Document:

Feasibility, Development and Commercialization Agreement

			
	 Confidential Materials omitted and filed separately with the
 Securities and Exchange Commission. Asterisks denote omissions.
	  	Exhibit 10.9

  
 FEASIBILITY,
DEVELOPMENT AND COMMERCIALIZATION AGREEMENT 
  
 This Feasibility,
Development and Commercialization Agreement (this “Agreement”) is made as of July 22, 2002, by and between Voyager Pharmaceutical Corporation, a Delaware corporation with its principal place of business at 8540 Colonnade Center Drive,
Raleigh, NC 27615 (“Voyager”), and Southern Biosystems, Inc., an Alabama corporation with its principal place of business at 756 Tom Martin Drive, Birmingham, Alabama 35211 (“SBS”). 
  
 RECITALS 
  
 WHEREAS, Voyager is the owner of United States Patent No. 6,242,421, covering the treatment and prevention of
Alzheimer’s disease; 
  
 WHEREAS, SBS is in the business of
developing, commercializing and manufacturing biodegradable polymers, biomedical devices and controlled-release products for biomedical and nonbiomedical applications including products based on the DURIN(TM) System; 
  
 WHEREAS, Voyager desires to develop and commercialize a pharmaceutical
product that implements Voyager’s patented Alzheimer’s Disease treatment methodology; 
  
 WHEREAS, Voyager desires to obtain certain rights to use SBS’s proprietary drug delivery technology in connection with the development and
commercialization of such a pharmaceutical product, and SBS desires to grant Voyager such rights, all on the terms and conditions set forth herein; and 
  
 WHEREAS, Voyager desires that SBS assist it in the development and commercialization of such a pharmaceutical product by performing certain feasibility,
development, regulatory and manufacturing activities relating to such a product, and SBS desires to perform such activities, all on the terms and conditions set forth herein. 
  
 AGREEMENT 
  
 NOW, THEREFORE, in consideration of the recitals and the mutual covenants and promises contained herein, and for other good and valuable consideration,
the receipt and sufficiency of which are hereby acknowledged, the parties hereto, intending to be legally bound, do hereby agree as follows: 
  
 ARTICLE I. DEFINITIONS 
  
 Section 1.1 “Active Agent” shall mean leuprolide acetate. 
  
 Section 1.2 “Affiliate” of a Person shall mean any other Person that directly, or indirectly through one or more
intermediaries, controls, is controlled by or is under common control with such first Person. “Control” and, with correlative meanings, the terms “controlled by” and “under common control with” shall mean ownership of
shares of stock having at least 

  

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50% of the voting power entitled to vote for the election of directors in the case of a corporation and at least 50% of the interest in profits in the case
of a business entity other than a corporation. 
  
 Section 1.3
“Agreement” shall have the meaning set forth in the preamble hereto. 
  
 Section 1.4 “Applicable Law” shall mean the applicable laws, rules, regulations, including any rules, regulations, guidelines, or other requirements of the Regulatory Authorities, that may be in effect from
time to time in the Territory. 
  
 Section 1.5 “Chair”
shall have the meaning set forth in Section 6.1. 
  
 Section 1.6
“Clinical Milestone Target Date” shall have the meaning set forth in Section 4.2(a). 
  
 Section 1.7 “Clinical Trial Plan” shall have the meaning set forth in Section 4.2(a). 
  
 Section 1.8 “Clinical Trials” shall mean Phase I, Phase II, Phase III and such other tests and studies in human subjects or patients that are
required by the Regulatory Authorities from time to time in connection with the Product pursuant to Applicable Law or otherwise. 
  
 Section 1.9 “CMC Data” shall mean any and all information contained in, as well as data supporting, the Chemistry, Manufacturing and Control
section of an IND or NDA for the Product, and any similar information or data required with respect to any other Regulatory Approval. 
  
 Section 1.10 “Commercially Reasonable Efforts” shall mean, with respect to the research, development, Manufacture or commercialization of the
Product, efforts and resources commonly used in the research-based pharmaceutical industry for a product of similar commercial potential at a similar stage in its lifecycle, taking into consideration its safety and efficacy, its cost to develop, the
competitiveness of alternative products, its proprietary position, the likelihood of regulatory approval, its profitability, and all other relevant factors. Commercially Reasonable Efforts shall be determined on a market-by-market basis in the
Territory. Commercially Reasonable Efforts with respect to Voyager’s diligence in conducting Clinical Trials and pursuing Marketing Authorization with respect to the Product in the United States will be evaluated in view of, among other
factors, Voyager’s timely achievement of Clinical Milestone Target Dates (as changed from time to time in accordance with Section 4.2(a)) and Voyager and SBS’s timely satisfaction of their respective obligations hereunder. 
  
 Section 1.11 “Confidential Information” shall mean (a) any and all
information or material that, at any time before or after the date hereof, has been or is provided or communicated to the Receiving Party by or on behalf of the Disclosing Party pursuant to this Agreement or in connection with the transactions
contemplated hereby or any discussions or negotiations with respect thereto; any data, ideas, concepts or techniques contained therein; and any modifications thereof or derivations therefrom and (b) the existence and terms of this Agreement.
Confidential Information may be disclosed either orally, visually, in writing, by delivery of materials containing Confidential Information or in any other form now known or hereafter invented. 
  

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 Section 1.12 “Deposit” shall have the meaning set forth in Section 7.1. 
  
 Section 1.13 “Development Activities” shall have the meaning set
forth in Section 3.2. 
  
 Section 1.14 “Development
Costs” shall have the meaning set forth in Section 7.1. 
  
 Section 1.15 “Development Evaluation Materials” shall have the meaning set forth in Section 3.6. 
  
 Section 1.16 “Development Formulations” shall mean the various Product prototypes developed by SBS in connection with performing the Development
Activities and provided to Voyager for evaluation in accordance with the Development Plan. 
  
 Section 1.17 “Development Plan” shall have the meaning set forth in Section 3.2. 
  
 Section 1.18 “Disclosing Party” shall mean the party disclosing Confidential Information. 
  
 Section 1.19 “Effective Date” shall mean the date first above
written. 
  
 Section 1.20 “Exploit” shall mean to make,
have made, import, use, sell, offer for sale or otherwise dispose of a product or process, including the research, development, registration, modification, enhancement, improvement, Manufacture, storage, formulation, optimization, export, transport,
distribution, promotion or marketing of a product or process. 
  
 Section 1.21 “FDA” shall mean the United States Food and Drug Administration and any successor agency thereto. 
  
 Section 1.22 “Feasibility Activities” shall mean all tests, studies and other activities that are performed in connection with the Feasibility
Program, including the preparation of the Final Report. 
  
 Section 1.23 “Feasibility Evaluation Materials” shall have the meaning set forth in Section 2.3. 
  
 Section 1.24 “Feasibility Plan” shall mean the detailed program set forth in Exhibit 1.24 for developing a formulation of the Product that meets
the Product Specifications and evaluating the feasibility of such formulation, as the same shall be amended from time to time in accordance with Section 6.1. 
  
 Section 1.25 “Feasibility Program” shall have the meaning set forth in Section 2.1. 
  
 Section 1.26 “FFDCA” shall have the meaning set forth in Section
5.4. 
  
 Section 1.27 “Final Report” shall mean the
detailed analysis and evaluation of the Feasibility Program which shall (a) describe the methodology employed and the results achieved by SBS in conducting the Feasibility Program, (b) provide recommendations for additional 

  

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development of the Product, and (c) be in such form and include such other information as set forth in the Feasibility Plan. 
  
 Section 1.28 “Firm Order” shall have the meaning set forth in
Section 5.2. 
  
 Section 1.29 “First Commercial Sale”
shall mean the first sale for use or consumption by the general public of the Product in a country in the Territory after Regulatory Approval for the marketing and sale of the Product has been obtained in such country. 
  
 Section 1.30 “GAAP” shall mean United States generally accepted
accounting principles consistently applied. 
  
 Section 1.31
“GLP” shall mean the current good laboratory practices applicable from time to time pursuant to Applicable Law. 
  
 Section 1.32 “GMP” shall mean the current good manufacturing practices applicable from time to time to the Manufacturing of the Product or any
intermediate thereof pursuant to Applicable Law. 
  
 Section 1.33
“IND” shall mean an investigational new drug application filed with the FDA for authorization to commence human clinical trials, and its equivalent in other countries or regulatory jurisdictions in the Territory. 
  
 Section 1.34 “Indemnification Claim Notice” shall have the meaning
set forth in Section 12.3. 
  
 Section 1.35 “Indemnified
Party” shall have the meaning set forth in Section 12.3. 
  
 Section 1.36 “Indemnifying Party” shall have the meaning set forth in Section 12.3. 
  
 Section 1.37 “Invention” shall mean any discovery, improvement, process, formula, data, invention, know-how, trade secret, procedure, device,
marketing study or other intellectual property, whether or not patentable, including any enhancement in the manufacture, formulation, ingredients, preparation, presentation, means of delivery, dosage or packaging of a product or any discovery or
development of a new indication for a product. 
  
 Section 1.38
“Joint Development Team” shall have the meaning set forth in Section 6.1. 
  
 Section 1.39 “Joint Inventions” shall have the meaning set forth in Section 8.1. 
  
 Section 1.40 “Losses” shall have the meaning set forth in Section 12.1. 
  
 Section 1.41 “Major Market” shall mean each of Canada, France, Germany, Italy, Japan, the United Kingdom and the
United States. 
  
 Section 1.42 “Manufacture” and
“Manufacturing” shall mean, with respect to the Product, the manufacturing, processing, formulating, packaging, labeling, holding and quality control testing of such Product. 
  

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 Section 1.43 “Manufacturing Cost” shall have the meaning set forth in Section 5.3. 

 
 Section 1.44 “Manufacturing Process” shall mean any process or
step thereof that is necessary or useful for Manufacturing the Product or any intermediate thereof. 
  
 Section 1.45 “Marketing Authorization” shall mean an approved New Drug Application as defined in the FFDCA and the regulations promulgated
thereunder, or any corresponding foreign application, registration or certification, necessary or reasonably useful to market the Product in countries or regulatory jurisdictions in the Territory other than the United States, including applicable
pricing and reimbursement approvals. 
  
 Section 1.46
“Minimum Royalty” shall have the meaning set forth in Section 7.3. 
  
 Section 1.47 “Net Sales” shall mean, with respect to any Person for any period, the gross amount invoiced by such Person and its Affiliates and sublicensees for the sale of the Product to unrelated third
Persons in bona fide arms’ length transactions, less deductions, in their normal and customary amounts for: (a) normal and customary trade, quantity and cash discounts and sales returns and allowances, including (i) those granted on account of
price adjustments, billing errors, rejected goods, damaged goods, returns and rebates, (ii) administrative and other fees and reimbursements and similar payments to wholesalers and other distributors, buying groups, pharmacy benefit management
organizations, health care insurance carriers and other institutions, (iii) allowances, rebates and fees paid to distributors and (iv) chargebacks; (b) freight, postage, shipping and insurance expenses to the extent that such items are included in
the gross amount invoiced; (c) customs and excise duties and other duties related to the sales to the extent that such items are included in the gross amount invoiced; (d) rebates and similar payments made with respect to sales paid for by any
governmental or regulatory authority such as, by way of illustration and not in limitation of the parties’ rights hereunder, federal or state Medicaid, Medicare or similar state programs or any equivalent programs of a country other than the
United States; (e) sales and other taxes and duties directly related to the sale or delivery of the Product (but not including taxes assessed against the income derived from such sale); (f) distribution expenses to the extent that such items are
included in the gross amount invoiced; and (g) any such invoiced amounts that are not collected by such Person or its Affiliates or sublicensees. Any of the deductions listed above that involves a payment by such Person or its Affiliates or its
sublicensees shall be taken as a deduction in the calendar quarter in which the payment is accrued by such entity. Deductions pursuant to subsection (g) above shall be taken in the calendar quarter in which such sales are no longer recorded as a
receivable. For purposes of determining Net Sales, (x) the Product shall be deemed to be sold when invoiced and a “sale” shall not include transfers or dispositions for charitable, promotional, pre-clinical, clinical, regulatory or
governmental purposes, (y) sales between or among such Person, its Affiliates and sublicensees shall be excluded from the computation of Net Sales and (z) Net Sales shall include the portion of the price charged for separate products sold along with
or for use in connection with the Product which is in excess of the fair market value of such products if they were not sold along with or in connection with the Product as reasonably determined by such Person. Net Sales shall include any amounts
received by such Person, its Affiliates or sublicensees in connection with the transfer of Product to an unrelated third Person to the extent any such amounts are prepayments of, or can be offset or credited against, Product sales to such unrelated
third Person. If the Product is transferred or delivered by or for such Person to a third Person but 

  

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no invoice is delivered, Net Sales shall be determined based on the average gross selling price invoiced by such Person for the Product during the three (3)
month period immediately preceding such transfer or delivery. 
  
 Section 1.48 “Person” shall mean an individual, sole proprietorship, partnership, limited partnership, limited liability partnership, corporation, limited liability company, business trust, joint stock company, trust,
unincorporated association, joint venture or other similar entity or organization, including a government or political subdivision, department or agency of a government. 
  
 Section 1.49 “Phase I” shall mean all tests and studies in subjects that are required by the Regulatory
Authorities from time to time pursuant to Applicable Law or otherwise to obtain sufficient data of safety, metabolism and pharmacokinetic properties and clinical pharmacology to permit initiation of Phase II for the Product, including the trials
referred to in 21 C.F.R. ss. 312.21(a), as amended. 
  
 Section
1.50 “Phase II” shall mean all tests and studies in subjects that are required by the Regulatory Authorities from time to time pursuant to Applicable Law or otherwise, in addition to Phase I, to obtain sufficient data as to efficacy and
dosing to permit initiation of Phase III for the Product, including the trials referred to in 21 C.F.R. ss. 312.21(b), as amended. 
  
 Section 1.51 “Phase III” shall mean all tests and studies using an extensive patient base (other than Phase I and Phase II) that are intended to
provide substantial evidence of efficacy and safety in support of Marketing Authorization for the Product, including all tests and studies that are required by the FDA from time to time, pursuant to Applicable Law or otherwise, as Phase III tests
and studies for the Product. 
  
 Section 1.52 “Product”
shall mean a biodegradable polymeric implant [**] for the treatment of Alzheimer’s Disease in humans that utilizes the SBS Technology or the SBS Improvements and contains the Active Agent. 
  
 Section 1.53 “Product Specifications” shall mean the written
specifications and quality control testing procedures for the Product determined by Voyager and amended, modified or supplemented from time to time in accordance with Section 5.8. 
  
 Section 1.54 “Project Information and Inventions” shall have the meaning set forth in Section 8.1. 
  
 Section 1.55 “Receiving Party” shall mean the party receiving
Confidential Information. 
  
 Section 1.56 “Recipients”
shall have the meaning set forth in Section 10.1. 
  
 Section 1.57
“Regulatory Approval” shall mean any and all approvals (including pricing and reimbursement approvals), licenses, registrations or authorizations of any Regulatory Authority, necessary for the Exploitation of the Product in a country in
the Territory, including any (a) approval of the Product, including any IND, Marketing Authorization and supplements and amendments thereto; (b) pre- and post-approval marketing authorizations (including any 

  

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prerequisite Manufacturing approval or authorization related thereto); (c) labeling approval; and (d) technical, medical and scientific licenses. 

 
 Section 1.58 “Regulatory Authority” shall mean any applicable
supra-national, federal, national, regional, state, provincial or local regulatory agencies, departments, bureaus, commissions, councils or other government entities regulating or otherwise exercising authority with respect to the Exploitation of
the Product in the Territory. 
  
 Section 1.59 “SBS”
shall have the meaning set forth in the preamble hereto. 
  
 Section 1.60 “SBS Improvements” shall mean any and all Inventions created, developed or acquired as a result of or in connection with the Agreement, including the Feasibility Activities, the Development Activities or SBS’s
Manufacturing of the Product hereunder that relate (i) solely to the SBS Technology including implant and accessory devices used in connection therewith or (ii) the application of the SBS Technology to or the combination of the SBS Technology with
agents, features or processes. 
  
 Section 1.61 “SBS
Indemnified Parties” shall have the meaning set forth in Section 12.2. 
  
 Section 1.62 “SBS Technology” shall mean any and all proprietary technical information, formulations, processes, know-how, data, specifications, methods of manufacture or use, characterization methods,
characterization results, and other proprietary information to the extent not generally known, whether or not patentable, owned by SBS relating to its proprietary bioerodable polymeric implant technology (DURIN(TM) Biodegradable Implants) for
imparting controlled release or other performance-enhancing qualities to products, including any patents (issued, pending, or subsequently filed and including all divisionals, continuations, continuations-in-part or other related United States and
foreign applications). 
  
 Section 1.63 “Terminated
Country” shall have the meaning set forth in Section 4.2. 
  
 Section 1.64 “Territory” shall mean all countries of the entire world except any Terminated Countries. 
  
 Section 1.65 “Test Formulations” shall mean the various Product prototypes developed by SBS in connection with performing the Feasibility
Activities and provided to Voyager for evaluation in accordance with the Feasibility Plan. 
  
 Section 1.66 “Testing Laboratory” shall have the meaning set forth in Section 5.6. 
  
 Section 1.67 “Third Party Claim” shall have the meaning set forth in Section 12.3. 
  
 Section 1.68 “Unique Dose Product” shall mean a controlled release pharmaceutical product that delivers the Active
Agent and with respect to which [**]. 
  
 Section 1.69
“Voyager” shall have the meaning set forth in the preamble hereto. 
  

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 Section 1.70 “Voyager Patents” shall mean any and all patents, patent applications, and other
intellectual property owned or controlled by Voyager related to the treatment and prevention of Alzheimer’s disease, including United States Patent No. 6,242,421. 
  
 Section 1.71 “Voyager Development Recommendations” shall have the meaning set forth in Section 3.6. 
  
 Section 1.72 “Voyager Feasibility Recommendations” shall have the
meaning set forth in Section 2.3. 
  
 Section 1.73 “Voyager
Indemnified Parties” shall have the meaning set forth in Section 12.1. 
  
 ARTICLE II. FEASIBILITY PROGRAM 
  
 Section 2.1 Conduct of Feasibility Program. SBS shall conduct and complete all tests, studies and other activities set forth in, or required in order to obtain the information set forth in, the Feasibility Plan (the “Feasibility
Program”); provided that SBS may, at its sole discretion, elect to have selected Feasibility Activities be performed by its Affiliates and further may subcontract standard tasks and services to third Person providers of such services; provided
that SBS shall be responsible for ensuring that the performance of all Feasibility Activities by its Affiliates or third Persons complies with the terms of this Agreement and in no event shall any such delegation or subcontract release SBS from any
of its obligations under this Agreement. SBS shall use Commercially Reasonable Efforts to complete the Feasibility Program in accordance with the timeline set forth in the Feasibility Plan. SBS represents, warrants and covenants that it shall
perform the Feasibility Program in good scientific manner and in compliance in all material respects with all Applicable Laws and good, professional clinical and laboratory practices (but not under GLP), and shall endeavor to achieve the objectives
of the Feasibility Program efficiently and expeditiously. Moreover, SBS shall proceed diligently with the Feasibility Program by allocating sufficient time, effort, equipment, and skilled personnel to complete the Feasibility Program successfully
and promptly. Notwithstanding the foregoing, the parties acknowledge and agree that there can be no assurances that the objectives of the Feasibility Program can be achieved, or that they can be achieved in the time set forth in the Feasibility
Plan. 
  
 Section 2.2 Costs and Expenses. 
  
 (a) Subject to Section 7.1 and except as provided in Section
2.2(b), SBS shall be solely responsible for all costs and expenses incurred in connection with the performance of the Feasibility Activities, including costs and expenses of personnel, laboratory facilities and equipment, chemicals (other than the
Active Agent) and other supplies. 
  
 (b) SBS
shall obtain, from a vendor approved by Voyager and at Voyager’s expense, all Active Agent necessary to complete the Feasibility Activities. SBS estimates that approximately [**] of Active Agent will be required for the completion of the
Feasibility Activities. 
  

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 Section 2.3 Test Formulations. SBS shall from time to time provide Voyager with (a) sufficient quantities
of the various Test Formulations of the Product as the same are developed during the performance of the Feasibility Program and (b) such technical and other information regarding such Test Formulations as Voyager may reasonably require, in each case
to enable Voyager to evaluate the scientific and commercial viability of such Test Formulations (collectively, the “Feasibility Evaluation Materials”). Voyager may evaluate the Test Formulations received from SBS and provide
recommendations to the Joint Development Team for changes to the Feasibility Program (the “Voyager Feasibility Recommendations”), including the development of the Product. Any Test Formulations provided by SBS will be used by Voyager for
research purposes only and shall not be used in humans. 
  
 Section 2.4 Reporting Requirements. 
  
 (a) At approximately the midpoint of the completion of the Feasibility Program, SBS shall provide Voyager with a written progress report which shall describe the Feasibility Activities that SBS has performed to date and evaluate the work
performed in relation to the goals of the Feasibility Plan 
  
 (b) Within forty-five (45) days after completion of the Feasibility Program, SBS shall provide Voyager with the Final Report. Within thirty (30) days of Voyager’s receipt of the Final Report, the parties shall
meet, at such time and place as the parties may agree, to review the Final Report, including the results of the Feasibility Program contained therein. 
  
 (c) In addition to the written reports specified in clauses (a) and (b) above, SBS shall provide such other information as may be
reasonably requested by Voyager relating to the Feasibility Program from time to time. 
  
 Section 2.5 Rights and Remedies. If SBS defaults in the performance of any of its material obligations under this Article II, which default has not been cured by SBS within sixty (60) days after receiving written
notice thereof from Voyager, then Voyager may, in its sole discretion, terminate (a) the rights and obligations of the parties under Article II, Article III, Article V or Article VI on an Article-by-Article basis, or under all such Articles (in
which event the license granted pursuant to Section 8.2(a) shall also terminate) or (b) the rights and obligations of the parties under Section 4.2(c) (in which event the license granted pursuant to Section 8.2(c) shall also terminate), in each case
by providing immediate written notice to SBS, in which event Voyager shall have the right to perform or have performed by a third Person all feasibility, development, regulatory or Manufacturing activities related to the Product previously allocated
to SBS under the terminated provisions. The rights and remedies provided in this Section 2.5 shall be cumulative and in addition to any other rights or remedies that may be available to Voyager. 
  
