Document:

Packaging and Supply Agreement,dated as of June 16, 2008

 Exhibit 10.15 
 Execution Copy 
 PACKAGING AND SUPPLY AGREEMENT 
 This PACKAGING AND SUPPLY AGREEMENT (the “Agreement”) effective as of June 16, 2008 (the “Effective Date”), is
entered into by and between SHARP CORPORATION, a corporation organized and existing under the laws of Pennsylvania having its principal office at 7451 Keebler Way, Allentown, Pennsylvania 18106 (“Sharp”) and Transcept
Pharmaceuticals, Inc., a Delaware corporation having its principal office at 1003 W. Cutting Blvd., Suite 110, Pt. Richmond, CA 94804 (“Manufacturer”). 
 WITNESSETH: 
 WHEREAS, Manufacturer desires to engage Sharp to Package (as defined below) the Product (as
defined below) and supply Packaged Product (as defined below) to Manufacturer or its Designee (as defined below) pursuant to orders from Manufacturer or its Designee from time to time, all in accordance with the terms and conditions set forth in
this Agreement; and 
 WHEREAS, Sharp desires to accept such engagement under the terms and conditions set forth in this Agreement;

 NOW, THEREFORE, in consideration of these premises and the covenants, agreements and stipulations hereinafter set forth, and for other
good and valuable consideration the receipt and sufficiency of which are hereby acknowledged, the parties hereto, intending to be legally bound, agree as follows: 
 1. Definitions. 
 1.1 “Affiliate” shall mean, with respect to
a party hereto, any corporation, firm, partnership or other entity, which controls, is controlled by or is under common control with a party hereto. For purposes of this definition, “control” shall mean: (i) the ownership of at least
fifty percent (50%) of the shares of the subject entity entitled to vote in the election of directors (or, in the case of an entity that is not a corporation, for the election of the corresponding managing authority), or (ii) if not
meeting the preceding criteria, ownership of the voting stock, or other voting rights to elect directors or management authority of the controlled entity, at the maximum ownership amount permitted in the country where such controlled entity exists.

 1.2 “Agency” shall mean any federal, state or local governmental regulatory authority (domestic or
foreign) involved in regulating any aspect of the development, market approval, packaging, sale, distribution or use of the Product, the Packaging or the Packaged Product or the sale of any of the foregoing, including the FDA (as defined below), the
United States Department of Justice Drug Enforcement Administration and the EMEA (as defined below). 
 1.3
“Applicable Laws” shall mean all laws, ordinances, rules and regulations of any Agency or other governmental authority that apply to the sale, manufacture, distribution and development of the Product, Sharp’s Packaging and
storage of Product and storage and supply of 

  

  
 Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. 

 
Packaged Product, or this Agreement, including without limitation (a) all applicable federal, state and local laws and regulations; (b) the U.S.
Federal Food, Drug and Cosmetic Act, (c) regulations and guidelines of the FDA and other Agencies, and ICH guidelines and (d) cGMP, and if applicable, current Good Laboratory Practices and current Good Clinical Practices promulgated by the
FDA and other Agencies. 
 1.4 “Brand Image” shall have the meaning set forth in Section 8.1. 
 1.5 “Calendar Quarter” shall mean a three-month period commencing on January 1, April 1, July 1 or
October 1, as applicable. 
 1.6 “cGMP” shall mean all laws, regulations and standards relating to the
Packaging and storage of the Products and the storage of the Packaged Products (domestic or foreign), including but not limited to, the FDA current Good Manufacturing Practices, as set forth in the Title 21 of the United States Code of Federal
Regulations and the EEC Good Manufacturing Guidelines, Volume IV, (and in European Community Directive 91/356/EEC) as such Regulations and Guidelines may be revised from time to time, as interpreted by the ICH Guideline, and any other applicable
laws, guidelines and regulations. In the event of a conflict between the FDA and the EEC standards, Sharp shall adhere to the more stringent standard so the Packaged Product may be distributed in either territory. 
 1.7 “Confidential Information” shall mean any and all information that, if disclosed in tangible form, is marked
“confidential” or with other similar designation to indicate its confidential or proprietary nature or, if disclosed orally, is indicated orally to be confidential or proprietary by the party disclosing the information at the time of the
disclosure and is confirmed in writing as confidential or proprietary by the disclosing party within forty-five (45) days after such disclosure. 
 1.8 “Designee” shall mean a party with whom Manufacturer has a relationship with in connection with the Product (including but not limited to a partner, supplier or distributor) who does not provide
outsourced contract packaging services to third parties. 
 1.9 “EMEA” shall mean the European Medicines
Evaluation Agency or any successor agency having substantially the same function. 
 1.10 “Facilities” shall
mean Sharp’s manufacturing facilities located at 23 Carland Road, Conshohocken, Pennsylvania 19428, and 7451 Keebler Way, Allentown, Pennsylvania 19106 and/or any other facility as may be designated by Sharp from time to time during the Term
and approved in advance in writing by the Manufacturer for use. 
 1.11 “FDA” shall mean the United States
Food and Drug Administration or any successor agency having substantially the same function. 
 1.12 “Firm Order”
shall mean a firm order as described in Section 4.2(b). 
  

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 1.13 “ICH Guideline” shall mean the Harmonized Tripartite Guideline of
the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. 
 1.14 “Labeling” shall mean the design and specifications for the artwork and text required for the labels and packaging inserts for Packaged Product, in each case in the form provided by Manufacturer to Sharp. 

1.15 “Manufacturer Carrier” shall mean a carrier with whom Manufacturer has an agreement to ship Packaged Products
upon receipt of them from Sharp in accordance with Section 5.2. 
 1.16 “Manufacturer Information” shall
mean the Product, Labeling and Specifications in the form provided by Manufacturer to Sharp hereunder and used by Sharp in accordance with the Specifications (in the case of Product and Labeling) and Manufacturer’s written instructions.

 1.17 “Packaged Product(s)” shall mean the Products as contained in the Packaging produced by Sharp under
the Agreement and in accordance with the Specifications and Manufacturer’s written instructions 
 1.18
“Package/Packaging” shall mean all the physical and operation services and materials necessary for the packaging and labeling of the Product as set forth in and in accordance with the Specifications, which contain the Product in the
form required by the Specifications. 
 1.19 “Packaging Materials” shall mean the components and other
materials utilized by Sharp in connection with the processing, packaging and labeling of the Products, in accordance with the Specifications, which shall either be supplied by Manufacturer or purchased by Sharp on Manufacturer’s behalf.

 1.20 “Price” shall mean the price to be paid by Manufacturer to Sharp for the Packaged Products as set
forth on Exhibit B and as may be adjusted in accordance with Section 5.1. 
 1.21
“Products” shall mean the products described on Exhibit A to be manufactured by or on behalf of Manufacturer and shipped to Sharp for packaging. Upon the parties’ mutual written consent, the parties may from time
to time during the Term amend Exhibit A to remove, add or substitute Products. 
 1.22 “Purchase
Order” shall have the meaning set forth in Section 4.2(b). 
 1.23 
 1.24 “Revised Purchase Order” shall have the meaning set forth in Section 4.2(c). 
  

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 1.25 “Specifications” shall mean the specifications for the Packaging of
Product set forth in Exhibit C, which may be revised and refined during the Term upon the prior mutual written agreement of Sharp and Manufacturer in accordance with this Agreement. 
 1.26 “Start-Up Activities” shall have the meaning set forth on Exhibit D. 
 1.27 “Term,” “Initial Term” and “Subsequent Term” shall have the meanings set forth in
Section 11.1. 
 1.28 “Tooling” shall mean the tooling made for the Packaging of the Products and listed on
Exhibit E. 
 The definitions in this Section 1 shall apply equally to both the singular and plural forms of the terms
defined. The words “include,” “includes” and “including” shall be deemed to be followed by the phrase “without limitation.” The words “day” or “year” means a calendar day or year,
respectively, unless otherwise specified. All references herein to Sections and Exhibits shall be deemed references to Sections of this Agreement and Exhibits to this Agreement unless the context shall otherwise require. 
 2. Nature of Engagement 
 2.1 Engagement. Manufacturer hereby engages Sharp, and Sharp hereby accepts Manufacturer’s engagement, as Manufacturer’s independent contractor to store and Package the Products (including affixing any labels and packaging
inserts in accordance with the Labeling approved by Manufacturer) and store and supply the Packaged Products, in each case in accordance with: (i) the Specifications; (ii) Applicable Laws and (iii) the terms and conditions of this
Agreement. In addition, Sharp will be responsible for procuring, inspecting and purchasing adequate Packaging Materials, as necessary to fill the Manufacturer Purchase Orders, unless otherwise agreed to by the parties in writing. Sharp shall be a
nonexclusive supplier of the foregoing services with respect to the Products and the Packaged Products. 
 2.2 Labeling and
Materials. Manufacturer will approve and specify all Labeling to be used on each Packaged Product, including from time to time any changes or modifications to such Labeling. Sharp will only use Manufacturer-approved Labeling (and only such
Labeling) on the Packaged Products, and will not use such Labeling on any other product or for purposes other than the performance of the Packaging services in accordance with this Agreement. In the event that Manufacturer changes or modifies the
Labeling for Packaged Product, Sharp will: (A) with respect to Product not then Packaged at the time of such Labeling change or modification, Package such Product on a going-forward basis; and (B) with respect to Packaged Product in
Sharp’s control or possession that has already been Packaged in accordance with the prior Labeling specifications, either (i) re-sticker such Packaged Product to comply with the modified Labeling specifications or, if in Sharp’s
commercially reasonable discretion such re-stickering is not practicable, (ii) re-work and re-Package such Product to comply with the modified Labeling specifications. Manufacturer will reimburse Sharp for any reasonable and documented
out-of-pocket expenses and production costs to the extent incurred by Sharp in connection with any change of Labeling of Packaged Product described in the foregoing sentence. 
  

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 2.3 Independent Contractor. Sharp shall be deemed an independent contractor with
respect to the terms and provisions of this Agreement and shall not in any respect act as an agent or employee of Manufacturer. Neither party shall be liable for any of the debts or obligations of the other and neither party shall have any authority
or right to act for or incur any liability of any kind, express or implied, in the name of or on behalf of the other party. All persons employed by Sharp in connection with the storage, Packaging and supply of the Products and the Packaged Products
to Manufacturer shall be employees or agents of Sharp and under no circumstances shall Sharp or any of its employees or agents be deemed to be employees or agents of Manufacturer. 
 3. Start-Up Activities. 
 3.1 Start-Up Activities. Sharp shall complete to the reasonable satisfaction of Manufacturer the Start-Up Activities in accordance with the time schedule set forth on Exhibit D. Any
protocols and reports prepared by Sharp in connection with the Start-Up Activities shall be subject to Manufacturer’s prior review and approval. Sharp shall permit a representative of Manufacturer to observe and review the Start-Up Activities
at the Facilities during normal business hours and upon reasonable notice. The validation reports produced in connection with the Start-Up Activities shall be deemed Confidential Information of Sharp and Manufacturer for purposes of Article 12 of
this Agreement. The costs associated with the Start-Up Activities shall be as agreed upon by the parties and shall be borne by Manufacturer. 
 3.2 Purchase and Installation of Equipment Molds and Tooling. Sharp shall be responsible for installing at its Facilities any and all new equipment, molds and/or modifications to existing equipment and molds
necessary for the Packaging of the Products and for preparing the Packaged Products for shipment, and all costs and expenses associated therewith; provided, however, that Manufacturer shall be responsible for the documented and reasonable costs and
expenses associated with the development and manufacturing of the Tooling (which shall be paid by Manufacturer as set forth in Section 5.1(d)), but in no event shall such costs and expenses exceed estimated costs and expenses set forth in
Exhibit E. Sharp shall maintain and store the Tooling at the Facilities and shall retain all right, title and interest in and to the Tooling during and after the Term; provided, however that Sharp shall use the Tooling only in
connection with the packaging of Products for Manufacturer and shall not modify the Tooling without the consent of Manufacturer. 
 4.
Agreement to Supply; Forecasts; Purchase Orders. 
 4.1 Generally. During the Term, Sharp shall store and
Package the Products and store and supply to Manufacturer the Packaged Products pursuant to Manufacturer Purchase Orders (as defined below) submitted to Sharp under Firm Orders, all in accordance with the Specifications and the terms of this
Agreement, and Manufacturer shall pay for the Packaged Products in accordance with Section 5 of this Agreement. For purposes of clarity, Manufacturer may order Packaging and Packaged Product hereunder through its Designee, and Sharp agrees to
perform such Packaging and supply such Packaged Product to such Designee pursuant to the terms of this Agreement. 
  

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 Manufacturer agrees that, in the event that it delegates one or more of its responsibilities hereunder to
a Designee, unless otherwise agreed to in writing by the parties, Manufacturer shall remain fully responsible for the performance of such responsibilities (including any payment obligations under this Agreement). Sharp shall maintain:
(i) sufficient inventories of Packaging Materials in order to satisfy the Firm Orders volumes and (ii) [***] ([***]) [***]. 
 4.2 Forecasts and Firm Orders. 
 (a) Beginning on the date hereof and hereafter on or
prior to the fifth day preceding each calendar month of the Term, Manufacturer shall provide Sharp with a twelve (12) month rolling forecast (each, a “Forecast”) of Manufacturer’s quantity and delivery date requirements for the
Packaged Products. 
 (b) The first three (3) months of each Forecast shall constitute a firm order (“Firm
Order”) and shall be binding upon Manufacturer (whether or not Sharp receives a Purchase Order in connection with such [***] month period). For the purposes of ordering packaging materials and scheduling capacity, Manufacturer shall
provide Sharp with purchase orders on its standard form setting forth (i) the quantity of Packaged Product ordered; (ii) the delivery date for such order; and (iii) the lot numbers to be applied to such Packaged Product (each, a
“Purchase Order”) in connection with such three (3) month period for the Packaged Products to be supplied during such period. So long as the quantity and delivery date requirements set forth in the Purchase Orders during
such three (3) month period are consistent with the applicable Firm Order, Sharp shall respond with an order acknowledgment within five (5) business days. If the quantity and delivery date requirements set forth in the Purchase Orders are not
consistent with the applicable Firm Order, or in the event that Manufacturer desires to subsequently amend a Purchase Order, then the parties shall cooperate in good faith to develop a mutually agreeable purchase order (a “Revised Purchase
Order”) at least [***] ([***]) days prior to the scheduled start of production; provided, however that in the event a Revised Purchase Order is not agreed upon by the parties, Manufacturer shall be obligated to purchase and
Sharp shall be obligated to supply all Packaged Products arising from such Firm Order. 
 (c) If any such Revised Purchase
Order requires a decrease in the production volume of the Packaged Products requested in the Finn Order, Manufacturer shall be responsible for (i) [***]. Notwithstanding anything to the contrary in this Section 4.2(c), Manufacturer shall
not be obligated to reimburse Sharp for Packaging Materials that are used for subsequent orders of Packaged Products placed by Manufacturer and Packaging Materials that are used by Sharp on behalf of its other customers. Upon payment of the costs
related to a Revised Purchase Order, Sharp shall upon request deliver to Manufacturer, at Manufacturer’s expense, any unused Packaging Materials and other components paid for by Manufacturer. 
  

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 [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. 

