under any Sublicense [***];
collectively “ Sublicensing Fee ”.
3.6
Payments . The Royalty and Sublicensing Fee described in Sections 3.4 and 3.5 respectively, shall accrue as of the date of Prothena’s receipt of Gross Sales and Sublicensing Revenue, and shall be paid by Prothena within [***] after the end of the relevant reporting period (as determined in accordance with Section 3.12 and concurrently with receipt by UHN of the Royalty Report.
3.7
Past Patent Cost Reimbursement . Upon execution of this Agreement, and within [***] days of receiving an itemized invoice regarding same from UHN, Prothena shall reimburse all patent costs paid by UHN in filing and maintaining the patents and patent applications in the UHN Background IP up to and including the Effective Date. Such costs through the Effective Date are estimated to be [***].
3.8
Patent Milestone Payment . Within [***] days of receiving an invoice regarding same from UHN, Prothena shall pay to UHN [***] upon issuance of a first United States patent [***].
3.9
Milestone Payments . As additional consideration under the Agreement, Prothena shall pay to UHN the following one-time milestone payments for the first Licensed Product as a Therapeutic in the first indication to meet such milestone. Prothena shall promptly provide Notice to UHN of the fulfillment of a milestone (whether such milestone is achieved by Prothena or its Affiliate or Sublicensee). Each noted milestone payment is payable within [***] days following receipt of an invoice for the applicable amount:
(a)
[***];
(b)
[***];
(c)
[***];
(d)
[***];
(e)
[***];

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In the event that a regulatory authority allows one or more clinical trial phases to be combined (including e.g. a Phase1/2 Clinical Trial, a Phase 2/3 Clinical Trial etc.) milestone payments for each of the milestone events encompassed within the combined clinical trial will be due and payable upon the dosing of a first human subject in the combined clinical trial. The above milestones payments shall be payable one time only, regardless of indication, for the first Licensed Product to reach such stage.
3.10
Interest . All undisputed monies payable to UHN by Prothena hereunder and not paid when due bear interest at the prime rate of interest quoted by the Bank of Canada, plus [***] per annum until the date paid to UHN. UHN will be entitled to that interest in addition to any other rights or remedies available to it in respect of Prothena’s payment default. Prothena shall notify UHN of any dispute before the due date for the relevant payment, and thereafter the parties will use good faith efforts to promptly resolve the dispute, including discussions between the parties’ respective executive leaders.
3.11
Withholdings . In the event that Prothena is required by any law to withhold and/or make payments to tax authorities in respect of any payments payable by Prothena to UHN under this Agreement, the liability of Prothena under this Agreement shall be to that extent satisfied, and such amounts shall be deemed to have been paid to UHN on their due dates, provided that Prothena shall furnish to UHN acceptable evidence of such payments.
3.12
Royalty Report . Prothena shall prepare a report (the “ Royalty Report ”), setting out the Gross Sales, the Net Sales (including an itemized statement of any permitted discounts, refunds and taxes deducted) from Prothena, Affiliates and Sublicensees, along with Sublicensing Revenue and calculations of any Royalties and Sublicensing Fees that are payable to UHN. Prothena shall prepare and provide Royalty Reports on an annual basis (“Yearly Period”) upon UHN’s written request, unless UHN requests in writing that a Royalty Reports be provided for a Quarterly Period. Royalty Reports shall be due within [***] days after the end of the relevant reporting period. If no payments are due for any reporting period, then the Royalty Report shall so state.
3.13
Complete Records . Prothena shall keep true and accurate records and books of account containing all data reasonably required for the computing and verification of all payments owed by Prothena to UHN, including records for Gross Sales and Net Sales, all in accordance with generally accepted accounting principles. Prothena shall contractually require all Prothena Affiliates and Sublicensees to keep same and provide a copy of same to Prothena for purposes of inspection pursuant to Section 3.14. Such records shall be maintained by Prothena for at least [***] years from the date of the payment to which such records are relevant.
3.14
Inspection of Records . The records specified in this Agreement shall be available for inspection by UHN or their duly appointed auditor, but not more than once per Yearly Period,

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upon reasonable written notice and during normal business hours at the principal place of business of Prothena, for the sole purpose of verifying payments owed under this Agreement. The costs of any such inspection shall be borne by UHN unless the report of an auditor shows that the Royalty Report was understated by more than [***] in respect of the period under review, in which case UHN’s reasonable out of pocket costs of the examination shall be fully paid by Prothena. Prothena may require such auditor to enter into a commercially reasonable confidentiality agreement with Prothena prior to being provided with any such records.
3.15
Discrepancy in Records . In the event that the records inspection conducted under Section 3.14 reveals any undisputed underpayment of royalties due to UHN, Prothena will promptly pay UHN the full amount of the undisputed underpayment together with interest thereon at the rate of interest referred to in Section 3.10 herein. In the event that the records inspection conducted under Section 3.14 reveals any overpayment of royalties by Prothena, the overpaid amount will, in Prothena’s discretion, be credited against future amounts payable to UHN hereunder or promptly refunded to Prothena.
3.16
Commercialization Diligence . As part of Prothena’s ongoing obligation, Prothena agrees to utilize commercially reasonable efforts to [***].
ARTICLE 4 – REPRESENTATIONS, WARRANTIES AND LIABILITY
4.1
UHN Reps & Warranties. UHN represents and warrants to Prothena that:
(a)
it is duly incorporated and organized and validly existing under the laws of Ontario, and has all requisite corporate power and authority to enter into and perform its obligations under this Agreement;
(b)
it has taken all necessary corporate action, steps and proceedings to approve or authorize, validly and effectively, the execution and delivery of this Agreement and perform its obligations hereunder;
(c)
the execution and delivery of this Agreement by UHN and the performance of its obligations hereunder shall not result in either a breach or violation of any of the provisions of, or constitute a default under, or conflict with or cause the acceleration of, any obligation of UHN under:
(i)
any agreement to which UHN is a party or is otherwise bound by;
(ii)
any judgment, decree, order or award of any court, governmental body or arbitrator having jurisdiction over UHN;
(iii)
any license, permit, approval, consent or authorization held by UHN; or

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(iv)
any applicable law, statute, ordinance, regulation or rule.
(d)
as of the Effective Date, UHN is the sole owner of all right, title and interest in and to the UHN Background IP and to the best of its knowledge UHN and Prothena are jointly the sole owners of the Foreground IP.
4.2
Prothena Reps & Warranties . Prothena represents and warrants to UHN that:
(a)
it is duly organized and validly existing under the laws of Ireland and has all the requisite corporate power and authority to enter into and perform its obligations under this Agreement;
(b)
it has taken all necessary corporate action, steps and proceedings to approve or authorize, validly and effectively, the execution and delivery of this Agreement and the performance of its obligations hereunder and to cause all necessary meetings of directors and shareholders of Prothena to be held for such purposes; and
(c)
the execution and delivery of this Agreement by Prothena and the performance of its obligations hereunder shall not result in either a breach or violation of any of the provisions of, or constitute a default under, or conflict with or cause the acceleration of, any obligation of Prothena under:
(i)
any agreement to which Prothena is a party or is otherwise bound by;
(ii)
any of the terms and provisions of the organizational documents or by-laws, or resolutions of the board of directors (or any committee thereof), of Prothena;
(iii)
any judgment, decree, order or award of any court, governmental body or arbitrator having jurisdiction over Prothena;
(iv)
any license, permit, approval, consent or authorization held by Prothena; or
(v)
any applicable law, statute, ordinance, regulation or rule.
4.3
Limitations of Liability . Except as otherwise expressly set out in this agreement:
(a)
each Party expressly disclaims any and all implied or express warranties and makes no express or implied warranties of any kind, including warranties of merchantability, safety or fitness for any particular purpose of the Licensed Intellectual Property, or that the Licensed Intellectual Property can be exploited to generate revenues;
(b)
UHN does not warrant or represent that issued Patents are valid, or pending Patent Applications will issue, or when issued will be valid, or that the practice or

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exploitation of any Licensed Intellectual Property provided to Prothena pursuant to this agreement, does not, or will not, constitute infringement of rights of persons not parties hereto. Notwithstanding the foregoing, UHN warrants that it has not granted rights to Third Parties that would conflict with those granted to Prothena under this agreement; and
(c)
neither Party shall be liable to the other Party for any indirect, special, consequential, exemplary or punitive damage or loss of business or loss of profits suffered by such other Party resulting from the use or other exploitation of the Licensed Intellectual Property, including without limitation the sale of any Licensed Product(s) or Licensed Services. Furthermore, UHN makes no representation that the Licensed Intellectual Property is free from defect.
ARTICLE 5 – FURTHER COVENANTS AND OBLIGATIONS.
5.1
Prothena Covenants . Prothena covenants and agrees for the benefit of UHN that it shall:
(a)
exercise the License granted herein or otherwise exploit the Licensed Intellectual Property in accordance this Agreement, and with all applicable laws, statutes, ordinances, regulations, guidelines and rules, including, all applicable statutes and regulations and applicable guidelines set forth by the Canadian Institutes of Health Research (CIHR), National Institutes of Health (NIH) or other governmental agencies where applicable;
(b)
cause to be applied to Licensed Products where appropriate any markings required by applicable government statutes and laws to maintain continued validity and enforcement of UHN Background IP and Foreground IP; and
(c)
use commercially reasonable efforts to develop and commercialize Licensed Product(s).
ARTICLE 6 – MANAGEMENT OF INTELLECTUAL PROPERTY RIGHTS
6.1
IP Rights Ownership . As between the Parties, UHN shall retain ownership of the UHN Background IP and UHN and Prothena shall retain joint ownership of the Foreground IP. If either UHN or Prothena desires to file a continuation-in-part patent application that includes claims that are entitled to claim the benefit of a priority date of any patent or application in the UHN Background IP or the Foreground IP, the Parties will negotiate in good faith the strategy for filing and ownership of any such patent application(s) with a view to maximizing the patent coverage for the subject inventions. The Parties agree to revisit an ownership decision made pursuant to the prior sentence if, during the course of patent prosecution, a Party reasonably believes that different ownership of any such patent application would be beneficial for obtaining a granted patents (e.g., in order to overcome an obviousness rejection

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over another patent or patent application owned by a Party). The Parties will document their agreement regarding any such continuation-in-part patent application by way of amendment to this Agreement.
6.2
Patent Prosecution . Prothena and UHN will assume joint responsibility to control the preparing, filing, prosecuting, obtaining and maintaining the UHN Background IP, at Prothena’s sole cost and expense and using patent counsel acceptable to UHN (acting reasonably) during the Term. With input from UHN, Prothena shall continue to have the responsibility to control the preparing, filing, prosecuting, obtaining and maintaining the Foreground IP, at Prothena’s sole cost and expense and using patent counsel acceptable to UHN (acting reasonably) during the Term. For purposes of the UHN Background IP, UHN will provide Prothena with (a) a copy of any proposed document pertaining to the prosecution for review and comment reasonably in advance of filing, and (b) will keep Prothena informed in a timely manner of the status of such filing, prosecution and maintenance, including (i) by providing Prothena in a timely manner with copies of all material communications received from or filed in patent office(s) with respect to such UHN Background IP, and (ii) by providing to Prothena, a reasonable time prior to taking or failing to take any action that would materially affect the scope or validity of any such filing, prior written notice of such proposed action or inaction so that Prothena has a reasonable opportunity to review and comment. For purposes of the Foreground IP, Prothena (a) will provide UHN with a copy of any proposed patent application constituting Foreground IP for review and comment reasonably in advance of filing, and (b) will keep UHN informed in a timely manner of the status of such filing, prosecution and maintenance, including (i) by providing UHN in a timely manner with copies of all material communications received from or filed in patent office(s) with respect to such filing, and (ii) by providing to UHN, a reasonable time prior to taking or failing to take any action that would materially affect the scope or validity of any such filing, prior written notice of such proposed action or inaction so that UHN have a reasonable opportunity to review and comment. In the event that Prothena decides to (x) forego or cease prosecution, or (y) cease maintenance, of any Patent or Patent Application within the UHN Background IP or Foreground IP in any jurisdiction, UHN may (in its sole discretion and expense, except to the extent such abandonment would reasonably benefit the prosecution or maintenance of the remaining Patents and Patent Applications within the UHN Background IP or Foreground IP) continue such prosecution or maintenance and Prothena shall have no further obligations in respect of such Patent or Patent Application in such jurisdiction, and such Patent or Patent Application will no longer be licensed to Prothena as part of the Licensed Intellectual Property.
6.3
Cooperation and Notice . As provided for in this Article 6, a Party shall cooperate with the other Party in the preparation, filing, prosecution and maintenance of any Patents or Patent Applications within the UHN Background IP and Foreground IP, including executing all

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papers and instruments required in order to enable the Party to apply for, to prosecute and to maintain applications and registrations in any country.
6.4
Infringement . Each Party will immediately notify the other Party upon becoming aware of any infringement or threatened infringement of the Licensed Intellectual Property by a Third Party (“Infringement Notice”). The Parties shall co-operate fully in the abatement of such infringement without litigation. If the infringing activity of potential commercial significance by the infringer has not been abated within [***] days following the date of the Infringement Notice, Prothena and/or its Sublicensee(s) shall have the first right to institute suit for patent infringement against the infringer. UHN may voluntarily join such suit, but may not thereafter commence suit against the infringer for the acts of infringement that are the subject of Prothena’s or its Sublicensee(s)’ suit or any judgment rendered in that suit. If deemed a necessary party by a court of competent jurisdiction, UHN shall join the suit at [***]. Prothena and/or its Sublicensee(s) shall be responsible for all reasonable costs, including (a) legal fees and disbursements incurred by Prothena, (b) reasonable legal fees and disbursements incurred by UHN at the request of Prothena, and (c) awards by the Court against UHN or Prothena pertaining to the enforcement by Prothena of any Licensed Intellectual Property. If UHN desires to enforce any Licensed Intellectual Property after Prothena has declined in writing to do so, then UHN may do so at its sole cost and expense and shall keep Prothena reasonably apprised of the progress of any such enforcement activities. Any monies, including compensatory and other non-compensatory damages or recovery, actually received by a Party from a Third Party as a result of any action or settlement shall first go to reimburse Prothena, and/or its Sublicensee(s) and UHN for all costs incurred in the action. If after such reimbursement any funds shall remain from such damages or other sums recovered, such funds [***]; provided, however, that (a) if [***], (b) if [***], and (c) if [***].
In the event that any Third Party brings or asserts a claim against Prothena, Prothena Affiliate, Sublicensee or UHN that the manufacture, use, sale, distribution, marketing or importation of the Licensed Intellectual Property, Licensed Product or Licensed Services infringes rights in Patents or Patent Applications owned or otherwise controlled by such Third Party (an “ Infringement Suit ”), the following shall apply:
(a)
the Party receiving a claim, or learning of the threat of such a claim, shall give the other Party prompt written notice detailing as many facts as possible concerning the claim;
(b)
Prothena, in its sole discretion, shall have the first right, but not an obligation, to defend against the Infringement Suit;
(c)
if Prothena does not take steps to defend against the Infringement Suit within [***] days after the date that notice thereof was received from or delivered to UHN, and

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the Infringement Suit relates to a Licensed Product or Licensed Services, UHN may take such legally permissible action as it deems necessary or appropriate to defend against the Infringement Suit, but shall not be obligated to do so;
(d)
the Party defending against the Infringement Suit (in this Subsection, the “ Litigating Party ”) shall have the right to control such litigation and shall bear all legal expenses (including court costs and legal fees), but it shall have no right to settle any dispute in any manner which would abridge the rights of the other Party under this Agreement. By way of example and not by way of limitation, neither Party may stipulate or admit to the invalidity or unenforceability of any Licensed Intellectual Property without the other Party’s prior written consent. Before any action is taken by either Party which could abridge the rights of the other Party hereunder, the Parties agree, in good faith, to consult with each other with a goal of adopting a mutually satisfactory position;
(e)
the Litigating Party shall keep the other Party fully informed of the actions and positions taken or proposed to be taken by the Litigating Party and the actions and positions taken by all other parties to such litigation; and
(f)
in the event that Prothena defends against the Infringement Suit, UHN may elect to participate formally in the Infringement Suit to the extent that the court may permit, provided that any additional expenses generated by UHN’s formal participation shall be paid by UHN.
Where either Prothena or UHN wishes to act alone pursuant to this Section 6.4, but formalities require participation of the other Party, then the other Party shall join in the proceeding to the extent necessary for formalities. Each of Prothena and UHN will cooperate with the other Party in making available all necessary documents and witnesses for any legal proceedings, without charging any fees to the other Party, but the other Party shall reimburse reasonable out of pocket costs and expenses.
6.5
No Actions . The Parties agree to not knowingly take any action which would jeopardize the obtaining or maintaining of the Licensed Intellectual Property, except in compliance with Sections 6.2, 6.3 and 6.4. Notwithstanding the foregoing, nothing in this Agreement shall prohibit Prothena from challenging the validity of UHN Background IP in a court of law; provided, however, that upon the filing of a claim challenging the validity of a Patent within UHN Background IP, UHN shall have the right to terminate this Agreement immediately upon notice.
ARTICLE 7 – CONFIDENTIAL INFORMATION

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7.1
Confidentiality . A Receiving Party shall take all reasonable measures, and at least the same measures as it takes in respect of its own Confidential Information of a similar nature, to keep confidential the Confidential Information of the Disclosing Party. A Receiving Party may disclose such Confidential Information to those of its directors, officers, employees, subcontractors, consultants and agents (collectively, “ Representatives ”) having a need to know such information in connection with exercising the Receiving Party’s rights and/or fulfilling the Receiving Party’s obligations under this Agreement With respect to Prothena, Representatives also include proposed and actual Sublicensees. A Receiving Party will ensure that any of its Representatives having access to the Confidential Information of the Disclosing Party are under a legal obligation to maintain such Confidential Information in confidence and are duly informed of this obligation. A Receiving Party will neither use nor disclose to any other party any of the Confidential Information of the Disclosing Party except as expressly permitted hereunder. The terms of this Agreement are the Confidential Information of both Parties.
7.2
Equitable Relief . The Parties acknowledge that a breach of this Article 7 by either Party or any of its representatives may cause irreparable harm and that the non-breaching Party may be entitled to equitable relief, including injunction and specific performance, as a remedy for any such breach. Such remedies shall not be deemed to be the exclusive remedies but shall be in addition to all other remedies available at law or equity.
7.3
Disclosure to Advisors . Notwithstanding the confidentiality obligations of this Agreement, each Party shall be permitted to disclose the terms of this Agreement without the prior written consent of the other Party to those of its directors, officers, employees, advisors, shareholders, investors, potential investors, underwriters, partners, potential partners, potential acquirers under circumstances that reasonably ensure the confidentiality thereof.
7.4
Other Permitted Disclosures . Notwithstanding the confidentiality obligations of this Agreement, a Receiving Party shall be permitted to disclose the Confidential Information of the Disclosing Party without the prior written consent of the Disclosing Party (a) to the extent required to be disclosed by law (including the securities laws, regulations and listing requirements in Canada, United States and other jurisdictions) or an order of a court, tribunal, or government agency, provided that to the extent legally permissible the Receiving Party (i) gives to the Disclosing Party prompt written notice of the required disclosure in order to allow the Disclosing Party reasonable opportunity to seek a confidentiality order or the like, and (ii) cooperates with efforts of the Disclosing Party (at the Disclosing Party’s expense) in connection therewith; and (b) as required to be disclosed in connection with the filing with, or approval, certification or endorsement from, any governmental body or medical protocol, in each case for the Licensed Product or Licensed Services.
ARTICLE 8 – PUBLICATION

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8.1
Publications . Subject to Section 6 and UHN’s prior written consent, Prothena shall acknowledge the contribution of UHN investigator(s) in Prothena’s related academic Publications in accordance with scientific custom. No Publication by a Party shall disclose the Confidential Information of the other Party without the prior written consent of such other Party.
ARTICLE 9 – TERM & TERMINATION
9.1
Term . Unless earlier terminated pursuant to Sections 9.2, the term of this Agreement shall be for the period of time beginning on the Effective Date and ending on the expiration date of the longest-lived Licensed Intellectual Property (the “ Term ”) .
9.2
Earlier Termination . This Agreement shall terminate prior to the expiration of the Term:
(a)
automatically without the obligation to provide notice upon the filing of a petition for relief under the United States Bankruptcy Code by or against Prothena as a debtor or alleged debtor;
(b)
at the discretion of UHN, effective upon sixty (60) days written notice to Prothena, if Prothena materially breaches Sections 3.2 to 3.10, 4.2, 5.1, Article 11 or Section 14.4 and fails to remedy the breach within sixty (90) days after being given written notice thereof by UHN;
(c)
as permitted under Section 6.5;
(d)
at the discretion of Prothena upon ninety (90) days written notice to UHN; or
(e)
by mutual written agreement of the Parties.
9.3
Effects of Early Termination . In the event of the earlier termination of this Agreement prior to expiration of the Term pursuant to Section 9.2:
(a)
the License will be terminated, all of UHN’s Interest in the Licensed Intellectual Property shall revert to UHN, and within [***] days either destroy or return to UHN (at the request of UHN in its sole discretion) all UHN Confidential Information;
(b)
Prothena shall within [***] days of the date of such earlier termination, pay UHN all current amounts then owed to UHN pursuant to this Agreement; for purposes of certainty and clarity, no term or provision of this Agreement shall be construed to waive the payment of any monies to UHN accrued at the date of said earlier termination, or arising thereafter; and
(c)
No termination of this Agreement shall be construed as a termination of any valid Sublicense of any Sublicensee hereunder, and thereafter each such Sublicensee shall

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be considered a direct licensee of UHN, provided that: (i) such Sublicensee is then in full compliance with all material terms and conditions of its Sublicense, and (ii) such Sublicensee agrees in writing to assume all material and relevant obligations (including, without limitation, those of a financial nature) of Prothena under this Agreement.
ARTICLE 10 – INDEMNIFICATION
10.1
Indemnification . Prothena agrees to indemnify, save harmless, and defend UHN and its directors, officers, research staff, employees, research trainees, students, and agents (collectively, “ UHN Indemnitees ”), against any and all Third Party claims, suits, losses, damages, costs, fees, and expenses (including reasonable legal expenses) (collectively, “ Claims ”), arising out of (a) any product liability claims with respect to any Licensed Product or Licensed Services, (b) any Intellectual Property infringement or alleged infringement claims, and (c) any damages, losses, or liabilities whatsoever with respect to death or injury to any person and damage to any property arising from this Agreement and the License granted herein, including, without limitation, the manufacture, design, distribution, and offer for sale of Licensed Product(s) or Licensed Services or otherwise arising from any exploitation of the Licensed Intellectual Property, except in each case to the extent caused by the negligence or willful misconduct of UHN or any of the other UHN Indemnitees or otherwise arising from UHN’s breach of its obligations under this Agreement (including any representations, warranties or covenants under this Agreement).
10.2
Indemnification Procedure . Upon the assertion of any Claim, UHN shall promptly notify Prothena thereof and Prothena shall appoint counsel to represent the applicable UHN Indemnitees with respect to such Claim for which indemnification is sought. The UHN Indemnitees shall cooperate with Prothena in defense and settlement of such Claim. Neither Prothena nor the UHN Indemnitees shall enter into any settlement agreement with any Third Party without the consent of the other Party, which consent shall not be unreasonably withheld; provided that affected UHN Indemnitees shall be permitted in their sole discretion to settle any such Claim if they have first irrevocably waived in writing their rights to indemnification hereunder with respect to such Claim.
ARTICLE 11 – INSURANCE
11.1
Prothena Insurance . No later than [***] days prior to the sooner of the first use of Licensed Intellectual Property with humans or first sale of Licensed Product(s), Prothena, at Prothena’s expense, shall obtain and maintain general liability, product liability and/or clinical trial liability insurance (the “ Prothena Insurance ”) applicable to clinical trials and/or sale of Licensed Products and/or Licensed Services, of a minimum of [***], naming UHN as an additional insured. Prothena shall provide to UHN a Certificate of Insurance evidencing compliance with this provision within [***] days prior to such first use. Prothena shall, at

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its own expense, obtain and maintain the Prothena Insurance from the date required by this Section 11.1 until the end of the Term.
11.2
Sublicensee Insurance . Unless said activities are otherwise covered by Prothena Insurance, any Sublicense shall require Sublicensee(s), at the Sublicensee(s) expense, to obtain and maintain liability insurance at a level commensurate with the Prothena Insurance, naming Prothena and UHN as additional insured; provided, however, that if the Sublicensee is a substantial multi-national entity which has a policy of self-insuring, then at UHN and Prothena’s reasonable discretion Sublicensee may self-insure. Sublicense agreements shall require Sublicensee(s) to provide to Prothena and to UHN a Certificate of Insurance evidencing compliance with this provision prior to the earlier of the first use of the Licensed Intellectual Property with humans or first sale of Licensed Product(s) under any Sublicense. In no event shall the Sublicensee(s) use the Licensed Intellectual Property with humans or engage in the sale of Licensed Product(s) or Licensed Services under this or any sublicense agreement prior to the delivery to UHN of the Certificate of Insurance or an indication of self-insurance, as applicable. The Sublicense shall provide that Sublicensee(s) (at no expense to UHN) shall obtain and maintain from the date required by this Section 11.2 until the end of the term of the Sublicense, a policy of appropriate liability insurance (or self-insurance, if applicable) at a level commensurate with the Prothena Insurance.
11.3
Qualified Insurance . All insurance policies required in accordance with this Article 11 shall be obtained, prior to the initiation of any clinical trial involving Licensed Products, from an insurance company qualified to offer protection in the jurisdictions where Licensed Intellectual Property is to be exploited or Licensed Products or Licensed Services are offered for sale.
11.4
Notice . All insurance policies required in accordance with this Article 11 shall provide for [***] days written notice by the insurer to Prothena by registered or certified mail in the event of any modification, cancellation or termination of such insurance policy. Prothena shall promptly inform UHN if the amount of Prothena Insurance should fail to meet the levels required under Section 11.1.
11.5
Copy of Policy . Prothena shall, on written request, provide UHN with a copy of the insurance policy in force at the time of the request and this provision shall survive the early termination or expiration of this Agreement for a period of [***].
11.6
Incomplete Insurance . In the event Prothena (or Sublicensee, as appropriate) is unable to obtain the insurance coverage required by Section 11.1, or if any portion of the Prothena Insurance / Sublicensee insurance corresponding to that required by Section 11.1 is cancelled and not immediately replaced, Prothena shall promptly inform UHN and UHN shall be free to terminate this Agreement upon [***] days written notice to Prothena.

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ARTICLE 12 – DISPUTE RESOLUTION
12.1
Reasonable Efforts . Before filing any lawsuit or claim in court, the Parties agree to make reasonable efforts to resolve amicably among themselves any dispute arising out of or relating to this Agreement (including the breach of this Agreement).
12.2
Referral for Resolution . If the Parties are unable to resolve the dispute under Section 12.1 within [***] days of written notice of one Party to the other Party of such dispute, then before filing any lawsuit or claim in court, the dispute shall be referred to the Vice President, Research of UHN (or designate) and an executive (or designate) of Prothena for their discussion and resolution for an additional period of [***] days. The Parties may further agree to mediation of the dispute, but in no event is mediation mandatory.
12.3
Interim Protection . This Article 12 shall not prevent a Party from applying to a court of competent jurisdiction for interim protection such as, by way of example, an interim injunction.
ARTICLE 13 – NOTICE
13.1
Notice . All notices which are required or permitted to be given hereunder (“ Notices ”) including judicial payment notices must be in writing. All such Notices must be sent as follows:
to UHN:
Attention:    [***]
Director, Technology Development & Commercialization
University Health Network
101 College Street – Suite 150
Heritage Building – MaRS Centre
Toronto, Ontario, Canada M5G 1L7
Telephone No.: [***]
Facsimile No.: [***]
E-mail: [***]
to Prothena:
Attention:    Director
Prothena Biosciences Limited
Adelphi Plaza, Upper George’s Street
Dun Laoghaire, Co.

Dublin, Ireland A96 T927

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With a copy to:
Legal Department
Prothena Biosciences Inc
650 Gateway Boulevard South
San Francisco, CA 94080
Telephone No.: (650) 837-8550
Facsimile No.: (650) 837-8560
or to such other address as a Party may designate by Notice given in accordance with this Article 13. Any such Notice may be delivered by hand, by registered mail, or sent by facsimile or electronically, and will be deemed to have been delivered on the date of delivery if delivered by hand, five (5) days after mailing if sent by registered mail, or on the first business day following the date of sending if sent by facsimile or electronically with confirmation of delivery.
ARTICLE 14 – GENERAL
14.1
Entire Agreement . The Parties hereto acknowledge that this Agreement and its Schedules is the entire agreement and understanding of the Parties as to the subject matter hereof, and supersedes all prior discussions, agreements and writings in respect hereto.
14.2
General Assurances . The Parties agree to do all such things and to execute such instruments and documents as may be reasonably necessary or desirable in order to carry out the provisions and intent of this Agreement.
14.3
Assignment . This Agreement may not be assigned or otherwise transferred by Prothena without the express written consent of UHN, such consent not to be unreasonably withheld, provided, however, that Prothena may, without prior consent, assign the License Agreement and/or the rights and obligations thereunder to (i) a Prothena Affiliate, or (ii) a Third Party in connection with the transfer or sale of all or substantially all of Prothena’s assets relating to the subject matter of this Agreement, or that part encompassing or otherwise associated with the development and commercialization of the Licensed Intellectual Property (an “ Asset Transfer ”), or (iii) in connection with a change in control, merger, acquisition, consolidation or similar transaction involving Prothena or its ultimate parent entity. In the event of an Asset Transfer, a “ License Transfer Fee ”, payable to UHN in accordance with the following:
(a)
[***]
(b)
[***]

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Payment of the License Transfer fee shall be made by Prothena to UHN within [***] days after the closing of such sale and/or transfer and/or assignment and/or disposition, or as otherwise agreed by the Parties. At UHN’s request, Prothena shall provide written evidence in support of the calculation of the License Transfer Fee.
The License Agreement shall be binding upon and inure to the benefit of the Parties’ respective successors and permitted assigns. Any purported assignment or transfer in violation of this section shall be void. The Parties agree to notify the other Party of any such assignment.
14.4
No Use of Names . Except as required for the purposes of complying with the provisions of this Agreement or as required by applicable laws, rules and regulations, and except as set forth below, neither Party shall use the name, logo, trade-mark or trade-name of the other Party in connection with any Licensed Product(s), publicity, promotion news release, advertising or similar public statements or otherwise without the prior written consent of the other Party, which consent shall not be unreasonably withheld. The Parties have agreed upon the text of a press release to be issued by Prothena following execution of this Agreement by both Parties.
14.5
No Joint Venture . Each Party is and will remain at all times independent of each other. The Parties are not and shall not be considered to be joint venturers, partners or agents of each other and neither of them shall have the power to bind or obligate the other except as set forth in this Agreement. The Parties mutually covenant and agree that neither shall they, in any way, incur any contractual or other obligation in the name of the other, nor shall they have liability for any debts incurred by the other. No representation will be made or acts taken by any of the Parties which could establish any apparent relationship of agency, joint venture, partnership or employment.
14.6
Waiver . No amendment, supplement or waiver of any provision of this Agreement shall be binding on any Party unless consented to in writing by such Party. No waiver of any provision of this Agreement shall constitute a waiver of any other provision, nor shall any waiver constitute a continuing waiver unless otherwise expressly provided. Further, no failure or delay by any Party in exercising any right or remedy shall operate as a waiver thereof, nor shall any single or partial exercise or waiver of any right or remedy preclude its further exercise or the exercise of any other right or remedy.
14.7
Joint Preparation . This Agreement shall be deemed to be jointly prepared by the Parties, and any ambiguity herein shall not be construed for or against any single Party.
14.8
Governing Law . This Agreement shall be governed by the laws of New York. Subject to Article 12, the Parties irrevocably and unconditionally submit to the exclusive jurisdiction

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the courts of New York and all courts competent to hear appeals therefrom in connection with any matters arising under this Agreement.
14.9
Severability of Provisions . In the event that any provisions of this Agreement are determined to be invalid or unenforceable by a court of competent jurisdiction in any jurisdiction, the remainder of this Agreement shall remain in full force and effect without said provision in said jurisdiction and such determination shall not affect the validity or enforceability of such provision or this Agreement in any other jurisdiction. The Parties shall in good faith negotiate a substitute clause for any provision declared invalid or unenforceable, which shall most nearly approximate the intent of the Parties in entering this Agreement.
14.10
Force Majeure . In the event that any one of the Parties is prevented from fulfilling any of its obligations herein by acts of God, war, terrorism, strikes, riots, storms, fires, governmental orders or restrictions or any other cause beyond its control, the payment of royalties, or the applicable pro rata portion thereof, shall be suspended during the full period of any such prevention, but payment of royalties which have accrued for payment prior to or after such cause shall not be excused. UHN will have the right to terminate this Agreement in the event that Prothena is unable to fulfill a material obligation for a period of at least [***] months.
14.11
Survival . The termination or expiration of this Agreement shall not relieve the Parties of any obligations accruing prior to such expiration or termination, and any such expiration or termination shall be without prejudice to the rights of either Party against the other Party. Articles 1, 6, 7, 8, 10, 12 and 13 in their entirety, Article 11 (for the period of time wherein Prothena/Sublicensees have an obligation to maintain insurance), and Sections 3.14 (for the period of time stated therein), 3.15 (for the period of time Prothena is required to maintain records under Section 3.14), 3.16 (for the period of time Prothena is required to maintain records under Section 3.14), 4.3, 9.3, 14.1, 14.3, 14.4, 14.5, 14.6, 14.7, 14.8, 14.9, 14.10 and 14.11.
14.12
Counterparts. This Agreement may be executed in counterparts each of which shall be deemed an original but all of which together shall constitute one and the same instrument. Transmission by facsimile, email or other form of electronic transmission of an executed counterpart of this Agreement shall be deemed to constitute due and sufficient delivery of such counterpart.
The Parties are executing this Agreement so as to be effective on the Effective Date.
UNIVERSITY HEALTH NETWORK
PROTHENA BIOSCIENCES LIMITED
Per: /s/ Christopher J. Paige    
Per: /s/ Yvonne Tchrakian    
Name: Dr. Christopher J. Paige
Title: Executive Vice President Research
Name: Yvonne Tchrakian
Title: Director

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SCHEDULE “A”

UHN BACKGROUND INTELLECTUAL PROPERTY

[***]

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SCHEDULE “B”
FOREGROUND INTELLECTUAL PROPERTY
A.
[***]

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Exhibit 10.3

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

CONFIDENTIAL
EXECUTION VERSION









MASTER COLLABORATION AGREEMENT
 
by and among
 
PROTHENA BIOSCIENCES LIMITED
 
And
 
CELGENE SWITZERLAND LLC
 
 
 
 
 
Dated as of March 20, 2018







TABLE OF CONTENTS
Page


ARTICLE 1
DEFINITIONS    1
ARTICLE 2
COLLABORATION AND DEVELOPMENT    18
2.1
Collaboration Overview    18
2.2
Program Development    18
2.3
Research Term Extension    22
2.4
Disputes Regarding Antibodies and Lead Candidates    23
2.5
Celgene Phase 1 Portion Participation Right    24
2.6
Regulatory Responsibilities    27
2.7
Subcontracting    28
2.8
Audit    29
2.9
Material Transfer    29
2.10
Compliance Provisions    30
2.11
Global License Agreement    32
ARTICLE 3
OPTIONS    32
3.1
Option Grant    32
3.2
Government Approvals    35
ARTICLE 4
GOVERNANCE    37
4.1
Generally    37
4.2
Joint Steering Committee    38
4.3
Patent Committee    42
4.4
Manufacturing Committee    44
ARTICLE 5
EXCLUSIVITY    45
5.1
Exclusivity    45
5.2
Failure to Exercise Phase 1 Option    45
5.3
Prothena Exception for Active Immunotherapeutic Approaches      46
ARTICLE 6
FINANCIAL TERMS    47
6.1
Upfront Payment    47
6.2
Equity Investment    47
6.3
Option Fees    47
6.4
Additional Payment Terms    48
ARTICLE 7
LICENSES; INTELLECTUAL PROPERTY    50

 
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TABLE OF CONTENTS
(continued)
Page


7.1
Licenses to Celgene    50
7.2
Grant Back for Lapsed Targets    50
7.3
Rights Retained by the Parties    50
7.4
No Implied Licenses    50
7.5
Insolvency    50
7.6
Ownership    51
7.7
Prosecution and Maintenance of Prothena Collaboration Patents and Program Patents    53
7.8
Enforcement of Prothena Collaboration Patents and Program Patents    55
7.9
Matters Involving Joint Program Patents    56
7.10
Common Interest Agreement    56
7.11
License Filing    57
7.12
Defense of Claims Brought by Third Parties    57
7.13
Celgene Activities    57
ARTICLE 8
CONFIDENTIALITY    57
8.1
Nondisclosure    57
8.2
Collaboration Specific Confidential Information    58
8.3
Exceptions    58
8.4
Authorized Disclosure    59
8.5
Terms of this Agreement    60
8.6
Securities Filings    60
8.7
Publicity    61
8.8
Permitted Publications    62
8.9
Re-Publication; Re-Presentation    63
8.10
Use of Names    63
8.11
Relationship to Existing Confidentiality Agreement    63
8.12
Clinical Trials Registry    63
8.13
U.S. License Agreement; Global License Agreement    63
ARTICLE 9
REPRESENTATIONS AND WARRANTIES; COVENANTS    64
9.1
Representations and Warranties of Both Parties    64
9.2
Representations and Warranties of Prothena    65
9.3
Additional Representations, Warranties and Covenants of Prothena    67

 
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TABLE OF CONTENTS
(continued)
Page


9.4
Representations and Warranties of Celgene    68
9.5
Prothena Covenants    68
9.6
Disclaimer    68
ARTICLE 10
INDEMNIFICATION; INSURANCE    69
10.1
Indemnification by Celgene    69
10.2
Indemnification by Prothena    69
10.3
Procedure    70
10.4
Insurance    70
10.5
LIMITATION OF LIABILITY    71
ARTICLE 11
TERM AND TERMINATION    71
11.1
Term; Expiration    71
11.2
Termination for Breach    71
11.3
Voluntary Termination    72
11.4
Termination for Bankruptcy    72
11.5
Termination for Patent Challenge    72
11.6
Effects of Expiration or Termination    73
11.7
Certain Additional Remedies of Celgene in Lieu of Termination    73
11.8
Surviving Provisions    74
ARTICLE 12
MISCELLANEOUS    75
12.1
Severability    75
12.2
Notices    75
12.3
Force Majeure    76
12.4
Assignment    77
12.5
Waivers and Modifications    78
12.6
WAIVER OF JURY TRIAL    78
12.7
Choice of Law; Dispute Resolution    78
12.8
Relationship of the Parties    79
12.9
No Third Party Beneficiaries    80
12.10
Entire Agreement    80
12.11
Counterparts    80
12.12
Equitable Relief    80

 
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TABLE OF CONTENTS
(continued)
Page


12.13
Interpretation    80
12.14
Further Assurances    81
12.15
Extension to Affiliates    81


    

 
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LIST OF SCHEDULES
SCHEDULE 1.14    CERTAIN EXISTING COLLABORATION CANDIDATES
SCHEDULE 1.42    IN-LICENSE AGREEMENTS AND OTHER THIRD PARTY
AGREEMENTS
SCHEDULE 1.66    CERTAIN PROTHENA COLLABORATION PATENTS
SCHEDULE [***]    [***]
LIST OF EXHIBITS
EXHIBIT A    FORM OF GLOBAL LICENSE AGREEMENT
EXHIBIT B    FORM OF U.S. LICENSE AGREEMENT


[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.



MASTER COLLABORATION AGREEMENT
This MASTER COLLABORATION AGREEMENT (this “ Agreement ”) is entered into and made effective as of March 20, 2018 (the “ Effective Date ”) by and among Prothena Biosciences Limited, an Irish limited company (“ Prothena ”) and Celgene Switzerland LLC , a Delaware limited liability company (“ Celgene ”). Celgene and Prothena are each referred to herein by name or as a “ Party ”, or, collectively, as the “ Parties ”.
RECITALS
WHEREAS , Prothena is a drug discovery company;
WHEREAS , Celgene possesses expertise in the development and commercialization of pharmaceutical products;
WHEREAS , Prothena may carry out research and development activities with respect to Antibodies that Target a Collaboration Target (with a focus on the treatment of neurodegenerative conditions including Alzheimer’s disease, amyotrophic lateral sclerosis, progressive supranuclear palsy, frontotemporal dementia, Parkinson’s disease, corticobasal degeneration, chronic traumatic encephalopathy and other proteinopathies of a Collaboration Target), with the goal of discovering, identifying, generating and developing lead candidates with respect to each Collaboration Target and Filing an IND with the FDA for a Phase 1 Clinical Trial for each Collaboration Target;
WHEREAS , if Prothena identifies any lead candidates with respect to a particular Collaboration Target and Files an IND with the FDA for such lead candidate for such Collaboration Target, then Celgene shall have the exclusive option to enter into a U.S. License Agreement with Prothena with respect to Antibodies that Target such Collaboration Target, on the terms and subject to the conditions set forth herein;
WHEREAS , if Celgene exercises its option to enter into a U.S. License Agreement with respect to a given Collaboration Target, then Prothena may thereafter carry out a Phase 1 Clinical Trial for such Collaboration Target, and Celgene shall have the exclusive option to enter into a Global License Agreement (as defined below) with Prothena with respect to Antibodies that Target such Collaboration Target, on the terms and subject to the conditions set forth herein.
NOW, THEREFORE , in consideration of the foregoing and the mutual agreements set forth below, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:
ARTICLE 1
DEFINITIONS
Unless specifically set forth to the contrary herein, the following terms shall have the respective meanings set forth below:
1.1      Affiliate ” means any Person which, directly or indirectly through one or more intermediaries, controls, is controlled by or is under common control with a Party. For purposes

1
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of this definition, the term “control” (including, with correlative meanings, the terms “controlled by” and “under common control with”) as used with respect to a Person means (a) direct or indirect ownership of fifty percent (50%) or more of the voting securities or other voting interest of any Person (including attribution from related parties), or (b) the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of such Person, whether through ownership of voting securities, by contract, as a general partner, as a manager, or otherwise.
1.2      Antibody ” means any [***] antibody (including [***]), [***] whether human, humanized, chimeric, murine, synthetic or from any other source.
1.3      Antitrust Law ” means the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and the rules and regulations promulgated thereunder (the “ HSR Act ”), the Sherman Act, as amended, the Clayton Act, as amended, the Federal Trade Commission Act, as amended, and any other Applicable Laws of the United States, a state or territory thereof, or any foreign government or supranational body (including the European Commission) that are designed to prohibit, restrict or regulate actions having the purpose or effect of monopolization or restraint of trade.
1.4      Applicable Law ” or “ Applicable Laws ” means all applicable laws, statutes, rules, regulations, orders, judgments or ordinances having the effect of law of any national, multinational, federal, state, provincial, county, city or other political subdivision, including, to the extent applicable, GCP, GLP and GMP, as well as all applicable data protection and privacy laws, rules and regulations, including, to the extent applicable, the United States Department of Health and Human Services privacy rules under the Health Insurance Portability and Accountability Act (“ HIPAA ”) and the Health Information Technology for Economic and Clinical Health Act and the EU Data Protection Directive (Council Directive 95/46/EC) and applicable laws implementing the EU Data Protection Directive and, when in force, the General Data Protection Regulation (2016/679).
1.5      Biomarker ” means a parameter or characteristic in a patient or Patient Sample, the measurement of which is useful (a) for purposes of selecting appropriate therapies or patient populations or monitoring disease susceptibility, severity or state, or monitoring therapies for such patient and/or (b) for predicting the outcome of a particular treatment of such patient.
1.6      Biosimilar Application ” means an application or submission filed with a Regulatory Authority for marketing authorization of a Biosimilar Product.
1.7      “Biosimilar Product” means, with respect to a given Collaboration Product, a biological product (a) that contains (i) an identical active ingredient(s) as the Collaboration Candidate in such Collaboration Product, or (ii) a “highly similar” active ingredient(s) to the Collaboration Candidate in such Collaboration Product, as the phrase “highly similar” is used in 42 U.S.C. § 262(i)(2), and subject to the factors set forth in FDA’s Guidance for Industry, “Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product,” (February 2012), at Section VI, or any successor FDA guidance thereto, (b) for which Regulatory Approval is obtained by referencing Regulatory Materials of such Collaboration Product, (c) is approved for use in such country (or region) pursuant to a Regulatory Approval process governing approval of interchangeable or biosimilar biologics as described in 42 U.S.C. §§ 262, or a similar process for

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Regulatory Approval in any country (or region) outside the United States, or any other similar provision that comes into force, or is the subject of a notice with respect to such Collaboration Product under 42 U.S.C. § 262(l)(2) or any other similar provision that comes into force in such country (or region), and (d) is sold in the same country as such Collaboration Product by any Third Party that is not a sublicensee of Celgene or its Affiliates with respect to the Prothena IP and did not purchase such product in a chain of distribution that included any of Celgene or any of its Affiliates or its sublicensees.
1.8      BPCIA ” means Biologics Price Competition and Innovation Act of 2009, as amended.
1.9      Business Day ” means a day on which banking institutions in New York City, New York are open for business, excluding any Saturday or Sunday.
1.10      Calendar Quarter ” means the period beginning on the Effective Date and ending on the last day of the calendar quarter in which the Effective Date falls, and thereafter each successive period of three (3) consecutive calendar months ending on the last day of March, June, September, or December, respectively; provided that the final Calendar Quarter shall end on the last day of the Term.
1.11      Calendar Year ” means the period beginning on the Effective Date and ending on December 31 of the calendar year in which the Effective Date falls, and thereafter each successive period of twelve (12) consecutive calendar months beginning on January 1 and ending on December 31; provided that the final Calendar Year shall end on the last day of the Term.
1.12      “Celgene IP” means Patents and Know-How Controlled (other than through the grant of a license from Prothena to Celgene pursuant to this Agreement) by Celgene or any of its Affiliates (including any Know-How that is created, conceived, discovered, first generated, invented, first made or first reduced to practice by or on behalf of Celgene or any of its Affiliates pursuant to the conduct of activities under this Agreement, including Celgene Phase 1 Know-How). For the avoidance of doubt, Celgene IP excludes (i) Know-How that is created, conceived, discovered, first generated, invented, first made or first reduced to practice by or on behalf of Prothena, solely or jointly with a Third Party, (ii) [***], and (iii) Joint Program IP.
1.13      Clinical Trial ” means a human clinical trial, including any Phase 1 Clinical Trial, Phase 2 Clinical Trial or Registration Enabling Clinical Trial, any study incorporating more than one of these phases, or any human clinical trial commenced after Regulatory Approval.
1.14      Collaboration Candidate ” means, on a Program-by-Program basis, (i) the Antibodies that Target the Collaboration Target under such Program that are Developed under such Program and (ii) Related Antibodies with respect to any Antibodies described in the foregoing clause (i); it being understood and agreed that a “Lead Candidate” and a “Development Candidate” shall remain included in the definition of “Collaboration Candidate”. Notwithstanding the foregoing, a “Collaboration Candidate” shall exclude any proprietary Antibody owned or otherwise controlled (through license or otherwise, other than as a result of a license from Prothena hereunder) by Celgene or any of its Affiliates and that is Developed or acquired outside the scope of a Program. The

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Antibodies listed on Schedule 1.14 (broken down on a Program-by-Program basis) shall be included as Collaboration Candidates with respect to the applicable Program.
1.15      Collaboration Product ” means, on a Program-by-Program basis, any product that constitutes, incorporates, comprises or contains a Collaboration Candidate from such Program, whether or not as the sole active ingredient, and in all forms, presentations, and formulations (including manner of delivery and dosage). For clarity, different forms, formulations, presentations or dosage strengths of a given Collaboration Product that constitute, incorporate, comprise or contain the same Collaboration Candidate shall be considered the same Collaboration Product for purposes of this Agreement.
1.16      Collaboration Target ” means each of (i) Tau, including Derivatives thereof, (ii) [***], including Derivatives thereof (this clause (ii), the “[***] Target ”), (iii) TDP-43, including Derivatives thereof and (iv) in the event that the JSC agrees in writing to substitute any of the foregoing targets in (i), (ii) or (iii) with a replacement target as set forth in Section 4.2.5(a), such replacement target (including Derivatives thereof). Collaboration Targets shall exclude all Lapsed Targets and Derivatives thereof.
1.17      Commercialization ” means any and all activities directed to the commercialization of a product (which may include related diagnostic products, if applicable), including commercial manufacturing (including Manufacturing) and commercial supply of a product, marketing, detailing, promotion, market research, distributing, order processing, handling returns and recalls, booking sales, customer service, administering and commercially selling such product, importing, exporting and transporting such product for commercial sale, and seeking of pricing and reimbursement of a product (if applicable), whether before or after Regulatory Approval has been obtained (including making, having made, using, importing, selling and offering for sale such product (or related diagnostic product, if applicable)), as well all regulatory compliance with respect to the foregoing. For clarity, “Commercialization” does not include any Clinical Trial commenced after Regulatory Approval. When used as a verb, “ Commercialize ” means to engage in Commercialization.
1.18      Commercially Reasonable Efforts ” means, with respect to Celgene in relation to an obligation under this Agreement with respect to a Collaboration Candidate or Collaboration Product, such efforts that are consistent with the efforts and resources normally used by Celgene in the exercise of its commercially reasonable business practices relating to performance of an obligation for a similar pharmaceutical compound or product (including the research, development, manufacture and commercialization of a pharmaceutical compound or product), as applicable, at a similar stage in its research, development or commercial life as the relevant Collaboration Candidate or Collaboration Product, and that has commercial and market potential similar to the relevant Collaboration Candidate or Collaboration Product, taking into account issues of intellectual property coverage, safety and efficacy, stage of development, product profile , competitiveness of the marketplace, proprietary position, regulatory exclusivity, anticipated or approved labeling, present and future market and commercial potential, the likelihood of receipt of Regulatory Approval, profitability (including pricing and reimbursement status achieved or likely to be achieved), amounts payable to licensors of patents or other intellectual property rights, [***] and legal issues.

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1.19      Confidential Information ” means, with respect to a Party, all confidential and proprietary information and materials, including Know-How, marketing plans, strategies, and customer lists, in each case, that are disclosed by or on behalf of such Party to the other Party pursuant to this Agreement, regardless of whether any of the foregoing are marked “confidential” or “proprietary” or communicated to the other Party by or on behalf of the disclosing Party in oral, written, visual, graphic or electronic form.
1.20      Control ”, “ Controls ” or “ Controlled ” means, with respect to any intellectual property (including Know-How) or Confidential Information, the ability of a Party or its Affiliates, as applicable, (whether through ownership or license (other than a license granted in this Agreement)) to grant to the other Party the licenses or sublicenses as provided herein, or to otherwise disclose such intellectual property or Confidential Information to the other Party, without violating the terms of any then-existing agreement with any Third Party at the time such Party or its Affiliates, as applicable, would be required hereunder to grant the other Party such license or sublicenses as provided herein or to otherwise disclose such intellectual property or Confidential Information to the other Party.
1.21      Data Lock ” means, with respect to a Clinical Trial being conducted by or on behalf of Prothena (or by or on behalf of Celgene with respect to a Phase 1 Clinical Trial if it exercises the Celgene Phase 1 Portion Participation Right) for a Development Candidate under the Collaboration, the locking by or on behalf of Prothena (or by or on behalf of Celgene with respect to a Phase 1 Clinical Trial if it exercises the Celgene Phase 1 Portion Participation Right) of the database that contains the data for such Clinical Trial following completion of such Clinical Trial in order to prevent or control any further changes to such data after review, query resolution and reasonable determination by Prothena (or Celgene, if applicable) (in accordance with industry standards) that such database is ready for analysis.
1.22      Derivative ” means, with respect to a Collaboration Target, all [***] thereof.
1.23      Development ” means (i) research activities (including drug discovery, identification and/or synthesis) with respect to a product (which may include related diagnostic products, if applicable), and/or (ii) preclinical and clinical drug development activities, and other development activities, with respect to a product (which may include related diagnostic products, if applicable), including test method development and stability testing, toxicology, formulation, process development, qualification and validation, manufacture scale-up, development-stage manufacturing (including Manufacturing), quality assurance/quality control, Clinical Trials (including Clinical Trials and other studies commenced after Regulatory Approval), statistical analysis and report writing, the preparation and submission of INDs and MAAs, regulatory affairs with respect to the foregoing and all other activities necessary or useful or otherwise requested or required by a Regulatory Authority or as a condition or in support of obtaining or maintaining a Regulatory Approval. When used as a verb, “ Develop ” means to engage in Development.
1.24      Development Candidate ” means a Lead Candidate that is the subject of an IND Filed with the FDA for a Program for which Celgene has exercised its IND Option in accordance with Section 3.1.1.

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1.25      Dollars ” or “$” means the legal tender of the United States.
1.26      EEA ” means all countries that are officially recognized as member states of the European Economic Area at any particular time.
1.27      End of Discovery Portion Date ” means, with respect to a given Program, the date on which Prothena delivers to Celgene the first complete IND Data Package, if any, for such Program, in accordance with Section 2.2.2(d).
1.28      End of Phase 1 Date ” means, with respect to a given Program, the earlier of (a) (i) the date on which Prothena delivers to Celgene the first complete Phase 1 Data Package, if any, for such Program, in accordance with Section 2.2.3(b) or (ii) the date deemed the “End of Phase 1 Date” pursuant to Section 2.5.2 (as applicable), or (b) such other date as approved by the JSC with respect to such Program (this clause (b), an “ Alternative End of Phase 1 Date ” for a given Program).
1.29      EU ” means all countries that are officially recognized as member states of the European Union at any particular time.
1.30      Executive Officers ” means Prothena’s Chief Executive Officer and Celgene’s Executive Vice President, Research and Early Development (or such Executive Vice President’s designee).
1.31      File ” or “ Filing ” means, with respect to an IND, the filing of an IND with, and acceptance of such IND by, the FDA.
1.32      Global License Agreement ” means a Global License Agreement in the form attached hereto as Exhibit A .
1.33      Good Clinical Practices ” or “ GCP ” means the applicable then-current ethical and scientific quality standards for designing, conducting, recording, and reporting trials that involve the participation of human subjects as are required by applicable Regulatory Authorities or Applicable Law in the relevant jurisdiction, including in the United States, Good Clinical Practices established through FDA guidances, and, outside the United States, Guidelines for Good Clinical Practice – ICH Harmonized Tripartite Guideline (ICH E6).
1.34      Good Laboratory Practices ” or “ GLP ” means the applicable then-current good laboratory practice standards as are required by applicable Regulatory Authorities or Applicable Law in the relevant jurisdiction, including in the United States, those promulgated or endorsed by the FDA in U.S. 21 C.F.R. Part 58, or the equivalent thereof as promulgated or endorsed by the applicable Regulatory Authorities outside of the United States.
1.35      Good Manufacturing Practices ” or “ GMP ” means all applicable standards relating to manufacturing practices for fine chemicals, intermediates, bulk products and/or finished pharmaceutical products, as are required by applicable Regulatory Authorities or Applicable Law in the relevant jurisdiction, including, as applicable, (a) all applicable requirements detailed in the FDA’s current Good Manufacturing Practices regulations, U.S. 21 C.F.R. Parts 210 and 211, (b) all

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applicable requirements detailed in the EMA’s “The Rules Governing Medicinal Products in the European Community, Volume IV, Good Manufacturing Practice for Medicinal Products”, and (c) all Applicable Laws promulgated by any Governmental Authority having jurisdiction over the manufacture of the applicable compound or pharmaceutical product, as applicable.
1.36      Governmental Authority ” means any (a) federal, state, local, municipal, foreign or other government, (b) governmental or quasi-governmental authority of any nature (including any governmental division, subdivision, department, agency, bureau, branch, office, commission, council, board, instrumentality, officer, official, representative, organization, unit, body or entity and any court or other tribunal), (c) multinational governmental organization or body or (d) entity or body exercising, or entitled to exercise, any executive, legislative, judicial, administrative, regulatory, police, military or taxing authority or power of any nature.
1.37      IND ” means an investigational new drug application (including any amendment or supplement thereto) submitted to the FDA pursuant to U.S. 21 C.F.R. Part 312, including any amendments thereto. References herein to IND shall include, to the extent applicable, any comparable filing(s) outside the U.S. for the investigation of any product in any other country or group of countries (such as a Clinical Trial Application in the EU).
1.38      IND Data Package ” means, with respect a given Program for which an IND has been Filed with the FDA, the following: (i) a reasonably detailed analysis of the key data related to the Lead Candidate(s) from such Program, (ii) [***], (iii) [***], (iv) [***], (v) a list of [***], as well as a [***], and (vi) [***].
1.39      IND Option Term ” means, with respect to a given Program, the period beginning on the Effective Date and ending [***] ([***]) days after the End of Discovery Portion Date with respect to such Program ([***]); provided that, in the event that Celgene exercises its IND Option for a given Program in accordance with this Agreement, then the IND Option Term for such Program shall automatically be extended until the Parties execute the U.S. License Agreement for such Program, and upon execution thereof, the IND Option Term for such Program shall automatically be deemed to expire.
1.40      Indication ” means an entirely separate and distinct disease or medical condition in humans (i) [***], and/or (ii) [***]. For clarity, (a) [***], (b) [***] and (c) [***].
1.41      Initial Research Term ” means the period beginning on the Effective Date and ending on the six (6) year anniversary thereof.
1.42      In-License Agreements ” means any agreement between Prothena (or its Affiliates, as applicable) and any Third Party pursuant to which such Third Party licenses to Prothena (or its Affiliates, as applicable) any Patents or Know-How included in the Prothena IP, including those set forth on Schedule 1.42 .
1.43      Know-How ” means all proprietary (a) information, techniques, technology, practices, trade secrets, inventions, methods (including methods of use or administration or dosing), knowledge, data, results and software and algorithms, including pharmacological, toxicological and

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clinical test data and results, compositions of matter, chemical structures, protein sequences, and formulations, sequences, processes, formulae, techniques, research data, reports, standard operating procedures, batch records, manufacturing data, analytical and quality control data, analytical methods (including applicable reference standards), assays and research tools, in each case, whether patentable or not; and (b) tangible manifestations thereof, including any and all of the foregoing relating to Program Biological and Chemical Materials.
1.44      Lapsed Target ” means (i) any Collaboration Target that is deemed to be a “Lapsed Target” pursuant to Section 3.1.3(a) or Section 4.2.5, or (ii) any other Collaboration Target that the Parties mutually agree in writing should be a “Lapsed Target”. It is understood and agreed that a “Lapsed Target” shall not be included in the definition of a “Collaboration Target”.
1.45      Lead Candidate ” means, with respect to a given Program, any Collaboration Candidate that Targets the Collaboration Target under such Program that (i) satisfies the Lead Candidate Criteria, or (ii) if no Collaboration Candidate has satisfied the Lead Candidate Criteria at the time when Celgene exercises its IND Option for a given Program, the Collaboration Candidate under such Program that is at the most advanced stage of Development under such Program. It is understood and agreed that a “Development Candidate” shall remain included in the definition of “Lead Candidate”.
1.46      Lead Candidate Criteria ” means the criteria approved by the JSC after the Effective Date in order to determine if a given Collaboration Candidate could be a Lead Candidate, as such criteria may be amended from time to time by the JSC.
1.47      Manufacture ” means all activities related to the manufacturing of a product or diagnostic product or, in either case, any component or ingredient thereof, including test method development and stability testing, formulation, process development, manufacturing scale-up whether before or after Regulatory Approval, manufacturing any product or diagnostic product in bulk or finished form for Development or Commercialization (as applicable), including filling and finishing, packaging, labeling, shipping and holding, in-process and finished product testing, release of a product or diagnostic product or, in either case, any component or ingredient thereof, quality assurance and quality control activities related to manufacturing and release of a product or diagnostic product, and regulatory activities related to any of the foregoing.
1.48      Marketing Authorization Application ” or “ MAA ” means a Marketing Authorization Application, Biologics License Application or similar application, as applicable, and all amendments and supplements thereto, submitted to the FDA, or any equivalent filing in a country or regulatory jurisdiction other than the U.S. with the applicable Regulatory Authority, to obtain marketing approval for a pharmaceutical or diagnostic product, in a country or in a group of countries.
1.49      Option Term ” means, with respect to a given Program, the IND Option Term for such Program and the Phase 1 Option Term for such Program.
1.50      Patents ” means (a) all patents and patent applications in any country or supranational jurisdiction worldwide, (b) any substitutions, divisionals, continuations, continuations-in-part, reissues, renewals, registrations, confirmations, re-examinations, extensions,

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supplementary protection certificates and the like of any such patents or patent applications, and (c) foreign counterparts of any of the foregoing.
1.51      Patient Sample ” means tissue, fluid, or cells collected from a patient, or components of the foregoing.
1.52      Person ” means any individual, partnership, joint venture, limited liability company, corporation, firm, trust, association, unincorporated organization, governmental authority or agency, or any other entity not specifically listed herein.
1.53      Personal Data ” means any information relating to an identified or identifiable individual or otherwise as defined under Applicable Laws.
1.54      Phase 1 Clinical Trial ” means a human clinical trial of a product that would satisfy the requirements of U.S. 21 C.F.R. Part 312.21(a) (as amended), or a similar clinical study prescribed by the Regulatory Authorities in a foreign country, and is intended to (a) determine the safety, pharmacokinetics and pharmacodynamic parameters in healthy individuals or patients, and (b) following the foregoing clause (a), further evaluate safety and pharmacokinetics (including exploration of trends of a biomarker-based or clinical endpoint-based efficacy relationship to dose which need not be designed to be statistically significant) of the product, whether or not in combination with concomitant treatment, and which provides sufficient evidence of safety to be included in filings for a Phase 2 Clinical Trial or a Registration Enabling Clinical Trial with Regulatory Authorities.
1.55      Phase 1 Data Package ” means, with respect to a given Program for which a Phase 1 Clinical Trial is conducted, the following: (i) a reasonably detailed analysis of the data and applicable endpoints of the Phase 1 Clinical Trial after Data Lock (“ Phase 1 Data ”), including [***]; (ii) [***]; (iii) [***]; (iv) [***]; (v) [***]; (vi) [***]; (vii) [***]; (viii) [***]; (ix) [***]; (x) [***]; (xi) [***]; (xii) a list of [***], as well as a [***]; and (xiii) [***].
1.56      Phase 1 Option Term ” means, with respect to a given Program, the period commencing upon exercise of the IND Option with respect to such Program and ending [***] ([***]) days after the End of Phase 1 Date with respect to such Program ([***]); provided that, in the event that Celgene exercises its Phase 1 Option for a given Program in accordance with this Agreement, then the Phase 1 Option Term for such Program shall automatically be extended until the Parties execute the Global License Agreement for such Program, and upon execution thereof, the Phase 1 Option Term for such Program shall automatically be deemed to expire.
1.57      Phase 1 Term ” means, with respect to a given Program, the period commencing upon exercise of the IND Option with respect to such Program and ending upon the earlier of (i) the End of Phase 1 Date with respect to such Program and (ii) the exercise by Celgene of its Phase 1 Option with respect to such Program.
1.58      Phase 2 Clinical Trial ” means a human clinical trial of a product that would satisfy the requirements of U.S. 21 C.F.R. Part 312.21(b), as amended, and is intended to explore a variety of doses, dose response, and duration of effect, and to generate evidence of clinical safety and

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effectiveness for a particular Indication or Indications in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.
1.59      Primary Patent Countries ” means [***].
1.60      Program ” means a Development program hereunder with respect to a given Collaboration Target undertaken by or on behalf of Prothena or its Affiliates with respect to such Collaboration Target, including all Collaboration Candidates that Target such Collaboration Target and all Program Biological and Chemical Materials with respect thereto; it being understood and agreed that if, at any time during the Research Term, two (2) or more Collaboration Candidates each Target the same applicable Collaboration Target, then each such Collaboration Candidate shall be deemed part of the same applicable Program for purposes of this Agreement (and any applicable U.S. License Agreement and Global License Agreement, as applicable). For the avoidance of doubt, each Collaboration Target shall be the subject of a separate Program. For clarity, (i) if a Collaboration Candidate binds to more than one Collaboration Target it shall be deemed part of the Program in which such Collaboration Candidate was primarily Developed and (ii) any activities undertaken pursuant to a U.S. License Agreement or Global License Agreement shall not be part of the Program, except as expressly set forth in Section 2.3.1 of a U.S. License Agreement and Section 2.1.3(a) of a Global License Agreement.
1.61      Program Biological and Chemical Materials ” means, on a Program-by-Program basis, any and all compositions of matter, cells, cell lines, assays, animal models, imaging agents, Patient Samples, Biomarkers and any other physical, biological or chemical material, that are Controlled by Prothena or its Affiliates and [***] the Collaboration Target or Collaboration Candidates under such Program (or the Development, Manufacture or Commercialization thereof), including physical embodiments of such Program’s Collaboration Candidates and any diagnostics intended for use with such Collaboration Candidates, in each case, (i) created, conceived, discovered, first generated, invented, first made or first reduced to practice by or on behalf of Prothena or its Affiliates, whether solely or jointly with any Third Party, in such Program or (ii) otherwise utilized by or on behalf of Prothena or its Affiliates in such Program. To the extent the Program Biological and Chemical Materials are created, conceived, discovered, first generated, invented, first made or first reduced to practice under a given Program, such Program Biological and Chemical Materials shall be “Program Know-How” hereunder, and to the extent the Program Biological and Chemical Materials are not created, conceived, discovered, first generated, invented, first made or first reduced to practice under a given Program, but are otherwise utilized in such Program, such Program Biological and Chemical Materials shall be “Prothena Collaboration Know-How” hereunder.
1.62      Program IP ” means, collectively:
(a)      Program Know-How ” which means any and all Know-How that is created, conceived, discovered, first generated, invented, first made or first reduced to practice, in each case (i) by or on behalf of [***], (ii) by or on behalf of [***] or (iii) by or on behalf of [***], but expressly excluding any Joint Program Know-How.

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(b)      Program Patents ” which means any Patents Controlled by Prothena or its Affiliates that claim or cover any Program Know-How, but expressly excluding any Joint Program Patents.
1.63      Prosecution and Maintenance ” or “ Prosecute and Maintain ” means, with regard to a Patent, the preparation, filing, prosecution and maintenance of such Patent, as well as re-examinations, reissues, appeals, and requests for patent term adjustments and patent term extensions with respect to such Patent, together with the initiation or defense of interferences, oppositions, inter partes review, re-examinations, derivations, post-grant proceedings and other similar proceedings (or other defense proceedings with respect to such Patent, but excluding the defense of challenges to such Patent as a counterclaim in an infringement proceeding) with respect to the particular Patent, and any appeals therefrom. For clarification, “Prosecution and Maintenance” or “Prosecute and Maintain” shall not include any other enforcement actions taken with respect to a Patent.
1.64      Prothena Collaboration IP ” means all Prothena Collaboration Know-How and Prothena Collaboration Patents.
1.65      Prothena Collaboration Know-How ” means any and all Know-How that is Controlled by Prothena or its Affiliates on or after the Effective Date that is (a) necessary or [***] to research, develop, make, have made, import, use, offer to sell, sell or otherwise exploit any Collaboration Target, Collaboration Candidate or Collaboration Product or (b) [***], including any Know-How related to diagnostics intended for use with any such Collaboration Candidate or Collaboration Product, but expressly excluding Joint Program Know-How and Program Know-How.
1.66      Prothena Collaboration Patents ” means any and all Patents that are Controlled by Prothena or its Affiliates on or after the Effective Date that claim or cover (a) any Collaboration Target, Collaboration Candidate or Collaboration Product, or the research, development, making, having made, import, use, offering to sell, selling or other exploitation of any of the foregoing, or (b) any Prothena Collaboration Know-How; but expressly excluding Joint Program Patents and Program Patents. Prothena Collaboration Patents shall include the Patents set forth on Schedule 1.66 .
1.67      Prothena IP ” means the Prothena Collaboration Patents, the Prothena Collaboration Know-How, the Program Patents and the Program Know-How , as well as Prothena’s (and its Affiliates’) right, title and interest in and to the Joint Program IP.
1.68      Prothena Platform Patent ” means a Patent within the Prothena Collaboration Patents that [***] claims the Prothena Platform Technology.
1.69      “[***]” means [***], which shall [***]; but in any case excluding [***].
1.70      Registration Enabling Clinical Trial ” means (a) a human clinical trial of a product that would satisfy the requirements of U.S. 21 C.F.R. Part 312.21(c), as amended, and is intended to (i) establish that the product is safe and efficacious for its intended use, (ii) define

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contraindications, warnings, precautions and adverse reactions that are associated with the product in the dosage range to be prescribed, and (iii) support Regulatory Approval for such product, or (b) a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than in the United States.
1.71      Regulatory Approval ” means all approvals, licenses and authorizations of the applicable Regulatory Authority necessary for the marketing and sale of a pharmaceutical or diagnostic product for a particular Indication in a country or region (including separate pricing or reimbursement approvals, as necessary), and including the approvals by the applicable Regulatory Authority of any expansion or modification of the label for such Indication.
1.72      Regulatory Authority ” means any national or supranational Governmental Authority, including the U.S. Food and Drug Administration (and any successor entity thereto) (the “ FDA ”) in the U.S., the European Medicines Agency (and any successor entity thereto) (the “ EMA ”) in the EU and the Ministry of Health, Labour and Welfare of Japan, or the Pharmaceuticals and Medical Devices Agency of Japan (or any successor to either of them) as the case may be (the “ MHLW ”) in Japan, or any health regulatory authority in any country or region that is a counterpart to the foregoing agencies, in each case, that holds responsibility for development and commercialization of, and the granting of Regulatory Approval for, a pharmaceutical or diagnostic product, as applicable, in such country or region.
1.73      Regulatory Materials ” means the regulatory registrations, applications, authorizations and approvals (including approvals of MAAs, supplements and amendments, pre- and post-approvals, pricing and reimbursement approvals, and labeling approvals), Regulatory Approvals and other submissions made to or with any Regulatory Authority for research, development (including the conduct of Clinical Trials), manufacture, or commercialization of a pharmaceutical or diagnostic product in a regulatory jurisdiction, together with all related correspondence to or from any Regulatory Authority and all documents referenced in the complete regulatory chronology for each MAA, including all Drug Master Files (if any), INDs and supplemental biologics license applications (sBLAs) and foreign equivalents of any of the foregoing.
1.74      Related Antibody ” means, with respect to a given Antibody, any (a) [***] or (b) [***], and in each case of (a) and (b), that [***].
1.75      Research Extension Period means the period commencing at the end of the Initial Research Term and ending on (i) the twelve (12) month anniversary of the end of the Initial Research Term, if the Initial Research Term is extended pursuant to Section 2.3.1, (ii) the twenty-four (24) month anniversary of the end of the Initial Research Term if the Initial Research Term is extended pursuant to Section 2.3.2, or (iii) the end of the extension period agreed to by the Parties, if the Initial Research Term is extended pursuant to Section 2.3.3.
1.76      Research Plan ” means, with respect to a given Program, a research and development plan (which may be developed and adopted by the JSC after the Effective Date, and may be amended from time to time by the JSC pursuant to Section 4.2.3) for the activities of the Collaboration that may be conducted by or on behalf of Prothena for such Program, (i) during the Research Term, with the goal of discovering, identifying, generating and developing Collaboration

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Candidates and Lead Candidates for the Collaboration Target under such Program, and Filing an IND with the FDA for a Phase 1 Clinical Trial for a Lead Candidate for such Collaboration Target, with a focus on the treatment of neurodegenerative conditions including Alzheimer’s disease, amyotrophic lateral sclerosis, progressive supranuclear palsy, frontotemporal dementia, Parkinson’s disease, corticobasal degeneration, chronic traumatic encephalopathy and other proteinopathies of such Collaboration Target, and (ii) during the Phase 1 Term for such Program, with the goal of advancing Development Candidates from such Program to completion of Phase 1 Clinical Trial.
1.77      Research Term ” means the Initial Research Term plus, if applicable, the Research Extension Period.
1.78      Target ” means, with respect to a given Antibody and a given Collaboration Target, that such Antibody [***]; provided that, [***]. For the purposes of the “Target” definition, “[***]” means [***].
1.79      Territory ” means worldwide.
1.80      Third Party ” means any Person other than Prothena or Celgene that is not an Affiliate of Prothena or of Celgene.
1.81      Third Party Claim ” means any and all suits, claims, actions, proceedings or demands brought by a Third Party.
1.82      Third Party Damages ” means all losses, costs, claims, damages, judgments, liabilities and expenses payable to a Third Party by a Party (or the Prothena Indemnitees or Celgene Indemnitees, as applicable) under a Third Party Claim (including reasonable attorneys’ fees and other reasonable out-of-pocket costs of litigation in connection therewith).
1.83      United States ” or “ U.S. ” means the United States of America and all of its territories and possessions.
1.84      “[***]” means [***].
1.85      U.S. License Agreement ” means a U.S. License Agreement in the form attached hereto as Exhibit B .
1.86      Violation ” means that Prothena or any of its officers or directors or any other Prothena personnel (or other permitted agents of Prothena performing activities hereunder including any of Prothena’s Affiliates, Third Party contractors and their respective officers and directors) has been: (1) convicted of any of the felonies identified among the exclusion authorities listed on the U.S. Department of Health and Human Services, Office of Inspector General (OIG) website, including 42 U.S.C. 1320a-7(a) (http://oig.hhs.gov/exclusions/authorities.asp); (2) identified in the OIG List of Excluded Individuals/Entities (LEIE) database (http://exclusions.oig.hhs.gov/) or otherwise excluded from contracting with the federal government (see the System for Award Management (formerly known as the Excluded Parties Listing System) at http://sam.gov/portal/public/SAM/); or (3) listed by any U.S. federal agency as being suspended, debarred, excluded or

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otherwise ineligible to participate in federal procurement or non-procurement programs, including under 21 U.S.C. 335a (http://www.fda.gov/ora/compliance_ref/debar/) (each of (1), (2) and (3) collectively the “ Exclusions Lists ”).
1.87      Additional Definitions . Each of the following terms has the meaning described in the corresponding section of this Agreement indicated below:
Definition:
Section:
Active Immunotherapeutic Approaches
5.3.1
Agreement
Preamble
Alliance Manager
4.1.3
Alternative End of Phase 1 Date
1.28
Celgene
Preamble
Celgene Indemnitees
10.2
Celgene Phase 1 Know-How
2.5.3
Celgene Phase 1 Portion Participation Right
2.5.1(b)
Celgene Product
4.2.7
Celgene Proposed Terms
5.3.2
Clearance Date
3.2.2
Collaboration
2.1
Collaboration Non-Specific IP
8.2
Collaboration Material Transfer Agreement
2.9.1
Collaboration Specific IP
8.2
Competing Compound
5.1
Confirmation Notice
2.4.1
Cure Period
11.2.1
Disclosing Party
8.1
Discovery Portion
2.1
Dispute
12.7.2
DOJ
3.2.2
Effective Date
Preamble
Electronic Delivery
12.11
EMA
1.72
Excluded Claim
12.7.3(d)
Exclusion Lists
1.86
Existing Confidentiality Agreement
8.11
First Extended Research Term
2.3.1
Force Majeure
12.3
FTC
3.2.2
FDA
1.72
Grant
5.3.2

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Definition:
Section:
Grant Notice
5.3.2
HIPAA
1.4
HSR Act
1.3
HSR Filing
3.2.2
Implementation Date
3.2.2
IND Option
3.1.1
IND Option Exercise Fee
6.3.1
IND Option Exercise Notice
3.1.3(a)
Indemnitee
10.3
Indemnitor
10.3
Indirect Taxes
6.4.2(b)
Insolvency Event
11.4
Investment Agreements
6.2
Joint Program IP
7.6.4
Joint Program Know-How
7.6.4
Joint Program Patent
7.6.4
JSC
4.2.1
Manufacturing Committee
4.4.1
Material Receiving Party
2.9.1
MHLW
1.72
Negotiation Period
5.3.2
[***]
[***]
Notice Period
5.3.2
Officials
2.10.2
Option
3.1
Participation Term Extension
2.5.4
Party or Parties
Preamble
Patent Committee
4.3.1
Patent Liaison
4.1.4
Patent Strategy
4.3.4
Payee Party
6.4.2(b)
Paying Party
6.4.2(b)
Payment
2.10.2
Permitted Celgene Purpose
2.9.1
Phase 1 Data
1.55
Phase 1 Development Portion
2.1
Phase 1 Option
3.1.2
Phase 1 Option Exercise Fee
6.3.2
Phase 1 Option Exercise Notice
3.1.3(b)
Program Assets
3.1.5(a)
Program Know-How
1.62(a)

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Definition:
Section:
Program Patents
1.62(b)
Program Regulatory Materials
2.6.1(a)
[***]
[***]
Prothena
Preamble
Prothena Indemnitees
10.1
Publishing Party
8.8.1
Qualified Scientist
2.4.3
Receiving Party
8.1
Regulatory Transfer Date
2.6.1(b)
Right of First Negotiation
5.3.2
Scientific Panel
2.4.3
SEC
8.4.1(a)
Securities Regulators
8.6
Subcommittee
4.1.1(b)
Subcontracting Essential Provisions
2.7
Tax Benefit
6.4.2(c)
Term
11.1
Transferred Prothena Materials
2.9.1
Transferring Party
2.9.1
Upfront Payment
6.1

ARTICLE 2
COLLABORATION AND DEVELOPMENT
2.1      Collaboration Overview . Pursuant to this Agreement and as further provided in this Article 2, with respect to each Collaboration Target, (a) Prothena may conduct discovery activities with the goal of discovering, identifying and generating Collaboration Candidates that Target such Collaboration Target, and (b) Prothena may conduct pre-clinical Development activities (including comparator reference research and proprietary antibodies as required for the characterization of the Program antibodies) with respect to Collaboration Candidates with the goal of (i) identifying and further Developing Lead Candidates that Target such Collaboration Target and (ii) Filing an IND with the FDA for a Phase 1 Clinical Trial for a Lead Candidate for such Collaboration Target, and with a focus on the treatment of neurodegenerative conditions including Alzheimer’s disease, amyotrophic lateral sclerosis, progressive supranuclear palsy, frontotemporal dementia, Parkinson’s disease, corticobasal degeneration, chronic traumatic encephalopathy and other proteinopathies of a Collaboration Target (clauses (a) and (b), the “ Discovery Portion ”), (c) if Celgene exercises its IND Option with respect to a given Program as more specifically provided in Article 3, then Prothena may conduct further Development activities with the goal of advancing Development Candidates that Target the applicable Collaboration Target to completion of Phase 1 Clinical Trial, and with a focus on the treatment of neurodegenerative conditions including Alzheimer’s disease, amyotrophic lateral sclerosis, progressive supranuclear palsy, frontotemporal dementia, Parkinson’s disease, corticobasal degeneration, chronic traumatic encephalopathy and other proteinopathies of a Collaboration Target (clause (c), the “ Phase 1 Development Portion ”) ((a), (b) and (c), the “ Collaboration ”). In addition, (x) in the event that Celgene exercises its IND Option with respect to one or more Programs as more specifically provided in Article 3, then the Parties shall enter into U.S. License Agreement for such Program(s) and (y) in the event that Celgene exercises its Phase 1 Option for one or more Programs as more specifically provided in Article 3, the Parties shall enter into a Global License Agreement for such Program(s).

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2.2      Program Development .
2.2.1      Generally .
(a)      During the Research Term, for each Collaboration Target, Prothena may conduct discovery activities to characterize, identify and generate Antibodies to become Collaboration Candidates that Target such Collaboration Target, and thereafter may pre-clinically Develop Collaboration Candidates to identify Lead Candidates that Target such Collaboration Target and File an IND with the FDA for a Phase 1 Clinical Trial for such Lead Candidates. In connection therewith, Prothena shall provide regular updates to Celgene at JSC meetings in accordance with Section 4.2, including providing reasonable data and information related to the Collaboration Targets and Collaboration Candidates for purposes of informing Celgene of the progress of the Programs and enabling robust discussions regarding the Programs.
(b)      In the event that Celgene exercises its IND Option with respect to a given Program, then during the Phase 1 Term for such Program, Prothena may conduct further Development activities with respect to the Development Candidates from such Program through completion of the Phase 1 Clinical Trial. In connection therewith, Prothena shall provide regular updates to Celgene at JSC meetings in accordance with Section 4.2, together with all material data and information in Prothena’s and its Affiliates’ possession relating to such Development Candidates for such Program and the applicable Collaboration Target.
(c)      To the extent that Prothena, at its discretion, conducts a Program, Prothena shall be responsible for the Manufacture of Collaboration Candidates and Collaboration Products for use in such Program, and the associated costs, in connection therewith.
(d)      If Prothena conducts Development activities under the Collaboration, Prothena may provide to Celgene a Research Plan, if any, and any updates thereto promptly after any modifications to a Research Plan are made; provided that activities conducted with respect to each separate Collaboration Target shall be considered as separate Program under a Research Plan. For the avoidance of doubt, if any Development activities are undertaken by or on behalf of Prothena or its Affiliates for a given Collaboration Target, or for Antibodies that Target a given Collaboration Target, then such activities shall be deemed to be undertaken under the Program for such Collaboration Target pursuant to this Agreement (and such Antibodies shall be deemed to be “Collaboration Candidates” for such Program), even if such activities are not included in a Research Plan. Prothena shall be responsible for research strategy and the conduct of activities under any Research Plan during the Research Term.
(e)      For the avoidance of doubt, (i) each Collaboration Target shall only be the subject of a single Program and (ii) each Program shall only include activities conducted with respect to one Collaboration Target.
2.2.2      Discovery Portion .
(a)      Collaboration Candidate Research . During the Research Term, Prothena shall notify Celgene, on a regular basis at JSC meetings, of Collaboration Candidates

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identified by or on behalf of Prothena or its Affiliates in the course of its ongoing research activities pursuant to a Program, as well as any material developments or new material data or information relating to previously identified Collaboration Candidates. The identity of such Collaboration Candidates shall be included in the minutes of the JSC meeting.
(b)      Lead Candidate Designation . During the Research Term, Prothena shall notify Celgene, on a regular basis at JSC meetings, of Collaboration Candidates identified by or on behalf of Prothena or its Affiliates in the course of its ongoing research activities pursuant to a Program that satisfies the Lead Candidate Criteria, as well as notify Celgene with respect to material developments or new data or information in Prothena’s (or its Affiliates’) possession relating to such Lead Candidates. The identity of such Lead Candidates shall be included in the minutes of the JSC meeting. The Lead Candidate Criteria for the Collaboration Target described in Section 1.16(i) (i.e., Tau) shall be determined by the JSC within [***] ([***]) days after the Effective Date, and for each other Collaboration Target, at such time as the JSC agrees, but in no event later than [***] of the Effective Date. The Lead Candidate Criteria for each Collaboration Target may be amended from time to time by the JSC. For clarity, there may be more than one Lead Candidate for a given Program.
(c)      IND Filing . Subject to Section 2.6, Prothena shall provide to Celgene (i) at least [***] ([***]) days prior to the expected filing of an IND for a particular Lead Candidate, [***], and a copy of the proposed draft IND, and Prothena shall consider in good faith any comments of Celgene with respect thereto, (ii) a final copy of the IND within [***] ([***]) days after filing the IND, and (iii) any communications to and from any Regulatory Authority with respect to such IND promptly following receipt or submission of such communications, as applicable. Prothena shall not (and Prothena shall ensure that its Affiliates do not) file any INDs with respect to any Collaboration Candidates under any Program other than Lead Candidates.
(d)      IND Data Package . Within [***] ([***]) days after Filing of the first IND with the FDA for a Lead Candidate from a given Program ([***]), Prothena shall provide to Celgene (or a Third Party advisor designated by Celgene) the IND Data Package for such Program (which, for clarity, shall specify all then-existing Lead Candidates from such Program). If Celgene designates a Third Party advisor to receive the IND Data Package, such Third Party advisor shall, prior to receiving such IND Data Package, be bound by confidentiality obligations and restrictions on use consistent with those set forth in Article 8. Upon receipt of the complete IND Data Package, Celgene (or its designee) shall review such IND Data Package, and Celgene (or its designee) shall notify Prothena, no later than [***] ([***]) days after receiving such IND Data Package, of [***]. If [***], the IND Option Term with respect to such Program shall [***].
2.2.3      Phase 1 Development Portion .
(a)      Conduct of Phase 1 Clinical Studies . In the event that Celgene exercises its IND Option for a given Program, then (i) the Phase 1 Development Portion of the Collaboration may commence with respect to the Development Candidates from such Program, (ii) Prothena may commence one or more Phase 1 Clinical Trials for such Program, and (iii) Prothena may update a Research Plan for such activities. Subject to Section 2.5, Prothena shall be responsible for the clinical strategy and conduct of such Phase 1 Clinical Trials. For the avoidance of doubt, if

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Celgene has exercised its IND Option for a given Program, the Phase 1 Development Portion of the Collaboration with respect to such Program may continue beyond the end of the Research Term until delivery of the Phase 1 Data Package for such Program.
(b)      Phase 1 Data Package . If a Phase 1 Clinical Trial is conducted for a Development Candidate in a given Program, within [***] ([***]) days after Data Lock for the applicable Clinical Trial ([***]), Prothena shall provide to Celgene (or a Third Party advisor designated by Celgene) the Phase 1 Data Package for such Program. If Celgene designates a Third Party advisor to receive the Phase 1 Data Package, such Third Party advisor shall, prior to receiving such Phase 1 Data Package, be bound by confidentiality obligations and restrictions on use consistent with those set forth in Article 8. Upon receipt of the complete Phase 1 Data Package, Celgene (or its designee) shall review such Phase 1 Data Package, and Celgene (or its designee) shall, no later than [***] ([***]) days after receiving such Phase 1 Data Package, notify Prothena of [***]. If [***], the Phase 1 Option Term with respect to such Program shall [***]. For the avoidance of doubt, with respect to a given Program, during the period from the end of the End of Phase 1 Date until the end of the Phase 1 Option Period for such Program, no further activities shall be conducted by or on behalf of Prothena with respect to such Program (including the Collaboration Target, Collaboration Candidates or Collaboration Product thereunder), unless agreed to by Celgene in writing (such agreement not to be unreasonably withheld).
(c)      Final Study Report . As soon as possible, but in all cases within [***] ([***]) months after Data Lock for the applicable Clinical Trial, Prothena shall provide to Celgene (or a Third Party advisor designated by Celgene) the final study report for the Phase 1 Clinical Trial for such Program (which shall be prepared in accordance with customary practice that meets the standards of ICH Topic E3 of ICH Guidelines for Structure and Content of Clinical Study Reports dated July 1996).
2.2.4      Costs . Prothena shall be solely responsible for any and all costs and expenses in connection with the performance, in its discretion, of any Program, except for any activities undertaken by Celgene pursuant to Section 2.5 for such Program.
2.2.5      Records; Results .
(a)      Prothena (with respect to all Development and Manufacturing activities conducted by or on behalf of it hereunder) and, if Celgene conducts a Phase 1 Clinical Trial pursuant to Section 2.5 under a Program, Celgene (with respect to such Phase 1 Clinical Trial conducted pursuant to Section 2.5) shall maintain (and shall cause their Affiliates to maintain) complete, current and accurate records of all such activities, and all data and other information resulting from such activities, and such Party shall retain the same for a period of no less than [***] ([***]) years from their creation (or such longer period of time as may be required by Applicable Law). Such records shall fully and properly reflect all work done and results achieved in the performance of such activities in good scientific manner appropriate for regulatory and patent purposes, and shall be prepared and maintained in accordance with Applicable Law, including, as applicable, ICH GCP, GLP and GMP record keeping requirements where applicable. Prothena (with respect to all studies, including Clinical Trials and all IND-enabling studies, conducted by or on behalf of it hereunder) and, if Celgene conducts a Phase 1 Clinical Trial pursuant to Section 2.5

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under a Program, Celgene (with respect to such Phase 1 Clinical Trial conducted pursuant to Section 2.5) shall document such studies in formal written study records according to Applicable Laws, including national and international guidelines such as, to the extent applicable, ICH, GCP, GLP and GMP. Each Party shall have the right to review and copy such records as reasonably requested by such Party.
(b)      At least [***] ([***]) Business Days in advance of each JSC meeting, (i) Prothena shall provide the JSC written progress reports on the status of any activities undertaken by or on behalf of Prothena under each Program including (a) the identification of any Collaboration Candidates and potential Lead Candidates and Development Candidates, and (b) reasonably detailed summaries of data associated with the activities with respect to each Program and (ii) if Celgene conducts a Phase 1 Clinical Trial pursuant to Section 2.5 under a Program, Celgene shall provide the JSC written progress report on the status of any activities undertaken with respect to such Phase 1 Clinical Trial conducted pursuant to Section 2.5, including reasonably detailed summaries of data associated with the activities with respect to such Phase 1 Clinical Trial. In addition, in furtherance of the Collaboration, Prothena shall provide Celgene such other data and information regarding the Programs, the Collaboration Targets and Collaboration Candidates as Celgene may reasonably request.
2.2.6      Activities Under Collaboration . Prothena may (in its discretion) conduct (or have conducted) Development activities during the Research Term for Antibodies that Target a Collaboration Target only pursuant to a Program under this Agreement, and subject to Celgene’s Options hereunder.
2.3      Research Term Extension .
2.3.1      Extension by Celgene . Celgene shall have the right, in its sole discretion, to extend the Research Term for an additional twelve (12) months from the end of the Initial Research Term (the Initial Research Term as extended by such additional twelve (12) month period, the “ First Extended Research Term ”) by providing Prothena with written notice of such election no later than [***] ([***]) days prior to the end of the Initial Research Term and by paying Prothena an extension fee of Ten Million Dollars ($10,000,000) within [***] ([***]) days after delivery of such notice.
2.3.2      Additional Extension by Celgene . In the event that Celgene exercises its extension right pursuant to Section 2.3.1, then Celgene shall have the additional right, in its sole discretion, to extend the Research Term for an additional twelve (12) months from the end of the First Extended Research Term (for a total of twenty-four (24) months beyond the Initial Research Term) by providing Prothena with written notice of such election no later than [***] ([***]) days prior to the end of the First Extended Research Term and by paying Prothena an extension fee of Ten Million Dollars ($10,000,000) within [***] ([***]) days after delivery of such notice.
2.3.3      Extension by Mutual Agreement . Without limiting Celgene’s rights under Section 2.3.1 and 2.3.2, the Parties may mutually agree in writing (in each Party’s discretion) to extend the Research Term. In such case, the Parties shall agree to the specific period of time that the Research Term will be extended.

