Exhibit 99.1

Master Manufacturing Services Agreement

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 240.24b-2.

Master Manufacturing Services Agreement

28 November 2016

Master Manufacturing Services Agreement

Table of Contents

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Master Manufacturing Services Agreement

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Master Manufacturing Services Agreement

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Master Manufacturing Services Agreement

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Master Manufacturing Services Agreement

MASTER MANUFACTURING SERVICES AGREEMENT

THIS MASTER MANUFACTURING SERVICES AGREEMENT (the “Agreement”) is made as of 28 November 2016 (the “ Effective Date ”)

B E T W E E N:

PATHEON UK LIMITED

a corporation existing under the laws of England

of Kingfisher Drive, Covingham, Swindon, SN3 5BZ

(“ Patheon ”),

- and –

NEUROCRINE BIOSCIENCES, INC. ,

a corporation existing under the laws of Delaware

of 12780 El Camino Real, San Diego 92130, California, USA, on behalf of itself and its wholly-owned subsidiaries

(collectively “ Client ” ).

THIS AGREEMENT WITNESSES THAT in consideration of the rights conferred and the obligations assumed herein, and for other good and valuable consideration (the receipt and sufficiency of which are acknowledged by each party), and intending to be legally bound the parties agree as follows:

ARTICLE 1

STRUCTURE OF AGREEMENT AND INTERPRETATION

This Agreement establishes the general terms and conditions under which Patheon or any Affiliate of Patheon may perform Manufacturing Services for Client or any Affiliate of Client, at the manufacturing site where the Affiliate of Patheon resides. This “master” form of agreement is intended to allow the parties, or any of their Affiliates, to contract for the manufacture of multiple Products through Patheon’s global network of manufacturing sites through the issuance of site specific Product Agreements without having to re-negotiate the basic terms and conditions contained herein.

This Agreement is structured so that a Product Agreement may be entered into by the parties for the manufacture of a particular Product or multiple Products at a Patheon manufacturing site. Each Product Agreement will be governed by the terms and conditions of this Agreement unless the parties to the Product Agreement expressly modify the terms and conditions of this Agreement in the Product Agreement. Unless otherwise agreed by the parties, each Product Agreement will be in the general form and contain the information set forth in Appendix 1 hereto.

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The following terms will, unless the context otherwise requires, have the respective meanings set out below and grammatical variations of these terms will have corresponding meanings:

“ Active Materials ”, “Active Pharmaceutical Ingredients” or “API” means the materials listed in a Product Agreement on Schedule D;

“ Active Materials Credit Value ” means the value of the Active Materials for certain purposes of this Agreement, as set forth in a Product Agreement on Schedule D;

“ Actual Annual Yield ” or “ AAY ” has the meaning specified in Section 2.3(a);

“ Actual Yearly Volume ” or “ AYV ” has the meaning specified in Section 4.2.1;

For this definition, “control” means the ownership of shares carrying at least a majority of the votes for the election of the directors of a corporation;

“Annual Product Review Report” means the annual product review report prepared by Patheon or an Affiliate of Patheon as described in Title 21 of the United States Code of Federal Regulations, Section 211.180(e);

“ Annual Report” means the annual report to the FDA which is required to be prepared and filed by Client regarding the Product as described in Title 21 of the United States Code of Federal Regulations, Section 314.81(b)(2);

“ Annual Volume ” means the minimum volume of Product to be manufactured in any Year of this Agreement as set forth in a Product Agreement on Schedule B;

“ Applicable Laws ” means (i) for Patheon, the Laws of the jurisdiction where the Manufacturing Site is located; and (ii) for Client, the Laws of all jurisdictions where the Products are manufactured, distributed, and marketed as these are agreed and understood by the parties in this Agreement;

“ Authority ” means any governmental or regulatory authority, department, body or agency or any court, tribunal, bureau, commission or other similar body, whether federal, state, provincial, county or municipal;

“ Breach Notice ” has the meaning specified in Section 8.2(a);

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“ Business Day ” means a day other than a Saturday, Sunday or a day that is a statutory holiday in the United States, United Kingdom or the jurisdiction where the Manufacturing Site is located.;

“ Capital Equipment Agreement ” means a separate agreement that the parties may enter into that will address responsibility for the purchase of capital equipment and facility modifications that may be required to perform the Manufacturing Services under a particular Product Agreement;

“ cGMPs ” means, as applicable, current good manufacturing practices as described in:

together with the latest Health Canada, FDA and EMA guidance documents pertaining to manufacturing and quality control practice, all as updated, amended and revised from time to time;

“Client Intellectual Property” means Intellectual Property generated or derived by Client before entering into this Agreement, or by Patheon while performing any Manufacturing Services or otherwise generated or derived by Patheon in its business which Intellectual Property is specific to, or dependent upon, Client’s Active Material or Product;

“ Client Property ” has the meaning specified in Section 8.3(a)(v);

“ Client-Supplied Components ” means those Components to be supplied by Client or that have been supplied by Client;

“ Change Control Procedure ” has the meaning specified in Section 6.10(a);

“ Components ” means, collectively, all packaging components, raw materials, ingredients, and other materials (including labels, product inserts and other labelling for the Products) required to manufacture the Products in accordance with the Specifications, other than the Active Materials;

“ Confidential Information ” has the meaning specified in Section 11.1;

“ Conversion Fee ” means the Price for performing the Manufacturing Services excluding the cost of Components;

“ CTD ” has the meaning specified in Section 7.9(c);

“C-TPAT ” has the meaning specified in Section 2.1(f);

“ Deficiencies ” have the meaning specified in Section 7.9(d);

“ Deficiency Notice ” has the meaning specified in Section 6.1(a);

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“Delivery Date” means the date scheduled for shipment of Product under a Firm Order as set forth in Section 5.1(d);

“Disclosing Party ” has the meaning specified in Section 11.1;

“ EMA ” means the European Medicines Agency;

“ FDA ” means the United States Food and Drug Administration;

“ Firm Orders ” have the meaning specified in Section 5.1(c);

“ Force Majeure Event ” has the meaning specified in Section 13.7;

“ GST ” has the meaning specified in Section 13.16(a)(iii);

“ Health Canada ” means the section of the Canadian Government known as Health Canada and includes, among other departments, the Therapeutic Products Directorate and the Health Products and Food Branch Inspectorate;

“ Importer of Record ” has the meaning specified in Section 3.2(a);

“ Initial Product Term ” has the meaning specified in Section 8.1;

“ Initial Term ” has the meaning specified in Section 8.1;

“ Intellectual Property ” includes, without limitation, rights in patents, patent applications, formulae, trademarks, trademark applications, trade-names, Inventions, copyrights, industrial designs, trade secrets, and know how;

“ Invention ” means information about any innovation, improvement, development, discovery, computer program, device, trade secret, method, know-how, process, technique or the like, whether or not written or otherwise fixed in any form or medium, regardless of the media on which it is contained and whether or not patentable or copyrightable;

“ Inventory ” means all inventories of Components and work-in-process produced or held by Patheon for the manufacture of the Products but, for greater certainty, does not include the Active Materials;

“ Laws ” means all laws, statutes, ordinances, regulations, rules, by-laws, judgments, decrees or orders of any Authority;

“Long Term Forecast ” has the meaning specified in Section 5.1(a);

“ Manufacturing Services ” means the commercial manufacturing, quality control, quality assurance, stability testing, packaging, and related services, as set forth in this Agreement, required to manufacture Product or Products using the Active Materials and Materials.

“ Manufacturing Site ” means the facility owned and operated by Patheon or an Affiliate of Patheon where the Manufacturing Services will be performed as identified in a Product Agreement;

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“Materials” means all Components and other materials routinely required to manufacture the Products in accordance with the Specifications, other than the Active Materials;

“ Maximum Credit Value ” means the maximum value of Active Materials that may be credited by Patheon under this Agreement, as set forth in a Product Agreement on Schedule D;

“ Minimum Order Quantity ” means the minimum number of batches of a Product to be produced during the same cycle of manufacturing as set forth in a Product Agreement on Schedule B;

“ Obsolete Stock ” has the meaning specified in Section 5.2(b);

“ Patheon Competitor ” means a business that derives greater than […***…]% of its revenues from performing contract pharmaceutical development or commercial manufacturing services;

“Patheon Intellectual Property” means Intellectual Property generated or derived by Patheon before performing any Manufacturing Services, developed by Patheon while performing the Manufacturing Services, or otherwise generated or derived by Patheon in its business which Intellectual Property is not specific to, or dependent upon, Client’s Active Material or Product including, without limitation, Inventions and Intellectual Property which may apply to manufacturing processes or the formulation or development of drug products, drug product dosage forms or drug delivery systems unrelated to the specific requirements of the Product(s);

“Price” means the fees to be charged by Patheon for performing the Manufacturing Services, and includes the cost of Components (other than Client-Supplied Components), certain cost items as set forth in a Product Agreement on Schedule B, and annual stability testing fees as set forth in a Product Agreement on Schedule C;

“ Product(s) ” means the product(s) listed in a Product Agreement on Schedule A;

“ Product Agreement ” means the agreement between Patheon and Client issued under this Agreement in the form set forth in Appendix 1 (including Schedules A to D) under which Patheon will perform Manufacturing Services at a particular Manufacturing Site;

“ Product Claims ” have the meaning specified in Section 6.3(c);

“ Quality Agreement ” means the agreement between the parties entering into a Product Agreement, or between the applicable Affiliate of Patheon and Client if the Manufacturing Services are subcontracted to such Affiliate by Patheon, that sets out the quality assurance standards for the Manufacturing Services to be performed by Patheon for Client;

“ Recall ” has the meaning specified in Section 6.2(a);

“ Recipient ” has the meaning specified in Section 11.1;

“ Regulatory Approval ” has the meaning specified in Section 7.9(a);

“ Regulatory Authority ” means the FDA, EMA, and Health Canada and any other foreign regulatory agencies competent to grant marketing approvals for pharmaceutical products including the Products in the Territory;

“ Remediation Period ” has the meaning specified in Section 8.2(a);

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“ Representatives ” means a party’s directors, officers, employees, advisers, agents, consultants, subcontractors, service partners, professional advisors, or representatives;

“Resident Jurisdiction ” has the meaning specified in Section 13.16(a)(i);

“ Shortfall ” has the meaning specified in Section 2.3(b);

“ Specifications ” means the file, for each Product, which is given by Client to Patheon in accordance with the procedures listed in a Product Agreement on Schedule A and which contains documents relating to each Product, including, without limitation:

all as updated, amended and revised from time to time by Client in accordance with the terms of this Agreement;

“Surplus” has the meaning specified in Section 2.3(c);

“ Target Yield ” has the meaning specified in Section 2.3(a);

“ Target Yield Determination Batches ” has the meaning specified in Section 2.3(a);

“ Tax ” or “ Taxes ” have the meaning specified in Section 13.16(a);

“ Technical Dispute ” has the meaning specified in Section 12.2;

“ Technology Transfer and Scale-Up Services ” means the technology transfer and scale-up services specified in Exhibit D and referred to in Section 2.2.

“ Territory ” means the geographic area described in a Product Agreement where Products manufactured by Patheon will be distributed by Client;

“ Third Party Rights ” means the Intellectual Property of any third party;

“ VAT ” has the meaning specified in Section 13.16(d);

“ Year ” means in the first year of this Agreement or in the first year of a Product Agreement, the period from the Effective Date up to and including December 31 of the same calendar year, and thereafter will mean a calendar year; and

“ Yearly Forecast Volume ” or “ YFV ” has the meaning specified in Section 4.2.1.

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Unless otherwise agreed in a Product Agreement, all monetary amounts expressed in this Agreement are in US Dollars.

The division of this Agreement into Articles, Sections, Subsections, an Appendix, Schedules and Exhibits and the insertion of headings are for convenience of reference only and will not affect the interpretation of this Agreement. Unless otherwise indicated, any reference in this Agreement to a Section, Appendix, Schedule or Exhibit refers to the specified Section, Appendix, Schedule or Exhibit to this Agreement. In this Agreement, the terms “ this Agreement ”, “ hereof ”, “ herein ”, “ hereunder ” and similar expressions refer to this Agreement as a whole and not to any particular part, Section, Appendix, Schedule or Exhibit of this Agreement.

Except as otherwise expressly stated or unless the context otherwise requires, all references to the singular will include the plural and vice versa.

Appendix 1 (including the Schedules thereto) and the following Exhibits are attached to, incorporated in, and form part of this Agreement:

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ARTICLE 2

PATHEON’S MANUFACTURING SERVICES

Patheon will perform the Manufacturing Services for the Territory for the Price specified in a Product Agreement in Schedules B and C to manufacture Products for Client. Schedule B to a Product Agreement sets forth a list of cost items that are included in the Price for Products; all cost items that are not included in the Price are subject to additional fees to be paid by Client which will be the subject of a written agreement between the Parties. Patheon may amend the fees set out in Schedules B and C to a Product Agreement as set forth in Article 4. Patheon may change the Manufacturing Site for the Products only with the prior written consent of Client, this consent not to be unreasonably withheld, provided, however, Patheon acknowledges that avoidance of a cost increase is a valid reason for Client to withhold consent. In performing the Manufacturing Services, Patheon and Client agree that:

In the event that Client requests a stability program to be terminated early, any costs associated with the disposal of any remaining drug product or shipment of any remaining drug product back to Client will be charged to Client at a price to be agreed in good faith between the parties.

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2.2     Technology Transfer and Scale-Up Services and Additional Services

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2.3     Active Material Yield .

Quantity Received: The total quantity of Active Materials and Client-Supplied Components that complies with the Specifications and is received at the Manufacturing Site during the applicable period.

Quantity Dispensed: The total quantity of Active Materials and Client-Supplied Components dispensed at the Manufacturing Site during the applicable period. The Quantity Dispensed is calculated by adding the Quantity Received to the inventory of Active Materials that complies with the Specifications held at the beginning of the applicable period, less the inventory of Active Materials that complies with the Specifications held at the end of the period. The Quantity Dispensed will only include Active Materials received and dispensed in commercial manufacturing of Products, and will not include any (i) Active Materials that must be retained by Patheon as samples, (ii) Active Materials contained in Product that must be retained as samples, (iii) Active Materials used in testing (if applicable), and (iv) Active Materials received or dispensed in technical transfer activities or development activities during the applicable period, including without limitation, any regulatory, stability, validation or test batches manufactured during the applicable period.

Quantity Converted: The total amount of Active Materials and Client-Supplied Components contained in the Products manufactured with the Quantity Dispensed (including any additional Products produced in accordance with Section 6.3(a) or 6.3(b), delivered by Patheon, and not rejected, recalled or returned in accordance with Sections 6.1 or 6.2 because of Patheon’s failure to perform the Manufacturing Services in accordance with Specifications, cGMPs, and Applicable Laws.

Within […***…] days after the end of each Year, Patheon will prepare an annual reconciliation of Active Materials and Client-Supplied Components on the reconciliation report form set forth in Exhibit C including the calculation of the “ Actual Annual Yield ” or “ AAY ” for the Product at the Manufacturing Site during the Year. AAY is the percentage of the Quantity Dispensed that was converted to Products and is calculated as follows:

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After Patheon has produced a minimum of […***…] successful commercial production batches of Product and has produced commercial production batches for at least […***…] at the Manufacturing Site (collectively, the “ Target Yield Determination Batches ”), the parties will agree on the target yield for the Product at the Manufacturing Site (each, a “ Target Yield ”). The Target Yield will be revised annually to reflect the actual manufacturing experience as agreed to by the parties.

Shortfall = [(Target Yield – […***…]%) – AAY] * Active Materials Credit Value * Quantity Dispensed

Surplus = [AAY — Target Yield] * Active Materials Credit Value * Quantity Dispensed

Each credit under this Section 2.3 will be summarized on the reconciliation report prepared in the form set forth in Exhibit C. Upon expiration or termination of a Product Agreement, any remaining Shortfall credit amount owing under this Section 2.3 will be paid to Client.

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ARTICLE 3

CLIENT’S OBLIGATIONS

Client will pay Patheon for performing the Manufacturing Services and the Additional Services according to the Prices specified in Schedules B and C in a Product Agreement. These Prices may be subject to adjustment under other parts of this Agreement. Client will also pay Patheon for performing the Technology Transfer and Scale-Up Services according to the Prices specified in the applicable Technology Transfer Services Agreement (as described in Section 2.2(c)).

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ARTICLE 4

CONVERSION FEES AND COMPONENT COSTS

The Price for the first Year listed in Schedules B and C in a Product Agreement will be subject to the adjustments set forth in Sections 4.2 and 4.3. The Price may also be increased or decreased by Patheon at any time upon written notice to Client if there are changes to the underlying manufacturing, packaging or testing assumptions as agreed by the Parties, subject to the Change Control Procedure outline in Section 6.10 and set forth in a revised Schedule B of the Product Agreement.

After the first Year of the Product Agreement, Patheon may adjust the Price effective January 1 ^st of each Year as follows:

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On the execution of a Product Agreement, Client will give to Patheon a forecast, by […***…], of the volume of Product required for the first […***…] of the Product Agreement (the “ Yearly Forecast Volume ” or “ YFV ”) that will become part of the Product Agreement. The Yearly Forecast Volume shall be updated on a […***…] basis as provided in Section 5.1(c). The first […***…] of the Yearly Forecast Volume will be binding upon Client; the next […***…] will be binding upon Client at […***…]%, the next […***…will be binding upon Client at […***…]% and the final […***…] will be binding upon Client at […***…]%. Upon receipt of a Yearly Forecast Volume, Patheon shall reserve capacity to the extent required by the binding commitment.

Client shall be obliged to order and purchase an annual binding minimum amount of Product equal to USD$[…***…] (based on small scale commercial manufacturing) or USD$[…***…] (based on full scale commercial manufacturing) as applicable. If in any Year the amount of Product purchased by Client is less than USD$[…***…] or USD$[…***…] as applicable (i.e. payments of the Price received by Patheon) (“ Actual Annual Purchase Amount ”) then Client shall pay Patheon the shortfall between USD$[…***…] or USD$[…***…] as applicable and the Actual Annual Purchase Amount. Patheon shall be entitled to invoice Client for any shortfall following 31 December of each Year.

Amendments to the Specifications or the Quality Agreement requested by Client will be implemented only following a technical and cost review that Patheon will perform subject to Section 6.10. Amendments to the Specifications, the Quality Agreement, or the Manufacturing Site requested by Patheon will only be implemented following the written approval of Client subject to Section 6.10. If Client accepts a proposed Price change, the proposed change in the Specifications or the Quality Agreement and the associated scope of work will be implemented at Client’s cost, and the Price change will become effective, only for those orders of Product that are manufactured under the revised Specifications. In addition, Client agrees to purchase, at the price paid by Patheon (including all costs incurred by Patheon for the purchase, handling, and transport of the Inventory), all Inventory held under the “old” Specifications and purchased or maintained by Patheon in order to fill Firm Orders or under Section 5.2, if the Inventory can no longer be used under the revised Specifications. Open purchase orders for Components no longer required under any revised Specifications that were placed by Patheon with suppliers in order to fill Firm Orders or under Section 5.2 will be cancelled where possible, but if the orders may not be cancelled without penalty, they will be assigned to and paid for by Client. Additional

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payments or price increases may also be required to compensate Patheon for fees and other expenses incurred by Patheon to comply with Regulatory Authority requirements or changes in Applicable Laws which apply solely to the Manufacturing Services provided herein.

If Client decides to have Patheon perform Manufacturing Services for the Product for countries outside the Territory, then Client will inform Patheon of the packaging requirements for each new country and Patheon will prepare a quotation for consideration by Client of any additional costs for Components (other than Client-Supplied Components). The agreed additional packaging requirements and related packaging costs and change over fees will be set out in a written amendment to this Agreement.

The Parties agree to share cost improvement measures related to the Manufacturing Services. All cost improvement investments specific for such Product shall require consent. Patheon shall be entitled to receive reimbursement for reasonable costs which it incurred in developing such cost improvements. Cost improvement benefits concerning such Manufacturing Services shall be allocated equitably between the parties to be reflected in the Price. Client shall pay such Price to Patheon in accordance with the provisions as set forth in this Agreement.

ARTICLE 5

ORDERS, SHIPMENT, INVOICING, PAYMENT

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(a)    Client understands and acknowledges that Patheon will rely on the Firm Orders and rolling forecasts submitted under Sections 5.1(a), and (b) in ordering the Components (other than Client-Supplied Components) required to meet the Firm Orders. In addition, Client understands that to ensure an orderly supply of the Components , Patheon may want to purchase the Components in sufficient volumes to meet the production requirements for Products during part or all of the forecasted periods referred to in Section 5.1(a) or to meet the production requirements of any longer period agreed to by Patheon and Client. Accordingly, Client authorizes Patheon to purchase Components to satisfy the Manufacturing Services requirements for Products for the first […***…] contemplated in the most recent forecast given by Client under Section 5.1(a). Patheon may make other purchases of Components to meet Manufacturing Services requirements for longer periods if agreed to in writing by the parties.

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Client will give Patheon written authorization to order Components for any launch quantities of Product requested by Client which will be considered a Firm Order when accepted by Patheon.

(b)    Client will reimburse Patheon for the cost of Components ordered by Patheon under Firm Orders or under Section 5.2(a) that are not included in finished Products manufactured for Client within […***…] after the forecasted […***…] for which the purchases have been made (or for a longer period as the parties may agree) or if the Components have expired or are rendered obsolete due to changes in artwork or applicable regulations during the period (collectively, “ Obsolete Stock ”). This reimbursement will include Patheon’s cost to purchase (plus a […***…]% handling fee) and destroy the Obsolete Stock. If any non-expired Components are used in Products subsequently manufactured for Client or in third party products manufactured by Patheon, Client will receive credit for any costs of those Components previously paid to Patheon by Client.

(c)    If Client fails to take possession or arrange for the destruction of non-expired Components within […***…] of purchase or, in the case of the delivery of conforming finished Product not accepted by Client within […***…] of manufacture, Client will pay Patheon USD$[…***…] per pallet, per month thereafter for storing the Components or finished Product. Storage fees for Components or Product which contain controlled substances or require refrigeration will be charged at USD$[…***…] per pallet per month. Storage fees are subject to a one pallet minimum charge per month. Patheon may ship finished Product held by it longer than […***…] to Client at Client’s expense on […***…] days’ written notice to Client.