 Section 2.6 [**] Technology. The parties acknowledge and agree that Voyager
is currently in discussions with [**] regarding the use or acquisition of certain data and technology that may be relevant to the Product and that may accelerate, or eliminate the necessity for, the performance of certain Feasibility Activities and
Development Activities. In the event that Voyager acquires the right to use such data and technology, the parties shall negotiate in good faith amendments to the terms of this Agreement that provide for the acceleration or elimination 

  

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of such Feasibility Activities and Development Activities; provided that in no event shall the method for calculating Development Costs or manufacturing
Costs, the royalties payable by Voyager pursuant to Section 7.3, or, except as expressly set forth in the succeeding proviso, the milestone payments payable by Voyager pursuant to Section 7.2 be amended or changed as a result of the use of such data
and technology; provided further, however, that in the event that the use of such data and technology obviates the need for performance of Phase I trials for the Product, Voyager shall pay the $[**] milestone otherwise payable pursuant to Section
7.2(a) within [**] days after receipt by Voyager of written notification from FDA that Phase I trials for the Product are not required. 
  
 ARTICLE III. DEVELOPMENT ACTIVITIES 
  
 Section 3.1 Election to Proceed. Voyager shall notify SBS in writing, within [**] days after SBS’s submission to Voyager of the Final Report, whether
Voyager elects to proceed with further development of the Product. If Voyager notifies SBS that it does not wish to proceed with further development, or if Voyager does not deliver notice within such [**] day period, then this Agreement shall be
deemed to have been terminated pursuant to Section 11.2(a) as of the time of delivery of such notice or the end of such [**] day period, as the case may be. 
  
 Section 3.2 Development Plan. 
  
 (a) Upon the election by Voyager to proceed with development of the Product pursuant to Section 3.1, the parties shall consult to develop
as soon as reasonably practicable a written plan (the “Development Plan”) that sets forth (i) further development activities with respect to the Product that are necessary or desirable to enable Voyager to commence Clinical Trials for the
Product (including Manufacturing Process development as required and the production by SBS of Product formulations for preclinical, toxicology and other studies) (the “Development Activities”), (ii) the party responsible for performing
each Development Activity, and (iii) an estimated timeline for completion of critical development milestones in accordance with Section 3.3(b). In the event of any dispute between the parties with respect to the contents of the Development Plan,
such dispute will be submitted to the Joint Development Team and resolved by the Joint Development Team in accordance with Section 6.1. The Development Plan may be amended from time to time by the Joint Development Team in accordance with Section
6.1. 
  
 (b) Prior to commencing any Development
Activities, SBS shall provide Voyager with a good faith, non-binding estimate of the total amount of Development Costs required to complete the Development Activities. 
  
 Section 3.3 Conduct of Development Activities. 
  
 (a) Each of SBS and Voyager shall provide funding, conduct and complete all tests, studies and other
activities set forth in, or required in order to obtain the information set forth in, the Development Plan for which it is assigned responsibility; provided that SBS may, at its sole discretion, elect to have selected Development Activities
allocated to it under the Development Plan be performed by its Affiliates and further may subcontract standard tasks and services to third Person providers of such services; provided that SBS shall be responsible for 

  

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ensuring that the performance of all Development Activities by its Affiliates or third Persons complies with the terms of this Agreement and in no event
shall any such delegation or subcontract release SBS from any of its obligations under this Agreement. Each of SBS and Voyager represents, warrants and covenants that it shall perform the Development Activities for which it is assigned
responsibility in good scientific manner and in compliance in all material respects with all requirements of Applicable Laws and good clinical and laboratory practices and under such regulatory standards (for example GLP or GMP) as shall be
specified in the Development Plan, and shall endeavor to achieve the objectives of the Development Plan efficiently and expeditiously. Moreover, each of SBS and Voyager shall proceed diligently with the Development Plan by allocating sufficient
time, effort, equipment, and skilled personnel to complete the Development Activities for which it is assigned responsibility successfully and promptly. 
  
 (b) The Development Plan will include good faith estimates for critical development milestones, such as completion of a GLP toxicity
study, package development, trocar development, manufacturing of an initial batch of clinical materials under GMP, and preparation of documentation for submission an IND (toxicity, CMC, and initial stability). 
  
 Section 3.4 Costs and Expenses. 
  
 (a) Subject to Section 7.1 and except as provided in Section
3.4(b), SBS shall be solely responsible for all costs and expenses incurred in connection with the performance of the Development Activities for which it is assigned responsibility, including costs and expenses of personnel, laboratory facilities
and equipment, chemicals (other than the Active Agent) and other supplies. 
  
 (b) SBS shall obtain, from a vendor approved by Voyager and at Voyager’s expense all Active Agent necessary to complete the Development Activities for which SBS is assigned responsibility. 
  
 Section 3.5 Reporting Requirements. 
  
 (a) Within thirty (30) days after the end of each calendar
quarter in which Development Activities are performed, SBS shall provide to Voyager a written progress report, which shall describe the Development Activities it has performed during such calendar quarter, evaluate the work performed in relation to
the goals of the Development Plan, and provide such other information as may be reasonably requested by Voyager with respect to the Development Activities. 
  
 (b) In addition to the written reports specified in subsection (a) above, SBS shall provide such other information as may be reasonably
requested by Voyager relating to the Development Activities from time to time. 
  

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 Section 3.6 Development Formulations. SBS shall from time to time provide Voyager with (a) sufficient
quantities of the various Development Formulations as the same are developed during the performance of the Development Activities and (b) such technical and other information regarding such Development Formulations as Voyager may reasonably require,
in each case to enable Voyager to evaluate the scientific and commercial viability of such Development Formulations (collectively, the “Development Evaluation Materials”). Voyager may evaluate the Development Formulations received from SBS
and provide recommendations to the Joint Development Team for changes to the Development Plan (the “Voyager Development Recommendations”). 
  
 Section 3.7 Regulatory Records. SBS shall maintain records of all Feasibility Activities and Development Activities conducted by it in sufficient detail
and in good scientific manner appropriate for patent and regulatory purposes, which shall be substantially complete and materially accurate and shall reflect all work done and results achieved in the performance of the Feasibility Activities and
Development Activities, and which shall be retained by SBS for at least five (5) years after the termination of this Agreement, or for such longer period as may be required by Applicable Law. Voyager shall have the right, during normal business
hours and upon reasonable notice, to inspect and copy any such records. 
  
 Section 3.8 Rights and Remedies. If SBS defaults in the performance of any of its material obligations under this Article III, which default has not been cured by SBS within sixty (60) days after receiving written notice thereof from
Voyager, then Voyager may, in its sole discretion, terminate (a) the rights and obligations of the parties under Article III, Article V or Article VI on an Article-by-Article basis or under all such Articles (in which event the license granted
pursuant to Section 8.2 (a) shall also terminate) or (b) Section 4.2(c) (in which event the license granted pursuant to Section 8.2(c) shall also terminate), in each case by providing immediate written notice to SBS, in which event Voyager shall
have the right to perform or have performed by a third Person all development, regulatory and Manufacturing activities related to the Product previously allocated to SBS under the terminated provisions. The rights and remedies provided in this
Section 3.8 shall be cumulative and in addition to any other rights or remedies that may be available to Voyager. 
  
 ARTICLE IV. REGULATORY APPROVALS 
  
 Section 4.1 Regulatory Approvals. Within ninety (90) days following the completion of the Development Activities, Voyager shall notify SBS in writing in the event that Voyager elects to commence Clinical Trials with
respect to the Product. If Voyager notifies SBS that it does not wish to proceed with Clinical Trials, or if Voyager does not deliver notice within such ninety (90) day period, then this Agreement shall be deemed to have been terminated pursuant to
Section 11.2(a) as of the time of delivery of such notice or the end of such ninety (90) day period, as the case may be. Voyager shall have the sole right to develop the appropriate strategy for obtaining and maintaining Regulatory Approvals in the
Territory. All INDs, Marketing Authorizations and other filings, applications or requests pursuant to or in connection with the Regulatory Approvals shall be made in the name of, and shall be owned solely by, Voyager or its designee. Voyager shall
have the sole right to conduct all communications with the Regulatory Authorities with regard to the Product. 
  

 -12- 

 Section 4.2 Voyager Diligence. 
  
 (a) If Voyager elects to proceed with Clinical Trials for the Product, Voyager shall use Commercially
Reasonable Efforts to conduct all required Clinical Trials and obtain the Regulatory Approvals necessary to Exploit the Product in the United States as soon as reasonably practicable. Voyager shall use Commercially Reasonable Efforts to
commercialize the Product in the United States during the term of this Agreement commencing as soon as reasonably practicable after receipt of required Regulatory Approvals. At the same time as Voyager provides SBS with written notice of its intent
to conduct Clinical Trials pursuant to Section 4.1, Voyager shall provide SBS with a written outline of its Clinical Trial strategy and timeline to support Regulatory Approval in the United States (the “Clinical Trial Plan”). The Clinical
Trial Plan will include Voyager’s good faith estimate as to the target dates for (i) IND filing, (ii) start of Phase III and (iii) NDA filing to support Regulatory Approval in the United States (each, a “Clinical Milestone Target
Date”). Voyager shall review the Clinical Trial Plan at least on a quarterly basis and may in its reasonable discretion change such plan and any Clinical Milestone Target Date therein at any time. Voyager promptly shall notify SBS in writing in
the event of any material change to the Clinical Trial Plan or in the event that any Clinical Milestone Target Date is delayed by one calendar quarter or more. At SBS’s request, Voyager shall provide SBS the reasons for such change. If Voyager
defaults in the performance of any of its material obligations under this Section 4.2(a), which default has not been cured by Voyager within sixty (60) days after receiving written notice thereof from SBS, then SBS may, in its sole discretion,
terminate this Agreement by providing immediate written notice to Voyager. 
  
 (b) If Voyager has not applied for Regulatory Approval in (i) each other Major Market within [**] after obtaining Regulatory Approval for the Product in the United States or (ii) in each country in the Territory other
than a Major Market within [**] after obtaining Regulatory Approval for the Product in the United States, or has not made the First Commercial Sale in any country [**] after receipt of Regulatory Approval in such country, then SBS may, upon [**]
days prior written notice to Voyager (unless Voyager applies for such Regulatory Approval or makes such First Commercial Sale within such [**] day period), terminate the rights granted to Voyager under Section 8.2 with respect to such country (each,
a “Terminated Country”). 
  
 (c) SBS
may elect, at its sole discretion, to Exploit the Product in any Terminated Country by providing [**] days prior written notice to Voyager. 
  
 (d) The remedies set forth in this Section 4.2 shall be exclusive and in lieu of any other remedies that may be available to SBS pursuant
to any statutory or common law or equity with respect to any Losses of any kind or nature suffered by SBS directly or indirectly resulting from or arising out of any failure by Voyager to perform its obligations under this Section 4.2 . 

 
 Section 4.3 Cooperation of SBS. SBS shall cooperate with any and all
reasonable requests for assistance from Voyager with respect to the development and commercialization of the Product and obtaining and maintaining Regulatory Approvals for the Product, including by: 
  
 (a) making its employees, consultants and other scientific
staff available upon reasonable notice during normal business hours at their respective places of employment to consult with Voyager on issues arising during such development and commercialization; 
  

 -13- 

 (b) making its employees, consultants and other scientific staff available upon
reasonable notice during normal business hours to attend meetings with Regulatory Authorities concerning the Product; 
  
 (c) disclosing and making available to Voyager, in whatever form Voyager may reasonably request, all biological, chemical,
pharmacological, toxicological, pharmaceutical, physical and analytical, clinical, safety, Manufacturing and quality control data and other information related to the Product, the Manufacturing Process and the SBS Technology owned or controlled by
SBS as is necessary or desirable to prepare, file, obtain and maintain any Regulatory Approval; and 
  
 (d) SBS shall prepare and provide to Voyager all CMC Data with respect to the Product necessary to obtain and maintain Regulatory
Approvals and in a form suitable for filing by Voyager with Regulatory Authorities. 
  
 Section 4.4 Review of Filings. Voyager shall provide SBS with the opportunity for a timely review and comment on all regulatory filings proposed to be made with respect to the Product prior to their submission to a
Regulatory Authority and will promptly provide SBS with copies of all communications to or from any Regulatory Authority with respect to the Product. SBS shall perform such review promptly after such filings are provided by Voyager. 
  
 Section 4.5 Rights and Remedies. If SBS defaults in the performance of any of
its material obligations under this Article IV, which default has not been cured by SBS within [**] days after receiving written notice thereof from Voyager, then Voyager may, in its sole discretion, terminate (a) the rights and obligations of the
parties under Section 4.3, 4.4 or Article V on a case-by-case basis or under all such provisions (in which event the license granted pursuant to Section 8.2(a) shall also terminate) or (b) the rights and obligations of the parties under Section
4.2(c) (in which event the license granted pursuant to Section 8.2(c) shall also terminate), in each case by providing immediate written notice to SBS, in which event Voyager shall have the right to perform or have performed by a third Person all
regulatory and Manufacturing activities related to the Product previously allocated to SBS under the terminated provisions. The rights and remedies provided in this Section 4.5 shall be cumulative and in addition to any other rights or remedies that
may be available to Voyager. 
  
 ARTICLE V. MANUFACTURING

  
 Section 5.1 Supply Obligations. SBS shall supply Voyager with,
and Voyager shall purchase from SBS, (a) all of Voyager’s clinical requirements of the Product and placebos necessary in connection with Clinical Trials and (b) all of Voyager’s commercial requirements of the Product; provided that SBS
shall not be required to supply a number of units of Product in any calendar quarter that exceeds the reasonable maximum quarterly manufacturing capacity of SBS’s manufacturing facility in Birmingham, Alabama on the date of this Agreement
unless SBS otherwise agrees. These supply and purchase obligations shall continue until the earlier to occur 

  

 -14- 

 
of (i) the effective date of SBS’s election to discontinue supply of Voyager’s commercial requirements of Product, which effective date shall be
specified in a written notice delivered by SBS to Voyager not less than [**] prior to such effective date; provided that in no event may SBS elect to terminate its supply obligations prior to the second anniversary of the First Commercial Sale of
the Product in the Territory, (ii) the termination of this Agreement and (iii) the termination of these supply and purchase obligations with respect to the Product in accordance with Sections 2.5, 3.8, 4.5 and 5.6. SBS may, in its sole discretion,
subcontract with a qualified contract manufacturer in order to fulfill SBS’s supply obligations to Voyager hereunder; provided that in no event shall any such subcontract release SBS from any of its obligations under this Agreement, including
its obligation to deliver Product that complies with the warranty set forth in Section 5.4. 
  
 Section 5.2 Forecasting, Order and Delivery of Products. 
  
 (a) Forecasting. Within ninety (90) days of Voyager’s election to commence Clinical Trials with respect to the Product, Voyager shall
submit an estimate of the quantities of the Product (and placebos, if any) that Voyager expects to purchase from SBS during the succeeding [**] calendar quarters. Thereafter, on or before the thirtieth (30th) day of each following calendar quarter,
Voyager shall submit an updated forecast of its requirements of the Product from SBS for the succeeding [**] calendar quarters. These forecasts shall be non-binding and shall be used by SBS for planning purposes only. 
  
 (b) Firm Orders. Not later than ninety (90) days prior to
commencement of each calendar quarter, Voyager shall submit to SBS a purchase order for such quantities of the Product (and placebos, if any) as Voyager commits to purchase from SBS during such calendar quarter, with a statement of the dates on
which delivery shall be required and shipping instructions therefore (a “Firm Order”). SBS shall confirm to Voyager in writing, within five (5) days after receipt thereof, the receipt by SBS of each Firm Order submitted in accordance with
this Section 5.2, and shall be obligated to deliver the specified quantity of the Product (and placebos) in accordance with the delivery schedule set forth in such Firm Order. SBS shall exercise its best efforts to comply with changes to a Firm
Order that Voyager may request after receipt by SBS of such Firm order but shall not be liable for its inability to do so. Firm Orders may be amended by mutual agreement of the parties. In the event that the terms of any Firm Order are not
consistent with this Agreement, the terms of this Agreement shall prevail. 
  
 (c) Delivery and Risk of Loss. SBS shall deliver the quantities of the Product (and placebos) set forth in each Firm order on the delivery date specified therein, to a location designated in writing by Voyager, FOB
(as defined in the UCC) SBS’s facility in Birmingham, Alabama. Title to the Products shall pass to Voyager at the time of delivery. 
  
 (d) Invoice and Payment. SBS shall promptly invoice Voyager for all quantities of the Product delivered in accordance herewith. Invoices
shall be accompanied by a certificate of analysis and a certificate of compliance with the warranty set forth in Section 5.4 for each invoiced batch of the Product, in such form as is reasonably acceptable to Voyager. Subject to Section 5.6, payment
with respect to a shipment shall be due thirty (30) days after receipt by Voyager of such shipment of the Product and the invoice and certificates with respect thereto; provided, however, that if Voyager rejects such shipment pursuant to Section
5.6, then payment shall be due within sixty (60) days after receipt by Voyager of notice from the Testing 

  

 -15- 

 
Laboratory that the invoiced Product is conforming or, subject to Section 5.6, receipt by Voyager of replacement Product, as the case may be. In the event of
any inconsistency between an invoice and this Agreement, the terms of this Agreement shall control. All payments shall be made in accordance with Section 7.4. 
  

Section 5.3 Price. The parties hereby agree that the price (the “Manufacturing Cost”) for Voyager’s requirements of: 
  
 (a) clinical supplies of the Product (and placebos) shall be
equal to [**] in accordance with all Applicable Laws calculated in accordance with Exhibit 5.3. 
  
 (b) commercial supplies of the Product shall be equal to [**]. 
  
 SBS shall notify Voyager in advance of any material increase in Manufacturing Cost. 
  
 Section 5.4 Warranty. SBS warrants that, at the time of delivery of the
Product to Voyager: (a) such Product will have been Manufactured, held and shipped in accordance with the Regulatory Approvals for the Product, applicable GMP and all other Applicable Law; (b) such Product will have been Manufactured in accordance,
and be in conformity, with the Product Specifications and will conform with the certificate of analysis provided pursuant to Section 5.2; (c) such Product will not be adulterated or misbranded under the Federal Food, Drug, and Cosmetic Act, as
amended (the “FFDCA”), and similar provisions of the laws of other countries as to which Regulatory Approvals have been granted with respect to the Product; (d) title to such Product will pass to Voyager as provided herein free and clear
of any security interest, lien or other encumbrance; (e) such Product will have been Manufactured in facilities that are in material compliance all Applicable Laws at the time of such Manufacture (including applicable inspection requirements of FDA
and other Regulatory Authorities); and (f) such Product may be introduced into interstate commerce pursuant to the FFDCA. 
  
 Section 5.5 Non-Conforming Product. SBS shall not deliver to Voyager any Product that fails to conform in any respect to the warranty set forth in Section
5.4. In the event that any Product shall fail to pass the quality control testing conducted by SBS, (i) SBS shall notify Voyager thereof within one (1) business day, (ii) SBS shall not release the batch from which such Product was taken, and (iii)
the parties shall agree upon appropriate corrective steps to be taken. Voyager, at its option, may investigate the cause of such failure, or require SBS to do so, in which case SBS shall provide Voyager with a written report summarizing the results
of the SBS’s investigation, all at the expense of SBS. 
  
 Section 5.6 Failure or Inability to Supply Product. 
  
 (a) Notification of Inability to Supply. In the event that SBS, at any time during the term of this Agreement, shall have reason to believe that it will be unable to supply Voyager with the full quantity of the
Product forecasted to be ordered or actually ordered by Voyager in a timely manner and in conformity with the warranty set forth in Section 5.4 (whether by reason of force majeure or otherwise), SBS shall promptly notify Voyager thereof. Promptly
thereafter, the parties shall meet to discuss how Voyager shall obtain such full quantity of conforming Product. Compliance by SBS with this Section 5.6 shall not relieve SBS of any 

  

 -16- 

 
other obligation or liability under this Agreement, including any obligation or liability under clause (b) or (c) below. 
  
 (b) Failure to Supply Conforming Product. In the event that
Voyager reasonably determines, within thirty (30) days after delivery thereof by SBS, that any Product supplied by SBS does not conform to the warranty set forth in Section 5.4, Voyager shall give SBS notice thereof (including a sample of such
Product). SBS shall undertake appropriate testing of such sample and shall notify Voyager whether it has confirmed such non-conformity within thirty (30) days after receipt of such notice from Voyager. If SBS notifies Voyager that it has not
confirmed such non-conformity, the parties shall submit the disputed batch to an independent testing laboratory mutually acceptable to the parties (the “Testing Laboratory”) for testing. The findings of the Testing Laboratory shall be
binding on the parties, absent manifest error. The expenses of the Testing Laboratory shall be borne by SBS if the testing confirms the non-conformity and otherwise by Voyager. If the Testing Laboratory or SBS confirms that a batch of Product does
not conform to the warranty set forth in Section 5.4, SBS shall promptly (i) supply Voyager with a conforming quantity of the Product at SBS’s expense or (ii) reimburse Voyager for all reasonable costs Voyager may have directly incurred with
respect to such non-conforming Product, including any Manufacturing Cost paid by Voyager with respect to such Product, which costs Voyager shall have the right to offset against any payments owed by Voyager to SBS under this Agreement. The rights
and remedies provided in this clause shall be cumulative and in addition to any other rights or remedies that may be available to Voyager. 
  
 (c) Rights and Remedies. 
  
 (i) If SBS fails [**] or more times within any [**] consecutive month period to supply the full quantity of Product specified in a Firm
Order by the delivery date specified therein and in conformity with the warranty set forth in Section 5.4, Voyager may, in its sole discretion, terminate (A) the rights and obligations of the parties under Article V (in which event the license
granted Section 8.2(a) shall also terminate) or (B) the rights and obligations of the parties under Section 4.2(c) (in which event the license granted pursuant to Section 8.2(c) shall also terminate), in each case by providing immediate written
notice to SBS, and thereafter Voyager may Manufacture Product itself or purchase its requirements for Product from a third Person. The rights and remedies provided in this Section 5.6 shall be cumulative and in addition to any other rights or
remedies that may be available to Voyager. 
  
 Section 5.7 Costs
and Expenses. SBS shall be solely responsible for all costs and expenses incurred in connection with the Manufacture of supplies of the Product pursuant to this Article V, including costs and expenses of personnel, testing, including quality control
and stability, Manufacturing facilities and equipment, the Active Agent, raw materials, excipients, labeling, packaging materials and all other supplies of any kind used in connection with Manufacturing the Product (and placebos), which costs shall
be included in the calculation of Manufacturing Costs in accordance with Section 5.3; provided, however, that Voyager (i) shall reimburse to SBS, within 30 days after receipt of an invoice and reasonable supporting documentation therefor, the cost
of any piece of Manufacturing equipment or other fixed asset procured by SBS after the date hereof and required to manufacture the Product hereunder; provided that the cost of such equipment or asset is [**] or less, and (ii) may, if it so
determines in its sole and absolute discretion, purchase (and retain title to) and make available for use by 

  

 -17- 

 
SBS any other piece of Manufacturing equipment or other fixed asset that SBS requests for use in connection with the Manufacture of the Product; provided
further, that Voyager, in its sole discretion but upon reasonable advance notice to SBS, may from time to time, at its cost, supply to SBS materials (including the Active Agent) to be used in the Manufacture of the Product, in which event the cost
of such materials shall not be included in calculating Manufacturing Cost for the Products for which they were used. 
  