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2.4      Disputes Regarding Antibodies and Lead Candidates .
2.4.1      Antibodies . If [***] during the Research Term either Party has a reasonable belief that an Antibody that is being researched or Developed by or on behalf of Prothena (or its Affiliates) Targets a given Collaboration Target, and wishes to confirm whether or not such Antibody Targets such Collaboration Target, then either Party may issue a notice to the other Party with respect thereto (a “ Confirmation Notice ”). The Parties shall discuss in good faith for a period of [***] ([***]) days whether or not such Antibody Targets the applicable Collaboration Target. In the event that the Parties do not agree in writing within such [***] ([***]) day period whether or not such Antibody Targets the applicable Collaboration Target, either Party may issue a written notice to the other Party requesting the independent evaluation described in Section 2.4.3. [***]
2.4.2      Lead Candidates . If during the Research Term either Party wishes to determine whether or not a given Collaboration Candidate satisfies the Lead Candidate Criteria, then either Party may issue a notice to the other Party with respect thereto. The Parties shall discuss in good faith for a period of [***] ([***]) days whether or not such Collaboration Candidate satisfies the Lead Candidate Criteria. In the event that the Parties do not agree in writing within such [***] ([***]) day period whether or not such Collaboration Candidate satisfies the Lead Candidate Criteria, either Party may issue a written notice to the other Party requesting the independent evaluation described in Section 2.4.3. [***]
2.4.3      Scientific Panel . In the event that either of the Parties wishes to have a panel of three Qualified Scientists appointed as provided in this Section 2.4 (each such panel of three Qualified Scientists, a “ Scientific Panel ”) to determine whether or not (i) a given Antibody that is being Developed by or on behalf of Prothena (or its Affiliates) Targets a given Collaboration Target or (ii) a given Collaboration Candidate satisfies the Lead Candidate Criteria, then in each such case the Parties agree to the procedure as provided in this Section 2.4.3. Within [***] ([***]) days following any such request for a Scientific Panel, [***] shall [***] and, if [***]. Each Scientific Panel shall act as follows: (1) [***]; (2) [***]; and (3) [***]. The Scientific Panel shall [***]. The [***] shall be [***]. For purposes of this Agreement, “ Qualified Scientist ” shall mean any scientist (A) [***], and (B) [***]. Notwithstanding the foregoing, in no event shall a Party be entitled to request that a Scientific Panel review any specific matter for which a Scientific Panel has previously rendered a decision.
2.5      Celgene Phase 1 Portion Participation Right .
2.5.1      Phase 1 Portion Participation Right .
(a)      At the final meeting of the JSC prior to expiration of the Term (but in any case at least [***] ([***]) days prior to expiration of the Term) or at any time prior thereto at the written request of Celgene from time to time , with respect to any Programs for which Celgene has exercised its IND Option but for which the Phase 1 Option Term has not yet expired, Prothena shall (a) prepare and provide to Celgene a written list setting forth the Collaboration Target under any such Program and all Lead Candidates and Development Candidates that Target the Collaboration Target under the applicable Program, (b) prepare and provide to Celgene a summary of the status of the Development activities under any such Program and (c) provide to Celgene all

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available data and information then in Prothena’s (or its Affiliates’) Control related to the Collaboration Target, Lead Candidates and/or Development Candidates under any such Program, including a summary of [***] as well as the status of and information related to any Phase 1 Clinical Trial. Upon request by Celgene the Parties shall promptly meet to discuss each such Collaboration Target (including the Lead Candidates and Development Candidates under the applicable Program) and data and information relating thereto as provided to Celgene pursuant to this Section 2.5.1(a).
(b)      Following exercise of its IND Option for a given Program, Celgene shall have the right, at its discretion upon written notice to Prothena, to take over such Program (as and to the extent determined by Celgene, on a Program-by-Program basis) to continue the Development of Collaboration Candidates and Collaboration Products under such Program to completion of the Phase 1 Clinical Trial (the “ Celgene Phase 1 Portion Participation Right ”). If Celgene decides to take over such Program, then in the event that any Phase 1 Clinical Trial has been commenced by or on behalf of Prothena as of the time Celgene exercises its Celgene Phase 1 Portion Participation Right, the Parties will coordinate in good faith the conduct of such Phase 1 Clinical Trial, which may include, at Celgene’s written request, the transition of the conduct of such Phase 1 Clinical Trial to Celgene or wind-down of such Phase 1 Clinical Trial (in accordance with Applicable Law and ethical standards applicable to such Phase 1 Clinical Trial). In the event that Celgene exercises its Celgene Phase 1 Portion Participation Right with respect to one or more Programs, then the following shall apply:
(i)      Prothena shall transition such Program to Celgene (or its designee) as and to the extent reasonably requested by Celgene, including by providing to Celgene (or its designee) all Program Biological and Chemical Materials necessary [***] for Celgene to continue activities under such Program to completion of the Phase 1 Clinical Trial for such Program, as well as providing access to the physical embodiments of all Prothena IP, that is necessary [***] for Celgene to continue such activities under such Program;
(ii)      except as otherwise directed by Celgene, and subject to completion of the transfer to Celgene of the Program Regulatory Materials pursuant to Section 2.6.1(b) and the safety database and other safety information pursuant to Section 2.6.3, Prothena shall reasonably promptly wind-down and cease activities under such Program;
(iii)      Subject to the terms and conditions of this Agreement, Prothena shall grant, and hereby does grant to Celgene, a non-exclusive, worldwide, fully paid-up, royalty-free right and license, with the right to grant sublicenses (through multiple tiers), under the Prothena IP solely to Develop Collaboration Candidates and Collaboration Products under such Program to completion of a Phase 1 Clinical Trial for such Collaboration Candidates and Collaboration Products.
(iv)      Prothena shall use reasonable efforts to supply to Celgene ([***]), or if Prothena is not manufacturing ([***]) Collaboration Product to cooperate with Celgene [***] supply of, Collaboration Product for Celgene’s conduct of the Phase 1 Clinical Trial for such Program;

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(v)      all matters related to such Program shall continue to be within the purview of the JSC or any Subcommittee until such time as Celgene exercises its Phase 1 Option for such Program provided that [***];
(vi)      Celgene shall be solely responsible for any costs incurred by it (or its Affiliates) in its conduct of any Phase 1 Clinical Trial pursuant to the Celgene Phase 1 Portion Participation Right; and
(vii)      Celgene shall use Commercially Reasonable Efforts to commence and conduct such Phase 1 Clinical Trial;
(viii)      the provisions of Section 3.2 shall apply, mutatis mutandis , as applicable.
(c)      In the event that Celgene exercises its Celgene Phase 1 Portion Participation Right for a given Program, at the request of either Party, the Parties shall negotiate in good faith and enter into an appropriate agreement to document the rights granted to Celgene pursuant to this Section 2.5.1.
(d)      In the event that Prothena determines to abandon or cease a given Program during the Phase 1 Development Portion, then Prothena shall notify Celgene thereof in writing (and Prothena shall not abandon or cease such Program for a period of [***] ([***]) days thereafter), and if Celgene thereafter notifies Prothena in writing within [***] ([***]) days of receipt by it of Prothena’s notice that Celgene intends to exercise its Celgene Phase 1 Portion Participation Right for such Program, then the provisions of this Section 2.5.1 shall apply with respect to such Program, mutatis mutandis .
2.5.2      Phase 1 Option . In the event that (i) Celgene exercises its Celgene Phase 1 Portion Participation Right for a given Program, and (ii) Celgene completes a Phase 1 Clinical Trial with respect to a Lead Candidate from such Program, then Celgene shall notify Prothena of Data Lock for such Phase 1 Clinical Trial and Prothena shall provide a Phase 1 Data Package to Celgene for such Program within [***] ([***]) days after the Data Lock for such Phase 1 Clinical Trial in accordance with this Agreement (provided that, for clarity, Prothena shall not be required to include in the Phase 1 Data Package any Phase 1 Data generated by Celgene in the performance of such Phase 1 Clinical Trial). Celgene shall have the right to exercise its Phase 1 Option with respect to such Program as set forth in Article 3 (including entering into a Global License Agreement for such Program with Prothena), with the date that Prothena so delivers the complete Phase 1 Data Package for such Program being deemed be the End of Phase 1 Date for such Program, and the provisions of Article 3 shall apply in connection therewith, mutatis mutandis . For the avoidance of doubt, no additional amounts shall be payable by Celgene upon exercise by Celgene of the Celgene Phase 1 Portion Participation Right, and the Phase 1 Option Exercise Fee shall only be payable if, and when, Celgene determines to exercise its Phase 1 Option for such Program as set forth in Article 3.
2.5.3      Data and other Know-How . For clarity, the data and other Know-How that is created, conceived, discovered, first generated, invented, first made or first reduced to practice,

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in each case, [***], and all intellectual property rights therein, shall, as between the Parties, be owned by Celgene (“ Celgene Phase 1 Know-How ”), and [***].
2.5.4      Continuation of Agreement . In the event that Celgene exercises its Celgene Phase 1 Portion Participation Right under this Section 2.5 with respect to one or more Programs, then, unless this Agreement is otherwise terminated in accordance with Article 11, the Term shall continue with respect to the applicable Programs until the end of the Phase 1 Option Term for such Program (“ Participation Term Extension ”) and the provisions of this Agreement shall continue with respect to the applicable Programs during the Participation Term Extension to allow Celgene to exercise its rights as set forth in this Section 2.5 (including the terms related to Celgene’s Options in connection with such Program). Notwithstanding the foregoing, if the Parties enter into a Global License Agreement for a given Program, then the Participation Term Extension for such Program shall automatically end and this Agreement shall no longer apply with respect to such Program (except as otherwise expressly set forth herein). If the Participation Term Extension extends beyond the periods for which the provisions of Section 5.1 applies, then the provisions of Section 5.1 shall continue to apply for the duration of the Participation Extension Term, but solely with respect to the Collaboration Target that is the subject of the Program(s) for which Celgene exercised its rights under this Section 2.5.
2.6      Regulatory Responsibilities .
2.6.1      Regulatory Materials .
(a)      On a Program-by-Program basis, commencing on the Effective Date until the Regulatory Transfer Date, Prothena shall have the right, in consultation with Celgene, to prepare, file and maintain all Regulatory Materials (including any Regulatory Approvals) necessary for the Development and Manufacture of any Collaboration Candidates and Collaboration Products for such Program (collectively, the “ Program Regulatory Materials ”), and to interact with Regulatory Authorities in connection with the Development and Manufacture of any Collaboration Candidates and Collaboration Products for such Program. Prothena will provide Celgene with a reasonable opportunity to comment substantively on all material Regulatory Materials prior to filing or taking material action, and will reasonably and in good faith consider any comments and actions recommended by Celgene, including with respect to filing strategy. In addition, Prothena will allow Celgene or its representative to attend any and all meetings with Regulatory Authorities to the extent such attendance is not prohibited or limited by such Regulatory Authority.
(b)      If Celgene exercises its Phase 1 Portion Participation Right for a given Program, then immediately after such exercise, Prothena shall initiate the transfer of all Program Regulatory Materials, including for clarity any IND for the relevant Collaboration Candidates and/or Collaboration Products that are the subject of such Program to Celgene. The date on which such Program Regulatory Materials are transferred to Celgene shall be the “ Regulatory Transfer Date ” for such Program. Thereafter, Celgene shall have the right, in consultation with Prothena, to prepare, file, and maintain such Program Regulatory Materials, and to interact with Regulatory Authorities in connection with the Development and, as applicable, Manufacture of such Collaboration Candidates and Collaboration Products for such Program in accordance with the terms and conditions of Section 2.5. Additionally, with respect to any Phase 1 Clinical Trial conducted by

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Celgene pursuant to Section 2.5, Celgene will provide Prothena with a reasonable opportunity to comment substantively on all material Program Regulatory Materials prior to filing or taking material action, and will reasonably and in good faith consider any comments and actions recommended by Prothena, including with respect to filing strategy. In addition, with respect to any Phase 1 Clinical Trial conducted by Celgene pursuant to Section 2.5, Celgene will allow Prothena or its representative to attend any and all meetings with Regulatory Authorities to the extent such attendance is not prohibited or limited by such Regulatory Authority. For clarity, if the Regulatory Transfer Date does not occur prior to the expiration of the Option Term for such Program, Section 2.6.1(a) (and not this Section 2.6.1(b)) shall apply.
2.6.2      Right of Reference . On a Program-by-Program basis, Celgene (and its designees) shall have, and Prothena (on behalf of itself and its Affiliates) hereby grants to Celgene (and its designees), access and a right of reference (without any further action required on the part of Prothena or its Affiliates, whose authorization to file this consent with any Regulatory Authority is hereby granted) to all Regulatory Materials (including any Regulatory Approvals) with respect to Collaboration Candidates or Collaboration Products, and all data contained or referenced in any such Regulatory Materials (including any Regulatory Approvals), for Celgene (and its designees) solely to the extent necessary for Celgene to exercise its rights and perform hereunder.
2.6.3      Safety Information . On a Program-by-Program basis, commencing on the Effective Date until the expiration of the Option Term for such Program, Prothena shall be responsible for reporting, in accordance with Applicable Law, all safety information to Regulatory Authorities with respect to the Programs (unless Celgene exercises its Celgene Phase 1 Portion Participation Right pursuant to Section 2.5.1, in which case Celgene shall be so responsible with respect to any Phase 1 Clinical Trial conducted pursuant to Section 2.5). Prothena (or Celgene, if it exercises its Phase 1 Portion Participation Right, with respect to any conduct of the Phase 1 Clinical Trial pursuant to Section 2.5) shall, to the extent permitted by Applicable Law, (a) promptly provide the other Party with all safety information related to serious adverse events (as defined and within the time periods required under the relevant Clinical Trial protocol, if applicable) [***] and (b) provide the other Party with all other information concerning the pharmaceutical safety of each Lead Candidate at least once per [***].
2.6.4      License Agreement . In the event that a U.S. License Agreement (but no Global License Agreement) is entered into with respect to a given Program, then the provisions of such U.S. License Agreement shall control with respect to regulatory responsibilities with respect to such Program in the United States. In the event that a Global License Agreement is entered into with respect to a given Program, then the provisions of such Global License Agreement shall control with respect to regulatory responsibilities with respect to such Program worldwide.
2.7      Subcontracting . Subject to the terms of this Agreement, each Party shall have the right to engage Affiliates or Third Party subcontractors to perform its obligations under this Agreement. Such Party shall ensure that any such Affiliate or subcontractor shall [***] and shall perform such work consistent with the terms of this Agreement; provided, however, that any Party engaging an Affiliate or a Third Party subcontractor hereunder shall remain fully responsible and obligated for such activities. In addition, to the extent a Party engages an Affiliate or a Third Party

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subcontractor to perform any activities under a Program, such Party shall in all cases (i) [***]; provided that if (a) [***] and (b) [***], then [***]; and (ii) with respect to [***], obtain Control of any and all other Know-How and Patent Rights which are otherwise used in the performance of such activities, as more particularly described in Section 7.6. The Party engaging an Affiliate or Third Party subcontractor shall ensure that such Affiliate or Third Party subcontractor, as applicable, complies with all applicable provisions of this Agreement, including Sections 2.2.5, 2.8, 2.10, 7.6 and Article 8 (the “ Subcontracting Essential Provisions ”). Without limiting the foregoing, prior to subcontracting to any subcontractor for the performance of any portion of a Program, each Party shall (i) notify the other Party in writing thereof, and (ii) have entered into a written agreement with such subcontractor that complies with the terms and conditions of this Agreement, including the Subcontracting Essential Provisions (and such Party shall, upon the other Party’s request, provide a true, correct and complete copy of each agreement promptly after such agreement is entered into; provided that such agreement may be redacted to the extent not related to the Program). Each Party hereby expressly waives any requirement that the other Party exhaust any right, power or remedy, or proceed against any subcontractor for any obligation or performance hereunder, prior to proceeding directly against such Party with respect to any failure of such Party to perform its obligations under this Agreement through such subcontractor.
2.8      Audit . Celgene shall have the right, at its own cost, to audit and inspect the activities conducted by or on behalf of Prothena under the applicable Programs and, if Celgene exercises its Celgene Phase 1 Portion Participation Right with respect to a given Program, Prothena shall have the right, at its own cost, to audit and inspect the activities conducted by or on behalf of Celgene with respect to the Phase 1 Clinical Trial conducted pursuant to Section 2.5 for such Program, which, in each case, shall include the right to access records and facilities as reasonably requested by the auditing Party (and in any event on not less than [***] ([***]) days’ notice) to confirm compliance with the requirements of, and performance under, this Agreement. Such audit and inspection shall not be performed more than [***] and shall be reasonably coordinated in advance between the Parties.
2.9      Material Transfer .
2.9.1      Transfer . On a Program-by-Program basis, commencing on the Effective Date until the expiration of the Research Term (or expiration of the Option Term for such Program, if later), Prothena shall transfer to Celgene certain biological or chemical materials (including Patient Samples) created or utilized hereunder, including reasonably sufficient quantities of any Collaboration Candidates and Collaboration Products (the “ Transferred Prothena Materials ”), in each case, that are reasonably requested by Celgene to the extent necessary or reasonably useful for the following purposes (the “ Permitted Celgene Purposes ”): (i) to determine whether a given Collaboration Candidate may be a Lead Candidate pursuant to Section 2.2.2(b), (ii) to evaluate whether to exercise its Options with respect to such Program, (iii) [***] and (iv) for such other purposes as may be agreed to by the Parties in writing. Celgene shall be the “ Material Receiving Party ” and Prothena shall be the “ Transferring Party ” for the Transferred Prothena Materials. For the avoidance of doubt, this Section 2.9.1 shall not apply to any transfers of materials or data as part of Celgene’s exercise of its Celgene Phase 1 Portion Participation Right (or otherwise under any U.S. License Agreement or Global License Agreement). All transfers of such Transferred

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Prothena Materials by the Transferring Party to the Material Receiving Party shall be documented in a material transfer agreement in a form to be agreed upon in good faith by the Parties, which agreement shall contain customary material transfer agreement provisions contained in agreements for the transfer of similar materials in the pharmaceutical industry or otherwise as necessary to comply with obligations to Third Parties (if applicable), and shall set forth the type and name of the Transferred Prothena Material transferred, the amount of the Transferred Prothena Material transferred and the date of the transfer of such Transferred Prothena Material (each, a “ Collaboration Material Transfer Agreement ”). The Material Receiving Party shall only use the Transferred Prothena Materials provided pursuant to this Section 2.9.1 for the Permitted Celgene Purposes and the Material Receiving Party agrees that such Transferred Prothena Materials shall be used in compliance with Applicable Law and the terms and conditions of the material transfer agreement and this Agreement. The data that is generated by the Material Receiving Party pursuant to the Permitted Celgene Purposes under this Section 2.9.1 shall be deemed to be Program Know How; provided that Prothena shall grant, and hereby does grant, to Celgene a fully-paid up, royalty-free, worldwide, nonexclusive license (with the right to grant sublicenses through multiple tiers) to use such Program Know-How for [***].
2.9.2      License; Ownership . At the time the Transferring Party provides the Transferred Prothena Materials to the Material Receiving Party as provided herein and to the extent not separately licensed under this Agreement, subject to the terms and conditions of this Agreement, the Transferring Party shall grant, and hereby grants, to the Material Receiving Party a non-exclusive license under the Patents and Know-How Controlled by the Transferring Party necessary to use such Transferred Prothena Materials solely for the Purposes. Except as otherwise provided under this Agreement (or a U.S. License Agreement or Global License Agreement, as applicable), all such Transferred Prothena Materials delivered by the Transferring Party to the Material Receiving Party shall remain the sole property of the Transferring Party, shall only be used by the Material Receiving Party in furtherance of the Purposes, and, subject to Article 11, shall be returned to the Transferring Party or destroyed, in the Transferring Party’s sole discretion, upon the earliest of (i) termination of this Agreement, (ii) completion of the Purposes, or (iii) discontinuation of the use of such Transferred Prothena Materials by the Material Receiving Party. With respect to Transferred Prothena Materials transferred pursuant to Section 2.9.1, the Material Receiving Party shall cause the Transferred Prothena Materials not to be delivered to any Third Party without the prior written consent of the Transferring Party unless such Third Party is a Third Party subcontractor as set forth in Section 2.7.
2.10      Compliance Provisions . With respect to any activities conducted by or on behalf of a Party under this Agreement, the following shall apply:
2.10.1      General . To the extent that activities are conducted by or on behalf of a Party or its Affiliates pursuant to this Agreement, including all Development and Manufacturing of Collaboration Candidates and Collaboration Products, such Party shall [***] that such activities are conducted in compliance with all Applicable Laws (including, to the extent applicable, GCP, GLP and GMP), and good business ethics, and such Party will promptly notify the other Party in writing after it becomes aware of any deviations from any of the foregoing. In addition, each Party hereby certifies that it has not employed or otherwise used in any capacity, and will not employ or

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otherwise use in any capacity, the services of any Person (i) debarred under United States law (including Section 21 USC 335a) or any foreign equivalent thereof or (ii) that is the subject of an FDA debarment investigation or proceeding (or similar proceeding by any Regulatory Authority outside the United States), in each case, in performing any portion of the activities hereunder, including any Development and Manufacturing of Collaboration Candidates and Collaboration Products. Each Party will notify the other Party in writing immediately if any such debarment occurs or comes to its attention, and will, with respect to any person or entity so debarred promptly remove such person or entity from performing any such activities, function or capacity related to any such activities.
2.10.2      Governments and International Public Organizations . Neither Party will make any payment (and each Party shall ensure that its Affiliates and subcontractors do not make any payment), either directly or indirectly, of money or other assets, including any compensation such Party derives from this Agreement (hereinafter collectively referred to as a “ Payment ”), to government or political party officials, officials of international public organizations, candidates for public office, or representatives of other businesses or persons acting on behalf of any of the foregoing (hereinafter collectively referred to as “ Officials ”) where such Payment would constitute a violation of any Applicable Law. In addition, regardless of legality, neither Party will make any Payment (and will ensure that its Affiliates and subcontractors make no payment), either directly or indirectly to Officials if such Payment is for the purpose of influencing decisions or actions with respect to the subject matter of this Agreement or any other aspect of a Party’s business.
2.10.3      No Authority . Each Party acknowledges that no employee of the other Party or its Affiliates will have authority to give any direction, either written or oral, relating to the making of any commitment by such Party or its agents to any Third Party in violation of terms of this or any other provisions of this Agreement.
2.10.4      Exclusions Lists . Prothena, and Celgene if it conducts any Development under this Agreement pursuant to Section 2.5, will not use (and will cause its Affiliates and subcontractors not to use) in the performance of the Program any Person (including any employee, officer, director or Third Party contractor) who is (or has been) on the Exclusions List, or who is (or has been) in Violation, in the performance of any activities hereunder. [***] After the execution of this Agreement, Prothena, and Celgene if it conducts any Development under this Agreement pursuant to Section 2.5, will notify the other Party in writing immediately if any such Violation occurs or comes to its attention.

2.10.5      Personal Data . Prothena, and Celgene if it conducts any Development under this Agreement pursuant to Section 2.5, shall ensure that all Personal Data is processed in accordance with Applicable Laws, including the fair and lawful collection and processing of such Personal Data, the disclosure of such Personal Data to Celgene in accordance with this Agreement and the transfer of such Personal Data (including any transfer from inside the EEA to outside the EEA). Prothena, and Celgene if it conducts any Development under this Agreement pursuant to Section 2.5, shall promptly notify the other Party if it becomes aware that any data provided to the other Party is inaccurate or has been unlawfully obtained or processed or, where consent to process

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Personal Data has been provided, consent is withdrawn or such Party becomes aware that consent may not be reliable.
2.11      Global License Agreement . Notwithstanding the foregoing provisions of this Article 2, if a Global License Agreement is entered into with respect to a given Program, then, except as otherwise expressly set forth in such Global License Agreement, Prothena’s conduct of the Program hereunder shall cease, and the provisions of such Global License Agreement shall control with respect to such Program.
ARTICLE 3
OPTIONS
3.1      Option Grant . Subject to the terms and conditions of this Agreement, on a Program-by-Program basis, Prothena hereby grants to Celgene the following exclusive options (each, an “ Option ”):
3.1.1      IND Option . Prothena hereby grants to Celgene an exclusive Option, exercisable at any time during the applicable IND Option Term, in Celgene’s sole discretion, to enter into a U.S. License Agreement with respect to such Program (including all applicable Collaboration Candidates and Collaboration Products thereunder) on the terms and conditions set forth in the U.S. License Agreement (the Option pursuant to this Section 3.1.1 for a given Program, the “ IND Option ”). For the avoidance of doubt, (i) Celgene shall not be required to exercise any IND Option, even if an IND is Filed for such Program and (ii) if Celgene determines to exercise its IND Option for a given Program, Celgene shall only be required to exercise its IND Option for a given Program one (1) time (and shall only be required to pay the IND Option Exercise Fee for such Program one (1) time) regardless of the number of Collaboration Candidates, Lead Candidates and Development Candidates under such Program. Prothena acknowledges and agrees that all IND Options granted by Prothena to Celgene as set forth herein will be granted by Prothena exclusively to Celgene until the end of the applicable IND Option Term, and Prothena shall not (and shall procure that its Affiliates do not) grant any options (or other rights) to any other Person that would conflict with or are inconsistent with the IND Options granted to Celgene hereunder.
3.1.2      Phase 1 Option . In the event that Celgene exercises its IND Option for a given Program, Prothena hereby grants to Celgene an exclusive Option, exercisable at any time during the applicable Phase 1 Option Term, in Celgene’s sole discretion, to enter into a Global License Agreement with respect to such Program (including all applicable Collaboration Candidates and Collaboration Products thereunder) on the terms and conditions set forth in the Global License Agreement (the Option pursuant to this Section 3.1.2 for a given Program, the “ Phase 1 Option ”). For the avoidance of doubt, (i) Celgene shall not be required to exercise any Phase 1 Option, even if a Phase 1 Clinical Trial is completed for such Program and (ii) if Celgene determines to exercise its Phase 1 Option for a given Program, Celgene shall only be required to exercise its Phase 1 Option for a given Program one (1) time (and shall only be required to pay the Phase 1 Option Exercise Fee for such Program one (1) time) regardless of the number of Collaboration Candidates, Lead Candidates and Development Candidates under such Program. Prothena acknowledges and agrees that all Phase 1 Options granted by Prothena to Celgene as set forth herein will be granted by Prothena exclusively to Celgene until the end of the applicable Phase 1 Option Term, and Prothena

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shall not (and shall procure that its Affiliates do not) grant any options (or other rights) to any other Person that would conflict with or are inconsistent with the Phase 1 Options granted to Celgene hereunder.
3.1.3      Option Exercise .
(a)      IND Option . On a Program-by-Program basis, during the applicable IND Option Term, Celgene shall have the right, but not the obligation, to exercise the IND Option for such Program in its sole discretion by delivering written notice of such exercise to Prothena prior to the end of the IND Option Term (the “ IND Option Exercise Notice ”). Within [***] ([***]) days following each IND Option Exercise Notice delivery, and subject to Section 3.2, Celgene [***] and Prothena shall enter into a U.S. License Agreement with respect to such Program (including completing the exhibits and schedules thereto). On a Program-by-Program basis, if Celgene fails to provide its IND Option Exercise Notice before the expiration of the applicable IND Option Term, then (i) Celgene’s IND Option shall expire with respect to such Program, and (ii) the Collaboration Target under such Program shall be deemed a “ Lapsed Target ” and shall thereafter be excluded from the definition of Collaboration Target. For the avoidance of doubt, if a Collaboration Target becomes a “Lapsed Target” pursuant to this Section 3.1.3(a), then the licenses granted by Prothena pursuant to Section 7.1.1 with respect to such Lapsed Target and Collaboration Candidates and Collaboration Products [***] Targeting such Lapsed Target [***] shall terminate, and subject to the rights and licenses granted to Celgene hereunder (and under any U.S. License Agreement and Global License Agreement), Prothena shall have the right to pursue, outside of this Agreement, Development and Commercialization of Antibodies or other compounds that Target such Lapsed Target (but excluding, in all cases, the Development or Commercialization of any Antibodies that Target any remaining Collaboration Target); provided that for clarity, the foregoing is not intended to be a grant to Prothena of any rights or licenses to any intellectual property of Celgene (or its Affiliates) or otherwise.
(b)      Phase 1 Option . On a Program-by-Program basis, during the applicable Phase 1 Option Term, Celgene shall have the right, but not the obligation, to exercise the Phase 1 Option for such Program in its sole discretion by delivering written notice of such exercise to Prothena prior to the end of the Phase 1 Option Term (the “ Phase 1 Option Exercise Notice ”). Within [***] ([***]) days following each Phase 1 Option Exercise Notice delivery, and subject to Section 3.2, Celgene [***] and Prothena shall enter into a Global License Agreement with respect to such Program (including completing the exhibits and schedules thereto). On a Program-by-Program basis, if Celgene fails to provide its Phase 1 Option Exercise Notice before the expiration of the applicable Phase 1 Option Term, then Celgene’s Phase 1 Option shall expire with respect to such Program. For the avoidance of doubt, subject to the rights and licenses granted to Celgene hereunder (and under any U.S. License Agreement and Global License Agreement), Prothena shall have the right to pursue, outside of this Agreement, Development and Commercialization of Antibodies or other compounds that Target the Collaboration Target in respect of which Celgene has not exercised its Phase 1 Option prior to the expiry of the applicable Phase 1 Option Term (but excluding, in all cases, the Development or Commercialization of any Antibodies that Target any remaining Collaboration Target); provided that if a U.S. License Agreement relating to such Collaboration Target is in force, all clinical Development and Commercialization activities

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must occur outside of the United States; and for clarity, the foregoing is not intended to be a grant to Prothena of any rights or licenses to any intellectual property of Celgene (or its Affiliates) or otherwise.
(c)      Certain Remedies . Each Party agrees and acknowledges that if Celgene exercises the applicable Option, then any failure of a Party to thereafter enter into the applicable U.S. License Agreement or Global License Agreement, as applicable, in accordance with this Section 3.1.3 would cause severe and irreparable damage to the other Party, for which money damages may represent an insufficient remedy, and in such event, notwithstanding the provisions of Section 12.7, each Party shall be authorized and entitled to seek from any court of competent jurisdiction specific performance with respect to such violation as well as any other relief permitted by Applicable Law, and may obtain that relief without making a showing of insufficiency of money damages or irreparable harm. Each Party agrees to waive any requirement that the other Party post bond as a condition for obtaining any such relief. The remedies described in this Section 3.1.3(c) shall be in addition to any other remedies available to a Party hereunder or at law or in equity.
3.1.4      Option Payments . The amounts payable by Celgene, if any, in connection with the exercise of an Option for a given Program shall be as set forth in Section 6.3.
3.1.5      Covenant .
(a)      No Conflicts . On a Program-by-Program basis, commencing on the Effective Date until expiration of the Option Term for such Program, Prothena shall not, and shall cause its Affiliates not to (a) assign, transfer, convey, encumber (through any liens, charges, security interests, mortgages, or similar actions) or dispose of, or enter into any agreement with any Third Party to assign, transfer, convey, encumber (through lien, charge, security interest, mortgage, or similar action) or dispose of, any [***] (collectively, the “ Program Assets ”), except to the extent such assignment, transfer, conveyance, encumbrance or disposition would not conflict or be inconsistent with any of the rights or licenses granted to Celgene hereunder, including the Options, (b) license or grant to any Third Party, or agree to license or grant to any Third Party, any rights to any Program Assets if such license or grant would conflict or be inconsistent with any of the rights or licenses granted to Celgene hereunder, including the Options, or (c) disclose any Confidential Information relating to the Program Assets to any Third Party if such disclosure could reasonably be deemed to impair or conflict in any respect with any of the rights or licenses granted to Celgene hereunder, including the Options. During the Option Term for a given Program, Prothena shall maintain Control of all [***] such that the foregoing are unencumbered and available to license to Celgene in accordance with this Agreement and, if applicable, any U.S. License Agreement and Global License Agreement.
(b)      Ordinary Course of Business . Without limiting the provisions of Section 3.1.5(a), subject to the other applicable terms and conditions of this Agreement, during the Option Term for a given Program, Prothena shall operate and maintain the Program Assets in the ordinary course of business, and in compliance with Applicable Law, including not terminating, amending or otherwise modifying or permitting to be terminated, amended or modified, any agreements that license any Prothena Collaboration IP to Prothena (or its Affiliates) in any manner

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that would impair or conflict in any respect with any of the rights or license granted to Celgene hereunder, including the Options.
3.1.6      Tax Matters . Notwithstanding anything to the contrary in the Agreement, any U.S. License Agreement or Global License Agreement, including the use of the term “option” (or any derivation thereof), the Parties hereby agree and acknowledge that none of the Options will be treated as options for US federal (or applicable state or local) income tax purposes, and the Parties agree not to take any position inconsistent with the foregoing.
3.2      Government Approvals .
3.2.1      Efforts . Each of Prothena and Celgene will use its commercially reasonable good faith efforts to eliminate any concern on the part of any Governmental Authority regarding the legality of any proposed U.S. License Agreement or Global License Agreement under any Antitrust Law, including, if required by federal or state antitrust authorities, promptly taking all steps to secure government antitrust clearance, including 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. Notwithstanding the foregoing, this Section 3.2.1 and the term “commercially reasonable good faith efforts” do not require that either Party [***].
3.2.2      Filings . [***], each of Prothena and Celgene will, within [***] ([***]) [***] after the execution of a U.S. License Agreement (or such later time as may be agreed to in writing by the Parties) or the execution of a Global License Agreement (or such later time as may be agreed to in writing by the Parties), as applicable, file with the U.S. Federal Trade Commission (“ FTC ”) and the Antitrust Division of the U.S. Department of Justice (“ DOJ ”) any HSR Filing required of it under the HSR Act in the reasonable opinion of [***] with respect to the transactions contemplated by such U.S. License Agreement or such Global License Agreement, as applicable, as well as any other similar filing with any other Governmental Authority as reasonably determined by [***]. The Parties shall cooperate with one another to the extent necessary in the preparation of any such HSR Filing (as well as any other similar filing with any other Governmental Authority as reasonably determined by [***]). Each Party shall be responsible for its own costs and expenses associated with any HSR Filing as well as any other similar filing with any other Governmental Authority as reasonably determined by [***]. In the event that the Parties make an HSR Filing (or any other similar filing with any other Governmental Authority as reasonably determined by [***]) under this Section 3.2.2, the relevant U.S. License Agreement or Global License Agreement, as applicable, shall terminate (i) at the election of [***], in the event that the FTC or DOJ (or other applicable Governmental Authority) obtains a preliminary injunction under the HSR Act (or other applicable Antitrust Law) against the Parties to enjoin the transactions contemplated by such U.S. License Agreement or Global License Agreement, as applicable, or (ii) at the election of [***], in the event that the Clearance Date shall not have occurred on or prior to [***] ([***]) [***] after the effective date of the HSR Filing (or other similar filing with any other Governmental Authority as reasonably determined by [***]). Notwithstanding anything to the contrary contained herein, except for the terms and conditions of this Section 3.2.2, none of the terms and conditions (i) contained in the applicable U.S. License Agreement (including the obligation of Celgene to make any payments

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thereunder), as well as the obligation of Celgene to pay the IND Option Exercise Fee hereunder or (ii) contained in the applicable Global License Agreement (including the obligation for Celgene to make any payments thereunder), as well as the obligation of Celgene to pay the Phase 1 Option Exercise Fee hereunder), as applicable, shall be effective until the “ Implementation Date ,” which is agreed and understood to mean the later of (A) the date of execution of the U.S. License Agreement or the date of execution date of the Global License Agreement, as applicable, or (B) if a determination is made by [***] pursuant to this Section 3.2.2 that a notification of the U.S. License Agreement or the Global License Agreement, as applicable, is required to be made under the HSR Act (or any other similar filing with any other Governmental Authority as reasonably determined by [***]), the Clearance Date. As used herein: (x) “ Clearance Date ” means the earliest date on which the Parties have actual knowledge that all applicable waiting periods under the HSR Act (and other applicable Antitrust Law, as reasonably determined by [***], as applicable) with respect to the transactions contemplated by a U.S. License Agreement or Global License Agreement, as applicable, have expired or have been terminated; and (y) “ HSR Filing ” means a filing by Prothena and Celgene with the FTC and the DOJ of a Notification and Report Form for Certain Mergers and Acquisitions (as that term is defined in the HSR Act) with respect to the matters set forth in the U.S. License Agreement or Global License Agreement, as applicable, together with all required documentary attachments thereto.
3.2.3      Information Exchange . Each of Prothena and Celgene will, in connection with any HSR Filing (as well as any other similar filing with any other Governmental Authority as reasonably determined by [***]), (i) reasonably cooperate with each other in connection with any communication, filing or submission and in connection with any investigation or other inquiry (including any proceeding initiated by a private party); (ii) keep the other Party and/or its counsel informed of any communication received by such Party from, or given by such Party to, the FTC, the DOJ or any other Governmental Authority (including any communication received or given in connection with any proceeding by a private party), in each case regarding the transactions contemplated by any proposed U.S. License Agreement or Global License Agreement, as applicable; (iii) consult with each other in advance of any meeting or conference with the FTC, the DOJ or any other Governmental Authority (or, in connection with any proceeding by a private party, with such private party), and to the extent permitted by the FTC, the DOJ or such other Governmental Authority (or such private party), give the other Party and/or their counsel the opportunity to attend and participate in such meetings and conferences; and (iv) permit the other Party and/or its counsel to review in advance any submission, filing or communication (and documents submitted therewith) intended to be given by it to the FTC, the DOJ or any other Governmental Authority (or, in connection with any proceeding by a private party, to such private party); provided that materials may be redacted to remove references concerning [***]. Prothena and Celgene, as each deems advisable and necessary, may reasonably designate any competitively sensitive material to be provided to the other under this Section 3.2.3 as “Antitrust Counsel Only Material.” Such materials and the information contained therein shall be given only to the outside antitrust counsel of the recipient and will not be disclosed by such outside counsel to employees, officers or directors of the recipient unless express permission is obtained in advance from the source of the materials (Prothena or Celgene, as the case may be) or the applicable Party’s legal counsel.

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3.2.4      Assistance . Subject to this Section 3.2, at the reasonable request of Celgene, Prothena and Celgene shall cooperate and use respectively all reasonable efforts to make all other registrations, filings and applications, 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 for the consummation of the transactions as contemplated by any U.S. License Agreement or Global License Agreement, as applicable, in accordance with applicable Antitrust Laws.
3.2.5      No Further Obligations . If a U.S. License Agreement or Global License Agreement, as applicable, is terminated pursuant to this Section 3.2, then, notwithstanding any provision in this Agreement to the contrary, neither Party shall have any obligation to the other Party with respect to the subject matter of such U.S. License Agreement or Global License Agreement, as applicable, including any payment obligations on the part of Celgene, including under Section 6.3 (and to the extent any payments have been made under Section 6.3, such amounts shall be [***] refunded from Prothena to Celgene); provided that Celgene shall be permitted to [***], to comply with any Antitrust Law (in which event no such payments under Section 6.3 shall be refunded by Prothena).
ARTICLE 4
GOVERNANCE
4.1      Generally .
4.1.1      Committees .
(a)      Establishment . Pursuant to this Article 4, the Parties will establish a JSC within the timeframes set forth in Section 4.2.1. The JSC shall have decision-making authority with respect to the matters within its purview to the extent expressly and as more specifically provided herein.
(b)      Subcommittees . From time to time, the JSC may establish subcommittees to oversee particular projects or activities, as the JSC deems necessary or advisable (each, a “ Subcommittee ”); provided that the JSC may not grant any responsibilities to a Subcommittee that are beyond the scope of the responsibilities of the JSC as set forth herein. Each Subcommittee shall consist of such number of members as the JSC determines is appropriate from time to time. Such members shall be individuals with expertise and responsibilities in the relevant areas. Such Subcommittees shall operate under the same principles as are set forth in this Article 4 for the committee forming such Subcommittee. As of the Effective Date, the JSC hereby establishes the Patent Committee as a Subcommittee and the Manufacturing Committee as a Subcommittee.
4.1.2      Execution of Global License Agreement, U.S. License Agreement or Exercise of Rights under Section 2.5 . On a Program-by-Program basis, upon execution of the applicable Global License Agreement for such Program (or following the exercise of Celgene’s rights under Section 2.5 with respect to such Program, if earlier), such Program (including the Collaboration Target, Collaboration Candidates and Collaboration Products) and matters related thereto (including the Prothena IP licensed to Celgene in connection therewith that specifically

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relates to such Program, the Collaboration Target, Collaboration Candidate or Collaboration Product (including the composition of matter or method of use thereof)) shall no longer continue to be within the purview of the JSC or any Subcommittee (except as expressly set forth in any U.S. License Agreement). In addition, on a Program-by-Program basis, upon execution of the applicable U.S. License Agreement for such Program, the activities under such U.S. License Agreement shall not be within the purview of the JSC or any Subcommittee (except as expressly set forth in such U.S. License Agreement).
4.1.3      Alliance Managers . Promptly after the Effective Date, each Party shall appoint an individual to act as alliance manager for such Party, which may be one of the representatives of such Party on the JSC (each, an “ Alliance Manager ”). The Alliance Managers shall be the primary point of contact for the Parties regarding the activities contemplated by this Agreement and shall facilitate all such activities hereunder. The Alliance Managers shall attend all meetings of the JSC and shall be responsible for assisting the JSC in performing its oversight responsibilities. The name and contact information for each Party’s Alliance Manager, as well as any replacement(s) chosen by such Party, in its sole discretion, from time to time, shall be promptly provided to the other Party in accordance with Section 12.2.
4.1.4      Patent Liaisons . Promptly after the Effective Date, each Party shall appoint an individual to act as a patent liaison for such Party (each, a “ Patent Liaison ”). The Patent Liaisons shall be the primary point of contact for the Parties regarding intellectual property-related activities and matters contemplated by this Agreement and shall facilitate all such activities and matters hereunder. The name and contact information for each Party’s Patent Liaison, as well as any replacement(s) chosen by such Party, in its sole discretion, from time to time, shall be promptly provided to the other Party in accordance with Section 12.2.
4.2      Joint Steering Committee .
4.2.1      Establishment; Meetings . Within [***] ([***]) days after the Effective Date, the Parties shall establish a joint steering committee (the “ JSC ”) as more fully described in this Section 4.2. Subject to Section 4.1.2, the JSC shall have review, oversight and decision-making responsibilities for those activities performed under the Programs to the extent expressly and as more specifically provided in Section 4.2.3. Each Party agrees to keep the JSC informed of its progress and activities hereunder with respect to the Collaboration. The first scheduled meeting of the JSC shall be held no later than [***] ([***]) days after establishment of the JSC unless otherwise agreed by the Parties. After the first scheduled meeting of the JSC until the JSC is disbanded, the JSC shall meet in person or telephonically [***], or more or less frequently as the Parties mutually deem appropriate, on such dates and at such places and times as provided herein or as the Parties shall agree, provided the JSC shall meet [***]. In any case where a matter within the JSC’s authority arises, the JSC shall convene a meeting and consider such matter as soon as reasonably practicable, but in no event later than [***] ([***]) days after the matter is first brought to the JSC’s attention (or, if earlier, at the next regularly scheduled JSC meeting). The JSC shall disband upon the expiration or termination of this Agreement in its entirety. Meetings that are held in person shall be at such location as the Parties may agree. The members of the JSC may also convene or be polled or consulted from time to time by means of telecommunications, video conferences, electronic mail

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or correspondence, as deemed necessary or appropriate. Each Party will bear all expenses it incurs in regard to participating in all meetings of the JSC, including all travel and living expenses.
4.2.2      Membership . The JSC shall be comprised of three (3) representatives (or such other number of representatives as the Parties may mutually agree) from each of Celgene and Prothena. Each representative of a Party shall have sufficient seniority and expertise to participate on the JSC as determined in such Party’s reasonable judgment. [***] shall have the right to designate the chairperson of the JSC. Each Party may replace any or all of its representatives on the JSC at any time upon written notice to the other Party in accordance with Section 12.2. Each Party may, subject to the other Party’s prior approval, invite non-member representatives of such Party and any Third Party to attend meetings of the JSC as non-voting participants; provided that (i) any such representative or Third Party is bound by obligations of confidentiality, non-disclosure and non-use consistent with those set forth in Article 8 and is obligated to assign inventions to the relevant Party as necessary to effect the intent of Section 7.6 prior to attending such meeting, (ii) such non-member representative or Third Party shall not have any voting or decision-making authority on the JSC and (iii) with respect to any Third Party, such Third Party shall be approved by the other Party in writing (such approval not to be unreasonably withheld) prior to attendance at such meeting.
4.2.3      Responsibilities . Except as otherwise set forth in this Section 4.2, the JSC may perform the following functions, subject to the final decision-making authority as set forth in Section 4.2.4: (a) oversee, review and monitor progress of the Programs, including serving as a forum for exchanging information and facilitating discussions regarding the conduct of the Programs; (b) on a Program-by-Program basis, review and amend a Research Plan; (c) review and discuss the Collaboration Targets, and discuss and approve any replacement Collaboration Targets (in accordance with Section 4.2.5(a)); (d) review and comment on Collaboration Candidates, Lead Candidates and Development Candidates; (e) [***]; (f) manage the strategic direction of the Programs; (g) oversee implementation of the Collaboration in accordance with this Agreement; (h) subject to Article 8, discuss a communications strategy for the results of any Program (including publications in journals, posters, presentations at conferences and abstracts submitted in advance of conferences) for communications prior to the exercise of the Phase 1 Option for such Program, (i) discuss and attempt to resolve any disputes in any Subcommittees; (j) discuss material issues regarding the enforcement and defense of Prothena IP; (k) determine the Alternative End of Phase 1 Date for a given Program, if any, (l) determine the Lead Candidate Criteria, and any amendments thereto, (m) approve the [***] and (n) perform such other responsibilities as may be mutually agreed by the Parties from time to time. For purposes of clarity, the JSC shall not have any authority beyond the specific matters set forth in this Section 4.2.3 (or otherwise expressly set forth in this Agreement), and in particular shall not have any power to amend, modify, interpret or waive the terms of this Agreement, any U.S. License Agreement or any Global License Agreement, or to alter, diminish, expand or waive compliance by a Party with a Party’s obligations under this Agreement, or any U.S. License Agreement or any Global License Agreement.
4.2.4      Decisions . Except as otherwise set forth in this Agreement, all decisions of the JSC shall be made by consensus, with each Party having one (1) vote. If the JSC cannot agree on a matter for which the JSC has decision-making authority within [***] ([***]) [***] after it has met and attempted to reach such decision, then either Party may, by written notice to the other, have

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such issue referred to the Executive Officers for resolution. The Parties’ respective Executive Officers shall meet within [***] ([***]) [***] after such matter is referred to them, and shall negotiate in good faith to resolve the matter. If the Executive Officers are unable to resolve the matter within [***] ([***]) [***], or such other longer time frame the Executive Officers may otherwise agree upon, after the matter is referred to them in accordance with this Section 4.2.4, then, except as otherwise set forth in this Agreement, [***] shall have the final decision making authority; provided that [***] shall [***] in making such final decision. Notwithstanding the foregoing, in exercising [***]’s final decision making authority, [***] shall not have the right to exercise its final decision-making authority to: (i) determine that [***], or that [***]; (ii) determine that milestone events or other events have or have not occurred; (iii) make a decision that is stated to require the mutual agreement or mutual consent of the Parties (or that is subject to the determination of [***] as set forth herein); (iv) determine any matter which is the subject of the dispute resolution provided for in Section 2.4; (v) modify a Party’s rights or reduce a Party’s obligations under this Agreement, any U.S. License Agreement or any Global License Agreement, or otherwise amend, modify, interpret or waive the terms of this Agreement, any U.S. License Agreement or any Global License Agreement; (vi) determine any Alternative End of Phase 1 Date for a given Program, (vii) determine the Lead Candidate Criteria, or any amendments thereto, (viii) approve any replacement Collaboration Targets in accordance with Section 4.2.5(a) (including the identity of the new target, the existing Collaboration Target that is being replaced [***]); (ix) determine to [***] that Target the Collaboration Target for such Program or (x) approve the [***]; and any of the foregoing decisions or determinations shall require mutual agreement of the Parties. Any final decision made by [***] in the course of exercising its final decision-making authority must be consistent with the terms of this Agreement and within the scope of authority delegated to the JSC under this Agreement.
4.2.5      Replacement Targets; Lapsed Targets .
(a)      From time to time during the Research Term, the JSC may discuss alternative targets to bring into the Collaboration as potential Collaboration Targets to replace a then-existing Collaboration Target. Subject to Section 4.2.4, if the JSC unanimously consents in writing, then the Parties may replace an existing Collaboration Target with an alternative target; provided that for selection of a replacement for a Collaboration Target, as part of such written consent, the JSC shall specifically identify the new target as well as the existing Collaboration Target that is being replaced [***]. In the event that the JSC so agrees to replace a given existing Collaboration Target with a new Collaboration Target, then (i) the existing Collaboration Target that is being replaced shall be deemed to be a “Lapsed Target” for purposes of this Agreement, and the Program for such replaced Collaboration Target shall promptly cease, (ii) the new target [***] shall be deemed to be a “Collaboration Target” for purposes of this Agreement, such Collaboration Target shall be the subject of a separate Program under the Collaboration, and the JSC may update the Research Plan for such new Program, and (iii) if agreed to by the JSC as part of the mutual written consent, [***].
(b)      During the Research Term, Celgene shall also have the right, in its discretion, to notify Prothena in writing that it is no longer interested in considering whether to exercise its IND Option for a given Collaboration Target, in which case, (i) such Collaboration

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Target shall be deemed to be a “Lapsed Target” for purposes of this Agreement and (ii) the Program for such Collaboration Target shall promptly cease.
(c)      Subject to the rights and licenses granted to Celgene hereunder (and under any U.S. License Agreement and Global License Agreement), Prothena shall have the right to pursue, outside of this Agreement, Development and Commercialization of Antibodies that Target any Lapsed Target ([***]); provided that for clarity, the foregoing is not intended to be a grant to Prothena of any rights or licenses to any intellectual property of Celgene (or its Affiliates) or otherwise.
4.2.6      [***] . The JSC shall also review and determine if [***]. If the JSC determines unanimously (for clarity, without [***] having a final decision making right) that [***], then the Parties shall negotiate in good faith [***].
4.2.7      Exceptions for Celgene Products and Celgene IP . Notwithstanding the provisions of Section 4.2.4 or anything to the contrary contained herein, no activities performed by or on behalf of Prothena hereunder, including any activities under any Programs, may involve any product that is being researched, developed, marketed or sold by or on behalf of Celgene (or any of its Affiliates) (a “ Celgene Product ”) (provided that such Celgene Product is publicly known or Celgene has otherwise notified Prothena of such Celgene Product) or otherwise involve any Celgene IP, in each case, without Celgene’s prior written consent (in its sole discretion), and such decisions and determinations shall not be under the purview of the JSC (or Prothena). In the event that Celgene approves any such activities with respect to any such Celgene Product or Celgene IP, then at the request of Celgene, the Parties shall negotiate in good faith and enter into a separate agreement with respect to the terms and conditions under which such activities may be undertaken under this Agreement with respect to any Celgene Product or Celgene IP.
4.2.8      Minutes . Prothena shall be responsible for preparing and circulating minutes of each meeting of the JSC, setting forth, inter alia , an overview of the discussions at the meeting and a list of any actions, decisions or determinations approved by the JSC. A draft of such minutes shall be circulated by Prothena to all members of the JSC within [***] ([***]) days after the applicable meeting. Such minutes shall be effective only after such minutes have been approved by both Parties in writing. Definitive minutes of all JSC meetings shall be finalized no later than [***] ([***]) days after the meeting to which the minutes pertain.
4.3      Patent Committee .
4.3.1      Establishment . Within [***] ([***]) days after the Effective Date, the Parties shall establish a patent Subcommittee (the “ Patent Committee ”) as more fully described in this Section 4.3. The Patent Committee shall facilitate the discussion and coordination of Patent Prosecution and Maintenance matters with respect to Prothena Collaboration Patents and Program Patents, in accordance with and subject to the terms of Article 7.
4.3.2      Meetings . The Patent Committee shall convene at such times, places and frequencies as the Patent Committee determines is necessary. In any case where a matter within the Patent Committee’s authority arises, the Patent Committee shall convene a meeting and consider

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such matter as soon as reasonably practicable, but in no event later than [***] ([***]) days after the matter is first brought to the Patent Committee’s attention (or, if earlier, at the next regularly scheduled Patent Committee meeting). The Patent Committee shall disband upon the expiration or termination of this Agreement. Meetings of the Patent Committee that are held in person shall be at such location as the Parties may agree but it is expected by the Parties that meetings of the Patent Committee will generally be held by means of telecommunications or video conferences and only in the event that the Parties agree to do so will meetings be held in person. The members of the Patent Committee also may convene or be polled or consulted from time to time by means of telecommunications, video conferences, electronic mail or correspondence, as deemed necessary or appropriate. Each Party will bear all expenses it incurs in regard to participating in all meetings of the Patent Committee, including all travel and living expenses.
4.3.3      Membership . The Patent Committee shall be comprised of one (1) representative (or such other number of representatives as the Parties may mutually agree) from each of Celgene and Prothena (who shall be employees of such Party or its Affiliates), which shall include the Patent Liaison for each such Party. Each Party may replace any or all of its representatives on the Patent Committee at any time upon written notice to the other Party in accordance with Section 12.2. Each representative of a Party shall have sufficient seniority and expertise in the Prosecution and Maintenance of Patents to participate on the Patent Committee as determined in such Party’s reasonable judgment. Each Party may, subject to the other Party’s prior approval, invite Third Parties or non-member representatives of such Party to attend meetings of the Patent Committee as non-voting participants; provided that (i) any such representative or Third Party is bound by obligations of confidentiality, non-disclosure and non-use consistent with those set forth in Article 8 and is obligated to assign inventions to the relevant Party as necessary to effect the intent of Section 7.6 prior to attending such meeting, (ii) such non-member representative or Third Party shall not have any voting or decision-making authority on the Patent Committee and (iii) with respect to any Third Party, such Third Party shall be approved by the other Party in writing (such approval not to be unreasonably withheld) prior to attendance at such meeting. [***] shall have the right to designate the chairperson of the Patent Committee.
4.3.4      Responsibilities . The Patent Committee shall perform the following functions: (a) discuss material issues and provide input to each other regarding the Prosecution and Maintenance of Prothena Collaboration Patents, Joint Program Patents and Program Patents, (b) coordinate the implementation of Prothena’s strategies for the protection of the Prothena Collaboration Patents and Program Patents, including (i) the filing and prosecution of continuing or divisional Patent applications with respect to Prothena Collaboration Patents and Program Patents, as appropriate to [***] (the foregoing referred to herein as the “ Patent Strategy ”); (b) serve as a forum for exchanging information and facilitating discussions regarding patentability and freedom to operate assessments with respect to the Programs; and (c) perform such other responsibilities as may be mutually agreed by the Parties from time to time. The Patent Committee shall also be responsible for coordinating the implementation of Prothena’s strategies for Prothena Collaboration Patents and Program Patents but shall not have authority to decide such matters, which decisions are reserved to the Parties by Sections 7.7 and 7.8. For clarity, the Patent Committee shall be a forum for discussion only and shall not have any decision-making authority and shall not have any power to amend, modify, interpret or waive the terms of this Agreement, any U.S. License Agreement

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or any Global License Agreement, or to alter or waive compliance by a Party with a Party’s obligations under this Agreement, any U.S. License Agreement or any Global License Agreement.
4.3.5      Minutes . A representative of Prothena shall be responsible for preparing and circulating minutes of each meeting of the Patent Committee, setting forth, inter alia , an overview of the discussions at the meeting and a list of any actions, decisions or determinations approved by the Patent Committee. A draft of such minutes shall be circulated by Prothena to all members of the Patent Committee within [***] ([***]) days after the applicable meeting. Such minutes shall be effective only after such minutes have been approved by both Parties in writing. Definitive minutes of all Patent Committee meetings shall be finalized no later than [***] ([***]) days after the meeting to which the minutes pertain.
4.4      Manufacturing Committee .
4.4.1      Establishment . Within [***] ([***]) days after the Effective Date, the Parties shall establish a manufacturing Subcommittee (the “ Manufacturing Committee ”) as more fully described in this Section 4.4. The Manufacturing Committee shall facilitate the discussion and coordination of Manufacturing matters with respect to Collaboration Candidates and Collaboration Products under a given Program. The Manufacturing Committee shall be a forum for discussion and coordination, but shall have no decision making authority. For the avoidance of doubt, Manufacturing matters with respect to activities under a U.S. License Agreement or Global License Agreement shall be outside the purview of the Manufacturing Committee.
4.4.2      Meetings . The Manufacturing Committee shall convene at such times, places and frequencies as the Manufacturing Committee determines is necessary, but in all cases no less than [***] (unless otherwise agreed to by the Parties). In any case where a matter within the Manufacturing Committee’s purview arises, the Manufacturing Committee shall convene a meeting and consider such matter as soon as reasonably practicable, but in no event later than [***] ([***]) days after the matter is first brought to the Manufacturing Committee’s attention (or, if earlier, at the next regularly scheduled Manufacturing Committee meeting). The Manufacturing Committee shall disband upon the expiration or termination of this Agreement. Meetings of the Manufacturing Committee that are held in person shall be at such location as the Parties may agree but it is expected by the Parties that meetings of the Manufacturing Committee will generally be held by means of telecommunications or video conferences and only in the event that the Parties agree to do so will meetings be held in person. The members of the Manufacturing Committee also may convene or be polled or consulted from time to time by means of telecommunications, video conferences, electronic mail or correspondence, as deemed necessary or appropriate. Each Party will bear all expenses it incurs in regard to participating in all meetings of the Manufacturing Committee, including all travel and living expenses.
4.4.3      Membership . The Manufacturing Committee shall be comprised of two (2) representatives (or such other number of representatives as the Parties may mutually agree) from each of Celgene and Prothena (who shall be employees of such Party or its Affiliates). Each Party may replace any or all of its representatives on the Manufacturing Committee at any time upon written notice to the other Party in accordance with Section 12.2. Each representative of a Party shall have sufficient seniority and expertise in Manufacturing matters to participate on the

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Manufacturing Committee as determined in such Party’s reasonable judgment. Each Party may, subject to the other Party’s prior approval, invite Third Parties or non-member representatives of such Party to attend meetings of the Manufacturing Committee as non-voting participants; provided that (i) any such representative or Third Party is bound by obligations of confidentiality, non-disclosure and non-use consistent with those set forth in Article 8 and is obligated to assign inventions to the relevant Party as necessary to effect the intent of Section 7.6 prior to attending such meeting, and (ii) with respect to any Third Party, such Third Party shall be approved by the other Party in writing (such approval not to be unreasonably withheld) prior to attendance at such meeting. [***] shall have the right to designate the chairperson of the Manufacturing Committee.
4.4.4      Responsibilities . The Manufacturing Committee shall perform the following functions: (a) discuss material issues and provide input to each other regarding the Manufacture of Collaboration Candidates and Collaboration Products, including pre-formulation, formulation, manufacturability and supply sources with respect to Collaboration Candidates and Collaboration Products, as well as the selection of any Third Party manufacturers (including any agreements to be entered into with such Third Party manufacturers); (b) serve as a forum for exchanging information and facilitating discussions regarding Manufacturing matters with respect to the Programs; and (c) perform such other responsibilities as may be mutually agreed by the Parties from time to time.
4.4.5      Minutes . A representative of Prothena shall be responsible for preparing and circulating minutes of each meeting of the Manufacturing Committee, setting forth, inter alia , an overview of the discussions at the meeting. A draft of such minutes shall be circulated by Prothena to all members of the Manufacturing Committee within [***] ([***]) days after the applicable meeting. Such minutes shall be effective only after such minutes have been approved by both Parties in writing. Definitive minutes of all Manufacturing Committee meetings shall be finalized no later than [***] ([***]) days after the meeting to which the minutes pertain.
ARTICLE 5     
EXCLUSIVITY
5.1      Exclusivity . During the Term, and subject to Sections 5.2 and 5.3, Prothena shall not and shall ensure its Affiliates shall not, anywhere in the world: (i) alone or with or through any Third Party, research [***], Develop, Manufacture or Commercialize (a) any Collaboration Target or any Competing Compound, or (b) any diagnostic product intended for use, or Developed or approved for use with, with any Collaboration Target (including any diagnostic product intended for use, or Developed or approved for use with any Competing Compound), in each case, other than in performance of a Program pursuant to this Agreement (including engaging Third Party subcontractors to perform the Program activities in accordance with this Agreement); (ii) grant a license, sublicense or other rights to any Third Party to conduct any of the activities in the foregoing clause (i), other than in performance of Collaboration activities (including engaging Third Party subcontractors to perform the Collaboration activities in accordance with this Agreement) pursuant to a Program under this Agreement; or (iii) transfer, assign, convey or otherwise sell (a) any Competing Compound or (b) any diagnostic product intended for use, or Developed or approved for use with any Collaboration Target, including any diagnostic product intended for use, or

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Developed or approved for use with any Competing Compound. As used herein, the term “ Competing Compound ” means [***]. For clarity, the restrictions described in this Section 5.1 shall not apply to any Lapsed Targets.
5.2      Failure to Exercise Phase 1 Option . In the event that Celgene exercises its IND Option with respect to a given Program, but does not exercise its Phase 1 Option with respect to such Program by the end of the Phase 1 Option Term for such Program, then, notwithstanding the provisions of Section 5.1, from and after the end of such Phase 1 Option Term the provisions of Section 5.1 shall no longer apply with respect to the Collaboration Target that was the subject of such Program, solely with respect to activities conducted by Prothena or its Affiliates or sublicensees outside of the United States (and, for the avoidance of doubt, the provisions of Section 5.1 shall continue to apply to such Collaboration Target with respect to activities conducted in the United States).
5.3      Prothena Exception for Active Immunotherapeutic Approaches .
5.3.1      Exception for Active Immunotherapeutic Approaches . Notwithstanding the provisions of Section 5.1, but subject to the provisions of Section 5.3.2, Prothena and its Affiliates (themselves, but not with or through any Third Parties) may conduct research, development, manufacture and commercialization of Active Immunotherapeutic Approaches outside of this Agreement; provided that no Collaboration Candidates or Collaboration Products are utilized in the conduct of any such activities (including no use of a Collaboration Candidate or Collaboration Product for an Active Immunotherapeutic Approach). As used herein, “ Active Immunotherapeutic Approaches ” means [***].
5.3.2      Celgene Right of First Negotiation . During the Research Term [***], in the event that [***] with respect to [***], [***] will [***]. [***] will [***] (a “[***]”). If [***], [***] will [***] which [***] will [***]. If [***], the Parties will [***]. Until [***] or the [***], as applicable, [***]. If [***] that it [***], then [***]. For the avoidance of doubt, this Section 5.3.2 [***]. For clarity, [***].
ARTICLE 6
FINANCIAL TERMS
6.1      Upfront Payment . In consideration for the rights granted to Celgene under this Agreement, Celgene shall pay to Prothena within [***] ([***]) [***] after the Effective Date a one-time upfront payment of one hundred million Dollars ($100,000,000) (the “ Upfront Payment ”).
6.2      Equity Investment . The Parties acknowledge and agree that simultaneously with the execution of this Agreement, the Parties are entering into that certain Share Subscription Agreement and certain additional agreements related thereto (collectively, the “ Investment Agreements ”) with respect to an equity investment by Celgene (or its Affiliate) in Prothena Corporation plc. Prothena further agrees and acknowledges that Prothena’s entering into, and performance of, this Agreement is an essential factor for Celgene entering into the Investment Agreements, without which Celgene would not have entered into the Investment Agreements.

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6.3      Option Fees .
6.3.1      IND Option Exercise Fee . Subject to Section 3.2, in the event that Celgene exercises (in its discretion) its IND Option for a given Program, the Parties shall enter into the U.S. License Agreement for such Program in accordance with Section 3.1.3(a). In such case, Celgene shall, within [***] ([***]) days after the effective date of the U.S. License Agreement for such Program, pay to Prothena a non-refundable payment (except as otherwise set forth in Section 3.2.5) in the amount of the IND Option Exercise Fee for such Program. For the avoidance of doubt, in the event that Celgene exercises (in its discretion) its IND Option for a given Program, Celgene shall only be obligated to pay the IND Option Exercise Fee one (1) time for such Program regardless of the number of Collaboration Candidates, Lead Candidates or Development Candidates under such Program. As used herein, the term “ IND Option Exercise Fee ” shall mean, for a given Program, an amount equal to (i) Eighty Million Dollars ($80,000,000) [***].
6.3.2      Phase 1 Option Exercise Fee . Subject to Section 3.2, in the event that Celgene exercises (in its discretion) its Phase 1 Option for a given Program, the Parties shall enter into the Global License Agreement for such Program in accordance with Section 3.1.3(b). In such case, Celgene shall, within [***] ([***]) days after the effective date of the Global License Agreement for such Program, pay to Prothena a non-refundable payment (except as otherwise set forth in Section 3.2.5) in the amount of the Phase 1 Option Exercise Fee for such Program. For the avoidance of doubt, in the event that Celgene exercises (in its discretion) its Phase 1 Option for a given Program, Celgene shall only be obligated to pay the Phase 1 Option Exercise Fee one (1) time for such Program regardless of the number of Collaboration Candidates, Lead Candidates or Development Candidates under such Program. As used herein, the term “ Phase 1 Option Exercise Fee ” shall mean, for a given Program, an amount equal to Fifty-Five Million Dollars ($55,000,000).
6.4      Additional Payment Terms .
6.4.1      Currency . All payments hereunder shall be made in Dollars by wire transfer to a bank designated in writing by Prothena (if the payment is to be made to Prothena) or by Celgene (if the payment is to be made by Celgene).
6.4.2      Taxes; Withholding .
(a)      Generally . Each Party will pay any and all income taxes levied on account of all payments it receives under this Agreement except as otherwise provided in this Section 6.4.2.
(b)      Tax Withholding . Each Party shall be entitled to deduct and withhold from any amounts payable under this Agreement, any U.S. License Agreement or any Global License Agreement such taxes as are required to be deducted or withheld therefrom under any provision of Applicable Law. The Party that is required to make such withholding (the “ Paying Party ”) will : (i) deduct those taxes from such payment, (ii) timely remit the taxes to the proper taxing authority, and (iii) send evidence of the obligation together with proof of tax payment to the other Party (the “ Payee Party ”) on a timely basis following that tax payment; provided, however, that before making any such deduction or withholding, the Paying Party shall give the Payee Party notice of the intention

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to make such deduction or withholding (such notice shall include an explanation of the reason for and the calculation of the proposed deduction or withholding and shall be given before such deduction or withholding is required in order for such Payee Party to obtain reduction of or relief from such deduction or withholding). Each Party agrees to reasonably cooperate with the other Party in claiming refunds or exemptions from such deductions or withholdings under any relevant agreement or treaty which is in effect to ensure that any amounts required to be withheld pursuant to this Section 6.4.2(b) are reduced in amount to the fullest extent permitted by Applicable Law. In addition, the Parties shall cooperate in accordance with Applicable Laws to minimize indirect taxes (such as value added tax, sales tax, consumption tax and other similar taxes (“ Indirect Taxes ”)) in connection with this Agreement or any U.S. License Agreement or Global License Agreement, as applicable. Notwithstanding anything to the contrary in this Section 6.4.2(b), the Parties acknowledge and agree that Celgene will not, absent a change in Applicable Law or relevant circumstance between the Effective Date and the date of the payment pursuant to Section 6.1, deduct or withhold from the amounts payable pursuant to Section 6.1 any amount in respect of any taxes provided that Prothena provides Celgene with [***].
(c)      Tax Gross-up. Notwithstanding the foregoing, if (a) any Party redomiciles, assigns its rights or obligations or extends its rights under this Agreement or any U.S. License Agreement or Global License Agreement, (b) as a result of such redomiciliation, assignment or extension, such Party (or its assignee) is required by Applicable Law to [***], or such redomiciliation, assignment or extension results in [***], and (c) such [***] exceed the amount of [***] that would have been applicable but for such redomiciliation, assignment or extension, then any such amount payable shall [***] so that, after making all required [***], as the case may be, the Payee Party (or its assignee) [***]. The [***] (A) [***] to the extent such [***] but for [***], and (B) [***]. For purposes of the preceding sentence, “ Tax Benefit ” shall mean any cash refund or credit for Taxes resulting in a reduction in the amount of Taxes otherwise owed by the Payee Party as a result of [***] relating to payments by the Paying Party, as reasonably determined by Payee Party. Solely for purposes of this Section 6.4.2(c), a Party's “domicile” shall include its jurisdiction of incorporation or tax residence and a “redomiciliation” shall include a reincorporation or other action resulting in a change in tax residence of the applicable Party or its assignee, or resulting in the attribution of any amounts payable to a branch or permanent establishment located outside the country of tax residence of the applicable Party or its assignee.
(d)      Tax Documentation . Prothena has provided a properly completed and duly executed IRS Form W-8BEN-E to Celgene. Prior to the receipt of any payment under this Agreement, each recipient Party (and any other recipient of payments under this Agreement) shall, to the extent it is legally permitted to, provide to the other Party, at the time or times reasonably requested by such other Party or as required by Applicable Law, such properly completed and duly executed documentation (for example, IRS Forms W-8 or W-9 or foreign equivalents) as will permit payments made under this Agreement to be made without, or at a reduced rate of, withholding for taxes.
6.4.3      Prothena Third Party Agreements . Notwithstanding anything to the contrary, Prothena shall be solely responsible for all costs and payments of any kind (including all upfront fees, annual payments, milestone payments and royalty payments) arising under any agreements

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between Prothena (or any of its Affiliates) and any Third Party, which costs or payments arise in connection with, or as a result of, the activities hereunder, including the Development, Manufacture or Commercialization of Collaboration Candidates or Collaboration Products.
ARTICLE 7
LICENSES; INTELLECTUAL PROPERTY
7.1      Licenses to Celgene .
7.1.1      Performance under Agreement . Subject to the terms and conditions of this Agreement, Prothena hereby grants to Celgene a non-exclusive, worldwide, fully paid-up, royalty-free right and license, with the right to grant sublicenses (through multiple tiers), under the Prothena IP for Celgene to conduct its activities and perform its obligations under this Agreement, including as set forth in Section 2.4 and 2.9.
7.1.2      Research and Development License . Prothena hereby grants to Celgene a non-exclusive, worldwide, fully paid-up, royalty-free, perpetual and irrevocable right and license, with the right to grant sublicenses (through multiple tiers), under its rights in [***] for [***].
7.2      Grant Back for Lapsed Targets . If a Collaboration Target under a Program becomes a Lapsed Target pursuant to Sections 3.1.3(a) or 4.2.5, then effective upon the date that a Collaboration Target becomes a Lapsed Target pursuant to Sections 3.1.3(a) or 4.2.5, and subject to the terms and conditions of this Agreement, Celgene shall, and hereby does, grant to Prothena an non-exclusive, fully paid-up, worldwide royalty-free, perpetual and irrevocable right and license, with the right to grant sublicenses (through multiple tiers), under its rights in any and all (i) Celgene Phase 1 Know-How (from such Program) Controlled by Celgene and [***] to Develop and Commercialize Antibodies Targeting such Lapsed Target or products containing such Antibodies, and (ii) all Patents Controlled (as of the date that the applicable Collaboration Target becomes a Lapsed Target) by Celgene claiming such Celgene Phase 1 Know-How, in each case, to research, develop, manufacture, use, sell, offer for sale and import Antibodies Targeting such Lapsed Target and products containing such Antibodies, for all purposes. Additionally, Celgene shall transfer to Prothena within a reasonable time after a Collaboration Target becomes a Lapsed Target, at Prothena’s request [***], any and all Program Regulatory Materials pertaining to Collaboration Candidates Targeting such Lapsed Target that were transferred to Celgene pursuant to Section 2.6.1(b).
7.3      Rights Retained by the Parties . For purposes of clarity, each Party retains all rights under Know-How and Patents Controlled by such Party not expressly granted to the other Party pursuant to this Agreement.
7.4      No Implied Licenses . Except as explicitly set forth in this Agreement, neither Party shall be deemed by estoppel or implication to have granted the other Party any license or other right to any intellectual property of such Party.
7.5      Insolvency . In the event that this Agreement is terminated due to the rejection of this Agreement by or on behalf of a Party due to an Insolvency Event, all licenses and rights to licenses

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granted under or pursuant to this Agreement by a Party to the other Party are and shall otherwise be deemed to be licenses of rights to “intellectual property”. The Parties agree that each Party, as a licensee of such rights under this Agreement, shall retain and may fully exercise all of its rights and elections under any applicable insolvency statute, and that upon commencement of an Insolvency Event by or against the other Party, such Party shall be entitled to a complete duplicate of or complete access to (as such Party deems appropriate), any such intellectual property and all embodiments of such intellectual property. Such intellectual property and all embodiments thereof shall be promptly delivered to such Party (i) upon any such commencement of a bankruptcy proceeding (or other Insolvency Event) upon written request therefor by such Party, unless the other Party elects to continue to perform all of its obligations under this Agreement or (ii) if not delivered under (i) above, upon the rejection of this Agreement by or on behalf of the other Party, then upon written request therefor by such Party. The provisions of this Section 7.5 shall be (1) without prejudice to any rights a Party may have arising under any applicable insolvency statute or other Applicable Law and (2) effective only to the extent permitted by Applicable Law.
7.6      Ownership .
7.6.1      Inventions . Notwithstanding the provisions of Section 12.7.1, inventorship of Know-How shall be determined by application of U.S. patent law pertaining to inventorship, and, except as provided for in Sections 7.6.2, 7.6.3 and 7.6.4, ownership of Know-How shall be determined by inventorship.
7.6.2      Ownership of Prothena Collaboration IP and Celgene IP .
(a)      Prothena . As between the Parties (including their respective Affiliates), Prothena will retain all right, title and interest in and to all Prothena Collaboration IP, except to the extent that any such rights are licensed or granted to Celgene under this Agreement, any U.S. License Agreement or any Global License Agreement. Prothena shall [***] that all Patents, Know-How and other intellectual property (other than Program IP and Celgene IP, if any) utilized in the performance of a Program falls within the Prothena Collaboration IP and is and remains during the Term and the term of any applicable U.S. License and Global License Agreement Controlled by Prothena such that Prothena has the full rights to grant the rights and licenses to the Prothena Collaboration IP to Celgene hereunder (and under any U.S. License Agreement and any Global License Agreement), including the Options (including that such Patents, Know-How and other intellectual property remains unencumbered such that Prothena is able to grant such rights and licenses to Celgene).
(b)      Celgene . As between the Parties (including their respective Affiliates), Celgene (or its Affiliate) will retain all right, title and interest in and to all Celgene IP, except as otherwise expressly set forth herein, including all rights to Prosecute and Maintain, and enforce any such Celgene IP, and no rights or licenses are granted to Prothena hereunder with respect to any Celgene IP except as expressly provided in Section 7.2. In the event that Prothena desires to utilize any Celgene IP not subject to Section 7.2 for the performance of a Program, then Prothena may request such right in writing from Celgene (which writing shall identify the particular Celgene IP that Prothena would like to use), and if Celgene agrees, in its sole discretion, the Parties shall

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negotiate and enter into a separate agreement setting for the terms and conditions under which Prothena may utilize such Celgene IP.
7.6.3      Ownership of Program IP .
(a)      As between the Parties (including their respective Affiliates), Prothena will solely own and Control all Program IP. Celgene shall, and hereby does, assign to Prothena all of Celgene’s interest in any and all Program Know-How that falls within Section 1.62(a)(iii) and all Program Patents claiming such Program Know-How. Celgene shall, and shall require its Affiliates to, take all reasonable actions and execute all documents necessary to effect the intent of the preceding sentence. As between the Parties (and their respective Affiliates) and any Third Party, Prothena will solely own and Control all Program IP; provided that if (a) [***] and (b) [***].
(b)      If any Program IP is created, conceived, discovered, first generated, invented, first made or first reduced to practice pursuant to this Agreement by any Third Party that is in contractual privity with or otherwise engaged by Prothena or its Affiliates, [***], Prothena [***] include in such agreement with such Third Party an obligation to [***] to Prothena [***] such Program IP to enable Prothena to grant to Celgene the rights provided for in this Agreement and any U.S. License Agreement and Global License Agreement for the duration of this Agreement, and if applicable any U.S. License Agreement and Global License Agreement.
7.6.4      Joint Program IP . The Parties shall each own an equal, undivided interest in any and all Know-How that is created, conceived, discovered, first generated, invented, first made or first reduced to practice, in each case, jointly by or on behalf of Prothena or its Affiliates, on the one hand, and Celgene or its Affiliates, on the other hand, pursuant to the conduct of activities under this Agreement at any time during the Term, (the “ Joint Program Know-How ”), and (b) any Patents that claim any Joint Program Know-How (the “ Joint Program Patents ”, together with Joint Program Know-How the “ Joint Program IP ”). Each Party shall assign, and hereby assigns, to the other Party, a joint equal and undivided interest in and to such Joint Program IP (provided, however, that for clarity, the foregoing joint ownership rights with respect to Joint Program IP shall not be construed as granting, conveying or creating any license or other rights to any of the other Party’s other intellectual property, unless otherwise expressly set forth in this Agreement), and at the request of a Party, the other Party will execute such documents (including any necessary assignments) to effect such joint ownership of such Joint Program IP. Each Party shall have the right to disclose (except as otherwise set forth in Section 8.2) and exploit the Joint Program IP without a duty of seeking consent or accounting to the other Party, except as expressly provided in the U.S. License Agreement or the Global License Agreement; provided that, such rights shall be subject to the rights and licenses (including the Options) granted to Celgene and Prothena hereunder (and under any U.S. License Agreement or Global License Agreement), including the obligations of Prothena as set forth in Article 5.
7.6.5      Ownership of Collaboration Candidates . Prothena shall [***] that it owns and Controls all Collaboration Candidates such that it is able to grant the rights and licenses to Celgene hereunder (and under a U.S. License Agreement and Global License Agreement) with respect to such Collaboration Candidates.

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7.6.6      Further Actions . Each Party shall cause its and its Affiliates’ employees, consultants, sublicensees, agents and contractors to, as applicable, (i) assign or (ii) grant a license (as set forth in Section 7.6.3(a)), to such Party, in and under such Person’s right, title and interest in and to any and all Program IP or Joint Program IP, and intellectual property rights therein, as is necessary to effect the intent of this Section 7.6.
7.7      Prosecution and Maintenance of Prothena Collaboration Patents and Program Patents .
7.7.1      Pre-Phase 1 Option Exercise .Subject to Section 7.7.2, on a Program-by-Program basis, the provisions of this Section 7.7.1 shall apply with respect to Prothena Collaboration Patents and Program Patents for such Program prior to the execution of a Global License Agreement (or the expiration of the Phase 1 Option Term if Celgene does not timely exercise its Phase 1 Option) with respect to such Program.
(a)      Prothena First Right . Subject to Section 7.7.1(b), Prothena shall have the first right (but not the obligation) to Prosecute and Maintain the Prothena Collaboration Patents and Program Patents; provided that Prothena shall [***] Prosecute and Maintain the Prothena Collaboration Patents and Program Patents in the Primary Patent Countries ([***]). All such Prosecution and Maintenance by Prothena shall be through patent counsel [***]. Prothena shall keep Celgene informed as to material developments with respect to the Prosecution and Maintenance of such Patents including by providing copies of all substantive office actions, examination reports, communications or any other substantive documents to or from any patent office, including notice of all interferences, reissues, re-examinations, inter partes reviews, derivations, post grant proceedings, oppositions or requests for patent term extensions. Prothena shall also provide Celgene with a reasonable opportunity to comment substantively on the Prosecution and Maintenance of such Patents prior to taking material actions (including the filing of initial applications), and will in good faith consider any comments made by and actions recommended by Celgene, provided however that Celgene provides its comments reasonably in advance of any applicable filing deadlines.
(b)      Back-Up Right . If Prothena in any country decides not to file, or decides not to participate in any interferences, reissues, re-examinations, inter partes reviews, post grant proceedings or oppositions with respect to, a Prothena Collaboration Patent or a Program Patent, in each case other than a Prothena Platform Patent, or intends to allow such Patent to lapse or become abandoned without having first filed a substitute, it shall notify and consult with Celgene of such decision or intention at least [***] ([***]) days prior to the date upon which the subject matter of such Patent shall become unpatentable or such Patent shall lapse or become abandoned, Celgene shall thereupon have the right (but not the obligation) upon written notice to Prothena to assume the Prosecution and Maintenance thereof, at Celgene’s expense with counsel of its choice ([***]). For clarity, the provisions of this Section 7.7.1(b) shall not (i) limit Prothena’s obligations to Prosecute and Maintain the Prothena Collaboration Patents and Program Patents in the Primary Patent Countries as set forth in Section 7.7.1(a), or (ii) apply to a Prothena Collaboration Patent or Program Patent solely claiming or covering a Lapsed Target or an Antibody that Targets a Lapsed Target (and no other Collaboration Target).

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(c)      Cooperation in Prosecution and Maintenance .
(i)      Further Assurances . If Celgene determines to undertake the Prosecution and Maintenance of a Prothena Collaboration Patent or Program Patent in accordance with this Section 7.7, Prothena agrees to make its employees, agents and consultants reasonably available to Celgene (and to Celgene’s authorized attorneys, agents or representatives), to enable Celgene to undertake such Prosecution and Maintenance. In addition, Prothena shall (and shall cause its Affiliates and its and their employees, agents and consultants to) provide reasonable assistance to Celgene (and to Celgene’s authorized attorneys, agents or representatives), to enable Celgene to undertake such Prosecution and Maintenance, including by executing powers of attorney and other documents for Celgene to undertake such Prosecution and Maintenance.
(ii)      Assistance . The Parties shall reasonably cooperate with one another, through the Patent Committee (including their respective Patent Liaisons), with respect to the Prosecution and Maintenance of the Prothena Collaboration Patents and Program Patents for which either Party is responsible for Prosecution and Maintenance pursuant to this Section 7.7, including in the furtherance of the Patent Strategy. [***], the Parties shall cooperate with one another to [***], in each case that are applicable to a Collaboration Target or Collaboration Candidate, as applicable, if practicable to [***].
(d)      Costs of Prosecution and Maintenance . Except as otherwise expressly set forth in this Section 7.7.1, each Party shall be responsible for all costs and expenses associated with its Prosecution and Maintenance activities under this Section 7.7.1 with respect to Prothena Collaboration Patents and Program Patents for which it is responsible pursuant to Sections 7.7.1(a) or 7.7.1(b), as applicable.
7.7.2      Post-IND Option Exercise . On a Program-by-Program basis, after Celgene’s execution of a U.S. License Agreement with respect to such Program, Prosecution and Maintenance of the Prothena Collaboration Patents and Program Patents for such Program in the United States shall be in accordance with the applicable U.S. License Agreement for such Program. In the event that a given Prothena Collaboration Patent or Program Patent relates to multiple Programs, then the provisions of this Section 7.7.2 shall control over the provisions of Section 7.7.1.
7.7.3      Post-Phase 1 Option Exercise . On a Program-by-Program basis, after execution of a Global License Agreement with respect to such Program, Prosecution and Maintenance of the Prothena Collaboration Patents and Program Patents for such Program shall be in accordance with the applicable Global License Agreement for such Program. In the event that a given Prothena Collaboration Patent or Program Patent relates to multiple Programs, then the provisions of this Section 7.7.3 shall control over the provisions of Section 7.7.1, Section 7.7.2 and the provisions of the applicable U.S. License Agreement for such Program.
7.8      Enforcement of Prothena Collaboration Patents and Program Patents .
7.8.1      Prior to Exercise of Phase 1 Option . Subject to Section 7.8.2, on a Program-by-Program basis, the provisions of this Section 7.8.1 shall apply with respect to Prothena

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Collaboration Patents and Program Patents for such Program prior to the exercise of Celgene’s IND Option with respect to such Program.
(a)      Notice . If any Party learns of an infringement or threatened infringement by a Third Party of any Prothena Collaboration Patent or Program Patent in each case other a Prothena Platform Patent (including in connection with any Biosimilar Application referencing a Collaboration Product (regardless of whether such notice or copy is provided under any Applicable Laws) including under the BPCIA or the United States Patient Protection and Affordable Care Act or its successor provisions, or any similar provisions in a country outside the United States, as applicable), such Party shall promptly notify the other Party and shall provide such other Party with available evidence of such infringement, and following such notification, the Parties shall confer.
(b)      Enforcement . As between the Parties, subject to the remaining provisions of this Section 7.8.1, Prothena shall have the sole right, but not the obligation, to institute, prosecute, and control any action or proceeding (which may include settlement or otherwise seeking to secure the abatement of such infringement) with respect to any infringement of any Prothena Collaboration Patent or Program Patent in each case other than a Prothena Platform Patent (including in connection with any Biosimilar Application referencing a Collaboration Product (regardless of whether such notice or copy is provided under any Applicable Laws) including under the BPCIA or the United States Patient Protection and Affordable Care Act or its successor provisions, or any similar provisions in a country outside the United States, as applicable), by counsel of its own choice, in Prothena’s own name and under Prothena’s direction and control, including the right to control the defense of any challenges to such Patents as a counterclaim in such infringement proceeding as well as the defense of declaratory judgment actions.
(c)      Consultation . Prothena will keep Celgene regularly informed of the status and progress of such enforcement efforts. Prothena shall consult with Celgene and will take comments of Celgene into good faith consideration with respect to the infringement or claim construction of any claim in any Prothena Collaboration Patent or Program Patent in each case other a Prothena Platform Patent.
(d)      Settlement . A settlement or consent judgment or other voluntary final disposition of a suit with respect to Prothena Collaboration Patents or Program Patents in each case other than a Prothena Platform Patent, under this Section 7.8.1 may be entered into without the consent of Celgene; provided, however, that any such settlement, consent judgment or other disposition of any action or proceeding by Prothena under this Section 7.8.1 shall not, without the prior written consent of Celgene, (i) impose [***] liability or obligation on Celgene or any of its Affiliates, (ii) conflict with [***] the subject matter claimed in the applicable Prothena Collaboration Patent or Program Patent, (iii) include the grant of any license, covenant or other rights to any Third Party that would conflict with [***] the rights or licenses (including Options) granted to Celgene under this Agreement, any U.S. License Agreement or any Global License Agreement, or (iv) [***].
(e)      Costs and Recoveries . Prothena shall bear all costs incurred in connection with its activities under this Section 7.8.1. Any damages or other monetary awards

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recovered in any action, suit or proceeding brought under this Section 7.8.1 to the extent related to any Prothena Collaboration Patents or Program Patents shall be shared as follows:
(i)      the amount of such recovery actually received shall first be applied to reimburse costs and expenses incurred by each Party in connection with such action (including, for this purpose, [***] counsel); and
(ii)      [***] any additional sums recovered by it under such proceeding.
7.8.2      Post-IND Option Exercise . On a Program-by-Program basis and after Celgene’s exercise of its IND Option with respect to such Program, enforcement of the Prothena Collaboration Patents and Program Patents for such Program in the United States shall be in accordance with the applicable U.S. License Agreement for such Program. In the event that a given Prothena Collaboration Patent or Program Patent relates to multiple Programs, then the provisions of this Section 7.8.2 shall control over the provisions of Section 7.8.1.
7.8.3      Post-Phase 1 Option Exercise . On a Program-by-Program basis and after Celgene’s exercise of its Phase 1 Option with respect to such Program, enforcement of the Prothena Collaboration Patents and Program Patents for such Program shall be in accordance with the applicable Global License Agreement for such Program. In the event that a given Prothena Collaboration Patent or Program Patent relates to multiple Programs, then the provisions of this Section 7.8.3 shall control over the provisions of Section 7.8.1, Section 7.8.2 and the provisions of the applicable U.S. License Agreement for such Program.
7.9      Matters Involving Joint Program Patents . The Prosecution and Maintenance, and the enforcement and defense, of any Joint Program Patents shall be jointly managed by the Parties through independent patent counsel (mutually agreed to by the Parties) jointly representing the Parties, including any costs and recoveries regarding same. Prior to either Party publishing any Joint Program Know-How, the Parties will discuss if a Joint Program Patent claiming such Joint Program Know-How should be filed.
7.10      Common Interest Agreement . At the request of either party, the Parties shall negotiate in good faith to enter into a common interest agreement to govern their discussion of Patent matters.
7.11      License Filing . At the request of Celgene, Prothena shall, and shall cause its Affiliates to assist in any license registration processes with applicable Governmental Authorities that may be available for the protection of Celgene’s interests in this Agreement.
7.12      Defense of Claims Brought by Third Parties . If a Party becomes aware of any actual or potential claim that the Development or Manufacture of any Collaboration Target, Collaboration Candidate or Collaboration Product by or on behalf of Prothena pursuant to the conduct of a Program under this Agreement infringes the intellectual property rights of any Third Party, such Party shall promptly notify the other Party. In any such instance, the Parties shall as soon as practicable thereafter meet (which may be through the JSC) to discuss in good faith regarding the best response to such notice.