 (d) Nothing printed or written on any Manufacturer Purchase Order outside of the scope
described in Section 4.2(b), or on any Sharp order acknowledgement or on any other similar form or document, shall modify or expand either party’s obligations under this Agreement. In the event of any inconsistency between the terras of
any Purchase Order or Sharp order acknowledgement, on the one hand, and the terms of this Agreement, on the other hand, the terms of this Agreement shall prevail. 
 4.3 Production Requirements. Subject to the terms of this Agreement, Sharp shall (a) devote the necessary production capacity
to fulfill the quantity and delivery date requirements set forth in each Purchase Order, and (b) use commercially reasonable efforts to make available sufficient additional production capacity to comply with (i) Manufacturer Purchase
Orders that have quantity and delivery date requirements that are more onerous than the Firm Order for such Calendar Quarter (ii) change orders that shorten the delivery date requirements or require an increase in the production volume of the
Packaged Products requested in the Firm Order. 
 4.4 Manufacturer’s Supply Obligations. Sharp’s obligations
to fulfill any Firm Order are subject to Manufacturer’s obligation to provide Sharp with the following items within the following time periods: 
 (a) At least [***] ([***]) [***] prior to Sharp’s commencement of the production of the Packaged Products, any text, graphics or other artwork to be printed by Sharp on the Packaging Materials, all of which
shall be in conformity with the regulations of the United States Food and Ding Administration and any other applicable Agency; 
 (b) At least [***] ([***]) [***] prior to Sharp’s commencement of the production of the Packaged Products, any Packaging Materials that are to be supplied by Manufacturer; 
 (c) At least [***] ([***]) [***] prior to Sharp’s commencement of the production of the Packaged Products, the lot and expiry
information of the Products; and 
 (d) At least [***] ([***]) [***] prior to Sharp’s commencement of the production
of the Packaged Products, the Products. 
 4.5 Storage Facilities; Inventory. Sharp agrees to provide adequate storage
space for the Products and the Packaged Products. Sharp will keep adequate inventories of Packaging Materials on hand or with suppliers to accommodate variations in packaging that may be required by Manufacturer hereunder. 
 4.6 Packaged Product Samples. Sharp shall provide Manufacturer with representative lot samples of Packaged Products promptly upon
request. Such Packaged Product samples shall be shipped to Manufacturer in accordance with the provisions set forth in Section 5.2. 
  

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 [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. 

 5. Price; Payment; Shipping Instructions. 
 5.1 Determination of Prices. 
 (a) The Prices to be paid to Sharp by Manufacturer for the supply of the Packaged Products (including storage) shall be as set forth on Exhibit B (the “Packaging Fee”). The Packaging Fee for
the Product will not be increased during the first year of the Initial Term. Thereafter, the Parties will review the Packaging Fee on an annual basis, and any increase or decrease shall become effective on the anniversary of the Effective Date.
Sharp shall submit to Manufacturer any documentation supporting any increase or decrease in labor or Packaging Materials costs for the upcoming year [***] ([***]) days prior to the anniversary of the Effective Date, which increase with respect
to the labor component of the Packaging Fee may not exceed a [***] ([***]) increase from the Packaging Fee for the immediately prior year. Manufacturer and Sharp shall execute an amended Exhibit B to this Agreement to adjust the
Packaging Fee for the upcoming year as mutually agreed to in accordance with this Section 5.1(a). 
 Notwithstanding the foregoing, at
any time during the Initial Term or thereafter, Sharp may adjust the Prices set forth on Exhibit B in accordance with the following (any such adjustment shall be reflected by a written amendment to Exhibit B): 

(i) During the Term Sharp shall be entitled to increase the Prices (a) for labor charges, Packaging Materials costs and any other
costs incurred by Sharp as a result of (1) Revised Purchase Orders that have quantity and delivery date requirements that are more onerous than the Firm Order for such [***] period or (2) change orders that shorten the delivery date
requirements or require an increase in the production volume of the Packaged Products requested in the Firm Order; provided that the Price adjustment will equal the increase in the direct or indirect out-of-pocket costs incurred by Sharp,
(b) in the event that there is an increase greater than [***] ([***]) in the cost of the Packaging Materials, in which case Sharp will pass through the amount of the increase in excess of such [***] ([***]) to Manufacturer after
providing Customer with written documentation supporting any such increase and (c) in the event that a forecast projects a material decrease from the anticipated volumes set forth in the initial forecast, provided that the parties shall
renegotiate in good faith the Prices that shall apply to the new volume levels. 
 (ii) Prior to the commencement of any
Subsequent Term, the parties shall renegotiate in good faith the Prices that shall apply to such Subsequent Term. The parties shall take into account in any such renegotiations Sharp’s production rates and costs of production as of the end of
the then current Term. 
 (b) Notwithstanding the foregoing, Sharp will use commercially reasonable efforts to limit any Price
increases pursuant to Section 5.1(a)(i) and Section 5.1(a)(ii). Sharp agrees to provide to Manufacturer back-up documentation of all costs changes in detail reasonably sufficient to justify changes in Price. 
 c) The Prices set forth on Exhibit B do not include use, consumption, or excise taxes of any taxing authority. The amount of
such taxes, if any, will be added to the Price of the Packaged Products in effect at the time of shipment thereof and shall be reflected in the invoices submitted to 

  

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 [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. 

 
Manufacturer by Sharp pursuant to Section 5.3. Manufacturer shall pay the amount of such taxes to Sharp in accordance with the payment provisions
relating to shipments of Packaged Products set forth in Section 5.3. Sharp shall provide Manufacturer prompt notice of any such taxes that are initially assessed against Sharp or that Sharp receives notice of from a tax or other government
authority. Notwithstanding the foregoing, each party shall bear and pay all federal, state and local taxes based upon or measured by its net income, and all franchise taxes based upon its corporation existence, or its general corporate right to
transact business. 
 (d) The Price for the [***] of this Agreement shall also include a pro rata portion of the costs and
expenses directly related to the Tooling based on the quantity set forth in the initial [***] ([***]) [***] rolling forecast provided pursuant to Section 4.2. At the end of such [***] ([***]) [***] period, if the full amount of such
Tooling costs and expenses have not been recovered by Sharp hereunder, Sharp shall invoice Manufacturer for the unpaid balance. 
 5.2 Shipping. Sharp shall deliver the quantities of Packaged Product ordered by Manufacturer on the dates specified in Manufacturer Purchase Orders submitted in accordance with Section 4.2(c). Sharp shall arrange for the
shipment of the Packaged Products in accordance with Manufacturer’s instructions, all of which shipments shall be made F.O.B. (UCC) Sharp’s loading docks at the Facilities. Manufacturer shall provide Sharp with a list of the Manufacturer
Carriers and Sharp shall schedule freight pick up by a Manufacturer Carrier, load the Manufacturer Carrier’s trailer and complete any necessary documentation relating thereto. Manufacturer shall pay outbound freight delivery costs. All Packaged
Products delivered hereunder shall be suitably packed for shipment by Sharp in accordance with good commercial practices with respect to protection of such Packaged Product during transportation and marked for shipment to Manufacturer’s
specified receiving point. 
 5.3 Invoices. Sharp shall submit invoices to Manufacturer for all shipments of Packaged
Products hereunder upon delivery of such Packaged Products to the Manufacturer Carrier at the Facilities. All invoices will be sent to the address specified in the applicable Manufacturer Purchase Order, and each invoice will state the aggregate,
type and Price for Packaged Product in a given shipment, plus any insurance, taxes, or other costs incident to the purchase or shipment initially paid by Sharp but to be borne by Manufacturer under this Agreement pursuant to Section 5.2. Each
invoice shall be payable within [***] ([***]) [***] of the date of such invoice. 
 5.4 Risk of Loss. Title to all
Packaged Products, all work in process to produce Packaged Products and/or any other property of Manufacturer supplied to Sharp in connection with the Packaging services shall at all times remain with Manufacturer. Risk of loss for Products, the
Packaged Products and any other property of Manufacturer supplied by Manufacturer to Sharp in connection with the Packaging services shall remain with Sharp while such items are in the possession of Sharp, until risk of loss to such items is
transferred to Manufacturer, and Sharp agrees to carry the insurance described in Section 10 below to cover such risk of loss. Sharp shall reimburse Manufacturer for all such property at Manufacturer’s actual cost of such property.

  

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 [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. 

 5.5 Non-Conforming Packaged Products. 
 (a) Manufacturer shall have the right, within [***] ([***]) [***] of Sharp’s delivery of Packaged Products to the Manufacturer
Carrier, to give Sharp written notice of rejection of all or the portion of such shipment of Packaged Products that fails to conform to the Specifications or which otherwise breaches Sharp’s warranties, covenants and obligations under this
Agreement. In the event Manufacturer and/or its agent(s) believes that the Packaged Products fails to conform to the Specifications or which otherwise breaches Sharp’s warranties, covenants and obligations under this Agreement (i.e., are
“defective or non-conforming”) Manufacturer and/or its agent(s) shall send to Sharp, within the [***] ([***]) day period described above, a written notice of rejection. If Sharp agrees that the Packaged Products are defective or
non-conforming, Sharp, at Manufacturer’s option, will either promptly replace such quantities of Packaged Products and ship them to Manufacturer and/or its agent(s) (in each case at no charge to Manufacturer), or shall issue a full credit for
the Packaging costs for that particular batch to Manufacturer. Except as provided for in Section 5.5(c) below, any such claim of a defective or non-conforming shipment which is not made within such [***] ([***]) day period shall be deemed
to have been waived by Manufacturer. 
 (b) If Sharp does not agree with Manufacturer’s and/or its agents’
determination regarding the defective or non-conforming Packaged Products, then after reasonable efforts to resolve the disagreement (but in all cases, within [***] ([***]) days of Manufacturer providing notice rejection), the dispute shall be
submitted for determination by an independent laboratory/expert mutually selected by the parties and the decision of such independent laboratory/expert shall be final and binding on the parties with respect to whether the Packaged Products in
question conforms to the Specifications therefor and the warranties given by Sharp in Section 7.1 below. In the event that the independent laboratory/expert decides that the Packaged Products in question are not defective or non-conforming,
such Packaged Products shall be deemed accepted by Manufacturer. In the event that the independent laboratory/expert decides that the Packaged Products in question are defective or non-conforming, Sharp shall either, in Manufacturer’s sole
discretion: (i) use its best efforts to replace such Packaged Products at no charge to Manufacturer within the shortest possible time after Sharp’s receipt of notice regarding the independent laboratory/expert’s decision; or
(ii) promptly issue a full credit for Packaging costs for that particular batch to Manufacturer. The independent laboratory/expert’s fees and the prevailing party’s out-of-pocket costs incurred in connection with the independent
laboratory/expert’s decision shall be borne by the party against whom the independent laboratory/expert’s decision is given. In the event all or part of a shipment of Packaged Product is rejected prior to Manufacturer’s payment
therefor, Manufacturer may withhold such payment until receipt of replacement Packaged Product that are not defective or non-conforming (or determination by an independent laboratory/expert that such Packaged Product are not defective or
non-conforming. 
 (c) Latent Defects. In the event either party becomes aware of any defect in any batch of Packaged
Product that is not discoverable upon a reasonable inspection or incoming quality assurance testing, it shall promptly (and in no case later than [***] ([***]) business days after becoming aware) notify the other party in writing (identifying
the batch(es) involved), and the rejection provisions of Section 5.5(a) shall apply notwithstanding any expiration of the [***] ([***]) 

  

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 [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. 

 
day period described therein. In the event Manufacturer fails to provide such notice of defect within [***] days after it becomes aware of any defect
therein, Manufacturer shall be deemed to have accepted such batch and the recovery portions of Section 5.5(a) shall not apply to such batch. 
 (d) Supply of Products for Defective Packaging; Lost or Destroyed Product. In the event Sharp is required to replace non-conforming or defective Packaging pursuant to paragraph (a), (b) or (c) of this
Section 5.5 Manufacturer shall supply Sharp with sufficient quantities of the Products in order for Sharp to replace such Packaging, and Sharp shall reimburse Manufacturer for the quantities of Product provided by Manufacturer in connection
therewith. The price at which Manufacturer supplies Products to Sharp pursuant to this provision shall equal Manufacturer’s documented out of pocket cost of purchasing such Products (“Manufacturer’s Cost of Product”).
In the event Sharp otherwise loses or destroys any Product, Sharp shall reimburse Manufacturer for all such Product at Manufacturer’s Cost of Product. 
 6. Quality Control; Access; Inspection; Samples. 
 6.1 Modification of
Specifications. Manufacturer will send any request for a change in the Specifications to Sharp in writing, and Sharp will promptly respond to such request and make such requested changes, subject to the provisions of this Section 6.1.
Manufacturer will evaluate in good faith any change to the Specifications suggested by Sharp. All modifications to Specifications shall be in writing and shall be signed by an authorized representative of Manufacturer and Sharp. If the modifications
result in a change in Sharp’s manufacturing costs, the parties shall agree upon an appropriate adjustment to the Price under this Agreement. If the modifications result in a delay in delivery, the parties will negotiate a reasonable extension
of the affected lead times. The parties will work together in good faith to timely implement any change to the Specifications and no change to the Specifications will be implemented unless and until the parties have agreed upon the following:
(1) the implementation date of such change and (2) any increase or decrease in costs, expenses or fees associated with such change. 
 6.2 Storage Requirements. Sharp shall use the Products and the Packaging Material on a first in, first out basis and shall not use either the Products or the Packaging Material beyond the shelf life required
under any Applicable Laws. 
 6.3 Notices Regarding Packaging Materials. Sharp shall promptly contact Manufacturer, c/o
Manufacturer’s Quality Assurance Department (or such other persons or departments as Manufacturer may instruct) in the event that Sharp anticipates making changes to any Packaging Material or in the event Sharp considers any current Packaging
Material to be nonconforming with the Specifications or Applicable Laws; provided that Sharp shall not change any Packaging Material without the prior written consent of Manufacturer. 
 6.4 Quality Agreement; Quality Tests and Checks. The parties have negotiated and entered into a quality agreement of even date
herewith with respect to the quality assurance and Packaging of Product by Sharp hereunder, which shall be attached hereto as Exhibit F (“Quality Agreement”). Prior to each shipment of Packaged Products, Sharp shall
perform all in-process and finished product tests or checks necessary to assure the quality of the Packaged Products and to 

  

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ensure that the Packaged Product conforms to the Specification and Applicable Laws, Sharp also agrees to perform any tests or checks required by the
Specifications or Applicable Laws. For purposes of this Agreement, such tests shall be considered routine and shall be performed at Sharp’s expense. All tests and test results shall be performed, documented and summarized by Sharp in accordance
with the Specifications and Applicable Laws. Each shipment of Packaged Products shall also be accompanied by a certificate of analysis in a form reasonably acceptable to Manufacturer describing all requirements of the Specifications and Applicable
Laws and certifying that the Packaged Products have been Packaged, controlled and released at the Facility in accordance with the Specifications and Applicable Laws. The parties hereto will negotiate in good faith any unanticipated burdens resulting
from changes made to Applicable Laws after the date hereof. 
 6.5 Batch Records; Samples. Sharp shall maintain batch
records sufficient to trace the history of each batch, and representative samples from each batch of Packaged Product manufactured hereunder, for record keeping, stability testing, and other regulatory purposes, including as may be required by the
Specifications or Applicable Laws, for as long as required by such Applicable Laws. Sharp’s Packaged Product records shall be sufficient such that Sharp shall be capable of responding to Packaged Product inquiries by Manufacturer within [***]
of notification, including providing the code date and the location of the Packaged Products in question. Subject to the foregoing, Sharp shall notify Manufacturer before disposing of any such records and samples, and Manufacturer shall have the
option of having such records and samples delivered to Manufacturer or its Designee. 
 6.6 Recalls. Manufacturer shall
have sole responsibility for initiating and managing any recall or withdrawal of the Packaged Products, and, except as expressly provided in this Section 6.6 below, shall bear all costs and expenses relating thereto. Upon receiving from any
authority having jurisdiction any direction to withdraw or recall any Packaged Product from the market, the receiving party shall promptly notify the other party. At Manufacturer’s sole cost and expense (except as expressly provided in this
Section 6.6 below), Sharp shall provide such assistance as Manufacturer may reasonably request in connection with any such withdrawal or recall. For clarity, except as expressly provided in this Section 6.6 below, Sharp shall have no
liability with respect to any withdrawal or recall. Notwithstanding anything to the contrary in this Section 6.6, Sharp shall be liable for the costs of recalls of Packaged Product to the extent such recalls are due to Sharp’s gross
negligence or willful misconduct, provided that Sharp’s total liability for such recalls shall be limited to [***]. 
 6.7 Facilities. Sharp agrees to perform the Packaging of the Products at the Facility and shall not Package or store the Products at any other location without the prior written consent of Manufacturer, In the event Sharp fails or
anticipates it will fail to maintain the Facilities in accordance with the Specifications and Applicable Laws, or in the event Sharp receives any notice from any federal, state or local governmental or regulatory authority with respect to its
maintenance of the Facilities and only if such maintenance or notice effects the Products, Sharp shall promptly notify Manufacturer, c/o Manufacturer’s Quality Assurance Department at Manufacturer’s contact information listed in
Section 13.6 (or such other persons or departments as Manufacturer may instruct), provide copies of such notice to Manufacturer and, if such notice relates specifically to the Packaged Products, provide a copy of Sharp’s response to such
authority. 
  

