MASTER AGREEMENT FOR PHARMACEUTICAL DEVELOPMENT AND MANUFACTURING SERVICES

Subject to Sections 6B, 6C and 6D, Client shall defend, indemnify and hold Patheon, its affiliates and their respective directors, officers, employees and agents (collectively, “Patheon Indemnitees”) harmless from and against any and all third-party actions, causes of action, costs (including reasonable legal fees), claims, damages, liabilities and expenses (collectively, “Losses”) relating to or arising from:

This indemnity shall not apply to the extent that such Losses are:

Subject to Sections 6A, 6C and 6D, Patheon shall defend, indemnify and hold the Client Indemnitees harmless from and against any and all Losses resulting from, relating to or arising from:

This indemnity shall not apply to the extent that such Losses are:

Each Party’s agreement to indemnify, defend and hold the other Party harmless is conditioned on the indemnified Party (i) providing written notice to the indemnifying Party of any claim for which it is seeking indemnification hereunder promptly after the indemnified Party has knowledge of such claim; (ii) permitting the indemnifying Party to assume full responsibility to investigate, prepare for and defend against any such claim or demand; (iii) assisting the indemnifying Party, at the indemnifying Party’s reasonable expense, in the investigation of, preparation for and defense of any such claim or demand; and (iv) not compromising or settling such claim or demand without the indemnifying Party’s written consent.

PATHEON MAKES NO WARRANTY OF ANY KIND, EITHER EXPRESSED OR IMPLIED, BY FACT OR LAW, OTHER THAN THOSE EXPRESSLY SET FORTH IN THIS CONTRACT. PATHEON MAKES NO WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE OR WARRANTY OF MERCHANTABILITY FOR THE CLIENT’S PRODUCT.

Shipments (if applicable) of Client’s Product will be made [***] unless otherwise mutually agreed. Risk of loss or damage to the Product, and title to such Product will transfer to the Client when the Product is loaded onto the carrier’s vehicle by Patheon for shipment at the [***]. The Product will be packaged and transported in accordance with the Client’s instructions. Any shipment from Client to Patheon will be made [***] to the relevant Patheon’s facility unless otherwise mutually agreed.

The following provisions shall apply to any Services that include, in part or in whole, the preparation, manufacture or packaging of pharmaceuticals for human use in clinical studies (collectively, “GMP Services”):

Each party represents, warrants and covenants to the other that as of the Effective Date:

(a) It has all requisite power and authority (corporate and otherwise) to enter into this Contract and carry out the provisions hereof, and has duly authorized by all necessary action the execution and delivery hereof by the officer or individual whose name is signed on its behalf below.

(b) Its execution and delivery of this Contract and the performance of its obligations hereunder do not and will not conflict with or result in a breach of or a default under its organizational instruments or any other material agreement, instrument, order, law or regulation applicable to it or by which it may be bound.

(c) This Contract has been duly and validly executed and delivered by it and constitutes its valid and legally binding obligation, enforceable in accordance with its terms, except as enforcement may be limited by bankruptcy, insolvency or other laws of general application relating to or affecting the enforcement of creditors’ rights and except as enforcement is subject to general equitable principles.

(d) Each party shall comply with all applicable laws, rules and regulations in connection with the performance of this Contract.

(a) Subject to Section 11 (c), excluding retained samples or stability samples, and unless otherwise agreed between the parties, if Client requests in writing that Patheon store Materials (defined below), Client will pay storage costs to Patheon at a mutually agreed upon rate if manufactured Product, clinical trial materials, placebo, development, feasibility, scale-up, registration, validation or any other batches, components, raw materials or supplies (collectively “Materials”) are stored at Patheon for more than thirty (30) days after their release for shipment by Patheon.