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7.13      Celgene Activities . Notwithstanding anything to the contrary in this Agreement, any U.S. License Agreement or any Global License Agreement, in no event may Prothena or its Affiliates Prosecute and Maintain, or enforce, by virtue of this Agreement, any U.S. License Agreement and/or any Global License Agreement, any Patent that claims or covers any Antibody Targeting a Collaboration Target, or any product constituting, incorporating, comprising or containing any such Antibody, that Celgene or any of its Affiliates Develops, Manufactures or Commercializes under this Agreement, any U.S. License Agreement or any Global License Agreement, unless such Patent is included in the Prothena Collaboration Patents and Program Patents as expressly set forth in Article 7 of this Agreement or in the applicable provisions of any U.S. License Agreement or any Global License Agreement, as applicable.
ARTICLE 8
CONFIDENTIALITY
8.1      Nondisclosure . Each Party agrees that a Party (the “ Receiving Party ”) receiving Confidential Information of the other Party (the “ Disclosing Party ”) pursuant to this Agreement shall (a) maintain in confidence such Confidential Information using not less than the efforts such Receiving Party uses to maintain in confidence its own proprietary information of similar kind and value, but in no event less than a reasonable degree of efforts, (b) not disclose such Confidential Information to any Third Party without the prior written consent of the Disclosing Party, except for disclosures expressly permitted pursuant to this Article 8, and (c) not use such Confidential Information for any purpose except those permitted by this Agreement, any U.S. License Agreement or any Global License Agreement, including, in the case of Celgene, the exercise of the rights and licenses (including Options) granted to Celgene hereunder and thereunder (it being understood that this clause (c) shall not create or imply any rights or licenses not expressly granted under this Agreement). The obligations of confidentiality, non-disclosure and non-use under this Section 8.1 shall be in full force and effect during the Term and for a period of [***] ([***]) years thereafter. The Receiving Party will return all copies of or destroy (and certify such destruction in writing) the Confidential Information of the Disclosing Party disclosed or transferred to it by the other Party pursuant to this Agreement, within [***] ([***]) days after the termination or expiration of this Agreement; provided, however, that a Party may retain (i) Confidential Information of the other Party to exercise rights and licenses which expressly survive such termination or expiration pursuant to this Agreement (including, in the case of Celgene as the receiving Party, exercising its rights and licenses under a U.S. License Agreement or Global License Agreement, as applicable, and in such case, Celgene shall not be required to return or destroy any Confidential Information of Prothena), and (ii) one (1) copy of all other Confidential Information in archives solely for the purpose of establishing the contents thereof. Without limiting the foregoing, [***] will keep confidential, and will cause its Affiliates and its and their employees, consultants, licensees, sublicensees and professional advisors to keep confidential, [***] on confidentiality terms at least as protective as the confidentiality provisions of this Agreement (without regard to Section 8.3).
8.2      Collaboration Specific Confidential Information . Notwithstanding anything to the contrary contained herein, the Parties agree and acknowledge that any Collaboration Specific IP shall be deemed to be Confidential Information of each Party (without regard to Section 8.3), and each Party shall be deemed to be the Disclosing Party with respect to the Collaboration Specific IP.

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As used herein, (a) the term “ Collaboration Specific IP ” means, with respect to a given Program, (i) [***], (ii) [***], and (iii) [***]; and (b) the term “ Collaboration Non-Specific IP ” means all Prothena Platform Technology within the Prothena Collaboration Know-How, and other Collaboration Know-How and Program Know-How other than Collaboration Specific IP; provided that, in the event that Celgene does not exercise its IND Option for a given Program, then the Collaboration Specific IP with respect to such Program shall thereafter no longer be deemed to be Collaboration Specific IP pursuant to this Section 8.2, solely to the extent that such Collaboration Specific IP does not include Collaboration Specific IP relating to a different Program. For clarity, Collaboration Non-Specific IP shall be deemed to be the Confidential Information of Prothena.
8.3      Exceptions .
8.3.1      General . The obligations in Section 8.1 shall not apply with respect to any portion of the Confidential Information of the Disclosing Party that the Receiving Party can show by competent written proof:
(a)      was known to the Receiving Party or any of its Affiliates, without any obligation to keep it confidential or any restriction on its use, prior to disclosure by the Disclosing Party;
(b)      is subsequently disclosed to the Receiving Party or any of its Affiliates by a Third Party lawfully in possession thereof and without any obligation to keep it confidential or any restriction on its use;
(c)      is published by a Third Party or otherwise becomes publicly available or enters the public domain, either before or after it is disclosed to the Receiving Party, without any breach by the Receiving Party of its obligations hereunder;
(d)      is published by a Party in accordance with Section 8.7 without any breach by such Party of its obligations hereunder; or
(e)      is independently developed by or for the Receiving Party or its Affiliates without reference to or reliance upon the Disclosing Party’s Confidential Information.
Any combination of features or disclosures shall not be deemed to fall within the foregoing exclusions merely because individual features are published or available to the general public or in the rightful possession of the Receiving Party unless the combination itself and principle of operation are published or available to the general public or in the rightful possession of the Receiving Party.
8.4      Authorized Disclosure .
8.4.1      Disclosure . Notwithstanding Section 8.1, the Receiving Party may disclose Confidential Information belonging to the Disclosing Party in the following instances:
(a)      subject to Section 8.6, to comply with Applicable Law (including the rules and regulations of the U.S. Securities and Exchange Commission (“ SEC ”) or any national securities exchange) or with judicial process (including prosecution or defense of litigation), if, in

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the reasonable opinion of the Receiving Party’s counsel, such disclosure is necessary for such compliance or for such judicial process (including prosecution or defense of litigation);
(b)      is disclosed to governmental or other regulatory agencies in order to obtain Patents or to gain or maintain approval to conduct Clinical Trials under this Agreement, in each case, in accordance with this Agreement, but such disclosure shall only be to the extent reasonably necessary to obtain such Patents or authorizations, and provided that reasonable steps are taken to ensure confidential treatment of such Confidential Information (if available);
(c)      to any of its officers, employees, consultants, agents or Affiliates (including, (i) [***] (ii) in the case of either Party to such Party’s subcontractors for purpose of such subcontractor performing obligations of such Party under this Agreement) as it deems necessary or advisable in the course of conducting activities in accordance with this Agreement in order to carry out its responsibilities or exercise its rights under this Agreement (including the exercise of the rights and licenses (including, the evaluation of its Options) granted to the relevant Party hereunder, and (iii) in the case of either Party, to such Party’s actual or potential acquirers; provided that each such disclosee is bound by written confidentiality obligations and non-use obligations no less restrictive than those set forth in this Article 8 to maintain the confidentiality thereof and not to use such Confidential Information except as expressly permitted by this Agreement; provided, however, that, in each of the above situations in this Section 8.4.1(c), the Receiving Party shall remain responsible for any failure by any Person who receives Confidential Information from such Receiving Party pursuant to this Section 8.4.1(c) to treat such Confidential Information as required under this Article 8; and
(d)      disclosure, solely on a “need to know basis” to its advisors (including attorneys and accountants) in connection with activities hereunder; provided that, prior to any such disclosure, each disclosee must be bound by written obligations of confidentiality, non-disclosure and non-use no less restrictive than the obligations set forth in this Article 8 (provided, however, that in the case of legal advisors, no written agreement shall be required), which for the avoidance of doubt, will not permit use of such Confidential Information for any purpose except those expressly permitted by this Agreement; provided, however, that, in each of the above situations in this Section 8.4.1(d), the Receiving Party shall remain responsible for any failure by any Person who receives Confidential Information from such Receiving Party pursuant to this Section 8.4.1(d) to treat such Confidential Information as required under this Article 8.
8.4.2      Terms of Disclosure . If and whenever any Confidential Information is disclosed in accordance with this Section 8.4, such disclosure shall not cause any such information to cease to be Confidential Information except to the extent that such disclosure results in a public disclosure of such information (other than by breach of this Agreement). Where reasonably possible and subject to Section 8.6, the Receiving Party shall notify the Disclosing Party of the Receiving Party’s intent to make any disclosures pursuant to Section 8.4.1(a) sufficiently prior to making such disclosure so as to allow the Disclosing Party adequate time to take whatever action it may deem appropriate to protect the confidentiality of the information, and the Receiving Party will provide reasonable assistance to the Disclosing Party with respect thereto; provided that, in such event, the Receiving Party will use reasonable measures to ensure confidential treatment of such information

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and shall only disclose such Confidential Information of the Disclosing Party as is necessary for the purposes of Section 8.4.1(a), as applicable.
8.4.3      Collaboration Specific IP . Neither Party shall disclose the Collaboration Specific IP without the prior written consent of the other Party, other than pursuant to Section 8.4.1.
8.5      Terms of this Agreement . The Parties agree that this Agreement and the terms hereof shall be deemed to be Confidential Information of both Prothena and Celgene, and each Party agrees not to disclose any of them without the prior written consent of the other Party, except that each Party may disclose any of them in accordance with the provisions of Sections 8.4 and/or 8.6, as applicable.
8.6      Securities Filings; Disclosure under Applicable Law . Each Party acknowledges and agrees that the other Party may submit this Agreement to (or file this Agreement with) the SEC or any national securities exchange in any jurisdiction (collectively, the “ Securities Regulators ”), or to other Persons as may be required by Applicable Law, and if a Party does submit this Agreement to (or file this Agreement with) any Securities Regulators, or other Persons as may be required by Applicable Law, such Party agrees to consult with the other Party with respect to the preparation and submission of a confidential treatment request for this Agreement. Notwithstanding the foregoing, if a Party is required by Applicable Law or any Securities Regulator to make a disclosure of the terms of this Agreement in a filing or other submission as required by Applicable Law or Securities Regulator, and (a) such Party has provided copies of the disclosure to the other Party reasonably in advance of such filing or other disclosure under the circumstances, (b) such Party has promptly notified the other Party in writing of such requirement and any respective timing constraints, and (c) such Party has given the other Party a reasonable time under the circumstances from the date of notice by such Party of the required disclosure to comment upon and request confidential treatment for such disclosure, then such Party will have the right to make such disclosure at the time and in the manner reasonably determined by its counsel to be required by Applicable Law or Securities Regulator. Notwithstanding the foregoing, it is hereby understood and agreed that if a Party seeks to make a disclosure as required by Applicable Law or Securities Regulator as set forth in this Section 8.6, and the other Party provides comments within the respective time periods or constraints specified herein or within the respective notice, the Party seeking to make such disclosure or its counsel, as the case may be, will in good faith consider incorporating such comments.
8.7      Publicity .
8.7.1      Press Release . Subject to Sections 8.4 and 8.6 and this Section 8.7, each Party agrees not to, and agrees to cause their Affiliates not to, issue any press release or other public statement disclosing this Agreement, the activities hereunder, or the transactions contemplated hereby unless such press release or other public statement is approved by the other Party in writing; provided that either Party shall be authorized to make any disclosure, without the approval of the other Party, that is required by Applicable Law (including the U.S. Securities Act of 1933, as amended, and the U.S. Securities Exchange Act of 1934, as amended) or the rules of any Securities Regulator, or by judicial process, subject to and in accordance with Sections 8.4 and 8.6, as applicable. Without limiting the foregoing, and subject to the foregoing proviso, in the event that

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Prothena desires to issue an initial press release regarding the execution of this Agreement, Prothena shall have the right to do so provided that (i) [***] and (ii) [***].
8.7.2      Additional Restrictions on Disclosure . Without limiting any other restrictions on disclosure as set forth in this Article 8, on a Program-by-Program basis, with respect to any press release or other public statement proposed to be made by Prothena prior to Celgene’s exercise of the Phase 1 Option for such Program, if such press release or public statement discloses any information with respect to [***], such press release or other public statement may not be issued without Celgene’s prior written consent, except for such disclosures by Prothena as required by Applicable Law or Securities Regulators (solely and to the extent Prothena’s counsel determines such disclosure is required by Applicable Law or Securities Regulators); provided that (i) in such case Prothena shall use reasonable efforts to afford Celgene a reasonable period of time to review any such disclosure and any comments made by Celgene will be considered in good faith, and (ii) any information that has been previously publicly disclosed in accordance with this Agreement may be disclosed again as long as such disclosure does not exceed the scope of such prior public disclosure. Subject to the foregoing, in the event Celgene proposes that Prothena use specific wording or language with respect thereto, Prothena shall in good faith consider incorporating such wording or language. This Section 8.7.2 shall not apply, on a Program-by-Program basis following the expiration of the Phase 1 Option Term for the applicable Program if the Phase 1 Option has not been exercised.
8.7.3      Previously Issued Public Statements . The contents of any press release or other public statement that has been reviewed and approved by a reviewing Party may be re-released by the publishing Party or by such reviewing Party without a requirement for re-approval.
8.8      Permitted Publications .
8.8.1      Publication . In the event either Party (or its Affiliates) (the “ Publishing Party ”) desires to publish or present any information (including publications in journals, posters, presentations at conferences and abstracts submitted in advance of conferences) with respect to [***], subject to Sections 8.4, 8.6 and 8.7, the Publishing Party shall provide the other Party with a copy of such proposed publication or presentation no less than [***] ([***]) days prior(provided that the other Party shall use Commercially Reasonable Efforts to accommodate a shorter time period if required due to circumstances outside of the Publishing Party’s control) prior to its intended submission for publication or public disclosure. For the avoidance of doubt, the foregoing shall apply with respect to each proposed publication or presentation regardless of whether a prior publication or presentation was provided (e.g., if an abstract is provided in accordance with this Section 8.8.1 and a Publishing Party wishes to publish the corresponding full manuscript, the full manuscript must be provided to the other Party pursuant to this Section 8.8.1). The other Party shall respond in writing promptly and in no event later than [***] ([***]) days after receipt of the proposed material (provided that the other Party shall use Commercially Reasonable Efforts to accommodate a shorter time period if notified by the Publishing Party and required due to circumstances outside of the Publishing Party’s control), with one or more of the following:
(a)      comments on the proposed material, which the Publishing Party shall consider in good faith; and/or

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(b)      a specific statement of concern, based upon the need to seek patent protection or to block publication or public disclosure (including publications in journals, posters, presentations at conferences and abstracts submitted in advance of conferences) if such other Party reasonably determines that the proposed disclosure is intellectual property that should be maintained as a trade secret to protect any Collaboration Target, Collaboration Candidate or Collaboration Product that is the subject of such Program, in which event the Publishing Party agrees not to submit such publication or make such presentation that contains such information until :
(i)      with respect to publication or presentation of Collaboration Non-Specific IP, the other Party is given [***] to seek patent protection for any such Collaboration Non-Specific IP in such publication or presentation which it believes is patentable or to resolve any other issues, or
(ii)      with respect to publication or presentation of Collaboration Specific IP, [***] for the other Party to (x) enable further development and optimization of such Collaboration Specific IP (including related Collaboration Candidates and Collaboration Products), (y) seek patent protection for any such Collaboration Specific IP in such publication or presentation which it believes is patentable or (z) resolve any other issues; and/or
(c)      an identification of the other Party’s Confidential Information that is contained in the material reviewed, which the Publishing Party shall remove, if requested by the other Party.
Notwithstanding the foregoing, if Celgene fails to exercise the IND Option during the IND Option Term for a Program, then Section 8.8.1(b) shall no longer apply with respect to publications or presentations relating solely to such Program (and to no other Programs).
8.8.2      Prothena Subcontractors . Except with respect to any subcontractors of Prothena who are [***] engaged by Prothena to perform research under a Program and who are [***], Prothena shall [***] that no publication or presentation is made by any subcontractors or Affiliates of Prothena, with respect to the [***], except in accordance with Section 8.8.1.
8.9      Re-Publication; Re-Presentation . The contents of any publication or presentation that has been reviewed and approved by a reviewing Party may be re-released by the Publishing Party or the reviewing Party without a requirement for re-approval.
8.10      Use of Names . Except as otherwise expressly set forth herein, no Party (or its respective Affiliates) shall use the name, trademark, trade name or logo of the other Party or its Affiliates, or its or their respective employee(s), in any publicity, promotion, news release or other public disclosure relating to this Agreement or its subject matter, without the prior written permission of the other Party; provided that such permission shall not be required to the extent use thereof may be required by Applicable Law or Securities Regulators, including the rules of any securities exchange or market on which a Party’s (or its Affiliate’s) securities are listed or traded.
8.11      Relationship to Existing Confidentiality Agreement . This Agreement supersedes that certain Mutual Confidentiality Agreement entered into between Prothena and Celgene, effective

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as of March 6, 2017 (the “ Existing Confidentiality Agreement ”); provided that all “Confidential Information” disclosed by the “Disclosing Party” thereunder shall be deemed Confidential Information of the Disclosing Party hereunder (subject to Section 8.2) and shall be subject to the terms and conditions of this Agreement (or U.S. License Agreement or Global License Agreement, as applicable, pursuant to Section 8.13) and the “Receiving Party” thereunder shall be bound by and obligated to comply with such terms and conditions as if they were the Receiving Party hereunder. The foregoing shall not be interpreted as a waiver of any remedies available to the “Disclosing Party” under the Existing Confidentiality Agreement as a result of any breach, prior to the Effective Date, by the “Receiving Party”, of its obligations pursuant to the Existing Confidentiality Agreement.
8.12      Clinical Trials Registry . Either Party shall have the right to publish registry information and customary summaries of data and results from any Phase 1 Clinical Trials conducted by or on behalf of such Party under this Agreement, on its clinical trials registry or on a government-sponsored database such as www.clinicaltrials.gov, without requiring the consent of the other Party. The Parties shall reasonably cooperate if required or reasonably requested by the Party seeking such publication in order to facilitate any such publication by such Party.
8.13      U.S. License Agreement; Global License Agreement . Notwithstanding the foregoing provisions of this Article 8, (a) if a U.S. License Agreement is entered into with respect to a given Program, then to the extent there is a conflict between the provisions of this Article 8 and the provisions of Article 7 of such U.S. License Agreement, the provisions of Article 7 of such U.S. License Agreement shall control with respect to Confidential Information related to such Program and (b) if a Global License Agreement is entered into with respect to a given Program, then the provisions of such Global License Agreement shall control with respect to Confidential Information related to such Program in lieu of this Article 8.
ARTICLE 9
REPRESENTATIONS AND WARRANTIES; COVENANTS
9.1      Representations and Warranties of Both Parties . Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:
(a)      such Party is duly organized, validly existing and in good standing under the Applicable Law of the jurisdiction of its formation and has full corporate power and authority to enter into this Agreement, and to carry out the provisions hereof;
(b)      such Party has taken all necessary corporate action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder;
(c)      this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, binding obligation, enforceable against it in accordance with its terms, except to the extent that enforcement of the rights and remedies created hereby is subject to (i) bankruptcy, insolvency, reorganization, moratorium and other similar laws of general

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application affecting the rights and remedies of creditors, or (ii) laws governing specific performance, injunctive relief and other equitable remedies;
(d)      the execution, delivery and performance of this Agreement by such Party does not breach or conflict with any agreement or any provision thereof, or any instrument or understanding, oral or written, to which such Party (or any of its Affiliates) is a party or by which such Party (or any of its Affiliates) is bound, nor violate any Applicable Law of any Governmental Authority having jurisdiction over such Party (or any of its Affiliates);
(e)      no government authorization, consent, approval, license, exemption of or filing or registration with any court or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, under any Applicable Law currently in effect, is or will be necessary for, or in connection with, the transaction contemplated by this Agreement, or for the performance by it of its obligations under this Agreement (including, in the case of Prothena, the grant of the rights to Celgene hereunder, including the Options), except (i) as may be required to conduct Clinical Trials or to seek or obtain Regulatory Approvals or applicable Regulatory Materials or (ii) as set forth in Section 3.2; and
(f)      it has obtained all necessary authorizations, consents and approvals of any Third Party that is required to be obtained by it as of the Effective Date for, or in connection with, the transaction contemplated by this Agreement, or for the performance by it of its obligations under this Agreement (including, in the case of Prothena, the grant of the rights to Celgene hereunder, including the Options), except (i) as may be required to conduct Clinical Trials or to seek or obtain Regulatory Approvals or applicable Regulatory Materials or (ii) as set forth in Section 3.2.
9.2      Representations and Warranties of Prothena . Prothena hereby represents and warrants to Celgene, as of the Effective Date, that:
(a)      Schedule 1.66 contains a complete and accurate list of all Patents included in the Prothena IP that claim or cover any Collaboration Target or any Antibodies (or any products constituting, incorporating, comprising or containing any such Antibody) that Target any Collaboration Target, including the composition or use of any of the foregoing, and Prothena Controls all such Patents. Except for the Prothena IP, Prothena and its Affiliates do not own or control (by license or otherwise), as of the Effective Date, any Patent or Know-How that is necessary or useful to Develop, Manufacture or Commercialize any Collaboration Targets or any Antibodies (or any products constituting, incorporating, comprising or containing any such Antibody) that Target any Collaboration Target. To Prothena’s and its Affiliates’ actual knowledge all issued Patents within the Prothena IP are in full force and effect, and are not invalid or unenforceable, in whole or in part;
(b)      no claim has been issued or served, or written threat of a claim or litigation made by any Person, against Prothena or its Affiliates that alleges that any Prothena IP is invalid or unenforceable;
(c)      neither Prothena nor its Affiliates own or otherwise control (through license or otherwise) any Antibodies (or any products constituting, incorporating, comprising or

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containing any such Antibody) that Target a Collaboration Target other than as set forth on Schedule 1.14 ;
(d)      [***];
(e)      Except with respect to payment obligations under vendor agreements existing as of the Effective Date and entered into by Prothena or its Affiliates in the ordinary course of business and not specifically for the purposes of this Agreement (which payment obligations are Prothena’s (or its Affiliates’, as applicable) sole responsibility), neither Prothena nor its Affiliates are subject to any payment obligations to Third Parties as a result of the execution or performance of this Agreement, or the research, development, manufacture or commercialization of any Collaboration Target or any Antibodies (or any products constituting, incorporating, comprising or containing any such Antibody) that Target any Collaboration Target;
(f)      Prothena has the full right and authority to grant all of the rights and licenses granted to Celgene (or purported to be granted to Celgene) hereunder; and neither Prothena nor its Affiliates have granted any right or license to any Third Party relating to any of the Prothena IP or any other Program Assets, Collaboration Targets or Antibodies (or any products constituting, incorporating, comprising or containing any such Antibody) that Target any Collaboration Target, that would conflict with [***] any of the rights or licenses (including the Options) granted to Celgene hereunder;
(g)      Prothena is the sole and exclusive owner of the Prothena IP, except for the Prothena Collaboration IP that is licensed to Prothena (or its Affiliates) pursuant to the In-License Agreements set forth on Schedule 1.42 on a nonexclusive or exclusive basis (as set forth on Schedule 1.42 ). All Affiliates of Prothena have exclusively licensed or assigned all of their right, title and interest in and to the Prothena IP to Prothena. Neither Prothena nor its Affiliates have granted any mortgage, pledge, claim, security interest, lien or other charge of any kind on the Prothena IP or other Program Assets, and the Prothena IP and the other Program Assets are free and clear of any mortgage, pledge, claim, security interest, lien or charge of any kind;
(h)      neither Prothena nor its Affiliates have received any written notice of any claim that any Patent or Know-How (including any trade secret right) owned or controlled by a Third Party would be infringed or misappropriated by the Development, Manufacture, or Commercialization of any Collaboration Target or any Antibodies (or any products constituting, incorporating, comprising or containing any such Antibody) that Target any Collaboration Target;
(i)      to Prothena’s and its Affiliates’ actual knowledge, (i) the Development and Manufacture of any Collaboration Target or any Antibodies (or any products constituting, incorporating, comprising or containing any such Antibody) that Target any Collaboration Target, as conducted by or on behalf of Prothena or its Affiliates prior to the Effective Date, has not violated, infringed or misappropriated any intellectual property or proprietary right of any Third Party and (ii) [***];
(j)      there are no claims, judgments, settlements, litigations, suits, actions, disputes, arbitration, judicial or legal administrative or other proceedings or governmental

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investigations pending or, to Prothena’s or its Affiliates’ actual knowledge, threatened against Prothena or its Affiliates which would reasonably be expected to adversely affect or restrict the ability of Prothena to consummate or perform the transactions contemplated under this Agreement (or pursuant to a U.S. License Agreement or Global License Agreement), or which would affect the Prothena IP or other Program Assets, or Prothena’s Control thereof, or any Collaboration Target or any Antibodies (or any products constituting, incorporating, comprising or containing any such Antibody) that Target any Collaboration Target;
(k)      neither Prothena nor its Affiliates have issued a claim against a Third Party alleging that a Third Party is infringing or has infringed or misappropriated any Prothena IP, and, to Prothena’s and its Affiliates’ actual knowledge, no issued Patents within the Prothena IP are being infringed and no trade secrets within the Prothena IP are being misappropriated by any Third Party;
(l)      neither Prothena nor its Affiliates have employed or otherwise used in any capacity, the services of any Person suspended, proposed for debarment or debarred under United States law, including under 21 U.S.C. § 335a, or any foreign equivalent thereof, with respect to any Collaboration Target, or any Antibodies (or any products constituting, incorporating, comprising or containing any such Antibody) that Target any Collaboration Target. All Manufacture and Development (including non-clinical studies and Clinical Studies) related to any Collaboration Target, or any Antibodies (or any products constituting, incorporating, comprising or containing any such Antibody) that Target any Collaboration Target, conducted by on behalf of Prothena or its Affiliates prior to the Effective Date has been conducted in accordance with all Applicable Laws (including, to the extent applicable, GCP, GLP and GMP);
(m)      neither Prothena nor its Affiliates have entered into any agreement under which Prothena or its Affiliates (i) has obtained a license or sublicense of rights from a Third Party to any Collaboration Target, or to any Antibodies (or any products constituting, incorporating, comprising or containing any such Antibody) that Target any Collaboration Target, or to any Prothena IP, except for the In-License Agreements set forth on Schedule 1.42 , or (ii) has granted a license, sublicense, option or right to a Third Party that remains in effect as of the Effective Date to research, develop, manufacture or commercialize any Collaboration Target or any Antibodies (or any products constituting, incorporating, comprising or containing any such Antibody) that Target any Collaboration Target, except (1) with respect to licenses or rights granted pursuant to the agreements set forth on Schedule 1.42 that were entered into in the ordinary course of business [***] performing activities on behalf of Prothena and (2) [***]. The agreements set forth on Schedule 1.42 do not conflict with [***] the rights or licenses (including the Options) granted to Celgene hereunder;
(n)      with respect to each In-License Agreement, (i) it is in full force and effect; (ii) neither Prothena nor its Affiliates is in breach thereof; and (iii) neither Prothena nor its Affiliates has received any notice from the counterparty to such In-License Agreement of Prothena’s breach or notice of threatened breach by Prothena or its Affiliates thereof;
(o)      Prothena has disclosed to Celgene all material information and data, and all material correspondences to/from any Regulatory Authority, existing as at the Effective Date in the possession or control of Prothena or its Affiliates, in each case related to any Collaboration

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Target or Antibodies (or any products constituting, incorporating, comprising or containing any such Antibody) that Target any Collaboration Target; and
(p)      Prothena has not obtained or filed, any INDs, MAAs or Regulatory Approvals or any other form of regulatory application for approval of Clinical Trials, marketing or other purpose, for any Antibodies (or any products constituting, incorporating, comprising or containing any such Antibody) that Target any Collaboration Target and, to Prothena’s and its Affiliates actual knowledge, no other Person has obtained, or filed for, any such INDs, MAAs or Regulatory Approvals.
9.3      Additional Representations, Warranties and Covenants of Prothena . Prothena hereby further represents, warrants and covenants to Celgene that:
9.3.1      With respect to the In-License Agreements, (a) Prothena (or its Affiliates, as applicable) shall not breach, or commit any acts or permit the occurrence of any omissions that would cause the material breach or termination, of any In-License Agreement and (b) Prothena shall (or shall cause its Affiliates to, as applicable) satisfy all of its obligations under each In-License Agreement in all material respects and shall, or shall cause its Affiliates to, as applicable, maintain each In-License Agreement in full force and effect. Prothena shall, or shall cause its Affiliates to, as applicable, enforce it rights under each In-License Agreement to the extent necessary to preserve Celgene’s rights under this Agreement or any U.S. License Agreement or Global License Agreement. Prothena shall not, and shall cause its Affiliates not to, [***] unless Prothena otherwise obtains Celgene’s prior written consent (such consent not to be unreasonably withheld) if doing so [***] under this Agreement or any U.S. License Agreement or Global License Agreement. Prothena will provide Celgene with prompt written notice of any claim of a breach of which it is aware under any of the In-License Agreements or notice of termination of any In-License Agreement.
9.3.2      Prothena shall promptly notify Celgene in writing if any additional Prothena Collaboration Patents that claim or cover any Collaboration Target or any Antibodies (or any products constituting, incorporating, comprising or containing any such Antibody) that Target any Collaboration Target, including the composition or use of any of the foregoing, becomes known to Prothena that are not listed on Schedule 1.66 .
9.4      Representations and Warranties of Celgene . Celgene hereby represents and warrants to Prothena, as of the Effective Date, that:
9.4.1      there are no claims, judgments, settlements, litigations, suits, actions, disputes, arbitration, judicial or legal administrative or other proceedings or governmental investigations pending or, to Celgene’s actual knowledge, threatened against Celgene which would reasonably be expected to adversely affect or restrict the ability of Celgene to consummate or perform the transactions contemplated under this Agreement (or pursuant to a U.S. License Agreement or Global License Agreement); and
9.4.2      Celgene is a limited liability company organized under the laws of Delaware and wholly owned by Celgene Switzerland SA, which is incorporated in, and a tax resident of,

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Switzerland. Celgene is disregarded as separate from its owner, Celgene Switzerland SA, for U.S. federal income tax purposes.
9.5      Prothena Covenants . Prothena hereby covenants to Celgene that:
9.5.1      Prothena shall not (and shall ensure that its Affiliates do not) grant any right or license to any Third Party relating to any of the Program Assets (including Prothena IP) or with respect to any Collaboration Target, Collaboration Candidates or Collaboration Products, which conflict with, [***] any of the rights or licenses (including the Options) granted to Celgene hereunder.
9.6      Disclaimer . EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATIONS OR EXTENDS ANY WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED (AND EACH PARTY HEREBY EXPRESSLY DISCLAIMS ANY AND ALL REPRESENTATIONS AND WARRANTIES NOT EXPRESSLY PROVIDED IN THIS AGREEMENT), INCLUDING WITH RESPECT TO ANY PATENTS OR KNOW-HOW, OR MATERIALS, INCLUDING WARRANTIES OF VALIDITY OR ENFORCEABILITY, MERCHANTABILITY, FITNESS FOR A PARTICULAR USE OR PURPOSE, PERFORMANCE, AND NONINFRINGEMENT OF ANY THIRD PARTY PATENTS OR OTHER INTELLECTUAL PROPERTY RIGHTS. WITHOUT LIMITING THE FOREGOING, NEITHER PARTY MAKES ANY REPRESENTATION, WARRANTY OR GUARANTEE THAT THE PROGRAMS WILL BE SUCCESSFUL, OR THAT ANY OTHER PARTICULAR RESULTS WILL BE ACHIEVED WITH RESPECT TO THE PROGRAMS, ANY COLLABORATION TARGET, ANY COLLABORATION CANDIDATE OR ANY COLLABORATION PRODUCT HEREUNDER.
ARTICLE 10
INDEMNIFICATION; INSURANCE
10.1      Indemnification by Celgene . Celgene shall indemnify, defend and hold harmless Prothena and its Affiliates, and its and their respective directors, officers, employees, agents, successors and assigns (collectively, the “ Prothena Indemnitees ”), from and against any and all Third Party Damages to the extent arising out of or relating to, directly or indirectly, any Third Party Claim based upon:
(a)      the gross negligence or willful misconduct of Celgene or its Affiliates or its or their respective directors, officers, employees or agents, in connection with Celgene’s performance of its obligations under this Agreement;
(b)      any breach by Celgene of any of its representations, warranties, covenants, agreements or obligations under this Agreement; or
(c)      in the event that any Phase 1 Clinical Trial for a Collaboration Candidate or Collaboration Product is performed by Celgene pursuant to Section 2.5.1(b), any claim by or on behalf of clinical trial subjects for personal injury or death arising out of such Phase 1 Clinical Trial;

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in each case (a)-(c), provided, however, that such indemnity shall not apply to the extent Prothena has an indemnification obligation pursuant to Section 10.2(a) or (b) for such Third Party Damages.
10.2      Indemnification by Prothena . Prothena shall indemnify, defend and hold harmless Celgene, its Affiliates and its and their respective directors, officers, employees, agents, successors and assigns (collectively, the “ Celgene Indemnitees ”), from and against any and all Third Party Damages to the extent arising out of or relating to, directly or indirectly, any Third Party Claim based upon:
(a)      the gross negligence or willful misconduct of Prothena or its Affiliates or its or their respective directors, officers, employees or agents, in connection with Prothena’s performance of its obligations under this Agreement; or
(b)      any breach by Prothena of any of its representations, warranties, covenants, agreements or obligations under this Agreement; or
(c)      any claim for personal injury or death arising out of the Development, Manufacture or Commercialization of any Collaboration Candidate or Collaboration Product by or on behalf of Prothena or its Affiliates;
in each case (a)-(c), provided, however, that such indemnity shall not apply to the extent Celgene has an indemnification obligation pursuant to Section 10.1(a) or (b) for such Third Party Damages.
10.3      Procedure . If a Party is seeking indemnification under Section 10.1 or 10.2, as applicable (the “ Indemnitee ”), it shall inform the other Party (the “ Indemnitor ”) of the claim giving rise to the obligation to indemnify pursuant to Section 10.1 or 10.2, as applicable, as soon as reasonably practicable after receiving notice of the claim (provided, however, any delay or failure to provide such notice shall not constitute a waiver or release of, or otherwise limit, the Indemnitee’s rights to indemnification under Section 10.1 or 10.2, as applicable, except to the extent that such delay or failure materially prejudices the Indemnitor’s ability to defend against the relevant claims). The Indemnitor shall have the right to assume the defense of any such claim for which the Indemnitee is seeking indemnification pursuant to Section 10.1 or 10.2, as applicable. The Indemnitee shall cooperate with the Indemnitor and the Indemnitor’s insurer as the Indemnitor may reasonably request, and at the Indemnitor’s cost and expense. The Indemnitee shall have the right to participate, at its own expense and with counsel of its choice, in the defense of any claim or suit that has been assumed by the Indemnitor. The Indemnitor shall not settle any claim without the prior written consent of the Indemnitee, not to be unreasonably withheld; provided, however, that the Indemnitor shall not be required to obtain such consent if the settlement (i) involves only the payment of money and will not result in the Indemnitee (or other Prothena Indemnitees or Celgene Indemnitees, as applicable) becoming subject to injunctive or other similar type of relief, (ii) does not require an admission by the Indemnitee (or other Prothena Indemnitees or Celgene Indemnitees, as applicable) and (iii) does not adversely affect the rights or licenses granted to the Indemnitee (or its Affiliate) under this Agreement (or under a U.S. Commercial License Agreement or a Global License Agreement). The Indemnitee shall not settle or compromise any such claim without the prior written consent of the Indemnitor, which it may provide in its sole discretion. If the Parties cannot agree as to the application of Section 10.1 or 10.2, as applicable, to any claim, pending resolution of the

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dispute pursuant to Section 12.7, the Parties may conduct separate defenses of such claims, with each Party retaining the right to claim indemnification from the other Party in accordance with Section 10.1 or 10.2, as applicable, upon resolution of the underlying claim. In each case, the Indemnitee shall reasonably cooperate with the Indemnitor, and shall make available to the Indemnitor all pertinent information under the control of the Indemnitee, which information shall be subject to Article 8.
10.4      Insurance . During the Term and for a period of [***] ([***]) years thereafter, each Party shall maintain, at its cost, a program of insurance and/or self-insurance against liability and other risks associated with its activities and obligations under this Agreement (including, with respect to its Clinical Trials), and its indemnification obligations hereunder, in such amounts, subject to such deductibles and on such terms as are customary for such Party for the activities to be conducted by it under this Agreement. It is understood that such insurance shall not be construed to create a limit on either Party’s liability with respect to its indemnification obligations under this Article 10, or otherwise.
10.5      LIMITATION OF LIABILITY . NEITHER PROTHENA NOR CELGENE, NOR ANY OF THEIR RESPECTIVE AFFILIATES, WILL BE LIABLE TO THE OTHER PARTY OR ITS AFFILIATES UNDER OR IN CONNECTION WITH THIS AGREEMENT FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL OR PUNITIVE OR EXEMPLARY DAMAGES (INCLUDING LOST PROFITS OR LOST REVENUES), WHETHER LIABILITY IS ASSERTED IN CONTRACT, TORT (INCLUDING NEGLIGENCE AND STRICT PRODUCT LIABILITY), INDEMNITY, CONTRIBUTION OR OTHERWISE, AND IRRESPECTIVE OF WHETHER THAT PARTY OR ANY REPRESENTATIVE OF THAT PARTY HAS BEEN ADVISED OF, OR OTHERWISE MIGHT HAVE ANTICIPATED THE POSSIBILITY OF, ANY SUCH LOSS OR DAMAGE. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 10.5 IS INTENDED TO OR SHALL LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER SECTIONS 10.1 OR 10.2 IN CONNECTION WITH ANY THIRD PARTY CLAIMS [***].
ARTICLE 11     
TERM AND TERMINATION
11.1      Term; Expiration . This Agreement shall become effective on the Effective Date and, unless earlier terminated in accordance with this Article 11, shall remain in effect until the last to occur of the following: (i) expiration of all IND Option Terms; (ii) expiration of all Phase 1 Option Terms, (iii) expiration of the Research Term and (iv) the end of any Participation Term Extension (the “ Term ”).
11.2      Termination for Breach .
11.2.1      Material Breach . This Agreement may be terminated by a Party (a) on a Program-by-Program basis prior to Celgene's exercise of its IND Option for such Program, for the material breach by the other Party of this Agreement with respect to such Program, or (b) on a Program-by-Program basis after Celgene's exercise of its IND Option for such Program, if a U.S. License Agreement or a Global License Agreement for such Program is terminated for material

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breach by the other Party; provided in each of (a) or (b) that the breaching Party has not cured such breach within ninety (90) days after the date of written notice to the breaching Party of such breach (or thirty (30) days in the case of a breach as a result of non-payment of any amounts due under this Agreement) (the “ Cure Period ”), which notice shall describe such breach in reasonable detail and shall state the non-breaching Party's intention to terminate this Agreement with respect to a given Program, pursuant to this Section 11.2.1 with respect to such Program. For clarity, the Cure Period for any allegation made as to a material breach under this Agreement with respect to a given Program, for events described in Sections 11.2.1(a) or (b) will run from the date that written notice was first provided to the breaching Party by the non-breaching Party. Any such termination of this Agreement with respect to a given Program, under this Section 11.2.1 shall become effective at the end of the Cure Period, unless the breaching Party has cured such breach prior to the expiration of such Cure Period, or, if such breach is not susceptible to cure within the Cure Period, then such Cure Period shall be extended for an additional [***] ([***]) days so long as the breaching Party [***]. For the avoidance of doubt, termination of any particular Program(s) pursuant to this Section 11.2.1 shall not terminate (i) this Agreement with respect to any other Program(s), or (ii) any U.S. License Agreement or Global License Agreement. The Parties understand and agree that [***].
11.2.2      Disagreement as to Material Breach . Notwithstanding Section 11.2.1, if the Parties in good faith disagree as to whether there has been a material breach of this Agreement pursuant to Section 11.2.1, then: (a) the Party that disputes that there has been a material breach may contest the allegation by referring such matter, within [***], for resolution to the Executive Officers, who shall meet promptly to discuss the matter and determine, within [***], whether or not a material breach has occurred pursuant to Section 11.2.1; provided that if the Executive Officers are unable to resolve such dispute within such [***] ([***]) [***] period after it is referred to them, the matter will be resolved as provided in Section 12.7; (b) the relevant Cure Period with respect thereto will be tolled from the date the breaching Party notifies the non-breaching Party of such dispute and through the resolution of such dispute in accordance with the applicable provisions of this Agreement; (c) during the pendency of such dispute, all of the terms and conditions of this Agreement shall remain in effect and the Parties shall continue to perform all of their respective obligations hereunder; and (d) if it is ultimately determined that the breaching Party committed such material breach, then the breaching Party shall have the right to cure such material breach, after such determination, within the Cure Period (as may be extended in accordance with Section 11.2.1) which shall commence as of the date of such determination.
11.3      Voluntary Termination . Celgene may terminate this Agreement at will, in its sole discretion, in its entirety or with respect to one or more Programs upon sixty (60) days’ prior written notice to Prothena at any time. For the avoidance of doubt, any such termination of any particular Program(s) pursuant to this Section 11.3 shall not terminate any other Program(s), and further provided that any such termination of this Agreement with respect to a Program shall only occur if any U.S. License Agreement or Global License Agreement in effect for such Program is also being terminated.
11.4      Termination for Bankruptcy . If either Party makes a general assignment for the benefit of, or an arrangement or composition generally with, its creditors, appoints or suffers appointment of an examiner or of a receiver or trustee over all or substantially all of its property,

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passes a resolution for its winding up or files a petition under any bankruptcy or insolvency act or law or has any such petition filed against it which is not dismissed, discharged, bonded or stayed within ninety (90) days after the filing thereof (each, an “ Insolvency Event ”), the other Party may terminate this Agreement in its entirety effective immediately upon written notice to such Party, provided that, in connection therewith, the provisions of Section 7.5 shall apply. Notwithstanding the foregoing, this Agreement may only be terminated in its entirety pursuant to this Section 11.4 in connection with the termination of all U.S. License Agreements and Global License Agreements.
11.5      Termination for Patent Challenge. Prothena shall have the right to terminate this Agreement upon written notice if Celgene or any Affiliate of Celgene challenges the validity, scope or enforceability of or otherwise opposes any Patent included in the Prothena IP that is licensed to Celgene under this Agreement, in each case through a formal proceeding (other than as may be necessary or reasonably required to assert a cross-claim or a counter-claim or to respond to a court request or order or administrative law, request or order). If a sublicensee of Celgene with respect to any Prothena IP challenges the validity, scope or enforceability of or otherwise opposes any Patent included in such Prothena IP under which such sublicensee is sublicensed, in each case through a formal proceeding (other than as may be necessary or reasonably required to assert a cross-claim or a counter-claim or to respond to a court request or order or administrative law, request or order), then Celgene shall, upon written notice from Prothena, terminate such sublicense.
11.6      Effects of Expiration or Termination .
11.6.1      Termination by Prothena Pursuant to Section 11.2, 11.4 or 11.5, or by Celgene Pursuant to Section 11.3 . In the event of termination of this Agreement in its entirety or in part with respect to any one or more Programs (i) by Celgene pursuant to Section 11.3 or (ii) by Prothena pursuant to Sections 11.2 or 11.4, upon the effective date of such termination:
(a)      except as set forth in Section 11.8, all rights (including all unexercised Options granted to Celgene hereunder) and licenses granted herein with respect to all terminated Programs shall terminate; provided, however, the licenses granted to Prothena in Section 7.2 for such Program shall continue;
(b)      any and all Collaboration Specific IP solely related to the terminated Programs shall thereafter no longer be deemed to be Collaboration Specific IP; and
(c)      each Party shall return or destroy all Confidential Information of the other Party with respect to the terminated Programs as required by Article 8.
11.6.2      Termination by Celgene Pursuant to Section 11.2 or 11.4 . In the event of termination of this Agreement in its entirety or in part with respect to any one or more Programs by Celgene pursuant to Section 11.2 or 11.4, upon the effective date of such termination:
(a)      except as set forth in Section 11.8, all rights (including all unexercised Options granted to Celgene hereunder) and licenses granted herein with respect to all terminated Programs shall terminate;

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(b)      any and all Collaboration Specific IP solely related to the terminated Programs shall thereafter no longer be deemed to be Collaboration Specific IP; and
(c)      each Party shall return or destroy all Confidential Information of the other Party with respect to the terminated Programs, as required by Article 8, except for any Celgene Phase 1 Program Know-How from such terminated Program that is licensed to Prothena under Section 7.2.
11.7      Certain Additional Remedies of Celgene in Lieu of Termination . In the event that (i) Celgene notifies Prothena in writing of a material breach of this Agreement by Prothena, either in its entirety or with respect to a given Program(s), and (ii) Celgene would have the right to terminate this Agreement in its entirety or with respect to a given Program(s), as applicable pursuant to Section 11.2, then in lieu of Celgene terminating pursuant to Section 11.2, and without limiting any other rights or remedies of Celgene, Celgene may elect to have this Agreement continue in full force and effect (in its entirety or with respect to the affected Program(s), as applicable) by providing written notice to Prothena, and, with respect to any Program(s) for which the applicable IND Option Term or Phase 1 Option Term, as applicable, has not yet expired, Celgene shall be entitled to (but shall not be required to), by written notice to Prothena (which election may be made by Celgene on a Program-by-Program basis):
(a)      [***]; and/or
(b)      [***];
provided that, in either such case or (a) and/or (b), without limiting any other rights or remedies of Celgene, any and all amounts thereafter payable by Celgene hereunder or under any U.S. License Agreement and any Global License Agreement (including milestones and royalties) with respect to any Programs for which Celgene made such election in (a) and/or (b) above, as applicable, shall be reduced by [***].
11.8      Surviving Provisions .
11.8.1      Accrued Rights; Remedies . Termination or expiration of this Agreement for any reason shall be without prejudice to any rights that shall have accrued to the benefit of any Party prior to such termination or expiration, and any and all damages or remedies (whether in law or in equity) arising from any breach hereunder, each of which shall survive termination or expiration of this Agreement. Such termination or expiration shall not relieve any Party from obligations which are expressly indicated to survive termination or expiration of this Agreement. Except as otherwise expressly set forth in this Agreement, the termination provisions of this Article 11 are in addition to any other relief and remedies available to either Party under this Agreement and at Applicable Law.
11.8.2      Survival . Without limiting the provisions of Section 11.8.1, the rights and obligations of the Parties set forth in the following Sections and Articles of this Agreement shall survive the expiration or termination of this Agreement, in addition to those other terms and conditions that are expressly stated to survive termination or expiration of this Agreement: Article 1 (to the extent the definitions are used in other surviving provisions), Section 2.2.5(a), Section

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2.4.1 (solely as to the second to last sentence therein), Section 2.4.2 (solely as to the last sentence therein), Section 2.5.3, Section 2.6.2-2.6.4, Section 2.8 (but only until the fifth (5 th ) anniversary after the termination or expiration of this Agreement), Section 2.9.1 (solely as to the last sentence therein), Section 2.9.2, Section 3.1.6, Section 3.2, Section 4.1.2, Section 4.3 (solely for the purposes of effectuating Section 6.7 of any U.S. License Agreement effective as of the termination or expiration of this Agreement), Section [***], Article 6 (as to payment obligations accrued prior to the effectiveness of termination or expiration of this Agreement), Section 7.1.2, Sections 7.2-7.6, Section 7.9 (solely if there is no U.S. License Agreement or Global License Agreement for the Program covering the applicable Joint Program Patents), Section 7.13, Article 8, Section 9.6, Article 10, Section 11.6, Section 11.7, Section 11.8, and Article 12.
11.8.3      Relationship to U.S. License Agreements and Global License Agreements . Termination of this Agreement in its entirety or with respect to a given Program shall not affect in any way the terms or provisions of any then-existing executed U.S. License Agreement (including any U.S. License Agreement for a terminated Program) or Global License Agreement (including any Global License Agreement for a terminated Program), and such U.S. License Agreement and Global License Agreement shall continue in full force and effect in accordance with its terms and conditions.
ARTICLE 12
MISCELLANEOUS
12.1      Severability . If any one or more of the terms or provisions of this Agreement is held by a court of competent jurisdiction to be void, invalid or unenforceable in any situation in any jurisdiction, such holding shall not affect the validity or enforceability of the remaining terms and provisions hereof or the validity or enforceability of the invalid, void or unenforceable term or provision in any other situation or in any other jurisdiction, and the term or provision shall be considered severed from this Agreement solely for such situation and solely in such jurisdiction, unless the invalid, void or unenforceable term or provision is of such essential importance to this Agreement that it is to be reasonably assumed that the Parties would not have entered into this Agreement without the invalid, void or unenforceable term or provision. If the final judgment of such court declares that any term or provision hereof is invalid, void or unenforceable, the Parties agree to (a) reduce the scope, duration, area or applicability of the term or provision or to delete specific words or phrases to the minimum extent necessary to cause such term or provision as so reduced or amended to be enforceable, and (b) make a good faith effort to replace any invalid, void or unenforceable term or provision with a valid and enforceable one such that the objectives contemplated by the Parties when entering this Agreement may be realized.
12.2      Notices . Any notice required or permitted to be given by this Agreement shall be in writing and in English and shall be (a) delivered by hand or by overnight courier with tracking capabilities, (b) mailed postage prepaid by first class, registered, or certified mail, or (c) delivered by facsimile followed by delivery via either of the methods set forth in Sections 12.2(a) and (b), in each case, addressed as set forth below unless changed by notice so given:

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If to Celgene:
Celgene Switzerland LLC
    AON House
30 Woodbourne Ave.
Pembroke HM 08, Bermuda
Attention:     [***]
    
With copies to:
Celgene Corporation
    86 Morris Avenue
    Summit, New Jersey 07901
U.S.A.
    Attention:    General Counsel
    Facsimile:    (908) 673-2771
    
If to Prothena:
Prothena Biosciences Limited    
Adelphi Plaza    
Upper George’s Street
Dun Laoghaire, Co. Dublin, A96 T927
Ireland        
Attention:     Company Secretary
    Facsimile:     +353-1-686-5675
With copies to:
Prothena Biosciences Inc
331 Oyster Point Boulevard
    South San Francisco, CA 94080
U.S.A.
    Attention:     Vice President, Business Development
    Facsimile:     +1 650-837-8560
Any such notice shall be deemed given on the date received, except any notice received after 5:30 p.m. (in the time zone of the receiving party) on a Business Day or received on a non-Business Day shall be deemed to have been received on the next Business Day. A Party may add, delete, or change the person or address to which notices should be sent at any time upon written notice delivered to the other Parties in accordance with this Section 12.2.
12.3      Force Majeure . A Party shall not be liable for delay or failure in the performance of any of its obligations hereunder if such delay or failure is due to a cause beyond the reasonable control of such Party, including acts of God, fires, earthquakes, acts of war, terrorism, or civil unrest, or hurricane or other inclement weather (“ Force Majeure ”); provided, however, that the affected

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Party promptly notifies the other Party and further provided that the affected Party shall use its commercially reasonable efforts to avoid or remove such causes of non-performance and to mitigate the effect of such occurrence, and shall continue performance in accordance with the terms of this Agreement whenever such causes are removed. When such circumstances arise, the Parties shall negotiate in good faith any modifications of the terms of this Agreement that may be necessary or appropriate in order to arrive at an equitable solution.
12.4      Assignment .
12.4.1      Generally . Except as expressly permitted herein, this Agreement may not be assigned or transferred by any Party, nor may any Party assign or transfer any rights or obligations created by this Agreement, except as expressly permitted hereunder without the prior written consent of the other Party, which consent will not be unreasonably withheld.
12.4.2      Celgene . Notwithstanding the limitations in Section 12.4.1, but subject to Section 6.4.2, Celgene may assign or transfer this Agreement, or any rights or obligations hereunder in whole or in part, to (a) one or more Affiliates (provided, however, that Celgene shall remain fully and unconditionally liable and responsible to the non-assigning Party hereto for the performance and observance of all such duties and obligations by such Affiliate); or (b) its successor in interest in connection with its merger, consolidation, or sale of all or substantially all of its assets or that portion of its business pertaining to the subject matter of this Agreement.
12.4.3      Prothena . Notwithstanding the limitations in Section 12.4.1, but subject to Section 6.4.2 and the remaining provisions of this Section 12.4.3, Prothena may assign or transfer this Agreement, or any rights or obligations hereunder in whole or in part, to (a) one or more Affiliates (provided, however, that a Party assigning to an Affiliate shall remain fully and unconditionally liable and responsible to the non-assigning Party hereto for the performance and observance of all such duties and obligations by such Affiliate); or (b) its successor in interest in connection with its merger, consolidation, or sale of all or substantially all of its assets.
12.4.4      Intellectual Property of Acquirer . Notwithstanding anything to the contrary in this Agreement, if a Party is acquired by a Third Party after the Effective Date, then with respect to any intellectual property rights controlled by the Third Party acquiring party or its affiliates (other than one of the Parties to this Agreement or its Affiliates immediately prior to such acquisition) involved in any assignment of this Agreement by such Party to such Third Party acquirer, such intellectual property rights shall not be included in the technology and intellectual property rights licensed to the other Party hereunder to the extent held immediately prior to such transaction by such acquirer or its affiliate (other than the relevant Party to this Agreement or its Affiliates immediately prior to such acquisition) and developed outside the scope of activities conducted with respect to the Collaboration, any Program, any U.S. License Agreement or any Global License Agreement. The Prothena IP shall also exclude any intellectual property developed by such Third Party acquirer after such acquisition; provided that (i) such intellectual property is developed independently of the activities under the Collaboration, any Program, any U.S. License Agreement or any Global License Agreement [***], (ii) Prothena and its Affiliates put in place firewalls and other protections to [***] and (iii) [***].

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12.4.5      All Other Assignments Null and Void . The terms of this Agreement will be binding upon and will inure to the benefit of the successors, heirs, administrators and permitted assigns of the applicable Party. Any purported assignment in violation of this Section 12.4 will be null and void ab initio .
12.5      Waivers and Modifications . The failure of any Party to insist on the performance of any obligation hereunder shall not be deemed to be a waiver of such obligation. Waiver of any breach of any provision hereof shall not be deemed to be a waiver of any other breach of such provision or any other provision on such occasion or any succeeding occasion. No waiver, modification, release, or amendment of any obligation under or provision of this Agreement shall be valid or effective unless in writing and signed by the Parties.
12.6      WAIVER OF JURY TRIA L. EXCEPT AS LIMITED BY APPLICABLE LAW, EACH PARTY HERETO HEREBY IRREVOCABLY WAIVES ALL RIGHT TO TRIAL BY JURY IN ANY ACTION, PROCEEDING OR COUNTERCLAIM (WHETHER BASED IN CONTRACT, TORT OR OTHERWISE) ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE ACTIONS OF ANY PARTY HERETO IN THE NEGOTIATION, ADMINISTRATION, PERFORMANCE AND ENFORCEMENT HEREOF.
12.7      Choice of Law; Dispute Resolution .
12.7.1      Choice of Law . This Agreement shall be governed by, enforced and construed in accordance with the laws of the State of New York and the patent laws of the United States without reference to any rules of conflict of laws or renvoi and excluding the United Nations Convention on Contracts for the International Sales of Goods; provided, however, that with respect to matters involving the validity or infringement of intellectual property rights in a given country, such matter may be brought in the applicable country (in accordance with Section 12.7.3) and the Applicable Laws of the applicable country shall apply (subject to Section 7.6.1).
12.7.2      Exclusive Dispute Resolution Mechanism . The Parties agree that the procedures set forth in Section 12.7.3 will be the exclusive mechanism for resolving any dispute (whether in contract, tort or otherwise), controversy or claim between the Parties arising out of or in connection with this Agreement, any Party’s rights or obligations under this Agreement, breach of this Agreement or the transactions contemplated by this Agreement (each, a “ Dispute ”); provided that decisions that are subject to the decision making authority of the JSC or a given Party, as expressly set forth in this Agreement, will not be subject to the provisions of Section 12.7.3 so long as such decisions are made in accordance with this Agreement.
12.7.3      Jurisdiction .
(a)      Except as otherwise set forth in this Section 12.7.3, the sole jurisdiction and venue for all actions, suits and proceedings arising out of any Dispute (except in respect of an Excluded Claim, where jurisdiction is non-exclusive) will be the state and federal courts located in the Borough of Manhattan in New York, New York, USA. Each Party hereby irrevocably and unconditionally (a) consents to submit to the exclusive jurisdiction of the state and federal courts located in the Borough of Manhattan in New York, New York, USA for any action,

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suit or proceeding arising out of such Dispute, and (b) waives any objection to the laying of venue of any action, suit or proceeding arising out of such Dispute in the state and federal courts of the Borough of Manhattan in New York, New York, USA and agrees not to plead or claim in any such court that any such action, suit or proceeding brought in any such court has been brought in an inconvenient forum. Each of the Parties agrees that process may be served upon it in the manner specified in Section 12.2 and irrevocably waives and covenants not to assert or plead any objection which it might otherwise have to such jurisdiction, or to such manner of service of process. It shall be a condition precedent to the commencement of any action in court or other tribunal (save an action for an interim injunction or provisional relief) in respect of any Dispute relating to this Agreement that the Parties have sought to resolve the Dispute by either Party notifying the other Party in writing for resolution to the Executive Officers who shall meet (whether in person or via teleconference) within [***] ([***]) [***] of such notice to seek resolution in good faith. If the Executive Officers are unable to resolve the Dispute at such meeting, either Party may pursue any remedy available to such Party at law or in equity, subject to the terms and conditions of this Agreement, including this Section 12.7.3.
(b)      Notwithstanding the provisions of Section 12.7.3(a), either Party may, without waiving any remedy under this Agreement, seek from any court having jurisdiction equitable relief, including any injunctive or provisional relief and specific performance to protect the rights or property of that Party. Such remedies will not be deemed to be the exclusive remedies for a breach of this Agreement but will be in addition to all other remedies available at law or equity. In addition, notwithstanding the provisions of Section 12.7.3(a) either Party may bring an action in any court having jurisdiction to enforce an award rendered pursuant to Section 12.7.3(a).
(c)      Until final resolution of the dispute through judicial determination, (i) this Agreement will remain in full force and effect and (ii) the time periods for cure as to any termination will be tolled. The Parties further agree that any payments made pursuant to this Agreement pending resolution of the dispute shall be refunded if a court determines that such payments are not due.
(d)      As used in this Section 12.7, the term “ Excluded Claim ” means a dispute, controversy or claim that concerns (i) the validity or infringement of a Patent, trademark or copyright, or (ii) any antitrust, anti-monopoly or competition law or regulation, whether or not statutory.
12.8      Relationship of the Parties . Prothena and Celgene are independent contractors under this Agreement. Nothing contained herein is intended or is to be construed so as to constitute (a) Prothena as a partner, agent, or joint venturer of Celgene or (b) Celgene as a partner, agent or joint venturer of Prothena. Neither Prothena nor Celgene, respectively, shall have any express or implied right or authority to assume or create any obligations on behalf of or in the name of Celgene or Prothena, respectively, or to bind Celgene or Prothena, respectively, to any contract, agreement, or undertaking with any Third Party.
12.9      No Third Party Beneficiaries . There are no express or implied Third Party beneficiaries hereunder. The provisions of this Agreement are for the exclusive benefit of the Parties,

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and no other person or entity shall have any right or claim against any Party by reason of these provisions or be entitled to enforce any of these provisions against any Party.
12.10      Entire Agreement . This Agreement, together with the attached Exhibits (including the form of U.S. License Agreement and the form of Global License Agreement) and Schedules, as well as any and all executed U.S. License Agreements and Global License Agreements, contains the entire agreement by the Parties with respect to the subject matter hereof and supersedes any prior express or implied agreements, understandings and representations, either oral or written, which may have related to the subject matter hereof in any way, including the Existing Confidentiality Agreement (as set forth in Section 8.11) and any and all term sheets relating to the transactions contemplated by this Agreement and exchanged between the Parties prior to the Effective Date . If a U.S. License Agreement is entered into with respect to a given Program, then to the extent there is a conflict between the provisions of this Agreement and the provisions of such U.S. License Agreement, the provisions of such U.S. License Agreement shall control with respect to such Program. If a Global License Agreement is entered into with respect to a given Program, then to the extent there is a conflict between the provisions of this Agreement (or the provisions of any prior U.S. License Agreement for such Program), the provisions of such Global License Agreement shall control with respect to such Program.
12.11      Counterparts . This Agreement may be executed in counterparts with the same effect as if both Parties had signed the same document. All such counterparts shall be deemed an original, shall be construed together, and shall constitute one and the same instrument. Any such counterpart, to the extent delivered by means of a fax machine or by .pdf, .tif, .gif, .jpeg or similar attachment to electronic mail (any such delivery, an “ Electronic Delivery ”) shall be treated in all manner and respects as an original executed counterpart and shall be considered to have the same binding legal effect as if it were the original signed version thereof delivered in person. No Party hereto shall raise the use of Electronic Delivery to deliver a signature or the fact that any signature or agreement or instrument was transmitted or communicated through the use of Electronic Delivery as a defense to the formation of a contract, and each Party forever waives any such defense, except to the extent that such defense relates to lack of authenticity.
12.12      Equitable Relief; Cumulative Remedies . Notwithstanding anything to the contrary herein, the Parties shall be entitled to seek equitable relief, including injunction and specific performance, as a remedy for any breach of this Agreement. Such remedies shall not be deemed to be the exclusive remedies for a breach of this Agreement but shall be in addition to all other remedies available at law or equity. The Parties further agree not to raise as a defense or objection to the request or granting of such relief that any breach of this Agreement is or would be compensable by an award of money damages. No remedy referred to in this Agreement is intended to be exclusive, but each shall be cumulative and in addition to any other remedy referred to in this Agreement or otherwise available under Applicable Law.
12.13      Interpretation .
12.13.1      Generally . This Agreement has been diligently reviewed by and negotiated by and among the Parties, and in such negotiations each of the Parties has been represented by competent (in house or external) counsel, and the final agreement contained herein, including

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the language whereby it has been expressed, represents the joint efforts of the Parties and their counsel. Accordingly, in interpreting this Agreement or any provision hereof, no presumption shall apply against any Party as being responsible for the wording or drafting of this Agreement or any such provision, and ambiguities, if any, in this Agreement shall not be construed against any Party, irrespective of which Party may be deemed to have authored the ambiguous provision.
12.13.2      Definitions; Interpretation . The definitions of the terms herein shall apply equally to the singular and plural forms of the terms defined and where a word or phrase is defined herein, each of its other grammatical forms shall have a corresponding meaning. Whenever the context may require, any pronoun shall include the corresponding masculine, feminine, and neuter forms. The word “will” shall be construed to have the same meaning and effect as the word “shall.” The word “any” shall mean “any and all” unless otherwise clearly indicated by context. The words “including,” “includes,” “include,” “for example,” and “e.g.” and words of similar import will be deemed to be followed by the words “without limitation.” The word “or” is disjunctive but not necessarily exclusive. The words “hereof,” “herein” and “herewith” and words of similar import shall, unless otherwise stated, be construed to refer to this Agreement as a whole and not to any particular provision of this Agreement. Unless the context requires otherwise or otherwise specifically provided, (i) all references herein to Articles, Sections, Schedules or Exhibits shall be construed to refer to Articles, Sections, Schedules and Exhibits of this Agreement and (ii) reference in any Section to any subclauses are references to such subclauses of such Section.
12.13.3      Subsequent Events . Unless the context requires otherwise, (i) any definition of or reference to any agreement, instrument, or other document herein shall be construed as referring to such agreement, instrument, or other document as from time to time amended, supplemented, or otherwise modified (subject to any restrictions on such amendments, supplements, or modifications set forth herein), (ii) any reference to any Applicable Law herein shall be construed as referring to such Applicable Law as from time to time enacted, repealed, or amended, and (iii) any reference herein to any Person shall be construed to include the Person’s successors and assigns (subject to Section 12.4).
12.13.4      Headings . Headings, captions and the table of contents are for convenience only and are not to be used in the interpretation of this Agreement.
12.13.5      Prior Drafts . No prior draft of this Agreement nor any course of performance or course of dealing shall be used in the interpretation or construction of this Agreement.
12.13.6      Independent Significance . Although the same or similar subject matters may be addressed in different provisions of this Agreement, the Parties intend that, except as reasonably apparent on the face of the Agreement or as expressly provided in this Agreement, each such provision shall be read separately, be given independent significance and not be construed as limiting any other provision of this Agreement (whether or not more general or more specific in scope, substance or content).
12.14      Further Assurances . Each Party shall execute, acknowledge and deliver such further instruments, and do all such other ministerial, administrative or similar acts, as may be reasonably

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necessary or appropriate in order to carry out the expressly stated purposes and the clear intent of this Agreement.
12.15      Extension to Affiliates . Subject to Sections 6.4.2 and 12.4, Celgene shall have the right to extend the rights, licenses, immunities and obligations granted in this Agreement to one or more of its Affiliates. All applicable terms and provisions of this Agreement shall apply to any such Affiliate to which this Agreement has been extended to the same extent as such terms and provisions apply to Celgene. Celgene shall remain fully liable for any acts or omissions of such Affiliates.
[Signature Page Follows]


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IN WITNESS WHEREOF, and intending to be legally bound hereby, the Parties have caused this MASTER COLLABORATION AGREEMENT to be executed by their respective duly authorized officers as of the Effective Date.




PROTHENA BIOSCIENCES LIMITED





CELGENE SWITZERLAND LLC
 
 
 
 
By: /s/ Yvonne Tchrakian    
By: /s/ Kevin Mello    
 
 
Name: Yvonne Tchrakian    
Name: Kevin Mello    
 
 
Title: Director    
Title: Manager    
 
 
 
 
 
 


[Signature Page to Master Collaboration Agreement]
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.



Schedule 1.14
Certain Existing Collaboration Candidates
1. Tau:
[***]
2. [***]
3. TDP-43:
[***]


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Schedule 1.42
In-License Agreements and Other Third Party Agreements
[***]

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.





Schedule 1.66
Certain Prothena Collaboration Patents
[***]


[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.



Schedule [***]
[***]
[***]


[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.



Exhibit A
Form of Global License Agreement
(See Attached)


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FINAL FORM





GLOBAL LICENSE AGREEMENT
 
by and among
 
 
PROTHENA BIOSCIENCES LIMITED
 
 
and
 
 
CELGENE SWITZERLAND LLC
 
 
Dated as of ___________ __, 20__







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TABLE OF CONTENTS 1  

LIST OF SCHEDULES 2  
SCHEDULE 1.27    EXISTING IND
SCHEDULE 1.28    EXISTING PROGRAM AGREEMENTS
SCHEDULE 1.39    IN-LICENSE AGREEMENTS AND OTHER THIRD PARTY
AGREEMENTS
SCHEDULE 1.44    LICENSED PROGRAM ANTIBODIES
SCHEDULE 1.46(b)    LICENSED PROGRAM PATENTS
SCHEDULE 1.48    LICENSED TARGET
SCHEDULE 1.63    PROTHENA LICENSED COLLABORATION PATENTS
SCHEDULE [***]    [***]
SCHEDULE 8.2    EXCEPTIONS TO PROTHENA REPRESENTATIONS AND
WARRANTIES
SCHEDULE 8.4    EXCEPTIONS TO CELGENE REPRESENTATIONS AND
WARRANTIES





















__________________________
1 To be inserted in final version.
2 All Schedules to be completed prior to execution of the Agreement.


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GLOBAL LICENSE AGREEMENT
This GLOBAL LICENSE AGREEMENT (this “ Agreement ”) is entered into and made effective as of __________ ___, 20__ (the “ Effective Date ”) by and between Prothena Biosciences Limited , an Irish limited company ( “ Prothena ”) and Celgene Switzerland LLC , a Delaware limited liability company (“ Celgene ”) 3 . Celgene and Prothena are each referred to herein by name or as a “ Party ” or, collectively, as the “ Parties ”.
RECITALS
WHEREAS , Prothena and Celgene entered into that certain Master Collaboration Agreement, dated as of March 20, 2018 (the “ Master Collaboration Agreement ”), pursuant to which, among other things, Prothena has conducted research and development programs with respect to certain targets (each, a “ Program ”) and Celgene has an exclusive option to obtain an exclusive license to research, develop, manufacture and commercialize Antibodies that Target such targets;
WHEREAS , pursuant to the terms of the Master Collaboration Agreement, upon exercise by Celgene of its Phase 1 Option (as defined in the Master Collaboration Agreement) with respect to a given Program, the Parties are obligated to enter into a Global License Agreement with respect to such Program;
WHEREAS , Celgene has exercised its Phase 1 Option (as defined in the Master Collaboration Agreement) with respect to the Licensed Program, and, as such, the Parties are entering into this Agreement pursuant to which, among other things, Prothena grants to Celgene exclusive rights and licenses with respect to the research, development, manufacture and commercialization of Licensed Antibodies and Licensed Products in the Territory, on the terms and subject to the conditions set forth herein; and
WHEREAS , Celgene and Prothena have previously entered into that certain U.S. License Agreement with respect to the Licensed Program (the “ Licensed Program U.S. License Agreement ”), and, pursuant to the terms of the Licensed Program U.S. License Agreement, such Licensed Program U.S. License Agreement automatically terminates upon entering into this Agreement, and the Parties intend for this Agreement to supersede the Licensed Program U.S. License Agreement.
NOW, THEREFORE , in consideration of the foregoing and the mutual agreements set forth below, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:
ARTICLE 1.
DEFINITIONS
Unless specifically set forth to the contrary herein, the following terms shall have the respective meanings set forth below. Capitalized terms used, but not defined, herein will have the meanings ascribed to them in the Master Collaboration Agreement.

3 [***]                        1

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1.1      Accounting Standards ” means U.S. generally accepted accounting principles (“ GAAP ”) or, to the extent that Celgene adopts International Financial Reporting Standards (“ IFRS ”), then “Accounting Standards” shall mean IFRS, in either case consistently applied.
1.2      Affiliate ” means any Person which, directly or indirectly through one or more intermediaries, controls, is controlled by or is under common control with a Party. For purposes of this definition, the term “control” (including, with correlative meanings, the terms “controlled by” and “under common control with”) as used with respect to a Person means (a) direct or indirect ownership of fifty percent (50%) or more of the voting securities or other voting interest of any Person (including attribution from related parties), or (b) the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of such Person, whether through ownership of voting securities, by contract, as a general partner, as a manager, or otherwise.
1.3      Annual Net Sales ” means, on a Licensed Product-by-Licensed Product basis, total Net Sales by Celgene, its Affiliates and Sublicensees in the Territory of such Licensed Product in a particular Calendar Year, calculated in accordance with Accounting Standards consistently applied.
1.4      Antibody ” means any [***] antibody (including [***]), [***] whether human, humanized, chimeric, murine, synthetic or from any other source.
1.5      Applicable Law ” or “ Applicable Laws ” means all applicable laws, statutes, rules, regulations, orders, judgments or ordinances having the effect of law of any national, multinational, federal, state, provincial, county, city or other political subdivision, including, to the extent applicable, GCP, GLP and GMP, as well as all applicable data protection and privacy laws, rules and regulations, including, to the extent applicable, the United States Department of Health and Human Services privacy rules under the Health Insurance Portability and Accountability Act (“ HIPAA ”) and the Health Information Technology for Economic and Clinical Health Act and the EU Data Protection Directive (Council Directive 95/46/EC) and applicable laws implementing the EU Data Protection Directive and, when in force, the General Data Protection Regulation (2016/679).
1.6      Biomarker ” means a parameter or characteristic in a patient or Patient Sample, the measurement of which is useful (a) for purposes of selecting appropriate therapies or patient populations or monitoring disease susceptibility, severity or state, or monitoring therapies for such patient and/or (b) for predicting the outcome of a particular treatment of such patient.
1.7      Biosimilar Application ” means an application or submission filed with a Regulatory Authority for marketing authorization of a Biosimilar Product.
1.8      “Biosimilar Product” means, with respect to a given Licensed Product, a biological product (a) that contains (i) an identical active ingredient(s) as the Licensed Antibody in such Licensed Product, or (ii) a “highly similar” active ingredient(s) to the Licensed Antibody in such Licensed Product, as the phrase “highly similar” is used in 42 U.S.C. § 262(i)(2), and subject to the factors set forth in FDA’s Guidance for Industry, “Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product,” (February 2012), at Section VI, or any successor FDA guidance thereto, (b) for which Regulatory Approval is obtained by referencing Regulatory

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Materials of such Licensed Product, (c) is approved for use in such country (or region) pursuant to a Regulatory Approval process governing approval of interchangeable or biosimilar biologics as described in 42 U.S.C. §§ 262, or a similar process for Regulatory Approval in any country (or region) outside the United States, or any other similar provision that comes into force, or is the subject of a notice with respect to such Licensed Product under 42 U.S.C. § 262(l)(2) or any other similar provision that comes into force in such country (or region), and (d) is sold in the same country as such Licensed Product by any Third Party that is not a Sublicensee of Celgene or its Affiliates with respect to the Prothena IP and did not purchase such product in a chain of distribution that included any of Celgene or any of its Affiliates or its Sublicensees.
1.9      BPCIA ” means Biologics Price Competition and Innovation Act of 2009, as amended.
1.10      Business Day ” means a day on which banking institutions in New York City, New York, are open for business, excluding any Saturday or Sunday.
1.11      Calendar Quarter ” means the period beginning on the Effective Date and ending on the last day of the calendar quarter in which the Effective Date falls, and thereafter each successive period of three (3) consecutive calendar months ending on the last day of March, June, September, or December, respectively; provided that the final Calendar Quarter shall end on the last day of the Term.
1.12      Calendar Year ” means the period beginning on the Effective Date and ending on December 31 of the calendar year in which the Effective Date falls, and thereafter each successive period of twelve (12) consecutive calendar months beginning on January 1 and ending on December 31; provided that the final Calendar Year shall end on the last day of the Term.
1.13      Celgene IP” means Patents and Know-How owned or otherwise controlled (through license or otherwise, but excluding through grant of a license from Prothena to Celgene pursuant to this Agreement) by Celgene or any of its Affiliates (including any Know-How that is created, conceived, discovered, first generated, invented, first made or first reduced to practice by or on behalf of Celgene or any of its Affiliates pursuant to the conduct of activities under this Agreement). For the avoidance of doubt, Celgene IP excludes (i) Know-How that is created, conceived, discovered, first generated, invented, first made or first reduced to practice by or on behalf of Prothena, solely or jointly with a Third Party; (ii) Joint Program IP (as defined under the Master Collaboration Agreement); (iii) [***], and (iv) Joint IP.
1.14      Change of Control ” in respect of a Person (an “ Acquired Person ”) shall be deemed to have occurred upon any of the following occurring after the Effective Date: (i) any Person or group of Persons that is not an Affiliate of such Acquired Person becomes the beneficial owner (directly or indirectly) of more than fifty percent (50%) of the voting shares; (ii) such Acquired Person consolidates with or merges into or with another Person that is not an Affiliate of such Acquired Person pursuant to a transaction in which more than fifty percent (50%) of the voting shares of the acquiring or resulting entity outstanding immediately after such consolidation or merger is not held by the holders of the outstanding voting shares of such Acquired Person immediately

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preceding such consolidation or merger; and/or (iii) that Acquired Person sells or transfers to another Person that is not an Affiliate of such Acquired Person all or substantially all of its assets.
1.15      Clinical Trial ” means a human clinical trial, including any Phase 1 Clinical Trial, Phase 2 Clinical Trial or Registration Enabling Clinical Trial, any study incorporating more than one of these phases, or any human clinical trial commenced after Regulatory Approval.
1.16      Commercialization ” means any and all activities directed to the commercialization of a product (which may include related diagnostic products, if applicable), including commercial manufacturing (including Manufacturing) and commercial supply of a product, marketing, detailing, promotion, market research, distributing, order processing, handling returns and recalls, booking sales, customer service, administering and commercially selling such product, importing, exporting and transporting such product for commercial sale, and seeking of pricing and reimbursement of a product (if applicable), whether before or after Regulatory Approval has been obtained (including making, having made, using, importing, selling and offering for sale such product (or related diagnostic product, if applicable)), as well all regulatory compliance with respect to the foregoing. For clarity, “Commercialization” does not include any Clinical Trial commenced after Regulatory Approval. When used as a verb, “ Commercialize ” means to engage in Commercialization.
1.17      Commercially Reasonable Efforts ” means, with respect to Celgene in relation to an obligation under this Agreement with respect to a Licensed Antibody or Licensed Product, such efforts that are consistent with the efforts and resources normally used by Celgene in the exercise of its commercially reasonable business practices relating to performance of an obligation for a similar pharmaceutical compound or product (including the research, development, manufacture and commercialization of a pharmaceutical compound or product), as applicable, at a similar stage in its research, development or commercial life as the relevant Licensed Antibody or Licensed Product, and that has commercial and market potential similar to the relevant Licensed Antibody or Licensed Product, taking into account issues of intellectual property coverage, safety and efficacy, stage of development, product profile, competitiveness of the marketplace, proprietary position, regulatory exclusivity, anticipated or approved labeling, present and future market and commercial potential, the likelihood of receipt of Regulatory Approval, profitability (including pricing and reimbursement status achieved or likely to be achieved), amounts payable to licensors of patents or other intellectual property rights, [***], and legal issues.
1.18      Confidential Information ” means, with respect to a Party, all confidential and proprietary information and materials, including Know-How, marketing plans, strategies, and customer lists, in each case, that are disclosed by or on behalf of such Party to the other Party pursuant to this Agreement, regardless of whether any of the foregoing are marked “confidential” or “proprietary” or communicated to the other Party by or on behalf of the disclosing Party in oral, written, visual, graphic or electronic form.
1.19      Control ”, “ Controls ” or “ Controlled ” means, with respect to any intellectual property (including Know-How) or Confidential Information, the ability of a Party or its Affiliates, as applicable, (whether through ownership or license (other than a license granted in this Agreement)) to grant to the other Party the licenses or sublicenses as provided herein, or to otherwise disclose such intellectual property or Confidential Information to the other Party, without violating

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the terms of any then-existing agreement with any Third Party at the time such Party or its Affiliates, as applicable, would be required hereunder to grant the other Party such license or sublicenses as provided herein or to otherwise disclose such intellectual property or Confidential Information to the other Party.
1.20      Cover ”, “ Covering ” or “ Covered ” means, with reference to a Patent claim, that such Patent has a Valid Claim that claims the [***], and that the sale of a Licensed Antibody (or product incorporating such Licensed Antibody) would infringe such Valid Claim in the country in which such activity occurs without a license thereto (or ownership thereof); provided, that with respect to method of use, such method of use is for an Indication for which Regulatory Approval has been received (as set forth on the approved labeling for the applicable Licensed Product incorporating such Licensed Antibody) for such Licensed Antibody in such country.
1.21      “Derivative” means, with respect to a Licensed Target, all [***] thereof.
1.22      Development ” means (i) research activities (including drug discovery, identification and/or synthesis) with respect to a product (which may include related diagnostic products, if applicable), and/or (ii) preclinical and clinical drug development activities, and other development activities, with respect to a product (which may include related diagnostic products, if applicable), including test method development and stability testing, toxicology, formulation, process development, qualification and validation, manufacture scale-up, development-stage manufacturing (including Manufacturing), quality assurance/quality control, Clinical Trials (including Clinical Trials and other studies commenced after Regulatory Approval), statistical analysis and report writing, the preparation and submission of INDs and MAAs, regulatory affairs with respect to the foregoing and all other activities necessary or useful or otherwise requested or required by a Regulatory Authority or as a condition or in support of obtaining or maintaining a Regulatory Approval. When used as a verb, “ Develop ” means to engage in Development.
1.23      Diagnostic Product ” means, on a Licensed Product-by-Licensed Product basis, any diagnostic product (which may include a Licensed Antibody or Licensed Product being used as a diagnostic product) which is necessary or reasonably useful (a) for the [***] in a patient or Patient Sample, and/or (b) to [***] in a patient or Patient Sample, and/or (c) to [***] to achieve improved safety or effectiveness, in each case of (a), (b) and (c), which is intended for use or is Developed or approved for use in connection with a therapeutic Licensed Antibody or Licensed Product (which may include [***]).
1.24      Dollars ” or “$” means the legal tender of the United States.
1.25      EU ” means all countries that are officially recognized as member states of the European Union at any particular time.
1.26      Executive Officers ” means Prothena’s Chief Executive Officer and Celgene’s Executive Vice President, Research and Early Development (or such Executive Vice President’s designee).