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 [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. 

 6.8 Inspections and Audits. Manufacturer and its representatives shall have access
at reasonable times and with reasonable frequency to Sharp’s Facilities for the purpose of conducting inspections of the Facility and performing quality control audits with respect to the processing or storage of the Packaged Products or
Packaging Materials, and Manufacturer shall have access at reasonable times and with reasonable frequency to the results of any tests relating to the Packaged Products performed by Sharp or at Sharp’s direction and the records and samples
required to be retained pursuant to Section 6.5 and 6.9. Sharp shall use its reasonable efforts to ensure that Manufacturer has similar access to the facilities, data and records of Sharp’s suppliers or agents. Such inspections, audits and
visits shall be conducted by Manufacturer or its representatives, provided that any representative is not a competitor of Sharp, upon reasonable notice and during normal business hours. 
 6.9 Retention of Samples and Records. Sharp shall retain, and upon request at reasonable times and with reasonable frequency, by
Manufacturer, provide to Manufacturer, (i) copies of the quality control records maintained in accordance with Section 6.5 and otherwise in relation to the Packaged Products, (ii) copies of testing results of all the tests performed
in relation to the Packaged Products, (iii) samples of the Packaging Materials and (iv) all other records and documents related to the Packaging Services, Packaging Materials, Product or Packaged Product or this Agreement required to be
retained under Applicable Laws. All such records will be maintained by Sharp for a minimum of [***] ([***]) [***] following the termination or expiration of this Agreement or such longer time period as may be required by Applicable Law or by
Section 6.5 of this Agreement. 
 6.10 Government Inspections, Seizures and Recalls. Sharp shall permit the
FDA and other Agencies to conduct inspections of the Facility as they may request, including pre-approval inspections, and shall cooperate with such Agencies with respect to the inspections and any related matters, in each case which is related to
the Products, Packaging, Packaged Products or this Agreement. Sharp hereby agrees to advise Manufacturer promptly (within [***] ([***]) [***]) of any proposed or unannounced inspection by any Agency of the Product(s), Packaged Products or
Packaging process or procedures and will, to the extent possible, permit a representative of Manufacturer to be present at such inspections and assist in the preparation thereof, including actions taken by Sharp to remedy conditions cited in the
inspections, and shall promptly provide a report of the results of the inspection issued by the inspectors to Manufacturer and a copy of the Sharp response to the inspection report, and all subsequent correspondences referring to the aforementioned
inspection(s) (including, but not limited to, FDA Form 483). If applicable, Sharp shall promptly send retained samples of Packaged Products seized by such Agency. Sharp shall keep Manufacturer informed about the results and conclusions of each
regulatory inspection, and if Sharp fails such inspection or is required to take actions to be in compliance with the inspector’s requirements, Sharp shall inform Manufacturer, in writing, of the steps Sharp is taking and/or response to the
inspector if Sharp disagrees with the inspector’s assessment. Similarly, Sharp agrees to promptly notify and provide Manufacturer copies of any request, directive or other communication of the FDA or other Agency relating to Products,
Packaging, Packaged Products or this Agreement, and to cooperate with Manufacturer in responding to such requests, directives and communications. 
  

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 [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. 

 6.11 Legal and Regulatory Filings and Requests. Sharp and Manufacturer shall
cooperate and be diligent in responding to all requests for information from, and in making all required filings with, regulatory authorities having jurisdiction to make such requests or require such filings. Sharp shall promptly provide
Manufacturer, as reasonably requested, with all available information in Sharp’s control necessary or useful for Manufacturer to apply for, obtain, and maintain regulatory approvals for the Product in any country, including without limitation
information relating to the facilities, or the process, methodology, raw materials and intermediates used in the manufacture, processing, or packaging of the Product and all information required to be submitted in the chemistry, manufacturing and
controls (CMC) section of an IND or a NDA or other regulatory filings, or required or requested to be provided to any Agency. Sharp shall obtain and comply with all licenses, consents, permits and regulations which may from time to time be required
by appropriate legal and regulatory authorities with respect the performance of its obligations hereunder. 
 6.12
Complaints. In connection with any Packaged Product complaints forwarded by Manufacturer to Sharp, Sharp shall conduct a commercially reasonable investigation of such complaint (including reviewing its records and testing the Packaged
Product), at no additional cost to Manufacturer. 
 7. Warranties; Limitation of Liability. 
 7.1 General Warranties. Sharp represents, covenants and warrants that (a) the Products shall be stored, handled, processed and
Packaged, and the Packaging shall be labeled at the Facility in accordance with, the Specifications, cGMPs and any other Applicable Laws; (b) the Packaged Products and Packaging furnished by Sharp to Manufacturer under this Agreement
(i) shall be of the quality specified in, and shall conform to, the Specifications and any Applicable Laws, (ii) shall be stored and supplied in conformity with the Specifications, cGMPs and any other Applicable Laws, (iii) shall not
contain any Packaging Materials provided by or on behalf of Sharp, which Packaging Material has not been used or stored in accordance with the Specifications, cGMPs and any other Applicable Laws; (c) it will not introduce any materials that
would cause the Packaged Products to be adulterated within the meaning of Section 501 of the Food, Drug and Cosmetic Act, as amended (the “Act”); (d) the Packaged Products shall not be misbranded within the meaning of the Act
(except with respect to any copy approved by Manufacturer, for which Manufacturer shall bear responsibility); (e) no materials supplied by Sharp shall be an article which may not, under the provisions of the Act or any other Applicable Law be
introduced into interstate commerce; and (f) neither it nor any of its representatives and employees have been debarred pursuant to the Act, or subject to a similar sanction from another Agency, nor have debarment proceedings against Sharp or
any of its employees been commenced, and Sharp will promptly notify Manufacturer in writing if any such proceedings have commenced or if Sharp or any of its employees are debarred by the FDA or other Agencies and (g) title to all Packaged
Product provided to Manufacturer under this Agreement shall pass as provided in this Agreement, free and clear of any security interest, lien, or other encumbrance. 
  

 14 

 7.2 Intellectual Property Warranties. Sharp represents and warrants to
Manufacturer that: (i) Sharp has all necessary authority and right, title and interest, including through patents and licenses, to use all processes, techniques, know-how and other methods used to perform the Packaging services; and
(ii) except to the extent solely due to the Specifications, Product, Packaging and Packaged Product, Sharp’s performance of its obligations under this Agreement will not violate or infringe upon any trademark, tradename, copyright, patent
or other rights held by any person or entity. 
 7.3 Disclaimer; Limitation of Liability. OTHER THAN THE WARRANTIES
EXPRESSLY STATED IN THIS AGREEMENT, (A) NEITHER PARTY MAKES ANY OTHER WARRANTIES, EITHER ORAL OR WRITTEN, EXPRESS OR IMPLIED, AND BOTH PARTIES HEREBY DISCLAIM LIABILITY FOR ANY IMPLIED WARRANTY, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY
AND ANY IMPLIED WARRANTY OF FITNESS FOR A PARTICULAR PURPOSE WITH RESPECT TO PACKAGING, PACKAGED PRODUCTS OR THE PRODUCTS, AND (B) EXCEPT TO THE EXTENT SUCH PARTY MAY BE REQUIRED TO INDEMNIFY THE OTHER PURSUANT TO SECTION 9 OR IN THE CASE OF
WILLFUL MISCONDUCT, IN NO EVENT SHALL EITHER PARTY HAVE ANY LIABILITY TO THE OTHER FOR ANY EXEMPLARY, PUNITIVE, INCIDENTAL, INDIRECT, SPECIAL OR CONSEQUENTIAL DAMAGES, WHETHER BASED ON CONTRACT, TORT, STRICT LIABILITY OR ANY OTHER THEORY OR FORM OF
ACTION, EVEN IF AN AUTHORIZED REPRESENTATIVE OF SUCH PARTY IS ADVISED OF THE POSSIBILITY OR LIKELIHOOD OF SAME AND (C) EXCEPT WITH RESPECT TO SHARP’S OBLIGATIONS UNDER SECTION 9, THE OBLIGATIONS OF SHARP SET FORTH IN SECTION 5.5 TO REPLACE
NONCONFORMING PACKAGED PRODUCTS AND IN SECTION 6.6 WITH RESPECT TO RECALLS SHALL BE, AS APPLICABLE, MANUFACTURER’S EXCLUSIVE REMEDY FOR NONCONFORMING PACKAGED PRODUCTS. 
 8. Intellectual Property Rights. 
 8.1 Intellectual Property Rights of Manufacturer; Grant of License. Except as specifically set forth in Section 8.3, all right, title and interest in and to any trademarks, trade names, slogans, logos,
copyrights, trade dress, know-how and goodwill associated with the Products and the Packaged Products (“Brand Image”) and all rights to any improvements or modifications to the Brand Image (including any developed or suggested by
Sharp) are and shall remain owned solely by Manufacturer. Manufacturer hereby grants to Sharp a non-exclusive, royalty-free license solely to use the Brand Image as may be necessary for Sharp’s fulfillment of its obligations under this
Agreement during the Term. Except as set forth in the immediately preceding sentence, Sharp shall have no other rights to use the Brand Image. 
  

 15 

 8.2 Ownership of Product/Packaged Product. All Packaged Product paid for by
Manufacturer in accordance with Section 5.3, shall be the sole property of Manufacturer and all rights and title in and to the Packaged Product, excluding any patents, trademarks, know-how and any other intellectual property rights of Sharp,
shall vest in and to Manufacturer at such time, and Manufacturer shall own all containers that the Product is packaged in, including any verbiage or markings on such containers, regardless of whether such verbiage or markings are trademarks or
trade-designs. If the Packaged Products include any patents, trademarks, know-how or any other intellectual property rights of Sharp, Sharp hereby grants to Manufacturer a perpetual, irrevocable, fully paid-up, royalty free non-exclusive license,
with the right to grant and authorize sublicenses, to use such rights in connection with the sale and distribution of the Packaged Products. 
 8.3 Ownership of Other Property. All right, title and interest in and to (i) the Tooling (subject to the usage limitations set forth in Section 3.2), (ii) any and all dies, molds, printing plates
and other equipment or supplies, and any and all methods or processes, in each case, used by Sharp in connection with processing and Packaging of the Products, and (iii) any and all modifications or improvements to any of the foregoing
(including any developed or suggested by Manufacturer), are and shall remain owned solely by Sharp. Nothing in this Agreement, except as provided in Section 8.2, shall be construed to grant to Manufacturer any right to any trademark, trade
name, copyright, patent or other proprietary technology or know- how owned by Sharp. 
 9. Indemnification. 
 9.1 Sharp’s Indemnification of Manufacturer. Sharp shall defend, indemnify and hold Manufacturer and its Affiliates and the
officers, directors, employees, consultants and agents thereof (each, a “Manufacturer Indemnified Party”) harmless from and against any and all losses, liabilities, damages, claims for damages, suits, recoveries, judgments or
executions (including reasonable attorneys’ fees and expenses) (collectively, “Damages”) that may be incurred by any Manufacturer Indemnified Party arising out of or on account of any claim, complaint, suit, proceed or cause of
action brought against any of them by a third party (each, a “Claim”) resulting from: (i) any negligent, reckless or intentionally wrongful act or omission to act on the part of Sharp or its officers, directors, employees, consultants
or agents, (ii) any violation of Applicable Laws or breach by Sharp of any of its covenants, agreements, representations and/or warranties set forth herein, or (iii) actual or alleged infringement of the Packaging or Packaged Product on
the proprietary or intellectual property rights of another person or entity (except to the extent the infringement is solely due to the Manufacturer Information). 
 9.2 Manufacturer’s Indemnification of Sharp. Manufacturer shall defend, indemnify and hold Sharp and its Affiliates and the
officers, directors, employees, consultants and agents thereof (each, a “Sharp Indemnified Party”) harmless from and against any and all Damages that may be incurred by any Sharp Indemnified Party arising out of or on account of any
Claim resulting from (i) the possession, sale, use or consumption of any Products or Packaged Products (in each case other than to the extent such Claim is due to Sharp’s negligent performance of the services under this Agreement or breach
of this Agreement) or any other product of Manufacturer (other than to the extent such Claim is due to Sharp’s negligent performance of services), (ii) any violation of 

  

 16 

 
Applicable Laws or breach by Manufacturer of any of its covenants, agreements, representations and/or warranties set forth herein, (iii) any negligent,
reckless or intentionally wrongful act or omission to act on the part of Manufacturer or its officers, directors, employees consultants or agents or (iv) any actual or alleged infringement of the Brand Image, the Product or the Packaged Product
on the proprietary or intellectual property rights of another person or entity to the extent the infringement is due to the Manufacturer Information. 
 9.3 Procedure for Indemnification. Each Indemnified Party shall promptly notify in writing the Indemnifying Party of the assertion of any Claim with respect to which the indemnification set forth in this
Section may relate (which shall also constitute the notice required by Section 9.3); provided, however, that the failure to give notice shall not limit or otherwise reduce the indemnity provided for in this Agreement except to the extent that
failure to give notice materially prejudices the rights of the Indemnifying Party. The Indemnifying Party shall have the right, upon notice to the Indemnified Party within ten (10) business days after the receipt of any such notice, to
undertake the defense of or, with the consent of the Indemnified Party (which consent shall not be unreasonably withheld), to settle or compromise such Claim. The failure of the Indemnifying Party to undertake the defense of or to settle or
compromise such a Claim shall constitute a waiver of the Indemnifying Party’s rights under this Section 9.4 and shall preclude the Indemnifying Party from disputing the manner in which the Indemnified Party may conduct the defense of such
Claim; provided, that the Indemnified Party shall not settle or compromise such Claim without the prior written approval of the Indemnifying Party (which approval shall not be unreasonably withheld). The election by the Indemnifying Party, pursuant
to this Section 9.4 to undertake the defense of a Claim shall not preclude the Indemnified Party from participating or continuing to participate in such defense, so long as such party bears its own legal fees and expenses for so doing;
provided, however, the Indemnified Party shall not take any actions that would materially affect the defense and settlement of such Claim without the prior written consent of the Indemnifying Party, such consent not to be unreasonably withheld. The
Indemnified Parties and its employees, at the Indemnifying Party’s request and expense, shall provide reasonably full information and reasonable assistance to the Indemnifying Party and its legal representatives with respect to Claims for which
indemnification is sought hereunder. 
 9.4 Survival. The indemnification obligations set forth in this Section 9
shall survive the expiration or termination of this Agreement. 
 10. Insurance. 
 10.1 Coverage. Sharp shall acquire and maintain at its sole cost and expense: (i) Statutory Worker’s Compensation
Insurance and Employer’s Liability Insurance; (ii) all risk coverage for physical loss or damage to materials including Products and Packaged Products while at the Facilities or under its control; and (iii) Products Liability, Bodily
Injury and Property Damage Insurance (with a Broad Form Vendor’s Endorsement naming Manufacturer, its subsidiaries and affiliated companies and the officers, directors, employees and agents thereof, as well as its authorized distributors and
customers as additional insureds) with limits of not less than [***] per occurrence and [***] in the aggregate. Sharp agrees to designate Manufacturer as an “additional insured” vendor under such policy. Sharp shall use reasonable efforts
to cause its subcontractors to provide the aforementioned coverages. 
  