Client may order Manufacturing Services for batches of Products only in multiples of the Minimum Order Quantities as set out in Schedule B to a Product Agreement.

Delivery of Products will be made EXW (Incoterms 2010) packaged ready for export, including such items required to confirm shipment of goods under controlled condition such as temp tales, documentation suitable for export of the supplied product under controlled conditions and other measures required to satisfy EC Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use (2013/C 343/01) and other Regulatory Authority’s guidance. Title and risk of loss will pass to Client when Products are delivered to the carrier at the Facility. All Products must be free and clear of any liens and encumbrances. In amplification of the provisions regarding EXW Incoterms ^® 2010, and not in limitation thereof, Patheon shall directly or indirectly through Client, upon reasonable request of Client and at Client ’s cost and risk (and as agent for Client), provide assistance in the following (but the following shall remain obligations of Client) (i) addressing special shipping requirements, (ii) obtaining licenses, official authorizations, clearances, customs, or any other documents and/or Information, including security related Information that Client may require for the export, import or transport of the Products to the final destination; and/or (iii) making a contract for carriage and/or insurance. Patheon shall also assist in loading the packed Products in any container, collecting vehicle or other means of transport at the Facility. Client shall, upon request of Patheon, provide Information required for taxation or reporting purposes in respect of the export of the Products.

Invoices will be sent by email to the email address given by Client to Patheon. Invoices will be issued when the Product is released by Patheon. Patheon will also submit to Client, with each shipment of Products, a duplicate copy of the invoice covering the shipment. Patheon will also give Client an invoice covering any Inventory or Components which are to be purchased by Client under Section 5.2 of this Agreement. Each invoice will, to the extent applicable, identify Client’s Manufacturing Services

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purchase order number, Product numbers, names and quantities, unit price, freight charges, and the total amount to be paid by Client. Client will pay all invoices within […***…] days of the date thereof; provided, however, if Client rejects any portion of a shipment pursuant to Section 6.1, no payment shall be required until resolution of the rejected shipment has been reached. If any portion of an invoice is disputed, Client will pay Patheon for the undisputed amount and the parties will use good faith efforts to reconcile the disputed amount as soon as practicable. Interest on undisputed past due accounts will accrue at […***…]% per month which is equal to an annual rate of […***…]%.

ARTICLE 6

QUALITY MANAGEMENT

(a)     Product Claims . Client has the right to reject any portion of any shipment of Product that was not manufactured in accordance with the Specifications, cGMPs, or Applicable Laws, without invalidating any remainder of the shipment. Client will inspect the Product manufactured by Patheon immediately upon receipt and will give Patheon written notice (a “ Deficiency Notice ”) of all claims for Product that was not manufactured in accordance with the Specifications, cGMPs, or Applicable Laws, within […***…] days after Client’s receipt thereof (or, in the case of any defects not reasonably susceptible to discovery upon receipt of the Product, such defect to be defined as a “Latent Defect”, within […***…] days after discovery by Client, but not after the expiration date of the Product). If Client fails to give Patheon the Deficiency Notice within the applicable […***…] day period, then the delivery will be deemed to have been accepted by Client on the […***…] day after delivery or discovery, as applicable. Patheon will have no liability for any deficiency for which it has not received notice within the applicable […***…] day period.

(b)     Determination of Deficiency . Upon receipt of a Deficiency Notice, Patheon will have […***…] days to advise Client by notice in writing if it disagrees with the contents of the Deficiency Notice. If Client and Patheon fail to agree within […***…] days after Patheon’s notice to Client as to whether any Product identified in the Deficiency Notice was not manufactured in accordance with the Specifications, cGMPs, or Applicable Laws, the parties will proceed as follows: (i) if the issue is believed to be caused by a raw material deficiency, laboratory error or a suspect analytical method, representatives from both parties will jointly test the Product and/or materials side by side in the same laboratory to determine if a raw material or testing deficiency is the root cause and whether the Product and/or materials is acceptable; or (ii) if the issue is believed to be process related, representatives from both parties will jointly evaluate the Patheon deviation report to determine if any other investigation could identify the root cause and proceed as determined. If, after the joint testing or investigation has been performed, the parties still cannot agree on the root cause, executives from both parties will meet and use good faith efforts to resolve the deficiency and liability issues. If the parties’ executives are unable to resolve the dispute within […***…] days, the dispute will be handled as a Technical Dispute under Section 12.2.

(c)     Shortages and Price Disputes . Claims for shortages in the amount of Product shipped by Patheon or a Price dispute will be dealt with by reasonable agreement of the parties. Any claim for a shortage or a Price dispute will be deemed waived if it has not been presented within […***…] days of the date of invoice, with the exception of Product subject to a Latent Defect which shall be notified […***…] days from discovery.

(d)     Product Rejection for Finished Product Specification Failure . Internal process specifications will be defined and agreed upon and set out in Schedule A of a Product Agreement. If after a full investigation as set forth in Section 6.1(b), it is determined that Patheon manufactured Product in accordance with (i) the agreed upon process specifications, (ii) the batch production record, (iii) Patheon’s standard operating procedures for manufacturing (including requirements relating to maintenance and operation of equipment), (iv) cGMPs and (v) Applicable Laws, and, despite the manufacturing being

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performed by Patheon in accordance with all of the foregoing, a batch or portion of batch of Product does not meet a finished Product specification, and no root cause is determined for the out of specification result following the full investigation a set forth in Section 6.1(b), Client will pay Patheon the applicable fee per unit for the non-conforming Product if it has not been released for shipment by Patheon. Patheon shall not release for shipment any Product that does not meet a finished Product specification and Client shall not be obliged to pay for any such released Product. The API in the non-conforming Product will be included in the “Quantity Converted” for purposes of calculating the “Actual Annual Yield” under Section 2.3(a).

(a)     Records and Notice . Patheon and Client will each maintain records necessary to permit a Recall of any Product delivered to Client or customers of Client. Each party will promptly notify the other by telephone (to be confirmed in writing) of any information which might affect the marketability, safety or effectiveness of the Product or which might result in the Recall or seizure of the Product. Upon receiving this notice or upon this discovery, each party will stop making any further shipments of any Product in its possession or control until a decision has been made whether a Recall or some other corrective action is necessary. The decision to initiate a Recall or to take some other corrective action, if any, will be made and implemented by Client. “ Recall ” will mean any action (i) by Client to recover title to or possession of quantities of the Product sold or shipped to third parties (including, without limitation, the voluntary withdrawal of Product from the market); or (ii) by any regulatory authorities to detain or destroy any of the Product. Recall will also include any action by either party to refrain from selling or shipping quantities of the Product to third parties which would be subject to a Recall if sold or shipped.

(b)     Recalls . If (i) any Regulatory Authority issues a directive, order or, following the issuance of a safety warning or alert about a Product, a written request that any Product be Recalled, (ii) a court of competent jurisdiction orders a Recall, or (iii) Client determines that any Product should be Recalled or that a “Dear Doctor” letter is required relating the restrictions on the use of any Product, Patheon will co-operate as reasonably required by Client, having regard to all Applicable Laws and regulations.

(c)     Product Returns . Client will have the responsibility for handling customer returns of the Product. Patheon will give Client any assistance that Client may reasonably require to handle the returns.

(a)     Defective Product . If Client rejects Product under Section 6.1 and the deficiency is determined to have arisen from Patheon’s failure to provide the Manufacturing Services in accordance with the Specifications, cGMPs or Applicable Laws, Patheon will credit Client’s account for Patheon’s invoice price for the defective Product. If Client previously paid for the defective Product, Patheon will promptly, at Client’s election, either: (i) refund the invoice price for the defective Product; (ii) offset the amount paid against other amounts due to Patheon hereunder; or (iii) replace the Product with conforming Product, (if Patheon is able to manufacture the replacement Product at the same Manufacturing Site as that of the rejected Product), without Client being liable for payment therefor under Section 3.1, contingent upon the receipt from Client of all Active Materials and Client-Supplied Components required for the manufacture of the replacement Product. For greater certainty, Patheon’s responsibility for any loss of Active Materials in defective Product will be captured and calculated in the Active Materials Yield under Section 2.3.

(b)     Recalled Product . If a Recall or return results from, or arises out of, a failure by Patheon to perform the Manufacturing Services in accordance with the Specifications, cGMPs, or Applicable Laws, Patheon will be responsible for the documented out-of-pocket expenses of the Recall or return and will use its commercially reasonable efforts to replace the Recalled or returned Products with new Products, contingent upon the receipt from Client of all Active Materials and Client-Supplied Components required

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for the manufacture of the replacement Products. For greater certainty, Patheon’s responsibility for any loss of Active Materials in Recalled Product will be captured and calculated in the Active Materials Yield under Section 2.3. If Patheon is unable to replace the Recalled or returned Products (except where this inability results from a failure to receive the required Active Materials and Client-Supplied Components), then Client may request Patheon to reimburse Client for the price that Client paid to Patheon for Manufacturing Services for the affected Products. In all other circumstances, Recalls, returns, or other corrective actions will be made at Client’s cost and expense.

(c)    Except as set forth in Sections 6.3(a) and (b) above and Sections 6.4,6.5. and 6.6 and 10.1 and 10.2 below, Patheon will not be liable to Client nor have any responsibility to Client for any deficiencies in, or other liabilities associated with, any Product manufactured by it, (collectively, “ Product Claims ”). For greater certainty but not limitation, Patheon will have no obligation for any Product Claims to the extent the Product Claim (i) is caused by deficiencies in the Specifications, the safety, efficacy, or marketability of the Product or any distribution thereof, (ii) results from a defect in a Component that is not reasonably discoverable by Patheon using the test methods set forth in the Specifications prior to use of the applicable Component in the performance of the Manufacturing Services, (iii) results from a defect in the Active Materials, Client-Supplied Components or Components supplied by a Client designated additional source that is not reasonably discoverable by Patheon using the test methods set forth in the Specifications, (iv) is caused by actions of Client or third parties occurring after the Product is shipped by Patheon under Section 5.4, (v) is due to packaging design or labelling defects or omissions for which Patheon has no responsibility, (vi) is due to any unascertainable reason despite Patheon having performed the Manufacturing Services in accordance with the Specifications, cGMPs, and Applicable Laws, or (vii) is due to any other breach by Client of its obligations under this Agreement.

(d)    Patheon will only be required to replace or refund any batch or portion of a batch of recalled Product and will only be liable for Active Material contained therein to the extent (i) the Product is unsold, returned, destroyed or otherwise disposed of by Client in accordance with the terms of this Agreement or (ii) the Product has been recalled by Client for a Latent Defect (as described in Section 6.1(a)) and such Product has been placed on the market and cannot be recovered and the Latent Defect could not have been detected by Client. The quantity of API contained in this Product will be included in the Quantity Dispensed but not in the Quantity Converted for purposes of calculating the Shortfall in Section 2.3(b).

Client will not dispose of any damaged, defective, returned, or Recalled Products for which it intends to assert a claim against Patheon without Patheon’s prior written authorization to do so. Alternatively, Patheon may instruct Client to return the Products to Patheon. Patheon will bear the cost of transportation and disposition for any damaged, defective, returned or Recalled Products for which it bears responsibility under Section 6.3. In all other circumstances, Client will bear the cost of disposition, including all applicable fees for Manufacturing Services, for any damaged, defective, returned, or Recalled Products.

Client will have the sole responsibility for responding to questions and complaints from its customers. Questions or complaints received by Patheon from Client’s customers, healthcare providers or patients will be promptly referred to Client. Patheon will co-operate as reasonably required to allow Client to determine the cause of and resolve any questions and complaints. This assistance will include follow-up investigations, including testing. In addition, Patheon will give Client all agreed upon information that will enable Client to respond properly to questions or complaints about the Product as set forth in the Quality Agreement. Unless it is determined that the cause of the complaint resulted from a

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failure by Patheon to perform the Manufacturing Services in accordance with the Specifications, cGMPs, and Applicable Laws, all costs incurred under this Section 6.5 will be borne by Client.

Except for the indemnity set forth in Section 10.3 and subject to the limitations set forth in Sections 10.1 and 10.2, the remedies described in this Article 6 will be Client’s sole remedy in contract, tort, equity or otherwise for any failure by Patheon to provide the Manufacturing Services in accordance with the Specifications, cGMPs, and Applicable Laws.

A Quality Agreement shall be executed within […***…] days following the execution of a Product Schedule. The Client and Patheon’s Affiliate shall in good faith negotiate and execute a Quality Agreement concerning the Products and Markets, covering the appropriate activities under this Agreement. Upon execution and delivery of the Quality Agreement by both Client and Patheon’s Affiliate, the Quality Agreement shall automatically become part of this Agreement.

The terms contained in the Quality Agreement are intended to complement the terms of this Agreement, and they shall be interpreted as complementary to the extent possible. In the event of a conflict between the terms of the Quality Agreement and the terms of this Agreement, the terms of this Agreement shall control with respect to business, financial and legal matters, and the terms of the Quality Agreement shall control with respect to quality control and quality assurance matters related to the Product (including, without limitation, manufacturing, testing, storage, release, change management and validation activities); provided, however, that the inclusion of a particular term or level of detail in the Quality Agreement where such term or level of detail is absent from this Agreement shall not be deemed to constitute a conflict between the two agreements. Only where competing terms in the two agreements conflict in terms of the principal focus of an express prescription or prohibition in the agreements shall a conflict between the two agreements be deemed to exist.

Any breach of the Quality Agreement shall be deemed a breach of this Agreement.

(a)     Client Requested Changes . Client shall be entitled to change the Specifications for a Product from time to time, and Patheon shall make all revisions to the Specifications requested by Client, in accordance with the change control procedure set forth in the Quality Agreement (the “ Change Control Procedure ”). Client retains the right and responsibility for final approval of the Specifications for the Products. Except to the extent provided in Section 6.10(b) below, Client shall pay Patheon the amounts incurred in implementing a change to the Specifications requested by Client under this Section 6.10(a), as determined in accordance with the Change Control Procedure. Client shall reimburse Patheon for the agreed Price with Client’s prior written approval in implementing a change to the Specifications requested by Client under this Section 6.10(a). Patheon agrees to use commercially reasonable efforts to minimize its costs associated with any Specification change. At the request of Client, Patheon shall evaluate the estimated costs and timing of potential revisions to the Specifications.

(b)     Patheon Changes . Patheon shall not make any revisions to the Specifications without prior written consent of Client in accordance with the Change Control Procedure. Client retains the right and responsibility for final approval of the Specifications for Products. All requests by Patheon for such revisions shall be submitted in writing to Client. Patheon shall notify Client, in writing and in reasonable

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detail, of (i) Patheon’s suggested change; (ii) the reasons for the suggested change; (iii) the perceived benefits of the suggested change to Patheon and Client, respectively; and (iv) the estimated costs and timing of implementing such change. If the Parties implement a change in the Specifications hereunder, they shall negotiate any changes in any affected Firm Order to provide reasonable accommodation for changed circumstances. Responsibility for documenting all revisions to the Specifications, subject to Client’s approval, will be identified in accordance with the Change Control Procedure, as applicable.

(c)    Payment for Certain Changes. Either Party may request a Specifications change intended to maintain high standards or compliance with Regulatory Acts and Applicable Laws or to bring the Specifications into compliance with high standards or Regulatory Acts and Applicable Laws. Payment for changes required for compliance with Regulatory Acts or Applicable Laws will be made per the following standards:

(d)    Changes in Labeling and Packaging. From time to time CLIENT may require labeling or packaging changes that will affect the Product. These changes may either be initiated by CLIENT, pursuant to Section 6.10(a) above, or may be a requirement resulting from cGMPs changes. Payment will be subject to 6.10(a) and (b) above.

ARTICLE 7

CO-OPERATION

The Parties shall establish a steering committee, consisting of at least one business executive and one senior technical executive from both Parties (“Steering Committee”). The Steering Committee will meet at least quarterly, through face-to-face meetings at a mutually convenient location or via telephone conferences and/or videoconferences, at times to be mutually agreed. The Steering Committee will discuss and resolve any overarching questions or issues and discuss future plans and the relationship between the Parties. The Steering Committee shall not have the authority to modify, supplement, amend or terminate this Agreement. If the Steering Committee is unable to resolve any such differences, the matter(s) shall be escalated to the Chief Financial Officer for the client and a Vice President for Patheon (the “ Senior Executives ”). If the Senior Executives are unable to resolve any such differences, the matter shall be handled pursuant to Article 12.0 of this Agreement.

Upon execution of this Agreement, each party will appoint one of its employees to be a “ Relationship Manager ” responsible for liaison between the parties with respect to the Manufacturing Services covered

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under the relevant Product Agreement and the and Technology Transfer and Scale-Up Services under the relevant Technology Transfer Services Agreement (as described in Section 2.2(c)). The Relationship Managers and appropriate quality assurance and technical personnel from both Parties agree to meet no less than quarterly to review the business relationship including but not limited to, supply, demand, process deviations, metrics, change controls, and project status.

Subject to Section 7.9, each party may communicate with any governmental agency, including but not limited to governmental agencies responsible for granting Regulatory Approval for the Products, regarding the Products if, in the opinion of that party’s counsel, the communication is necessary to comply with the terms of this Agreement or the requirements of any law, governmental order or regulation. Unless, in the reasonable opinion of its counsel, there is a legal prohibition against doing so, a party will permit the other party to accompany and take part in any communications with the agency, and to receive copies of all communications from the agency.

Patheon will keep records of the manufacture, testing, and shipping of the Products, and retain samples of the Products as are necessary to comply with Applicable Laws, as well as to assist with resolving Product complaints and other similar investigations. Unless otherwise agreed to in the Quality Agreement, copies of the records and samples will be retained for one year following the date of Product expiry, or longer if required by law or regulation, following which time Client will be contacted concerning the delivery and destruction of the documents and/or samples of Products. Patheon reserves the right to destroy or return to Client, at Client’s sole expense, any document or samples for which the retention period has expired if Client fails to arrange for destruction or return within […***…] days of receipt of notice from Patheon. Client is responsible for retaining samples of the Products necessary to comply with the legal/regulatory requirements applicable to Client.

Client may inspect Patheon reports and records relating to this Agreement during normal business hours and with reasonable advance notice, but a Patheon representative must be present during the inspection.

Patheon will give Client reasonable access at agreed times to the areas of the Manufacturing Site in which the Products are manufactured, stored, handled, or shipped to permit Client to verify that the Manufacturing Services are being performed in accordance with the Specifications, cGMPs, and Applicable Laws. But, with the exception of “for-cause” audits, Client will be limited each Year to the following: i) […***…] cGMP-type audit, lasting no more than […***…] days, and involving no more than […***…] auditors; and ii) […***…] physical inventory to inspect and count Active Materials and Client-Supplied Materials. Client may request additional cGMP-type audits, additional audit days, or the participation of additional auditors subject to payment to Patheon of a fee of USD$[…***…] for each additional audit day and USD$[…***…] per audit day for each additional auditor. The right of access set forth in Sections 7.5 and 7.6 will not include a right to access or inspect Patheon’s financial records. Patheon will support the first Pre- Approval Inspection (“PAI”) of the FDA or equivalent regulatory inspection for other jurisdictions (where applicable) and provide a copy of the resulting report to Client at no cost . Additional PAI or equivalent support will be subject to additional fees.

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Patheon will notify Client within […***…] of any inspections by any governmental agency specifically involving the Products, and Client will have the right to be present at the Manufacturing Site (but not to participate in the inspection unless requested by the applicable authority) for all such inspections. Patheon will also notify Client of receipt of any form 483s or warning letters or any other significant regulatory action which Patheon’s quality assurance group determines could impact the regulatory status of the Products.

Patheon will supply on an annual basis no fewer than […***…] days prior to the date the Annual Report is due by client, the data required to be in the Annual Product Review Report, which includes all Product data in its control, including release test results, complaint test results, and all investigations (in manufacturing, testing, and storage), that Client reasonably requires in order to complete any filing under any applicable regulatory regime, including any Annual Report that Client is required to file with the FDA. Any additional data or report requested by Client beyond the scope of cGMPs and customary FDA requirements, including Continuous Process Verification data, will be subject to an additional fee to be agreed upon between Patheon and Client.

(a)     Regulatory Authority . Client will have the sole responsibility at Client’s expense for filing all documents with all Regulatory Authorities and taking any other actions that may be required for the receipt and/or maintenance of Regulatory Authority approval for the commercial manufacture, distribution and sale of the Products (“ Regulatory Approval ”) and will provide copies thereof to Patheon on request. Patheon will assist Client, to the extent consistent with Patheon’s obligations under this Agreement, to obtain Regulatory Authority approval for the commercial manufacture, distribution and sale of all Products as quickly as reasonably possible.

(b)     Verification of Data . Prior to filing any documents with any Regulatory Authority that incorporate data generated by Patheon, Client will give Patheon a copy of the documents incorporating this data to give Patheon the opportunity to verify the accuracy and regulatory validity of those documents as they relate to Patheon generated data. Patheon generally requires […***…] days to perform this review but the parties (i) may agree to a shorter time for the review as needed or (ii) shall agree to a shorter time for the review if submission to a Regulatory Authority is required prior to the […***…] day period expiration.

(c)     Verification of CTD . Prior to filing with any Regulatory Authority any documentation which is or is equivalent to the Quality Module (Drug Product Section) of the Common Technical Document (all such documentation herein referred to as “ CTD ”) related to any Marketing Authorization, such as a US New Drug Application, US Abbreviated New Drug Application, US Biologics Licence Application, or EU Marketing Authorisation Application, Client will give Patheon a copy of the CTD as well as all supporting documents which have been relied upon to prepare the CTD. This disclosure will permit Patheon to verify that the CTD accurately describes the validation or scale-up work that Patheon has performed and the manufacturing processes that Patheon will perform under this Agreement. Patheon requires […***…] days to perform this review but the parties may agree to a shorter time for the review as needed. Client will give Patheon copies of all relevant filings at the time of submission which contain CTD information regarding the Product.

(d)     Deficiencies . If, in Patheon’s sole discretion, acting reasonably, Patheon determines that any of the information given by Client under clauses (b) and (c) above is inaccurate or deficient in any manner whatsoever (the “ Deficiencies ”), Patheon will notify Client in writing of the Deficiencies. The parties will work together to have the Deficiencies resolved prior to the date of filing of the relevant

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application and in any event before any pre-approval inspection or before the Product is placed on the market if a pre-approval inspection is not performed.