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1.27      Existing IND ” means the IND for the conduct of Phase 1 Clinical Trials under the Licensed Program as more particularly identified on Schedule 1.27 .
1.28      Existing Program Agreements ” means any agreement between Prothena (or its Affiliates, as applicable) and any Third Party solely related to the Development or Manufacture of any Licensed Antibodies or Licensed Products, in effect as of the Effective Date, as set forth on Schedule 1.28 .
1.29      Field ” means any and all uses or purposes, including the treatment, prophylaxis, palliation, diagnosis or prevention of any human or animal disease, disorder or condition.
1.30      First Commercial Sale ” means, on a Licensed Product-by-Licensed Product and country-by-country basis, the first sale of such Licensed Product in such country for use or consumption by the general public (following receipt of all Regulatory Approvals that are required in order to sell such Licensed Product in such country) and for which any of Celgene or its Affiliates or Sublicensees has invoiced sales of Licensed Products in the Territory; provided, however, that the following shall not constitute a First Commercial Sale: (a) any sale to an Affiliate or Sublicensee, unless the Affiliate or Sublicensee is the last Person in the distribution chain of the Licensed Product; or (b) any use of such Licensed Product in Clinical Trials or non-clinical development activities with respect to such Licensed Product by or on behalf of a Party, or disposal or transfer of such Licensed Product for a bona fide charitable purpose, compassionate use or samples.
1.31      Global License Agreement ” means each Global License Agreement entered into between the Parties (or their respective Affiliates, as applicable) pursuant to the Master Collaboration Agreement. When used in this Agreement, references to Global License Agreements are references to Global License Agreements other than this Agreement.
1.32      Good Clinical Practices ” or “ GCP ” means the applicable then-current ethical and scientific quality standards for designing, conducting, recording, and reporting trials that involve the participation of human subjects as are required by applicable Regulatory Authorities or Applicable Law in the relevant jurisdiction, including in the United States, Good Clinical Practices established through FDA guidances, and, outside the United States, Guidelines for Good Clinical Practice – ICH Harmonized Tripartite Guideline (ICH E6).
1.33      Good Laboratory Practices ” or “ GLP ” means the applicable then-current good laboratory practice standards as are required by applicable Regulatory Authorities or Applicable Law in the relevant jurisdiction, including in the United States, those promulgated or endorsed by the FDA in U.S. 21 C.F.R. Part 58, or the equivalent thereof as promulgated or endorsed by the applicable Regulatory Authorities outside of the United States.
1.34      Good Manufacturing Practices ” or “ GMP ” means all applicable standards relating to manufacturing practices for fine chemicals, intermediates, bulk products and/or finished pharmaceutical products, as are required by applicable Regulatory Authorities or Applicable Law in the relevant jurisdiction, including, as applicable, (a) all applicable requirements detailed in the FDA’s current Good Manufacturing Practices regulations, U.S. 21 C.F.R. Parts 210 and 211, (b) all applicable requirements detailed in the EMA’s “The Rules Governing Medicinal Products in the

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European Community, Volume IV, Good Manufacturing Practice for Medicinal Products”, and (c) all Applicable Laws promulgated by any Governmental Authority having jurisdiction over the manufacture of the applicable compound or pharmaceutical product, as applicable.
1.35      Governmental Authority ” means any (a) federal, state, local, municipal, foreign or other government, (b) governmental or quasi-governmental authority of any nature (including any governmental division, subdivision, department, agency, bureau, branch, office, commission, council, board, instrumentality, officer, official, representative, organization, unit, body or entity and any court or other tribunal), (c) multinational governmental organization or body or (d) entity or body exercising, or entitled to exercise, any executive, legislative, judicial, administrative, regulatory, police, military or taxing authority or power of any nature.
1.36      IND ” means an investigational new drug application (including any amendment or supplement thereto) submitted to the FDA pursuant to U.S. 21 C.F.R. Part 312, including any amendments thereto. References herein to IND shall include, to the extent applicable, any comparable filing(s) outside the U.S. for the investigation of any product in any other country or group of countries (such as a Clinical Trial Application in the EU).
1.37      Indication ” means an entirely separate and distinct disease or medical condition in humans (i) [***], and/or (ii) [***]. For clarity, (a) [***], (b) [***] and (c) [***].
1.38      Initiation ” means, with respect to a given Clinical Trial, the administration of the first dose of Licensed Product to the first properly enrolled subject in such Clinical Trial in accordance with the protocol for such Clinical Trial.
1.39      In-License Agreements ” means any agreement between Prothena (or its Affiliates, as applicable) and any Third Party pursuant to which such Third Party licenses to Prothena (or its Affiliates, as applicable) any Patents or Know-How included in the Prothena IP, including those set forth on Schedule 1.39 .
1.40      Know-How ” means all proprietary (a) information, techniques, technology, practices, trade secrets, inventions, methods (including methods of use or administration or dosing), knowledge, data, results and software and algorithms, including pharmacological, toxicological and clinical test data and results, compositions of matter, chemical structures and formulations, sequences, processes, formulae, techniques, research data, reports, standard operating procedures, batch records, manufacturing data, analytical and quality control data, analytical methods (including applicable reference standards), assays and research tools, in each case, whether patentable or not; and (b) tangible manifestations thereof, including any and all of the foregoing relating to Licensed Program Biological and Chemical Materials.
1.41      Licensed Antibody ” means (a) any Licensed Program Antibody and (b) any other Antibody that is a variant, fragment, derivative or other modification of a Licensed Program Antibody, that (i) Targets the Licensed Target, (ii) is made by or on behalf of Celgene or its Affiliates or Sublicensees during the Term in the course of its activities performed under this Agreement (or during the term of the Licensed Program U.S. License Agreement in the course of its activities performed thereunder) and (iii) is claimed (or was claimed in an issued Patent that has subsequently

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expired) as a composition of matter in a Licensed Program Patent set forth on Schedule 1.46(b) , a Prothena Licensed Collaboration Patent set forth on Schedule 1.63 , or Joint Program Patent (as defined in the Master Collaboration Agreement) as applicable, or any substitutions, divisionals, continuations, continuations-in-part, reissues, renewals, registrations, confirmations, re-examinations, extensions, supplementary protection certificates and the like of any such Licensed Program Patents, Prothena Licensed Collaboration Patents or Joint Program Patents (as defined in the Master Collaboration Agreement).
1.42      Licensed Product ” means any product that constitutes, incorporates, comprises or contains a Licensed Antibody, whether or not as the sole active ingredient, and in all forms, presentations, and formulations (including manner of delivery and dosage). For clarity, different forms, formulations, presentations or dosage strengths of a given Licensed Product that constitute, incorporate, comprise or contain the same Licensed Antibody shall be considered the same Licensed Product for purposes of this Agreement. Licensed Products shall include, in all cases, any Licensed Program Product.
1.43      Licensed Program ” means the Development program undertaken by or on behalf of Prothena pursuant to the Master Collaboration Agreement with respect to the Licensed Target.
1.44      Licensed Program Antibody ” means, with respect to the Licensed Program, (i) the Collaboration Candidates (as defined in the Master Collaboration Agreement) that Target the Licensed Target and that were Developed under such Licensed Program pursuant to the Master Collaboration Agreement, including those as set forth on Schedule 1.44 and (ii) all Related Antibodies with respect to any Antibody described in the foregoing clause (i) provided that such Related Antibodies are claimed (or were claimed in an issued Patent that has subsequently expired) as a composition of matter in a Licensed Program Patent set forth on Schedule 1.46(b) , a Prothena Licensed Collaboration Patent set forth on Schedule 1.63 , or a Joint Program Patent (as defined in the Master Collaboration Agreement) as applicable, or any substitutions, divisionals, continuations, continuations-in-part, reissues, renewals, registrations, confirmations, re-examinations, extensions, supplementary protection certificates and the like of any such Licensed Program Patents or Prothena Licensed Collaboration Patents. For the avoidance of doubt, Licensed Program Antibodies are included within the definition of Licensed Antibody.
1.45      Licensed Program Biological and Chemical Materials ” means, with respect to the Licensed Program, any and all compositions of matter, cells, cell lines, assays, animal models, imaging agents, Patient Samples, Biomarkers and any other physical, biological or chemical material, that are Controlled by Prothena or its Affiliates and [***], the Licensed Target or Licensed Program Antibodies (or the Development, Manufacture or Commercialization thereof), including physical embodiments of the Licensed Program Antibodies and any diagnostics related to such Licensed Program Antibodies, in each case, (i) created, conceived, discovered, first generated, invented, first made or first reduced to practice by or on behalf of Prothena or its Affiliates, whether solely or jointly with any Third Party, in such Licensed Program under the Master Collaboration Agreement or (ii) otherwise utilized by or on behalf of Prothena or its Affiliates in the Licensed Program under the Master Collaboration Agreement. To the extent the Licensed Program Biological and Chemical Materials were created, conceived, discovered, first generated, invented, first made

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or first reduced to practice under the Licensed Program under the Master Collaboration Agreement, such Licensed Program Biological and Chemical Materials shall be “Licensed Program Know-How” hereunder, and to the extent the Licensed Program Biological and Chemical Materials were not created, conceived, discovered, first generated, invented, first made or first reduced to practice under the Licensed Program under the Master Collaboration Agreement, but were otherwise utilized in the development of the Licensed Program under the Master Collaboration Agreement, such Licensed Program Biological and Chemical Materials shall be “Prothena Licensed Collaboration Know-How” hereunder.
1.46      Licensed Program IP ” means, collectively:
(a)      Licensed Program Know-How ” which means any and all Know-How that was created, conceived, discovered, first generated, invented, first made or first reduced to practice, in each case (i) by or on behalf of [***], (ii) by or on behalf of [***], or (iii) by or on behalf of [***]. For the avoidance of doubt, Licensed Program Know-How (i) includes ‘Program Know-How’ (as defined in the Master Collaboration Agreement) related to the Licensed Program but (ii) expressly excludes any Know-How created, conceived, discovered, first generated, invented, first made or first reduced to practice in the course of activities performed under this Agreement or the Licensed Program U.S. License Agreement, and any Joint Program Know-How (as defined in the Master Collaboration Agreement); and
(b)      Licensed Program Patents ” which means any Patents in the Territory Controlled by Prothena or its Affiliates that claim or cover any Licensed Program Know-How, including the Patents set forth on Schedule 1.46(b) . For the avoidance of doubt, Licensed Program Patents, include ‘Program Patents’ (as defined in the Master Collaboration Agreement) related to the Licensed Program, but expressly exclude Joint Program Patents (as defined in the Master Collaboration Agreement).
1.47      Licensed Program Product ” means, with respect to the Licensed Program, any product that constitutes, incorporates, comprises or contains a Licensed Program Antibody, whether or not as the sole active ingredient, and in all forms, presentations, and formulations (including manner of delivery and dosage). For clarity, different forms, formulations, presentations or dosage strengths of a given Licensed Program Product that constitutes, incorporates, comprises or contains the same Licensed Program Antibody shall be considered the same Licensed Program Product for purposes of this Agreement. For the avoidance of doubt, Licensed Program Products are included within the definition of Licensed Products.
1.48      Licensed Target ” means the target set forth on Schedule 1.48 , including Derivatives thereof.
1.49      Major Markets ” means the United Kingdom, France, Germany, Italy and Spain.
1.50      Manufacture ” means all activities related to the manufacturing of a product or diagnostic product or, in either case, any component or ingredient thereof, including test method development and stability testing, formulation, process development, manufacturing scale-up whether before or after Regulatory Approval, manufacturing any product or diagnostic product in bulk or finished form for Development or Commercialization (as applicable), including filling and finishing, packaging, labeling, shipping and holding, in-process and finished product testing, release of a product or diagnostic product or, in either case, any component or ingredient thereof, quality

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assurance and quality control activities related to manufacturing and release of a product or diagnostic product, and regulatory activities related to any of the foregoing.
1.51      Marketing Authorization Application ” or “ MAA ” means a Marketing Authorization Application, Biologics License Application or similar application, as applicable, and all amendments and supplements thereto, submitted to the FDA, or any equivalent filing in a country or regulatory jurisdiction other than the U.S. with the applicable Regulatory Authority, to obtain marketing approval for a pharmaceutical or diagnostic product, in a country or in a group of countries.
1.52      Net Sales ” means, in respect of a given Licensed Product, the total [***] amounts [***] for all sales of such Licensed Product in the Territory for use in the Field by Celgene, its Affiliates or Sublicensees to Third Party customers (including to distributors), less the following deductions [***] so as to arrive at “net sales” under Accounting Standards as reported by Celgene, its Affiliates or Sublicensees, as applicable, in such Person’s financial statements:
(a)      [***];
(b)      [***];
(c)      [***];
(d)      [***]; and
(e)      [***].
There shall be no double counting in determining the foregoing deductions from gross amounts invoiced to calculate Net Sales. The calculations set forth in this definition of “Net Sales” shall be determined in accordance with Accounting Standards.
Sales or other transfers between Celgene and its Affiliates or Sublicensees, as well as any transfers or dispositions of any Licensed Products for (i) [***], (ii) [***], (iii) [***] or (iv) [***], in each case, shall be excluded from the computation of Net Sales.
The calculations set forth in this section shall be determined in accordance with Accounting Standards. If any Licensed Product is, or is sold as part of, a Combination Product, Net Sales shall be calculated assuming that the gross sale price of each unit is equal to the product of (i) Net Sales of the Combination Product calculated as above ( i.e. , calculated as for a non-Combination Product), and (ii) the fraction [***], where:
[***]
For purposes of this definition, “ Combination Product ” means any pharmaceutical product that (a) contains two or more active ingredients, including both (1) a Licensed Antibody and (2) one or more other compounds (which may be Antibodies) but that are not a Licensed Antibody, either as a fixed dose product, co-formulated product or co-packaged product, and sold for a single price, and (b) is Developed or Commercialized, alone or together with a Third Party, by Celgene or any

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of its Affiliates or Sublicensees. Any vehicles, adjuvants and excipients used in conjunction with any Licensed Antibody shall not be treated as active ingredients for the purposes of this definition.
1.53      Patents ” means (a) all patents and patent applications in any country or supranational jurisdiction worldwide, (b) any substitutions, divisionals, continuations, continuations-in-part, reissues, renewals, registrations, confirmations, re-examinations, extensions, supplementary protection certificates and the like of any such patents or patent applications, and (c) foreign counterparts of any of the foregoing.
1.54      Patient Sample ” means tissue, fluid, or cells collected from a patient, or components of the foregoing.
1.55      Person ” means any individual, partnership, joint venture, limited liability company, corporation, firm, trust, association, unincorporated organization, governmental authority or agency, or any other entity not specifically listed herein.
1.56      Phase 1 Clinical Trial ” means a human clinical trial of a product that would satisfy the requirements of U.S. 21 C.F.R. Part 312.21(a) (as amended), or a similar clinical study prescribed by the Regulatory Authorities in a foreign country, and is intended to (a) determine the safety, pharmacokinetics and pharmacodynamic parameters in healthy individuals or patients, and (b) following the foregoing clause (a), further evaluate safety and pharmacokinetics (including exploration of trends of a biomarker-based or clinical endpoint-based efficacy relationship to dose which need not be designed to be statistically significant) of the product, whether or not in combination with concomitant treatment and which provides sufficient evidence of safety to be included in filings for a Phase 2 Clinical Trial or a Registration Enabling Clinical Trial with Regulatory Authorities.
1.57      Phase 1 Option Exercise Fee ” shall mean the Phase 1 Option Exercise Fee (as defined in the Master Collaboration Agreement) for the Licensed Program.
1.58      Phase 2 Clinical Trial ” means a human clinical trial of a product that would satisfy the requirements of U.S. 21 C.F.R. Part 312.21(b), as amended, and is intended to explore a variety of doses, dose response, and duration of effect, and to generate evidence of clinical safety and effectiveness for a particular Indication or Indications in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.
1.59      Prosecution and Maintenance ” or “ Prosecute and Maintain ” means, with regard to a Patent, the preparation, filing, prosecution and maintenance of such Patent, as well as re-examinations, reissues, appeals, and requests for patent term adjustments and patent term extensions with respect to such Patent, together with the initiation or defense of interferences, oppositions, inter partes review, derivations, re-examinations, post-grant proceedings and other similar proceedings (or other defense proceedings with respect to such Patent, but excluding the defense of challenges to such Patent as a counterclaim in an infringement proceeding) with respect to the particular Patent, and any appeals therefrom. For clarification, “Prosecution and Maintenance” or

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“Prosecute and Maintain” shall not include any other enforcement actions taken with respect to a Patent.
1.60      Prothena IP ” means the Prothena Licensed Collaboration Patents, the Prothena Licensed Collaboration Know-How, the Licensed Program Patents and the Licensed Program Know-How, as well as Prothena’s (and its Affiliates’) right, title and interest in and to the Joint IP and any Joint Program IP (as defined under the Master Collaboration Agreement).
1.61      Prothena Licensed Collaboration IP ” means all Prothena Licensed Collaboration Know-How and Prothena Licensed Collaboration Patents
1.62      Prothena Licensed Collaboration Know-How ” means any and all Know-How that is Controlled by Prothena or its Affiliates on or after the Effective Date that (a) is necessary or [***] to research, develop, make, have made, import, use, offer to sell, sell or otherwise exploit any Licensed Target, Licensed Program Antibody or Licensed Program Product or (b) is or was [***], including (i) any diagnostics related to any such Licensed Program Antibody or Licensed Program Product and (ii) Know-How conceived, created, discovered, first generated, invented, first made or first reduced to practice by or on behalf of a Prothena or its Affiliates, whether solely or jointly with any Third Party, in the course of activities performed under this Agreement; but expressly excluding Joint Know-How, Joint Program Know-How (as defined in the Master Collaboration Agreement) and Licensed Program Know-How.
1.63      Prothena Licensed Collaboration Patents ” means any and all Patents in the Territory that are Controlled by Prothena or its Affiliates on or after the Effective Date that claim or cover (a) any Licensed Target, any Licensed Program Antibody or any Licensed Program Product, or the research, development, making, having made, import, use, offering to sell, selling or other exploitation of any of the foregoing, or (b) any Prothena Licensed Collaboration Know-How; but expressly excluding Joint Patents, Joint Program Patents (as defined in the Master Collaboration Agreement) and Licensed Program Patents. Prothena Licensed Collaboration Patents shall include the Patents set forth on Schedule 1.63 .
1.64      Prothena Platform Patent ” means a Patent within the Prothena Licensed Collaboration Patents that [***] claims the Prothena Platform Technology.
1.65      “[***]” means [***], which shall [***]; but in any case excluding [***].
1.66      Registration Enabling Clinical Trial ” means (a) a human clinical trial of a product that would satisfy the requirements of U.S. 21 C.F.R. Part 312.21(c), as amended, and is intended to (i) establish that the product is safe and efficacious for its intended use, (ii) define contraindications, warnings, precautions and adverse reactions that are associated with the product in the dosage range to be prescribed, and (iii) support Regulatory Approval for such product, or (b) a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.
1.67      Regulatory Approval ” means all approvals, licenses and authorizations of the applicable Regulatory Authority necessary for the marketing and sale of a pharmaceutical or

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diagnostic product for a particular Indication in a country or region (including separate pricing or reimbursement approvals, as necessary), and including the approvals by the applicable Regulatory Authority of any expansion or modification of the label for such Indication.
1.68      Regulatory Authority ” means any national or supranational Governmental Authority, including the U.S. Food and Drug Administration (and any successor entity thereto) (the “ FDA ”) in the U.S., the European Medicines Agency (and any successor entity thereto) (the “ EMA ”) in the EU and the Ministry of Health, Labour and Welfare of Japan, or the Pharmaceuticals and Medical Devices Agency of Japan (or any successor to either of them) as the case may be (the “ MHLW ”) in Japan, or any health regulatory authority in any country or region that is a counterpart to the foregoing agencies, in each case, that holds responsibility for development and commercialization of, and the granting of Regulatory Approval for, a pharmaceutical or diagnostic product, as applicable, in such country or region.
1.69      Regulatory-Based Exclusivity ” means, on a Licensed Product-by-Licensed Product and country-by-country basis, that Celgene or any of its Affiliates or Sublicensees has been granted the exclusive legal right by a Regulatory Authority in such country to market and sell the Licensed Product in such country, in each case, such that market exclusivity is maintained for Celgene (or its Affiliate or Sublicensee, as applicable) in such country with respect to such Licensed Product as a result of such grant by such Regulatory Authority.
1.70      Regulatory Materials ” means the regulatory registrations, applications, authorizations and approvals (including approvals of MAAs, supplements and amendments, pre- and post-approvals, pricing and reimbursement approvals, and labeling approvals), Regulatory Approvals and other submissions made to or with any Regulatory Authority for research, development (including the conduct of Clinical Trials), manufacture, or commercialization of a pharmaceutical or diagnostic product in a regulatory jurisdiction, together with all related correspondence to or from any Regulatory Authority and all documents referenced in the complete regulatory chronology for each MAA, including all Drug Master Files (if any), INDs and supplemental biologics license applications (sBLAs) and foreign equivalents of any of the foregoing. The Regulatory Materials shall include the Existing IND.
1.71      Related Antibody ” means, with respect to a given Antibody, any (a) [***] or (b) [***], and in each case of (a) and (b), that [***].
1.72      Royalty Term ” means, on a Licensed Product-by-Licensed Product and country-by-country basis, the period of time commencing on the First Commercial Sale of such Licensed Product in such country of sale and expiring upon the latest of (a) the first date on which there is no Valid Claim of a Patent within the Licensed Program Patents, Prothena Licensed Collaboration Patents or Joint Program Patents (as defined in the Master Collaboration Agreement), in each case, that Covers such Licensed Product in such country of sale, (b) the expiration of Regulatory-Based Exclusivity for such Licensed Product in such country of sale and (c) the [***] ([***]) year anniversary of the date of First Commercial Sale of such Licensed Product in such country of sale.
1.73      Select Indication ” means each of the following separate and distinct Indications: [***] such other Indications as the Parties may mutually agree in writing to be expressly included

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as a “Select Indication” for purposes of this Agreement; provided that such indication is identified as an approved use for the applicable Licensed Product in the approved label for such Licensed Product in the applicable country.
1.74      Sublicensee ” means, with respect to Celgene, a Third Party to whom Celgene has granted a sublicense, either directly or indirectly, under the Prothena IP licensed to Celgene by Prothena pursuant to this Agreement, to Develop, Manufacture and/or Commercialize Licensed Antibodies and Licensed Products in the Field in the Territory, but excluding any Third Party acting as a distributor and excluding Prothena and its Affiliates.
1.75      Target” means, with respect to a given Antibody and the Licensed Target, that such Antibody [***]. For the purposes of the “Target” definition, “[***]” means [***]. 4
1.76      Territory ” means worldwide.
1.77      Third Party ” means any Person other than Prothena or Celgene that is not an Affiliate of Prothena or of Celgene.
1.78      Third Party Claim ” means any and all suits, claims, actions, proceedings or demands brought by a Third Party.
1.79      Third Party Damages ” means all losses, costs, claims, damages, judgments, liabilities and expenses payable to a Third Party by a Party (or the Prothena Indemnitees or Celgene Indemnitees, as applicable) under a Third Party Claim (including reasonable attorneys’ fees and other reasonable out-of-pocket costs of litigation in connection therewith).
1.80      United States ” or “ U.S. ” means the United States of America and all of its territories and possessions.
1.81      U.S. License Agreement ” shall mean each U.S. License Agreement entered into between the Parties (or their respective Affiliates, as applicable) pursuant to the Master Collaboration Agreement.
1.82      Valid Claim ” means a claim of a Patent within the Licensed Program Patents, Prothena Licensed Collaboration Patents, or Joint Program Patents (as defined in the Master Collaboration Agreement) in the Territory that has issued and has not expired, lapsed, been cancelled or abandoned, or been dedicated to the public, disclaimed, or held unenforceable, invalid, revoked or cancelled by a court or administrative agency of competent jurisdiction in an order or decision from which no appeal has been or can be taken, including through opposition, reexamination, reissue, disclaimer, inter partes review, post grant procedures or similar proceedings [***].
1.83      Additional Definitions . Each of the following terms has the meaning described in the corresponding section of this Agreement indicated below:
Definition:
Section:
Acquired Person
1.14

4 [***] For the purposes of the “Target” definition, “[ ***] ” means [***]
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Definition:
Section:
Active Immunotherapeutic Approaches
4.2.1
Agreement
Preamble
Celgene
Preamble
Celgene Acquired Competing Antibody
4.5.2
Celgene Exclusivity Term
4.5.1
Celgene Indemnitees
9.2
Celgene Proposed Terms
4.2.2
Celgene Share
6.8.4
Celgene Third Party Payments
5.3.4
Combination Product
1.52
Competing Antibody
4.5.1
Competing Compound
4.1
Cure Period
10.2.1
Disclosing Party
7.1
Dispute
11.7.2
Electronic Delivery
11.11
Effective Date
Preamble
EMA
1.68
Excluded Claim
11.7.3(d)
Existing Regulatory Materials
2.2.1
FDA
1.68
[***]
[***]
Force Majeure
11.3
GAAP
1.1
Grant
4.2.2
Grant Notice
4.2.2
HIPAA
1.5
IFRS
1.1
Indemnitee
9.3
Indemnitor
9.3
Indirect Taxes
5.6.2(b)
Insolvency Event
10.4
Joint IP
6.6.4
Joint Know-How
6.6.4
Joint Patent
6.6.4
Licensed Program Assets
2.4
Licensed Program Confidential Information
7.11
Licensed Program Inventory
2.3.4
Licensed Program Know-How
1.46(a)
Licensed Program Non-Specific IP
7.2
Licensed Program Patents
1.46(b)

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Definition:
Section:
Licensed Program Specific IP
7.2
Licensed Program U.S. License Agreement
Recitals
Master Collaboration Agreement
Recitals
MHLW
1.68
Negotiation Period
4.2.2
[***]
[***]
Notice Period
4.2.2
Ongoing Clinical Trial
2.1.3(a)
Ongoing Prothena Development Activities
2.1.3(c)
Party or Parties
Preamble
Patent Liaison
6.7
Payee Party
5.6.2(b)
Paying Party
5.6.2(b)
Per Licensed Product Annual Net Sales
5.3.1
Program
Recitals
Prothena
Preamble
Prothena Acquired Competing Compound
4.4
Prothena Indemnitees
9.1
Prothena Licensor
8.3.3
Prothena Ongoing Program Activities
2.1.3(d)
Prothena Reversion Antibodies
10.8.1
Publishing Party
7.8.1
Receiving Party
7.1
Regulatory Milestone Payment
5.4.1
Right of First Negotiation
4.2.2
Sales Milestone Payment
5.5.1
SEC
7.4.1(a)
Securities Regulators
7.6
Tax Benefit
5.6.2(c)
Term
10.1.1
Transition Plan
2.3.6

ARTICLE 2.     
DEVELOPMENT, MANUFACTURE AND COMMERCIALIZATION
2.1     Development, Manufacturing and Commercialization .
2.1.1     General . From and after the Effective Date, and subject to the terms and conditions of this Agreement, (i) Celgene will have the sole right (and shall solely control, at its discretion), itself and/or with or through its Affiliates, Sublicensees or other Third Parties, to Develop, Manufacture and Commercialize Licensed Antibodies and Licensed Products in the Field in the Territory, and (ii) Prothena and its Affiliates shall not have any right to, and shall not, conduct

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any Development, Manufacture or Commercialization of any Licensed Antibodies or Licensed Products in the Field in the Territory.
2.1.2     Diligence . From and after the Effective Date, and subject to the terms and conditions of this Agreement, Celgene, itself and/or with or through its Affiliates, Sublicensees or other Third Parties, will use Commercially Reasonable Efforts to (i) [***], and (ii) [***].
2.1.3     Prothena Activities in Support of Licensed Program . Notwithstanding the provisions of Section 2.1.1, as and to the extent requested by Celgene in writing, Prothena shall conduct the following activities as reasonably directed by Celgene:
(a)     Ongoing Clinical Trials . If any Clinical Trial(s) that were being conducted by or on behalf of Prothena under the Licensed Program pursuant to the Master Collaboration Agreement have not been completed as of the Effective Date (an “ Ongoing Clinical Trial ”), then, at Celgene’s written election, Prothena will, at its expense, either wind-down and terminate such Ongoing Clinical Trial or continue to perform such Ongoing Clinical Trial. In the event Celgene elects that an Ongoing Clinical Trial should be wound-down and terminated, Prothena shall cause such Ongoing Clinical Trial to be wound-down and terminated promptly. In the event that Celgene elects the Ongoing Clinical Trial to continue, then Prothena shall continue to be responsible for the performance of, and shall continue to perform, such Ongoing Clinical Trial in accordance with (i) the Research Plan (as defined in the Master Collaboration Agreement) as in existence as of the Effective Date, (ii) the terms of the applicable Clinical Trial protocol as in existence as of the Effective Date (as may be amended as required by Applicable Law and applicable guidance issued from time to time by the by the relevant Regulatory Authority) and (iii) otherwise in accordance with the reasonable directions of Celgene, until completion of such Clinical Trial. In such case, the performance of such Clinical Trial by or on behalf of Prothena shall continue to be governed by the terms and conditions of the Master Collaboration Agreement as if the Licensed Program were continuing under the Master Collaboration Agreement solely with respect to such Ongoing Clinical Trial, mutatis mutandis (including that Know-How conceived, created, discovered, first generated, invented, first made or first reduced to practice, by or on behalf of Prothena or its Affiliates, whether solely or jointly with any Third Party, pursuant to the conduct of such Ongoing Clinical Trial, shall be Licensed Program Know-How hereunder); provided that, notwithstanding the provisions of the Master Collaboration Agreement, Celgene shall have the right to make decisions and determinations with respect to the conduct of such Ongoing Clinical Trial, and Prothena shall comply with all such reasonable decisions and determinations, provided that Celgene consults with and reasonably considers Prothena’s comments with respect thereto prior to making any such decision or determination. In addition, Celgene shall have the right, at any time, to notify Prothena to cease performance of an Ongoing Clinical Trial, and in such case, Prothena shall immediately wind-down any such Ongoing Clinical Trial.
(b)     Transition Supply . If Prothena was supplying (or having supplied) any Licensed Antibody and/or Licensed Product for any Clinical Trial(s) or other Development activities conducted with respect to the Licensed Program under the Master Collaboration Agreement, then, at Celgene’s written request, Prothena will be responsible for supplying, and shall supply, to Celgene (or its designee) Licensed Antibody(ies) and/or Licensed Product(s), for use in

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Development by or on behalf of Celgene hereunder for a period not to exceed [***] ([***]) [***] (or such longer period of time as agreed to by the Parties), as and to the extent requested by Celgene; provided that Celgene shall pay to Prothena a reasonable, fair value cost for such supply, which cost shall be negotiated in good faith and agreed to by the Parties prior to such supply. In such case, at the request of Celgene, the Parties shall negotiate in good faith and enter into an appropriate supply agreement (including a quality agreement) for Prothena to supply (or have supplied) Licensed Antibody and/or Licensed Product, as applicable, to Celgene (or its designee). Notwithstanding the foregoing, if Prothena has engaged a Third Party contract manufacturer for the supply of Licensed Antibodies and/or Licensed Products, and the agreement with such Third Party prohibits the supply to Celgene in accordance with the foregoing (provided that Prothena used good faith efforts not to include such prohibition during negotiations), then in lieu of the foregoing supply obligation, Prothena shall take such actions as reasonably requested by Celgene to facilitate the negotiations between Celgene and Prothena’s Third Party contract manufacturer of an appropriate supply agreement (including a quality agreement) for the supply of Licensed Antibody and/or Licensed Product, as applicable, to Celgene (or its designee).
(c)     Other Continuing Development Activities . Without limiting the other obligations of Prothena hereunder (including as set forth in this Section 2.1.3), in the event that the Parties mutually agree in writing that Prothena or its Affiliates will conduct any other specific Development activities for Celgene after the Effective Date with respect to the Licensed Program (in addition to those set forth in the foregoing provisions of this Section 2.1.3) (the “ Ongoing Prothena Development Activities ”), then, in such case, the Parties shall negotiate in good faith and enter into a separate services agreement pursuant to which Prothena (or its Affiliates, as applicable) shall perform such Ongoing Prothena Development Activities.
(d)     Prothena Ongoing Program Activities . Prothena’s obligations as set forth in this Section 2.1.3, as applicable, are the “ Prothena Ongoing Program Activities ”.
2.1.4     Celgene Progress Updates . During the Term until such time as Celgene has submitted a MAA for at least one Licensed Product in the United States and at least one country in the EU (or through centralized EU filing) for a Select Indication, Celgene and Prothena shall meet at least [***] to discuss the progress of Celgene’s material Development and Commercialization activities with respect to Licensed Products pursuant to this Agreement. Such meeting shall be either in person or telephonically as agreed to by the Parties. In addition, during the Term until such time as Celgene has submitted an MAA for at least one Licensed Product in the United States or at least one country in the EU (or through centralized EU filing) for a Select Indication, at least [***] (or more frequently as agreed to by the Parties), Celgene shall submit to Prothena a written report summarizing the progress of Celgene’s material Development and Commercialization activities with respect to Licensed Products pursuant to this Agreement since the last report.
2.1.5     JSC . For the avoidance of doubt, the JSC (as defined in the Master Collaboration Agreement) and each Subcommittee (as defined in the Master Collaboration Agreement) shall no longer oversee or review any of the matters under this Agreement, and shall have no decision-making authority in connection therewith.
2.2     Regulatory .

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2.2.1     Transfer of Existing Regulatory Materials . Subject to Section 2.2.2, Prothena shall assign and transfer (and hereby does assign and transfer), or cause to be assigned and transferred to the extent not owned by Prothena, to Celgene (or its designee), promptly (but in all cases within [***] ([***]) days) after the Effective Date any and all Regulatory Materials (including the Existing IND) for any Licensed Antibodies and/or Licensed Products held or generated by or on behalf of Prothena or its Affiliates (the “ Existing Regulatory Materials ”), including providing true, accurate and complete hard and electronic copies thereof to Celgene. Thereafter Celgene (or its designee) shall have the sole right, in its discretion, to file, maintain and hold title to, all Existing Regulatory Materials. Notwithstanding the foregoing, at the election of Celgene, Celgene may notify Prothena in writing that it does not desire to take assignment and transfer of certain Regulatory Materials (as so determined by Celgene) and in such case, Prothena shall not assign or transfer to Celgene (or its designee) such designated Regulatory Materials.
2.2.2     Prothena Ownership for Ongoing Clinical Trials . Notwithstanding the foregoing Section 2.2.1, in the event Prothena continues to be responsible for the performance of an Ongoing Clinical Trial pursuant to and in accordance with Section 2.1.3(a), Prothena will retain ownership of any Existing Regulatory Materials (including the Existing IND) for the corresponding Licensed Antibodies and Licensed Products related to such Ongoing Clinical Trial until completion of such Ongoing Clinical Trial, following which, the provisions of Section 2.2.1 shall apply with respect to such Existing Regulatory Materials.
2.2.3     Safety Information . Celgene shall have the right to report all safety information to Regulatory Authorities with respect to the Licensed Antibodies and/or Licensed Products in the Territory hereunder, provided that Prothena shall also have such right with respect to safety data arising from any Ongoing Clinical Trial prior to the transfer of Existing Regulatory Materials to Celgene pursuant to Section 2.2.2.
2.2.4     Right of Reference; Access to Data . Pending such time as the Existing Regulatory Materials are transferred and assigned to Celgene (or its designee), or in the event of failure to transfer and assign any Existing Regulatory Materials to Celgene (or its designee), as required by Section 2.2.1 or 2.2.2 (as applicable), Celgene (and its designees) shall have, and Prothena (on behalf of itself and its Affiliates) hereby grants to Celgene (and its designees), access and a right of reference (without any further action required on the part of Prothena or its Affiliates, whose authorization to file this consent with any Regulatory Authority is hereby granted) to all such Existing Regulatory Materials and all data contained or referenced in any Existing Regulatory Materials for Celgene (and its designees) to exercise its rights and perform its obligations hereunder. In all cases, Celgene (and its designees) shall have access to all data contained or referenced in any Existing Regulatory Materials, and Prothena shall ensure that Celgene (and its designees) are afforded such access.
2.2.5     Regulatory Matters . In the event that Celgene determines that any regulatory filings for any Licensed Antibodies and/or Licensed Products are required for any activities hereunder, including INDs, MAAs and other Regulatory Approvals (as applicable), then Celgene (or its designee) shall have the sole right, in its discretion, to seek to obtain and maintain such regulatory filings (in its or its designee’s name). In addition, Celgene (or its designee) shall have

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the sole right to communicate and otherwise interact with Regulatory Authorities with respect to the Licensed Antibodies and/or Licensed Products, including with respect to any Regulatory Materials in connection therewith. Prothena (and its Affiliates) shall have no right to, and shall not, make any regulatory filings related to any Licensed Antibodies and/or Licensed Products or otherwise interact with any Regulatory Authorities with respect to the Licensed Antibodies and/or Licensed Products; provided that, as and to the extent reasonably requested by Celgene in writing, Prothena shall interact with Regulatory Authorities in connection with Licensed Antibodies and/or Licensed Products with respect to matters related to the Licensed Program activities conducted by or on behalf of Prothena under the Master Collaboration Agreement or with respect to any Prothena Ongoing Program Activities. Notwithstanding the foregoing, until such time as a given Existing Regulatory Material is assigned and transferred to Celgene in accordance with Section 2.2.1 or 2.2.2 (as applicable), Prothena shall be responsible for all communications and interactions with Regulatory Authorities with respect to such Existing Regulatory Material; provided that, in connection with any such activities by Prothena, Prothena shall, to the extent reasonably requested by Celgene, consult and coordinate with Celgene with respect thereto (including allowing Celgene to attend or participate in any meetings or other interactions with Regulatory Authorities to the extent such attendance is not prohibited or limited by such Regulatory Authority) and Prothena shall accommodate and comply with any reasonable requests made by Celgene in connection therewith (including that Prothena shall submit to Celgene a copy of any proposed filings and correspondence with any Regulatory Authority for Celgene’s review and approval prior to submission thereof). At the request of Celgene, Prothena shall reasonably assist Celgene in communications and filings with Regulatory Authorities with respect to the Licensed Antibodies and/or Licensed Products.
2.2.6     Pharmacovigilance . At the written request of Celgene, within [***] ([***]) days after such request, Prothena and Celgene (or its designee(s)) will enter into a pharmacovigilance agreement in order to, among other things, coordinate safety matters and share of safety information with respect to Licensed Products.
2.3     Assistance; Technology Transfer .
2.3.1     General . Prothena shall (and shall cause its Affiliates to) cooperate with Celgene (and its designees) and provide reasonable assistance to Celgene (and its designees) to enable Celgene (and its designees) to Develop, Manufacture and Commercialize Licensed Antibodies and Licensed Products, as and to the extent requested reasonably by Celgene, including (i) conducting a technology transfer to Celgene with respect to the Licensed Program Know-How and Prothena Licensed Collaboration Know-How, (ii) providing Celgene (and its designees) reasonable assistance with respect to regulatory and Manufacturing transition matters related to Licensed Antibodies and Licensed Products and (iii) providing Celgene (and its designees) with reasonable access by teleconference or in-person (as requested by Celgene) to Prothena personnel (and personnel of its Affiliates and Third Party contractors) involved in the Development or Manufacture of Licensed Antibodies and Licensed Products to assist with the transition and answer questions related to Licensed Antibodies, Licensed Products and Diagnostic Products.
2.3.2     Additional Specific Transition Assistance . Without limiting the provisions of Section 2.3, as soon as reasonably practicable following the Effective Date (but in all cases,

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within [***] ([***]) days after the Effective Date or such other period of time as agreed to by the Parties), and thereafter during the Term as may be reasonably requested by Celgene from time to time, Prothena shall (i) disclose to Celgene (and its designees) in English (including by providing hard and electronic copies thereof) all Licensed Program Know-How and Prothena Licensed Collaboration Know-How, including any materials and documentation (including data and protocols) included therein and any other physical embodiments thereof, (ii) transfer to Celgene (and its designees) all Licensed Program Biological and Chemical Materials, as well as [***] and Celgene and its designees shall have the full right to utilize all of the foregoing in connection with the Development, Manufacture or Commercialization of Licensed Antibodies and Licensed Products, and (iii) assist Celgene (and its designees) in responding to regulatory inquiries with respect to Licensed Program Antibodies and Licensed Program Products.
2.3.3     Manufacturing Technology Transfer . Without limiting the provisions of Sections 2.3 and 2.3.2, as soon as reasonably practicable following the Effective Date (but in all cases, within [***] ([***]) days after the Effective Date or such other period of time as agreed to by the Parties), Prothena shall transfer, and thereafter continue, during the Term as may be reasonably requested by Celgene from time to time, the transfer (from Prothena, its Affiliates or its Third Party contract manufacturers) to Celgene (and its designees), copies in English (in writing and in an electronic format) of all data, information and other Know-How in the Control of Prothena or its Affiliates ([***]) that is related to the Manufacture of any Licensed Antibodies or Licensed Products, in order to enable Celgene (and its designees) to Manufacture the Licensed Antibodies and Licensed Products, including to replicate the process employed by or on behalf of Prothena to Manufacture any Licensed Antibodies and Licensed Products. Such transfer shall include all [***]. In addition, at the reasonable request of Celgene from time to time, Prothena shall make its employees and consultants (including personnel of its Affiliates and Third Party contract manufacturers) available to Celgene (and its designees) to provide reasonable consultation and technical assistance in order to ensure an orderly transition of the manufacturing technology and operations to Celgene (and its designees) and to assist Celgene (and its designees) in its Manufacture of any Licensed Antibodies and Licensed Products.
2.3.4     Inventory Transfer . At the written request of Celgene, Prothena shall promptly assign and transfer to Celgene (or its designee) and deliver to Celgene (or its designee) (at a location to be specified by Celgene to Prothena), any or all (as and to the extent requested by Celgene) inventory of Licensed Antibodies and Licensed Products held by or on behalf of Prothena or its Affiliates as of the Effective Date (including any such inventory held at any contract manufacturer or any other location); provided that Celgene shall pay to Prothena a reasonable, fair value cost for such transferred inventory, which cost shall be negotiated in good faith and agreed to by the Parties prior to such transfer (the “ Licensed Program Inventory ”).
2.3.5     Assignment of Certain Existing Agreements .
(a)    At the written request of Celgene, Prothena shall (or shall cause its Affiliates to, as applicable), to the extent legally permissible (provided that, to the extent consent is required from the relevant counterparty, Prothena shall (or shall cause its Affiliates to, as applicable) use reasonable efforts to obtain such consent) (i) assign to Celgene (or its designee) any

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or all (as designated by Celgene) Existing Program Agreements and/or (ii) assist Celgene (or its Affiliate) in entering into new agreements directly with the counterparties to the Existing Program Agreements to cover the subject matter of such Existing Program Agreements, as applicable, in each case of (i) and/or (ii), as and to the extent requested by Celgene in writing. If any Existing Program Agreement is assigned to Celgene, Prothena shall be solely responsible for, and shall indemnify and hold harmless Celgene and all other Celgene Indemnitees from and against any costs and other Third Party Damages arising from, or relating to, any such Existing Program Agreement as a result of, or in connection with, events or occurrences prior to the date of such assignment (including, for clarity, any payments that accrued prior to the date of such assignment, but which do not become payable until after the date of such assignment).
(b)    [***].
2.3.6     Transition Plan . In order to facilitate the transition as set forth in this Section 2.3, at the request of Celgene, the Parties shall work together in good faith and establish a transition plan setting forth certain additional reasonable transition activities to be undertaken by or on behalf of Prothena in order to fully transition the Development, Manufacture and Commercialization of Licensed Antibodies and Licensed Products to Celgene (and its designees) (the “ Transition Plan ”). Once established, Prothena shall use commercially reasonable efforts to [***] perform its activities under the Transition Plan.
2.4     Covenant . Except as otherwise expressly permitted under this Agreement, commencing on the Effective Date until the end of the Term, Prothena shall not and shall cause its Affiliates not to (a) assign, transfer, convey, encumber(through a lien, charge, security interest, mortgage or similar encumbrance) or dispose of, or enter into any agreement with any Third Party to assign, transfer, convey, encumber (through a lien, charge, security interest, mortgage or similar encumbrance) or dispose of, any [***] (collectively, the “ Licensed Program Assets ”), except to the extent such assignment, transfer, conveyance, encumbrance or disposition would not conflict with, be inconsistent with or adversely affect in any respect any of the rights or licenses granted to Celgene hereunder, (b) license or grant to any Third Party, or agree to license or grant to any Third Party, any rights to any Licensed Program Assets if such license or grant could conflict with, be inconsistent with or adversely affect in any respect any of the rights or licenses granted to Celgene hereunder, or (c) [***] the Licensed Program Assets to any Third Party if such [***] could impair or conflict in any respect with any of the rights or licenses granted to Celgene hereunder.
2.5     Other Antibodies and Products Developed by Celgene . Notwithstanding anything to the contrary contained herein, if Celgene (or any of its Affiliates), alone or with any Third Party, determines to Develop, Manufacture or Commercialize any Antibodies (or any product containing an Antibody), other than Licensed Antibodies or Licensed Products, then Celgene may do so in its sole discretion, without any obligations to Prothena with respect thereto, and Prothena shall have no rights in connection therewith, provided that Celgene’s or its Affiliates’ conduct of any such activities shall not modify or obviate Celgene’s obligations under this Agreement.
2.6     Licensed Program U.S. License Agreement . The Parties hereby agree and acknowledge that this Agreement supersedes the Licensed Program U.S. License Agreement in its

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entirety and any activities conducted under the Licensed Program U.S. License Agreement shall be deemed to have been conducted under this Agreement.
ARTICLE 3.     
ANTITRUST AND COMPETITION LAW COMPLIANCE
3.1     Antitrust Compliance . For the avoidance of doubt, the Parties shall continue to comply with Section 3.2 of the Master Collaboration Agreement, and such provisions shall apply to this Agreement as if set forth directly herein, mutatis mutandis .
ARTICLE 4.     
EXCLUSIVITY
4.1     Prothena Exclusivity . During the Term, Prothena shall not and shall ensure that its Affiliates shall not, anywhere in the world: (i) alone or with or through any Third Party, research [***], Develop, Manufacture or Commercialize (a) the Licensed Target or any Competing Compound, or (b) any diagnostic product intended for use, or Developed or approved for use with, the Licensed Target (including any diagnostic product intended for use, or Developed or approved for use with, any Competing Compound), in each case, other than Prothena’s performance of the Prothena Ongoing Program Activities (including engaging its Affiliates or Third Party subcontractors to perform the Prothena Ongoing Program Activities in accordance with this Agreement) as specifically set forth in Section 2.1.3; (ii) grant a license, sublicense or other rights to any Third Party to conduct any of the activities in the foregoing clause (i), other than Prothena’s performance of the Prothena Ongoing Program Activities (including engaging its Affiliates or Third Party subcontractors to perform the Prothena Ongoing Program Activities in accordance with this Agreement) as specifically set forth in Section 2.1.3; or (iii) transfer, assign, convey or otherwise sell (a) any Competing Compound or any diagnostic product intended for use, or (b) Developed or approved for use with, the Licensed Target (including any diagnostic product intended for use, or Developed or approved for use with any Competing Compound). As used herein, the term “ Competing Compound ” means [***].
4.2     Prothena Exception for Active Immunotherapeutic Approaches .
4.2.1     Exception for Active Immunotherapeutic Approaches . Notwithstanding the provisions of Section 4.1, but subject to the provisions of Section 4.2.2, Prothena and its Affiliates (themselves, but not with or through any Third Parties) may conduct research, development, manufacture and commercialization of Active Immunotherapeutic Approaches outside of this Agreement; provided that no Licensed Antibodies or Licensed Products are utilized in the conduct of any such activities (including no use of a Licensed Antibody or Licensed Product for an Active Immunotherapeutic Approach). As used herein, “ Active Immunotherapeutic Approaches ” means [***].
4.2.2     Celgene Right of First Negotiation . During the Term, in the event that [***] with respect to [***] will [***]. [***] will [***] (a “[***]”). If [***], [***] will [***] which [***] will [***]. If [***], the Parties will [***]. Until [***] or the [***], as applicable, [***]. If [***] that it [***], then [***]. For the avoidance of doubt, this Section 4.2.2 [***] For clarity, [***].

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4.3     Master Collaboration Agreement . For the avoidance of doubt, the provisions of Article 5 of the Master Collaboration Agreement shall not limit in any way the provisions of this Article 4.
4.4     Exceptions for Change of Control . Notwithstanding the provisions of Section 4.1, if following the Effective Date, Prothena undergoes a Change of Control with a Third Party who (itself or through any of its affiliates existing prior to the date of the Change of Control) owns or has rights to a Competing Compound (but excluding any Licensed Antibody or Licensed Product) that is in ongoing clinical development or being commercialized by such Third Party (or its affiliate) as of the date of the Change of Control (a “ Prothena Acquired Competing Compound ”), then Prothena (including the acquiring Person in the Change of Control (and such acquiring Person’s affiliates)) shall not be in breach of the provisions of Section 4.1 as a result of [***]; provided that (i) such activities are conducted independently of the activities of this Agreement and without use of any Prothena IP ([***]) and (ii) no personnel who are conducting any activities pursuant to this Agreement (or have conducted activities pursuant to the Master Collaboration Agreement) are involved in the conduct of such activities with respect to the Prothena Acquired Competing Compound.
4.5     Celgene Exclusivity .
4.5.1     Celgene Exclusivity . During the period from the Effective Date until [***] (the “ Celgene Exclusivity Term ”), neither Celgene nor its Affiliates will, anywhere in the world, alone or with or through any Third Party, either (a) sell any Competing Antibody that has an approved label for treatment of an Indication for which Celgene or its Affiliates has conducted a Registration Enabling Clinical Trial for a Licensed Product hereunder (as set forth in the protocol for such Registration Enabling Clinical Trial) or (b) conduct a Registration Enabling Clinical Trial for any Competing Antibody for treatment of an Indication (as set forth in the protocol for such Registration Enabling Clinical Trial) for which Celgene has conducted a Registration Enabling Clinical Trial for a Licensed Product hereunder (as set forth in the protocol for such Registration Enabling Clinical Trial) (provided that, for the avoidance of doubt, this Section 4.5.1 shall not prohibit (i) use of an Competing Antibody as a comparator in a Registration Enabling Clinical Trial or (ii) Celgene or any of its Affiliates providing proprietary products (that are not Competing Antibodies) to a Third Party for such Third Party’s use in a clinical trial of Competing Antibodies), in each case of (a) and (b), other than Celgene’s exercise of its rights and performance of its obligations with respect to Licensed Antibodies and Licensed Products pursuant to this Agreement (including engaging Third Party subcontractors to perform the such rights and obligations in accordance with this Agreement). As used herein, the term “ Competing Antibody ” means [***].
4.5.2     Exceptions for Change of Control . Notwithstanding the provisions of Section 4.5.1, if during the Celgene Exclusivity Term, Celgene (or any of its Affiliates) undergoes a Change of Control with a Third Party who (itself or through any of its affiliates existing prior to the date of the Change of Control) owns or has rights to a Competing Antibody (but excluding any Licensed Antibody or Licensed Product) that is in ongoing clinical development or being commercialized by such Third Party (or its affiliate) as of the date of the Change of Control (a “ Celgene Acquired Competing Antibody ”), then Celgene and its Affiliates (including the acquiring Person in the

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Change of Control (and such acquiring Person’s affiliates)) shall not be in breach of the provisions of Section 4.5.1 as a result of [***]; provided that (i) such activities are conducted independently of the activities of this Agreement and without use of any Prothena IP ([***]) and (ii) no personnel who are conducting any Registration Enabling Clinical Trial activities pursuant to this Agreement are involved in the conduct of Registration Enabling Clinical Trial activities with respect to the Celgene Acquired Competing Antibody.
ARTICLE 5.     
FINANCIAL TERMS
5.1     Option Exercise Fee . Subject to Section 3.2 of the Master Collaboration Agreement, the Parties acknowledge and agree that Celgene will pay the Phase 1 Option Exercise Fee (as defined in the Master Collaboration Agreement) for the Licensed Program in accordance with the Master Collaboration Agreement.
5.2     Reimbursement of Certain CMC Expenses . Subject to Section 3.2 of the Master Collaboration Agreement, Celgene will reimburse Prothena for the reasonable, documented and verifiable out-of-pocket costs that were incurred by Prothena under the Master Collaboration Agreement, after the End of Phase 1 Date (as defined in the Master Collaboration Agreement) for the Licensed Program but prior to the Effective Date of this Agreement, for chemistry, manufacturing and controls (CMC) activities conducted by Prothena specifically for preparation for any Registration Enabling Clinical Trials of Licensed Product; provided that (a) such amounts and such activities were approved in writing in advance by Celgene prior to Prothena undertaken such activities and (b) in all cases, Celgene shall not be obligated to reimburse Prothena for any such amounts in excess of $[***] ([***]). Subject to Section 3.2 of the Master Collaboration Agreement, Prothena shall promptly after the Effective Date issue an invoice to Celgene for the amounts set forth in this Section 5.2, and Celgene shall pay to Prothena the undisputed portion of such invoice within [***] ([***]) days after receipt of such invoice.
5.3     Royalties .
5.3.1     Licensed Product Royalties . Subject to the terms of this Section 5.3 (and subject further to Section 5.6), Celgene shall pay Prothena royalties on Annual Net Sales, on a Licensed Product-by-Licensed Product basis during the applicable Royalty Term, equal to the following portions of Annual Net Sales of the applicable Licensed Product multiplied by the applicable royalty rate set forth below for such portion of Annual Net Sales during the applicable Royalty Term for each such Licensed Product, which royalties shall be paid in accordance with Section 5.3.7 (the “ Per Licensed Product Annual Net Sales ”). For clarity, the royalties (and royalty tiers) shall be calculated separately on a Licensed Product-by-Licensed Product basis.

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Per Licensed Product Annual Net Sales for a Given Licensed Product in a Given Calendar Year
Royalty Rate
Portion of Per Licensed Product Annual Net Sales of a given Licensed Product in a given Calendar Year above [***]
[***]%
Portion of Per Licensed Product Annual Net Sales of a given Licensed Product in a given Calendar Year above [***]
[***]%
Portion of Per Licensed Product Annual Net Sales of a given Licensed Product in a given Calendar Year above [***]
[***]%
Portion of Per Licensed Product Annual Net Sales of a given Licensed Product in a given Calendar Year above [***]
[***]%
Portion of Per Licensed Product Annual Net Sales of a given Licensed Product in a given Calendar Year above [***]
[***]%
Portion of Per Licensed Product Annual Net Sales of a given Licensed Product in a given Calendar Year above [***]
[***]%
Portion of Per Licensed Product Annual Net Sales of a given Licensed Product in a given Calendar Year above [***]
[***]%
Portion of Per Licensed Product Annual Net Sales of a given Licensed Product in a given Calendar Year above [***]
[***]%
Portion of Per Licensed Product Annual Net Sales of a given Licensed Product in a given Calendar Year above [***]
[***]%
Portion of Per Licensed Product Annual Net Sales of a given Licensed Product in a given Calendar Year above [***]
[***]%

The applicable royalty rate set forth in the table above will apply only to that portion of the Per Licensed Product Annual Net Sales of a given Licensed Product during a given Calendar Year that falls within the indicated range. For clarity, (i) if no royalty is payable on a given unit of Licensed Product (e.g., following the Royalty Term for such Licensed Product in a given country), then the Net Sales of such unit of Licensed Product shall not be included for purposes of determining the royalties or royalty tiers and (ii) Net Sales of a given Licensed Product will not be combined with Net Sales of any other Licensed Product for purposes of determining the foregoing royalties or royalty tiers. Only one royalty shall be payable by Celgene to Prothena for each sale of a Licensed Product.
By way of example, if Per Licensed Product Annual Net Sales of a given Licensed Product by Celgene, its Affiliates and Sublicensees were $[***] for a given Calendar Year, then the royalties payable with respect to such Per Licensed Product Annual Net Sales for such Licensed Product for such Calendar Year, subject to adjustment as set forth in this Section 5.3, would be: [***].

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5.3.2     Royalty Term . Celgene’s royalty obligations to Prothena under Section 5.3.1 shall apply on a Licensed Product-by-Licensed Product and country-by-country basis only during the applicable Royalty Term for such Licensed Product in such country. Following expiration of the applicable Royalty Term for a given Licensed Product in a given country, as applicable, no further royalties will be payable in respect of sales of such Licensed Product in such country and thereafter the license granted to Celgene hereunder with respect to such Licensed Product in such country will automatically become fully paid-up, perpetual, irrevocable and royalty-free.
5.3.3     Reductions .
(a)     Reductions for No Valid Claim . The royalty amounts payable with respect to Per Licensed Product Annual Net Sales shall be reduced on a Licensed Product-by-Licensed Product and country-by-country basis, to [***] percent ([***]%) of the amounts otherwise payable pursuant to Section 5.3.1 during any portion of the applicable Royalty Term in which both: (i) [***] and (ii) [***].
(b)     Royalty Reduction for Biosimilar Product . If, on a Licensed Product-by-Licensed Product and country-by-country and Calendar Quarter-by-Calendar Quarter basis,
(i)    [***]; or
(ii)    [***];
then the royalties payable with respect to Per Licensed Product Annual Net Sales of such Licensed Product pursuant to Section 5.3.1 in such country during such Calendar Quarter shall be reduced to [***], of the royalties otherwise payable pursuant to Section 5.3.1. [***].
5.3.4     Royalty Offset for Third Party Payments . If Celgene (or any of its Affiliates or Sublicensees) obtains a right or license under intellectual property of a Third Party (whether prior to, or after, the Effective Date), where the research, development, making, using, selling, offering for sale, or importing of any Licensed Product (or any Licensed Antibody contained in such Licensed Product) by or on behalf of Celgene (or any of its Affiliates or Sublicensees) would result in a payment to such Third Party, then Celgene may deduct from the royalty payments that would otherwise have been due under Section 5.3.1 with respect to Per Licensed Product Annual Net Sales in a particular Calendar Quarter, an amount equal to [***] percent ([***]%) of [***] (“ Celgene Third Party Payments ”) during such Calendar Quarter. Notwithstanding the foregoing, in no event shall the royalties payable on Per Licensed Product Annual Net Sales be reduced by more than [***] percent ([***]%) in any Calendar Quarter by operation of this Section 5.3.4; [***].
5.3.5     Cumulative Effect of Royalty Reductions and Offsets . In no event shall the royalty reductions or offsets described in Sections 5.3.3(a), 5.3.3(b) and 5.3.4, alone or together, reduce the royalties payable by Celgene for a given Calendar Quarter pursuant to Section 5.3.1 to less than [***] percent ([***]%) of the amounts otherwise payable by Celgene for a given Calendar Quarter pursuant to Section 5.3.1. [***]

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5.3.6     Compulsory Licenses . If a compulsory license is granted to a Third Party with respect to a Licensed Product in any country in the Territory with a royalty rate lower than the royalty rate provided by Section 5.3.1 (as adjusted pursuant to Section 5.3.3), then the royalty rate to be paid by Celgene on Per Licensed Product Annual Net Sales in such country under Section 5.3.1 shall be reduced [***].
5.3.7     Payment of Royalties . Celgene shall: (a) within [***] ([***]) days following the end of each Calendar Quarter in which a royalty payment pursuant to Section 5.3.1 accrues, provide to Prothena a report specifying for such Calendar Quarter (i) the number of Licensed Products sold that are subject to such royalty, (ii) the Per Licensed Product Annual Net Sales that are subject to such royalty, (iii) the applicable royalty rate under this Agreement, (iv) the royalty calculation and royalties payable in U.S. Dollars and (v) any reduction to the royalty applied by Celgene pursuant to any one or more of Sections 5.3.3 and 5.3.4; and (b) make the royalty payments owed to Prothena hereunder in accordance with such royalty report in arrears, within [***] ([***]) days from the end of the Calendar Quarter in which such payment accrues.
5.4     Regulatory Milestones.
5.4.1     Regulatory Milestones . Subject to the terms of this Section 5.4 (and subject further to Section 5.6), Celgene will notify Prothena within [***] ([***]) days following the first achievement by Celgene under this Agreement and after the Effective Date of each milestone event described below in this Section 5.4 with respect to the first (and only the first) Licensed Product to achieve such milestone event under this Agreement, and Celgene shall thereafter pay the applicable amounts set forth below associated with the applicable milestone event in accordance with Section 5.4.2 (each, a “ Regulatory Milestone Payment ”):

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Regulatory Approval Milestone Event
Regulatory Milestone Payment
1.    Receipt under this Agreement of all Regulatory Approvals for a Licensed Product for the first Select Indication in the U.S. issued by the FDA; [***]    (the “ First U.S. Approval Milestone ”)

[***] Dollars ($[***])
2.    Receipt under this Agreement of all Regulatory Approvals for a Licensed Product for the first Select Indication in the EU issued by the EMA; [***]
[***] Dollars ($[***])
3.    Receipt under this Agreement of all Regulatory Approvals for a Licensed Product for the first Select Indication in Japan issued by the MHLW; [***]
[***] Dollars ($[***])
4.    Receipt under this Agreement of all Regulatory Approvals for a Licensed Product for a second Select Indication [***] in the U.S. issued by the FDA; [***]

[***] Dollars ($[***])
5.    Receipt under this Agreement of all Regulatory Approvals for a Licensed Product for a second Select Indication [***] in the EU issued by the EMA; [***]
[***] Dollars ($[***])
6.    Receipt under this Agreement of all Regulatory Approvals for a Licensed Product for a second Select Indication [***] in Japan issued by the MHLW; [***]
[***] Dollars ($[***])

Each of the foregoing milestones in this Section 5.4.1 shall be payable a maximum of one (1) time as set forth in the foregoing chart regardless of the number of Licensed Products achieving the applicable milestone event ( i.e. , a maximum of six (6) Regulatory Milestone Payments may be made pursuant to this Section 5.4.1), and no Regulatory Milestone Payment shall be due hereunder for subsequent or repeated achievement of such milestone event. For the avoidance of doubt, the maximum amount payable by Celgene pursuant to this Section 5.4.1 is [***] Dollars ($[***]) assuming that each of the milestone events in this Section 5.4.1 were achieved.
5.4.2     Invoice and Payment of Regulatory Milestone Payments . Following receipt of notification by Celgene to Prothena that Celgene has achieved the applicable milestone event triggering a Regulatory Milestone Payment hereunder, Prothena shall invoice Celgene for the applicable Regulatory Milestone Payment, and Celgene shall pay such Regulatory Milestone Payment within [***] ([***]) days after receipt of the invoice therefor.
5.5     Sales Milestones .
5.5.1     Sales Milestones . Subject to the terms of this Section 5.5 (and subject further to Section 5.6), Celgene will notify Prothena within [***] ([***]) days after the end of the Calendar Quarter during which a given milestone event described below in this Section 5.5 was first achieved by Celgene under this Agreement and after the Effective Date with respect to the Licensed Products,

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and Celgene shall thereafter pay the applicable amounts set forth below associated with the applicable milestone event in accordance with Section 5.5.2 (each, a “ Sales Milestone Payment ”):
Sales Milestone Event

Sales Milestone Payment
First achievement of Per Licensed Product Annual Net Sales of the Licensed Products in any single Calendar Year exceeding [***] Dollars ($[***])

[***] Dollars ($[***])
First achievement of Per Licensed Product Annual Net Sales of the Licensed Products in any single Calendar Year exceeding [***] Dollars ($[***])

[***] Dollars ($[***])
First achievement of Per Licensed Product Annual Net Sales of the Licensed Products in any single Calendar Year exceeding [***] Dollars ($[***])

[***] Dollars ($[***])
First achievement of Per Licensed Product Annual Net Sales of the Licensed Products in any single Calendar Year exceeding [***] Dollars ($[***])

[***] Dollars ($[***])


Each of the foregoing milestones in this Section 5.5.1 shall be payable a maximum of one (1) time as set forth in the foregoing chart regardless of the number of times the applicable milestone event was achieved (i.e., a maximum of four (4) Sales Milestone Payments may be made pursuant to this Section 5.5.1), and no Sales Milestone Payment shall be due hereunder for subsequent or repeated achievement of such milestone event. For the avoidance of doubt, the maximum amount payable by Celgene pursuant to this Section 5.5.1 is [***] Dollars ($[***]) assuming that each of the milestone events in this Section 5.5.1 were achieved.
5.5.2     Invoice and Payment of Sales Milestone Payments . Following receipt of notification by Celgene to Prothena that Celgene has achieved the applicable milestone event triggering a Sales Milestone Payment hereunder, Prothena shall invoice Celgene for the applicable Sales Milestone Payment, and Celgene shall pay such Sales Milestone Payment within [***] ([***]) days after receipt of the invoice therefor.
5.6     Additional Payment Terms .
5.6.1     Currency . All payments hereunder shall be made in U.S. Dollars by wire transfer to a bank designated in writing by Prothena. Conversion of sales recorded in local currencies to Dollars shall be performed in a manner consistent with Accounting Standards and Celgene’s normal practices used to prepare its audited financial statements for internal and external reporting purposes.

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5.6.2     Taxes; Withholding .
(a)     Generally . Each Party will pay, any and all income taxes levied on account of all payments it receives under this Agreement except as otherwise provided in this Section 5.6.2.
(b)     Tax Withholding . Each Party shall be entitled to deduct and withhold from any amounts payable under this Agreement such taxes as are required to be deducted or withheld therefrom under any provision of Applicable Law. The Party that is required to make such withholding (the “ Paying Party ”) will (i) deduct those taxes from such payment, (ii) timely remit the taxes to the proper taxing authority, and (iii) send evidence of the obligation together with proof of tax payment to the other Party (the “ Payee Party ”) on a timely basis following that tax payment; provided, however, that before making any such deduction or withholding, the Paying Party shall give the Payee Party notice of the intention to make such deduction or withholding (such notice shall include an explanation of the reason for and the calculation of the proposed deduction or withholding and shall be given before such deduction or withholding is required in order for such Payee Party to obtain reduction of or relief from such deduction or withholding). Each Party agrees to reasonably cooperate with the other Party in claiming refunds or exemptions from such deductions or withholdings under any relevant agreement or treaty which is in effect to ensure that any amounts required to be withheld pursuant to this Section 5.6.2(b) are reduced in amount to the fullest extent permitted by Applicable Law. In addition, the Parties shall cooperate in accordance with Applicable Laws to minimize indirect taxes (such as value added tax, sales tax, consumption tax and other similar taxes (“ Indirect Taxes ”)) in connection with this Agreement.
(c)     Tax Gross Up.     Notwithstanding the foregoing, if (a) any Party redomiciles, assigns its rights or obligations or extends its rights under this Agreement, (b) as a result of such redomiciliation, assignment or extension, such Party (or its assignee) is required by Applicable Law to [***], or such redomiciliation, assignment or extension results in [***], and (c) such [***] exceed the amount of [***] that would have been applicable but for such redomiciliation, assignment or extension, then any such amount payable shall [***] so that, after making all required [***], as the case may be, the Payee Party (or its assignee) [***]. The [***] (A) [***] to the extent such [***] but for [***], and (B) [***]. For purposes of the preceding sentence, “ Tax Benefit ” shall mean any cash refund or credit for Taxes resulting in a reduction in the amount of Taxes otherwise owed by the Payee Party as a result of [***] relating to payments by the Paying Party, as reasonably determined by Payee Party. Solely for purposes of this Section 5.6.2(c), a Party’s “domicile” shall include its jurisdiction of incorporation or tax residence and a “redomiciliation” shall include a reincorporation or other action resulting in a change in tax residence of the applicable Party or its assignee, or resulting in the attribution of any amounts payable to a branch or permanent establishment located outside the country of tax residence of the applicable Party or its assignee.
(d)     Tax Documentation . Prothena has provided a properly completed and duly executed IRS Form W-8BEN-E to Celgene. Prior to the receipt of any payment under this Agreement, each recipient Party (and any other recipient of payments under this Agreement) shall, to the extent it is legally permitted to, provide to the other Party, at the time or times reasonably requested by such other Party or as required by Applicable Law, such properly completed and duly

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executed documentation (for example, IRS Forms W-8 or W-9 or foreign equivalents) as will permit payments made under this Agreement to be made without, or at a reduced rate of, withholding for taxes.
5.7     Other Global License Agreements . For the avoidance of doubt, a Licensed Product hereunder will only be eligible for milestone and royalty payments under this Agreement, and shall not be eligible for, or counted towards, milestone or royalty payments under any other Global License Agreement (i.e., a given Licensed Product will be eligible for, and counted towards, milestone and royalty payments only under one Global License Agreement).
5.8     U.S. License Agreement . Notwithstanding the provisions of Sections 5.3, 5.4 and 5.5, in the event that Celgene (or its Affiliate) has previously paid any royalty payments or milestone payments under the Licensed Program U.S. License Agreement, then Celgene shall not be required to make payments of any royalties or milestones payable hereunder for the same net sales or same milestone event (i.e., royalties and milestones shall be payable a maximum of one time, if payable, whether achieved under this Agreement or under the Licensed Program U.S. License Agreement). By way of example, (i) if [***], and/or (ii) if a given Sales Milestone Payment (as defined in the Licensed Program U.S. License Agreement) was paid under the Licensed Program U.S. License Agreement, then no Sales Milestone Payment shall be due hereunder for the achievement of the same milestone event.
5.9     Records Retention by Celgene; Review by Prothena .
5.9.1     Records . With respect to royalty and milestone payments to be made under Sections 5.3 or 5.5 of this Agreement, Celgene agrees to keep and shall procure that its Affiliates keep, for at least [***] ([***]) years from the end of the Calendar Year to which they pertain, complete and accurate records of sales by Celgene or its Affiliates (including sales by Sublicensees), as the case may be, of each Licensed Product, in sufficient detail to allow the accuracy of the payments made hereunder to be confirmed.
5.9.2     Review . Subject to the other terms of this Section 5.9.2, during the Term, at the request of Prothena, which shall not be made more frequently than [***], upon at least [***] ([***]) days’ prior written notice from Prothena, [***], Celgene shall permit an independent, nationally-recognized certified public accountant selected by Prothena and reasonably acceptable to Celgene to inspect (during regular business hours) the relevant records required to be maintained by Celgene under Section 5.9.1; provided that such audit right shall not apply to records beyond [***] ([***]) years from the end of the Calendar Year to which they pertain. In every case the accountant must have previously entered into a confidentiality agreement with both Parties having confidentiality obligations and non-use obligations no less restrictive than those set forth in Article 7 and limiting the disclosure and use of such information by such accountant to authorized representatives of the Parties and the purposes germane to Section 5.9.1. Results of any such review shall be binding on both Parties absent manifest error. The accountant shall report to Prothena only whether the particular amount being audited was accurate, and if not, the amount of any discrepancy, and the accountant shall not report any other information to Prothena. Prothena shall treat the results of any such accountant’s review of Celgene’s records as Confidential Information of Celgene subject to the terms of Article 7. If any review reveals a deficiency or overpayment in the calculation and/

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or payment of royalties or Sales Milestone Payments by Celgene, then (a) Celgene or Prothena as applicable shall promptly pay (or refund, as applicable) the other Party the amount of such deficiency or overpayment, as applicable, and (b) if such deficiency is by more than the greater of (i) [***] or (ii) [***], Celgene shall, within [***] ([***]) days after receipt of an invoice therefor, pay the reasonable out-of-pocket costs and expenses incurred by Prothena for the independent accountant in connection with the review.
5.9.3     Records Final . Upon the expiration of [***] ([***]) years following the end of a given Calendar Year, subject and without prejudice to the determination of any review commenced prior to such [***] pursuant to Section 5.9.2, the calculation of royalties and Sales Milestone Payments payable with respect to such Calendar Year shall be binding and conclusive upon Prothena, and Celgene (and its Affiliates) shall be released from any liability or accountability with respect to such royalties for such Calendar Year.
5.10     Prothena Third Party Agreements . Notwithstanding anything to the contrary herein, but subject to Section 2.3.5(b), Prothena shall be solely responsible for all costs and payments of any kind (including all upfront fees, annual payments, milestone payments and royalty payments) arising under any agreements between Prothena (or any of its Affiliates) and any Third Party (including under any In-License Agreement or other Existing Program Agreement), which costs or payments arise in connection with, or as a result of, the activities hereunder, including the Development, Manufacture or Commercialization of Licensed Antibodies or Licensed Products unless and until such agreements have been assigned to Celgene pursuant to Section 2.3.5.
5.11     Diagnostic Products . Notwithstanding anything to the contrary contained herein, [***].
5.12     Additional Provisions . Notwithstanding anything to the contrary herein, the terms and provisions of this Article 5 are subject to Section 11.7 of the Master Collaboration Agreement and Sections 10.7 and 10.10 of this Agreement.
ARTICLE 6.     
LICENSES; INTELLECTUAL PROPERTY
6.1     License to Celgene . Subject to the terms and conditions of this Agreement, Prothena hereby grants to Celgene an exclusive right and license, with the right to grant sublicenses (through multiple tiers), under the Prothena IP to research, develop (including Develop), make (including Manufacture), have made (including have Manufactured), use, offer for sale, sell, import, Commercialize and otherwise exploit Licensed Antibodies and Licensed Products, including Diagnostic Products, in the Field in the Territory.
6.2     License to Celgene for Other Targets. In the event that, during the Term, Celgene modifies a Licensed Program Antibody in the course of its Development activities hereunder such that such Licensed Program Antibody specifically binds to a target other than (i) the Licensed Target or (ii) any other Collaboration Target (e.g., a bispecific antibody), then, at the request of Celgene, Celgene and Prothena shall negotiate in good faith a license under intellectual property of Prothena or its Affiliates, as applicable, that is specific to such other target or Antibodies to such other target.

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6.3     Rights Retained by the Parties . For purposes of clarity, each Party retains all rights under Know-How and Patents Controlled by such Party not expressly granted to the other Party pursuant to this Agreement. In addition, Prothena retains the right to perform the Prothena Ongoing Program Activities in accordance with this Agreement.
6.4     No Implied Licenses . Except as explicitly set forth in this Agreement, the Master Collaboration Agreement, any U.S. License Agreement or any other Global License Agreement, neither Party shall be deemed by estoppel or implication to have granted to the other Party any license or other right to any intellectual property of such Party.
6.5     Insolvency . In the event that this Agreement is terminated due to the rejection of this Agreement by or on behalf of Prothena due to an Insolvency Event, all licenses and rights to licenses granted under or pursuant to this Agreement by Prothena to Celgene are and shall otherwise be deemed to be licenses of rights to “intellectual property”. The Parties agree that Celgene, as a licensee of such rights under this Agreement, shall retain and may fully exercise all of its rights and elections under any applicable insolvency statute, and that upon commencement of an Insolvency Event by or against Prothena, Celgene shall be entitled to a complete duplicate of or complete access to (as Celgene deems appropriate), any such intellectual property and all embodiments of such intellectual property. Such intellectual property and all embodiments thereof shall be promptly delivered to Celgene (i) upon any such commencement of a bankruptcy proceeding (or other Insolvency Event) upon written request therefore by Celgene, unless Prothena elects to continue to perform all of its obligations under this Agreement or (ii) if not delivered under (i) above, upon the rejection of this Agreement by or on behalf of Prothena, then upon written request therefore by Celgene. The provisions of this Section 6.5 shall be (1) without prejudice to any rights Celgene may have arising under any applicable insolvency statute or other Applicable Law and (2) effective only to the extent permitted by Applicable Law.
6.6     Ownership .
6.6.1     Inventorship . Notwithstanding the provisions of Section 11.7.1, inventorship of Know-How shall be determined by application of U.S. patent law pertaining to inventorship, and, except as provided for in Sections 6.6.2, 6.6.3 and 6.6.4, ownership of Know-How shall be determined by inventorship.
6.6.2     Ownership of Collaboration IP and Celgene IP .
(a)     Prothena . As between the Parties (including their respective Affiliates), Prothena will retain all right, title and interest in and to all Prothena Licensed Collaboration IP, except to the extent that any such rights are licensed or granted to Celgene under this Agreement or the Master Collaboration Agreement. Prothena shall [***] that all Patents, Know-How and other intellectual property (other than Licensed Program IP and Celgene IP, if any) utilized in the performance of the Licensed Program under the Master Collaboration Agreement falls within the Prothena Licensed Collaboration IP and is and remains during the Term Controlled by Prothena such that Prothena has the full rights to grant the rights and licenses to the Prothena Licensed Collaboration IP to Celgene hereunder (including that such Patents, Know-How and other

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intellectual property remains unencumbered such that Prothena is able to grant such rights and licenses to Celgene).
(b)     Celgene . As between the Parties (including their respective Affiliates), Celgene (or its Affiliate) will retain all right, title and interest in and to all Celgene IP, including all rights to Prosecute and Maintain, and enforce any such Celgene IP, and no rights or licenses are granted to Prothena hereunder with respect to any Celgene IP.
6.6.3     Ownership of Licensed Program IP .
(a)     Prothena . As between the Parties (including their respective Affiliates), Prothena will solely own and Control all Licensed Program IP. Celgene shall, and hereby does, assign to Prothena all of Celgene’s interest in any and all Licensed Program Know-How that falls within Section 1.46(a)(iii) and all Licensed Program Patents claiming such Licensed Program Know-How. Celgene shall, and shall require its Affiliates to, take all reasonable actions and execute all documents necessary to effect the intent of the preceding sentence. As between the Parties (and their respective Affiliates) and any Third Party, Prothena will solely own and Control all Licensed Program IP; provided that if (a) [***] and (b) [***].
(b)    If any Licensed Program IP is created, conceived, discovered, first generated, invented, first made or first reduced to practice pursuant to the Master Collaboration Agreement by any Third Party that is in contractual privity with or otherwise engaged by Prothena or its Affiliates, Prothena [***] include in such agreement with such Third Party an obligation to [***] to Prothena [***] such Licensed Program IP to enable Prothena to grant to Celgene a license thereunder as provided in this Agreement for the duration of this Agreement.
6.6.4     Joint IP . The Parties shall each own an equal, undivided interest in: (a) any and all Know-How that is created, conceived, discovered, first generated, invented, first made or first reduced to practice, in each case, jointly by or on behalf of Prothena or its Affiliates, on the one hand, and Celgene or its Affiliates, on the other hand, pursuant to the conduct of activities under this Agreement at any time during the Term (the “ Joint Know-How ”), and (b) any Patents that claim any Joint Know-How (the “ Joint Patents ”, together with Joint Know-How the “ Joint IP ”). Each Party shall assign, and hereby assigns, to the other Party, a joint equal and undivided interest in and to such Joint IP (provided, however, that for clarity, the foregoing joint ownership rights with respect to Joint IP shall not be construed as granting, conveying or creating any license or other rights to any of the other Party’s other intellectual property, unless otherwise expressly set forth in this Agreement), and at the request of a Party, the other Party will execute such documents (including any necessary assignments) to effect such joint ownership of such Joint IP. Each Party shall have the right to disclose (except as otherwise set forth in Section 7.2) and exploit the Joint IP without a duty of seeking consent or accounting to the other Party except as expressly provided in this Agreement; provided that, such rights shall be subject to the rights and licenses granted to Celgene and Prothena hereunder (or under the Master Collaboration Agreement, any other Global License Agreement or any U.S. License Agreement), including the obligations of Prothena as set forth in Article 4. The Parties hereby acknowledge and agree that any and all Joint IP (as defined in the Licensed Program U.S. License Agreement) shall be deemed to be Joint IP under this Agreement,

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and from and after the Effective Date, the provisions of this Agreement shall apply with respect to all such Joint IP (as defined in the Licensed Program U.S. License Agreement).
6.7     Patent Liaisons . Promptly after the Effective Date, each Party shall appoint an individual to act as a patent liaison for such Party (each, a “ Patent Liaison ”). The Patent Liaisons shall be the primary point of contact for the Parties regarding intellectual property-related activities and matters contemplated by this Agreement, as and to the extent requested by Celgene from time to time. The name and contact information for each Party’s Patent Liaison, as well as any replacement(s) chosen by such Party, in its sole discretion, from time to time, shall be promptly provided to the other Party in accordance with Section 11.2.
6.8     Prosecution and Maintenance of Prothena Licensed Collaboration Patents and Licensed Program Patents . Following the Effective Date, the provisions of this Section 6.8 shall apply with respect to the Prothena Licensed Collaboration Patents and Licensed Program Patents.
6.8.1     Prothena Platform Patents . Prothena shall [***] Prosecute and Maintain the Prothena Platform Patents. All such Prosecution and Maintenance by Prothena shall be through patent counsel [***]. Prothena shall keep Celgene informed as to material developments with respect to the Prosecution and Maintenance of such Patents including by providing copies of all substantive office actions, examination reports, communications or any other substantive documents to or from any patent office, including notice of all interferences, reissues, re-examinations, inter partes reviews, derivations, post grant proceedings, oppositions or requests for patent term extensions. Prothena shall also provide Celgene with a reasonable opportunity to comment substantively on the Prosecution and Maintenance of such Prothena Platform Patents prior to taking material actions (including the filing of initial applications), and will in good faith consider any comments made by and actions recommended by Celgene, provided, however, that Celgene provides its comments reasonably in advance of any applicable filing deadlines.
6.8.2     Other Prothena Licensed Collaboration Patents and Licensed Program Patents .
(a)     [***] First Right . [***] shall have the first right (but not the obligation) to Prosecute and Maintain the Prothena Licensed Collaboration Patents (other than Prothena Platform Patents) and Licensed Program Patents using patent counsel of [***] choosing ([***]). [***] shall keep [***] informed as to material developments with respect to the Prosecution and Maintenance of such Patents including by providing copies of all substantive office actions, examination reports, communications or any other substantive documents to or from any patent office, including notice of all interferences, reissues, re-examinations, inter partes reviews, derivations, post grant proceedings, oppositions or requests for patent term extensions. [***] shall also provide [***] with a reasonable opportunity to comment substantively on the Prosecution and Maintenance of such Prothena Licensed Collaboration Patents (other than Prothena Platform Patents) and Licensed Program Patents prior to taking material actions (including the filing of initial applications), and will in good faith consider any comments made by and actions recommended by [***], provided, however, that [***] does so consistent with any applicable filing deadlines.

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(b)     [***] Back-Up Right . If [***] in any country decides not to file a Prothena Licensed Collaboration Patent (other than Prothena Platform Patents) or Licensed Program Patent or intends to allow such Patent to lapse or become abandoned without having first filed a substitute, it shall notify and consult with [***] of such decision or intention at least [***] ([***]) days prior to the date upon which the subject matter of such Patent shall become unpatentable or such Patent shall lapse or become abandoned, and, if after such consultation between the Parties, [***] still intends not to file such Prothena Licensed Collaboration Patent (other than Prothena Platform Patents) or Licensed Program Patent, [***] shall thereupon have the right (but not the obligation) to assume the Prosecution and Maintenance thereof at [***] expense with counsel of its choice. [***]
6.8.3     Cooperation in Prosecution and Maintenance .
(a)     Further Assurances . If Celgene determines to undertake the Prosecution and Maintenance of a Prothena Licensed Collaboration Patent or Licensed Program Patent (other than a Prothena Platform Patent) in accordance with this Section 6.8, Prothena agrees to make its employees, agents and consultants reasonably available to Celgene (and to Celgene’s authorized attorneys, agents or representatives) to enable Celgene to undertake such Prosecution and Maintenance. In addition, Prothena shall (and shall cause its Affiliates and its and their employees, agents and consultants to) provide reasonable assistance to Celgene (and to Celgene’s authorized attorneys, agents or representatives) to enable Celgene to undertake such Prosecution and Maintenance, including by executing powers of attorney and other documents for Celgene to undertake such Prosecution and Maintenance.
(b)     Assistance . The Parties shall reasonably cooperate with one another with respect to the Prosecution and Maintenance of the Prothena Licensed Collaboration Patents and Licensed Program Patents for which either Party is responsible for Prosecution and Maintenance pursuant to this Section 6.8. [***], the Parties shall cooperate with one another to [***], in each case that are applicable to the Licensed Target or Licensed Program Antibody, as applicable, if practicable to [***].
6.8.4     Costs of Prosecution and Maintenance . Except as otherwise expressly set forth in this Section 6.8.4, each Party shall be responsible for all costs and expenses associated with its Prosecution and Maintenance activities under this Section 6.8 with respect to Prothena Licensed Collaboration Patents and Licensed Program Patents for which it is responsible pursuant to Sections 6.8.1 or 6.8.2, as applicable. Notwithstanding the foregoing provisions of this Section 6.8.4, [***]. If any Prothena Licensed Collaboration Patents or Licensed Program Patents claim or cover [***] and such Prothena Licensed Collaboration Patent or Licensed Program Patent, as applicable, is [***], then Prothena shall [***], and [***] for the Prosecution and Maintenance of such Prothena Licensed Collaboration Patent or Licensed Program Patent, as applicable, pursuant to Section [***] shall [***].

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6.9     Enforcement of Prothena Licensed Collaboration Patents and Licensed Program Patents .
6.9.1     Notice . If any Party learns of an infringement or threatened infringement by a Third Party of any Prothena Licensed Collaboration Patent or Licensed Program Patent, in each case other than a Prothena Platform Patent, in the Territory (including in connection with any Biosimilar Application referencing a Licensed Product (regardless of whether such notice or copy is provided under any Applicable Laws) including under the BPCIA or the United States Patient Protection and Affordable Care Act or its successor provisions, or any similar provisions in a country outside the United States, as applicable) such Party shall promptly notify the other Party and shall provide such other Party with available evidence of such infringement, and following such notification, the Parties shall confer.
6.9.2     [***] First Right . Subject to the remaining provisions of this Section 6.9.2, [***] shall have the first right, but not the obligation, to institute, prosecute, and control any action or proceeding (which may include settlement or otherwise seeking to secure the abatement of such infringement) with respect to any infringement of any (i) Prothena Licensed Collaboration Patent or (ii) Licensed Program Patent, in each case other than a Prothena Platform Patent, (including in connection with any Biosimilar Application referencing a Licensed Product (regardless of whether such notice or copy is provided under any Applicable Laws), including under the BPCIA or the United States Patient Protection and Affordable Care Act or its successor provisions, or any similar provisions in a country outside the United States, as applicable), by counsel of its own choice, in [***]’s own name [***] and under [***]’s direction and control, including the right to control the defense of any challenges to such Patents as a counterclaim in such infringement proceeding as well as the defense of declaratory judgment actions. Prothena retains all rights to enforce the Prothena Platform Patents against any actual or threatened infringement.
6.9.3     [***] Back-Up Right . If [***] determines not to institute an action or proceeding with respect to a given infringement of any Prothena Licensed Collaboration Patent or Licensed Program Patent pursuant to Section 6.9.3, it shall notify and consult with [***] of such decision, and, subject to the remaining provisions of this Section 6.9.3, [***] shall thereupon have the right (but not the obligation) to institute an action or proceeding with respect to such infringement of such Prothena Licensed Collaboration Patent or Licensed Program Patent, as applicable, at [***]'s expense with counsel of its choice. Notwithstanding the foregoing provisions of this Section 6.9.3, if [***] has any reasonable grounds for believing that [***]’s exercise of its backup enforcement right with respect to any Patent as set forth in this Section 6.9.3 [***], then [***] shall not be permitted to enforce such Patent without the prior consent of [***], in [***]’s discretion.
6.9.4     [***] . Notwithstanding the foregoing Sections 6.9.2 and 6.9.3, the Parties must agree in writing prior to either Party initiating any action or proceeding with respect to any infringement of any Prothena Licensed Collaboration Patent or Licensed Program Patent with respect to any [***].
6.9.5     Joinder . In the case of any enforcement action or proceeding set forth in Section [***] controlled by Celgene, Prothena will (and will cause its Affiliates to) join any such action or proceeding as a party at Celgene's expense (and Prothena will use commercially reasonable

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efforts to cause any Third Party as necessary to join such action or proceeding as a party) if doing so is necessary for the purposes of establishing standing or is otherwise required by Applicable Law to pursue such action or proceeding. Prothena may, at its option, participate in such enforcement action or proceeding at its own expense. In the case of any enforcement action or proceeding controlled by Prothena pursuant to Section [***], Celgene may, at its option, participate in such enforcement action or proceeding at its own expense. Celgene will join any such action or proceeding controlled by Prothena as a party at Prothena’s expense (and Celgene will use commercially reasonable efforts to cause any Third Party as necessary to join such action or proceeding as a party) if doing so is necessary for the purposes of establishing standing or is otherwise required by Applicable Law to pursue such action or proceeding. Celgene will bear all costs and expenses incurred by it arising out of such enforcement action or proceeding controlled by Celgene, and Prothena will bear all costs and expenses incurred by it arising out of such enforcement action or proceeding controlled by Prothena.
6.9.6     Consultation; Cooperation . The enforcing Party will keep the non-enforcing Party regularly informed of the status and progress of such enforcement efforts with respect to any Prothena Licensed Collaboration Patent or Licensed Program Patent, in each case other than a Prothena Platform Patent. The enforcing Party shall consult with the non-enforcing Party and will take comments of the non-enforcing Party into good faith consideration with respect to the infringement or claim construction of any claim in any such Prothena Licensed Collaboration Patent or Licensed Program Patent. The non-enforcing Party will provide to the enforcing Party reasonable cooperation in such enforcement, at such enforcing Party’s request and expense.
6.9.7     Settlement . A settlement or consent judgment or other voluntary final disposition of a suit with respect to the Prothena Licensed Collaboration Patents or Licensed Program Patents, in each case other than a Prothena Platform Patent, under this Section 6.9 may be entered into without the consent of the Party not bringing suit; provided, however, that any such settlement, consent judgment or other disposition of any action or proceeding by the Party bringing suit under this Section 6.9 shall not, without the prior written consent of the Party not bringing suit, such consent not to be unreasonably withheld, (i) impose [***] liability or obligation on the Party not bringing suit or any of its Affiliates, (ii) conflict with [***] of the subject matter claimed in the applicable Prothena Licensed Collaboration Patents or Licensed Program Patents, (iii) [***], include the grant of any license, covenant or other rights to any Third Party that would conflict with [***] the rights or licenses granted to Celgene under this Agreement, the Master Collaboration Agreement, any other Global License Agreement or any U.S. License Agreement, or (iv) [***].
6.9.8     Costs and Recoveries . Except as otherwise set forth in this Section 6.9.8, each Party shall bear all of its costs incurred in connection with its activities under this Section 6.9.8. Any damages or other monetary awards recovered in any action, suit or proceeding brought under this Section 6.9.8 to the extent related to any Prothena Licensed Collaboration Patents or Licensed Program Patents shall be shared as follows:
(a)    the amount of such recovery actually received by the Party controlling such action shall first be applied to reimburse costs and expenses incurred by each Party in connection with such action (including, for this purpose, [***] counsel); and

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(b)    any remaining proceeds shall be (i) for any action controlled by Celgene, retained by, or provided to, Celgene [***], and (ii) for any action controlled by Prothena, retained by, or provided to, Prothena [***].
6.9.9     Biosimilar Applications . Notwithstanding the foregoing provisions of this Section 6.9, if either Party receives a copy of a Biosimilar Application referencing a Licensed Product, whether or not such notice or copy is provided under any Applicable Laws (including under the BPCIA, the United States Patient Protection and Affordable Care Act, or its successor provisions, or any similar provisions in a country outside the United States, as applicable), or otherwise becomes aware that such a Biosimilar Application has been submitted to a Regulatory Authority for marketing authorization (such as in an instance described in 42 U.S.C. §262(l)(2)), the remainder of this Section 6.9.9 shall apply. Such Party shall promptly, but in any event within [***] ([***]) Business Days, notify the other Party. The owner of the relevant Patents shall then seek permission to view the Biosimilar Application, information regarding the process or processes used to manufacture the product that is the subject of the Biosimilar Application, and related confidential information from the filer of the Biosimilar Application if necessary under 42 U.S.C. §262(l)(1)(B)(iii). If either Party receives any equivalent or similar communication or notice in the United States or any other jurisdiction, the Party receiving such communication or notice shall within [***] ([***]) Business Days notify the other Party of such communication or notice to the extent permitted by Applicable Laws. Regardless of the Party that is the “reference product sponsor,” as defined in 42 U.S.C. §262(l)(1)(A), for purposes of such Biosimilar Application:
(a)    [***] the outside counsel and in-house counsel who shall receive confidential access to the Biosimilar Application, information regarding the process or processes used to manufacture the product that is the subject of the Biosimilar Application, and any related confidential information pursuant to 42 U.S.C. §262(l)(1)(B)(ii).
(b)    In each case, after consulting with [***] and considering [***]’s comments in good faith, [***] shall have the right to (a) list any patents, including those Patents within the Prothena IP, as required pursuant to 42 U.S.C. §262(l)(3)(A) or 42 U.S.C. §262(l)(7), (b) respond to any communications with respect to such lists from the filer of the Biosimilar Application, (c) negotiate with the filer of the Biosimilar Application as to whether to utilize a different mechanism for information exchange other than that specified in 42 U.S.C. §262(l)(1), and (d) as to the Patents that will be subject to the litigation procedure as described in 42 U.S.C. §262(l)(4), decide which Patent or Patents shall be selected for litigation under 42 U.S.C. §262(l)(5)(B)(i)(II), and commence such litigation under 42 U.S.C. §262(l)(6). [***]
(c)    [***] shall have the right, after consulting with [***], to identify Patents, including those Patents within the Prothena IP, or respond to relevant communications under any equivalent or similar listing to those described in the preceding clause (b) in any other jurisdiction outside of the United States. [***].
(d)    [***] shall cooperate with [***]’s reasonable requests in connection with the foregoing activities to the extent required or permitted by Applicable Laws. [***] shall consult with [***] prior to identifying any Patents within the Prothena IP to a Third Party as contemplated by this Section 6.9.9. [***] shall consider in good faith advice and suggestions with

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respect thereto received from [***], and notify [***] of any such lists or communications promptly after they are made.
(e)    Each Party shall within [***] ([***]) Business Days after receiving any notice of commercial marketing provided by the filer of a Biosimilar Application pursuant to 42 U.S.C. §262(l)(8)(A), notify the other Party. To the extent permitted by Applicable Law, [***] shall have the first right, but not the obligation, to seek an injunction against such commercial marketing as permitted pursuant to 42 U.S.C. §262(l)(8)(B) and to file an action for infringement. [***]. Except as otherwise provided in this Section 6.9.9, any such action shall be subject to the terms and conditions of Section 6.9.1 through 6.9.8.
(f)    The Parties recognize that procedures other than those set forth above in this Section 6.9.9 may apply with respect to Biosimilar Applications. In the event that the Parties determine that certain provisions of Applicable Laws in the United States or in any other country in the Territory apply to actions taken by the Parties with respect to Biosimilar Applications under this Section 6.9.8 in such country, the Parties shall comply with any such Applicable Laws in such country (and any relevant and reasonable procedures established by Parties) in exercising their rights and obligations with respect to Biosimilar Applications under this Section 6.9.9. Notwithstanding the provisions of this Section 6.9.9, nothing in this Section 6.9.9 shall grant any rights to Prothena with respect to any Celgene IP.
6.10     Patent Term Extensions . Prothena shall reasonably cooperate with Celgene, including providing reasonable assistance to Celgene (including executing any documents as may reasonably be required), in efforts to seek and obtain patent term restoration or supplemental protection certificates or the like or their equivalents in any country in the Territory, where applicable to Prothena Licensed Collaboration Patents or Licensed Program Patents or any other Patents Controlled by Celgene (or any of its Affiliates), in each case other than a Prothena Platform Patent, including as may be available to the Parties under the provisions of the U.S. Drug Price Competition and Patent Term Restoration Act of 1984 or comparable laws outside the United States of America, in each case, in connection with any Licensed Product. In the event that elections with respect to obtaining such patent term restoration or supplemental protection certificates or the like or their equivalents are to be made in connection therewith, [***] shall have the right to make the election and [***]. Without limiting the foregoing, [***].
6.11     Regulatory Data Protection . [***] (or its designee) shall have the sole right to list, with the applicable Regulatory Authorities in the Territory, all applicable Patents (including any Prothena Licensed Collaboration Patents or Licensed Program Patents) for any Licensed Product, including all so called “Purple Book” listings required under the U.S. Public Health Service Act, and all similar listings in any other relevant countries, [***]. For the avoidance of doubt, [***] will retain final decision-making authority as to the listing of all applicable Patents for any Licensed Product, regardless of which Party owns such Patent, and [***] shall reasonably assist [***] in connection therewith.
6.12     Matters Involving Joint Patents . The Prosecution and Maintenance, and the enforcement and defense, of any Joint Patents shall be jointly managed by the Parties through independent patent counsel (mutually agreed to by the Parties) jointly representing the Parties,

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including any costs and recoveries regarding same. Prior to either Party publishing any Joint Know-How, the Parties will discuss if a Joint Patent claiming such Joint Know-How should be filed.
6.13     Common Interest Agreement . At the request of either Party, the Parties shall negotiate in good faith to enter into a common interest agreement to govern their discussion of Patent matters.
6.14     License Filing . At the request of [***], [***] shall, and shall cause its Affiliates to, assist in any license registration processes with applicable Governmental Authorities that may be available for the protection of [***]’s interests in this Agreement.
6.15     Defense of Claims Brought by Third Parties . If a Party becomes aware of any actual or potential claim that the Development, Manufacture or Commercialization of a Licensed Antibody or Licensed Product by or on behalf of Celgene pursuant to this Agreement infringes the intellectual property rights of any Third Party, such Party shall promptly notify the other Party. In any such instance, the Parties shall as soon as practicable thereafter meet to discuss in good faith regarding the best response to such notice; provided that Celgene shall have the final decision-making authority in connection therewith. Except as set forth in Section 9.2 (and without limiting Celgene’s rights under Section 9.2), Celgene shall have the sole right, but not the obligation, to defend and dispose of (including through settlement or license) such claim. [***] by or on behalf of [***] (or any of its Affiliates or Sublicensees) in connection with [***] to the extent relating to the Development, Manufacture or Commercialization of a Licensed Antibody or Licensed Product, shall be [***], and [***].
ARTICLE 7.     
CONFIDENTIALITY
7.1     Nondisclosure . Each Party agrees that a Party (the “ Receiving Party”) receiving Confidential Information of the other Party (the “ Disclosing Party ”) pursuant to this Agreement shall (a) maintain in confidence such Confidential Information using not less than the efforts such Receiving Party uses to maintain in confidence its own proprietary information of similar kind and value, but in no event less than a reasonable degree of efforts, (b) not disclose such Confidential Information to any Third Party without the prior written consent of the Disclosing Party, except for disclosures expressly permitted pursuant to this Article 7, and (c) not use such Confidential Information for any purpose except those permitted by this Agreement, including, in the case of Celgene, the exercise of the rights and licenses granted to Celgene hereunder (it being understood that this clause (c) shall not create or imply any rights or licenses not expressly granted under this Agreement). The obligations of confidentiality, non-disclosure and non-use under this Section 7.1 shall be in full force and effect during the Term and for a period of [***] ([***]) years thereafter. The Receiving Party will return all copies of or destroy (and certify such destruction in writing) the Confidential Information of the Disclosing Party disclosed or transferred to it by the other Party pursuant to this Agreement, within [***] ([***]) days after the termination or expiration of this Agreement; provided, however, that a Party may retain (i) Confidential Information of the other Party to exercise rights and licenses which expressly survive such termination or expiration pursuant to this Agreement, and (ii) one (1) copy of all other Confidential Information in archives solely for the purpose of establishing the contents thereof. Without limiting the foregoing, [***] will keep confidential, and will cause its Affiliates and its and their employees, consultants, licensees,

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sublicensees, professional advisors and Affiliates to keep confidential, [***] on confidentiality terms at least as protective as the confidentiality provisions of this Agreement (without regard to Section 7.3).
7.2     Licensed Program Specific Confidential Information . Notwithstanding anything to the contrary contained herein, the Parties agree and acknowledge that any Licensed Program Specific IP shall be deemed to be Confidential Information of Celgene (without regard to Section 7.3), and Celgene shall be deemed to be the Disclosing Party with respect to the Licensed Program Specific IP. As used herein, (a) the term “ Licensed Program Specific IP ” means, (i) [***], (ii) [***], and (iii) [***]; and (b) the term “ Licensed Program Non-Specific IP ” means all Prothena Platform Technology within the Prothena Licensed Collaboration Know-How, and other Prothena Licensed Collaboration Know-How and Licensed Program Know-How other than Licensed Program Specific IP. For clarity, Licensed Program Non-Specific IP shall be deemed to be the Confidential Information of Prothena.
7.3     Exceptions .
7.3.1     General . The obligations in Section 7.1 shall not apply with respect to any portion of the Confidential Information of the Disclosing Party that the Receiving Party can show by competent written proof:
(a)    was known to the Receiving Party or any of its Affiliates, without any obligation to keep it confidential or any restriction on its use, prior to disclosure by the Disclosing Party;
(b)    is subsequently disclosed to the Receiving Party or any of its Affiliates by a Third Party lawfully in possession thereof and without any obligation to keep it confidential or any restriction on its use;
(c)    is published by a Third Party or otherwise becomes publicly available or enters the public domain, either before or after it is disclosed to the Receiving Party, without any breach by the Receiving Party of its obligations hereunder;
(d)    is published by a Party in accordance with Section 7.8 without any breach by such Party of its obligations hereunder; or
(e)    is independently developed by or for the Receiving Party or its Affiliates without reference to or reliance upon the Disclosing Party’s Confidential Information.
Any combination of features or disclosures shall not be deemed to fall within the foregoing exclusions merely because individual features are published or available to the general public or in the rightful possession of the Receiving Party unless the combination itself and principle of operation are published or available to the general public or in the rightful possession of the Receiving Party.