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 [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. 

 10.2 Certificates of Insurance, Maintenance of Coverage. Promptly after the
Effective Date, Sharp shall submit certificates of such insurance to Manufacturer (which shall include an agreement by the insurer not to cancel such coverage except upon [***] prior written notice to Manufacturer). Sharp shall maintain such
insurance coverage in effect for Manufacturer’s benefit throughout the Term. Sharp shall also carry and maintain in effect at all times relevant hereto all other insurance required by statute or law. 
 11. Term; Termination. 
 11.1 Initial Term; Term. The initial term of this Agreement shall commence
on the Effective Date and shall expire on the close of business on the Fifth (5th) anniversary of date on which the Product receives FDA
approval of a New Drug Application (the “Initial Term”). This Agreement may be extended for additional three (3) year periods (such additional periods are each a “Subsequent Term,” and collectively with the
Initial Term, the “Term”) by a mutual written agreement reached by the parties not later than one hundred eighty (180) days prior to the end of the Initial Term or any Subsequent Term. 
 11.2 Termination. Notwithstanding Section 11.1, this Agreement may be terminated upon the occurrence of any of the following:

 (a) The parties may terminate this Agreement by mutual written consent at any time; 
 (b) Either party may terminate this Agreement by giving [***] ([***]) days written notice to the other party in the event the other
party has breached any representation, warranty or obligation contained in this Agreement and/or has defaulted in the performance of any of its duties or obligations hereunder in any material respect and such breach or default has not been remedied
within [***] ([***]) days after written notice of the breach or default has been received; Notwithstanding the foregoing, if during such [***] ([***]) day period, the allegedly breaching party disputes that it has materially breached this
Agreement, then the other party shall not have the right to terminate this Agreement until it has been finally determined in accordance with Section 13.6 below that the allegedly breaching party has materially breached this Agreement, and such
party fails to comply herewith within [***] ([***]) days thereafter; provided, however, that the parties hereby agree that failure to make payments (other than those payments that are being disputed in good faith) pursuant to this Agreement
shall constitute a material breach. 
 (c) Either party may terminate this Agreement if a voluntary petition in bankruptcy
should be filed by the other party under the United States Bankruptcy Code, if an involuntary petition under the United States Bankruptcy Code should be filed against the other party, or if a receiver should be appointed for the other party or its
property or if the other party makes an assignment for the benefit of creditors. 
  

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 [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. 

 (d) Either party may terminate this Agreement pursuant to Section 13.2. 

11.3 Effect of Expiration or Termination. 
 (a) The expiration or termination of this Agreement shall not release either party from any of its obligations accrued prior to the
effective date of termination and shall not affect the status of any Firm Orders outstanding as of the effective date of such termination or expiration, and each party shall remain responsible for the performance of its respective obligations and
agreements which are expressly stated to be obligations which survive the termination of this Agreement. Furthermore, the rights to terminate provided for hereinabove are in addition to any other light, remedy, or election either party may have
hereunder or at law or in equity. 
 (b) Within [***] ([***]) days of the effective date of the expiration or termination
of this Agreement for any reason other than a termination by Manufacturer pursuant to Section 11.2 (b) (due to Sharp’s breach), Manufacturer shall purchase at Sharp’s cost any Packaging Materials that (i) Sharp has purchased
exclusively for Manufacturer in accordance with this Agreement for the Packaging of Packaged Products, (ii) cannot be used for another Sharp customer, and (iii) cannot be returned to the supplier for reimbursement. Manufacturer shall not
be obligated to purchase any quantities of Packaging Materials under this Section 11.3(b) in excess of the supply amounts required under Section 4.1. 
 (c) Upon the effective date of expiration or termination of this Agreement for any reason whatsoever, Sharp shall immediately deliver to
Manufacturer or its Designee, in accordance with Manufacturer’s instructions, all Products, and all text, graphics and other artwork, Packaging Materials and any other materials purchased or provided by Manufacturer. Sharp shall also deliver to
Manufacturer or its Designee all Packaged Products ordered by Manufacturer pursuant to Section 4.2 hereunder, and shall invoice Manufacturer therefor in accordance with the terms of Section 5.3. 
 (d) Upon any termination or expiration of this Agreement: (a) Confidential Information exchanged between Manufacturer and Sharp, and
all copies thereof, shall be promptly returned or destroyed by the receiving party to the disclosing party; provided that each party may keep a copy of the other’s Information for archival purposes; and (b) the license granted to Sharp by
Manufacturer in Section 8.1 shall terminate. 
 11.4 Continuing Obligations. Termination or expiration of this
Agreement shall not relieve a party from any liability that, at the time of such termination or expiration, has already accrued to the other party. The rights and obligations of each of the parties under the provisions of Sections 1, 5.2-5.5, 6, 7,
8.2, 9, 11.3,12 and 13 of this Agreement shall continue notwithstanding the termination of this Agreement for any reason. 
  

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 [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. 

 12. Confidentiality. 
 12.1 Confidentiality. Sharp and Manufacturer agree to keep secret and confidential any and all Confidential Information disclosed
by the other party hereunder or through any prior disclosure and not to disclose such Confidential Information to any person or entity, except (i) to the employees of such party having a need to know the information in order to fulfill such
party’s obligations hereunder; or (ii) as required by an Agency. Each party shall use the Confidential Information of the other solely for the purpose of carrying out the obligations contained in the Agreement. Notwithstanding the
foregoing and anything herein to the contrary, Manufacturer may disclose Sharp Confidential Information to the extent reasonably necessary for it to exercise its rights under this Agreement to develop and commercialize Finished Product, including
disclosing Sharp Confidential Information to those of its contractors and consultants (but in no event to any other pharmaceutical industry contract packager) that have a need to know; provided that such contractor or consultant has entered into a
confidentiality agreement with Manufacturer which contains the restrictions on use and disclosure of Sharp Confidential Information at least as protective as those set forth in this Section 12.1. The obligations imposed by this Article 12 shall
not apply to any Confidential Information: 
 (i) which at the time of disclosure to the receiving party is in the public
domain; 
 (ii) which, after disclosure, becomes part of the public domain by publication or otherwise, through no fault of
the receiving party; 
 (iii) which at the time of disclosure is already in the receiving party’s possession, except
through prior disclosure by the disclosing party or its Affiliates, and such possession can be properly documented by the receiving party in its written records, and was not made available to the receiving party by any person or party owing an
obligation of confidentiality to the disclosing party (with respect to such Confidential Information); 
 (iv) which is
rightfully made available to the receiving party from sources independent of the disclosing party; 
 (v) notwithstanding
anything herein to the contrary, the receiving party shall be allowed to disclose the Confidential Information of the disclosing party to the extent such Confidential Information is required to be disclosed in the course of litigation or other legal
or administrative proceedings; provided that in all such cases the party receiving the Confidential Information shall, to the extent permitted, give the other party prompt notice of the pending disclosure and shall reasonably cooperate in such other
party’s attempts, at such other party’s sole expense, to seek an order maintaining the confidentiality of the Confidential Information; or 
 (vi) which is required to be disclosed by applicable laws; provided that in all such cases the party receiving the Confidential Information shall, to the extent permitted, give the other party prompt notice of the
pending disclosure and shall reasonably cooperate in such other party’s attempts, at such other party’s sole expense, to seek an order maintaining the confidentiality of the Confidential Information. 
 12.2 Term. The obligation of confidentiality and nonuse set forth in this Article 12 shall survive for a period of [***]
([***]) [***] beyond the termination or expiration of this Agreement. 
  

 20 
  

  
 [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. 

 12.3 Ownership of Confidential Information. Confidential Information shall remain
the exclusive property of the disclosing party. In no event shall any of either party’s Confidential Information, technology, know-how, intellectual property (or rights thereto) become the property of the other party. 
 12.4 Confidential Terms. Each party shall treat the terms of this Agreement as the Confidential Information of the other party.
Notwithstanding anything to the contrary, however, each party may disclose the terms of this Agreement (a) to advisors, actual or potential investors, acquisition partners, sublicensees, and others on a need to know basis under circumstances
that reasonably ensure the confidentiality thereof, or (b) as required by securities or other applicable laws or regulations, such as SEC regulations; provided that the disclosing party shall limit such disclosure by redacting information not
required to be disclosed and shall remain responsible for any disclosure by said third party, and that no disclosure will be made in any event to any parties that are known by the disclosing party to be competitors of the non-disclosing party.

 13. Miscellaneous. 
 13.1 Authority to Enter Into Agreement. Each party represents and warrants (i) that it has the corporate power and authority to enter into this Agreement and perform its obligations hereunder to enter into
this Agreement, and that in so doing it has not materially violated the terms and conditions of any contract or other agreement to which it may be a party, and (ii) this Agreement has been duly executed and delivered on behalf of such party and
constitutes a legal, valid and binding obligation, enforceable against such party in accordance with its terms. 
 13.2
Force Majeure. Performance under this Agreement shall be excused to the extent prevented or delayed, in whole or part, by any event or circumstance, which is beyond the reasonable control of the party whose performance is to be excused
hereunder and was not reasonably foreseeable as of the Effective Date, including but not limited to fire, flood, explosion, unavoidable breakdown of machinery, widespread product tampering by third parties, governmental acts or regulations, war,
labor difficulties, shortages or unavailability of materials, or any act of God. The party affected shall promptly notify in writing the non-affected party of the event of force majeure, the probable duration of the delay and the termination of such
event. During the period that the performance by one of the parties of its obligations under this Agreement has been suspended by reason of an event of force majeure, the other party may likewise suspend the performance of all or part of its
obligations hereunder to the extent that such suspension is commercially reasonable, except that Manufacturer may not suspend its obligation to make payment pursuant to Section 5.3 for Packaged Products previously delivered by Sharp. Any delay
caused by an event of force majeure shall toll the Term, which shall be extended by the length thereof. In the event a force majeure prevents performance by one party for more than six (6) months, the other party shall have the right to
terminate this Agreement subject to Section 11.3. 
 13.3 Public Announcements. The parties agree to determine
jointly the contents of any public announcement informing the public about the existence of this Agreement between the parties and, except as may be required by law or the rules of any national securities exchange, neither party shall issue or cause
the issuance of any such public announcement relating to this Agreement without the express prior approval of an executive officer of the other party. 
  

 21 

 13.4 Amendments. Except to the extent otherwise provided in Section 5.1 of
this Agreement with respect to amendments to Exhibit B, this Agreement may not be modified, amended or altered except pursuant to a written instrument signed by both parties. 
 13.5 Governing Law. This Agreement is made subject to the laws of the State of Delaware, without reference to principles of
conflicts of laws, and excluding the 1980 U.N. Convention on Contracts for the International Sale of Goods. Each party agrees that suit may be instituted at any federal court in the Eastern District of Pennsylvania or in state court in Leheigh
County in the Commonwealth of Pennsylvania and each waives any objection which such party may now or hereafter have to the laying of the venue of any such action, suit or proceeding, and irrevocably submits to the jurisdiction of any such court. Any
and all service of process and any other notice in any such action, suit or proceeding shall be effective against a party if given as provided in Section. 
 13.5 Assignment. Neither party may, without the prior written consent of the other party, delegate, transfer, convey, assign or pledge any of its rights or obligations under this Agreement to any other person,
firm or corporation; provided however, that such consent shall not be unreasonably withheld. Notwithstanding the foregoing, neither party need obtain any consent in the event such party assigns this Agreement (i) to an Affiliate and
(ii) to an entity that succeeds to all or substantially all of such party’s business or assets; provided, in each of cases (i) and (ii) such assignee assumes in writing the assignor’s obligation under this Agreement and
agrees to be bound by the terms and conditions hereof. 
 13.6 Notice. Any and all notices permitted or required to be
given hereunder will be deemed duly given: (a) upon actual delivery, if delivery is by hand; (b) three (3) business days after delivery into the official mail, if delivery is by postage paid registered or certified return receipt
request mail; (c) one business day after delivery to an overnight carrier, if delivery is made by overnight carrier guaranteeing next business day delivery; or (d) upon receipt of evidence of successful transmission, if delivery is by
facsimile. Each such notice shall be sent to the respective party at the address of facsimile number indicated below or at any other address as the respective party may designate by notice delivered pursuant hereto. 
 If to Manufacturer: 
 Transcept Pharmaceuticals, Inc. 
 1003 W. Cutting Blvd., Suite 110 
 Pt. Richmond, CA 94804 
 Attention: Dennie Dyer, V.P. of Operations- 
 Tel: 510-215-3500 
 Fax: 510-215-3535 
 Email: ddyer@transcept.com 
  

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 If to Sharp: 
 Sharp Corporation 
 7451 Keebler Way 
 Allentown, Pennsylvania 18106 
 Attention: CFO 
 Telecopier Number: (610) 481-0362 
 13.7 Subcontractors. Sharp shall not subcontract any of the services
to be performed by Sharp or any of its other obligations hereunder to another entity without Manufacturer’s prior written approval. In any case, Sharp shall remain completely responsible for all such services and obligations that are
subcontracted. All subcontractors hereunder shall be bound by the terms and conditions herein, with respect to the subcontracted services and obligations, as if named together with Sharp. 
 13.8 Entire Agreement. This Agreement, including all Exhibits attached hereto (including the Quality Agreement), contains the
entire understanding of the parties, superseding in all respects any and all prior oral or written agreements or understandings pertaining to the subject matter hereof. Notwithstanding the foregoing, to the extent the terms and conditions of the
body of this Agreement conflict with the terms and conditions of any Exhibit hereto (including without limitation, the Quality Agreement), the terms and conditions of the body of this Agreement shall govern. No addition to or amendment, modification
or waiver of any provision shall be binding unless in writing and signed by a duly authorized representative of each party hereto. 
 13.9 Severability. If and to the extent that any court of competent jurisdiction holds any provision or part of this Agreement to be invalid or unenforceable, such holding shall in no way affect the validity of the remainder of this
Agreement. 
 13.10 Waiver. A waiver by either party of any of the terms and conditions of this Agreement in any
instance shall not be deemed or construed to be a waiver of such term or condition for the future. 
 13.11 Headings.
Headings in this Agreement are included for ease of reference only and have no legal effect. 
 13.12 Counterparts.
This Agreement may be executed in two or more counterparts, each of which shall be deemed an original and all of which together shall constitute one and the same instrument. Any facsimile signature of either party shall constitute a legal, valid and
binding execution hereof by such party. 
  

 23 

 IN WITNESS WHEREOF, the parties have caused this Agreement to be duly executed in their respective names
and on their behalf, as of the date first above written. 
  

			
	TRANSCEPT PHARMACEUTICALS, INC.
		