(e)     Client Responsibility . In reviewing the documents referred to in clause (b) above, Patheon’s role will be limited to verifying the accuracy of the description of the work undertaken or to be undertaken by Patheon. Subject to the foregoing, Patheon will not assume any responsibility for the accuracy of any application for receipt of an approval by a Regulatory Authority. Client is solely responsible for the preparation and filing of the application for approval by the Regulatory Authority and any relevant costs will be borne by Client.

(f)     Inspection by Regulatory Authorities . If Client does not give Patheon the documents requested under subsections (b) and (c) above within the time specified and if Patheon reasonably believes that Patheon’s standing with a Regulatory Authority may be jeopardized, Patheon may, in its sole discretion, delay or postpone any inspection by the Regulatory Authority until Patheon has reviewed the requested documents and is satisfied with their contents.

(g)     Pharmacovigilance. Client will be responsible, at its expense, for all pharmacovigilance obligations for the Products pursuant to Applicable Laws. Unless required by Applicable Law, neither party will be obliged to exchange with the other party any information or data which it compiles pursuant to pharmacovigilance obligations or activities.

(h)     No Patheon Responsibility . Patheon will not assume any responsibility for the accuracy or cost of any application for Regulatory Approval. If a Regulatory Authority, or other governmental body, requires Patheon to incur fees, costs or activities in relation to the Products which Patheon considers unexpected and extraordinary, then Patheon will notify Client in writing and the parties will discuss in good faith appropriate mutually acceptable actions, including fee/cost sharing, or termination of all or any part of this Agreement. Patheon will be not be obliged to undertake these activities or to pay for the fees or costs if, in Patheon’s sole discretion, doing so is commercially inadvisable for Patheon.

ARTICLE 8

TERM AND TERMINATION

This Agreement will become effective as of the Effective Date and will continue until December 31, 2021 (the “ Initial Term ”), unless terminated earlier by one of the parties in accordance herewith. This Agreement will automatically renew after the Initial Term for successive terms of two Years each if there is a Product Agreement in effect, unless either party gives written notice to the other party of its intention to terminate this Agreement at least 18 months prior to the end of the then current term. In any event, the legal terms and conditions of this Agreement will continue to govern any Product Agreement in effect as provided in Section 1.2. Each Product Agreement will have an initial term from the Effective Date of the Product Agreement until December 31 of the Year agreed to by the parties in the Product Agreement (each, an “ Initial Product Term ”). Product Agreements will automatically renew after the Initial Product Term for successive terms of two Years each unless either party gives written notice to the other party of its intention to terminate the Product Agreement at least 18 months prior to the end of the then current term.

(a)    Either party at its sole option may terminate this Agreement or a Product Agreement upon written notice where the other party has failed to remedy a material breach of any of its representations, warranties, or other obligations under this Agreement or the Product Agreement within

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90 days following receipt of a written notice (the “ Remediation Period ”) of the breach from the aggrieved party that expressly states that it is a notice under this Section 8.2(a) (a “ Breach Notice ”). The aggrieved party’s right to terminate this Agreement or a Product Agreement under this Section 8.2(a) may only be exercised for a period of 60 days following the expiry of the Remediation Period (where the breach has not been remedied) and if the termination right is not exercised during this period then the aggrieved party will be deemed to have waived the breach of the representation, warranty, or obligation described in the Breach Notice. The termination of a Product Agreement under this Section 8.2(a) will not affect this Agreement or any other Product Agreements where there has been no material breach of the other Product Agreements.

(b)    Either party at its sole option may immediately terminate this Agreement or a Product Agreement upon written notice, but without prior advance notice, to the other party if: (i) the other party is declared insolvent or bankrupt by a court of competent jurisdiction; (ii) a voluntary petition of bankruptcy is filed in any court of competent jurisdiction by the other party; or (iii) this Agreement or a Product Agreement is assigned by the other party for the benefit of creditors.

(c)    Client may terminate a Product Agreement upon 30 days’ prior written notice if any Authority takes any action, or raises any objection, that prevents Client from importing, exporting, purchasing, or selling the Product. But if this occurs, Client must still fulfill all of its obligations under Section 8.3 below and under any Capital Equipment Agreement regarding the Product.

(d)    Client may terminate a Product Agreement upon six months’ prior written notice if it intends to no longer order Manufacturing Services for a Product due to the Product’s discontinuance in the market.

(e)    Patheon may terminate this Agreement or a Product Agreement upon six months’ prior written notice if Client assigns under Section 13.6 any of its rights under this Agreement or a Product Agreement to an assignee that, in the opinion of Patheon acting reasonably, is: (i) not a credit worthy substitute for Client; or (ii) a Patheon Competitor; or (iii) an entity with whom Patheon has had prior unsatisfactory business relations. Client may terminate this Agreement or a Product Agreement upon six months’ prior written notice if Patheon assigns under 13.6 any of its rights under this Agreement or a Product Agreement to an assignee that, in the opinion of Client acting reasonably, is: (i) not a credit worthy substitute for Patheon; or (ii) a Client Competitor, or (iii) an entity with whom Client has had prior unsatisfactory business relations.

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ARTICLE 9

REPRESENTATIONS, WARRANTIES AND COVENANTS

Each party covenants, represents, and warrants that it has the full right and authority to enter into this Agreement and that it is not aware of any impediment that would inhibit its ability to perform its obligations hereunder.

Client covenants, represents, and warrants that:

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Patheon covenants, represents, and warrants that:

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PATHEON MAKES NO WARRANTY OR CONDITION OF ANY KIND, EITHER EXPRESSED OR IMPLIED, BY FACT OR LAW, OTHER THAN THOSE EXPRESSLY SET FORTH IN THIS AGREEMENT. PATHEON MAKES NO WARRANTY OR CONDITION OF FITNESS FOR A PARTICULAR PURPOSE NOR ANY WARRANTY OR CONDITION OF MERCHANTABILITY FOR THE PRODUCTS.

ARTICLE 10

REMEDIES AND INDEMNITIES

Under no circumstances whatsoever will either party be liable to the other in contract, tort, negligence, breach of statutory duty, or otherwise for (i) any (direct or indirect) loss of profits, of production, of anticipated savings, of business, or goodwill or (ii) any reliance damages, including but not limited to costs or expenditures incurred to evaluate the viability of entering into this Agreement or to prepare for performance under this Agreement or (iii) for any other liability, damage, costs, penalty, or expense of any kind incurred by the other party of an indirect or consequential nature, regardless of any notice of the possibility of these damages.

(a)     Defective or Recalled Product . Patheon’s maximum aggregate liability to Client for any obligation to refund, or offset any defective Product under Section 6.3(a) will not exceed […***…]% of the Price for the defective or recalled Product as applicable . This Section 10.2(a) will not be subject to Section 10.2(c).

(b)     Active Materials . Except as expressly set forth in Section 2.3, under no circumstances will Patheon be responsible for any loss or damage to the Active Materials. Patheon’s maximum responsibility for loss or damage to the Active Materials will not exceed the Maximum Credit Value set forth in Schedule D of a Product Agreement. This Section 10.2(b) will not apply to loss or damage to the Active Materials that occurs during storage at the Manufacturing Site, provided such loss is recoverable under Patheon’s insurance policy (subject to any deductible amounts applied by the insurer) and not subject to any policy exclusions, and, more specifically, such Active Materials were not lost or damaged due to an error or errors in processing or manufacturing.

(c)     Maximum Liability . Except for Patheon’s obligations to […***…], Patheon’s maximum aggregate liability to Client in any Year under this Agreement or any Product Agreement for any reason whatsoever, including, without limitation, any liability arising under Section 6.3(b) relating to the expenses of a Recall or Product return, Sections 2.3 or 10.3 hereof or resulting from

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any and all breaches of its representations, warranties, or any other obligations under this Agreement or any Product Agreement will not exceed on a per Product basis […***…]% of revenues (being payments of the Price) per Year received by Patheon under the applicable Product Agreement during the Year in which the underlying event occurred that gave rise to the liability (e.g. the date of the incident or manufacture) unless the liability arises out of Patheon’s […***…], in which case, Patheon’s maximum aggregate liability to Client in any Year under this Agreement or any Product Agreement will not exceed on a per Product basis […***…]% of revenues per Year received by Patheon under the applicable Product Agreement during the Year in which the underlying event occurred that gave rise to the liability .

(d)     Death, Personal Injury and Fraudulent Misrepresentation . Nothing contained in this Agreement shall act to exclude or limit either party’s liability for personal injury or death caused by the negligence of either party or fraudulent misrepresentation.

(a)    Patheon agrees to defend and indemnify Client, its officers and employees, against all losses, damages, costs, claims, demands, judgments and liability to, from and in favour of third parties (other than Affiliates) for any claim of personal injury or property damage to the extent that the injury or damage is the result of a failure by Patheon to perform the Manufacturing Services in accordance with the Specifications, cGMPs, and Applicable Laws except to the extent that the losses, damages, costs, claims, demands, judgments, and liability are due to the negligence or wrongful act(s) of Client, its officers, employees, or Affiliates.

(b)    If a claim occurs, Client will: (a) promptly notify Patheon of the claim; (b) use commercially reasonable efforts to mitigate the effects of the claim; (c) reasonably cooperate with Patheon in the defense of the claim; and (d) permit Patheon to control the defense and settlement of the claim, all at Patheon’s cost and expense.

(a)    Client agrees to defend and indemnify Patheon, its officers and employees, against all losses, damages, costs, claims, demands, judgments and liability to, from and in favour of third parties (other than Affiliates) for any claim of infringement or alleged infringement of any Third Party Rights in the Products, or any portion thereof, or any claim of personal injury or property damage to the extent that the injury or damage arises other than from (i) a breach of the relevant Product Agreement by Patheon or (ii) the gross negligence or wrongful act(s) of Patheon, including, without limitation, any representation or warranty contained herein, except to the extent that the losses, damages, costs, claims, demands, judgments, and liability are due to the negligence or wrongful act(s) of Patheon, its officers, employees, or Affiliates.

(b)    If a claim occurs, Patheon will: (a) promptly notify Client of the claim; (b) use commercially reasonable efforts to mitigate the effects of the claim; (c) reasonably cooperate with Client in the defense of the claim; and (d) permit Client to control the defense and settlement of the claim, all at Client’s cost and expense.

This Agreement (including, without limitation, this Article 10) is reasonable and creates a reasonable allocation of risk for the relative profits the parties each expect to derive from the Products. Patheon assumes only a limited degree of risk arising from the manufacture, distribution, and use of the Products because Client has developed and holds the marketing approval for the Products, Client requires Patheon to manufacture and label the Products strictly in accordance with the Specifications,

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and Client, not Patheon, is best positioned to inform and advise potential users about the circumstances and manner of use of the Products.

ARTICLE 11

CONFIDENTIALITY

“Confidential Information” means any information disclosed by the Disclosing Party to the Recipient (whether disclosed in oral, written, electronic or visual form) that is non-public, confidential or proprietary including, without limitation, information relating to the Disclosing Party’s patent and trademark applications, process designs, process models, drawings, plans, designs, data, databases and extracts therefrom, formulae, methods, know-how and other intellectual property, its clients or client confidential information, finances, marketing, products and processes and all price quotations, manufacturing or professional services proposals, information relating to composition, proprietary technology, and all other information relating to manufacturing capabilities and operations. In addition, all analyses, compilations, studies, reports or other documents prepared by any party’s Representatives containing the Confidential Information will be considered Confidential Information. Samples or materials provided hereunder as well as any and all information derived from the approved analysis of the samples or materials will also constitute Confidential Information. For the purposes of this ARTICLE 11, a party or its Representative receiving Confidential Information under this Agreement is a “Recipient,” and a party or its Representative disclosing Confidential Information under this Agreement is the “Disclosing Party.”

The Recipient will use the Confidential Information solely for the purpose of meeting its obligations under this Agreement. The Recipient will keep the Confidential Information strictly confidential and will not disclose the Confidential Information in any manner whatsoever, in whole or in part, other than to those of its Representatives who (i) have a need to know the Confidential Information for the purpose of this Agreement; (ii) have been advised of the confidential nature of the Confidential Information and (iii) have obligations of confidentiality and non-use to the Recipient no less restrictive than those of this Agreement. Recipient will protect the Confidential Information disclosed to it by using reasonable precautions to prevent the unauthorized disclosure, dissemination or use of the Confidential Information, which precautions will in no event be less than those exercised by Recipient with respect to its own confidential or proprietary Confidential Information of a similar nature.

The obligations of confidentiality will not apply to the extent that the information:

(a)    is or becomes publicly known through no breach of this Agreement or fault of the Recipient or its Representatives;

(b)    is in the Recipient’s possession at the time of disclosure by the Disclosing Party other than as a result of the Recipient’s breach of any legal obligation;

(c)    is or becomes known to the Recipient on a non-confidential basis through disclosure by sources, other than the Disclosing Party, having the legal right to disclose the Confidential Information, provided that the other source is not known by the Recipient to be bound by any obligations (contractual, legal, fiduciary, or otherwise) of confidentiality to the Disclosing Party with respect to the Confidential Information;

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(d)    is independently developed by the Recipient without use of or reference to the Disclosing Party’s Confidential Information as evidenced by Recipient’s written records; or

(e)    is expressly authorized for release by the written authorization of the Disclosing Party.

Any combination of information which comprises part of the Confidential Information are not exempt from the obligations of confidentiality merely because individual parts of that Confidential Information were publicly known, in the Recipient’s possession, or received by the Recipient, unless the combination itself was publicly known, in the Recipient’s possession, or received by the Recipient.

Neither party will take any photographs or videos of the other party’s facilities, equipment or processes, nor use any other audio or visual recording equipment (such as camera phones) while at the other party’s facilities, without that party’s express written consent.

Notwithstanding any other provision of this Agreement, the Recipient may disclose Confidential Information of the Disclosing Party to the extent required, as advised by counsel, in response to a valid order of a court or other governmental body or as required by law, regulation or stock exchange rule. But the Recipient will advise the Disclosing Party in advance of the disclosure to the extent practicable and permissible by the order, law, regulation or stock exchange rule and any other applicable law, will reasonably cooperate with the Disclosing Party, if required, in seeking an appropriate protective order or other remedy, and will otherwise continue to perform its obligations of confidentiality set out herein. If any public disclosure is required by law, the parties will consult concerning the form of announcement prior to the public disclosure being made.

The Disclosing Party will use reasonable efforts to summarize in writing the content of any oral disclosure or other non-tangible disclosure of Confidential Information within […***…] days of the disclosure, but failure to provide this summary will not affect the nature of the Confidential Information disclosed if the Confidential Information was identified as confidential or proprietary when disclosed orally or in any other non-tangible form.

Upon the written request of the Disclosing Party, the Recipient will promptly return the Confidential Information to the Disclosing Party or, if the Disclosing Party directs, destroy all Confidential Information disclosed in or reduced to tangible form including any copies thereof and any summaries, compilations, analyses or other notes derived from the Confidential Information except for one copy which may be maintained by the Recipient for its records. The retained copy will remain subject to all confidentiality provisions contained in this Agreement.

The parties acknowledge that monetary damages may not be sufficient to remedy a breach by either party of this Article 11 and agree that the non-breaching party will be entitled to seek in any court of competent jurisdiction (notwithstanding Section 13.17 below) specific performance, injunctive and/or other equitable relief to prevent breaches of this Article 11 and to specifically enforce the provisions hereof in addition to any other remedies available at law or in equity. These remedies will not

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be the exclusive remedies for breach of this Article 11 but will be in addition to any and all other remedies available at law or in equity.

ARTICLE 12

DISPUTE RESOLUTION

If any dispute arises out of this Agreement or any Product Agreement (other than a dispute under Section 6.1(b) or a Technical Dispute, as defined herein), the parties will first try to resolve it amicably. In that regard, any party may send a notice of dispute to the other, and each party will appoint, within […***…] Business Days from receipt of the notice of dispute, a single representative having full power and authority to resolve the dispute. The representatives will meet as necessary in order to resolve the dispute. If the representatives fail to resolve the matter within one month from their appointment, or if a party fails to appoint a representative within the […***…] Business Day period set forth above, the dispute will immediately be referred to the […***…] (or another officer as he/she may designate) of each party who will meet and discuss as necessary to try to resolve the dispute amicably. Should the parties fail to reach a resolution under this Section 12.1, the dispute will be referred to a court of competent jurisdiction in accordance with Section 13.17.

If a dispute arises (other than disputes under Section 12.1) between the parties that is exclusively related to technical aspects of the manufacturing, packaging, labelling, quality control testing, handling, storage, or other activities under this Agreement (a “ Technical Dispute ”), the parties will make all reasonable efforts to resolve the dispute by amicable negotiations. In that regard, […***…] of each party will, as soon as possible and in any event no later than […***…] Business Days after a written request from either party to the other, meet in good faith to resolve any Technical Dispute. If, despite this meeting, the parties are unable to resolve a Technical Dispute within a reasonable time, and in any event within […***…] Business Days of the written request, the Technical Dispute will, at the request of either party, be referred for determination to an expert in accordance with Exhibit A. If the parties cannot agree that a dispute is a Technical Dispute, Section 12.1 will prevail. For greater certainty, the parties agree that the release of the Products for sale or distribution under the applicable marketing approval for the Products will not by itself indicate compliance by Patheon with its obligations for the Manufacturing Services and further that nothing in this Agreement (including Exhibit A) will remove or limit the authority of the relevant qualified person (as specified by the Quality Agreement) to determine whether the Products are to be released for sale or distribution.

ARTICLE 13

MISCELLANEOUS

(a)    For the term of this Agreement, Client hereby grants to Patheon a non-exclusive, paid-up, royalty-free, non-transferable license of Client’s Intellectual Property which Patheon must use in order to perform the Manufacturing Services.

(b)    All Client Intellectual Property will be the exclusive property of Client.

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Master Manufacturing Services Agreement

(c)    All Patheon Intellectual Property will be the exclusive property of Patheon. Patheon hereby grants to Client a perpetual, irrevocable, non-exclusive, paid-up, royalty-free, transferable license to use the Patheon Intellectual Property used by Patheon to perform the Manufacturing Services to enable Client to manufacture the Product(s).

(d)    Each party will be solely responsible for the costs of filing, prosecution, and maintenance of patents and patent applications on its own Inventions.

(e)    Either party will give the other party written notice, as promptly as practicable, of all Inventions which can reasonably be deemed to constitute improvements or other modifications of the Products or processes or technology owned or otherwise controlled by the party.

Neither party has, nor will it acquire, any interest in any of the other party’s Intellectual Property unless otherwise expressly agreed to in writing. Neither party will use any Intellectual Property of the other party, except as specifically authorized by the other party or as required for the performance of its obligations under this Agreement.

Each party will maintain commercial general liability insurance, including blanket contractual liability insurance covering the obligations of that party under this Agreement through the term of this Agreement and for a period of three years thereafter. This insurance will have policy limits of not less than (i) USD$ […***…] for each occurrence for personal injury or property damage liability; and (ii) USD$ […***…] in the aggregate per annum for product and completed operations liability. If requested each party will give the other a certificate of insurance evidencing the above and showing the name of the issuing company, the policy number, the effective date, the expiration date, and the limits of liability. The insurance certificate will further provide for a minimum of […***…] days’ written notice to the insured of a cancellation of, or material change in, the insurance. If a party is unable to maintain the insurance policies required under this Agreement through no fault of its own, then the party will forthwith notify the other party in writing and the parties will in good faith negotiate appropriate amendments to the insurance provision of this Agreement in order to provide adequate assurances.

The parties are independent contractors and this Agreement and any Product Agreement will not be construed to create between Patheon and Client any other relationship such as, by way of example only, that of employer-employee, principal agent, joint-venturer, co-partners, or any similar relationship, the existence of which is expressly denied by the parties.

Neither party’s failure to require the other party to comply with any provision of this Agreement or any Product Agreement will be deemed a waiver of the provision or any other provision of this Agreement or any Product Agreement, with the exception of Sections 6.1 and 8.2 of this Agreement.

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Master Manufacturing Services Agreement

Neither party will be liable for the failure to perform its obligations under this Agreement or any Product Agreement if the failure is caused by an event beyond that party’s reasonable control, including, but not limited to, riots, quarantines, communicable disease outbreaks, wars, acts of terrorism, fires, floods, storms, interruption of or delay in transportation, defective equipment, lack of or inability to obtain fuel, power or components, or compliance with any order or regulation of any government entity acting within colour of right (a “ Force Majeure Event ”). A party claiming a right to excused performance under this Section 13.7 will immediately notify the other party in writing of the extent of its inability to perform, which notice will specify the event beyond its reasonable control that prevents the performance. Neither party will be entitled to rely on a Force Majeure Event to relieve it from an obligation to pay money (including any interest for delayed payment) which would otherwise be due and payable under this Agreement or any Product Agreement.

Additional Products may be added to, or existing Products deleted from, any Product Agreement by amendments to the Product Agreement including Schedules A, B, C and D as applicable.

Unless otherwise agreed in a Product Agreement, any notice, approval, instruction or other written communication required or permitted hereunder will be sufficient if made or given to the other party by personal delivery or confirmed receipt email or by sending the same by first class mail, postage prepaid to the respective addresses or electronic mail addresses set forth below:

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Master Manufacturing Services Agreement

If to Client:

Neurocrine Biosciences Inc.

12780 El Camino Real

San Diego 92130

California, USA

Attention: Darin Lippoldt, Chief Legal Officer

Email address: […***…]

If to Patheon:

Patheon UK Limited

Kingfisher Drive

Covingham

Swindon

SN3 6BZ

United Kingdom

Attention: Legal Director

Email address: […***…]

or to any other addresses or electronic mail addresses given to the other party in accordance with the terms of this Section 13.9. Notices or written communications made or given by personal delivery, or electronic mail will be deemed to have been sufficiently made or given when sent (receipt acknowledged), or if mailed, five days after being deposited in the United States, Canada, or European Union mail, postage prepaid or upon receipt, whichever is sooner.

If any provision of this Agreement or any Product Agreement is determined by a court of competent jurisdiction to be invalid, illegal, or unenforceable in any respect, that determination will not impair or affect the validity, legality, or enforceability of the remaining provisions, because each provision is separate, severable, and distinct.