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7.4     Authorized Disclosure .
7.4.1     Disclosure . Notwithstanding Section 7.1, the Receiving Party may disclose Confidential Information belonging to the Disclosing Party in the following instances:
(a)    subject to Section 7.6, to comply with Applicable Law (including the rules and regulations of the U.S. Securities and Exchange Commission (“ SEC ”) or any national securities exchange) or with judicial process (including prosecution or defense of litigation), if, in the reasonable opinion of the Receiving Party’s counsel, such disclosure is necessary for such compliance or for such judicial process (including prosecution or defense of litigation);
(b)    is disclosed to governmental or other regulatory agencies in order to obtain Patents or to gain or maintain approval to conduct Clinical Trials or to market Licensed Product under this Agreement, in each case, in accordance with this Agreement, but such disclosure shall only be to the extent reasonably necessary to obtain Patents or authorizations, and provided that reasonable steps are taken to ensure confidential treatment of such Confidential Information (if available);
(c)    to any of its officers, employees, consultants, agents or Affiliates (including, (i) [***], (ii) in the case of either Party, to such Party’s subcontractors for purpose of such subcontractor performing obligations of such Party under this Agreement) as it deems necessary or advisable in the course of conducting activities in accordance with this Agreement in order to carry out its responsibilities or exercise its rights under this Agreement (including the exercise of the rights and licenses granted to the relevant Party hereunder), and (iii) in the case of either Party, to such Party’s actual or potential acquirers; provided that each such disclosee is bound by written confidentiality obligations and non-use obligations no less restrictive than those set forth in this Article 7 to maintain the confidentiality thereof and not to use such Confidential Information except as expressly permitted by this Agreement; provided, however, that, in each of the above situations in this Section 7.4.1(c), the Receiving Party shall remain responsible for any failure by any Person who receives Confidential Information from such Receiving Party pursuant to this Section 7.4.1(c) to treat such Confidential Information as required under this Article 7; and
(d)    disclosure, solely on a “need to know basis” to its advisors (including attorneys and accountants) in connection with activities hereunder; provided that, prior to any such disclosure, each disclosee must be bound by written obligations of confidentiality, non-disclosure and non-use no less restrictive than the obligations set forth in this Article 7 (provided, however, that in the case of legal advisors, no written agreement shall be required), which for the avoidance of doubt, will not permit use of such Confidential Information for any purpose except those expressly permitted by this Agreement; provided, however, that, in each of the above situations in this Section 7.4.1(d), the Receiving Party shall remain responsible for any failure by any Person who receives Confidential Information from such Receiving Party pursuant to this Section 7.4.1(d) to treat such Confidential Information as required under this Article 7.
7.4.2     Terms of Disclosure . If and whenever any Confidential Information is disclosed in accordance with this Section 7.4, such disclosure shall not cause any such information to cease to be Confidential Information except to the extent that such disclosure results in a public

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disclosure of such information (other than by breach of this Agreement). Where reasonably possible and subject to Section 7.6, the Receiving Party shall notify the Disclosing Party of the Receiving Party’s intent to make any disclosures pursuant to Section 7.4.1(a) sufficiently prior to making such disclosure so as to allow the Disclosing Party adequate time to take whatever action it may deem appropriate to protect the confidentiality of the information, and the Receiving Party will provide reasonable assistance to the Disclosing Party with respect thereto; provided that, in such event, the Receiving Party will use reasonable measures to ensure confidential treatment of such information and shall only disclose such Confidential Information of the Disclosing Party as is necessary for the purposes of Section 7.4.1(a), as applicable.
7.4.3     Licensed Program Specific IP . [***] shall not disclose the Licensed Program Specific IP without the prior written consent of [***], other than pursuant to Section 7.4.1.
7.5     Terms of this Agreement . The Parties agree that this Agreement and the terms hereof shall be deemed to be Confidential Information of both Prothena and Celgene, and each Party agrees not to disclose any of them without the prior written consent of the other Party, except that each Party may disclose any of them in accordance with the provisions of Sections 7.4 and/or 7.6, as applicable.
7.6     Securities Filings ; Disclosure under Applicable Law . Each Party acknowledges and agrees that the other Party may submit this Agreement to (or file this Agreement with) the SEC or any national securities exchange in any jurisdiction (collectively, the “ Securities Regulators ”), or to other Persons as may be required by Applicable Law, and if a Party does submit this Agreement to (or file this Agreement with) any Securities Regulators, or other Persons as may be required by Applicable Law, such Party agrees to consult with the other Party with respect to the preparation and submission of a confidential treatment request for this Agreement. Notwithstanding the foregoing, if a Party is required by Applicable Law or any Securities Regulator to make a disclosure of the terms of this Agreement in a filing or other submission as required by Applicable Law or Securities Regulator, and (a) such Party has provided copies of the disclosure to the other Party reasonably in advance of such filing or other disclosure under the circumstances, (b) such Party has promptly notified the other Party in writing of such requirement and any respective timing constraints, and (c) such Party has given the other Party a reasonable time under the circumstances from the date of notice by such Party of the required disclosure to comment upon and request confidential treatment for such disclosure, then such Party will have the right to make such disclosure at the time and in the manner reasonably determined by its counsel to be required by Applicable Law or Securities Regulator. Notwithstanding the foregoing, it is hereby understood and agreed that if a Party seeks to make a disclosure as required by Applicable Law or Securities Regulator as set forth in this Section 7.6, and the other Party provides comments within the respective time periods or constraints specified herein or within the respective notice, the Party seeking to make such disclosure or its counsel, as the case may be, will in good faith consider incorporating such comments.
7.7     Publicity .
7.7.1     Press Release; Public Statements . Subject to Section 7.4, 7.6 and this Section 7.7, Prothena agrees not (and shall cause its Affiliates not to) to issue any press release or other

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public statement disclosing this Agreement, the activities hereunder, or the transactions contemplated hereby, unless such press release or other public statement is approved by Celgene in writing; provided that Prothena shall be authorized to make any disclosure, without the approval of Celgene, that is required by Applicable Laws (including the U.S. Securities Act of 1933, as amended, and the U.S. Securities Exchange Act of 1934, as amended) or the rules of any Securities Regulator, or by judicial process, subject to and in accordance with Sections 7.4 and 7.6, as applicable. Without limiting the foregoing, and subject to the foregoing proviso, in the event that Prothena desires to issue an initial press release regarding the execution of this Agreement, Prothena shall have the right to do so provided that (i) [***] and (ii) [***]. For the avoidance of doubt, [***].
7.7.2     Additional Restrictions on Disclosure . Without limiting any other restrictions on disclosure set forth in this Article 7 with respect to any press release or other public statement proposed to be made by Prothena, if such press release or public statement discloses, with respect to such Licensed Program, [***], such press release or other public statement may not be issued without Celgene’s prior written consent, except, for such disclosures by Prothena as required by Applicable Law or Securities Regulators (solely and to the extent Prothena’s counsel determines such disclosure is required by Applicable Law or Securities Regulators); provided that (i) in such case Prothena shall use reasonable efforts to afford Celgene a reasonable period of time to review any such disclosure and any comments made by Celgene will be considered in good faith and (ii) any information that has been previously publicly disclosed in accordance with this Agreement may be disclosed again as long as such disclosure does not exceed the scope of such prior public disclosure. Subject to the foregoing, in the event Celgene proposes that Prothena use specific wording or language with respect thereto, Prothena shall in good faith consider incorporating such wording or language.
7.7.3     Previously Issued Public Statements . The contents of any press release or other public statement that has been reviewed and approved by a reviewing Party may be re-released by the publishing Party or by such reviewing Party without a requirement for re-approval.
7.8     Permitted Publications of Results .
7.8.1     Publication . In the event Prothena (the “ Publishing Party ”) desires to publish or present any information (including publications in journals, posters, presentations at conferences and abstracts submitted in advance of conferences) with respect to the results of the Licensed Program (including the results of a Phase 1 Clinical Trial under the Licensed Program), or with respect to the Licensed Target, any Licensed Antibody or Licensed Product, the Publishing Party shall provide Celgene with a copy of such proposed publication or presentation no less than [***] ([***]) days (provided that the other Party shall use Commercially Reasonable Efforts to accommodate a shorter time period if required due to circumstances outside of the Publishing Party’s control) prior to its intended submission for publication or public disclosure. For the avoidance of doubt, the foregoing shall apply with respect to each proposed publication or presentation regardless of whether a prior publication or presentation was provided (e.g., if an abstract is provided in accordance with this Section 7.8.1 and the Publishing Party wishes to publish the corresponding full manuscript, the full manuscript must be provided to Celgene pursuant to this Section 7.8.1). Celgene shall respond in writing promptly and in no event later than [***] ([***]) days after receipt

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of the proposed material (provided that the other Party shall use Commercially Reasonable Efforts to accommodate a shorter time period if notified by the Publishing Party and required due to circumstances outside of the Publishing Party’s control), with one or more of the following:
(a)    comments on the proposed material, which the Publishing Party shall consider in good faith; and/or
(b)    a specific statement of concern, based upon the need to seek patent protection or to block publication or public disclosure (including publications in journals, posters, presentations at conferences and abstracts submitted in advance of conferences) if Celgene reasonably determines that the proposed disclosure is intellectual property that should be maintained as a trade secret to protect the Licensed Target or any Licensed Antibody and/or Licensed Product, in which event the Publishing Party agrees not to submit such publication or make such presentation that contains such information until:
(i)    with respect to publication or presentation of Licensed Program Non-Specific IP, Celgene is given [***], to seek patent protection for any such Licensed Program Non-Specific IP in such publication or presentation which it believes is patentable or to resolve any other issues, or
(ii)    with respect to publication or presentation of Licensed Program Specific IP, [***] for Celgene to (x) enable further development and optimization of such Licensed Program Specific IP (including related Licensed Antibodies and Licensed Products), (y) seek patent protection for any such Licensed Program Specific IP in such publication or presentation which it believes is patentable or (z) resolve any other issues; and/or
(c)    an identification of Celgene’s Confidential Information that is contained in the material reviewed, which the Publishing Party shall remove, if requested by Celgene.
Notwithstanding the foregoing or anything to the contrary contained herein, the restrictions set forth in this Section 7.8.1 shall not apply to publications or presentations by Celgene (or its Affiliates or sublicensees) and Celgene (and its Affiliates and sublicensees) shall be free to make publications and presentations with respect to results of the Licensed Program, the Licensed Target, Licensed Antibody and/or Licensed Product without the prior review or consent of Prothena.
7.8.2      Re-Publication; Re-Presentation . The contents of any publication or presentation that has been reviewed and approved by a reviewing Party may be re-released by the Publishing Party or the reviewing Party without a requirement for re-approval.
7.9      Use of Names . Except as otherwise expressly set forth herein, no Party (or its respective Affiliates) shall use the name, trademark, trade name or logo of the other Party or its Affiliates, or its or their respective employee(s) in any publicity, promotion, news release or other public disclosure relating to this Agreement or its subject matter, without the prior written permission of the other Party; provided that such permission shall not be required to the extent use thereof may be required by Applicable Law, including the rules of any securities exchange or market on which a Party’s (or its Affiliate’s) securities are listed or traded.

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7.10      Clinical Trials Registry . Celgene (and its Affiliates and designees) shall have the right to publish registry information and summaries of data and results from any Clinical Trials conducted in connection with activities under this Agreement, on its clinical trials registry or on a government-sponsored database such as www.clinicaltrials.gov, without requiring the consent of Prothena. The Parties shall reasonably cooperate if required or reasonably requested by Celgene in order to facilitate any such publication by Celgene (and its Affiliates and designees).
7.11      Relationship to Master Collaboration Agreement and Licensed Program U.S. License Agreement . Except as otherwise expressly stated in this Article 7, this Agreement supersedes the provisions of Article 8 of the Master Collaboration Agreement and the provisions of Article 7 of the Licensed Program U.S. License Agreement with respect to any Confidential Information related to the Licensed Program, the Licensed Target, Licensed Antibodies or Licensed Products (the “ Licensed Program Confidential Information ”); provided that, except as otherwise set forth herein, all “Confidential Information” of the “Disclosing Party” thereunder that is Licensed Program Confidential Information shall be deemed Confidential Information of the Disclosing Party hereunder and shall be subject to the terms and conditions of this Agreement and the “Receiving Party” shall be bound by and obligated to comply with such terms and conditions as if they were the Receiving Party hereunder, subject in all cases to Section 7.2. The foregoing shall not be interpreted as a waiver of any remedies available to the “Disclosing Party” as a result of any breach, prior to the Effective Date, by the “Receiving Party”, of its obligations pursuant to Article 8 of the Master Collaboration Agreement or pursuant to Article 7 of the Licensed Program U.S. License Agreement, as applicable.


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ARTICLE 8.     
REPRESENTATIONS AND WARRANTIES; COVENANTS
8.1     Representations and Warranties of Both Parties . Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:
(a)    such Party is duly organized, validly existing and in good standing under the Applicable Law of the jurisdiction of its formation and has full corporate power and authority to enter into this Agreement, and to carry out the provisions hereof;
(b)    such Party has taken all necessary corporate action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder;
(c)    this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, binding obligation, enforceable against it in accordance with its terms, except to the extent that enforcement of the rights and remedies created hereby is subject to (i) bankruptcy, insolvency, reorganization, moratorium and other similar laws of general application affecting the rights and remedies of creditors, or (ii) laws governing specific performance, injunctive relief and other equitable remedies;
(d)    the execution, delivery and performance of this Agreement by such Party does not breach or conflict with any agreement or any provision thereof, or any instrument or understanding, oral or written, to which such Party (or any of its Affiliates) is a party or by which such Party (or any of its Affiliates) is bound, nor violate any Applicable Law of any Governmental Authority having jurisdiction over such Party (or any of its Affiliates);
(e)    no government authorization, consent, approval, license, exemption of or filing or registration with any court or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, under any Applicable Law currently in effect, is or will be necessary for, or in connection with, the transaction contemplated by this Agreement, or for the performance by it of its obligations under this Agreement, except (i) as may be required to conduct Clinical Trials or to seek or obtain Regulatory Approvals or applicable Regulatory Materials or (ii) as set forth in Section 3.2 of the Master Collaboration Agreement; and
(f)    it has obtained all necessary authorizations, consents and approvals of any Third Party that is required to be obtained by it as of the Effective Date for, or in connection with, the transaction contemplated by this Agreement, or for the performance by it of its obligations under this Agreement, except (i) as may be required to conduct Clinical Trials or to seek or obtain Regulatory Approvals or applicable Regulatory Materials or (ii) as set forth in Section 3.2 of the Master Collaboration Agreement.
8.2      Representations and Warranties of Prothena . Except as set forth on Schedule 8.2, Prothena hereby represents and warrants to Celgene, as of the Effective Date, that: 5

5 [***]
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(a)     Schedules 1.46(b) and 1.63 contain a complete and accurate list of all Patents included in the Prothena IP that claim or cover any Licensed Target, Licensed Antibodies or Licensed Products, including the composition or use of any of the foregoing, and Prothena Controls all such Patents. Except for the Prothena IP, (i) Prothena and its Affiliates do not own or control (by license or otherwise), as of the Effective Date, any Patent or Know-How that is necessary or useful to Develop, Manufacture or Commercialize the Licensed Target, Licensed Antibodies or Licensed Products and (ii) no other Know-How or Patents arose from, or were used in, the performance of the Licensed Program under the Master Collaboration Agreement. To Prothena’s and its Affiliates’ actual knowledge, all issued Patents within the Prothena IP are in full force and effect, and are not invalid or unenforceable, in whole or in part;
(b)    no claim has been issued or served, or written threat of a claim or litigation made by any Person, against Prothena or its Affiliates that alleges that any Prothena IP is invalid or unenforceable;
(c)    neither Prothena nor its Affiliates own or otherwise control (through license or otherwise) any Antibodies (or any products constituting, incorporating, comprising or containing any such Antibody) that Target the Licensed Target, other than the Licensed Program Antibodies (all of which are set forth on Schedule 1.44 ) and the Licensed Program Products;
(d)    [***];
(e)    neither Prothena nor its Affiliates are subject to any payment obligations to Third Parties as a result of the execution or performance of this Agreement, or the research, development, manufacture or commercialization of the Licensed Target or any Antibodies (or any products constituting, incorporating, comprising or containing any such Antibody) that Target the Licensed Target;
(f)    Prothena has the full right and authority to grant all of the rights and licenses granted to Celgene (or purported to be granted to Celgene) hereunder; and neither Prothena nor its Affiliates have granted any right or license to any Third Party relating to any of the Prothena IP or any other Licensed Program Asset, Licensed Target or Antibody (or any products constituting, incorporating, comprising or containing any such Antibody) that Targets the Licensed Target, that would conflict with [***] any of the rights or licenses granted to Celgene hereunder;
(g)    Prothena is the sole and exclusive owner of the Prothena IP, except for the Prothena Licensed Collaboration IP that is exclusively licensed to Prothena (or its Affiliates) pursuant to the In-License Agreements set forth on Schedule 1.39 . All Affiliates of Prothena have exclusively licensed or assigned all of their right, title and interest in and to the Prothena IP to Prothena. Neither Prothena nor its Affiliates have granted any mortgage, pledge, claim, security interest, lien or other charge of any kind on the Prothena IP or other Licensed Program Asset, and the Prothena IP and the other Licensed Program Assets are free and clear of any mortgage, pledge, claim, security interest, lien or charge of any kind;
(h)    neither Prothena nor its Affiliates have received any written notice of any claim that any Patent or Know-How (including any trade secret right) owned or controlled

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by a Third Party would be infringed or misappropriated by the Development, Manufacture, or Commercialization of the Licensed Target, Licensed Antibody or Licensed Product;
(i)    to Prothena’s and its Affiliates’ actual knowledge, (i) the Development and Manufacture of the Licensed Target, any Licensed Antibody or Licensed Product, as conducted by or on behalf of Prothena or its Affiliates prior to the Effective Date, has not violated, infringed or misappropriated any intellectual property or proprietary right of any Third Party and (ii) [***];
(j)    there are no claims, judgments, settlements, litigations, suits, actions, disputes, arbitration, judicial or legal administrative or other proceedings or governmental investigations pending or, to Prothena’s or its Affiliates’ knowledge, threatened against Prothena or its Affiliates which would reasonably be expected to adversely affect or restrict the ability of Prothena to consummate or perform the transactions contemplated under this Agreement, or which would affect the Prothena IP or other Licensed Program Assets, or Prothena’s Control thereof, or the Licensed Target or any Licensed Antibody or Licensed Product;
(k)    neither Prothena nor its Affiliates have issued a claim against a Third Party alleging that a Third Party is infringing or has infringed or misappropriated any Prothena IP, and, to Prothena’s and its Affiliates’ actual knowledge, no issued Patents within the Prothena IP are being infringed and no trade secrets within the Prothena IP are being misappropriated by any Third Party;
(l)    neither Prothena nor its Affiliates have employed or otherwise used in any capacity, the services of any Person suspended, proposed for debarment or debarred under United States law, including under 21 U.S.C. § 335a, or any foreign equivalent thereof, with respect to the Licensed Target, the Licensed Antibodies or Licensed Products or otherwise in performing any portion of the Licensed Program. All Manufacture and Development (including non-clinical studies and Clinical Studies) related to the Licensed Target, Licensed Antibodies or Licensed Products conducted by or on behalf of Prothena or its Affiliates prior to the Effective Date (including the conduct of the Licensed Program under the Master Collaboration Agreement) has been conducted in accordance with all Applicable Laws (including, to the extent applicable, GCP, GLP and GMP);


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(m)    neither Prothena nor its Affiliates have entered into any agreement under which Prothena or its Affiliates (i) has obtained a license or sublicense of rights from a Third Party to the Licensed Target, or to any Antibodies (or any products constituting, incorporating, comprising or containing any such Antibody) that Target the Licensed Target, or to any Prothena IP, except for the In-License Agreements set forth on Schedule 1.39 , or (ii) has granted a license, sublicense, option or right to a Third Party that remains in effect as of the Effective Date to research, develop, manufacture or commercialize the Licensed Target or any Antibodies (or any products constituting, incorporating, comprising or containing any such Antibody) that Target the Licensed Target, except (1) with respect to licenses or rights granted pursuant to the agreements set forth on Schedule 1.39 that were entered into in the ordinary course of business [***] performing activities on behalf of Prothena [and (2) [*** ]] 6 . The agreements set forth on Schedule 1.39 do not conflict with [***] the rights or licenses granted to Celgene hereunder; 7
(n)    other than the Existing Program Agreements, Prothena (or its Affiliates, as applicable) has not entered into any agreement relating to the Development, Manufacture, Commercialization or other exploitation of the Licensed Target, Licensed Antibodies or Licensed Products, or the Prothena IP ;
(o)    with respect to each Existing Program Agreement and In-License Agreement, (i) it is in full force and effect; (ii) Prothena (or its Affiliate, as applicable) is not in breach thereof; (iii) Prothena (or its Affiliate, as applicable) has not received any notice from the counterparty to such Existing Program Agreement or In-License Agreement, as applicable, of Prothena’s (or its Affiliate’s, as applicable) breach or notice of threatened breach by Prothena (or its Affiliate, as applicable) thereof and (iv) Prothena has provided Celgene with a true, correct and complete copy of each Existing Program Agreement and In-License Agreement;
(p)    Prothena has disclosed to Celgene all material information and data, and all material correspondences to/from any Regulatory Authority, existing as at the Effective Date in the possession or control of Prothena or its Affiliates, in each case related to the Licensed Program, Licensed Target, Licensed Antibodies or Licensed Products;
(q)    the Licensed Program Inventory to be provided to Celgene hereunder was (and at all times up until delivery of such Licensed Program Inventory hereunder shall remain) manufactured, packaged, labeled, tested, stored and handled in accordance with all Applicable Laws (including GMPs), and specifications therefor, and such Licensed Program Inventory is not adulterated or misbranded under Applicable Law and is not an article that could not, under the provisions of the Applicable Law, be introduced into interstate commerce. All such Licensed Program Inventory is free and clear of all encumbrances (including through lien, charge, security interest, mortgage, encumbrance or otherwise); and
(r)    other than the Existing IND, Prothena has not obtained, or filed, any INDs, MAAs or Regulatory Approvals or any other form of regulatory application for approval of Clinical Trials, marketing or other purpose, for any Licensed Antibodies or Licensed Products and, to Prothena’s and it Affiliates’ actual knowledge, no other Person has obtained, or filed for, any such INDs, MAAs or Regulatory Approvals. The Existing IND is in full force and good standing,

6 [***]
7 [***]
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and neither Prothena nor its Affiliates have received any notice in writing, or otherwise has knowledge of any facts, which have, or reasonably could have, led Prothena to believe that the Existing IND is not currently in, or may not remain in, good standing with the FDA or other applicable Regulatory Authority.
8.3      Additional Representations, Warranties and Covenants of Prothena . Prothena hereby further represents, warrants and covenants to Celgene that:
8.3.1      With respect to the In-License Agreements, (a) Prothena (or its Affiliates, as applicable) shall not breach, or commit any acts or permit the occurrence of any omissions that would cause the breach or termination, of any In-License Agreement and (b) Prothena shall (or shall cause its Affiliates to, as applicable) satisfy all of its obligations under each In-License Agreement in all material respects and shall, or shall cause its Affiliates to, as applicable, maintain each In-License Agreement in full force and effect. Prothena shall, or shall cause its Affiliates to, as applicable, enforce its rights under each In-License Agreement to the extent necessary to preserve Celgene’s rights under this Agreement. Prothena shall not, and shall cause its Affiliates not to, [***] if doing so [***] under this Agreement. Prothena will provide Celgene with prompt written notice of any claim of a breach of which it is aware under any of the In-License Agreements or notice of termination of any In-License Agreement.
8.3.2      With respect to the Existing Program Agreements, (a) Prothena (or its Affiliate, as applicable) shall not breach, or commit any acts or permit the occurrence of any omissions that would cause the breach or termination, of any Existing Program Agreement and (b) Prothena shall (or shall cause its Affiliates to, as applicable) satisfy all of its obligations under each Existing Program Agreement in all material respects and shall, or shall cause its Affiliates to, as applicable, maintain each Existing Program Agreement in full force and effect, unless Prothena otherwise obtains Celgene’s prior written consent (such consent not to be unreasonably withheld). Prothena shall, or shall cause its Affiliates to, as applicable, enforce its rights under each Existing Program Agreement to the extent necessary to preserve Celgene’s rights under this Agreement. Prothena shall not, and shall cause its Affiliates not to, [***] under this Agreement. Except as set forth in Section 2.3.5, Prothena shall not, and shall cause its Affiliates not to assign or otherwise transfer any Existing Program Agreement. Prothena will provide Celgene with prompt written notice of any claim of a breach of which it is aware under any of the Existing Program Agreements or notice of termination of any Existing Program Agreement.
8.3.3      In-License Agreements . [***] on case-by-case basis, Prothena shall (or shall cause its Affiliates to, as applicable) execute a written agreement, in a form reasonably acceptable to Celgene, with each Third Party that is a counterparty to the applicable In-License Agreement (each such counterparty, a “ Prothena Licensor ”) within [***] ([***]) days after the date of such request, pursuant to which (a) in the event of an early termination of such In-License Agreement, at the request of Celgene, such Prothena Licensor shall grant a direct license to Celgene with respect to the intellectual property licensed to Prothena under such In-License Agreement, on the same terms under which such Prothena Licensor grants such license to Prothena (or its Affiliate, as applicable) under such In-License Agreement, (b) such Prothena Licensor agrees to and acknowledges the rights granted to Celgene hereunder with respect to any intellectual property

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licensed to Prothena (or its Affiliate, as applicable) under such In-License Agreement, including the rights as set forth in this Section 8.3.3, and (c) [***].
8.3.4      Notwithstanding anything to the contrary contained herein, [***].
8.3.5      Prothena shall promptly notify Celgene in writing if any Patents in the Prothena IP that claim or cover any Licensed Target, Licensed Antibodies or Licensed Products, including the composition or use of any of the foregoing, becomes known to Prothena that are not listed on Schedule 1.46(b) or 1.63 .
8.4      Representations and Warranties of Celgene . Except as set forth on Schedule 8.4 , Celgene hereby represents and warrants to Prothena, as of the Effective Date, that:
8.4.1    there are no claims, judgments, settlements, litigations, suits, actions, disputes, arbitration, judicial or legal administrative or other proceedings or governmental investigations pending or, to Celgene’s actual knowledge, threatened against Celgene which would reasonably be expected to adversely affect or restrict the ability of Celgene to consummate or perform the transactions contemplated under this Agreement.
8.5     Covenants .
8.5.1     Mutual Covenants . Each Party hereby covenants to the other Party that:
(a)    such Party and its Affiliates shall perform its activities pursuant to this Agreement in compliance (and shall ensure compliance by any of its subcontractors) with all Applicable Laws, including, to the extent applicable, GCP, GLP and GMP.
8.5.2      Prothena Covenants . Prothena hereby covenants to Celgene that:
(a)    Neither Prothena nor its Affiliates shall grant any right or license to any Third Party relating to any of the intellectual property rights it owns or Controls (including the Prothena IP and other Licensed Program Assets), or otherwise with respect to any Licensed Antibody, Licensed Product or Diagnostic Product which conflict with, [***] any of the rights or licenses granted to Celgene hereunder; and
(b)    Except with respect to the performance of the Prothena Ongoing Program Activities in accordance with Section 2.1.3 (or as otherwise expressly agreed to by Celgene in writing, including as set forth in Section 2.1.3(c)), neither Prothena nor its Affiliates shall use (and neither shall grant any Third Party the right to use) any Licensed Antibodies, Licensed Products or Diagnostic Products for any purposes in the Territory.
8.6      Disclaimer . EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATIONS OR EXTENDS ANY WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED (AND EACH PARTY HEREBY EXPRESSLY DISCLAIMS ANY AND ALL REPRESENTATIONS AND WARRANTIES NOT EXPRESSLY PROVIDED IN THIS AGREEMENT), INCLUDING WITH RESPECT TO ANY

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PATENTS OR KNOW-HOW, OR MATERIALS, INCLUDING WARRANTIES OF VALIDITY OR ENFORCEABILITY, MERCHANTABILITY, FITNESS FOR A PARTICULAR USE OR PURPOSE, PERFORMANCE, AND NONINFRINGEMENT OF ANY THIRD PARTY PATENTS OR OTHER INTELLECTUAL PROPERTY RIGHTS. WITHOUT LIMITING THE FOREGOING, NEITHER PARTY MAKES ANY REPRESENTATION, WARRANTY OR GUARANTEE THAT THE LICENSED PROGRAM WILL BE SUCCESSFUL, OR THAT ANY OTHER PARTICULAR RESULTS WILL BE ACHIEVED WITH RESPECT TO THE LICENSED PROGRAM, THE LICENSED TARGET, ANY LICENSED ANTIBODY OR ANY LICENSED PRODUCT HEREUNDER.
ARTICLE 9.     
INDEMNIFICATION; INSURANCE
9.1      Indemnification by Celgene . Celgene shall indemnify, defend and hold harmless Prothena and its Affiliates and its and their respective directors, officers, employees, agents, successors and assigns (collectively, the “ Prothena Indemnitees ”), from and against any and all Third Party Damages to the extent arising out of or relating to, directly or indirectly, any Third Party Claim based upon:
(a)    the gross negligence or willful misconduct of Celgene or its Affiliates or its or their respective directors, officers, employees or agents, in connection with Celgene’s performance of its obligations under this Agreement;
(b)    any breach by Celgene of any of its representations, warranties, covenants, agreements or obligations under this Agreement; or
(c)    any claim for personal injury or death arising out of the Development, Manufacture or Commercialization of the Licensed Antibodies and Licensed Products in the Territory by or on behalf of Celgene or its Affiliates or Sublicensees during the Term;
in each case (a)-(c), provided, however, that such indemnity shall not apply to the extent Prothena has an indemnification obligation pursuant to Section 9.2(a) or (b) for such Third Party Damages.
9.2      Indemnification by Prothena . Prothena shall indemnify, defend and hold harmless Celgene, its Affiliates and its and their respective directors, officers, employees, agents, successors and assigns (collectively, the “ Celgene Indemnitees ”), from and against any and all Third Party Damages to the extent arising out of or relating to, directly or indirectly, any Third Party Claim based upon:
(a)    the gross negligence or willful misconduct of Prothena or its Affiliates or its or their respective directors, officers, employees or agents, in connection with Prothena’s performance of its obligations under this Agreement;
(b)    any breach by Prothena of any of its representations, warranties, covenants, agreements or obligations under this Agreement; or

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(c)    any claim for personal injury or death arising out of the Development, Manufacture or Commercialization of the Licensed Antibodies (including Reversion Antibodies) and Licensed Products (including products containing Reversion Antibodies) by or on behalf of Prothena or its Affiliates or sublicensees;
in each case (a)-(c), provided, however, that such indemnity shall not apply to the extent Celgene has an indemnification obligation pursuant to Section 9.1(a) or (b) for such Third Party Damages.
9.3      Procedure . If a Party is seeking indemnification under Section 9.1 or 9.2, as applicable (the “ Indemnitee ”), it shall inform the other Party (the “ Indemnitor ”) of the claim giving rise to the obligation to indemnify pursuant to Section 9.1 or 9.2, as applicable, as soon as reasonably practicable after receiving notice of the claim (provided, however, any delay or failure to provide such notice shall not constitute a waiver or release of, or otherwise limit, the Indemnitee’s rights to indemnification under Section 9.1 or 9.2, as applicable, except to the extent that such delay or failure materially prejudices the Indemnitor’s ability to defend against the relevant claims). The Indemnitor shall have the right to assume the defense of any such claim for which the Indemnitee is seeking indemnification pursuant to Section 9.1 or 9.2, as applicable. The Indemnitee shall cooperate with the Indemnitor and the Indemnitor’s insurer as the Indemnitor may reasonably request, and at the Indemnitor’s cost and expense. The Indemnitee shall have the right to participate, at its own expense and with counsel of its choice, in the defense of any claim or suit that has been assumed by the Indemnitor. The Indemnitor shall not settle any claim without the prior written consent of the Indemnitee, not to be unreasonably withheld; provided, however, that the Indemnitor shall not be required to obtain such consent if the settlement (i) involves only the payment of money and will not result in the Indemnitee (or other Prothena Indemnitees or Celgene Indemnitees, as applicable) becoming subject to injunctive or other similar type of relief, (ii) does not require an admission by the Indemnitee (or other Prothena Indemnitees or Celgene Indemnitees, as applicable) and (iii) does not adversely affect the rights or licenses granted to the Indemnitee (or its Affiliate) under this Agreement. The Indemnitee shall not settle or compromise any such claim without the prior written consent of the Indemnitor, which it may provide in its sole discretion. If the Parties cannot agree as to the application of Section 9.1 or 9.2, as applicable, to any claim, pending resolution of the dispute pursuant to Section 11.7 the Parties may conduct separate defenses of such claims, with each Party retaining the right to claim indemnification from the other Party in accordance with Section 9.1 or 9.2, as applicable, upon resolution of the underlying claim. In each case, the Indemnitee shall reasonably cooperate with the Indemnitor, and shall make available to the Indemnitor all pertinent information under the control of the Indemnitee, which information shall be subject to Article 7.
9.4      Insurance . During the Term and for a period of [***] ([***]) years thereafter, each Party shall maintain, at its cost, a program of insurance and/or self-insurance against liability and other risks associated with its activities and obligations under this Agreement (including, with respect to its Clinical Trials), and its indemnification obligations hereunder, in such amounts, subject to such deductibles and on such terms as are customary for such Party for the activities to be conducted by it under this Agreement. It is understood that such insurance shall not be construed

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to create a limit on either Party’s liability with respect to its indemnification obligations under this Article 9, or otherwise.
9.5      LIMITATION OF LIABILITY . NEITHER PROTHENA NOR CELGENE, NOR ANY OF THEIR RESPECTIVE AFFILIATES, WILL BE LIABLE TO THE OTHER PARTY OR ITS AFFILIATES UNDER OR IN CONNECTION WITH THIS AGREEMENT FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL OR PUNITIVE OR EXEMPLARY DAMAGES (INCLUDING LOST PROFITS OR LOST REVENUES), WHETHER LIABILITY IS ASSERTED IN CONTRACT, TORT (INCLUDING NEGLIGENCE AND STRICT PRODUCT LIABILITY), INDEMNITY, CONTRIBUTION OR OTHERWISE, AND IRRESPECTIVE OF WHETHER THAT PARTY OR ANY REPRESENTATIVE OF THAT PARTY HAS BEEN ADVISED OF, OR OTHERWISE MIGHT HAVE ANTICIPATED THE POSSIBILITY OF, ANY SUCH LOSS OR DAMAGE. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 9.5 IS INTENDED TO OR SHALL LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER SECTIONS 9.1 OR 9.2 IN CONNECTION WITH ANY THIRD PARTY CLAIMS [***].
ARTICLE 10.     
TERM AND TERMINATION
10.1      Term; Expiration .
10.1.1      Term . Subject to Section 3.2 of the Master Collaboration Agreement, this Agreement shall become effective on the Effective Date and, unless earlier terminated in accordance with this Article 10, shall remain in effect until it expires as follows (the “ Term ”):
(a)    on a Licensed Product-by-Licensed Product and country-by-country basis, this Agreement shall expire on the date of the expiration of the Royalty Term with respect to such Licensed Product in such country; and
(b)    in its entirety upon the expiration of all applicable Royalty Terms under this Agreement with respect to all Licensed Products in all countries in the Territory.
10.1.2      Effect of Expiration . After the expiration of the Term pursuant to Section 10.1.1 above, the following terms shall apply:
(a)     Licenses after Licensed Product Expiration . After expiration of the Term with respect to a given Licensed Product in a given country pursuant to Section 10.1.1(a), the licenses set forth in Section 6.1 with respect to such Licensed Product (and the Licensed Antibody contained therein) and related Diagnostic Products in such country will automatically become fully paid-up, perpetual, irrevocable and royalty-free.
(b)     Licenses after Expiration of Agreement . After expiration of the Term with respect to this Agreement in its entirety pursuant to Section 10.1.1(b), all licenses set forth in Section 6.1 will automatically become fully paid-up, perpetual, irrevocable and royalty-free.

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10.2      Termination for Breach .
10.2.1      Material Breach . This Agreement may be terminated by a Party for the material breach by the other Party of this Agreement provided that the breaching Party has not cured such breach within ninety (90) days after the date of written notice to the breaching Party of such breach (or thirty (30) days in the case of a breach as a result of non-payment of any amounts due under this Agreement) (the “ Cure Period ”), which notice shall describe such breach in reasonable detail and shall state the non-breaching Party's intention to terminate this Agreement. For clarity, but subject to Section 10.2.2, the Cure Period for any allegation made as to a material breach under this Agreement will run from the date that written notice was first provided to the breaching Party by the non-breaching Party. Any such termination of this Agreement under this Section 10.2.1 shall become effective at the end of the Cure Period, unless the breaching Party has cured such breach prior to the expiration of such Cure Period, or, if such breach is not susceptible to cure within the Cure Period, then such Cure Period shall be extended for an additional [***] ([***]) days so long as the breaching Party [***]. For the avoidance of doubt, termination of this Agreement pursuant to this Section 10.2.1 shall terminate the Master Collaboration Agreement solely with respect to the Licensed Program but shall not terminate the Master Collaboration Agreement with respect to any other Programs or any U.S. License Agreement or other Global License Agreement for any other Program.
10.2.2      Disagreement as to Material Breach . Notwithstanding Section 10.2.1, if the Parties in good faith disagree as to whether there has been a material breach of this Agreement pursuant to Section 10.2.1, then: (a) the Party that disputes that there has been a material breach may contest the allegation by referring such matter, within [***], for resolution to the Executive Officers, who shall meet promptly to discuss the matter and determine, within [***], whether or not a material breach has occurred pursuant to Section 10.2.1; provided that if the Executive Officers are unable to resolve such dispute within such [***] ([***]) [***] period after it is referred to them, the matter will be resolved as provided in Section 11.7; (b) the relevant Cure Period with respect thereto will be tolled from the date the breaching Party notifies the non-breaching Party of such dispute and through the resolution of such dispute in accordance with the applicable provisions of this Agreement; (c) subject to Section 10.10, during the pendency of such dispute, all of the terms and conditions of this Agreement shall remain in effect and the Parties shall continue to perform all of their respective obligations hereunder; and (d) if it is ultimately determined that the breaching Party committed such material breach, then the breaching Party shall have the right to cure such material breach, after such determination, within the Cure Period (as may be extended in accordance with Section 10.2.1) which shall commence as of the date of such determination.
10.3      Voluntary Termination . Celgene may terminate this Agreement at will, in its sole discretion, in its entirety upon sixty (60) days’ prior written notice to Prothena at any time.
10.4      Termination for Bankruptcy . If either Party makes a general assignment for the benefit of, or an arrangement or composition generally with, its creditors, appoints or suffers appointment of an examiner or of a receiver or trustee over all or substantially all of its property, passes a resolution for its winding up or files a petition under any bankruptcy or insolvency act or law or has any such petition filed against it which is not dismissed, discharged, bonded or stayed

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within ninety (90) days after the filing thereof (each, an “ Insolvency Event ”), the other Party may terminate this Agreement in its entirety, effective immediately upon written notice to such Party, provided that, in connection therewith, the provisions of Section 6.5 shall apply.
10.5      Termination for Patent Challenge . Prothena shall have the right to terminate this Agreement upon written notice if Celgene or any Affiliate of Celgene challenges the validity, scope or enforceability of or otherwise opposes any Patent included in the Prothena IP that is licensed to Celgene under this Agreement, in each case through a formal proceeding (other than as may be necessary or reasonably required to assert a cross-claim or a counter-claim or to respond to a court request or order or administrative law, request or order). If a Sublicensee of Celgene with respect to any Prothena IP challenges the validity, scope or enforceability of or otherwise opposes any Patent included in such Prothena IP under which such Sublicensee is sublicensed, in each case through a formal proceeding (other than as may be necessary or reasonably required to assert a cross-claim or a counter-claim or to respond to a court request or order or administrative law, request or order) then Celgene shall, upon written notice from Prothena, terminate such sublicense.
10.6      Effects of Expiration or Termination; Additional Remedies .
10.6.1      Termination by Prothena Pursuant to Section 10.2, 10.4 or 10.5, or by Celgene Pursuant to Section 10.3 . In the event this Agreement is terminated by Prothena pursuant to Section 10.2, 10.4 or 10.5, or by Celgene pursuant to Section 10.3, upon the effective date of such termination:
(a)    the Master Collaboration Agreement (if not previously expired or terminated) shall also terminate automatically with respect to the Licensed Program (but not any other Program);
(b)    except as set forth in this Section 10.6.1, or Sections 10.8 or 10.9, all rights and licenses granted herein shall terminate;
(c)    any and all Collaboration Specific IP shall thereafter no longer be deemed to be Collaboration Specific IP;
(d)    each Party shall return or destroy all Confidential Information of the other Party as required by Article 7; and
(e)    notwithstanding the foregoing provisions of this Section 10.6.1, the licenses granted to Celgene hereunder shall survive for [***] ([***]) [***] following the effective date of termination in order for Celgene (and its Affiliates, Sublicensees and distributors), at Celgene’s discretion, during the [***] ([***])-[***] period immediately following the effective date of termination, to (i) finish or otherwise wind-down any ongoing Clinical Trials with respect to any Licensed Antibodies, Licensed Products or Diagnostic Products hereunder and (ii) finish and sell any [***] Licensed Antibodies, Licensed Products or Diagnostic Products remaining in inventory (provided that Celgene shall pay royalties on Annual Net Sales of such Licensed Products sold by Celgene during such period (provided that the applicable Royalty Term is still ongoing) as an to the extent Celgene would otherwise be required to pay such royalties as set forth in Section

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5.3); provided that, for clarity, Celgene shall have no obligation to undertake such activities, in each case of (i) and (ii), as and to the extent determined by Celgene.
10.6.2      Termination by Celgene Pursuant to Section 10.2 or 10.4 . In the event this Agreement is terminated by Celgene pursuant to Section 10.2 or 10.4, upon the effective date of such termination:
(a)    the Master Collaboration Agreement (if not previously expired or terminated) shall also terminate automatically with respect to the Licensed Program (but not any other Program);
(b)    except as set forth in this Section 10.6.2 or Sections 10.8 or 10.9, all rights and licenses granted herein shall terminate;
(c)    any and all Collaboration Specific IP hall thereafter no longer be deemed to be Collaboration Specific IP;
(d)    each Party shall return or destroy all Confidential Information of the other Party as required by Article 7; and
(e)    notwithstanding the foregoing provisions of this Section 10.6.2, the licenses granted to Celgene hereunder shall survive for [***] ([***]) [***] following the effective date of termination in order for Celgene (and its Affiliates, Sublicensees and distributors), at Celgene’s discretion, during the [***] ([***])-[***] period immediately following the effective date of termination, to (i) finish or otherwise wind-down any ongoing Clinical Trials with respect to any Licensed Antibodies, Licensed Products or Diagnostic Products hereunder and (ii) finish and sell [***] any Licensed Antibodies, Licensed Products or Diagnostic Products remaining in inventory (provided that Celgene shall pay royalties on Annual Net Sales of such Licensed Products sold by Celgene during such period (provided that the applicable Royalty Term is still ongoing) as an to the extent Celgene would otherwise be required to pay such royalties as set forth in Section 5.3); provided that, for clarity, Celgene shall have no obligation to undertake such activities, in each case of (i) and (ii), as and to the extent determined by Celgene.
10.7      Certain Additional Remedies of Celgene in Lieu of Termination . In the event that (i) Celgene notifies Prothena in writing of a material breach of this Agreement by Prothena, and (ii) Celgene would have the right to terminate this Agreement pursuant to Section 10.2, then in lieu of Celgene terminating pursuant to Section 10.2, and without limiting any other rights or remedies of Celgene, Celgene may elect to have this Agreement continue in full force and effect by providing written notice thereof to Prothena; provided, however, that if Celgene so elects to continue this Agreement, then from and after such time as Celgene delivers such written notice to Prothena, any and all amounts thereafter payable by Celgene hereunder (including Regulatory Milestone Payments, Sales Milestone Payments and royalties) shall be reduced by [***].
10.8      Prothena Reversion Antibodies . If this Agreement terminates, except for any termination by Celgene pursuant to Section 10.2 or 10.4, then the provisions of this Section 10.8

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(and for the avoidance of doubt, the provisions of this Section 10.8 shall not apply in the case of termination by Celgene pursuant to Section 10.2 or 10.4).
10.8.1      Reversion. All Licensed Program Antibodies that were the subject of Clinical Trials conducted by Celgene pursuant to this Agreement shall be automatically and immediately deemed “ Prothena Reversion Antibodies ”. Celgene shall grant and hereby grants to Prothena a non-exclusive, royalty-free, license in the Territory, with the right to grant sublicenses through multiple tiers, under any Patents and/or Know-How Controlled by Celgene or its Affiliates as of the termination effective date claiming or covering [***], into the Prothena Reversion Antibodies as they exist as of such termination effective date, solely as necessary to research, Develop, Manufacture, use, import, offer for sale, sell, and Commercialize Prothena Reversion Antibodies [***] in the Field in the Territory; [***].
10.8.2      Effects of Reversion. With respect to each Prothena Reversion Antibody:
(a)    Except to the extent not permitted pursuant to any agreements between Celgene and a Third Party, Celgene shall provide to Prothena, within a reasonable time, at Prothena's request (provided that such request was made within [***] ([***]) days after the effective date of termination), subject to [***], copies of (i) [***] Clinical Trial data and results generated by or on behalf of Celgene or its Affiliates in the Development of Prothena Reversion Antibodies pursuant to this Agreement, and (ii) [***] relating to the manufacture of such Prothena Reversion Antibodies; in each case, to the extent in Celgene’s possession as of the termination effective date [***]. For clarity, Prothena shall have the right to use the foregoing [***] solely in connection with the exercise of Prothena’s rights under Section 10.8.1;
(b)    Celgene shall transfer within a reasonable time to Prothena, at Prothena’s request (provided that such request was made within [***] ([***]) days after the effective date of termination), [***], [***] Regulatory Filings [***] for the Prothena Reversion Antibodies [***] by Celgene or its Affiliates as of the termination effective date; [***];
(c)    Celgene shall otherwise cooperate reasonably with Prothena to provide a transfer of the materials described in the foregoing provisions of this Section 10.8.2, [***];
(d)    As and to the extent a Third Party is Manufacturing such Prothena Reversion Antibody for Celgene or its Affiliate, Celgene shall use reasonable efforts, at Prothena’s request (provided that such request was made within [***] ([***]) days after the effective date of termination) [***], to [***]. Additionally, at Prothena’s request (provided that such request was made within [***] ([***]) days after the effective date of termination), Celgene shall transfer to Prothena [***] such Prothena Reversion Antibody owned by Celgene and then in Celgene’s possession, for a price equal to [***];
(e)    To the extent that Celgene or its Affiliate owns any trademark(s) and/or domain names that [***] a Prothena Reversion Antibody that [***] for the Commercialization of a Prothena Reversion Antibody (as [***], but not including any marks that include, in whole or part, any corporate name or logo of Celgene or its Affiliate), Prothena shall have the right to [***].

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Prothena shall exercise such right by written notice to Celgene within [***] ([***]) days after such Licensed Antibody or Licensed Product becomes a Prothena Reversion Antibody; and
(f)    If Celgene or its Affiliate has obtained a license from a Third Party and Prothena is a sublicensee under such license pursuant to Section 10.8.1, then [***]. Notwithstanding the provisions of Section 10.8.1, Prothena shall not get a sublicense of any Third Party intellectual property pursuant to Section 10.8.1 unless such sublicense is allowed pursuant to and in accordance with the agreement between Celgene and such Third Party.
10.9      Surviving Provisions .
10.9.1      Accrued Rights; Remedies . Termination or expiration of this Agreement for any reason shall be without prejudice to any rights that shall have accrued to the benefit of any Party prior to such termination or expiration, and any and all damages or remedies (whether in law or in equity) arising from any breach hereunder, each of which shall survive termination or expiration of this Agreement. Such termination or expiration shall not relieve any Party from obligations which are expressly indicated to survive termination or expiration of this Agreement. Except as otherwise expressly set forth in this Agreement, the termination provisions of this Article 10 are in addition to any other relief and remedies available to either Party under this Agreement and at Applicable Law.



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10.9.2      Survival . Without limiting the provisions of Section 10.9.1, the rights and obligations of the Parties set forth in the following Sections and Articles of this Agreement shall survive the expiration or termination of this Agreement, in addition to those other terms and conditions that are expressly stated to survive termination or expiration of this Agreement: [Article 1 (to the extent the definitions are used in other surviving provisions), Section 2.3.5(a) (solely as to the last sentence therein) Article 5 (as to payment obligations accrued prior to the effectiveness of termination or expiration of this Agreement), Section 6.3, Section 6.4, Section 6.5, Section 6.6, Section 6.12 (solely if there is no U.S. License Agreement or other Global License Agreement covering the applicable Joint Patents), Article 7, Section 8.6, Article 9, Section 10.1.2, Section 10.6, Section 10.8, Section 10.9, Section 10.10, Section 10.11, and Article 11.]. 8
10.10      [***] . Notwithstanding anything to the contrary contained herein, in the event notice of termination of this Agreement is given [***].
10.11      Relationship to Other Agreements . Termination of this Agreement shall not affect in any way the terms or provisions of any other then-existing executed Global License Agreements or U.S. License Agreements.
ARTICLE 11.     
MISCELLANEOUS
11.1     Severability . If any one or more of the terms or provisions of this Agreement is held by a court of competent jurisdiction to be void, invalid or unenforceable in any situation in any jurisdiction, such holding shall not affect the validity or enforceability of the remaining terms and provisions hereof or the validity or enforceability of the invalid, void or unenforceable term or provision in any other situation or in any other jurisdiction, and the term or provision shall be considered severed from this Agreement solely for such situation and solely in such jurisdiction, unless the invalid, void or unenforceable term or provision is of such essential importance to this Agreement that it is to be reasonably assumed that the Parties would not have entered into this Agreement without the invalid, void or unenforceable term or provision. If the final judgment of such court declares that any term or provision hereof is invalid, void or unenforceable, the Parties agree to (a) reduce the scope, duration, area or applicability of the term or provision or to delete specific words or phrases to the minimum extent necessary to cause such term or provision as so reduced or amended to be enforceable, and (b) make a good faith effort to replace any invalid, void or unenforceable term or provision with a valid and enforceable one such that the objectives contemplated by the Parties when entering this Agreement may be realized.
11.2     Notices . Any notice required or permitted to be given by this Agreement shall be in writing and in English and shall be (a) delivered by hand or by overnight courier with tracking capabilities, (b) mailed postage prepaid by first class, registered, or certified mail, or (c) delivered by facsimile followed by delivery via either of the methods set forth in Sections 11.2(a) and (b), in each case, addressed as set forth below unless changed by notice so given:

8 To be updated in final version
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If to Celgene:
Celgene Switzerland LLC
AON House
30 Woodbourne Ave.
Pembroke HM 08, Bermuda
Attention:    [***]

With copies to:
Celgene Corporation
    86 Morris Avenue
    Summit, New Jersey 07901 U.S.A.
    Attention:    General Counsel
    Facsimile:    (908) 673-2771
If to Prothena:
Prothena Biosciences Limited

Adelphi Plaza
Upper George’s Street
Dun Laoghaire, Co. Dublin A96 T927
Ireland    
Attention:     Company Secretary
Facsimile:     +353-1-686-5675

With copies to:

Prothena Biosciences Inc.
331 Oyster Point Boulevard
South San Francisco, CA, 94080
U.S.A.
Attention:    Vice President, Business Development
Facsimile:     +1 650-837-8560
Any such notice shall be deemed given on the date received, except any notice received after 5:30 p.m. (in the time zone of the receiving party) on a Business Day or received on a non-Business Day shall be deemed to have been received on the next Business Day. A Party may add, delete, or change the person or address to which notices should be sent at any time upon written notice delivered to the other Parties in accordance with this Section 11.2.
11.3     Force Majeure . A Party shall not be liable for delay or failure in the performance of any of its obligations hereunder if such delay or failure is due to a cause beyond the reasonable control of such Party, including acts of God, fires, earthquakes, acts of war, terrorism, or civil unrest,

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or hurricane or other inclement weather (“ Force Majeure ”); provided, however, that the affected Party promptly notifies the other Party and further provided that the affected Party shall use its commercially reasonable efforts to avoid or remove such causes of non-performance and to mitigate the effect of such occurrence, and shall continue performance in accordance with the terms of this Agreement whenever such causes are removed. When such circumstances arise, the Parties shall negotiate in good faith any modifications of the terms of this Agreement that may be necessary or appropriate in order to arrive at an equitable solution.
11.4     Assignment .
11.4.1     Generally . Except as expressly permitted herein, this Agreement may not be assigned or transferred by any Party, nor may any Party assign or transfer any rights or obligations created by this Agreement, except as expressly permitted hereunder without the prior written consent of the other Party, which consent will not be unreasonably withheld.
11.4.2     Celgene . Notwithstanding the limitations in Section 11.4.1, and subject to Section 5.6.2 and the remaining provisions of this Section 11.4.2, Celgene may assign or transfer this Agreement, or any rights or obligations hereunder in whole or in part, to (a) one or more Affiliates (provided, however, that Celgene shall remain fully and unconditionally liable and responsible to the non-assigning Party hereto for the performance and observance of all such duties and obligations by such Affiliate); or (b) its successor in interest in connection with its merger, consolidation, or sale of all or substantially all of its assets or that portion of its business pertaining to the subject matter of this Agreement.
11.4.3     Prothena . Notwithstanding the limitations in Section 11.4.1, and subject to Section 5.6.2 and the remaining provisions of this Section 11.4.3, Prothena may assign or transfer this Agreement, or any rights or obligations hereunder in whole or in part, to (a) one or more Affiliates (provided, however, Prothena shall remain fully and unconditionally liable and responsible to the non-assigning Party hereto for the performance and observance of all such duties and obligations by such Affiliate); or (b) its successor in interest in connection with its merger, consolidation, or sale of all or substantially all of its assets.
11.4.4     Intellectual Property of Acquirer . Notwithstanding anything to the contrary in this Agreement, if a Party is acquired by a Third Party after the Effective Date, then with respect to any intellectual property rights controlled by the Third Party acquiring party or its affiliates (other than one of the Parties to this Agreement or its Affiliates immediately prior to such acquisition) involved in any assignment of this Agreement by such Party to such Third Party acquirer, such intellectual property rights shall not be included in the technology and intellectual property rights licensed to the other Party hereunder to the extent held immediately prior to such transaction by such acquirer or its affiliate (other than the relevant Party to this Agreement or its Affiliates immediately prior to such acquisition), and developed outside the scope of activities conducted with respect to the Collaboration, any Program, any U.S. License Agreement or any Global License Agreement. The Prothena IP shall also exclude any intellectual property developed by such Third Party acquirer after such acquisition; provided that (i) such intellectual property is developed independently of the activities under this Agreement, the Collaboration, any Program, the

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Collaboration Agreement, any U.S. License Agreement or any Global License Agreement [***], (ii) Prothena and its Affiliates put in place firewalls and other protections to [***] and (iii) [***].
11.4.5     All Other Assignments Null and Void . The terms of this Agreement will be binding upon and will inure to the benefit of the successors, heirs, administrators and permitted assigns of the applicable Party. Any purported assignment in violation of this Section 11.4 will be null and void ab initio .
11.5     Waivers and Modifications . The failure of any Party to insist on the performance of any obligation hereunder shall not be deemed to be a waiver of such obligation. Waiver of any breach of any provision hereof shall not be deemed to be a waiver of any other breach of such provision or any other provision on such occasion or any succeeding occasion. No waiver, modification, release, or amendment of any obligation under or provision of this Agreement shall be valid or effective unless in writing and signed by the Parties.
11.6     WAIVER OF JURY TRIAL . EXCEPT AS LIMITED BY APPLICABLE LAW, EACH PARTY HERETO HEREBY IRREVOCABLY WAIVES ALL RIGHT TO TRIAL BY JURY IN ANY ACTION, PROCEEDING OR COUNTERCLAIM (WHETHER BASED IN CONTRACT, TORT OR OTHERWISE) ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE ACTIONS OF ANY PARTY HERETO IN THE NEGOTIATION, ADMINISTRATION, PERFORMANCE AND ENFORCEMENT HEREOF.
11.7     Choice of Law; Dispute Resolution .
11.7.1     Choice of Law . This Agreement shall be governed by, enforced and construed in accordance with the laws of the State of New York without reference to any rules of conflict of laws or renvoi and excluding the United Nations Convention on Contracts for the International Sales of Goods; provided, however, that with respect to matters involving the validity or infringement of intellectual property rights in a given country, such matter may be brought in the applicable country (in accordance with Section 11.7.3) and the Applicable Laws of the applicable country shall apply (subject to Section 6.6.1).
11.7.2     Exclusive Dispute Resolution Mechanism . The Parties agree that the procedures set forth in Section 11.7.3 will be the exclusive mechanism for resolving any dispute (whether in contract, tort or otherwise), controversy or claim between the Parties arising out of or in connection with this Agreement, any Party’s rights or obligations under this Agreement, breach of this Agreement or the transactions contemplated by this Agreement (each, a “ Dispute ”); provided that decisions that are subject to the decision making authority of a given Party, as expressly set forth in this Agreement, will not be subject to the provisions of Section 11.7.3 so long as such decisions are made in accordance with this Agreement.
11.7.3     Jurisdiction .
(a)    Except as otherwise set forth in this Section 11.7.3, the sole jurisdiction and venue for all actions, suits and proceedings arising out of any Dispute (except in respect of an Excluded Claim, where jurisdiction is non-exclusive) will be the state and federal

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courts located in the Borough of Manhattan in New York, New York, USA. Each Party hereby irrevocably and unconditionally (a) consents to submit to the exclusive jurisdiction of the state and federal courts located in the Borough of Manhattan in New York, New York, USA for any action, suit or proceeding arising out of such Dispute, and (b) waives any objection to the laying of venue of any action, suit or proceeding arising out of such Dispute in the state and federal courts of the Borough of Manhattan in New York, New York, USA and agrees not to plead or claim in any such court that any such action, suit or proceeding brought in any such court has been brought in an inconvenient forum. Each of the Parties agrees that process may be served upon it in the manner specified in Section 11.2 and irrevocably waives and covenants not to assert or plead any objection which it might otherwise have to such jurisdiction, or to such manner of service of process. It shall be a condition precedent to the commencement of any action in court or other tribunal (save an action for an interim injunction or provisional relief) in respect of any Dispute relating to this Agreement that the Parties have sought to resolve the Dispute by either Party notifying the other Party in writing for resolution to the Executive Officers who shall meet (whether in person or via teleconference) within [***] ([***]) [***] of such notice to seek resolution in good faith. If the Executive Officers are unable to resolve the Dispute at such meeting, either Party may pursue any remedy available to such Party at law or in equity, subject to the terms and conditions of this Agreement, including this Section 11.7.3.
(b)    Notwithstanding the provisions of Section 11.7.3(a), either Party may, without waiving any remedy under this Agreement, seek from any court having jurisdiction any equitable relief, including any injunctive or provisional relief and specific performance to protect the rights or property of that Party. Such remedies will not be deemed to be the exclusive remedies for a breach of this Agreement but will be in addition to all other remedies available at law or equity. In addition, notwithstanding the provisions of Section 11.7.3(a) either Party may bring an action in any court having jurisdiction to enforce an award rendered pursuant to Section 11.7.3(a).
(c)    Until final resolution of the dispute through judicial determination, (i) this Agreement will remain in full force and effect and (ii) the time periods for cure as to any termination will be tolled. The Parties further agree that any payments made pursuant to this Agreement pending resolution of the dispute shall be refunded if a court determines that such payments are not due.
(d)    As used in this Section 11.7, the term “ Excluded Claim ” means a dispute, controversy or claim that concerns (i) the validity or infringement of a Patent, trademark or copyright, or (ii) any antitrust, anti-monopoly or competition law or regulation, whether or not statutory.
11.8      Relationship of the Parties . Prothena and Celgene are independent contractors under this Agreement. Nothing contained herein is intended or is to be construed so as to constitute (a) Prothena as a partner, agent, or joint venturer of Celgene or (b) Celgene as a partner, agent or joint venturer of Prothena. Neither Prothena nor Celgene, respectively, shall have any express or implied right or authority to assume or create any obligations on behalf of or in the name of Celgene or Prothena, respectively, or to bind Celgene or Prothena, respectively, to any contract, agreement, or undertaking with any Third Party.

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11.9      Third Party Beneficiaries . There are no express or implied Third Party beneficiaries hereunder. The provisions of this Agreement are for the exclusive benefit of the Parties, and no other person or entity shall have any right or claim against any Party by reason of these provisions or be entitled to enforce any of these provisions against any Party.
11.10      Entire Agreement . This Agreement, together with the attached Exhibits and Schedules and the Master Collaboration Agreement, contains the entire agreement by the Parties with respect to the subject matter hereof and supersedes any prior express or implied agreements, understandings and representations, either oral or written, which may have related to the subject matter hereof in any way, including any and all term sheets relating to the transactions contemplated by this Agreement and exchanged between the Parties prior to the Effective Date. In the event of a conflict between the provisions of this Agreement and the Master Collaboration Agreement with respect to the Licensed Program, the provisions of this Agreement shall control.
11.11      Counterparts . This Agreement may be executed in counterparts with the same effect as if both Parties had signed the same document. All such counterparts shall be deemed an original, shall be construed together, and shall constitute one and the same instrument. Any such counterpart, to the extent delivered by means of a fax machine or by .pdf, .tif, .gif, .jpeg or similar attachment to electronic mail (any such delivery, an “ Electronic Delivery ”) shall be treated in all manner and respects as an original executed counterpart and shall be considered to have the same binding legal effect as if it were the original signed version thereof delivered in person. No Party hereto shall raise the use of Electronic Delivery to deliver a signature or the fact that any signature or agreement or instrument was transmitted or communicated through the use of Electronic Delivery as a defense to the formation of a contract, and each Party forever waives any such defense, except to the extent that such defense relates to lack of authenticity.
11.12      Equitable Relief; Cumulative Remedies . Notwithstanding anything to the contrary herein, the Parties shall be entitled to seek equitable relief, including injunction and specific performance, as a remedy for any breach of this Agreement. Such remedies shall not be deemed to be the exclusive remedies for a breach of this Agreement but shall be in addition to all other remedies available at law or equity. The Parties further agree not to raise as a defense or objection to the request or granting of such relief that any breach of this Agreement is or would be compensable by an award of money damages. No remedy referred to in this Agreement is intended to be exclusive, but each shall be cumulative and in addition to any other remedy referred to in this Agreement or otherwise available under Applicable Law.
11.13      Interpretation .
11.13.1      Generally . This Agreement has been diligently reviewed by and negotiated by and among the Parties, and in such negotiations each of the Parties has been represented by competent (in-house or external) counsel, and the final agreement contained herein, including the language whereby it has been expressed, represents the joint efforts of the Parties and their counsel. Accordingly, in interpreting this Agreement or any provision hereof, no presumption shall apply against any Party as being responsible for the wording or drafting of this Agreement or any such provision, and ambiguities, if any, in this Agreement shall not be construed against any Party, irrespective of which Party may be deemed to have authored the ambiguous provision.

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11.13.2      Definitions; Interpretation . The definitions of the terms herein shall apply equally to the singular and plural forms of the terms defined and where a word or phrase is defined herein, each of its other grammatical forms shall have a corresponding meaning. Whenever the context may require, any pronoun shall include the corresponding masculine, feminine, and neuter forms. The word “will” shall be construed to have the same meaning and effect as the word “shall.” The word “any” shall mean “any and all” unless otherwise clearly indicated by context. The words “including,” “includes,” “include,” “for example,” and “e.g.” and words of similar import will be deemed to be followed by the words “without limitation.” The word “or” is disjunctive but not necessarily exclusive. The words “hereof,” “herein” and “herewith” and words of similar import shall, unless otherwise stated, be construed to refer to this Agreement as a whole and not to any particular provision of this Agreement. Unless the context requires otherwise or otherwise specifically provided, (i) all references herein to Articles, Sections, Schedules or Exhibits shall be construed to refer to Articles, Sections, Schedules and Exhibits of this Agreement and (ii) reference in any Section to any subclauses are references to such subclauses of such Section.
11.13.3      Subsequent Events . Unless the context requires otherwise, (i) any definition of or reference to any agreement, instrument, or other document herein shall be construed as referring to such agreement, instrument, or other document as from time to time amended, supplemented, or otherwise modified (subject to any restrictions on such amendments, supplements, or modifications set forth herein), (ii) any reference to any Applicable Law herein shall be construed as referring to such Applicable Law as from time to time enacted, repealed, or amended, and (iii) any reference herein to any Person shall be construed to include the Person’s successors and assigns (subject to Section 11.4).
11.13.4      Headings . Headings, captions and the table of contents are for convenience only and are not to be used in the interpretation of this Agreement.
11.13.5      Prior Drafts . No prior draft of this Agreement nor any course of performance or course of dealing shall be used in the interpretation or construction of this Agreement.
11.13.6      Independent Significance . Although the same or similar subject matters may be addressed in different provisions of this Agreement, the Parties intend that, except as reasonably apparent on the face of the Agreement or as expressly provided in this Agreement, each such provision shall be read separately, be given independent significance and not be construed as limiting any other provision of this Agreement (whether or not more general or more specific in scope, substance or content).
11.14      Further Assurances . Each Party shall execute, acknowledge and deliver such further instruments, and do all such other ministerial, administrative or similar acts, as may be reasonably necessary or appropriate in order to carry out the expressly stated purposes and the clear intent of this Agreement.
11.15      Extension to Affiliates . Subject to Sections 5.6.2 and 11.4, Celgene shall have the right to extend the rights, licenses, immunities and obligations granted in this Agreement to one or more of its Affiliates. All applicable terms and provisions of this Agreement shall apply to any such

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Affiliate to which this Agreement has been extended to the same extent as such terms and provisions apply to Celgene. Celgene shall remain fully liable for any acts or omissions of such Affiliates.
  
[Signature Page Follows]


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IN WITNESS WHEREOF, and intending to be legally bound hereby, the Parties have caused this GLOBAL LICENSE AGREEMENT to be executed by their respective duly authorized officers as of the Effective Date.






PROTHENA BIOSCIENCES LIMITED









CELGENE SWITZERLAND LLC
 
 
 
 
By:    
By:    
 
 
Name:    
Name:    
 
 
Title:    
Title:    
 
 





[Signature Page to Global License Agreement]
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.



Schedule 1.27
Existing IND


[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.



Schedule 1.28
Existing Program Agreements

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.




Schedule 1.39
In-License Agreements and Other Third Party Agreements

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.




Schedule 1.44
Licensed Program Antibodies

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.




Schedule 1.47(b)
Licensed Program Patents

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.




Schedule 1.49
Licensed Target

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.




Schedule 1.63
Prothena Licensed Collaboration Patents


[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.




Schedule [***]
[***]



[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.




Schedule 8.2
Exceptions to Prothena Representations and Warranties

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.




Schedule 8.4
Exceptions to Celgene Representations and Warranties



[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.




Exhibit B
Form of U.S. License Agreement
(See Attached)


[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

FINAL FORM



U.S. LICENSE AGREEMENT
 
by and among
 
 
PROTHENA BIOSCIENCES LIMITED
 
 
and
 
 
CELGENE SWITZERLAND LLC
 
 
Dated as of ___________ __, 20__



[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.





TABLE OF CONTENTS 1  

LIST OF SCHEDULES 2  

SCHEDULE 1.28    EXISTING PROGRAM AGREEMENTS
SCHEDULE 1.40    IN-LICENSE AGREEMENTS AND OTHER THIRD PARTY
AGREEMENTS
SCHEDULE 1.45    LICENSED PROGRAM ANTIBODIES
SCHEDULE 1.47(b)    LICENSED PROGRAM PATENTS
SCHEDULE 1.49    LICENSED TARGET
SCHEDULE 1.64    PROTHENA LICENSED COLLABORATION PATENTS
SCHEDULE [***]    [***]
SCHEDULE 8.2    EXCEPTIONS TO PROTHENA REPRESENTATIONS AND
WARRANTIES
SCHEDULE 8.4    EXCEPTIONS TO CELGENE REPRESENTATIONS AND
WARRANTIES




1 To be inserted in final version.
2 All Schedules to be completed prior to execution of the Agreement.

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.



U.S. LICENSE AGREEMENT
This U.S. LICENSE AGREEMENT (this “ Agreement ”) is entered into and made effective as of __________ ___, 20__ (the “ Effective Date ”) by and between Prothena Biosciences Limited , an Irish limited company (“ Prothena ”) and Celgene Switzerland LLC , a Delaware limited liability company (“ Celgene ”). 3 Celgene and Prothena are each referred to herein by name or as a “ Party ” or, collectively, as the “ Parties ”.
RECITALS
WHEREAS , Prothena and Celgene entered into that certain Master Collaboration Agreement, dated as of March 19, 2018 (the “ Master Collaboration Agreement ”), pursuant to which, among other things, Prothena has conducted research and development programs with respect to certain targets (each, a “ Program ”) and Celgene has an exclusive option to obtain an exclusive license to research, develop, manufacture and commercialize Antibodies that Target such targets;
WHEREAS , pursuant to the terms of the Master Collaboration Agreement, upon exercise by Celgene of its IND Option (as defined in the Master Collaboration Agreement) with respect to a given Program, the Parties are obligated to enter into a U.S. License Agreement with respect to such Program; and
WHEREAS , Celgene has exercised its IND Option (as def in the Master Collaboration Agreement) with respect to the Licensed Program, and, as such, the Parties are entering into this Agreement pursuant to which, among other things, Prothena grants to Celgene exclusive rights and licenses with respect to the research, development, manufacture and commercialization of Licensed Antibodies and Licensed Products in the Territory, on the terms and subject to the conditions set forth herein.
NOW, THEREFORE , in consideration of the foregoing and the mutual agreements set forth below, and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the Parties hereby agree as follows:
ARTICLE 1.
DEFINITIONS
Unless specifically set forth to the contrary herein, the following terms shall have the respective meanings set forth below. Capitalized terms used, but not defined, herein will have the meanings ascribed to them in the Master Collaboration Agreement.
1.1      Accounting Standards ” means U.S. generally accepted accounting principles (“ GAAP ”) or, to the extent that Celgene adopts International Financial Reporting Standards (“ IFRS ”), then “Accounting Standards” shall mean IFRS, in either case consistently applied.
1.2      Affiliate ” means any Person which, directly or indirectly through one or more intermediaries, controls, is controlled by or is under common control with a Party. For purposes of this definition, the term “control” (including, with correlative meanings, the terms “controlled

3 Celgene may change the Celgene parties to this Agreement prior to execution.
1
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by” and “under common control with”) as used with respect to a Person means (a) direct or indirect ownership of fifty percent (50%) or more of the voting securities or other voting interest of any Person (including attribution from related parties), or (b) the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of such Person, whether through ownership of voting securities, by contract, as a general partner, as a manager, or otherwise.
1.3      Annual Net Sales ” means, on a Licensed Product-by-Licensed Product basis, total Net Sales by Celgene, its Affiliates and Sublicensees in the Territory of such Licensed Product in a particular Calendar Year, calculated in accordance with Accounting Standards consistently applied.
1.4      Antibody ” means any [***] antibody (including [***]), [***] whether human, humanized, chimeric, murine, synthetic or from any other source.
1.5      Applicable Law ” or “ Applicable Laws ” means all applicable laws, statutes, rules, regulations, orders, judgments or ordinances having the effect of law of any national, multinational, federal, state, provincial, county, city or other political subdivision, including, to the extent applicable, GCP, GLP and GMP, as well as all applicable data protection and privacy laws, rules and regulations, including, to the extent applicable, the United States Department of Health and Human Services privacy rules under the Health Insurance Portability and Accountability Act (“ HIPAA ”) and the Health Information Technology for Economic and Clinical Health Act and the EU Data Protection Directive (Council Directive 95/46/EC) and applicable laws implementing the EU Data Protection Directive and, when in force, the General Data Protection Regulation (2016/679).
1.6      Biomarker ” means a parameter or characteristic in a patient or Patient Sample, the measurement of which is useful (a) for purposes of selecting appropriate therapies or patient populations or monitoring disease susceptibility, severity or state, or monitoring therapies for such patient and/or (b) for predicting the outcome of a particular treatment of such patient.
1.7      Biosimilar Application ” means an application or submission filed with a Regulatory Authority for marketing authorization of a Biosimilar Product.
1.8      “Biosimilar Product” means, with respect to a given Licensed Product, a biological product (a) that contains (i) an identical active ingredient(s) as the Licensed Antibody in such Licensed Product, or (ii) a “highly similar” active ingredient(s) to the Licensed Antibody in such Licensed Product, as the phrase “highly similar” is used in 42 U.S.C. § 262(i)(2), and subject to the factors set forth in FDA’s Guidance for Industry, “Quality Considerations in Demonstrating Biosimilarity to a Reference Protein Product,” (February 2012), at Section VI, or any successor FDA guidance thereto, (b) for which Regulatory Approval is obtained by referencing Regulatory Materials of such Licensed Product, (c) is approved for use in such country (or region) pursuant to a Regulatory Approval process governing approval of interchangeable or biosimilar biologics as described in 42 U.S.C. §§ 262, or a similar process for Regulatory Approval in any country (or region) outside the United States, or any other similar provision that comes into force, or is the subject of a notice with respect to such Licensed Product under 42 U.S.C. § 262(l)(2) or any other similar provision that comes into force in such country (or region), and (d) is sold in the same country as such Licensed Product by any Third Party that is not a Sublicensee of Celgene or its

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Affiliates with respect to the Prothena IP and did not purchase such product in a chain of distribution that included any of Celgene or any of its Affiliates or its Sublicensees.
1.9      BPCIA ” means Biologics Price Competition and Innovation Act of 2009, as amended.
1.10      Business Day ” means a day on which banking institutions in New York City, New York, are open for business, excluding any Saturday or Sunday.
1.11      Calendar Quarter ” means the period beginning on the Effective Date and ending on the last day of the calendar quarter in which the Effective Date falls, and thereafter each successive period of three (3) consecutive calendar months ending on the last day of March, June, September, or December, respectively; provided that the final Calendar Quarter shall end on the last day of the Term.
1.12      Calendar Year ” means the period beginning on the Effective Date and ending on December 31 of the calendar year in which the Effective Date falls, and thereafter each successive period of twelve (12) consecutive calendar months beginning on January 1 and ending on December 31; provided that the final Calendar Year shall end on the last day of the Term.
1.13      Celgene IP” means Patents and Know-How owned or otherwise controlled (through license or otherwise, but excluding through grant of a license from Prothena to Celgene pursuant to this Agreement) by Celgene or any of its Affiliates (including any Know-How that is, created, conceived, discovered, first generated, invented, first made or first reduced to practice by or on behalf of Celgene or any of its Affiliates pursuant to the conduct of activities under this Agreement). For the avoidance of doubt, Celgene IP excludes (i) Know-How that is created, conceived, discovered, first generated, invented, first made or first reduced to practice by or on behalf of Prothena, solely or jointly with a Third Party; (ii) Joint Program IP (as defined under the Master Collaboration Agreement); (iii) [***], and (iv) Joint IP.
1.14      Celgene Phase 1 Portion Participation Right ” means the Celgene Phase 1 Portion Participation Right (as defined in the Master Collaboration Agreement) for the Licensed Program.
1.15      Change of Control ” in respect of a Person (an “ Acquired Person ”) shall be deemed to have occurred upon any of the following occurring after the Effective Date: (i) any Person or group of Persons that is not an Affiliate of such Acquired Person becomes the beneficial owner (directly or indirectly) of more than fifty percent (50%) of the voting shares; (ii) such Acquired Person consolidates with or merges into or with another Person that is not an Affiliate of such Acquired Person pursuant to a transaction in which more than fifty percent (50%) of the voting shares of the acquiring or resulting entity outstanding immediately after such consolidation or merger is not held by the holders of the outstanding voting shares of such Acquired Person immediately preceding such consolidation or merger; and/or (iii) that Acquired Person sells or transfers to another Person that is not an Affiliate of such Acquired Person all or substantially all of its assets.