	By:	 	Illegible
	Title:	 	CEO
	Date:	 	June 26, 2008
		
		 	/s/ Thomas Soloway
		 	Thomas Soloway, CFO
	
	SHARP CORPORATION
		
	By:	 	 
	Title:	 	 
	Date:	 	 

  

 24 

 Execution Copy 
 EXHIBIT A 
 PRODUCTS 

 Execution Copy  
 EXHIBIT B 
 PRICES 
 All purchases shall be made F.O.B. Sharp’s dock. Subject to the adjustments described in Section 5.1, and as offered on the attached
quotations, the Prices are as follows: 
  

					
	 Product
	  	Sharp Design	  	Price Per 1000
		  		  	
		  		  	
		  		  	

 Overtime Charged 

 Execution Copy 
 EXHIBIT C 
 SPECIFICATIONS 

 Execution Copy 
 EXHIBIT D 
 START-UP ACTIVITIES 
 As used in the Agreement, “Start-Up Activities” shall mean those activities required by the Manufacturer and/or Sharp that are necessary to
commence packaging of Products. The Start-Up Activities shall be completed in accordance with the following time schedule and are estimated to be completed at the following costs: 
  

					
	 Activity
	  	 Time Schedule
	  	 Estimated Costs

			
	 1)      Development of Package Design
	  		  	
			
	 2)      Development/Manufacturing of Tooling
	  		  	
			
	 3)      Equipment Modifications
	  		  	
			
	 4)      Packaging Room Modifications
	  		  	
			
	 5)      Packaging Trials
	  		  	
			
	 6)      Validation Protocols
	  		  	
			
	 7)      Validation Run
	  		  	
		
	 8)      Validation Report
	  	[2 Weeks after Validation Run]

 EXHIBIT E 
 TOOLING 
  

			
	 Tooling Description
	  	 Estimated Costs

		  	
		  	
		  	

 EXHIBIT F 
 QUALITY AGREEMENT 
 [To be attached] 

 Contract Packaging 
 Quality Agreement 
 by and between 
  

			
	Supplier Name:	  	Sharp Corporation
	Address:	  	 7451 Keebler Way
 Allentown, PA 18106

 (“Supplier”) 
 and 
  

			
	Sponsor Name:	  	Transcept Pharmaceuticals, Inc.
	Address:	  	1003 West Cutting Blvd., Suite 110, Pt. Richmond, CA 94804

 (“Transcept”) 
 WHEREAS, Transcept and Supplier have entered into that certain Packaging and Supply Agreement (the “Supply Agreement”) setting forth the terms and conditions of Supplier’s packaging of Product and
supply of Packaged Product for Transcept; and 
 WHEREAS, Supplier and Transcept wish to define the individual responsibilities of the parties as to the
quality aspects of packaging of Product and release of Product Packaged Product not already defined in the Supply Agreement to ensure compliance with the approved Product application and/or Transcept requirements. 
 WHEREAS, in order to define such individual responsibilities, this Contract Packaging Quality Agreement (“Quality Agreement”) takes the form, in part, of a
detailed listing of activities associated with pharmaceutical packaging, analysis, and release of Product. Unless otherwise indicated, Responsibility for each activity is assigned to either Transcept, Supplier, or is assigned to both Supplier and
Transcept 
 NOW THEREFORE, in consideration of the parties’ agreement to perform the activities provided in this Quality Agreement and for other
valuable consideration the receipt and sufficiency of which is hereby acknowledged, and intending to be legally bound, Supplier and Transcept agree as provided in this Quality Agreement below, and have caused this Agreement to be duly executed in
their respective names and on their behalf, as of the Effective Date. 
  

					
	Transcept Pharmaceuticals	 		 	Sharp Corporation
			
	  	 		 	  
	Signature	 		 	Signature
			
	/s/ Grace Scheibner, 09 June, 2008	 		 	/s/ Marc Feinberg, 18 June, 2008
	Name Grace Scheibner	 		 	Name Marc Feinberg
			
	  	 		 	  
	Title Associate Director, Quality Systems	 		 	Title Vice President Quality Assurance

					
	Transcept Pharmaceuticals	 		 	Sharp Corporation
			
	  	 		 	  
	Signature	 		 	Signature
			
	/s/ Sharon Sakai	 		 	MF 6/12/08
	Name Sharon Sakai, Ph. D.	 		 	Name
			
	  	 		 	  
	 Title Senior Director, Regulatory Affairs
	 		 	Title

 Contents 
  

	1.	Effective Date 

  

	2.	Scope; Entire Agreement; Definitions 

  

	3.	Amendments to Quality Agreement 

  

	4.	Term of Quality Agreement 

  

	5.	Non-Disclosure and Non-Use 

  

	6.	Use of Third Parties 

  

	7.	Survival Clause 

  

	8.	Assignment 

  

	9.	Resolution of Quality Issues 

  

	10.	Debarment 

  

	11.	Choice of Law; Venue; Miscellaneous 

  

	12.	Security Policies 

  

	13.	Quality Responsibilities Table 

  

	 	A.	Compliance Requirements 

  

	 	B.	Right to Audit 

  

	 	C.	Regulatory Inspections and Exchanges 

  

	 	D.	Regulatory Documentation 

  

	 	E.	Animal Derived Materials 

  

	 	F.	Buildings and Facilities 

  

	 	G.	Personnel and Training 

  

	 	H.	Sub-Contracting and Testing 

  

	 	I.	Change Control 

  

	 	J.	Validation/Qualification 

  

	 	K.	Preventative Maintenance and Calibration 

  

	 	L.	Investigations 

  

	 	M.	Documentation and Records 

  

	 	N.	Annual Product Reviews 

  

	 	O.	Annual Product Report (if applicable) 

  

	 	P.	Production and In-Process Controls, Packaging and Labeling 

  

	 	Q.	Process Equipment 

  

	 	R.	Reprocess 

  

	 	S.	Rework 

  

	 	T.	Laboratory Controls 

  

	 	U.	Retest 

  

	 	V.	Stability (if applicable to service being provided) 

  

	 	W.	Storage and Distribution 

	X.	Control, Disposal and Destruction of Production Materials 

  

	Y.	Complaints 

  

	Z.	Field Alerts, Biological Product Deviation Reports and Recalls 

 Appendices: 
 Appendix 1: (Contacts and Responsibilities) 
 Appendix 2: (Contacts for Notices) 
 Appendix 3: (Product Security-Supplier Requirements) 

	1.	Effective Date 

 The Effective Date of this Quality Agreement shall
be June 9, 2008 (the “Effective Date”). 
  

	2.	Scope; Entire Agreement; Definitions 

 This Quality Agreement, which
includes the Appendices attached hereto, outlines the responsibilities of Supplier and Transcept with respect to the quality assurance of the Product packaged by Supplier for Transcept, to the extent such responsibilities are not already provided
for in the Supply Agreement. 
 This Quality Agreement is in addition to the Supply Agreement, and together such agreements represent the entire
understanding of the parties with respect to the subject matter thereof and supersede all other prior understandings between the parties with respect to such subject matter, whether written or oral. If there are any direct conflicts between the
terms of this Quality Agreement and the Supply Agreement, the provisions in the Supply Agreement shall govern and control. 
 All capitalized terms that are
undefined herein shall have the meanings ascribed to them in the Supply Agreement. 
  

	3.	Amendments to Quality Agreement 

 This Quality Agreement may be
amended by the written consent of both parties. 
 The parties agree to amend terms of this Quality Agreement that must be amended in order that the Product
continue to meet Applicable Laws, as may exist from time to time. 
 If an amendment to this Quality Agreement is proposed, the proposing party will
circulate the proposed amendment to the appropriate contact person at Supplier and Transcept for review and internal approval. The appropriate contact person at Supplier and Transcept is listed in Appendix 1 (each, a “Responsible
Person”). 
  

	4.	Term of Quality Agreement 

 This Quality Agreement shall commence on
the Effective Date and shall remain in effect for the longer of (i) as long as the Supplier supplies Product to Transcept, and (ii) the term of the Supply Agreement, in each case unless the Quality Agreement is terminated earlier in
accordance with the terms of this Quality Agreement. 
 Transcept may terminate this Quality Agreement upon thirty (30) days written notice to Supplier.

  

	5.	Non-Disclosure and Non-Use 

 It is understood that the parties
obligations under Article 12 of the Supply Agreement shall apply with respect to the information and/or materials exchanged between the parties under this Quality Agreement. 

	6.	Use of Third-Parties 

 Supplier shall not use in any capacity the
services of any third-party to package, label, inspect, test, release, handle and/or process Product for Transcept unless Transcept provides its prior written consent. A condition of such written consent is that Supplier shall have entered into a
written quality agreement defining the respective quality responsibilities of Supplier and the third-party and shall provide for confidentiality and non-disclosure of all Transcept confidential information under obligations of confidentiality
similar to and requiring at least the same degree (or greater) of protection for Transcept confidential information as the obligations of confidentiality and nondisclosure between Supplier and Transcept under the Supply Agreement. 
  

	7.	Survival Clause 

 All regulatory obligations contained herein that
are required of either party or both parties by an applicable regulatory authority shall survive termination of this Quality Agreement. 
  

	8.	Assignment 

 Supplier shall not assign any or all of its rights or
obligations under this Quality Agreement without Transcept’s prior written consent. Transcept shall have the right to assign any or all of its rights or obligations under this Quality Agreement without the consent of Supplier. In the event of
an assignment, the assigning party shall continue to be bound by all pre-existing obligations under this Quality Agreement including all obligations of confidentiality and non-disclosure. 
  

	9.	Resolution of Quality Issues 

 Quality related disagreements between
Supplier and Transcept that are not resolved in the normal course of business between Transcept and Supplier shall be brought to the attention of the Responsible Person for each party. If both parties agree that a resolution of the disagreement is
reasonably possible, then both Supplier and Transcept agree to work jointly to develop a strategy for such resolution. Supplier and Transcept further agree to record such resolution in writing. 
  

	10.	Debarment 

 Supplier warrants and represents that it is not debarred
under the Generic Drug Enforcement Act of 1992, 21 U.S.C. 335[a] (the “Generic Drug Enforcement Act”), and that it has not been convicted of a crime for which it could be debarred under the Generic Drug Enforcement Act. In connection with
the Product, the Supplier further warrants and represents, in that it shall not use in any capacity the services of any person debarred under the Generic Drug Enforcement Act, or convicted of a crime for which a person can be debarred under the
Generic Drug Enforcement Act. 

	11.	Choice of Law; Venue; Miscellaneous 

  

	 	a.	This Quality Agreement shall be construed and the relationship between the parties determined in accordance with the laws of the State of Delaware, without regard to the conflicts
of law principles thereof, and excluding the 1980 U.N. Convention on Contracts for the International State of Goods. This Quality Agreement is made subject to the laws of the State of Delaware, without reference to principles of conflicts of laws,
and excluding the 1980 U.N. Convention on Contracts for the International Sale of Goods. Each party agrees that suit may be instituted at any federal court in the Eastern District of Pennsylvania or in state court in Leheigh County in the
Commonwealth of Pennsylvania and each waives any objection which such party may now or hereafter have to the laying of the venue of any such action, suit or proceeding, and irrevocably submits to the jurisdiction of any such court. Any and all
service of process and any other notice in any such action, suit or proceeding shall be effective against a party if given as provided in Section 13.6 of the Supply Agreement. 

  

	 	b.	All appendices to this Quality Agreement are attached hereto and incorporated herein by reference. In this Quality Agreement, unless the contrary intention appears: (a) the
words “including” and “include” mean “including, but not limited to”; (b) the singular includes the plural and vice versa; (c) a reference to a person or entity (including Supplier or Transcept) includes a
reference to the person’s executors, administrators, successors, substitutes and assigns; and (f) headings are for reference only and do not form part of this contract. 

  

	12.	Security Policy 

 Supplier agrees to comply with the Security Policy
attached hereto as Appendix 3. 

	13.	Quality Responsibilities Table 

 Table Key: N = Not Applicable

  

									
	 §
	  	 Responsibilities
	  	N	  	Transcept	  	Sharp
					
		  	 [***]
	  		  		  	

  

  
 [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. 

									
	 §
	  	 Responsibilities
	  	N	  	Transcept	  	Sharp
					
		  	 [***]
	  		  		  	

  

  
 [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. 

									
	 §
	  	 Responsibilities
	  	N	  	Transcept	  	Sharp
					
		  	 [***]
	  		  		  	

  

  
 [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. 

									
	 §
	  	 Responsibilities
	  	N	  	Transcept	  	Sharp
					
		  	 [***]
	  		  		  	

  

  
 [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. 

									
	 §
	  	 Responsibilities
	  	N	  	Transcept	  	Sharp
					
		  	 [***]
	  		  		  	

  

  
 [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. 

									
	 §
	  	 Responsibilities
	  	N	  	Transcept	  	Sharp
					
		  	 [***]
	  		  		  	

  

  
 [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. 

									
	 §
	  	 Responsibilities
	  	N	  	Transcept	  	Sharp
					
		  	 [***]
	  		  		  	

  

  
 [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. 

									
	 §
	  	 Responsibilities
	  	N	  	Transcept	  	Sharp
					
		  	 [***]
	  		  		  	

  

  
 [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. 

									
	 §
	  	 Responsibilities
	  	N	  	Transcept	  	Sharp
					
		  	 [***]
	  		  		  	

  

  
 [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. 

 APPENDIX 1: (Contacts and Responsibilities) 
  

					
	 Sharp
	  	 Transcept

			
	 	  	 Quality Assurance
	  	 Quality Assurance

	Name	  	Andrew Harakai	  	Grace Scheibner
	Title	  	Director of Quality Assurance	  	Associate Director, Quality Systems
	Phone/Fax	  	610-366-8751/610-397-2145	  	510-215-3571/510-215-3535
	Address
(mail/delivery)	  	7451 Keebler Way
Allentown, PA 18106	  	1003 West Cutting Blvd.
Suite 110 Pt.
Richmond, CA 94804
	Electronic	  	andrew.harakal@sharpcorporation.com	  	gscheibner@transcept.com
			
	 	  	 VALIDATION
	  	 VALIDATION

	Name	  	Frank Davidowski	  	Grace Scheibner
	Title	  	Director of Validation	  	Associate Director, Quality Systems
	Phone/Fax	  	610-366-8897/610-397-2152	  	510-215-3571/510-215-3535
	Address
(mail/delivery)	  	7451 Keebler Way
Allentown, PA 18106	  	1003 West Cutting Blvd,
Suite 110
Pt. Richmond, CA 94804
	Electronic	  	Frank.davidowski@sharpcorporation.com	  	gscheibner@transcept.com
			
	 	  	 Account Manager
	  	 Commodity Manager

	Name	  	Bryan Monahan	  	Dennie Dyer
	Title	  	Account Executive	  	Vice President Operations
	Phone/Fax	  	610-366-8764	  	510-215-3580/510-215-3535
	Address
(mail/delivery)	  	7451 Keebler Way
AlIontown, PA 18106	  	1003 West Cutting Blvd.
Suite 110
Pt. Richmond, CA 94804
	Electronic	  	Bryan.Monahan@sharpcorporatton.com	  	ddyer@transcept.com

 APPENDIX 2: Page 2 (Contacts and Responsibilities) 
 Contract Person for Notices 
 (including Notices of Amendment, Assignment 
 Termination, Resolution of Quality Issues) 
  

					
	 	  	 Supplier
	  	 Transcept

	Name	  	Marc M. Feinberg	  	Grace Scheibner
	Title	  	Vice President of Quality Assurance	  	Associate Director, Quality Systems
	Phone/Fax	  	610-366-8748/610-397-2126	  	510-215-3571/510-215-3535
	Address
(mail/delivery)	  	7451 Keebler Way
Allentown, PA 18106	  	 1003 West Cutting Blvd.
 Suite 110
 Pt. Richmond, CA 94804

			
	 What a Copy to:
	  	 Supplier
	  	 Transcept

	Name	  		  	Sharon Sakal, Ph. D.
	Title	  		  	Senior Director, Regulatory Affairs
	Phone/Fax	  		  	510-215-3515/510-215-3535
	Address
(mail/delivery)	  		  	1003 West Cutting Blvd.
Suite 110
Pt. Richmond, CA 94804
	Electronic	  		  	ssakai@transcept.com

 APPENDIX 3: Product Security- Supplier Requirements 
  

	I.	Keys: 

  

	 	a.	Supplier must have adequate key control measures in place to ensure the security of any / ail areas that contain Transcept material. 