 Section 5.8 Amendment of Product Specifications and Manufacturing Process. 
  
 (a) Rights and Limitations. Voyager reserves the right to amend, modify or supplement the Product
Specifications or the Manufacturing Process unilaterally and in its sole discretion for the purpose of complying with the Regulatory Approvals, GMP, other Applicable Law, or, upon ninety (90) days prior notice, for any other reasonable business
purpose. Voyager shall promptly supply SBS with appropriate documentation relating to any such changes to the Product Specifications or Manufacturing Process to the extent that such changes affect SBS’s Manufacturing of the Product hereunder.
In the event that SBS cannot reasonably implement or comply with such changes to Product Specifications (it being acknowledged and agreed by SBS that increase in Manufacturing Cost shall not constitute a valid justification for failure to implement
or comply with such changes), then SBS shall not be required to implement or comply with such changes. SBS may not amend, modify or supplement the Product Specifications or the Manufacturing Process for the Product in any respect without the prior
written consent of Voyager, which consent shall not be unreasonably withheld or delayed. 
  
 (b) Amendment to Regulatory Approvals; Costs and Expenses. In the event that Voyager amends, modifies or supplements the Product
Specifications or the Manufacturing Process for the Product, or consents to any such amendment, modification or supplement by SBS, SBS shall provide to Voyager any such documentation or other information with respect thereto as Voyager may
reasonably request in order to obtain or maintain any Regulatory Approval or comply with GMP or Applicable Law. Voyager shall reimburse SBS for reasonable costs that are actually incurred by SBS in connection with any such change requested by
Voyager, including reasonable costs of capital equipment and process upgrades, obsolescence of raw materials, goods-in-process, packaging materials and supplies and finished goods not suitable for use in the business or operations of SBS or any of
its Affiliates; provided, however, that Voyager’s liability for such reimbursement shall be limited to levels of inventory that are customary in pharmaceutical manufacturing operations. SBS shall be solely responsible for any and all costs and
expenses incurred by it or Voyager and its Affiliates and sublicensees as a result of any amendment, modification or supplementation of the Product Specifications or the Manufacturing Processes by SBS not requested by Voyager, or requested by
Voyager as a result of SBS’s failure to Manufacture Product in conformity with the warranty set forth in Section 5.4, which costs shall not be included in the Manufacturing Costs. 
  
 Section 5.9 Testing, Assays, Stability and Quality Assurance. 
  
 (a) Testing Requirements. With respect to the Product or any intermediate thereof Manufactured or supplied
by SBS, SBS shall be responsible for the performance of and compliance with all Product testing required by the Product Specifications, the Manufacturing Processes and Regulatory Approvals for the Product and all Applicable Law. SBS agrees to

  

 -18- 

 
implement and maintain such processing control procedures as Voyager may reasonably request, including the assignment of identification numbers to each lot
of Product and the maintenance of production records, quality control records, batch records and related information. 
  
 (b) Retention of Samples. SBS shall take and retain, for such period as may be required by Applicable Law or such longer period as
otherwise reasonably required by Voyager, samples of Product (i) sufficient to satisfy SBS’s obligations under this Agreement, GMP and Applicable Law with respect to its Manufacturing of the Product, (ii) sufficient to perform quality control
testing and stability testing in accordance with this Agreement, the Regulatory Approvals for the Product, GMP and all other Applicable Law, and (iii) as otherwise reasonably required by Voyager, and in each case shall specify the control number and
the date of Manufacture thereof. Further, SBS shall submit to Voyager, upon Voyager’s written request, such samples, materials and quality control records as Voyager may reasonably request. 
  
 (c) Stability Testing. SBS shall perform stability testing
of the Product in accordance with the Product Specifications, the Manufacturing Process, the Regulatory Approvals, GMP and other Applicable Law, and such other requirements and processes as Voyager shall reasonably determine from time to time. If
SBS confirms a stability failure with respect to the Product, SBS shall notify Voyager thereof within twenty-four (24) hours and the parties shall discuss in good faith appropriate corrective action. SBS shall promptly implement any such corrective
action. 
  
 (d) Maintenance of Facilities. SBS
shall ensure, that any and all necessary licenses, registrations, and Regulatory Authority approvals have been obtained in connection with any facilities and equipment used in connection with the manufacture of the Product by SBS. SBS shall maintain
such facilities and equipment in a state of repair and operating efficiency consistent with the requirements of the Product Specifications, the Regulatory Approvals, the Manufacturing Processes, GMP and all other Applicable Law. Prior to each use of
any equipment in Manufacturing the Product, SBS shall implement a cleaning validation protocol with respect to such equipment, including the cleaning and maintenance thereof, in accordance with any procedures reasonably established by Voyager and
notified to SBS, the Product Specifications, the Regulatory Approvals and the Manufacturing Processes, GMP and all other Applicable Law. SBS shall maintain in such facilities adequate and segregated (if required) holding accommodations for the
Product, the Active Agent, and the excipients, packaging components, and other items used in Manufacturing the Product in accordance with the Product Specifications, the Regulatory Approvals and the Manufacturing Process, GMP and all other
Applicable Law. If required under Applicable Law, all Product shall be held by SBS in a separate segregated area until delivery to Voyager. 
  
 (e) Quality Assurance Procedures. Without limitation of the foregoing, SBS agrees to implement, in connection with the Manufacture of the
Product, quality assurance and quality control procedures, including validation protocols, process change procedures and methods of statistical analysis for cleaning validation that are reasonably satisfactory to Voyager. 
  
 Section 5.10 Inspection by Voyager. SBS agrees that Voyager and its agents
shall have the right, upon reasonable prior notice to SBS, to inspect any facility at which the Product or any intermediate thereof is manufactured as well as the Manufacturing of the Product and any 

  

 -19- 

 
intermediates thereof, as applicable, including inspection of (a) the materials used in the Manufacture of the Product, (b) the holding facilities for such
materials, (c) the equipment used in the Manufacture of the Product, and (d) all records relating to such Manufacturing and each such manufacturing facility. Following such audit, Voyager shall discuss its observations and conclusions with SBS and
corrective actions shall be agreed upon by Voyager and SBS within thirty (30) days thereafter. SBS shall implement such corrective action within sixty (60) days after the parties reach such agreement, unless otherwise agreed in writing by the
parties. 
  
 Section 5.11 Notification of Inspections;
Communications. SBS shall notify Voyager by telephone within one (1) business day, and in writing within five (5) business days, after learning thereof, of any proposed or unannounced visit or inspection of any facility at which the Product, or any
intermediate thereof, is Manufactured, or of any Manufacturing Process used in connection with the Manufacture of the Product, by any Regulatory Authority, and shall permit Voyager or its agents to be present and participate in such visit or
inspection. SBS shall provide to Voyager a copy of any report and other written communications received from such Regulatory Authority in connection with such visit or inspection, and any written communications received from such Regulatory
Authority relating to the Product or any facility or Manufacturing Process used in connection with the Manufacture of the Product, within three (3) business days after receipt thereof, and shall consult with Voyager concerning the response of SBS to
each such communication. SBS shall provide Voyager with a copy of all draft responses for comment as soon as possible and all final responses for review and approval, which shall not be unreasonably withheld or delayed, within five (5) business days
prior to submission thereof. 
  
 Section 5.12 Manufacturing
Records. SBS shall maintain, or cause to be maintained, (i) all records necessary to comply with GMP and all other Applicable Law relating to the Manufacture of the Product, (ii) all Manufacturing records, standard operating procedures, equipment
log books, batch records, laboratory notebooks and all raw data relating to the Manufacturing of the Product, and (iii) such other records as Voyager may reasonably require in order to ensure compliance by SBS with the terms of this Agreement. All
such material shall be retained for such period as may be required by GMP and all other Applicable Law or for such longer period as Voyager may reasonably require; provided, however, that all records relating to the Manufacturing, stability and
quality control of each batch of the Product shall be retained at least until the first anniversary of the end of the approved shelf life for all Product from such batch. 
  
 Section 5.13 Labeling. Voyager shall specify all labeling to be used on the Product and the packaging thereof. SBS agrees to
use such labeling (and only such labeling) on the Product, and not to use such labeling on any other product. To the extent permissible under Applicable Law, at SBS’s request (and expense if compliance with such request increases any costs
related to the Product), Voyager shall cause the packaging of the Product to display, in a manner reasonably acceptable to SBS and Voyager, the name and logo of SBS (or an Affiliate) and to identify SBS as a developer or such Product. SBS shall
grant Voyager appropriate licenses in order to fulfill its obligations under this Section 5.13. 
  

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 ARTICLE VI. JOINT DEVELOPMENT TEAM 
  
 Section 6.1 Joint Development Team. Upon initiation of the Feasibility Program, the parties shall establish a joint
development team (the “Joint Development Team”) which shall consist of two (2) representatives appointed by each party. The chairperson of the Joint Development Team shall be a representative of Voyager (the “Chair”). Each party
may, from time to time, change one or more of its representatives by written notice to the other party. The Joint Development Team shall be responsible for and establish procedures for the management of the Feasibility and Development Programs in
accordance with the Feasibility and Development Plans and shall serve as points of contact between the parties to coordinate activities and ensure that the parties perform their respective obligations (if any) diligently in accordance with the
Feasibility Plan and the Development Plan. The Joint Development Team shall meet at least once per month (either by telephone or in person, as agreed to by SBS and Voyager) to review the planning and the progress of the Feasibility and Development
Programs and to consider recommendations regarding, and to make changes to, the Feasibility and Development Plans and performance of the Feasibility and Development Programs. In performing its functions, the Joint Development Team shall attempt to
reach all decisions by consensus. However, if the members cannot reach consensus with respect to any decision within a reasonable time period (which shall not be more than thirty (30) days) after careful consideration, the matter shall be referred
to the chief executive officers of Voyager and SBS for review and discussion. In the event the CEOs of Voyager and SBS cannot reach agreement within a reasonable time period (which shall not be more than thirty (30) days), then the Chair shall make
the final decision, which shall be final and binding on the parties. Notwithstanding the foregoing, nothing herein, and no decision made under this Section, shall be deemed to modify or supersede the express terms or conditions of this Agreement, or
any decision or decision-making authority otherwise expressly provided for in this Agreement. 
  
 ARTICLE VII. PAYMENTS 
  
 Section
7.1 Development Costs. 
  
 (a) Voyager shall pay
SBS’s fully allocated development cost calculated in accordance with Exhibit 7.1 (the “Development Costs”) for all Feasibility Activities, Development Activities and activities under and pursuant to Article IV, in each case performed
by SBS. 
  
 (b) The estimated total Development
Costs necessary to complete all Feasibility Activities is set forth in the Feasibility Plan, although the actual Development Costs therefor may differ. Completion of the Feasibility Plan with less effort than estimated may result in lower charges;
however, additional effort from unexpected results or changes requested by Voyager may result in higher charges. SBS will not exceed the estimated costs without prior written approval from Voyager. 
  
 (c) Voyager shall pay to SBS [**] upon execution of this
Agreement (the “Deposit”). 
  

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 (d) SBS shall submit to Voyager, not later than twenty (20) business days after the end
of each month during the term of this Agreement in which Development Costs are incurred, an invoice which shall set forth the actual amount of Development Costs incurred during the prior month. Voyager, within thirty (30) days of receipt of each
such invoice, (i) shall pay the amount specified in such invoice, less twenty (20) percent of such invoiced amount until such time as the Deposit has been fully credited, and (ii) thereafter shall pay the full amount of each such invoice. Charges
for reimbursement of purchases of Active Agent by SBS in connection with the performance of the Feasibility Activities and the Development Activities shall be invoiced separately from time to time and shall be paid by Voyager within thirty (30) days
of receipt thereof. All invoices shall be sent to Voyager at the address specified in Section 13.1 unless Voyager designates otherwise in writing to SBS. 
  
 Section 7.2 Milestone Payments. Voyager shall make the milestone payments specified below to SBS within thirty (30) days following achievement of the
corresponding milestone event, except that in the case of the Approval of first NDA (or equivalent) milestone event, payment shall be paid by Voyager within sixty (60) days following achievement of such milestone event: 
  

			
	 Milestone Event

	  	 Milestone Payment

	 (a)     [**]
	  	[**]
	 (b)     [**]
	  	[**]
	 (c)     [**]
	  	[**]
	 (d)     [**]
	  	[**]

  
 Section 7.3 Voyager
Royalties. 
  
 (a) Subject to the terms and
conditions of this Section 7.3, Voyager shall pay to SBS the following royalties based on aggregate Net Sales of the Product by Voyager, its Affiliates and sublicensees in the Territory during each calendar year (or part thereof): 
  
 [**] of Net Sales for that portion of aggregate Net Sales in such calendar
year that is less than or equal to [**] ; 
  
 [**] of Net Sales
for that portion of aggregate Net Sales in such calendar year that exceeds [**] but is less than or equal to [**]; and 
  
 [**] of Net Sales for that portion of aggregate Net Sales in such calendar year that exceeds [**] 
  
 provided that Voyager shall pay SBS at least [**] in royalties annually (the “Minimum
Royalty”) commencing with the year in which the First Commercial Sale in any country in the Territory is made. In the event that the First Commercial Sale is made at some time other than the beginning of a calendar year, the Minimum Royalty for
such first year shall be prorated. 
  
 (b)
Voyager’s royalty payment obligations under this Section 7.3 shall commence with the First Commercial Sale of the Product and shall terminate on the termination 

  

 -22- 

 
of this Agreement. To the extent that royalties may not be collected in a certain country in the Territory under Applicable Law for the full royalty term
hereunder, then the royalty due on sales in such country shall terminate after the maximum period under which royalties may be collected under Applicable Law without effect on the royalties due hereunder with respect to sales made in other countries
in the Territory. 
  
 (c) Royalties shall be
payable on a quarterly basis, within sixty (60) days after the end of each calendar quarter, based upon the Net Sales during such calendar quarter (or a ratable portion of the Minimum Royalty, if greater), commencing with the calendar quarter in
which the First Commercial Sale of the Product is made by Voyager. Royalties shall be calculated in accordance with GAAP and with the terms of this Section 7.3. Only one royalty payment will be due on Net Sales even though the Manufacture, sale or
use of a Product may be covered by more than one SBS Technology or SBS Improvement in a country. The amount paid by Voyager as a Minimum Royalty with respect to any quarter shall be fully creditable against royalties due based on Net Sales of
Product for any other quarter during the same calendar year. 
  
 (d) Each royalty payment hereunder shall be accompanied by a statement showing (a) Net Sales during the applicable calendar quarter, (b) the number of units of the Product sold by Voyager on a country-by-country basis
during the applicable calendar quarter, and (c) the amount of royalties due hereunder. 
  
 (e) In the event that a court or a governmental agency of competent jurisdiction requires Voyager or a Voyager Affiliate or sublicensee to
grant a compulsory license to a third Person permitting such third Person to make and sell the Product in a jurisdiction in the Territory despite Voyager having exerted all reasonable efforts to oppose the granting of such compulsory license, then
all Net Sales by such compulsory sublicensee shall be excluded from the royalty calculations set forth in Section 7.3(a) and the royalty rate to be paid by Voyager on such Net Sales by such compulsory sublicensee shall be the lesser of (i) the
applicable royalty rate provided in Section 7.3(a) with respect to such Net Sales, and (ii) [**] of the royalty rate under such compulsory license, during the time period when such compulsory license is in effect and being exercised. 
  
 Section 7.4 Method of Payment. All payments to SBS under this Agreement shall
be made by deposit of United States Dollars in the requisite amount to such bank account as SBS may from time to time designate by notice to Voyager. With respect to sales outside the United States, payments shall be calculated based on currency
exchange rates for the calendar quarter for which remittance is made for royalties. For each currency, such exchange rate shall equal the arithmetic average of the daily exchange rates (obtained as described below) during the calendar quarter; each
daily exchange rate shall be obtained from The Wall Street Journal, Eastern United States Edition, or, if not so available, as otherwise agreed by the parties. 
  

Section 7.5 SBS Royalties. 
  
 (a) If SBS elects to Exploit the Product in any Terminated Countries pursuant to Section 4.2(c), subject to the terms and conditions of
this Section 7.5, SBS shall pay to Voyager the following royalties based on aggregate Net Sales of the Product by SBS, its Affiliates and licensees in all Terminated Countries during each calendar year (or part thereof): 
  
 [**] of Net Sales for that portion of aggregate Net Sales in such calendar
year that is less than or equal to [**]; 
  

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 [**] of Net Sales for that portion of aggregate Net Sales in such calendar year that exceeds [**] but is
less than or equal to [**]; and 
  
 [**] of Net Sales for that
portion of aggregate Net Sales in such calendar year that exceeds [**]. 
  
 (b) SBS’s royalty payment obligations under this Section 7.5 shall commence with the first commercial sale of the Product in any Terminated Country and shall terminate on the termination of this Agreement. To the
extent that royalties may not be collected in a certain Terminated Country under Applicable Law for the full royalty term hereunder, then the royalty due on sales in such country shall terminate after the maximum period under which royalties may be
collected under Applicable Law without effect on the royalties due hereunder with respect to sales made in other Terminated Countries. 
  
 (c) Royalties shall be payable on a quarterly basis, within sixty (60) days after the end of each calendar quarter, based upon the Net
Sales during such calendar quarter, commencing with the calendar quarter in which the first commercial sale of the Product is made by SBS, its Affiliates or sublicensees in any Terminated Country. Royalties shall be calculated in accordance with
GAAP and with the terms of this Section 7.5. 
  
 (d) Each royalty payment hereunder shall be accompanied by a statement showing (a) Net Sales during the applicable calendar quarter, (b) the number of units of the Product sold by SBS, its Affiliates and sublicensees in the Terminated
Countries on a country-by-country basis during the applicable calendar quarter, and (c) the amount of royalties due hereunder. 
  
 (e) All payments to Voyager under this Agreement shall be made by deposit of United States Dollars in the requisite amount to such bank
account as Voyager may from time to time designate by notice to SBS. With respect to sales outside the United States, payments shall be calculated based on currency exchange rates for the calendar quarter for which remittance is made for royalties.
For each currency, such exchange rate shall equal the arithmetic average of the daily exchange rates (obtained as described below) during the calendar quarter; each daily exchange rate shall be obtained from The Wall Street Journal, Eastern United
States Edition, or, if not so available, as otherwise agreed by the parties. 
  
 Section 7.6 Recordkeeping and Audit. 
  
 (a) SBS shall keep, or shall cause to be kept, complete and accurate books and records of all information necessary, and in sufficient detail, to determine all Development Costs, Active Agent costs, and Manufacturing
Costs payable by Voyager to SBS pursuant to this Agreement and Net Sales in the Terminated Countries (if any) and the royalties payable by SBS to Voyager pursuant to this Agreement for the previous seven (7) calendar years. 
  

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 (b) Voyager shall keep, or shall cause to be kept, complete and accurate books and
records of all information necessary, and in sufficient detail, to determine Net Sales in the Territory and the royalties payable by Voyager to SBS pursuant to this Agreement for the previous seven (7) calendar years. 
  
 (c) Voyager shall have the right, no more than once during
any twelve (12) consecutive month period during the term of this Agreement and the twelve (12) months following the termination hereof, to have the books and records kept by SBS pursuant to Section 7.6(a) (and all related work papers and other
information and documents) examined by an independent accounting firm of national standing reasonably acceptable to SBS to verify SBS’s calculations of the amounts of Development Costs, Active Agent costs, and Manufacturing Costs invoiced by
SBS to Voyager hereunder and the accuracy of the information contained in the reports delivered by SBS pursuant to Section 7.5(d) and SBS’s calculation of the royalties payable hereunder. If Voyager shall dispute any such calculation, Voyager
promptly shall notify SBS and Voyager and SBS shall use good faith efforts to resolve such dispute. If Voyager and SBS are unable to resolve such dispute within [**] days after Voyager notifies SBS of such dispute, then an independent accounting
firm mutually agreed to by Voyager and SBS shall resolve such dispute and such accountant’s resolution shall be final and binding on the parties. Each party shall cooperate with such accountant’s investigation. If, and only if, it shall be
determined pursuant to the procedures set forth in this clause (c) that (i) SBS invoiced Voyager an amount greater than [**] of the total amount actually owed by Voyager or (ii) SBS paid Voyager an amount less than [**] of the total royalty amount
actually owed by SBS, then in each case SBS shall reimburse Voyager for all of its costs related to such examination and shall pay all costs and expenses of the mutually agreed accountant, if any; otherwise Voyager shall bear all of its costs
related to such examination and shall pay all costs and expenses of the mutually agreed accountant, if any. 
  
 (d) SBS shall have the right, no more than once during any twelve (12) consecutive month period during the term of this Agreement and the
twelve (12) months following the termination hereof, to have the books and records kept by Voyager pursuant to Section 7.6(b) (and all related work papers and other information and documents) examined by an independent accounting firm of national
standing reasonably acceptable to Voyager to verify the accuracy of the information contained in the reports delivered by Voyager pursuant to Section 7.3(d) and Voyager’s calculation of the royalties payable hereunder. If SBS shall dispute any
such information or calculation, SBS promptly shall notify Voyager and SBS and Voyager shall use good faith efforts to resolve such dispute. If SBS and Voyager are unable to resolve such dispute within [**] days after SBS notifies Voyager of such
dispute, then an independent accounting firm mutually agreed to by SBS and Voyager shall resolve such dispute and such accountant’s resolution shall be final and binding on the parties. Each party shall cooperate with such accountant’s
investigation. If, and only if, it shall be determined pursuant to the procedures set forth in this clause (d) that Voyager paid SBS an amount less than [**] of the total royalty amount actually owed by Voyager, then Voyager shall reimburse SBS for
all of its costs related to such examination and shall pay all costs and expenses of the mutually agreed accountant, if any; otherwise SBS shall bear all of its costs related to such examination and shall pay all costs and expenses of the mutually
agreed accountant, if any. 
  

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 (e) If, as a result of the procedures set forth in clause (c) or (d) above, any amount
paid by a party pursuant to the terms hereof shall be found to have been incorrectly calculated, the appropriate party promptly shall pay to the other party the amount necessary to correct such payment error. 
  
 (f) All financial books and records maintained by the
parties pursuant hereto shall be maintained in accordance with GAAP. 
  
 ARTICLE VIII. INTELLECTUAL PROPERTY 
  
 Section 8.1
Ownership 
  
 (a) SBS shall own all right, title
and interest in and to the SBS Technology and the SBS Improvements. Voyager shall, and shall cause its Affiliates, sublicensees and subcontractors hereunder to, promptly disclose in writing to SBS the development, making, conception or reduction to
practice of any SBS Technology and the SBS Improvements and shall and does hereby, and shall cause its Affiliates, sublicensees and subcontractors to, assign to SBS any and all right, title or interest Voyager or its Affiliates, sublicensees or
subcontractors may have in or to the SBS Technology and the SBS Improvements. Voyager hereby appoints, and shall cause its Affiliates, sublicensees and subcontractors to appoint, SBS as their attorney-in-fact for the purpose of executing such
documents in their respective names as may be necessary or desirable to carry out the purposes of this subsection. 
  