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1.16      Clinical Trial ” means a human clinical trial, including any Phase 1 Clinical Trial, Phase 2 Clinical Trial or Registration Enabling Clinical Trial, any study incorporating more than one of these phases, or any human clinical trial commenced after Regulatory Approval.
1.17      Commercialization ” means any and all activities directed to the commercialization of a product (which may include related diagnostic products, if applicable), including commercial manufacturing (including Manufacturing) and commercial supply of a product, marketing, detailing, promotion, market research, distributing, order processing, handling returns and recalls, booking sales, customer service, administering and commercially selling such product, importing, exporting and transporting such product for commercial sale, and seeking of pricing and reimbursement of a product (if applicable), whether before or after Regulatory Approval has been obtained (including making, having made, using, importing, selling and offering for sale such product (or related diagnostic product, if applicable)), as well all regulatory compliance with respect to the foregoing. For clarity, “Commercialization” does not include any Clinical Trial commenced after Regulatory Approval. When used as a verb, “ Commercialize ” means to engage in Commercialization.
1.18      Commercially Reasonable Efforts ” means, with respect to Celgene in relation to an obligation under this Agreement with respect to a Licensed Antibody or Licensed Product, such efforts that are consistent with the efforts and resources normally used by Celgene in the exercise of its commercially reasonable business practices relating to performance of an obligation for a similar pharmaceutical compound or product (including the research, development, manufacture and commercialization of a pharmaceutical compound or product), as applicable, at a similar stage in its research, development or commercial life as the relevant Licensed Antibody or Licensed Product, and that has commercial and market potential similar to the relevant Licensed Antibody or Licensed Product, taking into account issues of intellectual property coverage, safety and efficacy, stage of development, product profile, competitiveness of the marketplace, proprietary position, regulatory exclusivity, anticipated or approved labeling, present and future market and commercial potential, the likelihood of receipt of Regulatory Approval, profitability (including pricing and reimbursement status achieved or likely to be achieved), amounts payable to licensors of patents or other intellectual property rights, [***], and legal issues.
1.19      Confidential Information ” means, with respect to a Party, all confidential and proprietary information and materials, including Know-How, marketing plans, strategies, and customer lists, in each case, that are disclosed by or on behalf of such Party to the other Party pursuant to this Agreement, regardless of whether any of the foregoing are marked “confidential” or “proprietary” or communicated to the other Party by or on behalf of the disclosing Party in oral, written, visual, graphic or electronic form.
1.20      Control ”, “ Controls ” or “ Controlled ” means, with respect to any intellectual property (including Know-How) or Confidential Information, the ability of a Party or its Affiliates, as applicable, (whether through ownership or license (other than a license granted in this Agreement)) to grant to the other Party the licenses or sublicenses as provided herein, or to otherwise disclose such intellectual property or Confidential Information to the other Party, without violating the terms of any then-existing agreement with any Third Party at the time such Party or its Affiliates, as applicable, would be required hereunder to grant the other Party such license or sublicenses as

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provided herein or to otherwise disclose such intellectual property or Confidential Information to the other Party.
1.21      Cover ”, “ Covering ” or “ Covered ” means, with reference to a Patent claim, that such Patent claim has a Valid Claim that claims the [***], and that the sale of a Licensed Antibody (or product incorporating such Licensed Antibody) would infringe such Valid Claim in the country in which such activity occurs without a license thereto (or ownership thereof); provided, that with respect to method of use, such method of use is for an Indication for which Regulatory Approval has been received (as set forth on the approved labeling for the applicable Licensed Product incorporating such Licensed Antibody) for such Licensed Antibody in such country.
1.22      “Derivative” means, with respect to a Licensed Target, all [***] thereof.
1.23      Development ” means (i) research activities (including drug discovery, identification and/or synthesis) with respect to a product (which may include related diagnostic products, if applicable), and/or (ii) preclinical and clinical drug development activities, and other development activities, with respect to a product (which may include related diagnostic products, if applicable), including test method development and stability testing, toxicology, formulation, process development, qualification and validation, manufacture scale-up, development-stage manufacturing (including Manufacturing), quality assurance/quality control, Clinical Trials (including Clinical Trials and other studies commenced after Regulatory Approval), statistical analysis and report writing, the preparation and submission of INDs and MAAs, regulatory affairs with respect to the foregoing and all other activities necessary or useful or otherwise requested or required by a Regulatory Authority or as a condition or in support of obtaining or maintaining a Regulatory Approval. When used as a verb, “ Develop ” means to engage in Development.
1.24      Diagnostic Product ” means, on a Licensed Product-by-Licensed Product basis, any diagnostic product (which may include a Licensed Antibody or Licensed Product being used as a diagnostic product) which is necessary or reasonably useful (a) for the [***] in a patient or Patient Sample, and/or (b) to [***] in a patient or Patient Sample, and/or (c) to [***] to achieve improved safety or effectiveness, in each case of (a), (b) and (c), which is intended for use or is Developed or approved for use in connection with a therapeutic Licensed Antibody or Licensed Product (which may include [***]).
1.25      Dollars ” or “$” means the legal tender of the United States.
1.26      EU ” means all countries that are officially recognized as member states of the European Union at any particular time.
1.27      Executive Officers ” means Prothena’s Chief Executive Officer and Celgene’s Executive Vice President, Research and Early Development (or such Executive Vice President’s designee).
1.28      Existing Program Agreements ” means any agreement between Prothena (or its Affiliates, as applicable) and any Third Party solely related to the Development or Manufacture of

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any Licensed Antibodies or Licensed Products, in effect as of the Effective Date, as set forth on Schedule 1.28 .
1.29      Field ” means any and all uses or purposes, including the treatment, prophylaxis, palliation, diagnosis or prevention of any human or animal disease, disorder or condition.
1.30      First Commercial Sale ” means, on a Licensed Product-by-Licensed Product basis in the Territory, the first sale of such Licensed Product in the Territory for use or consumption by the general public (following receipt of all Regulatory Approvals that are required in order to sell such Licensed Product in the Territory) and for which any of Celgene or its Affiliates or Sublicensees has invoiced sales of Licensed Products in the Territory; provided, however, that the following shall not constitute a First Commercial Sale: (a) any sale to an Affiliate or Sublicensee, unless the Affiliate or Sublicensee is the last Person in the distribution chain of the Licensed Product; or (b) any use of such Licensed Product in Clinical Trials or non-clinical development activities with respect to such Licensed Product by or on behalf of a Party, or disposal or transfer of such Licensed Product for a bona fide charitable purpose, compassionate use or samples.
1.31      Global License Agreement ” means each Global License Agreement entered into between the Parties (or their respective Affiliates, as applicable) pursuant to the Master Collaboration Agreement.
1.32      Good Clinical Practices ” or “ GCP ” means the applicable then-current ethical and scientific quality standards for designing, conducting, recording, and reporting trials that involve the participation of human subjects as are required by applicable Regulatory Authorities or Applicable Law in the relevant jurisdiction, including in the United States, Good Clinical Practices established through FDA guidances, and, outside the United States, Guidelines for Good Clinical Practice – ICH Harmonized Tripartite Guideline (ICH E6).
1.33      Good Laboratory Practices ” or “ GLP ” means the applicable then-current good laboratory practice standards as are required by applicable Regulatory Authorities or Applicable Law in the relevant jurisdiction, including in the United States, those promulgated or endorsed by the FDA in U.S. 21 C.F.R. Part 58, or the equivalent thereof as promulgated or endorsed by the applicable Regulatory Authorities outside of the United States.
1.34      Good Manufacturing Practices ” or “ GMP ” means all applicable standards relating to manufacturing practices for fine chemicals, intermediates, bulk products and/or finished pharmaceutical products, as are required by applicable Regulatory Authorities or Applicable Law in the relevant jurisdiction, including, as applicable, (a) all applicable requirements detailed in the FDA’s current Good Manufacturing Practices regulations, U.S. 21 C.F.R. Parts 210 and 211, (b) all applicable requirements detailed in the EMA’s “The Rules Governing Medicinal Products in the European Community, Volume IV, Good Manufacturing Practice for Medicinal Products”, and (c) all Applicable Laws promulgated by any Governmental Authority having jurisdiction over the manufacture of the applicable compound or pharmaceutical product, as applicable.
1.35      Governmental Authority ” means any (a) federal, state, local, municipal, foreign or other government, (b) governmental or quasi-governmental authority of any nature (including

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any governmental division, subdivision, department, agency, bureau, branch, office, commission, council, board, instrumentality, officer, official, representative, organization, unit, body or entity and any court or other tribunal), (c) multinational governmental organization or body or (d) entity or body exercising, or entitled to exercise, any executive, legislative, judicial, administrative, regulatory, police, military or taxing authority or power of any nature.
1.36      IND ” means an investigational new drug application (including any amendment or supplement thereto) submitted to the FDA pursuant to U.S. 21 C.F.R. Part 312, including any amendments thereto. References herein to IND shall include, to the extent applicable, any comparable filing(s) outside the U.S. for the investigation of any product in any other country or group of countries (such as a Clinical Trial Application in the EU).
1.37      IND Option Exercise Fee ” shall mean the IND Option Exercise Fee (as defined in the Master Collaboration Agreement) for the Licensed Program.
1.38      Indication ” means an entirely separate and distinct disease or medical condition in humans (i) [***], and/or (ii) [***]. For clarity, (a) [***], (b) [***] and (c) [***].
1.39      Initiation ” means, with respect to a given Clinical Trial, the administration of the first dose of Licensed Product to the first properly enrolled subject in such Clinical Trial in accordance with the protocol for such Clinical Trial.
1.40      In-License Agreements ” means any agreement between Prothena (or its Affiliates, as applicable) and any Third Party pursuant to which such Third Party licenses to Prothena (or its Affiliates, as applicable) any Patents or Know-How included in the Prothena IP, including those set forth on Schedule 1.40 .
1.41      Know-How ” means all proprietary (a) information, techniques, technology, practices, trade secrets, inventions, methods (including methods of use or administration or dosing), knowledge, data, results and software and algorithms, including pharmacological, toxicological and clinical test data and results, compositions of matter, chemical structures and formulations, sequences, processes, formulae, techniques, research data, reports, standard operating procedures, batch records, manufacturing data, analytical and quality control data, analytical methods (including applicable reference standards), assays and research tools, in each case, whether patentable or not; and (b) tangible manifestations thereof, including any and all of the foregoing relating to Licensed Program Biological and Chemical Materials.
1.42      Licensed Antibody ” means (a) any Licensed Program Antibody and (b) any other Antibody that is a variant, fragment, derivative or other modification of a Licensed Program Antibody that (i) Targets the Licensed Target, (ii) is made by or on behalf of Celgene or its Affiliates or Sublicensees during the Term in the course of its activities performed under this Agreement and (iii) is claimed (or was claimed in an issued Patent that has subsequently expired) as a composition of matter in a Licensed Program Patent set forth on Schedule 1.47(b), Prothena Licensed Collaboration Patent set forth on Schedule 1.64 , or Joint Program Patent (as defined in the Master Collaboration Agreement) as applicable, or any substitutions, divisionals, continuations, continuations-in-part, reissues, renewals, registrations, confirmations, re-examinations, extensions,

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supplementary protection certificates and the like of any such Licensed Program Patents, Prothena Licensed Collaboration Patents or Joint Program Patents (as defined in the Master Collaboration Agreement).
1.43      Licensed Product ” means any product that constitutes, incorporates, comprises or contains a Licensed Antibody, whether or not as the sole active ingredient, and in all forms, presentations, and formulations (including manner of delivery and dosage). For clarity, different forms, formulations, presentations or dosage strengths of a given Licensed Product that constitute, incorporate, comprise or contain the same Licensed Antibody shall be considered the same Licensed Product for purposes of this Agreement. Licensed Products shall include, in all cases, any Licensed Program Product.
1.44      Licensed Program ” means the Development program undertaken by or on behalf of Prothena pursuant to the Master Collaboration Agreement with respect to the Licensed Target.
1.45      Licensed Program Antibody ” means, with respect to the Licensed Program, (i) the Collaboration Candidates (as defined in the Master Collaboration Agreement) that Target the Licensed Target that were Developed under such Licensed Program pursuant to the Master Collaboration Agreement, including those as set forth on Schedule 1.45 and (ii) all Related Antibodies with respect to any Antibody described in the foregoing clause (i) provided that such Related Antibodies are claimed (or were claimed in an issued Patent that has subsequently expired) as a composition of matter in a Licensed Program Patent set forth on Schedule 1.47(b) , a Prothena Licensed Collaboration Patent set forth on Schedule 1.64 , or a Joint Program Patent (as defined in the Master Collaboration Agreement) as applicable, or any substitutions, divisionals, continuations, continuations-in-part, reissues, renewals, registrations, confirmations, re-examinations, extensions, supplementary protection certificates and the like of any such Licensed Program Patents or Prothena Licensed Collaboration Patents. For the avoidance of doubt, Licensed Program Antibodies are included within the definition of Licensed Antibody.
1.46      Licensed Program Biological and Chemical Materials ” means, with respect to the Licensed Program, any and all compositions of matter, cells, cell lines, assays, animal models, imaging agents, Patient Samples, Biomarkers and any other physical, biological or chemical material, that are Controlled by Prothena or its Affiliates and [***] the Licensed Target or Licensed Program Antibodies (or the Development, Manufacture or Commercialization thereof), including physical embodiments of the Licensed Program Antibodies and any diagnostics related to such Licensed Program Antibodies, in each case, (i) created, conceived, discovered, first generated, invented, first made or first reduced to practice by or on behalf of Prothena or its Affiliates, whether solely or jointly with any Third Party, in such Licensed Program under the Master Collaboration Agreement or (ii) otherwise utilized by or on behalf of Prothena or its Affiliates in the Licensed Program under the Master Collaboration Agreement. To the extent the Licensed Program Biological and Chemical Materials were created, conceived, discovered, first generated, invented, first made or first reduced to practice under the Licensed Program under the Master Collaboration Agreement, such Licensed Program Biological and Chemical Materials shall be “Licensed Program Know-How” hereunder, and to the extent the Licensed Program Biological and Chemical Materials were not created, conceived, discovered, first generated, invented, first made or first reduced to practice

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under the Licensed Program under the Master Collaboration Agreement, but were otherwise utilized in the development of the Licensed Program under the Master Collaboration Agreement, such Licensed Program Biological and Chemical Materials shall be “Prothena Licensed Collaboration Know-How” hereunder.
1.47      Licensed Program IP ” means, collectively:
(a)      Licensed Program Know-How ” which means any and all Know-How that was created, conceived, discovered, first generated, invented, first made or first reduced to practice, in each case (i) by or on behalf of [***], (ii) by or on behalf of [***], or (iii) by or on behalf of [***]. For the avoidance of doubt, Licensed Program Know-How (i) includes ‘Program Know-How’ (as defined in the Master Collaboration Agreement) related to the Licensed Program but (ii) expressly excludes any Know-How created, conceived, discovered, first generated, invented, first made or first reduced to practice in the course of activities performed under this Agreement and any Joint Program Know-How (as defined in the Master Collaboration Agreement); and
(b)      Licensed Program Patents ” which means any Patents in the Territory Controlled by Prothena or its Affiliates that claim or cover any Licensed Program Know-How, including the Patents set forth on Schedule 1.47(b) . For the avoidance of doubt, Licensed Program Patents, include ‘Program Patents’ (as defined in the Master Collaboration Agreement) related to the Licensed Program, but expressly exclude Joint Program Patents (as defined in the Master Collaboration Agreement).
1.48      Licensed Program Product ” means, with respect to the Licensed Program, any product that constitutes, incorporates, comprises or contains a Licensed Program Antibody, whether or not as the sole active ingredient, and in all forms, presentations, and formulations (including manner of delivery and dosage). For clarity, different forms, formulations, presentations or dosage strengths of a given Licensed Program Product that constitutes, incorporates, comprises or contains the same Licensed Program Antibody shall be considered the same Licensed Program Product for purposes of this Agreement. For the avoidance of doubt, Licensed Program Products are included within the definition of Licensed Products.
1.49      Licensed Target ” means the target set forth on Schedule 1.49 , including Derivatives thereof.
1.50      Manufacture ” means all activities related to the manufacturing of a product or diagnostic product or, in either case, any component or ingredient thereof, including test method development and stability testing, formulation, process development, manufacturing scale-up whether before or after Regulatory Approval, manufacturing any product or diagnostic product in bulk or finished form for Development or Commercialization (as applicable), including filling and finishing, packaging, labeling, shipping and holding, in-process and finished product testing, release of a product or diagnostic product or, in either case, any component or ingredient thereof, quality assurance and quality control activities related to manufacturing and release of a product or diagnostic product, and regulatory activities related to any of the foregoing.

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1.51      Marketing Authorization Application ” or “ MAA ” means a Marketing Authorization Application, Biologics License Application or similar application, as applicable, and all amendments and supplements thereto, submitted to the FDA, or any equivalent filing in a country or regulatory jurisdiction other than the U.S. with the applicable Regulatory Authority, to obtain marketing approval for a pharmaceutical or diagnostic product, in a country or in a group of countries.
1.52      Net Sales ” means, in respect of a given Licensed Product, the total [***] amounts [***] for all sales of such Licensed Product in the Territory for use in the Field by Celgene, its Affiliates or Sublicensees to Third Party customers (including to distributors), less the following deductions [***] so as to arrive at “net sales” under Accounting Standards as reported by Celgene, its Affiliates or Sublicensees, as applicable, in such Person’s financial statements:
(a)      [***];
(b)      [***];
(c)      [***];
(d)      [***]; and
(e)      [***].
There shall be no double counting in determining the foregoing deductions from gross amounts invoiced to calculate Net Sales. The calculations set forth in this definition of “Net Sales” shall be determined in accordance with Accounting Standards.
Sales or other transfers between Celgene and its Affiliates or Sublicensees, as well as any transfers or dispositions of any Licensed Products for (i) [***], (ii) [***], (iii) [***] or (iv) [***], in each case, shall be excluded from the computation of Net Sales.
The calculations set forth in this section shall be determined in accordance with Accounting Standards. If any Licensed Product is, or is sold as part of, a Combination Product, Net Sales shall be calculated assuming that the gross sale price of each unit is equal to the product of (i) Net Sales of the Combination Product calculated as above ( i.e. , calculated as for a non-Combination Product), and (ii) the fraction [***], where:
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For purposes of this definition, “ Combination Product ” means any pharmaceutical product that (a) contains two or more active ingredients, including both (1) a Licensed Antibody and (2) one or more other compounds (which may be Antibodies) but that are not a Licensed Antibody, either as a fixed dose product, co-formulated product or co-packaged product, and sold for a single price, and (b) is Developed or Commercialized, alone or together with a Third Party, by Celgene or any of its Affiliates or Sublicensees. Any vehicles, adjuvants and excipients used in conjunction with any Licensed Antibody shall not be treated as active ingredients for the purposes of this definition.

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1.53      Patents ” means (a) all patents and patent applications in any country or supranational jurisdiction worldwide, (b) any substitutions, divisionals, continuations, continuations-in-part, reissues, renewals, registrations, confirmations, re-examinations, extensions, supplementary protection certificates and the like of any such patents or patent applications, and (c) foreign counterparts of any of the foregoing.
1.54      Patient Sample ” means tissue, fluid, or cells collected from a patient, or components of the foregoing.
1.55      Person ” means any individual, partnership, joint venture, limited liability company, corporation, firm, trust, association, unincorporated organization, governmental authority or agency, or any other entity not specifically listed herein.
1.56      Phase 1 Clinical Trial ” means a human clinical trial of a product that would satisfy the requirements of U.S. 21 C.F.R. Part 312.21(a) (as amended), or a similar clinical study prescribed by the Regulatory Authorities in a foreign country, and is intended to (a) determine the safety, pharmacokinetics and pharmacodynamic parameters in healthy individuals or patients, and (b) following the foregoing clause (a), further evaluate safety and pharmacokinetics (including exploration of trends of a biomarker-based or clinical endpoint-based efficacy relationship to dose which need not be designed to be statistically significant) of the product, whether or not in combination with concomitant treatment and which provides sufficient evidence of safety to be included in filings for a Phase 2 Clinical Trial or a Registration Enabling Clinical Trial with Regulatory Authorities.
1.57      Phase 1 Option ” shall mean the Phase 1 Option (as defined in the Master Collaboration Agreement) for the Licensed Program.
1.58      Phase 1 Option Term ” shall mean the Phase 1 Option Term (as defined in the Master Collaboration Agreement) for the Licensed Program.
1.59      Phase 2 Clinical Trial ” means a human clinical trial of a product that would satisfy the requirements of U.S. 21 C.F.R. Part 312.21(b), as amended, and is intended to explore a variety of doses, dose response, and duration of effect, and to generate evidence of clinical safety and effectiveness for a particular Indication or Indications in a target patient population, or a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.
1.60      Prosecution and Maintenance ” or “ Prosecute and Maintain ” means, with regard to a Patent, the preparation, filing, prosecution and maintenance of such Patent, as well as re-examinations, reissues, appeals, and requests for patent term adjustments and patent term extensions with respect to such Patent, together with the initiation or defense of interferences, oppositions, inter partes review, derivations, re-examinations, post-grant proceedings and other similar proceedings (or other defense proceedings with respect to such Patent, but excluding the defense of challenges to such Patent as a counterclaim in an infringement proceeding) with respect to the particular Patent, and any appeals therefrom. For clarification, “Prosecution and Maintenance” or

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“Prosecute and Maintain” shall not include any other enforcement actions taken with respect to a Patent.
1.61      Prothena IP ” means the Prothena Licensed Collaboration Patents, the Prothena Licensed Collaboration Know-How, the Licensed Program Patents and the Licensed Program Know-How, as well as Prothena’s (and its Affiliates’) right, title and interest in and to the Joint IP and any Joint Program IP (as defined under the Master Collaboration Agreement).
1.62      Prothena Licensed Collaboration IP ” means all Prothena Licensed Collaboration Know-How and Prothena Licensed Collaboration Patents
1.63      Prothena Licensed Collaboration Know-How ” means any and all Know-How that is Controlled by Prothena or its Affiliates on or after the Effective Date that (a) is necessary or [***] to research, develop, make, have made, import, use, offer to sell, sell or otherwise exploit any [***], Licensed Program Antibody or Licensed Program Product or (b) is or was [***], including (i) any diagnostics related to any such Licensed Program Antibody or Licensed Program Product and (ii) Know-How conceived, created discovered, first generated, invented, first made or first reduced to practice by or on behalf of a Prothena or its Affiliates, whether solely or jointly with any Third Party, in the course of activities performed under this Agreement; but expressly excluding Joint Know-How, Joint Program Know-How (as defined in the Master Collaboration Agreement) and Licensed Program Know-How.
1.64      Prothena Licensed Collaboration Patents ” means any and all Patents in the Territory that are Controlled by Prothena or its Affiliates on or after the Effective Date that claim or cover (a) any Licensed Target, any Licensed Program Antibody or any Licensed Program Product, or the research, development, making, having made, import, use, offering to sell, selling or other exploitation of any of the foregoing, or (b) any Prothena Licensed Collaboration Know-How; but expressly excluding Joint Patents, Joint Program Patents (as defined in the Master Collaboration Agreement) and Licensed Program Patents. Prothena Licensed Collaboration Patents shall include the Patents set forth on Schedule 1.64 .
1.65      Prothena Platform Patent ” means a Patent within the Prothena Licensed Collaboration Patents that [***] claims the Prothena Platform Technology.
1.66      “[***]” means [***], which shall [***]; but in any case excluding [***].
1.67      Registration Enabling Clinical Trial ” means (a) a human clinical trial of a product that would satisfy the requirements of U.S. 21 C.F.R. Part 312.21(c), as amended, and is intended to (i) establish that the product is safe and efficacious for its intended use, (ii) define contraindications, warnings, precautions and adverse reactions that are associated with the product in the dosage range to be prescribed, and (iii) support Regulatory Approval for such product, or (b) a similar clinical study prescribed by the relevant Regulatory Authorities in a country other than the United States.
1.68      Regulatory Approval ” means all approvals, licenses and authorizations of the applicable Regulatory Authority necessary for the marketing and sale of a pharmaceutical or

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diagnostic product for a particular Indication in a country or region (including separate pricing or reimbursement approvals, as necessary), and including the approvals by the applicable Regulatory Authority of any expansion or modification of the label for such Indication.
1.69      Regulatory Authority ” means any national or supranational Governmental Authority, including the U.S. Food and Drug Administration (and any successor entity thereto) (the “ FDA ”) in the U.S., the European Medicines Agency (and any successor entity thereto) (the “ EMA ”) in the EU and the Ministry of Health, Labour and Welfare of Japan, or the Pharmaceuticals and Medical Devices Agency of Japan (or any successor to either of them) as the case may be (the “ MHLW ”) in Japan, or any health regulatory authority in any country or region that is a counterpart to the foregoing agencies, in each case, that holds responsibility for development and commercialization of, and the granting of Regulatory Approval for, a pharmaceutical or diagnostic product, as applicable, in such country or region.
1.70      Regulatory-Based Exclusivity ” means, on a Licensed Product-by-Licensed Product basis in the Territory, that Celgene or any of its Affiliates or Sublicensees has been granted the exclusive legal right by a Regulatory Authority in the Territory to market and sell the Licensed Product in the Territory, in each case, such that market exclusivity is maintained for Celgene (or its Affiliate or Sublicensee, as applicable) in the Territory with respect to such Licensed Product as a result of such grant by such Regulatory Authority.
1.71      Regulatory Materials ” means the regulatory registrations, applications, authorizations and approvals (including approvals of MAAs, supplements and amendments, pre- and post-approvals, pricing and reimbursement approvals, and labeling approvals), Regulatory Approvals and other submissions made to or with any Regulatory Authority for research, development (including the conduct of Clinical Trials), manufacture, or commercialization of a pharmaceutical or diagnostic product in a regulatory jurisdiction, together with all related correspondence to or from any Regulatory Authority and all documents referenced in the complete regulatory chronology for each MAA, including all Drug Master Files (if any), INDs and supplemental biologics license applications (sBLAs) and foreign equivalents of any of the foregoing.
1.72      Related Antibody ” means, with respect to a given Antibody, any (a) [***], or (b) [***], and in each case of (a) and (b), that [***].
1.73      Royalty Term ” means, on a Licensed Product-by-Licensed Product basis in the Territory, the period of time commencing on the First Commercial Sale of such Licensed Product in the Territory and expiring upon the latest of (a) the first date on which there is no Valid Claim of a Patent within the Licensed Program Patents, Prothena Licensed Collaboration Patents or Joint Program Patents (as defined in the Master Collaboration Agreement) in each case, that Covers such Licensed Product in the Territory, (b) the expiration of Regulatory-Based Exclusivity for such Licensed Product in the Territory and (c) the [***] ([***]) year anniversary of the date of First Commercial Sale of such Licensed Product in the Territory.
1.74      Select Indication ” means each of the following separate and distinct Indications: [***] such other Indications as the Parties may mutually agree in writing to be expressly included as a “Select Indication” for purposes of this Agreement; provided that such indication is identified

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as an approved use for the applicable Licensed Product in the approved label for such Licensed Product in the applicable country.
1.75      Sublicensee ” means, with respect to Celgene, a Third Party to whom Celgene has granted a sublicense, either directly or indirectly, under the Prothena IP licensed to Celgene by Prothena pursuant to this Agreement, to Develop, Manufacture and/or Commercialize Licensed Antibodies and Licensed Products in the Field in the Territory, but excluding any Third Party acting as a distributor and excluding Prothena and its Affiliates.
1.76      Target” means, with respect to a given Antibody and the Licensed Target, that such Antibody [***]. For the purposes of the “Target” definition, “[***]” means [***]. 4  
1.77      Territory ” means the United States.
1.78      Third Party ” means any Person other than Prothena or Celgene that is not an Affiliate of Prothena or of Celgene.
1.79      Third Party Claim ” means any and all suits, claims, actions, proceedings or demands brought by a Third Party.
1.80      Third Party Damages ” means all losses, costs, claims, damages, judgments, liabilities and expenses payable to a Third Party by a Party (or the Prothena Indemnitees or Celgene Indemnitees, as applicable) under a Third Party Claim (including reasonable attorneys’ fees and other reasonable out-of-pocket costs of litigation in connection therewith).
1.81      United States ” or “ U.S. ” means the United States of America and all of its territories and possessions.
1.82      U.S. License Agreement ” shall mean each U.S. License Agreement entered into between the Parties (or their respective Affiliates, as applicable) pursuant to the Master Collaboration Agreement. When used in this Agreement, references to U.S. License Agreements are references to U.S. License Agreements other than this Agreement.
1.83      Valid Claim ” means a claim of a Patent within the Licensed Program Patents, Prothena Licensed Collaboration Patents, or Joint Program Patents (as defined in the Master Collaboration Agreement) in the Territory that has issued and has not expired, lapsed, been cancelled or abandoned, or been dedicated to the public, disclaimed, or held unenforceable, invalid, revoked or cancelled by a court or administrative agency of competent jurisdiction in an order or decision from which no appeal has been or can be taken, including through opposition, reexamination, reissue, disclaimer, inter partes review, post grant procedures or similar proceedings [***].
1.84      Additional Definitions . Each of the following terms has the meaning described in the corresponding section of this Agreement indicated below:
Definition:
Section:
Acquired Person
1.15

4 [***] For the purposes of the “Target” definition, “[ ***] ” means [***]
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Definition:
Section:
Active Immunotherapeutic Approaches
4.2.1
Agreement
Preamble
Celgene
Preamble
Celgene Acquired Competing Antibody
4.4.2
Celgene Exclusivity Term
4.4.1
Celgene Indemnitees
9.2
Celgene Proposed Terms
4.2.2
Celgene Share
6.8.2(d)
Celgene Third Party Payments
5.2.4
Clinical Trial Preliminary Activities Outside Date
10.5
Combination Product
1.52
Competing Antibody
4.4.1
Competing Compound
4.1
Cure Period
11.2.1
Disclosing Party
7.1
Dispute
11.7.2
Electronic Delivery
12.11
Effective Date
Preamble
EMA
1.69
Excluded Claim
11.7.3(d)
FDA
1.69
[***]
[***]
Force Majeure
11.3
GAAP
1.1
Grant
4.2.2
Grant Notice
4.2.2
HIPAA
1.5
IFRS
1.1
Indemnitee
9.3
Indemnitor
9.3
Indirect Taxes
5.5.2(b)
Insolvency Event
10.4
Joint IP
6.6.4
Joint Know-How
6.6.4
Joint Patents
6.6.4
Licensed Program Assets
2.5
Licensed Program Confidential Information
7.11
Licensed Program Know-How
1.46(a)
Licensed Program Non-Specific IP
7.2
Licensed Program Patents
1.46(b)
Licensed Program Specific IP
7.2

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Definition:
Section:
Master Collaboration Agreement
Recitals
MHLW
 
Negotiation Period
4.2.2
[***]
[***]
Notice Period
4.2.2
Ongoing Prothena Development Activities
2.3.3
Party or Parties
Preamble
Patent Liaison
6.7
Payee Party
5.5.2(b)
Paying Party
5.5.2(b)
Per Licensed Product Annual Net Sales
5.2.1
Program
Recitals
Prothena
Preamble
Prothena Indemnitees
9.1
Prothena Licensor
8.3.3
Prothena Ongoing Program Activities
2.3
Prothena Reversion Antibodies
10.10.1
Publishing Party
8.8.1
Receiving Party
7.1
Regulatory Milestone Payment
5.3.1
Right of First Negotiation
4.2.2
Sales Milestone Payment
5.4.1
SEC
8.4.1(a)
Securities Regulators
7.6
Tax Benefit
5.5.2(c)
Term
10.1.1
Transfer Date
2.2.1(a)

ARTICLE 2.     
DEVELOPMENT, MANUFACTURE AND COMMERCIALIZATION
2.1      Development, Manufacturing and Commercialization .
2.1.1      General . From and after the Effective Date, and subject to the terms and conditions of this Agreement (including Sections 2.2, 2.3, and 2.8), (i) Celgene will have the sole right (and shall solely control, at its discretion), itself and/or with or through its Affiliates, Sublicensees or other Third Parties, to Develop, Manufacture and Commercialize Licensed Antibodies and Licensed Products in the Field in the Territory, and (ii) Prothena and its Affiliates shall not have any right to, and shall not, conduct any Development, Manufacture or Commercialization of any Licensed Antibodies or Licensed Products in the Field in the Territory.
2.1.2      Diligence . From and after the end of the Phase 1 Option Term, and subject to the terms and conditions of this Agreement (including Sections 2.2, 2.3, and 2.8), Celgene, itself

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and/or with or through its Affiliates, Sublicensees or other Third Parties, will use Commercially Reasonable Efforts to (i) [***], and (ii) [***].
2.1.3      Celgene Progress Updates . During the Term until such time as Celgene has submitted a MAA for at least one Licensed Product in a Select Indication in the Territory, Celgene and Prothena shall meet at least [***] to discuss the progress of Celgene’s material Development and Commercialization activities with respect to Licensed Products pursuant to this Agreement. Such meeting shall be either in person or telephonically as agreed to by the Parties. In addition, during the Term until such time as Celgene has submitted an MAA for at least one Licensed Product for a Select Indication in the Territory, at least [***] (or more frequently as agreed to by the Parties), Celgene shall submit to Prothena a written report summarizing the progress of Celgene’s material Development and Commercialization activities with respect to Licensed Products pursuant to this Agreement since the last report.
2.2      Regulatory .
2.2.1      Regulatory Materials .
(a)      Subject to Section 2.3, and subject further to Section 2.6.1(b) of the Master Collaboration Agreement with respect to the Licensed Program, until the end of the Phase 1 Option Term for the Licensed Program (the “ Transfer Date ”), Prothena shall have the right, in consultation with Celgene, to prepare, file and maintain all Regulatory Materials (including any Regulatory Approvals) necessary for the Development and Manufacture of any Licensed Program Antibodies and/or Licensed Program Products in the Territory hereunder, and to interact with Regulatory Authorities in connection with the Development and Manufacture of any Licensed Program Antibodies and/or Licensed Program Products in the Territory hereunder. Prothena will provide Celgene with a reasonable opportunity to comment substantively on all material Regulatory Materials prior to filing or taking material action, and will reasonably and in good faith consider any comments and actions recommended by Celgene, including with respect to filing strategy. In addition, Prothena will allow Celgene or its representative to attend any and all meetings with Regulatory Authorities to the extent such attendance is not prohibited or limited by such Regulatory Authority.
(b)      Subject to Section 2.3, after the Transfer Date, Celgene shall have the right, in consultation with Prothena, to prepare, file and maintain all Regulatory Materials (including any Regulatory Approvals) necessary for the Development, Manufacture and Commercialization of any Licensed Program Antibodies and/or Licensed Program Products in the Territory hereunder, and to interact with Regulatory Authorities in connection with the Development, Manufacture and Commercialization of any Licensed Program Antibodies and/or Licensed Program Products in the Territory hereunder. Celgene will provide Prothena with a reasonable opportunity to comment substantively on all material Regulatory Materials, but only if such Regulatory Materials directly impact regulatory matters with respect to Licensed Program Antibodies and/or Licensed Program Products outside the Territory, prior to filing or taking material action, and will reasonably and in good faith consider any comments and actions recommended by Prothena, including with respect to filing strategy. In addition, Celgene will allow Prothena or its representative to attend any and all meetings with Regulatory Authorities with respect to Licensed Program Antibodies and/

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or Licensed Program Products in the Territory to the extent such attendance is not prohibited or limited by such Regulatory Authority, but only if such meeting directly impact regulatory matters with respect to Licensed Program Antibodies and/or Licensed Program Products outside the Territory.
2.2.2      Safety Information . Prior to the Transfer Date, Prothena shall have the right to report all safety information to Regulatory Authorities with respect to the Licensed Program Antibodies and/or Licensed Program Products in the Territory hereunder, and shall promptly provide Celgene with all information concerning the pharmaceutical safety of Licensed Program Antibodies and/or Licensed Program Products in the Territory. After the Transfer Date, Celgene shall have the right to report all safety information to Regulatory Authorities with respect to the Licensed Program Antibodies and/or Licensed Program Products in the Territory hereunder, and shall promptly provide Prothena with all such information concerning the pharmaceutical safety of Licensed Program Antibodies and/or Licensed Program Products in the Territory.
2.2.3      Step-In Right of Celgene. In the event that Prothena does not undertake any activities allocated to Prothena in the provisions of Section 2.2.1 or 2.2.2 in any respect, then, upon written notice from Celgene to Prothena, Celgene (or its designee) shall have the right to do so, and Prothena shall provide Celgene with reasonable assistance in connection therewith.
2.2.4      Right of Reference; Access to Data . Celgene (and its designees) shall have, and Prothena (on behalf of itself and its Affiliates) hereby grants to Celgene (and its designees), access and a right of reference (without any further action required on the part of Prothena or its Affiliates, whose authorization to file this consent with any Regulatory Authority is hereby granted) to all Regulatory Materials with respect to the Licensed Program Antibodies and/or Licensed Program Products in the Territory that are Controlled by Prothena (or its Affiliates) and all data contained or referenced in any such Regulatory Materials for Celgene (and its designees) solely to the extent necessary for Celgene to exercise its rights and perform its obligations hereunder.
2.2.5      Additional Regulatory Activities by Celgene . For the avoidance of doubt, without limiting any other rights or remedies of Celgene, Celgene shall have the right to undertake any regulatory activities, including to prepare, file and maintain all Regulatory Materials (including any Regulatory Approvals) necessary for the Development, Manufacture and Commercialization of any Licensed Antibodies and/or Licensed Products in the Territory hereunder, and to interact with Regulatory Authorities in connection with the Development, Manufacture and Commercialization of any Licensed Antibodies and/or Licensed Products in the Territory hereunder, to the extent such activities are not performed by Prothena.
2.2.6      Pharmacovigilance . At the written request of Celgene, within [***] ([***]) days after such request, Prothena and Celgene (or its designee(s)) will enter into a pharmacovigilance agreement in order to, among other things, coordinate safety matters and share of safety information with respect to Licensed Products.
2.3      Prothena Ongoing Activities in Support of Licensed Program .

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2.3.1      Prothena Ongoing Program Activities . Notwithstanding the provisions of Section 2.1.1 or Section 2.2.1, Prothena shall have the right to continue to conduct Development activities (and related activities, including as set forth in Section 2.5.1(b)(iv) of the Master Collaboration Agreement with respect to the Licensed Program) for the Licensed Program under, and in accordance with, the Master Collaboration Agreement, through the first to occur of (i) the end of the Phase 1 Option Term for the Licensed Program, or (ii) Celgene’s exercise of the Celgene Phase 1 Portion Participation Right; provided, however, that if thereafter, in the event that Prothena desires to conduct any Development activities (or related activities) in the Territory that are not set forth in the Master Collaboration Agreement or this Agreement, Prothena may only conduct such activities to the extent requested by Celgene in writing, or otherwise with the prior written consent of Celgene.
2.3.2      Transition Supply . If Prothena was supplying (or having supplied) any Licensed Antibody and/or Licensed Product for any Clinical Trial(s) or other Development activities conducted with respect to the Licensed Program under the Master Collaboration Agreement, then, at Celgene’s written request, Prothena will be responsible for supplying, and shall supply, to Celgene (or its designee) Licensed Antibody(ies) and/or Licensed Product(s), for use in Development by or on behalf of Celgene hereunder for a period not to exceed [***] ([***]) [***] (or such longer period of time as agreed to by the Parties), as and to the extent requested by Celgene; provided that Celgene shall pay to Prothena a reasonable, fair value cost for such supply, which cost shall be negotiated in good faith and agreed to by the Parties prior to such supply. In such case, at the request of Celgene, the Parties shall negotiate in good faith and enter into an appropriate supply agreement (including a quality agreement) for Prothena to supply (or have supplied) Licensed Antibody and/or Licensed Product, as applicable, to Celgene (or its designee). Notwithstanding the foregoing, if Prothena has engaged a Third Party contract manufacturer for the supply of Licensed Antibodies and/or Licensed Products, and the agreement with such Third Party prohibits the supply to Celgene in accordance with the foregoing (provided that Prothena used good faith efforts not to include such prohibition during negotiations), then in lieu of the foregoing supply obligation, Prothena shall take such actions as reasonably requested by Celgene to facilitate the negotiations between Celgene and Prothena’s Third Party contract manufacturer of an appropriate supply agreement (including a quality agreement) for the supply of Licensed Antibody and/or Licensed Product, as applicable, to Celgene (or its designee).
2.3.3      Other Continuing Development Activities . Without limiting the other obligations of Prothena hereunder (including as set forth in this Section 2.3), in the event that the Parties mutually agree in writing that Prothena or its Affiliates will conduct any other specific Development activities for Celgene after the Effective Date with respect to the Licensed Program (in addition to those set forth in the foregoing provisions of this Section 2.3) (the “ Ongoing Prothena Development Activities ”), then, in such case, the Parties shall negotiate in good faith and enter into a separate services agreement pursuant to which Prothena (or its Affiliates, as applicable) shall perform such Ongoing Prothena Development Activities.
Prothena’s obligations as set forth in the foregoing clauses 2.3.1 through 2.3.3, as applicable, are the “ Prothena Ongoing Program Activities ”.

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2.4      Assistance; Technology Transfer . Prothena shall (and shall cause its Affiliates to) cooperate with Celgene (and its designees) and provide reasonable assistance to Celgene (and its designees) to enable Celgene (and its designees) to Develop, Manufacture and Commercialize Licensed Antibodies and Licensed Products, as and to the extent requested reasonably by Celgene, including (i) conducting a technology transfer to Celgene with respect to the Licensed Program Know-How and Prothena Licensed Collaboration Know-How, (ii) providing Celgene (and its designees) reasonable assistance with respect to regulatory and Manufacturing transition matters related to Licensed Antibodies and Licensed Products and (iii) providing Celgene (and its designees) with reasonable access by teleconference or in-person (as requested by Celgene) to Prothena personnel (and personnel of its Affiliates and Third Party contractors) involved in the Development or Manufacture of Licensed Antibodies and Licensed Products to assist with the transition and answer questions related to Licensed Antibodies, Licensed Products and Diagnostic Products.
2.5      Covenant . Except as otherwise expressly permitted under this Agreement, commencing on the Effective Date until the end of the Term, Prothena shall not and shall cause its Affiliates not to (a) assign, transfer, convey, encumber (through a lien, charge, security interest, mortgage or similar encumbrance) or dispose of, or enter into any agreement with any Third Party to assign, transfer, convey, encumber (through a lien, charge, security interest, mortgage or similar encumbrance) or dispose of, any [***] (collectively, the “ Licensed Program Assets ”), except to the extent such assignment, transfer, conveyance, encumbrance or disposition would not conflict with, be inconsistent with or adversely affect in any respect any of the rights or licenses granted to Celgene hereunder, (b) license or grant to any Third Party, or agree to license or grant to any Third Party, any rights to any Licensed Program Assets if such license or grant could conflict with, be inconsistent with or adversely affect in any respect any of the rights or licenses granted to Celgene hereunder, or (c) [***] the Licensed Program Assets to any Third Party if such [***] could impair or conflict in any respect with any of the rights or licenses granted to Celgene hereunder.
2.6      Other Antibodies and Products Developed by Celgene . Notwithstanding anything to the contrary contained herein, if Celgene (or any of its Affiliates), alone or with any Third Party, determines to Develop, Manufacture or Commercialize any Antibodies (or any product containing an Antibody), other than Licensed Antibodies or Licensed Products, then Celgene may do so in its sole discretion, without any obligations to Prothena with respect thereto, and Prothena shall have no rights in connection therewith, provided that Celgene’s or its Affiliates’ conduct of any such activities shall not modify or obviate Celgene’s obligations under this Agreement.
2.7      Non-Exercise of Phase 1 Option for Licensed Program . In the event that Celgene does not exercise its Phase 1 Option for the Licensed Program in accordance with the Master Collaboration Agreement prior to the end of the Phase 1 Option Term for the Licensed Program, and Prothena desires (itself or with or through a Third Party) to continue the Development of the Licensed Program Antibodies and Licensed Program Products in the Field in the Territory, then at the written request of Prothena, Celgene shall discuss in good faith the terms under which Celgene may be willing to grant rights to Prothena under the Prothena IP for Prothena (itself or with or through a Third Party) to continue the Development of the Licensed Program Products in the Field in the Territory (including the Manufacture of Licensed Program Antibodies and Licensed Program Products in connection therewith), and to thereafter Commercialize Licensed Program Antibodies

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and Licensed Program Products in the Field in the Territory; provided that, for the avoidance of doubt, the provisions of Article 5 (other than Section 5.7) shall not apply with respect to any such activities.
2.8      No Global License Agreement . For the avoidance of doubt, in the event that Celgene does not exercise its Phase 1 Option for the Licensed Program for the Licensed Program, this Agreement shall remain in full force and effect unless and until this Agreement expires or is otherwise terminated in accordance with the terms hereof.
ARTICLE 3.     
ANTITRUST AND COMPETITION LAW COMPLIANCE
3.1      Antitrust Compliance . For the avoidance of doubt, the Parties shall continue to comply with Section 3.2 of the Master Collaboration Agreement, and such provisions shall apply to this Agreement as if set forth directly herein, mutatis mutandis .
ARTICLE 4.     
EXCLUSIVITY
4.1      Prothena Exclusivity . During the Term, Prothena shall not and shall ensure that its Affiliates shall not, anywhere in the world: (i) alone or with or through any Third Party, research [***], Develop, Manufacture or Commercialize (a) the Licensed Target or any Competing Compound, or (b) any diagnostic product intended for use, or Developed or approved for use with, the Licensed Target (including any diagnostic product intended for use, or Developed or approved for use with, any Competing Compound), in each case, other than Prothena’s performance of the Prothena Ongoing Program Activities (including engaging its Affiliates or Third Party subcontractors to perform the Prothena Ongoing Program Activities in accordance with this Agreement) as specifically set forth in Section 2.3; (ii) grant a license, sublicense or other rights to any Third Party to conduct any of the activities in the foregoing clause (i), other than Prothena’s performance of the Prothena Ongoing Program Activities (including engaging its Affiliates or Third Party subcontractors to perform the Prothena Ongoing Program Activities in accordance with this Agreement) as specifically set forth in Section 2.3; or (iii) transfer, assign, convey or otherwise sell (a) any Competing Compound or any diagnostic product intended for use, or (b) Developed or approved for use with, the Licensed Target (including any diagnostic product intended for use, or Developed or approved for use with, any Competing Compound). As used herein, the term “ Competing Compound ” means [***].
4.2      Prothena Exception for Active Immunotherapeutic Approaches .
4.2.1      Exception for Active Immunotherapeutic Approaches . Notwithstanding the provisions of Section 4.1, but subject to the provisions of Section 5.3.2, Prothena and its Affiliates (themselves, but not with or through any Third Parties) may conduct research, development, manufacture and commercialization of Active Immunotherapeutic Approaches outside of this Agreement; provided that no Licensed Antibodies or Licensed Products are utilized in the conduct of any such activities (including no use of a Licensed Antibody or Licensed Product for an Active

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Immunotherapeutic Approach). As used herein, “ Active Immunotherapeutic Approaches ” means [***].
4.2.2      Celgene Right of First Negotiation . During the Term, in the event that [***] with respect to [***], [***] will [***]. [***] will [***] (a “[***]”). If [***], [***] will [***] which [***] will [***]. If [***], the Parties will [***]. Until [***] or the [***], as applicable, [***]. If [***] that it [***], then [***]. For the avoidance of doubt, this Section 4.2.2 [***]. For clarity, [***].
4.3      Master Collaboration Agreement . For the avoidance of doubt, the provisions of this Article 4 shall not limit in any way the provisions of Article 5 of the Master Collaboration Agreement.
4.4      Celgene Exclusivity .
4.4.1      Celgene Exclusivity . If Celgene does not exercise the Phase 1 Option for the Licensed Program prior to the end of the Phase 1 Option Term, then, for a period of [***] (the “ Celgene Exclusivity Term ”), neither Celgene nor its Affiliates will, anywhere in the Territory, alone or with or through any Third Party, either (a) sell any Competing Antibody that has an approved label for treatment of an Indication for which Celgene or its Affiliates has conducted a Registration Enabling Clinical Trial for a Licensed Product hereunder (as set forth in the protocol for such Registration Enabling Clinical Trial) or (b) conduct a Registration Enabling Clinical Trial for any Competing Antibody for treatment of an Indication (as set forth in the protocol for such Registration Enabling Clinical Trial) for which Celgene has conducted a Registration Enabling Clinical Trial for a Licensed Product hereunder (as set forth in the protocol for such Registration Enabling Clinical Trial) (provided that, for the avoidance of doubt, this Section 4.4.1 shall not prohibit (i) use of an Competing Antibody as a comparator in a Registration Enabling Clinical Trial or (ii) Celgene or any of its Affiliates providing proprietary products (that are not Competing Antibodies) to a Third Party for such Third Party’s use in a clinical trial of Competing Antibodies), in each case of (a) and (b), other than Celgene’s exercise of its rights and performance of its obligations with respect to Licensed Antibodies and Licensed Products pursuant to this Agreement (including engaging Third Party subcontractors to perform the such rights and obligations in accordance with this Agreement). As used herein, the term “ Competing Antibody ” means [***].
4.4.2      Exceptions for Change of Control . Notwithstanding the provisions of Section 4.4.1, if during the Celgene Exclusivity Term, Celgene (or any of its Affiliates) undergoes a Change of Control with a Third Party who (itself or through any of its affiliates existing prior to the date of the Change of Control) owns or has rights to a Competing Antibody (but excluding any Licensed Antibody or Licensed Product) that is in ongoing clinical development or being commercialized by such Third Party (or its affiliate) as of the date of the Change of Control (a “ Celgene Acquired Competing Antibody ”), then Celgene and its Affiliates (including the acquiring Person in the Change of Control (and such acquiring Person’s affiliates)) shall not be in breach of the provisions of Section 4.4.1 as a result of [***]; provided that (i) such activities are conducted independently of the activities of this Agreement and without use of any Prothena IP ([***]) and (ii) no personnel who are conducting any Registration Enabling Clinical Trial activities pursuant to this Agreement are involved in the conduct of Registration Enabling Clinical Trial activities with respect to the Celgene Acquired Competing Antibody.

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ARTICLE 5.     
FINANCIAL TERMS
5.1      Option Exercise Fee . Subject to Section 3.2 of the Master Collaboration Agreement, the Parties acknowledge and agree that Celgene will pay the IND Option Exercise Fee (as defined in the Master Collaboration Agreement) for the Licensed Program in accordance with the Master Collaboration Agreement.
5.2      Royalties .
5.2.1      Licensed Product Royalties . Subject to the terms of this Section 5.2 (and subject further to Section 5.5), Celgene shall pay Prothena royalties on Annual Net Sales, on a Licensed Product-by-Licensed Product basis during the applicable Royalty Term, equal to the following portions of Annual Net Sales of the applicable Licensed Product multiplied by the applicable royalty rate set forth below for such portion of Annual Net Sales during the applicable Royalty Term for each such Licensed Product, which royalties shall be paid in accordance with Section 5.2.7 (the “ Per Licensed Product Annual Net Sales ”). For clarity, the royalties (and royalty tiers) shall be calculated separately on a Licensed Product-by-Licensed Product basis.

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Per Licensed Product Annual Net Sales for a Given Licensed Product in a Given Calendar Year
Royalty Rate
Portion of Per Licensed Product Annual Net Sales of a given Licensed Product in a given Calendar Year above [***]
[***]%
Portion of Per Licensed Product Annual Net Sales of a given Licensed Product in a given Calendar Year above [***]
[***]%
Portion of Per Licensed Product Annual Net Sales of a given Licensed Product in a given Calendar Year above [***]
[***]%
Portion of Per Licensed Product Annual Net Sales of a given Licensed Product in a given Calendar Year above [***]
[***]%
Portion of Per Licensed Product Annual Net Sales of a given Licensed Product in a given Calendar Year above [***]
[***]%
Portion of Per Licensed Product Annual Net Sales of a given Licensed Product in a given Calendar Year above [***]
[***]%
Portion of Per Licensed Product Annual Net Sales of a given Licensed Product in a given Calendar Year above [***]
[***]%
Portion of Per Licensed Product Annual Net Sales of a given Licensed Product in a given Calendar Year above [***]
[***]%
Portion of Per Licensed Product Annual Net Sales of a given Licensed Product in a given Calendar Year above [***]
[***]%
Portion of Per Licensed Product Annual Net Sales of a given Licensed Product in a given Calendar Year above [***]
[***]%

The applicable royalty rate set forth in the table above will apply only to that portion of the Per Licensed Product Annual Net Sales of a given Licensed Product during a given Calendar Year that falls within the indicated range. For clarity, (i) if no royalty is payable on a given unit of Licensed Product (e.g., following the Royalty Term for such Licensed Product), then the Net Sales of such unit of Licensed Product shall not be included for purposes of determining the royalties or royalty tiers and (ii) Net Sales of a given Licensed Product will not be combined with Net Sales of any other Licensed Product for purposes of determining the foregoing royalties or royalty tiers. Only one royalty shall be payable by Celgene to Prothena for each sale of a Licensed Product.
By way of example, if Per Licensed Product Annual Net Sales of a given Licensed Product by Celgene, its Affiliates and Sublicensees were $[***] for a given Calendar Year, then the royalties payable with respect to such Per Licensed Product Annual Net Sales for such Licensed Product for such Calendar Year, subject to adjustment as set forth in this Section 5.2, would be: [***].

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5.2.2      Royalty Term . Celgene’s royalty obligations to Prothena under Section 5.2.1 shall apply on a Licensed Product-by-Licensed Product basis in the Territory only during the applicable Royalty Term for such Licensed Product. Following expiration of the applicable Royalty Term for a given Licensed Product, as applicable, no further royalties will be payable in respect of sales of such Licensed Product in the Territory and thereafter the license granted to Celgene hereunder with respect to such Licensed Product will automatically become fully paid-up, perpetual, irrevocable and royalty-free.
5.2.3      Reductions .
(a)      Reductions for No Valid Claim . The royalty amounts payable with respect to Per Licensed Product Annual Net Sales shall be reduced on a Licensed Product-by-Licensed Product basis, to [***] percent ([***]%) of the amounts otherwise payable pursuant to Section 5.2.1 during any portion of the applicable Royalty Term in which both: (i) [***] and (ii) [***].
(b)      Royalty Reduction for Biosimilar Product . If, on a Licensed Product-by-Licensed Product and Calendar Quarter-by-Calendar Quarter basis in the Territory,
(i)      [***]; or
(ii)      [***];
then the royalties payable with respect to Per Licensed Product Annual Net Sales of such Licensed Product pursuant to Section 5.2.1 during such Calendar Quarter shall be reduced to [***], of the royalties otherwise payable pursuant to Section 5.2.1. [***].
5.2.4      Royalty Offset for Third Party Payments . If Celgene (or any of its Affiliates or Sublicensees) obtains a right or license under intellectual property of a Third Party (whether prior to, or after, the Effective Date), where the research, development, making, using, selling, offering for sale, or importing of any Licensed Product (or any Licensed Antibody contained in such Licensed Product) by or on behalf of Celgene (or any of its Affiliates or Sublicensees) would result in a payment to such Third Party, then Celgene may deduct from the royalty payments that would otherwise have been due under Section 5.2.1 with respect to Per Licensed Product Annual Net Sales in a particular Calendar Quarter, an amount equal to [***] percent ([***]%) of [***] (“ Celgene Third Party Payments ”) during such Calendar Quarter. Notwithstanding the foregoing, in no event shall the royalties payable on Per Licensed Product Annual Net Sales be reduced by more than [***] percent ([***]%) in any Calendar Quarter by operation of this Section 5.2.4; [***].
5.2.5      Cumulative Effect of Royalty Reductions and Offsets . In no event shall the royalty reductions and offsets described in Sections 5.2.3(a), 5.2.3(b) and 5.2.4, alone or together, reduce the royalties payable by Celgene for a given Calendar Quarter pursuant to Section 5.2.1 to less than [***] percent ([***]%) of the amounts otherwise payable by Celgene for a given Calendar Quarter pursuant to Section 5.2.1. [***]

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5.2.6      Compulsory Licenses . If a compulsory license is granted to a Third Party with respect to a Licensed Product in the Territory with a royalty rate lower than the royalty rate provided by Section 5.2.1 (as adjusted pursuant to Section 5.2.3), then the royalty rate to be paid by Celgene on Per Licensed Product Annual Net Sales under Section 5.2.1 shall be reduced [***].
5.2.7      Payment of Royalties . Celgene shall: (a) within [***] ([***]) days following the end of each Calendar Quarter in which a royalty payment pursuant to Section 5.2.1 accrues, provide to Prothena a report specifying for such Calendar Quarter (i) the number of Licensed Products sold that are subject to such royalty, (ii) the Per Licensed Product Annual Net Sales that are subject to such royalty, (iii) the applicable royalty rate under this Agreement, (iv) the royalty calculation and royalties payable in U.S. Dollars and (v) any reduction to the royalty applied by Celgene pursuant to any one or more of Sections 5.2.3 and 5.2.4; and (b) make the royalty payments owed to Prothena hereunder in accordance with such royalty report in arrears, within [***] ([***]) days from the end of the Calendar Quarter in which such payment accrues.
5.3      Regulatory Milestones .
5.3.1      Regulatory Milestones . Subject to the terms of this Section 5.3 (and subject further to Section 5.5), Celgene will notify Prothena within [***] ([***]) days following the first achievement by Celgene under this Agreement and after the Effective Date of each milestone event described below in this Section 5.3 with respect to the first (and only the first) Licensed Product to achieve such milestone event under this Agreement, and Celgene shall thereafter pay the applicable amounts set forth below associated with the applicable milestone event in accordance with Section 5.3.2 (each, a “ Regulatory Milestone Payment ”):
Regulatory Approval Milestone Event
Regulatory Milestone Payment
1. Receipt under this Agreement of all Regulatory Approvals for a Licensed Product for the first Select Indication in the U.S. issued by the FDA; [***] (the “ First U.S. Approval Milestone ”)

[***] Dollars ($[***])
2. Receipt under this Agreement of all Regulatory Approvals for a Licensed Product for a second Select Indication [***] in the U.S. issued by the FDA; [***]

[***] Dollars ($[***])

Each of the foregoing milestones in this Section 5.3.1 shall be payable a maximum of one (1) time as set forth in the foregoing chart regardless of the number of Licensed Products achieving the applicable milestone event ( i.e. , a maximum of two (2) Regulatory Milestone Payments may be made pursuant to this Section 5.3.1), and no Regulatory Milestone Payment shall be due hereunder for subsequent or repeated achievement of such milestone event. For the avoidance of doubt, the maximum amount payable by Celgene pursuant to this Section 5.3.1 is [***] Dollars ($[***]) assuming that each of the milestone events in this Section 5.3.1 were achieved.

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5.3.2      Invoice and Payment of Regulatory Milestone Payments . Following receipt of notification by Celgene to Prothena that Celgene has achieved the applicable milestone event triggering a Regulatory Milestone Payment hereunder, Prothena shall invoice Celgene for the applicable Regulatory Milestone Payment, and Celgene shall pay such Regulatory Milestone Payment within [***] ([***]) days after receipt of the invoice therefor.
5.4      Sales Milestones .
5.4.1      Sales Milestones . Subject to the terms of this Section 5.4 (and subject further to Section 5.5), Celgene will notify Prothena within [***] ([***]) days after the end of the Calendar Quarter during which a given milestone event described below in this Section 5.4 was first achieved by Celgene under this Agreement and after the Effective Date with respect to the Licensed Products, and Celgene shall thereafter pay the applicable amounts set forth below associated with the applicable milestone event in accordance with Section 5.4.2 (each, a “ Sales Milestone Payment ”):
Sales Milestone Event

Sales Milestone Payment
First achievement of Per Licensed Product Annual Net Sales of the Licensed Products in any single Calendar Year exceeding [***] Dollars ($[***])

[***] Dollars ($[***])
First achievement of Per Licensed Product Annual Net Sales of the Licensed Products in any single Calendar Year exceeding [***] Dollars ($[***])

[***] Dollars ($[***])
First achievement of Per Licensed Product Annual Net Sales of the Licensed Products in any single Calendar Year exceeding [***] Dollars ($[***])

[***] Dollars ($[***])
First achievement of Per Licensed Product Annual Net Sales of the Licensed Products in any single Calendar Year exceeding [***] Dollars ($[***])

[***] Dollars ($[***])


Each of the foregoing milestones in this Section 5.4.1 shall be payable a maximum of one (1) time as set forth in the foregoing chart regardless of the number of times the applicable milestone event was achieved (i.e., a maximum of four (4) Sales Milestone Payments may be made pursuant to this Section 5.4.1), and no Sales Milestone Payment shall be due hereunder for subsequent or repeated achievement of such milestone event. For the avoidance of doubt, the maximum amount payable by Celgene pursuant to this Section 5.4.1 is [***] Dollars ($[***]) assuming that each of the milestone events in this Section 5.4.1 were achieved.

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5.4.2      Invoice and Payment of Sales Milestone Payments . Following receipt of notification by Celgene to Prothena that Celgene has achieved the applicable milestone event triggering a Sales Milestone Payment hereunder, Prothena shall invoice Celgene for the applicable Sales Milestone Payment, and Celgene shall pay such Sales Milestone Payment within [***] ([***]) days after receipt of the invoice therefor.
5.5      Additional Payment Terms .
5.5.1      Currency . All payments hereunder shall be made in U.S. Dollars by wire transfer to a bank designated in writing by Prothena. Conversion of sales recorded in local currencies to Dollars shall be performed in a manner consistent with Accounting Standards and Celgene’s normal practices used to prepare its audited financial statements for internal and external reporting purposes.
5.5.2      Taxes; Withholding .
(a)      Generally . Each Party will pay any and all income taxes levied on account of all payments it receives under this Agreement except as otherwise provided in this Section 5.5.2.
(b)      Tax Withholding . Each Party shall be entitled to deduct and withhold from any amounts payable under this Agreement such taxes as are required to be deducted or withheld therefrom under any provision of Applicable Law. The Party that is required to make such withholding (the “ Paying Party ”) will (i) deduct those taxes from such payment, (ii) timely remit the taxes to the proper taxing authority, and (iii) send evidence of the obligation together with proof of tax payment to the other Party (the “ Payee Party ”) on a timely basis following that tax payment; provided, however, that before making any such deduction or withholding, the Paying Party shall give the Payee Party notice of the intention to make such deduction or withholding (such notice shall include an explanation of the reason for and the calculation of the proposed deduction or withholding and shall be given before such deduction or withholding is required in order for such Payee Party to obtain reduction of or relief from such deduction or withholding). Each Party agrees to reasonably cooperate with the other Party in claiming refunds or exemptions from such deductions or withholdings under any relevant agreement or treaty which is in effect to ensure that any amounts required to be withheld pursuant to this Section 5.5.2(b) are reduced in amount to the fullest extent permitted by Applicable Law. In addition, the Parties shall cooperate in accordance with Applicable Laws to minimize indirect taxes (such as value added tax, sales tax, consumption tax and other similar taxes (“ Indirect Taxes ”)) in connection with this Agreement.
(c)      Tax Gross-Up . Notwithstanding the foregoing, if (a) any Party redomiciles, assigns its rights or obligations or extends its rights under this Agreement, (b) as a result of such redomiciliation, assignment or extension, such Party (or its assignee) is required by Applicable Law to [***] or such redomiciliation, assignment or extension results in [***], and (c) such [***] exceed the amount of [***] that would have been applicable but for such redomiciliation, assignment or extension, then any such amount payable shall [***] so that, after making all required [***], as the case may be, the Payee Party (or its assignee) [***]. The [***] (A) [***] to the extent such [***] but for [***], and (B) [***]. For purposes of the preceding sentence, “ Tax Benefit ” shall

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mean any cash refund or credit for Taxes resulting in a reduction in the amount of Taxes otherwise owed by the Payee Party as a result of [***] relating to payments by the Paying Party, as reasonably determined by Payee Party. Solely for purposes of this Section 5.5.2(c), a Party’s “domicile” shall include its jurisdiction of incorporation or tax residence and a “redomiciliation” shall include a reincorporation or other action resulting in a change in tax residence of the applicable Party or its assignee, or resulting in the attribution of any amounts payable to a branch or permanent establishment located outside the country of tax residence of the applicable Party or its assignee
(d)      Tax Documentation . Prothena has provided a properly completed and duly executed IRS Form W-8BEN-E to Celgene. Prior to the receipt of any payment under this Agreement, each recipient Party (and any other recipient of payments under this Agreement) shall, to the extent it is legally permitted to, provide to the other Party, at the time or times reasonably requested by such other Party or as required by Applicable Law, such properly completed and duly executed documentation (for example, IRS Forms W-8 or W-9 or foreign equivalents) as will permit payments made under this Agreement to be made without, or at a reduced rate of, withholding for taxes
5.5.3      Other U.S. License Agreements . For the avoidance of doubt, a Licensed Product hereunder will only be eligible for milestone and royalty payments under this Agreement, and shall not be eligible for, or counted towards, milestone or royalty payments under any other U.S. License Agreement (i.e., a given Licensed Product will be eligible for, and counted towards, milestone and royalty payments only under one U.S. License Agreement).
5.6      Records Retention by Celgene; Review by Prothena .
5.6.1      Records . With respect to royalty and milestone payments to be made under Sections 5.2 or 5.4 of this Agreement, Celgene agrees to keep and shall procure that its Affiliates keep, for at least [***] ([***]) years from the end of the Calendar Year to which they pertain, complete and accurate records of sales by Celgene or its Affiliates (including sales by Sublicensees), as the case may be, of each Licensed Product, in sufficient detail to allow the accuracy of the payments made hereunder to be confirmed.
5.6.2      Review . Subject to the other terms of this Section 5.6.2, during the Term, at the request of Prothena, which shall not be made more frequently than [***], upon at least [***] ([***]) days’ prior written notice from Prothena, [***], Celgene shall permit an independent, nationally-recognized certified public accountant selected by Prothena and reasonably acceptable to Celgene to inspect (during regular business hours) the relevant records required to be maintained by Celgene under Section 5.6.1; provided that such audit right shall not apply to records beyond [***] ([***]) years from the end of the Calendar Year to which they pertain. In every case the accountant must have previously entered into a confidentiality agreement with both Parties having confidentiality obligations and non-use obligations no less restrictive than those set forth in Article 7 and limiting the disclosure and use of such information by such accountant to authorized representatives of the Parties and the purposes germane to Section 5.6.1. Results of any such review shall be binding on both Parties absent manifest error. The accountant shall report to Prothena only whether the particular amount being audited was accurate, and if not, the amount of any discrepancy, and the accountant shall not report any other information to Prothena. Prothena shall treat the results

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[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.



of any such accountant’s review of Celgene’s records as Confidential Information of Celgene subject to the terms of Article 7. If any review reveals a deficiency or overpayment in the calculation and/or payment of royalties or Sales Milestone Payments by Celgene, then (a) Celgene or Prothena as applicable shall promptly pay (or refund, as applicable) the other Party the amount of such deficiency or overpayment, as applicable, and (b) if such deficiency is by more than the greater of (i) [***] or (ii) [***], Celgene shall, within [***] ([***]) days after receipt of an invoice therefor, pay the reasonable out-of-pocket costs and expenses incurred by Prothena for the independent accountant in connection with the review.
5.6.3      Records Final . Upon the expiration of [***] ([***]) years following the end of a given Calendar Year, subject and without prejudice to the determination of any review commenced prior to such [***] pursuant to Section 5.6.2, the calculation of royalties and Sales Milestone Payments payable with respect to such Calendar Year shall be binding and conclusive upon Prothena, and Celgene (and its Affiliates) shall be released from any liability or accountability with respect to such royalties for such Calendar Year.
5.7      Prothena Third Party Agreements . Notwithstanding anything to the contrary herein, Prothena shall be solely responsible for all costs and payments of any kind (including all upfront fees, annual payments, milestone payments and royalty payments) arising under any agreements between Prothena (or any of its Affiliates) and any Third Party (including under any In-License Agreement or other Existing Program Agreement), which costs or payments arise in connection with, or as a result of, the activities hereunder, including the Development, Manufacture or Commercialization of Licensed Antibodies or Licensed Products.
5.8      Diagnostic Products . Notwithstanding anything to the contrary contained herein, [***].
5.9      Additional Provisions . Notwithstanding anything to the contrary herein, the terms and provisions of this Article 5 are subject to Section 11.7 of the Master Collaboration Agreement and Sections 10.9 and 10.12 of this Agreement.
ARTICLE 6.     
LICENSES; INTELLECTUAL PROPERTY
6.1      License to Celgene . Subject to the terms and conditions of this Agreement, Prothena hereby grants to Celgene an exclusive right and license, with the right to grant sublicenses (through multiple tiers), under the Prothena IP to research, develop (including Develop), make (including Manufacture), have made (including have Manufactured), use, offer for sale, sell, import, Commercialize and otherwise exploit Licensed Antibodies and Licensed Products, including Diagnostic Products, in the Field in the Territory.
6.2      License to Celgene for Other Targets . In the event that, during the Term, Celgene modifies a Licensed Program Antibody in the course of its Development activities hereunder such that such Licensed Program Antibody specifically binds to a target other than (i) the Licensed Target or (ii) any other Collaboration Target (e.g., a bispecific antibody), then, at the request of Celgene,

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Celgene and Prothena shall negotiate in good faith a license under intellectual property of Prothena or its Affiliates, as applicable, that is specific to such other target or Antibodies to such other target.
6.3      Rights Retained by the Parties . For purposes of clarity, each Party retains all rights under Know-How and Patents Controlled by such Party not expressly granted to the other Party pursuant to this Agreement. In addition, Prothena retains the right to perform the Prothena Ongoing Program Activities in accordance with this Agreement.
6.4      No Implied Licenses . Except as explicitly set forth in this Agreement, the Master Collaboration Agreement, any other U.S. License Agreement or any Global License Agreement, neither Party shall be deemed by estoppel or implication to have granted to the other Party any license or other right to any intellectual property of such Party.
6.5      Insolvency . In the event that this Agreement is terminated due to the rejection of this Agreement by or on behalf of Prothena due to an Insolvency Event, all licenses and rights to licenses granted under or pursuant to this Agreement by Prothena to Celgene are and shall otherwise be deemed to be licenses of rights to “intellectual property”. The Parties agree that Celgene, as a licensee of such rights under this Agreement, shall retain and may fully exercise all of its rights and elections under any applicable insolvency statute, and that upon commencement of an Insolvency Event by or against Prothena, Celgene shall be entitled to a complete duplicate of or complete access to (as Celgene deems appropriate), any such intellectual property and all embodiments of such intellectual property. Such intellectual property and all embodiments thereof shall be promptly delivered to Celgene (i) upon any such commencement of a bankruptcy proceeding (or other Insolvency Event) upon written request therefore by Celgene, unless Prothena elects to continue to perform all of its obligations under this Agreement or (ii) if not delivered under (i) above, upon the rejection of this Agreement by or on behalf of Prothena, then upon written request therefore by Celgene. The provisions of this Section 6.5 shall be (1) without prejudice to any rights Celgene may have arising under any applicable insolvency statute or other Applicable Law and (2) effective only to the extent permitted by Applicable Law.
6.6      Ownership .
6.6.1      Inventorship . Notwithstanding the provisions of Section 11.7.1, inventorship of Know-How shall be determined by application of U.S. patent law pertaining to inventorship, and, except as provided for in Sections 6.6.2, 6.6.3 and 6.6.4, ownership of Know-How shall be determined by inventorship.
6.6.2      Ownership of Collaboration IP and Celgene IP .
(a)      Prothena . As between the Parties (including their respective Affiliates), Prothena will retain all right, title and interest in and to all Prothena Licensed Collaboration IP, except to the extent that any such rights are licensed or granted to Celgene under this Agreement or the Master Collaboration Agreement. Prothena shall [***] that all Patents, Know-How and other intellectual property (other than Licensed Program IP and Celgene IP, if any) utilized in the performance of the Licensed Program under the Master Collaboration Agreement falls within the Prothena Licensed Collaboration IP and is and remains during the Term Controlled by Prothena

31
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such that Prothena has the full rights to grant the rights and licenses to the Prothena Licensed Collaboration IP to Celgene hereunder (including that such Patents, Know-How and other intellectual property remains unencumbered such that Prothena is able to grant such rights and licenses to Celgene).
(b)      Celgene . As between the Parties (including their respective Affiliates), Celgene (or its Affiliate) will retain all right, title and interest in and to all Celgene IP, including all rights to Prosecute and Maintain, and enforce any such Celgene IP, and no rights or licenses are granted to Prothena hereunder with respect to any Celgene IP.
6.6.3      Ownership of Licensed Program IP .
(a)      Prothena . As between the Parties (including their respective Affiliates), Prothena will solely own and Control all Licensed Program IP. Celgene shall, and hereby does, assign to Prothena all of Celgene’s interest in any and all Licensed Program Know-How that falls within Section 1.47(a)(iii) and all Licensed Program Patents claiming such Licensed Program Know-How. Celgene shall, and shall require its Affiliates to, take all reasonable actions and execute all documents necessary to effect the intent of the preceding sentence. As between the Parties (and their respective Affiliates) and any Third Party, Prothena will solely own and Control all Licensed Program IP; provided that if (a) [***] and (b) [***].
(b)      If any Licensed Program IP is created, conceived, discovered, first generated, invented, first made or first reduced to practice pursuant to the Master Collaboration Agreement by any Third Party that is in contractual privity with or otherwise engaged by Prothena or its Affiliates, Prothena [***] include in such agreement with such Third Party an obligation to [***] to Prothena [***] such Licensed Program IP to enable Prothena to grant to Celgene a license thereunder as provided in this Agreement for the duration of this Agreement.
6.6.4      Joint IP . The Parties shall each own an equal, undivided interest in: (a) any and all Know-How that is created, conceived, discovered, first generated, invented, first made or first reduced to practice, in each case, jointly by or on behalf of Prothena or its Affiliates, on the one hand, and Celgene or its Affiliates, on the other hand, pursuant to the conduct of activities under this Agreement at any time during the Term (the “ Joint Know-How ”), and (b) any Patents that claim any Joint Know-How (the “ Joint Patents ”, together with Joint Know-How the “ Joint IP ”). Each Party shall assign, and hereby assigns, to the other Party, a joint equal and undivided interest in and to such Joint IP (provided, however, that for clarity, the foregoing joint ownership rights with respect to Joint IP shall not be construed as granting, conveying or creating any license or other rights to any of the other Party’s other intellectual property, unless otherwise expressly set forth in this Agreement), and at the request of a Party, the other Party will execute such documents (including any necessary assignments) to effect such joint ownership of such Joint IP. Each Party shall have the right to disclose (except as otherwise set forth in Section 7.2) and exploit the Joint IP without a duty of seeking consent or accounting to the other Party except as expressly provided in this Agreement; provided that, such rights shall be subject to the rights and licenses granted to Celgene and Prothena hereunder (or under the Master Collaboration Agreement, any Global License Agreement or any other U.S. License Agreement), including the obligations of Prothena as set forth in Article 4.

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6.7      Patent Liaisons . Prior to the end of the Phase 1 Option Term for the Licensed Program, the Patent Committee under the Master Collaboration Agreement shall remain established, and shall continue to perform the functions set forth in Section 4.3 and Article 7 of the Master Collaboration Agreement with respect to the Prothena Licensed Collaboration Patents and Licensed Program Patents. Following the end of the Phase 1 Option Term for the Licensed Program, the Patent Committee under the Master Collaboration Agreement shall no longer oversee or review any matters with respect to the Prothena Licensed Collaboration Patents or Licensed Program Patents, and promptly following the end of the Phase 1 Option Term for the Licensed Program, each Party shall appoint an individual to act as a patent liaison for such Party pursuant to this Agreement (each, a “ Patent Liaison ”). The Patent Liaisons shall be the primary point of contact for the Parties regarding intellectual property-related activities and matters contemplated by this Agreement, as and to the extent requested by Celgene from time to time. The name and contact information for each Party’s Patent Liaison, as well as any replacement(s) chosen by such Party, in its sole discretion, from time to time, shall be promptly provided to the other Party in accordance with Section 11.2.
6.8      Prosecution and Maintenance of Prothena Licensed Collaboration Patents and Licensed Program Patents .
6.8.1      Prior to End of the Phase 1 Option Term . Prior to the expiration of the Phase 1 Option Term for the Licensed Program, the provisions of Section 7.7 of the Master Collaboration Agreement shall apply with respect to the Prothena Licensed Collaboration Patents and Licensed Program Patents.
6.8.2      Following Phase 1 Option Term . Following the expiration of the Phase 1 Option Term for the Licensed Program, the provisions of this Section 6.8.2 shall apply with respect to the Prothena Licensed Collaboration Patents and Licensed Program Patents.
(a)      [***] First Right . Subject to Section 6.8.2(b), [***] shall be required to, and shall, Prosecute and Maintain the Prothena Licensed Collaboration Patents and Licensed Program Patents in the Territory. All such Prosecution and Maintenance by [***] shall be through patent counsel reasonably acceptable to [***]. [***] shall keep [***] informed as to material developments with respect to the Prosecution and Maintenance of such Patents including by providing copies of all substantive office actions, examination reports, communications or any other substantive documents to or from any patent office, including notice of all interferences, reissues, re-examinations, inter partes reviews, derivations, post grant proceedings, oppositions or requests for patent term extensions. [***] shall also provide [***] with a reasonable opportunity to comment substantively on the Prosecution and Maintenance of such Prothena Licensed Collaboration Patents and Licensed Program Patents prior to taking material actions (including the filing of initial applications), and will in good faith incorporate any comments made by and actions recommended in good faith by [***], provided, however, that [***] provides its comments reasonably in advance of any applicable filing deadlines.
(b)      [***] Back-Up Right . If [***] in the Territory decides not to file a Prothena Licensed Collaboration Patent or Licensed Program Patent, in each case other than a Prothena Platform Patent, or intends to allow such Patent to lapse or become abandoned without having first filed a substitute, it shall notify and consult with [***] of such decision or intention at

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least [***] ([***]) days prior to the date upon which the subject matter of such Patent shall become unpatentable or such Patent shall lapse or become abandoned, and [***] shall thereupon have the right (but not the obligation) upon written notice to [***] to assume the Prosecution and Maintenance thereof at [***] expense with counsel of its choice ([***]). For clarity, the provisions of this Section 6.8.2(b) shall not limit Prothena’s obligations to Prosecute and Maintain the Prothena Licensed Collaboration Patents and Licensed Program Patents in the Territory as set forth in Section 6.8.2(b).
(c)      Cooperation in Prosecution and Maintenance .
(i)      Further Assurances . If Celgene determines to undertake the Prosecution and Maintenance of a Prothena Licensed Collaboration Patent or Licensed Program Patent in accordance with this Section 6.8.2, Prothena agrees to make its employees, agents and consultants reasonably available to Celgene (and to Celgene’s authorized attorneys, agents or representatives) to enable Celgene to undertake such Prosecution and Maintenance. In addition, Prothena shall (and shall cause its Affiliates and its and their employees, agents and consultants to) provide reasonable assistance to Celgene (and to Celgene’s authorized attorneys, agents or representatives) to enable Celgene to undertake such Prosecution and Maintenance, including by executing powers of attorney and other documents for Celgene to undertake such Prosecution and Maintenance.
(ii)      Assistance . The Parties shall reasonably cooperate with one another with respect to the Prosecution and Maintenance of the Prothena Licensed Collaboration Patents and Licensed Program Patents for which either Party is responsible for Prosecution and Maintenance pursuant to this Section 6.8.2. [***], the Parties shall cooperate with one another to [***], in each case that are applicable to the Licensed Target or Licensed Program Antibody, as applicable, if practicable to [***].
(d)      Costs of Prosecution and Maintenance . Except as otherwise expressly set forth in this Section 6.8.2, each Party shall be responsible for all costs and expenses associated with its Prosecution and Maintenance activities under this Section 6.8.2 with respect to Prothena Licensed Collaboration Patents and Licensed Program Patents for which it is responsible pursuant to Sections 6.8.2(a) or 6.8.2(b), as applicable. Notwithstanding the foregoing provisions of this Section 6.8.2, [***]. If any Prothena Licensed Collaboration Patents or Licensed Program Patents claim or cover [***] and such Prothena Licensed Collaboration Patent or Licensed Program Patent, as applicable, is [***], and [***] for the Prosecution and Maintenance of such Prothena Licensed Collaboration Patent or Licensed Program Patent, as applicable, pursuant to Section [***] shall [***].
6.9      Enforcement of Prothena Licensed Collaboration Patents and Licensed Program Patents .
6.9.1      Prior to the end of the Phase 1 Option Term . Prior to the end of the Phase 1 Option Term for the Licensed Program, the provisions of Section 7.7 of the Master Collaboration Agreement shall apply with respect to the Prothena Licensed Collaboration Patents and Licensed Program Patents.