  

	 	b.	Key issuance must be documented. 

  

	 	c.	Keys must be audited. 

  

	 	d.	If keys are lost, Jocks for critical areas must be changed. 

  

	II.	Access Control: 

  

	 	a.	General access to the facility must be controlled through: 

  

	 	i.	Designated entry point(s). 

  

	 	ii.	Visitor/non-empioyee registration. 

  

	 	b.	Building alarm 

  

	 	i.	Building must have a burglar alarm system for after-hours protection Transcept materials. 

  

	III.	Materials Storage: 

  

	 	a.	Transcept components/materials must be adequately isolated from materials of third parties and secured prior to, during and after production. 

  

	 	b.	All templates/dies/stamps must be kept in locked storage containers. 

  

	 	c.	All product security materials must be kept in locked storage with access limited to a minimal number of employees. 

  

	IV.	Logical Security: 

  

	 	a.	Any network or workstation computer that contains Transcept materials or information must have the password protection: 

  

	 	i.	Forced changed logon passwords. 

  

	 	ii.	Automatic inactivity passwords. 

  

	 	b.	Any LAN/WAN system containing Transcept materials must have adequate antivirus and firewall protection. 

  

	 	c.	Any LAN/WAN system must be adequately secure from unauthorized physical access. 

  

	 	d.	All outdated Transcept material maintained on backup media must be destroyed on a regular basis. 

  

	V.	Waste Material: 

  

	 	a.	All waste materials must be destroyed or defaced in accordance with applicable laws to prevent reuse. 

  

	 	b.	Any contract waste disposal company utilized to transport and dispose of Transcept waste materials must be contractually obligated to destroy all items to prevent reuse.

  

	VI.	Reconciliation: 100 % reconciliation is required including items such as holograms from outside sources.Supply and License Agreement,dated as of June 27, 2006

 Exhibit 10.16 
 Execution Copy 
 SUPPLY AND LICENSE AGREEMENT 
 This Supply and License Agreement (hereinafter referred to as “Agreement”), effective as
of the 27th day of June, 2006 (the “Effective Date”), is made by and between SPI Pharma, Inc., a Delaware corporation with its principal
offices at 321 Cherry Lane, New Castle, Delaware 19720 (hereinafter referred to as “Supplier”) and TransOral Pharmaceuticals, Inc., a Delaware corporation with its principal offices at 1003 W. Cutting Blvd., Suite 110, Pt. Richmond,
California 94804 (hereinafter referred to as “Purchaser”). Purchaser and Supplier are sometimes referred to herein individually as a “Party” or collectively as the “Parties”. 
 WHEREAS, the Supplier is a manufacturer of the Products (as defined below); 
 WHEREAS, the Purchaser desires to purchase the Products from the Supplier and to obtain a license from Supplier to use on a nonexclusive basis certain
technology and intellectual property rights associated with the Products (as more specifically described herein, the “License”); and 
 WHEREAS, Supplier is willing to supply the Products to the Purchaser and provide the License. 
 NOW, THEREFORE, in consideration of
the covenants, conditions and obligations expressed herein, and intending to be legally bound thereby, the Parties hereto agree as follows: 
  

	1.	DEFINITIONS 

 Terms defined in the preamble of this
Agreement have the meanings set forth therein, and the following terms have the meanings set forth below. 
 “Affiliate”
means, with respect to each Party, any company or other entity which directly or indirectly controls or is controlled by or is under common control with that Party. An entity shall be regarded as in control of another entity for purposes of this
definition if it owns or controls fifty percent (50%) or more of the shares of the subject entity entitled to vote in the election of directors (or, in the case of an entity that is not a corporation, for the election of the corresponding
managing authority). 
 “API” means the active pharmaceutical ingredient Zolpidem Tartrate. 
 “Applicable Laws” means all laws, ordinances, rules and regulations of any governmental or regulatory authority that apply to the
Products, Supplier’s manufacture and supply of the Products, or this Agreement, including without limitation (a) all applicable federal, state and local laws and regulations; (b) the U.S. Federal Food, Drug and Cosmetic Act
(“FDCA”), (c) regulations and guidelines of the FDA and other Regulatory Agencies, and ICH guidelines and (d) GMP, and if applicable, current Good Laboratory Practices and current Good Clinical Practices promulgated by the FDA
and other Regulatory Agencies. 
 “Facility” means: (i) Supplier’s GMP manufacturing facility located in Grand
Haven, Michigan; or (ii) any other GMP manufacturing facility meeting the requirements of this Agreement, provided that Supplier has given Purchaser at least six (6) months’ prior written notice that it will manufacture Product for
Purchaser at such other facility. 
  

  
 Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. 

 “FDA” means the United States Food and Drug Administration, or any successor agency
thereto. 
 “Finished Product” means a product comprising a Product together with the API, with the quantity of API
contained in each unit of such product [***]. 
 “GMP” means current good manufacturing practice and standards as provided
for (and as amended from time to time) in the Current Good Manufacturing Practice Regulations of the U.S. Code of Federal Regulations Title 21 (Parts 11, 210, 211, 820), the FDA Guidance for Industry Q7A ICH Good Manufacturing Practice for Active
Pharmaceutical Ingredients and the IPEC (The International Pharmaceutical Excipients Council) Good Manufacturing Practices Guide for Bulk Pharmaceutical Excipients. 
 “Know-How” means all tangible or intangible technical, scientific and other know-how, trade secrets, knowledge, technology, ideas, concepts, formulae, procedures, methods, processes, protocols,
analytical methods, techniques, materials and results of experimentation and testing, including samples, data, results, discoveries, inventions (whether patentable or unpatentable), and other information including preclinical data and clinical
results, and other intellectual property, in written, electronic or any other form, owned or controlled by or licensed to (with the right to assign or sublicense) the subject Party or any Affiliate thereof existing as of the Effective Date and that
come into existence during the Term. 
 “Licensed Technology” means, collectively, the Patent Rights and Know-How in each
case that (A) are owned by Supplier or its Controlled Affiliates or licensed by a third party to Supplier or its Controlled Affiliates as of the Effective Date and (B) pertain to the Product and/or cover the development, manufacture,
importation, sales or offer for sale of the Product pursuant to the license set forth in Section 4.1. An entity shall be regarded as a “Controlled Affiliate” of Supplier if Supplier owns or directly or indirectly controls fifty
percent (50%) or more of the shares of such entity entitled to vote in the election of directors (or in the case of an entity that is not a corporation, for the election of the corresponding managing authority) of such entity. 
 “Patent Rights” mean all present and future patent applications and issued patents, owned, controlled or licensed (with the right to
assign or grant sublicenses) by the specified Party or any Affiliate thereof, including but not limited to any provisionals, divisionals, continuations, continuations-in-part, reissues, reexaminations, or extensions derived therefrom, as well as all
foreign and international patent applications, granted patents and all counterparts thereof including, without limitation, substitutions, confirmations, registrations, revalidations, supplemental protection certificates, administrative protection
certificates (or other governmental actions) that provide exclusive rights to the patent holders in any jurisdiction in the Territory. 
 “Phase III Clinical Trial” means human clinical trials, the principal purpose of which is to establish safety and efficacy in patients with the disease being studied as required in 21 C.F.R. §312. 
  

 -2- 
  

  
 [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. 

 [***] means [***]. 
 [***] means [***]. 
 “Product” means [***]. 
 “Regulatory Agency” means any governmental regulatory authority involved in regulating any aspect of the conduct, development,
manufacture, market approval, sale, distribution, packaging or use of the Product and/or Finished Product, including the FDA and the European Medicines Evaluation Agency (“EMEA”). 
 “Regulatory Approval” means a required consent, license, approval or other authorization of a Regulatory Agency having authority over
the manufacture, use, storage, import, export, clinical testing, transport, marketing, sale or distribution of the Product and/or Finished Product, as applicable, in all or any portion of the Territory. 
 “Similar Product” means a proprietary product of Supplier that is functionally similar to [***] (e.g. [***]). 
 “Specifications” means the specifications for each type of Product that are attached hereto as Exhibit A and Exhibit B, as applicable,
and which may be amended from time to time by the mutual written agreement of the Parties. 
 “Term” has the meaning given
in Section 9.1 of this Agreement. 
 “Territory” means [***]. 
  

	2.	PURCHASE AND SALE OF PRODUCT 

 2.1. Supply of
Product. During the Term of this Agreement, Supplier agrees to supply to Purchaser, and Purchaser agrees to purchase from Supplier, all quantities of each type of Product ordered by Purchaser pursuant to purchase orders submitted to Supplier
under Firm Orders in accordance with the terms of this Agreement and subject to the terms of Article 5 below. No change in Specifications will be made without the mutual written agreement of Supplier and Purchaser. Purchaser may purchase Product
hereunder through its designee, and Supplier agrees to supply Product to such designee pursuant to the terms of this Agreement; provided, however, that Purchaser has provided the name of such designee to Supplier in advance, and such designee has
agreed in writing with Purchaser to be bound by: (i) the restrictions of Section 4.1 with respect to such designee’s use of Products that it receives pursuant to this Agreement; (ii) the confidentiality obligations of Article 10
with respect to any of Supplier’s Information that such designee receives pursuant to this Agreement; and (iii) the audit provisions of the last sentence of Section 6.6 with respect to such designee’s use of Products that it
receives pursuant to this Agreement. 
  

 -3- 
  

  
 [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. 

 2.2. Quantity. 
 2.2.1. Product purchase quantity is projected to be [***]. The Parties acknowledge that these quantities are estimates only and shall in
no case be binding upon Purchaser. 
 2.2.2. The quantity of each Product Supplier is obligated to supply hereunder and
Purchaser is obligated to purchase hereunder for each calendar quarter shall be as set forth in Article 5 hereof. 
 2.3. Orders.
Orders shall be documented by written or electronic purchase order form submitted to Supplier [***] prior to requested delivery, and will provide for shipment in accordance with reasonable delivery schedules and lead times as may be agreed upon from
time to time by Supplier and Purchaser so long as the maximum lead time [***] unless otherwise agreed to by the Parties. 
 2.4.
Packaging. Products shall be shipped packaged in containers in accordance with the applicable Specifications or as otherwise agreed by the Parties in writing. Each such container will be individually labeled with a description of its
contents, including the manufacturer lot number, quantity and type of Product, date of manufacture and expiration date. 
  

	3.	PRICE OF PRODUCT; DELIVERY 

 3.1. Purchase
Price. The purchase price for each type of Product shall be [***]. Future pricing of Product [***] will be [***]. Notwithstanding the foregoing, if Supplier enters into a [***] arrangement with any third party in [***] similar to this Agreement
for the supply of Product to such third party on terms or conditions [***]) [***] to such third party than those provided to Purchaser under this Supply Agreement, then Purchaser shall be provided [***] including, without limitation, the [***] being
provided by Supplier to such third party. 
 3.2. Delivery. Supplier shall deliver the quantities of each type of Product ordered by
Purchaser on the dates specified in Purchaser’s purchase orders submitted in accordance with Section 2.3 above. All Product shipments shall be delivered FOB (UCC) Supplier’s shipping point in [***]. The carrier shall be selected by
agreement between Purchaser and Supplier, except that if no such agreement is reached, Purchaser shall select the carrier. All Product delivered hereunder shall be suitably packed for shipment by Supplier in accordance with good commercial practice
with respect to protection of such Product during transportation and marked for shipment to Purchaser’s specified receiving point. 
  

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 [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. 

	4.	LICENSE FEES AND INTELLECTUAL PROPERTY RIGHTS 

 4.1.
License. Pursuant to the terms of this Agreement and for the Term, the Supplier hereby grants to the Purchaser a [***] license under the Licensed Technology (including the right to grant and authorize sublicenses): (i) for the limited
purpose of using the Product as an ingredient in the Finished Product in the Territory; and (ii) to manufacture, market, sell, use, import and distribute the Finished Product in the Territory; and to have any of the foregoing done on its
behalf. Notwithstanding the foregoing, Purchaser shall not be allowed to grant a sublicense under the license granted to it by Supplier in this Section 4.1 unless such sublicensee has agreed in writing with Purchaser to be bound by:
(x) the restrictions of this Section 4.1 above with respect to such sublicensee’s use of Products that it receives pursuant to this Agreement; (y) the confidentiality obligations of Article 10 with respect to any of
Supplier’s Information that such sublicensee receives pursuant to this Agreement; and (iii) the audit provisions of the last sentence of Section 6.6 with respect to such sublicensee’s use of Products that it receives pursuant to
this Agreement. Purchaser agrees to provide written notice to Supplier upon its grant of any sublicenses hereunder. 
 4.2. License
Fees. Purchaser agrees to pay Supplier for use and sale of both types of Product a one-time [***] license fee in the amount of [***] (the “License Fee”) payable as provided below. 
 4.2.1. Supplier acknowledges that Purchaser has already paid to Supplier a portion of the License Fee in the amount of [***] as provided
by the terms of that certain Supply Term Sheet by and between the Parties dated February 20, 2006. 
 4.2.2. Purchaser
agrees to pay to Supplier the remaining [***] of the License Fee upon the first to occur of: (i) the first dosing of a Finished Product in a human subject in a Phase III Clinical Trial conducted by Purchaser; and (ii) December 31,
2006. 
 4.2.3. Upon the commercial launch of a Finished Product by Purchaser, Supplier agrees to credit an amount of [***] of
the License Fee (the “Credit Amount”) towards Purchaser’s future purchases of Product in the form of a [***] on the amounts that would otherwise be due to Supplier on each such future purchase by Purchaser of Product until the Credit
Amount has been fully credited against such purchases. 
 4.2.4. If Purchaser determines, in its sole discretion, that neither
Product will be used in its products containiing API due to regulatory, business or other issues, then at Purchaser’s option either (a) the License Fee can be applied in full by Purchaser towards the Licensing Fee associated with any Finished
Product in the Future or (b) the Credit Amount can be applied in full by Purchaser toward Purchaser’s purchase of any Product in the form of a [***] on Supplier’s list price for such Product until the Credit Amount has been fully credited
against such purchases. 
 4.3. No Implied License. There are no implied licenses under this Agreement, and any rights not expressly
granted to the Purchaser hereunder are reserved by the Supplier. 
  

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 [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. 

 4.4. Intellectual Property Rights. 
 4.4.1. The Parties understand and agree that, except as otherwise expressly provided in this Agreement, no right, title or interest is
provided by one Party to the other Party with respect to any Know-How, Patent Rights or other intellectual property of the Party. 
 4.4.2. Supplier shall own the entire right, title and interest in and to (i) all Know- How, Patent Rights and other proprietary rights existing and owned by it on the Effective Date and (ii) all Know-How, Patent Rights and other
proprietary rights in respect of the Product developed, discovered, made or conceived by Supplier. 
 4.4.3. Purchaser shall
own the entire right, title and interest in and to (i) all Know-How, Patent Rights and other proprietary rights existing and owned by it on the Effective Date and (ii) all Know-How, Patent Rights and other proprietary rights in respect of
the Finished Product developed, discovered, made or conceived by Purchaser. 
  