This Agreement, together with the applicable Product Agreement and the Quality Agreement, constitutes the full, complete, final and integrated agreement between the parties relating to the subject matter hereof and supersedes all previous written or oral negotiations, commitments, agreements, transactions, or understandings concerning the subject matter hereof. Any modification, amendment, or supplement to this Agreement or any Product Agreement must be in writing and signed by authorized representatives of both parties. In case of conflict, the prevailing order of documents will be this Agreement, the Product Agreement, and the Quality Agreement.

No terms, provisions or conditions of any purchase order or other business form or written authorization used by Client or Patheon will have any effect on the rights, duties, or obligations of the parties under or otherwise modify this Agreement or any Product Agreement, regardless of any failure of Client or Patheon to object to the terms, provisions, or conditions unless the document specifically refers to this Agreement or the applicable Product Agreement and is signed by both parties.

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Master Manufacturing Services Agreement

For greater certainty, nothing in this Agreement or any Product Agreement will confer or be construed as conferring on any third party any benefit or the right to enforce any express or implied term of this Agreement or any Product Agreement.

This Agreement and any Product Agreement may be executed in two or more counterparts, by original, facsimile or “pdf” signature, each of which will be deemed an original, but all of which together will constitute one and the same instrument.

Patheon will not make any use of Client’s name, trademarks or logo or any variations thereof, alone or with any other word or words, without the prior written consent of Client, which consent will not be unreasonably withheld. Despite this, Client agrees that Patheon may include Client’s name and logo in customer lists or related marketing and promotional material for the purpose of identifying users of Patheon’s Manufacturing Services.

    (a)    Client will bear all taxes, duties, levies and similar charges (and any related interest and penalties) (“ Tax ” or “ Taxes ”), however designated, imposed as a result of the provision by the Patheon of Services under this Agreement, except:

    (b)    If Client is required to bear a tax, duty, levy or similar charge under this Agreement by any state, federal, provincial or foreign government, including, but not limited to, Value Added Tax, Client will pay the tax, duty, levy or similar charge and any additional amounts to the appropriate taxing authority as are necessary to ensure that the net amounts received by Patheon hereunder after all such payments or withholdings equal the amounts to which Patheon is otherwise entitled under this Agreement as if the tax, duty, levy or similar charge did not exist.

    (c)    Patheon will not collect an otherwise applicable tax if Client’s purchase is exempt from Patheon’s collection of the tax and a valid tax exemption certificate is furnished by Client to Patheon.

    (d)    If Section 13.16 (a)(iii) does not apply, any payment due under this Agreement for the provision of Services to Client by Patheon is exclusive of value added taxes, turnover taxes, sales taxes or similar taxes, including any related interest and penalties (hereinafter all referred to as “ VAT ”). If any VAT is payable on a Service supplied by Patheon to Client under this Agreement, this VAT will be added to the invoice amount and will be for the account of (and reimbursable to Patheon by) Client. If VAT on

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Master Manufacturing Services Agreement

the supplies of Patheon is payable by Client under a reverse charge procedure (i.e., shifting of liability, accounting or payment requirement to recipient of supplies), Client will ensure that Patheon will not effectively be held liable for this VAT by the relevant taxing authorities or other parties. Where applicable, Patheon will use its reasonable commercial efforts to ensure that its invoices to Client are issued in such a way that these invoices meet the requirements for deduction of input VAT by Client, if Client is permitted by law to do so.

    (e)    Any Tax that Client pays, or is required to pay, but which Client believes should properly be paid by Patheon pursuant hereto may not be offset against sums due by Client to Patheon whether due pursuant to this Agreement or otherwise.

This Agreement and any Product Agreement, unless otherwise agreed by the parties in the Product Agreement and then only for purposes of that Product Agreement, will be construed and enforced in accordance with the laws of England and subject to the exclusive jurisdiction of the courts thereof. The UN Convention on Contracts for the International Sale of Goods will not apply to this Agreement.

[Signature page to follow]

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Master Manufacturing Services Agreement

IN WITNESS WHEREOF, the duly authorized representatives of the parties have executed this Agreement as of the Effective Date.

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Master Manufacturing Services Agreement

APPENDIX 1

FORM OF PRODUCT AGREEMENT

(Includes Schedules A to D)

PRODUCT AGREEMENT

This Product Agreement (this “ Product Agreement ”) is issued under the Master Manufacturing Services Agreement dated 28 November 2016 between Patheon UK Limited and Neurocrine Biosciences Inc. (the “ Master Agreement ”), and is entered into [        ]     , 2016 (the “ Effective Date ”), between Patheon UK Limited, a corporation existing under the laws of England [or applicable founding jurisdiction for Patheon Affiliate] , having a principal place of business at Kingfisher Drive, Covingham, Swindon, SN3 5BZ, England (“ Patheon ”) and Neurocrine Biosciences Inc, 12780 El Camino Real, San Diego 92130, California, USA (“ Client ”).

The terms and conditions of the Master Agreement are incorporated herein except to the extent this Product Agreement expressly references the specific provision in the Master Agreement to be modified by this Product Agreement. All capitalized terms that are used but not defined in this Product Agreement will have the respective meanings given to them in the Master Agreement.

The Schedules to this Product Agreement are incorporated into and will be construed in accordance with the terms of this Product Agreement.

40

Master Manufacturing Services Agreement

IN WITNESS WHEREOF, the duly authorized representatives of the parties have executed this Product Agreement as of the Effective Date set forth above.

41

Master Manufacturing Services Agreement

SCHEDULE A

PRODUCT LIST AND SPECIFICATIONS

Product List

[ Details to be set out in the applicable Product Agreement ]

Specifications

Prior to the start of commercial manufacturing of Product under this Agreement Client will give Patheon the originally executed copies of the Specifications as approved by the applicable Regulatory Authority. If the Specifications received are subsequently amended, then Client will give Patheon the revised and originally executed copies of the revised Specifications. Upon acceptance of the revised Specifications, Patheon will give Client a signed and dated receipt indicating Patheon’s acceptance of the revised Specifications.

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Master Manufacturing Services Agreement

SCHEDULE B

MINIMUM ORDER QUANTITY, ANNUAL VOLUME, AND PRICE

[Insert Price Table]

Manufacturing Assumptions :

Packaging Assumptions :

Testing Assumptions :

[ … *** … ]

Omitted pages have been filed separately with the Commission.

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Master Manufacturing Services Agreement

SCHEDULE C

ANNUAL STABILITY TESTING [and VALIDATION ACTIVITIES (if applicable)]

Patheon and Client will agree in writing on any stability testing to be performed by Patheon on the Products. This agreement will specify the commercial and Product stability protocols applicable to the stability testing and the fees payable by Client for this testing including the Price for the Product withdrawn for the stability testing.

[NTD: Schedule C should clearly indicate when and/or under what conditions Patheon’s responsibility to perform stability testing will end]

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Master Manufacturing Services Agreement

SCHEDULE D

ACTIVE MATERIALS

[End of Product Agreement]

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Master Manufacturing Services Agreement

EXHIBIT A

TECHNICAL DISPUTE RESOLUTION

Technical Disputes which cannot be resolved by negotiation as provided in Section 12.2 will be resolved in the following manner:

1.     Appointment of Expert . Within […***…] Business Days after a party requests under Section 12.2 that an expert be appointed to resolve a Technical Dispute, the parties will jointly appoint a mutually acceptable expert with experience and expertise in the subject matter of the dispute. If the parties are unable to so agree within the […***…] Business Day period, or if there is a disclosure of a conflict by an expert under Paragraph 2 hereof which results in the parties not confirming the appointment of the expert, then an expert (willing to act in that capacity hereunder) will be appointed by an experienced arbitrator on the roster of the American Arbitration Association.

2.     Conflicts of Interest . Any person appointed as an expert will be entitled to act and continue to act as an expert even if at the time of his appointment or at any time before he gives his determination, he has or may have some interest or duty which conflicts or may conflict with his appointment if before accepting the appointment (or as soon as practicable after he becomes aware of the conflict or potential conflict) he fully discloses the interest or duty and the parties will, after the disclosure, have confirmed his appointment.

3.     Not Arbitrator . No expert will be deemed to be an arbitrator and the provisions of the American Arbitration Act or of any other applicable statute (foreign or domestic) and the law relating to arbitration will not apply to the expert or the expert’s determination or the procedure by which the expert reaches his determination under this Exhibit A.

4.     Procedure . Where an expert is appointed:

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Master Manufacturing Services Agreement

For greater certainty, the release of the Products for sale or distribution under the applicable marketing approval for the Products will not by itself indicate compliance by Patheon with its obligations for the Manufacturing Services and further that nothing in this Agreement (including this Exhibit A) will remove or limit the authority of the relevant qualified person (as specified by the Quality Agreement) to determine whether the Products are to be released for sale or distribution.

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Master Manufacturing Services Agreement

EXHIBIT B

QUARTERLY ACTIVE MATERIALS AND CLIENT SUPPLIED COMPONENTS INVENTORY REPORT

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Master Manufacturing Services Agreement

Capitalized terms used in this report have the meanings given to the terms in the Agreement.    

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Master Manufacturing Services Agreement

EXHIBIT C

REPORT OF ANNUAL ACTIVE MATERIALS INVENTORY RECONCILIATION

AND CALCULATION OF ACTUAL ANNUAL YIELD

((E / D) * 100)

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Master Manufacturing Services Agreement

Based on the foregoing reimbursement calculation Patheon will reimburse Client the amount of EUR                      .

Based on the foregoing reimbursement calculation Patheon may carry forward one Year a Surplus Credit in the amount of EUR                      .

Capitalized terms used in this report have the meanings given to the terms in the Agreement.

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Master Manufacturing Services Agreement

EXHIBIT D

TECHNOLOGY TRANSFER AND SCALE-UP SERVICES

[…***…]

Omitted pages have been filed separately with the Commission.

53 - 91

Exhibit 99.2

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 240.24b-2.

PRODUCT AGREEMENT

(INGREZZA ^TM (valbenazine))

This Product Agreement (this “ Product Agreement ”) is issued under the Master Manufacturing Services Agreement dated 28 November 2016 between Patheon UK Limited and Neurocrine Biosciences Inc. (the “ Master Agreement ”), and is entered into 28 November 2016 (the “ Effective Date ”), between Patheon UK Limited, a corporation existing under the laws of England, having a principal place of business at Kingfisher Drive, Covingham, Swindon, SN3 5BZ, England (“ Patheon ”) and Neurocrine Biosciences Inc, 12780 El Camino Real, San Diego 92130, California, USA (“ Client ”).

The terms and conditions of the Master Agreement are incorporated herein except to the extent this Product Agreement expressly references the specific provision in the Master Agreement to be modified by this Product Agreement. All capitalized terms that are used but not defined in this Product Agreement will have the respective meanings given to them in the Master Agreement.

The Schedules to this Product Agreement are incorporated into and will be construed in accordance with the terms of this Product Agreement.

[…***…]

IN WITNESS WHEREOF, the duly authorized representatives of the parties have executed this Product Agreement as of the Effective Date set forth above.

2

SCHEDULE A

PRODUCT LIST AND SPECIFICATIONS

Product List

[…***…]

3

SCHEDULE B

MINIMUM ORDER QUANTITY, ANNUAL VOLUME, AND PRICE

[…***…]

Omitted pages have been filed separately with the Commission.

4-7

SCHEDULE C

ANNUAL STABILITY TESTING

[…***…]

Omitted pages have been filed separately with the Commission.

8-9

SCHEDULE D

ACTIVE MATERIALS

[…***…]

10

Exhibit 99.3

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4)

and 240.24b-2.

COMMERCIAL PACKAGING AGREEMENT

This Commercial Packaging Agreement (“ Agreement ”) is made as of this 12th day of December, 2016 (“ Effective Date ”), by and among Neurocrine Biosciences Inc., a corporation organized under the laws of Delaware, with offices at 12780 El Camino Real, San Diego, California, 92130, USA (“Client”) and AndersonBrecon Inc., an Illinois corporation, doing business as PCI of Illinois , with a place of business at 4545 Assembly Drive, Rockford, IL 61109 ( “ PCI ”).

RECITALS

A.    Client is a pharmaceutical company that develops, markets and sells pharmaceutical products;

B.    PCI specializes in packaging for the pharmaceutical industry and has certain technical and commercial information and know-how relating to, among other things, performing packaging and labeling of pharmaceutical and other products, into various sized primary and secondary containers; and

C.    Client desires to engage PCI to provide certain commercial packaging services to Client, and PCI desires to provide such services, all pursuant to the terms and conditions set forth in this Agreement.

THEREFORE, in consideration of the mutual covenants, terms and conditions set forth below, the parties agree as follows:

ARTICLE 1

DEFINITIONS

The following terms have the following meanings in this Agreement:

1.1    “ Affiliate(s) ” means, with respect to PCI, Client or any third party, any corporation, firm, partnership or other entity that controls, is controlled by or is under common control with such entity. For the purposes of this definition, “ control ” shall mean the ownership of at least 50% of the voting share capital of an entity or any other comparable equity or ownership interest.

1.2    “ Applicable Laws ” means (i) all laws, ordinances, rules and regulations, as amended from time to time, of the United States applicable to the Packaging or any aspect thereof and the obligations of PCI or Client, as the context requires, under this Agreement, including cGMP, and (ii) to the extent mutually agreed upon the parties in writing, any applicable laws, rules and regulations of one or more foreign jurisdictions relating directly to PCI’s obligations under this Agreement.

1.3    “ Authorization to Package ” means a document, signed by a Client representative or designee and provided to PCI prior to the commencement of Packaging of such product, indicating the Bulk Product has been authorized to be Packaged.

1.4    “ Authorization to Transfer ” means a document, signed by a Client representative or designee and provided to PCI, authorizing PCI to transfer the Packaged Product from the Facility.

1.5    “ Batch ” means a defined quantity of Bulk Product that has been or is being Packaged in accordance with the Specifications.

1.6    “ Bulk Product ” means bulk and work in process product of Client to be Packaged that is specified in Attachment A .

1.7    “ Business Day ” means any day other than a Saturday, Sunday or a national holiday in the United States.

1.8    “ Certificate of Analysis ” means a certificate indicating the Bulk Product’s conformance to the applicable Specifications, signed by a Client representative or designee and provided to PCI prior to the commencement of Packaging of such Bulk Product.

1.9    “ Certificate of Conformance ” means, with respect to a Client-supplied Material other than Bulk Product, a certificate indicating such Client-supplied Material’s conformance with all required testing and other applicable Specifications, signed by a representative of the supplier of such material and provided to PCI prior to the commencement of Packaging using such material.

1.10    “ Certificate of Release ” means a certificate indicating that the Packaging conforms with the Specifications, signed by a PCI representative and provided to Client following the completion of Packaging in accordance with the Quality Agreement.

1.11    “ cGMP ” means all applicable laws, regulations and standards of the United States of America relating to the Packaging including but not limited to, the FDA current Good Manufacturing Practices, as set forth in the Title 21 of the United States Code of Federal Regulations as such regulations and guidelines may be revised from time to time and equivalent non-U.S. regulations solely to the extent such non-U.S. jurisdictions are otherwise included in the definition of “Applicable Laws.”

1.12    “ Client ” has the meaning set forth in the introductory paragraph, or any successor or permitted assign.

1.13    “ Client Indemnitees ” has the meaning set forth in Section 13.1.

1.14    “ Client Intellectual Property ” means all Intellectual Property and embodiments thereof owned by or licensed to Client as of the date hereof or after by Client.

1.15    “ Client Material Loss ” has the meaning set forth in Section 3.1(h).

1.16    “ Client-supplied Materials ” means any materials to be supplied by or on behalf of Client to PCI for Packaging, as provided in Attachment A , including Bulk Product, artwork and labeling.

1.17    “ Confidential Information ” has the meaning set forth in Section 10.2.

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1.18    “ Contract Year ” means each consecutive twelve (12) month period beginning on the Effective Date or anniversary thereof, as applicable.

1.25     “FDA” means the United States Food and Drug Administration or any successor Regulatory Authority having substantially the same function.

1.26     “FD&C Act” means the U.S. Federal Food, Drug and Cosmetic Act, as amended or supplemented from time to time.

1.27    “ Firm Commitment ” has the meaning set forth in Section 4.1.

1.28    “ Intellectual Property ” means all intellectual property (whether or not patented), including without limitation, brands, patents, patent applications, formulae, know-how, trade secrets, copyrights, trademarks, trademark applications, trade names, trade dress, trade secrets, industrial designs, designs, concepts, technical information, manuals, standard operating procedures, instructions, specifications, inventions, processes, data, improvements and developments.

1.32    “ Packaged Product ” means the finished Packaging produced by PCI under this Agreement.

1.33    “ PCI ” has the meaning set forth in the introductory paragraph, or any successor or permitted assign.

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1.41    “ Raw Materials ” means all raw materials, supplies, components and packaging, as provided in Attachment A , but excluding Client-supplied Materials, necessary to Package and ship Packaged Product according to the Specifications.

1.42    “ Recall ” has the meaning set forth in Section 9.6.

1.43    “ Regulatory Approval ” means any approvals, permits, product and/or establishment licenses, registrations or authorizations, including approvals pursuant to U.S. Investigational New Drug applications, New Drug Applications and Abbreviated New Drug Applications (or equivalent non-U.S. filings, such as European marketing authorization applications), as applicable, of any Regulatory Authorities that are necessary or advisable in connection with the development, manufacture, testing, use, storage, exportation, importation, transport, promotion, marketing, distribution or sale of Packaged Product.

1.44    “ Regulatory Authority ” means any federal, state or local governmental or regulatory bodies, agencies, departments, bureaus, courts or other entities in the United States (including the FDA) responsible for (A) the regulation (including pricing) of any aspect of pharmaceutical or medicinal products intended for human use or (B) health, safety or environmental matters generally, and any equivalent non-U.S. governmental or regulatory bodies solely to the extent such non-U.S. jurisdictions are otherwise included in the definition of “Applicable Laws.”

1.48    “ Supplier ” has the meaning set forth in Section 3.3(a).

1.49    “ Term ” has the meaning set forth in Section 16.1.

ARTICLE 2

PROCESSING & RELATED SERVICES

2.1     Supply and Purchase of Packaging . PCI shall Package Bulk Product in accordance with the Specifications, Applicable Laws and the terms and conditions of this Agreement and the Quality Agreement for the consideration provided herein. Client shall be responsible for the manufacturing and testing of Bulk Products at the manufacturer. As agreed in

4

writing by the Parties, including as required by the Specifications and the Quality Agreement, PCI shall be responsible for incoming testing of Bulk Products and testing of Packaged Products. Client shall be responsible for the transportation, sale and distribution of the Packaged Product.

2.2     Other Related Services . PCI shall provide such related services (including tooling purchases and repair; analytical work; stability; auditing of Suppliers; and retain storage) other than Packaging, as agreed to in writing by the parties from time to time. Such writing shall include the scope and fees for any such services and be appended to this Agreement. The terms and conditions of this Agreement shall govern and apply to such services.

ARTICLE 3

MATERIALS

3.1     Client-Supplied Materials .

(a)     Supply . Client or a Supplier on Client’s behalf shall supply to PCI for Packaging, at Client’s sole cost and risk, Client-supplied Materials, including Bulk Product, in quantities sufficient to meet Client’s requirements for Packaging, as set forth in Article 4. Client shall deliver or cause to be delivered such items, together with associated Certificates of Analysis, Certificates of Conformance, lot numbers, expiration dates and Authorizations to Package to the Facility no later than […***…] days before, but not earlier than […***…] days before, the Delivery Date for the Packaged Product in which such items will be used by PCI. If PCI fails to receive the foregoing on a timely basis, PCI shall have the right to delay delivery of the related Packaged Product within the Firm Commitment and store such items, at Client’s expense. The preceding supply schedule for Client-supplied Materials may be adjusted upon mutual agreement of the parties if Client is launching a new product. PCI shall use such items solely and exclusively for Packaging hereunder. Prior to first delivery of any such items, Client shall provide to PCI a copy of all associated material safety data sheets, safe handling instructions and health and environmental information, and shall promptly provide any updates, or revisions thereto.

(b)     Conformity . Within […***…] days of receipt of Client-supplied Materials by PCI, PCI shall confirm that the labels on such items conform to their accompanying packing slip. Unless otherwise expressly required by the Specifications, PCI shall have no obligation to test such items to confirm that they meet the associated Specifications, Certificate of Analysis or Certificate of Conformance or otherwise; but in the event that PCI detects a nonconformity with Specifications, PCI shall give Client prompt notice of such nonconformity. PCI shall not be liable for any defects in Client-supplied Materials, or in Packaging or Packaged Product as a result of defective Client-supplied Materials, unless PCI failed to properly perform the foregoing obligations. PCI shall follow Client’s reasonable written instructions in respect of return or disposal of defective Client-supplied Materials, at Client’s sole cost and risk.

(c)     Customs . Client shall be solely responsible for the proper release and clearance of Client-supplied Materials to be provided by Client or a Supplier for U.S. and foreign customs purposes, including any return thereof required by any Regulatory Authority following improper or unauthorized release, and Client acknowledges that it is the owner of such items for customs purposes. Client shall reimburse PCI for any and all costs, charges and expenses incurred by PCI in connection with customs clearance and release of any such Client-supplied

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Materials. Notwithstanding anything to the contrary herein, if any delay in customs clearance or release of any Client-supplied Materials occurs such that PCI cannot supply the quantity of Packaged Product to Client by the Delivery Dates specified in accepted Purchase Orders, then PCI shall not be obligated to supply Packaged Product to Client hereunder until full and proper customs clearance or release is obtained by Client.

(d)     Title and Risk of Loss for Client-supplied Materials . Title and risk of loss to Client-supplied Materials shall remain with Client while such items are in the possession of PCI and for the duration of the services for each relevant Product. PCI’s liability for any loss to such Client-supplied Materials shall be solely as set forth in Section 3.1(h). Client shall obtain and maintain insurance for Client-supplied Materials in accordance with Section 15.1.

(e)     Artwork and Packaging . Client shall provide or approve, prior to the procurement of applicable components, all artwork, advertising and packaging information necessary for Packaging. Such artwork, advertising and packaging information is and shall remain the exclusive property of Client, and Client shall be solely responsible for the content thereof. Such artwork, advertising and packaging information or any reproduction thereof may not be used by PCI in any manner other than performing its obligations hereunder. PCI requires no less than […***…] calendar days’ notice of changes in artwork, advertising and packaging information; provided, however, that PCI will work with Client in good faith to expedite copy changes on a quicker basis. If Client provides PCI with less notice of changes in artwork, advertising and packaging information, PCI shall not be responsible for any delay in the delivery of Packaged Products to which such changes apply.