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6.9.2      Following Phase 1 Option Term . Following the end of the Phase 1 Option Term for the Licensed Program, the provisions of this Section 6.9.2 shall apply with respect to the Prothena Licensed Collaboration Patents and Licensed Program Patents in the Territory, and the provisions of Master Collaboration Agreement shall continue to apply with respect to the Prothena Licensed Collaboration Patents and Licensed Program Patents outside the Territory.
(a)      Notice . If any Party learns of an infringement or threatened infringement by a Third Party of any Prothena Licensed Collaboration Patent or Licensed Program Patent, in each case other than a Prothena Platform Patent, in the Territory (including in connection with any Biosimilar Application referencing a Licensed Product (regardless of whether such notice or copy is provided under any Applicable Laws) including under the BPCIA or the United States Patient Protection and Affordable Care Act or its successor provisions, or any similar provisions in a country outside the United States, as applicable) such Party shall promptly notify the other Party and shall provide such other Party with available evidence of such infringement, and following such notification, the Parties shall confer.
(b)      [***] First Right . Subject to the remaining provisions of this Section 6.9.2, [***] shall have the first right, but not the obligation, to institute, prosecute, and control any action or proceeding (which may include settlement or otherwise seeking to secure the abatement of such infringement) with respect to any infringement of any (i) Prothena Licensed Collaboration Patent or (ii) Licensed Program Patent, in each case other than a Prothena Platform Patent, (including in connection with any Biosimilar Application referencing a Licensed Product (regardless of whether such notice or copy is provided under any Applicable Laws), including under the BPCIA or the United States Patient Protection and Affordable Care Act or its successor provisions, or any similar provisions in a country outside the United States, as applicable), by counsel of its own choice, in [***]’s own name [***] and under [***]’s direction and control, including the right to control the defense of any challenges to such Patents as a counterclaim in such infringement proceeding as well as the defense of declaratory judgment actions. Prothena retains all rights to enforce the Prothena Platform Patents against any actual or threatened infringement.
(c)      [***] Back-Up Right . If [***] determines not to institute an action or proceeding with respect to a given infringement of any Prothena Licensed Collaboration Patent or Licensed Program Patent pursuant to Section 6.9.2(b), it shall notify and consult with [***] of such decision, and, subject to the remaining provisions of this Section 6.9.2, [***] shall thereupon have the right (but not the obligation) to institute an action or proceeding with respect to such infringement of such Prothena Licensed Collaboration Patent or Licensed Program Patent, as applicable, at [***]’s expense with counsel of its choice. Notwithstanding the foregoing provisions of this Section 6.9.2(c), if [***] has any reasonable grounds for believing that [***]’s exercise of its backup enforcement right with respect to any Patent as set forth in this Section 6.9.2(c) [***], then [***] shall not be permitted to enforce such Patent without the prior consent of [***], in [***]’s discretion.
(d)      [***] . Notwithstanding the foregoing Sections 6.9.2(b) and 6.9.2(c), the Parties must agree in writing prior to either Party initiating any action or proceeding with respect

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to any infringement of any Prothena Licensed Collaboration Patent or Licensed Program Patent with respect to any [***].
(e)      Joinder . In the case of any enforcement action or proceeding set forth in Section [***] controlled by Celgene, Prothena will (and will cause its Affiliates to) join any such action or proceeding as a party at Celgene’s expense (and Prothena will use commercially reasonable efforts to cause any Third Party as necessary to join such action or proceeding as a party) if doing so is necessary for the purposes of establishing standing or is otherwise required by Applicable Law to pursue such action or proceeding. Prothena may, at its option, participate in such enforcement action or proceeding at its own expense. In the case of any enforcement action or proceeding controlled by Prothena pursuant to Section [***], Celgene may, at its option, participate in such enforcement action or proceeding at its own expense. Celgene will join any such action or proceeding controlled by Prothena as a party at Prothena’s expense (and Celgene will use commercially reasonable efforts to cause any Third Party as necessary to join such action or proceeding as a party) if doing so is necessary for the purposes of establishing standing or is otherwise required by Applicable Law to pursue such action or proceeding. Celgene will bear all costs and expenses incurred by it arising out of such enforcement action or proceeding controlled by Celgene, and Prothena will bear all costs and expenses incurred by it arising out of such enforcement action or proceeding controlled by Prothena.
(f)      Consultation; Cooperation . The enforcing Party will keep the non-enforcing Party regularly informed of the status and progress of such enforcement efforts with respect to any Prothena Licensed Collaboration Patent or Licensed Program Patent, in each case other than a Prothena Platform Patent. The enforcing Party shall consult with the non-enforcing Party and will take comments of the non-enforcing Party into good faith consideration with respect to the infringement or claim construction of any claim in any such Prothena Licensed Collaboration Patent or Licensed Program Patent. The non-enforcing Party will provide to the enforcing Party reasonable cooperation in such enforcement, at such enforcing Party’s request and expense. In addition, Prothena shall (a) keep Celgene regularly informed of the status and progress of enforcement efforts with respect to any foreign counterparts of such Prothena Licensed Collaboration Patents and Licensed Program Patents and (b) consult with Celgene and will take comments of Celgene into good faith consideration with respect to the infringement or claim construction of any claim in any foreign counterparts of such Prothena Licensed Collaboration Patents and Licensed Program Patents.
(g)      Settlement . A settlement or consent judgment or other voluntary final disposition of a suit with respect to the Prothena Licensed Collaboration Patents or Licensed Program Patents, in each case other than a Prothena Platform Patent, under this Section 6.9.2 may be entered into without the consent of the Party not bringing suit; provided, however, that any such settlement, consent judgment or other disposition of any action or proceeding by the Party bringing suit under this Section 6.9.2 shall not, without the prior written consent of the Party not bringing suit, such consent not to be unreasonably withheld, (i) impose [***] liability or obligation on the Party not bringing suit or any of its Affiliates, (ii) conflict with [***] of the subject matter claimed in the applicable Prothena Licensed Collaboration Patents or Licensed Program Patents, (iii) [***], include the grant of any license, covenant or other rights to any Third Party that would conflict with [***]

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the rights or licenses granted to Celgene under this Agreement, the Master Collaboration Agreement, any Global License Agreement or any other U.S. License Agreement, or (iv) [***].
(h)      Costs and Recoveries . Except as otherwise set forth in this Section 6.9.2, each Party shall bear all of its costs incurred in connection with its activities under this Section 6.9.2. Any damages or other monetary awards recovered in any action, suit or proceeding brought under this Section 6.9.2 to the extent related to any Prothena Licensed Collaboration Patents or Licensed Program Patents shall be shared as follows:
(i)      the amount of such recovery actually received by the Party controlling such action shall first be applied to reimburse costs and expenses incurred by each Party in connection with such action (including, for this purpose, [***] counsel); and
(ii)      any remaining proceeds shall be (A) for any action controlled by Celgene, retained by, or provided to, Celgene [***], and (B) for any action controlled by Prothena, retained by, or provided to, Prothena [***].
(i)      Biosimilar Applications . Notwithstanding the foregoing provisions of this Section 6.9.2, if either Party receives a copy of a Biosimilar Application referencing a Licensed Product, whether or not such notice or copy is provided under any Applicable Laws (including under the BPCIA, the United States Patient Protection and Affordable Care Act, or its successor provisions, or any similar provisions in a country outside the United States, as applicable), or otherwise becomes aware that such a Biosimilar Application has been submitted to a Regulatory Authority for marketing authorization (such as in an instance described in 42 U.S.C. §262(l)(2)), the remainder of this Section 6.9.2(i) shall apply. Such Party shall promptly, but in any event within [***] ([***]) Business Days, notify the other Party. The owner of the relevant Patents shall then seek permission to view the Biosimilar Application, information regarding the process or processes used to manufacture the product that is the subject of the Biosimilar Application, and related confidential information from the filer of the Biosimilar Application if necessary under 42 U.S.C. §262(l)(1)(B)(iii). If either Party receives any equivalent or similar communication or notice in the United States or any other jurisdiction, the Party receiving such communication or notice shall within [***] ([***]) Business Days notify the other Party of such communication or notice to the extent permitted by Applicable Laws. Regardless of the Party that is the “reference product sponsor,” as defined in 42 U.S.C. §262(l)(1)(A), for purposes of such Biosimilar Application:
(i)      [***] the outside counsel and in-house counsel who shall receive confidential access to the Biosimilar Application, information regarding the process or processes used to manufacture the product that is the subject of the Biosimilar Application, and any related confidential information pursuant to 42 U.S.C. §262(l)(1)(B)(ii).
(ii)      In each case, after consulting with [***] and considering [***]’s comments in good faith, [***] shall have the right to (a) list any patents, including those Patents within the Prothena IP, as required pursuant to 42 U.S.C. §262(l)(3)(A) or 42 U.S.C. §262(l)(7), (b) respond to any communications with respect to such lists from the filer of the Biosimilar Application, (c) negotiate with the filer of the Biosimilar Application as to whether to utilize a different mechanism for information exchange other than that specified in 42 U.S.C. §262(l)(1),

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and (d) as to the Patents that will be subject to the litigation procedure as described in 42 U.S.C. §262(l)(4), decide which Patent or Patents shall be selected for litigation under 42 U.S.C. §262(l)(5)(B)(i)(II), and commence such litigation under 42 U.S.C. §262(l)(6). [***]
(iii)      [***] shall cooperate with [***]’s reasonable requests in connection with the foregoing activities to the extent required or permitted by Applicable Laws. [***] shall consult with [***] prior to identifying any Patents within the Prothena IP to a Third Party as contemplated by this Section 6.9.2(i). [***] shall consider in good faith advice and suggestions with respect thereto received from [***], and notify [***] of any such lists or communications promptly after they are made.
(iv)      Each Party shall within [***] ([***]) Business Days after receiving any notice of commercial marketing provided by the filer of a Biosimilar Application pursuant to 42 U.S.C. §262(l)(8)(A), notify the other Party. To the extent permitted by Applicable Law, [***] shall have the first right, but not the obligation, to seek an injunction against such commercial marketing as permitted pursuant to 42 U.S.C. §262(l)(8)(B) and to file an action for infringement. [***]. Except as otherwise provided in this Section 6.9.2(i), any such action shall be subject to the terms and conditions of Section 6.9.2(a) through 6.9.2(h).
(v)      The Parties recognize that procedures other than those set forth above in this Section 6.9.2(i) may apply with respect to Biosimilar Applications. In the event that the Parties determine that certain provisions of Applicable Laws in the United States apply to actions taken by the Parties with respect to Biosimilar Applications under this Section 6.9.2(i), the Parties shall comply with any such Applicable Laws (and any relevant and reasonable procedures established by Parties) in exercising their rights and obligations with respect to Biosimilar Applications under this Section 6.9.2(i). Notwithstanding the provisions of this Section 6.9.2(i), nothing in this Section 6.9.2(i) shall grant any rights to Prothena with respect to any Celgene IP.
6.10      Patent Term Extensions . Prothena shall reasonably cooperate with Celgene, including providing reasonable assistance to Celgene (including executing any documents as may reasonably be required), in efforts to seek and obtain patent term restoration or supplemental protection certificates or the like or their equivalents in the Territory, where applicable to Prothena Licensed Collaboration Patents or Licensed Program Patents or any other Patents Controlled by Celgene (or any of its Affiliates), in each case other than a Prothena Platform Patent, including as may be available to the Parties under the provisions of the U.S. Drug Price Competition and Patent Term Restoration Act of 1984, in connection with any Licensed Product. In the event that elections with respect to obtaining such patent term restoration or supplemental protection certificates or the like or their equivalents are to be made in connection therewith, [***] shall have the right to make the election and [***]. Without limiting the foregoing, [***].
6.11      Regulatory Data Protection . [***] (or its designee) shall have the sole right to list, with the applicable Regulatory Authorities in the Territory, all applicable Patents (including any Prothena Licensed Collaboration Patents or Licensed Program Patents) for any Licensed Product, including all so called “Purple Book” listings required under the U.S. Public Health Service Act, [***]. For the avoidance of doubt, [***] will retain final decision-making authority as to the listing

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of all applicable Patents for any Licensed Product, regardless of which Party owns such Patent, and [***] shall reasonably assist [***] in connection therewith.
6.12      Matters Involving Joint Patents . The Prosecution and Maintenance, and the enforcement and defense, of any Joint Patents shall be jointly managed by the Parties through independent patent counsel (mutually agreed to by the Parties) jointly representing the Parties, including any costs and recoveries regarding same. Prior to either Party publishing any Joint Know-How, the Parties will discuss if a Joint Patent claiming such Joint Know-How should be filed.
6.13      Common Interest Agreement . At the request of either Party, the Parties shall negotiate in good faith to enter into a common interest agreement to govern their discussion of Patent matters.
6.14      License Filing . At the request of [***], [***] shall, and shall cause its Affiliates to, assist in any license registration processes with applicable Governmental Authorities that may be available for the protection of [***]’s interests in this Agreement.
6.15      Defense of Claims Brought by Third Parties . If a Party becomes aware of any actual or potential claim that the Development, Manufacture or Commercialization of a Licensed Antibody or Licensed Product by or on behalf of Celgene pursuant to this Agreement infringes the intellectual property rights of any Third Party, such Party shall promptly notify the other Party. In any such instance, the Parties shall as soon as practicable thereafter meet to discuss in good faith regarding the best response to such notice; provided that Celgene shall have the final decision-making authority in connection therewith. Except as set forth in Section 9.2 (and without limiting Celgene’s rights under Section 9.2), Celgene shall have the sole right, but not the obligation, to defend and dispose of (including through settlement or license) such claim. [***] or on behalf of [***] (or any of its Affiliates or Sublicensees) in connection with [***] to the extent relating to the Development, Manufacture or Commercialization of a Licensed Antibody or Licensed Product, shall be [***], and [***].
ARTICLE 7.     
CONFIDENTIALITY
7.1      Nondisclosure . Each Party agrees that a Party (the “ Receiving Party”) receiving Confidential Information of the other Party (the “ Disclosing Party ”) pursuant to this Agreement shall (a) maintain in confidence such Confidential Information using not less than the efforts such Receiving Party uses to maintain in confidence its own proprietary information of similar kind and value, but in no event less than a reasonable degree of efforts, (b) not disclose such Confidential Information to any Third Party without the prior written consent of the Disclosing Party, except for disclosures expressly permitted pursuant to this Article 7, and (c) not use such Confidential Information for any purpose except those permitted by this Agreement, including, in the case of Celgene, the exercise of the rights and licenses granted to Celgene hereunder (it being understood that this clause (c) shall not create or imply any rights or licenses not expressly granted under this Agreement). The obligations of confidentiality, non-disclosure and non-use under this Section 7.1 shall be in full force and effect during the Term and for a period of [***] ([***]) years thereafter. The Receiving Party will return all copies of or destroy (and certify such destruction in writing) the Confidential Information of the Disclosing Party disclosed or transferred to it by the other Party

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pursuant to this Agreement, within [***] ([***]) days after the termination or expiration of this Agreement; provided, however, that a Party may retain (i) Confidential Information of the other Party to exercise rights and licenses which expressly survive such termination or expiration pursuant to this Agreement, (ii) one (1) copy of all other Confidential Information in archives solely for the purpose of establishing the contents thereof and (iii) Celgene may retain Confidential Information of Prothena in the event that the Parties (or their respective Affiliates) enter into a Global License Agreement for the Licensed Program, and in such case, Celgene shall not be required to return or destroy any Confidential Information of Prothena. Without limiting the foregoing, [***] will keep confidential, and will cause its Affiliates and its and their employees, consultants, licensees, sublicensees, professional advisors and Affiliates to keep confidential, [***] on confidentiality terms at least as protective as the confidentiality provisions of this Agreement (without regard to Section 7.3).
7.2      Licensed Program Specific Confidential Information . Notwithstanding anything to the contrary contained herein, the Parties agree and acknowledge that any Licensed Program Specific IP shall be deemed to be Confidential Information of Celgene (without regard to Section 7.3), and Celgene shall be deemed to be the Disclosing Party with respect to the Licensed Program Specific IP. As used herein, (a) the term “ Licensed Program Specific IP ” means, (i) [***], (ii) [***], and (iii) [***]; and (b) the term “ Licensed Program Non-Specific IP ” means all Prothena Platform Technology within the Prothena Licensed Collaboration Know-How, and other Prothena Licensed Collaboration Know-How and Licensed Program Know-How other than Licensed Program Specific IP. For clarity, Licensed Program Non-Specific IP shall be deemed to be the Confidential Information of Prothena.
7.3      Exceptions .
7.3.1      General . The obligations in Section 7.1 shall not apply with respect to any portion of the Confidential Information of the Disclosing Party that the Receiving Party can show by competent written proof:
(a)      was known to the Receiving Party or any of its Affiliates, without any obligation to keep it confidential or any restriction on its use, prior to disclosure by the Disclosing Party;
(b)      is subsequently disclosed to the Receiving Party or any of its Affiliates by a Third Party lawfully in possession thereof and without any obligation to keep it confidential or any restriction on its use;
(c)      is published by a Third Party or otherwise becomes publicly available or enters the public domain, either before or after it is disclosed to the Receiving Party, without any breach by the Receiving Party of its obligations hereunder;
(d)      is published by a Party in accordance with Section 7.8 without any breach by such Party of its obligations hereunder; or

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(e)      is independently developed by or for the Receiving Party or its Affiliates without reference to or reliance upon the Disclosing Party’s Confidential Information.
Any combination of features or disclosures shall not be deemed to fall within the foregoing exclusions merely because individual features are published or available to the general public or in the rightful possession of the Receiving Party unless the combination itself and principle of operation are published or available to the general public or in the rightful possession of the Receiving Party.
7.4      Authorized Disclosure .
7.4.1      Disclosure . Notwithstanding Section 7.1, the Receiving Party may disclose Confidential Information belonging to the Disclosing Party in the following instances:
(a)      subject to Section 7.6, to comply with Applicable Law (including the rules and regulations of the U.S. Securities and Exchange Commission (“ SEC ”) or any national securities exchange) or with judicial process (including prosecution or defense of litigation), if, in the reasonable opinion of the Receiving Party’s counsel, such disclosure is necessary for such compliance or for such judicial process (including prosecution or defense of litigation);
(b)      is disclosed to governmental or other regulatory agencies in order to obtain Patents or to gain or maintain approval to conduct Clinical Trials or to market Licensed Product under this Agreement, in each case, in accordance with this Agreement, but such disclosure shall only be to the extent reasonably necessary to obtain Patents or authorizations, and provided that reasonable steps are taken to ensure confidential treatment of such Confidential Information (if available);
(c)      to any of its officers, employees, consultants, agents or Affiliates (including, (i) [***], (ii) in the case of either Party, to such Party’s subcontractors for purpose of such subcontractor performing obligations of such Party under this Agreement) as it deems necessary or advisable in the course of conducting activities in accordance with this Agreement in order to carry out its responsibilities or exercise its rights under this Agreement (including the exercise of the rights and licenses granted to the relevant Party hereunder), and (iii) in the case of either Party, to such Party’s actual or potential acquirers; provided that each such disclosee is bound by written confidentiality obligations and non-use obligations no less restrictive than those set forth in this Article 7 to maintain the confidentiality thereof and not to use such Confidential Information except as expressly permitted by this Agreement; provided, however, that, in each of the above situations in this Section 7.4.1(c), the Receiving Party shall remain responsible for any failure by any Person who receives Confidential Information from such Receiving Party pursuant to this Section 7.4.1(c) to treat such Confidential Information as required under this Article 7; and
(d)      disclosure, solely on a “need to know basis” to its advisors (including attorneys and accountants) in connection with activities hereunder; provided that, prior to any such disclosure, each disclosee must be bound by written obligations of confidentiality, non-disclosure and non-use no less restrictive than the obligations set forth in this Article 7 (provided, however, that in the case of legal advisors, no written agreement shall be required), which for the avoidance

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of doubt, will not permit use of such Confidential Information for any purpose except those expressly permitted by this Agreement; provided, however, that, in each of the above situations in this Section 7.4.1(d), the Receiving Party shall remain responsible for any failure by any Person who receives Confidential Information from such Receiving Party pursuant to this Section 7.4.1(d) to treat such Confidential Information as required under this Article 7.
7.4.2      Terms of Disclosure . If and whenever any Confidential Information is disclosed in accordance with this Section 8.4, such disclosure shall not cause any such information to cease to be Confidential Information except to the extent that such disclosure results in a public disclosure of such information (other than by breach of this Agreement). Where reasonably possible and subject to Section 7.6, the Receiving Party shall notify the Disclosing Party of the Receiving Party’s intent to make any disclosures pursuant to Section 8.4.1(a) sufficiently prior to making such disclosure so as to allow the Disclosing Party adequate time to take whatever action it may deem appropriate to protect the confidentiality of the information, and the Receiving Party will provide reasonable assistance to the Disclosing Party with respect thereto; provided that, in such event, the Receiving Party will use reasonable measures to ensure confidential treatment of such information and shall only disclose such Confidential Information of the Disclosing Party as is necessary for the purposes of Section 8.4.1(a), as applicable.
7.4.3      Licensed Program Specific IP . [***] shall not disclose the Licensed Program Specific IP without the prior written consent of [***], other than pursuant to Section 8.4.1
7.5      Terms of this Agreement . The Parties agree that this Agreement and the terms hereof shall be deemed to be Confidential Information of both Prothena and Celgene, and each Party agrees not to disclose any of them without the prior written consent of the other Party, except that each Party may disclose any of them in accordance with the provisions of Sections 8.4 and/or 7.6, as applicable.
7.6      Securities Filings; Disclosure under Applicable Law . Each Party acknowledges and agrees that the other Party may submit this Agreement to (or file this Agreement with) the SEC or any national securities exchange in any jurisdiction (collectively, the “ Securities Regulators ”), or to other Persons as may be required by Applicable Law, and if a Party does submit this Agreement to (or file this Agreement with) any Securities Regulators, or other Persons as may be required by Applicable Law, such Party agrees to consult with the other Party with respect to the preparation and submission of a confidential treatment request for this Agreement. Notwithstanding the foregoing, if a Party is required by Applicable Law or any Securities Regulator to make a disclosure of the terms of this Agreement in a filing or other submission as required by Applicable Law or Securities Regulator, and (a) such Party has provided copies of the disclosure to the other Party reasonably in advance of such filing or other disclosure under the circumstances, (b) such Party has promptly notified the other Party in writing of such requirement and any respective timing constraints, and (c) such Party has given the other Party a reasonable time under the circumstances from the date of notice by such Party of the required disclosure to comment upon and request confidential treatment for such disclosure, then such Party will have the right to make such disclosure at the time and in the manner reasonably determined by its counsel to be required by Applicable Law or Securities Regulator. Notwithstanding the foregoing, it is hereby understood and agreed

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that if a Party seeks to make a disclosure as required by Applicable Law or Securities Regulator as set forth in this Section 7.6, and the other Party provides comments within the respective time periods or constraints specified herein or within the respective notice, the Party seeking to make such disclosure or its counsel, as the case may be, will in good faith consider incorporating such comments.
7.7      Publicity .
7.7.1      Press Release; Public Statements . Subject to Section 8.4, 7.6 and this Section 8.7, Prothena agrees not to (and shall cause its Affiliates not to) issue any press release or other public statement disclosing this Agreement, the activities hereunder, or the transactions contemplated hereby, unless such press release or other public statement is approved by Celgene in writing; provided that Prothena shall be authorized to make any disclosure, without the approval of Celgene, that is required by Applicable Laws (including the U.S. Securities Act of 1933, as amended, and the U.S. Securities Exchange Act of 1934, as amended) or the rules of any Securities Regulator, or by judicial process, subject to and in accordance with Sections 8.4 and 7.6, as applicable. Without limiting the foregoing, and subject to the foregoing proviso, in the event that Prothena desires to issue an initial press release regarding the execution of this Agreement, Prothena shall have the right to do so provided that (i) [***] and (ii) [***]. For the avoidance of doubt, [***].
7.7.2      Additional Restrictions on Disclosure . Without limiting any other restrictions on disclosure set forth in this Article 7, with respect to any press release or other public statement proposed to be made by Prothena, if such press release or public statement discloses, with respect to such Licensed Program, [***], such press release or other public statement may not be issued without Celgene’s prior written consent, except, for such disclosures by Prothena as required by Applicable Law or Securities Regulators (solely and to the extent Prothena’s counsel determines such disclosure is required by Applicable Law or Securities Regulators); provided that (i) in such case Prothena shall use reasonable efforts to afford Celgene a reasonable period of time to review any such disclosure and any comments made by Celgene will be considered in good faith and (ii) any information that has been previously publicly disclosed in accordance with this Agreement may be disclosed again as long as such disclosure does not exceed the scope of such prior public disclosure. Subject to the foregoing, in the event Celgene proposes that Prothena use specific wording or language with respect thereto, Prothena shall in good faith consider incorporating such wording or language.
7.7.3      Previously Issued Public Statements . The contents of any press release or other public statement that has been reviewed and approved by a reviewing Party may be re-released by the publishing Party or by such reviewing Party without a requirement for re-approval.
7.8      Permitted Publications of Results .
7.8.1      Publication . In the event Prothena (the “ Publishing Party ”) desires to publish or present any information (including publications in journals, posters, presentations at conferences and abstracts submitted in advance of conferences) with respect to the results of the Licensed Program (including the results of a Phase 1 Clinical Trial under the Licensed Program), or with respect to the Licensed Target, any Licensed Antibody or Licensed Product, the Publishing

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Party shall provide Celgene with a copy of such proposed publication or presentation no less than [***] ([***]) days (provided that the other Party shall use Commercially Reasonable Efforts to accommodate a shorter time period if required due to circumstances outside of the Publishing Party’s control) prior to its intended submission for publication or public disclosure. For the avoidance of doubt, the foregoing shall apply with respect to each proposed publication or presentation regardless of whether a prior publication or presentation was provided (e.g., if an abstract is provided in accordance with this Section 7.8.1 and the Publishing Party wishes to publish the corresponding full manuscript, the full manuscript must be provided to Celgene pursuant to this Section 7.8.1). Celgene shall respond in writing promptly and in no event later than [***] ([***]) days after receipt of the proposed material (provided that the other Party shall use Commercially Reasonable Efforts to accommodate a shorter time period if notified by the Publishing Party and required due to circumstances outside of the Publishing Party’s control), with one or more of the following:
(a)      comments on the proposed material, which the Publishing Party shall consider in good faith; and/or
(b)      a specific statement of concern, based upon the need to seek patent protection or to block publication or public disclosure (including publications in journals, posters, presentations at conferences and abstracts submitted in advance of conferences) if Celgene reasonably determines that the proposed disclosure is intellectual property that should be maintained as a trade secret to protect the Licensed Target or any Licensed Antibody and/or Licensed Product, in which event the Publishing Party agrees not to submit such publication or make such presentation that contains such information until:
(i)      with respect to publication or presentation of Licensed Program Non-Specific IP, Celgene is given [***], to seek patent protection for any such Licensed Program Non-Specific IP in such publication or presentation which it believes is patentable or to resolve any other issues, or
(ii)      with respect to publication or presentation of Licensed Program Specific IP, [***] for Celgene to (x) enable further development and optimization of such Licensed Program Specific IP (including related Licensed Antibodies and Licensed Products), (y) seek patent protection for any such Licensed Program Specific IP in such publication or presentation which it believes is patentable or (z) resolve any other issues; and/or
(c)      an identification of Celgene’s Confidential Information that is contained in the material reviewed, which the Publishing Party shall remove, if requested by Celgene.
Notwithstanding the foregoing or anything to the contrary contained herein, the restrictions set forth in this Section 7.8.1 shall not apply to publications or presentations by Celgene (or its Affiliates or sublicensees) and Celgene (and its Affiliates and sublicensees) shall be free to make publications and presentations with respect to results of the Licensed Program, the Licensed Target, Licensed Antibody and/or Licensed Product without the prior review or consent of Prothena.

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7.8.2      Re-Publication; Re-Presentation . The contents of any publication or presentation that has been reviewed and approved by a reviewing Party may be re-released by the Publishing Party or the reviewing Party without a requirement for re-approval.
7.9      Use of Names . Except as otherwise expressly set forth herein, no Party (or its respective Affiliates) shall use the name, trademark, trade name or logo of the other Party or its Affiliates, or its or their respective employee(s) in any publicity, promotion, news release or other public disclosure relating to this Agreement or its subject matter, without the prior written permission of the other Party; provided that such permission shall not be required to the extent use thereof may be required by Applicable Law, including the rules of any securities exchange or market on which a Party’s (or its Affiliate’s) securities are listed or traded.
7.10      Clinical Trials Registry . Celgene (and its Affiliates and designees) shall have the right to publish registry information and summaries of data and results from any Clinical Trials conducted in connection with activities under this Agreement, on its clinical trials registry or on a government-sponsored database such as www.clinicaltrials.gov, without requiring the consent of Prothena. The Parties shall reasonably cooperate if required or reasonably requested by Celgene in order to facilitate any such publication by Celgene (and its Affiliates and designees).
7.11      Relationship to Master Collaboration Agreement . Except as otherwise expressly stated in this Article 7, this Agreement supersedes the provisions of Article 8 of the Master Collaboration Agreement with respect to any Confidential Information related to the Licensed Program. the Licensed Target, Licensed Antibodies or Licensed Products (the “Licensed Program Confidential Information ”); provided that, except as otherwise set forth herein, all “Confidential Information” of the “Disclosing Party” thereunder that is Licensed Program Confidential Information shall be deemed Confidential Information of the Disclosing Party hereunder and shall be subject to the terms and conditions of this Agreement and the “Receiving Party” shall be bound by and obligated to comply with such terms and conditions as if they were the Receiving Party hereunder, subject in all cases to Section 7.2. The foregoing shall not be interpreted as a waiver of any remedies available to the “Disclosing Party” as a result of any breach, prior to the Effective Date, by the “Receiving Party”, of its obligations pursuant to Article 8 of the Master Collaboration Agreement.
7.12      Global License Agreement . Notwithstanding the foregoing provisions of this Article 7, if a Global License Agreement is entered into with respect to the Licensed Program, then the provisions of such Global License Agreement shall control with respect to Confidential Information related to the Licensed Program in lieu of this Article 7.
ARTICLE 8.     
REPRESENTATIONS AND WARRANTIES; COVENANTS
8.1      Representations and Warranties of Both Parties . Each Party hereby represents and warrants to the other Party, as of the Effective Date, that:

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(a)      such Party is duly organized, validly existing and in good standing under the Applicable Law of the jurisdiction of its formation and has full corporate power and authority to enter into this Agreement, and to carry out the provisions hereof;
(b)      such Party has taken all necessary corporate action on its part to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder;
(c)      this Agreement has been duly executed and delivered on behalf of such Party, and constitutes a legal, valid, binding obligation, enforceable against it in accordance with its terms, except to the extent that enforcement of the rights and remedies created hereby is subject to (i) bankruptcy, insolvency, reorganization, moratorium and other similar laws of general application affecting the rights and remedies of creditors, or (ii) laws governing specific performance, injunctive relief and other equitable remedies;
(d)      the execution, delivery and performance of this Agreement by such Party does not breach or conflict with any agreement or any provision thereof, or any instrument or understanding, oral or written, to which such Party (or any of its Affiliates) is a party or by which such Party (or any of its Affiliates) is bound, nor violate any Applicable Law of any Governmental Authority having jurisdiction over such Party (or any of its Affiliates);
(e)      no government authorization, consent, approval, license, exemption of or filing or registration with any court or governmental department, commission, board, bureau, agency or instrumentality, domestic or foreign, under any Applicable Law currently in effect, is or will be necessary for, or in connection with, the transaction contemplated by this Agreement, or for the performance by it of its obligations under this Agreement, except (i) as may be required to conduct Clinical Trials or to seek or obtain Regulatory Approvals or applicable Regulatory Materials or (ii) as set forth in Section 3.2 of the Master Collaboration Agreement; and
(f)      it has obtained all necessary authorizations, consents and approvals of any Third Party that is required to be obtained by it as of the Effective Date for, or in connection with, the transaction contemplated by this Agreement, or for the performance by it of its obligations under this Agreement, except (i) as may be required to conduct Clinical Trials or to seek or obtain Regulatory Approvals or applicable Regulatory Materials or (ii) as set forth in Section 3.2 of the Master Collaboration Agreement.


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8.2      Representations and Warranties of Prothena . Except as set forth on Schedule 8.2 Prothena hereby represents and warrants to Celgene, as of the Effective Date, that: 3  
(a)      Schedules 1.47(b) and 1.64 contain a complete and accurate list of all Patents included in the Prothena IP that claim or cover any Licensed Target, Licensed Antibodies or Licensed Products, including the composition or use of any of the foregoing, and Prothena Controls all such Patents. Except for the Prothena IP, (i) Prothena and its Affiliates do not own or control (by license or otherwise), as of the Effective Date, any Patent or Know-How that is necessary or useful to Develop, Manufacture or Commercialize the Licensed Target, Licensed Antibodies or Licensed Products and (ii) no other Know-How or Patents arose from, or were used in, the performance of the Licensed Program under the Master Collaboration Agreement. To Prothena’s and its Affiliates’ actual knowledge, all issued Patents within the Prothena IP are in full force and effect, and are not invalid or unenforceable, in whole or in part;
(b)      no claim has been issued or served, or written threat of a claim or litigation made by any Person, against Prothena or its Affiliates that alleges that any Prothena IP is invalid or unenforceable;
(c)      neither Prothena nor its Affiliates own or otherwise control (through license or otherwise) any Antibodies (or any products constituting, incorporating, comprising or containing any such Antibody) that Target the Licensed Target, other than the Licensed Program Antibodies (all of which are set forth on Schedule 1.45 ) and the Licensed Program Products;
(d)      [***];
(e)      neither Prothena nor its Affiliates are subject to any payment obligations to Third Parties as a result of the execution or performance of this Agreement, or the research, development, manufacture or commercialization of the Licensed Target or any Antibodies (or any products constituting, incorporating, comprising or containing any such Antibody) that Target the Licensed Target;
(f)      Prothena has the full right and authority to grant all of the rights and licenses granted to Celgene (or purported to be granted to Celgene) hereunder; and neither Prothena nor its Affiliates have granted any right or license to any Third Party relating to any of the Prothena IP or any other Licensed Program Asset, Licensed Target or Antibody (or any products constituting, incorporating, comprising or containing any such Antibody) that Targets the Licensed Target, that would conflict with or [***] any of the rights or licenses granted to Celgene hereunder;
(g)      Prothena is the sole and exclusive owner of the Prothena IP, except for the Prothena Licensed Collaboration IP that is exclusively licensed to Prothena (or its Affiliates) pursuant to the In-License Agreements set forth on Schedule 1.40 . All Affiliates of Prothena have exclusively licensed or assigned all of their right, title and interest in and to the Prothena IP to Prothena. Neither Prothena nor its Affiliates have granted any mortgage, pledge, claim, security interest, lien or other charge of any kind on the Prothena IP or other Licensed Program Asset, and the Prothena IP and the other Licensed Program Assets are free and clear of any mortgage, pledge, claim, security interest, lien or charge of any kind;

3 [***]
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(h)      neither Prothena nor its Affiliates have received any written notice of any claim that any Patent or Know-How (including any trade secret right) owned or controlled by a Third Party would be infringed or misappropriated by the Development, Manufacture, or Commercialization of the Licensed Target, Licensed Antibody or Licensed Product;
(i)      to Prothena’s and its Affiliates’ actual knowledge, (i) the Development and Manufacture of the Licensed Target, any Licensed Antibody or Licensed Product, as conducted by or on behalf of Prothena or its Affiliates prior to the Effective Date, has not violated, infringed or misappropriated any intellectual property or proprietary right of any Third Party and (ii) [***];
(j)      there are no claims, judgments, settlements, litigations, suits, actions, disputes, arbitration, judicial or legal administrative or other proceedings or governmental investigations pending or, to Prothena’s or its Affiliates’ knowledge, threatened against Prothena or its Affiliates which would reasonably be expected to adversely affect or restrict the ability of Prothena to consummate or perform the transactions contemplated under this Agreement, or which would affect the Prothena IP or other Licensed Program Assets, or Prothena’s Control thereof, or the Licensed Target or any Licensed Antibody or Licensed Product;
(k)      neither Prothena nor its Affiliates have issued a claim against a Third Party alleging that a Third Party is infringing or has infringed or misappropriated any Prothena IP, and, to Prothena’s and its Affiliates’ actual knowledge, no issued Patents within the Prothena IP are being infringed and no trade secrets within the Prothena IP are being misappropriated by any Third Party;
(l)      neither Prothena nor its Affiliates have employed or otherwise used in any capacity, the services of any Person suspended, proposed for debarment or debarred under United States law, including under 21 U.S.C. § 335a, or any foreign equivalent thereof, with respect to the Licensed Target, the Licensed Antibodies or Licensed Products or otherwise in performing any portion of the Licensed Program. All Manufacture and Development (including non-clinical studies and Clinical Studies) related to the Licensed Target, Licensed Antibodies or Licensed Products conducted by or on behalf of Prothena or its Affiliates prior to the Effective Date (including the conduct of the Licensed Program under the Master Collaboration Agreement) has been conducted in accordance with all Applicable Laws (including, to the extent applicable, GCP, GLP and GMP);
(m)      neither Prothena nor its Affiliates have entered into any agreement under which Prothena or its Affiliates (i) has obtained a license or sublicense of rights from a Third Party to the Licensed Target, or to any Antibodies (or any products constituting, incorporating, comprising or containing any such Antibody) that Target the Licensed Target, or to any Prothena IP, except for the In-License Agreements set forth on Schedule 1.40 , or (ii) has granted a license, sublicense, option or right to a Third Party that remains in effect as of the Effective Date to research, develop, manufacture or commercialize the Licensed Target or any Antibodies (or any products constituting, incorporating, comprising or containing any such Antibody) that Target the Licensed Target, except (1) with respect to licenses or rights granted pursuant to the agreements set forth on Schedule 1.40 that were entered into in the ordinary course of business [***] performing activities

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on behalf of Prothena [and (2) [*** ] 6 . The agreements set forth on Schedule 1.40 do not conflict with [***] the rights or licenses granted to Celgene hereunder; 7  
(n)      other than the Existing Program Agreements, Prothena (or its Affiliates, as applicable) has not entered into any agreement relating to the Development, Manufacture, Commercialization or other exploitation of the Licensed Target, Licensed Antibodies or Licensed Products, or the Prothena IP;
(o)      with respect to each Existing Program Agreement and In-License Agreement, (i) it is in full force and effect; (ii) Prothena (or its Affiliate, as applicable) is not in breach thereof; (iii) Prothena (or its Affiliate, as applicable) has not received any notice from the counterparty to such Existing Program Agreement or In-License Agreement, as applicable, of Prothena’s (or its Affiliate’s, as applicable) breach or notice of threatened breach by Prothena (or its Affiliate, as applicable) thereof and (iv) Prothena has provided Celgene with a true, correct and complete copy of each Existing Program Agreement and In-License Agreement;
(p)      Prothena has disclosed to Celgene all material information and data, and all material correspondences to/from any Regulatory Authority, existing as at the Effective Date in the possession or control of Prothena or its Affiliates, in each case related to the Licensed Program, Licensed Target, Licensed Antibodies or Licensed Products; and

(q)      Prothena has not obtained, or filed, any INDs, MAAs or Regulatory Approvals or any other form of regulatory application for approval of Clinical Trials, marketing or other purpose, for any Licensed Antibodies or Licensed Products and, to Prothena’s and its Affiliates’ actual knowledge, no other Person has obtained, or filed for, any such INDs, MAAs or Regulatory Approvals.
8.3      Additional Representations, Warranties and Covenants of Prothena . Prothena hereby further represents, warrants and covenants to Celgene that:
8.3.1      With respect to the In-License Agreements, (a) Prothena (or its Affiliates, as applicable) shall not breach, or commit any acts or permit the occurrence of any omissions that would cause the breach or termination, of any In-License Agreement and (b) Prothena shall (or shall cause its Affiliates to, as applicable) satisfy all of its obligations under each In-License Agreement in all material respects and shall, or shall cause its Affiliates to, as applicable, maintain each In-License Agreement in full force and effect. Prothena shall, or shall cause its Affiliates to, as applicable, enforce its rights under each In-License Agreement to the extent necessary to preserve Celgene’s rights under this Agreement. Prothena shall not, and shall cause its Affiliates not to, [***] if doing so [***] under this Agreement. Prothena will provide Celgene with prompt written notice of any claim of a breach of which it is aware under any of the In-License Agreements or notice of termination of any In-License Agreement.

6 [***]
7 [***]
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8.3.2      With respect to the Existing Program Agreements, (a) Prothena (or its Affiliates, as applicable) shall not breach, or commit any acts or permit the occurrence of any omissions that would cause the breach or termination, of any Existing Program Agreement and (b) Prothena shall (or shall cause its Affiliates to, as applicable) satisfy all of its obligations under each Existing Program Agreement in all material respects and shall, or shall cause its Affiliates to, as applicable, maintain each Existing Program Agreement in full force and effect, unless Prothena otherwise obtains Celgene’s prior written consent (such consent not to be unreasonably withheld). Prothena shall, or shall cause its Affiliates to, as applicable, enforce its rights under each Existing Program Agreement to the extent necessary to preserve Celgene’s rights under this Agreement. Prothena shall not, and shall cause its Affiliates not to, [***] under this Agreement. Prothena shall not, and shall cause its Affiliates not to assign or otherwise transfer any Existing Program Agreement. Prothena will provide Celgene with prompt written notice of any claim of a breach of which it is aware under any of the Existing Program Agreements or notice of termination of any Existing Program Agreement.
8.3.3      In-License Agreements . [***] on case-by-case basis, Prothena shall (or shall cause its Affiliates to, as applicable) execute a written agreement, in a form reasonably acceptable to Celgene, with each Third Party that is a counterparty to the applicable In-License Agreement (each such counterparty, a “ Prothena Licensor ”) within [***] ([***]) days after the date of such request, pursuant to which (a) in the event of an early termination of such In-License Agreement, at the request of Celgene, such Prothena Licensor shall grant a direct license to Celgene with respect to the intellectual property licensed to Prothena under such In-License Agreement, on the same terms under which such Prothena Licensor grants such license to Prothena (or its Affiliate, as applicable) under such In-License Agreement, (b) such Prothena Licensor agrees to and acknowledges the rights granted to Celgene hereunder with respect to any intellectual property licensed to Prothena (or its Affiliate, as applicable) under such In-License Agreement, including the rights as set forth in this Section 8.3.3, and (c) [***].
8.3.4      Notwithstanding anything to the contrary contained herein, [***].
8.3.5      Prothena shall promptly notify Celgene in writing if any Patents in the Prothena IP that claim or cover any Licensed Target, Licensed Antibodies or Licensed Products, including the composition or use of any of the foregoing, becomes known to Prothena that are not listed on Schedule 1.47(b) or 1.64 .
8.4      Representations and Warranties of Celgene . Except as set forth on Schedule 8.4 , Celgene hereby represents and warrants to Prothena, as of the Effective Date, that:
8.4.1      there are no claims, judgments, settlements, litigations, suits, actions, disputes, arbitration, judicial or legal administrative or other proceedings or governmental investigations pending or, to Celgene’s actual knowledge, threatened against Celgene which would reasonably be expected to adversely affect or restrict the ability of Celgene to consummate or perform the transactions contemplated under this Agreement.
8.5      Covenants .

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8.5.1      Mutual Covenants . Each Party hereby covenants to the other Party that:
(a)      such Party and its Affiliates shall perform its activities pursuant to this Agreement in compliance (and shall ensure compliance by any of its subcontractors) with all Applicable Laws, including, to the extent applicable, GCP, GLP and GMP.
8.5.2      Prothena Covenants . Prothena hereby covenants to Celgene that:
(a)      Neither Prothena nor its Affiliates shall grant any right or license to any Third Party relating to any of the intellectual property rights it owns or Controls (including the Prothena IP and other Licensed Program Assets), or otherwise with respect to any Licensed Antibody, Licensed Product or Diagnostic Product which conflict with, [***] any of the rights or licenses granted to Celgene hereunder; and
(b)      Except with respect to the performance of the Prothena Ongoing Program Activities in accordance with Section 2.3 (or as otherwise expressly agreed to by Celgene in writing, including as set forth in Section 2.7), neither Prothena nor its Affiliates shall use (and neither shall grant any Third Party the right to use) any Licensed Antibodies, Licensed Products or Diagnostic Products for any purposes in the Territory.
8.6      Disclaimer . EXCEPT AS OTHERWISE EXPRESSLY PROVIDED IN THIS AGREEMENT, NEITHER PARTY MAKES ANY REPRESENTATIONS OR EXTENDS ANY WARRANTY OF ANY KIND, EITHER EXPRESS OR IMPLIED (AND EACH PARTY HEREBY EXPRESSLY DISCLAIMS ANY AND ALL REPRESENTATIONS AND WARRANTIES NOT EXPRESSLY PROVIDED IN THIS AGREEMENT), INCLUDING WITH RESPECT TO ANY PATENTS OR KNOW-HOW, OR MATERIALS, INCLUDING WARRANTIES OF VALIDITY OR ENFORCEABILITY, MERCHANTABILITY, FITNESS FOR A PARTICULAR USE OR PURPOSE, PERFORMANCE, AND NONINFRINGEMENT OF ANY THIRD PARTY PATENTS OR OTHER INTELLECTUAL PROPERTY RIGHTS. WITHOUT LIMITING THE FOREGOING, NEITHER PARTY MAKES ANY REPRESENTATION, WARRANTY OR GUARANTEE THAT THE LICENSED PROGRAM WILL BE SUCCESSFUL, OR THAT ANY OTHER PARTICULAR RESULTS WILL BE ACHIEVED WITH RESPECT TO THE LICENSED PROGRAM, THE LICENSED TARGET, ANY LICENSED ANTIBODY OR ANY LICENSED PRODUCT HEREUNDER.
ARTICLE 9.     
INDEMNIFICATION; INSURANCE
9.1      Indemnification by Celgene . Celgene shall indemnify, defend and hold harmless Prothena and its Affiliates and its and their respective directors, officers, employees, agents, successors and assigns (collectively, the “ Prothena Indemnitees ”), from and against any and all Third Party Damages to the extent arising out of or relating to, directly or indirectly, any Third Party Claim based upon:

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(a)      the gross negligence or willful misconduct of Celgene or its Affiliates or its or their respective directors, officers, employees or agents, in connection with Celgene’s performance of its obligations under this Agreement;
(b)      any breach by Celgene of any of its representations, warranties, covenants, agreements or obligations under this Agreement; or
(c)      any claim for personal injury or death arising out of the Development, Manufacture or Commercialization of the Licensed Antibodies and Licensed Products in the Territory by or on behalf of Celgene or its Affiliates or Sublicensees during the Term;
in each case (a)-(c), provided, however, that such indemnity shall not apply to the extent Prothena has an indemnification obligation pursuant to Section 9.2(a) or (b) for such Third Party Damages.
9.2      Indemnification by Prothena . Prothena shall indemnify, defend and hold harmless Celgene, its Affiliates and its and their respective directors, officers, employees, agents, successors and assigns (collectively, the “ Celgene Indemnitees ”), from and against any and all Third Party Damages to the extent arising out of or relating to, directly or indirectly, any Third Party Claim based upon:
(a)      the gross negligence or willful misconduct of Prothena or its Affiliates or its or their respective directors, officers, employees or agents, in connection with Prothena’s performance of its obligations under this Agreement;
(b)      any breach by Prothena of any of its representations, warranties, covenants, agreements or obligations under this Agreement; or
(c)      any claim for personal injury or death arising out of the Development, Manufacture or Commercialization of the Licensed Antibodies (including Reversion Antibodies) and Licensed Products (including products containing Reversion Antibodies) by or on behalf of Prothena or its Affiliates or sublicensees;
in each case (a)-(c), provided, however, that such indemnity shall not apply to the extent Celgene has an indemnification obligation pursuant to Section 9.1(a) or (b) for such Third Party Damages.
9.3      Procedure . If a Party is seeking indemnification under Section 9.1 or 9.2, as applicable (the “ Indemnitee ”), it shall inform the other Party (the “ Indemnitor ”) of the claim giving rise to the obligation to indemnify pursuant to Section 9.1 or 9.2, as applicable, as soon as reasonably practicable after receiving notice of the claim (provided, however, any delay or failure to provide such notice shall not constitute a waiver or release of, or otherwise limit, the Indemnitee’s rights to indemnification under Section 9.1 or 9.2, as applicable, except to the extent that such delay or failure materially prejudices the Indemnitor’s ability to defend against the relevant claims). The Indemnitor shall have the right to assume the defense of any such claim for which the Indemnitee is seeking indemnification pursuant to Section 9.1 or 9.2, as applicable. The Indemnitee shall cooperate with the Indemnitor and the Indemnitor’s insurer as the Indemnitor may reasonably

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request, and at the Indemnitor’s cost and expense. The Indemnitee shall have the right to participate, at its own expense and with counsel of its choice, in the defense of any claim or suit that has been assumed by the Indemnitor. The Indemnitor shall not settle any claim without the prior written consent of the Indemnitee, not to be unreasonably withheld; provided, however, that the Indemnitor shall not be required to obtain such consent if the settlement (i) involves only the payment of money and will not result in the Indemnitee (or other Prothena Indemnitees or Celgene Indemnitees, as applicable) becoming subject to injunctive or other similar type of relief, (ii) does not require an admission by the Indemnitee (or other Prothena Indemnitees or Celgene Indemnitees, as applicable) and (iii) does not adversely affect the rights or licenses granted to the Indemnitee (or its Affiliate) under this Agreement. The Indemnitee shall not settle or compromise any such claim without the prior written consent of the Indemnitor, which it may provide in its sole discretion. If the Parties cannot agree as to the application of Section 9.1 or 9.2, as applicable, to any claim, pending resolution of the dispute pursuant to Section 11.7 the Parties may conduct separate defenses of such claims, with each Party retaining the right to claim indemnification from the other Party in accordance with Section 9.1 or 9.2, as applicable, upon resolution of the underlying claim. In each case, the Indemnitee shall reasonably cooperate with the Indemnitor, and shall make available to the Indemnitor all pertinent information under the control of the Indemnitee, which information shall be subject to Article 7.
9.4      Insurance . During the Term and for a period of [***] ([***]) years thereafter, each Party shall maintain, at its cost, a program of insurance and/or self-insurance against liability and other risks associated with its activities and obligations under this Agreement (including, with respect to its Clinical Trials), and its indemnification obligations hereunder, in such amounts, subject to such deductibles and on such terms as are customary for such Party for the activities to be conducted by it under this Agreement. It is understood that such insurance shall not be construed to create a limit on either Party’s liability with respect to its indemnification obligations under this Article 9, or otherwise.
9.5      LIMITATION OF LIABILITY . NEITHER PROTHENA NOR CELGENE, NOR ANY OF THEIR RESPECTIVE AFFILIATES, WILL BE LIABLE TO THE OTHER PARTY OR ITS AFFILIATES UNDER OR IN CONNECTION WITH THIS AGREEMENT FOR ANY INDIRECT, INCIDENTAL, CONSEQUENTIAL, SPECIAL OR PUNITIVE OR EXEMPLARY DAMAGES (INCLUDING LOST PROFITS OR LOST REVENUES), WHETHER LIABILITY IS ASSERTED IN CONTRACT, TORT (INCLUDING NEGLIGENCE AND STRICT PRODUCT LIABILITY), INDEMNITY, CONTRIBUTION OR OTHERWISE, AND IRRESPECTIVE OF WHETHER THAT PARTY OR ANY REPRESENTATIVE OF THAT PARTY HAS BEEN ADVISED OF, OR OTHERWISE MIGHT HAVE ANTICIPATED THE POSSIBILITY OF, ANY SUCH LOSS OR DAMAGE. NOTWITHSTANDING THE FOREGOING, NOTHING IN THIS SECTION 9.5 IS INTENDED TO OR SHALL LIMIT OR RESTRICT THE INDEMNIFICATION RIGHTS OR OBLIGATIONS OF ANY PARTY UNDER SECTIONS 9.1 OR 9.2 IN CONNECTION WITH ANY THIRD PARTY CLAIMS [***].
ARTICLE 10.     
TERM AND TERMINATION

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10.1      Term; Expiration .
10.1.1      Term . Subject to Section 3.2 of the Master Collaboration Agreement, this Agreement shall become effective on the Effective Date and, unless earlier terminated in accordance with this Article 10, shall remain in effect until it expires as follows (the “ Term ”):
(a)      on a Licensed Product-by-Licensed Product basis, this Agreement shall expire on the date of the expiration of the Royalty Term with respect to such Licensed Product; and
(b)      in its entirety upon the expiration of all applicable Royalty Terms under this Agreement with respect to all Licensed Products in the Territory.
10.1.2      Effect of Expiration . After the expiration of the Term pursuant to Section 10.1.1 above, the following terms shall apply:
(a)      Licenses after Licensed Product Expiration . After expiration of the Term with respect to a given Licensed Product pursuant to Section 10.1.1(a), the licenses set forth in Section 6.1 with respect to such Licensed Product (and the Licensed Antibody contained therein) and related Diagnostic Products will automatically become fully paid-up, perpetual, irrevocable and royalty-free.
(b)      Licenses after Expiration of Agreement . After expiration of the Term with respect to this Agreement in its entirety pursuant to Section 10.1.1(b), all licenses set forth in Section 6.1 will automatically become fully paid-up, perpetual, irrevocable and royalty-free.
10.2      Termination for Breach .
10.2.1      Material Breach . This Agreement may be terminated by a Party for the material breach by the other Party of this Agreement provided that the breaching Party has not cured such breach within ninety (90) days after the date of written notice to the breaching Party of such breach (or thirty (30) days in the case of a breach as a result of non-payment of any amounts due under this Agreement) (the “ Cure Period ”), which notice shall describe such breach in reasonable detail and shall state the non-breaching Party’s intention to terminate this Agreement. For clarity, but subject to Section 10.2.2, the Cure Period for any allegation made as to a material breach under this Agreement will run from the date that written notice was first provided to the breaching Party by the non-breaching Party. Any such termination of this Agreement under this Section 10.2.1 shall become effective at the end of the Cure Period, unless the breaching Party has cured such breach prior to the expiration of such Cure Period, or, if such breach is not susceptible to cure within the Cure Period, then such Cure Period shall be extended for an additional [***] ([***]) days so long as the breaching Party [***]. For the avoidance of doubt, termination of this Agreement pursuant to this Section 10.2.1 shall terminate the Master Collaboration Agreement solely with respect to the Licensed Program but shall not terminate the Master Collaboration Agreement with respect to any other Programs or any other U.S. License Agreement or Global License Agreement for any other Program.

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10.2.2      Disagreement as to Material Breach . Notwithstanding Section 10.2.1, if the Parties in good faith disagree as to whether there has been a material breach of this Agreement pursuant to Section 11.2.1, then: (a) the Party that disputes that there has been a material breach may contest the allegation by referring such matter, within [***], for resolution to the Executive Officers, who shall meet promptly to discuss the matter and determine, within [***], whether or not a material breach has occurred pursuant to Section 11.2.1; provided that if the Executive Officers are unable to resolve such dispute within such [***] ([***]) [***] period after it is referred to them, the matter will be resolved as provided in Section 11.7; (b) the relevant Cure Period with respect thereto will be tolled from the date the breaching Party notifies the non-breaching Party of such dispute and through the resolution of such dispute in accordance with the applicable provisions of this Agreement; (c) subject to Section 10.12, during the pendency of such dispute, all of the terms and conditions of this Agreement shall remain in effect and the Parties shall continue to perform all of their respective obligations hereunder; and (d) if it is ultimately determined that the breaching Party committed such material breach, then the breaching Party shall have the right to cure such material breach, after such determination, within the Cure Period (as may be extended in accordance with Section 10.2.1) which shall commence as of the date of such determination.
10.3      Voluntary Termination . Celgene may terminate this Agreement at will, in its sole discretion, in its entirety upon sixty (60) days’ prior written notice to Prothena at any time.
10.4      Termination for Bankruptcy . If either Party makes a general assignment for the benefit of, or an arrangement or composition generally with, its creditors, appoints or suffers appointment of an examiner or of a receiver or trustee over all or substantially all of its property, passes a resolution for its winding up or files a petition under any bankruptcy or insolvency act or law or has any such petition filed against it which is not dismissed, discharged, bonded or stayed within ninety (90) days after the filing thereof (each, an “ Insolvency Event ”), the other Party may terminate this Agreement in its entirety, effective immediately upon written notice to such Party, provided that, in connection therewith, the provisions of Section 6.5 shall apply.
10.5      Termination for Failure to Commence Preliminary Activities in Support of Clinical Trial . In the event that (i) Celgene does not exercise its Phase 1 Option for the Licensed Program in accordance with the Master Collaboration Agreement prior to the end of the Phase 1 Option Term for the Licensed Program and (ii) Celgene (or its Affiliates or Sublicensees) does not, within [***] ([***]) months after the end of the Phase 1 Option Term for the Licensed Program (the “ Clinical Trial Preliminary Activities Outside Date ”), engage in any activities in support of an IND for a Clinical Trial for a Licensed Product, then Prothena may terminate this Agreement in its entirety upon [***] ([***]) days’ prior written notice to Celgene; provided that such termination notice is provided within [***] ([***]) days after the Clinical Trial Preliminary Activities Outside Date. Notwithstanding the foregoing, the Clinical Trial Preliminary Activities Outside Date shall be automatically extended by one day for each day that Celgene (or its Affiliates or Sublicensees, as applicable) is delayed from engaging in activities in support of the commencement of a Clinical Trial for a Licensed Product caused by reasons outside the reasonable control of Celgene (or its Affiliates or Sublicensees, as applicable), including delays caused by Regulatory Authorities (including regulatory or clinical hold).

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10.6      Termination for Patent Challenge . Prothena shall have the right to terminate this Agreement upon written notice if Celgene or any Affiliate of Celgene challenges the validity, scope or enforceability of or otherwise opposes any Patent included in the Prothena IP that is licensed to Celgene under this Agreement, in each case through a formal proceeding (other than as may be necessary or reasonably required to assert a cross-claim or a counter-claim or to respond to a court request or order or administrative law, request or order). If a Sublicensee of Celgene with respect to any Prothena IP challenges the validity, scope or enforceability of or otherwise opposes any Patent included in such Prothena IP under which such Sublicensee is sublicensed in each case through a formal proceeding (other than as may be necessary or reasonably required to assert a cross-claim or a counter-claim or to respond to a court request or order or administrative law, request or order), then Celgene shall, upon written notice from Prothena, terminate such sublicense.
10.7      Termination Upon Execution of Global License Agreement for Licensed Program . This Agreement shall automatically terminate if the Parties (or their respective Affiliates, as applicable) enter into a Global License Agreement for the Licensed Program in accordance with the terms of the Master Collaboration Agreement.
10.8      Effects of Expiration or Termination; Additional Remedies .
10.8.1      Termination by Prothena Pursuant to Section 10.2, 10.4, 10.5 or 10.6, or by Celgene Pursuant to Section 10.3. In the event this Agreement is terminated by Prothena pursuant to Section 10.2, 10.4 ,10.5 or 10.6, or by Celgene pursuant to Section 10.3, upon the effective date of such termination:
(a)      the Master Collaboration Agreement (if not previously expired or terminated) shall also terminate automatically with respect to the Licensed Program (but not any other Program);
(b)      except as set forth in this Section 10.8.1 or Sections 10.10 or 10.11, all rights and licenses granted herein shall terminate;
(c)      any and all Collaboration Specific IP shall thereafter no longer be deemed to be Collaboration Specific IP;
(d)      each Party shall return or destroy all Confidential Information of the other Party as required by Article 7; and
(e)      notwithstanding the foregoing provisions of this Section 10.8.1, the licenses granted to Celgene hereunder shall survive for [***] ([***]) [***] following the effective date of termination in order for Celgene (and its Affiliates, Sublicensees and distributors), at Celgene’s discretion, during the [***] ([***])-[***] period immediately following the effective date of termination, to (i) finish or otherwise wind-down any ongoing Clinical Trials with respect to any Licensed Antibodies, Licensed Products or Diagnostic Products hereunder and (ii) finish and sell any [***] Licensed Antibodies, Licensed Products or Diagnostic Products remaining in inventory (provided that Celgene shall pay royalties on Annual Net Sales of such Licensed Products

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sold by Celgene during such period (provided that the applicable Royalty Term is still ongoing) as an to the extent Celgene would otherwise be required to pay such royalties as set forth in Section 5.2); provided that, for clarity, Celgene shall have no obligation to undertake such activities, in each case of (i) and (ii), as and to the extent determined by Celgene.
10.8.2      Termination by Celgene Pursuant to Section 10.2 or 10.4 . In the event this Agreement is terminated by Celgene pursuant to Section 10.2 or 10.4, upon the effective date of such termination:
(a)      the Master Collaboration Agreement (if not previously expired or terminated) shall also terminate automatically with respect to the Licensed Program (but not any other Program);
(b)      except as set forth in this Section 10.8.2 or Sections 10.10 or 10.11, all rights and licenses granted herein shall terminate;
(c)      any and all Collaboration Specific IP hall thereafter no longer be deemed to be Collaboration Specific IP;
(d)      each Party shall return or destroy all Confidential Information of the other Party as required by Article 7; and
(e)      notwithstanding the foregoing provisions of this Section 10.8.2, the licenses granted to Celgene hereunder shall survive for [***] ([***]) [***] following the effective date of termination in order for Celgene (and its Affiliates, Sublicensees and distributors), at Celgene’s discretion, during the [***] ([***])-[***] period immediately following the effective date of termination, to (i) finish or otherwise wind-down any ongoing Clinical Trials with respect to any Licensed Antibodies, Licensed Products or Diagnostic Products hereunder and (ii) finish and sell [***] any Licensed Antibodies, Licensed Products or Diagnostic Products remaining in inventory (provided that Celgene shall pay royalties on Annual Net Sales of such Licensed Products sold by Celgene during such period (provided that the applicable Royalty Term is still ongoing) as an to the extent Celgene would otherwise be required to pay such royalties as set forth in Section 5.2); provided that, for clarity, Celgene shall have no obligation to undertake such activities, in each case of (i) and (ii), as and to the extent determined by Celgene.
10.8.3      Termination Pursuant to Section 10.7 . In the event this Agreement is terminated pursuant to Section 10.7, upon the effective date of such termination, except as set forth in Section 10.11, all rights and licenses granted herein shall terminate.
10.9      Certain Additional Remedies of Celgene in Lieu of Termination . In the event that (i) Celgene notifies Prothena in writing of a material breach of this Agreement by Prothena, and (ii) Celgene would have the right to terminate this Agreement pursuant to Section 10.2, then in lieu of Celgene terminating pursuant to Section 10.2, and without limiting any other rights or remedies of Celgene, Celgene may elect to have this Agreement continue in full force and effect by providing written notice thereof to Prothena; provided, however, that if Celgene so elects to continue this

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Agreement, then from and after such time as Celgene delivers such written notice to Prothena, any and all amounts thereafter payable by Celgene hereunder or under any Global License Agreement entered into with respect to the Licensed Program (including Regulatory Milestone Payments, Sales Milestone Payments and royalties) shall be reduced by [***].
10.10      Prothena Reversion Antibodies . If this Agreement terminates, except for any termination by Celgene pursuant to Section 10.2 or 10.4 or termination pursuant to Section 10.7, then the provisions of this Section 10.10 (and for the avoidance of doubt, the provisions of this Section 10.10 shall not apply in the case of termination by Celgene pursuant to Section 10.2 or 10.4 or termination pursuant to Section 10.7).
10.10.1      Reversion. All Licensed Program Antibodies that were the subject of Clinical Trials conducted by Celgene pursuant to this Agreement shall be automatically and immediately deemed “ Prothena Reversion Antibodies ”. Celgene shall grant and hereby grants to Prothena a non-exclusive, royalty-free, license in the Territory, with the right to grant sublicenses through multiple tiers, under any Patents and/or Know-How Controlled by Celgene or its Affiliates as of the termination effective date claiming or covering [***], into the Prothena Reversion Antibodies as they exist as of such termination effective date, solely as necessary to research, Develop, Manufacture, use, import, offer for sale, sell, and Commercialize Prothena Reversion Antibodies [***] in the Field in the Territory; [***].
10.10.2      Effects of Reversion. With respect to each Prothena Reversion Antibody:
(a)      Except to the extent not permitted pursuant to any agreements between Celgene and a Third Party, Celgene shall provide to Prothena, within a reasonable time, at Prothena’s request (provided that such request was made within [***] ([***]) days after the effective date of termination), subject to [***], copies of (i) [***] Clinical Trial data and results generated by or on behalf of Celgene or its Affiliates in the Development of Prothena Reversion Antibodies pursuant to this Agreement, and (ii) [***] relating to the manufacture of such Prothena Reversion Antibodies; in each case, to the extent in Celgene’s possession as of the termination effective date [***]. For clarity, Prothena shall have the right to use the foregoing [***] solely in connection with the exercise of Prothena’s rights under Section 10.10.1;
(b)      Celgene shall transfer within a reasonable time to Prothena, at Prothena’s request (provided that such request was made within [***] ([***]) days after the effective date of termination), [***], [***] Regulatory Filings in the Territory [***] for the Prothena Reversion Antibodies [***] by Celgene or its Affiliates as of the termination effective date; [***];
(c)      Celgene shall otherwise cooperate reasonably with Prothena to provide a transfer of the materials described in the foregoing provisions of this Section 10.10.2, [***];
(d)      As and to the extent a Third Party is Manufacturing such Prothena Reversion Antibody for Celgene or its Affiliate, Celgene shall use reasonable efforts, at Prothena’s request (provided that such request was made within [***] ([***]) days after the effective date of

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termination) [***], to [***]. Additionally, at Prothena’s request (provided that such request was made within [***] ([***]) days after the effective date of termination), Celgene shall transfer to Prothena [***] such Prothena Reversion Antibody owned by Celgene and then in Celgene’s possession, for a price equal to [***];
(e)      To the extent that Celgene or its Affiliate owns any trademark(s) and/or domain names that [***] a Prothena Reversion Antibody in the Territory that [***] for the Commercialization of a Prothena Reversion Antibody (as [***], but not including any marks that include, in whole or part, any corporate name or logo of Celgene or its Affiliate), Prothena shall have the right to [***]. Prothena shall exercise such right by written notice to Celgene within [***] ([***]) days after such Licensed Antibody or Licensed Product becomes a Prothena Reversion Antibody; and
(f)      If Celgene or its Affiliate has obtained a license from a Third Party and Prothena is a sublicensee under such license pursuant to Section 10.10.1, then [***]. Notwithstanding the provisions of Section 10.10.1, Prothena shall not get a sublicense of any Third Party intellectual property pursuant to Section 10.10.1 unless such sublicense is allowed pursuant to and in accordance with the agreement between Celgene and such Third Party.
10.11      Surviving Provisions .
10.11.1      Accrued Rights; Remedies . Termination or expiration of this Agreement for any reason shall be without prejudice to any rights that shall have accrued to the benefit of any Party prior to such termination or expiration, and any and all damages or remedies (whether in law or in equity) arising from any breach hereunder, each of which shall survive termination or expiration of this Agreement. Such termination or expiration shall not relieve any Party from obligations which are expressly indicated to survive termination or expiration of this Agreement. Except as otherwise expressly set forth in this Agreement, the termination provisions of this Article 10 are in addition to any other relief and remedies available to either Party under this Agreement and at Applicable Law.

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10.11.2      Survival . Without limiting the provisions of Section 11.8.1, the rights and obligations of the Parties set forth in the following Sections and Articles of this Agreement shall survive the expiration or termination of this Agreement, in addition to those other terms and conditions that are expressly stated to survive termination or expiration of this Agreement: [Article 1 (to the extent the definitions are used in other surviving provisions), Article 5 (as to payment obligations accrued prior to the effectiveness of termination or expiration of this Agreement), Section 6.3, Section 6.4, Section 6.5, Section 6.6, Section 6.12 (solely if there is no other U.S. License Agreement or Global License Agreement covering the applicable Joint Patents), Article 7, Section 8.6, Article 9, Section 10.1.2, Section 10.8, Section 10.9, Section 10.10, Section 10.11, Section 10.12, Section 10.13, and Article 11]. 6
10.12      [***] . Notwithstanding anything to the contrary contained herein, in the event notice of termination of this Agreement is given [***].
10.13      Relationship to Other Agreements . Termination of this Agreement shall not affect in any way the terms or provisions of any other then-existing executed U.S. License Agreements or Global License Agreements.
ARTICLE 11.     
MISCELLANEOUS
11.1     Severability . If any one or more of the terms or provisions of this Agreement is held by a court of competent jurisdiction to be void, invalid or unenforceable in any situation in any jurisdiction, such holding shall not affect the validity or enforceability of the remaining terms and provisions hereof or the validity or enforceability of the invalid, void or unenforceable term or provision in any other situation or in any other jurisdiction, and the term or provision shall be considered severed from this Agreement solely for such situation and solely in such jurisdiction, unless the invalid, void or unenforceable term or provision is of such essential importance to this Agreement that it is to be reasonably assumed that the Parties would not have entered into this Agreement without the invalid, void or unenforceable term or provision. If the final judgment of such court declares that any term or provision hereof is invalid, void or unenforceable, the Parties agree to (a) reduce the scope, duration, area or applicability of the term or provision or to delete specific words or phrases to the minimum extent necessary to cause such term or provision as so reduced or amended to be enforceable, and (b) make a good faith effort to replace any invalid, void or unenforceable term or provision with a valid and enforceable one such that the objectives contemplated by the Parties when entering this Agreement may be realized.
11.2     Notices . Any notice required or permitted to be given by this Agreement shall be in writing and in English and shall be (a) delivered by hand or by overnight courier with tracking capabilities, (b) mailed postage prepaid by first class, registered, or certified mail, or (c) delivered by facsimile followed by delivery via either of the methods set forth in Sections 11.2(a) and (b), in each case, addressed as set forth below unless changed by notice so given:

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If to Celgene:
Celgene Switzerland LLC
AON House
30 Woodbourne Ave.
Pembroke HM 08, Bermuda
Attention:    [***]
With copies to:
Celgene Corporation
    86 Morris Avenue
    Summit, NJ 07901
U.S.A.
    Attention:    General Counsel
    Facsimile:    (908) 673-2771
If to Prothena:
Prothena Biosciences Limited
Adelphi Plaza
Upper George’s Street
Dun Laoghaire, Co. Dublin A96 T927
Ireland    
Attention:     Company Secretary
Facsimile:     +353-1-686-5675
With copies to:

Prothena Biosciences Inc.
331 Oyster Point Boulevard
South San Francisco, CA, 94080
U.S.A.
Attention: Vice President, Business Development
Facsimile:     +1 650-837-8560
Any such notice shall be deemed given on the date received, except any notice received after 5:30 p.m. (in the time zone of the receiving party) on a Business Day or received on a non-Business Day shall be deemed to have been received on the next Business Day. A Party may add, delete, or change the person or address to which notices should be sent at any time upon written notice delivered to the other Parties in accordance with this Section 11.2.
11.3     Force Majeure . A Party shall not be liable for delay or failure in the performance of any of its obligations hereunder if such delay or failure is due to a cause beyond the reasonable control of such Party, including acts of God, fires, earthquakes, acts of war, terrorism, or civil unrest, or hurricane or other inclement weather (“ Force Majeure ”); provided, however, that the affected Party promptly notifies the other Party and further provided that the affected Party shall use its

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commercially reasonable efforts to avoid or remove such causes of non-performance and to mitigate the effect of such occurrence, and shall continue performance in accordance with the terms of this Agreement whenever such causes are removed. When such circumstances arise, the Parties shall negotiate in good faith any modifications of the terms of this Agreement that may be necessary or appropriate in order to arrive at an equitable solution.
11.4      Assignment .
11.4.1      Generally . Except as expressly permitted herein, this Agreement may not be assigned or transferred by any Party, nor may any Party assign or transfer any rights or obligations created by this Agreement, except as expressly permitted hereunder without the prior written consent of the other Party, which consent will not be unreasonably withheld.
11.4.2      Celgene . Notwithstanding the limitations in Section 11.4.1, and subject to Section 5.5.2 and the remaining provisions of this Section 11.4.2, Celgene may assign or transfer this Agreement, or any rights or obligations hereunder in whole or in part, to (a) one or more Affiliates (provided, however, that Celgene shall remain fully and unconditionally liable and responsible to the non-assigning Party hereto for the performance and observance of all such duties and obligations by such Affiliate); or (b) its successor in interest in connection with its merger, consolidation, or sale of all or substantially all of its assets or that portion of its business pertaining to the subject matter of this Agreement.
11.4.3      Prothena . Notwithstanding the limitations in Section 11.4.1, and subject to Section 5.5.2 and the remaining provisions of this Section 11.4.3, Prothena may assign or transfer this Agreement, or any rights or obligations hereunder in whole or in part, to (a) one or more Affiliates (provided, however, that Prothena shall remain fully and unconditionally liable and responsible to the non-assigning Party hereto for the performance and observance of all such duties and obligations by such Affiliate); or (b) its successor in interest in connection with its merger, consolidation, or sale of all or substantially all of its assets.
11.4.4      Intellectual Property of Acquirer . Notwithstanding anything to the contrary in this Agreement, if a Party is acquired by a Third Party after the Effective Date, then with respect to any intellectual property rights controlled by the Third Party acquiring party or its affiliates (other than one of the Parties to this Agreement or its Affiliates immediately prior to such acquisition) involved in any assignment of this Agreement by such Party to such Third Party acquirer, such intellectual property rights shall not be included in the technology and intellectual property rights licensed to the other Party hereunder to the extent held immediately prior to such transaction by such acquirer or its affiliate (other than the relevant Party to this Agreement or its Affiliates immediately prior to such acquisition), and developed outside the scope of activities conducted with respect to the Collaboration, any Program, any U.S. License Agreement or any Global License Agreement. The Prothena IP shall also exclude any intellectual property developed by such Third Party acquirer after such acquisition; provided that (i) such intellectual property is developed independently of the activities under this Agreement, the Collaboration, any Program, the Collaboration Agreement, any U.S. License Agreement or any Global License Agreement [***], (ii) Prothena and its Affiliates put in place firewalls and other protections to [***] and (iii) [***].

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11.4.5      All Other Assignments Null and Void . The terms of this Agreement will be binding upon and will inure to the benefit of the successors, heirs, administrators and permitted assigns of the applicable Party. Any purported assignment in violation of this Section 11.4 will be null and void ab initio .
11.5      Waivers and Modifications . The failure of any Party to insist on the performance of any obligation hereunder shall not be deemed to be a waiver of such obligation. Waiver of any breach of any provision hereof shall not be deemed to be a waiver of any other breach of such provision or any other provision on such occasion or any succeeding occasion. No waiver, modification, release, or amendment of any obligation under or provision of this Agreement shall be valid or effective unless in writing and signed by the Parties.
11.6      WAIVER OF JURY TRIAL . EXCEPT AS LIMITED BY APPLICABLE LAW, EACH PARTY HERETO HEREBY IRREVOCABLY WAIVES ALL RIGHT TO TRIAL BY JURY IN ANY ACTION, PROCEEDING OR COUNTERCLAIM (WHETHER BASED IN CONTRACT, TORT OR OTHERWISE) ARISING OUT OF OR RELATING TO THIS AGREEMENT OR THE ACTIONS OF ANY PARTY HERETO IN THE NEGOTIATION, ADMINISTRATION, PERFORMANCE AND ENFORCEMENT HEREOF.
11.7      Choice of Law; Dispute Resolution .
11.7.1      Choice of Law . This Agreement shall be governed by, enforced and construed in accordance with the laws of the State of New York without reference to any rules of conflict of laws or renvoi and excluding the United Nations Convention on Contracts for the International Sales of Goods; provided, however, that with respect to matters involving the validity or infringement of intellectual property rights in a given country, such matter may be brought in the applicable country (in accordance with Section 11.7.3) and the Applicable Laws of the applicable country shall apply (subject to Section 6.6.1).
11.7.2      Exclusive Dispute Resolution Mechanism . The Parties agree that the procedures set forth in Section 11.7.3 will be the exclusive mechanism for resolving any dispute (whether in contract, tort or otherwise), controversy or claim between the Parties arising out of or in connection with this Agreement, any Party’s rights or obligations under this Agreement, breach of this Agreement or the transactions contemplated by this Agreement (each, a “ Dispute ”); provided that decisions that are subject to the decision making authority of a given Party, as expressly set forth in this Agreement, will not be subject to the provisions of Section 11.7.3 so long as such decisions are made in accordance with this Agreement.
11.7.3      Jurisdiction .
(a)      Except as otherwise set forth in this Section 11.7.3, the sole jurisdiction and venue for all actions, suits and proceedings arising out of any Dispute (except in respect of an Excluded Claim, where jurisdiction is non-exclusive) will be the state and federal courts located in the Borough of Manhattan in New York, New York, USA. Each Party hereby irrevocably and unconditionally (a) consents to submit to the exclusive jurisdiction of the state and federal courts located in the Borough of Manhattan in New York, New York, USA for any action,

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suit or proceeding arising out of such Dispute, and (b) waives any objection to the laying of venue of any action, suit or proceeding arising out of such Dispute in the state and federal courts of the Borough of Manhattan in New York, New York, USA and agrees not to plead or claim in any such court that any such action, suit or proceeding brought in any such court has been brought in an inconvenient forum. Each of the Parties agrees that process may be served upon it in the manner specified in Section 12.2 and irrevocably waives and covenants not to assert or plead any objection which it might otherwise have to such jurisdiction, or to such manner of service of process. It shall be a condition precedent to the commencement of any action in court or other tribunal (save an action for an interim injunction or provisional relief) in respect of any Dispute relating to this Agreement that the Parties have sought to resolve the Dispute by either Party notifying the other Party in writing for resolution to the Executive Officers who shall meet (whether in person or via teleconference) within [***] ([***]) [***] of such notice to seek resolution in good faith. If the Executive Officers are unable to resolve the Dispute at such meeting, either Party may pursue any remedy available to such Party at law or in equity, subject to the terms and conditions of this Agreement, including this Section 11.7.3.
(b)      Notwithstanding the provisions of Section 11.7.3(a), either Party may, without waiving any remedy under this Agreement, seek from any court having jurisdiction any equitable relief, including any injunctive or provisional relief and specific performance to protect the rights or property of that Party. Such remedies will not be deemed to be the exclusive remedies for a breach of this Agreement but will be in addition to all other remedies available at law or equity. In addition, notwithstanding the provisions of Section 11.7.3(a) either Party may bring an action in any court having jurisdiction to enforce an award rendered pursuant to Section 11.7.3(a).
(c)      Until final resolution of the dispute through judicial determination, (i) this Agreement will remain in full force and effect and (ii) the time periods for cure as to any termination will be tolled. The Parties further agree that any payments made pursuant to this Agreement pending resolution of the dispute shall be refunded if a court determines that such payments are not due.
(d)      As used in this Section 11.7, the term “ Excluded Claim ” means a dispute, controversy or claim that concerns (i) the validity or infringement of a Patent, trademark or copyright, or (ii) any antitrust, anti-monopoly or competition law or regulation, whether or not statutory.
11.8      Relationship of the Parties . Prothena and Celgene are independent contractors under this Agreement. Nothing contained herein is intended or is to be construed so as to constitute (a) Prothena as a partner, agent, or joint venturer of Celgene or (b) Celgene as a partner, agent or joint venturer of Prothena. Neither Prothena nor Celgene, respectively, shall have any express or implied right or authority to assume or create any obligations on behalf of or in the name of Celgene or Prothena, respectively, or to bind Celgene or Prothena, respectively, to any contract, agreement, or undertaking with any Third Party.
11.9      Third Party Beneficiaries . There are no express or implied Third Party beneficiaries hereunder. The provisions of this Agreement are for the exclusive benefit of the Parties, and no

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other person or entity shall have any right or claim against any Party by reason of these provisions or be entitled to enforce any of these provisions against any Party.
11.10      Entire Agreement . This Agreement, together with the attached Exhibits and Schedules and the Master Collaboration Agreement, contains the entire agreement by the Parties with respect to the subject matter hereof and supersedes any prior express or implied agreements, understandings and representations, either oral or written, which may have related to the subject matter hereof in any way, including any and all term sheets relating to the transactions contemplated by this Agreement and exchanged between the Parties prior to the Effective Date. In the event of a conflict between the provisions of this Agreement and the Master Collaboration Agreement with respect to the Licensed Program, the provisions of this Agreement shall control.
11.11      Counterparts . This Agreement may be executed in counterparts with the same effect as if both Parties had signed the same document. All such counterparts shall be deemed an original, shall be construed together, and shall constitute one and the same instrument. Any such counterpart, to the extent delivered by means of a fax machine or by .pdf, .tif, .gif, .jpeg or similar attachment to electronic mail (any such delivery, an “ Electronic Delivery ”) shall be treated in all manner and respects as an original executed counterpart and shall be considered to have the same binding legal effect as if it were the original signed version thereof delivered in person. No Party hereto shall raise the use of Electronic Delivery to deliver a signature or the fact that any signature or agreement or instrument was transmitted or communicated through the use of Electronic Delivery as a defense to the formation of a contract, and each Party forever waives any such defense, except to the extent that such defense relates to lack of authenticity.
11.12      Equitable Relief; Cumulative Remedies . Notwithstanding anything to the contrary herein, the Parties shall be entitled to seek equitable relief, including injunction and specific performance, as a remedy for any breach of this Agreement. Such remedies shall not be deemed to be the exclusive remedies for a breach of this Agreement but shall be in addition to all other remedies available at law or equity. The Parties further agree not to raise as a defense or objection to the request or granting of such relief that any breach of this Agreement is or would be compensable by an award of money damages. No remedy referred to in this Agreement is intended to be exclusive, but each shall be cumulative and in addition to any other remedy referred to in this Agreement or otherwise available under Applicable Law.
11.13      Interpretation .
11.13.1      Generally . This Agreement has been diligently reviewed by and negotiated by and among the Parties, and in such negotiations each of the Parties has been represented by competent (in-house or external) counsel, and the final agreement contained herein, including the language whereby it has been expressed, represents the joint efforts of the Parties and their counsel. Accordingly, in interpreting this Agreement or any provision hereof, no presumption shall apply against any Party as being responsible for the wording or drafting of this Agreement or any such provision, and ambiguities, if any, in this Agreement shall not be construed against any Party, irrespective of which Party may be deemed to have authored the ambiguous provision.

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[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.



11.13.2      Definitions; Interpretation . The definitions of the terms herein shall apply equally to the singular and plural forms of the terms defined and where a word or phrase is defined herein, each of its other grammatical forms shall have a corresponding meaning. Whenever the context may require, any pronoun shall include the corresponding masculine, feminine, and neuter forms. The word “will” shall be construed to have the same meaning and effect as the word “shall.” The word “any” shall mean “any and all” unless otherwise clearly indicated by context. The words “including,” “includes,” “include,” “for example,” and “e.g.” and words of similar import will be deemed to be followed by the words “without limitation.” The word “or” is disjunctive but not necessarily exclusive. The words “hereof,” “herein” and “herewith” and words of similar import shall, unless otherwise stated, be construed to refer to this Agreement as a whole and not to any particular provision of this Agreement. Unless the context requires otherwise or otherwise specifically provided, (i) all references herein to Articles, Sections, Schedules or Exhibits shall be construed to refer to Articles, Sections, Schedules and Exhibits of this Agreement and (ii) reference in any Section to any subclauses are references to such subclauses of such Section.
11.13.3      Subsequent Events . Unless the context requires otherwise, (i) any definition of or reference to any agreement, instrument, or other document herein shall be construed as referring to such agreement, instrument, or other document as from time to time amended, supplemented, or otherwise modified (subject to any restrictions on such amendments, supplements, or modifications set forth herein), (ii) any reference to any Applicable Law herein shall be construed as referring to such Applicable Law as from time to time enacted, repealed, or amended, and (iii) any reference herein to any Person shall be construed to include the Person’s successors and assigns (subject to Section 11.4).
11.13.4      Headings . Headings, captions and the table of contents are for convenience only and are not to be used in the interpretation of this Agreement.
11.13.5      Prior Drafts . No prior draft of this Agreement nor any course of performance or course of dealing shall be used in the interpretation or construction of this Agreement.
11.13.6      Independent Significance . Although the same or similar subject matters may be addressed in different provisions of this Agreement, the Parties intend that, except as reasonably apparent on the face of the Agreement or as expressly provided in this Agreement, each such provision shall be read separately, be given independent significance and not be construed as limiting any other provision of this Agreement (whether or not more general or more specific in scope, substance or content).
11.14      Further Assurances . Each Party shall execute, acknowledge and deliver such further instruments, and do all such other ministerial, administrative or similar acts, as may be reasonably necessary or appropriate in order to carry out the expressly stated purposes and the clear intent of this Agreement.
11.15      Extension to Affiliates . Subject to Sections 5.5.2 and 11.4, Celgene shall have the right to extend the rights, licenses, immunities and obligations granted in this Agreement to one or more of its Affiliates. All applicable terms and provisions of this Agreement shall apply to any such

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[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.



Affiliate to which this Agreement has been extended to the same extent as such terms and provisions apply to Celgene. Celgene shall remain fully liable for any acts or omissions of such Affiliates.
[Signature Page Follows]


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[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.



IN WITNESS WHEREOF, and intending to be legally bound hereby, the Parties have caused this U.S. LICENSE AGREEMENT to be executed by their respective duly authorized officers as of the Effective Date.



PROTHENA BIOSCIENCES LIMITED






CELGENE SWITZERLAND LLC
 
 
 
 
By:    
By:    
 
 
Name:    
Name:    
 
 
Title:    
Title:    
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 





[Signature Page to U.S. License Agreement]
[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.



Schedule 1.28
Existing Program Agreements

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.




Schedule 1.40
In-License Agreements and Other Third Party Agreements

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.




Schedule 1.45
Licensed Program Antibodies

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.




Schedule 1.47(b)
Licensed Program Patents

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.




Schedule 1.49
Licensed Target

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.




Schedule 1.64
Prothena Licensed Collaboration Patents

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.




Schedule [***]
[***]



[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.




Schedule 8.2
Exceptions to Prothena Representations and Warranties

[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.




Schedule 8.4
Exceptions to Celgene Representations and Warranties





[***] Certain information in this document has been omitted and filed separately with the Securities and Exchange Commission. Confidential treatment has been requested with respect to the omitted portions.

Exhibit 10.4






SHARE SUBSCRIPTION AGREEMENT
 
By and Between
 
Celgene Switzerland LLC
 
and
 
Prothena Corporation plc
 
Dated as of March 20, 2018






PROTHENA CORPORATION PLC
SHARE SUBSCRIPTION AGREEMENT
THIS SHARE SUBSCRIPTION AGREEMENT (the “ Agreement ”) is made and entered into as of March 20, 2018 (the “ Signing Date ”), by and between Prothena Corporation plc, an Irish public limited company (the “ Company ”), and Celgene Switzerland LLC, a Delaware limited liability company (the “ Subscriber ”).
WHEREAS, the Company and the Subscriber are entering into that certain Master Collaboration Agreement, by and between the Company and Subscriber, of even date herewith (the “ Collaboration Agreement ”);
WHEREAS, the obligations in the Collaboration Agreement are conditioned upon the execution and delivery of this Agreement, pursuant to which the Subscriber will subscribe for and the Company will issue to the Subscriber a number of its Ordinary Shares (as defined herein), as provided for herein; and
WHEREAS, the Subscriber desires to subscribe for, and the Company desires to issue, the Shares (as defined herein) on the terms and conditions set forth herein;
NOW, THEREFORE, in consideration of the foregoing recitals and the mutual promises, representations, warranties and covenants hereinafter set forth and for other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged, the parties hereto agree as follows:
1. Definitions .  When used in this Agreement, the following terms shall have the respective meanings specified below:

Action ” shall mean any action, cause or action, suit, prosecution, investigation, litigation, arbitration, hearing, order, claim, complaint or other proceeding (whether civil, criminal, administrative, investigative or informal) by or before any Governmental Authority or arbitrator.
Affiliate ” shall mean, with respect to any Person, another Person which controls, is controlled by or is under common control with such Person. A Person shall be deemed to control another Person if such Person possesses, directly or indirectly, the power to direct or cause the direction of the management and policies of such Person, whether through the ownership of voting securities, by contract or otherwise. For the purposes of this Agreement, in no event shall the Subscriber or any of its Affiliates be deemed Affiliates of the Company or any of its Affiliates, nor shall the Company or any of its Affiliates be deemed Affiliates of the Subscriber or any of its Affiliates.
beneficially owns ” (including the correlative terms “ beneficial ownership ,” “ beneficially owned, ” “ beneficial owner ” or “ beneficially owning ”) shall mean beneficial ownership within the meaning of Rule 13d-3 and Rule 13d-5 under the Exchange Act.

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Business Day ” shall mean any day except Saturday, Sunday and any day on which banking institutions in New York, New York, generally are closed as a result of federal, state or local holiday.
Change of Control ” shall mean, with respect to a Person, any of the following events: (i) any Person is or becomes the beneficial owner (as such term is defined in Rule 13d-3 under the Exchange Act, except that a Person shall be deemed to have beneficial ownership of all shares that any such Person has the right to acquire, whether such right which may be exercised immediately or only after the passage of time), directly or indirectly, of a majority of the total voting power represented by all shares of such Person’s outstanding capital stock; (ii) such Person consolidates with or merges into another corporation or entity, or any corporation or entity consolidates with or merges into such Person, other than (A) a merger or consolidation which would result in the voting securities of such Person outstanding immediately prior to such merger or consolidation continuing to represent (either by remaining outstanding or by being converted into voting securities of the surviving entity or any parent thereof) a majority of the combined voting power of the voting securities of such Person or such surviving entity or any parent thereof outstanding immediately after such merger or consolidation, or (B) a merger or consolidation effected to implement a recapitalization of such Person (or similar transaction) in which no Person becomes the beneficial owner, directly or indirectly, of a majority of the total voting power of all shares of capital stock of such Person or (iii) such Person conveys, transfers or leases all or substantially all of its assets, to any Person other than a wholly owned Affiliate of such Person.
Code ” shall mean the United States Internal Revenue Code of 1986, as amended.
Consent ” shall mean any, internal or external, approval, authorization, consent, license, franchise, Order, registration, notification, permit, certification, clearance, waiver or other confirmation of or by a Governmental Authority, other Person or company body.
Contract ” shall mean, with respect to any Person, any written agreement, contract, commitment, indenture, note, bond, loan, license, sublicense, lease, sublease, undertaking, statement of work or other arrangement to which such Person is a party or by which any of its properties or assets are subject.
control ” (including the correlative terms “ controlled by ,” “ controlling ” and “ under common control with ”), as applied to any Person, shall mean the possession, directly or indirectly, of the power to direct or cause the direction of the management and policies of that Person, whether through the ownership or voting of securities, by contract or otherwise.
Controlled Affiliate ” shall mean, with respect to a Person, an Affiliate of such Person controlled by such Person.
Disposition ” or “ Dispose of ” shall mean any (i) offer, pledge, sale, contract to sell, sale of any option or contract to purchase, purchase of any option or contract to sell, grant of any option, right or warrant for the sale of, or other disposition of or transfer of any Ordinary Shares or Ordinary Share Equivalents, including, without limitation, any “short sale” or similar arrangement, or (ii) swap, hedge, derivative instrument, or any other agreement or any transaction that transfers, in whole or in part, directly or indirectly, the economic consequence of ownership of Ordinary Shares

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or Ordinary Share Equivalents, whether any such swap or transaction is to be settled by delivery of securities, in cash or otherwise.
Employee Benefit Plan ” shall mean any “employee benefit plan” (as such term is defined in Section 3(3) of ERISA, whether or not subject to ERISA), any severance, employment, incentive or bonus, retention, change in control, deferred compensation, termination pay, profit sharing, retirement, welfare, post-employment welfare, fringe benefit, vacation or paid time off, equity or equity-based or any other plan, policy, program, agreement, contract or arrangement that is sponsored, maintained, contributed to, or required to be contributed to by the Company or any of its Subsidiaries or under or with respect to which the Company or any of its Subsidiaries has any current or contingent liability or obligation.
Environmental Law ” shall mean all national, supra-national, federal, state, local and foreign Laws concerning public health and safety, worker health and safety, pollution or protection of the environment; including without limitation all those relating to the generation, handling, transportation, treatment, storage, disposal, release, exposure to or cleanup of hazardous materials, substances or wastes, including petroleum, asbestos, polychlorinated biphenyls, asbestos, noise or radiation.
ERISA ” shall mean the United States Employee Retirement Income Security Act of 1974, as amended, and the rulings and regulations thereunder.
Exchange Act ” shall mean the U.S. Securities Exchange Act of 1934, as amended, and the rules and regulations promulgated thereunder.
FDA ” shall mean the U.S. Food and Drug Administration.
FDCA ” shall mean the U.S. Federal Food, Drug and Cosmetic Act.
GAAP ” shall mean generally accepted accounting principles in the United States.
Governmental Authority ” shall mean any court, agency, authority, department, regulatory body or other instrumentality of any government or country or of any national, federal, state, provincial, regional, county, city or other political subdivision of any such government or country or any supranational organization of which any such country is a member.
Health Care Laws   means statutes, laws, ordinances, rules and regulations applicable to the Company for the ownership, testing, development, manufacture, packaging, processing, use, labeling, promotion, storage, import, export or disposal of any product manufactured or distributed by the Company, including without limitation, the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 301, et seq., similar laws of other Governmental Authorities and the regulations promulgated pursuant to such laws.
Intellectual Property ” shall mean all intellectual property and other similar proprietary rights in any jurisdiction, including such rights in and to: (a) any patent (including all reissues, divisions, continuations, continuations-in-part and extensions thereof), patent application, patent disclosure or other patent right, (b) any trademark, service mark, trade name, business name, brand

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name, slogan, logo, trade dress and all other indicia of origin together with all goodwill associated therewith, and all registrations, applications for registration, and renewals for any of the foregoing, (c) any copyright, work of authorship (whether or not copyrightable), design, design registration, database rights, and all registrations, applications for registration, and renewals for any of the foregoing (and including in all website content and software), (d) any Internet domain names, and (e) any trade secret, confidential information, know-how and inventions, including processes and formulations.
Knowledge ” shall mean, when used with respect to the Company, the actual or constructive knowledge of any officer of the Company, after due inquiry.
Law ” or “ Laws ” shall mean all laws, statutes, rules, regulations, orders, judgments, injunctions and ordinances of any Governmental Authority.
Leased Real Property ” shall mean all leasehold or subleasehold estates and all other rights to use or occupy any land, buildings, structures, improvements, fixtures or other interest in real property held by the Company or any of its Subsidiaries pursuant to any Lease.
Leases ” shall mean all leases, subleases, licenses, concessions and other Contracts pursuant to which the Company or any of its Subsidiaries holds any Leased Real Property as tenant, sublease, licensee or concessionaire (including the rights to all security deposits and other amounts and instruments deposited by or on behalf of the Company or and of its Subsidiaries thereunder) and all material amendments, extensions, renewals, guaranties and other agreements with respect thereto.
Liens ” shall mean a lien, charge, security interest, encumbrance, right of first refusal, preemptive right or other restriction.
Lock-Up Period ” shall mean the period from and after the Closing Date until the earlier of (i) the six-month anniversary of the Closing Date or (ii) the expiration of the Term (as defined in the Collaboration Agreement) or earlier termination of the Collaboration Agreement.
Material Adverse Effect ” shall mean any change, event or occurrence (each, an “ Effect ”) that, individually or when taken together with all other effects that have occurred prior to the date of determination of the occurrence of the Material Adverse Effect, is or is likely to be materially adverse to the business, clinical or pre-clinical programs, intellectual property, condition (financial or other), assets, liabilities or results of operations of the Company and its Subsidiaries, taken as a whole; provided , however , that in no event shall any of the following occurring after the date hereof, alone or in combination, be deemed to constitute, or be taken into account in determining whether a Material Adverse Effect has occurred: (i) changes in the Company’s industry generally or in conditions in the global economy or capital or financial markets generally, including changes in interest or exchange rates, (ii) any Effect caused by the announcement or pendency of the transactions contemplated by the Transaction Agreements, or the identity of the Subscriber or any of its Affiliates as the Subscriber in connection with the transactions contemplated by this Agreement or as a participant in the Collaboration Agreement, (iii) the performance of this Agreement, the Collaboration Agreement and the transactions contemplated hereby and thereby, including

5



compliance with the covenants set forth herein and therein, or any action taken or omitted to be taken by the Company at the request or with the prior consent of the Subscriber, (iv) changes in general legal, regulatory, political, economic or business conditions or changes to GAAP or interpretations thereof occurring after the date hereof that, in each case, generally affect the biotechnology or biopharmaceutical industries, (v) acts of war, sabotage or terrorism occurring after the date hereof, or any escalation or worsening of any such acts of war, sabotage or terrorism or (vi) earthquakes, hurricanes, floods or other natural disasters occurring after the date hereof, provided , however , that with respect to clauses (i), (iv), (v) and (vi), such effects, alone or in combination, may be deemed to constitute, or be taken into account in determining whether a Material Adverse Effect has occurred, but only to the extent such effects disproportionately affect the Company and its Subsidiaries compared to other participants in the biotechnology or biopharmaceutical industries.
Material Contract ” shall mean any Contract entered into by the Company or any of its Subsidiaries that is required under the Exchange Act to be filed as an exhibit to a Company SEC Document pursuant to Item 601(b)(10) of Regulation S-K.
Nasdaq ” shall mean the Nasdaq Stock Market LLC.
Ordinary Share Equivalents ” means any securities of the Company which would entitle the holder thereof to acquire at any time Ordinary Shares, including, without limitation, any debt, preferred shares, rights, options, warrants or other instrument that is at any time convertible into or exercisable or exchangeable for, or otherwise entitles the holder thereof to receive, Ordinary Shares.
Ordinary Shares ” shall mean ordinary shares, par value $0.01 per share, of the Company.
Order ” shall mean any assessment, award, decision, injunction, judgment, order, ruling, verdict or writ entered, issued, made, or rendered by any court, administrative agency, or other Governmental Authority or by any arbitrator.
Permitted Liens ” shall mean (a) mechanics’, materialman’s, workmens’, repairmens’, warehousemen’s, supplier’s, vendor’s, carrier’s and other similar Liens arising or incurred in the ordinary course of business by operation of Law securing amounts that are not yet due and payable, (b) Liens for Taxes, assessments and other charges of Governmental Authorities not yet due and payable and Taxes being contested in good faith, (c) Liens arising under original purchase price conditional sales Contracts and equipment leases with third parties, (d) pledges or deposits to secure obligations under workers or unemployment compensation Laws or to secure other statutory obligations, (e) easements, covenants, conditions and restrictions of record affecting title to the Leased Real Property which do not or would not materially impair the use or occupancy of any Leased Real Property in the operation of the business conducted thereon as of the date of this Agreement, and (f) any zoning, or other governmentally established restrictions of encumbrances.
Permitted Transferee ” shall mean an Affiliate of the Subscriber that is wholly owned, directly or indirectly, by the Subscriber; it being understood that for purposes of this definition “wholly owned” shall mean an Affiliate in which the Subscriber owns, directly or indirectly, at least ninety-nine percent (99%) of the outstanding capital stock or ownership interests of such Affiliate; provided , however , that no such Person shall be deemed a Permitted Transferee for any purpose

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under this Agreement unless: (a) the Subscriber shall have, within five days prior to such transfer, furnished to the Company written notice of the name and address of such Permitted Transferee, details of its status as a Permitted Transferee and details of the Ordinary Shares or Ordinary Share Equivalents to be transferred, (b) the Permitted Transferee, prior to or simultaneously with such Transfer, shall have agreed in writing to be subject to and bound by all restrictions and obligations set forth in this Agreement as though it were the Subscriber hereunder, and (c) the Subscriber acknowledges that it continues to be bound by all restrictions and obligations set forth in this Agreement.
Person ” shall mean any individual, partnership, limited liability company, firm, corporation, trust, unincorporated organization, government or any department or agency thereof or other entity, as well as any syndicate or group that would be deemed to be a Person under Section 13(d)(3) of the Exchange Act.
SEC ” shall mean the U.S. Securities and Exchange Commission.
Securities Act ” shall mean the U.S. Securities Act of 1933, as amended, and the rules and regulations promulgated thereunder.
Standstill Period ” shall mean the period from and after the Closing Date until the earliest of (i) the one-year anniversary of the Closing Date, (ii) the date the Company publicly announces its intent to initiate or consummate any merger, consolidation, acquisition, scheme, business combination or other extraordinary transaction in which the Company or any of its Subsidiaries is a constituent entity or party, (iii) the submission or announcement of the intent to make any bona fide offer or attempt by any third party to acquire all or a substantial portion of the securities or assets of the Company through any means, process or structure and (iv) the expiration of the Term (as defined in the Collaboration Agreement) or earlier termination of the Collaboration Agreement.
Tax ” or “ Taxes ” shall mean any federal, state, local, or non-U.S. income, gross receipts, license, payroll, employment, excise, severance, stamp, occupation, premium, windfall profits, environmental, customs duties, capital stock, franchise, profits, withholding, social security (or similar), unemployment, disability, real property, personal property, sales, use, transfer, registration, value added, alternative or add-on minimum, estimated, or other tax of any kind whatsoever, including any interest, penalty, or addition thereto, whether disputed or not.
Tax Authority ” shall mean any Governmental Authority having jurisdiction with respect to any Tax.
Tax Return ” shall mean any return, declaration, report, claim for refund, or information return or statement relating to Taxes, including any schedule or attachment thereto, and including any amendment thereof, required to be filed with a Tax Authority.
Third Party ” shall mean any Person (other than a Governmental Authority) other than the Subscriber, the Company or any Affiliate of the Subscriber or the Company.
Transaction Agreements ” shall mean this Agreement and the Collaboration Agreement.