 (b) Voyager shall own all right, title and interest in and to (i) the Voyager Patents and (ii) any and all Inventions and other
intellectual property created, developed or acquired as a result of or in connection with the Agreement including the Feasibility Activities, the Development Activities or SBS’s Manufacturing of the Product hereunder, relating to clinical uses
of the Active Agent (whether for treatment of Alzheimer’s Disease or otherwise) (the “Project Information and Inventions”); provided, however, that the Project Information and Inventions shall not include any right, title or interest,
express or implied, in or to the SBS Technology or the SBS Improvements. SBS shall, and shall cause its Affiliates, sublicensees and subcontractors to, promptly disclose in writing to Voyager the development, making, conception or reduction to
practice of any Project Information and Inventions and shall and does hereby, and shall cause its Affiliates, sublicensees and subcontractors to, assign to Voyager any and all right, title or interest SBS or its Affiliates, sublicensees and
subcontractors may have in or to the Project Information and Inventions. SBS hereby appoints, and shall cause its Affiliates, sublicensees and subcontractors to appoint, Voyager as their attorney-in-fact for the purpose of executing such documents
in their respective names as may be necessary or desirable to carry out the purposes of this subsection. 
  
 (c) Any Inventions and other intellectual property created, developed or acquired as a result of or in connection with the Feasibility
Activities, the Development Activities or SBS’s Manufacturing of the Product hereunder (including any data or information generated as a result of or in connection with the Feasibility Activities and Development Activities, regardless of
whether such data or information is included in any report or information delivered by SBS to Voyager hereunder), other than the Inventions owned by either SBS or Voyager exclusively as set forth in Section 8.1(a) and (b), shall be jointly owned by
the 

  

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parties (“Joint Inventions”). Except as otherwise set forth herein or agreed upon in writing by the parties, each party shall have all the rights
and privileges of a joint owner under the patent laws of the United States with respect to the Joint Inventions, including the right to exploit and grant licenses and sublicenses to patents covering Joint Inventions, without accounting to the other
party. Each party shall, and shall cause its Affiliates to, promptly disclose in writing to the other party the development, making, conception or reduction to practice of any Joint Invention. Additionally, each party agrees to cooperate with and
provide reasonable assistance to the other party in filing, prosecuting and perfecting patent and other intellectual property rights covering Inventions related to the subject matter of this Agreement owned by the other party at the other
party’s expense. 
  
 (d) It is understood
and agreed that, except as expressly provided in Section 8.2 hereof, nothing contained in this Agreement or otherwise shall be construed to mean that one party will obtain any rights, by implication or otherwise, in or to any proprietary right of
the other party. In particular, SBS will not obtain any right, title or interest in or to the Voyager Patents and Project Information and Inventions and Voyager will not obtain any right, title or interest in or to the SBS Technology and SBS
Improvements, except as provided in Section 8.2 hereof. 
  
 (e) Any and all information or material related to an Invention assigned to a party pursuant to the terms of this Agreement shall constitute Confidential Information of such party which shall be deemed the Disclosing
Party with respect to such Confidential Information. 
  
 Section
8.2 License Grants. 
  
 (a) Voyager hereby grants
to SBS a limited, royalty-free, nonexclusive license, without right to sublicense (except to the extent, and only to the extent, necessary to permit a qualified contract manufacturer to Manufacture Product in accordance with Section 5.1), under the
Voyager Patents and Project Information and Inventions solely to perform its obligations under Article II, Article III and Article V, which grant shall expire on the termination of this Agreement for any reason or otherwise in accordance with
Sections 2.5, 3.8, 4.5 or 5.6. 
  
 (b) SBS hereby
grants to Voyager a worldwide, royalty-bearing, exclusive (including with regard to SBS and its Affiliates) license, with right to sublicense (subject to Section 8.2(d)), under the SBS Technology and the SBS Improvements, to Manufacture, have
Manufactured, import, use, sell, offer for sale and otherwise Exploit the Product in the Territory, which grant shall expire on the termination of this Agreement for any reason. 
  
 (c) In the event that SBS has the right and elects to Exploit the Product in any Terminated Country pursuant
to Section 4.2(c), Voyager hereby grants to SBS in such Terminated Country a royalty bearing, exclusive license, with the right to sublicense (subject to Section 8.2(e)) under the Voyager Patents and Project Information and Inventions, and the right
to use all regulatory filings, Clinical Trial data and CMC data and all other intellectual property owned by Voyager, in each case to the extent solely related to the Product, and the right to cross-reference any and all regulatory filings with
respect to the Product, solely for purposes of Exploiting the Product in such Terminated Country, which grant shall expire on the termination of this Agreement for any reason or otherwise in accordance with Section 2.5, 3.8, 4.5 or 5.6. 

 

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 (d) Voyager may sublicense its rights under Section 8.2(b), subject to the following
conditions: (i) such sublicense shall be subject to the terms and conditions of this Agreement; and (ii) the rights of SBS under this Agreement shall not be prejudiced, reduced or limited in any way as a result of such sublicense of rights.
Additionally, if Voyager sublicenses its rights to develop or commercialize the Product (other than ordinary distributor arrangements), it shall: (1) provide SBS with a copy of the proposed sublicense agreement in a time frame that reasonably
permits SBS to review and comment on the sublicense agreement and a final copy of the sublicense agreement; and (2) the sublicense agreement shall be subject to the approval of SBS which shall not be unreasonably withheld or delayed. 
  
 (e) SBS may sublicense its rights under Section 8.2(c),
subject to the following conditions: (i) such sublicense shall be subject to the terms and conditions of this Agreement; and (ii) the rights of Voyager under this Agreement shall not be prejudiced, reduced or limited in any way as a result of such
sublicense of rights. Additionally, if SBS sublicenses its rights to develop or commercialize the Product (other than ordinary distributor arrangements), it shall: (1) provide Voyager with a copy of the proposed sublicense agreement in a time frame
that reasonably permits Voyager to review and comment on the sublicense agreement and a final copy of the sublicense agreement; and (2) the sublicense agreement shall be subject to the approval of Voyager which shall not be unreasonably withheld or
delayed. 
  
 Section 8.3 Prosecution and Maintenance of
Intellectual Property Rights. The responsibility for preparing, filing and prosecuting patent applications and for maintaining patents and other intellectual property rights (and for managing any interference proceedings relating to the foregoing)
covering any Invention owned by a party, and all costs related thereto, shall be the responsibility of such party. The parties shall by mutual agreement prepare, file and prosecute patent applications and maintain patents and other intellectual
property rights (and manage any interference proceedings relating to the foregoing) covering any Joint Invention, and all costs related thereto, shall be shared equally between the parties. 
  
 Section 8.4 Third Person Litigation. 
  
 (a) Regarding SBS Technology and Improvements. In the event
that during the term of this Agreement any Person institutes against SBS or Voyager any action that alleges that the use of the SBS Technology or the SBS Improvements in connection with the Exploitation of the Product in the Territory in accordance
with the terms hereof infringes the intellectual property rights held by such Person, then, as between SBS and Voyager, SBS, at its sole expense, shall have the sole obligation to contest, and assume direction and control of the defense of, such
action, including the right to settle such action on terms determined by SBS; provided that in no event shall SBS enter into any settlement that adversely affects the interests of Voyager or its Affiliates, whether under this Agreement or otherwise,
without Voyager’s prior written consent, which shall not be unreasonably withheld or delayed. Voyager, at SBS’s expense, shall use all reasonable efforts to assist and cooperate with SBS as reasonably requested by SBS in such action. If,
as a result of any such action, a judgment is entered by a court of competent jurisdiction from which no appeal can be taken or from which no appeal is taken within the time permitted for appeal, or a settlement is entered into by SBS, such that any
SBS Technology or the SBS Improvements cannot be used in connection with the Exploitation of the Product in the Territory without infringing the intellectual property rights of such Person, then 

  

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Voyager shall have the right either to (i) terminate this Agreement immediately or (ii) take such actions as it deems necessary to protect its interests,
including the right to obtain a license from such Person and to offset the cost of such license against any amounts owed to SBS hereunder; provided that the amount offset by Voyager shall not exceed [**] of the royalty rate then payable by Voyager
pursuant to Section 7.3. 
  
 (b) Regarding the
Voyager Patents. In the event that during the term of this Agreement any Person institutes against SBS any action that alleges that the use of the Voyager Patents in connection with the Exploitation of the Product in the Territory in accordance with
the terms hereof infringes the intellectual property rights held by such Person, then, as between SBS and Voyager, Voyager, at its sole expense, shall have the sole obligation to contest, and assume direction and control of the defense of, such
action, including the right to settle such action on terms determined by Voyager; provided that in no event shall Voyager enter into any settlement that adversely affects the interests of SBS or its Affiliates, whether under this Agreement or
otherwise, without SBS’s prior written consent, which shall not be unreasonably withheld or delayed. SBS, at Voyager’s expense, shall use all reasonable efforts to assist and cooperate with Voyager as reasonably requested by Voyager in
such action. If, as a result of any such action, a judgment is entered by a court of competent jurisdiction from which no appeal can be taken or from which no appeal is taken within the time permitted for appeal, or a settlement is entered into by
Voyager, such that Voyager cannot develop or commercialize the Product in a country in the Territory, then SBS shall have the right to terminate the rights granted to Voyager under Section 8.2 with respect to such country. 
  
 Section 8.5 Exclusivity. 
  
 (a) During the term of this Agreement and, in the event of
termination of this Agreement by Voyager pursuant to Section 11.2(b) or (c), for a period of [**] after termination hereof, SBS shall not, and shall cause its Affiliates not to, (a) conduct any activity, either on its own or through its Affiliates,
or with, for the benefit of, or sponsored by any Person, that has as its goal or intent discovering, identifying, Exploiting or otherwise commercializing any Unique Dose Product, or (b) grant any license or other rights to any Person to utilize any
intellectual property owned or controlled by SBS or its Affiliates (including the SBS Technology, SBS Improvements or Joint Inventions) for the purpose of discovering, identifying, Exploiting or otherwise commercializing any Unique Dose Product, in
each case other than as expressly provided in this Agreement. 
  
 (b) SBS acknowledges and agrees that the restrictions set forth in clause (a) above are reasonable and necessary to protect the legitimate interests of Voyager and that Voyager would not have entered into this
Agreement in the absence of such restrictions, and that any violation or threatened violation of any provision of clause (a) above will result in irreparable injury to Voyager. SBS also acknowledges and agrees that in the event of a violation or
threatened violation of any provision of clause (a) above, Voyager shall be entitled to preliminary and permanent injunctive relief, without the necessity of proving irreparable injury or actual damages and without the necessity of having to post a
bond, as well as to an equitable accounting of all earnings, profits and other benefits arising from any such violation. The rights provided in the immediately preceding sentence shall be cumulative and in addition to any other rights or remedies
that may be available to Voyager. Nothing in this Section 8.5 is intended, or 

  

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should be construed, to limit Voyager’s right to preliminary and permanent injunctive relief or any other remedy for a breach of any other provision of
this Agreement. 
  
 (c) Voyager acknowledges and
agrees that SBS may develop and commercialize, either for itself, its Affiliates, or for third parties, products, other than Unique Dose Products during the period specified in clause (a) above, which contain the Active Agent intended for uses other
than for treatment of Alzheimer’s Disease but which may be used or prescribed in a manner similar to the Product without authorization from SBS, and that SBS may have no control over such use or prescription. 
  
 Section 8.6 Technology Transfer. If (a) necessary to permit Voyager to
exercise its rights pursuant to Sections 2.5, 3.8, 4.5, or 5.6(c), or (b) SBS is unable or unwilling to supply Voyager with all of its commercial requirements for Product, or (c) SBS elects not to continue supply of Voyager’s commercial
requirements pursuant to Section 5.1(i), then in any such case SBS shall (i) promptly disclose to Voyager or its designee such SBS Technology and SBS Improvements and any know-how related thereto as is necessary or useful for Voyager or such
designee to develop, Manufacture and commercialize the Product, and (ii) from time to time thereafter, as reasonably requested by Voyager, have its representatives meet with representatives of Voyager or its designee to enable Voyager or such
designee to develop, Manufacture and sell the Product; provided that SBS may require any designee of Voyager to enter into a reasonable and customary confidentiality agreement with SBS that requires that Confidential Information communicated to such
designee by SBS pursuant to this Section 8.6 shall be kept confidential and used only in performance of such designee’s obligations to Voyager, and provided further that Voyager shall be responsible for the compliance by any designee that is
not approved in advance by SBS (which approval shall not be unreasonably withheld or delayed) with the terms and conditions of such confidentiality agreement. Voyager shall reimburse SBS for any reasonable expenses incurred by SBS in connection with
any transfer pursuant to clause (b) or (c) above. 
  
 ARTICLE IX.
REPRESENTATIONS AND WARRANTIES 
  
 Section 9.1 Representations and
Warranties of Each Party. Each party hereby represents, warrants and covenants to the other party as follows: 
  
 (a) Such party (i) is duly incorporated and in good standing under the laws of the jurisdiction of its incorporation, (ii) has full power
and authority to own its property and assets and to carry on its business as it is now being conducted and as it is contemplated to be conducted by this Agreement, (iii) has the power and authority and the legal right to enter into this Agreement
and perform its obligations hereunder, and (iv) has taken all necessary action on its part required to authorize the execution and delivery of this Agreement and the performance of its obligations hereunder. This Agreement has been duly executed and
delivered on behalf of such party and constitutes a legal, valid and binding obligation of such party and is enforceable against it in accordance with its terms subject to the effects of bankruptcy, insolvency or other laws of general application
affecting the enforcement of creditor rights and judicial principles affecting the availability of specific performance and general principles of equity, whether enforceability is considered a proceeding at law or equity. 
  

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 (b) Such party is not aware of any pending or threatened litigation (and has not received
any communication) that alleges that such party’s activities related to this Agreement have violated, or that by conducting the activities contemplated herein such party would violate, any of the intellectual property rights of any other
Person. 
  
 (c) All necessary consents, approvals
and authorizations of all regulatory and governmental authorities and other Persons required to be obtained by such party in connection with the execution and delivery of this Agreement and the performance of its obligations hereunder have been
obtained. 
  
 (d) The execution and delivery of
this Agreement and the performance of such party’s obligations hereunder (i) do not and will not conflict with or violate any requirement of applicable law or regulation or any provision of the articles of incorporation or bylaws of such party
and (ii) do not and will not conflict with, violate, or breach, or constitute a default or require any consent under, any contractual obligation or court or administrative order by which such party is bound. 
  
 Section 9.2 Additional Representations of SBS. SBS represents, warrants and
covenants to Voyager as follows: 
  
 (a) SBS owns
all right, title and interest in and to the SBS Technology and the SBS Technology is not subject to any lien, encumbrance or claim of ownership by any third Person. 
  
 (b) To SBS’s knowledge and belief, the SBS Technology has not and does not infringe upon,
misappropriate or otherwise violate the patent or intellectual property rights of any other Person. 
  
 (c) There is no claim, litigation, judgment or settlement pending or existing, or to SBS’s knowledge and belief threatened, with or
against SBS relating to the SBS Technology. 
  
 (d) To SBS’s knowledge and belief, there is no pre-clinical or clinical data or information concerning the SBS Technology that suggests that there may exist quality, toxicity, safety or efficacy concerns that could reasonably be
expected to impair the utility or safety of the Product. 
  
 (e) Neither SBS nor any of its Affiliates has been debarred or is subject to debarment and neither SBS nor any of its Affiliates will use in any capacity, in connection with the services to be performed under this
Agreement, any Person who has been debarred pursuant to Section 306 of the FFDCA, or who is the subject of a conviction described in such section. SBS agrees to inform Voyager in writing immediately if it or any Person who is performing services
hereunder is debarred or is the subject of a conviction described in Section 306, or if any action, suit, claim, investigation or legal or administrative proceeding is pending or, to the best of SBS’s knowledge, is threatened, relating to the
debarment or conviction of SBS or any Person performing services hereunder. 
  

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 Section 9.3 Additional Representations of Voyager. Voyager represents, warrants and covenants to SBS as
follows: 
  
 (a) Voyager owns all right, title
and interest in and to the Voyager Patents and the Voyager Patents are not subject to any lien, encumbrance or claim of ownership by any third Person. 
  
 (b) To Voyager’s knowledge and belief, the Voyager Patents have not and do not infringe upon, misappropriate or otherwise violate the
patent or intellectual property rights of any other Person. 
  
 (c) There is no claim, litigation, judgment or settlement pending or existing, or to the best of Voyager’s knowledge and belief threatened, with or against Voyager relating to the Voyager Patents. 
  
 (d) To Voyager’s knowledge and belief, there is no
pre-clinical or clinical data or information concerning the Active Agent that suggests that there may exist quality, toxicity, safety or efficacy concerns that could reasonably be expected to impair the utility or safety of the Product. 

 
 Section 9.4 Disclaimer of Other Warranties. EXCEPT AS SET FORTH IN THIS
AGREEMENT, THE PARTIES MAKE NO REPRESENTATIONS AND EXTEND NO WARRANTIES OF ANY KIND, EITHER EXPRESS OR IMPLIED, INCLUDING BUT NOT LIMITED TO WARRANTIES OF QUALITY, MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR NON-INFRINGEMENT 
  
 ARTICLE X. CONFIDENTIALITY 
  
 Section 10.1 Confidential Information. Except to the extent expressly
permitted by this Agreement and subject to the provisions of Sections 10.2 and 10.3, at all times during the term of this Agreement and for ten (10) years following the termination hereof, the Receiving Party (a) shall keep completely confidential
and shall not publish or otherwise disclose any Confidential Information furnished to it by the Disclosing Party, except to those of the Receiving Party’s employees, Affiliates, sublicensees, subcontractors or consultants who have a need to
know such information (collectively, “Recipients”) to perform such Party’s obligations hereunder (and who shall be advised of the Receiving Party’s obligations hereunder and who are bound by confidentiality obligations with
respect to such Confidential Information no less onerous than those set forth in this Agreement) and (b) shall not use Confidential Information of the Disclosing Party directly or indirectly for any purpose other than performing its obligations or
exercising its rights hereunder. The Receiving Party shall be jointly and severally liable for any breach by any of its Recipients of the restrictions set forth in this Agreement. 
  
 Section 10.2 Exceptions to Confidentiality. The Receiving Party’s obligations set forth in this Agreement shall not
extend to any Confidential Information of the Disclosing Party: 
  
 (a) that is or hereafter becomes part of the public domain by public use, publication, general knowledge or the like through no wrongful act, fault or negligence on the part of a Receiving Party or its Recipients;

  

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 (b) that is received from a third party without restriction and without breach of any
agreement between such third party and the Disclosing Party; 
  
 (c) that the Receiving Party can demonstrate by competent evidence was already in its possession without any limitation on use or disclosure prior to its receipt from the Disclosing Party; 
  
 (d) that is generally made available to third parties by the
Disclosing Party without restriction on disclosure; or 
  
 (e) that the Receiving Party can demonstrate by competent evidence was independently developed by the Receiving Party. 
  
 Section 10.3 Disclosure 
  
 (a) Each party may disclose Confidential Information to the extent that such disclosure is: 
  
 (i) made in response to a valid order of a court of
competent jurisdiction or other governmental body of a country or any political subdivision thereof of competent jurisdiction; provided, however, that the Receiving Party shall first have given notice to the Disclosing Party and given the Disclosing
Party a reasonable opportunity to quash such order and to obtain a protective order requiring that the Confidential Information and/or documents that are the subject of such order be held in confidence by such court or governmental body or, if
disclosed, be used only for the purposes for which the order was issued; and provided further that if a disclosure order is not quashed or a protective order is not obtained, the Confidential Information disclosed in response to such court or
governmental order shall be limited to that information which is legally required to be disclosed in such response to such court or governmental order; or 
  
 (ii) otherwise required by law or regulation, in the opinion of outside legal counsel to the Receiving Party, which shall be provided to
the Disclosing Party at least 24 hours prior to the Receiving Party’s disclosure of the Confidential Information pursuant to this Section 10.3; 
  
 (b) Voyager may disclose Confidential Information to the extent that such disclosure is: 
  
 (i) made to the Regulatory Authorities as required in
connection with any filing, application or request for Regulatory Approval; provided, however, that reasonable measures shall be taken to assure confidential treatment of such information; 
  
 (ii) made to third Persons as may be necessary or useful in
connection with the Exploitation of the SBS Technology and SBS Improvements licensed to Voyager hereunder, including subcontracting and sublicensing transactions in connection therewith, provided that Voyager shall in each case obtain from the
proposed third Person recipient a written confidentiality undertaking containing confidentiality obligations no less onerous than those set forth in this Article X; or 
  

 -33- 

 (iii) a disclosure of the existence and terms of this Agreement to existing or potential
securityholders of Voyager; provided, however, that reasonable measures shall be taken to assure confidential treatment of such information. 
  
 Section 10.4 Notification. The Receiving Party shall notify the Disclosing Party immediately, and cooperate with the Disclosing Party as the Disclosing
Party may reasonably request, upon the Receiving Party’s discovery of any loss or compromise of the Disclosing Party’s Confidential Information. 
  
 Section 10.5 Remedies. Each party agrees that the unauthorized use or disclosure of any information by the Receiving Party in violation of this Agreement
will cause severe and irreparable damage to the Disclosing Party. In the event of any violation of this Article X, the Receiving Party agrees that the Disclosing Party shall be authorized and entitled to obtain from any court of competent
jurisdiction injunctive relief, whether preliminary or permanent, without the necessity of proving irreparable harm or monetary damages, as well as any other relief permitted by applicable law. The Receiving Party agrees to waive any requirement
that the Disclosing Party post bond as a condition for obtaining any such relief. 
  
 Section 10.6 Use of Names. Neither party shall mention or otherwise use the name, insignia, symbol, trademark, trade name or logotype of the other party (or any abbreviation or adaptation thereof) in any publication,
press release, promotional material or other form of publicity without the prior written approval of such other party in each instance. The restrictions imposed by this Section 10.6 shall not prohibit either party from making any disclosure
identifying the other party that is required by Applicable Law. Further, Voyager and its Affiliates and sublicensees shall have the right to use the name of SBS and its Affiliates to the extent necessary in connection with the Exploitation of the
SBS Technology and SBS Improvements as contemplated by this Agreement, including subcontracting and sublicensing transactions in connection therewith. 
  