	5.	FORECASTS AND FIRM ORDERS 

 5.1. Forecasts. Upon the Effective Date of this Agreement and by December 31st of each year of the Term
(excluding December 31st of the last year of the Term, unless this Agreement is extended by the mutual written consent of the Parties), the
Purchaser shall provide Supplier with an estimated non-binding forecast of its requirements for each type of Product for the following calendar year. In addition, the Purchaser shall by the end of each calendar quarter provide a rolling forecast on
a quarterly basis of its requirements for the Product for the following four calendar quarters (“Ql”, “Q2”, “Q3” and “Q4”). 
 5.2. Firm Orders. 
 5.2.1. The forecast given by Purchaser for Ql shall constitute a
firm order (“Firm Order”) for the Product for Ql and Purchaser shall be obligated to purchase, and Supplier shall be obligated to supply, such quantities and types of Products pursuant to one or more purchase orders submitted to
Supplier during Ql, in each case within the applicable ranges specified in Section 5.2.2 below. 
 5.2.2. It is
understood and agreed that the forecasted quantities of Product for Q2, Q3 and Q4 shall not be binding upon Purchaser in any respect, and Purchaser shall not be liable with respect to its good faith efforts to provide such non-binding forecasts.
Notwithstanding the foregoing, the Firm Order for the then current Ql may not be for an amount [***] of the immediately preceding forecast for each such calendar quarter and Supplier shall [***] of such forecasted amount, in each case unless
otherwise agreed by the Parties in writing; provided, however, that Supplier shall use commercially reasonable efforts to fill the amounts of any Firm Order [***] cap described above. 
  

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 [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. 

	6.	QUALITY 

 6.1. Specifications. The Supplier
agrees that all Product supplied hereunder shall conform to the Specifications applicable to such Product and shall be manufactured at the Facility in accordance with Applicable Laws, including GMP manufacturing and record keeping procedures.

 6.2. Quality Control. Prior to each shipment of Product, Supplier shall perform quality control testing procedures and inspections
to verify that the Product to be shipped conforms fully to the applicable Specifications. Each shipment of Product shall be accompanied by a certificate of analysis in a form acceptable to Purchaser and describing all current requirements of the
Specifications, results of tests performed certifying that the Product supplied have been manufactured, controlled and released at the Facility in accordance with the Specifications and Applicable Laws. 
 6.3. Batch Records; Samples. Supplier shall maintain batch records sufficient to trace the history of each batch, and representative samples from
each batch of Product manufactured hereunder, for record keeping, stability testing, and other regulatory purposes, including as may be required by the Specifications or Applicable Laws, for as long as required by such Applicable Laws. Upon the
request of Purchaser and so long as Supplier is required to maintain such records, Supplier shall provide Purchaser reasonable access to and copies of such records and samples. 
 6.4. Rejected Products. Purchaser’s receipt of Product delivered hereunder shall be an unqualified acceptance; provided, however, that
Purchaser may reject such Product within [***] after such receipt if during such period Purchaser or its designee discovers, upon inspection of such Product, that such Product fails to conform with the Specifications therefor or otherwise fails to
conform to the warranties given by Supplier in Article 12 below. Such rejection shall be accomplished by giving written notice to Supplier and, upon request from Supplier, Purchaser shall return the rejected Product in accordance with
Supplier’s reasonable instructions and at Supplier’s expense, provided that such instructions comply with all Applicable Laws. Supplier shall use its best efforts to replace rejected Product within the [***] and in any event within [***]
after Supplier’s receipt of notice thereof. In the event all or part of a shipment of Product is rejected prior to Purchaser’s payment therefor, Purchaser may withhold such payment until receipt of replacement Product that conform with the
Specifications therefor and to the warranties given by Supplier in Article 12 below. The Parties shall use their reasonable efforts to resolve any dispute that may arise pursuant to this Section. If the Parties fail to agree, within [***] of
Purchaser providing notice of rejection, whether any delivery of the Products supplied by Supplier to Purchaser conform to the Specifications therefor and the warranties given by Supplier in Article 12, the dispute shall be determined by an
independent laboratory/expert mutually selected by the Parties and the decision of such independent laboratory/expert shall be final and binding on the Parties with respect to whether the Products in question conform to the Specifications therefor
and the warranties given by Supplier in Article 12. In the event that the independent laboratory/expert decides that the Products in question conform to the Specifications and the warranties given by Supplier in Article 12, such Products shall be
deemed accepted by Purchaser. In the event that the independent laboratory/expert decides that the Products in question do not conform to the Specifications and/or the warranties given by Supplier in Article 12, Supplier 

  

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 [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. 

 
shall use its best efforts to replace such Products within the shortest possible time and in any event within [***] after Supplier’s receipt of notice
regarding the independent laboratory/expert’s decision. For purposes of clarity, only disputes between the Parties regarding conformance of the Products as expressly described in this Section 6.4 above shall be resolved by an independent
laboratory/expert, and all other disputes between the Parties shall be governed by the provisions of Section 14.8 below. The independent laboratory/expert’s fees and the prevailing Party’s out-of-pocket costs incurred in connection
with the independent laboratory/expert’s decision shall be borne by the Party against whom the independent laboratory/expert’s decision is given. 
 6.5. Latent Defects. In the event either Party becomes aware of any defect in any batch of Product that is not discoverable upon a reasonable inspection or incoming quality assurance testing as set forth in the
Specifications, it shall immediately (and in no case later than [***] after reaching such awareness) notify the other Party in writing (identifying the batch(es) involved), and the rejection provisions of Section 6.4 above shall apply
notwithstanding any expiration of the [***] period described therein. In the event Purchaser fails to provide such notice of defect [***], Purchaser shall be deemed to have accepted such batch and the recovery portions of Section 6.4 shall not
apply to such batch. 
 6.6. Audits. Purchaser shall have the right to conduct,
upon reasonable notice and at its own expense, a periodic (limited to one audit per year) site and quality audit of the portion of the Facility used to manufacture and/or supply the Products hereunder during normal business hours, including
Supplier’s relevant books and records related thereto, in order to determine Supplier’s compliance with Applicable Laws and this Agreement. In addition, Purchaser shall be entitled to review Supplier’s standard operating procedures
applicable to its manufacture and supply of the Products hereunder, including with respect to quality control. Supplier shall have the right to conduct, upon reasonable notice and at its own expense, a periodic (limited to one audit per year) audit
of the manufacturing records of the Purchaser, through a mutually agreed 3rd party auditor, provided that the scope of such audit shall be limited
to the extent necessary to confirm Purchaser’s adherence to the restrictions on Purchaser’s use of Product contained in the License granted in Section 4.1 this Agreement. 
 6.7. Recalls on Finished Product. Responsibility for the initiation of and liability for recalls of the Finished Product shall be solely that of
the Purchaser; provided, however, that to the extent a recall is attributable to [***]. 
  

	7.	INVOICING AND PAYMENT 

 7.1. Invoices;
Payment. Supplier shall submit an invoice to Purchaser upon shipment of Product ordered by Purchaser under this Agreement. All invoices will be sent to the address specified in the applicable purchase order, and each invoice will state the
aggregate, type and unit price for Product in a given shipment, plus any insurance, taxes, or other costs incident to the purchase or shipment initially paid by Supplier but to be borne by Purchaser under this Agreement pursuant to Section 7.3
below. All invoices for Product purchased by Purchaser shall be paid net thirty (30) days upon receipt by Purchaser of the applicable invoice that is the subject of such invoice. 
  

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 [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. 

 7.2. Invoice for License Fee. Supplier will promptly invoice Purchaser for the remaining balance
of the License Fee described in Section 4.2.2, and Purchaser agrees to pay such amount on the applicable date described in Section 4.2.2. 
 7.3. Taxes. Any and all taxes (other than taxes levied or measured by income), or other charges of any nature imposed by any competent governmental authority, which shall become payable by reason of the sale of the Product to
Purchaser hereunder, shall be paid by the Supplier and the Supplier may either bill the same to the Purchaser separately or add the same to the price of the Product sold hereunder. 
 7.4. Currency. All amounts payable by Purchaser hereunder will be made in United States Dollars. 
  

	8.	FAILURE TO SUPPLY 

 8.1. Notice. Without
limiting Supplier’s obligations to supply Products to Purchaser under Article 2 above, Supplier shall give Purchaser prompt written notice if Supplier becomes aware that it will not be able to supply Purchaser’s orders for Product as
required under this Agreement, and Supplier shall give Purchaser [***] written notice prior to any discontinuation by it of the manufacture or sale of a Product line. 
 8.2. Supply Failure. In the event that Supplier actually fails to supply [***] of the quantities of a type of Product in a particular calendar quarter or [***] in any [***] calendar quarters, in each case
pursuant to orders submitted by Purchaser pursuant to and in accordance with the terms and conditions of this Agreement (including Article 5) within [***] of the dates specified in such orders in compliance with this Agreement, such event shall be
deemed a “Supply Failure.” In the event of a Supply Failure: 
 8.2.1. Supplier shall allocate the Product that it
has in inventory, or is able to produce, on a reasonable pro-rated basis, among Supplier’s customers for Product (including Purchaser, its Affiliates, sublicensees and distributors) based on the forecasts of Purchaser, and Supplier’s other
customers; and 
 8.2.2. Purchaser may, at its sole option: (i) elect to include any Similar Product under the terms of
this Agreement, with the purchase price and lead times for Supplier’s supply of such Similar Product to be negotiated in good faith by the Parties, provided, however, that such purchase price shall not exceed the purchase price for Product
described in Section 3.1 of this Agreement; or (ii) terminate this Agreement immediately upon written notice to Supplier. In the event that, following a Supply Failure, Purchaser elects to include a Similar Product under the terms of this
Agreement pursuant to the terms of part (i) of this Section 8.2.2, and Supplier subsequently reasonably demonstrates to Purchaser that it has removed the cause of the Supply Failure and is able to supply quantities of Product in accordance
with the terms of this 

  

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 [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. 

 
Agreement (including, without limitation, in accordance with Supplier’s Product supply obligations under Article 5), Supplier shall have the right to
adjust the price for future quantities of such Similar Product purchased by Purchaser hereunder to Supplier’s commercial list price for such Similar Product, subject to any adjustments provided for under Section 3.1. For clarity, in the
event that the events described in the foregoing sentence occur, such Similar Product shall still be included under the terms of this Agreement, subject to Supplier’s right to adjust the price of such Similar Product as described in the
foregoing sentence. 
 8.3. This Article 8 shall in no way limit any of Purchaser’s legal, equitable or other remedies
for Supplier’s breach of its obligations to supply Product to Purchaser under Article 2. 
  

	9.	TERM AND TERMINATION 

 9.1. Term of
Agreement. Unless earlier terminated as described below, this Agreement shall be effective as of the Effective Date and shall remain in effect for a period of five (5) years thereafter (the “Term”). 
 9.2. Termination. This Agreement may be terminated by either Party as follows: 
 9.2.1. Upon [***] prior written notice to the other Party, in the event of a breach of this Agreement by such other Party, which breach is
not cured within such [***] period, provided, however, if during such [***] period, the allegedly breaching Party disputes that it has materially breached this Agreement, then the other Party shall not have the right to terminate this Agreement
until it has been finally determined in accordance with Section 14.8 below that the allegedly breaching Party has materially breached this Agreement, and such Party fails to comply herewith within [***] thereafter; or 
 9.2.2. Upon prior written notice to the other Party: (i) if the other Party is declared insolvent or bankrupt by a court of competent
jurisdiction, (ii) if a voluntary or involuntary petition in bankruptcy is filed in any court of competent jurisdiction against the other Party and such petition is not dismissed within [***] after filing, (iii) if the other Party shall
make or execute an assignment of substantially all of its assets for the benefit of creditors, or (iv) substantially all of the assets of such other Party are seized or attached and not released within [***] thereafter. 
 9.3. Effect of Termination. 
 9.3.1. Termination or expiration of this Agreement shall not relieve a Party from any liability that, at the time of such termination or expiration, has already accrued to the other Party. 
 9.3.2. The provisions of Articles 1 and 9-14, and Sections 4.4, 6.3, 6.5 and 6.7 of this Agreement shall survive the expiration or
termination of this Agreement for any reason. Notwithstanding anything to the contrary in Section 4.1, the license granted to Purchaser under Section 4.1, and the restrictions contained therein, shall survive any expiration or termination
of this Agreement solely with respect to any Product received by Purchaser prior to such expiration or termination. 
  

 -10- 
  

  
 [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. 

	10.	CONFIDENTIAL INFORMATION 

 10.1. Information.
The Parties may from time to time disclose to each other Information. As used herein, “Information” means any information disclosed by one Party to the other Party that (i), if disclosed in tangible form, is marked “confidential”
or with other similar designation to indicate its confidential or proprietary nature; (ii), if disclosed orally, is indicated orally to be confidential or proprietary by the Party disclosing the information at the time of the disclosure and is
confirmed in writing as confidential or proprietary by the disclosing Party within [***] after such disclosure; or (iii) is disclosed during an audit under Section 6.6. Notwithstanding the foregoing, Information shall not include any
information to the extent that such information (i) is or becomes generally available to the public through no fault of the receiving Party; (ii) can be demonstrated in writing to have been known by the receiving Party, other than under an
obligation of confidentiality, at the time of its disclosure by the other Party or to have been independently developed after the date of disclosure by the receiving Party without the application or use of the disclosing Party’s Information; or
(iii) becomes known to the other Party from a source other than the disclosing Party without breach of this Agreement by such Party, provided, that such source has the lawful right to disclose such Information to such Party. 
 10.2. Confidentiality. During the Term and [***] thereafter, each of the Parties and their respective employees and agents shall hold in
confidence all Information of the other Party. Nothing contained in this Article 10 shall prevent either Party from disclosing any Information of the other Party to the extent reasonable necessary in complying with applicable governmental laws,
regulations (such as SEC regulations) or orders (including court orders); provided that if a Party is required by law to make any such disclosure of the other Party’s Information, other than pursuant to a confidentiality agreement, it will give
reasonable advance notice to the other Party of such disclosure and will use its reasonable efforts to secure confidential treatment of such Information. Notwithstanding the foregoing and anything herein to the contrary: Purchaser may disclose
Supplier Information: (A) that is contained in Product certificates of analysis or compliance, pricing information, Specifications or assay methods related to the Specifications to those of its contractors and consultants who have a need to
know and have agreed in writing to be bound by the confidentiality obligations of this Article 10; and (B) to the extent required by Regulatory Agencies in connection with Finished Product containing Product. 
 10.3. Confidential Terms. Each Party shall treat the terms of this Agreement as the Information of the other Party. Notwithstanding anything to
the contrary, however, each Party may disclose the terms of this Agreement (a) to advisors, actual or potential investors, acquisition partners, sublicensees, and others on a need to know basis under circumstances that reasonably ensure the
confidentiality thereof, or (b) as required by securities or other applicable laws or regulations, such as SEC regulations. 
  

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 [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. 