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Transfer ” by any Person means directly or indirectly, to sell, transfer, assign, pledge, encumber, hypothecate or similarly Dispose of, either voluntarily or involuntarily, or to enter into any contract, option or other arrangement or understanding with respect to the sale, transfer, assignment, pledge, encumbrance, hypothecation or similar Disposition of, any securities beneficially owned by such Person or of any interest (including any voting interest) in any securities beneficially owned by such Person. For the avoidance of doubt, a transfer of control of the direct or indirect beneficial ownership of securities is a Transfer of such securities for purposes of this Agreement.
Transfer Agent ” shall mean Computershare Trust Company, N.A., or any successor transfer agent of the Company, as applicable.
WARN Act ” shall mean the Worker Adjustment and Retraining Notification Act of 1988, as amended and any similar or related Law.
2.      Closing, Delivery and Payment .
2.1      Closing .  Subject to the terms and conditions hereof, and in reliance on the representations, warranties, covenants and other agreements hereinafter set forth, at the closing of the transactions contemplated hereby (the “ Closing ”), the Company hereby agrees to issue to the Subscriber, and the Subscriber agrees to subscribe for, 1,170,960 Ordinary Shares (the “ Shares ”) at a price of $42.70 per Share, free and clear of all Liens and any withholding for Taxes, for an aggregate price of $49,999,992.00 (the “ Share Price ”).  The Closing shall take place remotely via the exchange of documents and signatures, as soon as practicable, but in no event later than at 2:00 p.m. Eastern Time on the first Business Day immediately following the date on which the last of the conditions set forth in Section 6 has been satisfied or waived (other than those conditions that by their nature can only be satisfied at the Closing), or at such other date and time as the Company and Subscriber shall mutually agree (which date and time are designated as the “ Closing Date ”).
2.2      Delivery and Payment .  At the Closing, subject to the terms and conditions hereof, the Company will instruct the Transfer Agent to deliver to the Subscriber, via book entry to the applicable balance account registered in the name of the Subscriber, the Shares, against payment of the Share Price in U.S. dollars by wire transfer of immediately available funds to the order of the Company.
2.3      Deliveries at Closing .
(a)      Deliveries by the Company . At the Closing, the Company shall deliver or cause to be delivered to the Subscriber the following items:
(i) a true copy of the constitution (the “ Constitution ”) of the Company;

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(ii)      a copy of the irrevocable instructions to the Transfer Agent instructing the Transfer Agent to deliver the Shares to Subscriber on an expedited basis;
(iii)      a legal opinion of A&L Goodbody, the Company’s Irish counsel, addressed to the Subscriber, and dated the Closing Date, in substantially the form provided to the Subscriber on the date hereof;
(iv)      a legal opinion of Latham & Watkins LLP, U.S. counsel for the Company, addressed to the Subscriber, and dated the Closing Date, in substantially the form provided to the Subscriber on the date hereof;
(v)      a certificate, dated as of the Closing Date, signed by the Company’s principal financial officer confirming that the conditions to the Closing set forth in Section 6.1 have been satisfied; and
(vi)      all such other documents, certificates and instruments as the Subscriber may reasonably request in order to give effect to the transactions contemplated hereby.
(b)      Deliveries by the Subscriber .  At the Closing, the Subscriber shall deliver or cause to be delivered to the Company the Share Price, by wire transfer of immediately available funds to one or more accounts designated by the Company, such designation to be made via written notice to the Subscriber no later than three (3) Business Days prior to the Closing Date.
3.      Representations and Warranties of the Company .  The Company hereby represents and warrants to the Subscriber that the following representations are true and complete as of the Closing Date, except as otherwise indicated or as set forth in the Company SEC Documents, and only to the extent such Company SEC Documents are specifically referenced in such representation or warranty.

3.1      Organization, Good Standing and Qualification .
(a)      The Company is duly incorporated and validly existing as a public limited company under the laws of Ireland.  The Company has all requisite corporate power and authority to own and operate its properties, to execute and deliver this Agreement, to carry out the provisions of this Agreement (including, but not limited to, the issuance and delivery of the Shares) and to carry on its business as presently conducted and as presently proposed to be conducted. Each of the Company’s Subsidiaries (as defined herein) is an entity duly incorporated or otherwise organized, validly existing and in good standing (to the extent such concept exists in the relevant jurisdiction) under the Laws of the jurisdiction of its incorporation or organization, as applicable, and has all requisite power and authority to carry on its business to own and use its properties. Each of the Company and its Subsidiaries

9



is duly qualified to do business as a foreign entity and is in good standing (to the extent such concept exists in the relevant jurisdiction) in each jurisdiction in which the conduct of its business or its ownership or leasing of property makes such qualification necessary, except to the extent any failure to so qualify has not had and would not reasonably be expected to have a Material Adverse Effect.
(b)      During the twelve (12) months preceding the Signing Date, neither the Company nor any of its Subsidiaries has taken any action nor have any other steps been taken or Actions commenced or, to the Company’s Knowledge, threatened against any of them, for their winding up or dissolution or for any of them to enter into any arrangement, scheme or composition for the benefit of creditors, or for the appointment of a receiver, administrator, liquidator, trustee or similar officer of any of them, or any of their respective properties, revenues or assets.
3.2      Subsidiaries .  The Company has disclosed all of its subsidiaries required to be disclosed (a) in an exhibit to its Annual Report on Form 10-K filed with the SEC or (b) in its subsequent filings under the Exchange Act (the “ Subsidiaries ”).  The Company owns, directly or indirectly, all of the capital stock or other equity interests of each Subsidiary free and clear of any Liens, and all of the issued and outstanding shares of capital stock of each Subsidiary are validly issued and are fully paid and, if applicable in the relevant jurisdiction, non-assessable, and free of preemptive and similar rights.
3.3      Capitalization .
(a)      The authorized share capital of the Company, immediately prior to the Signing Date, consists of 100,000,000 Ordinary Shares, par value $0.01 per share, of which 38,564,428 Ordinary Shares were issued and outstanding, and 10,000 Euro Deferred Shares, par value €22 per share, none of which were issued and outstanding.  Under the Company’s Amended and Restated 2012 Long Term Incentive Plan (the “ Plan ”), immediately prior to the Signing Date, (i) options to acquire 5,311,125 Ordinary Shares have been granted and are outstanding and (ii) 1,275,708 Ordinary Shares remained available for future issuance to directors, employees and consultants of the Company, its Subsidiaries or the Company’s Affiliates.  Since the Signing Date, the Company has not issued any equity securities, other than those issued pursuant to the Plan.
(b)      Except as set forth in the Constitution, and other than the Ordinary Shares reserved for issuance under the Plan, there are no outstanding options, rights (including conversion or preemptive rights and rights of first refusal), proxy or shareholder agreements, or agreements of any kind for the purchase or acquisition from the Company or any of its Subsidiaries of any of its securities, including the Shares.  No Person is entitled to preemptive rights, rights of first refusal, rights of participation or similar rights with respect to any securities of the Company or any of its Subsidiaries, including with respect to the issuance of Shares contemplated hereby.  There are no voting agreements, registration rights agreements or other agreements of any kind among the Company or any of its

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Subsidiaries and any other Person relating to the securities of the Company or any of its Subsidiaries, including the Shares.
(c)      All of the issued and outstanding Ordinary Shares have been duly authorized and validly issued and are fully paid and were issued in compliance with all applicable Laws concerning the issuance of securities.  The Shares have been duly and validly authorized and, when issued and paid for pursuant to this Agreement, will be validly issued, and fully paid. The Shares (i) will not be subject to pre-emptive rights and (ii) shall be free and clear of all Liens, except for restrictions on transfer imposed by applicable securities Laws or contained herein.
(d)      Neither the Company nor any of its Subsidiaries owns or holds the right to acquire any stock, partnership, interest, joint venture interest or other equity ownership interest in any Person.
3.4      Authorization; Binding Obligations .  All corporate action on the part of the Company and its board of directors necessary for the authorization of this Agreement, the performance of all obligations of the Company hereunder at the Closing and the issuance and delivery of the Shares pursuant hereto, has been taken. No further action is required on the part of the Company, its board of directors, or its shareholders prior to the Closing for the consummation of the transactions contemplated by this Agreement.  This Agreement has been duly executed and delivered by the Company and, assuming due authorization, execution and delivery by the Subscriber, constitutes valid and binding obligations of the Company enforceable in accordance with their terms, except (a) as limited by applicable bankruptcy, insolvency, reorganization, fraudulent conveyance, moratorium or other Laws of general application affecting enforcement of creditors’ rights, (b) general principles of equity that restrict the availability of equitable remedies and (c) to the extent that the enforceability of indemnification provisions may be limited by applicable Laws.
3.5      Company SEC Documents; Financial Statements; Nasdaq .
(a)      Since December 31, 2014, the Company has timely filed with (or submitted to) the SEC all of the reports and other documents required to be filed by (or submitted to) it under the Exchange Act and Securities Act and any required amendments to any of the foregoing (inclusive of any exhibits or other materials incorporated by reference into any such filings and submissions, the “ Company SEC Documents ”).  As of their respective filing dates, each of the Company SEC Documents complied in all material respects with the requirements of the Securities Act and the Exchange Act applicable to such Company SEC Documents, and, when filed, no Company SEC Documents contained an untrue statement of a material fact or omitted to state a material fact required to be stated therein or necessary in order to make the statements therein, in light of the circumstances under which they were made, not misleading.  None of the Company’s Subsidiaries is subject to the periodic reporting requirements of the Exchange Act. As of the date hereof, there are no outstanding or unresolved comments in comment letters from the SEC staff with respect

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to any of the Company SEC Documents and the Company has not been notified that any of the Company SEC Documents is the subject of ongoing SEC review or outstanding investigation.
(b)      The financial statements of the Company included in the Company SEC Documents when filed complied as to form in all material respects with applicable accounting requirements and the published rules and regulations of the SEC with respect thereto, have been prepared in accordance with GAAP applied on a consistent basis during the periods involved (except as may be indicated in the notes thereto) and fairly present in all material respects the financial position of the Company as of the dates thereof and the results of its operations and cash flows for the periods then ended.  Except for liabilities incurred in the ordinary course of business subsequent to the date of the most recent balance sheet contained in the Company SEC Documents, the Company has no liabilities, whether absolute or accrued, contingent or otherwise, other than (i) trade payables and accrued expenses incurred in the ordinary course of business consistent with past practice, (ii) liabilities not required to be reflected in the Company’s financial statements pursuant to GAAP and (iii) those that would not, individually or in the aggregate, be material to the Company and its Subsidiaries taken as a whole. Neither the Company nor any of its Subsidiaries has or is subject to any “Off-Balance Sheet Arrangement” (as defined in Item 303(a)(4)(ii) of Regulation S-K promulgated under the Securities Act).
(c)      The Ordinary Shares are listed on the Nasdaq Global Select Market, and the Company has not received any notification that, and has no Knowledge that, Nasdaq is contemplating terminating such listing.
(d)      The Company’s registered public accounting firm is KPMG LLP. To the Company’s Knowledge, KPMG LLP are independent public accountants with respect to the Company within the meaning of the Securities Act and Exchange Act and the applicable published rules and regulations thereunder.
3.6      Obligations to Related Parties. None of the members of the Company’s board of directors, affiliates, senior executives, key employees or, to the Company’s Knowledge, 5% shareholders of the Company or any members of their immediate families, is indebted to the Company or party to a transaction with the Company required to be disclosed in the Company SEC Documents under Item 404 of Regulation S-K that is not so disclosed.
3.7      Sarbanes-Oxley; Internal Accounting Controls . The Company is in compliance with the requirements of the Sarbanes-Oxley Act of 2002, including the rules and regulations of the SEC promulgated thereunder, and of the Companies Act 2014, in each case as applicable to it as of the date hereof. The Company maintains a system of internal accounting controls sufficient to provide reasonable assurance that: (a) transactions are executed in accordance with management’s general or specific authorizations, (b) transactions are recorded as necessary to permit preparation of financial statements in

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conformity with GAAP and the Companies Act 2014 and to maintain asset accountability, (c) access to assets is permitted only in accordance with management’s general or specific authorization, and (d) the recorded accountability for assets is compared with the existing assets at reasonable intervals and appropriate action is taken with respect to any differences. The Company has established disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the Company and designed such disclosure controls and procedures to provide reasonable assurance that information required to be disclosed by the Company in the reports it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms.
3.8      Compliance with Other Instruments .  The Company is not in violation or default of any term of its Constitution and the Company and its Subsidiaries are not in material breach of any Material Contract.  The execution, delivery, and performance of and compliance with this Agreement, and the issuance and delivery of the Shares pursuant hereto, will not, with or without the passage of time or giving of notice, (i) conflict with or result in a violation of the constitution, articles of association, charter, certificate of incorporation, bylaws or other organizational or constitutive documents of the Company or any of its Subsidiaries, in each case as in effect on Closing Date, (ii) result in any violation of any Law or Order to which the Company, any of its Subsidiaries or any of their respective assets is subject, (iii) (A) conflict with or result in a breach, violation of, or constitute a default under, (B) give any third party the right to modify, terminate or accelerate, or cause any modification, termination or acceleration of, any obligation under or (C) require Consent under, any Material Contract to which the Company or any of its Subsidiaries is a party that has not been obtained or waived, or (iv) result in the creation of any Lien upon any of the Company’s or any Subsidiary’s assets or capital stock, except in the case of any of clauses (iii) and (iv) above, as would not reasonably be expected to have a Material Adverse Effect.  Neither the execution, delivery or performance of this Agreement by the Company, nor the consummation by it of the obligations and transactions contemplated hereby (including the issuance of the Shares) requires any Consent, other than (i) filings required under applicable U.S. federal and state securities Laws and (ii) the notification of the issuance and delivery of the Shares to Nasdaq.
3.9      Litigation .  There is no material: (i) Action pending or, to the Company’s Knowledge, threatened, against the Company or any of its Subsidiaries which, if determined adversely to the Company or any of its Subsidiaries would have a Material Adverse Effect or (ii) Order in effect against the Company or any of its Subsidiaries.
3.10      Compliance with Laws; Permits .  The Company and its Subsidiaries are not, and since January 1, 2013 have not been, in violation in any material respect of any applicable Law (including any Health Care Law) in respect of the conduct of its business or the ownership of its properties.  The Company and each of its Subsidiaries has all franchises, permits, licenses and any similar authority necessary for the conduct of

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its business as now being conducted by it, except those the lack of which would not reasonably be expected to have a Material Adverse Effect.
3.11      Offering Valid .  Assuming the accuracy of the representations and warranties of the Subscriber contained in Section 4.5, the issuance and delivery of the Shares will be exempt from the registration requirements of the Securities Act, and will have been registered or qualified (or are exempt from registration and qualification) under the registration, permit or qualification requirements of all applicable securities Laws.  Neither the Company nor any agent on its behalf has solicited or will solicit any offers to sell or has offered to sell or will offer to sell all or any part of the Shares to any person or persons so as to bring the issuance and delivery of such Shares by the Company within the registration requirements of the Securities Act or the securities Laws of Ireland.
3.12      Investment Company .  The Company is not, and after giving effect to the transactions contemplated by the Transaction Agreements will not be, an “investment company” or a company “controlled” by an “investment company,” within the meaning of the Investment Company Act of 1940, as amended.
3.13      Absence of Changes.  Since December 31, 2016, (a) the Company and each of its Subsidiaries has conducted its business operations in the ordinary course of business consistent with past practice, (b) there have been no events, occurrences or developments that have had or would reasonably be expected to have, either individually or in the aggregate, a Material Adverse Effect, (c) the Company has not declared or made any dividend or distribution of cash, shares of capital stock or other property to its shareholders or purchased, redeemed or made any agreements to purchase or redeem any shares of its capital stock (other than in connection with repurchases of unvested shares issued to employees of the Company), and (d) the Company has not issued any equity securities to any officer, director or Affiliate, except Ordinary Shares issued in the ordinary course issued pursuant to existing Company equity incentive plans or executive and director compensation arrangements.
3.14      Tax Matters .
(a)      (i) the Company and each of its Subsidiaries has timely prepared and filed all federal and all other material Tax Returns required to have been filed by each of them with all appropriate Tax Authorities and timely paid all Taxes shown thereon (except for Taxes contested in good faith), (ii) all such Tax Returns are true, correct and complete in all material respects and (iii) all Taxes that the Company or any of its Subsidiaries is required to withhold or to collect for payment have been duly withheld and collected and paid to the proper Tax Authority or third party when due (except for Taxes contested in good faith).
(b)      Neither the Company nor any of its Subsidiaries (i) has been a member of an affiliated group filing a consolidated federal income U.S. Tax Return (other

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than a group the common parent of which was the Company or any of its Subsidiaries) or (ii) has any material liability for the Taxes of any Person (other than the Company or any of its Subsidiaries) under U.S. Treas. Reg. § 1.1502-6 (or any similar provision of state, local, or non-U.S. Law), as a transferee or successor, by Contract, or otherwise (excluding Contracts entered into in the ordinary course of business and not primarily related to Taxes).
(c)      Neither the Company nor any of its Subsidiaries has distributed stock of another Person, or has had its stock distributed by another Person, in a transaction that was purported or intended to be governed in whole or in part by Section 355 or 361 of the Code.
(d)      Neither the Company nor any of its Subsidiaries is or has been a party to any “listed transaction,” as defined in Section 6707A(c)(2) of the Code and U.S. Treas. Reg. § 1.6011-4(b)(2).
(e)      Neither the Company nor any Subsidiary has ever been, nor will they be at the Closing, a United States Real Property Holding Corporation within the meaning of Section 897(c)(2) of the Code during the applicable period specified in Section 897(c)(1)(A)(ii) of the Code.
3.15      Property . The Company does not own any real property. Except as would not reasonably be expected to, individually or in the aggregate, have a Material Adverse Effect, (a) the Company and each of its Subsidiaries has the right to use or occupy the Leased Real Property under valid and binding Leases and (b) the Company and its Subsidiaries have good and valid title to, or a valid license to use or leasehold interest in, all of their respective material tangible assets, free and clear of all Liens (other than Permitted Liens).
3.16      Employee Benefits Matters .
(a)      Except as would not reasonably be expected to have a Material Adverse Effect, (i) each Employee Benefit Plan (and each related trust, insurance Contract, or fund) has been maintained, funded and administered in accordance with its terms and in compliance with the applicable requirements of Law, including ERISA and the Code and other applicable Laws and (ii) all contributions, distributions, reimbursements and premium payments due with respect to each Employee Benefit Plan have been timely made or properly accrued. Each Employee Benefit Plan that is intended to meet the requirements of a “qualified plan” under Section 401(a) of the Code has received a favorable determination letter (or may rely on a favorable opinion letter) issued by the United States Internal Revenue Service and to the Company's Knowledge, nothing has occurred that would reasonably be expected to have a material adverse effect on the qualification of such Employee Benefit Plan.
(b)      Except as would not reasonably be expected to have a Material Adverse Effect, (i) neither the Company nor any of its Subsidiaries maintains, sponsors,

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contributes to, has any obligation to contribute to, or has any current or potential liability or obligation under or with respect to (A) a “defined benefit plan” (as such term is defined in Section 3(35) of ERISA), (B) a “multiple employer plan” (within the meaning of Section 210 of ERISA or Section 413(c) of the Code), (C) a “multiemployer plan” as defined in Section 3(37) of ERISA, or (D) a “multiple employer welfare arrangement” (as such term is defined in Section 3(40) of ERISA) or any equivalent plan to any of the foregoing in any other jurisdiction, including but not limited to Ireland; (ii) no Employee Benefit Plan provides and neither the Company nor any of its Subsidiaries has any current or potential obligation to provide post-termination or post-retirement health, life or other welfare benefits other than as required under Section 4980B of the Code or any similar state Law; and (iii) neither the Company nor any of its Subsidiaries has any current or potential liability or obligation by reason of at any time being treated as a single employer under Section 414 of the Code with any other Person.
(c)      Except as would not reasonably be expected to have a Material Adverse Effect, (i) there have been no prohibited transactions (as defined in Section 406 of ERISA or Section 4975 of the Code) and no breach of fiduciary duty (as determined under ERISA) with respect to any Employee Benefit Plan, (ii) the Company and its Subsidiaries have, for purposes of each Employee Benefit Plan, correctly classified those individuals performing services for the Company or any of its Subsidiaries as employees or non-employees, and (iii) there do not exist any pending or, to the Company’s Knowledge, threatened claims (other than routine undisputed claims for benefits) or Actions with respect to any Employee Benefit Plan.
(d)      The transactions contemplated by the Transaction Agreements will not (either alone or in combination with another event) (i) cause the acceleration of vesting in, or payment of, any material benefits or compensation under any Employee Benefit Plan, (ii) require the funding of any material amount of compensation or benefits due to any manager, employee, officer, director, shareholder or other service provider (whether current, former or retired) of the Company or any of its Subsidiaries or their beneficiaries and, (iii) otherwise materially accelerate or materially increase any liability or obligation under any Employee Benefit Plan.
3.17      Labor Matters .
(a)      Neither the Company nor any of its Subsidiaries is a party to or bound by any collective bargaining agreement or other Contract or relationship with any union, labor organization, or other collective bargaining representative. There are no strikes, work stoppages or any other material labor disputes against the Company or any of its Subsidiaries pending or, to the Company’s Knowledge, threatened, and no such disputes have occurred since January 1, 2015. No union organization or decertification activities are underway or, to the Company’s Knowledge, threatened with respect to employees of the Company or any of its Subsidiaries.

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(b)      Each of the Company and its Subsidiaries is, and at all times since January 1, 2015, has been in compliance in all material respects with all applicable Laws and codes of conduct respecting employment and employment practices, including provisions thereof relating to terms and conditions of employment, wages and hours, overtime, classification of employees and independent contractors, immigration, and the withholding and payment of social security and other employment Taxes.
(c)      Since January 1, 2015, neither the Company nor any of its Subsidiaries has implemented any plant closing or layoff of employees that could implicate the WARN Act and result in material liability to the Company and its Subsidiaries, taken as a whole.
3.18      Intellectual Property .
(a)      The Company owns all right, title and interest in and to, or has the valid and enforceable right to use pursuant to a written Contract, all Intellectual Property used in the conduct of the business of the Company as currently conducted (collectively, the “ Company Intellectual Property ”) free and clear of any Liens, except Permitted Liens, except where the failure to be in such compliance would reasonably be expected to have a Material Adverse Effect, and, to the Company’s Knowledge, the owners of any Intellectual Property licensed to Company have taken necessary actions to maintain and protect such Intellectual Property, except where the failure to be in such compliance would reasonably be expected to have a Material Adverse Effect.
(b)      To the Company’s Knowledge, (i) the Company has not infringed, misappropriated, or otherwise violated, or is not currently infringing, misappropriating, or otherwise violating, any Intellectual Property of any other Person and there are no Actions pending or threatened alleging any of the foregoing, including any unsolicited offers for the Company to obtain a license to any Intellectual Property of another Person, and (ii) no Person is infringing, misappropriating or violating the rights of the Company with respect to any Company Intellectual Property, except where it is not reasonably expected to have a Material Adverse Effect.
3.19      FDA and Regulatory Matters .
(a)      There is no actual or, to the Company’s Knowledge, threatened enforcement action or investigation by the FDA or any other Governmental Authority, which, if determined adversely to the Company or any of its Subsidiaries would have a Material Adverse Effect. The Company has no Knowledge or reason to believe that the FDA or any Governmental Authority is considering such action. The operation of the business of the Company, including the manufacture, import, export, testing, development, processing, packaging, labeling, storage, marketing, sales, and distribution of the Company’s product candidates is, and at all times has been, in material compliance with all applicable laws and permits, or within the FDA’s exercise of enforcement discretion.

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(b)      All material reports, documents, claims, permits and notices required to be filed with, maintained for or furnished to the FDA or any Governmental Authority have been so filed, maintained or furnished by the Company. All such reports, documents, claims and notices were complete and accurate in all material respects on the date filed or furnished (or were corrected in or supplemented by a subsequent filing), such that no liability exists with respect to such filing, and remain complete and accurate.
(c)      The Company has not received any FDA Form 483, notice of adverse finding, warning letters, untitled letters or other correspondence or notice from the FDA or any Governmental Authority (i) alleging or asserting material noncompliance with any applicable laws or permits and the Company has no Knowledge or reason to believe that the FDA or any Governmental Authority is considering such action or (ii) materially contesting the pre-market clearance or approval of, the uses of or the labeling or promotion of any of the Company’s product candidates.
(d)      Each of the Company’s product candidates subject to the FDCA that has been developed, manufactured, tested or distributed by or on behalf of the Company is being or has been developed, manufactured, tested or distributed in compliance with all material applicable requirements under the FDCA and comparable laws in any non-U.S. jurisdiction, including those relating to investigational use, pre-market clearance or approval, biologics licensing, registration and listing, good manufacturing practices, labeling, advertising, record keeping and filing of required reports.
(e)      The preclinical tests and clinical trials conducted by the Company, and to Company’s Knowledge the clinical trials conducted by third parties, in each case described in, or the results of which are referred to in, the Company SEC Documents, were, and if still pending, are being, conducted in all material respects in accordance with protocols and procedures filed with the appropriate regulatory authorities for each such trial; each description of the results of such preclinical tests and clinical trials contained in the Company SEC Documents is accurate and complete in all material respects and fairly presents the data derived from such preclinical tests and clinical trials, and the Company has no knowledge of any other studies or tests the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Company SEC Documents.
3.20      Environmental Matters . Except as would not reasonably be expected to, individually or in the aggregate, have a Material Adverse Effect: (a) no notice, notification, demand, request for information, citation, summons, complaint or Order has been received since January 1, 2015 by, and no Action is pending or, to the Company’s Knowledge, threatened by any Person against, the Company or any of its Subsidiaries, and no penalty has been assessed against the Company or any of its Subsidiaries, in each case, with respect to any matters relating to or arising out of any Environmental Law and (b) the Company and its Subsidiaries are, and since January 1, 2015 have been, in compliance in all material respects with all applicable Environmental Laws, including any Consent required by Environmental Laws.

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3.21      Insurance . Except as has not had, and would not reasonably be expected to have, individually or in the aggregate, a Company Material Adverse Effect, (a) all insurance policies (“ Policies ”) with respect to the business and assets of the Company and its Subsidiaries are in full force and effect, (b) neither the Company nor any of its Subsidiaries is in breach or default, and neither the Company nor any of its Subsidiaries has taken any action or failed to take any action that, with notice or the lapse of time, would constitute such a breach or default, or permit termination or modification of any of the Policies, and (c) the Company and its Subsidiaries have not received any written notice of cancellation or threatened cancellation of any of the Policies or of any claim pending regarding the Company or any of its Subsidiaries under any of such Policies as to which coverage has been questioned, denied or disputed by the underwriters of such Policies. The Company and its Subsidiaries maintain insurance with reputable insurers in such amounts and against such risks as is customary for the industries in which it and its Subsidiaries operate and as the management of the Company has in good faith determined to be prudent and appropriate.
3.22      Takeover Protections . The Company and its board of directors have taken all necessary action, if any, in order to render inapplicable any control share acquisition, business combination, poison pill (including any distribution under a rights agreement) or other similar anti-takeover provision under the Constitution or the laws of Ireland that is or would reasonably be expected to become applicable to Subscriber as a result of the transactions contemplated by this Agreement, including, without limitation, the Company’s issuance of the Shares and the Subscriber’s ownership of the Shares.
3.23      Anti-Corruption and Anti-Bribery Laws . Neither the Company and its Subsidiaries, nor, to the Company’s Knowledge, any of their respective director, officer, agent, employee or other authorized person acting on behalf of the Company is aware of or has taken any action, directly or indirectly, that could result in a violation or a sanction for violation by such persons of the Foreign Corrupt Practices Act of 1977, the Prevention of Corruption Acts 1899 to 2010 or the U.K. Bribery Act 2010, each as may be amended, or similar law of any other relevant jurisdiction, or the rules or regulations thereunder; and the Company has instituted and maintain policies and procedures to ensure compliance therewith. No part of the proceeds from the issuance and delivery of the Shares will be used, directly or indirectly, in violation of the Foreign Corrupt Practices Act of 1977, the Prevention of Corruption Acts 1899 to 2010 or the U.K. Bribery Act 2010, each as may be amended, or similar law of any other relevant jurisdiction, or the rules or regulations thereunder.
3.24      Economic Sanctions . None of the Company, any of its Subsidiaries or, to the Knowledge of the Company, any director, officer, agent, employee, Affiliate or representative or other authorized person acting on behalf of the Company or any of its subsidiaries is a Person currently the subject or target of any sanctions administered or enforced by the United States Government or any Governmental Authority in Ireland or

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elsewhere including, without limitation, the U.S. Department of the Treasury’s Office of Foreign Assets Control (“ OFAC ”), the United Nations Security Council (“ UNSC ”), the European Union, Her Majesty’s Treasury (“ HMT ”), or other relevant sanctions authority (collectively, “ Sanctions ”), nor is the Company located, organized or resident in a country or territory that is the subject of Sanctions; and the Company will not directly or indirectly use the proceeds of the issuance of the Shares, or lend, contribute or otherwise make available such proceeds to any Subsidiaries, joint venture partners or other Person, to fund any activities of or business with any Person, or in any country or territory, that, at the time of such funding, is the subject of Sanctions or in any other manner that will result in a violation by any Person (including any Person participating in the transaction) of Sanctions. Within the past five (5) years, to the Knowledge of the Company, it has neither been the subject of any governmental investigation or inquiry regarding compliance with Sanctions nor has it been assessed any fine or penalty in regard to compliance with Sanctions.
3.25      Money Laundering .  The operations of the Company and its Subsidiaries are and have been conducted at all times in compliance with applicable financial record-keeping and reporting requirements of the Currency and Foreign Transactions Reporting Act of 1970 and The Criminal Justice (Money Laundering and Terrorist Financing ) Act 2010, each as amended, and applicable money laundering statutes and applicable rules and regulations thereunder (collectively, the “ Money Laundering Laws ”), and no action, suit or proceeding by or before any court or governmental agency, authority or body or any arbitrator involving the Company with respect to the Money Laundering Laws is pending or, to the Company’s Knowledge, threatened.
3.26      Certain Fees . No person or entity will have, as a result of the transactions contemplated by this Agreement, any valid right, interest or claim against or upon the Company or the Subscriber for any commission, fee or other compensation pursuant to any agreement, arrangement or understanding entered into by or on behalf of the Company, with respect to the issuance and delivery of the Shares.
3.27      Disclosure . None of the Company SEC Documents contain any untrue statement of a material fact or omit a material fact necessary to make each statement contained therein, in light of the circumstances in which they were made, not misleading.
3.28      No “Bad Actor” Disqualification . The Company has conducted a factual inquiry including the procurement of relevant questionnaires from each of the Company’s executive officers and directors or other means to determine whether any of the Company’s executive officers or directors is subject to any of the “bad actor” disqualifications described in Rule 506(d)(1)(i) to (viii) under the Securities Act (“ Disqualification Events ”). Neither the Company, nor, to the Company’s Knowledge, after conducting such factual inquiries, any other Covered Person, is subject to Disqualification Events, except for a Disqualification Event covered by Rule 506(d)(2) or (d)(3) under the Securities Act. The Company has complied, to the extent applicable, with any disclosure

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obligations under Rule 506(e) under the Securities Act. “ Covered Persons ” are those persons specified in Rule 506(d)(1) under the Securities Act, including the Company; any predecessor or affiliate of the Company; any director, executive officer, other officer participating in the offering, general partner or managing member of the Company; any beneficial owner of 20% or more of the Company’s outstanding voting equity securities, calculated on the basis of voting power; any promoter (as defined in Rule 405 under the Securities Act) connected with the Company in any capacity at the time of the issuance and delivery of the Shares; and any person that has been or will be paid (directly or indirectly) remuneration for solicitation of subscribers in connection with the issuance and delivery of the Shares (a “ Solicitor ”), any general partner or managing member of any Solicitor, and any director, executive officer or other officer participating in the offering of any Solicitor or general partner or managing member of any Solicitor.
4.      Representations and Warranties of the Subscriber .  The Subscriber hereby represents and warrants as of the date hereof to the Company as follows:

4.1      Organization; Good Standing .  The Subscriber is a limited liability company duly organized, validly existing and in good standing under the laws of the State of Delaware.  The Subscriber has or will have all requisite power and authority to enter into this Agreement, to subscribe for the Shares and to perform its obligations under and to carry out the other transactions contemplated by this Agreement, and no further approval or authorization by any of its members or other equity owners, as the case may be, is required.
4.2      Requisite Power and Authority .  The Subscriber has all necessary power and authority to execute and deliver this Agreement and all action on the Subscriber’s part required for the lawful execution and delivery of this Agreement has been taken.  This Agreement been duly and validly executed and delivered by the Subscriber and its obligations hereunder, assuming due authorization, execution and delivery by the Company, are valid and binding obligations of the Subscriber, enforceable in accordance with their terms, except (a) as limited by applicable bankruptcy, insolvency, reorganization, moratorium or other Laws of general application affecting enforcement of creditors’ rights, (b) as limited by general principles of equity that restrict the availability of equitable remedies, and (c) to the extent that the enforceability of indemnification provisions may be limited by applicable Laws.
4.3      No Conflicts .  The execution, delivery and performance of this Agreement and compliance with the provisions thereof by the Subscriber will not, with or without the passage of time or giving of notice: (i) conflict with or result in a violation of the certificate of incorporation, bylaws, or other organizational or constitutive documents of the Subscriber as in effect on the Closing Date, (ii) result in any violation of any Law or Order to which the Subscriber or any of its assets is subject, (iii) (A) conflict with or result in a breach, violation of, or constitute a default under, or (B) give any third party the right to modify, terminate or accelerate, or cause any modification, termination or acceleration

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of, any obligation under any Contract to which the Subscriber is a party, or (iv) result in the creation of any Lien upon any of the Subscriber’s assets or equity interests, except in the case of any of clauses (ii), (iii) and (iv) above, as would not reasonably be expected to materially impair of the ability of the Subscriber to perform its obligations under this Agreement and the transactions contemplated hereby in any material respect.
4.4      No Governmental Authority or Third Party Consents .  No Consent is required to be obtained or filed by the Subscriber in connection with the authorization, execution and delivery of any of this Agreement or with the subscription for the Shares.
4.5      Investment Representations .  The Subscriber hereby represents and warrants as follows:
(a)      Subscriber Acknowledgements . The Subscriber acknowledges that the Shares have not been registered under the Securities Act or under any state or foreign securities laws.  The Subscriber (i) acknowledges that it is acquiring the Shares pursuant to an exemption from registration under the Securities Act solely for investment with no present intention to distribute any of the Shares to any person in violation of applicable securities Laws, (ii) will not Dispose of any of the Shares, except in compliance with the registration requirements or exemption provisions of the Securities Act and any other applicable securities Laws, (iii) does not presently have any agreement, plan or understanding, directly or indirectly, with any Person to distribute or effect any distribution of any of the Shares (or any securities which are derivatives thereof) to or through any Person, (iv) is not a registered broker-dealer under Section 15 of the Exchange Act or an entity engaged in a business that would require it to be so registered as a broker-dealer and (v) is not purchasing the Shares as a result of any advertisement, article, notice or other communication regarding Shares published in any newspaper, magazine or similar media or broadcast over television or radio or presented at any seminar or any other general advertisement.
(b)      Status . At the time the Subscriber was offered the Shares, it was, and as of the date hereof is, an “accredited investor” (as that term is defined by Rule 501 of the Securities Act) and (i) has been furnished with or has had full access to all the information that it considers necessary or appropriate to make an informed investment decision with respect to the Shares, (ii) has had an opportunity to discuss with management of the Company the intended business and financial affairs of the Company and, in connection therewith, obtained information necessary to verify any information furnished to it or to which it had access (it being agreed and understood that this clause does not affect the Company’s representations and warranties contained in Section 3) and (iii) can bear the economic risk of (A) an investment in the Shares indefinitely and (B) a total loss in respect of such investment.  The Subscriber has such knowledge and experience in business and financial matters so as to enable it to understand and evaluate the risks of and form an investment decision with respect to its investment in the Shares and to protect its own interest in

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connection with such investment. The Subscriber understands that there is no assurance that any exemption from registration under the Securities Act will be available to transfer the Shares and that, even if available, such exemption may not allow the Subscriber to transfer all or any portion of the Shares under the circumstances, in the amounts or at the times the Subscriber might propose.
(c)      Ownership .  Neither the Subscriber nor any of its Controlled Affiliates is the owner of record or the beneficial owner of Ordinary Shares or Ordinary Share Equivalents.
4.6      Brokers and Finders . No Person will have, as a result of the transactions contemplated by this Agreement, any valid right, interest or claim against or upon the Company or the Subscriber for any commission, fee or other compensation pursuant to any agreement, arrangement or understanding entered into by or on behalf of the Subscriber.
4.7      United States Investor . The Subscriber is a United States person (as defined by Section 7701(a)(30) of the Code).
5.      Covenants and Agreements .

5.1      Transfer Restrictions. 
(a)      The Subscriber understands that the Shares shall be subject to restrictions on resale pursuant to applicable securities Laws and that any certificates representing the Shares or the applicable balance account of the Subscriber with the Company’s Transfer Agent shall bear transfer restrictions with the effect of the following applicable legends:
(i) “THESE SECURITIES HAVE NOT BEEN REGISTERED UNDER THE SECURITIES ACT OF 1933, AS AMENDED.  THEY MAY NOT BE SOLD, OFFERED FOR SALE, PLEDGED OR HYPOTHECATED IN THE ABSENCE OF A REGISTRATION STATEMENT IN EFFECT WITH RESPECT TO THE SECURITIES UNDER THE SECURITIES ACT OR AN OPINION OF COUNSEL (WHICH COUNSEL SHALL BE REASONABLY SATISFACTORY TO PROTHENA CORPORATION PLC) THAT SUCH REGISTRATION IS NOT REQUIRED OR UNLESS SOLD PURSUANT TO RULE 144 OF THE SECURITIES ACT.”; and
(ii) any legend required by other applicable securities Laws.
(b)      Subject to the restrictions set forth in Section 5.2 below, the Shares shall not bear the transfer restrictions set forth in Section 5.1(a)(i): (i) following a sale of Shares pursuant to an effective registration statement covering the resale of such Shares, (ii) following any sale of Shares pursuant to Rule 144 promulgated under the Securities Act (“ Rule 144 ”) (or any successor provision then in effect), or (iii) if such legend is not required

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under applicable requirements of the Securities Act (including judicial interpretations and pronouncements issued by the staff of the Commission). In addition, the Shares shall not bear the transfer restrictions set forth in Section 5.1(a)(ii) following a sale of Shares if, following a sale, the Shares are not required to carry a legend pursuant to such applicable securities Laws referred to in Section 5.1(a)(ii). Notwithstanding the foregoing, the Company shall direct the Transfer Agent to remove the transfer restriction set forth in Section 5.1(a)(i) applicable to the Shares upon the written request of the Subscriber, within two Business Days of the Company’s receipt of such request, at such time as the Shares may be transferred without the requirement that the Company be in compliance with the public information requirements and without volume or manner-of-sale restrictions under Rule 144. The Subscriber, or if the Transfer Agent requires, the Company, shall provide such opinions of counsel (which counsel shall be reasonably satisfactory to the Company) reasonably requested by the Transfer Agent in connection with the removal of legends pursuant to this Section 5.1(b). In addition, if the Subscriber requests that the Transfer Agent transfer the Shares, the Subscriber shall provide such other documentation, including for the avoidance of doubt a duly completed stock transfer form, reasonably requested by the Transfer Agent in connection with the onward transfer of the Shares at least two Business Days prior to the intended transfer date.
5.2      Standstill.  During the Standstill Period, the Subscriber, or any of its Controlled Affiliates, shall not:
(i) without the express written consent of the Company, directly or indirectly acquire any additional equity securities (including Ordinary Shares and Ordinary Share Equivalents) of the Company, if after giving effect to such acquisition the Subscriber, or any of its Controlled Affiliates, would, directly or indirectly, own more than 9.9% of the then outstanding share capital of the Company;
(ii) directly or indirectly encourage or support a tender, exchange or other offer or proposal by a Third Party;
(iii) publicly propose (x) any merger, consolidation, business combination, tender or exchange offer, purchase of the Company’s assets or businesses, or similar transaction involving the Company or (y) any recapitalization, restructuring, liquidation or other extraordinary transaction with respect to the Company;
(iv) directly or indirectly, seek to have called any meeting of the shareholders of the Company, propose or nominate for election to the Company’s board of directors any person whose nomination has not been approved by a majority of the Company’s board of directors or cause to be voted in favor of such person for election to the Company’s board of directors any Ordinary Shares of the then outstanding share capital of the Company or Ordinary Share Equivalents other than as contemplated by Section 5.4;

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(v) directly or indirectly, solicit proxies or consents or become a participant in a solicitation (as such terms are defined in Regulation 14A under the Exchange Act) in opposition to the recommendation of a majority of the Company’s board of directors with respect to any matter, or seek to advise or influence any Third Party, with respect to voting of any Ordinary Shares of the then outstanding share capital of the Company or Ordinary Share Equivalents;
(vi) deposit any Ordinary Shares of the then outstanding share capital of the Company or Ordinary Share Equivalents in a voting trust or subject any Ordinary Shares of the then outstanding share capital of the Company or Ordinary Share Equivalents to any arrangement or agreement with respect to the voting of such Ordinary Shares of the then outstanding share capital of the Company or Ordinary Share Equivalents other than as contemplated by Section 5.4;
(vii) act in concert with any Third Party to take any action in clauses (i) through (vi) above, or form, join or in any way participate in a “partnership, limited partnership, syndicate, or other group” with any Third Party within the meaning of Section 13(d)(3) of the Exchange Act with respect to the equity securities of the Company;
(viii) enter into discussions, negotiations, arrangements or agreements with any Third Party relating to the foregoing actions referred to in clauses (i) through (vi) above; provided , however , that the mere voting in accordance with Section 5.4 of any voting securities of the Company held by the Subscriber, its executive officers or directors, or its Controlled Affiliates shall not constitute a violation of any of clauses (i) through (vii) above.
Notwithstanding the foregoing, (A) none of the Subscriber’s executive officers or directors shall be restricted from purchasing Ordinary Shares or Ordinary Share Equivalents for his or her personal account (other than through a tender or exchange offer), tendering his or her Ordinary Shares or Ordinary Share Equivalents into a Third Party tender or exchange offer, voting his or her Ordinary Shares, or Ordinary Share Equivalents in any way he or she determines, or depositing his or her Ordinary Shares or Ordinary Share Equivalents into a voting trust or subjecting them to any arrangement or agreement with respect to the voting of such Ordinary Shares or Ordinary Share Equivalents; (B) if any executive officer or director of the Subscriber serves as a member of the Company’s board of directors, any action he or she takes in the performance of his or her duties as a member of the Company’s board of directors shall not be deemed to violate this Section 5.2, except if he or she takes such action at the direction of Subscriber or an Affiliate thereof; and (C) the foregoing restrictions in this Section 5.2 shall not (i) restrict the Subscriber or its subsidiaries from engaging in private, non-public discussions regarding a transaction otherwise prohibited by this Section 5.2 with the Company’s board of directors; and (ii) prohibit the Subscriber or its subsidiaries from acquiring securities of, or from entering into any merger or other business combination with, another Person that beneficially owns securities of the Company.
5.3      Lock-Up . During the Lock-Up Period, the Subscriber shall not and shall cause its Controlled Affiliates not to, without the prior consent of the Company, directly or indirectly, Dispose of (a) any of the Shares, or any Ordinary Shares or Ordinary Share

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Equivalents beneficially owned by the Subscriber or any of its Controlled Affiliates as of the Signing Date, together with any Ordinary Share, or Ordinary Share Equivalents issued in respect thereof as a result of any stock split, stock dividend, share exchange, merger, consolidation or similar recapitalization, and (b) any Ordinary Shares or Ordinary Share Equivalents issued as (or issuable upon the exercise of any warrant, right or other security that is issued as) a dividend or other distribution with respect to, or in exchange or in replacement of, the Ordinary Shares or Ordinary Share Equivalents described in clause (a) of this sentence, but excluding Ordinary Shares acquired after the Closing Date; provided , however , that the foregoing shall not prohibit the Subscriber or its Controlled Affiliates from Transferring Ordinary Shares or Ordinary Share Equivalents (i) to a Permitted Transferee, (ii) to the Company, (iii) with the prior written consent of the Company, (iv) if the Subscriber’s auditors determine that the Company’s financial results must be consolidated with the Subscriber’s in the Subscriber’s financial statements pursuant to the principles of consolidation under GAAP, Dispositions made in order to reduce the Subscriber’s ownership of the Company’s voting securities to such amount as would not require such consolidation under GAAP, or (v) pursuant to a bona fide third party tender offer, merger, consolidation or other similar transaction made to holders of the Shares involving a change of control of the Company; provided further , that in the event that the tender offer, merger, consolidation, scheme of arrangement or other such transaction is not consummated, the Subscriber shall remain subject to the restrictions contained herein.
5.4      Voting of Securities .  During the Standstill Period, in any vote of the shareholders of the Company (including, without limitation, with respect to the election of directors), except as provided by Section 5.5, the Subscriber shall vote all voting securities of the Company as to which it is entitled to vote in accordance with the recommendation of a majority of the Company’s board of directors.
5.5      Change of Control . Notwithstanding Section 5.4, the Subscriber may vote, or execute a written consent with respect to, any or all of the voting securities of the Company as to which they are entitled to vote or execute a written consent, as they may determine in their sole discretion with respect to any transaction the consummation of which would result in a Change of Control of the Company.
5.6      Offering Lock-Up . The Subscriber shall, if requested by the Company and an underwriter of Ordinary Shares or Ordinary Share Equivalents in connection with any public offering involving an underwriting of Ordinary Shares or Ordinary Share Equivalents, agree not to Dispose of any Ordinary Shares or Ordinary Share Equivalents for a specified period of time, such period of time not to exceed 90 days (a “ Lock-Up Agreement ”). Any Lock-Up Agreement shall be in writing in a form reasonably satisfactory to the Company and the underwriter(s) in such offering. The Company may impose stop transfer instructions with respect to the Ordinary Shares or Ordinary Share Equivalents subject to the foregoing restrictions until the end of the specified period of time. The foregoing provisions of this Section 5.6 shall not apply (a) if the Subscriber owns less

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than 10% of Ordinary Shares of the outstanding share capital of the Company, or (b) to the sale of any shares to an underwriter pursuant to an underwriting agreement, and shall be applicable to the Subscriber only if all officers and directors are subject to the same restrictions.
5.7      Further Assurances .  Subject to the terms and conditions of this Agreement, each of the Company and the Subscriber agrees to use its reasonable best efforts to take, or cause to be taken, all actions, and to do, or cause to be done, and assist the other party hereto in doing, all things reasonably necessary, proper or advisable to obtain satisfaction of the conditions precedent to the consummation of the transactions contemplated at the Closing, including:  (a) obtaining all necessary Consents and the making of all filings and the taking of all steps as may be necessary, including convening any prerequisite meetings of bodies of the Company, to obtain a required Consent or avoid an Action by any Governmental Authority, (b) the defending of any Actions challenging this Agreement or any other Transaction Agreements or the consummation of the transactions contemplated hereby or thereby, including seeking to have any stay or temporary restraining order entered by any court or other Governmental Authority vacated or reversed, and (c) the execution and delivery of any additional instruments necessary to consummate the transactions contemplated by, and to fully carry out the purposes of, this Agreement and the other Transaction Agreements.
5.8      Securities Law Disclosure; Publicity .  No public release or announcement concerning the transactions contemplated hereby or by any other Transaction Agreement, including the public filing of any Transaction Agreement pursuant to applicable securities Laws, shall be issued by the Company or the Subscriber without the prior consent of the Company (in the case of a release or announcement by the Subscriber) or the Subscriber (in the case of a release or announcement by the Company) (which consents shall not be unreasonably withheld, conditioned or delayed), except for any such release or announcement as may be required by securities Law or other applicable Law or the applicable rules or regulations of any securities exchange or securities market, in which case the Company or the Subscriber, as the case may be, shall allow the Subscriber or the Company, as applicable, reasonable time to comment on such release or announcement in advance of such issuance and the disclosing party shall consider the other party’s comments in good faith.  Following execution and delivery of this Agreement, the Company shall issue a press release substantially in the form set forth in Exhibit A .
5.9      Integration .  The Company shall not sell, offer for sale or solicit offers to buy or otherwise negotiate in respect of any security (as defined in Section 2 of the Securities Act) that would be integrated with the offer or sale of the Shares in a manner that would require the registration under the Securities Act of the Shares to be issued to the Subscriber hereunder for purposes of the rules and regulations of any of the following markets or exchanges on which the Ordinary Shares of the Company is listed or quoted for trading on the date in question (including the OTC Markets Group, the OTC Bulletin Board,

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the Nasdaq Capital Market, the Nasdaq Global Market, the Nasdaq Global Select Market, the NYSE American or the New York Stock Exchange), such that it would require shareholder approval prior to the closing of such other transaction unless shareholder approval is obtained before the closing of such subsequent transaction.
5.10      Notification . After the date hereof and prior to the Closing Date, the Company shall promptly deliver to the Subscriber a written notice of any event or development that would, or could reasonably be expected to, result in any condition to Closing set forth in Section 6, not to be satisfied.
5.11      Registration Rights .  The Company covenants and agrees as follows:
(a)      Within 30 days following a written request by the Subscriber at any time after the expiration of the Lock-Up Period (or any earlier termination or waiver by the Company thereof), or such earlier time as the Company in its sole discretion may agree in writing, the Company shall file a prospectus supplement or a registration statement to register the resale of the Registrable Shares on a Form S-3ASR or Form S-3 registration statement under the Securities Act and use reasonable best efforts to have such registration statement declared effective, if the Company is not eligible to use Form S-3ASR, and maintain the effectiveness of such registration statement for a period ending on the date the Subscriber no longer holds Registrable Shares.
(b)      All expenses incurred in connection with registrations, filings or qualifications pursuant to this Section 5.11, including all registration, filing and qualification fees; printers’ and accounting fees; and fees and disbursements of counsel for the Company, shall be borne and paid by the Company. All (i) underwriting discounts and selling commission, but only to the extent that the Subscriber intends to distribute the Registrable Shares by means of an underwriting, (ii) fees and disbursements of counsel for Subscriber and (iii) transfer taxes incurred in connection with the sale of any Shares by Subscriber (collectively “ Selling Expenses ”) shall be borne by Subscriber. For the avoidance of doubt, the Company shall not bear any Selling Expenses in connection with its obligations under this Agreement.
(c)      For the purposes of this Section 5.11,
(i) Losses ” means any loss, damage, claim or liability (joint or several) to which a party hereto may become subject under the Securities Act, the Exchange Act, or other federal or state law, insofar as such loss, damage, claim or liability arises out of and is based upon: (A) any untrue statement or alleged untrue statement of a material fact contained in any registration statement of the Company registering the resale of the Registrable Shares, including any preliminary prospectus or final prospectus contained therein or any amendments or supplements thereto or (B) an omission or alleged omission to state in such registration statement a material fact required to be stated therein, or necessary to make the statements therein not misleading.

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(ii) Registrable Shares ” means the Shares held by Subscriber, including, without limitation, any Ordinary Shares paid, issued or distributed in respect of any such Shares by way of stock dividend, stock split or distribution, or in connection with a combination of shares, recapitalization, reorganization, merger or consolidation, or issued in exchange for or in replacement of the Shares, or otherwise, but excluding Ordinary Shares acquired after the Closing Date, provided , however , that the Shares will not be “Registrable Shares” (A) after the Shares have been sold pursuant to an effective registration statement or in compliance with Rule 144 or other exemptions from registration or (B) when the Shares held by the Subscriber could, in the opinion of counsel satisfactory to the Company, be sold by the Subscriber in a single transaction without the volume and manner of sale limitations under Rule 144 unless the Subscriber has taken action, without the consent or agreement of the Company, subsequent to the date hereof to cause such Shares not to be eligible for such sale under Rule 144.
(d)      With a view to making available to the Subscriber the benefits of Rule 144, during the 12-month period following the Closing Date, the Company covenants that it will use reasonable best efforts to (i) file in a timely manner all reports and other documents required, if any, to be filed by it under the Securities Act and the Exchange Act and the rules and regulations adopted thereunder and (ii) make available information necessary to comply with Rule 144 with respect to resales of the Shares under the Securities Act, at all times, to the extent required from time to time to enable the Subscriber to resell Shares without registration under the Securities Act within the limitation of the exemptions provided by Rule 144 (if available with respect to resales of the Shares), as such rule may be amended from time to time.
(e)      To the extent permitted by law, the Company will indemnify and hold harmless the Subscriber, and the partners, members, officers and directors of the Subscriber (collectively, “ Subscriber Indemnified Parties ”), against any Losses, and the Company will pay to the Subscriber Indemnified Parties any legal or other reasonable and documented expenses incurred thereby in connection with investigating or defending any claim or proceeding from which Losses may result, as such expenses are incurred; provided , however , that the indemnity agreement contained in this Section 5.11(e) shall not apply (i) to amounts paid in settlement of any such claim or proceeding if such settlement is effected without the consent of the Company, which consent shall not be unreasonably withheld, (ii) any Losses to the extent that they arise out of or are based upon actions or omissions made in reliance upon and in conformity with written information furnished by or on behalf of any Subscriber Indemnified Party expressly for use in connection with such registration or (iii) to the extent it is judicially determined that any Subscriber Indemnified Party is not entitled to indemnification hereunder.
(f)      Promptly after receipt by the Subscriber under this Section 5.11 of notice of the commencement of any action (including any governmental action) for which a Subscriber Indemnified Party may be entitled to indemnification hereunder, the Subscriber Indemnified Party will, if a claim in respect thereof is to be made against the Company under

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this Section 5.11(f), give the Company notice of the commencement thereof.  The Company shall have the right to participate in such action and, to the extent the Company so desires, and to assume the defense thereof with counsel mutually satisfactory to the Subscriber Indemnified Parties and the Company; provided , however , that the Subscriber Indemnified Parties shall have the right to retain one separate counsel for all such Subscriber Indemnified Parties, with the reasonable and documented fees and expenses to be paid by the Company, if representation of the Subscriber by the counsel retained by the Company would be inappropriate due to actual or potential conflict of interest between the Subscriber Indemnified Parties and the Company.  The failure to give notice to the Company within a reasonable time of the commencement of any such action shall relieve the Company of any liability to the Subscriber Indemnified Parties under this Section 5.11(f), only to the extent that such failure materially prejudices the Company’s ability to defend such action.  The failure to give notice to the Company will not relieve it of any liability that it may have to the Subscriber otherwise than under this Section 5.11(f).
(g)      To provide for just and equitable contribution to joint liability under the Securities Act in any case in which contribution under the Securities Act may be required on the part of the Subscriber Indemnified Parties, then such parties will contribute to the aggregate losses, claims, damages, liabilities, or expenses to which they may be subject (after contribution from others) in such proportion as is appropriate to reflect the relative fault of the Company and each Subscriber Indemnified Party in connection with the statements, omissions, or other actions that resulted in such loss, claim, damage, liability, or expense, as well as to reflect any other relevant equitable considerations.  The relative fault of the Company and each Subscriber Indemnified Party shall be determined by reference to, among other things, whether the untrue or allegedly untrue statement of a material fact, or the omission or alleged omission of a material fact, relates to information supplied by the Company or by a Subscriber Indemnified Party and the parties’ relative intent, knowledge, access to information, and opportunity to correct or prevent such statement or omission; provided , however , that, in any such case (x) the Subscriber will not be required to contribute any amount in excess of the public offering price of all such Registrable Shares offered and sold by the Subscriber pursuant to such registration statement, and (y) no Person guilty of fraudulent misrepresentation (within the meaning of Section 11(f) of the Securities Act) will be entitled to contribution from any Person who was not guilty of such fraudulent misrepresentation.
5.12      Nasdaq Matters . Prior to the Closing, the Company shall (a) take all actions which are necessary, including providing appropriate notice to Nasdaq of the transactions contemplated by this Agreement, for the Shares purchased at the Closing to remain listed on the Nasdaq Global Select Market and (b) comply with all listing, reporting, filing, and other obligations under the rules of Nasdaq and of the SEC.
5.13      PFIC Reporting. If the Company determines it or any of its controlled Subsidiaries was a “passive foreign investment company” (as defined in Section

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1297(a) of the Code) (a “PFIC”) for any taxable year in which the Subscriber holds Shares in the Company, the Company shall (a) notify the Subscriber of such determination, and (b) if requested in writing by the Subscriber, provide to Subscriber such information as the Subscriber, in consultation with the Company, reasonably determines is required for the Subscriber to (i) complete its U.S. Internal Revenue Service Form 8621 with respect to such entity and (ii) make an election to treat such entity as a “qualified electing fund” under Section 1295 of the Code.
5.14.    Controlled Foreign Corporation . If the Company determines it was a “controlled foreign corporation” within the meaning of Section 957 of the Code (a “CFC”) for any taxable year in which the Subscriber holds Shares in the Company, the Company shall (a) notify the Subscriber of such determination and, (b) for any taxable year in which the Company is a CFC and the Subscriber is a “United States shareholder” (as defined in Section 951(b) of the Code), provide to the Subscriber such information as the Subscriber, in consultation with the Company, reasonably determines is required for the Subscriber to timely comply with its filing obligations under the Code, including, but not limited to, its U.S. Internal Revenue Service Form 5471.
6.      Conditions to Closing .

6.1      Conditions to Subscriber’s Obligations at the Closing .  The Subscriber’s obligation to subscribe for the Shares at the Closing is subject to the satisfaction, at or prior to the Closing Date, of the following conditions (unless waived in writing by the Subscriber):
(a)      Representations and Warranties .  The representations and warranties made by the Company in Section 3 shall be true and correct in all material respects as of the Signing Date and the Closing Date as if made on such date, except to the extent any such representation and warranty is (i) already qualified by materiality, in which case it shall be true and correct as of such dates or (ii) specifically made as of a particular date, in which case it shall be true and correct in all material respects as of such date.
(b)      Performance of Obligations .  The Company shall have performed and complied in all material respects with all agreements and conditions herein required to be performed or complied with by the Company on or before the Closing Date.
(c)      Legal Investment .  The issuance of the Shares shall be legally permitted by all Laws to which the Subscriber and the Company are subject.
(d)      No Orders .  No Order shall be in effect preventing the consummation of the transactions contemplated by the Transaction Agreements.
(e)      Closing Deliverables .  The Company shall deliver or cause to be delivered to the Subscriber all items listed in Section 2.3(a).

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(f)      Collaboration Agreement .  The Company shall have executed the Collaboration Agreement, the Effective Date (as such term is defined in the Collaboration Agreement) of the Collaboration Agreement shall occur immediately prior to the Closing, no material breach by the Company of any term of or obligation under the Collaboration Agreement shall have occurred and be continuing, and the Collaboration Agreement shall not have been terminated in accordance with its terms.
(g)      Consents, Permits and Waivers .  All Consents necessary or appropriate for consummation of the transactions contemplated by the Transaction Agreements shall have been obtained, including the approval of the board of directors of the Company. 
(h)      Material Adverse Effect .  No Material Adverse Effect shall have occurred and be continuing.
(i)      The Company’s Nasdaq Listing .  The Company’s Ordinary Shares shall continue to be listed on the Nasdaq Global Select Market.
6.2      Conditions to Company’s Obligations at the Closing .  The Company’s obligation to issue and sell Shares at the Closing is subject to the satisfaction, on or prior to the Closing Date, of the following conditions (unless waived in writing by the Company):
(a)      Representations and Warranties .  The representations and warranties in Section 4 made by the Subscriber shall be true and correct in all material respects as of the Signing Date and the Closing Date as if made on such date, except to the extent any such representation and warranty is (i) already qualified by materiality, in which case it shall be true and correct as of such dates or (ii) specifically made as of a particular date, in which case it shall be true and correct in all material respects as of such date.
(b)      Performance of Obligations .  The Subscriber shall have performed and complied with all agreements and conditions herein required to be performed or complied with by the Subscriber on or before the Closing Date.
(c)      Legal Investment .  The issuance of the Shares shall be legally permitted by all Laws to which the Subscriber and the Company are subject.
(d)      No Orders .  No Order shall be in effect preventing the consummation of the transactions contemplated by the Transaction Agreements.
(e)      Closing Deliverables .  The Subscriber shall deliver or cause to be delivered to the Company all items listed in Section 2.3(b).
(f)      Collaboration Agreement .  The Subscriber shall have executed the Collaboration Agreement, the Effective Date (as such term is defined in the Collaboration Agreement) of the Collaboration Agreement shall occur immediately prior to the Closing, no material breach by the Subscriber of any term of or obligation under the Collaboration

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Agreement shall have occurred and be continuing, and the Collaboration Agreement shall not have been terminated in accordance with its terms.
(g)      Consents, Permits and Waivers .  All Consents necessary or appropriate for consummation of the transactions contemplated by the Transaction Agreements shall have been obtained. 
7.      Miscellaneous .
7.1      Termination . This Agreement may be terminated at any time prior to the Closing by:
(a)      mutual written consent of the Company and the Subscriber;
(b)      either the Company or the Subscriber, upon written notice to the other no earlier than ten Business Days following the Signing Date (the “ Termination Date ”), if the Closing has not been consummated by the Termination Date;
(c)      either the Company or the Subscriber, upon written notice to the other, if any of the conditions to the Closing set forth in Section 6.1(c), 6.1(d), 6.1(g), 6.2(c), 6.2(d) or 6.2(g) as applicable, despite the use of reasonable efforts shall have become incapable of fulfillment by the Termination Date and shall not have been waived in writing by the other party within ten Business Days after receiving receipt of written notice of an intention to terminate pursuant to this clause (c); provided , however , that the right to terminate this Agreement under this Section 7.1(c) shall not be available to any party whose failure to fulfill any obligation under this Agreement has been the cause of, or resulted in, the failure to consummate the transactions contemplated hereby prior to the Termination Date;
(d)      the Company, upon written notice to the Subscriber, so long as the Company is not then in breach of its representations, warranties, covenants or agreements under this Agreement such that any of the conditions set forth in Section 6.1(a) despite the use of reasonable efforts could not be satisfied by the Termination Date, (i) upon a material breach of any covenant or agreement on the part of the Subscriber set forth in this Agreement, or (ii) if any representation or warranty of the Subscriber shall have been or become untrue, in each case such that any of the conditions set forth in Section 6.2(a) or 6.2(b), as applicable, could not be satisfied by the Termination Date (each (i) and (ii), a “ Terminating Subscriber Breach ”); except that, if such Terminating Subscriber Breach is curable by the Subscriber through the exercise of its reasonable best efforts, then, for a period of up to thirty days after receipt by the Subscriber of notice from the Company of such breach, but only as long as the Subscriber continues to use its reasonable best efforts to cure such Terminating Subscriber Breach (the “ Subscriber Cure Period ”), such termination shall not be effective and the Termination Date shall be automatically extended until the end of the Subscriber Cure Period, and such termination shall become effective only if the Terminating Subscriber Breach is not cured within the Subscriber Cure Period; or

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(e)      the Subscriber, upon written notice to the Company, so long as the Subscriber is not then in breach of its representations, warranties, covenants or agreements under this Agreement such that any of the conditions set forth in Section 6.2(a) or 6.2(b), as applicable, despite the use of reasonable efforts could not be satisfied by the Termination Date, (i) upon a material breach of any covenant or agreement on the part of the Company set forth in this Agreement, or (ii) if any representation or warranty of the Company shall have been or become untrue, in each case such that any of the conditions set forth in Section 6.1(a), 6.1(b), 6.1(h) or 6.1(i), as applicable, could not be satisfied by the Termination Date (each (i) and (ii), a “ Terminating Company Breach ”); except that, if such Terminating Company Breach is curable by the Company through the exercise of its reasonable best efforts, then, for a period of up to thirty days after receipt by the Company of notice from the Subscriber of such breach, but only as long as the Company continues to use its reasonable best efforts to cure such Terminating Company Breach (the “ Company Cure Period ”), such termination shall not be effective and the Termination Date shall be automatically extended until the end of the Company Cure Period, and such termination shall become effective only if the Terminating Company Breach is not cured within the Company Cure Period.
7.2      Effect of Termination . In the event of the termination of this Agreement pursuant to Section 7.1, (a) this Agreement (except for this Section 7, and any definitions set forth in this Agreement and used in such sections) shall forthwith become void and have no effect, without any liability on the part of any party hereto or its Affiliates, and (b) all filings, applications and other submissions made pursuant to this Agreement, to the extent practicable, shall be withdrawn from the agency or other Person to which they were made or appropriately amended to reflect the termination of the transactions contemplated hereby; provided , however , that nothing contained in this Section 7.2 shall relieve any party from liability for fraud or any intentional or willful breach of this Agreement; provided , however , that, a failure of a Party to consummate the subscription for Shares in breach of this Agreement shall be deemed to be intentional and willful.
7.3      Governing Law; Waiver of Jury Trial .  This Agreement shall be governed by and construed in accordance with the Laws of the State of New York, without regard to the conflict of laws principles thereof that would require the application of the Law of any other jurisdiction. The parties irrevocably and unconditionally submit to the exclusive jurisdiction of the United States District Court for the Southern District of New York solely and specifically for the purposes of any action or proceeding arising out of or in connection with this Agreement. EACH OF THE PARTIES TO THIS AGREEMENT HEREBY AGREES THAT JURISDICTION AND VENUE IN ANY SUIT, ACTION OR PROCEEDING BROUGHT BY ANY PARTY ARISING OUT OF OR RELATING TO THIS AGREEMENT (INCLUDING ANY SUIT, ACTION OR PROCEEDING SEEKING EQUITABLE RELIEF) SHALL PROPERLY AND EXCLUSIVELY LIE IN THE STATE AND FEDERAL COURTS LOCATED IN THE STATE OF NEW YORK (THE “ CHOSEN COURTS ”). EACH PARTY HERETO FURTHER AGREES NOT TO BRING ANY SUCH

34



SUIT, ACTION OR PROCEEDING IN ANY COURT OTHER THAN THE CHOSEN COURTS PURSUANT TO THE FOREGOING SENTENCE (OTHER THAN UPON APPEAL). BY EXECUTION AND DELIVERY OF THIS AGREEMENT, EACH PARTY IRREVOCABLY SUBMITS TO THE JURISDICTION OF THE CHOSEN COURTS FOR ITSELF AND IN RESPECT OF ITS PROPERTY WITH RESPECT TO SUCH SUIT, ACTION OR PROCEEDING. THE PARTIES HERETO IRREVOCABLY AGREE THAT VENUE WOULD BE PROPER IN EACH OF THE CHOSEN COURTS, AND HEREBY WAIVE ANY OBJECTION THAT ANY SUCH CHOSEN COURT IS AN IMPROPER OR INCONVENIENT FORUM FOR THE RESOLUTION OF SUCH SUIT, ACTION OR PROCEEDING. TO THE EXTENT NOT PROHIBITED BY APPLICABLE LAW WHICH CANNOT BE WAIVED, EACH PARTY HERETO HEREBY WAIVES AND COVENANTS THAT IT WILL NOT ASSERT (WHETHER AS PLAINTIFF, DEFENDANT OR OTHERWISE) ANY RIGHT TO TRIAL BY JURY IN ANY FORUM IN RESPECT OF ANY ISSUE OR ACTION, CLAIM, CAUSE OF ACTION OR SUIT (IN CONTRACT, TORT OR OTHERWISE) INQUIRY, PROCEEDING OR INVESTIGATION ARISING OUT OF OR BASED UPON THIS AGREEMENT OR THE SUBJECT MATTER HEREOF OR IN ANY WAY CONNECTED WITH OR RELATED OR INCIDENTAL TO THE TRANSACTIONS CONTEMPLATED HEREBY, IN EACH CASE WHETHER NOW EXISTING OR HEREAFTER ARISING. EACH PARTY HERETO ACKNOWLEDGES THAT IT HAS BEEN INFORMED BY THE OTHER PARTIES HERETO THAT THIS SECTION 7.3 CONSTITUTES A MATERIAL INDUCEMENT UPON WHICH THEY ARE RELYING AND WILL RELY IN ENTERING INTO THIS AGREEMENT. ANY PARTY HERETO MAY FILE AN ORIGINAL COUNTERPART OR A COPY OF THIS SECTION 7.3 WITH ANY COURT AS WRITTEN EVIDENCE OF THE CONSENT OF EACH SUCH PARTY TO THE WAIVER OF ITS RIGHT TO TRIAL BY JURY.
7.4      Survival .  The representations, warranties, covenants and agreements made herein shall survive the Closing.
7.5      Successors and Assigns . The provisions hereof shall inure to the benefit of, and be binding upon the parties hereto and their respective successors and permitted assigns.  This Agreement, and any rights and obligations hereunder, may not be assigned by any party hereto without the consent of the other party, provided , however , that the Subscriber may assign its rights and obligations hereunder in whole or in part to any Permitted Transferee or to any successor of the Subscriber as a result of a Change of Control of the Subscriber, provided further , that in the case of such permitted assignment, the assignee shall agree in writing to be bound by the provisions of this Agreement and the Subscriber shall not be relieved of its obligations hereunder.
7.6      Entire Agreement .  This Agreement, the exhibits and schedules hereto, the other Transaction Agreement, and the other documents delivered pursuant hereto constitute the full and entire understanding and agreement between the parties with regard

35



to the subjects hereof and no party shall be liable for or bound to any other in any manner by any oral or written representations, warranties, covenants and agreements except as specifically set forth herein and therein.
7.7      Severability .  In the event one or more of the provisions of this Agreement should, for any reason, be held to be invalid, illegal or unenforceable in any respect, such invalidity, illegality or unenforceability shall not affect any other provisions of this Agreement, and this Agreement shall be construed as if such invalid, illegal or unenforceable provision had never been contained herein.  Upon such determination that any provision of this Agreement, or the application of any such provision, is invalid, illegal, void or unenforceable, the Company and the Subscriber shall negotiate in good faith to modify this Agreement so as to effect the original intent of the Company and the Subscriber as closely as possible to the fullest extent permitted by Law in an acceptable manner to the end that the transactions contemplated hereby and the other Transaction Agreement are fulfilled to the greatest extent possible.
7.8      Amendment .  No provision in this Agreement shall be supplemented, deleted or amended except in a writing executed by an authorized representative of each of the Subscriber and the Company.  Any amendment effected in accordance with this Section 7.8 shall be binding upon each holder of Shares subscribed for under this Agreement at the time outstanding, each future holder of all such Shares, and the Company, and any amendment not effected in accordance with this Section 7.8 shall be void and of no effect.
7.9      Waivers; Delays or Omissions .  It is agreed that no delay or omission to exercise any right, power or remedy accruing to any party, upon any breach, default or noncompliance by another party under this Agreement, shall impair any such right, power or remedy, nor shall it be construed to be a waiver of any such breach, default or noncompliance, or any acquiescence therein, or of or in any similar breach, default or noncompliance thereafter occurring.  It is further agreed that any Consent of any kind or character on any party’s part of any breach, default or noncompliance under this Agreement or any waiver on such party’s part of any provisions or conditions of the Agreement must be in writing and shall be effective only to the extent specifically set forth in such writing.  All remedies, either under this Agreement, by Law, or otherwise afforded to any party, shall be cumulative and not alternative.  Any waiver effected in accordance with this Section 7.9 shall be binding upon each holder of Shares subscribed for under this Agreement at the time outstanding, each future holder of all such Shares, and the Company, and any waiver not effected in accordance with this Section 7.9 shall be void and of no effect.
7.10      Specific Performance .  Each of the Company and the Subscriber hereby acknowledges and agrees that the failure of the Company or the Subscriber to perform their respective agreements and covenants hereunder will cause irreparable injury to the Subscriber or the Company, for which damages, even if available, will not be an adequate

36



remedy. Accordingly, each of the Company and the Subscriber hereby agrees that the Subscriber and the Company shall be entitled to seek the issuance of specific performance equitable relief by any court of competent jurisdiction to compel performance of the Company’s or the Subscriber’s obligations.
7.11      Notices . Any and all notices or other communications or deliveries required or permitted to be provided hereunder shall be in writing and shall be deemed given and effective on the earliest of (a) the Business Day following the date of mailing, if sent by U.S. nationally recognized overnight courier service with next day delivery specified, (b) upon confirmation via electronic return receipt if such notice or communication is delivered via email at an email address specified in this Section 7.11 or (c) upon actual receipt by the party to whom such notice is required to be given. The address for such notices and communications shall be as follows:
If to the Company:
Prothena Corporation plc
Upper George’s Street
Dún Laoghaire
Co. Dublin, A96 T927, Ireland
Attention:     Company Secretary
E-mail:     yvonne.tchrakian@prothena.com

with copies to (which will not constitute notice) to:
Prothena Corporation plc
c/o Prothena Bioscience Inc
331 Oyster Point Boulevard
South San Francisco, CA 94080, U.S.A.
Attention:         Chief Financial Officer
E-mail:        tran.nguyen@prothena.com

Latham & Watkins LLP
140 Scott Drive
Menlo Park, CA 94025, U.S.A.
Attention:     Alan C. Mendelson, Esq.
Kathleen M. Wells, Esq.
E-mail:    alan.mendelson@lw.com
Kathleen.wells@lw.com

If to the Subscriber:
Celgene Switzerland LLC
86 Morris Avenue
Summit, NJ 07901, U.S.A.

37



Attention:         Gerald F. Masoudi
E-mail:        gmasoudi@celgene.com

with a copy (which will not constitute notice) to:
Morgan, Lewis & Bockius LLP
502 Carnegie Center
Princeton, NJ 08540, U.S.A.
Attention:     Alan Leeds, Esq.
Emilio Ragosa, Esq.
E-mail:     Alan.Leeds@morganlewis.com
Emilio.Ragosa@morganlewis.com

7.12      Expenses .  Unless otherwise specified herein, each party shall pay all costs and expenses that it incurs with respect to the negotiation, execution, delivery and performance of this Agreement.
7.13      Titles and Subtitles .  The titles of the sections and subsections of the Agreement are for convenience of reference only and are not to be considered in construing this Agreement.
7.14      Pronouns .  All pronouns contained herein, and any variations thereof, shall be deemed to refer to the masculine, feminine or neutral, singular or plural, as to the identity of the parties hereto may require.  The words “include,” “includes” and “including” will be deemed to be followed by the phrase “without limitation”. The meanings given to terms defined herein will be equally applicable to both the singular and plural forms of such terms. All references to “dollars” or “$” will be deemed references to the lawful money of the United States of America.  All exhibits attached hereto and all other attachments hereto are hereby incorporated herein by reference and made a part hereof.
7.15      Third Party Beneficiaries .  None of the provisions of this Agreement shall be for the benefit of or enforceable by any Third Party, including any creditor of any party hereto.  No Third Party shall obtain any right under any provision of this Agreement or shall by reason of any such provision make any claim in respect of any debt, liability or obligation (or otherwise) against any party hereto.
7.16      No Strict Construction .  This Agreement has been prepared jointly and will not be construed against either party.  In the event an ambiguity or question of intent or interpretation arises, this Agreement shall be construed as if drafted jointly by the parties hereto, and no presumption or burden of proof shall arise favoring or disfavoring any party hereto by virtue of the authorship of any provisions of this Agreement.
7.17      Execution . This Agreement may be executed in two or more counterparts, all of which when taken together shall be considered one and the same

38



agreement and shall become effective when counterparts have been signed by each party and delivered to the other party, it being understood that both parties need not sign the same counterpart. In the event that any signature is delivered by facsimile transmission, or by e-mail delivery of a “.pdf” data file, such signature shall create a valid and binding obligation of the party executing (or on whose behalf such signature is executed) with the same force and effect as if such facsimile signature page were an original thereof.
[ Signature Page to Follow ]
 

39



IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the date set forth in the first paragraph hereof.

Company:
Prothena Corporation plc

By: /s/ Yvonne Tchrakian    
Name: Yvonne Tchrakian
Title:     Company Secretary

[ Signature Page to the Prothena Share Subscription Agreement ]


IN WITNESS WHEREOF, the parties hereto have executed this Agreement as of the date set forth in the first paragraph hereof.

Subscriber:
Celgene Switzerland LLC

By: /s/     Kevin Mello    
Name:     Kevin Mello
Title:     Manager
 


[ Signature Page to the Prothena Share Subscription Agreement ]


EXHIBIT A
COMPANY PRESS RELEASE






PROTHENASSAEXECUTIONV_IMAGE1.JPG

Prothena Announces Global Neuroscience Research & Development Collaboration with Celgene for Novel Therapies for Patients with Neurodegenerative Diseases
Prothena to receive a $100 million upfront payment and a $50 million equity investment by Celgene, with potential license payments and regulatory and commercial milestones, plus additional royalties on net sales from licensed programs
Collaboration focuses on preclinical programs targeting proteins implicated in several neurodegenerative diseases, including tau, TDP-43 and an undisclosed third target
Prothena to host an investor conference call and webcast today at 5:00 PM ET  

DUBLIN, Ireland – March 20, 2018 – Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company focused on the discovery, development and commercialization of novel therapies in the neuroscience and orphan categories, today announced a global collaboration with Celgene Corporation (NASDAQ:CELG) through a subsidiary, to develop new therapies for a broad range of neurodegenerative diseases. The multi-year research and development collaboration is focused on three proteins implicated in the pathogenesis of several neurodegenerative diseases, including tau, TDP-43 and an undisclosed target. For each of the programs, Celgene has an exclusive right to license clinical candidates in the U.S. at the investigational new drug (IND) filing and if exercised, would also have a right to expand the license to global rights at the completion of Phase 1. Following the exercise of global rights, Celgene will be responsible for funding all further global clinical development and commercialization. Under the terms of the collaboration, Prothena will receive a $100 million upfront payment and a $50 million equity investment by Celgene, plus future potential exercise payments and regulatory and commercial milestones for each licensed program. Prothena will also receive additional royalties on net sales of any resulting marketed products.
 
“Prothena has a legacy of innovation in neuroscience and a team with a deep understanding of biological approaches that target protein misfolding disorders. Our collaboration leverages each company’s core expertise in protein homeostasis and protein clearance to target proteins that are the underlying cause of many neurodegenerative and orphan diseases. The programs we have chosen to collaborate on have the potential to provide foundational assets from which we can build new therapeutic approaches to these currently untreatable neurological disorders” said Richard Hargreaves, PhD, Corporate Vice President Neuroscience and Imaging for Celgene.

“We are excited to be working with Celgene, a leading global biopharmaceutical company with deep expertise in targeting critical biological pathways involved in protein homeostasis and an extensive track record of successfully bringing forward innovative new therapies based on this





biology,” said Gene Kinney, PhD, President and Chief Executive Officer of Prothena. “As we build our pipeline of novel therapies across the neuroscience and orphan disease categories, this collaboration provides Prothena the opportunity to work with a premier scientific partner and the resources and flexibility to advance these programs while continuing to expand our proprietary discovery activities and further supports our efforts to deliver a diversified pipeline of therapies to alter the course of devastating diseases.”

Collaboration Agreement Overview

Prothena will receive an upfront payment and equity investment, and is eligible to receive exercise payments and regulatory and commercial milestones, plus additional royalties on net sales based on the following collaboration deal terms:

Prothena will receive an upfront payment of $100 million
Celgene will make a $50 million equity investment in Prothena by subscribing to approximately 1.2 million of Prothena’s ordinary shares at $42.57 per share
For programs reaching commercialization, Prothena will receive tiered royalties on net sales

The targets encompassed in this collaboration are implicated in the pathogenesis of several neurodegenerative diseases for which there are no current disease modifying therapies, including the following:

Tau, a protein implicated in diseases including Alzheimer's disease (AD), progressive supranuclear palsy (PSP), frontotemporal dementia (FTD), chronic traumatic encephalopathy (CTE) and other tauopathies. Prothena has identified antibodies targeting novel epitopes on the tau protein with the ability to block misfolded tau from binding to cells and to inhibit cell-to-cell transmission, preventing downstream functional toxic effects.
TDP-43 , a protein implicated in diseases including amytrophic lateral sclerosis (ALS) and the most common subtype of FTD, behavioral variant FTD (bvFTD), a proportion of AD and other TDP-43 proteinopathies. Prothena has generated antibodies that target multiple epitopes on the TDP-43 protein and is using proprietary in vitro screening methodology to select those that may be the most potent and efficacious in inhibiting toxicity and cell-to-cell transmission of misfolded TDP-43 species.

Citi is acting as financial advisor to Prothena and Latham & Watkins LLP is acting as legal counsel to Prothena. Morgan Lewis is acting as legal counsel to Celgene.

Investor Conference Call and Webcast Details

Prothena management will host a conference call and webcast to discuss the collaboration today, March 20, at 5:00 PM ET. The conference call and webcast will be made available on the Company's website at www.prothena.com under the Investors tab in the Events and Presentations




section. Following the conference call and webcast, a replay will be available on the Company's website for at least 90 days.

To access the conference call via dial-in, please dial (877) 887-5215 (U.S./Canada toll free) or (315) 625-3069 (international) five minutes prior to the start time and refer to conference ID number 8469456. A replay of the call will be available until March 27 via dial-in at (855) 859-2056 (U.S./Canada toll free) or (404) 537-3406 (international), Conference ID Number 8469456.

About Prothena
Prothena Corporation plc is a global, late-stage clinical biotechnology company establishing fully integrated research, development and commercial capabilities and focused on advancing new therapies in the neuroscience and orphan categories. Fueled by its deep scientific understanding built over decades of research in protein misfolding, Prothena seeks to fundamentally change the course of grave or currently untreatable diseases associated with this biology. Prothena’s pipeline of antibody therapeutic candidates targets a number of indications including AL amyloidosis (NEOD001), Parkinson’s disease and other related synucleinopathies (PRX002/RG7935) and ATTR amyloidosis (PRX004). The Company continues discovery of additional novel therapeutic approaches against targets such as tau, Aβ (Amyloid beta) and ALECT2 where its deep scientific understanding of disease pathology can be leveraged. For more information, please visit the Company's website at www.prothena.com .
Forward-looking Statements by Prothena

This press release contains forward-looking statements by Prothena. These statements relate to, among other things, potential future payments and royalties we might receive under the collaboration with Celgene; our ability to advance a growing pipeline of novel therapies in the neuroscience and orphan disease categories; our ability to advance any of the programs that are the subject of the collaboration with Celgene; the potential of those programs to lead to new therapeutic approaches to currently untreatable neurological disorders;  the potential targeting of novel epitopes on misfolded forms of tau protein and LECT2 protein; and the capabilities of our proprietary in vitro screening methodology for TDP-43. These statements are based on estimates, projections and assumptions that may prove not to be accurate, and actual results could differ materially from those anticipated due to known and unknown risks, uncertainties and other factors, including but not limited to the risks, uncertainties and other factors described in the “Risk Factors” sections of Prothena’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on February 26, 2018 and Prothena’s subsequent Quarterly Reports on Form 10-Q filed with the SEC. Prothena undertakes no obligation to update publicly any forward-looking statements contained in this press release as a result of new information, future events or changes in Prothena’s expectations.

Contact:

Ellen Rose, Head of Communications
650-922-2405
ellen.rose@prothena.com





Exhibit 31.1
CERTIFICATION OF CHIEF EXECUTIVE OFFICER
PURSUANT TO SECTION 302 OF
THE SARBANES-OXLEY ACT OF 2002
I, Gene G. Kinney, certify that:
1.
I have reviewed this Quarterly Report on Form 10-Q of Prothena Corporation plc;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b)
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c)
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d)
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
(a)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(b)
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date:
May 8, 2018
/s/ Gene G. Kinney
 
 
Gene G. Kinney
 
 
President and Chief Executive Officer
 
 
(Principal Executive Officer)





Exhibit 31.2
CERTIFICATION OF CHIEF FINANCIAL OFFICER
PURSUANT TO SECTION 302 OF
THE SARBANES-OXLEY ACT OF 2002
I, Tran B. Nguyen, certify that:
1.
I have reviewed this Quarterly Report on Form 10-Q of Prothena Corporation plc;
2.
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3.
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4.
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a)
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b)
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c)
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d)
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5.
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
(a)
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(b)
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date:
May 8, 2018
/s/ Tran B. Nguyen
 
 
Tran B. Nguyen
 
 
Chief Financial Officer
 
 
(Principal Financial Officer)





Exhibit 32.1
CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER
AND PRINCIPAL FINANCIAL OFFICER
PURSUANT TO 18 U.S.C. SECTION 1350,
AS ADOPTED PURSUANT TO SECTION 906
OF THE SARBANES-OXLEY ACT OF 2002
Pursuant to the requirement set forth in Rule 13a-14(b) of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. §1350), Gene G. Kinney, President and Chief Executive Officer of Prothena Corporation plc (the “Company”) and Tran B. Nguyen, Chief Financial Officer of the Company, each hereby certify that, to the best of his knowledge:
1.
The Company’s Quarterly Report on Form 10-Q for the fiscal year ended March 31, 2018 , to which this Certification is attached as Exhibit 32.1 (the “Report”) fully complies with the requirements of Section 13(a) or Section 15(d) of the Exchange Act; and
2.
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

Date:
May 8, 2018
/s/ Gene G. Kinney
 
 
Gene G. Kinney
 
 
President and Chief Executive Officer
 
 
(Principal Executive Officer)
 
 
 
 
 
 
 
 
/s/ Tran B. Nguyen
 
 
Tran B. Nguyen
 
 
Chief Financial Officer
 
 
(Principal Financial Officer)
 
 
 
 
 
 


A signed original of this written statement required by Rule 13a-14(b) of the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350 has been provided to the Registrant and will be retained by the Registrant and furnished to the Securities and Exchange Commission or its staff upon request.
This certification accompanies the Form 10-K to which it relates, is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of the Registrant under the Securities Act of 1933 or the Securities Exchange Act of 1934 (whether made before or after the date of the Form 10-K), irrespective of any general incorporation language contained in such filing.