(f)     Expired Client-Supplied Materials . Client will be required to dispose of any Client-supplied Materials that have expired within […***…] calendar days of such expiration. PCI will manage destruction of such expired Client-supplied Materials if requested by Client and will invoice Client for the costs thereof. Notwithstanding anything to the contrary herein, PCI reserves the right to refuse to accept deliveries of new Client-supplied Materials pursuant to Section 3.1(a) until Client or its authorized agent has removed, or has authorized PCI to dispose of, all expired Client-supplied Material in PCI’s possession.

(g)     Loss Allowance . For each type of Packaged Product, the parties will mutually agree by […***…] on […***…] allowance for the […***…] for Bulk Product and other Client-supplied Materials that are not converted to Packaged Product (“ Loss Allowance ”). The initial Loss Allowance for each product shall be established after the first […***…] packaging lots following the validation campaign, instructed by data from such packaging lots. If the parties do not agree, PCI will propose a commercially reasonable Loss Allowance. If Client does not agree with such proposal, the Loss Allowance will be determined in accordance with the provisions of Section 18.10 below. The Loss Allowance shall be adjusted in the event of any changes to the Specifications, including without limitation any changes to the Bulk Product.

(h)     Liability for Loss . PCI’s liability to Client for any loss or damage, other than as a result of PCI’s willful misconduct, to Client-supplied Materials is limited to: (i) process scrap arising from the Packaging operations, (ii) Client-supplied Materials that are not reasonably recoverable from Defective Packaging attributable to PCI Fault or (iii) Client-supplied Materials lost or damaged due to PCI’s negligence or gross negligence in its handling or

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storing the Client-supplied Materials (collectively, “ Client Material Loss ”), but only to the extent that such Client Material Loss exceeds the Loss Allowance. When calculating the amount of Client Material Loss, the following shall not be counted as issued to the line for Packaging: (i) Client-supplied Materials used for samples and testing, (ii) Packaged Product that must be retained by PCI as samples, pursuant to this Agreement, the Quality Agreement or Applicable Laws, and (iii) Client-supplied Materials that are non-conforming to Specifications. Notwithstanding any other provision of this Agreement, PCI shall be liable to Client for all loss or damage to Client-supplied materials that results from PCI’s willful misconduct.

(i)     Annual Reconciliation of Excess Loss; Reimbursement . Within […***…] days following the end of each Contract Year, PCI will perform a reconciliation for each type of Packaged Product for the prior Contract Year and will calculate for applicable Client-supplied Materials (i) the Client Material Loss and (ii) the amount, if any, by which the Client Material Loss exceeds the Loss Allowance (such excess referred to as the “ Excess Loss ”). PCI will reimburse Client for Excess Loss, if any, at Client’s cost to produce or acquire the Client-supplied Materials subject to the limitation set forth in Section 14.1. For purposes of this Section 3.1(i), “cost” shall mean (i) for Client-supplied Materials produced by Client or its Affiliate, material, fully-burdened labor and overhead costs to manufacture the Client-supplied Materials and (ii) for Client-supplied Materials purchased from unaffiliated third parties, the actual out of pocket costs paid to the third parties related to the acquisition of the Client-supplied Materials.

3.2     Raw Materials .

(a)     Procurement . PCI shall be responsible for procuring, inspecting and releasing adequate Raw Materials as necessary to meet the Firm Commitment, unless otherwise agreed to by the parties in writing. PCI shall rely on the Firm Commitment for purchasing Raw Materials for use in the Packaged Products forecasted. To the extent practicable, PCI will procure Raw Materials on a quarterly basis based on projected quarterly requirements in an effort to reduce costs of such components and materials. Notwithstanding anything to the contrary herein, if the lead time necessary to acquire Raw Materials is greater than […***…] days, PCI shall submit orders for such Raw Materials based on the Rolling Forecast in a timely manner, and Client shall be liable for such costs incurred by PCI in the event that Client fails to purchase sufficient quantities of Packaged Products as provided in the Rolling Forecast on which PCI relied. In the event that the quantity of Packaged Products in any Rolling Forecast provided by Client pursuant to Article 4 decreases or increases significantly from one Rolling Forecast to the next, PCI reserves the right (i) to purchase the Raw Materials required for such Packaged Products on a periodic basis as needed to meet such fluctuating requirements and (ii) in accordance with Section 7.2, to adjust the Pricing for such Packaged Products to reflect the costs of such fluctuating purchases.

(b)     Title and Risk of Loss for Raw Materials . Title and risk of loss with respect to the Raw Materials used for the Packaged Products will remain with PCI until PCI delivers Packaged Products to a common carrier for shipment to Client.

(c)     Reimbursement for Raw Materials . In the event of (i) a Specification change for any reason, (ii) obsolescence of any Raw Material or (iii) further to Article 16, termination or expiration of this Agreement, Client shall bear the cost of any unused Raw Materials plus […***…]%, so long as PCI purchased such Raw Materials in quantities consistent with

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Client’s most recent Firm Commitment, the Supplier’s minimum purchase obligations and Section 3.2(a). Payment will be due within […***…] days of Client’s receipt of PCI’s invoice.

(d)     Storage . […***…] days after receipt at PCI, Raw Materials or Client-supplied Materials, including Bulk Product, held in inventory will be subject to the storage and carrying costs as set forth on Attachment B, but only if no purchase orders have been submitted for Packaged Product to be delivered in the following month sufficient to utilize the Raw Materials or Client-supplied Materials. In the event that the storage and carrying costs are not included on Attachment B, such charge shall be $[…***…] per month per pallet.

3.3     Mandated Supplier .

(a)     Use of Supplier . In certain instances, Client may require a specific supplier, manufacturer or vendor (“ Supplier ”) to be used for Raw Materials or to furnish Client-supplied Materials. In such an event, (i) such Supplier will be identified in the Specifications or otherwise in writing, (ii) Client shall be responsible for the timeliness, quantity and quality of supply of Raw Materials or Client-supplied Materials from such Supplier, (iii) PCI shall not be liable for any defects in Raw Materials or Client-supplied Materials from such Supplier, or in Packaging or Packaged Product as a result of such defective Raw Materials or Client-supplied Materials, unless PCI failed to properly perform any testing required by the Specifications, and (iv) Raw Materials from such Supplier shall be deemed, for all purposes hereunder including required supply schedule and liability, Client-supplied Materials. If a Supplier fails to deliver the appropriate quantity and quality of Raw Materials or Client-supplied Materials on the required supply schedule and PCI is unable to resolve the issue with Supplier, PCI shall so notify Client of such supply issue and Client shall, to the extent practicable, have a discussion with the Supplier in an effort to resolve such failure. Client shall have no obligation to continue such discussion with the Supplier following the initial discussion or after such offer of an initial discussion, if the Supplier refuses such discussion. If a Supplier refuses such discussion or fails to supply PCI with Raw Materials or Client-supplied Materials such that PCI cannot supply Packaged Product to Client, then, to the extent of such failure, PCI shall not be obligated to supply Packaged Product to Client hereunder until such failure to supply is remedied, either with the Supplier or with an alternate supplier.

(b)     Costs . If the cost of the Raw Material from any such Supplier is greater than PCI’s costs for the same raw material of equal quality from other suppliers, PCI shall add the difference between PCI’s cost of the Raw Material and the Supplier’s cost of the Raw Material to the Pricing. Client will be responsible for all costs associated with qualification of any such Supplier that has not been previously qualified (as described in Section 3.3(c)) by PCI.

(c)     Qualification . Client acknowledges and agrees that any Supplier mandated by Client (i) must meet PCI’s requirements for credit approval and (ii) prior to the delivery of any Raw Materials or Client-supplied Materials by such Supplier to the Facility, must pass either (A) the quality audit conducted by PCI or, (B) if Client acknowledges in writing to PCI no later than […***…] days after selection of the Supplier that Client shall be solely responsible for conducting all quality audits of such Supplier, the quality audit conducted by Client. Notwithstanding anything to the contrary herein, Client further acknowledges and agrees that PCI shall not be required to utilize or contract with any Supplier that fails to meet the foregoing credit and audit requirements.

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ARTICLE 4

PURCHASE ORDERS & FORECASTS

4.1     Forecast . On or before the […***…] day of each […***…], beginning at least […***…] days prior to the first expected delivery of a Packaged Product, Client shall furnish to PCI a written […***…]-month rolling forecast of the quantities of Bulk Product that Client intends to have PCI Package during such period (“ Rolling Forecast ”). The Rolling Forecast shall be submitted in […***…] buckets and in Excel spreadsheet format and shall include […***…] quantity requirements by Client Packaged Product SKU and the proposed delivery date(s). The first […***…] of such Rolling Forecast shall constitute a binding order for the quantities of Product specified therein (“ Firm Commitment ”) and the following […***…] of the Rolling Forecast shall be non-binding, good faith estimates. Notwithstanding anything to the contrary herein, if the lead time necessary to schedule production is greater than […***…] days, PCI shall schedule production based on the Rolling Forecast in a timely manner. In the event PCI believes it may not be able to meet the requirements of any Rolling Forecast, it shall notify Client within […***…] days of receipt of such Rolling Forecast, and the parties shall agree in good faith appropriate modifications to the Rolling Forecast.

4.2     Purchase Orders .

(a)    From time to time as provided in this Section 4.2(a), Client shall submit to PCI a binding, non-cancelable purchase order for Packaging specifying the number of Batches, in whole Batch increments, to be Packaged, the Batch size (to the extent the Specifications permit Batches of different sizes), the proposed delivery date(s) for each Batch, and the lot numbers to be applied to such Batches (“ Purchase Order ”). Concurrently with the submission of each Rolling Forecast, Client shall submit a Purchase Order for the portion of the Firm Commitment which is not already subject to Purchase Order. Purchase Orders for Packaging quantities of Bulk Product in excess of the Firm Commitment shall be submitted by Client at least […***…] days in advance of the delivery date(s) requested in the Purchase Order.

(b)    Provided that a Purchase Order is consistent with the Firm Commitment and other terms and conditions of this Agreement, within […***…] days following receipt of a Purchase Order, PCI may issue a written acknowledgement to Client that it accepts such Purchase Order with the proposed delivery date(s) or reasonable alternative delivery date(s), in which event the parties shall promptly reach mutual agreement on acceptable delivery date(s). The term “ Delivery Date(s) ” refers to the firm date(s), as agreed upon by the parties pursuant to this Section 4.2(b), upon which PCI must deliver to Client or authorized agent of Client the Packaged Products.

(c)    PCI reserves the right to reject the portion of any Purchase Orders in excess of […***…]% of the Firm Commitment or otherwise not given in accordance with this Agreement.

(d)    Notwithstanding Section 4.2(c), PCI shall use commercially reasonable efforts to Package Bulk Product in excess of the quantities specified in the Firm Commitment, subject to PCI’s other supply commitments and packaging and equipment capacity; provided ,

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that PCI’s failure to Package Bulk Product quantities in excess of […***…]% of the quantities specified in the Firm Commitment shall not constitute a breach of this Agreement by PCI. Within […***…] days of receipt of a Purchase Order for quantities of Packaged Product in excess of the applicable Rolling Forecast, PCI will notify Client of PCI’s capacity to supply such excess quantity.

(e)    Notwithstanding any amounts due to PCI under Section 7.1, if Client fails to place Purchase Orders sufficient to satisfy the Firm Commitment, Client shall, within […***…] days of receipt of invoice, pay to PCI the Pricing for all Bulk Product that would have been Packaged if Client had placed Purchase Orders sufficient to satisfy the Firm Commitment.

4.3     PCI’s Cancellation of Purchase Orders . Notwithstanding Section 4.4, PCI reserves the right to cancel all, or any part of, a Purchase Order upon […***…] days’ written notice to Client, and PCI shall have no further obligations or liability with respect to such Purchase Order, if Client refuses or fails to timely supply conforming Client-supplied Materials in accordance with Section 3.1, including artwork or related information and such failure by Client to supply such Client-supplied Materials is the primary reason PCI is unable to fulfill all or part of such Purchase Order. Any such cancellation of Purchase Orders shall not constitute a breach of this Agreement by PCI nor shall it absolve Client of its obligation in respect of the Firm Commitment.

4.4     Client ’ s Modification or Cancellation of Purchase Orders . Client may modify the Delivery Date or quantity of Bulk Product to be packaged in a Purchase Order only by submitting a written change order to PCI at least […***…] days in advance of the original Delivery Date covered by such change order. Such change order shall be effective and binding against PCI only upon the written approval of PCI, and notwithstanding the foregoing, Client shall remain responsible for the Firm Commitment. In no event shall PCI be required to incur any costs or suffer any losses in connection with such change order or its efforts to accommodate such a change. Any such costs or losses incurred by PCI shall be paid for by Client.

4.5     Unplanned Delay or Elimination of Packaging . PCI shall use commercially reasonable efforts to meet the Purchase Orders, subject to the terms and conditions of this Agreement. PCI shall provide Client with as much advance notice as possible (and will use commercially reasonable efforts to provide at least […***…] days’ advance notice where possible) if PCI determines that any Packaging will be delayed or cancelled for any reason.

4.6     Observation of Packaging . In addition to Client’s audit right pursuant to Section 9.5, Client may send a reasonable number of representatives to the Facility to observe Packaging, upon reasonable advance written request to PCI. Such representatives shall abide by all PCI safety rules and other applicable employee policies and procedures, and Client shall be responsible for such compliance and must have the appropriate insurance in place to cover such responsibilities. Client shall indemnify and hold harmless PCI for any Losses resulting from an action, omission or other activity of such representatives while on PCI’s premises. PCI reserves the right to require such representatives to enter into separate confidentiality agreements directly with PCI in such persons’ individual capacities on terms substantially similar to those set forth in Article 10.

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ARTICLE 5

TESTING; SAMPLES; RELEASE

5.1     Releasing; Rejection . PCI shall provide Client or its designee with a completed Batch Record according to Section 9.1. Upon review and acceptance of such batch record including resolution of any deviations, PCI will then provide Client with a Certificate of Release for each Batch consistent with the requirements in the Quality Agreement. Client shall notify PCI in writing that it agrees with this release according to terms of the Quality Agreement. Client is subsequently responsible for final release of Packaged Product to the market. Unless within […***…] days after Client’s physical receipt of a Batch, including batch records (“ Review Period ”), Client or its designee notifies PCI in writing (an “ Exception Notice ”) that the Packaging of such Batch does not meet the warranty set forth in Section 12.1 (“ Defective Packaging ”), and provides a sample of the alleged Defective Packaging, the Packaging shall be deemed accepted by Client and Client shall have no right to reject such Batch. Such acceptance will not apply in the case of any Defective Packaging not reasonably susceptible to discovery upon receipt of the Packaged Product, such defect to be defined as a “Latent Defect”. Client will use commercially reasonable efforts to report Latent Defects as soon as possible but in any event not later than […***…] days after discovery by Client, but not after the expiration date of the Product.

5.2    Upon timely receipt of an Exception Notice from Client, PCI shall conduct an appropriate investigation in its discretion to determine whether or not it agrees with Client that the Packaging is Defective Packaging and to determine the cause of any nonconformity. If PCI agrees that Packaging is Defective Packaging and determines that the cause of nonconformity is attributable solely to PCI’s negligence, willful misconduct, or failure to meet the warranty set forth in Section 12.1 (“ PCI Fault ”), then Section 5.4 shall apply. For avoidance of doubt, where the cause of nonconformity cannot be determined or assigned as above, it shall not be deemed PCI Fault.

5.3     Discrepant Results . In the event of a disagreement between the parties regarding whether Packaging is Defective Packaging and/or whether the cause of the nonconformity is PCI Fault, which disagreement cannot be resolved by the parties within […***…] days of the date of the completion of PCI’s investigation, the parties shall cause a mutually agreeable independent third party to review records, test data and to perform comparative tests and/or analyses on samples of the alleged Defective Packaging and its components, including Client-supplied Materials. The independent party’s determination as to whether or not Packaging is Defective Packaging and the cause of any nonconformity shall be final and binding. Unless otherwise agreed to by the parties in writing, the costs associated with such testing and review shall be borne by PCI if Packaging is Defective Packaging attributable to PCI Fault, and by Client in all other circumstances.

5.4     Defective Packaging . PCI will, at the sole option of Client after good faith consultation with PCI, either re-Package at its cost any Batch of Defective Packaging attributable to PCI Fault (and Client shall be liable to pay for either the rejected Batch(es) or the replacement Batch(es), but not both), or credit any payments made by Client for such Batch. THE FOREGOING OBLIGATION OF PCI TO RE-PACKAGE (REGARDLESS OF COST) OR CREDIT PAYMENTS MADE BY CLIENT AND REIMBURSE FOR CLIENT MATERIALS IN THE EVENT OF EXCESS LOSS UNDER SECTION 3.1(i) SHALL BE CLIENT’S SOLE AND EXCLUSIVE REMEDY UNDER THIS AGREEMENT FOR DEFECTIVE PACKAGING AND IS IN LIEU OF ANY OTHER WARRANTY, EXPRESS OR IMPLIED.

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5.5     Supply of Material for Defective Packaging . In the event PCI re-Packages pursuant to Section 5.4, Client shall supply PCI with sufficient quantities of Client-supplied Materials in order for PCI to complete such re-Packaging and any Client-supplied Materials in the Defective Packaging that are destroyed or that cannot be re-packaged shall be included in the Excess Loss calculations under Section 3.1(i). Any such re-packaging shall be done on an expedited basis including to the extent that PCI determines in good faith to be necessary to provide on an expedited basis, use of overtime, such overtime costs to be the responsibility of PCI.

ARTICLE 6

DELIVERY

6.1     Delivery . PCI shall deliver Packaged Product Ex Works (Incoterms 2010) the Facility promptly following PCI’s receipt of the Authorization to Transfer, which shall be provided by Client no more than […***…] days after PCI’s issuance of a Certificate of Release, provided , that Client’s failure to provide the Authorization to Transfer in such timeframe shall be deemed as authorizing PCI to tender the Packaged Product for delivery. Notwithstanding the prior sentence, the parties agree that PCI shall be responsible for the loading of the Packaged Product on the carrier’s trucks and shall bear the costs of such loading. Client shall qualify at least […***…] to deliver Packaged Product. Client will schedule carrier for Packaged Product pick-up no later than […***…] days after Client’s release of the Packaged Product according to terms in the Quality Agreement (“ Pick-Up Date ”). If the Packaged Product is to be exported out of the United States, Client shall be solely responsible for obtaining all required export or import licenses available to the Packaged Product prior to such export or import and shall reimburse PCI for any and all costs, charges, expenses and import and export duties for delivery and transportation of Packaged Product from the Facility. PCI should not be listed as the exporter (U.S. Principle Party in Interest) on any documentation relating to the export.

6.2     Failure to Take Delivery; Storage . Upon written agreement of the parties, or if Client fails to take delivery of any Packaged Product according to Section 6.1 , PCI shall store such Packaged Product according to Specifications and cGMP requirements as Client’s agent. If Client or its authorized agent fails to take delivery within […***…] calendar days of the Delivery Date, Client shall be billed $[…***…] per pallet of unshipped Packaged Product at such time and thereafter on the […***…] day of each month until Client or its authorized agent releases and takes delivery of such Packaged Product. For each such Batch of stored Packaged Product, Client agrees that: (A) Client has made a fixed commitment to purchase the Packaging of such Packaged Product, (B) Client has title and risk of loss for such Packaged Product, (C) such Packaging for Packaged Product shall be on a bill and hold basis for legitimate business purposes, and (D) if no rescheduled Delivery Date is determined at the time of billing, PCI shall have the right to ship such Packaged Product to Client within […***…] after billing. Within […***…] Business Days following a written request from PCI, Client shall provide PCI with a letter confirming items (A) through (D) of this Section 6.2 for each Batch of stored Packaged Product.

ARTICLE 7

PAYMENTS

7.1     Fees . In consideration for PCI performing services hereunder:

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(a)    Client shall pay PCI the pricing for Packaging set forth on Attachment B (“ Pricing ”). Such fees shall be paid within […***…] days following date of invoice, which invoice shall be submitted to Client by PCI upon delivery of Packaged Product as provided in Section 6.1 or the entry of the Packaged Products into storage as provided in Section 6.2.

(b)     Other Fees . Client shall pay PCI for all other fees and expenses of PCI owing in accordance with the terms of this Agreement, including pursuant to Sections 2.2, 6.2 and 16.3. Such fees and expenses shall be paid within […***…] days following date of invoice, which invoice shall be submitted to Client by PCI as and when appropriate.

7.2     Pricing Adjustment . The Pricing shall be adjusted following advance written notice from PCI to Client and shall be effective on […***…] of each year of the Term as follows: (i) labor costs shall be subject to annual increase to reflect any increase in the Producer Price Index, commodity code 06-38 for Pharmaceutical Preparations, issued by the Bureau of Labor Statistics, United States Department of Labor over the prior calendar year (based on the publication by the U.S. Department of Labor of the PPI on or about October 15th of the prior calendar year); (ii) cost in Raw Materials shall be subject to annual increase to reflect any increase in PCI’s costs over the prior calendar year, including any increases imposed by a Supplier; and (iii) production costs shall be subject to annual increase to reflect any reduction in purchase volume level below anticipated purchase volume over the prior calendar year. In addition, the parties acknowledge and agree that the Pricing is based on PCI performing order runs of consistent size and frequency and that the Pricing shall be subject to review and adjustment promptly following the occurrence of any unanticipated fluctuation in order run sizes or frequency or fluctuations in forecasted quantities as described in Sections 4.1 and 4.2. For example, such adjustment may include an increase in the Pricing due to reduced order run sizes. In addition, the parties shall negotiate in good faith changes to the Pricing resulting from changes to Applicable Laws that are reasonably likely to materially increase the cost of providing the services.