 Section 10.7 Press Releases. Except as expressly provided in Section 10.3, neither party shall make a press release or other public announcement regarding
this Agreement, the terms hereof or the transactions contemplated hereby without the prior written approval of the other party. Each party shall provide the other with the proposed text of any such press release or public announcement for review and
approval, which approval shall not be unreasonably withheld, as early as possible, but in no event less than five (5) business days in advance of the publication, communication or dissemination thereof; provided, however, that the receiving party
shall be deemed to have approved any such press release or public announcement if it fails to notify the proposing party in writing of any objections to such press release or public announcement within four (4) business days of receipt by the
receiving party of the text of such public announcement. 
  
 ARTICLE XI. TERM AND TERMINATION 
  
 Section 11.1 Term.
This Agreement shall commence as of the Effective Date and shall remain in force until the terminated in accordance with this Article XI. 
  

 -34- 

 Section 11.2 Termination In addition to any other provision of this Agreement expressly providing for
termination of this Agreement, this Agreement may be terminated as follows: 
  
 (a) Voyager may terminate this Agreement at any time for any reason by giving SBS [**] days’ prior written notice. 
  
 (b) Voyager may terminate this Agreement pursuant to Section 8.4 in accordance with the terms thereof. 
  
 (c) This Agreement may be terminated at any time by either
party: 
  
 (i) to the extent permissible under
Applicable Law, immediately upon written notice if the other party shall file in any court or agency, pursuant to any statute or regulation of any state or country, a petition in bankruptcy or insolvency or for reorganization or for an arrangement
or for the appointment of a receiver or trustee of that party or of its assets, or if the other party proposes a written agreement of composition or extension of its debts, or if the other party shall be served with an involuntary petition against
it, filed in any insolvency proceeding, and such petition shall not be dismissed within [**] days after the filing thereof, or if the other party shall propose or be a party to any dissolution or liquidation, or if the other party shall make an
assignment for the benefit of its creditors, 
  
 (ii) in the event of any default by the other party in the performance of any of its material obligations herein contained, including a party’s failure to pay the other amounts when due, which default has not been cured by the
defaulting party within [**] days after receiving written notice thereof from the nondefaulting party, or 
  
 (iii) pursuant to Section 13.2. 
  
 Section 11.3 Effect of Termination. 
  
 (a) The termination of this Agreement shall be without prejudice to any rights or obligations of the parties that may have accrued prior
to such termination, and the provisions of Sections 3.7, 5.5, 5.12, 7.6, 8.1, 8.3, 8.5, Articles I, IX, X, XII and XIII, and this Section 11.3 shall survive the termination of this Agreement. Except as otherwise expressly provided herein,
termination of this Agreement in accordance with the provisions hereof shall not limit remedies that may otherwise be available in law or equity. 
  
 (b) Upon termination of this Agreement, (i) each party, at the request of the other, shall return all data, files, records and other
materials in its possession or control containing or comprising the other party’s Inventions or other Confidential Information except one copy of which may be retained for archival purposes and (ii) all licenses and other rights granted by each
party to the other under Section 8.2 shall terminate. 
  
 (c) Upon termination of this Agreement by Voyager pursuant to Section 11.2(a), Voyager shall pay SBS in accordance with the terms hereof, to the extent such amount exceeds any uncredited amount of the Deposit at the time of such
termination, for all activities performed by SBS under this Agreement through the date of termination and for all costs not 

  

 -35- 

 
refundable to SBS or otherwise useable by SBS or its Affiliates in respect of which SBS reasonably made commitments in connection with the performance of its
obligations hereunder before the date of delivery of such notice of termination, and Voyager shall have no other liability or obligation to SBS in respect of such termination. 
  
 (d) SBS shall have the right to retain any portion of the Deposit uncredited at the time of termination of
this Agreement unless this Agreement is terminated by Voyager pursuant to Section 11.2(b) or (c), or upon termination of the parties’ rights and obligations under Article II pursuant to Section 2.5, in which event SBS promptly shall refund to
Voyager the balance of the Deposit, if any, uncredited at the time of such termination. 
  
 Section 11.4 Rights in Bankruptcy. All rights and licenses granted under or pursuant to this Agreement by SBS are, and shall otherwise be deemed to be, for purposes of Section 365(n) of the United States Bankruptcy
Code, licenses of right to “intellectual property” as defined under Section 101 of the United States Bankruptcy Code. The parties agree that Voyager, as licensee, and SBS, as licensor, of such rights under this Agreement, shall retain and
may fully exercise all of its rights and elections under the United States Bankruptcy Code. The parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against SBS under the United States Bankruptcy Code,
Voyager shall be entitled to a complete duplicate of (or complete access to, as appropriate) any such intellectual property and all embodiments of such intellectual property, which, if not already in Voyager’s possession, shall be promptly
delivered to it (a) upon any such commencement of a bankruptcy proceeding upon Voyager’s written request therefor, unless the party subject to such proceeding elects to continue to perform all of its obligations under this Agreement or (b) if
not delivered under (a) above, following the rejection of this Agreement by or on behalf of SBS upon written request therefor by Voyager. The parties further agree that, in the event of the commencement of a bankruptcy proceeding by or against
Voyager under the United States Bankruptcy Code, and an assignment of this Agreement is made for the benefit of creditors of Voyager, then the rights and obligations of Voyager under this Agreement may be transferred and assigned only to another
Person engaged in the business of developing and commercializing pharmaceutical products that would reasonably be capable of performing the obligations set forth in this Agreement. 
  
 ARTICLE XII. INDEMNIFICATION 
  
 Section 12.1 SBS Indemnification. SBS shall indemnify Voyager, its Affiliates and their respective directors, officers, employees and agents (the
“Voyager Indemnified Parties”), and defend and save each of them harmless, from and against any and all claims, lawsuits, losses, damages, liabilities, penalties, costs and expenses (including reasonable attorneys’ fees and
disbursements) (collectively, “Losses”) incurred by any of them in connection with, arising from or occurring as a result of (i) the breach by SBS of any of its obligations under this Agreement, (ii) the breach or inaccuracy of any
representation or warranty made by SBS in this Agreement, (iii) any Third Party Claim made by any Person relating to the use of the SBS Technology or the SBS Improvements by Voyager, its Affiliates or sublicencees, including any claim of
infringement or misappropriation of the patent, trademark or other intellectual property rights of such Person; or (iv) the enforcement by Voyager of its rights under this Section 12.1, except, in each case, for those Losses for which Voyager has an
obligation to indemnify SBS Indemnified 

  

 -36- 

 
Parties pursuant to Section 12.2, as to which Losses each party shall indemnify the other to the extent of their respective liability for the Losses.

  
 Section 12.2 Voyager Indemnification. Voyager shall indemnify
SBS, its Affiliates and their respective directors, officers, employees and agents (the “SBS Indemnified Parties”), and defend and save each of them harmless, from and against any and all Losses incurred by any of them in connection with,
arising from or occurring as a result of (i) the breach by Voyager of any of its obligations under this Agreement, (ii) the breach or inaccuracy of any representation or warranty made by Voyager in this Agreement, (iii) any Third Party Claim made by
any Person relating to the use of the Voyager Patents by SBS, including any claim of infringement or misappropriation of the patent, trademark or other intellectual property rights of such Person, (iv) any Third Party Claim made by any Person
relating to death, personal injury or property damage arising out of or resulting from the Exploitation of the Product (unless such Third Party Claim arises or results from the breach or inaccuracy of any representation or warranty made by SBS
herein or any breach by SBS of any of its obligations hereunder), or (v) the enforcement by SBS of its rights under this Section 12.2, except, in each case, for those Losses for which SBS has an obligation to indemnify Voyager Indemnified Parties
pursuant to Section 12.1, as to which Losses each party shall indemnify the other to the extent of their respective liability for the Losses. 
  
 Section 12.3 Indemnification Procedure. 
  
 (a) Notice of Claim. The indemnified party (the “Indemnified Party”) shall give the indemnifying party (the “Indemnifying
Party”) prompt written notice (an “Indemnification Claim Notice”) of any Losses or discovery of facts upon which such Indemnified Party intends to base a request for indemnification under Section 12.1 or 12.2, but in no event shall
the Indemnifying Party be liable for any Losses that result from any delay in providing such notice. Each Indemnification Claim Notice must contain a description of the claim and the nature and amount of such Loss (to the extent that the nature and
amount of such Loss are known at such time). The Indemnified Party shall furnish promptly to the Indemnifying Party copies of all papers and official documents received in respect of any Losses. 
  
 (b) Third Party Claims. The obligations of an Indemnifying
Party under this Article XII with respect to Losses arising from claims of any third Person that are subject to indemnification as provided for in Section 12.1 or 12.2 (a “Third Party Claim”) shall be governed by and be contingent upon the
following additional terms and conditions: 
  
 (i) Control of Defense. At its option, the Indemnifying Party may assume the defense of any Third Party Claim by giving written notice to the Indemnified Party within thirty (30) days after the Indemnifying Party’s receipt of an
Indemnification Claim Notice. The assumption of the defense of a Third Party Claim by the Indemnifying Party shall not be construed as an acknowledgment that the Indemnifying Party is liable to indemnify any Indemnified Party in respect of the Third
Party Claim, nor shall it constitute a waiver by the Indemnifying Party of any defenses it may assert against any Indemnified Party’s claim for indemnification. Upon assuming the defense of a Third Party Claim, the Indemnifying Party may
appoint as lead counsel in the defense of the Third Party Claim any legal counsel selected by the Indemnifying Party which shall be reasonably acceptable to the Indemnified Party. In the 

  

 -37- 

 
event the Indemnifying Party assumes the defense of a Third Party Claim, the Indemnified Party shall immediately deliver to the Indemnifying Party all
original notices and documents (including court papers) received by any Indemnified Party in connection with the Third Party Claim. Subject to clause (ii) below, if the Indemnifying Party assumes the defense of a Third Party Claim, the Indemnifying
Party shall not be liable to the Indemnified Party for any legal expenses subsequently incurred by such Indemnified Party in connection with the analysis, defense or settlement of the Third Party Claim. In the event that it is ultimately determined
that the Indemnifying Party is not obligated to indemnify, defend or hold harmless an Indemnified Party from and against the Third Party Claim, the Indemnified Party shall reimburse the Indemnifying Party for any and all costs and expenses
(including attorneys’ fees and costs of suit) and any Losses incurred by the Indemnifying Party in its defense of the Third Party Claim with respect to such Indemnified Party. 
  
 (ii) Right to Participate in Defense. Without limiting Section 12.3(b)(i), any Indemnified Party shall be
entitled to participate in, but not control, the defense of such Third Party Claim and to employ counsel of its choice for such purpose; provided, however, that such employment shall be at the Indemnified Party’s own expense unless (A) the
employment thereof has been specifically authorized by the Indemnifying Party in writing, (B) the Indemnifying Party has failed to assume the defense and employ counsel in accordance with Section 12.3(b)(i) (in which case the Indemnified Party shall
control the defense), or (C) the interests of the Indemnified Party and the Indemnifying Party with respect to such Third Party Claim are sufficiently adverse to prohibit the representation by the same counsel of both parties under applicable law,
ethical rules or equitable principles 
  
 (iii)
Settlement. With respect to any Losses relating solely to the payment of money damages in connection with a Third Party Claim and that will not result in the Indemnified Party’s becoming subject to injunctive or other relief or otherwise
adversely affect the business of the Indemnified Party in any manner, and as to which the Indemnifying Party shall have acknowledged in writing the obligation to indemnify the Indemnified Party hereunder, the Indemnifying Party shall have the sole
right to consent to the entry of any judgment, enter into any settlement or otherwise dispose of such Loss, on such terms as the Indemnifying Party, in its sole discretion, shall deem appropriate. With respect to all other Losses in connection with
Third Party Claims, where the Indemnifying Party has assumed the defense of the Third Party Claim in accordance with Section 12.3(b)(i), the Indemnifying Party shall have authority to consent to the entry of any judgment, enter into any settlement
or otherwise dispose of such Loss provided that it obtains the prior written consent of the Indemnified Party (which consent shall not be unreasonably withheld or delayed). The Indemnifying Party shall not be liable for any settlement or other
disposition of a Loss by an Indemnified Party that is reached without the written consent of the Indemnifying Party. Regardless of whether the Indemnifying Party chooses to defend or prosecute any Third Party Claim, no Indemnified Party shall admit
any liability with respect to, or settle, compromise or discharge, any Third Party Claim without the prior written consent of the Indemnifying Party (which consent shall not be unreasonably withheld or delayed). 
  
 (iv) Cooperation. Regardless of whether the Indemnifying
Party chooses to defend or prosecute any Third Party Claim, the Indemnified Party shall cooperate in the defense or prosecution thereof and shall furnish such records, information and testimony, 

  

 -38- 

 
provide such witnesses and attend such conferences, discovery proceedings, hearings, trials and appeals as may be reasonably requested in connection
therewith. Such cooperation shall include access during normal business hours afforded to the Indemnifying Party to, and reasonable retention by the Indemnified Party of, records and information that are reasonably relevant to such Third Party
Claim, and making employees and agents available on a mutually convenient basis to provide additional information and explanation of any material provided hereunder, and the Indemnifying Party shall reimburse the Indemnified Party for all its
reasonable out-of-pocket expenses in connection therewith. 
  
 (v) Expenses. Except as provided above, the reasonable and verifiable costs and expenses, including fees and disbursements of counsel, incurred by the Indemnified Party in connection with any Third Party Claim shall
be reimbursed on a calendar quarter basis in arrears by the Indemnifying Party, without prejudice to the Indemnifying Party’s right to contest the Indemnified Party’s right to indemnification and subject to refund in the event the
Indemnifying Party is ultimately held not to be obligated to indemnify the Indemnified Party. 
  
 Section 12.4 Insurance. Commencing not later than thirty (30) days prior to the first use in humans of the Product and thereafter for at least five (5) years after the expiration or termination of this Agreement, each
party shall obtain from a licensed and reputable insurer, and maintain on an on-going basis, products liability insurance with at least [**] in coverage for each occurrence. Coverage shall be on a per occurrence rather than a claims made basis. The
policy shall name the other party to this Agreement and its Affiliates as an additional insured. The policy shall provide that each of the parties will be notified of the cancellation or any restrictive amendment of the policy at least thirty (30)
days prior to the effective date of such cancellation or amendment. None of the parties shall violate, or permit to be violated, any conditions of such insurance policy, and each of the parties shall at all times satisfy the requirements of the
insurance company writing said policy. At either party’s request, the other party shall provide the requesting party with a certificate of such policy within 15 days of the request. 
  
 Section 12.5 Limitation on Damages. EXCEPT WITH RESPECT TO THE GROSS NEGLIGENCE OR INTENTIONAL MISCONDUCT OF A PARTY, SUCH
PARTY SHALL NOT BE LIABLE TO THE OTHER, WHETHER PURSUANT TO THE FOREGOING INDEMNIFICATION OBLIGATIONS OR OTHERWISE, FOR SPECIAL, EXEMPLARY OR CONSEQUENTIAL DAMAGES, INCLUDING BUSINESS INTERRUPTION OR LOST PROFITS, OR PUNITIVE DAMAGES; PROVIDED,
HOWEVER, THIS EXCLUSION IS NOT INTENDED TO, NOR SHALL, EXCLUDE ACTUAL OR COMPENSATORY DAMAGES OF THE AFFECTED PARTY, INCLUDING SPECIAL, EXEMPLARY OR CONSEQUENTIAL DAMAGES OWED TO THIRD PARTIES AS A RESULT OF A THIRD PARTY CLAIM. 
  
 ARTICLE XIII. MISCELLANEOUS 
  
 Section 13.1 Notices. All notices, requests and other communications
hereunder must be in writing and will be deemed to have been duly given only if delivered personally against written receipt or by facsimile transmission with answer back confirmation or mailed (postage prepaid by certified or registered mail,
return receipt requested) or by overnight courier to the parties at the following addresses or facsimile numbers: 
  

			
	If to Voyager to:	  	Voyager Pharmaceutical Corporation
	 	  	8540 Colonnade Center Drive
	 	  	Suite 409
	 	  	Raleigh, NC 27615
	 	  	Attention: David Corcoran, Esq.
	 	  	Facsimile: (919) 846-4881

  

 -39- 

			
		
	With a copy to:	  	Covington & Burling
	 	  	1201 Pennsylvania Avenue, NW
	 	  	Washington, DC 20004
	 	  	Attention: Elizabeth Stotland Weiswasser, Esq.
	 	  	Facsimile: (202) 778-5111
		
	If to SBS to:	  	Dr. Wallace B. Smith
	 	  	President
	 	  	Southern BioSystems, Inc.
	 	  	756 Tom Martin Drive
	 	  	Birmingham, AL 35211-4467
	 	  	Facsimile: (205) 917-2240
		
	With a copy to:	  	Jean Liu
	 	  	Vice President & General Counsel
	 	  	DURECT Corporation
	 	  	10240 Bubb Road
	 	  	Cupertino, CA 95014
	 	  	Facsimile: (408) 777-3577

  
 All such notices, requests and other
communications will (a) if delivered personally to the address as provided in this Section, be deemed given upon receipt, (b) if delivered by facsimile to the facsimile number as provided in this Section, be deemed given upon receipt by sender of
the answer back confirmation and (c) if delivered by mail in the manner described above or by overnight courier to the address as provided in this Section, be deemed given three (3) business days after deposit with the postal service or one (1)
business day after acceptance by the overnight courier service (in each case regardless of whether such notice, request or other communication is received by any other Person to whom a copy of such notice, request or other communication is to be
delivered pursuant to this Section). Any party from time to time may change its address, facsimile number or other information for the purpose of notices to that party by giving notice specifying such change to the other parties hereto. 

 
 Section 13.2 Force Majeure. Neither party shall be liable for delay in
delivery or nonperformance in whole or in part, nor shall the other party have the right to terminate this Agreement except as otherwise specifically provided in this Section 13.2, where delivery or performance has been affected by a condition
beyond a party’s reasonable control, including fires, floods, embargoes, shortages, epidemics, quarantines, war, acts of war (whether war be declared or not), terrorism, insurrections, riots, civil commotion, strikes, lockouts or other labor
disturbances, acts of God or acts, omissions or delays in acting by any governmental authority; provided that the party affected by such a condition shall, within ten days of its occurrence, give 

  

 -40- 

 
notice to the other Party stating the nature of the condition, its anticipated duration and any action being taken to avoid or minimize its effect. The
suspension of performance shall be of no greater scope and no longer duration than is reasonably required and the nonperforming party shall use its best efforts to remedy its inability to perform; provided, however, that in the event the suspension
of performance continues for sixty (60) days after the date of the occurrence, and such failure to perform would constitute a material breach of this Agreement in the absence of such force majeure event, the nonaffected Party may terminate this
Agreement immediately by written notice to the other party. 
  
 Section 13.3 Entire Agreement; Amendment. This Agreement, including the Exhibits hereto, embodies all the terms and conditions and obligations of the contract between the parties hereto and supersedes and cancels all previous agreements and
understandings, whether oral or in writing, in respect of the subject matter hereof and may not be amended or modified except by an express declaration in writing signed on behalf of Voyager and SBS by duly authorized officers and referring
specifically to this Agreement. 
  
 Section 13.4 Further
Assurances. Each party shall duly execute and deliver, or cause to be duly executed and delivered, such further instruments and do and cause to be done such further acts and things, including the filing of such assignments, agreements, documents and
instruments, as may be necessary or as the other party may reasonably request in connection with this Agreement or to carry out more effectively the provisions and purposes hereof, or to better assure and confirm unto such other party its rights and
remedies under this Agreement. 
  
 Section 13.5 Successors and
Assigns. The terms and provisions hereof shall inure to the benefit of, and be binding upon, Voyager, SBS and their respective successors and permitted assigns. 
  

Section 13.6 Governing Law. This Agreement shall be governed and interpreted in accordance with the law of the State of Delaware excluding any
conflicts or choice of law rule or principle that might otherwise refer construction or interpretation of this Agreement to the substantive law of another jurisdiction. 
  
 Section 13.7 Assignment. Except as expressly provided herein, neither party may, without the prior written consent of the
other party, sell, transfer, assign, delegate, pledge, or otherwise dispose of, whether voluntarily, involuntarily, by operation of law or otherwise, this Agreement or any of its rights or duties hereunder; provided, however, that either may,
without such consent, assign this Agreement and its rights and obligations hereunder to an Affiliate, to the purchaser of all or substantially all of its assets related to a Product or its business, or to its successor entity or acquiror in the
event of a merger, consolidation or change in control of such. Any attempt to assign, transfer, subcontract or delegate any portion of this Agreement in violation of this Section shall be null and void. All validly assigned and delegated rights and
obligations of the parties hereunder shall be binding upon and inure to the benefit of and be enforceable by and against the successors and permitted assigns of Voyager or SBS, as the case may be. In the event either party assigns or delegates its
rights or obligations to another party in accordance with the terms hereof, the assignee or transferee shall assume all obligations of its assignor or transferor under this Agreement and the performance of such obligations shall be guaranteed in
writing by the assignor or transferor. 
  

 -41- 

 Section 13.8 Waiver. Any term or condition of this Agreement may be waived at any time by the party that
is entitled to the benefit thereof, but no such waiver shall be effective unless set forth in a written instrument duly executed by or on behalf of the party waiving such term or condition. No waiver by any party hereto of any term or condition of
this Agreement, in any one or more instances, shall be deemed to be or construed as a waiver of the same or any other term or condition of this Agreement on any future occasion. 
  
 Section 13.9 Severability. If any provision of this Agreement is held to be illegal, invalid or unenforceable under any
present or future law, and if the rights or obligations of any party under this Agreement will not be materially and adversely affected thereby, (a) such provision shall be fully severable, (b) this Agreement shall be construed and enforced as if
such illegal, invalid or unenforceable provision had never compromised a part hereof, (c) the remaining provisions of this Agreement shall remain in full force and effect and shall not be affected by the illegal, invalid or unenforceable provision
or by its severance herefrom, and (d) in lieu of such illegal, invalid or unenforceable provision, there shall be added automatically as a part of this Agreement a legal, valid and enforceable provision as similar in terms to such illegal, invalid
or unenforceable provision as may be possible and reasonably acceptable to the parties herein. 
  
 Section 13.10 Independent Contractors. The status of the parties under this Agreement shall be that of independent contractors. Nothing in this Agreement is intended or shall be deemed to constitute a partnership,
agency, employer, employee, or joint venture relationship between the parties. Neither party shall have the right to enter into any agreements on behalf of the other party, nor shall it represent to any Person that it has any such right or
authority. 
  