	11.	REGULATORY MATTERS 

 11.1. Product. The
Supplier shall be responsible for obtaining and maintaining all Regulatory Approvals for the Product in the Territory. Supplier shall maintain with the FDA a valid DMF for the Product that is in full compliance with applicable FDA requirements, and
Purchaser shall have the right to reference such DMF in its drug applications for the Finished Product. Supplier shall ensure that such DMF contains all material written and other information relating to the manufacture of Products in
Supplier’s possession or control that is necessary for Purchaser to apply for, obtain and thereafter maintain Regulatory Approvals for the Finished Products in the Territory, including without limitation information relating to that portion of
the Facility used in the manufacture of Products, process, methodology or components used in the manufacture of Products or other such information required to be submitted to Regulatory Agencies (collectively “Product Regulatory
Information”). In the event Regulatory Agencies do not accept Purchaser’s reference to Supplier’s DMF or otherwise require additional Product Regulatory Information for Purchaser to obtain and/or maintain Regulatory Approvals,
Supplier agrees to promptly provide all such required Product Regulatory Information to such Regulatory Agencies in the format required by such Regulatory Agencies. Supplier agrees to immediately inform Purchaser when any “pertinent”
changes (as described by the FDA in Part VII.A. of its Guideline for Drug Master Files and as required in 21 CFR 314. 420(c)) to current Product manufacturing practices, procedures are made and to provide updated information to Purchaser from time
to time, and to cooperate with Purchaser with respect to all reporting obligations relevant to the Finished Product under Applicable Laws. 
 11.2. Finished Product. The Purchaser shall be responsible for obtaining and maintaining all Regulatory Approvals with respect to the Finished Product in the Territory other than those Regulatory Approvals relating to the Product and
Supplier’s manufacture thereof, which shall be the responsibility of Supplier. The Purchaser shall provide the Supplier with (i) a copy of its NDA approval letter for Finished Product within a reasonable time after Purchaser’s receipt
thereof from the FDA, and (ii) copies of any equivalent Regulatory Approval notices for Finished Product from other applicable Regulatory Agencies within a reasonable time after receipt thereof; provided that in each case Purchaser may redact
any of its proprietary information from such copy. Supplier shall cooperate and provide reasonable assistance to Purchaser in connection with Purchaser’s obtainment and maintenance of Regulatory Approvals for Finished Product. 
 11.3. Regulatory Actions. Supplier shall permit the FDA and other Regulatory Agencies to conduct inspections of the Facility as they may request,
including pre-approval inspections, and shall cooperate with such Regulatory Agencies with respect to the inspections and any related matters, in each case which is related to the Product or Finished Product. Supplier shall give Purchaser a report
of the results of any such inspection, to the extent the findings of such inspection negatively affect the Supplier’s ability to meet its obligations hereunder to supply Product, if the GMP deficiencies associated with Product could lead to
further action by Regulatory Agencies such as a warning letter, or if such notice is required by Section 11.1 hereof. 
  

	12.	REPRESENTATIONS AND WARRANTIES 

 12.1.
General. Each Party represents and warrants that: (a) it has full power to enter into this Agreement and to grant to the other Party the rights granted to such other Party under this Agreement and (b) it has obtained all necessary
corporate approvals to enter into and execute the Agreement. 
  

 - 12 - 

 12.2. Product Warranties. Supplier represents and warrants that: 
 12.2.1. All Product supplied hereunder shall comply with the applicable Specifications and, if applicable, shall conform with the
information shown on the certificate of analysis provided for the particular shipment pursuant to Section 6.2 above; 
 12.2.2. The Facility, the manufacturing and supply activities contemplated herein, and all Product supplied hereunder shall comply with all Applicable Laws. Without limiting the foregoing, at the time of delivery to Purchaser, none of the
Product shall be adulterated or misbranded within the meaning of the FDCA, as amended and in effect at the time of shipment. 
 12.2.3. Title to all Product provided to Purchaser under this Agreement shall pass as provided in this Agreement, free and clear of any security interest, lien, or other encumbrance. 
 12.3. Personnel. Supplier represents and warrants to Purchaser that neither Supplier nor any of its employees have been “debarred” by
the FDA, or subject to a similar sanction from another Regulatory Agency, nor have debarment proceedings against Supplier or any of its employees been commenced. Supplier will promptly notify Purchaser in writing if any such proceedings have
commenced or if Supplier or any of its employees are debarred by the FDA or other Regulatory Agencies. 
 12.4. Third Party Intellectual
Property Rights. Supplier represents and warrants that, to Supplier’s knowledge, the [***] do not infringe any third party intellectual property rights. 
 12.5. Licensed Technology. Supplier represents and warrants that: (i) as of the Effective Date, the Licensed Technology contains all of the Know-How and Patent Rights owned, in-licensed or otherwise
controlled by Supplier and its Affiliates that pertain to the Product and/or that cover the development, manufacture, importation, sale or offer for sale of the Product; and (ii) during the Term, Supplier shall not encumber the Licensed
Technology in any way that would adversely affect Purchaser’s rights with respect to the Product as described in Section 4.1, including, without limitation, by granting licenses to other parties that conflict with the license granted to
Purchaser in Section 4.1 or by assigning the Licensed Technology to another party, including a Supplier Affiliate, separate from an assignment of this Agreement. If, during the Term, Know-How and/or Patent Rights of Supplier or its Affiliates
not included in the Licensed Technology are necessary for Purchaser to exercise its rights in Section 4.1 as contemplated in this Agreement, Supplier agrees that such Know-How and/or Patent Rights shall be included within the Licensed
Technology. 
 12.6. Disclaimer. EXCEPT AS PROVIDED IN THIS ARTICLE 12, NEITHER PARTY MAKES ANY WARRANTIES OR CONDITIONS (EXPRESS,
IMPLIED, STATUTORY OR OTHERWISE) WITH RESPECT TO THE SUBJECT MATTER HEREOF AND EACH PARTY EXPRESSLY DISCLAIMS ANY SUCH ADDITIONAL WARRANTIES INCLUDING, BUT NOT LIMITED TO, IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE,
EVEN IF THAT PURPOSE IS KNOWN TO SUPPLIER. 
  

 -13- 
  

  
 [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. 

	13.	INDEMNIFICATION 

 13.1. Indemnity by
Supplier. Supplier agrees to indemnify, protect, defend and hold harmless Purchaser, its directors, officers, employees, successors and assigns from and against any claims, damages, liability, harm, loss, costs, penalties, lawsuits, threats of
lawsuit or other governmental action, including reasonable attorneys’ fees, arising out of any claim, complaint, suit, proceeding, or cause of action brought or claimed by any third-party which arise out of: (i) Supplier’s breach of
this Agreement or of any warranty or representation made by Supplier to Purchaser under this Agreement; (ii) [***]; or (iii) the negligent or intentionally wrongful acts or omissions of Supplier. 
 13.2. Indemnity by Purchaser. Purchaser agrees to indemnify, protect, defend and hold harmless Supplier, its directors, officers, employees,
successors and assigns from and against any claims, damages, liability, harm, loss, costs, penalties, lawsuits, threats of lawsuit, recalls or other governmental action, including reasonable attorneys’ fees, arising out of any claim, complaint,
suit, proceeding, or cause of action brought or claimed by any third-party which (i) arise out of Purchaser’s breach of this Agreement or of any warranty or representation made to Supplier under this Agreement, or (ii) result from the
manufacture, sale, marketing, use or distribution by Purchaser of Finished Product (to the extent not attributable to any Product), including without limitation the negligent or intentionally wrongful acts or omissions of Purchaser; except in each
case to the extent that Supplier is obligated to indemnify, protect and defend Purchaser for such claims under Section 13.1 above. 
 13.3. Indemnification Procedure. A Party that intends to claim indemnification (“Indemnitee”) under this Article 13 shall promptly notify the indemnifying Party (“Indemnitor”) in writing of any third party claim,
suit, or proceeding included within the indemnification described in this Article 13 (each a “Claim”) with respect to which the Indemnitee intends to claim such indemnification, and the Indemnitor shall have sole control of the defense and
settlement of the Claim; provided that the Indemnitor shall not enter into any settlement that admits the fault of Indemnitee without the prior written consent of Indemnitee, such consent not to be unreasonably withheld. The Indemnitee shall have
the right to participate, at its own expense, with counsel of its own choosing in the defense or settlement of the Claim. The indemnification obligations under this Article 13 shall not apply to amounts paid in settlement of any Claim if such
settlement is effected without the consent of the Indemnitor. The Indemnitee and its employees, at the Indemnitor’s request and expense, shall provide full information and reasonable assistance to Indemnitor and its legal representatives with
respect to Claims. 
 13.4. Limitation of Liability. EXCEPT IN THE CASE OF WILLFUL BREACH OF THIS AGREEMENT, IN NO EVENT SHALL EITHER
PARTY BE LIABLE FOR ANY SPECIAL, INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES TO THE OTHER PARTY OR ANY OTHER PERSON (INCLUDING DAMAGES FOR LOSS OF BUSINESS PROFITS) ARISING FROM RELATING TO ANY CLAIM MADE UNDER THIS AGREEMENT. 
  

 -14- 
  

  
 [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. 

	14.	MISCELLANEOUS 

 14.1. Entire Agreement;
Amendment. This Agreement, including all Exhibits hereto, sets forth the entire agreement and understanding between the Parties and supersedes all previous agreements, promises, representations, understandings and negotiations, whether written
or oral, between the Parties with respect to the subject matter hereof; none of the terms of this Agreement shall be amended or modified except in writing signed by the Parties hereto. 
 14.2. Assignment. Neither party may assign or transfer any of its rights under this Agreement or delegate any of its obligations or duties under
this Agreement without the prior written consent of the other Party. Notwithstanding the foregoing, (i) Supplier may assign this Agreement to one of its Affiliates; and (ii) either Party may assign or transfer any of its rights or delegate
any of its obligations or duties under this Agreement, to a successor by way of merger, consolidation or the acquisition of substantially all of its business and assets relating hereto; provided that, in each of cases (i) and (ii), such
assignee assumes in writing the assignor’s obligations under this Agreement and agrees to be bound by the terms and conditions hereof. 
 14.3. Severability. If and solely to the extent that any provision of this Agreement shall be invalid or unenforceable, or shall, if kept effective in this Agreement, render this entire Agreement to be invalid or unenforceable, such
offending provision shall be of no effect and shall not affect the validity of the remainder of this Agreement or any of its provisions; provided, however, the Parties shall use their respective reasonable efforts to renegotiate the unenforceable
provisions to best accomplish the original intentions of the Parties with respect to such provisions. 
 14.4. Waivers. Any waiver of
the terms and conditions hereof must be explicitly in writing. A waiver by any Party of any term or condition of this Agreement in any one instance shall not be deemed or construed to be a waiver of such term or condition for any similar instance in
the future or of any subsequent breach hereof. All rights, remedies, undertakings, obligations and agreements contained in this Agreement shall be cumulative and none of them shall be a limitation of any other remedy, right, undertaking, obligation
or agreement. 
 14.5. Further Documents. Each Party hereto agrees to execute such further documents and take such further steps as
the other Parties reasonably determine may be necessary or desirable to effectuate the purposes of this Agreement. 
 14.6. Force
Majeure. No Party shall be liable for failure to perform or delay in performing obligations set forth in this Agreement, and no Party shall be deemed in breach or default of its obligations, if, to the extent and for so long as, such failure,
delay, breach or default is due to natural disasters or causes beyond the reasonable control of such Party. Availability or allocation of raw materials or labor shall not constitute a force majeure event. Any Party desiring to invoke the protection
offeree majeure hereunder shall promptly notify the other Party of such desire and shall use reasonable efforts to resume performance of its obligations. 
  

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 14.7. Governing Law. This Agreement is deemed to have been entered into in the State of Delaware,
and, subject to the dispute resolution procedure outlined in Section 14.8 below, its interpretation, construction, and the remedies for its enforcement or breach shall be governed by, and are to be applied pursuant to and in accordance with,
the laws of the State of Delaware, without reference to conflict of laws principles and excluding the 1980 U.N. Convention on Contracts for the International Sale of Goods. 
 14.8. Disputes. In the event of any dispute or claim arising out of or in connection with this Agreement, or the performance, breach or
termination thereof, either Supplier or Purchaser may, by written notice to the other Party, have such dispute referred to the Chief Executive Officers (or equivalent) of Supplier and Purchaser, for attempted resolution by good faith negotiations
within thirty (30) days after such notice is received by such other Party. If the Parties are unable to resolve such dispute within such thirty (30) day period, such dispute shall be finally settled by binding arbitration by Judicial
Arbitration and Mediation Services, Inc. (JAMS) under its rules of arbitration, by three (3) arbitrators appointed in accordance with said rules, unless the Parties to the dispute have agreed to have only one (1) arbitrator. The decision
and/or award rendered by the arbitrator(s) shall be written, final and non-appealable, and judgment on such decision and/or award may be entered in any court of competent jurisdiction. The arbitral proceedings and all pleadings and evidence shall be
in the English language. Any evidence originally in a language other than English shall be submitted with a certified English translation accompanied by an original or true copy thereof. In the event such dispute is referred to arbitration by
Supplier, the place of arbitration shall be San Francisco, California, and in the event such dispute is referred to arbitration by Purchaser, the place of arbitration shall be Wilmington, Delaware. The costs of any arbitration, including
administrative fees and fees of the arbitrator(s), shall be shared equally by the Parties to the dispute, unless otherwise determined by the arbitrator(s). Each Party shall bear the cost of its own attorneys’ and expert fees. The Parties agree
that, any provision of applicable law notwithstanding, they will not request, and the arbitrator shall have no authority to award, punitive or exemplary damages against any Party. 
 Notwithstanding the foregoing, a Party may at any time seek injunctive or other equitable relief for any breach or alleged breach by the other Party of this Agreement. 
 14.9. Notices. Any notice, consent or approval permitted or required under this Agreement shall be in writing sent by registered or certified
airmail (postage prepaid), overnight courier or by facsimile (with such facsimile to be promptly confirmed by registered or certified airmail, postage prepaid) and addressed as follows: 
  

			
	If to Supplier:	  	SPI Pharma, Inc.
		  	 321 Cherry Lane
 New Castle, DE 19720
 Attention: Joseph Rogus
 Fax No: 302-576-8567

		
	If to Purchaser:	  	TransOral Pharmaceuticals, Inc.
		  	1003 W. Cutting Blvd., Suite 110
		  	Pt. Richmond, CA 94804
		  	Attention: Glenn A. Oclassen Sr., CEO
		  	Fax No.: 510-215-3535

  

 - 16 - 

 All notices shall be deemed to be effective on the business day after delivery of such notice to the overnight courier,
the day such notice is received by addressee via registered or certified mail, or the day on which such notice is sent by facsimile. In case any Party changes its address at which notices are to be received, written notice of such change shall be
given as soon as practicable to the other Party. 
 14.10. Forms. The Parties recognize that, during the term of this Agreement, a
purchase order form, purchase order acknowledgment form or similar routine document (collectively, “Forms”) may be used to implement or administer provisions of this Agreement. Therefore, the Parties agree that the terms of this Agreement
shall prevail in the event of any conflict between this Agreement and the printed provisions of such Forms, or typed provisions of Forms that add to, vary, modify or are in conflict with the provisions of this Agreement. 
 14.11. Implied Obligations. This Agreement sets forth all of the rights and obligations of the Parties with respect to the subject matter hereof.

 14.12. Headings. Headings in this Agreement are included for ease of reference only and shall have no legal effect and shall not be
used in any way to construe or interpret this Agreement. 
 14.13. Relationship of the Parties. The relationship hereby established
between Purchaser and Supplier is solely that of independent contractors; this Agreement shall not create an agency, partnership, joint venture or employer/employee relationship, and nothing hereunder shall be deemed to authorize either Party to act
for, represent or bind the other except as expressly provided in this Agreement. 
 14.14. Counterparts. This Agreement may be
executed in two or more counterparts, each of which shall constitute an original and all of which together shall constitute a single instrument. 
  

 - 17 - 

 IN WITNESS WHEREOF, the Parties hereto have caused this Agreement to be executed as of the Effective Date
by their duly authorized officers. 
  

									
	TRANSORAL PHARMACEUTICALS, INC.	 		 	SPI PHARMA, INC.
					
	By:	 	/s/ Thomas Soloway	 		 	By:	 	/s/ R. Sarath Chandar
		 	Name: Thomas Soloway	 		 		 	Name: R. Sarath Chandar
		 	Title: CFO	 		 		 	Title: VP, GLOBAL MARKETING

  

 - 18 - 

 Execution Copy 
 EXHIBIT A 
 SPECIFICATIONS FOR [***] 
 [***] 
  

  
 [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission. 

 EXHIBIT B 
 SPECIFICATIONS FOR [***] 
 [***] 
  

  
 [***] Confidential treatment has been requested for portions of this exhibit. These portions have been omitted from this exhibit and have been filed separately with the Securities and Exchange Commission.

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