7.3     Payment Terms . Client shall make payment in U.S. dollars, and otherwise as directed in the applicable invoice. In the event payment is not received by PCI on or before the due date, then PCI may, in addition to any other remedies available at equity or in law, at its option, elect to do any one or more of the following: (A) charge interest on the outstanding sum from the due date (both before and after any judgment) at […***…]%) per month until paid in full (or, if less, the maximum amount permitted by Applicable Laws); (B) suspend any further performance hereunder until such invoice is paid in full; and/or (C) terminate this Agreement pursuant to Section 16.2(b).

7.4     Taxes . PCI shall bear and pay all federal, state and local taxes based upon or measured by its net income, and all franchise taxes based upon its corporation existence, or its general corporate right to transact business. Any other tax, however denominated and measured, imposed upon the Products, the Packaged Products or Packaging or upon their storage, inventory, sales, transportation, delivery, use or consumption shall be paid directly by Client, or if prepaid by PCI, shall be invoiced to Client, at cost, as a separate item and paid by Client to PCI.

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ARTICLE 8

CHANGES TO SPECIFICATIONS

All Specifications and any changes thereto agreed to by the parties from time to time shall be in writing, dated and signed by the parties. Any change to the Packaging process shall be deemed a Specification change. No change in the Specifications shall be implemented by PCI, whether requested by Client, requested by PCI or requested or required by any Regulatory Authority, until the parties have agreed in writing to such change, the implementation date of such change, and any increase or decrease in costs, expenses or fees associated with such change (including any change to Pricing). PCI shall respond promptly to any request made by Client for a change in the Specifications, and both parties shall use commercially reasonable, good faith efforts to agree to the terms of such change in a timely manner. As soon as possible after a request is made for any change in Specifications, PCI shall notify Client of the costs associated with such change and shall provide such supporting documentation as Client may reasonably require. Client shall pay all costs associated with such agreed upon changes. If there is a conflict between the terms of this Agreement and the terms of the Specifications, this Agreement shall control. PCI reserves the right to postpone effecting changes to the Specifications, or in the case of changes requested or required by any Regulatory Authority postpone Packaging under this Agreement, until such time as the parties agree to and execute the required written amendment.

ARTICLE 9

RECORDS; REGULATORY MATTERS

9.1     Batch Records and Data . Within […***…] days following the completion of Packaging of each Batch, PCI shall provide Client with properly completed copies of Batch records prepared in accordance with the Specifications; except in the event an unplanned deviation in the Packaging process occurs, PCI promptly notify Client according to terms in the Quality Agreement. PCI shall then provide such Batch records within […***…] days following resolution of the unplanned deviation. The “Review Period” begins upon receipt of the batch records.

9.2     Recordkeeping . PCI shall maintain materially complete and accurate books, records, reports and all other information relating to Packaging, including all information required to be maintained by Applicable Laws, in accordance with PCI standard operating procedures. Such information shall be maintained for a period of at least […***…] from the relevant Packaged Product expiration date or longer if required under Applicable Laws.

9.3     Regulatory Compliance . Client shall be solely responsible for and will obtain all Regulatory Approvals associated specifically with the Packaged Products, including any applications and amendments in connection therewith. Client shall use its best efforts to expedite and obtain all Regulatory Approvals necessary for PCI to commence Packaging at the Facility. PCI will be responsible to maintain all permits and licenses required by any Regulatory Authority with respect to the Facility generally.

9.4     Governmental Inspections and Requests . PCI shall promptly, but not later than […***…], advise Client if an authorized agent of any Regulatory Authority visits the Facility concerning the Packaging. PCI shall allow up to two Client representatives to be present at any scheduled regulatory inspection directly affecting the Packaged Product. PCI shall

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furnish to Client a copy of the relevant portions of any report by such Regulatory Authority within […***…] days of PCI’s receipt of such report. Further, upon receipt of a Regulatory Authority request to inspect the Facility or audit PCI’s books and records with respect to Packaging, PCI shall promptly notify Client, and shall provide Client with a copy of the relevant portions of any written document received from such Regulatory Authority.

9.5     Client Inspections and Audits .

(a)    During the Term, up to […***…] duly-authorized employees, agents and representatives of Client shall be granted access for a maximum of up to […***…] days (unless otherwise agreed to by PCI in writing) upon reasonable prior written notice and at reasonable times during regular business hours to (i) the portion of the Facility where PCI performs Packaging, (ii) relevant personnel involved in Packaging and (iii) Packaging records described in Section 9.2, in each case solely for the purpose of inspecting and verifying that PCI is Packaging in accordance with cGMPs and the Specifications.

(b)    Client will arrange audit visits with PCI Quality Management at least […***…] days in advance of such visit. Inspections shall be designed to minimize disruption of operations at the Facility. Client may not conduct an inspection under this Section 9.5 more than […***…] during any […***…] period; provided , that additional inspections may be conducted upon reasonable advance written notice in the event there is a material quality or compliance issue concerning Packaging. PCI will allow such an additional inspection within […***…] of the discovery of any material quality or compliance issue subject to the terms of the Quality Agreement.

(c)    During the Term, up to […***…] duly-authorized employees, agents and representatives of Client shall be granted access for a maximum of up to […***…] days (unless otherwise agreed to by PCI in writing) upon reasonable prior written notice and at reasonable times during regular business hours solely for the purpose of conducting an audit of Packaged Product, Client-supplied Materials, or other inventory of Client that is required to be audited for the purpose of preparing Client’s financial statements.

(d)    Employees, agents and representatives of Client performing an audit or inspection shall abide by all PCI safety rules and other applicable employee policies and procedures, and Client shall be responsible for such compliance and must have the appropriate insurance in place to cover such responsibilities. Client shall indemnify and hold harmless PCI for Losses resulting from any action, omission or other activity of such representatives while on PCI’s premises. PCI reserves the right to require such representatives to enter into separate confidentiality agreements directly with PCI in such persons’ individual capacities on terms substantially similar to those set forth in Article 10.

9.6     Recall . If a Regulatory Authority orders or requires the recall of any Packaged Product supplied hereunder or if Client or PCI believes a recall, field alert, Packaged Product withdrawal or field correction (“ Recall ”) may be necessary with respect to any Packaged Product supplied under this Agreement, the party receiving the notice from the Regulatory Authority or that holds such belief shall promptly notify the other party in writing. With respect to any Recall, PCI shall provide all necessary cooperation and assistance to Client. Client shall provide PCI with an advance copy, when possible, of any proposed submission to a Regulatory

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Authority in respect of any Recall, and shall consider in good faith any comments from PCI. Client is responsible for initiating a recall or Field letter. The cost of any Recall shall be borne by Client, and Client shall reimburse PCI for expenses incurred in connection with any Recall, in each case unless such Recall is caused solely by PCI’s gross negligence, willful misconduct, or breach of this Agreement, in which case PCI’s liability for such Recall costs and expenses is limited to a maximum of the lesser of (i) $[…***…] or (ii) the Pricing charged for the recalled Packaged Product, plus reimbursement for any Product that cannot be recovered from such recalled Packaged Product in accordance with the limitation set forth in Section 3.1(i). For purposes of clarification, Recall costs and expenses shall include, without limitation, notification to customers, Product retrieval, Product destruction, shipping and taxes. In the event that a Product is Recalled or Client is required to disseminate information relating to Packaged Product covered by this Agreement, Client shall so notify PCI within a reasonable time so as to enable PCI to provide Client with such assistance in connection with such Recall as may reasonably be requested by Client. PCI will comply with all such reasonable requests from Client. Client shall handle exclusively the organization and implementation of all Recalls of Products and Packaged Products. Any such Recall shall be implemented and administered in a manner which is appropriate and reasonable under the circumstances and in conformity with any requests or orders of the applicable Regulatory Authority, as well as to the extent not inconsistent with requests or orders of the applicable Regulatory Authority, accepted trade practices.

9.7     Duty to Inform . Client shall inform PCI promptly of any important information relating to the activity, side effects, toxicity and/or safety of the Products or Packaged Products that becomes known to Client during the term of this Agreement and that is relevant to the performance of the services by PCI.

9.8     Quality Agreement . Prior to the first Packaging hereunder, the parties shall negotiate in good faith and enter into a Quality Agreement substantially in the form attached hereto as Attachment C (the “ Quality Agreement ”). The Quality Agreement shall in no way determine liability or financial responsibility of the parties for the responsibilities set forth therein. In the event of a conflict between any of the provisions of this Agreement and the Quality Agreement with respect to quality-related activities, including compliance with cGMP, the provisions of the Quality Agreement shall govern. In the event of a conflict between any of the provisions of this Agreement and the Quality Agreement with respect to any commercial matters, including allocation of risk, liability and financial responsibility, the provisions of this Agreement shall govern.

ARTICLE 10

CONFIDENTIALITY AND NON-USE

10.1     Mutual Obligation . PCI and Client each agrees that it will not use the other party’s Confidential Information except in connection with the performance of its obligations hereunder and will not disclose the other party’s Confidential Information to any third party without the prior written consent of the other party, except as required by law, regulation or court or administrative order; provided , that prior to making any such legally required disclosure, the party making such disclosure shall give the other party as much prior notice of the requirement for and contents of such disclosure as is practicable under the circumstances. Notwithstanding the foregoing, each party may disclose the other party’s Confidential Information to any of its Affiliates that (A) need to know such Confidential Information for the purpose of performing

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under this Agreement, (B) are advised of the contents of this Article 10 and (C) agree to be bound by the terms of this Article 10. Without prejudice to the rights and remedies otherwise available to a party at law or in equity, the parties agree that a non-breaching party shall be entitled to seek equitable relief by way of specific performance and injunction or otherwise if the other party breaches or threatens to breach any of the provisions of this Article 10.

10.2     Definition . As used in this Agreement, the term “ Confidential Information ” includes all such information furnished by PCI or Client, or any of their respective representatives or Affiliates, to the other party or its representatives or Affiliates, whether furnished before, on or after the Effective Date and furnished in any form, including written, verbal, visual, electronic or in any other media or manner. Confidential Information includes all proprietary technologies, know-how, trade secrets, discoveries, inventions and any other Intellectual Property (whether or not patented), analyses, compilations, business or technical information and other materials prepared by either party, or any of their respective representatives or Affiliates, containing or based in whole or in part on any such information furnished by the other party or its representatives or Affiliates. Confidential Information also includes the existence of this Agreement and its terms.

10.3     Exclusions . Notwithstanding Section 10.2, Confidential Information does not include information that (A) is or becomes generally available to the public or within the industry to which such information relates other than as a result of a breach of this Agreement, (B) is already known by the receiving party at the time of disclosure as evidenced by the receiving party’s written records, (C) becomes available to the receiving party on a non-confidential basis from a source that the receiving party reasonably believes is entitled to disclose it on a non-confidential basis or (D) was or is independently developed by or for the receiving party without reference to the Confidential Information of the other party as evidenced by the receiving party’s written records.

10.4     No Implied License . Except as expressly set forth in Section 11.1, the receiving party will obtain no right of any kind or license under any Confidential Information of the disclosing party, including any patent application or patent, by reason of this Agreement. All Confidential Information will remain the sole property of the party disclosing such information or data, subject to Article 11.

10.5     Return of Confidential Information . Upon expiration or termination of this Agreement, the party receiving Confidential Information will cease its use and, upon request, within […***…] days either return or destroy (and certify as to such destruction) all Confidential Information of the other party, including any copies thereof, except for a single copy thereof which may be retained for the sole purpose of determining the scope of the obligations incurred under this Agreement. Notwithstanding the generality of the foregoing, nothing contained herein shall be construed as requiring the destruction of system wide back-up materials which may incidentally contain or have reference to Confidential Information.

10.6     Survival . The obligations of this Article will terminate […***…] years from the expiration or termination of this Agreement, except with respect to trade secrets, for which the obligations of this Article will continue for […***…].

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ARTICLE 11

***INTELLECTUAL PROPERTY

11.1     Ownership of Client Intellectual Property; License . All Client Intellectual Property, including any improvements thereto (except as such improvement may relate to packaging which shall be deemed PCI Intellectual Property), shall be the sole and exclusive property of Client. Client grants to PCI a non-exclusive, non-transferable, royalty-free license to use Client Intellectual Property solely to the extent necessary for PCI to perform its obligations under this Agreement. No other license to Client Intellectual Property is hereby granted.

11.2     Ownership of PCI Intellectual Property . All PCI Intellectual Property, including but not limited to any improvements to packaging processes, shall be the sole and exclusive property of PCI. No license or other right to PCI Intellectual Property is granted to Client.

11.3     Ownership of Deliverables . Except as set forth in Section 11.2, all data and information resulting from the conduct of Packaging and required to be delivered to Client hereunder shall be the sole property of Client and shall be subject to Client’s exclusive use, commercial or otherwise.

ARTICLE 12

REPRESENTATIONS AND WARRANTIES

12.1     PCI. PCI represents, warrants and undertakes to Client that Packaging shall have been performed in accordance with , cGMP, Applicable Laws and in conformance with the Specifications; provided , that PCI shall not be liable for defects attributable to Client-supplied Materials (including artwork and labeling).

12.2     Client . Client represents, warrants and undertakes to PCI that:

(a)    the Client-supplied Materials (including artwork and labeling) shall have been produced in accordance with and not violate Applicable Laws and shall comply with all applicable specifications;

(b)    no Client-supplied Materials shall, at the time of delivery, be (i) adulterated or misbranded within the meaning of the FD&C Act, or any similar law of any other jurisdiction, or (ii) an article which may not, under the provisions of the FD&C Act, or any similar law of any other jurisdiction, be introduced into interstate commerce;

(c)    no specific safe handling instructions, health and environmental information or material safety data sheets are applicable to any other Client-supplied Materials, except as provided to PCI in writing by Client in sufficient time for review and training by PCI;

(d)    all Packaged Product delivered to Client by PCI will be held, used and disposed of by or on behalf of the Client in accordance with all Applicable Laws, and Client will otherwise comply with all laws, rules, regulations and guidelines applicable to Client’s performance under this Agreement and its use of Packaged Product provided by PCI under this Agreement;

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(e)    Client will not release any Batch of Packaged Product if Client knows or can reasonably determine that Packaging does not comply with the Specifications;

(f)    Client has all necessary authority to use and to permit PCI to use pursuant to this Agreement all Intellectual Property related to Client-supplied Materials (including artwork and labeling), and the Packaging, including any copyrights, trademarks, trade dress, trade secrets, patents, inventions and developments; and

(g)    the work to be performed by PCI under this Agreement will not violate or infringe upon any trademark, trade name, copyright, patent, trade secret, trade dress or other Intellectual Property or other right held by any person or entity.

12.3     Limitations . THE REPRESENTATIONS AND WARRANTIES SET FORTH IN THIS ARTICLE 12 ARE THE SOLE AND EXCLUSIVE REPRESENTATIONS AND WARRANTIES MADE BY EACH PARTY TO THE OTHER PARTY, AND NEITHER PARTY MAKES ANY OTHER REPRESENTATIONS, WARRANTIES OR GUARANTEES OF ANY KIND WHATSOEVER, INCLUDING ANY IMPLIED WARRANTIES OF MERCHANTABILITY, NON-INFRINGEMENT OR FITNESS FOR A PARTICULAR PURPOSE.

ARTICLE 13

INDEMNIFICATION

13.1     Indemnification by PCI . PCI shall indemnify, defend and hold harmless Client, its Affiliates, and their respective directors, officers, employees, representatives, and agents (“ Client Indemnitees ”) from and against any and all suits, claims, losses, demands, liabilities, damages, costs and expenses (including reasonable attorneys’ fees and reasonable investigative costs) in connection with any suit, demand or action by any third party (“ Losses ”) arising out of or resulting from (A) any breach of its representations, warranties or obligations set forth in this Agreement or (B) any negligence or willful misconduct by PCI; in each case except to the extent that any of the foregoing arises out of or results from any Client Indemnitee’s negligence, willful misconduct or breach of this Agreement.

13.2     Indemnification by Client . Client shall indemnify, defend and hold harmless PCI, its Affiliates, and their respective directors, officers, employees, representatives, and agents (“ PCI Indemnitees ”) from and against any and all Losses arising out of or resulting from (A) any breach of its representations, warranties or obligations set forth in this Agreement, (B) any manufacture, labeling, packaging, sale, promotion, distribution or use of or exposure to Client-supplied Materials or Packaged Product, including product liability or strict liability, (C) Client’s exercise of control over the Packaging, to the extent that Client’s instructions or directions violate Applicable Laws, (D) use of a Supplier, (E) any actual or alleged infringement or violation of any third party Intellectual Property by Client’s Intellectual Property, products or components of Client, including Client-supplied Materials, information provided by Client or otherwise caused by Client, or (F) any negligence or willful misconduct by Client; in each case except to the extent that any of the foregoing arises out of or results from any PCI Indemnitee’s negligence, willful misconduct or breach of this Agreement.

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13.3     Indemnification Procedures . All indemnification obligations in this Agreement are conditioned upon the party seeking indemnification promptly notifying the indemnifying party of any claim or liability of which the party seeking indemnification becomes aware (including a copy of any related complaint, summons, notice or other instrument); provided , that failure to provide such notice within a reasonable period of time shall not relieve the indemnifying party of any of its obligations hereunder except to the extent the indemnifying party is materially prejudiced by such failure. The indemnifying party will assume and conduct the legal defense of the indemnified party in any suit that could result in claims under this Article 13. The indemnifying party will not settle any case without with prior written consent of the indemnified party and such consent shall not be unreasonably withheld or delayed. The indemnified party shall cooperate with the indemnifying party in the defense of any such claim or liability and any related settlement negotiations at the indemnifying party’s expense.

ARTICLE 14

LIMITATIONS OF LIABILITY

14.1    WITH RESPECT TO EACH TYPE OF BULK PRODUCT PACKAGED UNDER THIS AGREEMENT, PCI’S LIABILITY TO CLIENT UNDER THIS AGREEMENT WITH RESPECT TO ANY 12-MONTH PERIOD SHALL IN NO EVENT EXCEED THE NET FEES (EXCLUDING PASS THROUGH COSTS) PAID BY CLIENT OR PAYABLE BY CLIENT TO PCI UNDER THIS AGREEMENT DURING SUCH 12 MONTH PERIOD. FOR CLARITY, AS AN EXAMPLE BASED UPON INITIAL PACKAGING REQUIREMENTS, THE PRECEDING SENTENCE WOULD BE CALCULATED BASED UPON THE NET FEES (EXCLUDING PASS THROUGH COSTS) PAID BY CLIENT OR PAYABLE BY CLIENT TO PCI UNDER THIS AGREEMENT DURING SUCH 12 MONTH PERIOD FOR ALL PACKAGING OF VALBENAZINE DITOSYLATE 40MG & 80MG CAPSULES. EXCEPT IN THE CASE OF PCI’S GROSS NEGLIGENCE OR WILLFUL MISCONDUCT, IN NO 12 MONTH PERIOD SHALL PCI’S LIABILITY UNDER THIS AGREEMENT EXCEED $[…***…].

14.2    NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY FOR INDIRECT, INCIDENTAL, SPECIAL, PUNITIVE OR CONSEQUENTIAL DAMAGES OR LOSS OF REVENUES, PROFITS OR DATA ARISING OUT OF PERFORMANCE UNDER THIS AGREEMENT, WHETHER IN CONTRACT OR IN TORT, EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.

ARTICLE 15

INSURANCE

15.1     By Client . Client shall maintain (i) property insurance against the perils of physical loss, including those generally associated with “all risk” property insurance, flood, earth movement and theft, in amounts sufficient to protect all Client-supplied Materials at PCI’s facility or while in transit, and (ii) a commercial general liability insurance policy covering product liability and personal injury damages with limits of $[…***…] dollars) per occurrence. Client agrees to designate PCI as an “additional insured” under such general liability insurance policy. Client shall also carry and maintain in force at all times relevant hereto all other insurance required by law or statute.

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15.2     By PCI . PCI shall maintain (i) employer’s liability insurance with a limit of not less than […***…] dollars ($[…***…]), (ii) commercial general liability insurance with limits of […***…] dollars ($[…***…]) per occurrence and a general aggregate limit of […***…] dollars ($[…***…]), (iii) umbrella liability insurance, in excess of the above coverage, with a limit per occurrence of […***…] dollars ($[…***…]) and an aggregate limit of […***…] dollars ($[…***…]), and (iv) products liability insurance exclusive of the above coverage for general liability, with a per claim limit of […***…] dollars ($[…***…]) and an aggregate limit of […***…] dollars ($[…***…]).

15.3     General . The policies required in this Article 15 shall remain in effect throughout the term of this Agreement and shall not be canceled or subject to reduction or any other material modification without […***…] days’ prior written notice to the other party. Each party may self-insure all or any portion of the required insurance as long as, together with its Affiliates, its US GAAP net worth is greater than $[…***…] or its annual EBITDA (earnings before interest, taxes, depreciation and amortization) is greater than $[…***…]. Each required insurance policy, other than self-insurance, shall be obtained from an insurance carrier with an A.M. Best rating of at least A-. If any of the required policies of insurance are written on a claims made basis, such policies shall be maintained throughout the Term and for a period of at least three years thereafter. Upon the other party’s written request from time to time, each party shall promptly furnish to the other party a certificate of insurance or other evidence of the required insurance.

ARTICLE 16

TERM AND TERMINATION

16.1     Term . This Agreement shall commence on the Effective Date and shall continue until September 30, 2019, unless earlier terminated in accordance with Section 16.2 (as may be extended in accordance with this Section, the “ Term ”). The Term shall automatically be extended for successive two-year periods unless and until one party gives the other party at least one year prior written notice of its desire to terminate as of the end of the then-current Term.

16.2     Termination . This Agreement may be terminated immediately without further action:

(a)    by either party if the other party files a petition in bankruptcy, or enters into an agreement with its creditors, or applies for or consents to the appointment of a receiver, administrative receiver, trustee or administrator, or makes an assignment for the benefit of creditors, or suffers or permits the entry of any order adjudicating it to be bankrupt or insolvent and such order is not discharged within 30 days, or takes any equivalent or similar action in consequence of debt in any jurisdiction;

(b)    by either party if the other party materially breaches any of the provisions of this Agreement and such breach is not cured within 60 days after the giving of written notice requiring the breach to be remedied; provided , that in the case of a failure of Client to make payments in accordance with the terms of this Agreement, PCI may terminate this Agreement if such payment breach is not cured within 20 days of receipt of notice of non-payment from PCI; or

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(c)    by either party for any reason or no reason upon 24 months’ prior written notice to the other party; or

(d)    any required license, permit or certificate required of the other party to perform its obligations under this Agreement is not approved and/or issued, or is revoked, by any applicable Regulatory Authority.