 Section 13.11 Construction. Unless the context of
this Agreement otherwise requires: (a) words of any gender include each other gender; (b) words using the singular or plural number also include the plural or singular number, respectively; (c) the terms “hereof,” “herein,”
“hereby” and derivative or similar words refer to this entire Agreement; (d) the terms “Article,” “Section,” “Exhibit” or “clause” refer to the specified Article, Section, Exhibit or clause of this
Agreement; (e) the term “or” has, except where otherwise indicated, the inclusive meaning represented by the phrase “and/or”; and (f) the term “including” or “includes” means “including without
limitation” or “includes without limitation.” Whenever this Agreement refers to a number of days, such number shall refer to calendar days unless business days are specified. The captions of this Agreement are for convenience of
reference only and in no way define, describe, extend, or limit the scope or intent of this Agreement or the intent of any provision contained in this Agreement. The language of this Agreement shall be deemed to be the language mutually chosen by
the parties and no rule of strict construction shall be applied against either party hereto. 
  
 Section 13.12 Remedies. The remedies provided hereunder and under the governing law are cumulative and not exclusive. 
  
 Section 13.13 Counterparts. This Agreement may be executed in any number of counterparts, each of which shall be deemed to be an original, and all of
which, taken together, shall constitute one and the same instrument. 
  

 -42- 

  
 (The remainder of this page
is left blank intentionally.) 
  

 -43- 

  
 IN WITNESS WHEREOF, the
parties hereto have executed this Agreement on the day and year first above written. 
  

									
	 VOYAGER PHARMACEUTICAL CORPORATION
	 	 	 	 SOUTHERN BIOSYSTEMS, INC.

					
	 By:
	 	 /s/ David J. Corcoran
	 	 	 	 By:
	 	 /s/ W.B. Smith

	 Name:
	 	 David J. Corcoran
	 	 	 	 Name:
	 	 W.B. Smith

	 Title:
	 	 Vice President
	 	 	 	 Title:
	 	 President

  

 -44- 

  
 EXHIBIT 5.3 
  
 MANUFACTURING COSTS 
  
 “Manufacturing Costs” shall mean [**] 
  
 Examples of Manufacturing Costs 
  

					
	 A.
	 	 [**]
	    	 
			
	 B.
	 	 [**]
	    	 
			
	 C.
	 	 [**]
	    	 
			
	 	 	 -
	    	[**]
			
	 	 	 -
	    	[**]
			
	 	 	 -
	    	[**]
			
	 	 	 -
	    	[**]
			
	 	 	 -
	    	[**]
			
	 	 	 -
	    	[**]
			
	 	 	 -
	    	[**]
			
	 	 	 -
	    	[**]
			
	 	 	 -
	    	[**]
			
	 	 	 -
	    	[**]
			
	 	 	 -
	    	[**]
			
	 [**]
	 	 	    	 
			
	 [**]
	 	 	    	 

  

 -45- 

  
 EXHIBIT 7.1 
  
 DEVELOPMENT COSTS 
  
 “Development Costs” are the sum of: [**] 
  
 Examples of Development Costs 
  
 [**] 
  
 [**] 
 [**]

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

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

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

 -46-Master Services Agreement

 Exhibit 10.10 
  
 Confidential Materials omitted and filed separately with the Securities and Exchange Commission. 
 Asterisks denote omissions. 
  
 MASTER SERVICES AGREEMENT 
  
 This Master Services Agreement (“Agreement”) is made between Voyager Pharmaceutical Corporation which has a place of business at 8540 Colonnade
Center Drive, Suite 409, Raleigh, North Carolina 27615 (hereinafter “Sponsor”), and Quintiles, Inc., a North Carolina corporation having its principal place of business at 5927 South Miami Boulevard, Morrisville, North Carolina 27560
(hereinafter “Quintiles”). When signed by both parties, this Agreement will set forth the terms and conditions under which Quintiles agrees to provide certain services to Sponsor as set forth herein. 
  
 Recitals: 
  
 A. Sponsor is in the business of developing, manufacturing and/or
distributing pharmaceutical products, medical devices and/or biotechnology products. Quintiles is in the business of providing clinical trial services, research, and other services for the pharmaceutical, medical device and biotechnology industries
and has made significant, up-front investments in technologies related to those industries, building on important inventions and web-based technologies. 
  
 B. Sponsor and Quintiles desire to enter into this Agreement to provide the terms and conditions upon which Sponsor may engage Quintiles from time-to-time
to provide services for individual studies or projects by executing individual Work Orders (as defined below) specifying the details of the services and the related terms and conditions. 
  
 Agreement: 
  

	1.0	Scope of the Agreement; Work Orders; Nature of Services. 

  

	 	(a)	Scope of Agreement. As a “master” form of contract, this Agreement allows the parties to contract for multiple projects through the issuance of multiple Work Orders
(as discussed in Section 1(b) below), without having to re-negotiate the basic terms and conditions contained herein. This Agreement covers the provision of services by Quintiles and Quintiles’ corporate affiliates (see Section 18) and,
accordingly, this Agreement represents a vehicle by which Sponsor can efficiently contract with Quintiles and its corporate affiliates for a broad range of services. 

  

	 	(b)	Work Orders. The specific details of each project under this Agreement (each “Project”) shall be separately negotiated and specified in writing on terms and in a
form acceptable to the parties (each such writing, a “Work Order”). A sample Work Order is attached hereto as Exhibit A. Each Work Order will include, as appropriate, the scope of work, time line, and budget and payment schedule. Each Work
Order shall be subject to all of the terms and conditions of this Agreement, in addition to the specific details set forth in the Work Order. To the extent any terms or provisions of a Work Order conflict with the terms and provisions of this
Agreement, the terms and provisions of this Agreement shall control, except to the extent that the applicable Work Order expressly and specifically states an intent to supersede the Agreement on a specific matter. All Work Orders and other exhibits
hereto shall be deemed to be incorporated herein by reference. 

  

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	 	(c)	Nature of Services. The services covered by this Agreement may include strategic planning, expert consultation, clinical trial services, statistical programming and analysis,
data processing, data management, regulatory, clerical, project management, central laboratory services, preclinical services, pharmaceutical sciences services, medical device services, and other research and development services requested by
Sponsor and agreed to by Quintiles as set forth in the relevant Work Order (collectively, the “Services”). Quintiles and Sponsor, where appropriate, shall cooperate in the completion of a Transfer of Obligations Form in conjunction with
the relevant Work Order. Any responsibilities not specifically transferred in the Transfer of Obligations Form shall remain the regulatory responsibility of Sponsor. The Transfer of Obligations Form will be filed with the Food and Drug
Administration (“FDA”) by Sponsor where appropriate, or as required by law or regulation. 

  

	2.0	Payment of Fees and Expenses. Sponsor will pay Quintiles for fees, expenses and pass-through costs in accordance with the budget and payment schedule contained in each Work
Order. Unless otherwise agreed in a particular Work Order, the following shall apply: (a) Quintiles will invoice Sponsor monthly for the fees, expenses and pass-through costs incurred in performing the Services; and, (b) Sponsor shall pay each
invoice within [**] of the date of the invoice. If any portion of an invoice is disputed, then Sponsor shall pay the undisputed amounts as set forth in the preceding sentence and the parties shall use good faith efforts to reconcile the disputed
amount as soon as practicable. Sponsor shall pay Quintiles interest in an amount equal to one percent (1%) per month (or the maximum lesser amount permitted by law) of all undisputed amounts owing hereunder and not paid within thirty (30) days of
the date of the invoice. 

  

	3.0	Term. This Agreement shall commence on the date it has been signed by all parties and shall continue for a period of five (5) years from the date of execution, or until
terminated by either party in accordance with Section 17 below. The Agreement will automatically renew each year thereafter for a period of one year, unless either party notifies the other party in writing at least 30 days prior to the renewal date
that it does not want to renew the Agreement. 

  

	4.0	Change Orders. Any change in the details of a Work Order or the assumptions upon which the Work Order is based (including, but not limited to, changes in an agreed starting
date for a Project or suspension of the Project by Sponsor) may require changes in the budget and/or time lines, and shall require a written amendment to the Work Order (a “Change Order”). Each Change Order shall detail the requested
changes to the applicable task, responsibility, duty, budget, time line or other matter. The Change Order will become effective upon the execution of the Change Order by both parties, and Quintiles will be given a reasonable period of time within
which to implement the changes. Both parties agree to act in good faith and promptly when considering a Change Order requested by the other party. Without limiting the foregoing, Sponsor agrees that it 

  

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 will not unreasonably withhold approval of a Change Order, even if it involves a fixed price contract, if
the proposed changes in budgets or time lines result from, among other appropriate reasons, forces outside the reasonable control of Quintiles or changes in the assumptions upon which the initial budget or time lines were based, including, but not
limited to, the assumptions set forth in the budget or timelines. Quintiles reserves the right to postpone effecting material changes in the Project’s scope until such time as the parties agree to and execute the corresponding Change Order. For
any Change Order that affects the scope of the regulatory obligations that have been transferred to Quintiles, Quintiles and Sponsor shall execute a corresponding amendment to the Transfer of Obligations Form. Sponsor shall file such amendment where
appropriate, or as required by law or regulation. 
  

	5.0	Confidentiality. It is understood that during the course of this Agreement, Quintiles and its employees may be exposed to data and information that are confidential and
proprietary to Sponsor. All such data and information (hereinafter “Sponsor Confidential Information”) written or verbal, tangible or intangible, made available, disclosed, or otherwise made known to Quintiles and its employees as a result
of Services under this Agreement shall be considered confidential and shall be considered the sole property of Sponsor. All information regarding Quintiles’ operations, methods, and pricing and all Quintiles’ Property (as defined in
Section 6.0 below), disclosed by Quintiles to Sponsor in connection with this Agreement is proprietary, confidential information belonging to Quintiles (the “Quintiles Confidential Information”, and together with the Sponsor Confidential
Information, the “Confidential Information”). The Confidential Information shall be used by the receiving party and its employees only for purposes of performing the receiving party’s obligations hereunder. Each party agrees that it
will not reveal, publish or otherwise disclose the Confidential Information of the other party to any third party without the prior written consent of the disclosing party. Each party agrees that it will not disclose the terms of this Agreement or
any Work Order to any third party without the written consent of the other party, which shall not unreasonably be withheld. These obligations of confidentiality and nondisclosure shall remain in effect for a period of ten (10) years after the
completion or termination of the applicable Work Order. 

  
 The foregoing obligations shall not apply to Confidential Information to the extent that it: (a) is or becomes generally available to the public other than as a result of a disclosure by the receiving party; (b) becomes available to the
receiving party on a non-confidential basis from a source which is not prohibited from disclosing such information; (c) was developed independently of any disclosure by the disclosing party or was known to the receiving party prior to its receipt
from the disclosing party, as shown by contemporaneous written evidence; or, (d) is required by law or regulation to be disclosed. 
  

	6.0	Ownership and Inventions. All data and information generated or derived by Quintiles as the result of services performed by Quintiles under this Agreement shall be and remain
the exclusive property of Sponsor. Any inventions that may evolve from the data and information described above or as the result of services performed by Quintiles under this Agreement shall belong to Sponsor and Quintiles agrees to assign its
rights in all such inventions and/or related patents to Sponsor. Notwithstanding the foregoing, Sponsor 

  

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 acknowledges that Quintiles possesses certain inventions, processes, know-how, trade secrets,
improvements, other intellectual properties and other assets, including but not limited to analytical methods, procedures and techniques, procedure manuals, personnel data, financial information, computer technical expertise and software, which have
been independently developed by Quintiles and which relate to its business or operations (collectively “Quintiles’ Property”). Sponsor and Quintiles agree that any Quintiles’ Property or improvements thereto which are used,
improved, modified or developed by Quintiles under or during the term of this Agreement are the sole and exclusive property of Quintiles. 
  

	7.0	Records and Materials. At the completion of the Services by Quintiles, all materials, information and all other data owned by Sponsor, regardless of the method of storage or
retrieval, shall be delivered to Sponsor in such form as is then currently in the possession of Quintiles, subject to the payment obligations set forth in Section 2 herein. Alternatively, at Sponsor’s written request, such materials and data
may be retained by Quintiles for Sponsor for an agreed-upon time period, or disposed of pursuant to the written directions of Sponsor. Sponsor shall pay the costs associated with any of the above options and shall pay a to-be-determined fee for
storage by Quintiles of records and materials after completion or termination of the Services. Quintiles, however, reserves the right to retain, at its own cost and subject to the confidentiality provisions herein, copies of all materials that may
be needed to satisfy regulatory requirements or to resolve disputes regarding the Services. Nothing in this Agreement shall be construed to transfer from Sponsor to Quintiles any FDA or regulatory record-keeping requirements unless such transfer is
specifically provided for in the applicable Transfer of Obligations Form. 

  

	8.0	Independent Contractor Relationship. For the purposes of this Agreement, the parties hereto are independent contractors and nothing contained in this Agreement shall be
construed to place them in the relationship of partners, principal and agent, employer/employee or joint venturers. Neither party shall have the power or right to bind or obligate the other party, and neither party shall hold itself out as having
such authority. If, however, Sponsor desires to conduct clinical trials in one or more countries that require a local sponsor or representative, and Sponsor requests that Quintiles or its affiliates serve as its agent for that purpose, then
Quintiles may serve as Sponsor’s agent for the purpose of fulfilling local sponsor or representative duties. Sponsor shall pay Quintiles for such local representative services at Quintiles’ standard daily rates, unless otherwise specified
in the Work Order. 

  

	9.0	Regulatory Compliance; Inspections. Quintiles agrees that its Services will be conducted in compliance with all applicable laws, rules and regulations, including but not
limited to the Federal Food, Drug and Cosmetic Act and the regulations promulgated pursuant thereto, and with the standard of care customary in the contract research organization industry. Regarding the FDA’s electronic records and signatures
regulation, 21 CFR Part 11 (“Part 11”), Quintiles has a compliance plan in place as to its applicable database applications and electronic records systems and it is working diligently to implement its plan. Quintiles, however, is not
responsible for the compliance or noncompliance of applications or systems used by third parties (including, but not limited 

  

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 to, investigative sites or third party laboratories), or any Part 11 audits or assessments thereof,
unless such applications or systems are owned by Quintiles. Quintiles’ standard operating procedures will be used in performance of the Services, unless otherwise specifically stated in the Work Order. Quintiles certifies that it has not been
debarred under the Generic Drug Enforcement Act and that it will not knowingly employ any person or entity that has been so debarred to perform any Services under this Agreement. Sponsor represents and certifies that it will not require Quintiles to
perform any assignments or tasks in a manner that would violate any applicable law or regulation. Sponsor further represents that it will cooperate with Quintiles in taking any actions that Quintiles reasonably believes are necessary to comply with
the regulatory obligations that have been transferred to Quintiles. 
  
 Each party acknowledges that the other party may respond independently to any regulatory correspondence or inquiry in which such party or its affiliates is named. Each party, however, shall: a) notify the other party promptly of any FDA or
other governmental or regulatory inspection or inquiry concerning any study or Project of Sponsor in which Quintiles is providing Services, including, but not limited to, inspections of investigational sites or laboratories; b) forward to the other
party copies of any correspondence from any regulatory or governmental agency relating to such a study or Project, including, but not limited to, FDA Form 483 notices, and FDA refusal to file, rejection or warning letters, even if they do not
specifically mention the other party; and, c) obtain the written consent of the other party, which will not unreasonably be withheld, before referring to the other party or any of its affiliates in any regulatory correspondence. 
  
 Each party agrees that, during an inspection by the FDA or other regulatory
authority concerning any study or Project of Sponsor in which Quintiles, is providing Services, it will not disclose information and materials that are not required to be disclosed to such agency, without the prior consent of the other party, which
shall not unreasonably be withheld. Such information and materials includes, but are not limited to, the following: 1) financial data and pricing data (including, but not limited to, the budget and payment sections of the Work Order); 2) sales data
(other than shipment data); and, 3) personnel data (other than data as to qualification of technical and professional persons performing functions subject to regulatory requirements). 
  
 During the term of this Agreement, Quintiles will permit Sponsor’s representatives (unless such representatives are
competitors of Quintiles) to examine or audit the work performed hereunder and the facilities at which the work is conducted upon reasonable advance notice during regular business hours to determine that the Project assignment is being conducted in
accordance with the agreed task and that the facilities are adequate. All information disclosed, revealed to or ascertained by Sponsor in connection with any such audit or examination or in connection with any correspondence between Quintiles and
any regulatory authorities (including any FDA Form 483 notices) shall be deemed to constitute Quintiles Confidential Information for purposes of this Agreement. Sponsor shall reimburse Quintiles for its time and expenses (including reasonable
attorney fees and the costs of responding to findings) associated with any inspection, audit or investigation relating to the Services (“Inspection”) instigated by Sponsor or by a governmental authority, unless such Investigation finds
that Quintiles breached this Agreement or any applicable law or regulation. 
  

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	10.0	Relationship with Investigators. If a particular Work Order obligates Quintiles to contract with investigators or investigative sites (collectively,
“Investigators”) then Quintiles will use its standard Clinical Trial Agreement (“Global CTA”) form, a copy of which is attached hereto as Attachment C, along with certain local CTA forms (“Local CTAs”) that have
developed for use in certain countries based on local requirements with the benefit of local legal advice, which have been prepared in local language and English language where applicable. Any applicable Local CTAs will be made available for
inspection by the Sponsor upon request. If the Global CTA form or a Local CTA is updated, Quintiles will use its then current Global CTA form (or Local CTA as appropriate) as of the time of the Work Order. If Sponsor insists that any CTA form other
than the Global CTA and Local CTAs be used, then Sponsor shall pay all translation costs and additional negotiation time may be required. If an Investigator insists upon any material changes to any provisions that directly affect Sponsor, then
Quintiles shall submit the proposed material change to Sponsor, and Sponsor shall review, comment on and/or approve such proposed changes within five (5) working days. If the Global CTA form (or Local CTA, where applicable), or any changes approved
by Sponsor, differ from the terms of this Agreement or a Work Order (including, but not limited to, provisions allowing an Investigator to publish results or data that Quintiles is prohibited from revealing), then Quintiles shall have no liability
for any such approved provisions or changes. Unless otherwise stated in the applicable Work Order, the time incurred by Quintiles in negotiating CTA changes proposed by sites shall be billed at Quintiles’ Standard Rates. The parties acknowledge
and agree that Investigators shall not be considered the employees, agents, or subcontractors of Quintiles or Sponsor and that Investigators shall exercise their own independent medical judgment. Quintiles’ responsibilities with respect to
Investigators shall be limited to those responsibilities specifically set forth in this Agreement and the applicable Work Order. 

  
 If Quintiles will be paying Investigators on behalf of Sponsor, the parties will agree in the applicable Work Orders as to a schedule of amounts to be
paid to Investigators. Sponsor acknowledges and agrees Quintiles will only pay Investigators from advances or pre-payments received from Sponsor for Investigators’ services, and that Quintiles will not make payments to Investigators prior to
receipt of sufficient funds from Sponsor. Sponsor acknowledges and agrees that Quintiles will not be responsible for delays in a study or Project to the extent that such delays are caused by Sponsor’s failure to make adequate pre-payment for
Investigators’ services. Sponsor further acknowledges and agrees that payments for Investigators’ services are pass-through payments to third parties and are separate from payments for Quintiles’ Services. Sponsor agrees that it will
not withhold Investigator payments except to the extent that it has reasonable questions about the services performed by a particular Investigator. 
  

	11.0	Third Party Indemnifications and Agreements. If any investigative sites or any other third parties, including, but not limited to, Data Safety Monitoring Boards, independent
laboratories, Advisory Boards, or End Point Adjudication Committees (collectively, “Third Parties”), request an indemnification for loss or damage caused by the sponsor’s 

  

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 Project , then Sponsor shall provide such indemnification directly to the Third Party. If Sponsor
requests Quintiles’ assistance in negotiating the terms of such indemnities, Quintiles shall provide such negotiation services at its standard daily rates, unless otherwise agreed in the Work Order. Quintiles shall not sign such
indemnifications on Sponsor’s behalf unless Sponsor has expressly authorized Quintiles to act as its agent for such purpose or has given Quintiles a written power of attorney to sign such indemnifications. In countries in which local laws or
local ethics committees require that a local company must sign such indemnifications and Sponsor has no local presence, Quintiles will sign such indemnities only if the parties have entered into an agreement regarding local representative duties
containing the terms attached hereto as Attachment B, either as a part of a Work Order or as a separately signed agreement. 
  
 If Sponsor requests that Quintiles enter into agreements to retain Third Parties to perform services regarding the Project, such Third Parties shall be
independent contractors and shall not be considered the employees, agents, or subcontractors of Quintiles or Sponsor. Sponsor shall pay Quintiles for its reasonable time and expenses in negotiating and administering any such Third Party Agreements.

  

	12.0	Conflict of Agreements. Quintiles represents to Sponsor that it is not a party to any agreement which would prevent it from fulfilling its obligations under this Agreement
and that during the term of this Agreement, Quintiles agrees that it will not enter into any agreement to provide services which would in any way prevent it from providing the Services contemplated under this Agreement. Sponsor agrees that it will
not enter into an agreement with a third party that would alter or affect the regulatory obligations delegated to Quintiles in any study or Project without the written consent of Quintiles, which will not be unreasonably withheld.

  

	13.0	Publication. Project results may not be published or referred to, in whole or in part, by Quintiles or its affiliates without the prior expressed written consent of Sponsor.
Neither party will use the other party’s name in connection with any publication or promotion without the other party’s prior, written consent. 

  

	14.0	Limitation of Liability. Neither Quintiles, nor its affiliates, nor any of Quintiles’ or its affiliate’s directors, officers, employees, subcontractors or agents
shall have any liability of any type (including, but not limited to, contract, negligence, and tort liability), for any loss of profits, opportunity or goodwill, or any type of special, incidental, indirect or consequential damage or loss in
connection with or arising out of this Agreement, any Work Order, or the Services performed by Quintiles hereunder. In addition, in no event shall the collective, aggregate liability (including, but not limited to, contract, negligence and tort
liability) of Quintiles or its affiliates, or Quintiles’ or its affiliates’ directors, officers, employees, subcontractors and agents, under this Agreement or any Work Order hereunder exceed the amount of fees actually received by
Quintiles from Sponsor for the assignment or task from which such liability arose. 

  

	15.0	Indemnification. Sponsor shall indemnify, defend and hold harmless Quintiles and its affiliates, and its and their directors, officers, employees and agents (each, a
“Quintiles Indemnified Party”), from and against any and all losses, damages, liabilities, reasonable 

  

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 attorney fees, court costs, and expenses (collectively “Losses”), joint or several, resulting
or arising from any third-party claims, actions, proceedings, investigations or litigation relating to or arising from or in connection with this Agreement, any Work Order, or the Services contemplated herein (including, without limitation, any
Losses arising from or in connection with any study, test, device, product or potential product to which this Agreement or any Work Order relates), except to the extent such Losses are determined to have resulted solely from the negligence or
intentional misconduct of the Quintiles Indemnified Party seeking indemnity hereunder. 
  

	16.0	Indemnification Procedure. Quintiles shall give Sponsor prompt notice of any such claim or lawsuit (including a copy thereof) served upon it and shall fully cooperate with
Sponsor and its legal representatives in the investigation of any matter the subject of indemnification. Quintiles shall not unreasonably withhold its approval of the settlement of any claim, liability, or action covered by this Indemnification
provision. 