(b) Subject to Section 11(c), if Client fails to arrange for the pickup of all Materials as required under Section 4(e) following completion, termination or expiration of this Contract or an applicable Project Proposal, Patheon will charge:

(c) Patheon reserves the right to refuse to store any Materials under this Section 11, at its sole discretion at any time after thirty (30) days following the date of release for shipment, or at any time following expiry or termination of this Contract or any Project Proposal, provided that Patheon shall provide Client with thirty (30) days’ advance notice in writing of its refusal to continue to store Materials, in order to permit Client to make its own, alternative storage arrangements. Following expiry of the thirty-day limit, Client will be liable for all risk or loss of damage to the stored Material and it will be Client’s responsibility to have appropriate insurance coverage in place for such risk.

Client agrees that the Services described in Part A herein may be performed by an Affiliate of Patheon at the manufacturing facility where the Affiliate resides. Each Affiliate performing the Services will execute the appropriate Project Proposal which will bind the Affiliate to the terms and conditions contained herein. For purposes of this Agreement, “Affiliate” will mean a person or entity controlling, controlled by or under common control with a party to this Agreement, where control is defined as ownership, directly or indirectly, or more than fifty percent (50%) of the voting rights in the person or entity. Affiliates will be bound by the terms and conditions of this Contract. Except as set forth in this Section 12, Patheon shall not subcontract any of the Services without Client’s prior written consent.

Neither this Contract, nor any of either party’s rights hereunder, may be assigned or otherwise transferred by either party without the prior written consent of the other party, which consent will not be unreasonably withheld, except that either party may, without the other party’s consent, assign this Contract to any person or entity who shall become a successor to substantially all of the business or assets of the assigning company, whether by merger, sale of assets, sale of stock, or otherwise.

Except for payment obligations, neither party will be responsible for delay or failure in performance resulting from acts beyond the reasonable control and without the fault or negligence of the party, including, but not limited to, strikes or other labour disturbances, lockouts, quarantines, communicable disease outbreaks, riots, wars, acts of terrorism, fires, floods, storms, world-wide interruption of or delay in transportation, world-wide shortage of or inability to obtain fuel, power or components or compliance with any order or regulation of any government entity.

Any termination or expiration of this Contract will not affect any outstanding obligations or payments due hereunder prior to the termination or expiration, nor will it prejudice any other remedies that the parties may have under this Contract. The Confidentiality Agreement and Sections 4, 5, 6, 7, 9, 10 and 12 of the Contract will survive the expiration or termination of this Contract.

The parties are independent contractors and this Contract will not be construed to create between Patheon and the 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 Confidentiality Agreement entered into between the parties will apply to all confidential information about the parties and the Services to be conducted under this Contract and the Confidentiality Agreement is incorporated herein by reference. If the Confidentiality Agreement expires or terminates before the expiration or termination of this Contract, then the terms of the Confidentiality Agreement will nonetheless continue to govern the parties’ obligations of confidentiality for the term of this Contract and for 5 years thereafter. The parties agree that the Purpose under the Confidentiality Agreement is amended by execution of this Contract to allow for the purposes of this Contract, including Services.

Other than the Confidentiality 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, or otherwise modify, this Contract, regardless of any failure of Client or Patheon to object to such terms, provisions, or conditions unless such document specifically refers to this Contract and is signed by both parties.

Each party will maintain during the term of this Contract general liability and product liability insurance. Either party may request evidence of this insurance.

This Contract is the complete agreement between the parties with respect to this subject matter and supersedes all other prior agreements and understandings, whether written or oral, including, for greater certainty, the Material Transfer Agreement effective as of November 4, 2010. Any modifications, amendment or supplement to this Contract must be in writing and signed by authorized representatives of both parties.

This Contract may be signed in counterparts and by facsimile.

This Contract is governed by the laws of the State of New York without regard to any conflicts-of-law principle that directs the application to another jurisdiction’s law.

Any notice required or permitted to be given hereunder by either party shall be in writing and shall be deemed given on the date received if delivered personally or by reputable overnight delivery service, or three days after the date postmarked if sent by registered or certified mail, return receipt requested, postage prepaid to the addresses listed on the cover page hereof. A copy of any notice to Client must also be sent to the attention of Client’s General Counsel (fax: [***]).