16.3     Effect of Termination . Expiration or termination of this Agreement shall be without prejudice to any rights or obligations that accrued to the benefit of either party prior to such expiration or termination. In the event of a termination of this Agreement:

(a)    PCI shall promptly return to Client, at Client’s expense and at Client’s direction, any remaining inventory of Client-supplied Materials; provided , that PCI shall have no obligation to so return such items until all outstanding invoices sent by PCI to Client have been paid in full.

(b)    In accordance with the provisions regarding payment under this Agreement, Client shall pay PCI all invoiced amounts outstanding hereunder, plus, upon receipt of invoice therefore, for any (i) Packaging of Packaged Product that has been shipped pursuant to Purchase Orders but not yet invoiced, (ii) Packaging performed pursuant to Purchase Orders that has been completed but Packaged Product has not yet shipped, (iii) in-process Packaging pursuant to Purchase Orders (or, alternatively, Client may instruct PCI to complete such Packaging in process, and the resulting completed Packaged Product shall be governed by clause (ii)) and (iv) in addition to Client’s obligations under Section 3.2(c), all costs and expenses incurred, and all noncancellable commitments (including all Product specific tooling that has been, or remains to be, amortized) made, in connection with PCI’s performance of this Agreement, so long as such costs, expenses or commitments were made by PCI consistent with Client’s most recent Firm Commitment. To the extent that Client has previously paid for all or a portion of Product specific tooling through incremental increases in Pricing or otherwise, such amounts shall not be charged under this Section 16.3.

16.4     Survival . The rights and obligations of the parties shall continue under Article 11 (Intellectual Property), Article 13 (Indemnification), Article 14 (Limitations of Liability), Article 17 (Notice), Article 18 (Miscellaneous); under Article 10 (Confidentiality and Non-Use) and Article 15 (Insurance), in each case to the extent expressly stated therein; and under Sections 3.1(h) (Liability for Loss), 3.1(i) (Annual Reconciliation of Excess Loss; Reimbursement), 5.4 (Defective Packaging), 7.3 (Payment Terms), 7.4 (Taxes), 9.2 (Recordkeeping), 9.6 (Recall), 12.3 (Limitations on Warranties), 16.3 (Effect of Termination) and 16.4 (Survival), in each case in accordance with their respective terms if applicable, notwithstanding expiration or termination of this Agreement.

ARTICLE 17

NOTICE

All notices and other communications hereunder shall be in writing and shall be deemed given: (A) when delivered personally; (B) when delivered by facsimile transmission (receipt verified); (C) when received or refused, if mailed by registered or certified mail (return receipt requested), postage prepaid; or (D) when delivered if sent by express courier service, to the

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parties at the following addresses (or at such other address for a party as shall be specified by like notice; provided , that notices of a change of address shall be effective only upon receipt thereof):

ARTICLE 18

MISCELLANEOUS

18.1     Entire Agreement; Amendments . This Agreement, together with all Attachments and the Quality Agreement, constitutes the entire understanding between the parties, and supersedes any contracts, agreements or understandings (oral or written) of the parties (except for confidentiality agreements), with respect to the subject matter hereof including any prior quotations executed. No modification or amendment to this Agreement shall be effected by or result from the receipt, acceptance, signing or acknowledgment of any Party’s purchase orders, order acknowledgements, quotations, invoices, shipping documents or other business forms containing terms or conditions in addition to or different from the terms and conditions set forth in this Agreement, and the terms of this Agreement shall supersede any provision in any purchase order or other document that is in addition to or inconsistent with the terms of this Agreement. No term of this Agreement may be amended except upon written agreement of the parties, unless otherwise expressly provided in this Agreement.

18.2     Captions; Certain Conventions . The captions in this Agreement are for convenience only and are not to be interpreted or construed as a substantive part of this Agreement. Unless otherwise expressly provided herein or the context of this Agreement otherwise requires, (A) words of any gender include each other gender, (B) words such as “herein”, “hereof”, and “hereunder” refer to this Agreement as a whole and not merely to the particular provision in which such words appear, (C) words using the singular shall include the plural, and vice versa, (D) the words “include(s)” and “including” shall be deemed to be followed by the phrase “but not limited to”, “without limitation” or words of similar import, (E) the word “or” shall be deemed to include the word “and” (e.g., “and/or”) and (F) references to “Article,” “Section,” “subsection,” “clause” or other subdivision, or to an Attachment or other

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appendix, without reference to a document are to the specified provision or Attachment of this Agreement. This Agreement shall be construed as if it were drafted jointly by the parties.

18.3     Further Assurances . The parties agree to execute, acknowledge and deliver such further instruments and to take all such other incidental acts as may be reasonably necessary or appropriate to carry out the purpose and intent of this Agreement.

18.4     No Waiver . Failure by either party to insist upon strict compliance with any term of this Agreement in any one or more instances will not be deemed to be a waiver of its rights to insist upon such strict compliance with respect to any subsequent failure.

18.5     Severability . If any term of this Agreement is declared invalid or unenforceable by a court or other body of competent jurisdiction, the remaining terms of this Agreement will continue in full force and effect.

18.6     Independent Contractors . The relationship of PCI and Client is that of independent contractors, and neither will incur any debts or make any commitments for the other except to the extent expressly provided in this Agreement. Nothing in this Agreement is intended to create or will be construed as creating between the parties the relationship of joint ventures, co-partners, employer/employee or principal and agent. Neither PCI nor Client shall have any responsibility for the hiring, termination or compensation of the other’s employees or contractors or for any employee benefits of any such employee or contractor.

18.7     Successors and Assigns . This Agreement will be binding upon and inure to the benefit of the parties, their successors and permitted assigns. Neither party may assign this Agreement, in whole or in part, without the prior written consent of the other party, except that either party may, without the other party’s consent, assign this Agreement in its entirety to an Affiliate or to a successor to substantially all of the business or assets of the assigning party or the assigning party’s business unit responsible for performance under this Agreement.

18.8     No Third Party Beneficiaries . This Agreement shall not confer any rights or remedies upon any person or entity other than the parties named herein and their respective successors and permitted assigns.

18.9     Governing Law . This Agreement shall be governed by and construed under the laws of the state of Delaware, excluding its conflicts of law provisions. The United Nations Convention on Contracts for the International Sale of Goods shall not apply to this Agreement.

18.10     Alternative Dispute Resolution . If any dispute arises between the parties in connection with this Agreement, such dispute shall be presented to the respective presidents or senior executives of PCI and Client for their consideration and resolution. If such parties cannot reach a resolution of the dispute, then such dispute shall be resolved by binding alternative dispute resolution in accordance with the then existing commercial arbitration rules of CPR Institute for Dispute Resolution, 575 Lexington Avenue, New York, NY 10022 (or then current address in New York City). Arbitration shall be conducted in the jurisdiction of the defendant party, in the English language.

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18.11     Prevailing Party . In any dispute resolution proceeding between the parties in connection with this Agreement, the prevailing party will be entitled to recover its reasonable attorney’s fees and costs in such proceeding from the other party.

18.12     Publicity . Neither party will make any press release or other public disclosure regarding this Agreement or the transactions contemplated hereby without the other party’s express prior written consent, except as required under Applicable Laws, by any governmental agency or by the rules of any stock exchange on which the securities of the disclosing party are listed, in which case the party required to make the press release or public disclosure shall use commercially reasonable efforts to obtain the approval of the other party as to the form, nature and extent of the press release or public disclosure prior to issuing the press release or making the public disclosure.

18.13     Setoff . Without limiting either party’s rights under law or in equity, each of PCI and Client, and their respective Affiliates, parent or related entities, collectively or individually, may exercise a right of set-off against any and all amounts due to the other party. For purposes of this Section, PCI, its Affiliates, parent or related entities shall be deemed to be a single creditor.

18.14     Force Majeure . Except as to payments required under this Agreement, a party shall be liable in damages for, nor shall this Agreement be terminable or cancelable by reason of, any delay or default in such party’s performance hereunder if such default or delay is caused by events beyond such party’s reasonable control, including acts of God, law or regulation or other action or failure to act of any government or agency thereof, strikes, lockouts, slowdowns, delay of subcontractors or vendors, war (declared or undeclared) or insurrection, civil commotion, terrorism, destruction of production facilities or materials by earthquake, fire, flood or weather, labor disturbances, epidemic or failure of suppliers, public utilities or common carriers; provided , that the party seeking relief under this Section shall immediately notify the other party of such cause(s) beyond such party’s reasonable control. The party that may invoke this Section 18.14 shall use commercially reasonable efforts to reinstate its ongoing obligations to the other party as soon as practicable. If the cause(s) shall continue unabated for […***…] days, then both parties shall meet to discuss and negotiate in good faith what modifications to this Agreement should result from such cause(s).

18.15     Counterparts . This Agreement may be executed in one or more counterparts, each of which will be deemed an original but all of which together will constitute one and the same instrument. Any photocopy, facsimile or electronic reproduction of the executed Agreement shall constitute an original.

[Signature page follows]

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IN WITNESS WHEREOF , the parties have caused their respective duly authorized representatives to execute this Agreement effective as of the Effective Date.

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ATTACHMENT A

BULK PRODUCT, MATERIALS, and PACKAGING SPECIFICATIONS

[…***…]

Omitted pages have been filed separately with the Commission.

27-28

ATTACHMENT B

UNIT PRICING AND FEES

[…***…]

Omitted pages have been filed separately with the Commission.

29-31

ATTACHMENT C

FORM OF QUALITY AGREEMENT

See attached.

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Exhibit 99.4

***Text Omitted and Filed Separately

with the Securities and Exchange Commission.

Confidential Treatment Requested

Under 17 C.F.R. Sections 200.80(b)(4) and 240.24b-2.

LICENSE AGREEMENT

THIS LICENSE AGREEMENT (this “ Agreement ”) is made and entered into as of February 9, 2017 (the “ Effective Date ”)

by and between

BIAL – PORTELA  & CA, S.A., a Portuguese corporation having a principal place of business at À Avenida da Siderurgia Nacional, 4745-457 Coronado (S. Romão e S. Mamede), Portugal (hereinafter referred to as “ BIAL ”)

and

NEUROCRINE BIOSCIENCES, INC. , a Delaware corporation having a principal place of business at 12780 El Camino Real, San Diego, CA 92130, USA (hereinafter referred to as “ NBIX ”).

Each of NBIX and BIAL may be referred to herein as a “ Party ” or collectively as the “ Parties ”.

WITNESSETH

WHEREAS, BIAL Controls (as defined below) the BIAL Patents and BIAL Know-How (each as defined below), which relate to the compound BIA 9-1067 (as defined below) and its use in the treatment of human diseases and conditions, including Parkinson’s disease; and

WHEREAS, NBIX wishes to acquire licenses under the BIAL Patents, BIAL Know-How and Trademarks (as defined below) for the purpose of using, developing, marketing, distributing, importing, commercializing, offering for sale and selling the Licensed Products (as defined below) under the Trademark within the Field and Territory (each as defined below); and

WHEREAS, BIAL is willing to grant such licenses to NBIX under the terms and conditions of this Agreement; and

WHEREAS, BIAL is willing to manufacture and supply Licensed Products to NBIX for using, developing, marketing, distributing, importing, commercializing, offering for sale and selling the Licensed Products under the Trademark within the Field and Territory under the terms and conditions of this Agreement and a Supply Agreement (as defined below) to be entered into between the Parties; and

NOW, THEREFORE, in reliance on the foregoing recitals and in consideration of the mutual covenants and promises set forth herein, the Parties agree as follows:

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ARTICLE 1

DEFINITIONS

As used in this Agreement, the following terms have the following meanings:

1.1.     “ Affiliate ” means any person or entity that, as of the Effective Date or at any time during the Term, 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, “control” means (i)  the ownership of at least fifty percent (50%) of the voting securities of the entity or such lesser percentage which is the maximum allowed by applicable law; or (ii)  the ability to otherwise direct the management and operations of the entity.

1.2.     “ Agency ” means the FDA (as defined below), Health Canada or any other governmental entity(ies), and its or their successor bodies, whose authorization is required to market and sell any pharmaceutical product in Territory.

1.3.     “ Agency Interactions ” has the meaning set forth in Section 7.2(e).

1.4.     “ Agreed Sales Forecast ” has the meaning set forth in Section 8.3(d).

1.5.     “ Alleged Infringement ” has the meaning set forth in Section 12.2(a).

1.6.     “ Alleged Manufacturing Infringement ” has the meaning set forth in Section 12.2(b).

1.7.     “ Alleged Manufacturing Infringement Costs ” has the meaning set forth in Section 12.2(d).

1.8.     “ Alliance Manager ” has the meaning set forth in Section 5.8(a).

1.9.      “Alternative Trademarks” has the meaning set forth in Section 2.3(d).

1.10.     “ Annual Commercialization Plan ” has the meaning set forth in Section 8.2(a).

1.11.     “ Approval ” means the marketing authorization issued by an Agency for the commercialization of a Licensed Product within the Field and Territory.

1.12.     “ Assumptions ” has the meaning set forth in Section 8.3(e).

1.13.     “ BIA 9-1067 ” means […***…].

1.14.     “ BIA 9-1067 API ” means the active pharmaceutical ingredient of BIA 9-1067.

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1.15.      “BIA 9-1067 IND” means the IND No.[ …***…].

1.16.     “ BIAL Indemnitees ” has the meaning set forth in Section 16.2.

1.17.    “BIAL Know-How” means any and all research and development information, unpatented inventions, trade secrets, proprietary materials, or any other type of proprietary or confidential technical data or information, including without limitation, products, methods, techniques, processes, specifications, recipes, formulae, designs, plans, drawings, data, protocols, or non-clinical and clinical data (including, without limitation, Data), which are Controlled by BIAL or its Affiliates as of the Effective Date or during the Term and are either (i)  reasonably necessary for the use, development marketing, distribution, importation, commercialization, manufacture (other than the Manufacturing Know-How), offer for sale or sale of the Licensed Products, or (ii)  useful for the use, development marketing, distribution, importation, commercialization, manufacture (other than the Manufacturing Know-How), offer for sale or sale of the Licensed Products, and in such case (i) or (ii) to the extent that BIAL or its Affiliates have developed or used such know-how in connection with the Licensed Products. The term “BIAL Know-How” includes, without limitation, all proprietary and confidential information included in INDs/NDAs and any other regulatory filings and correspondence related to any Licensed Product and all Data and information to be submitted in support of such filings or correspondence, and information relating to marketing and commercialization, to the extent Controlled by BIAL or its Affiliates during the Term and related to Licensed Products, and BIAL’s interest in Development Intellectual Property jointly owned by the Parties; provided however that in the event that any Third Party becomes a BIAL Affiliate by merger with or by acquisition of BIAL or any of its Affiliates, any know-how of such Third Party in existence as of the effective date of such merger or acquisition shall not be included in BIAL Know-How so long as it is not used and was not generated in connection with the development, manufacture or commercialization of any Licensed Product. For greater certainty, the term “BIAL Know-How” does not include the Manufacturing Know-How.

1.18.     “ BIAL Logo ” means the logo included in Exhibit 2.4 , which BIAL may, at its own discretion, update from time to time.

1.19.     “ BIAL Patents ” means (i)  all US and Canadian Patents Controlled by BIAL or its Affiliates as of the Effective Date or during the Term, claiming or covering or which would be practiced by the use, development, marketing, distribution, import, commercialization, offer for sale and sale of the Licensed Products, including, without limitation, the BIAL Patents listed in Exhibit 2.1 ; (ii) any US and Canadian provisional, divisional, substitution, continuation or continuation-in-part applications based on, directly or indirectly, relying for priority on, or having identical disclosure as, any of the US or Canadian Patents in (i); (iii) any US and Canadian Patent issuing from any of the Patents in (i) or (ii); and (iv)  any extensions, patent term adjustments, reissues, supplemental examinations or reexaminations of any of the Patents in (i), (ii) and/or (iii). BIAL Patents also include any Patents covering any Development Intellectual Property owned solely by BIAL or one of its Affiliates or jointly by BIAL and its Affiliates. BIAL agrees to update Exhibit 2.1 from time to time with additional BIAL Patents;

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provided however that in the event that any Third Party becomes a BIAL Affiliate by merger with or by acquisition of BIAL or any of its Affiliates, any Patent of such Third Party in existence as of the effective date of such merger or acquisition shall not be included in BIAL Patents, so long as it does not cover any subject matter that is directly used or directly generated in connection with the development or commercialization of any Licensed Product.

1.20.      “BIAL Representatives” has the meaning set forth in Section 2.10(iii).

1.21.      “BIAL Representatives Costs” has the meaning set forth in Section 2.10(iii).

1.22.      “BIAL Studies” means the studies set out in Exhibit 6.4 .

1.23.     “ Blocking BIAL IP ” means any Patent or other Intellectual Property outside the Territory that is Controlled by BIAL (by ownership, license or otherwise) and which would be infringed by the use, manufacture, development, marketing, distribution, importation, commercialization, offer for sale or sale of any product or process that is claimed, covered or would be practiced by such Patent or Intellectual Property.

1.24.     “ Business Day ” means any of the days Monday through Friday less (i)  public holidays in Porto, Portugal, (ii)  public holidays in San Diego, California, United States of America, (iii)  first two (2) weeks of August of each Calendar Year, and (iv)  the period between 24 ^th December of a Calendar Year and 1 ^st January of the subsequent Calendar Year.

1.25.    “Calendar Quarter” means each period of three (3) months ending on 31 ^st March, 30 ^th June, 30 ^th September and 31 ^st December.

1.26.     “ Calendar Year ” means each twelve (12) months period starting on 1 ^st January and ending on 31 ^st December.

1.27.    “Change of Control” means, with respect to NBIX, any of the following events: (i)  a Third Party (or group of Third Parties acting in concert) directly or indirectly, acquires more than fifty percent (50%) of the then outstanding capital stock entitled to vote for the election of NBIX’s directors; or (ii)  a consolidation, reorganization or merger involving NBIX in which more than fifty percent (50%) of the then outstanding capital stock of the surviving entity entitled to vote for the election of directors is not held by the parties holding at least fifty percent (50%) of the outstanding shares of NBIX preceding such consolidation or merger; or (iii)  NBIX conveys, transfers or sells all or substantially all of its assets relating to Licensed Products.

1.28.     “ Change of Control Entity ” has the meaning set forth in Section 15.2(d)(i).

1.29.     “ Change of Control Notice ” has the meaning set forth in Section 2.11.

1.30.     “ Claim ” has the meaning set forth in Section 16.1.

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1.31.     “ Clinical Trials ” means Phase I Clinical Trials, Phase II Clinical Trials and/or Phase III Clinical Trials.

1.32.     “ Co-Promotion Agreement ” has the meaning set forth in Section 2.10(c).

1.33.     “ Co-Promotion Option ” has the meaning set forth in Section 2.10(a).

1.34.     “ Co-Promotion Plan ” has the meaning set forth in Section 2.10(b).

1.35.     “ Co-Promotion Steering Committee ” has the meaning set forth in Section 2.10(c)(vii).

1.36.     “ Combination Product ” means […***…].

1.37.     “ Commercial Year ” has the meaning set forth in Section 8.3(d).

1.38.    “Commercially Reasonable Efforts” means, with respect to a Party’s obligations under this Agreement, with respect to each Licensed Product, the level of efforts required to carry out a task in a diligent and sustained manner without undue interruption, pause or delay, which level is at least commensurate with the level of efforts that a similarly situated biopharmaceutical company, of similar size and resources, would devote to a product of similar commercial and market potential and at a similar stage of development or commercialization and having similar commercial and scientific advantages and disadvantages resulting from such company’s own research efforts ( i.e . explicitly ignoring the upfront, milestone, and royalty payments, but including payments for product supply and other payments related to the Co-Promotion Agreement due to BIAL under this Agreement), taking into account all relevant factors, including (without limitation) Patent coverage, safety, efficacy, product profile, competitiveness of the marketplace, proprietary position and profitability. Commercially Reasonable Efforts requires (without limitation) that NBIX (i)  promptly assigns responsibility for its obligations to specific employee(s) who are held accountable for progress and monitor such progress on an ongoing basis, (ii)  continues to seek to achieve specific and meaningful objectives for carrying out such obligations and (iii)  makes and/or implements decisions and allocates resources designed to make progress with respect to such objectives.

1.39.     “ Competing Product ” means […***…].

1.40.     “ COMT ” means catechol-O-methyl transferase.

1.41.     “ Confidential Information ” has the meaning set forth in Section 13.1(a).

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1.42.     “ Confidentiality Agreement ” has the meaning set forth in Section 13.1(a).

1.43.     “ Controlled ” means, with respect to any Intellectual Property (as defined below), the possession by a Party of the right, whether directly or indirectly, whether by ownership, license or otherwise, to grant a license, sublicense or other right to or under such Intellectual Property, as provided for in this Agreement, without violating the terms of any agreement, contract or any other arrangement with any Third Party. For the avoidance of doubt, Third Party Intellectual Property shall only be considered “Controlled” by a Party, if the Party has right to assign or grant a license, sublicense or otherwise grant rights to the other Party as provided for in this Agreement, at no additional cost (unless the other Party agrees to assume such cost) and without prior Third Party approval. The term “ Control ” or “ Controls ” used in this context will also have a correlative meaning.

1.44.     “ Data ” means any and all scientific, technical or test data pertaining to Licensed Product(s) (provided, that if any such scientific, technical and/or test data pertains to Licensed Product(s) and something other than Licensed Product(s), then only such scientific, technical and test data that pertains to Licensed Product(s) and not to something else) that is generated by or under the authority of NBIX or its Affiliates and contractors, or by or under the authority of BIAL or BIAL’s Affiliates and contractors (provided however that in the event that any Third Party becomes a BIAL Affiliate by merger with or by acquisition of BIAL or any of its Affiliates, any data of such Third Party in existence as of the effective date of such merger or acquisition shall not be included as Data) or by or under the authority of any Third Party licensee in respect of BIA 9-1067 and/or Licensed Products of BIAL outside the Territory, including, without limitation, research data, non-clinical data, clinical data and/or all submissions made in association with an IND or application for a Marketing Authorization filed in or outside the Territory with respect to such Licensed Product(s), in each case to the extent such data either (a)  is Controlled by BIAL or its Affiliates on the Effective Date or (b)  comes within a Party’s or its Affiliates’ Control during the Term (provided however that in the event that any Third Party becomes a BIAL Affiliate by merger with or by acquisition of BIAL or any of its Affiliates, any data of such Third Party in existence as of the effective date of such merger or acquisition shall not be included as Data unless BIAL Controls such Data prior to the effective date of such merger or acquisition or BIAL subsequently includes such data in regulatory filings in connection with the Licensed Product outside the Territory). Data shall not include any Manufacturing Know-How.