  

	17.0	Termination. Sponsor may terminate this Agreement or any Work Order without cause at any time during the term of the Agreement on sixty (60) day’s prior written notice
to Quintiles. Either party may terminate this Agreement or any Work Order for material breach upon thirty (30) days’ written notice specifying the nature of the breach, if such breach has not been substantially cured within the thirty (30) day
period. During the 30-day cure period for termination due to breach, each party will continue to perform its obligations under the Agreement. If the termination notice is not due to a breach, or if the cure period has expired without a substantial
cure of the breach, then the parties shall promptly meet to prepare a close-out schedule, and Quintiles shall cease performing all work not necessary for the orderly close-out of the Services or required by laws or regulations. If Quintiles
determines, in its sole discretion, that its continued performance of the Services contemplated by one or more Work Orders would constitute a potential or actual violation of regulatory or scientific standards of integrity, then Quintiles may
terminate the applicable Work Order(s) by giving written notice stating the effective date (which may be less than thirty days from the notice date) of such termination. Either party may terminate this Agreement or any Work Orders immediately upon
provision of written notice if the other party becomes insolvent or files for bankruptcy. Any written termination notice shall identify the specific Work Order or Work Orders that are being terminated. 

  
 If this Agreement or any Work Order is terminated, Sponsor shall pay
Quintiles for all Services performed in accordance with this Agreement and any applicable Work Order and reimburse Quintiles for all costs and expenses incurred in performing those Services, including all non-cancelable costs incurred prior to
termination but paid after the termination date. Sponsor shall pay for all the work actually performed in accordance with this Agreement and the applicable Work Order, even if the parties’ original payment schedule spreads-out payments for
certain services or defers payments for certain services until the end of the Study. If payments are unit or milestone based, and the Agreement or a Work Order is terminated after costs have been incurred toward achieving portions of one or more
incomplete units or milestones, Sponsor will pay Quintiles’ standard fees for actual work performed toward those incomplete units or milestones up to the date of termination, in addition to paying for completed units or 

  

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milestones. Sponsor shall pay for all actual costs, including time spent by Quintiles personnel (which shall be billed at Quintiles’ standard daily
rates in effect as of the date of the termination notice), incurred to complete activities associated with the termination and close-out of affected Projects, including the fulfillment of any regulatory requirements. 
  

	18.0	Relationship with Affiliates. Sponsor agrees that Quintiles may use the Services of its corporate affiliates to fulfill Quintiles’ obligations under this Agreement and
any Work Order. Any affiliate so used shall be subject to all of the terms and conditions applicable to Quintiles under this Agreement or any Work Order, and entitled to all rights and protections afforded Quintiles under this Agreement and any Work
Order. Quintiles agrees that Sponsor’s affiliates may use the services of Quintiles (and its affiliates) under this Agreement. In such event, such Sponsor’s affiliates shall be bound by all the terms and conditions of this Agreement and
any Work Order and entitled to all rights and protections afforded Sponsor under this Agreement and any Work Order. Any such affiliate of Sponsor or Quintiles may execute a Work Order directly. The term “affiliate” shall mean all entities
controlling, controlled by or under common control with Sponsor or Quintiles, as the case may be. The term “control” shall mean the ability to vote fifty percent (50%) or more of the voting securities of any entity or otherwise having the
ability to influence and direct the polices and direction of an entity. 

  

	19.0	Cooperation; Sponsor Delays; Disclosure of Hazards. Sponsor shall forward to Quintiles in a timely manner all documents, materials and information in Sponsor’s
possession or control necessary for Quintiles to conduct the Services. Quintiles shall not be liable to Sponsor nor be deemed to have breached this Agreement for errors, delays or other consequences arising from Sponsor’s failure to timely
provide documents, materials or information or to otherwise cooperate with Quintiles in order for Quintiles to timely and properly perform its obligations, and any such failure by Sponsor shall automatically extend any timelines affected by a time
period reasonably commensurate to take into account such failure, unless Sponsor agrees in writing to pay any additional costs that would be required to meet the original timeline. If Sponsor delays a project from its agreed starting date or
suspends performance of the project then either: a) Sponsor will pay the standard daily rate of the Quintiles’ personnel assigned to the project, based on the percentage of their time allocated to the project, for the period of the delay, in
order to keep the current team members; or, b) Quintiles may re-allocate the personnel at its discretion, and Sponsor will pay the costs of re-training new personnel. In addition, Sponsor will pay all non-cancelable costs and expenses incurred by
Quintiles due to the delay and will adjust all timelines to reflect additional time required due to the delay. Sponsor shall provide Quintiles with all information available to it regarding known or potential hazards associated with the use of any
substances supplied to Quintiles by Sponsor, and Sponsor shall comply with all current legislation and regulations concerning the shipment of substances by the land, sea or air. 

  

	20.0	Force Majeure. In the event either party shall be delayed or hindered in or prevented from the performance of any act required hereunder by reasons of strike, lockouts, labor
troubles, inability to procure materials or services, failure of power or restrictive government or judicial orders, or decrees, riots, insurrection, war, Acts of God, inclement weather or other reason or cause beyond that party’s control, then
performance of such act (except for the payment of money owed) shall be excused for the period of such delay. 

  

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	21.0	Notices and Deliveries. Any notice required or permitted to be given hereunder by either party hereunder shall be in writing and shall be deemed given on the date received if
delivered personally or by a reputable overnight delivery service, or three (3) days after the date postmarked if sent by registered or certified mail, return receipt requested, postage prepaid to the following addresses: 

 

			
	If to Quintiles:	 	If to Sponsor:
		
	 Quintiles, Inc.
 5927 South Miami Boulevard
 Morrisville, North Carolina 27560
 ATTN: Elena M. Mestre
	 	 Voyager Pharmaceutical Corporation
 8650 Colonnade
Drive, Suite 409
 Raleigh, North Carolina 27615
 ATTN: Timothy J.
Creech

		
	With a copy to:	 	 
		
	 Quintiles Transnational Legal Department
 P.O. Box
13979
 Research Triangle Park, North Carolina 27709-3979
 ATTN:
John Russell
	 	 

  
 If Sponsor delivers,
ships, or mails materials or documents to Quintiles, or requests that Quintiles deliver, ship, or mail materials or documents to Sponsor or to third parties, then the expense and risk of loss for such deliveries, shipments, or mailings shall be
borne by Sponsor. Quintiles disclaims any liability for the actions or omissions of third-party delivery services or carriers. All information transmitted by Quintiles pursuant to this agreement will be sent by the standard transmission method
selected by Quintiles (telephone, facsimile, mail, personal delivery or email). Sponsor hereby consents and authorizes Quintiles to send facsimiles relating to the Services, or relating to potential future services, to any office of Sponsor or
Sponsor’s affiliates. 
  

	22.0	Insurance. During the term of this Agreement to cover its obligations hereunder, each party shall maintain insurance coverage as follows: 1) (a) Professional Liability for
Quintiles in an amount of at least US$[**]; (b) Product Liability for Sponsor in an amount of at least US$[**]; and 2) General Liability in amounts of at least US$3,000,000.00. All insurance amounts may be obtained by full, individual primary policy
amount; a primary amount of less than minimum requirement enhanced by a blanket excess umbrella policy; or a combination of either. Each party shall provide the other party with a certificate of insurance upon request. The insured shall provide the
other party with at least thirty (30) days prior written notice of any material change, cancellation or expiration of the above-required insurance. 

  

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	23.0	Foreign Currency Exchange. The currency to be used for invoice and payment shall be the currency stated in the Budget or Table attached to the Work Order (the
“Contracted Currency”). If Quintiles incurs pass-through costs in a currency other than the Contracted Currency, then Sponsor shall reimburse Quintiles for Quintiles’ actual costs in the Contracted Currency based on the Oanda foreign
currency exchange rate (Oanda.com) for the applicable currencies on the last business Friday of the month. For Work Orders that involve the performance of Services by Quintiles or its affiliates in any countries that use currencies other than the
Contracted Currency, and the fees for such Services will exceed $500,000, then a currency exchange provision shall be included in the Work Order. 

  

	24.0	Inflation Adjustments. Where services in a Work Order are provided by Quintiles over multiple calendar years, Quintiles may increase its fees at the beginning of each
calendar year to reflect increases in Quintiles’ business costs on a prospective basis only. Quintiles’ overall costs may be increased for the next twelve (12) month period using the average percentage change in the wages/earnings survey
as published in the Economist (or as reported at www.economist.com) or the equivalent inflation index of the country where services are performed, over the preceding twelve (12) month period. 

  

	25.0	Data Protection. Quintiles and Sponsor agree to comply with all applicable privacy laws and regulations. If the Project will involve the collection or processing of personal
data (as defined by applicable data protection legislation) within the European Economic Area (“EEA”), then Sponsor shall serve as the controller of such data, as defined by the European Union (“EU”) Data Protection Directive
(the “Directive”), and Quintiles shall act only under the instructions of the Sponsor in regard to personal data. If Sponsor is not based in the EEA, but personal data will be gathered or processed in the EEA, Sponsor must appoint an EEA
company to act as its local representative for data protection purposes in order to comply with the Directive, and such designation is attached hereto and incorporated by reference. If Sponsor does not have an affiliate in the EEA and requests that
a Quintiles affiliate in the EEA serve as its local representative, then the parties shall negotiate a fee for such representative duties and shall enter into a Data Transfer Agreement between the parties containing the Standard Contractual Clauses
set forth by the EU Commission Decision of 15 June 2001 (Decision 2001/497/EC) before Quintiles will assume any such representative duties. If Sponsor is not based in the EEA, Quintiles will not export any personal data from the EEA unless Sponsor
has appointed a local representative. 

  

	26.0	Binding Agreement and Assignment. This Agreement shall be binding upon and inure to the benefit of Sponsor and Quintiles and their respective successors and permitted
assigns. Except as stated above in Section 18, neither party may assign any of its rights or obligations under this Agreement to any party without the express, written consent of the other party. 

  

	27.0	Choice of Law, Waiver and Enforceability. This Agreement shall be construed, governed, interpreted, and applied in accordance with the laws of the State of North
Carolina, exclusive of its conflicts of law provisions. The failure to enforce any right or provision herein shall not constitute a waiver of that right or provision. Any waiver of a 

  

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breach of a provision shall not constitute a waiver of any subsequent breach of that provision. If any provisions herein are found to be unenforceable on the
grounds that they are overly broad or in conflict with applicable laws, it is the intent of the parties that such provisions be replaced, reformed or narrowed so that their original business purpose can be accomplished to the extent permitted by
law, and that the remaining provisions shall not in any way be affected or impaired thereby. 
  

	28.0	Survival. The rights and obligations of Sponsor and Quintiles, which by intent or meaning have validity beyond such termination (including, but not limited to, rights with
respect to inventions, confidentiality, discoveries and improvements, indemnification and liability limitations) shall survive the termination of this Agreement or any Work Order. 

  

	29.0	Arbitration. Any controversy or claim arising out of or relating to this Agreement or the breach thereof shall be settled by arbitration administered by the American
Arbitration Association (“AAA”) under its Commercial Arbitration Rules, and judgment on the award rendered by the arbitrator shall be binding and may be entered in any court having jurisdiction thereof. Such arbitration shall be filed and
conducted at the office of the AAA closest to the Quintiles office having responsibility for the Project, and shall be conducted in English by one arbitrator mutually acceptable to the parties selected in accordance with AAA Rules. The arbitrator
shall not have the power to award any punitive damages or any damages excluded by this Agreement. 

  

	30.0	Entire Agreement, Headings and Modification. This Agreement, together with the applicable Work Orders, contains the entire understandings of the parties with respect to the
subject matter herein, and supersedes all previous agreements (oral and written), negotiations and discussions. The descriptive headings of the sections of this Agreement are inserted for convenience only and shall not control or affect the meaning
or construction of any provision hereof. Any modifications to the provisions herein must be in writing and signed by the parties. 

  
 IN WITNESS WHEREOF, this Agreement has been executed by the parties hereto through their duly authorized officers on the date(s) set forth below.

  
 ACKNOWLEDGED, ACCEPTED AND AGREED TO: 
  

							
	QUINTILES, INC.	 	 VOYAGER
 PHARMACEUTICAL CORPORATION

				
	By:	 	 /s/ Elena M. Mestre

	 	By:	 	 /s/ David Corcoran

	 	 	(signature)	 	 	 	(signature)
	Print Name:	 	Elena M. Mestre	 	Print Name:	 	David Corcoran
	Title:	 	Vice President	 	Title:	 	Executive Vice President & CFO
	Date:	 	April 1, 2005	 	Date:	 	3-31-05
			
	FEDERAL ID#: 56-1323952	 	 	 	 

  

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	 	  	CONFIDENTIAL

 EXHIBIT A 
 SAMPLE WORK ORDER 
  
 WORK ORDER 
  
 This Work Order (“Work
Order”) is between                      (“Sponsor”) and
                     (“Quintiles”) and relates to the Master Services Agreement dated
                             (the “Master Agreement”), which is incorporated by reference
herein. Pursuant to the Master Agreement, Quintiles has agreed to perform certain services in accordance with written work orders, such as this one, entered into from time-to-time. 
  
 The parties hereby agree as follows: 
  
 1. Work Order. This document constitutes a “Work Order” under the Master Agreement and this Work Order and
the services contemplated herein are subject to the terms and provisions of the Master Agreement. 
  
 2. Services and Payment of Fees and Expenses. The specific services contemplated by this Work Order (the “Services”) and the related
payment terms and obligations are set forth on the following attachments, which are incorporated herein by reference: 
  

					
	 	 	SCOPE OF WORK	 	ATTACHMENT 1
	 	 	PROJECT BUDGET	 	ATTACHMENT 2
	 	 	TIMELINE	 	ATTACHMENT 3
	 	 	PAYMENT SCHEDULE	 	ATTACHMENT 4
	 	 	TRANSFER OF OBLIGATIONS
(if applicable)	 	ATTACHMENT 5
	 	 	LOCAL REPRESENTATIVE DUTIES
(if applicable)	 	ATTACHMENT 6

  
 3. Term. The
term of this Work Order shall commence on the date of execution and shall continue until the services described in Attachment 1 are completed, unless this Work Order is terminated in accordance with the Master Agreement. If the Master
Agreement is terminated or expires, but this Work Order is not terminated or completed, then the terms of the Master Agreement shall continue to apply to this Work Order until the Work Order is either terminated or completed. 
  
 4. Affiliates and Subcontractors. Sponsor agrees that Quintiles may
use the services of its corporate affiliates to fulfill Quintiles’ obligations under this Work Order. Any such affiliates shall be bound by all the terms and conditions of, and be entitled to all rights and protections afforded under, the
Master Agreement and this Work Order. Any subcontractors or consultants (other than Quintiles’ affiliates) that will be used by Quintiles in performing the Services are listed below: 
  
 [Insert names of any subcontractors or consultants, other than Quintiles’
affiliates, that will be used] 
  

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 5. Amendments. No modification, amendment, or waiver of this Work Order shall be effective unless
in writing and duly executed and delivered by each party to the other. 
  
 6. Currency Exchange. [Insert currency exchange provision in all Work Orders in which Quintiles will earn fees or incur expenses in excess of one million U.S. Dollars in a currency differing from the invoice and payment
currency] 
  
 7. Inflation and Cost
Adjustment. [Insert cost adjustment provision and inflation provision, if appropriate.] 
  
 ACKNOWLEDGED, ACCEPTED AND AGREED TO: 
  

							
	 [Quintiles]
	 	[Sponsor]
				
	 By:
	 	  

	 	By:	 	

				
	 Title:
	 	  
  

	 	Title:	 	

				
	 Date:
	 	  
  

	 	Date:	 	

  

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 EXHIBIT B 
 SAMPLE LOCAL REPRESENTATIVE DUTIES ATTACHMENT 
  
 LOCAL REPRESENTATIVE DUTIES 
  
 WHEREAS, pursuant to the attached agreement (the “Agreement’) [Insert full name of sponsor] (“Sponsor”) desires to conduct clinical trials in one or more countries that require that local
sponsors or representatives must sign the indemnifications to investigative sites or other local entities, but Sponsor does not have offices in such countries; and, 
  
 WHEREAS [Insert full name of Quintiles company] and/or its affiliates (hereinafter, jointly, “Quintiles”)
has offices in such countries, and Sponsor has requested that Quintiles act as its local sponsor or representative (“Local Representative”) in such countries in conducting the clinical trials covered by the attached Agreement (the
“Clinical Trials”); 
  
 NOW THEREFORE, as part of the
attached Agreement, the parties hereby agree as follows: 
  
 1)
Quintiles agrees that it will act as Sponsor’s Local Representative for the Clinical Trials in the following country or countries that require that local sponsors or representatives must sign the indemnifications to sites or other entities:
[insert applicable countries, e.g., Australia, China, Denmark, Mexico or Singapore]; provided, however, that the following special requirements must be met: 
  
 a) Sponsor shall make Quintiles and its affiliates an additional insured on insurance policies covering the
Clinical Trials that are valid in each such country and that contain, at a minimum, the following types and amounts of insurance with an insurance company that is rated at least B, XXI by A.M. Best (or of an analogous rating by a similar
organization if Sponsor is not a United States company): Products liability insurance and professional liability insurance, having an aggregate coverage and per occurrence limit of not less than US$[**]. : 1) Professional Liability and Product
Liability with aggregate and per occurrence limits of at least US$[**]; 2) General Liability in amounts of at least US$5,000,000.00; 3) Workers compensation or foreign employer liability in amounts in accordance with local and national statute; and
4) Property in an amount of at least US$500,000.00 in accordance with local and national statute. All insurance amounts may be obtained by full, individual primary policy amount; a primary amount of less than minimum requirement enhanced by a
blanket excess umbrella policy; or a combination of either. Such insurance will remain in effect during the entire period of the Clinical Trials and for at least four years thereafter in either the form of a primary policy or an extended reporting
period endorsement. Said policies shall not be canceled or otherwise materially changed during that period without thirty (30) days prior written notice to Quintiles. Sponsor agrees to provide a certificate of insurance for the above-referenced
insurance within 10 days of the execution of this agreement to the Quintiles Project Manager for the Clinical Trials, with a copy to the following address: Quintiles Transnational Risk Management, 4709 Creekstone Drive, Durham, North Carolina,
27703, Attention, Barbara Allen. 
  

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	 	  	CONFIDENTIAL

 b) Quintiles shall perform all the monitoring for the Clinical Trials in countries with
such indemnification requirements, and Sponsor shall not use any other contract research organization in those countries to perform any duties or tasks for which Quintiles may be held responsible as Local Representative. 
  
 c) (This sub-section is applicable only if the Study Drug
has never before been tested in humans, or if the Clinical Trials involve testing on pregnant women, introduction of a live virus into humans who do not already have a terminal illness, or medical devices subject to tracking pursuant to 21 CFR Part
821, or if Quintiles has notified Sponsor in writing prior to the signing of the attached Agreement that Quintiles reasonably believes the Clinical Trials involve an unusually high degree of risk). Sponsor shall provide to Quintiles, within 10
days of the execution of the Agreement, a summary of the safety history and issues involving that drug, device or product, and will provide, within ten days of any such request, any additional safety or manufacturing information reasonably requested
by Quintiles. Upon receipt of such safety materials, Quintiles will assess the seriousness of the safety issues, the specific legal risks and obligations assumed by Quintiles in the country at issue, and the potential revenue and other benefits to
Quintiles in performing the Clinical Trials, and Quintiles shall have the option of notifying Sponsor, within 10 days of receipt of all the requested safety information, that it declines to enter into the indemnification agreements for a specific
country or countries. 
  
 2) Sponsor agrees that Quintiles will be
Sponsor’s authorized agent solely for the purpose of serving as Sponsor’s Local Representative in the above-listed countries and performing the duties and obligations that Quintiles and Sponsor agree in writing that Quintiles will perform.
If a local governmental authority instructs Quintiles, in its capacity as Local Representative, to fulfill duties or tasks that Sponsor and Quintiles have not agreed that Quintiles will perform, then Quintiles shall inform Sponsor of the
authority’s instructions, and either Sponsor shall perform the required duties or tasks, or Quintiles shall perform the required duties and tasks, and Sponsor shall pay for Quintiles’ time (at its standard daily rates) and expenses in
performing such duties and tasks. Sponsor hereby expressly acknowledges and agrees that the indemnification included in the attached Agreement applies to any and all claims, damages, costs, liabilities and expenses (including reasonable
attorney’s fees and court costs) of any type (“Losses”) arising from or in connection with Quintiles’ services as Local Representative for the Clinical Trials, including, but not limited to, any and all Losses incurred due to any
indemnifications entered into by Quintiles pursuant to Section 1 above. 
  
 3) If the attached Agreement is terminated, then Quintiles will cease acting as Local Representative, will terminate any indemnifications it has entered into as Local Representative, and will assign to Sponsor or Sponsor’s designate
any investigator agreements relating to the Clinical Trials that have been executed by Quintiles. In addition, Quintiles may cease acting as Local Representative and terminate any existing indemnifications if: a) Sponsor fails to maintain the
insurance required in Section 1; b) Quintiles is no longer providing all the monitoring in the countries listed above due to a modification of the attached Agreement; or, c) one or more serious adverse events occur such Quintiles reasonably believes
that subjects or patients will be 

  

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	 	  	CONFIDENTIAL

 
subjected to unacceptable safety risks. Sponsor agrees that Quintiles shall have no liability to Sponsor for any cessation of its Local Representative Duties
or termination of indemnifications pursuant to this Section. 
  
 4) If Sponsor requests that Quintiles act as its Local Representative for the Clinical Trials in any additional country not currently listed herein, and Quintiles agrees to act as the Local Representative in such country, then the terms of
this Attachment shall apply to Quintiles’ services as Local Representative in that country. 
  
 5) The terms of this Attachment shall form an integral part of, and are incorporated into, the attached Agreement. 
  

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 EXHIBIT C 
 SAMPLE CLINICAL TRIAL AGREEMENT FORM 
  
 CLINICAL TRIAL AGREEMENT 
  
 Made
between «INVNAME», having a place of business at «INVADD1», «INVADD2», «INVADD3»,, «INVADD4» (the “Investigator”), «SITENAME», having a place of
business at «SITEADD1», «SITEADD2», «SITEADD3», «SITEADD4» (the “Institution”), [if applicable, add <<Research Company>> at <<RCADD>>] (the “Research
Company”) and [insert name of Quintiles entity], having a place of business at [insert address] (“Quintiles”) representing the interests of [SPONSOR LEGAL NAME] (the “Sponsor”). 
  