1.45.      “Data Update Filings” has the meaning set forth in Section 7.2(f).

1.46.     “ Detail ” means, with respect to a Licensed Product in the Territory, a face-to-face contact between a sales representative of NBIX (or of BIAL or its Affiliate or its contractor in the case the Parties have executed a Co-Promotion Agreement and are co-promoting) and a physician or other medical professional licensed to prescribe drugs, during which promotional, scientific and/or medical information about the Licensed Products is discussed at length with such person in either a first position detail (as defined in the Annual Commercialization Plan) or a second position detail (as defined in the Annual Commercialization Plan), in each case as measured by each Party’s internal recording of such

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activity; provided that such meeting is consistent with and in accordance with the requirements of applicable law and this Agreement and the Co-Promotion Agreement. A Detail shall not include discussions at medical congress or meetings or any other form of communication that is not face to face and shall not include a reminder call in which the Licensed Products are not discussed at length or a Licensed Product sample drop if the sole purpose of the face to face contact was a sample drop. “Detailing” shall be construed accordingly. When used as a verb, “ Detail ” means to engage in a Detail.

1.47.     “ Development and Regulatory Plan ” has the meaning set forth in Section 6.2(a).

1.48.     “ Development Intellectual Property ” means any inventions or discoveries (whether or not patentable) made solely by or on behalf of one Party or its Affiliates or jointly by or on behalf of both Parties or their respective Affiliates in the performance of this Agreement, but only to the extent related to BIA 9-1067 or any Licensed Product. Development Intellectual Property does not include any Manufacturing Know-How or Patents to the extent that they claim or cover the manufacture of BIA 9-1067 API.

1.49.      “ Development License ” has the meaning set forth in Section 2.2.

1.50.     “ Development Studies ” means any Nonclinical Studies, Clinical Trials, Post-Approval Commitment (PAC) (or post-marketing requirement) Studies and Phase IV Studies in respect of BIA 9-1067 or Licensed Products carried out by or on behalf of NBIX in accordance with this Agreement.

1.51.     “ Difference ” has the meaning set forth in Section 8.3(g).

1.52.     “ Dispute ” has the meaning set forth in Section 17.1(a).

1.53.     “ Divestiture ” has the meaning set forth in Section 2.8(b).

1.54.     “ EMA ” means the European Medicines Agency and its successor bodies.

1.55.      “Excluded Claim” has the meaning set forth in Section 17.1(k).

1.56.     “ Exclusivity Rights ” means a marketing or data exclusivity right conferred by any Agency, including rights conferred in the United States under the Hatch-Waxman Act or the FDA Modernization Act of 1997 (including pediatric exclusivity), or rights similar thereto in Canada.

1.57.     “ Executive Officer ” means (a) with respect to NBIX, […***…] and (b) with respect to BIAL, an individual (i) […***…] or (ii) […***…].

1.58.     “ Existing Licensees ” has the meaning set forth in Section 9.2(c).

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1.59.     “ Extension Party ” has the meaning set forth in Section 11.4(e).

1.60.      “FDA” means the United States of America Food and Drug Administration.

1.61.     “ Field ” means […***…]. For certainty, Field includes the Initial Indication and any Subsequent Indications (both as defined below).

1.62.     “ First Development and Regulatory Plan ” has the meaning set forth in Section 6.3(a).

1.63.      “First Tentative Supply Price” has the meaning set forth in Paragraph 1.1(b)(ii) of Exhibit 4.

1.64.     “ For Cause Audit ” has the meaning set forth in Sections 7.6(b) and 7.6(d).

1.65.     “ Force Majeure ” has the meaning set forth in Section 17.3.

1.66.     “ Fully Burdened Manufacturing Cost ” means […***…]. Such costs shall be calculated in accordance with International Financial Reporting Standards and using BIAL’s or its Affiliates normal cost accounting and allocation methods and procedures, consistently applied historically and across all of BIAL’s and its Affiliates’ investigational medicinal products and commercial products.

1.67.     “ GAAP ” means US generally accepted accounting principles.

1.68.     “ GCPs ” or “ Good Clinical Practices ” means a standard for the design, conduct, performance, monitoring, auditing, recording, analysis, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and the rights, integrity, and confidentiality of the trial subjects are protected, as defined in ICH E6: Good Clinical Practice, April 1996, as amended.

1.69.     “ Generic Product ” means a Third Party pharmaceutical product that […***…].

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1.70.     “ Global Brand Identity ” means the designs and colors of Licensed Products’ trademark(s) and logos used by BIAL or its Affiliates or licensees outside the Territory and related guidance for their use and placement in promotional materials with respect to the Licensed Products.

1.71.     “ GLPs ” or “ Good Laboratory Practices ” means a quality system concerned with the organizational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported., as defined in the Organization for Economic Co-operation and Development (OECD) Principles of Good Laboratory Practice, as amended.

1.72.     “ GMPs ” or “ Good Manufacturing Practices ” means the then current Good Manufacturing Practices pursuant to the EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines, containing guidance documents for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human use laid down in Commission Directive 2003/94/EC, as may be amended from time to time. “GMP” also includes adherence to the then-current requirements of the European Pharmacopoeia and the relevant current ICH Quality Guidelines.

1.73.     “ GVPs ” or “ Good Pharmacovigilance Practices ” means a set of guidelines for the conduct of pharmacovigilance in the EU, drawn up based on Article 108a of Directive 2001/83/EC, by the European Medicines Agency in cooperation with competent authorities in Member States and interested parties, and applying to marketing authorization holders in the EU or the Territory.

1.74.     “ ICH ” means the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use.

1.75.     “ IMP ” or “ Investigational Medicinal Product ” means […***…].

1.76.     “ IND ” or “ Investigational New Drug Application ” means an investigational new drug application, clinical study application, clinical trial exemption, or similar application or submission for approval to conduct human clinical investigations filed with or submitted to a Regulatory Authority in conformance with the requirements of such Regulatory Authority.

1.77.     “ IND Filings ” has the meaning set forth in Section 7.2(c).

1.78.     “ Indemnification Claim Notice ” has the meaning set forth in Section 16.3.

1.79.     “ Indemnified Party ” has the meaning set forth in Section 16.3.

1.80.     “ Indemnifying Party ” has the meaning set forth in Section 16.3.

1.81.     “ Indemnitees ” has the meaning set forth in Section 16.3.

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1.82.     “ Initial BIAL Patent ” means the US patent […***…] and any patent term extension thereof.

1.83.     “ Initial Indication ” means […***…], as filed by BIAL with the European Medicines Agency, or any indication substantially similar thereto as recommended, required or approved by an Agency.

1.84.     “ Initial Product ” means a capsule formulation in fully finished and final packaged consumer form ready for sale and administration, […***…]. The definition of Initial Product may also include a capsule formulation in fully finished and final packaged consumer form ready for sale and administration, containing […***…] and in fully finished and final packaged consumer form, provided that […***…].

1.85.     “ Intellectual Property ” means any Patents (including, without limitation, the BIAL Patents and NBIX Patents), Development Intellectual Property, copyrights, designs, database rights, trademarks (including, without limitation, the Trademarks), know-how (including, without limitation, the BIAL Know-How and the NBIX Know-How), trade secrets, proprietary information or data (including, without limitation, any regulatory filings and related data), or any application for any of the foregoing, or any other forms of comparable property rights protected by applicable law.

1.86.     “ Interaction Agenda ” has the meaning set forth in Section 7.2(e).

1.87.     “ Joint Patent ” means a Patent covering Development Intellectual Property jointly owned by the Parties.

1.88.     “ JSC ” has the meaning set forth in Section 5.2.

1.89.     “ Kick-Off Meeting ” has the meaning set forth in Section 2.6(a).

1.90.     “ Knowledge of BIAL ” means BIAL’s and its Affiliates’ actual understanding and knowledge in good faith as possessed by its Executive Officers.

1.91.     “ Label Related Documents  & Materials ” has the meaning set forth in Section 7.2(a).

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1.92.     “ LCIA ” means the London Court of International Arbitration.

1.93.     “ Licensed Products ” means the Initial Product, any Subsequent Products and any Investigational Medicinal Product.

1.94.     “ Losses ” has the meaning set forth in Section 16.1.

1.95.     “ Manufacturing Know-How ” means manufacturing information, unpatented inventions, trade secrets, proprietary materials, or any other type of proprietary or confidential technical data or information, including, without limitation, methods, techniques, processes, specifications, recipes, formulae, designs, plans, drawings, data, or protocols, which are Controlled by BIAL or its Affiliates as of the Effective Date or during the Term and are either (i)  reasonably necessary for the manufacture of the BIA 9-1067 API, or (ii)  reasonably useful for the manufacture of BIA 9-1067 API to the extent that BIAL or its Affiliates have developed or used such know-how in connection with the BIA 9-067 API as of the Effective Date or during the Term; provided however that in the event that any Third Party becomes a BIAL Affiliate by merger with or by acquisition of BIAL or any of its Affiliates, any manufacturing know-how of such Third Party in existence as of the effective date of such merger or acquisition shall not be included in Manufacturing Know-How, unless such manufacturing know-how was Controlled by BIAL or its Affiliates prior to the effective date of such merger or acquisition, or it is used thereafter and Controlled by BIAL or its Affiliates in connection with the manufacture of the BIA 9-1067 API. For greater certainty, the Manufacturing Know-How is not included in the BIAL Know-How.

1.96.     “ Marketing Authorization ” means all approvals from the relevant Regulatory Authority necessary to import, market and sell a pharmaceutical product (including, without limitation, as and when applicable, all drug pricing and governmental reimbursement approvals, and Approval).

1.97.     “ Milestone Event ” has the meaning set forth in Section 3.1(b).

1.98.     “ Milestone Payments ” has the meaning set forth in Section 3.1(b).

1.99.      “ Minimum Detail Effort ” has the meaning set forth in Section 2.10(c)(i).

1.100.     “ Minimum Sales ” has the meaning set forth in Section 8.3(f).

1.101.     “ Minimum Supply Price ” has the meaning set forth in Paragraph 1.1(a) of Exhibit 4.

1.102.     “ NBIX Indemnitees ” has the meaning set forth in Section 16.1.

1.103.     “ NBIX Know-How ” means (a)  research and development or commercialization information, unpatented inventions, trade secrets, proprietary materials, or any other proprietary or confidential technical data or information, Development Intellectual Property, including without limitation, products, methods, techniques, processes, specifications, recipes, formulae, designs, plans,

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drawings, data, protocols or non-clinical and clinical studies (including, without limitation Data), which are generated by or under the authority of NBIX or its Affiliates and contractors or otherwise Controlled by NBIX during the Term (including without limitation any of the foregoing arising from any Development Studies), and are either (i)  reasonably necessary for the manufacture, use, development, marketing, distribution, importation, commercialization, offer for sale or sale of BIA 9-1067 or any Licensed Product, or (ii)  useful for the manufacture, development, marketing, distribution, importation, commercialization, offer for sale or sale of any Licensed Products to the extent that NBIX has developed or otherwise uses such know-how in connection with BIA 9-1067 or any Licensed Products. The term “NBIX Know-How” includes all information included in INDs/NDAs and any other regulatory filings and correspondence related to BIA 9-1067 or any Licensed Product and all Data and information submitted in support of such filings or correspondence, and information relating to marketing and commercialization, to the extent Controlled by NBIX during the Term and which relate to BIA 9-1067, the Initial Product or any other Licensed Products, and NBIX’s interest in Development Intellectual Property jointly owned by the Parties; provided however that in the event that any Third Party becomes an Affiliate of NBIX by merger with or by acquisition of NBIX or any of its Affiliates, any know-how of such Third Party in existence as of the effective date of such merger or acquisition shall not be included in NBIX Know-How so long as it is not used and was not generated in connection with the development, manufacture or commercialization of any Licensed Product.

1.104.     “ NBIX License ” has the meaning in Section 2.7(b).

1.105.     “ NBIX Patents ” means any and all Patents which are Controlled by NBIX and which: (i)  claim or cover or would be practiced by using, manufacturing, developing, marketing, distributing, importing, commercializing, offering for sale or selling BIA-9-1067 or the Licensed Products; or (ii)  claim or cover Development Intellectual Property Controlled by NBIX.

1.106.     “ NDA ” means a New Drug Application or similar application or submission for Approval of a pharmaceutical product filed with Regulatory Authority to obtain marketing approval for such product.

1.107.     “ Net Sales ” means the gross amounts invoiced by NBIX or its Affiliates (the “ Selling Party ”) on account of sales of the Licensed Products to the first Third Party in the distribution chain in the Territory, less the following deductions to the extent actually allowed and specifically allocated to the Licensed Products by the Selling Party in accordance with GAAP:

[ …***…]

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[…***…].

In no event shall any particular amount, identified above, be deducted more than once in calculating Net Sales (i.e., no “double counting” of reductions). Sales of the Licensed Products between the Selling Party and its Affiliates shall be excluded from the computation of Net Sales, but the subsequent resale of such the Licensed Products to the first Third Party in distribution chain shall be included within the computation of Net Sales. Any amounts hereunder shall be determined from the books and records of the Selling Party maintained in accordance with GAAP, consistently applied to all products of the Selling Party.

Notwithstanding the foregoing, “Net Sales” shall not include any amounts invoiced for sales of Licensed Products supplied for use in clinical trials conducted by or on behalf of NBIX (including investigator initiated studies where NBIX does not charge for Licensed Product), or under any early access, named patient, indigent access, patient assistance or other programs whereby patients received free Licensed Product, or as samples or donations.

In the event that the Parties agree that NBIX commercializes a Combination Product, the Parties will, in connection with the negotiation under Section 2.9, determine a reasonable allocation of Net Sales to BIA 9-1067 and the other active pharmaceutical ingredient(s) therein.

1.108.     “ Net Sales Estimation ” has the meaning set forth in Section 8.3(e).

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1.109.     “ Net Sales Volume ” means, for each applicable period, […***…].

1.110.     “ Net Selling Price ” means, for each applicable period, […***…].

1.111.     “ Nonclinical Study ” means any study of a product or active pharmaceutical ingredient which is not conducted in humans and which may be conducted in animals ( in vivo ) or in a test tube ( in vitro ).

1.112.     “ Non-Extension Party ” has the meaning set forth in Section 11.4(e).

1.113.     “ Opposition Contest ” has the meaning set forth in Section 11.2.

1.114.     “ Outside Territory KOL ” means healthcare providers outside of the Territory that have administered a Licensed Product in clinical trials, have published academic articles relating to a Product, or are otherwise regarded by BIAL, its Affiliates and licensees or NBIX, as the case may be, as a key opinion leader (“ KOL ”) for a Licensed Product or products in the same therapeutic class outside of the Territory.

1.115.     “ Patent ” means any and all patents, patent applications and patents issued from such patent applications, including, without limitation, divisions, continuations, continuations-in-part, reissues, renewals, extensions, supplementary protection certificates, and the like of any such patents and patent applications and foreign equivalents thereof.

1.116.     “ Phase I Clinical Trial ” means a clinical trial in humans the principal purpose of which is determining safety and/or metabolism, and/or pharmacokinetic properties and/or clinical pharmacology of such product, as described in 21 C.F.R. § 312.21(a), as amended from time to time.

1.117.     “ Phase II Clinical Trial ” means a clinical trial in humans of a product for an indication, the principal purpose of which is a determination of safety and efficacy for such indication in the target patient population over a range of doses and/or to obtain sufficient information about such product’s efficacy to permit the design of further clinical trials, as described in 21 C.F.R. § 312.21(b), as amended from time to time.

1.118.      “Phase III Clinical Trial” means a clinical trial in humans of a product for an indication on a sufficient number of subjects that is prospectively designed to statistically demonstrate that the product is safe and efficacious for its intended use, and to determine warnings, precautions, and adverse reactions that are associated with the product in the dosage range to be prescribed, and to support regulatory approval of the product for such indication or label expansion of the product, as described in 21 C.F.R. § 312.21(c), as amended from time to time.

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1.119.     “ Phase IV Studies ” means both post-marketing and pharmacoeconomic studies that are initiated by NBIX after Approval and are not requested, mandated or required by an Agency to support or maintain an Approval. Phase IV Studies does not include investigator initiated studies or Post-Approval Commitment Studies in the Territory.

1.120.     “ Post-Approval Commitment Studies ” means any study or data collection effort in respect of the Licensed Products which is requested, mandated or required by an Agency following an Approval for the Licensed Products in the Territory.

1.121.      “Process Modification Costs” has the meaning set forth in Section 12.2(d).

1.122.     “ Product Specifications ” means the specifications for the Initial Product, as such specifications shall be defined in the Quality Agreement , as may be amended or modified by BIAL from time to time in accordance with the terms of the Quality Agreement.

1.123.     “ Publishing Party ” has the meaning set forth in Section 9.3(b).

1.124.     “ Quality Agreement ” means a quality agreement between the Parties relating to the IMP and/or the Licensed Products.

1.125.     “ Recall Costs ” has the meaning set forth in Section 7.8(b).

1.126.      “Reconciliation Payment” has the meaning set forth in paragraph 1.2(a) of Exhibit 4.

1.127.     “ Regulatory Authority ” means any governmental and/or regulatory authority involved in granting approvals for the marketing, reimbursement and/or pricing of a pharmaceutical product including, without limitation, as and when applicable, the EMA in the European Union, and an Agency in the Territory.

1.128.     “ Representatives ” has the meaning set forth in Section 13.3(a).

1.129.      “Re-Manufacturing” has the meaning set forth in Section 7.9.

1.130.     “ Right to Object ”, with respect to a Development and Regulatory Plan, has the meaning set forth in Section 6.3(h), and with respect to any Label Related Documents & Materials, has the meaning set forth in Section 7.2(b).

1.131.     “ SDEA ” or “ Safety Data Exchange Agreement ” has the meaning set forth in Section 7.5(a).

1.132.     “ Subsequent Indication ” means any indication within the Field other than the Initial Indication.

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1.133.     “ Subsequent Product ” means: (a) […***…]; and (b)  any Combination Product.

1.134.     “ Subsequent Product Development ” has the meaning set forth in Section 2.9(a).

1.135.      “Subsequent Tentative Supply Price” has the meaning set forth in paragraph 1.1(b)(ii) of Exhibit 4.

1.136.      “ Supply Agreement ” has the meaning set forth in Section 4.1(b).

1.137.      “ Supply Price ” means the supply price for the Initial Product as set forth in Paragraph 1.1(a) of Exhibit 4.

1.138.      “Supply Price Report” has the meaning set forth in paragraph 1.2(a) of Exhibit 4.

1.139.      “Supply Related Filings” has the meaning set forth in Section 7.2(f).

1.140.      “Tentative Supply Price” has the meaning set forth in paragraph 1.1(b)(ii) of Exhibit 4.

1.141.      “ Term ” has the meaning set forth in Section 15.1(a).

1.142.     “ Termination Event ” has the meaning set forth in Section 15.2.

1.143.     “ Territory ” means the United States of America (“US”) and Canada.

1.144.     “ Territory KOL ” means healthcare providers in the Territory that have administered a Licensed Product in clinical trials, have published academic articles relating to a Licensed Product, or are otherwise regarded by BIAL, its Affiliates and licensees or NBIX, as the case may be, as a key opinion leader for a Licensed Product or products in the same therapeutic class in the Territory.

1.145.     “ Third Party ” means any person or entity who or which is neither a Party nor an Affiliate of a Party.

1.146.     “ Third Party License ” has the meaning set forth in Section 12.2(c).

1.147.     “ Trademark ” means the US and Canadian trademarks or trademark applications Controlled by BIAL and listed in Exhibit 2.3 , for use in conjunction with the Licensed Products within the Field and Territory, or any trademark that is selected by the Parties pursuant to the terms of Section 2.3(c). For the avoidance of doubt, the term “Trademarks” does not encompass the INN Opicapone, the BIAL Logo or any marks, brand names and/or other indicators of source not specifically listed in Exhibit 2.3.

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1.148.     “ Transfer Plan ” has the meaning set forth in Section 2.6(b).

1.149.     “ Unit ” means each single tablet, capsule or other pharmaceutical finished form of the Licensed Products as specifically applied to each dosage strength.

1.150.     “ US ” means the United States of America, including its territories and possessions.

1.151.      Interpretation . In this Agreement (except where the context otherwise requires):

(a)    any reference to a Recital, Section or Exhibit is a reference to the relevant recital, section or exhibit of or to this Agreement, and the Exhibits and Recitals form part of this Agreement;

(b)    the table of contents and section headings are included for convenience only and shall not affect the interpretation of this Agreement;

(c)    use of the singular includes the plural and vice versa;

(d)    use of any gender includes the other genders;

(e)    any reference to “persons” includes natural persons, firms, partnerships, companies, corporations, associations, organizations, governments, governmental agencies and departments, states, foundations and trusts (in each case whether or not having separate legal personality);

(f)    any reference to an English legal term for any action, remedy, method of judicial proceeding, legal document, legal status, court, official or any legal concept or thing shall, in respect of any jurisdiction other than England, be deemed to include a reference to what most nearly approximates in that jurisdiction to the English legal term;

(g)    the words “include”, “includes”, “including” and “such as” and “in particular” are to be construed as if they were immediately followed by the words “without limitation”; and

(h)    references to any statute or statutory provision shall include (i) any subordinate legislation made under it, (ii) any provision which it has modified or re-enacted (whether with or without modification) and (iii) any provision which subsequently supersedes it or re-enacts it (whether with or without modification).

ARTICLE 2

GRANT OF RIGHTS

2.1      Sole Commercialization License : BIAL grants to NBIX during the Term a sole and non-sublicensable license under the BIAL Patents and BIAL Know-How and BIAL’s interest in the jointly owned Development Intellectual Property and Joint Patents to use, market, distribute, import, commercialize, offer for sale and sell the Licensed Products under the Trademark within the Field and