			
	 PROTOCOL NUMBER:
	 	 
		
	 PROTOCOL TITLE:
	 	 
		
	 PROTOCOL DATE:
	 	 
		
	 SPONSOR:
	 	 
		
	 PRINCIPAL INVESTIGATOR:
	 	 «INVNAME»
 Note: If Investigator is not
a party to the Agreement, then Investigator must be an actual employee of the Institution, and the following language must be included after the Investigator’s name: “an employee of Institution”

  
 WHEREAS, the Investigator and
Institution [or “and Research Company”], if any, (hereafter, jointly, the “Site”) are willing to conduct a clinical trial (the “Study”), in accordance with the above-referenced protocol and any subsequent amendments
thereto (the “Protocol”) and Quintiles requests the Site to undertake such Study; 
  
 NOW THEREFORE, the following is agreed: 
  

	1.	Quintiles hereby appoints the Site to conduct the Study, and the Site agrees to ensure that the Site and the Site’s employees, agents, and staff will conduct the Study in
accordance with the Protocol, the terms of this agreement, including the Terms and Conditions attached as Attachment A, the Payment Schedule and Budget attached as Attachment B, and any other the attachments hereto, which all are incorporated by
reference herein (the “Agreement”), good clinical practices, and all applicable laws and regulations. The Site hereby confirms that it has enough time and resources to perform the Study according to the highest quality standards.

  

	2.	Payments shall be made in accordance with the provisions set forth in Attachment B, with the last payment being made after the Site completes all its obligations hereunder, and
Quintiles has received all completed case report forms (“CRFs”) and, if Quintiles requests, all other Confidential Information as defined in Attachment A, Section 2 (Confidential and Proprietary Information). The Site will act as an
independent 

  

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	 	  	CONFIDENTIAL

 contractor, and shall not be considered the employee or agent of Quintiles or Sponsor. Neither Quintiles
nor Sponsor shall be responsible for any employee benefits, pensions, workers’ compensation, withholding, or employment-related taxes as to the Site. The Site acknowledges and agrees that Investigator’s judgment with respect to
Investigator’s advice to and care of each subject is not affected by the compensation Site receives hereunder. The parties agree that the payee designated below is the proper payee for this Agreement, and that payments under this Agreement will
be made only to the following payee (the “Payee”): 
  

			
	 PAYEE NAME:
Please note: This
should be a business
 name and must match
the business name
used to file for your
tax EIN or other tax
ID number
	  	«PayeeName»
		
	 PAYEE ADDRESS: Please Note: this
 should be street address, not a PO Box
	  	 «Payee Address»
  

	  	 «PayeeAddress2»
  

	 	  	«Payee City», «Payee State» «PayeePostal_Code»
	 	  	 
		
	 	  	THE TAX ID MUST EXACTLY MATCH THE PAYEE NAME INDICATED ABOVE
		
	 TAX ID NUMBER
 [For Canada,Insert:
GST & PROVINCIAL TAX IF APPLICABLE]
	  	  

	  	 For Canada:
 GST tax number or applicable provincial
tax number

	 	  	  
  

		
	 	  	or Tax
exempt                                       
                                      
 

  
 If the Payee is in
the United States of America (“U.S.”), the Payee’s 9 Digit Tax Identification Number and SSN/EIN designation will be required before any payments can be made under this Agreement. 
  
 [For Canada include “If the Payee is in Canada the Payee’s applicable tax numbers
or Tax exempt status designation will be required before any payment can be made under this Agreement.”] 
  

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	 	  	CONFIDENTIAL

 Site will have thirty (30) days from the receipt of final payment to dispute any payment discrepancies
during the course of the Study. 
  
 The parties acknowledge
that the designated Payee is authorized to receive all of the payments for the services performed under this Agreement. If the Investigator is not the Payee, then the Payee’s obligation to reimburse the Investigator will be determined by a
separate agreement between Investigator and Payee, which may involve different payment amounts and different payment intervals than the payments made by Quintiles to the Payee. Investigator acknowledges that if Investigator is not the Payee,
Quintiles will not pay Investigator even if the Payee fails to reimburse Investigator. 
  

	3.	This Agreement will become effective on the date on which it is last signed by the parties and shall continue until completion or until terminated in accordance with the provision
in Attachment A. In the event of a conflict between the Protocol and this Agreement, the terms of the Agreement will govern. 

  

	4.	[INSERT ANY SPECIAL COUNTRY REQUIREMENTS, IF APPLICABLE] [For Sites in the European Union, the following language must be included due to Data Privacy laws and regulations:
Prior to and during the course of the Study, the Site and Site staff may provide personal data relating to its investigators, Site staff or other personnel, which may be subject to data privacy laws or regulations. Such personal data may include
names, contact information, work experience, qualifications, publications, resumes, educational background, performance information, facilities, staff capabilities, and other information relating to the Site’s conduct of clinical trials. If the
Site is in the European Union, the Sponsor would be the data controller for such personal data. The Site hereby consents to the use and processing of its personal data and the personal data of its investigators, staff and personnel for the following
purposes: a) the conduct of the Study; b) review by governmental or regulatory agencies, Sponsor, Quintiles, and their agents, and affiliates; c) satisfying legal or regulatory requirements; and, d) storage in databases for use in selecting sites in
future clinical trials. The Site further consents to the transfer of such data to countries other than the Site’s own country, even though data protection may not exist or be as developed in those countries as in the Site’s own country.
The Site agrees to ensure that its staff and personnel are aware that their personal data will be used, processed and stored for above-stated purposes and may potentially be transferred to other countries and that they consent to such use, storage
and transfer.” 

  
 ACKNOWLEDGED AND AGREED BY
[Insert legal name of Quintiles entity] 
  

			
	 By:
	 	  

	 Title:
	 	  

	 Date:
	 	  

  

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	 	  	CONFIDENTIAL

 ACKNOWLEDGED AND AGREED BY THE PRINCIPAL INVESTIGATOR: 
  

			
	  

	 <<INVNAME>>

		
	 Date:
	 	  

  

					
	ACKNOWLEDGED AND AGREED BY [Insert legal name of Institution], if applicable:
		
	 By:
	 	  

	
	 Title (must be authorized to sign on Institution’s
behalf):                                      
                                        
                             

		
	 Date:
	 	  

  
 ACKNOWLEDGED AND AGREED BY
[Insert legal name of Research Company], if applicable: 
  

			
	 By:
	  	  

	 Title (must be authorized to sign on Research Company’s
behalf):                                      
                                        
                 

		
	 Date:
	  	  

  

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 ATTACHMENT A 
 TERMS AND CONDITIONS 
  
 1) Conduct of
the Study. The parties to the attached agreement (the “Agreement”) agree that the clinical trial described therein (the “Study”) will be performed in strict accordance with the applicable protocol, and any subsequent
amendments thereto (the “Protocol”), applicable federal, state, and local laws, regulations and guidelines, and good clinical practices (“GCPs”). The Principal Investigator (the “Investigator”) shall review all case
report forms (“CRFs”) to ensure their accuracy and completeness, shall review and understand the information in the investigator’s brochure or device labeling instructions, as applicable, shall ensure that all informed consent
requirements are met, and shall ensure that all required reviews and approvals (or favorable opinions) by applicable regulatory authorities and Institutional Review Boards (“IRBs”) or Independent Ethics Committees (“IECs”) are
obtained. The Investigator and the institution(s) (the “Institution”), if any, conducting the trial (jointly, the “Site”) agree to ensure that all clinical data are accurate, complete, and legible. The Site shall promptly and
fully produce all data, records and information relating to the Study to Quintiles and the sponsor of the Study (the “Sponsor”) and their representatives during normal business hours, and shall assist them in promptly resolving any
questions and in performing audits or reviews of original subject records, reports, or data sources. The Site agrees to cooperate with the representatives of Quintiles and Sponsor who visit the Site, and the Site agrees to ensure that the employees,
agents and representatives of the Site do not harass, or otherwise create a hostile working environment for, such representatives. The Site shall use the drug, device, product or compound being tested (the “Investigational Product”), and
any comparator products provided in connection with the Study, solely for the purpose of properly completing the Study and shall maintain all Investigational Product and any comparator products in a locked, secured area at all times. Upon completion
or termination of the Study, the Site shall return all unused Investigational Product, comparator products, equipment, and materials and all Confidential Information (as defined below). 
  
 2) Confidential and Proprietary Information. All information (including, but not limited to, documents, descriptions, data, CRFs,
photographs, videos and instructions), and materials (including, but not limited to, the Investigational Product and comparator products), provided to the Site by Quintiles, Sponsor, or their agents, (whether verbal, written or electronic), and all
data, reports and information, relating to the Study or its progress (hereinafter, the “Confidential Information”) shall be the property of Sponsor. The Site shall keep the Confidential Information strictly confidential and shall disclose
it only to its employees involved in conducting the Study on a need-to-know basis. These confidentiality obligations shall continue until ten (10) years after completion of the Study, but shall not apply to Confidential Information to the extent
that it: a) is or becomes publicly available through no fault of the Site; b) is disclosed to the Site by a third party not subject to any obligation of confidence; c) must be disclosed to IRBs, IECs, or applicable regulatory authorities; d) must be
included in any subject’s informed consent form; e) is published in accordance with Article 3 herein; or, f) is required to be disclosed by applicable law. The existing inventions and technologies of Sponsor, Quintiles, or the Site are their
separate property and are not affected by this Agreement. Sponsor shall have exclusive ownership of any inventions or discoveries arising in whole or in part from Confidential Information or arising as a result of the Study. The Site will, at
Sponsor’s expense, execute any documents and give any testimony necessary for Sponsor to obtain patents in any country or to 

  

 22 

			
	 	  	CONFIDENTIAL

 
otherwise protect Sponsor’s interests in such inventions or discoveries. The Site agrees to comply with any applicable data privacy or data protection
legislation of the country in which the data originated. 
  
 3) Publication.
As this is a multi center trial, it is agreed that results from this study will not be made public until all data from the trial is completed. Site and Investigator will not publish any manuscript or materials relating to study without
Sponsor’s consent, and at least sixty (60) days prior to submitting or presenting a manuscript or other materials relating to the Study to a publisher, reviewer, or other outside persons, the Site shall provide to Sponsor a copy of all such
manuscripts and materials, and allow Sponsor sixty (60) days to review and comment on them. If the Sponsor requests, the Site shall remove any Confidential Information (other than Study results) from such manuscripts or materials prior to submitting
or presenting the materials. Further, upon request of Sponsor, the Site agrees to withhold any publication if there is a patentable invention until such time as Sponsor is able to secure adequate patent protection. No party hereto shall use any
other party’s name, or Sponsor’s name, in connection with any advertising, publication or promotion without prior written permission. 
  
 4) Inspection and Debarment. When given reasonable notice, the Site agrees to allow authorized Quintiles, Sponsor or regulatory authority personnel direct access
to the Site’s records relating to the Study, including subject medical records, for monitoring, auditing, and inspection purposes. The Site shall immediately notify Quintiles of, and provide Quintiles copies of, any inquiries, correspondence or
communications to or from any governmental or regulatory authority relating to the Study, including, but not limited to, requests for inspection of the Site’s facilities, and the Site shall permit Quintiles and Sponsor to attend any such
inspections. The Site will make reasonable efforts to separate, and not disclose, all confidential materials that are not required to be disclosed during such inspections. The Investigator and the Institution, if any, shall be jointly responsible
for maintaining essential Study documents for the time and in the manner specified by current good clinical practice (“GCP”) guidelines, local laws, and Sponsor requirements and shall take measures to prevent accidental or premature
destruction of these documents. If the Investigator leaves an institution, then responsibility for maintaining Study records shall be determined in accordance with applicable regulations. If an investigator or subinvestigator leaves an institution
or otherwise changes addresses, he or she shall promptly notify Sponsor and Quintiles of his or her new address. The Site represents and warrants that neither it, nor any of its employees, agents or other persons performing the Study under its
direction, has been debarred, disqualified or banned from conducting clinical trials or is under investigation by any regulatory authority for debarment or any similar regulatory action in any country, and the Site shall notify Quintiles immediately
if any such investigation, disqualification, debarment, or ban occurs. 
  
 5)
Termination. Quintiles may terminate this Agreement effective immediately upon written notice. The Site may terminate upon written notice if circumstances beyond the Site’s reasonable control prevent the Site from completing the Study, or
if the Site reasonably determines that it is unsafe to continue the Study. Upon receipt of notice of termination, the Site shall immediately cease any subject recruitment, follow the specified termination procedures, ensure that any required subject
follow-up procedures are completed, and make all reasonable efforts to minimize further costs, and Quintiles shall make a final payment for visits or milestones properly performed pursuant to this Agreement in the amounts specified in the Attachment
B; provided, 
  

 23 

			
	 	  	CONFIDENTIAL

 
however, that ten percent (10%) of this final payment will be withheld until final acceptance by Sponsor of all subject CRF pages and all data clarifications
issued and satisfaction of all other applicable conditions set forth in the Agreement. Neither Quintiles nor Sponsor shall be responsible to the Site for any lost profits, lost opportunities, or other consequential damages. If a material breach of
this Agreement appears to have occurred and termination may be required, then, except to the extent that subject safety may be jeopardized, Quintiles may suspend performance of all or part of this Agreement, including, but not limited to, subject
enrollment. 
  
 6) Claims and Disclaimers. The Site shall promptly notify
Quintiles and Sponsor in writing of any claim of illness or injury actually or allegedly due to an adverse reaction to the Investigational Product and allow Sponsor to handle such claim (including settlement negotiations), and shall cooperate fully
with Sponsor in its handling of the claim. Quintiles expressly disclaims any liability in connection with the Investigational Product, including any liability for any product claim arising out of a condition caused by or allegedly caused by the
administration of such product except to the extent that such liability is caused by the negligence, willful misconduct or breach of this Agreement by Quintiles. Neither Quintiles nor Sponsor will be responsible for, and the Site agrees, to the
extent allowed by law, to indemnify and hold them harmless from, any loss, claim, cost (including reasonable attorney fees) or demand arising from any injuries or damages resulting from the Site’s negligence, failure to adhere to the Protocol,
failure to obtain informed consent, unauthorized warranties, breach of this Agreement or willful misconduct. If the Site is in the U.S., it shall maintain professional liability insurance coverage with limits of not less than two hundred thousand
dollars ($200,000 USD) per occurrence and four hundred thousand dollars ($400,000 USD) aggregate throughout the term of this Study if the policy is an occurrence policy, and for an additional five (5) years after completion of the Study if such
insurance is a claims-made policy, and will provide, upon request, a certificate of insurance. If the Site is in Canada, the Investigator shall obtain, and maintain in good standing, membership with the Canadian Medical Protective Association. If
the Site is outside of the U.S. or Canada, it shall maintain a commercially reasonable level of insurance, and, upon request, shall provide a certificate of insurance to Quintiles; or, alternatively, if applicable insurance is provided by a
governmental agency, the Site shall satisfy all requirements necessary to remain eligible for such governmental insurance during the Study. 
  
 7) Financial Disclosure. If Quintiles or Sponsor provides financial disclosure forms to the Site pursuant to U.S. regulatory requirements, then the Site agrees
that, for each listed or identified investigator or subinvestigator who is directly involved in the treatment or evaluation of research subjects, it shall promptly return to Quintiles a financial disclosure form that has been completed and signed by
such investigator or subinvestigator, which shall disclose any applicable interests held by those investigators or subinvestigators or their spouses or dependent children. Quintiles may withhold payments if it does not receive a completed form from
each such investigator and subinvestigator. The Site shall ensure that all such forms are promptly updated as needed to maintain their accuracy and completeness during the Study and for one (1) year after its completion. The Site agrees that the
completed forms may be subject to review by governmental or regulatory agencies, Sponsor, Quintiles, and their agents, and the Site consents to such review. The Site further consents to the transfer of its financial disclosure data to the
Sponsor’s country of origin, and to the U.S. if the Site is outside of the U.S., even though data protection may not exist or be as developed in those countries as in the Site’s own country. 
  

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 8) Shipping of Dangerous Goods and Infectious Materials. The shipment of dangerous goods and infectious materials
(including infectious subject specimens) is subject to local, national, and international laws and regulations. The Site is responsible for ensuring that each individual who packages or handles any dangerous goods or infectious materials for
shipping from the Site complies with all applicable laws and regulations. 
  
 9) Additional Requirements for Medical Device Studies. If the Study will be used in support of an FDA investigational device exemption (IDE) application, then, in addition to all other provisions of this Agreement, the requirements
of this Section shall apply. The Investigator agrees to perform the Study in accordance with 21 CFR Section 812, including, but not limited to, Sections 812. 25, 812.100, 812.110, 812. 140, 812.145, and 812.150, and with the investigational plan as
defined in Section 812.25, and with all conditions of approval imposed by the reviewing IRB or IEC, or FDA. The Investigator shall supervise all testing of the device involving human subjects. If the Study is terminated, the Investigator shall
dispose of or return the device as directed by Quintiles or Sponsor, unless such disposal or return would jeopardize the rights, safety or welfare of a subject. 
  

10) Additional Contractual Provisions. This Agreement, including these Terms and Conditions, constitutes the sole and complete agreement between the parties and
replaces all other written and oral agreements relating to the Study. No amendments or modifications to this Agreement shall be valid unless in writing and signed by all the parties. Failure to enforce any term of this Agreement shall not constitute
a waiver of such term. If any part of this Agreement is found to be unenforceable, the rest of this Agreement will remain in effect. This Agreement shall be binding upon the parties and their successors and assigns. The Site shall not assign or
transfer any rights or obligations under this Agreement without the written consent of Quintiles. Upon Sponsor’s request, Quintiles may assign this Agreement to Sponsor or to a third party, and Quintiles shall not be responsible for any
obligations or liabilities under this Agreement that arise after the date of the assignment, and the Site hereby consents to such an assignment. Site will be given prompt notice of such assignment by the assignee. The terms of this Agreement that
contain obligations or rights that extend beyond the completion of the Study shall survive termination or completion of this Agreement. This Agreement shall be interpreted under the laws of the state or province and country in which such Site
conducts the Study. 
  

 25 

			
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 ATTACHMENT B 
  
 NAME COMPANY, NAME PROTOCOL 
 BUDGET AND PAYMENT SCHEDULE 
  
 A.
PAYMENT TERMS 
  
 Quintiles will reimburse the Payee monthly, on a completed
visit per subject basis in accordance with the attached budget. Ninety percent (90%) of each payment due, including any Screening Failure that may be payable under the terms of this Agreement, will be made based upon prior month enrollment data
confirmed by subject Case Report Forms (“CRFs”) received from the Site supporting subject visitation. The balance of monies earned, up to ten percent (10%), will be pro-rated upon verification of actual subject visits, and will be paid by
Quintiles to the Payee upon final acceptance by Sponsor of all CRFs pages, all data clarifications issued, the receipt and approval of any outstanding regulatory documents as required by Quintiles and/or Sponsor, the return of all unused supplies to
Quintiles, and upon satisfaction of all other applicable conditions set forth in the Agreement. 
  
 Major, disqualifying Protocol violations are not payable under this Agreement 
  
 B. ADVANCE PAYMENT: 
  
 Upon completion and receipt by Quintiles of all original contractual and regulatory documentation, Quintiles will pre-pay a portion of the monies that Site will be entitled, under Section A of this Budget and
Payment Schedule, to receive as it performs subject activities covered by such Section (the “Advance”). Consequently, as it performs these subject activities, Site will not receive payment for them from Quintiles under such Section, but
will instead incrementally earn the Advance. Once Site has earned the entire Advance, payments from Quintiles under such Section will resume for subsequent subject activities covered by such Section that are performed by Site. If, upon completion or
termination of this Agreement, the amount of the Advance exceeds the amount that Site is entitled to receive under such Section for all the subject activities covered by such Section that it performed up to that time, then Site shall promptly remit
the difference to Quintiles. The amount of the Advance is XXXXX Thousand Dollars ($XXXX). 
  
 Any expense or cost incurred by Site in performing this Agreement that is not specifically designated as reimbursable by Quintiles or Sponsor under the Agreement (including this Budget and Payment Schedule) is
Site’s sole responsibility. 
  
 C. SCREENING FAILURE PAYMENTS: [If screen
failure payments will not be made, be sure it’s stated explicitly] 
  
 Reimbursement for screen failures will be at the amount indicated on the screening visit of the attached budget, not to exceed XXX (X) screen failure paid to XXX (X) subject randomized. To be eligible for reimbursement of screening visit,
completed screening CRF pages must be submitted to Quintiles and any additional information, which may be requested by Quintiles to appropriately document the subject screening procedures. 
  

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 D. DISCONTINUED OR EARLY TERMINATION PAYMENTS: 
  
 Reimbursement for discontinued or early termination subjects will be prorated based on the number of confirmed completed visits. 

 
 E. ORIGINAL INVOICES: 
  
 Original Invoices pertaining to this Study for the following items must be submitted
to Quintiles for reimbursement at the following address: 
  
 Quintiles, Inc. 
 Attn: Name of Payments Analyst 
 Investigator Payment Administration Department 
 {Insert appropriate address} 
 Phone Number of Payments Analyst  
 1-888-267-2836 
  
 Please note that invoices will not be processed unless they reference the Sponsor name,
Protocol number and Investigator and will be included with the regular payments. After receipt and verification, reimbursement for invoices will be included with the next regularly scheduled payment for subject activity. 
  

	•	 	Subject Recruitment/Advertising 

  
 Advertising (e.g., newspapers, radio stations etc.) will be reimbursed for actual costs paid by the Site on a pass-through basis upon receipt of original supporting
invoices from third party vendors. Reimbursement will only be made if the advertisement(s) were previously approved by Quintiles, the Sponsor and the IRB/IEC. The reimbursement will NOT include overhead and will not exceed XXX Hundred Dollars ($XXX)
per randomized subject [or overall maximum amount]. Said invoices should be directed as instructed in this Attachment. 
  

	•	 	Institutional Review Boards (“IRBs”) or Independent Ethics Committees (“IECs”) Payments 

  
 IRB/IEC costs will be reimbursed on a pass-through basis and are not included in the
attached Budget. Any subsequent re-submissions or renewals, upon approval by Quintiles and Sponsor, will be reimbursed upon receipt of appropriate documentation. 
  
 NO OTHER ADDITIONAL FUNDING REQUESTS WILL BE CONSIDERED 
  
 The Budget is as follows: 
  

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 EXHIBIT * 
  
 DESIGNATION OF LOCAL REPRESENTATIVE FOR DATA PROTECTION PURPOSES [For use only if personal data will be collected or processed in the EEA and Sponsor is not located in
the EEA] 
  
 Pursuant to the European Union Data Protection Directive, Sponsor,
which is not located in the European Economic Area (“EEA”), hereby designates the following company to serve as its agent and representative for data protection purposes in the EEA (“Data Protection Representative”); 

 

			
	
	 	

	Name	 	Date

  
 If the designated Data Protection
Representative is Quintiles or a Quintiles Affiliate, the parties shall mutually agree upon a fee per country for each EEA country from which personal data will be exported to a location outside of the EEA pursuant to this Agreement. 
  

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